Are all In-Process Quality Records required in final QA Batch Record Review.

A

AshleyMae

#1
We are an FDA regulated and ISO 13485 certified medical device manufacturer. During our production of a new lot , there are many inprocess tests and associated records ( a new lot may take up to 6 months to build and 100's of rxns). these highly technical inprocess test data/quality records are reviewed and approved by independant subject matter experts. They are not forwarded to QA for final review. They are maintained within the department. Traceability of the inprocess activities is maintained.
Upon completion, specific key designated Quality Records demonstrating final production quality, material usage, and technical approvals are provided to QA for the final batch review and release.
Are we at risk for compliance issues (GMP, ISO13485) if we do not have QA ownership and oversight on all of the inprocess quality records as well ?
thank you
 
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C

Chance

#3
We are an FDA regulated and ISO 13485 certified medical device manufacturer. During our production of a new lot , there are many inprocess tests and associated records ( a new lot may take up to 6 months to build and 100's of rxns). these highly technical inprocess test data/quality records are reviewed and approved by independant subject matter experts. They are not forwarded to QA for final review. They are maintained within the department. Traceability of the inprocess activities is maintained.
Upon completion, specific key designated Quality Records demonstrating final production quality, material usage, and technical approvals are provided to QA for the final batch review and release.
Are we at risk for compliance issues (GMP, ISO13485) if we do not have QA ownership and oversight on all of the inprocess quality records as well ?
thank you
IMHO, you involve QA when the production is over, at the end of the loop. Are the QA folks not familiar with what to check during in-process, since you said it is highly technical? Why there is no involvement of QA in the in-process? Are the SME's part of the QA team? Is the in-process inspection could be better handled by SME"s rathen than QA's?
Do you have a procedure that specify who checks at what stage? Are the requirements on what to check specified in the procedure? Is it stated that QA will only check for final release? If this is the case, no matter who checks it during in-process, it does not matter as long as everybody knows what to look for when doing in-process inspections.

If there are customer complaints, who handles them? QA or SME's?
 
A

AshleyMae

#4
Thank you for the response --"Why there is no involvement of QA in the in-process? Are the SME's part of the QA team?" ---- is the exact question we have been encountering as well -- with new management reps --- The QA staff is not trained to analyze the data - they are authorized to review the final spec sheets and ensure the authorized SME has reviewed and signed off. - the SMEs do not report to quality they are the technical product owner in Research .

I like the concept of defining this policy in an SOP -- but I am getting resistance - the current feeling is that we are noncompliant and we should bring all records back to QA staff for final re-review requirements ---- so i thought I would reach out and see how others handle this issue. QA handles customer complaints.
thank you so much for your response.
 
J

Jo1974

#5
I would definitely have all documentation checked as part of the final approval, and demand that there are in-process QA checks. Where the QA staff don't have the technical expertise, I would train them! For in process checks, it may be prudent to complete a risk analysis for the process, and identify the places where a QA check would reduce the risk of errors, and provide training on what they should be checking for.

If a manufacturing takes months, it's better to identify and rectify a potential error mid-process where it can be fixed in good time, and with low risk than to fail a lot!!
 
#6
Presumably the processes are conducted to a Procedure which will state what records are required to be generated and by whom. The QA responsibility should then be to check that the procedure is being followed. QA might not have full understanding of the test details but can still audit the Procedure.
 
H

Harshila

#7
Re: QA Batch Record Review.

I need to add extra checks to when reviewing the batch records for release of products.
Some one suggested A memo to file but what should the memo say ? Any ideas

:thanx:
 
#9
Re: QA Batch Record Review.

I need to add extra checks to when reviewing the batch records for release of products.
Some one suggested A memo to file but what should the memo say ? Any ideas

:thanx:
Any specific reasons on why the memo points can not be built within the Batch Record review checklist ?
 
H

Harshila

#10
Re: QA Batch Record Review.

There exists a checklist, but other quality system procedures / processes are being reviewed to mitigate risk. ( if any)
 
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