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Failure Mode Effect Analysis
- Role of FMEA in Advanced Quality Planning (AQP)
- Inputs can come from QFD (House of Quality)
- Outputs influence the control plan (definition of critical to quality characteristics, and how to measure and control them)
- Application to risk based thinking
- What the FMEA is and what it does
- Failure modes and mechanisms
- FMEA Preparation
- Identification of failure modes and mechanisms
- Severity rating
- Occurrence rating Note, however, that the occurrence rating does not explicitly account for the frequency with which we are exposed to the risk in question. This is an important takeaway from the Army's Risk Management Process
- Detection rating
- Risk Priority Number (RPN). RPN is not, however, everything. High severity failure modes require attention regardless of the RPN. In addition, a limitation on RPN is the fact that it is the product of three ordinal numbers, e.g. a severity rating of 10 (danger to human life) is hundreds or thousands of times worse than 8 as opposed to 25% worse
- Actions to eliminate or reduce risks
- The FMEA is a living document rather than a once and done activity. That is, even after the highest priority failure modes have been addressed, others are then addressed
Overview of the webinar
FMEA is a risk assessment and mitigation process for product designs, processes, and even supply chains. It is a systematic approach that determines (1) how something might fail to perform its intended function, (2) the severity of the consequences of the failure, (3) the likelihood of the failure and (4) the likelihood of detecting the failure.
Assessment of the risk as shown above results in a risk priority number (RPN) which helps prioritize actions to prevent or at least mitigate each failure mode. High severity failures, however, require attention regardless of the RPN. In addition, the traditional occurrence rating (probability of individual failure) does not account for the frequency with which we are exposed to a risk. As an example, a component with a failure probability of 1 in 100,000 does not sound like a serious problem but, if a million of them are put into service, failure becomes a near certainty. This concept is made clear by the Army's Risk Management process.
The FMEA is itself a process with identifiable inputs and outputs. Inputs may come from customer requirements as defined in a quality function deployment (QFD, House of Quality) matrix. Outputs of the FMEA process include actions to eliminate or mitigate risks associated with the failure mode and closed loop follow up to ensure that they are effective. Outputs also include include critical to quality (CTQ) requirements that help define the process' control plan.
Who should attend?
- Senior Executives
- Strategic Leaders
- Quality Managers
- Product Managers
- Manufacturing and R&D Managers
- Quality Professionals/Consultants
- Presidents/Vice Presidents/CEOs
- ISO Coordinators/Management Representatives
- Engineers and Supervisors
- Laboratory Quality Professionals
- Accredited Auditors Requiring the Competency to Audit Quality
Why should you attend?
Failure Mode and Effects Analysis (FMEA), including design (DFMEA) and process (PFMEA), is an important part of advanced quality planning (AQP) or Advanced Product Quality Planning (APQP). The latter activities may be required by customers, especially in the automotive industry. FMEA also supports the new ISO 9001:2015 requirement for "Actions to Address Risks and Opportunities," although it played an important role in product and process planning under previous versions of ISO 9001 and also the corresponding automotive ISO/TS 16949 standard.
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.