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Risk analysis – FMEA. Workshops. FMEA 1. Simple risk assessment process!! Identifying risk Simple method for grading risk Determines appropriate risk reduction options Ultimately assesses risk to patient A pplications Equipment, facilities, products and processes Targets areas of concern.

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Risk analysis – FMEA


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    1. Risk analysis – FMEA Workshops

    2. FMEA 1 • Simple risk assessment process!! • Identifying risk • Simple method for grading risk • Determines appropriate risk reduction options • Ultimately assesses risk to patient • Applications • Equipment, facilities, products and processes • Targets areas of concern

    3. FMEA 2 • Severity of Impact • Negligible, minor, major, critical • Occurrence of problem • Frequency • Highly unlikely, unlikely, likely, high likely • Detection of problem • Easy, can be detected, difficult to detect, undetectable

    4. FMEA 3 RPN (Risk Priority Number) calculated RPN – numeric value to risk potential • Severity • 1-4 (1 is negligible) • Occurrence • 1-4 (1 is highly unlikely) • Detection • 1-4 (1 is easily detected) RPN = S x O x D (1-48) 1 – lowest risk to patient / highest GMP compliance

    5. FMEA 4 – Risk acceptance