Failure mode effects analysis (FMEA) is a key activity in advanced quality planning (AQP). Its purpose is to anticipate potential failure modes and their effects on product quality and safety, and to ensure that controls are implemented to counteract negative outcomes. Its service in this capacity supports ISO 9001:2015’s clause 6.1 that requires actions to address risks and opportunities proactively.
Design (DFMEA) and process (PFMEA) failure mode effects analysis are key elements of advanced quality planning (AQP). Their purpose is to identify potential failure modes, i.e. how the product or process could fail to meet customer requirements for quality or safety, and ensure that controls are implemented to counteract these undesirable outcomes. Deliverables include identification of critical to quality characteristics, and action plans for mitigating or eliminating risks associated with them.
This FMEA training course will however go beyond the textbook basics of traditional FMEA. A failure mode’s risk depends not only on its individual chance of occurrence as reflected by the occurrence rating in FMEA, but also on the frequency of exposure to the risk. Frequency of exposure is, in fact, addressed very explicitly in the Army’s Risk Management process but not in traditional FMEA. The Risk Priority Number (RPN) also has limitations noting that it is actually the product of three ordinal numbers: the severity, occurrence, and detection risks.
WHY SHOULD YOU ATTEND
FMEA is a key element of advanced quality planning, and it also supports several requirements of ISO 9001:2015 and ISO/TS 16949.The basics are covered in textbooks, but traditional FMEA overlooks the consideration that risk is not the individual chance of occurrence (as reflected by the Occurrence rating on a 1 to 10 scale), but this chance multiplied by the frequency of exposure. As an example, if the individual chance of occurrence is 1 in 2 million, this will be reflected as an occurrence rating of 1 (best possible). If this chance relates, however, to delivery of medications in a large hospital, and the job is done several millions of times a year, it is far more likely than not that 10-severity medication errors will occur. The Army’s Risk Management Process, in contrast, recognizes frequency of exposure as an issue. This underscores the need for engineering controls, or error-proofing, that make nonconformance’s physically impossible whenever possible.
RPN meanwhile has the drawback of being the multiplicative product of three ordinal numbers, so judgment must be applied to prioritize activities to reduce risks associated with each failure mode.
- Roles of quality function deployment (QFD), FMEA, and the control plan in AQP (APQP in automotive).
- Definition of critical and significant characteristics; those which affect product safety and customer satisfaction respectively. These are also known as critical to quality (CTQ) characteristics that must be assured by the control plan. The FMEA, therefore, plays a central role in definition of the control plan.
- Procedure for FMEA preparation, including definitions of failure mechanisms and modes, along with severity, occurrence, and detection ratings. The product of these ratings is the Risk Priority Number (RPN).
- Limitations of the RPN and the need to address failure modes with catastrophic severities regardless of their RPNs. Frequency of exposure to the risk in question also must be considered, as is done in the Army’s Risk Management Process but not by traditional FMEA.
- A key take away from the latter consideration is the need to make mistakes and failures physically impossible for jobs that are repeated multiple times. If it is possible to do the job wrong, it will eventually be done wrong regardless of the skill and diligence of the workers. Any Shigeo Shingo case study that begins with language like, “The job relied on worker vigilance to prevent defects” is a sure sign that defects were being produced—not because workers are not vigilant but because, if it is possible to do the job the wrong way, and the job is done enough times, mistakes become inevitable. This principle carries over, whenever possible, into controls for failure modes. The need for engineering controls (Army terminology), poke-yoke (error proofing), or Henry Ford’s “Can’t rather than don’t” principle cannot be overemphasized.
Attendees will learn:
- The role of FMEA in advanced quality planning (AQP)
- Definitions of critical and significant product or process characteristics.
- Basics of FMEA preparation including definitions of failure modes and failure mechanisms along with severity, occurrence, and detection ratings and calculation of the risk priority number (RPN). In addition, implementation of controls (countermeasures to the risks in question) should reduce the RPN.
- Practical considerations that go beyond the textbook aspects, including limitations of the traditional occurrence rating and the RPN. Risk is a function not only of the individual chance of occurrence of the undesirable event, but also the frequency with which we are exposed to it. RPN, while highly useful and widely accepted, is nonetheless the product of three ordinal numbers. As an example, a 10 severity risk (menace to human safety) multiplied by a 1 occurrence rating is far worse than a 5 severity risk multiplied by a 10 occurrence rating (more likely than not).
- Quality system requirements, including documentation and quality records, associated with FMEA.
WHO WILL BENEFIT
- Quality management professionals
- Engineers and technicians with quality management system responsibilities
- Design engineers
- People with responsibilities for ISO 9001:2015 or ISO/TS 16949 compliant systems
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