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How would you handle this situation?

Discussion in 'Coffee Break and Community Discussion Forum' started by QA Bee, Apr 14, 2016.

  1. QA Bee

    QA Bee Member

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    One of our product didn't pass QC and we had nonconformance documented.

    Our R&D decided to change the QC criteria just for that product and retested and wants to release it.
    There was no justification provided on why this change will have no impact on the product quality.

    We don't have any historical data to support this change. Design History File with this information doesn’t exist and/or stability on this product was also never performed. In my opinion, this need to be treated as a “Design Change” and should not be released "As Is".

    I also believe that it defeats the purpose of “QC Criteria” if we are able to change the criteria on the fly. Now, close this nonconformance - management wants me to sign off on this. I don't feel comfortable signing it the way its being released.
    How would you handle this situation? I have tried explaining R&D but they said, they have too much to work on and can't redesign one more product:(
     
  2. Candi1024

    Candi1024 Well-Known Member

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    I would want an engineering assessment done of why this wasn't a problem, and a variance attached to the part number for our records.

    I am assuming this doesn't create any safety issues, and the product is still good and within customer specs?
     
  3. hogheavenfarm

    hogheavenfarm Well-Known Member

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    Could be released under positive recall until you get some documentation.
    I have learned (the hard way) to keep a separate log on these things, as they always tend to bite back. Emails are your friend. Names, dates, and times go into my log and are filed with the product history, and I keep a separate copy in case those 'disappear'.
    Officially the MRB should make a determination and sign off on it. Ideally a waiver from the customer is the right way to go, but I have never seen that happen in real life.
    Sometimes however, the R&D team may know things about the product that others do not, (as in fit and function), so to them what is nonconforming is really not critical, but it would be nice to communicate that so the criteria can be modified.
     
  4. QA Bee

    QA Bee Member

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    Well, R&D is suggesting to change customer specs too but in my opinion, how would you release it based on just one single test without verifying it?
     
  5. QA Bee

    QA Bee Member

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    keeping a separate log or even keeping a memo in the file from me is the option I am thinking of too.

    its a small company so, MRB is myself, VP of Operations and R&D. so, its tough having another opinion:( I am sure R&D can justify with their technical background but they don't want to even justify in simple few words so I am given no justification.
     
  6. Candi1024

    Candi1024 Well-Known Member

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    The variance would be a statement saying that the one that was released (was it tested?) still fits form and function based on what some smart guy in R&D guy puts on paper, lol.

    Going forward I would want some sort of verification done, then you could do a design change. If you test the product you can run a verification while also producing it. Maybe that assessment above could be enough to initiate the design change. But I would certainly want something.
     
  7. Miner

    Miner Moderator Staff Member

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    Are you in a regulated industry?

    In non-regulated industries, a deviation to internal specifications (not customer specifications) can be a fairly common occurrence, but should be documented with a risk assessment and justification for why it is acceptable. In addition, if a deviation becomes necessary more than a few times, it should definitely drive an engineering change.

    One time at a previous employer, I was handed a request for a third time, and I asked how often this occurred. I was told every time this entire product line was made. I refused to sign and requested an engineering change. The engineering department pushed back but lost. They later found out that the original design engineer had omitted part of the circuit from the calculations used to set the specification.
     
  8. QA Bee

    QA Bee Member

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    We are regulated industry. Its Class 1 IVD Medical device.
     
  9. MarkMeer

    MarkMeer Well-Known Member

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    The extent of documentation would really depend on the nature of the product...

    Assuming the risk is reasonably low, I'd suggest:

    1. File the NCR on the unit that did not pass using the old criteria
    *2. File a change record to change the acceptance criteria, and include a justification & risk-assessment for revising the acceptance criteria
    3. Issue revised procedure/work-instruction with updated acceptance criteria
    4. Document in the NCR "use-as-is", and justify because it meets revised acceptance criteria (document re-test according to revised criteria)

    * You say "I am sure R&D can justify with their technical background but they don't want to even justify in simple few words so I am given no justification", but they will HAVE to do this. Until they do, the change doesn't go through, and the unit will have to remain segregated as pending NCR disposition.
     
  10. QA Bee

    QA Bee Member

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    Thanks Mark.

    This is exactly what I asked for 3 times already and we even discussed it. I am just getting "No can't do, deal with it attitude" and have been asked to sign off.

    I am thinking of attaching my memo there only and not sign off the NCR as well as Change Request.
     
  11. MarkMeer

    MarkMeer Well-Known Member

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    Sounds like someone's not doing their job.
    Presumably the engineers are ultimately responsible for establishing the acceptance criteria in the first place, so they need to be involved in any changes to it.

    If there is no justification and risk-assessment, the acceptance criteria doesn't get changed. It's as simple as that.

    Perhaps take it to higher management, citing them not fulfilling their responsibilities. But until they perform their duties, simply leave the change-request and NCR as pending, and the NC unit remains segregated/quarantined until they are closed.
     
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  12. drgnrider

    drgnrider Member

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    If they "tested" it and it met the criteria, they shouldn't have an issue giving a reason why. Sounds like someone THINKS the product should work, but doesn't want their name associated with it... :|

    Agree, time to escalate, hopefully will get the answers.
     
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  13. QA Bee

    QA Bee Member

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    Higher management is R&D head/CSO/CEO who doesn't believe in Quality at all.
    Unfortunately, I also report directly to him so bringing upto him is a walking into fire:(
     
  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    If this is as serious as it sounds, it may be time to start shopping for a new position. It sounds like a matter of time until this plays out in an unfavorable way. If that was to happen, better not be a party to it. I hope to be wrong about this.
     
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  15. MCW8888

    MCW8888 Well-Known Member

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    OK you need to go through the management of change process.
     
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  16. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I wonder if this issue would expose your employer to receiving FDA letter(s), or worse? If so, maybe it is time for a ROI analysis to compare those potential outcomes (what would be required, and what costs would be associated with an FDA letter?) and the associated recalls - which would result in costs you could forecast. Cost of Poor Quality might help if your management is not stuck in the "No one will know" mind set. $$$ might get his attention. These matters are not just about tiresome bureaucracy or ego. Depending on the feature(s) there could be costly consequences. If management does not know this, they should become informed.
     
  17. QA Bee

    QA Bee Member

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    FYI- I brought this issue up to CEO and I was told that my job here is to only sign what R&D gives me to sign without asking questions!

    So, here I am - looking out for a job. I can't keep going against my ethics:(
     
  18. normzone

    normzone Well-Known Member

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    That's no fun...some of us have been there before, myself included. Good luck in your search for your next home.
     
  19. Golfman25

    Golfman25 Well-Known Member

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    It's his company. Let him sign it. Shouldn't be a big deal.
     
  20. normzone

    normzone Well-Known Member

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    In a previous lifetime, we created the Stop Shipment / Shipment Authorization process. There was a log and the form. Anybody could initiate one - all they had to do was ask and the QE was the go-to guy.

    Training was conducted for all employees re the process. The minimum information you needed to provide was a P/N or a customer name, or a sales order, and the reason why you were concerned.

    QA could evaluate and approve shipment if they so chose, or it had to go to the President for signature. Our President signed a couple of these, then the first time a customer was upset the President did his " Who authorized this ? How could this have happened ? " routine. I showed him the form with his signature. He never signed another one again - from then on out it was " don't ship it until we fix the problem ".
     

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