LENGTH: 75 Minutes
Failure mode effects analysis (FMEA), including design (DFMEA) and process (PFMEA) are an important part of advanced quality planning (AQP). Their purpose is to identify potential failure modes (how the product or process could fail to meet customer requirements) along with their severity, likelihood of occurrence, and likelihood of detection and therefore interception. Deliverables include identification of critical to quality characteristics, and action plans for mitigating or eliminating risks associated with them.
The FMEA in turn determines the nature of the control plan. The control plan follows the process flowchart and describes the controls for each CTQ characteristic. This includes not only the nature of the gages or instruments that are used for assessment of quality, but also their adequacy in terms of repeatability and reproducibility (measurement systems analysis). It also includes the capability of the process itself, and again requires action plans for any deficiencies.
FMEAs and control plans are emphatically quality records that are subject to document control requirements, and they interact with other controlled documents such as work and inspection instructions. They also support provisions of the ISO 9001:2008 quality system standard (7.3, Design and Development, and 7.5, Production and Service), and are mandatory parts of the advanced product quality planning (APQP) for automotive applications. They are also emphatically living as opposed to static documents that drive continuous improvement.
What You Will Learn
- Learn not only what FMEAs and control plans are as isolated activities, but also how they fit into an overall quality system and especially advanced quality planning (AQP).
- Learn how FMEAs support provisions 7.3 and 7.5 of ISO 9001:2008, and also their mandatory role in the automotive sector.
- Realize that the risk priority number (RPN) is not the only factor in prioritization of improvement activities; critical product service characteristics require attention automatically.
- Recognize the synergy between FMEAs and control plans, and their roles as living documents (as opposed to static and finalized ones) whose purpose is to drive continuous improvement.
- Know the quality system considerations (documentation and quality records) that are associated with FMEAs and control plans.
Viewers of the On-Demand webinar get:
- Unlimited viewing of the webinar for one full year, including any updated versions
William A. Levinson, P.E., 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. Henry Ford's Lean Vision is a comprehensive overview of the lean manufacturing and organizational management methods that Ford employed to achieve unprecedented bottom line results, and Beyond the Theory of Constraints describes how Ford's elimination of variation from material transfer and processing times allowed him to come close to running a balanced factory at full capacity. Statistical Process Control for Real-World Applications shows what to do when the process doesn't conform to the traditional bell curve assumption.
HOW DOES THIS ALL WORK?
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