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Review of quality records

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Kymberly, May 2, 2020.

  1. Kymberly

    Kymberly New Member

    May 2, 2020
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    Before I moved to our QA group, there was an initiative to have the review of intermediate-level records done by the manufacturing/QC supervisors. (Meaning, buffers, stock solutions, up to vialed reagent records would be reviewed by the groups who perform the work and know the process and documents best.) The records would come to QA just to be filed in the document vault. The QA group would maintain review and release of the FINAL records (so after we put all of the parts together and want to release the assembled kit lot containing all reagents) in order to maintain some separation of the group who did the work and final review/release of product.

    Thoughts? Regulations or standards we'd be violating? I wasn't sure which board to post this to so please let me know if it should be somewhere else!
  2. yodon

    yodon Well-Known Member

    Aug 3, 2015
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    The standard doesn't impose any requirement on who reviews or approves; just that the records are properly controlled. Does your process enable (or encourage) fraud? Do you have proper data integrity? If you're in a defensible position regarding control and data integrity (and, well, you comply with your own procedures), you should probably be ok.
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

    Jul 30, 2015
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    In the "Rust Belt"
    The first thing you have to ensure is the purpose of the records and why they should be reviewed. I can keep records of my oil changes which includes; date performed, cost etc. There's a lot to record. But why would I need to review them?

    If the manager of the processes which create records aren't convinced of the need to look for trends then they won't bother looking at them. It has to be of a) value to their process and b) they have to be required to report out on what those records are indicating. This might simply be a symptom of other things which need correcting first.