Compliance Key INC - Life science webinars
AQP (or Advanced Product Quality Planning, APQP in the automotive industry) is required by IATF 16949:2016 (formerly ISO/TS 16949), and it supports the major ISO 9001:2015 clauses that relate to design control and planning for product realization. FMEA is a generally-accepted element of AQP, as is the control plan; the dynamic control plan improves on both of them to help drive continual improvement.
William A. Levinson, P.E., is Keynote Speaker at Compliance key Inc. He 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.
Overview
Failure mode effects analysis (FMEA) and the control plan, which describes controls for critical-to-quality (CTQ) process activities, are both important elements of advanced quality planning (AQP). The FMEA's outputs, which include identification of the CTQ activities, define the control plan so it comes almost naturally to add columns to the FMEA to include the control plan. The result is a dynamic control plan; a living document that not only documents the FMEA but helps drive continual improvement.
Why should you attend this webinar?
AQP (or Advanced Product Quality Planning, APQP in the automotive industry) is required by IATF 16949:2016 (formerly ISO/TS 16949), and it supports the major ISO 9001:2015 clauses that relate to design control and planning for product realization. FMEA is a generally-accepted element of AQP, as is the control plan; the dynamic control plan improves on both of them to help drive continual improvement.
Areas Covered in the Session:
- Apply the chemical process safety principle Management of Change (MOC) to product designs and processes. The key takeaway is that any change, whether in design, parts, raw materials, methods, personnel, and so on, creates the risk of unintended consequences. This is why FMEAs must be reassessed in response to changes.
- Recognize the role of FMEA, the control plan, and quality function deployment (QFD, House of Quality) in AQP.
- Recognize design and process FMEAs, and identify their deliverables.
- Recognize the failure mode as what goes wrong, and the failure mechanism as why it goes wrong.
- Know the basic procedure for constructing an FMEA.
- Assign severity, occurrence, and detection ratings to each failure mode, and multiply the ratings to get the risk priority number (RPN). Recognize, however, that RPN has limitations as a stand-alone quantifier of risk. High severity failure modes always require attention, and risk also is a function of the frequency of exposure (e.g. the number of times somebody does a job, or the number of parts in service).
- Recognize that the FMEA should initiate corrective action (such as design improvements) or implementation of controls to reduce RPNs, which drives continual improvement. An FMEA is a living document, and not a once-and-done activity.
- Extend the FMEA to include the control plan, and create a resulting dynamic control plan.
Who can Benefit:
Manufacturing and quality professionals, including especially those with AQP or APQP responsibilities.
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