Post Market/Production Risk Assessment

thisby_

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#1
Hi,

I hope I am not repeating a question, but I would really appreciate it if anyone could share a template for post-production risk assessment. I would like to include in the Safety Risk Management Process I am handling a form that would help quickly doing a risk assessment of a safety issue that happens in the field. We are currently using a Risk Review kind of form that takes quite some time to fill in and it would be great if we could have a form that can be quickly filled in.
The form should have a sort of actions to be taken based on the assessment, for example 1) Update Risk File (hazard analysis, usability analysis, etc.) 2) perform an HHE 3) No action required 4) Escale to CAPA process (?)

I hope this request makes sense and you can help me!

Thank you in advance,
Emilia
 
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