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Critical Dimensions/Parameters

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by Ranerd, Jul 22, 2021.

  1. Ranerd

    Ranerd New Member

    Jul 22, 2021
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    If the only thing changing on a device component drawing is the “critical” status of a specific feature, what would be the minimum evidence required to show its ok to remove? Risk assessment/review and evaluation of results from existing/periodic process validation activities?

    would there ever be an instance where validation activities would not need to be pointed to? How would you handle the potential case that reason for critical status is not explicitly called out in dfmea or pfmea, but possibly has an indirect impact on something else? Doing a regulatory assessment but just not sure we can say, yeah it’s ok to remove without pointing to actual evidence.

    thank you in advance!
  2. yodon

    yodon Well-Known Member

    Aug 3, 2015
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    I guess it's not possible to determine why the feature was flagged as critical in the first place?

    21 CFR 820 (not Part 11, by the way) says:

    Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.

    One might think that it was identified as critical per this requirement so you'll probably need a really good explanation. What you suggest is good (the risk assessment would be absolutely required - since all changes need to be evaluated for risk). Maybe a tolerance stack-up analysis might also help. I would agree that since you're not actually changing the design, a "paper validation" is probably sufficient.

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