MARKET PLACE
Take a data-led approach
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Manufacturers have a duty to themselves and to their customers to apply a philosophy of continual improvement throughout their businesses so that products are manufactured in the most efficient, effective and value-driven way possible. This article examines how a data-led methodology such as Six Sigma can help manufacturers do this (www.isixsigma.com).
In the past “continuous improvement” was often driven by engineering intuition rather than by fact-based analysis of the whole process. Consequently, it was sometimes the case that the “solution” caused problems elsewhere. To deliver consistent and meaningful continuous improvement it is necessary to employ a fact-based approach. Six Sigma uses the manufacturer’s own data, including data on production processes, product testing and quality inspections, to create better processes and products and remove unnecessary waste.
Fit to the business
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Like every methodology, Six Sigma needs to be applied appropriately. “Lean Sigma” is a popular term now used by organisations that take the most relevant elements of a classic Six Sigma toolkit and apply them to their own tasks. An improvement project should be timely and have a pre-agreed deliverable.
Manufacturers should seek to harvest the real contribution towards improvement that can be made by employees. By applying a Quality, Cost, Delivery, Safety, Morale (QCDSM) control and brainstorming ideas, organisations can identify Six Sigma projects that will make a tangible contribution. It is estimated that 98% of ideas generated through a QCDSM approach have true value and approximately 5% have exceptional value. Organisations will often find that ideas fall into three categories:
• Just do it: These are quick, cheap and worthwhile improvements such as reduce cost and gain a greater level of technical
support by purchasing direct from a manufacturer rather than through a distribution channel.
• KAISEN (the Japanese term for continuous improvement) projects: These need more robust data and resource planning. For example, inline with Good Manufacturing Practice, a batch changeover requires manufacturing machines to be shut down and thoroughly cleaned. This is lost manufacturing time that affects productivity. A recent focus by Bespak on reducing the time taken to changeover manufacturing machines achieved a 50% reduction. In addition, using a KAISEN approach to improvement, the company improved the productivity of particular machines by approximately 5%, which saved tens of thousands of pounds per year in lost time.
• Six Sigma projects: These tend to be tasks of significance and therefore need substantial multidisciplinary effort, resource and data.
Cost reduction
The commitment to waste reduction should run right throughout the business and although management focus is important, it is often employee commitment that is the decisive factor. Yet, too often employees equate waste elimination with a reduction in staff. Care should be taken to ensure that the continuous improvement programme does not fail because of this fundamental misunderstanding. Waste management is about making employees’ lives easier to ensure that best value is extracted from their time.
Device manufacturers should be mindful that amendments should not be made to the design or specification of the finished product. Although ISO 9000 (2000) Quality Management Systems provides for a measured element of continuous improvement, ISO 13485 Medical Devices Management Systems states that standards should be maintained, not improved and certainly not compromised. Therefore, a balanced approach to change must be maintained.
Elimination of bad days
Bad days, whether derived from unforeseen “glitches” or more systematic process issues, can have a long-term impact on the viability of the business. Without an appropriate resolution, the ultimate sanction can be a product recall and substantial financial penalties. The prevention of bad days is best served through a structured problem-solving methodology.
Define, Measure, Analyse, Improve, Control are the five phases of Six Sigma process improvement that lead logically from defining the problem to implementing a solution. By identifying the underlying cause and establishing best practice to ensure the solution remains in place, the number of bad days can be radically reduced and systematically erased.
Supplier control
Often smaller companies do not have the resources or expertise to employ a Six Sigma programme of their own. In these cases, their suppliers can play an important role in helping them eliminate waste and eradicate bad days. It is also essential that suppliers recognise how the smallest defect in the apparently least important component can have an effect throughout the supply chain. Many companies employing Six Sigma are now creating Continuous Improvement Teams that consist of specialists from quality, research and development, purchasing and operations and these can enable suppliers to improve their processes and product performance.
Summary
Six Sigma helps reduce development and manufacturing costs and ensures learning is retained and solutions maintained. There are a number of core ingredients to achieve this. The first is a measurable integration of the methodology inline with business strategies in three areas: cost reduction, business process re-engineering and supply chain involvement. The second is a long-term commitment from the company’s management and employees. The third requires the impact of the programmes to be quantified if further improvements are to be made and the momentum towards continuous improvement maintained.
The next step
The next step in implementing a successful Six Sigma programme is to recruit a Six Sigma Master Black Belt, that is, someone who has a demonstrable track record in the implementation and deployment of Six Sigma projects. He/she should have the necessary skills to train staff and advise and mentor across the entire organisation at all levels, and be flexible and able to adapt tools such as Six Sigma to the needs of the organisation rather than to try to implement a prescriptive textbook process. The programme also needs a senior management team that can recognise and accept that the change to a sustained continuous improvement environment is both required and a necessary part of a profitable business strategy.
Glenn Gooding, Six Sigma Black Belt, Bespak Europe, Bergen Way, Kings Lynn PE30 2JJ, UK, tel. +44 1553 691 000, e-mail: glenn.gooding@bespak.co.uk, www.bespak.com.





