Process Failure Mode Effects Analysis and Control Plan
Bill Levinson, P.E., FASQ, CQE is the principal of Levinson Productivity Systems, P.C. He is the author of several books on quality, productivity, and management.
The control plan that is required in automotive applications (APQP) can be appended to the PFMEA to create a dynamic control plan. The control the plan is, in fact, synergistic with identification of the process and product characteristics and the preventive and detection controls cited in the PFMEA.
- Know the role of PFMEA in advanced quality planning (AQP)
- Know the role of PFMEA in ISO 9001:2015 and IATF 16949:2016
- Gain a comprehensive overview of the new AIAG/VDA (2019) approach to PFMEA. Key points include:
- Use of structure and function analysis to help identify failure modes, failure causes (formerly known as failure mechanisms), and failure effects
- Correspondence between process and product characteristics, and prevention and detection controls respectively
- Risk assessment according to the nature of the prevention controls as opposed to the previous method which required a quantitative estimate of the nonconformance or defect rate (e.g. defects per million opportunities). This makes the PFMEA process much easier to use
- Replacement of the risk priority number (RPN) with an Action Priority of High, Medium, or Low
- Add a control plan to the PFMEA to obtain a dynamic control plan
- Simple examples will be provided to illustrate the process
Course Level - Intermediate; assumes some prior familiarity with PFMEA and advanced quality planning (AQP)
- Failure mode effects analysis (FMEA) and its role in advanced quality planning (AQP) or advanced product quality planning (APQP)
- Outputs of quality function deployment (QFD) become inputs for design FMEA, whose outputs identify critical to quality (CTQ) characteristics that must be addressed by process FMEA
- FMEA basics
- Group technology and product families make FMEA preparation easier
- The importance of management of change (MOC) cannot be overemphasized. Words like "new," "changed," or "different" indicate that risks must be reassessed
- Process FMEA, the key focus of the webinar
- Structure analysis identifies the process steps and also work elements (factors that can affect them). There is considerable synergy between the PFMEA's structure tree and the cause and effect (fishbone) diagram from basic quality management.
- Function analysis identifies what the process steps are supposed to accomplish, and lays the groundwork for the identification of failure modes. The negative of the process step's function (what doesn't happen that should, or happens that shouldn't) is the failure mode. Function analysis also identifies process characteristics (those usually subject to prevention controls) and product characteristics (which, when they must be assessed after product realization, are subject to detection controls).
- Failure analysis identifies the failure modes, which are the focus elements or starting points from which the failure effects (consequences) and failure causes (formerly known as failure mechanisms) are identified
- Risk analysis assesses:
o The severity of the failure
o Occurrence rating, based on the nature of the prevention controls rather than an estimate of the nonconforming or defective fraction
o Detection rating, based on the nature of the detection controls
o Action Priority based on the Severity, Occurrence, and Detection ratings, with Severity having the most weight and Detection the lowest
- Optimization means selection and verification of actions to reduce the risk
- Documentation means the PFMEA becomes a quality record. Don't forget to share relevant knowledge (read-across/replicate process, best practice deployment) with related activities.
- Occupational health and safety (OH&S) and manufacturing examples adapted from real-world case studies
- The control plan is synergistic with the PFMEA and even includes some of the same information (specifically, the nature of the prevention and detection controls). If the control plan is appended to the PFMEA, it becomes a dynamic control plan
- The control plan also includes information such as sampling frequency, the gages and instruments used, measurement systems analysis (where applicable), and the reaction plan that specifies what to do when a problem is detected
Who Should Attend
Quality managers, engineers, and technicians, and others with responsibility for advanced quality planning (AQP) or PPAP
Why Should You Attend
The newest (2019) approach for process failure mode effects analysis (PFMEA) from AIAG/VDA is a major improvement on previous approaches. It is a very structured and logical approach for the identification and assessment of risks associated with product realization processes. Two major improvements are (1) assessment of the Occurrence rating according to the nature of the preventive controls (technical or engineering controls are for example superior to administrative controls that rely on vigilance and compliance) and (2) replacement of the Risk Priority Number (RPN) with an Action Priority of High, Medium, or Low. This addresses the long-standing drawback with RPN as the product of three ordinal numbers. As an example, a failure mode with Severity = 10, Occurrence = 4, and Detection = 5 has the same RPN (200) as one with Severity =5, Occurrence = 4, and Detection = 10. The former can kill or seriously injure the customer while the latter will merely annoy the customer, although it is likely to happen more often.