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How to Design and Implement a Dynamic Control Plan
- Management of change (MOC) is a well-known chemical process safety principle, but it carries over into quality. Change management is important in ISO 9001:2015 which requires, for example, that changes in documents be reviewed to ensure there are no undesirable consequences, and the same principle applies to FMEA.
- FMEA and the control plan, which together become the dynamic control plan, are important elements of AQP. AQP also includes quality function deployment (QFD), whose outputs become inputs to the FMEA planning process.
- FMEA Basics:
- What it does
- Mode, mechanism, and effect
- Severity, Occurrence, and Detection ratings
- Risk Priority Number (RPN)Caveats about the RPN; it is the product of three ordinal numbers,and it does not necessarily reflect frequency of exposure to the risk (e.g. number of parts produced, number of times service is performed).
- High severity failure modes always require attention regardless of the RPN
- Development of the control plan
- Control Factors
- Control Methods
Combine the FMEA and control plan to get the dynamic control plan
Overview of the webinar
AQP and APQP include processes such as quality function deployment (QFD), which incorporates the voice of the customer into the planning process. Outputs from QFD become inputs into failure mode effects analysis (FMEA), which identifies failure modes for critical to quality (CTQ) product or service characteristics along with actions to reduce the risks that go with these failure modes. The outputs from the FMEA, in turn, define the control plan for the process that realizes the product or service. It is quite natural to extend the traditional FMEA to incorporate the control plan to generate one document rather than two separate ones, and this is known as a dynamic control plan
The dynamic control plan is emphatically not a once-and-done activity, but rather a living document that must evolve to reflect changes in product applications, product design, and/or the realization process. The Automotive Industry Action Group's (AIAG's) FMEA manual, in fact, says to revise the FMEA in response to "new" or "changed" conditions; the keywords "new" and "changed" reflect the risk management principle known as management of change (MOC). This principle is well known in the chemical process industry where any kind of change, including process startup as well as a new material or method, or change in personnel, creates the risk of unintended and unwanted consequences.
Who should attend?
Manufacturing engineer, design engineer, quality management professional.
Why should you attend?
The dynamic control plan extends the traditional failure mode effects analysis (FMEA) to incorporate the control plan into a single living document that responds to changes in the product design, product application, and/or realization process, and thus supports advanced quality planning (AQP) or advanced product quality planning (APQP). This webinar will cover the roles of FMEA and the control plan in AQP, the basics of how to prepare the FMEA as well as pitfalls regarding its traditional risk assessment approach (risk priority number), and how to extend the FMEA to incorporate the control plan and thus create a dynamic control plan.
The dynamic control plan also supports many clauses of ISO 9001:2015 (specifically those related to product design and the realization process, including controls for the latter) and IATF 16949.
Faculty - Mr.William A. Levinson
William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer and Six Sigma Black Belt. He is also the author of several books on quality, productivity and management, of which the most recent is The Expanded and Annotated My Life and Work: Henry Ford's Universal Code for World-Class Success.