Updating of forms contained in existing procedures

[Diane W]

Hi, if a procedure contains a risk assessment and the form used for the risk assessment is updated, would you expect the risk assessment to be updated using the new form when a procedure is updated or could you keep the existing risk assessment.

Thank you in advance for your help

 

[Ed Panek]

It's always better to have correct references in any QMS documents. When we moved to ISO 14971:2019 we updated all our QMS to reference it.

However, this appears to be a design output. As such, I would review the changes to the new form and determine risk and any updates you need to make. If after your review you don't think the changes must be applied retroactively you could draft a letter to file stating why its ok not to update it to the new form style. It depends on what was changed on the form I think.

 

[Chrisx]

In general, documents in the QMS only apply after the effective date. They don't generally apply retroactively, unless there is a good reason to do so. If the risk assessment is ever revised, then it should be updated to be on the current form. You could have an assessment in the change approval process to evaluate if the document should be applied retroactively.

 

[Golfman25]

Hi, if a procedure contains a risk assessment and the form used for the risk assessment is updated, would you expect the risk assessment to be updated using the new form when a procedure is updated or could you keep the existing risk assessment.

Thank you in advance for your help

Why are you updating the form and not the risk assessment itself? I think your answer lies in that answer.

 

[Renea Koski QAM]

If the form or "Template" is updated, but no additional information is required, (like re-arrange the format,) then I see no reason. Just use new form going foward. However, if your new form requests additional information not included in the old form, (like now you have to enter the part description or now you are using a different FMEA score chart . . .) then yes, you would want to update all Risk Assessments to be sure you cover all the information required.