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QC vs. QA on product release process

Discussion in 'Medical Devices (21 CFR Part 820)' started by siwing, Apr 4, 2020.

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Who is responsible to affix the status label when releasing a product? QC or QA?

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  2. QA

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  1. siwing

    siwing New Member

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    QC inspects product and QA reviews inspection record and release product. Who is responsible to affix the status label when releasing a product? QC or QA?
     
  2. Guy Léger

    Guy Léger Member

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    Although by definition the two terms are a little different, in practice the QA and QC are in the same department / service ... that means that some small tasks assigned to a QC can be done by a QA easily to simplify the progress of work, and vice versa ... But the responsibility lies with the QA
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Are they? I'm going to suggest that they are much more than that. The words "assurance" (confidence) and control mean quite different things. Since we are posting in the Medical Devices forum it might be worthwhile having someone who understands those (USA) regulations post an answer.
     
  4. yodon

    yodon Well-Known Member

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    I'm in the device sector and have seen a number of US manufacturing operations but I'm mostly on the design side. There are no regulations driving the "labels" (QA or QC) - you could call what QA does as "Fred" and QC as "Mary" as long as the required quality-related functions are performed. These are just my observations:
    • As @Guy Léger alludes to, companies tend to lump both functions under "Quality"
    • The "labels" are often used interchangeably (for right or wrong... again, just my observation)
    • QA tends to bookend the process - design through design transfer and then production release and postmarket and QC tends to be the activities within those bounds
    So, back to the OP's question: who applies the status label (which, in and of itself is a bit off - there's no requirement for a "status label" only that identification - whether final acceptance testing is pending, completed and passed or completed and failed - is properly maintained to avoid mix-up) is really up to the manufacturer. I think I've most often seen that this is kind of a 2-step thing: someone (most often with the QC label) conducts activities (typically final acceptance testing / sampling) to release the device / lot and then someone else (typically QA) does a review to ensure everything was done (all the i's dotted / t's crossed). Again, this is just my observation and there are no regulations driving what you call the roles or who does what (as long as they are competent to perform the required tasks).
     
    Andy Nichols and siwing like this.

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