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Question about Section 8.3.4 Rework

Discussion in 'US Medical Device Regulations' started by MIGUEL LUNA, Jan 6, 2020.

  1. MIGUEL LUNA

    MIGUEL LUNA Member

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    If a rework (a sorting of product within a lot) is performed in the Quality Lab. therefore lot traceability and control was under control by the same qc person that discovered a defect and they perform 100% sorting on that same lot does the lot really need to go thru a re-verification process by another qc person? I say no... cause I have controlled the lot and the 100% re-inspection was performed by a quality team member. ??
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Miguel.

    I deleted your other post in the new member introductions because you posted the above. Are you asking in respect to US Medical device regulations?
     
  3. yodon

    yodon Well-Known Member

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    Unless I'm not understanding, I would argue that your sorting is not a rework process. The QSR defines rework as "action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released to production." What actions are you taking on nonconforming product?
     
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  4. MIGUEL LUNA

    MIGUEL LUNA Member

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    yes and also specifically to ISO 13485 section 8.3.4
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Per Yodon's previous post, sorting isn't usually considered "rework". Typically, rework means performing some type of value-added activity on a (non-conforming) product to bring it into conformity with the agreed specifications/customer requirements. Usually, this rework is performed using an agreed upon method (maybe a work instruction) and then the results are re-inspected to ensure the specification has been met. This rework may or may not be agreed/authorized by the customer.
     
  6. MIGUEL LUNA

    MIGUEL LUNA Member

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    The only thing we (quality) would be doing with the lot is sorting out the bad from good parts and scrapping the bad parts.
     
  7. MIGUEL LUNA

    MIGUEL LUNA Member

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    I have read in other forums that have stated: Auditors/Inspectors classify a sort as a form of rework because we are doing to something with the lot to move/accept the lot to next operation.. we are not "rebuild" ing the non-conforming product. But MRB will review the lot and disposition "Rework to Sort" the lot. hope that helps for clarity.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes. Often auditors/inspectors get it wrong. "Sorting" means separating out the good from the non-conforming. What you do to the non-conforming products is rework.
     

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