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Process Failure modes and effects analysis

Process Failure modes and effects analysis. 2013. Basic philosophy. Risk based thinking is not industry dependent! Airline (1,895 air traffic control errors in 2012) Device (48 recalls in 2012) Pharma (45 recalls in 2012). To control risk, you need to know where it exists

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Process Failure modes and effects analysis

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  1. Process Failure modes and effects analysis 2013

  2. Basic philosophy • Risk based thinking is not industry dependent! • Airline (1,895 air traffic control errors in 2012) • Device (48 recalls in 2012) • Pharma (45 recalls in 2012) • To control risk, you need to know where it exists • Dynamic tool = control • Static tool = waste of time • Brainstorm, the more brains the better • You can never eliminate all risk

  3. Steps • Map all ACTUAL steps of your process • Best practice: Brainstorm with the actual hands on people • Pitfalls: Don’t just go off of SOP steps, may loose detail What are the steps in the process?

  4. Example: EO Clinical Batch Release Process

  5. Steps • List all things that could go wrong with the step • Best practice: Put it all down, even if crazy! Include human factors. • Pitfalls: Don’t avoid putting it down because of low risk What could go wrong with that step? What environmental or human factors could contribute (stress, flow of work, concentration)?

  6. Example: EO Clinical Batch Release Process

  7. Steps • List the effects of each failure mode identified • Best practice: Put it all down, even if crazy! • Pitfalls: Don’t avoid putting it down because of low risk What effects could result from the failure occurring?

  8. Example: EO Clinical Batch Release Process

  9. Scoring How bad could the effect of the failure be?

  10. Example: EO Clinical Batch Release Process Note: We only scored regulatory risk since the patient wouldn’t use a compromised device. You may want to also assess business risk

  11. Steps • List the causes of each failure mode identified • Best practice: Remember human factors • Pitfalls: Don’t avoid putting it down because of low occurrence What caused the failure to occur?

  12. Example: EO Clinical Batch Release Process

  13. steps How often does this failure mode occur?

  14. Example: EO Clinical Batch Release Process

  15. Steps • List any current controls you have to prevent that failure • Best practice: List only what is driven by the procedure • Pitfalls: Don’t include personal best practices What do you currently have in place to prevent the failure?

  16. Example: EO Clinical Batch Release Process

  17. Steps • List all the ways you can currently detect the failure • Best practice: List only what is driven by the procedure • Pitfalls: Don’t include tribal knowledge or personal best practices What do you currently have in place to detect occurrence of the failure?

  18. Example: EO Clinical Batch Release Process

  19. steps What is the probability of detecting the failure?

  20. Example: EO Clinical Batch Release Process

  21. Steps • Calculate the Risk Product Number (Severity x Occurrence x Detection) What is an acceptable threshold for your process?

  22. Example: EO Clinical Batch Release Process

  23. Steps • Calculate the Risk Product Number (Severity x Occurrence x Detection) What, if any, actions need to be taken to reduce the risk? Who is going to do them and when?

  24. Risk Mitigation Plan

  25. Steps • Close the loop from actions taken and calculate your new RPN Did your actions taken bring you to an acceptable risk?

  26. Lessons Learned • PFMEA is a useful tool when: • You are trying to change an existing process • You are designing a new process • You are performing root cause analysis (CAPA) • PFMEA must be the horse – not the cart • Procedural/Process changes after PFMEA can negate efforts or add new risks • Use dynamically to sync with current procedure • PFMEA is an excellent training tool • People performing the process learn the “WHYs” behind control points and “What” can happen if it is not done right

  27. Lessons Learned • Controls fail – redundancy is better • For high risks, don’t just rely on one control. Have a safety net! • Think outside the scope of your process • Consider defects of the process prior and how that effects yours • Audit process after actions • You typically discover new failure modes you missed the first time around • Use constant input from quality system (complaints, CAPAs, etc.) • Don’t rush, this takes time to do right • Some have taken me up to 5 meetings to complete

  28. QUESTIONS?

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