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 • Dynamic tool = control • Static tool = waste of time • Brainstorm, the more brains the better • You can never eliminate all risk

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?

Example: EO Clinical Batch Release Process

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)?

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?

Scoring How bad could the effect of the failure be?

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

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?

steps How often does this failure mode occur?

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?

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?

steps What is the probability of detecting the failure?

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

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?

Risk Mitigation Plan

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

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

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

QUESTIONS?

Process Failure modes and effects analysis