FMEA, Risk Assessment Contribution from B. Jentges written on 3/21/2002 at 09:39
FMEA is often used as tool for risk assessment. Part of the FMEA is the estimation of probability (What are the possible causes of this failure?). It is difficult to estimate this. Do we have to answer this question also in pharmaceutical FMEA for validation activities or can we use an abbreviated FMEA without probability? Answers to this contribution:
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