DRIVE
For Medical Device Manufacturing The EmsPT DRIVE programme provides our Medical Device customers with an extensive range of services and products enabling them to reach their business goals and achieve Manufacturing Operational Excellence. The programme starts with our initial visits and involves us staying engaged until the customer sees beneficial value and is making sustainable gains in manufacturing operations and performance.
ENAB LE
DRIVE is a field proven methodology that maximises on the value of investments. The DRIVE programme was developed from experience of the design and implementation of information driven improvement programmes within the Medical Device sector. In working with these customers we have collectively identified the four key business challenges that Medical Device manufacturers commonly face: • • • •
New Device Development and Line Extension Compliance Cost of Goods Customer Supply
There are many traditional methodologies to drive Manufacturing Operations and Performance including: • Lean Manufacturing • 6 Sigma • Kaizen When many of these process improvement techniques were first developed in the 1960s shop floor technology was not as sophisticated and comprehensive as it is now. Employee engagement correctly relied on very manual based manufacturing systems. During the course of process improvement programmes there is an initial accumulation of gains. These gains then become increasingly hard to acquire, resulting in a tapering off of improvement and possibly the reduction of levels of advancement. This is owing to unsustainable gains and the increasing level of difficulty in driving
Graph 1: Improvement Curves
the improvement program forward, illustrated above. To support this continued attainment, EmsPT’s MES solutions provide insight into six key pillars of Manufacturing Operational Excellence: • • • • • •
Performance Operations Compliance Agility Innovation Intelligence
EmsPT understands that Medical Device manufacturers have their own very specific challenges and requirements and our MES solutions and services are aligned to provide measurable business and operational benefit.
Introducing DRIVE Discover | ROI |Implement Value |Enable
Discovering Customer Goals (Examples from EmsPT Discovery Workshops) • “Releasing additional production capacity through a better understanding of our processes” • “Have the controlled flexibility to bring new products to market quicker” • “A solution bottlenecks”
offering
accurate
understanding
of
• “Spend less time on paper work & validation and more time in the production area”
EN ABLE
• “A system that assists with the evolution of the productivity and improvement culture within the business” • “Allowing more effective capital budget planning and approval”
A five step process to sustainable information driven improvement.
D
• “To deploy a unified solution across all lines and facilities to ensure like for like comparison and Benchmarking for improvements in line with KPI’s” • “Improve Quality, ensure consistency and reduce CAPAs”
iscover
The first stage is to Discover. In our initial visits to our Medical Device customers it is essential that we engage with them to discover the needs and issues of the business. This creates an environment for stimulation and discussion with engagement at different levels of the company, enabling the needs of the whole organisation to be discovered and considered. When the needs and goals are clear it is important to any company to be able to clearly evaluate the ROI of any projects proposed. During the discovery phase workshops are used to establish customer goals.
• “To understand how process variables effect production quality and have the ability to characterise our products” • “Improvement of product yield” • “Reduced energy consumption” • “Using existing factory automation infrastructure and validation effort to reduce time and cost of implementation” • “Reduce product failures in the field” • “To be able to identify 3% production efficiency gains”
3. The point at which manufacturing efficiency programmes become unsustainable
4. Automated manufacturing operational excellence solutions provide sustainable improvement
Graph 2: Goal and Improvements for Sustainability
The EmsPT DRIVE programme is delivered through a series of workshops
Example Manufacturing Performance Workshop Plant Visibility for Continuous Improvement Our customers tell us that they all have a continual need to do more with less, to increase productivity, reduce waste, improve quality and to increase shareholder value. By providing plant visibility our customers are able to make informed decisions on where to carry out targeted Continuous Improvement events. Objective The workshop is run as an interactive session enabling questions and answers to be facilitated between the facilitator and the delegates. This will allow us to explore and understand where plant visibility would be beneficial to production areas within your organisation. Who Needs to Attend? Our customers have received the most benefit from the process when the following representatives of their business have attended: • • • • •
Continuous Improvement Manager Production Manager Quality Manager Finance Manager Operations Manager
Agenda: Introductions • Your Personnel and their objectives for the Workshop Plant Tour • To gain a better understanding of your facility and its operations Your Business Goals & Vision Statement • What are your Business Goals? • Where are you now? • What do you want to achieve? • What initiatives have you already instigated?
Identifying how critical value adding processes can be affected resulting in lost efficiency and capacity • • • • • • • •
Downtime and OEE Change overs Effective use of labour Waste, quality and yield Effect of product variance The rising cost of energy The cost of data collection Product traceability
Use of data to drive Continuous Improvement How our customers are using data to drive continuous improvement programs. The following methodologies each use data to define, monitor and make improvements; • • •
6 Sigma Kaizen Lean Manufacturing
How much time are you spending collecting data rather than making improvements? The automated collection of data provides you with plant visibility. Next Actions EmsPT will provide a summary report which will outline the potential production areas that can be positively affected by using plant visibility. A follow up meeting is often found beneficial to enable EmsPT to work with our customers to present our findings and formulate the necessary steps to generate a ROI to support the investment in a data driven continuous improvement solution. Expectations To ensure the workshop provides the delegates with relevant information. Delegates are asked to provide the facilitator with three top level challenges from the workshop agenda that are deemed relevant to their organisational environment.
R
OI
In the next stage we work with our customers to provide Return On Investment (ROI) statements based on their needs, our experience and other customer successes. The ROI is generated through targeted workshops with the key stakeholders and information users. The workshops create an environment for discussion, discovery and understanding of how your manufacturing performance issues can be addressed and targeted. The ROI phase enables us to fully understand your issues and goals
and allows us to align our solutions with these needs. This approach provides our customers with a clear understanding of our services, solutions and experience and significantly aids the project approval stages. We discover and agree benefits and convert these benefits to a mutually agreed value, the accumulation of the benefit values offsets the cost over time and is also sustained into the future. From these numbers an ROI can be projected that is mutually agreed with the customer.
Discovered benefits have to be converted into financial savings through their believability and to what degree the benefit will transfer in practice. Many benefits will be readily apparent - others may be more obscure, hence the need to discover and evaluate all benefits that are available. The value of the benefits will offset costs over time.
Return On Investment The ROI formula is:
ROI = Savings (Year 1 + Year 2 + Year 3) /3 *100% Initial Cost
This shows the average savings over the period divided by the initial cost, usually shown as a percentage. The payback period can be calculated by projecting the sum of savings and cost over time and showing where the sum of savings to cost intersects the time line. This example assumes a three year ‘write off’ period (although this can be extended for industrial applications). The most readily understandable element of ROI is payback period – when do you fully recover the investment in the project? This is important, and EmsPT projects usually payback in 9-18 months, but the sustainability of improvement (seen in Graph 3 opposite as ‘Return’) is vital, this is similar to compound interest; without a return (the profit) there is little point in investing the capital simply to get one’s money back.
Reducing the payback period and having high and sustained return is a desirable target. The EmsPT DRIVE programme starts with a Discovery phase; it is here that benefits can be discovered that will convert to a monetary value. This conversion will depend upon believability and upon effective transfer (does one transfer the whole value?). The more believable benefits that can be obtained the quicker the benefit value will offset the cost of the project, thus the payback period will be reduced. Assuming that these benefits are sustainable (also part of the Discovery and the later Evaluation phases) then the project will show sustained return (on the investment) over the agreed write-off period (usually 3-5 years). This activity enhances the likelihood of a budget being acquired and also provides an agreed basis for the Enable and Evaluation phase (the last stage of the DRIVE programme).
Graph 3: Using ROI for Project Justification
A generalised and simplified ROI projection can be calculated during Discover and Implementation phases. When this is done it will provide a visual guide as to whether enough sustainable benefit has been discovered, thereby justifying a project in financial terms. Three examples are shown below that illustrate what you may see as this process develops. The target is to reduce the payback period and maximise the sustainability of benefits throughout the planned life of the system (shown in the main diagram left).
1. Diagnosis: More benefits need to be discovered to make the investment justifiable
2. Diagnosis: Benefits are unsustainable and produce no effective return on investment
3. Diagnosis: Insufficient benefits are producing longer time to payback and are lowering return
The Discovery phase leads to the identification of goals which have a measurable value for project ROI, actual customer examples are shown below: Goals
• Reduce OPEX by 5% • Drive OEE above 80% • Increase plant availability by 5% • Empower the operators • Improve first time right • Increase production output
Value
Goals
Value
The EmsPT real-time solution allows OEE to be monitored against product types and individual batch runs; this provides a better understanding of poor performing products and allows the true cost of production • Reduce OPEX by to be understood. 5% • Online quality Providing feedback to the • First time right operational staff on the current • Rework reductions production allows them to take • Raw material control of daily production. control Giving them full access to historical reports also promotes suggestions for improvements. Our customers have seen 5% increases in output by simply making operational staff aware of how production is running to target.
In a production environment where thousands of pounds of production can be scrapped or need rework, the need to monitor key process parameters in real-time using online SPC is essential.
Potential 5% OEE gain resulting in £ 550k additional profit.
Identified savings of £ 320k raw material & wasted processing time.
By monitoring online you are able to provide information to the operators regarding problems that are about to happen and that product is going to go out of specification. This information allows the operators to have a direct impact on first time right. Target areas: • Moisture content • Pack weight control • Mineral content
I
mplement
In Stage three we apply five principles to our project implementation taking into consideration excellence in people, technology, quality and support.
the programme and promotes a vision. Supporting the Champion. • Champion - Usually a Manager, they are able to DRIVE improvements and create a culture for improvement • Improvement Team - Site or Area based and come together to solve problems. The personnel should have varying roles • Process Owners - Part of the Improvement Team and have an excellent knowledge of the process area such as Operators or Supervisors The role of a Champion is critical to the success of the DRIVE programme. The Champion should control the following: • Agree a team plan of action – tasks, timelines, roles etc. • Delegate and be supportive • Ensure team observe and analyse • Share work between team members • Look for help or resources if not meeting plan • Maintain frequent and open communications • Ensure all ideas and improvements are documented The Champion should: •
1. World Class Technology EmsPT only partners with world-class vendors - the foundation for a successful business solution. 2. Proven Methodology EmsPT offers a scalable approach to your business requirements delivering yield benefits at each phase of development. 3. Skilled People Our team of consultants have the right technical skills and experience to deliver the best solution for your business. 4. Quality Quality is fundamental to all stages of our delivery. EmsPT works within recognised standards of ISO and GAMP. 5. Long Term Support Benefits are not limited to just project delivery - EmsPT ensures continuous return through sustainable support capabilities. From the Discovery and ROI phases we ensure the solutions are designed to meet your requirements for Manufacturing Performance Improvements. The success of a solution needs the support of a project team consisting of EmsPT’s and the customer’s personnel. We call this a DRIVE Team. It is critical that the DRIVE Team comprises key people with key responsibilities, thereby EmsPT can engage with issues that will become agreed challenges and the core of improvement success. Typically a team will have the following representation from a customer: • Sponsor - A Senior Manager who actively supports
• • •
Ideally be from outside the area being targeted for improvement Have some prior team leadership experience Have a facilitative or participative leadership style Be an active supporter of the DRIVE programme
From EmsPT you can expect a Project Manager, a DRIVE Practitioner and Project Engineers.
1. Everybody working to one goal 2. Continuous Improvement 3. Implement change without Micro Management 4. Keep it simple at every level 5. Clearer understanding across all areas and impacts on others 6. Visualisation 7. More dynamic issue management solutions 8. Agreed plans well in advance 9. See behind plans 10. Data accuracy 11.Simple growth of measurement related to previous pro duction against plan/OEE/data availability 12. Have real comments related to actual issues 13. One integrated database 14. One vision, one goal in line with business needs Everybody understanding & agreeing, one vision, one goal. Keep it simple – Visual – Accurate.
Illustration 1: As part of a workshop we establish a definition of “What Success Would Look Like” to you
V
E
Stage four is undertaken once a system is installed as it is important that our customers see beneficial use. Depending on your company’s Continuous Improvement Programmes that are already deployed, we are able to offer a range of services to help identify areas where additional value can be found in your processes.
The final stage is once the waste and value adding opportunities are identified; companies will need methodologies to DRIVE improvements. EmsPT is able to facilitate the deployment of information-driven methodologies to enable improvements to be made. This Enabling stage is to make sure that the appropriate focus is available to the programme and that a sponsor can authorise the changes that are recommended, thereby achieving the fullest deployment. In some cases EmsPT is asked to join the team to help guide this stage through setting an appropriate environment and by accessing appropriate information resources. The final Evaluation stage is to measure what has been achieved and to ensure that the fullest deployment has been undertaken, thereby ensuring the earliest possible payback and sustainable high benefit beyond payback. EmsPT’s DRIVE programme fully supports Continuous Improvement processes to utilise the methodologies in other improvement initiatives.
alue
By working with our Medical Device customers at the Discovery phase we will have worked jointly to identify their business goals and objectives, it is therefore crucial within the Value stage that we qualify what measurable success has been attained in the deployment of our MES solution. Our goal is to meet our customer’s expectations, enable them to realise operational benefits and achieve Manufacturing Operational Excellence.
nable & Evaluate
Enable & Evaluate Sessions are Run to Evaluate Success: Session 1 This session is run during the Implementation stage of DRIVE and is aimed at helping create the correct environment and engagement to release the identified Value aligned with the project goals and success criteria. In this session we will cover: • • • • • •
• • • • • •
Forming a project team and the roles What the Sponsor & Champion adds to the project How is the project being promoted within the company and its importance? Look at what success looks like to all the users, Operators, Supervisors, Shift Leaders and Senior management Gain a firm understanding of who the potential users of the system are, from daily users, improvement teams and overall consumers of the information Where resources will be needed to support the project and aid with identifying and releasing improvements; Operations, Engineering, Maintenance, Quality How and when will the teams meet to monitor daily and weekly performance? Any additional training requirements that may be required and how it is delivered? How problem solving is carried out and is any additional support needed? How are the successes going to be published Can we complete any of the success criteria? How is the project going to be made visible?
Session 2 Once the system has been installed on site and the data has been validated this session is usually run 1-2 weeks after the go live period. The following topics are usual areas for focus: • Validate if operational staff are engaged and understand the importance they have in driving success of the project
• • • • • • •
Meet with the users of the system. Do they need any clarification or additional training? Follow-up with the Sponsor and Champion Look at the information and locate some potential early areas for success During a proof of concept implementation start to capture items that would enhance the solution going forward Can we complete any of the success criteria? What action is needed to meet others? Consider if all the success criteria are achievable Look at the feedback the project team has gained from the users of the system
Session 3 These sessions are critical in evaluating overall success and planning further rollout or enhancements that would add further value. During this session we will cover: • • • • • • •
The progress made and review the vision going forward How have the improvements been captured and published? What have the benefits to the company been? Which of the success criteria have been meet and are there plans in place to achieve the others? What other benefits have we seen during the project that may not have been initially envisaged? What is the engagement of the solution in the Continuous Improvement Programme? Keeping the team together; as the solution becomes part of the company’s way of working some of the initial project teams may move onto new projects. Should their input be handed over to a new team member. Many programmes suffer from a lack of sustainability as focus is moved elsewhere
EmsPT - Streamlining Operations
Benefits of DRIVE The EmsPT DRIVE programme is not commenced with a solution in mind, it is rather a process of agreed discovery; with manufacturing professionals working alongside information driven solution experts. The goal is to share the joint aim of producing real and effective solutions to a set of challenges, which once identified and acted upon will deliver measurable business benefits. The DRIVE programme defines a vision of what is needed and an implementation plan to make it achievable. The DRIVE programme often results in a multi-phased delivery approach, where the value of benefits is re-invested into the subsequent phases, each step of the way being open to challenge and fine tuning of the initiative.
ENAB LE
The DRIVE programme brings a third party and objective view to improvement programmes focused on New Device Development & Line Extension, Compliance, Cost of Goods and Customer Supply. The increasing level of difficulty in delivering benefits over a period of time can be supported through automated manufacturing operational excellence solutions, allowing a company to readily see what can be done to make continuous improvements sustainable.
What Our Customers Say About DRIVE “Whilst working with EmsPT and their DRIVE program we identified a 10% improvement in capacity owing to lost time during extended changeovers”. Company A - Operations Manager “We saw the potential to recover 10% efficiency due to slow running equipment”. Company B - Continuous Improvement Manager
© EmsPT 20112 DRIVE
“While engaged with the DRIVE program it allowed all the personnel from Operators to the Plant Manager to express their goals and what success meant to them”. Company C - Project Manager
EmsPT Unit 1, Oakfield Road Cheadle Royal Business Park Cheadle SK8 3GX Telephone: +44 (0) 161 495 4694 Fax: +44 (0) 161 495 4690 Email: info@emspt.co.uk Web: www.emspt.co.uk EmsPT is a division of SolutionsPT Ltd.