What To Know
Failure Modes and Effects Analysis principles apply to design, services, processes or products. PFMEA offers a systematic approach to revealing possible weaknesses in any process (DFMEA applies the same methodologies to identifying design-related issues).
Process FMEA (PFMEA) uses the same step-by-step approach as DFMEA, but applies it to processes. Since quality management systems are at the heart of medical device approval, PFMEA can save time and money.
PFMEA looks at any process from the bottom up. Thus, it can be more practical than methods that start from the top and work down. PFMEA systematically seeks out every possible cause and failure mode.
PFMEAs eliminate or reduce process weaknesses, starting with the highest risk categories.
How We Can HelpMedical device production process requirements create practical challenges. We offer experts to help you achieve a production plan that produces consistently high quality results. For example, our consultants commonly help with:
- Applying PFMEA to increase protection against unwanted production surprises.
- Document known risks and associated mitigating actions already in place