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Validate Hand Tools

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by SoccSu8912, Mar 5, 2019.

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Simple IQ or No?

  1. Yes

    100.0%
  2. No

    0 vote(s)
    0.0%
  1. SoccSu8912

    SoccSu8912 Member

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    Hi,

    First post on here, I am very familiar with GRR & MSA studies. My question relates to measurement system validation.

    I am very familiar with IQ/OQ/PQ as they relate to automated measurement and more complex measurement systems that have risks (method bias and linearity changes, used for process control instead of release testing, etc.) and need scrutiny, my question is about hand tools. The risk needs to be evaluated, but once the risk is looked at, if a GRR seems sufficient (no significant bias, linearity, environmental, other concerns, etc.) with risk controls, how do you justify this?

    In your experience, do you validate (maybe just a simple IQ no OQ) hand tools such as calipers, height gages, micrometers, etc. and NA most of your standard paperwork? If not how do you justify not validating them if they are used to release product and just run a TMV, MSA, GRR? Do you use a reference standard (ASME, ANSI, etc.) to justify use without equipment validation (formal IQ, OQ, PQ)?

    We have STPs/SOPs on how to run specific tests with these tools (Few ISO 17025 or ASQ accredited QC technicians however), calibration systems in place, but I am wondering as we update paperwork and standard instructions, calibration instructions, if we need to go back and run simple IQs or if in your experience you use other standards to point to? Granted, I am trying to get out of this...but when the risk is low enough (big tolerances in comparison to accuracy, acceptance testing with no process control feedback, etc.) how do you look at this or justify no formal equipment validation?

    Thanks for your help on this one and sorry for the runon, just want to show I have actually put some thought into this.
     
  2. SoccSu8912

    SoccSu8912 Member

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  3. Miner

    Miner Moderator Staff Member

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    MSA consists of bias, linearity, stability and R&R. Bias and linearity studies should be covered by a well designed calibration program. Stability studies should be evaluated based on risk, looking at the tolerances and the product/gage sensitivity to environmental factors such as temperature. As you said, R&R studies are usually not the issue.
     
  4. SoccSu8912

    SoccSu8912 Member

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    Do you think gages like calipers, micrometers, height gages, etc. warrant qualification in low risk scenarios (IQ, OQ, PQ)? Any recommendations on how to approach justifying acceptance with only an MSA and no equipment qualification?
     
  5. Miner

    Miner Moderator Staff Member

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    My background is not in 21 CFR, but am strong in MSA. That's why I limited my answer to MSA. In other industries, gages such as calipers, mics, etc. can be extremely important and often do require an MSA. I cannot answer for your industry. Hopefully @Bev D will add her input to your qualification questions.
     
  6. SoccSu8912

    SoccSu8912 Member

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    Thanks that would be appreciated. We do require MSA for our hand gages, even though the extent varies due to risk/use. I'm struggling with Qualification justification one way or the other.
     
  7. Bev D

    Bev D Moderator Staff Member

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    My organization isn't fully covered by 21 CFR as it applies ot qualification, so I can't interpret or predict what your reviewers and auditors may require.
    logic would dictate that hadn't guages for static deimensions and features shouldn't require IQ - other than some type of calibration certificate traceable to NIST. OQ shouldn't apply as there are no 'input parameters' per se to adjust. a real MSA could be enough for PQ. and the justification for bias, method comparison, linearity should be simple logic as any risk assessment si upposed to be.

    do you have a regulatory person in your organization? they could probably give you a better answer than the logic one Miner and I have given
     
  8. SoccSu8912

    SoccSu8912 Member

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    @Bev D @Miner thank you, the input argument makes sense from a risk standpoint. We try to cover bias, linearity, stability in calibration and MSA for PQ, so this makes sense to me. Thanks for both of your feedback.
     
  9. Richard Billings

    Richard Billings Active Member

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    We have a set of verified gauge blocks with a certificate of traceability. The metrology guy verifies all production gauges using these blocks. We have an asset number on each device and a record of verification is kept for each. The frequency is normally once per year.
     

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