These are the Questions and Answers from STAT-A-MATRIX’s Lean Six Sigma webinar held on January 23, 2007. You can review the presentation slides in PDF format: Lean Six Sigma Integration for Business Excellence.
1. How does standardized work fit into QSR, CFR 820, and ISO 13485? Is it part of QMS control or is it separate?
Lean and Six Sigma are integrated into the quality management process. Recall the ISO 9000 standards, particularly ISO 9004. Appendix B of ISO 9004 categorizes continual improvement in different ways. One is through breakthrough improvement, which can be related to Six Sigma. The other way is through small steps, which relate to people, which is essentially Lean. When we look at typical characteristics of Lean and Six Sigma, we see that Six Sigma is top down and Lean is bottom up. If we look at other standards that derive from ISO 9000 like ISO 13485 and even QSR requirements that are similar to ISO 13485, the principles are the same. So, Lean and Six Sigma fit well into the ISO-based management systems since the management system requirements lay a foundation for effectiveness while Lean and Six Sigma rise above to build efficiency in organizational performance.
2. Is standardized work part of document control?
Yes, it is. One of the elements of document control is to ensure discipline.
3. Is the “Sustain” referred to in 5S part of QFR 820.22, Quality Audit?
One of the reasons we perform quality audits is to ensure that organizations meet quality criteria established for quality management systems such as ISO 13485 for FDA regulations. In addition, we need to learn whether or not organizations follow their own requirements and “Sustain” is one major requirement of any organization. Yes, “Sustain” is implicitly included in QFR 820.22, Quality Audit.
4. How does Lean Six Sigma apply to Process (re)Design?
Process (re)design is required when an organization does not have the existing capabilities to meet customer needs in developing new products or services. Lean Six Sigma provides a comprehensive set of tools, techniques, and approaches to allow an organization to gather customer requirements, develop specifications based on those requirements, develop and implement solutions to meet the requirements, and verify the requirements have been met by the new product or service. Solutions are built to drive out waste while aligning processes with customers.
5. If I have an existing Six Sigma program, can I incorporate Lean into it for an integrated Lean Six Sigma strategy?
Yes, many organizations that have started with Six Sigma are incorporating Lean into their programs. STAT-A-MATRIX can work with your organization to integrate Lean concepts and tools into your existing structure, giving you the ability to use the tools and techniques that are best suited for the specific problem being addressed. A primary benefit of incorporating Lean into a Six Sigma program is that Lean adds efficiency to the effectiveness provided by Six Sigma. The application of certain Lean tools (e.g., value stream mapping) leads to an optimization of resources through the elimination of waste.
6. How long does it take the Lean Six Sigma management philosophies to become established in an organization?
The integration normally takes two to five years; there are no shortcuts. Progress depends on how well top management leads the initiative. If top management is out front leading the effort, then Lean Six Sigma will permeate the organization quickly and more permanently.
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