Prugovecki sarta by kvaliteta.net

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo SINIŠA PRUGOVEČKI, LIDIJA SARTA Metroteka d.o.o., Zagreb sp@metroteka.com JOSEPH A. DEFEO Juran Global, Southington, CT, USA info@juran.com

JURAN’S QUALITY BY DESIGN METHODOLOGY IN LORIS2 METROLOGY WEB APPLICATION DEVELOPMENT Referat sa znanstvenog skupa / Conference paper Summary Metroteka Loris2 is a web application development project based on redefining measuring and monitoring equipment (MAME) management which would benefit both MAME users and independent MAME metrological confirmation service providers (calibration, qualification, adjustment, repair etc.). The core methodology employed for the Metroteka Loris2 project was Juran on Quality by Design (QbD), particularly for selecting product features on the basis of meeting the needs of users. This paper will provide an overview of how Quality by Design methodology can be used to assist in creating innovative software solutions for quality management. Key words: Juran, Quality by Design, metrology, web application 1. INTRODUCTION Juran`s Quality by Design Model is a universal methodology used for development planning of new products or services. This methodology incorporates two basic steps: 1. Designing product or service by providing features that meet customers’ needs. 2. Providing that capability of operational processes for product or service development is met. At this point it is important to stress that customers of product or service are not just paying customers or end users, but all those affected by that product or service, including employees within the organization that makes the product or service in question (internal customers). The goal of Quality by Design methodology implementation is to have the right features of service or product in order to satisfy all customers' needs and expectations and also to design the processes to produce those features in an effective and efficient kind of way. Quality planning steps of Quality by Design are: 1. Project and goals determination. (The project has to be established as a starting point of the design.) 2. Identifying customers, both internal and external. 3. What are the customers' needs? Determine, categorize and prioritize them.

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 190 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo 4. Designing product or service features to meet those needs. Features have to be listed and prioritized because it is impossible for all features to be accomplished. Some features will not survive to get to operational level. 5. Develop the process for providing those features. We need to have the capable process that can create required features. 6. Establish control of the process in order to validate transfer to operations and evaluate performance. Figure 1. Quality by Design steps

All those steps have their sub steps which are covered by methods and tools (e.g. affinity diagrams, benchmarking, flow diagrams, criticality analysis etc.) used to fulfill them through structured and systematic approach. Having this on mind, quality should be rather planned than tested. This means that if there are discrepancies in product quality and features and operational processes, it was planned that way. In other words QbD`s main goal is to avoid those discrepancies and failures later on. Taking all this into account and using QbD methodology as an approach, Metroteka started to develop a customer friendly and feature desirable product. This paper is based particularly on product features selection designed to satisfy customer needs (quality planning steps 2-4). 2. LORIS2 METROLOGY WEB APPLICATION DEVELOPMENT Loris2 is an online software in development for measuring and monitoring equipment (MAME) management, intended to benefit both MAME users and independent MAME service providers (calibration labs, qualification providers, repair services etc.). As was already mentioned, Loris2 web application is being developed using QbD methodology for quality to be planned and for product problems to be avoided. Steps that were taken for developing Loris2 are as follows. 2.1. Project and project`s goal determination Currently, MAME management is “stuck in the 20th century” and is a hustle for both users and service providers. MAME users face the following issues: 1. “Paperwork management” for quality audits is a hustle because of the need to keep extensive paper documentation on equipment that is difficult to access. 15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 191 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo 2. IT solutions supporting MAME management are “poor for purpose”, as are either: a. Specific to the each equipment manufacturer – can only cover part of the equipment and typically are focused only on instrument usage and not on external services. b. Part of a larger system (e.g. SAP) and too complicated to use (not customized for MAME management), too expensive to buy and maintain. c. Provided by the equipment end user and in that case - usually low quality, designed ad hoc. 3. Calibration and other external equipment service information is typically not used in daily work, but is sitting on the shelf between audits. This is a big missed opportunity to improve quality. A key obstacle to using the information is that it is currently provided in a very inconvenient format (paper certificate or pdf, with each calibration provider format different). It is clear that MAME end users would benefit from standards (ISO 9001, GMP/GLP/GDP…) compliant digital storage of certificates and reports (plus internal usage history) if it was designed in a much more user friendly way than paper records or current database solutions. Such a design should also facilitate scheduling of activities related to MAME maintenance, enhance prevention of out-of-tolerance events and improve safety in an organization through simple data visualizations. Also it should enable actual use of calibration results to improve measurement quality in day to day operations through simple interface. For calibration laboratories and other MAME service providers external to the equipment end user, Loris2 should present superior customer service platform and a better way to communicate with customers. 2.2. Identifying customers Second step in QbD is to identify all external and internal customers. In order to identify all external customers, Metroteka's experience in providing metrology and measurement service had to be employed. Table 1. External and Internal Customers External Customers Internal Customers Metroteka (sales) MAME end users: Laboratories Quality department Maintenance department IT Software developers MAME service providers: Providers (e.g. external calibration labs) Provider's sales Software customer support Other: Auditors (e.g. accreditation bodies, FDA, etc.)

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 192 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo All users that will use Loris2, directly or indirectly, are listed in Table 1. We can now understand that all further steps in Loris2 development should be determined according to this list and that this very important step will provide that design is going in the right direction. 2.3. Identifying customers needs Having all internal and external customers in mind, we proceeded to identify the needs and requirements for each of them, and after that they were categorized and prioritized. It is essential to stress that customer`s needs and requirements should be considered from their point of view. In order to do that it is very important to try and think like them. In this paper only the external customers needs will be analyzed in more detail, but these external customers will be divided in three groups according to Table 1 - MAME end users, MAME service providers, and auditors. (Service providers are not internal customers because we are talking about the development of software which they will use as external customers, very similar to the end users. Only from their point of view in providing their services they are internal customers, but that is not the case in designing software for their use.) Regarding real internal customers, in Table 1 they are listed as Metroteka (sales), software developers and software customer support. In further analysis only Metroteka (sales) will be mentioned to leave more emphasis on external customers' needs. Some future paper might deal with internal customers in detail, especially after some experience with the product (which is now in development phase) on the market. For categorization and prioritization of the customers' needs we used three levels of need importance based on interviews with potential product customers. In the scoring column "xxx" was counted as 5 points, "xx" was counted as 3 points and "x" as 1 point. It is important not to take the total scores literally, but they were very useful in separating more important and less important customers' needs.

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 193 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo Table 2. Identification of Customers Needs NEED

EU - LAB

EU QUALITY

EU MAINTEN.

EU - IT

PR - LAB

PR SALES

AUDITORS

METROTEKA

score

GENERAL

Reducing paperwork and saving time Easy administration of hierarchy

xx xx

xxx xxx

xx x

xxx

xx -

xx x

xx xxx

20 20

Single history record for each instrument

xxx

Compliance with ISO/GMP/etc. standards

xxx

User friendly and simple interface

xxx

All records easy and quick to find

xxx

Digital substitute for approval of records

xxx

All MAME records in one place

xxx

Paper records

ACTIVITIES* MANAGEMENT

Storage of external activity* reports

xxx

Scheduling external activities*

xxx

Maintaining external activity* intervals

xxx

Storage of internal activity* reports

Scheduling internal activities*

Maintaining internal activity* intervals

Reminding end users on due activities

xxx

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 194 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo NEED/IMPROVEMENT

EU - LAB

EU QUALITY

EU MAINTEN.

EU - IT

PR - LAB

PR SALES

AUDITORS

METROTEKA

score

COMMUNICATION

Better communication end user - provider

Better communication with other departments

Sending/recieving external activities* orders

Sending/receiving external activities* offers

QUALITY AND SAFETY IMPROVEMENTS

Speed up report delivery provider - end user

xxx

Avoid (mis)use of non-conformity equipment Reduce out-of-cal/out-of-order events => trends

xxx

Keep important notes on all equipment

xxx

Improve measurement accuracy

xxx

IT IMPROVEMENTS Easy installation on all computers/tablets/phones

xxx

Good (and fast) customer support

xxx

No hassle software updates

xxx

INTERNAL CUSTOMER - METROTEKA

Easy software delivery

xxx

Diversification of business

xxx

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 195 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo EU-LAB = end user laboratories; EU-QUALITY = end user quality department; EU-MAINTEN. = end user maintenance department; EU IT = end user IT department; PR-LAB = activity service providers; PR-SALES = activity service providers' sales; AUDITORS = accreditation bodies, other agencies like FDA etc.; METROTEKA = software provider * activities correspond to all periodical activities like: calibration, qualification, temperature mapping, regular maintenance etc.

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 196 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo 2.4. Designing features for Loris2 web application After categorization and prioritization of customers' needs we designed the features. All needs were covered by suitable high level features. At this point it was important to consult Metroteka's calibration service customers in their scope of expertise in correspondence with each feature. In this paper we will not go into details about each feature, but the most important features that were included in the development plan are: GENERAL PRODUCT FEATURES Equipment list (EL) - informative sortable equipment list with basic information Search engine (SE) - simple, but powerful one-line search with additional criteria Custom equipment tagging (CET) - customizable equipment tagging to match different and individual quality management systems for each organization History view (HV) - chronological overview of all activities for given equipment Digital signatures (DS) - ability to sign and approve documents without using paper Settings (S) - simple settings page with emphasis on administration of end user hierarchy ACTIVITY MANAGEMENT FEATURES Activity scheduling (AS) - scheduling of periodical external and internal equipment activities Activity reminders and alarms (ARAA) - reminders and alarms for activities Activity personalisation (AP) - dedication of each activity to different owner within end user QUALITY IMPROVEMENT FEATURES Error correction calculator (ECC) - simple tool for using calibration data to improve accuracy Trending graphs (TG) - graphical representation of long term equipment drift Out-of-cal/out-of-order alarms (OOA) - realtime alarm from service provider to end user Close to out-of-cal alarms (CTOA) - customizable realtime alarm for "near misses" Non-conformity tags (NCT) - digital tagging of non-conformity equipment PDF HANDLING FEATURES Document download (DD) - download of internal and external activity reports Document upload (DU) - upload of internal and external activity reports COMMUNICATION FEATURES Notes (N) - permanent note taking and reading on equipment (digital logbook) Communication box (CB) - box for communication between end user and provider IT FEATURES Web application independent of platform (WAIOP) - basic feature of the product Outsourced visual design (OVD) - development feature to assure that features are easy-to-use Dedicated 24/7 customer support (DCS) - post-development feature to assure customer satisfaction Automatic error reports (AER) - post-development feature to enable quick bug detection Automatic updates (AU) - post-development feature to enable quick bug resolution, continuous improvement of features, and new features We put all those features in the table to match what needs they cover which is shown in Table 3.

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 197 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo Table 3. Customer needs and product features NEED

EU LAB

EU QUALITY

EU MAINT.

EU - IT

PR LAB**

PR SALES

AUDITORS

METROTEKA

score

FEATURES

GENERAL IMPROVEMENTS

SE, CET, HV, AS, AP, OOA, CTOA

xxx

HV, N AS, TG, OOA, CTOA, NCT

CET, HV, N, OVD

EL, SE, CET, N

xxx

DD, DU

Reducing paperwork and saving time

xxx

Easy administration of hierarchy

xxx

Single history record for each instrument

xxx

Compliance with ISO/GMP/etc. standards

xxx

User friendly and simple interface

xxx

All records easy and quick to find

xxx

Digital substitute for approval of records

xxx

All MAME records in one place

xxx

Paper records

ACTIVITY* MANAGEMENT IMPROVEMENTS

Storage of external activity* reports

xxx

HV, DD, DU, N

Scheduling external activities*

xxx

AS, AP

Maintaining external activity* intervals

xxx

AS, ARAA, AP

Storage of internal activity* reports

HV, DD, DU, N

Scheduling internal activities*

AS, AP

Maintaining internal activity* intervals

AS, ARAA, AP

Reminding end users on due activities

xxx

AS, ARAA

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 198 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo NEED

EU LAB

EU QUALITY

EU MAINT.

EU - IT

PR LAB**

PR SALES

AUDITORS

METROTEKA

score

FEATURES

COMMUNICATION IMPROVEMENTS

Better communication end user - provider

Better communication with other departments

AS, ARAA, OOA, N CET, HV, AS, AP, TG, NCT, N

Sending/recieving external activities* orders

AS, AP, CB

Sending/receiving external activities* offers

AS, ARAA, AP, CB

QUALITY AND SAFETY IMPROVEMENTS

Speed up report delivery provider - end user

xxx

Avoid (mis)use of non-conformity equipment Reduce out-of-cal/out-of-order events => trends

xxx

OOA, CTOA ECC, OOA, CTOA, NCT, N AS, ARAA, AP, TG, CTOA

Keep important notes on all equipment

xxx

NCT, N

Improve measurement accuracy

xxx

ECC, CTOA

IT IMPROVEMENTS Easy installation on all computers/tablets/phones

xxx

WAIOP

Good (and fast) customer support

xxx

DCS, AER

No hassle software updates

xxx

AER, AU

INTERNAL CUSTOMER - METROTEKA

Easy software delivery

xxx

WAIOP

Diversification of business

xxx

everything

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 199 -

Siniša Prugovečki, Lidija Sarta, Joseph A. Defeo The most important use of Table 3. was in designing the exact look of the features having all the customers and customers' needs in mind. For example, CET feature (custom equipment tagging) was designed having in mind that: - reducing paperwork and saving time is crucial to quality departments, and important to laboratories, maintenance departments, activity service providers, their sales and auditors - user friendly and simple interface is crucial to laboratories and quality departments, important to maintenance departments and activity service providers and nice for providers' sales - better communication between end user departments is important to laboratories and quality departments and nice for maintenance departments, IT departments and service provider's sales Also, QbD made it easier for us to make decisions to drop the features such as CB feature (communication box) from the launch version of the product. It turned out that the CB feature which covers only needs connected with commercial communication between service providers and end users is not important to anyone except for service providers' sales. Such features can be implemented in the later design phases after the initial product launch. And most important of all, features that tackle needs that are the most important were set as the basis of all other features. For example, the need for easy installation on all computers, tablets and smartphones was covered by the feature that the product is web application independent of operating platform (e.g. Windows, Android, iOS...). In this case the need for easy installation was actually solved with no installation whatsoever. 3. CONCLUSION Following systematic and standardized approach, provided by Juran`s Quality by Design methodology, we managed to design and prioritize features according to customers' needs/demands and incorporate those in the development of Loris2 web application. Systematic approach made the design much easier to accomplish benefiting both customers and Metroteka. We avoided many future development problems and assured that the product will have all the most desirable features at launch time. Also, the framework was set for continuous future improvement of both product and its features because - "it was planned that way". LITERATURE [1] Juran, De Feo, Juran`s Quality Handbook, 6th Edition, McGraw Hill, 2010.

15. HRVATSKA KONFERENCIJA O KVALITETI 6. znanstveni skup Hrvatskog društva za kvalitetu 07. - 09. svibnja 2015. Primošten, Hrvatska

- 200 -