Integrating the FMEA process with problem investigation/RCA process and PFMEA

[v9991]

We are using the pFMEA for co-relating with the process controls. Further, we are using FMEA process in handling complaints & deviation process (FMEA to drive the Root cause analysis process)

I request guidance/precautions from the experts:

1. On the steps of integrating the RCA-FMEA process with pFMEA process.

Whenever an incident occurs [complaint/NCR/Change control], the risk-perceptions of 'risks/effects' and 'failure modes' are updated.

The 'updating' could be revising the earlier existing RPN (of the effect/failure modes) in the pFMEA OR including new effects/failure modes...

2. On the contents/index of the annual review report on risk management.

Thanks in advancevvg

[Coury Ferguson]

Any guidance that someone can provide on this topic?

[Bev D]

I'm not really sure what the question is?

[Murphys Law]

V999x - I would recommend you do NOT use FMEA as a tool for problem solving.

I would wait until root cause and corrrective actions determined before looking at PFMEA.

Take a look at the "8D" problem solving methodology (search this site and I am sure you'll find out what an 8D is. Each D = a Discipline but another way of looking at it is to break a problem up into individual modules.) "D7 = Prevent Reoccurance". under here is where I start to question what in the PFMEA needs to be updated.

To come back to the problem solving methodology, Within an 8D, I'd recommend you look at fishbone diagram or a Faulty Tree Analysis (FTA) to investigate root cause. It should give same mapping to process controls.

[quality.shesha]

In Reply to Parent Post by v9991

We are using the pFMEA for co-relating with the process controls. Further, we are using FMEA process in handling complaints & deviation process (FMEA to drive the Root cause analysis process)

I request guidance/precautions from the experts:

1. On the steps of integrating the RCA-FMEA process with pFMEA process.

Whenever an incident occurs [complaint/NCR/Change control], the risk-perceptions of 'risks/effects' and 'failure modes' are updated.

The 'updating' could be revising the earlier existing RPN (of the effect/failure modes) in the pFMEA OR including new effects/failure modes...

2. On the contents/index of the annual review report on risk management.

Thanks in advancevvg

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