Applying Risk to the Medical Device Document Control Program

Q

QAINOVA

#1
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:)
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi, I'm working on revising our current Document Control Program. Specifically regarding the method in which document changes are reviewed and approved. Our hope is to streamline the process 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 Research review all PCRs. Others (e.g. planning/purchasing, marketing, etc.) also review 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 critical element.
  • High = new design, new procedure, affects intended use, requires 510k submission or supplement

Any suggestions would be appreciated. Just want to make sure I'm not missing something.

Thanks
Robin:)
Suggestions for Robin?

Thank you for helping!!

Stijloor.
 

sagai

Quite Involved in Discussions
#3
Hi Robin,
I am not quite sure I share the entirely same view about the application of Risk Management as defined in ISO14971:2007.
The origin of this difference could origin from the way of Change Management handled.

According to my understanding document change does not initiate Risk Management related activities, it works in the opposite order, during the investigation of a change request for process, product feature, etc. could initiate risk related activities next to the others like error correction including modification in the documentation.
So sum it up, when there is a change request related somehow the safety and effectiveness of your already marketed product you should review the safety aspect of the change request and based on that create an action plan (in case there is no effect on safety, than also has to be documented for example in an impact analysis document).

I want to implement risk assessment to the change which will then determine who needs to approve the change.
I am not quite sure the purpose of the risk assessment fulfilled if it rarely determines who should be the approver of the change.
This issue indicates me more about the need to have a clear role based definition of reviewers and approvers, based on document types and the status of the product.


What type of examples would you apply to a change that would classify it as a 'low', 'medium' or 'high' risk change?
Actually when your product on the market, the risk relevance analysis of the change request should do that. I do not think the classification is so important, but the action plan related to the change request and that change is safety related, that is the important.

May be there are a slightly different interpretation as regard to change related risk among us, i would be happy to discuss and see others prospective.

br
Sz.
 
Q

QAINOVA

#4
Thank you for replying back to my question. I agree with your statement regarding the application of risk being followed by change. I guess my question wasn't clearly stated. My mistake....but your feedback gives me more food for thought.

:thanx:
 
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