Production and Post-Production and Complaint Handling


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Good morning,

I am currently reviewing our company risk management process and I am looking into examples of best practices for being compliant to the Clause 9-Production and Post- Production Information of ISO 14971.

I am interested in particular to know if anyone can advise best practices on how to review and handle complaints and how to use the results of such review as an input for the risk analysis. Can anyone provide some example of how complaint data is used to update the risk management file of a product?

For example, if a reportable and harmful event occurs, the CAPA team will perform an investigation and determine if such event is actually contemplated in the risk analysis. What is the trigger that would lead to an update of the risk management file? Do I have to make a risk/benefit analysis for each single occurrence of an harmful event? or what kind of practices can I establish to review occurrences of complaints and map them back into the risk analysis?

Thank you very much


Super Moderator
I'm struggling with how to reply with "best" practice - I think it's just standard practice.

If the investigation identifies new hazards, update the SHA and then the risk analysis documents as appropriate (e.g., FMEA).

If the investigation identifies new ways the risk is realized, update the risk analysis documents as appropriate.

If the investigation establishes that the severity or frequency of occurrence is greater than initially estimated, update the appropriate risk analysis documents. If this pushes the risk outside the acceptable range, potential design changes are warranted.

With the update to the risk analysis documents, additional mitigations may be identified. Those would need to be implemented and verified. Depending on the severity of the complaint, you may need to take measures outside of Risk Management (e.g., advisory notices, production stoppage, recalls, etc.).

Is any of that close to being helpful?
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