Auditor threatening Formal NC and CA for not enough PA

A

ABRSPLY

During our last re-certification audit, our auditor documented zero preventive actions for the calendar year. We are a small company and only manufacture 1 product. We have almost no customer complaints, no injuries, and our reject material is all fed back into the system. However, he is suggesting that if we do not have any preventive actions for the next year, he will issue a formal non conformance and corrective action. I do not feel this is justified with our history.
 

AndyN

Moved On
Hello and welcome to the Cove!

It seems a little unfair that, after 3 years, the auditor would slap an NC on you for something which should have happened during those 3 years! So, firstly, I'd appeal it and point out your CB auditor(s) have been delinquent in not bringing this to your attention in previous years (they didn't did they?)

Also, it's usual for even the smallest business to take some form of preventive actions. Do you do PM on your machines? That's preventive action! Do you calibrate measuring equipment and find them to be OK? That's preventive action! Do you carefully review a client's drawings/specs before you make something? DO you feedback questions to the client? That's preventive action!

You may just not realize you're doing it and, clearly, the auditor doesn't!:popcorn:
 

Bev D

Heretical Statistician
Leader
Super Moderator
Agree with Andy. Usually most companies get 'locked in' to the paradigm that Prevetnive Action should be on a 'form' like a corrective and forget that many of the normal everyday thaings they do are PAs. among those not mentioned by Andy:
  • 5S
  • SPC and other statistical analyses
  • FMEA
  • Risk assessment
  • mistake proofing
  • Ideas or suggestion programs
  • visual workplace (signs, lables, color designations)
 
A

ABRSPLY

We have had several preventive actions in the preceding two years. We already have a PM in place, a strict safety program with a monthly reward, a procedure for calibration, etc. We also provide monthly employee training. We have many continuous improvements each year. We just do not see any other areas that we have not covered that would be considered preventive action
 
T

t.PoN

I would not use the word "Threaten" .... geeees are you going into street fight?

Ok. I think there is two side of each story.
Now a company with zero reject, and zero nonconformity reports will suggest that the staff are not reporting non-conformities any more and that it cast the doubt of your auditors competency or impartiality.

Now this is only assumption that needs to be validated as true or false. one simple way to do it is your certification report. if there is many major weaknesses and your auditors report nothing then I would stand with your external auditor.
if there is drop in customer satisfaction or capturing defects on the audit filed, I will stand with your external auditor.

but if there is no sign, and he is going after a hunch or assumption, then I would "THREAT" to never deal with him/her again
 

Bev D

Heretical Statistician
Leader
Super Moderator
We have had several preventive actions in the preceding two years. We already have a PM in place, a strict safety program with a monthly reward, a procedure for calibration, etc. We also provide monthly employee training. We have many continuous improvements each year. We just do not see any other areas that we have not covered that would be considered preventive action

Yes those are preventive 'programs', but each time you take an action under that program it is a new preventive action. You simply need to point out the actions you've taken under these programs and your auditor should be fine with it. If he's not, you have grounds to contest the finding with the registrar. you ARE taking preventive actions...
 

cscalise

Starting to get Involved
I recently went through 3rd party lead auditor training and evaluation of evidence for PA was discussed. Many think that generating a preventative action in response to a CA meets the requirement. This typically isn't the case. One suggestion was to have the company hold (at least annually) a meeting that includes various departments to discuss/brainstorm potential areas for non-conformance and potential preventive measures. Minutes from this meeting can be used as evidence of preventative action activities. This can also be included in management review meeting minutes.
 
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