1 / 6

Risk analysis – FMEA

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.

aliya
Télécharger la présentation

Risk analysis – FMEA

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related