Hired a new gage tech to take over the calibration system after the previous person left the company. Unfortunately we found the previous person did a lot of things he shouldn't have. We are correcting the problems and the cause of why this was not detected beforehand but with our ISO 9001 re-registration coming up and not enough time to correct everything we need to plan our approach. Some of the main issues are many lost gages that are called out on work instructions to use, gages needing repair, gages well beyond due dates and gages with cal stickers but cant be found in the software system. Our internal audit is this coming week and we plan to write a finding on this but am not sure the best way to approuch this. I can not point to any customer issue that would be directly related to this but would such a situation fall under a major? If we write it as a minor with CA plan do you think this would be enough to prevent a 3rd party finding?
Gage calibration in disarray
- Thread starter qcman
- Start date
Why would you want to prevent a CB nonconformity, if you are:
a. Dealing with a major breakdown of a critical subset of the quality system
b. Aware of the issue
c. Working on a corrective action
Having an external pressure to have the issue resolved should be welcomed. If you are TRULY fixing the problem, with a permanent corrective action, having an external nonconformity should not be a problem
Internal nonconformances do not need to be qualified as major or minor. It is most certainly a nonconformance and would be identified as a major by a certification body auditor due to the extent of the issue.
Writing an internal nonconformance may or may not keep a certification body auditor from writing it up as a nonconformance. Some auditors believe they should not "double dip" by writing up something that has already been identified internally, but there is nothing anywhere that says they should not. This is especially true on initial registration as you can't get registered if there are any unresolved nonconformances.
My best advice would be to write it up internally and be prepared to show where you are with the resolution and take your chances.
I noticed Sidney responded with excellent comments while I was typing.
Writing an internal nonconformance may or may not keep a certification body auditor from writing it up as a nonconformance. Some auditors believe they should not "double dip" by writing up something that has already been identified internally, but there is nothing anywhere that says they should not. This is especially true on initial registration as you can't get registered if there are any unresolved nonconformances.
My best advice would be to write it up internally and be prepared to show where you are with the resolution and take your chances.
I noticed Sidney responded with excellent comments while I was typing.
As part of your CAPA, just some practical things come to mind. First, perform an inventory of what you actually have.
Of those, determine which ones you need which ones need to be calibrated. I would store/quarantine the rest.
I might get some unique ID numbers to place on them if you don’t already have them,
Of the ones you have left, determine which can have their current calibration status verified and which ones need current calibration.
Finally, I would recommend writing procedures and calling out required instruments by accuracy, model, etc. rather than exact numbers. That way when you purchase a backup/ replacement, you aren’t having to update your work instructions each time.
As far as receiving a non-conformity and such, this situation as you describe it, was NOT the sole responsibility of the last person in that position. That sounds like a woefully managed process that was allowed to have all kinds of weeds grow in and no one did anything.
I would start first and foremost by assessing/ mitigating any potential risk to your customers. Then develop control over the calibration program and the calibration instruments.
Of those, determine which ones you need which ones need to be calibrated. I would store/quarantine the rest.
I might get some unique ID numbers to place on them if you don’t already have them,
Of the ones you have left, determine which can have their current calibration status verified and which ones need current calibration.
Finally, I would recommend writing procedures and calling out required instruments by accuracy, model, etc. rather than exact numbers. That way when you purchase a backup/ replacement, you aren’t having to update your work instructions each time.
As far as receiving a non-conformity and such, this situation as you describe it, was NOT the sole responsibility of the last person in that position. That sounds like a woefully managed process that was allowed to have all kinds of weeds grow in and no one did anything.
I would start first and foremost by assessing/ mitigating any potential risk to your customers. Then develop control over the calibration program and the calibration instruments.
Ron Rompen
Trusted Information Resource
A couple of thoughts on this:
1) Internal audits do NOT need to be classified as major/minor. However, your 3rd party auditor would likely write this as a major nonconformance due to the extent of the 'damage' that exists.
2) Start working on a truly robust CA, which addresses not only the immediate problem, but also the root cause of the problem (why did it go undetected to allow it to get to this extent)
3) Since it is unlikely that you will complete the full CA in time for the audit, document what you are doing - create an action plan and timeline for completion of the actions, and keep it up to date. They may still write you up for the nonconformance, but this will be a part of how you will respond to it.
4) Don't sweat it too much. Things happen, and this is WHY you do internal and external audits.....if you haven't had a customer issue yet that is related to this fault, then you are still doing ok. You just need to get better.
1) Internal audits do NOT need to be classified as major/minor. However, your 3rd party auditor would likely write this as a major nonconformance due to the extent of the 'damage' that exists.
2) Start working on a truly robust CA, which addresses not only the immediate problem, but also the root cause of the problem (why did it go undetected to allow it to get to this extent)
3) Since it is unlikely that you will complete the full CA in time for the audit, document what you are doing - create an action plan and timeline for completion of the actions, and keep it up to date. They may still write you up for the nonconformance, but this will be a part of how you will respond to it.
4) Don't sweat it too much. Things happen, and this is WHY you do internal and external audits.....if you haven't had a customer issue yet that is related to this fault, then you are still doing ok. You just need to get better.
Tagin
Trusted Information Resource
I would focus aggressively on containment, since as you say, you don't have time to correct everything before the re-reg audit: ensure categorically that further damage is prevented, and thoroughly perform a documented review of produced product for potential N/Cs, and actions to resolve those N/Cs.
This issue is troubling in that it seems to reverberate far beyond a single bad gage tech, and I'd expect an auditor might ask:
- How was manufacturing proceeding with work instructions when gages couldn't be found, or were damaged?
- Why was manufacturing failing to escalate any gage issues they detected?
- Why did prior internal audits (or customer audits, etc.) not detect any of these issues?
- Where was management's oversight of the calibration process? (E.g., we have calibration status as one of our maintenance KPIs.)
Hello qcman!! My apologies if I sounded like I was criticizing your calibration system. However, I read this:
That to me... is more than a small issue. That's pretty much close to a complete lack of a quality calibration system.
- To me, this indicates individuals were completing work against a work instruction without having the instrument/equipment called out in it.
- Tagged instruments as if OK to use, but not part of the company's recall/instrument inventory system.
- Multiple past due instruments
Things happen. Granted.
I'm just suggesting that the company makes sure no bad product made it into the hands of the customers due to this; and you have effective plans to assure this doesn't occur again.Maybe to avoid the hassle and expense of paying an auditor to come back to close a major NC for one, and to avoid the stigma of a major for another.
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