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Introduction to Failure Mode Effects Analysis
Description :
Failure mode effects analysis (FMEA) is a key activity in planning for quality, and is central to advanced quality planning (AQP) and advanced product quality planning (APQP). It supports ISO 9001:2015 clause 8.3, “Design and Development” and clause 8.5.1, “Control of Production and Service.” This webinar will cover the basics of performing FMEA for product designs (DFMEA) and processes (PFMEA), including identification of failure modes, prioritization for actions to remove or mitigate them, and the status of FMEA as an ongoing rather than once-and-done activity.
Objective
  1. Know the role of FMEA in AQP and APQP, with inputs from quality function deployment (voice of the customer, house of quality) and outputs to the process control plan.
  2. Know how FMEA supports ISO 9001:2015 clauses 8.3 and 8.5.1
  3. Recognize FMEA as a cross-functional planning activity, with participation from multiple functions. As an example, the manufacturing department should participate in design FMEAs to ensure that parts are actually manufacturable.
  4. Recognize that quality must be designed into products—hence the importance of DFMEA—because there is a limit as to how much can be manufactured into a badly-designed product.
  5. Know the definition of critical, significant, and critical to quality (CTQ) product characteristics.
  6. Know the definition of failure modes (what goes wrong) and mechanisms (why it goes wrong, the underlying root cause).
  7. Know the process for preparation of an FMEA, including assignment of severity, occurrence, and detection ratings, and calculation of the risk priority number (RPN). Recognize, however, the limits of the RPN—the product of three ordinal numbers—in prioritization of the failure modes. Also know that the actual risk is proportional not only to the individual chance of occurrence, but also to the frequency to which we are exposed to the risk in question.
  8. Recognize that the FMEA is not a once-and-done quality record (although it is a quality record) but an ongoing continual improvement activity.
Areas Covered in the Session :
  • Role of the FMEA as a customer for quality function deployment—that is, from a process standpoint, the FMEA gets its inputs from QFD—and a supplier to the process control plan.
  • Definition of critical and significant product characteristics, which will in turn affect the severity ratings of the corresponding failure modes.
  • Definition of failure modes and failure mechanisms
  • Organization of the FMEA as a columnar table
  • Assignment of severity, occurrence, and detection ratings on 1-10 scales with 1 being best and 10 being worst
  • Calculation of the risk priority number as a product of these ratings. Note, however, that failure modes with severities of 9 and 10 always require attention regardless of the RPN, and also that the RPN is the product of three ordinal numbers. This means we cannot rely solely on the RPN to prioritize actions.
  • The stand-alone occurrence rating also is not comprehensive because risk is proportional not only to the individual chance of occurrence, but also the frequency with which we are exposed to it. The Army's Risk Management Process cites frequency of exposure, while traditional FMEA does not.
  • The FMEA is emphatically not a once-and-done activity that gets filed away as a quality record. It is a continual improvement activity that must be used whenever there is a change in the product and/or process.
Who Will Benefit:
  • Manufacturing and quality engineers
  • Manufacturing and quality managers
  • Technicians with responsibility for design and process FMEAs
  • Anybody involved in AQP or APQP
About Speaker:
William A. Levinson, P.E., FASQ, CFPIM, is the owner of Levinson Productivity Systems PC. He holds professional certifications from the American Society for Quality, APICS, and Society of Manufacturing Engineers.
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