Risk Management Plan Template - ISO 14971:2007 Compliant

rob73

looking for answers
#11
Mor628
If your complaint is non-product related i.e. missing inspections, then using the RM (ISO 14971) would not be appropriate.
Depending on how your QMS system is set up, you should be raising a corrective action (CAPA) to detail any containment, corrective or preventative actions, as well as a root cause/risk analysis. (i use the term "risk analysis" loosely here as this could mean a full process FMEA or a quality engineer listing the possible outcomes from the issue.)
If you are unsure about CAPA a quick search of elsmar will give you plenty to read.
 

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Marcelo

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#12
From what the auditor asked me, I understand that a customer complaint (or any post-production information) should feed back into the risk management process.
It may need to be fed back into RM (as a lot of other info). However, I would take care in feeding it back directly without evaluating if it really needs to be fed back. This usually means including an evaluation in the complaint decision flowchart to ask the question "Does this need to be fed back in the RM process"? Also, please see 4 - Production and post-production feedback loop in ISO TR 24971.

My question is where does it feedback to? Back to Residual risk, where I assess whether the failures identified in the complaint have been covered in the residual risk? And if they have what would be my next step?
Focusing on your example of failure, you would need in principle to verify if the failure is already identified in the risk analysis, not residual risk. If it's already identified, one of the questions to ask is, is that failure under our predicted failure rate? If it's not identified, I would ask "Why has it new been identified? Is it a new problem or is there a problem with my RM process?"and then I would need to initiate a risk analysis using this failure as an initiating event, for exemple.

Please not that the "where"really depends on the analysis of the problem, you may need to fed it back at different steps in the process depending on the problem.
 
M

Mor628

#13
Dear Marcelo,

Happy New Year to you!

Thanks for taking the time to explain this to me, especially pointing out the ISO TR 24791, such a good read! I really needed that.

Just following up with my last question, if the failure is under the predicted failure rate, then there is no further action taken?

Also, if I am using customer complaints to identify failures, and there is no root cause for that particular complaint, what would be the next step? For example, customer complaints about latex foley catheter balloon not inflating. However, when we test the samples and find no malfunction, do I then still need to view it as a potential hazard? Or do I do that only when my investigation has shown a genuine malfunction of the catheter balloon?
 

Ronen E

Problem Solver
Staff member
Moderator
#14
Dear Marcelo,

Happy New Year to you!

Thanks for taking the time to explain this to me, especially pointing out the ISO TR 24791, such a good read! I really needed that.

Just following up with my last question, if the failure is under the predicted failure rate, then there is no further action taken?

Also, if I am using customer complaints to identify failures, and there is no root cause for that particular complaint, what would be the next step? For example, customer complaints about latex foley catheter balloon not inflating. However, when we test the samples and find no malfunction, do I then still need to view it as a potential hazard? Or do I do that only when my investigation has shown a genuine malfunction of the catheter balloon?
Even if there's no technical malfunction it doesn't mean that there's no root cause. This can be a usability (use error) issue.

There is always a root cause. We just don't know it / can't identify it properly sometimes.
 
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