Invensys Protocol Magazine – "Quality – it’s a culture thing" by Gadgetboy

MAY/JU

NE 2013

Quality it’s a culture thing

Gautrain – a well-oiled machine Are you being misled by OEE? The roots of quality management Invensys’ commitment to quality Taking a good look at SPC X-CHANGE 2013 report-back Quality by Design – built-in rather than nailed-on quality

Six Sigma & Business Success

Reducing real-time process variation

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Contents

Contents MAY/JU

NE 2013

Editor’s notes

Gautrain – a complex, reliable and well-oiled machine with help from Kentz and Wonderware

The role of quality and Six Sigma in achieving business success

Protocol Magazine

Product profile: Wonderware MES Software / Quality

Product profile: Wonderware QI Analyst

Quality dictionary

X-CHANGE 2013 report-back

Invensys Operations Management Southern Africa appoints NIC Instruments and Engineering as distributor

Invensys Sentinel Services

Driving down manufacturing costs by reducing real-time process variation Quality by Design and Process Analytical Technology – an integrated framework of technologies

There’s always room for improvement

Customer FIRST

Do not be misled by OEE

2013 Training Schedule (Johannesburg)

The roots of quality management

Use Protocol Magazine to generate business opportunities

On the lighter side

Protocol crossword #60

Invensys – commitment to quality

Invensys and product quality management/SPC

Owner and Publisher: Invensys Operations Management Southern Africa

Marketing Manager: Jaco Markwat jaco.markwat@invensys.co.za

Editor: Denis du Buisson, GMT Services ddb@iafrica.com

Advertising Sales: Heather Simpkins, The Marketing Suite heather@marketingsuite.co.za

Distribution: Nikita Wagner nikita.wagner@invensys.co.za

Facebook: Twitter: YouTube:

Wonderware Southern Africa WonderwareSA WonderwareSA

Contributors Many thanks to the following for their contributions to this issue of Protocol: • Andre van Rooyen, EOH Consulting for the article on the role of quality and Six Sigma in achieving business success • Jim Frider, Marketing Manager, Invensys Wonderware for the article on driving down manufacturing costs by reducing real-time process variation • Douglas Lively, Regulatory Compliance Project Manager, Invensys Operations Management and Jonathon Thompson, Regulatory Compliance Services Manager, Invensys Operations Management for the article titled: Quality by Design and Process Analytical Technology – an integrated framework of technologies • Robert M. Williamson of Strategic Work Systems for the article on how not to be misled by OEE • John Coetzee of Aristotle Consulting for the article on the roots of quality management

www.protocolmag.co.za

May/June 2013 | 1

Editor’s Notes similar results. Today, China isn’t exactly

most definitely one in Quality. EVERYBODY

well known for its quality cars but they

in the company is responsible for what

too will get there. Although most of the

customers think of it. Your company exists

manufacturing approaches and technologies

for the benefit of your customers first and

came from the United States and Europe

your bottom line second. If you or your staff

initially, the single-minded fixation to excel is

didn’t know that, it’s time to recalibrate

part of the culture of these countries. Put the

heads on a group basis. Disgruntled

two together and the West got a wake-up

CEOs lead to disgruntled managers and

call it wasn’t expecting and probably

disgruntled everyone else – including

thought would never happen.

disgruntled customers who were looking to you as a source of quality products and

But let’s not take anything away from

excellent service. In other words, does your

the achievements of the West that has

company, like your products, do what it

always strived to build quality products

says on the box? Is your company “fit for

from the start because this was seen as

purpose”?

the competitive differentiator. From Swiss

Quality – it’s a culture thing One word that’s not defined in the dictionary

watches to German engineering and

The want to make things go right and to

American technological innovation, the West

improve continuously can’t be imposed on

has shown that it’s got what it takes.

anyone who’s “just doing their job” and

section of this magazine is “quality” -

couldn’t care less about the needs of others

which is strange because that’s what the

So, looking at what these countries have

or the company as a whole. Encouraging

magazine’s about. Well, can YOU define

produced that we experience on a personal

individuals to take responsibility for their

“quality”? Think about it for a moment.

level, what can we say about quality

actions within the overall framework of the

The difficulty is that “quality” applies

products? They’re dependable, durable,

company’s needs is the first step to instilling

to everything – products, services and

give value for money and do what it says

a culture of quality that will provide huge

everything else. That’s why definitions of

on the box – in other words, they’re “fit for

benefits to everyone inside and outside

“quality” tend to miss the mark depending

purpose”. There’s no doubt that a Rolls

the company. In today’s competitive and

on your viewpoint and they also tend

Royce or Maybach are supreme-quality cars

complex world, your company doesn’t really

to ramble on somewhat. I think that the

but do you really get your money’s worth? (I

have the luxury of a choice as to how it

number of words used to explain something

don’t know and I don’t think I ever will!)

should operate. Quality is best applied when

is inversely proportional to the clarity of the explanation.

it becomes part of the culture of individuals If you can’t measure it, you can’t control

and companies. It gives people pride in

it. So how do you measure quality?

their work and job satisfaction. It also lets

The Pocket Oxford Dictionary defines quality

Interestingly, the Quality measurement in

customers know that they’re not dealing

as: “the standard of how good something is

Overall Equipment Effectiveness or OEE (the

with a 9-5 culture and that their trust in your

as measured against other similar things”.

others being Availability and Performance)

company and its people was well-placed.

“General excellence”. “A distinctive

has nothing to do with product quality but

feature”. I think we can do better –

rather a lot to do with process quality. In

So then, what’s the definition of quality? I

especially as it applies to the industrial world

other words, you could be manufacturing

think a good start is “fit for purpose” – what

of mining and manufacturing. So I set out to

the most dreadful products but you would

do you think? – and should I call the Oxford

find a three-word definition for “quality”.

get an A+ if you did so with no rejects. So

dictionary editors?.

there must be another way of measuring Product quality: When Japan got back on

quality and, quite apart from quality

Until next time,

its feet after WWII, the goods they exported

assurance measurements, the most telling

Denis du Buisson

were branded as cheap, of poor quality and

measurement can only come from customer

ddb@iafrica.com

“plasticky”. The same can’t be said today.

satisfaction surveys and the colour of your

Japan is not only home to the largest car

bottom line.

manufacturer in the world but the Japanese automotive industry is renowned for its

Company quality: What do your customers

quality products that provide excellent value

think of you? If you don’t care, stop right

for money. The South Korean automotive

here because you’ve answered the question

industry has followed Japan’s lead with

in full. While there’s no “I” in team, there’s

2 | www.protocolmag.co.za

Gautrain – a complex, reliable & well-oiled machine with help from Kentz & Wonderware

About Gautrain Gautrain is an 80-kilometre mass rapid transit railway system in Gauteng Province, South Africa, which links Johannesburg, Pretoria and OR Tambo International Airport. It was built to relieve the traffic congestion in the Johannesburg–Pretoria traffic corridor and offer commuters a viable alternative to road transport. The project was completed with the opening on 7 June 2012 of the final section By any standards, Gautrain is a large and

Gautrain was not built for the 2010 FIFA

between Rosebank and Johannesburg Park

ambitious project. It is an 80-kilometre

World Cup as it was conceived before

Station, which had been delayed by problems

machine with 24 moving parts – the trains.

that event. Nor was it to be completed by

with excess water seeping into the tunnel

Overcoming its complexity, strict safety and

then, but in November 2009 the Bombela

between the two stations.

performance requirements, time constraints

Concessionaire proposed a new, less

and civil engineering challenges has

expensive plan for the route between OR

resulted in nothing less than a South African

Tambo International Airport and Sandton

Consortium, a partnership between Bombardier

engineering milestone.

to be completed in time for the World Cup

Transportation, Bouygues Travaux Publics,

Background

The rail system was built by Bombela

which was held in June and July of that year –

Murray & Roberts, the Strategic Partners Group

a challenge for engineering and construction

and the J&J Group.

solutions provider, Kentz (Pty) Ltd. because The project was constructed simultaneously

the trains rely on a massive and complex civil

Initial works for the Gautrain started in May

in two phases. The first involved the section

engineering and automation infrastructure.

2006 and construction went ahead after the

between OR Tambo International Airport,

Stations and tunnels are linked, monitored

signing of the Concession Agreement between

Sandton and Midrand. The second phase

and controlled through triple-redundant and

the Gauteng Provincial Government and

included the link between Johannesburg

distributed industrial automation systems

the Bombela Concession Company on 28

Park Station and Hatfield Station in Pretoria.

responsible for security, safety, ventilation, fire

September 2006.

The construction of the first phase was

detection and prevention as well as energy

scheduled to take 45 months and the

and escalator/lift monitoring and control. So,

second was for 54 months, with completion

bringing up the time schedule had more than

in 2010 and 2011 respectively.

a ripple effect.

Source: Wikipedia

May/June 2013 | 3

Figure 1: Subsystem access

• OCD1 which runs from OR Tambo airport

In total, six Kentz engineers were involved

to Sandton Station scheduled for August

over a period of about 2 ½ years to

2010, but this date was brought forward

implement the STMS and SAMS. “One

in order to be ready for the World Cup

of the most challenging aspects of the

in June

implementation was the requirement for

Project scope

99.7 percent availability,” says Sheldon • OCD2 which runs from Sandton to

Frade, Electrical Engineer at Kentz. “But who

Kentz was awarded two of the contracts

Park Station and then from Marlboro to

doesn’t like a challenge? So far, the system’s

which were:

Hatfield Station. The section between

real-world availability has exceeded this

Rosebank and Hatfield stations

demanding specification by quite a margin.”

• The tunnel ventilation system from Park

commenced operations in August 2011,

Station to Marlboro Portal. This included

while the remaining section between

In order to meet this objective in the

ventilation for various fire scenarios and

Rosebank and Johannesburg Park Station

available time, Kentz chose an Invensys

provision for pressurisation and the

was delivered in June 2012.

Wonderware suite of solutions including

removal of smoke. • The Station and Tunnel Management System (STMS) and Security Access Management System (SAMS) for the entire project. This meant the commissioning and integration of 11 sites over Gautrain’s 80km “shop floor” while meeting a demanding requirement for 99.7% system availability and some innovative operator interface approaches with multiple-domain alarming.

Implementation The implementation, which included 11 stations, each with its own independent PLC/SCADA system and redundant server, was split into two sub-projects scheduled for completion at their respective Operating Commencement Dates (OCDs):

4 | www.protocolmag.co.za

Figure 2: Gautrain’s Operations Control Centre (OCC) in Midrand

Gautrain – a complex, reliable & well-oiled machine with help from Kentz & Wonderware

Figure 3: Station and tunnel fire scenarios help operators choose the

Figure 4: Tunnel fire scenarios help operators trigger the appropriate

right course of action

response without delay

System Platform, InTouch HMI/SCADA,

autonomously until communications were

do the entire migration. ‘Stressful’ doesn’t

Historian and Historian Client - all based on

restored.”

quite do situation justice and I’m sure that

ArchestrA technology. “Although the initial

we couldn’t have done all this in time if

development time is naturally quite high

The redundancy philosophy extends to the

it wasn’t for ArchestrA technology,” says

because everything such as the graphics

fibre (and other) communication links as well

Frade.

screens has to be developed from scratch,

as to the PLC level with hot standby PLCs

when it comes to implementation, it’s very

running duplicated applications. Even crucial

Gautrain’s information network is controlled

easy and quick to develop new objects

hardware such as the 315kW ventilation fans

and monitored from the OCC in Midrand.

from existing templates using ArchestrA’s

and 75kW pumps will have multiple backups.

An individual station can only assume control

object-oriented technology,” adds Frade.

The pumps are used to remove seepage

if it is granted to qualified station personnel

“Another reason for choosing the ArchestrA-

water between Park Station and Rosebank.

at that station by the OCC.

redundancy - a must if we were to achieve

Although each station has its own InTouch-

One of the key features of the STMS

the 99.7 percent system availability figure.”

based system, the entire train network is

is provision for rapid response by the

represented by a single, global InTouch

operators in case of critical alarms or

But even that level of redundancy was not

application which provides an overview

emergencies. For example, if a train

enough to meet the specification. “While

of the entire system, as well as all the

operator spots a fire, he will immediately

dual-redundant servers at the Operation

information for each station individually.

contact the OCC and inform them of its

Control Centre (OCC) would ensure

“We did the development on a mocked-up

location. The OCC, which also has CCTV

continued network operation, a fault with

system which ran separately from the live

coverage of the event, will, in the case of

the fibre communications network would

system, so when it came to commissioning,

fire at a station, place that station into “Fire

leave the stations on their own. So we had

we transferred all the objects, templates,

Presumption” mode (figure 3) which switches

to introduce a third level of redundancy

graphics screens and everything else onto

off all non-essential equipment. In the case

whereby the stations could operate

the live system – in the 8 hours provided to

of a tunnel fire, the OCC operator will then

based System Platform is that is has built-in

select a fire scenario which best suits the information he has received to-date (figure 4)

“The flexibility of ArchestrA made it possible to create the extra redundancy and saved a lot of engineering time. It’s truly a pleasure to develop systems with this versatile tool.” Sheldon Frade, Electrical Engineer, Kentz (Pty) Ltd. Figure 5: Operating modes

May/June 2013 | 5

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Better Services

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Traffic that flows. Intelligent buildings that save energy. A public infrastructure that delivers whole new levels of service at lower cost. Systems, assets, people and the environment living in harmony. You have imagined ArchestrA, the Wonderware technology that lets you manage your infrastructure as you like in an integrated way. Open, scalable, affordable. Turn imagination into reality with Wonderware. Visit wonderware.com/Infrastructure for more info.

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6 | www.protocolmag.co.za © Copyright 2012. All rights reserved. Invensys, the Invensys logo, Avantis, Eurotherm, Foxboro, IMServ, InFusion, Skelta, SimSci-Esscor, Triconex and Wonderware are trademarks of Invensys plc, its subsidiaries or affiliates. All other brands and product names may be trademarks of their respective owners.

Gautrain – a complex, reliable & well-oiled machine with help from Kentz & Wonderware

Benefits

The selected scenario will cause the

Kentz is responsible for corrective as well as

appropriate sequence of actions to be taken

preventative maintenance on the systems

such as pressurising the tunnel to blow

under their care (STMS and SAMS). “Should

the smoke way from the train or station

an event occur with the parts of the system

significant layer of reliability, safety and

in question, operating fire doors, guiding

for which we are responsible, we have to be

uptime

passengers to safe havens, etc.

on site within two hours and the problem must be resolved within four hours,” says

• Triple system redundancy adds a

• Reduced engineering cost on similar

“It all sounds easy if you say it quickly but

Hennie van Tonder, Maintenance Technician

projects or modifications to this existing

each of these scenarios takes a great deal of

at Kentz. “Should there be an issue inside

installation

refining and testing because people’s safety

one of the tunnels, we have to wait for

depends on their effectiveness,” says Frade.

scheduled downtime which lasts from 22:00

• Faster operator response due to new

to 03:30 when one or more of the 80 fire

navigation techniques that help them

Another vital aspect of the system is that of

scenarios for the tunnels are checked on

establish alarms and identify faulty

power management and distribution. For

a daily basis. This was the same time slot

equipment

above-ground installations, power isn’t as

allocated for testing and commissioning.”

crucial as for those that are underground and where passengers can find themselves

Kentz uses Wonderware’s Historian and

trapped in cases of emergency. Four large

Historian Client to detect trends and

generators at Marlboro Portal will supply

potential problem areas. “This is most useful

the necessary power in the case where Park

because all maintenance requires a permit

Station and/or Sandton have power failures.

which is only available within 24 hours at the earliest. So, by detecting issues early, we

“The start-up procedure for these

can apply for permits well in advance and

generators isn’t trivial,” says Frade.

minimise delays,” says van Tonder.

“Isolators have to be opened before the generators can be started. They then have to be synchronised (phased) before various circuits can be brought back on line in a prescribed sequence.”

May/June 2013 | 7

The role of quality and Six Sigma in achieving business success Andre van Rooyen, EOH Consulting

Historical perspectives on quality

Definition of quality The simplest and most powerful definition in

The quality movement came to main

my opinion is still as follows:

prominence in the U.S.A. in the 1980s. Pre 1970s, the perception was that products

Quality is the ability to consistently meet

manufactured in the East (mainly Japan)

and exceed customer expectations

were of inferior quality and consumers in the US and Europe preferred to buy

Proctor and Gamble defines quality as

domestic goods. During the 1970s, however,

follows: total quality is the unyielding and

consumers started to notice that quality and

continually improving effort by everyone in

price of foreign products surpassed that

an organisation to understand, meet and

of domestic products. This forced western

exceed the expectations of customers.

organisations to reconsider their position and so the concept of Total Quality and Total

The ability to constantly produce quality is

Quality Management (TQM) became the

based on eight basic principles. These are

management buzzwords of the time.

also used as the basis for the International Standard for Quality management (ISO 9001:2008): 1.

Customer-focused organisation

Leadership

Involvement of people

Process approach

System approach to management

Continual improvement

Factual approach to decision making and

Mutually-beneficial supplier relationships

The achievement of quality as per the definition requires a change in the culture

8 | www.protocolmag.co.za

The role of quality and Six Sigma in achieving business success

causes for performance issues and optimising business processes. It was Peter Drucker who said that if you can’t measure it you can’t manage it. It is therefore a given that if a company wants to achieve quality and implement Six Sigma it has to, amongst other things, build the capability to measure performance at a process level as well as at an organisational level.

What is required for a culture of quality and deployment of Six Sigma? From the above, it becomes clear that there are key elements required to ensure an organisation’s ability to produce quality in a consistent fashion. These elements include: • The correct environment and culture – including leadership • Absolute focus on customers and their requirements • Understanding that an organisation consists of processes of the organisation. It further requires

utilises business processes to execute its

discipline, structure and focus. Deming

strategy and in order to be successful it has to

maintained that to achieve quality the

stabilise and optimise those core processes.

organisation has to embark on a continual

Six Sigma has many definitions but there are

journey of Plan, Do, Check and Act to review

elements that make it unique:

its various products and processes as well as the development of the total organisation in its pursuit of quality.

The emergence of Six Sigma

• A passion for measurement and information • Skilled individuals that can continuously improve processes through scientific methods

• Process quality is expressed a level of Sigma which is based on a calculation

• A project-management approach with

of number of defects per million

clear deliverables and specific roadmaps

opportunities. The higher the level of

and tool sets

Sigma the more efficient the process is

References

The pursuit of quality lead to the need for

performing. To achieve the level of Six

management approaches, toolsets and

Sigma (6σ) the process should deliver

methodologies to improve the delivery of

no more than 3,4 defects per million

1. J. Evans, W. Lindsey: The management

products and services to the customer

opportunities (d.p.m.o.)

and control of quality, South Western Learning , International Edition 2011

Six Sigma provides such a set of tools.

• A structured roadmap for problem

When Motorola won the much respected

solving namely Define, Measure, Analise,

2. American society for quality -

Malcolm Baldridge award for quality in

Improve and Control.

www.asq.org

the mid-eighties, peer companies such as General Electric, Honeywell, 3M were quick to

• Six Sigma is deployed by training

3. South African Quality Institute -

introduce similar management practices and

identified individuals in the tools of

Six Sigma was born. Six Sigma has become

problem solving at various levels of

a respected value adding tool to most major

competence called Yellow Belt, Green

Should you have any enquiries regarding

organisations over the last twenty years

Belt, Black Belt.

quality or lean Six Sigma please contact

wwwsaqi.co.za

Andre van Rooyen on 082 653 3048.

Definition of Six Sigma

• Six Sigma uses data (statistics) to solve problems . It relies heavily on information

Six Sigma acknowledges that any organisation

and using information to identify root

May/June 2013 | 9

Driving down manufacturing costs by reducing real-time process variation Jim Frider, Marketing Manager, Invensys Wonderware

Why quality is still important

is important since it allows operators to react immediately to a process that will adversely

In today’s global marketplace, the drive

affect product quality.

to improve business performance in manufacturing facilities is generating

Likewise, production output can be

a renewed look at product quality

increased by reducing the safety margin

management.

required to conform to specifications, leveraging the same accurate information

Since the 1980’s when modern quality

directly from the plant floor processes

management principles took hold first

to better understand actual process

in Japan and later in North America and

capabilities.

Europe, managing product quality has been a significant concern for most manufacturers.

Monitoring and managing process variation

Initially, adopting improved quality

helps reduce business risk by reducing the

management techniques allowed domestic

exposure to product recalls and regulatory

manufacturers to become more competitive

actions. We have all seen recent television

with offshore manufacturers.

reports focused on large and expensive product recalls – particularly in the food

However, today, over twenty years

industry. The largest of these product recalls

later, the growing emphasis is on using

can cost companies millions of dollars.

quality management as a tool to lower

Some companies have been so weakened

manufacturing costs, improve operational

that they were absorbed by a competitor or

output and to reduce business risk.

private equity firms.

Any plant manager today needs to cut

Reducing process variation can also help

cost out of the manufacturing process.

enter new markets by providing high-value

One way to do this is to improve first pass

products with a minimum of start-up issues –

quality. Often improving first pass quality

reducing the time to enter a new market.

can generate millions in material and labour savings. Detailed, real-time process data,

So, as you can see, effectively managing

formatted into a form that managers can

process variation can reduce costs, reduce

understand, is needed to enable pro-active

risks, improve financial performance and even

improvement activities.

expand new market opportunities. Now, let’s discuss the many aspects of quality.

Process variation data is particularly important since once process variation

The many faces of quality

limits are reached and a key parameter has

10 | www.protocolmag.co.za

gone out of specification, the part/product

Ensuring a quality product is not the result

is typically requires special handling and is

of a single inspection at the end of the

then scrapped or reworked. Real-time data

manufacturing line. It means instituting

Driving down manufacturing costs by reducing real-time process variation

quality management processes throughout

• Status of statistically-based process alarms

the manufacturing cycle; from process design, to raw material inspection, to the

Empowered with this collection of real-time

training of operators, to proper maintenance

process information operators can improve

and setup of process equipment, to the

first pass yield, avoid producing sub-quality

actual output of the manufacturing process:

output and save raw materials and labour.

the finished product. Stumbles along any part of this path can adversely affect plant

Engineering:

efficiency and, perhaps most importantly, customer satisfaction.

Manufacturing engineers are often the key process trouble-shooter/optimiser. They

The types of quality information needed vary

need; decision makers can deploy resources in a

depending on the groups and individuals throughout the factory or plant. Let’s look at

• Accurate and timely process variance data

more intelligent and cost effective manner.

• Type and frequency of nonconformities

Higher process variation equals higher manufacturing costs

the quality-related information requirements from the perspective of some key factory/ plant groups. • Operating parameters to correlate with

Quality - A user’s perspective:

process variance data One of the giants of quality control and

Most manufacturing facilities have quality departments that focus on procedural

• A means to institute standard operating procedures to improve quality

quality issues such as; • Operator training and certification • Standard operating procedures and

manufacturing is Genichi Taguchi. Dr. Taguchi focused on the costs of quality and helped develop the relationship between

Engineers need complete plant data records

process variation and manufacturing loss. He

at their fingertips to quick track down

formalised this relationship in the Taguchi

problems and to drive process optimisation

loss function:

and improvement efforts. Loss = k(X-T)2

documentation Specifications are formulated by engineers • Regulatory and environmental

to ensure a number of important results;

Where:

• Parts/products meet customers’

k = constant (cost-based and specific to a

compliance • Quality auditing • Acceptance sampling of on-going activities • Corrective and Preventative Actions (CAPA)

requirements • Parts “fit” together (in the case of discrete assembly) • Costs are minimised by reducing “giveaways” or excess materials

given process) (X-T) = divergence from a specific target parameter value This loss function provides manufacturers with valuable insight into the financial consequences of poor control of process

• Continuous improvement activities

• Risk of regulatory action (for under filling, chemical composition, etc.) is minimised.

• Product definition information like mean, standard deviations, control limits and

variation. Japanese manufacturers rapidly adopted these quality concepts after World War II along with the help from W. Edward

• Risk of product recalls is minimised

specifications limits

Deming. This led to the rise of the Japanese automobile industry and helped propel

Plant management: Operations:

them to their current world dominance in that field. By ruthlessly eliminating process

Plant managers need real-time process

variance their costs dropped to fractions of

To achieve operational excellence, operators

variation information to proactively manage

their North American competitors.

need to understand the following:

their manufacturing processes and the corresponding output.

• The condition of raw materials entering

can save manufacturers money. Now how do

the manufacturing process, work-in-

They also need data to prioritise between

process inventory and finished goods

a host of possible process improvement

• Real-time variance of key process parameters on manufacturing resources

So, it is clear that reducing process variation you reduce process variation?

options. Quality data, particularly real-time

Process variation is the dispersion of

process variance data, can help rank process

measured values around a specified value.

issues based on their potential business

Variation is affected by many factors

impacts. Armed with better information plant

including; people, equipment, operational

May/June 2013 | 11

systems for real-time and historical process data. Statistical methods are applied to these data and graphical control charts are generated and distributed to system stakeholders. Control charts are a very powerful way to visualise process variation over time or over a sample size. The most progressive manufacturers are using real-time control charts to reveal real-time variation trends and statistically-based alarms to efficiently detect and alert operators, managers and engineers to the most current process variation issues on the plant floor. Some leading-edge manufacturers are using SPC and real-time alarms in a closed loop system. In other words, when a SPC alarm is triggered, a process adjustment is automatically and immediately made, resulting in the reduction of the special procedures, raw materials, measurements

Every process has some level of acceptable

and the physical environment. A

variation, often referred to as conforming

specification is typically used to locate the

variation. However, once variation exceeds a

Using real-time SPC information, a

desired parameter value. Each specification

specified level it is classified as unacceptable

manufacturing plant can spot growing

defines the allowable limits of variation.

variation or nonconforming variation.

process variation levels before they reach

Specifications are important for a number of

Nonconforming variation can lead to quality

critical levels. Troubleshooting and root

reasons:

related scrap and lost manufacturing labour.

cause analysis techniques can then be

• Regulatory – Agencies require that

There are two primary causes of non-

SPC applications can help plants significantly

advertised ingredients or levels are

conforming variation; common causes and

reduce the number and severity of process

maintained. For instance, a can of soda

special causes.

variation problems – resulting in lower scrap,

cause of variation.

applied to the problem. Over time, real-time

with net weight of twelve ounces should

downgrade, rework, retest and special

not be “under-filled” or regulatory

• Common causes are inherent in the

agencies will get involved. Another

manufacturing process. They are in

example is the amount of ibuprofen

statistical control and can only be reduced

Leading manufacturers often take it one

in a tablet. If this level is exceeded or

by changing or improving the design of

step further and begin to attack the design

undercut, regulatory action is possible.

the process itself. Even on the best day

of their manufacturing processes in order to

in the manufacturing plant, this variation

squeeze more productivity from them. Here

exists.

again, statistical methods such as Statistical

• Cost – Many specifications are defined to keep down costs of manufacturing. For instance, if the same twelve ounce

handling costs.

Quality Control can be leveraged to design • Special causes produce unpredictable

better manufacturing processes with less

can of soda is “over-filled,” then the

and unacceptable variation and lead to

manufacturer is giving away product for

scrap, “downgrades,” rework, retesting

free.

and special handling. Real-time Statistical

Statistical Quality Control or SQC is a

Process Control or SPC focuses on

set of statistical tools including ANOVA

reducing this type of variation.

(Analysis of Variance), Regression and

• Engineering - Some specifications ensure that parts fit together or perform as

variation.

Multivariate Analysis. These tools leverage

designed. For example, in a discrete

SPC techniques can be used to detect,

historical data, so they are considered

manufacturing process that makes cars,

eliminate and prevent special causes of

“off-line” analyses. These powerful tools

the individual components must meet

variation. They can also be used to measure

require significant statistical, process and

physical specifications. If they don’t, then

the level of common causes of variation and

quality knowledge, but are invaluable in

the parts will not fit together or perform

support efforts to reduce these causes. SPC

understanding and improving the existing

properly. In another case, if the “widgets”

is a truly continuous improvement process.

manufacturing processes. SQC and SPC

are too large, then they may jam the

used together provide a compelling

conveyor system and the processing

Real-time SPC software systems typically

“one-two punch” against variation in

machinery.

tap plant automation systems, process

manufacturing.

databases or factory floor measurement

12 | www.protocolmag.co.za

Driving down manufacturing costs by reducing real-time process variation

Control charts

to help control and eliminate specific nonconformities, used when sample size

First developed by Bell Labs in the 1920s,

or inspection unit does not vary

the process control chart is a key tool for visualising process variance. The control

• u charts - A control chart for monitoring

chart is basically a specialised trend chart

the average number of nonconformities

(data value vs. time) that helps differentiate

per part or product or the rate of

between inherent or natural variation

nonconformities, used when sample size

(common cause variation) and abnormal

or inspection unit can vary

variation such as equipment wear or out-ofspec raw materials (special cause variation).

SPC rules and alarms

Control charts use process data from

No operator wants to be “glued” to their

either continuous data sources or discrete

control screens watching control charts.

data sources. Continuous or “variable”

To avoid wasting valuable time, many SPC

Processes found in almost any

data include data such as temperature

software applications provide the means to

manufacturing facility can benefit from

or pressure. Discrete or “attribute” data

automatically evaluate incoming process

real-time SPC monitoring. However, a

include counted data such as the number of

data relative to statistical rules or rule sets.

comprehensive range of SPC techniques

scratches or number of defects.

Rule sets such as the Western Electric,

Real-time SPC techniques to improve operations through reduced variability

are required by any real-time SPC software solution to ensure that the proper SPC

Wheeler, Nelson, AIAG, Juran and Hughes Variable control charts include;

technique can be applied to each process being monitored.

are commonly used. They help ensure that a wide range of manufacturing processes can

• X-bar (Mean) and R (Range) charts - Dual

be monitored using SPC techniques. These

chart plotting mean and sample range,

rules indicate if the process might be out of

Process data measured over “Time”

mean tracks data location and range

control. Once a process starts to drift, quality

generates a distribution of values which

tracks data spread, useful for small

parameters may move outside acceptable

can be studied statistically. Data “location”,

samples, easy to create and analyse

specifications. This may result in higher

“spread” and “shape” are all used in statistical analysis of plant data.

costs along with regulatory or engineering • X-bar (Mean) and s (Standard Deviation)

concerns.

charts - Dual chart plotting mean and “Location” is the ideal value for a process

standard deviation, suited to larger

Modern real-time SPC software applications

parameter. The Mean (average) the Median

sample sizes and better at detecting

can be configured or customised to

(half above, half below) and Mode (most

changes to data spread

trigger specific messages, visual and audio

frequent value) are commonly used statistical entities to measure process data relative to a location.

alerts or paper or web-based reports. • Individuals and Moving Range charts

Properly designed SPC rules and alarms

- Dual chart plotting measured value

can give manufacturers a competitive

per sample and the moving range

advantage through efficient detection and

Data “Spread” is used to measure how

(absolute value of the difference between

communication of process variation issues.

tightly a particular parameter is centred

measured values, X2 – X1), uses individual

around its location. The wider or broader

measurement values instead of the mean

the data spread, the greater the variation in

value of a subgroup of measurements,

the process parameter. This typically means

good for slowly moving or time-based

A convergence of three technologies is

greater manufacturing losses. Japanese

process values like temperature or pH

now making it possible for manufacturers to implement standardised real-time SPC

manufacturers helped demonstrate this principle. They focused strongly on

Attribute control charts include;

systems across their entire enterprise. These three technologies are; modern plant

minimising data spread. This resulted in less production waste and smaller warranty costs.

A convergence of technologies

• p charts - Used to monitor the percentage

automation systems with open data source

It also helped them to be more competitive

or proportion of nonconforming units

connectivity, modular industrial software

in the world market, capturing leadership in

over a specific time period or sample (for

architectures and the Web. Together they

many industries during the 1980s and 1990s.

example, 20% nonconforming parts per

are driving the creation of a new class of

hour)

industrial software applications that can scale functionally as well as physically.

Data “Shape,” as the name implies, is the measure of the physical distribution

• np charts - Displays the number of

of process data. A common statistical

nonconformities with a specific subgroup

Most manufacturers have implemented

distribution is the “normal” distribution -- or

(sample), best with constant sample sizes

small, localised SPC systems in their plants as part of a specific quality issue or initiative.

“bell curve” -- with which many people are familiar.

• c charts - Used to monitor the number of nonconformities per part or product, used

However, too often they have not met management’s expectations due to high

May/June 2013 | 13

architectures is beginning to become widespread. Based on Object Oriented Architecture concepts, these new industrial software architectures provide standardised templates for service configuration, communication, security and reporting. Developers can focus on the specific value-added content and not waste time developing security or communication functionality. Modular architectures can more easily accommodate company standards and broad physical scalability through template/instance functionality. System implementers can create standardised application objects that provided specific functional capabilities then provide them to others as templates. Plants then use these standardised templates to deploy instances of these templates to build their particular application – ensuring that company standards are adopted. For example, Wonderware offers SPC object templates for its System Platform. These templates can be deployed across a plant, across sites, or across the world, with consistency and according to company standards. These SPC templates are maintenance costs and limited project value.

In the 2000s, manufacturers realise they can

It was also difficult to create standardised

leverage this existing data connectivity to

SPC applications and then deploy them

help understand their plant’s operations

This template/instance method also

efficiently. These constraints are changing.

better and to gain a competitive advantage.

enables precise maintainability of standards

Real-time SPC systems are one such

through the parent/child relationship

Modern plant automation systems and

application aimed at improving productivity

of templates and instances. If the base

open data source connectivity

and competitiveness.

template is changed, then all deployed

Over the last twenty years many

Modular industrial software architectures

system, are automatically updated. Change

manufacturers have implemented modern

(component object- based)

management is built-in.

A key driver in the adoption of these systems

Almost every major manufacturer has some

Any number of instances can be deployed

has been open data source connectivity.

sort of “best-of-breed” SPC application

from a base template so physical scalability

OPC and other open standards have

running in their plant. Usually the system

is built-in. Thousands of individual instances

opened up the myriad of plant devices that

is a few years old and was purchased for

of a particular data configuration or analysis

measure plant processes. Actually OPC is an

a specific problem or issue. Most plant

template can be deployed from a single

acronym within an acronym, OPC is short for

workers do not use this data since the

library of templates.

OLE for Process Control, and OLE is short

data coming of the system was aimed at

for Object-Linking and Embedding).

consumption by the quality engineer. This

A centralised security model also makes

is the case for many data analysis systems

regulatory-based applications easier to build

The widespread adoption of modern plant

used in manufacturing plants today. Even

since all of the user security and change

automation systems in the 1980’s and 1990’s

in situations where a plant has successfully

management functionality is already built-in.

is now enabling manufacturers to tap into

implemented a SPC system, it has been

literally thousands of process measurements

difficult to duplicate this success in other

These new industrial software architectures

for almost nothing. These large automations

sister plants. Standards have been hard to

hold the promise of streamlining application

systems required a large data measurement

develop and maintain.

development, reducing system maintenance,

described later in this document.

instances of this template, anywhere on the

Windows-based plant automation systems.

infrastructure. Open data source connectivity

enforcing company standard practices and

standards were developed at the same time to

Now the availability of modular or

allowing large system scalability (functionally

lower the cost of gaining access to this data.

component-based industrial software

and physically).

14 | www.protocolmag.co.za

Driving down manufacturing costs by reducing real-time process variation

Information delivery

The in-line quality monitoring solution from

Customer successes

Wonderware lets you: European Cheese Dairy:

To derive the highest value from your quality management system you must

• Define quality variables and attributes. Using the Wonderware inline quality

distribute this information to a broad range of users. Real-time SPC control charts, including alarm data, can be presented

• Create product specification targets and limits. • Record values to these variables

industrial web portals. Operators can be

& attributes with both manual and

provided displays with a grid of SPC alarm

automatic data collection methods.

or manager concerned about the level

manufacturing process and increase production. Their normal target variation was:

indicators and only have to react once an alarm is violated. A process engineer

was able to significantly reduce variation of water content (in percent) in their cheese

to operators or plant managers via customisable operator displays or even

solution, a large European cheese maker

• Record product inspection and visual nonconformity data.

Target = Reject limit – 3 x Variation (w/ 100% confidence)

of variation from a specific production machine can monitor only the SPC data

• Display real-time control charts.

Using the quality monitoring they were able to narrow their target variation to:

associated with this machine and call in maintenance only when required.

• Trigger alarms on violations of SPC rules.

Target = Reject limit – 2.33 x Variation (w/

In-line quality monitoring – A Wonderware approach

• Analyse recorded quality parameters via

One approach to real-time SPC monitoring

The example application can be scaled

induced variation and began to see

that blends all of the technological

so you can implement it over multiple

increased production levels.

improvements seen in recent years

production lines, allowing the comparison of

is Wonderware’s example of Quality

equipment, lines and plants from a quality

They experienced no increase in scrap

Management using ArchestrA-based

performance perspective. Quality standards

and they achieved very significant financial

object technology. Wonderware provides a

can be implemented more easily since

benefits in the range of $200k - $300k per

preconfigured SPC software solution which

the inline quality example uses software

year, per dairy. Adding these up over many

provides the ability to capture, visualise and

templates that can be built once and copied

dairies, the numbers impress even more.

analyse real-time SPC data coming from a

over and over for different facilities.

99% confidence) portal-based reports.

Within three months of implementing the system, they had eliminated operator-

manufacturing process. It leverages existing

By keeping their improvement effort focused

plant automation and HMI systems, new

The goal is improved product consistency

and using very efficient software tools, they

modular ArchestrA technology software

over your entire manufacturing enterprise

experienced a very fast return, encouraging

architecture and web based reporting.

while maintaining corporate standards.

them to expand their quality monitoring

It facilitates the use of best practices

system into other areas of the plant.

and standards and can be easily scaled physically and functionally.

May/June 2013 | 15

International Paper Company:

Displaying money lost (â&#x20AC;&#x153;wasteâ&#x20AC;?) on SPC

software architectures, these manufacturers

charts was an enormous motivational

are developing enterprise level real-time

A paper company in the Pacific Northwest

factor for operators. Using this information,

SPC software systems that give immediate

wanted to increase yields and improve plant

operators steered their production

process feedback and also allow direct

financial performance.

processes such that the company saved

comparison of the quality performance of

over $1,000,000 in the first year using the

equipment, lines and entire plants. Process

Plant engineering developed a program

Wonderware quality monitoring system

variation issues are spotted before they

of collecting and displaying key process

and over $2,000,000 per year in subsequent

generate scrap, downgrades, rework, waste

parameters to operators. This increased

years.

and special handling and best practices are

operator awareness of those parameters that

shared with sister plants.

most affected product yield. It is interesting

So, deploying a real-time SPC solution

to note that a single engineer installed,

and tying it to financial performance has

These systems also help maintain product

configured and trained the operations and

made this innovative paper company

uniformity across globally diverse production

quality staff on the new Wonderware quality

more profitable and unlocked the process

facilities, helping ensure and protect

monitoring system on over one hundred

improvement spirit in plant personnel.

valuable brand integrity.

Summary

So, quality monitoring can be used to drive

systems. The key for success, however, was that plant

enhanced plant performance and superior

engineering went one step further and

Today, leading global manufacturers are

used a feature in the Wonderware system

working proactively to reduce process

to calculate and plot monetary losses on

variation to drive down manufacturing costs

SPC charts. These losses were based on

throughout their plants.

measurements that were above spec targets multiplied by the value (in dollars) of the

Leveraging the Web, existing plant

product.

automation investments and new modular

16 | www.protocolmag.co.za

financial results.

Quality by Design and Process Analytical Technology â&#x20AC;&#x201C; an integrated framework of technologies Douglas Lively, Regulatory Compliance Project Manager, Invensys Operations Management Jonathon Thompson, Regulatory Compliance Services Manager, Invensys Operations Management

May/June 2013 | 17

• Improve operator safety and reduce human errors through the proliferation of automation • Improve energy and material use and increase capacity • Facilitate continuous processing to improve efficiency and manage variability1 Most companies lack the resources to internally generate a PAT framework, so the search for an external PAT solution should start with a company that can provide an integrated framework of technologies and has a demonstrated history of process modelling and optimisation. Additionally, any integrated PAT framework must be compatible with existing, or legacy, systems

Introduction

• FDA guidance

Quality by Design (QbD) and Process

• A roadmap to success

that are already in place. One of the impediments to the implementation of PAT

Analytical Technology (PAT) promise to deliver a bigger, brighter future in terms of encouraging “the voluntary development

has been a misinterpretation of the term “Quality by Design.”

Process Analytical Technology (PAT) framework

and implementation of innovative

“Quality by Design” means that quality should be designed into any new system

pharmaceutical development, manufacturing

At first glance, possibly because of the

under consideration by a life sciences

and quality assurance” [1] while ensuring

semantics, it is easy to assume that PAT

company. This is certainly a must for any

patient safety and increasing profitability for

is one technology. The temptation that

“closed loop” system under consideration.

the life sciences industry.

comes from such a mindset is to search

Most companies, however, do not have

for one commercially available solution

the luxury of redesigning a manufacturing

No matter how you slice it, reducing raw

to provide a single PAT solution. PAT,

line from the ground up. Additionally,

material and batch losses, preventing scraps

however, is not one technology. Rather it

established lines that are highly productive

and rejects, insuring real-time release of

is a confluence of technologies integrated

should not be completely stopped for a long

product, increasing safety through the

into a PAT framework. A PAT framework of

period of time in order to be redesigned

proliferation of automated manufacturing

technologies works in harmony to “support

and re-implemented. Quality by Design

and facilitation of continuous process

innovation and efficiency in pharmaceutical

for such a system should be approached

improvement through management of

development, manufacturing and quality

from a retrospective view through the

variability and improved efficiencies can

assurance”. The framework is founded

introduction of an “open loop” system

lead to better product quality, enhanced

on process understanding to facilitate

which enables real-time data access without

consumer safety and increased profitability.

innovation and risk-based regulatory

disturbing an already working system,

As of this writing, QbD and PAT have not

decisions by industry and the agency. The

leading to the realisation of PAT goals and

produced the desired effect for life sciences

framework has two components: (1) a set

Quality improvement within an existing

on the scale demonstrated by non-regulated

of scientific principles and tools supporting

manufacturing system.

industries such as auto manufacturers,

innovation and (2) a strategy for regulatory

specialty chemicals and the oil and gas

implementation that will accommodate

industries. This paper seeks to review PAT

innovation.” 1

Quality by Design (QbD) The engine through which PAT objectives

basics with a focus on resolving issues that prevent implementation of QbD and PAT by

Intended benefits derived from a PAT

are to be accomplished is known as Quality

examining:

framework are as follows:

by Design (QbD). The idea behind the FDA

• PAT framework

• Reduce production cycle times by using

Quality by Design initiative is to better

• Quality by Design

understand the process and build quality

on-line, in-line and at-line measurements

into the product rather than “test it in” at

and controls

the end.

• Simulation

• Prevent rejects, scrap and re-processing

• Process understanding

• Real-time release

When QbD is absent, an organisation is forced to “test quality into the product,”

18 | www.protocolmag.co.za

which is an expensive and unreliable

Quality by Design and Process Analytical Technology – an integrated framework of technologies

way to achieve quality requirements. It also demonstrates that they have failed to mitigate the product risks that occur due to lack of design, poor planning and inadequate control of the manufacturing process. In any system, the absence of design leads to slipped deadlines, overextended budgets, frustrated employees, disappointed stakeholder expectations and possible harm to the public. Thus, it is imperative that an organisation budget “design phases” into their project, not as a one-time activity, but as an ongoing re-occurring activity to be met throughout the project. This implies that regular design reviews focused on QbD be included as part of the project life cycle development model. Quality by Design, however, goes well beyond simple project development. It also A common mistake occurs when a company

back to an operator who can then make

undertakes some type of PAT and simply

decisions about the trajectory of the batch. If

thinks that it can be achieved by the sheer

the batch is trending away from the “Golden

patient population; route of

amount of software and equipment that is

Batch” parameters, then the operator can

administration; and pharmacological,

purchased. They may achieve the collection

make adjustments to bring the batch back

toxicological and pharmacokinetic

of real-time data only to dump it into a

in line. This is open loop feedback. As the

characteristics of a drug are understood

statistical analysis package post-batch

controls and understanding become more

and managed.

requiring an army of statisticians to interpret

sophisticated, closed loop feedback can be

the data; and then engineers to make

used to automatically make the necessary

recommendations on how to improve the

adjustments to keep the process within the

biopharmaceutical characteristics of a

process. They end up with a statistical

Golden Batch profile.

drug are accounted for.

representation of what is happening in the

implies that: • The intended therapeutic objectives;

• The chemical, physical and

batch and are probably utilising some type

This level of batch understanding

• Design of a product and selection of

of Statistical Process Control but do not

allows for more sophisticated forms of

product components and packaging

realise the goals (e.g., real-time release)

Operational Excellence. This is where

based on drug attributes include:

envisioned by PAT.

Process Optimisation and Automated

Understanding the mechanisms

In R&D or early development it is critical to

an off-line program that understands the

of degradation, drug release and

model processes to gain the understanding

trends and patterns of the process. This

absorption

of what the key performance indicators are

tool can not only show where the process

for the product. This is the time when the

can be optimised for better performance,

model is used mostly for gathering data,

but can also see the degradation effects

trending and building the “golden batch.”

of the process equipment and suggest

Release come in. Process Optimisation is

Understanding the effects of product components on quality

modifications. Knowing what sources of variability are

Commercial production should have the requisite process data to understand what

The ultimate goal of these initiatives is an

Key Performance Indicators (KPIs) are crucial

understanding of the process that allows for

to the process and what the “Golden Batch”

automated release. The principles behind

criteria should be. The Golden Batch profile

this are that if you know the inputs and

is critical to quality parameters and contains

understand the effects of key variables, then

allowable deviations to produce an “ideal”

you should be able to accurately predict the

using principles of engineering, material

batch. A rigorous process model is used as a

quality of the final product before it gets

science and quality assurance to ensure

comparison during actual batch manufacture

tested. In fact, given the randomness of

acceptable and reproducible product

and has the ability to generate statistical

most sampling methods, this can be a better

quality and performance throughout a

process control (SPC) alarms in real time.

predictor of uniform quality within a batch.

product’s shelf life. 1

Real-time data and comparisons are fed

critical Understanding how the process manages variability • The design of manufacturing processes

May/June 2013 | 19

When implementing QbD and PAT

from actual events

Verify design

Framework Technologies a life sciences company should consider the following kinds of QbD and PAT developmental

• Initial process and product understanding

requirements:

capabilities that allows for real-time

after the fact

PAT installation is a strategic advantage for

specification ranges

any company that more than pays for itself over time. This is especially evident when

Identify the corresponding Critical

• Provide an end-to-end solution…from

system. “What if” scenarios and phasing

design ranges

can be planned and executed well before any portion of an already functioning line

Establish initial formulae showing how

is shutdown. Moreover, any shutdown,

the CPPs affect the CQAs at each step

whether on a new or legacy system, can

of the process

be minimised due to the ability to test the

PAT to modelling to visualisation to optimisation and ultimately to automated

working with the redesign of a retrospective

Process Parameters (CPPs) and their

• Consider applicable modelling and optimised processes from other industries

comprehensive simulation in place for any

Quality Attributes (CQAs) and their

monitoring, feedback and control versus statistical packages that only provide data

reliable simulation libraries are requirements for any simulation to be successful. Having

Identify the product’s Critical • Development of process modelling

Obtaining professionals, software and

system ahead of time. • Enhance production Improve batch scalability estimates

Process understanding and control

Decrease batch development time

A key aspect of implementing a QbD and

release capabilities • Develop and maintain a library of strong process models. This allows for fewer

PAT framework comes from understanding

deviations, higher quality product, less waste or rejects and provides a shorter

Manage scalability factors Reduce cycle time and optimise energy

• Create a PAT framework that provides

use • Real-time process control

technologies together and expecting them you need people with expertise and those people must function as a cohesive team.

analysis, process control and regulatory compliance

a group of compatible and compliant to work in an integrated framework. For this

an integrated harmony with Quality by Design, legacy/new equipment, data

and effectively controlling the process. This cannot be achieved by simply gathering

time to product release

Receive real-time SPC out-of-control alarms to prevent poor quality

Simulation

The PAT Team should be comprised of the necessary expertise to ensure that the PAT implementation is successful. Having the

“Expert Advice” process analysis

right project sponsor and key expertise from

As mentioned in the previous section, good

system to capture process knowledge

the laboratory, computer systems, regulatory,

Quality by Design implies that any system

and recommend corrective actions in

control systems and process engineering,

intended for PAT is modelled prior to

real-time

etc., are important to the success of the PAT

implementation:

implementation. Drill down capability

In R&D or early development it is critical to model processes to gain the understanding

Teams should share a common vision and Centralised alarm management

of what the key performance indicators are for the product. This is the time when the

view individual members as partners in achieving the same goal. This involves

• Regulatory compliance

model is used mostly for gathering data,

building trust and mutual understanding among team members. Communication is

trending and building the “golden batch.”

Test SOPs before implementation

Good modelling can only be achieved

Validate and test changes before

the key to a successful team. At all costs keep the lines of communication open.

through the realisation of comprehensive

cutover

rigorous simulation. The advantages of rigorous simulations are as follows: • Operator training simulation

Establish the right infrastructure. The monolithic infrastructures of the past are still

Maintain regulatory compliance with

needed but can be streamlined to produce

change control while reducing down

leaner, faster results. This represents a shift

time

away from the old way of accomplishing tasks to a new streamlined way that doesn’t

Bring technicians and operators up to speed faster

Test risk mitigations by replaying test scenarios utilising actual data

sacrifice quality. For instance, the laboratory may be rescaled to work directly with integrated manufacturing.

Exception handling procedures reinforced with real-time data collected

20 | www.protocolmag.co.za

Validate alarm management strategies Understand process limitations. Are

Quality by Design and Process Analytical Technology – an integrated framework of technologies

This has left the life sciences industry with an ambiguous path to follow. Without a clear mandate embodied by a Code of Federal Regulation governing the implementation of PAT framework technologies, the FDA has left the road to successful PAT implementation an unclear and indeterminate entity. This places the burden of proof squarely on the shoulders of the manufacturers. Since validation of existing systems is well defined and determinable it is unlikely that the life sciences industry will ever implement PAT on the scale that is seen in other non-regulated industries. As a result, there is a great deal of talk and cautious interest, but very little movement in the way there any fixed processing conditions or

generally has been hesitant to introduce

limitations? Is there a limited confirmation of

innovative systems into the manufacturing

quality during processing? Will sample sizes

sector for a number of reasons. One

How does a company embrace the benefits

be limited?

reason often cited is regulatory uncertainty,

of PAT for new and existing manufacturing

which may result from the perception that

lines? For a company to embrace PAT, it

Data from real-time acquisition should

our existing regulatory system is rigid

will need to look for resources that have

be determined during Quality by Design.

and unfavourable to the introduction of

PAT experience in non-regulated industries

Reduce data overload by monitoring only

innovative systems.” 1

and depth in the life sciences industry. A

high risk critical processes. Real-time data

of implementation.

resource with such a role can implement

is also used for feedback in a closed loop

This “hesitance,” however, is not

PAT framework technologies, while

system for controlling a process. This places

without merit. To produce a “validated”

understanding the nuances of validated

a mandate on QA/QC to allow the system to

manufacturing line even for a relatively

systems and the regulatory demand posed

maintain variable set points within a validated

simple formula is no small feat and

by each system.

range. The overall effect, however, should be

represents a huge investment of funds,

understood during Quality by Design reviews.

resources and labour to achieve and

Validation methodology itself must also

Additionally, the decision to use closed loop

maintain the validated state of a highly

change. Currently much of validation is

systems should be made during the design

productive line. The idea of “if it ain’t broke

binary in nature with no degree of variance

phase, when the proper instrumentation and

don’t fix it” makes a lot of sense. As a result,

in between. A requirement must exist and

process controls can be specified.

the life sciences industry tries to mitigate

be fully met to “pass” validation. This has

the risk of introducing new technologies by

been an impediment in the current life

maintaining the status quo.

sciences realm and will continue to be

The FDA should be seen as a partner in PAT framework implementations. Both site

so for PAT implementations. Validation

members and FDA representatives should

The FDA also shares a role in encouraging

needs to move forward by defining ranges

maintain trust and mutual understanding.

“hesitancy” in the very industry that it

within requirements and allowing for

Keeping regulatory staff on the team and

simultaneously encourages to adopt QbD

variability to “set points” within ranges.

updated on a regular basis will do a lot to

and PAT framework technologies. FDA

Moreover, change control and configuration

ease tensions and misgivings concerning

guidance for both QbD and PAT exists solely

management procedures should be altered

the implementation of new methodologies.

under the Centre for Drug Evaluation and

to embrace PAT variability without sacrificing

Moreover, having accurate, well-maintained

Research (CDER) but not (as of this writing)

control.

and documented risk analysis and risk

under the Code of Federal Regulation (CFR).

management principals, as well as accurate

Rather, the CDER has stated that the scope

traceability and up-to-date corrective and

of PAT fits squarely in the realm of previously

preventive action (CAPA) will provide a

released regulations embraced by 21 CFR

There are a number of benefits to

common ground for the FDA to air concerns

Part 11:

undertaking a QbD initiative, yet there

A roadmap to success

are also a number of roadblocks that have

and point the way to process improvement. “Within this scope, the guidance is applicable

prevented companies from actively pursuing

to all manufacturers of drug substances, drug

this process. The question is how to pursue

products and specified biologics (including

this level of control and knowledge with

The Life Sciences industry as a whole has

intermediate and drug product components)

minimal disruptions to business. Most of

been resistant to QbD and PAT framework

over the life cycle of the products (references

the roadblocks preventing this new age of

technologies, as lamented by the FDA itself,

to 21 CFR part 11 are merely examples of

operations have centred on three issues:

“Unfortunately, the pharmaceutical industry

related regulation).” 1

FDA guidance

May/June 2013 | 21

• If a specific strategy is implemented, will it be accepted by the FDA? • How does a life sciences organisation undertake such a large initiative?

modelling solution to an existing PAT framework. • Choose the right technology partner for the success of the project. In other industries, as well as in life sciences, it has

• How can implementation occur with minimal disruptions to current operations?

been demonstrated many times that the most successful projects result from early collaboration with the technology partner.

The answer to the first question is simple.

The selection of a partner can take

The FDA has demonstrated public support

place as soon as the desired end point

for the life sciences industry’s movement

is identified. In this way, the company

towards a Quality by Design operations

and the partner work hand in hand to

environment. There have been several case

evaluate the current state and build an

As with any project, the first steps are to

studies in which companies have already

implementation roadmap that leads to

determine where you are and where you are

successfully migrated their operations to

the desired end point.

going. After that, it is important to choose the right partners with open technologies, a

more automated processes. Some have even evolved to a system of automated batch

The final question is probably the most

comprehensive understanding of your needs

release. As with any major initiative, the key

difficult. Ideally, a QbD approach would be

and the experience to help guide you to

is to have a sound rationale for decisions

used from the beginning design of a new

your desired end state.

and sufficient documentation to support

process and a comprehensive architecture

those decisions. Partnering with the FDA in

would be built to support it. The reality,

the initial stages of QbD and PAT framework

however, is that most existing life sciences

design is key to understanding nuances of

operations have only pieces of the necessary

QbD and PAT represent more than just

the currently existing CFRs and facilitates a

supporting technologies to achieve a

one technology or commercial off the shelf

helpful stance from the FDA.

comprehensive QbD initiative. This is a

product that can be purchased from the

hurdle, but it is not a show stopper. The keys

local QbD/PAT merchant. Rather, it is a

to overcoming this hurdle are:

confluence of technologies that integrate

The second question is more complex.

into a cohesive framework to:

As with any large project, it is difficult to determine where to start. The first major

Summary

• A company should utilise as much of the • Reduce production cycle times by using

step is to decide where you are and where

existing framework as possible. The fewer

you want to go. Since QbD and PAT are not

new components that are added, the less

on-line, in-line and at-line measurements

single point solutions, there are numerous

down time and validation that will result.

and controls

possible end points to this type of initiative.

It is important to select technologies

A comprehensive program has a working

that are compatible with the existing

PAT infrastructure, rigorous on-line process

framework. • Real-time release

modelling with closed loop process feedback, process optimisation capabilities

• Prevent rejects, scrap and re-processing

• A phased approach to implementation • Improve operator safety and reduce

and automated batch release. However, a

should be utilised. Trying to implement

company, due to budgetary constraints or

too much at one time can result

human errors through the proliferation of

resource issues, may only want to implement

in extensive downtime. Choosing

automation

some of the technologies, or use a phased

technologies that are not only compatible

implementation to get from the current state

with existing products, but also with

to the desired state. Either way, the starting

future technologies allows for scalability.

increase capacity. Facilitate continuous

point is the same:

Scalability is critical to achieve any

processing to improve efficiency and

phased implementation. The opportunity

manage variability [1]

• A thorough study of the current state is

• Improve energy and material use and

for future expansion should always be

required to understand the next steps.

considered. No matter what the current

Additionally, Quality by Design works to

Most companies will find that they already

desired end point may be, it is important

fill the holes left by missing CFRs. QbD

have a number of the required tools in

to choose technologies that are open

does this by exceeding traditional project

place to implement a PAT framework.

platform and scalable. This will allow

boundaries to include:

for future capabilities and initiatives to • Determine the missing pieces to reach

continue to utilise the infrastructures that

• The intended therapeutic objectives;

the desired end point. For example, if the

are built today, which will minimise the

patient population; route of

end state is a process understanding and

impact of future initiatives. After all, QbD

administration; and pharmacological,

the ability to maintain tight control over

leads to process optimisation and the

toxicological and pharmacokinetic

key process parameters, the company

ability to continuously evolve and improve

characteristics of a drug are understood

may only need to add an on-line rigorous

operations.

and managed

22 | www.protocolmag.co.za

Quality by Design and Process Analytical Technology – an integrated framework of technologies

reluctant to embrace the new technology.

and Human Services, Food and Drug

biopharmaceutical characteristics of a

This places a greater responsibility

Administration - Centre for Drug Evaluation

drug are accounted for

on on-site personnel to interpret PAT

and Research (CDER) - Centre for Veterinary

requirements from previously existing CFRs

Medicine (CVM) - Office of Regulatory Affairs

such a 21 CFR Part 11, 21 CFR Part 210 and

(ORA) - Pharmaceutical CGMPs - September

211 and 21 CFR Part 820.

2004.

Finally, successful implementation comes

Bibliography

• The chemical, physical and

• Design of a product and selection of product components and packaging based on drug attributes • The design of manufacturing processes

from utilising current resources to establish a

using principles of Engineering, Material

clear and concise roadmap to success. This

Innovation and Continuous Improvement

Science and Quality Assurance to ensure

roadmap should:

in Pharmaceutical Manufacturing -

acceptable and reproducible product quality and performance throughout a product’s shelf life [1]

Pharmaceutical CGMPs for the 21st Century • Start with a study of the current existing

Working Group Report: A Summary of

PAT Framework or not

Learning, Contributions and Proposed Next

Comprehensive simulation is a requirement to achieving Quality by Design. Simulation works in harmony with Quality by Design,

- The PAT Team and Manufacturing Science

framework regardless of whether it is a

Steps for Moving towards the “Desired • Determine the missing pieces to reach the desired end point

State” of Pharmaceutical Manufacturing in the 21st Century.

compliance and process understanding to provide:

• Choose the right technology partner for the project • Utilise as much of the existing framework

• Real-time process control

- A Risk-Based Approach. Final Report. Department of Health and Human Services.

• Operator training simulation • Enhanced production

Pharmaceutical CGMPs for the 21st century

as possible • Use a phased approach to

U.S. Food and Drug Administration September 2004.

About the authors

implementation Douglas L. Lively is a Project Manager for

• Regulatory compliance • Consider the opportunity for future Understanding processes and the factors

expansion

Invensys Operations Management and is based in Cary, North Carolina. He is a Certified Quality Auditor through the

that control the processes goes beyond an understanding of equipment requirements

QbD and a PAT Integrated Framework of

American Society for Quality (ASQ) and his

and process flow. Rather, it reaches

Technologies are a true paradigm shift for

Project Management Certification is through

out to embrace team membership and

the Life Sciences industry. As with any new

the Project Management Institute (PMI). Mr.

commonality of purpose, as well as the need

way of thinking or new technology, it has

Lively has more than 10 years experience

for monitoring critical real-time processes

been slow to be accepted. However, the

in regulatory software compliance and has

and maintaining control strategies and FDA

benefits for those who have integrated

managed regulatory projects ranging from

compliance standards.

QbD and PAT Framework Technologies into

medical devices to LIMS and ERP systems.

their manufacturing processes have been Regulatory compliance with the FDA is a

increased efficiencies, reduced loss, better

Jonathon Thompson is a Regulatory

must and with the publication of “Guidance

product quality, enhanced consumer safety

Compliance Services Manager for Invensys

for Industry PAT — A Framework for

and increased revenues.

Operations Management and is based in Wyomissing, Pennsylvania. He is a certified

Innovative Pharmaceutical Development, Manufacturing and Quality Assurance,”

References

Manager of Quality and Operational Excellence with the American Society for

the FDA has made a great step forward in encouraging the Life Sciences industry to

1. Guidance for Industry PAT — A

Quality. Mr. Thompson has more than 10

adopt PAT Framework technologies. But due

Framework for Innovative Pharmaceutical

years experience in regulatory compliance.

to the lack of a Code of Federal Regulations

Development, Manufacturing and Quality

(CFR) governing PAT, the industry has been

Assurance – U.S. Department of Health

May/June 2013 | 23

The clearest path to modernisation. Bypass the risk and cost of obsolescence through our unique and comprehensive approach. To start mapping out your path, visit us at iom.invensys.com/Modernise.

Secure your future with Foxboro and Triconex

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24 | www.protocolmag.co.za ÂŠ Copyright 2012. All rights reserved. Invensys, the Invensys logo, Avantis, Eurotherm, Foxboro, IMServ, InFusion, Skelta, SimSci-Esscor, Triconex and Wonderware are trademarks of Invensys plc, its subsidiaries or affiliates. All other brands and product names may be trademarks of their respective owners.

There’s always room for improvement

Figure 1: Utilisation of production capacity in the South African manufacturing industry (Source: Statistics South Africa, February 2013)

Denis du Buisson, editor, Protocol magazine

To strive for perfection is an instinctive

business initiatives to squeeze even more

human trait among civilised communities.

out of manufacturing or mining plants.

Yet, many manufacturing companies,

The mere idea that things are as good as

when offered the tools to improve their

they’re ever going to get is the start of

productivity and performance, show a high

stagnation. Business can always be improved

degree of scepticism that any improvements

– especially when you think it can’t.

would be worthwhile or make any great difference to the company’s bottom line.

The old adage of “you can’t control what

In other words, they believe that they’ve

you can’t measure” is probably more true

reached a degree of operational efficiency

now than ever. Production processes, for

that would be difficult to improve.

example, are constantly being measured, compared to defined performance criteria

The major problem with this argument is that

and adjusted accordingly. This is the essence

they stop looking and settle into a comfort

of process control whose main duties

zone that could lead to stagnation, the

include:

overlooking of opportunities and reduced business success. Since their inception, manufacturing and mining companies have

1. Specify operational, cost, quality, safety, timing and customer need criteria

engaged in lean, six sigma and/or adaptive manufacturing initiatives to remove waste, reduce variation and increase productivity.

2. Produce end products to meet the criteria specified in (1).

Today, an improvement as low as 1% can be significant, especially if it is sustainable into

3. Monitor the production process to make

the future. Modern industrial software tools

sure it meets the criteria necessary to

provide accurate information that support

achieve (2) and change the process

May/June 2013 | 25

Figure 2: Some performance improvement initiatives that many

Figure 3: Some performance measurement initiatives that companies

companies have adopted in order to improve business

use in order to get better understanding and control of their processes

according to given guidelines if these

Key to the economic success of production

The impact of the world financial crisis

criteria aren’t being met

processes is the measurement of how well

in 2008 is clearly seen and logically, the

manufacturing companies are using their

main reason given for the decrease in the

production capacity (see figure 1). The

utilisation of production capacity was lack

or change existing criteria/guidelines

numbers were obtained on a quarterly basis

of demand – which leads to a decrease in

arising from necessary process changes

by Statistics South Africa from a population

turnover while overheads stay more or less

to achieve (1) (part of the continuous,

of approximately 980 large enterprises,

constant. These are the exact conditions

incremental improvement process)

which, in turn, is a subset of approximately

that not only require belt tightening but a

45 130 manufacturing enterprises (web site:

serious look at ways of improving production

www.statssa.gov.za).

efficiency.

4. Incorporate new criteria/guidelines

5. Go to (1) and repeat

Over the past decades, many initiatives have been tried worldwide in order to improve productivity and efficiency. Figure 2 shows some of the performance improvement initiatives that led to the development of the measurement tools shown in figure 3. One of the tools that has received a lot of attention because of its rapid results and diagnostic capabilities is OEE (Overall Equipment Effectiveness). At the shop floor level, there’s more than process control to consider. The next level up is monitoring the behaviour of the infrastructure that is responsible for productivity – humans and machines. Humans normally want things to go right but, to help them do this in the complex world of manufacturing, they need the proper tools such as ArchestrA Workflow. As to machines, they need to be evaluated with respect to their genuine contribution to the production process. One way of addressing the needs of both humans and machines to do a better job is through the use of OEE – a Figure 4: Determining Overall Equipment Effectiveness. Example: (.77)*(.65)*(.98)*100 = 49% OEE.

direct measurement of plant performance

World-standard OEE stands at 85% which is the result of 90% Availability, 95% Performance and

and profitability viewed from the viewpoint

99.9% Quality.

of production managers (see figure 4).

26 | www.protocolmag.co.za

There’s always room for improvement

is being highly utilised – only to have it break

or she’ll blow!’ Stretching the machine’s

down and thereby making it unavailable.

present capacity may result in many more

So, the answer is that we shouldn’t be

breakdowns and that’s why production is

optimising availability or utilisation as much

down. To the production crew, this will now

as we should be maximising economic value

have become “normal operating procedure”

(see figure 5). But, until now, we didn’t have

with everything working flat out. In this case,

good mechanisms in place to measure this.

everything that can be done to optimise

The lesson of historical information shows

efficiency is indeed being done but for the

us that it may even be sometimes necessary

wrong reasons. Where is the proof necessary

to lower the utilisation of assets in order to

with which to confront the bottling machine

increase their economic value.

supplier? The real-time measurement of OEE can supply that proof. Measurement

Figure 5: Optimising asset value rather than

The analysis of historical information lets us

alone will not deliver improvement and

see when things were running right during

doesn’t make anyone competitive. What

There are many arguments about OEE and

the manufacture of a certain product and

matters is what you do with the results.

how it can be cheated (e.g. subtracting

those same conditions can be used as a

shift changes, tea or lunch breaks and other

starting point when that product has to be

One argument used for not accepting high-

disruptions from total available hours),

manufactured again. Further optimisation

level performance measurement solutions

however, no one questions the fact that it is

through rigorous measurement will mean

is that “a few percent improvement is not

a vital measurement of plant performance

an even better starting point the next time.

going to justify the cost of the purchase”.

that is directly related to profitability. The

And so we have continuous incremental

Well, how do you know that it’s only a few

fact that the current world standard for

improvement.

percent if you’re not measuring it right now?

just availability or utilisation.

OEE stands at 85% may, in itself, be scaring

And “a few percent” can mean a great deal

production managers off considering

It’s all too easy to believe that what we see

adopting OEE because it may highlight

is the optimised evolution of what can or

some inadequacies in their processes. What

should be.

if they’re not up to world standards? Well,

– especially with more mature companies. Start-up companies usually have a limited customer base with a correspondingly

so what? Paper industry OEEs, for example,

For example, a bottling machine may be

limited turnover. Increasing their production

vary from the low 60% up to 85%. In batch

processing 3000 bottles an hour although

facilities doesn’t always mean a staggering

plants, where there is lots of chopping and

it was bought because it could do double

improvement in turnover ( Δ1 in figure 5). But

changing going on, one might be looking at

that. The reason comes straight out of Star

as company growth curves are rarely linear,

30% to 55% OEE.

Trek: ‘I cannie push her any harder cap’n

with maturity comes an accelerated increase

The most important contribution of OEE is its measurement of performance relative to the current situation. This measurement then provides a baseline for improvement rather than a basis for the comparison of absolute performance levels with peer companies locally and internationally. If you can’t measure it, you can’t improve it and it’s rather concerning that companies can continue to operate unperturbed while proclaiming that everything that can be done to optimise efficiency is being done. Where are the numbers? And even with the numbers, it’s not as simple as you may think. Optimising the three OEE variables of quality, availability and performance is like trying to juggle three slippery snakes with attitudes. For example, plant utilisation and plant availability are in fact opposing forces. One way to guarantee your car’s availability is to

Figure 6: The same performance increment in mature companies (Δ P2) as in start-up companies

leave it in the garage – but its utilisation will

(Δ P1) can lead to a substantial financial benefit (assuming a typical non-linear growth. NOTE: This

be zero. On the other hand, driving around

is actually a complex subject and difficult to illustrate. The above graphic is a simplistic approach

frantically all day long will mean that your car

towards illustrating the leverage of efficiency over turnover in a growing company.

May/June 2013 | 27

While achieving perfection may never be possible, it’s the incremental progress towards that goal that makes all the difference – both in terms of profits and human motivation.

the difference – both in terms of profits and

Manufacturing is visibility, responsiveness

human motivation.

and a direct and powerful link between the manufacturing shop floor, the supply

It’s predictable that, in future, determining

chain, external partners and the boardroom.

a company’s performance will include

Adaptive Manufacturing is also highly

measurement of all its processes including

focused on enabling and supporting

MES (Manufacturing Execution Systems)

business processes that operate in real

and business functions (ERP). What’s good

time, and in optimising these processes to

for the goose is good for the gander.

the mutual benefit of all stakeholders. The

Measurement is a yardstick and a guideline

result is that Adaptive Manufacturing can be

in turnover with the result that the same

that helps control and improve processes. It’s

applied to a broad range of manufacturing

incremental improvement in production

the very basis upon which those processes

companies and yield an equally broad

efficiency (although far more difficult to

are based. Managing an enterprise without

range of results, from better resource

achieve at higher levels) can yield far greater

real measurements is like navigating a ship

allocation to improved shop floor yields

returns (Δ2 in figure 6). In fact, SABMiller,

without a compass. But to measure the

to a more productive workforce. Adaptive

one of the world’s largest brewers, would

performance of the business at every level,

Manufacturing allows companies to set goals

currently be well-pleased with a mere 1%

it stands to reason that those levels must be

and milestones based on an accurate, real-

increase in production efficiency.

connected seamlessly.

time and comprehensive view of the plant

So, the bigger you are, the more leverage

Playing an increasingly important role in

chain and then execute, modify and rework

incremental improvement has on your

helping companies get the most from their

those goals and milestones in response to

bottom line. This, by itself, would give fuel

assets and competitive positions is the

rapidly-changing market dynamics.

to the argument that if you’re not a Boeing,

concept of “Adaptive Manufacturing”. The

Ford or SABMiller, then OEE is out of your

term was coined by enterprise software

Finally, adaptive manufacturing must be

league. But we mentioned earlier that

market leader SAP and is defined as:

based on integrated manufacturing solutions

OEE is a relative measurement. It doesn’t

“The ability to replenish the supply chain

that are able to support industry-specific

matter how big or how successful you are,

profitably while responding dynamically

business processes, conform to standards,

one thing you definitely need is a yardstick

to unpredictable change.” SAP maintains

be highly configurable and recognise the

to determine if you’re going up or down

that this provides the ability to “run

common needs but disparate environments

and, very importantly, what’s driving the

manufacturing at the speed of business and

of the shop floor and the top floor.

trend? Real-time OEE could well be that

to deliver superior performance through

yardstick. Even if you believe that you’re

higher visibility and responsiveness.”

floor and its interactions with the supply

at the theoretical 100% productivity level,

So, there’s a great deal that can be done to take manufacturing and mining enterprises

without measurement, how would you

Behind these concepts is a wide range

to the next level of excellence, productivity

know it and, more importantly, how could

of applications, technologies and

and profitability. There is always room for

you stay there? While achieving perfection

business processes that together enable

improvement.

may never be possible, it’s the incremental

manufacturers to both survive and

progress towards that goal that makes all

thrive. Central to the view of Adaptive

28 | www.protocolmag.co.za

Do not be misled by OEE

Do not be misled by OEE Overall equipment effectiveness (OEE) has

or part changes, start-up or adjustment

been used as one of the more important maintenance metrics since total productive

Performance efficiency losses: Minor stops

maintenance (TPM) came to the U.S. in the

(jams, circuit breaker trips, etc.) and reduced

late 1980s. OEE is the primary measure used

speed, cycle time, or capacity

in TPM to identify and quantify the major equipment-related losses and a metric for

Quality losses: Defects/rework, scrap and

rating equipment effectiveness.

yield (changeover, start-up losses)

OEE has become widely used in many

OEE, as a metric, is a calculated rating

plants with or without the elements of TPM

of equipment effectiveness represented

to quantify equipment effectiveness losses.

by Availability x Performance Efficiency x

This usage has also caused some confusion,

Quality Rate, each expressed in percent.

and has led to many misuses of the OEE

Robert M. Williamson, CMRP, CPMM, MIAM,

percentage calculation.

Let the confusion begin

The early Toyota Production System focused

This is where all the confusion begins. OEE

on eliminating waste to reduce cost. OEE

percentages became a metric to compare

was initially developed to identify the major

current equipment performance to world-

losses in equipment performance and

class performance, typically pegged at 85

reliability. TPM then became a company-

percent.

wide approach to eliminating them. Here is a

Strategic Work Systems, Inc. Columbus,

list of the original major losses:

North Carolina, USA

Once used as a benchmarking score for world-class, OEE then came to be used

Availability losses: Planned shutdown—

for comparing one piece of equipment to

Approved for reprint in Invensys’ Protocol

no production scheduled, planned

another, regardless of function or operating

Magazine by Robert M. Williamson,

maintenance; downtime—breakdowns and

environment. OEE has been extended to

15 Feb 2013

failures, changeover (product, size), tooling

specify overall plant effectiveness (OPE) by

May/June 2013 | 29

using an aggregate score for all equipment

OEE percentage rating: The OEE

maintenance where the entire organisation,

in the plant.

percentage calculation served no purpose

including operations and engineering,

other than a very high-level indicator of

focuses on eliminating the major losses.

These metrics have become widely used to

performance improvement or degradation.

compare levels of maintenance effectiveness

Today, entirely too much emphasis is placed

OEE data very quickly leads to root cause

and equipment performance to world-class

on trending and analysing the calculated

identification and elimination. OEE data

levels, and even a club to punish those

OEE rating.

answers the question—did we eliminate the

whose OEE slips. All of these uses are

root cause of poor equipment performance?

inaccurate, unfair comparisons and a gross

OEE as a calculated rating is not entirely

OEE data is the means to an end: improving

misuse of the original purposes of OEE.

accurate. It assumes the basic factors of

overall equipment effectiveness.

availability, efficiency and quality losses are OEE data: OEE was originally designed and

equally important. It is a rare situation when

However, calculating OEE ratings removes

developed to characterise and communicate

a 1 percent downtime loss has the same

our efforts further from eliminating the major

the major equipment-related losses.

business or financial impact as a 1 percent

losses to comparing OEE scores.

efficiency loss or a 1 percent quality loss. By capturing equipment performance

Be careful—OEE is a measure of equipment

OEE is not a maintenance measure

effectiveness, not maintenance effectiveness.

communicate the major losses for focused

OEE is not a measure of maintenance

For more information, contact Robert

improvement. This OEE data then could

effectiveness—it is a measure of the factors

at RobertMW2@cs.com or Robert M.

measure and communicate the effectiveness

that determine equipment effectiveness.

Williamson and visit his web site

of the focused improvement efforts and the

Maintenance alone can address very few

http://www.swspitcrew.com or

countermeasures put in place to eliminate

of the major losses captured for OEE. This

Strategic Work Systems

the major loss, or problem.

is why OEE is used in total productive

and reliability data and classifying it as a specific availability, efficiency, or quality

Don’t be misled by OEE.

loss, Pareto charts could be developed to

30 | www.protocolmag.co.za

The roots of quality management

The roots of quality management John Coetzee – Aristotle Consulting (Pty) Ltd

Introduction

at the heart of most (if not all) modern manufacturing and service industries today.

In the days of old, quality control was in the

The advent of social networking has allowed

customer’s hands. The customer had the

a disgruntled customer to instantly reach out

power to evaluate the value proposition of

to hundreds or even thousands of potential

the trade and if the product or service was

customers and warn them of their one poor

worth the price being paid, an exchange

experience. This is a very scary proposition

would happen. So basically, nothing has

for suppliers indeed, the very stuff of

changed, only the customer now has far

nightmares.

more suppliers and many more options to choose from and therefore even greater

In the original sense, quality purely means

power, resulting in quality control being

“to meet the customer’s needs”. While

May/June 2013 | 31

at its broadest definition, quality can be defined as the way an enterprise executes its processes, which is based on theory and knowhow to ensure that every facet of the enterprise performs to the same quality philosophy.

So where did the concept of quality and quality management begin? The earliest historical records of there being accountability for quality, are documented as early as 3000 BC, where the rule of law dictated that if a mason built a structure which happened to fail in some way and in so doing resulted in the death of an inhabitant, that mason should be punished by death. Think of the construction of

Figure 1: A typical Process Control Chart

the pyramids, where only incredibly small tolerances were allowed to ensure that the

in an internal company memo and then

(who taught methods for statistical analysis

overall structures worked as designed and

later published it in “Economic Control of

and control of quality) and Joseph Juran

are aligned in the various (insidious) ways we

Quality Manufactured Product” in 1931. This

(who taught the concepts of controlling

find them today. Again, the consequence

mechanism allowed for process variations

quality and managerial breakthrough) were

of poor quality workmanship here was likely

to be plotted and assigned as either a

coincidentally both students of Shewart and

to be the order of death by the Pharaoh.

common cause or a special/assignable cause

were sent to Japan to aid with the rebuilding

Luckily customers have become slightly

and in this way, it made the process quality

of the manufacturing industry there. They

more forgiving since then.

visible for scrutiny by all, thereby allowing

were joined by a communications specialist,

for focus on reducing these variations in the

Homer Sarasohn. Sarasohn was notably

manufacturing process.

the author of the book “Fundamentals

Suppliers became more organised with

of Industrial Management”. (This work

the advent of guilds in the 13th century. These guilds defined procedures for service

With control charts (figure 1), it is critical to

describes adopting a systems approach to

quality and then measured the work of

bring the production process into a state of

manufacturing, the integration of customer

artisans against these standards. The most

statistical control so that only common-cause

satisfaction with the continued product

superior works were marked with a special

variations occur. The process can then be

development cycle, focusing on the value

seal attesting to their higher quality. This

managed against predicted future outputs

of research and development, with the main

practice continued with skilled artisans until

and allow for the optimising of process

emphasis being on quality itself.)

the advent of industrialisation in the late

costs.

19th century. No longer was a single artisan

These three men, working in collaboration

responsible for the entire product, but

At this time, Shewart’s control charts

with the Union of Japanese Scientists and

instead each was specialised in a specific

were adopted by Deming who became

Engineers, set about the task of rebuilding

task, with the end product (usually) only

a significant champion and advocate of

the Japanese manufacturing industry. Early

being inspected at the end of the process,

his work over the next 50 years. Deming

on in the process, it became critically obvious

by a different employee.

was very instrumental in assisting with the

that the use of statistical quality control

re-birth of the Japanese manufacturing

methods only worked when they were

industry after World War II, and his

applied under a broader quality management

involvement is mentioned below.

culture and approach. In other words, it

Industrialisation 1911 is defined as a landmark in the field of quality management, with the publication

required the application of a total quality

During and Post World War II

of the work: “Principles of Scientific

management (TQM) philosophy. In line with this, Deming developed fourteen points

Management” by Fredrick Taylor. One of

Quality management became more

on quality management, to act as a set of

the key recommendations made is that

significant during World War II, particularly

management practices to help companies

there must be a quality control inspection

in the manufacture of weapons and

increase their quality and productivity.

of the final product, prior to delivery

munitions for all forces. The advent of

Decades later, the Emperor of Japan awarded

to the customer. Another leap forward

scientifically-developed sampling plans for

Deming the highest Japanese award for a

was achieved with the introduction of

the inspection of products became prevalent

civilian, in recognition of the decades of hard

statistical process charts by Walter Shewart.

in order to meet this high quality demand.

work and leadership he gave to the Japanese

Originally he introduced the concept

After the war and into the 1950s, Deming

people and their government.

32 | www.protocolmag.co.za

The roots of quality management

In Japan, over the next few years, incremental improvements to quality management and quality management tools were made. Some of these included: quality circles, control charts, histograms, Ishikawa diagram (fishbone diagrams) and scatter plots. One of these, the concept of “quality circles”, was formalised in 1960 by Dr. Kaoru Ishikawa as “the use of small groups to eliminate variation and improve processes”. Basically, a quality circle is a group of workers, acting under an elected team leader, who are trained to identify, analyse and solve work-related problems and then present their solutions to management, in order to improve the performance of the organisation and motivate and enrich the work of employees.

On to more modern times (the 1970s onwards…) Quality management had come of age and was now primed to drive a quality revolution in America. In 1979 Philip Crosby published his first book “Quality is Free – if you understand it” (describing amongst others, the concept of zero defects). This work is said to have played a significant role in the beginning of this American quality revolution. Soon after this book was published, Deming returned from Japan and wrote “Out of the Crisis”. He was also featured in an American programme “If Japan can do it, why can’t we?”. The Ford Motor Corporation was one of the first American companies to seek help from Deming after this broadcast. A quality programme was requested, but Deming

Figure 2: Annual growth in ISO 9000 certificates from September 1993 to December 2003

focused more on core management and

(courtesy ISO)

in particular the operation of managers. He noted that quality first had to be an

action. If it is not pervasive across

LinkedIn: http://www.linkedin.com/profile/

ethos within the business. Once this

an organisation, a critical link will fail

view?id=60025171&trk=tab_pro

was recognised and by moving toward

somewhere and the quality of the business,

building this quality culture at Ford, the

customer service experience or the end

company soon found itself profitable again.

product, will be negatively affected. I hope

The 1980s saw a watershed of American

you have enjoyed reading this brief history

Aristotle Consulting (Pty) Ltd is a Consulting

companies adopting quality management.

of quality management and find that it

company to the Manufacturing Industry;

1985 saw the launch of the now famous

conforms to the goal of six sigma, with less

as well as offering training in World-Class

“six sigma” initiative at Motorola, driven

than 3.4 defects per million opportunities –

Manufacturing concepts and other technical

by its then leader, Jack Welch. 1987 saw

we targeted zero :).

courses. Aristotle Consulting specialises

About Aristotle Consulting

in best practices for the management of

the publication of the ISO 9000 standard and as shown in figure 2, there has been

For more information contact:

technology strategies, product selection and

significant annual growth in the number of

John Coetzee

the operational management of your entire

ISO implementations since then.

Business Development Director

Manufacturing Systems portfolio.

Aristotle Consulting (Pty) Ltd

In closing

Landline: +27 79 517 5261 info@aristotleconsulting.co.za

Quality is a philosophy and not a specific

www.aristotleconsulting.co.za

May/June 2013 | 33

Invensys â&#x20AC;&#x201C; commitment to quality

34 | www.protocolmag.co.za

Invensys – commitment to quality

Invensys operations management quality organisation How is Invensys Operations Management structured to deliver high-quality, problem-free products and services?

To achieve the quality standards our clients demand, Invensys created a Quality Assurance organisation that spans across all aspects of our diverse business.

To achieve the quality standards our clients demand, Invensys Operations Management created a Quality Assurance organisation that spans across all aspects of our diverse business. This organisation, under the leadership of a Global Director of Quality, has the following major components: • A comprehensive procedural infrastructure designed to ensure that Invensys Operations Management is consistent in all areas, especially those areas that deal directly with clients • Regional and functional Quality Councils (Americas, Asia Pacific, Europe, Middle East and Africa) to ensure that we are responsive and adaptive to specific needs • A global set of client-focused quality metrics used to monitor performance and track continuous improvement • Internal audits and reviews that ensure compliance across the enterprise • Comprehensive training in Six Sigma, related quality tools and techniques to ensure Invensys Operations Management teams have the skills and capabilities required to meet our clients constantly evolving needs • Significant presence on numerous international standards committees and boards

May/June 2013 | 35

These capabilities help industrial companies run safer, operate more efficiently, extract useful knowledge from their operations to make faster, and better decisions.

Invensys Operations Management How does Invensys Operations Management enhance the capability and productivity of its clients? Invensys Operations Management is a leading provider of automation and information technologies, systems, software solutions, services and consulting to global manufacturing and infrastructure industries. The marketplace knows us from our premier brands â&#x20AC;&#x201C; Avantis, Eurotherm, Foxboro, IMServ, InFusion, SimSci-Esscor, Skelta, Triconex and Wonderware. Our solutions, which are used by more than 40,000 clients in over 200,000 plants and facilities around the world, include control and measurement instrumentation; safety, critical and distributed control systems; a wide range of real-time operations management software; and professional services. Enabled by our industry and production expertise and accelerated by an open software platform and partner ecosystem, our flexible approach perfectly blends automation and information technologies, services and expertise into highly effective solutions that solve problems and optimise the profitability of operationsâ&#x20AC;&#x201D;from single plant devices to multi-plant assets and locations. Combined, they provide the most comprehensive portfolio of solutions availableâ&#x20AC;&#x201D;all designed to measurably improve business performance and value in real time.

36 | www.protocolmag.co.za

Invensys – commitment to quality

Quality Management System

Nuclear Quality Assurance

How is the Invensys Operations Management Quality Management System (QMS) structured to deliver high-quality/problem-free products and services?

How is Invensys Operations Management structured to support the needs of our clients in the nuclear industry? The Invensys Operations Management Nuclear Quality Assurance

Our QMS enables us to:

programme was developed and implemented to comply with regulatory, industry and client quality requirements for products and

• Provide consistent, reliable and dependable products, services and

services provided to the nuclear industry.

solutions The Invensys Operations Management Nuclear Quality Assurance • Continually improve product quality and reliability

Manual documents the practices and procedures that have been established and maintained by each Invensys Operations Management

• Improve reliability and efficiency in our clients’ processes

facility involved in the design, manufacture and service of our nuclear products.

• Engineer and manufacture cost-effective products that are easy to install, easy to maintain and perform flawlessly

The following documents constitute the basis for the Invensys Operations Management Nuclear Quality Assurance programme:

• Ensure on-time delivery based on Lean/Six Sigma methodology • 10CFR50 Appendix B, Quality Assurance Criteria for Nuclear Power Our QMS is set by our client needs, translated into a set of quality

Plants and Fuel Reprocessing Plants

requirements at the division level and deployed across all our operations through documented quality programmes. Our quality mission, as stated in the Quality Policy, is as follows:

• ASME NQA-1-1994, Quality Assurance Basic Requirements for Nuclear Facility Applications and applicable Supplementary Requirements

Invensys Operations Management is committed to satisfying client requirements by implementing best practices through a formal quality

• 10CFR21, Reporting of Defects and Non-Compliance

management system and by continually improving our processes, products and services.

• IAEA 50-C-QA, Code on the Safety of Nuclear Power Plants: Quality Assurance

All processes driven by our clients’ requirements are translated into a defined and established set of value-added activities that are driven and structured around the QMS.

• CSA N286-05, Management System Requirements for Nuclear Power Plants

The six attributes of the QMS are:

• HAF003, Quality Assurance of Nuclear Power Plants

• KTA 1401, General Requirements Regarding Quality Assurance

Client-focused, repeatable and effective processes are assured through comprehensive definition and documentation.

• KEPIC-QAP, Nuclear Quality Assurance 2.

Metrics in QMS provide objective assessment of our processes, products and services to enable Invensys Operations management

Product assurance and regulatory compliance

to consistently track and improve performance. 3. Controls are effectively implemented to maintain processes, products and services to consistently meet clients’ requirements. 4. Continual improvement is integrated into our business processes, products, and services to ensure evolving client needs are satisfied.

How is Invensys Operations Management structured to support agency and/or product certification requirements? Required product safety certifications are obtained for all Invensys Operations Management product offerings prior to the sales release to our clients. In compliance with national statutory regulations,

5. Safety and reliability of our processes, products, and services comply with all applicable safety and regulatory standards.

products are routinely submitted for approval to the appropriate nationally recognised testing laboratories. Many Invensys Operations Management products are certified for use in explosive atmospheres,

6. Sustainability is included as a key component in the design,

hazardous locations and hold the appropriate certification(s).

manufacture and performance of our products and solutions.

Worldwide Certification These attributes are included in our annual goals deployment process to support continual improvement.

Invensys Operations Management maintains active membership

May/June 2013 | 37

in numerous and relevant international standards committees and

site-observed failure rates against those observed globally,

maintains the appropriate product certifications as required by our

giving Invensys Operations Management the ability to determine

clients. Many countries located outside Europe or North America

whether site failures are associated with site-specific issues (such

use IEC standards, Russian Federation certifies equipment to GOST

as grounding corrosive environments). This root-cause assessment

standards and closely follows CENELEC practice. Additionally, the

is very valuable in determining the corrective actions necessary to

IEC EX SCHEME, when fully adopted, will allow for internationally

ensure or restore site reliability.

recognised certification. This uses the IEC standards and IECrecognised test and certification bodies to issue mutually recognised

Predicted reliability values, based on the Mil-Hdbk-217 methodologies,

test reports and certificates.

and used by design and development teams to ensure new products meet our clients’ demanding reliability requirements when introduced

Continual improvement

into the market. Software reliability is assured using the Computer Aided Software Reliability Estimation (CASRE) tool to drive product

How is Invensys Operations Management structured to deal with ever evolving client needs and requirements?

stability, functionality and minimise performance issues prior to a product release. A “release-on-release” strategy using this tool ensures that each new release has fewer potential defects than the previous release. Supporting data is also provided to clients who plan to use our

The business world is a dynamic environment, with ever-increasing

products in IEC61511 (or ISA84.01) process safety (SIS) applications. For

product and process performance requirements. To support evolving

these requests, failure modes, effects and diagnostic analysis (FMEDA)

client needs, Invensys Operations Management must continually

data is now available on most products.

improve key products and processes in ways that clearly provide value. Client needs are determined via Global Satisfaction Surveys and

Field performance monitoring

Listening Posts such as Beta testing, user conferences and other unique settings and applications that provide direct client feedback. In order to continue to be successful in providing tangible value,

Does Invensys Operations Management have a process to notify our clients if a problem is discovered in any of our products?

Invensys Operations Management must remain in close contact with our ever-evolving clients, no matter how difficult the task. Each year

The Quality Data System (QDS) significantly reduces client risk by

Invensys Operations Management trains Continuous Improvement

allowing Invensys Operations Management to monitor product

Experts from across all businesses in DMAIC techniques, as well as in

performance in the global installed base. This unique capability allows

Lean Enterprise techniques, to support continuous improvement.

the rapid and timely identification of client issues and potential client issues, as well as targeted client notifications as required. This listening

Reliability modelling

post gives Invensys Operations Management the ability to identify, track and resolve issues that potentially impact a very small percentage

How does Invensys Operations Management ensure that our products have high reliability and low operational maintenance?

of client applications. This system is a unique capability in the market,

Product and system reliability are critical considerations to clients

QDS has the ability to record configuration, test, defect analysis and

running efficient and profitable facilities. To enable clients to effectively

repair data during the manufacturing product life cycle. QDS provides

and accurately evaluate different product application configurations

a complete history of the unit from the beginning to the end by

and strategies, a number of reliability-based models are now available

recording data when the unit is built and whenever the unit is tested or

for Invensys Operations Management products.

repaired in-house. For field returns, the data collection is initiated when

and coupled with our continuous improvement focus, is a significant reason for our high field-proven product reliability.

the client or representative makes the call. The return data includes “Field Proven” is our most accurate and requested reliability-based

information from the client regarding their location, the failures

model. Using global installed-base failure and installation data from

reported (symptoms) and all relevant information that would help the

our Quality Data System, we can accurately estimate client experienced

diagnostic process.

MTBF values. This capability has resulted in a number of unique estimates/assessments, which include:

Quality training

• Client system/subsystem MTBF estimates – critical to the assessment

How is Invensys Operations Management structured to support the training needs of our employees?

of alternative configurations, evaluation or expected maintenance and system up time.

Training is key to ensuring that skills and tools, which are critical to • Client spare estimates using the global field failure rate, client

supporting a continual improvement culture, remain current and

installed base and replenishment times – critical to “right-sizing” on

effective. In addition to competence and skills training, quality training

site spares to minimise down time and unnecessary inventory.

is available to all Invensys Operations Management employees:

• Site failure rate assessments – this involves statistically contrasting

38 | www.protocolmag.co.za

• The Continuous Improvement (CI) programme is designed to train,

Invensys – commitment to quality

reinforce concepts through classroom exercises, and culminate in a mentored Rapid Improvement effort (Kaizen) within the business. The programme prepares individuals to apply Six Sigma / Lean Enterprise principles to improve the business by applying the CI methodology within their normal role. The levels of training are summarised as Awareness, Individual Practitioner, Dedicated CI, and CI Leaders. Selecting the appropriate level of CI training is based on the candidates’ role in the business. Candidates for Dedicated and Leadership roles in CI have supplemental training and mentoring in addition to the standard programme. During the training cycle, CIE candidates identify an improvement project within their business role to execute using the CIE methodology and toolbox. Candidates define, gain sponsorship, and begin their projects during the training programme. Each candidate fulfils their project after course work completion under the mentorship of the Business CI Director in order to qualify for certification. • Self-Administered Training Modules – these modules support refresher training, as well as the training of those who find it difficult to attend one of the formal sessions. Modules cover numerous quality tools and techniques and include additional resources for deeper study, as well as access to subject matter experts for detailed questions. Modules are continually developed and new releases are prioritised based on an annual business needs survey. • Lead Auditor Training – audits are an important means to gauge process compliance. This training is focused on providing the necessary capability to both organise and manage the quality audit process. • Competence and Awareness Training – performed as necessary by Invensys Operations Management Quality professionals to support the ongoing needs of Invensys operations.

May/June 2013 | 39

The route to a simple solution is usually extraordinary Get an end to end solution tailor-made for your business with Business Connexion’s Professional Services When it comes to making extraordinary connections, nothing comes close to the human brain. That’s why it’s the inspiration behind our Professional Services. With our unique understanding of your business model, value chains and strategy, we can supply you with an end to end solution that helps you make the most of your Business Processes, Applications Portfolio, Application Management and third party solutions. With our unique integrated solutions, we can help you build systems that enable you to enhance and grow your business. We call it the amplifying power of Connective Intelligence™.

www.bcx.co.za 40 | www.protocolmag.co.za

May/June 2013 | 41

42 | www.protocolmag.co.za

Invensys and product quality management/SPC Delivering products with high quality – defined as “meeting specifications at the lowest possible cost” as well as “delivering the value a customer derives from a product or service” – is a top priority for manufacturers and industrial operations. Quality has many aspects and Invensys Operations Management applications have provided integrated quality management functionality to tens of thousands of companies worldwide. Invensys quality applications cover the gamut: from realtime process visibility to methods for data monitoring and alarming; historian data capture and reporting functionality to store and display voluminous process data for quality analysis; enterprise-wide SPC; integrated MES for specification management, genealogy, BOM enforcement, OEE and downtime monitoring; batch recipe management software to collect information on batch quality and recipe specifications; and underlying ArchestrA framework for monitoring and configuring data levels and application templates to deliver nearly any quality capability.

Key benefits

Key capabilities

• Regulatory adherence and

• Data monitoring and alarming

compliance • Best-in-class enterprise SPC, with database backbone • Respond to process variation in real-time • Productivity and cost of

• Advanced, interactive trending and charting • Government and regulatory reporting capabilities

manufacturing improvements • Historical data collection • Actionable, real-time qualityrelated information

• Integration with Laboratory Information Management Systems (LIMS) May/June 2013 | 43

Product profile: Wonderware MES Software / Quality Wonderware MES Software/Quality helps

In a nutshell ...

manufacturing companies reduce the cost and increase the efficiency and accuracy of

Summary

capturing and monitoring of critical quality information on the shop floor, in context

Wonderware MES Software/Quality

and in dynamic synchronisation with the

provides quality operations management

execution of work orders.

capabilities for sample data collection in work order execution context for both automated and manual production operations. Statistical Process Control (SPC) monitoring of sampled data helps improve product quality, minimize variations and improve yields by driving

Quality operations management on the shop floor improves product quality, compliance and operational efficiencies

• Increases operational efficiency and accuracy of quality data by automation of quality sampling procedures with enforcement or direct sampling from plant

quality closer to targets and within specification limits.

Wonderware MES Software/ Quality:

The desire for increased margins and

equipment or control systems.

the growing pressure of compliance with

Business Value

internal, governmental or safety regulations

• Improves product quality and reduces

requires tighter quality control and improved

losses through tighter control and

Using Wonderware MES Software/

quality procedure management in many

faster response to non-conformance or

Quality, manufacturers can increase

manufacturing industries. Balancing these

deviations, leveraging Statistical Process

operational efficiencies, product quality

quality requirements requires efficient

Control (SPC) monitoring of sampled data

and yields, quality data accuracy, and

in-line quality operations; minimal impact

with notifications of rule and limit viola

reduce quality losses. Increased

to operator efficiency; access to multiple

automation reduces the cost of

systems for data and recording; and

quality, regulatory and product safety

management of the plant/enterprise systems

securing compliance through dynamic

compliance.

landscape, to minimise complexity and lower

quality specification and sample

the total cost of ownership.

plan management for ever-changing

• Enhances operational agility while

production schedules, based on current Wonderware® MES Software is

work order execution status.

configurable, fully functional and highly scalable Manufacturing Execution System

• Improves compliance, product safety, and

(MES) software which can be applied

governance through complete electronic

to most industrial manufacturing and

system records of operational execution

production processes. Wonderware MES

and quality procedures.

Software includes real-time manufacturing operations, performance and quality

44 | www.protocolmag.co.za

• Complements enterprise quality

management, plus execution capabilities

management systems with sampling

for the shop floor. Comprehensive

execution capabilities on automated

enterprise integration and standardisation

process equipment, or for interoperability

capabilities facilitate use by any scale of

with integrated quality and manufacturing

business or enterprise.

operations.

Product profile: Wonderware MES Software / Quality

Electronic quality specification and sample plan execution management Wonderware MES Software/Quality allows the definition of individual quality specifications for products to be produced, equipment to be used and operations to be

• Reduce off-spec production through

gained through integration into ArchestrA

executed, or combinations of these to be

electronic application of correct

System Platform. System Platform provides

administered.

specification definitions based on current

the infrastructure for integration and data

work order data

collection from automated equipment, through the Quality Module’s new Sample

Quality specifications may include one or many characteristics (variables) with attached

• Enforce required quality product sampling

target values and specification limits, sample

rates by system generated sampling plans

plan and control rule definitions. “Out

and upcoming sample notification to

MES Software Objects connect with

of the box” quality specification version

operators

real-time information from control systems or plant automation devices, enabling

management ensures data consistency and supports the continuous adoption of product changes and process optimisation.

Recording Object.

• Improve response time to quality deviations by providing SPC control rule

automatic / semi-automatic information exchange and data collection.

violation notification to operators when When a scheduled work order process is

sample data and values are entered

started, the specified sampling plans are automatically generated and dynamically maintained in alignment with the work

Integration with ArchestrA system platform

Near real-time statistical process control (SPC) Sample data can be displayed instantly in SPC charts to production or quality

order execution progress, status and resources involved. Operator quality data

Automatic quality data sampling execution

operators for closed loop quality control.

entry requests and procedure enforcement,

from process equipment and controls is

Wonderware MES software includes rich

or automatic sampling from equipment/ instrumentation are executed by the system according to quality specifications. The software dynamically manages the quality data sampling requirements and increases the flexibility in scheduling and response to unplanned events by securing the proper quality documentation and control according to specifications, without additional intervention, which specifically removes distracting and difficult to manage tasks from operators. Using Wonderware MES Software’s execution management capabilities, customers can:

May/June 2013 | 45

Attribute charts include:

Wonderware Enterprise Integrator software, or through an open interface for data access.

• P

The full electronic data collection and data exchange between systems minimises cost,

• Np

potential data entry errors and the delay time for follow-up processes.

• C SPC trend and chart display capabilities.

• U

These include notifications for violations of control and specification limits. Additional

Extended manufacturing operations management capabilities

• Defects per Million opportunities (DPMO)

notifications can be configured based on a

Wonderware MES Software/Quality provides

characteristics.

Quality reporting for collaborative information access

Near real-time quality monitoring

Wonderware MES Software/Quality

eliminates time delays to non-conformance

includes a set of standard quality reports

notifications while minimising impact on

which are published to Wonderware

The integration of ArchestrA® Workflow

downstream operations. SPC analysis can be

Information Server (part of the ArchestrA

software with Wonderware MES Software

leveraged to “predict” quality issues and,

System Platform infrastructure) for flexible

allows users to implement electronic workflows

in response, trigger preventive actions to

information access via a web browser.

for Corrective and Preventive Action (CAPA),

large set of standard SPC rules indicating specific trends and behaviour of quality

users of Wonderware MES Software/ Operations an easy extension of their existing implementation and configuration with new quality capabilities when upgrading

Non-conformance (NC), material disposition,

avoid quality losses before they cost time and money.

to Wonderware MES Software 2012.

Interoperability for the enterprise

sign-off approvals, escalation of alarms, outof-control conditions, or any other event in a quality context.

• All Standard SPC charts are included: For enterprise integration, the collected • X-bar and Range or Sigma • X-individual and Moving Range • Moving Average and Range or Sigma

quality data is stored together with all of the

The native integration of Wonderware

additional operational work order execution

MES Software with ArchestrA System

data in the Wonderware MES Software

Platform provides the connection to

database. It can be flexibly provided to any

automation systems, data pre-processing

existing enterprise quality management

and the MES real-time execution engine,

system (ERP, custom, or LIMS) via the

as well as integration with additional software applications like IntelaTrac® for mobile operator procedure execution or Wonderware InBatch recipe management and batch execution software. Wonderware MES Software/Quality with Wonderware Intelligence Software enables you to gather, aggregate, contextualise, store, and report operational data from both Quality and other Wonderware and non-Wonderware data sources, using a dashboard to present Key Performance Indicators that are used to visualise, tune and maximise your operations.

46 | www.protocolmag.co.za

Product profile: Wonderware QI Analyst

In a nutshell ... Useful in nearly any vertical industry, Wonderware QI Analyst Statistical Process Control (SPC) software is an important part of any quality management programme. Performing both on-line and historical SPC, QI Analyst supports real-time process monitoring and alarms as well as historical reports to view process “health” over any period of time. Real-time SPC, analysis and reporting are equally easy. By storing process data in the QI Analyst database and linking to external data sources, users can leverage enterprise-wide SPC to reduce variation, reduce costs of manufacturing and increase productivity.

Business Value QI Analyst software can help you “predict” problems, before they cost you time and money! The results — improved product quality, increased productivity and reduced costs — can be dramatic. And they all can lead to higher profits!

Key benefits • Real-time data charting, calculations and alarms • Quick operator reaction to process problems

Improve product quality and accelerate margins

• Predict problems that are about to happen • Report the “health” of manufacturing processes

Manufacturing high-quality products at a competitive price requires a team effort. Wonderware’s QI Analyst software provides a versatile tool

Key capabilities

for collaborative decision making. QI Analyst software connects your entire quality team with near real-time Statistical Process Control (SPC)

• Full complement of SPC charts

information, enabling everyone to proactively reduce excessive process variations —instead of reacting to them after a problem occurs. In fact,

• Real-time and historical SPC

with real-time SPC data, QI Analyst software can help you “predict” problems, before they cost you time and money!

• Link to virtually any existing data source

Manage product quality to increase plant performance

• Database backbone • Enterprise SPC, accommodating many users at once

Wonderware’s QI Analyst software gives manufacturers the ability to monitor process variation in real time — an important indicator of

• 21 CFR Part 11 compliant

product quality. Using powerful SPC analysis techniques, operators and plant decision-makers can make immediate online adjustments to

• Integrated to InTouch HMI, Historian and System Platform

proactively ensure production quality and consistency. The software gives your production team the quality information and notifications it needs to adjust process parameters on the fly — lowering costs and improving product quality. Contrast with traditional off-line SPC systems—they use historical process data and don’t allow real-time corrections of process excursions. In addition, QI Analyst software can leverage historical data from most

May/June 2013 | 47

Operators and plant decision-makers can keep tabs on key process parameters, enabling them to proactively manage product quality and plant performance. The alarm dashboard control can be configured to meet each user’s unique information needs.

You don’t have to be a statistics expert to use QI analyst software Wonderware’s QI Analyst 8.0 software was created with ease of use as a primary goal, resulting in a product that is intuitive and is very easy to configure and use. Based on the Microsoft Windows operating system, QI Analyst software usually offers more than one way to accomplish the same task — minimising training time. Users across the globe rave about the QI data sources within the plant, empowering

making throughout the organisation.

Analyst software’s ease of configuration

manufacturers to transform common process

Customisable alarms can immediately alert

and use. You don’t need to be an expert

data into actionable process information.

key plant personnel regarding important

in statistics to use the product. Set up

The software can quickly analyse data,

quality issues (e.g., by sending dynamic

functional charts in minutes. The new

plot variations and provide information

messages to a pager).

Products/Parts feature empowers you

about the performance of your critical plant processes.

Get your first line of defence into the game

to configure charts for hundreds of your

View SPC charts from anywhere in the plant

products quickly and efficiently. Help is always just a click away, with an online tutorial and glossary to accelerate results.

QI Analyst’s ChartService, a Microsoft Windows service, automatically monitors

A comprehensive selection of SPC charts and powerful statistical tools

Operators are a plant’s first line of

your process data and reports on alarm

defence when if comes to product quality.

status via a new alarm dashboard. This

However, operators demand software

control can be embedded in an HMI,

solutions that do not adversely affect their

like Wonderware’s InTouch HMI or a

QI Analyst software automatically tests real-

activities. QI Analyst 8.0 software can be

customised industrial application to

time process data against statistical rules to

easily configured to provide the real-time

automatically communicate SPC alarm

detect trends, runs, patterns and outliers.

SPC information operators need to visualise

status. It can accommodate a large number

When a rule violation occurs, QI Analyst

and “steer” real-time product quality. SPC

of critical process parameters and send

software immediately charts the point in red.

information can be tailored to each user’s

information to a wide range of plant

In addition, customisable alarms alert you

individualised needs, so there is less to learn

personnel.

whenever key data goes out of specification;

and less resistance when implementing a real-time SPC system. The bottom line is that QI Analyst 8.0 software can give operators the quality information they need in real time, to positively affect product quality and plant profitability.

Make consistent, real-time decisions organisation-wide Wonderware’s QI Analyst software offers a rich selection of communication options, giving each member of your team immediate access to the same information — for consistent decision-

48 | www.protocolmag.co.za

Product profile: Wonderware QI Analyst

Attribute Charts:

the most precise statistical analysis of your unique processes.

• p • np

Put your product quality and process capabilities in context

• c The tighter integration of QI Analyst 8.0 • u

software with Wonderware’s InTouch HMI, Wonderware Historian and the state-of-the-

• Defects Per Million Opportunities (DPMO)

art ArchestrA System Platform enhances your system visualisation capabilities. QI Analyst

Special Charts and Analysis Tools:

software can also relate production and process-quality information to traceability,

• Run

equipment performance and overall manufacturing success. This integration of

• Histogram (view the data distribution)

production information enables improved documentation and improved production

• Scatter plot (view the correlation between so you can start solving quality problems

characteristics)

immediately. For example, if a rule violation occurs, the software can call your pager or send you an email. QI Analyst software is

processes. So, in essence, QI Analyst 8.0 software facilitates improvements in operational excellence and brand integrity,

• Paretos of nonconformities, causes, actions or rule violations

and fosters an integrated approach to production and performance management.

also integrated with Wonderware’s InTouch HMI and the Industrial Application Server’s alarm management features. So, if an SPC

Tailor statistical rule sets to fit your unique application

rule is violated, QI Analyst software can

Achieve enterprise-level scalability with one, consistent SPC solution

serve alarm information to these important

A number of industry-specific rule sets

plant information systems.

are delivered with QI Analyst software,

QI Analyst’s architecture can integrate

including Western Electric, AIAG, Juran,

with your current IT set up, enabling

You’re never more than a glance or an

Hughes, and Gitlow & Duncan. These

enterprise-level scalability. As a result,

alarm away from critical information. A

rule sets automatically detect process

all of your plants can use the same SPC

large library of statistics can be displayed

excursions for a host of different industries.

solution, minimising long-term ownership

for the overall process, or for any

QI Analyst software also facilitates the

costs. The distributed architecture of

individual process parameter — aiding

modification of supplied rule sets — or you

Version 8.0 can place real-time information

in continuous improvement efforts. Limit

can design your own rule sets to achieve

at the fingertips of every person in your

sets allow for the easy comparison of two sets of data, accelerating process analysis efforts. Lastly, save charts and workspaces as HTML files for easy posting within webbased applications. All standard SPC charts are included in QI Analyst software: • Variable Charts • X-bar and Range or Sigma • X-individual and Moving Range • Moving Average and Range or Sigma • Cumulative Summation of Means or Individuals • EWMA of Means or Individuals

May/June 2013 | 49

organisation — without disrupting your

such as the pharmaceutical and food and

current IT infrastructure.

beverage industries. Regulated industries

Quality personnel

have special recordkeeping requirements

The QI Analyst Workstation enables quality

that must be built into a SPC tool to allow

personnel to take measurements, enter data

for validating SPC applications. QI Analyst

automatically through their gages, or enter

8.0 software provides audit trails for changes

data manually to verify that the variables

in parameters, alarms and data. Version 8.0

or attributes entered yield a process that

The QI Analyst Controller assists power users

also supports Windows Integrated Security,

is stable and in control. Custom SPC

to create a broad range of SPC charts, and

making QI Analyst 8.0 software a good fit for

reports using Microsoft Excel spreadsheet

to perform many types of statistical analysis.

your plant’s existing user security model.

software or Word can be created and

Power users and system operators can access SPC information

The Controller also enables setup and

distributed to plant personnel.

maintenance capabilities. The QI Analyst

That’s why Wonderware’s QI Analyst 8.0

Workstation helps less technical users like

software is FDA 21 CFR Part 11 ready. It

system operators get access to real-time

simplifies and lowers the costs of creating

SPC charts and alarms, enabling them to

SPC systems in regulated industries such as

Using QI Analyst Controller, IT managers can

act on process issues before they get out of

pharmaceutical, food and beverage, power-

use QI Analyst software to manage all user

control.

generation and others.

accounts. The manager can set rights, define

Connect to legacy data sources

A variety of plant personnel can benefit from QI analyst software

IT managers

log-on profiles, and maintain the QI Analyst

Virtually any open process database that’s

network through a few intuitive, easy-to-use dialog boxes. The flexible security model is also easy-to-use. Also, because all the administrative data is maintained in one

accessible on your plant or enterprise

QI Analyst 8.0 software is designed to

database, one person should be able to

network can be used as a data source by QI

enhance today’s most powerful enterprise-

easily manage the QI Analyst network,

Analyst software. As a result, the majority

wide manufacturing systems, benefitting a

regardless of how large it gets.

of your plant’s legacy plant sources can be

wide range of functional groups.

Corporate personnel

tapped for valuable SPC monitoring and analysis. Plant performance monitoring

Quality managers

efforts can therefore be increased — driving

Corporate personnel can use QI Analyst

greater awareness of real-time product

Using the QI Analyst Controller, Quality

charts, alarms and tables to analyse real-time

quality and plant performance.

Managers can set up data tables (logical

SPC information when making decisions

groupings of variables and/or attributes to

about valuable plant assets and how

be collected and analysed), charts, statistical

to increase profitably.

Use QI analyst software throughout multinational manufacturing enterprises

rules, and alarms to maintain real-time control of online manufacturing processes.

QI Analyst product highlights

They can also analyse “old” process data QI Analyst software has been localised in

off-line, manipulating limits and probing

many major languages so that applications

the data for useful process improvement

can be used throughout modern multi-

information.

national manufacturing enterprises.

Integrate QI analyst software with your IT system

• Complete range of real-time and historical SPC charts and alarms • Broad connectivity to plant data sources

Plant-floor operators • Integration to ArchestrA Industrial Using the QI Analyst Workstation, plant

Application Server data sources

floor operators can watch the various You can integrate the software with your IT

process charts, enter data — manually

system using centralised setup and security

if not already automatically collected

features, with the extra benefit of flexibility

via direct communication links — and

for system customisation.

receive alarm notification if any of the charts

• Enhanced access to data in the InTouch HMI and Wonderware Historian • Rapid system and chart configuration

they are monitoring violate statistical rules. Wonderware’s QI Analyst software is

User workspaces can be set up for each

designed for organisations with large and

operator so that, upon login, the software

varied data sets, a complex IT structure and

automatically pulls up that operator’s charts,

a need for flexible system management.

re-establishes data links, and begins charting

integration into the InTouch HMI, Internet

and alarming. Alarm dashboards linked

Explorer browser and other applications

FDA 21 CFR part 11 ready

• Versatile ActiveX SPC chart control for

to the new Alarm Status Service can be configured to enable quick verifications of

Product quality is a key manufacturing

SPC alarm status via red-light/ green-light

concern in today’s regulated industries,

displays.

50 | www.protocolmag.co.za

• User-configurable SPC rules

• Powerful background monitoring of process data and alarms

Product profile: Wonderware QI Analyst

• ActiveX alarm status and dashboard control

recommended for Power Users, Quality Engineers and Administrators. The

• Microsoft Windows 7 with Service Pack 1 (x86 & 64 bit);

Controller can run on a specific device • Rapid set up support for large numbers of products and parts • Multi-lingual support

(PC) on a concurrent basis or on a Terminal Services Server. • QI Analyst 8.0 Workstation — Typically used on the plant floor, the Workstation

• FDA 21 CFR Part 11 ready • Powerful system administration functionality

QI Analyst 8.0 consists of:

• Microsoft Windows XP Professional with Service Pack 3; • Microsoft Windows Server 2003 with Service Pack 2.

enables basic SPC activities like data entry, charting, statistical calculations,

Database Requirements (for QI Analyst

rule evaluations and alarming.

Admin and Process Databases): Access 2000

The Workstation can run on a specific

and 2003 (for single node systems) SQL

device (PC), on a concurrent basis or on a

Server 2005 and 2008 (Express, Standard,

Terminal Services Server.

Enterprise, and R2 editions); Oracle 9, 10, and 11G R2.

• QI Analyst 8.0 Controller — A full-

Operating Systems

featured desktop application enables all basic SPC activities (data entry, charting, statistical calculations, rule evaluations

• Microsoft® Windows® 2008 Server with Service Pack 2;

and alarming), as well as complete set up, configuration and administration capabilities. The Controllers are

• Microsoft Windows 2008 R2 with Service Pack 1 (x86 & 64 bit);

May/June 2013 | 51

Quality dictionary Acronyms CFR

Code of Federal Regulation

QbD

Quality by Design

CPP

Critical Process Parameters

etc. when applied to a particular condition

non-conformant items, while the c-chart will

or circumstance. The idea is that with proper

show 10 faults.

processes, checks and testing, a desired outcome can be delivered with fewer

Nonconformities may also be tracked by

problems and unforeseen complications.

type or location which can prove helpful in

Best practices can also be defined as the

tracking down assignable causes.

most efficient (least amount of effort) and SOP

Standard Operating Procedure

CQA

Critical Quality Attributes

effective (best results) way of accomplishing

Examples of processes suitable for

a task, based on repeatable procedures that

monitoring with a c-chart include:

have proven themselves over time for large SPC

Statistical Process Control

FDA

Food and Drug Administration (USA)

numbers of people.

inspection unit in injection moulding or A given best practice is only applicable to

SQC

Statistical Quality Control

OEE

Overall Equipment Effectiveness

TQM

Total Quality Management

PAT

Process Analytical Technology

• Monitoring the number of voids per casting processes

particular condition or circumstance and may have to be modified or adapted for

• Monitoring the number of discrete

similar circumstances. In addition, a “best”

components that must be re-soldered per

practice can evolve to become better as

printed circuit board

improvements are discovered (see SOP). • Monitoring the number of product returns c-chart - In Statistical Quality Control, the

per day

21 CFR Part 11 – This deals with the United

c-chart is a type of control chart used to

States Food and Drug Administration

monitor “count”-type data, typically the

The Poisson distribution is the basis

(FDA) guidelines on electronic records

total number of nonconformities per unit. It

for the chart and requires the following

and electronic signatures. Part 11, as it is

is also occasionally used to monitor the total

assumptions:[2]

commonly called, defines the criteria under

number of events occurring in a given unit

which electronic records and electronic

of time.

signatures are considered to be trustworthy,

• The number of opportunities or potential locations for nonconformities is very large

reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

• The probability of nonconformity at any location is small and constant

Practically speaking, Part 11 requires drug makers, medical device manufacturers,

• The inspection procedure is the same

biotech companies, biologics developers,

for each sample and is carried out

CROs, and other FDA-regulated industries,

consistently from sample to sample

with some specific exceptions, to implement controls, including audits, system validations,

Control Charts – These are also known as

audit trails, electronic signatures, and

Shewhart charts or process-behaviour charts

documentation for software and systems

that are used as statistical process control

involved in processing electronic data that

tools used to determine if a manufacturing

are (a) required to be maintained by the FDA

or business process is in a state of statistical

predicate rules or (b) used to demonstrate

The c-chart differs from the p-chart in that

compliance to a predicate rule. A predicate

it accounts for the possibility of more than

rule is any requirement set forth in the

one nonconformity per inspection unit

Federal Food, Drug and Cosmetic Act,

and that (unlike the p-chart and u-chart),

the Public Health Service Act, or any FDA

it requires a fixed sample size. The p-chart

regulation other than Part 11.

models “pass”/”fail”-type inspection only,

control.

while the c-chart (and u-chart) give the Best Practice – This refers to a technique,

ability to distinguish between (for example)

method, process, activity, incentive or reward

2 items which fail inspection because of

which conventional wisdom regards as more

one fault each and the same two items

effective at delivering a particular outcome

failing inspection with 5 faults each; in

than any other technique, method, process,

the former case, the p-chart will show two

52 | www.protocolmag.co.za

A control chart consists of: • Points representing a statistic (e.g.,

Quality dictionary

a mean, range, proportion) of

taught statistical control methods as part

rather than the somewhat more abstract

measurements of a quality characteristic

of the overall material. This course was

proportion.

in samples taken from the process at

developed and taught by Homer Sarasohn

different times (the data)

and Charles Protzman in 1949-50. Sarasohn

Overall Equipment Effectiveness - OEE is

recommended W. Edwards Deming for

a hierarchy of metrics developed by Seiichi

further training in Statistical Methods.

Nakajima in 1960’s (based on Harrington

• The mean of this statistic using all the

Emerson way of thinking regarding to labour

samples is calculated (e.g., the mean of the means, mean of the ranges, mean of

The Economic and Scientific Section (ESS)

efficiency) which evaluates and indicates

the proportions)

group was also tasked with improving

how effectively a manufacturing operation is

Japanese management skills and Edgar

utilised. The results are stated in a generic

McVoy was instrumental in bringing Lowell

form which allows comparison between

Mellen to Japan to properly install the

manufacturing units in differing industries.

Training Within Industry (TWI) programs in

It is not, however, an absolute measure and

1951.

is best used to identify scope for process

• A centre line is drawn at the value of the mean of the statistic • The standard error (e.g., standard

performance improvement and how to get

deviation/sqrt(n) for the mean) of the statistic is also calculated using all the

Prior to the arrival of Mellen in 1951, the ESS

the improvement. If for example the cycle

samples

group had a training film to introduce the

time is reduced, the OEE can also reduce,

three TWI “J” programmes (Job Instruction,

even though more product is produced

Job Methods and Job Relations) ---the

for less resource. Another example is if

called “natural process limits”) that

film was titled “Improvement in 4 Steps”

one enterprise serves a high volume, low

indicate the threshold at which the

(Kaizen eno Yon Dankai). Thus the original

variety market and another enterprise serves

process output is considered statistically

introduction of “Kaizen” to Japan.

a low volume, high variety market. More

• Upper and lower control limits (sometimes

changeovers (set-ups) will lower the OEE in

‘unlikely’ and are drawn typically at 3 Japanese for “improvement”, or “change

comparison, but if the product is sold at a

for the better”, Kaizen refers to philosophy

premium, there could be more margin with

The chart may have other optional features,

or practices that focus on continuous

a lower OEE.

including:

improvement of processes in manufacturing,

standard errors from the centre line

engineering and business management. • Upper and lower warning limits, drawn

When used in the business sense and

as separate lines, typically two standard

applied to the workplace, Kaizen refers

errors above and below the centre line

to activities that continually improve all functions and involves all employees from

• Division into zones, with the addition

the CEO to the assembly line workers. It also

of rules governing frequencies of

applies to processes, such as purchasing and

observations in each zone

logistics that cross organisational boundaries into the supply chain. By improving

• Annotation with events of interest, as determined by the quality engineer in

standardised activities and processes, Kaizen aims to eliminate waste.

OEE measurement is also commonly used as a key performance indicator (KPI) in

charge of the process’ quality np-chart - In statistical quality control, the

conjunction with lean manufacturing efforts

Critical Process Parameters - Independent

np-chart is a type of control chart used to

to provide an indicator of success.

process parameters most likely to affect

monitor the number of nonconforming units

the quality attributes of a product or

in a sample. It is an adaptation of the p-chart

The three main variables from which OEE is

intermediate

and used in situations where personnel find

calculated are:

it easier to interpret process performance Critical Quality Attribute - Critical to quality

in terms of concrete numbers of units

• Availability: The portion of the OEE

is an attribute of a part, assembly, sub-

metric that represents the percentage

assembly, product, or process that is literally

of scheduled time that the operation is

critical to quality or more precisely, has a

available to operate. Often referred to as

direct and significant impact on its actual or

Uptime. Availability = Available Time /

perceived quality.

Scheduled Time

Kaizen – After WWII, to help restore Japan,

• Performance: The portion of the OEE

American occupation forces brought in

metric that represents the speed at which

American experts to help with the rebuilding

the work centre runs as a percentage of

of Japanese industry while The Civil

its designed speed. Performance = (Parts

Communications Section (CCS) developed

Produced * Ideal Cycle Time) / Available

a Management Training Programme that

Time

May/June 2013 | 53

(CQAs) of the product and then controlling

defects such as cracks or surface blemishes

that represents the good units produced

these CPPs within defined limits. This allows

for example.

as a percentage of the total units started.

manufacturers to produce products with

Commonly referred to as First Pass Yield

consistent quality and also helps to reduce

The quality of the outputs is at risk if any of

(FPY). Quality = Good output / Actual

waste & overall costs.

these three aspects is deficient in any way.

This mechanism for producing consistent

Quality control emphasises testing of

product quality & reducing waste presents

products to uncover defects and reporting

a good case for utilising continuous

to management who make the decision

manufacturing technologies. The control of

to allow or deny product release, whereas

p-chart - In statistical quality control, the

a steady state process when you understand

quality assurance attempts to improve

p-chart is a type of control chart used to

the upstream and downstream effects is an

and stabilise production (and associated

monitor the proportion of nonconforming

easier task as common cause variability is

processes) to avoid, or at least minimise,

units in a sample, where the sample

easier to define and monitor.

issues which led to the defect(s) in the first

• Quality: The portion of the OEE metric

Output OEE= Availability X Performance X Quality X 100

place.[citation needed] For contract work,

proportion nonconforming is defined as the ratio of the number of nonconforming units

Quality Control - Quality control, or QC

particularly work awarded by government

to the sample size, n.

for short, is a process by which entities

agencies, quality control issues are among

review the quality of all factors involved

the top reasons for not renewing a contract.

in production. This approach places an emphasis on three aspects.

Quality by Design - Quality by Design is a concept first outlined by well-known

• Elements such as controls, job

quality expert Joseph M. Juran in various

management, defined and well managed

publications, most notably Juran on Quality

processes, performance and integrity

by Design. Juran believed that quality could

criteria, and identification of records

be planned and that most quality crises and problems relate to the way in which quality

• Competence, such as knowledge, skills,

was planned in the first place.

experience, and qualifications While Quality by Design principles have • Soft elements, such as personnel,

been used to advance product and process

integrity, confidence, organisational

quality in every industry and particularly the

The p-chart only accommodates

culture, motivation, team spirit, and

automotive industry, they have most recently

“pass”/”fail”-type inspection as determined

quality relationships.

been adopted by the U.S. Food and Drug Administration (FDA) as a vehicle for the

by one or more go-no go gauges or tests, effectively applying the specifications to the

Controls include product inspection, where

transformation of how drugs are discovered,

data before they are plotted on the chart.

every product is examined visually, and often

developed and commercially manufactured.

Other types of control charts display the

using a stereo microscope for fine detail

magnitude of the quality characteristic under

before the product is sold into the external

Six Sigma – Six Sigma is a set of tools

study, making troubleshooting possible

market. Inspectors will be provided with lists

and strategies for process improvement

directly from those charts.

and descriptions of unacceptable product

originally developed by Motorola in 1986

Process Analytical Technology - Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyse and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA). PAT is a term used for describing a broader change in pharmaceutical manufacturing from static batch manufacturing to a more

Green indicates standard deviation on either side of the mean. For the normal distribution, this

dynamic approach. It involves defining

accounts for 68.27 percent of the set; while two standard deviations from the mean (grey and

the Critical Process Parameters (CPPs) of

green) account for 95.45 percent; three standard deviations (black, grey and green) account for

the equipment used to make the product,

99.73 percent; and four standard deviations account for 99.994 percent. The two points of the

which affect the Critical Quality Attributes

curve that are one standard deviation from the mean are also the inflection points.

54 | www.protocolmag.co.za

Quality dictionary

should be responsible for doing it. The solution goes beyond this by monitoring this workflow of responsibilities and its progress in much the same way as a SCADA system would for a production process. Statistical Process Control - The application of statistical techniques for measuring and and which resulted in $16–17 billion in

analysing the variation in a process.

savings to Motorola as of 2006. It seeks to improve the quality of process outputs

Total Quality Management - TQM is an

by identifying and removing the causes of

integrative philosophy of management

defects (errors) and minimising variability in

for continuously improving the quality of

manufacturing and business processes.

products and processes.

It uses a set of quality management

TQM is based on the premise that the

methods, including statistical methods, and

quality of products and processes is the

creates a special infrastructure of people

responsibility of everyone involved with the

within the organisation (“Champions”,

creation or consumption of the products or

nonconformities per lot of raw material

“Black Belts”, “Green Belts”, “Orange

services offered by an organisation, requiring

received where the lot size varies

Belts”, etc.) who are experts in these very

the involvement of management, workforce,

complex methods. Each Six Sigma project

suppliers and customers, to meet or exceed

carried out within an organisation follows

customer expectations.

low nonconformity levels.[1] Examples of processes suitable for monitoring with a u-chart include: • Monitoring the number of

• Monitoring the number of new infections in a hospital per day

a defined sequence of steps and has quantified financial targets (cost reduction

Cua, McKone, and Schroeder (2001)

and/or profit increase).

identified nine common TQM practices:

The term Six Sigma originated from

• Cross-functional product design

delivery trucks per day • As with the c-chart, the Poisson distribution is the basis for the chart and

terminology associated with manufacturing, specifically terms associated with statistical

• Monitoring the number of accidents for

• Process management

requires the same assumptions.

modelling of manufacturing processes. The maturity of a manufacturing process can

• Supplier quality management

its yield or the percentage of defect-free

• Customer involvement • Information and feedback

distribution, describing how far the numbers lie from the mean (expected value). In

manufactured are statistically expected to be free of defects (3.4 defects per million),

far a set of numbers is spread out. It is one of several descriptors of a probability

products it creates. A six sigma process is one in which 99.99966% of the products

Variance - In probability theory and statistics, the variance is a measure of how

be described by a sigma rating indicating

• Committed leadership

particular, the variance is one of the moments of a distribution. In that context,

although this defect level corresponds to only a 4.5 sigma level.

• Strategic planning

Standard Deviation – In statistics and

• Cross-functional training

it forms part of a systematic approach to distinguishing between probability

(represented by the symbol sigma, σ) shows

distributions. While other such approaches have been developed, those based on

probability theory, standard deviation • Employee involvement

moments are advantageous in terms of mathematical and computational simplicity.

how much variation or “dispersion” exists from the average (mean, or expected value).

u-chart - In statistical quality control, the

A low standard deviation indicates that the

u-chart is a type of control chart used to

The variance is a parameter describing in

data points tend to be very close to the

monitor “count”-type data where the

part either the actual probability distribution

mean; high standard deviation indicates that

sample size is greater than one, typically the

of an observed population of numbers, or

the data points are spread out over a large

average number of nonconformities per unit.

the theoretical probability distribution of a sample (a not-fully-observed population)

range of values. The u-chart differs from the c-chart in

of numbers. In the latter case a sample of

Standard Operating Procedure - The way

that it accounts for the possibility that the

data from such a distribution can be used

issues and events are handled routinely

number or size of inspection units for which

to construct an estimate of its variance: in

and according to a script. For example,

nonconformities are to be counted may

the simplest cases this estimate can be the

ArchestrA Workflow allows for the definition

vary. Larger samples may be an economic

sample variance.

of SOPs for a variety of situations and

necessity or may be necessary to increase

specifies what should be done and who

the area of opportunity in order to track very

May/June 2013 | 55

Xbar and R chart - In statistical quality

• The sample size is constant

control, the Xbar and R chart is a type of control chart used to monitor a variable’s data when samples are collected at regular

• The parameters μ and σ for the random variable are the same for each unit

• Humans must perform the calculations for the chart

and each unit is independent of its predecessors or successors

intervals from a business or industrial process.

The “chart” actually consists of a pair of

• The inspection procedure is the same

charts: One to monitor the process standard

for each sample and is carried out

deviation (as approximated by the sample

consistently from sample to sample

moving range) and another to monitor the process mean, as is done with the and s

Acknowledgement: Much of the above

and individuals control charts. The Xbar and

material is sourced from Wikipedia

R chart plots the mean value for the quality characteristic across all units in the sample xi, plus the range of the quality characteristic across all units in the sample as follows: R = xmax - xmin The chart is advantageous in the following

The normal distribution is the basis for

situations:

the charts and requires the following assumptions:

• The sample size is relatively small (say, n ≤ 10— and s charts are typically used for larger sample sizes)

• The quality characteristic to be monitored is adequately modelled by a normally distributed random variable

56 | www.protocolmag.co.za

X-CHANGE 2013 report-back

X-CHANGE 2013, Invensys Wonderware’s

history of leadership and innovation with

21st annual User Conference was held at

Foxboro contributing 100 years to this

Sun City from 21st to 24th April. As usual,

total and Wonderware 25 years – not an

the conference was a marked success with

inconsiderable achievement for any software

the attendance of more than 300 industry

company. From the first Windows-based

professionals from South Africa and abroad.

HMI (InTouch) and Unix-based DCSs to today’s cloud-based solutions and

The conference focused on how Invensys

immersive virtual reality operator training

solutions are geared towards helping

and process simulation (which started in

individuals make their companies more

the 1970s), Invensys innovation has always

successful. While there’s no lack of solutions,

placed the company as one of the industry

applications and technologies, it’s humans,

leaders world-wide and in every industry

at the end of the day, who have to make

but one - finance. In 2012 alone, Invensys

things go right – and that can’t be done

introduced no less than 30 new launches to

unless these tools are eminently useful,

the marketplace and we recently introduced

usable, user-friendly and integrated.

a brand new product known as the Universal I/O module (more about this in Grant

Keynote presentations

LeSueur’s presentation below).

Rob McGreevy, VP Platform and Applications, Invensys Operations Management - The future of industrial automation

These solution firsts have led to other

year award for our Workflow technologies,

firsts such as recognition of Invensys in the

Microsoft Partner of the Year award - and the

number one position regarding software

list goes on.

market share this year by ARC Research as well as a litany of other achievements

In 2012, Invensys enjoyed a $2 billion

Retrospective: Amongst its divisions,

including the Readers Choice Award for

turnover and double-digit sales growth,

Invensys has a cumulative 200-year

SCADA for 12 consecutive years, prize of the

especially with the more advanced

May/June 2013 | 57

applications. 135 000 sites and 850 000

improved training methods. Agility and

licences world-wide are supported by more

productivity will remain top of the agenda in

than 9000 employees. 12 percent of revenue

order to optimise the use of value-creating

is reinvested into research and development

assets.

where 315 technology experts allocate 33 percent of this resource on new solutions

Vision for the future: While the Internet

and 55 percent on improving existing

has made access to information easier than

platforms and solution integration. The rest

ever, access to the right information isn’t

is dedicated to operating system updates

so readily available. Google, for example,

and maintenance work.

may well supply several million references to a query and the answer one is looking for

The big picture at Invensys remains

may well be in there but who will have the

end-to-end manufacturing to business

patience and the time to find it? Wolfram

management.

Alpha, on the other hand, through the use of specialised interfaces or “solvers”, will

Business drivers and trends: It’s predicted

supply very specific information directly

that by 2016, over a billion people will

relevant to the question asked.

have smartphones (as opposed to cell phones) and mobility is the name of the

The same principle can be applied to the

game. We have more than 600 mobile

industrial manufacturing environment in

devices registered over 75 global industrial

order to support unscripted queries such

manufacturing sites using mobile application

as “what was our best batch number and

right now – this is apart from existing

who was the shift responsible?” or “what’s

IntelaTrac users. Vital plant information

our most profitable product line?” In other

“to-go” has become a real and present

words, information needs to be supplied in

necessity and those relevant and informative

context of the situation in which queries are

parts of our solutions are being enabled as

made.

downloadable “Apps”. Mobile devices can already do this. For Cloud computing is establishing itself as a

example, knowing your (GPS) location,

viable business enabler through its versatility

smartphones can point out places of

as well as significant operational cost

interest such as hotels and restaurants in the

reduction and complexity. Users need not

immediate vicinity.

concern themselves with hardware upgrades or service and can have access to as much

But more than showing information

computing power as and when needed. And

graphically, we believe that knowledgeable

then there’s “software as a service”. These

advice will form part of the information

two technologies combined provide end-

environment of the future. For example,

users with the solution they need running

a car navigation system, having mapped

on the hardware resources necessary

out your path from A to B, can redirect

to provide the results they want in the

you halfway because of an accident that

necessary time-frame – all with the minimal

just occurred on your route. Furthermore,

of in-house hardware and software and their

such a system can take into account past

administration. And with the exponential

information and, depending on the time

increase in computer capability, virtualisation

you choose to travel, find a route that avoids

means that one machine can accommodate

heavy traffic based on historical information.

many solutions simultaneously. Cloud computing and virtualisation abstract the

Similarly, an HMI screen could have overlays

question from the mechanism that supplies

of maintenance schedules for various items

the answer.

of plant equipment or warn of production

These are not just concepts but part of

stoppages because of potential problems with

on-going current development to add

Other considerations include dealing with

a particular machine and show what to do to

augmented reality to existing and new

increasing volumes of data “Big Data”

rectify the situation based on past, successful

solutions in order to facilitate collaboration

to provide the necessary granularity of

actions. The mobile workforce could, on their

between assets and resources and the

support for decision-making while the

rounds, point a smartphone camera at a piece

people who have to use them.

ageing workforce requires measures to be

of equipment and have its current operating

taken to replace their intellectual property

parameters and maintenance history overlaid

and empower their replacements through

on what they’re looking at.

58 | www.protocolmag.co.za

X-CHANGE 2013 report-back

John Krajewski, Tom Troy, and Grant LeSueur - Invensys Operations Management roadmap

Model-Driven Operations Management

tripping the plant and we would then turn

will allow companies to break away from

the key back to safety mode when finished.

application silos as they build a model that

Well, we’ve just introduced the very first

defines how people and applications come

software-based maintenance bypass solution

together to deliver a world-class process.

for safety systems which has been certified

John Krajewski, Director Product

One of the first things we need to do is

by the TÜV (Technischer Überwachungs-

Management, HMI/Supervisory, Invensys

deliver a composite application framework

Verein – German Technical Monitoring

– enabling operational excellence: We’re

that allows users to configure solutions

Association).

increasingly working towards incorporating

that cross application and organisational

best practices into our products in order to

boundaries. We’ll do this by delivering suites

We are also introducing new levels of

help our customers achieve higher levels

of application models that will provide a

security to counter cyber terrorism which go

of operational excellence. High on the

degree of flexibility that doesn’t exist today.

far beyond standard approaches and that

agenda is increasing the level of operational

Lastly, we don’t want to limit how people

are designed to safeguard the sovereign

awareness. We’re not just going to make it

interact with this type of solution by providing

interest of countries and the operating

possible, we’re going to make it easy.

the device-neutral content mentioned earlier.

systems they need to run their plants. In

Model-driven means having legacy and new

future you will hear terms such as “data

One way of improving situational awareness

applications as well as your people working

diodes” – things that are very difficult to

is by making the information on InTouch

together in a highly collaborative manner.

penetrate.

screens available anywhere and on any

With that in mind, ArchestrA Workflow will

device. We call this initiative Access

be enhanced to support Model-Driven

Regarding the implementation of control

Anywhere and it allows users to run InTouch

Operations Management.

systems, currently hardware has to be in place while the software that will run on it

from any browser. Situational awareness looks at three time frames: what happened,

Grant LeSueur, Director, Product

is being developed and configured. If this

what’s happening now and what will

Management, Invensys Operations

takes 18 months before commissioning,

happen in the future. To this end, we will be

Management – control and safety: At

it means that the plant will start running

providing a full and very extensive library of

Invensys, we are fortunate to have a

with 18-month-old hardware. Virtualisation,

process graphics.

common base for all applications which

through its ability to abstract software from

means that everything is based on the same

hardware, will be playing an increasingly

Later this year, we will be releasing a new

technology. This common base also means

important role in the deployment of control

version of Historian with the ability to store

that our ecology and technology partners

systems because systems can be designed

up to a million points as well as location and

are all on the same page. This is known as

to address functional requirements rather

process history information. We will also

the Enterprise Control System or ECS. It’s a

than hardware characteristics. An entire

announce a new release of System Platform,

system rather than a collection of random

virtual system could be designed in the

which has helped so many companies

applications and technologies.

office and its operation simulated before it is “printed” onto the latest hardware at the

define, maintain and enforce standards.

plant.

Regarding information reporting solutions, I

Engineers spend a lot of time configuring

encourage everyone to take a close look at

analogue input modules, analogue output

Overview. This is an exciting development

modules as well as their digital counterparts.

While products and applications help us

that merges and synchronises information

What if there could be one device whose

run plants, we really need to be better

from any number of disparate sources to

characteristics could be configured through

producers. To do this, we need industry-

provide context and meaning to otherwise

software? This is precisely what we’ve done

specific content and this is a focus area

disconnected data. Other upcoming

with our new universal I/O solution - a

where we are investing resources when

releases are enhancements to Intelligence

single I/O module that can be configured

creating new products.

and Corporate Energy Management. We’re

for virtually any instrument that can be

also looking at ways of unifying the approach

encountered in the field. This means that

to reporting.

control equipment can be delivered to site and wired to the field devices without

Tom Troy, Director, MES Solutions,

knowing the final plant requirements because

Invensys Operations Management –

it can be characterised as necessary later.

operations and execution roadmap: Since we’re in the business of providing solutions

As to safety, safety system should never

to industrial problems, the last thing we

have to do anything because as soon as

want to do is add more problems. That’s

they become active, it means that they are

why we’re working on providing device-

trying to cope with an abnormal situation.

neutral content as well as introducing a

But these systems have to be checked and

concept known as Model-Driven Operations

maintained so in the past, we would have a

Management.

key lock bypass arrangement which would allow for servicing of equipment without

May/June 2013 | 59

John King, Chief Financial Officer, EOH - Collective responsibility for job creation

context, we need to go way beyond the usual business concerns of efficiency, effectiveness, cutting jobs and productivity improvements.

One of the major challenges facing South Africa at the moment is the level of

The exciting thing is that if someone does

unemployment, and what’s tragic is that we

find a job, they have a better than 80 percent

have a lot of educated people that aren’t

chance of remaining employed for the rest

able to get jobs. And that’s where we as

of their lives. So what people need is a

EOH and all of you here today can help. We

break. But that’s a catch 22 situation where

can help bridge the gap between someone

no one wants to hire someone with no skills

being educated and that same person

and they can’t acquire the skills if they’re

being skilled. That gap can be filled with job

unemployed.

experience. So, we have started a number of initiatives, Some statistics regarding unemployment

one of which is to take at least 10 percent

in SA

of our total workforce as learners or interns. We have a system whereby the company

Government job creation funding (2011) • R10 billion for job creation, small enterprise development, and youth

• There are currently more than 7 million

will take in one student for every ten of its

unemployed in SA and half of them

employees. That student gets on-the-job

are less than 24 years old. So there are

training and gets a certificate of competence

millions of people that have never had

if deserved. So far we’ve either retained

a job. And if we include everyone who

most of these students for permanent jobs in

has given up looking for a job, the total

EOH or found them employment elsewhere.

number of unemployed rises to 10 million.

And the government pays for all or a great deal of this.

employment • Three quarters of the people that are • R9,5 billion to increase enrolment at FET colleges and skills development • R8,2 billion to improve school facilities

unemployed are under 35 and that’s

We can and should reclaim most if not all

tragic. They have their whole lives ahead

jobs outsourced to other countries because

of them but with no or limited prospects

the need for those jobs isn’t going away. We

for improvement.

are short of skills rather than short of jobs – and we have the means to fix that.

• R70 billion into the Expanded Public Works Programme

• Each year, the number of jobs created is only a small fraction of the number of people entering the job market.

• R9 billion National Treasury Jobs Fund to create 150 000 jobs over the next 3 years • R5 Billion is being used to introduce a youth employment subsidy to create

• Right now, we have over 600 000 unemployed university graduates. They have all been through tertiary education

It’s indisputable that what we can do with

and have degrees or diplomas but

technology has grown as a result of our

nowhere to go.

ability to interact with it. For example, trying

about 178 000 jobs • Similarly, each year there are about 600 • National Skills Fund (NSF) – Education Department received R41,1 billion

000 matriculants who remain unemployed for lengthy periods.

of which R9,6 billion are skills levies that go to the Sector Education and Training Authorities and the NSF

• With an unemployment rate of 24.9 percent, South Africa is the 28th worst country in the world insofar as unemployment is concerned – that’s out of 199 nations (visit http://www. indexmundi.com/g/r.aspx?v=74 for more statistics). We need to do something about this tremendous untapped human potential. As the private sector, we can create jobs. To do so effectively in the South African

60 | www.protocolmag.co.za

Fred Baumhardt, Head of Specialist Team Unit and CTO, Microsoft SA - Microsoft innovation

X-CHANGE 2013 report-back

to do on-line banking with a DOS green

to Model-driven MES, ArchestrA Workflow,

send this information to the ERP system

screen and a command line interface can be

Overview Client and many more, these

while complying with strict pharmaceutical

challenging to say the least whereas much of

presentations showed the connectivity and

validation processes.

the complexity goes away with a Graphical

flexibility necessary to unify the enterprise. Virtualisation helps improve the process

User Interface (GUI) and a mouse.

User presentations

environment at Exxaro Coal’s Grootegeluk Mine - Exxaro is an early adopter in

The next move is towards the Natural User Interface (NUI) which will make technology

12 end-user and system integrator

the virtualisation of their automation

a lot more natural and logical. For example,

presentations illustrated the successful

environment and it’s already showing

a unique PIN was meant to identify a credit

application of Invensys solutions in a number

benefits with hardware independence,

card holder as its legitimate owner. But this

of industries.

complete separation of process and corporate domains and increased security

can be a flimsy security measure which can now be replaced with any combination of

Getting the complete picture at Tronox

from web-based malware. But this is only the

RFID, face, iris and voice recognition (the last

Namakwa Sands - This project uses

tip of the iceberg of benefits.

three being natural “PINs”).

Wonderware Historian and Software Toolbox to bring together real-time data

Independence from PLC code standards

With the evolution of simpler access to

from disparate systems which, if viewed in

at Impala Platinum Refinery – This

computing environments, data centres have

isolation, could be very costly in terms of

presentation is about the implementation of

also had to evolve to keep up with functional

remedial action not being taken in time.

Wonderware’s System Platform and InTouch at Impala Platinum Refinery. This involved

demands. Today, personal and other systems are next to useless if they can’t go

Data integrity at Egoli Gas - Due to the

designing and implementing control module

somewhere for something. So, whether you

lack of electricity and networks at the

standards, navigation functions and user

know it or not, you already live in the cloud

remote stations, GSM-based telemetry had

functions that were independent of PLC

because you don’t care where something is

to be used. In order to minimise battery

code standards.

stored or where it comes from – nor does it

consumption, while maintaining data interval

matter.

requirements, a store-and-forward protocol

Wonderware Intelligence vs spreadsheets

had to be used. The time-stamped data

at Exxaro - Wonderware Intelligence has

But it does matter to some at the strategic

upload into the Wonderware Historian

been implemented at Exxaro as part of

and security levels and that’s why provision

was made possible through the Systems

their production reporting solution. The

has been made for private and public

Anywhere Data Warehouse, effectively

customer’s mandate was to replace their

clouds. Virtualisation and cloud computing

inserting data through a non standard route

Excel-based calculation and reporting

are critical to the future because of the cost

into the Wonderware Historian.

solution with a flexible, user-configurable, database reporting and analysis solution.

savings and information access benefits that can be realised from these technologies

Thin clients help BASF on multiple

which can combine computing and

fronts - Centralised computing with

Quicker response and diagnosis at

telecommunications in highly beneficial

increased security and scalability provided a

ArcelorMittal with Factory Widgets - The

ways such as guiding people through crisis

system with much higher up-time and easily

use of near-real-time widgets has simplified

situations.

changed hardware if needed. The products

access to vital plant and production

involved are InTouch Runtime and ACP

information leading to quicker response

ThinManager.

time to possible KPI deviations. This is

Apps have proved more desirable than

improving efficiency, making plant personnel

browsers because of their inherent knowledge of their users (no more entry of

Peace of mind at BASF with MDT’s

more aware of current conditions and

passwords and tedious selection criteria) and

AutoSave - A central feature of this installation

leading to quicker problem resolution.

their added security – both of which makes

is the quick and low risk recovery from

them much easier to use. As a result, it’s

unwanted PLC mistakes and ultimately

Legacy Operations Module to MES

predicted that users won’t be using browsers

less downtime in an industry with high cost

Migration at Imana Foods - The correct

for much longer but will opt for dedicated

implications should production lines stand idle.

way! - Imana Foods embarked on a strategy

apps instead.

to upgrade their Legacy Operations Module, Bottoms up approach for better

utilising a methodology developed by

packaging line information at Aspen

Invensys Wonderware. This allowed for a

Pharmacare - The need arose for better

seamless project execution building the core

44 sessions addressed a wide range of

synchronisation between the shop floor and

MES solution with progress and expansion

new products, enhancements to existing

Pharmacare’s Baan ERP system in order to

in mind. It also allowed for integrating new

solutions and approaches to various

provide better visibility of the packaging

MES functionality as well as prolonging the

problems. From System Platform 2014 with

information and reduce manual errors.

life of the MES solution for years to come.

its ability to handle multiple galaxies and

Wonderware’s System Platform and InTouch

InTouch 2014 with its new paradigm in HMI

were used to track and log the cases on each

World-class refinery control and

displays for increased situation awareness

pallet through barcodes and to automatically

safety - Based in Ndola, Zambia, Indeni

Mainstream presentations

May/June 2013 | 61

will showcase their extensive use of the

control and prepare them for any operating

administration and the management of

Foxboro I/A series control system they have

conditions â&#x20AC;&#x201C; evolving into an operator

backups and releases. MDTâ&#x20AC;&#x2122;s AutoSave for

selected to ensure optimal refinery control

training simulator.

System Platform helped Johnson Matthey

and output. Safety towards people and

change and progress without risk.

equipment is enabled with the Triconex

Better control at Johnson Matthey with

Emergency Shutdown System, fully

automatic backups from AutoSave for

integrated with the Foxboro control system.

System Platform - The changes made to

Apart from control and safety, DynSim

PCs and Wonderware System Platform

17 hardware and software solution vendors

enabled Indeni to train operators on plant

on a regular basis required complex

from across Southern Africa and overseas

Collaboration Expo

demonstrated their real solutions to real problems. Every year, leading local and international industry solution providers choose the unique opportunities offered by X-CHANGE to network with existing and potential customers and to showcase their capabilities. From instrumentation to software and from consulting to system integration, these solution suppliers are at the top of their game and combine their skills, knowledge and experience with Invensys solutions to provide world-class implementations to Africa and beyond. But why collaboration? Invensys solutions alone may not be able to fix the problem. They may require the expert implementation of professional system integrators who are keenly knowledgeable of the problems their Collaboration expo partners

62 | www.protocolmag.co.za

end-users are facing. And then there are

X-CHANGE 2013 report-back

the complementary hardware and software solutions required to provide end-users the cost-effective value and customised solutions they’re looking for. This is the world of Invensys Collaboration Partners who chose X-CHANGE 2013 to showcase their professional solutions. After all, they’re mostly responsible for the information sourcing, processing and delivery aspect of many mining and manufacturing companies in South Africa and in the rest of the continent.

Awards Invensys Operations Management Open awards The Best presenter award went to John Weber of Software Toolbox. From left to right: Deon van

• The Best HMI / SCADA Implementation

Aardt, John Weber, Rob McGreevy and Deon Barnard.

award went to Aspen Pharmacare and SI Business Connexion for their packaging line information project and integrating this with the company’s ERP system.

• The Best MES Implementation award went to Imana Foods and SI IT Dynamics for their migration from a legacy operations system to Wonderware MES

• The Best EMI Implementation award went to Exxaro Resources and SI Advansys for their implementation of a

The Innovation award went to Joao Bordalo of ArcelorMittal

flexible database reporting and analysis solution using Wonderware Intelligence.

System integrator awards

• Top SI: Control Systems Integration • Runner-up: Business Connexion • 2nd runner-up: Iritron • 3rd Runner-up: Age Technologies Dawid Sadie (left) and Grant LeSueur (right) present the Best Control and Safety Application

• 4th runner-up: Bytes Systems Integration

award to the Indeni Refinery team of Zambia

May/June 2013 | 63

New Invensys User Group Committee • Lucia Beukman SAB • John Bordalo ArcelorMittal • Jaco van Heerden ARM • Kevin Lawrence Nestlé • Wiseman Magagulo Coca Cola • James Mbewe Rand Water The Best SCADA/HMI Application award went to Aspen Pharmacare and SI Business Connexion.

• Jonathan Meyer Exxaro

Receiving the award is Sharon Brown of Business Connexion (centre) and Iain Gardner from Aspen Pharmacare to her left.

• Gawie Reyneke Lonmin Platinum

Media partner

A warm thank you to South African Instrumentation and Control magazine (Technews Publishing (Pty) Ltd.) for their support throughout the X-CHANGE 2013 campaign.

Thanks An event like X-CHANGE takes more than six months to plan and organise. From The Best MES Application award went to Imana Foods and SI IT Dynamics represented here by

the invitation of international guests and

Mujahid Khadabakash (2nd from left) and Murray Irvine.

call for presentations to venue logistics and awareness campaigns, this is no casual event and Wonderware Southern Africa would like to thank everyone who contributed towards making X-CHANGE 2013 the success it deserved to be on this, the 21st anniversary of the longest running and most successful conference of its type on the continent.

The Best EMI Application award went to Exxaro Resources and SI Advansys

64 | www.protocolmag.co.za

X-CHANGE 2013 report-back

“Thank you for being here on the 21st anniversary of X-CHANGE – you are all responsible for this impressive track record of success. I hope we can all meet again next year.”

The TOP SI award went to Control Systems Integration and was received by MD Dries van Schalkwyk (centre) and team

Mike le Plastrier, MD, Invensys Operations Management Southern Africa.

Conclusion Hardware, software and turnkey solutions are only effective to the degree that they are accepted, implemented and proved to deliver their intended results. And that’s where end-users come in. The pace of technology is predictably accelerating as more tools become available for the development of yet more tools. This is leading to increasingly rapid application development and a golden age of context-

New Invensys User Group Committee

rich rather than annoying information through intelligent devices and software that can sense what we need rather than flood our senses with irrelevance.

May/June 2013 | 65

Invensys Operations Management Southern Africa appoints NIC Instruments and Engineering as distributor a reputation in industry for the exclusive

successful partnership with Invensys”

well-known product brands it represents and the backup service offered with branches in

“We are well pleased with this appointment

Secunda, Vanderbijlpark, Rustenburg and

and confident that NIC with their application

Natal with other areas serviced through a

knowledge, professional support and

Wide range of Foxboro and Eurotherm

distributor network. In 1988, the Electrical

country-wide representation will do our range

measurement and instrumentation

and Instrumentation Construction Division

of professional Foxboro and Eurotherm

solutions get professional nation-wide

was started which offers complete turnkey

products justice,” said Invensys Operations

representation

packages involving supply, installation and

Management Southern Africa MD, Mike le

commissioning.

Plastrier. “Instrumentation is rapidly getting

Invensys Operations Management Southern

more sophisticated, capable and intelligent

Africa, a provider of technology systems,

“For NIC, it is really exciting to be part of

requiring an evolving approach towards

software solutions and consulting services

the well-known Foxboro brand,” says John

addressing end-user needs more effectively.

to the mining, manufacturing, chemical,

Ferreira, Sales/Marketing Director, NIC.

NIC has been doing that for decades.”

petrochemical, power, food and beverage

“Way back in the early 80s, all the directors

and infrastructure operations industries,

of NIC worked for AFH Devers, who were the

The range of Foxboro products that NIC

has announced that it has awarded NIC

distributor for Foxboro, so the association

Instruments and Engineering will handle

Instruments and Engineering (Pty) Ltd. the

goes back a long way. Flow Measurement is

include temperature, pressure and level

distributorship for the Invensys Foxboro

one of our strengths and we will be able to

instruments, magnetic, vortex and Coriolis

measurement and instrumentation range of

offer our own packaged mass and volumetric

flow meters, valve positioners, remote

products as well as the Invensys Eurotherm

flow solutions utilising the combination

terminal units, pneumatic instruments as

range of equipment and instrumentation.

of the Foxboro DP and Multivariable

well as liquid analytical instrumentation. The

The distributorship is for the whole of South

Transmitters. The products from Foxboro

Eurotherm range comprises temperature

Africa with the exception of the Vaal Triangle

and Eurotherm strongly complement our

and process controllers, power controllers,

which is covered by a different arrangement.

existing range and will now ensure that

graphic and chart recorders, sensors, signal

we are able to offer a more complete and

conditioners, valves and actuators and

NIC Instruments and Engineering was

technically-comprehensive package to our

solid-state relays.

founded in August 1986 and has developed

customers. We look forward to a long and

66 | www.protocolmag.co.za

s e c i v r t e r S o p p u S d an

May/June 2013 | 67

Invensys Sentinel Services In a Nutshell ... Invensys offers advanced remote services technology that enhances our ability to deliver higher availability and reliability of plant assets to your company.

Key benefits • Increased uptime • Frees you to focus on looking after production rather than control systems

Key features • 24/7/365 remote monitoring and notification of issues

Who’s supervising the supervisors?

We achieve this by installing special “agent software” on each Wonderware server located at your sites. These agents monitor

You trust your Invensys Wonderware

the system on a 24x7 basis to ensure that

Industrial IT solutions to supervise your

critical resources are performing within best

wealth-creating processes but who’s

practice norms.

• Detect and rectify issues or problems before they become mission-affecting • Provide better management of system resources to improve asset performance

supervising them? Let Invensys Sentinel • Streamline diagnosis process

Services (ISS) be your SCADA’s SCADA

If an unacceptable threshold is reached, an

by remotely and constantly monitoring

alarm is raised and Invensys engineers are

and reporting 24/7 on the KPIs of your

alerted before an issue develops. Remote

Wonderware-based systems so that

connectivity is also designed to ensure

potential problems can be nipped in the

that, if there is a problem, Invensys experts

bud. This will give you the peace of mind

can work with you to make appropriate

you need to focus on improving your

adjustments to correct the issue and return

company’s bottom line rather than looking

your system to normal operation quickly and

after systems.

easily.

Using technology to provide world-class support

The process

Reporting

• Fast and systematic event resolution eliminates trial and error and cuts costs • Clear and regular reports provide insight into possible improvements

Our event management system monitors

A key aspect of Invensys Sentinel Services is

Peak performance in our operating plants is a

anomalies or events that occur in the

feedback to you. As a result, we ensure that

continuous process that is being threatened

Wonderware customer environment and

we provide monthly system health status

on a daily basis. As skills scarcity increases,

focuses on detecting issues and generating

reports which include:

most production technicians are stretched

meaningful notifications. These notifications

to the limit with their daily tasks. Little time is

are reported to the Invensys Command

left to maintain the running software systems

Centre which offers a single point of contact

and very few can find the time to develop and

for customer incidents and requests.

maintain specialist knowledge to diagnose

• Overall health status for the month • Critical, major, medium and minor system issues and errors for that month

faults on these systems. • Changes or corrections made to fix As a result, Invensys offers ISS whose job is

errors that occurred in the Wonderware

to monitor the performance of your Invensys

environment

Wonderware assets — continuously.

68 | www.protocolmag.co.za

Invensys Sentinel Services

• Proposals for Wonderware system modifications to ensure that the system

Optional value-added services

conforms to best practice standards

• Anti-virus reporting

Monitored events

Zaine Domingo, ISS Product Manager — Invensys Operations Management

• Wonderware and Microsoft patch Monitoring includes examining the KPIs

management

of the Wonderware System Platform and Historian, hardware performance, event logs,

T +27 (0)11 607 8191 | 0800 INVENSYS | zaine.domingo@invensys.co.za

• Operating system platform support

Wonderware machines (where applicable) among others. There is also a monthly audit of OS, Windows and Wonderware version control, Wonderware licence status, IP configuration and more.

May/June 2013 | 69

In a nutshell ... Comprehensive Services Customer FIRST is not just technical support, it’s a comprehensive programme to help

Customer FIRST

you manage your systems and protect your investments.

Real Value

Maximise asset performance

customers and the loss of business that

Customer FIRST members enjoy the many

Downtime costs businesses millions of Rand

benefits of a closer collaborative relationship

- Customer FIRST support gives you options

with Invensys.

to maximise productivity by keeping your

• Responsive services • Depth of expertise • Proactive planning • Continuous performance monitoring • Emergency contingency provisioning • Deep discounts on hardware • Software and services

to meet contractual obligations to your

operations running smoothly.

may ensue. • Customer FIRST also gives you access to Invensys technical resources to help you ensure that your system is

Outages, both planned and unplanned,

back to capacity in as short a time as

are costly; businesses increasingly need to

possible. Our world-class global service

employ effective pre-emptive strategies

organisation is available locally, so the

to reduce risks and employ efficient and

help you need is never far away.

effective resourcing strategies to ensure that non-productive time is kept to a minimum.

Asset performance is not just about maximising availability though; you need

These important elements make the Customer FIRST membership an essential part of your

Customer FIRST is not just technical support,

to ensure that your assets are working to

business success.

it’s a comprehensive programme to help

their maximum potential. You also need

you manage your systems and maximise the

to minimise the risk to your business of

performance of your assets.

missed schedules, poor quality or regulatory

Good news for nonagreement customers Historically, customers without a valid Support Level Agreement or SLA who called into the support centre would have received lower priority than those customers with agreements. In future, we will continue to service such cases, however, we will require non-Customer FIRST customers to pay for the ad-hoc support via a support incident fee. The support incident fee structure has been set

violations, with the business consequences

Downtime hurts - Customer FIRST can help

that may follow. Customer FIRST gives you proactive remote

Even the most reliable equipment requires

health monitoring services to spot warning

downtime, perhaps for routine maintenance,

signs before problems occur and advanced

preventative maintenance, upgrades or

consulting services to tune your systems to

replacement. You need to ensure that

maximum performance.

downtime is kept to a minimum and to as a result.

Customer first – our mission: your success

• Customer FIRST provides you with

Customer FIRST membership gives you

ensure that there is minimal production loss

up to allow customers to still receive support

access to great hardware maintenance,

access to award-winning technical support,

even without a valid SLA. This policy is called

software maintenance and comprehensive

hardware and software maintenance

an Entitlement Management Policy which has

lifecycle management services to help

services, lifecycle management and remote

three aims:

you optimise your planned downtime and

Services, training and consulting services

minimise unplanned downtime events.

and much more. The programme provides

• To increase client satisfaction and provide an improved quality of service • To encourage the adoption of the Customer FIRST agreement • To employ a consistent policy for support delivery across regions, client bases and Invensys brands The support incident fee for providing support

you with comprehensive services and flexible Recovery time is critical and any delays

options to choose exactly the right kind of

in acquiring either replacement parts, or

programme to suit your business needs and

the expertise required to quickly resolve

help you to maximise asset performance.

problems, can have a significant financial impact on your business.

Contact information

• Customer FIRST provides you with timely

Support Telephone Number:

to non-agreement customers will apply to

access to critical spare parts with the

0861-WONDER (0861-966337) or

each incident and consists of an up-front fee to

ability to manage spares more easily and

0800-INVENSYS (Toll Free)

cover the first four hours and an hourly charge

ensure the reliability of your systems. E-mail:

thereafter if necessary. Once a purchase Order has been received, the incident will be assigned

What’s more, extended downtime presents

to a qualified support engineer.

other risks to your business such as failing

For more information, contact Technical Account Manager Nilen Bermal at: nilen.bermal@invensys.co.za 70 | www.protocolmag.co.za

support@wonderware.co.za or

support@invensys.co.za

2013 Training Schedule

2013 Training Schedule (Johannesburg)

Did you know that your bottom line is directly proportional to the effectiveness of your workforce?

As the owner of some of the world’s

Bundled courses

most popular, advanced and versatile industrial automation, information and

In addition to the above, we offer the

MES software solutions, you’ll want to

following bundled courses at reduced rates:

get the most from your investment and that includes getting the best training in the business. We routinely train about

to turn our product features into real

The dates shown apply to training at our offices in Bedfordview,

For maintenance and engineering personnel:

600 professionals like you every year not only on how to use our solutions but how

NOTE:

Johannesburg. Regional training is presented on demand. A minimum of six delegates is required to arrange

• InTouch only (includes InTouch

a course.

Fundamentals and InTouch Advanced)

Regional training venues:

business benefits. • InTouch and Historian (includes InTouch

InTouch Part 1 Fundamentals (includes New Graphics) • 1 – 5 July

Fundamentals, InTouch Advanced and

Durban: Khaya Lembali,

Historian)

Morningside.

• System Platform – Application Server (includes InTouch Fundamentals, InTouch

• 29 July – 2 August

Cape Town: Durbanville Conference Centre.

Advanced, Historian, System Platform and Application Server)

InTouch Part 2 Advanced (includes New Graphics)

For system integrators:

• TBA

• System Platform – Application Server

Port Elizabeth: Pickering Park Conference Centre, Newton Park.

(includes InTouch Fundamentals, InTouch

System Platform – Application Server (includes new graphics) • 22 – 26 July

Historian (includes Historian Client)

Advanced, Historian, System Platform and Application Server)

For non-technical personnel (operators, managers, supervisors): • Historian (includes ActiveFactory basics for non-technical staff)

• 19 – 22 August For all your training requirements, contact Emmi du Preez at emmi.dupreez@wonderware.co.za or training@invensys.co.za or call Emmi on 011 607 8286.

May/June 2013 | 71

Use Protocol Magazine to generate business opportunities Protocol magazine continues to be well

you’re a solution supplier) or recognition

The Guideline is in the form of prompts to

received on a bi-monthly basis by 6500

(if you’re an end-user)

which you supply the answers to the best of your ability. This, together with the graphical

industry professionals like you, at every level of the country’s leading mining and manufacturing companies. You can

• It must generate market awareness of your capabilities

information required, will be used to write the article which will be sent back to you for editing, approval, etc.

leverage this highly-qualified readership to be heard.

• It must do all that at a reasonable cost

How do you promote yourself right now?

Protocol magazine meets all these criteria.

The Permission to Publish form must be signed by the end-user of the installation and system integrator / solution vendor

Some of the things you might be doing could include inserting opinion pieces,

If you’re an end-user, your stakeholders are

(if applicable) before work on the article is

adverts, editorials and other material

most interested to know how well you’re

started. This ensures that all the work that

into South Africa’s leading manufacturing

looking after their interests by lowering costs

goes into compiling the story will not be

and mining magazines. A good choice

and improving efficiency. Your colleagues

wasted.

since these are excellent and professional

in the industry are keen to see how you’ve

publications that land on decision-makers’

implemented Wonderware solutions so that

You are free to use the completed success

desks every month.

they can evaluate if these will have the same

story in any marketing sense you wish and

benefits in their environments.

you have hundreds of examples on our web site and in past issues of A2ware and

What Protocol offers is all the advantages of a professional magazine with a large

If you’re a system integrator, end-users

circulation but the cherry on the cake is

want to know what you’ve done so that they

that all the readers of Protocol have one

can consider you as a solution supplier for

thing in common – Wonderware solutions

their next project.

FutureLinx.

Opinion Pieces: Once again, there’s no cost involved and

in the areas of SCADA, MES, EMI, BPM and enterprise integration – in fact, anything to

If you’re a hardware or software vendor,

you don’t have to worry about probably

do with industrial and corporate production

end-users and system integrators want to

not having majored in English. Decide on a

IT. Everything in Protocol is aimed at helping

know about how well your offerings work

central theme and the idea(s) you want to

end users get more from their Wonderware

in the Wonderware environment and how

put across, then jot down all the reinforcing

investment and trigger them to look at new

they can help them do a better and more

arguments you can think of (as well as

possibilities. Nobody wants to reinvent a

cost-effective job.

references if applicable). Also include any supporting graphics you feel will better

costly development or investigation wheel to stopping that happening.

What medium will work best for you?

Let’s think for a minute about your perfect

Success stories:

and what you have to offer will go a long way

illustrate the point. Send your draft article to your account manager

you:

They won’t cost you a cent and you don’t have to write them. Simply send an e-mail

• It must convey your message in a

to your account manager stating that you

professional manner to a large, targeted

have the makings of a good story and why

and qualified audience

you think it is so. You will then be sent a

• It must generate incremental business (if

72 | www.protocolmag.co.za

and, if necessary, we’ll make the necessary edits before returning it to you for approval.

promotion vehicle and what it should do for

Comments to the editor, Q&As, Product and/or service information:

Guideline and a Permission to Publish form

Send your submissions to Denis your

to complete and return.

account manager and they (as well as the

Use Protocol Magazine to generate business opportunities

answers) will be published in the next issue

So what are we really saying?

(if interesting and relevant).

and we have made it as easy as possible for As an end-user or supplier of Invensys

Material formats

In other words, what you have to say matters you to say it!

Wonderware and associated solutions, you form part of the world’s largest ecosystem

You will be talking to people with the same

Text – In Microsoft Word format

of professionals in the fields of industrial

reality as you and who have the same

Graphics – In PowerPoint, Bitmap or JPEG

automation and the delivery of actionable

problems and concerns.

format (the last two in the highest possible

intelligence from the shop floor to the top

resolution you have)

floor.

Advertising:

That makes you pretty special.

For all your advertising requirements –

That makes what you have to say significant

including the drafting of effective adverts

and important.

So, what we’re really saying is, use Protocol magazine to say what you believe needs to be said.

from scratch – contact Heather Simpkins at The Marketing Suite.

Did you know that if you don’t talk to anyone, they’re not likely to talk to you or send orders? May/June 2013 | 73

On the lighter side What happened next?

Ever wondered why aliens don’t contact us?

“They cut it? Do they bail it like hay?” “Not exactly, Lord. Most of them rake up

God was talking with St. Francis of Assisi one

the trimmings and put it in bags.”

day and... “They bag it? Why? Is it a cash crop? Do they “Hey Frank, you know all about gardens

sell it or use it for some other purpose?”

and nature. What in the world is going on down there on planet Earth? What

“No, my Lord. Just the opposite. They pay

happened to the dandelions, violets,

other people for the service of throwing it

thistle and stuff I started eons ago? I had

away. And then it is taken to trash dumps.”

a perfect, no-maintenance garden plan installed. Those plants grow in any type of

“Now let me get this straight. They fertilise

soil, withstand drought and multiply with

it to make it grow. And when it does grow,

abandon. The nectar from the long lasting

they cut it back down and pay to throw the

blossoms attracts butterflies, honey-bees

excess away?”

and flocks of songbirds. I expected to see a vast garden of colours by now. But all I see

“Yes, my Lord. “

are these green rectangles. What’s up with that?”

“These Suburbanites must be relieved in the summer when we cut back on the rain and

“It is the tribes that have settled there, Lord.

turn up the heat. That would surely slow the

The Suburbanites. They started calling your

growth process of the grass and should save

flowers “weeds” and have gone to great

them a lot of work and expense.”

lengths to kill those “weeds” and replace them with something they call grass.”

“My Lord? You aren’t going to believe this, but.... well it’s like this, when the grass

“Grass? But it’s so boring. It’s not colourful...

stops growing quickly due to decreased

It doesn’t attract butterflies, birds and bees,

rain and increased exposure to the sun, the

only grubs and sod worms. It’s way too

Suburbanites drag out hoses and pay more

sensitive to temperature, drought and a

money to water the grass so that they can

host of other climactic changes. Do these

continue to mow it down and pay to get rid

Suburbanites really want all that grass

of it.”

growing there?” “What nonsense! Well..... at least they have “Apparently so, Lord. They go to great

kept some of the trees. That was a sheer

pains to grow it, have created appointed

stroke of genius on my part if I do say so

committees called homeowners associations

myself. The trees grow leaves in the spring

to enforce its widespread use, they engage

to provide beauty and then offer shade

in incredible amounts of labour to keep

during the summer. In the autumn, as you

it green. For example, they begin each

know, those leaves fall to the ground and

spring by fertilising the grass and soil and

form a natural blanket to keep moisture in

poisoning any other plant that crops up in

the soil and protect the trees and bushes.

the lawn.

Plus, as they rot, the leaves form the compost that enhances the soil. It’s a natural

“Well, at least the spring rains and warm

cycle of life.”

weather probably make grass grow really fast. That must be making the Suburbanites

“Er.....you’d better sit down, Lord. These

really happy.”

Suburbanites have drawn a new circle of life. You see, as soon as the leaves fall, they rake

74 | www.protocolmag.co.za

“Apparently not, Lord.... As soon as it grows

them up into great piles and pay to have

a little, they cut it ---sometimes twice a week.”

them hauled away or burn them.”

On the lighter side

“No!? What do they do to protect the shrub and tree roots during the winter to keep the

• I’m reading a book about anti-gravity. I

What happened next?

just can’t put it down.

soil moist and loose?” • I did a theatrical performance about puns. “Well, my Lord. After throwing away the

It was a play on words.

leaves, they go out and buy something which they call mulch. They haul it home at great expense and effort and then spread it

• They told me I had type-A blood, but it was a Type-O.

around in place of the leaves.” • Why were the Indians here first? They had “And where do they get this mulch?” “Oh boy (sweating)....My Lord, they cut down trees and grind the trees up into small

reservations. • We are going on a class trip to the CocaCola factory. I hope there’s no pop quiz.

pieces with which to make the mulch.” • I didn’t like my beard at first. Then it grew “You’re kidding? .....You’re not kidding.

on me.

Enough. I don’t want to think about this anymore for the time being. Hmmm, St.

• Did you hear about the cross-eyed

Catherine, you’re in charge of the arts. What

teacher who lost her job because she

movie have you scheduled for us tonight?”

couldn’t control her pupils?

“It’s a comedy, Lord, a movie called “Dumb and Dumber”. It’s a stupid movie about......” “Never mind, I think I just heard the whole

• When you get a bladder infection urine trouble. • Broken pencils are pointless.

story from St. Francis.” • I tried to catch some fog, but I mist. A

Punography • I changed my iPod’s name to Titanic. It’s syncing now. • When chemists die, they barium.

thesaurus. • England has no kidney bank, but it does have a Liverpool. • I used to be a banker, but then I lost interest.

• Jokes about German sausage are the wurst.

• I dropped out of communism class because of lousy Marx.

• I know a guy who’s addicted to brake fluid. He says he can stop any time.

• All the toilets in New York’s police stations have been stolen, The police have

• How does Moses make his tea? Hebrews

nothing to go on.

it. • I got a job at a bakery because I kneaded • I stayed up all night to see where the sun

dough.

went. Then it dawned on me. • Haunted French pancakes give me the • This girl said she recognised me from

crepes.

the vegetarian club, but I’d never met herbivore.

May/June 2013 | 75

Protocol Crossword #60 When you’ve completed the crossword, the letters in the coloured boxes give the missing word in the following: Quality is best applied when it becomes part of the ___________ of individuals and companies. Note: This magazine contains the answers to a number of the clues. E-mail your answer to: editor@wonderware.co.za. The sender of the first correct answer received will get a hamper of Invensys Wonderware goodies.

Clues across: 1. A concept that promotes the idea that excellence is built in rather than added on (7,2,6) 13. Goes by horse (5) 14. Of the sea (7) 16. Encourage (4) 18. Sodium symbol (2) 20. World Meteorological Organisation (3) 21. Having to do with the collation and analysis of data (11) 26. Not women (3) 28. Exists (2) 29. Logistic Regression (statistical analysis) (2) 30. Appliance for cooking (5) 31. Nipple on an animal’s udder (4) 32. One of the OEE parameters (11) 34. Senior (abbr.) (2) 35. Overall Equipment Effectiveness (3) 37. Gold symbol (2) 38. Announcement that someone has died (abbr.) (4) 39. Palo _____ , Stanford University town in California (4) 40. Democratic German Republic (3) 41. Trigonometry (abbr.) (4) 43. Comparative word (2) 44. Elevated railway (2) 45. The act of keeping things working (11) 49. Roman Catholic (2) 50. Throat wrap (1,3) 51. Prize guy (5) 53. Enterprise Telecommunications Network (3) 55. Numerical Control (2) 56. Set of tools and strategies for process improvement originally developed by Motorola in 1986 (3,5) 59. Three points of the compass (3) 60. Prefix meaning “of the air” (4) 63. Low Tension (2) 64. In close proximity (4) 65. 30 cm audio discs were made of it (5) 67. A measure of how far a set of numbers is spread out (8) 69. Preposition (4) 70. Say categorically (5)

76 | www.protocolmag.co.za

71. __ Eliot, arguably the most important English-

52. Regretfully, an arch formed by two S-shaped curves

language poet of the 20th century (2)

meeting at a point (4)

72. For example (2)

54. A sharp, sudden physical pain (6)

73. Practical joke (3)

57. Imperial measurements (6)

76. The middle ages are often referred to as the “days

58. Mother (2)

of ____” (4)

61. Recreational vehicles (3)

77. It shows how much variation or “dispersion” exists

62. Breakfast food (3)

from the average (mean, or expected value) (9)

66. Cartoon bear (4)

78. Arithmetic problems (4)

68. Egyptian sun god (2) 71. Total Quality Management (3)

Clues down: 1. Hunchback of Notre Dame (9)

74. Car body (2) 75. Grand Turismo (2)

2. The extent or measurement of a surface (4) 3. Small (6) 4. The ego (2) 5. Beverages (4) 6. Ice (Afrikaans) (2) 7. Act (2) 8. European Community (2) 9. To join together pieces of cloth, for example (3) 10. Declaration of being (1,2) 11. Small person often lurking in gardens (5) 12. Nickel symbol (2) 15. They’re also known as Shewhart charts (7,6) 17. Base Transmitter Station (cellular networks) (3) 18. Inert gas (8) 19. It can have fine teeth (1,4) 22. Anyone stating that ArchestrA, for example, isn’t a good idea would be this (10) 23. Technical Staff Officer (3) 24. One of the OEE parameters (12) 25. The opposite of “borrowed” (4) 27. Christian festival (6) 31. Provoke playfully (5) 32. Not transient (9) 33. Enclosed, very hot chamber (7) 36. For example (2) 42. The thing (2) 43. Automated Carrier Landing System (4) 46. Blood type (2)

Answer to Protocol crossword #59: Question: What must you be alert to for situation awareness

47. Numbers (abbr.) (3) 48. Following age (4,4)

Answer: ENVIRONMENT

Measurement Under Control

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View our full range of measurement tools and instrumentation at: www.invensys.co.za or call 0800 INVENSYS for more information

May/June 2013 | 3

Monday

Tuesday

Thursday

Friday

Wednesday

Saturday

When market tastes change. You’ll be ready. Flexibly manage change, while maintaining product quality, consistency and safety with Wonderware and WonderwareMES MESsoftware. software.For Formore moreinformation, information,visit visitwonderware.com/FlexibleMES wonderware.com/FlexibleMES and get a free whitepaper called “Be ready for changing tastes, a new approach to plant software”.

0800 INVENSYS | contact@invensys.co.za | iom.invensys.co.za

© Copyright 2012. All rights reserved. Invensys, the Invensys logo, Avantis, Eurotherm, Foxboro, IMServ, InFusion, Skelta, SimSci-Esscor, Triconex and Wonderware are trademarks of Invensys plc, its subsidiaries or affiliates. All other brands and product names may be trademarks of their respective owners.

4 | www.protocolmag.co.za