Q
Hi, I'm working on revising our current Document Control Program. Specifically regarding the method in which document changes are reivewed and approved. Our hope is to streamline the proces to allow documents to pass through the system quicker yet ensure control over the changes is maintained. Given the FDA is looking at risk as it applies to various processes/procedure, I want to implement risk assessment to the change which will then determine who needs to approve the change. Currently we have QS, Operations/Mfg and Reserach review all PCRs. Others (e.g. planning/purchasing, maketing, etc.) also reivew but it depends on the changes being proposed. What type of examples would you apply to a change that would classify it as a 'low', 'medium' or 'high' risk change? We manufacturer IVD Class II medical devices.
To me:
Low = typo change, doesn't affect validation/process, change made for clarification purposes only.
Med = customer notification required, design change, change may have affect on validation/process. Depends on if the change affects a critial element.
High = new design, new procedure, affects intended use, requres 510k submission or supplement
Any suggestions would be appreciated. Just want to make sure I'm not missing something.
Thanks
Robin
To me:
Low = typo change, doesn't affect validation/process, change made for clarification purposes only.
Med = customer notification required, design change, change may have affect on validation/process. Depends on if the change affects a critial element.
High = new design, new procedure, affects intended use, requres 510k submission or supplement
Any suggestions would be appreciated. Just want to make sure I'm not missing something.
Thanks
Robin
