Audit Response Help Please. ISO9001

On what grounds
On what grounds? Can you even comprehend the gobblety-goop? What can you fix 1st?

A nonconformance is required to have a specific requirement that was not met...."A" is singular, not 145.67 different things.

How can you even start a cause analysis when you can't even figure out what the problem is? Out of the 145.67 things that were required you've got 289.654 things wrong.

Is the problem a document control thing? A record thing? Not following a procedure thing? Something wrong with your monitoring or measuring? Is it a competence thing? How about a crappy internal audit that didn't find all that junk? Is there a lack of leadership commitment? How about failure to implement your quality policy?

It is poorly thought out.

It is poorly written.

And it demonstrates the auditor ceased "sampling" and started digging turning himself into a very large hammer with you being a small nail with this statement alone ....
A larger sample was taken after observing several discrepancies during the stock check.

Had this been a Team thing and had I been the Team Lead and seen this, the auditor and I would have had a chat and the auditor might have been sent packing..........And I have done it!

Probably a stinking KPI of some kind that had to be met. Who knows? Or some "professional" that doesn't understand the terms "conformity assessment', "objective" or "impartial".
 
I suggest one request to the auditor for clarifications. Then escalate if you don't get a helpful response. If your business is processing customer owned tools then it appears you do have some process control issues to resolve.
 
I suggest one request to the auditor for clarifications.
1st - it should have been asked when initially told

2nd - clarification should have been asked at the closing meeting

3rd - I'd lay odds the auditor's response will not happen as desired.
 
On what grounds. I need to pick holes in this substantially to do that?
The "grounds" are that you do not agree with the auditor's interpretation of the clauses - you're requesting an official second opinion.

If you DO agree with the auditor's findings, then leave it be. Your choice.
 
There are few things more frustrating than trying to respond to a poorly written nonconformance. Any auditor that would write such a poorly written nonconformance needs educating, and that's not your job. Find another auditor.
 
Any auditor that would write such a poorly written nonconformance needs educating,
In the past I had to do some educating by saying "you're invited to leave" or not recommending qualification for cause.

I've done the same thing in the past when reviewing prospective instructors. Lack of competency comes out when a prospect gets the "deer in the headlights" look when asked a challenging question like "What's your experience?" or "What is 19011 and how do we apply it?"
 
In the past I had to do some educating by saying "you're invited to leave" or not recommending qualification for cause.
Had a few debates as well. One auditor in particular was receptive and would admit if he was incorrect after we explained our position. Dealt with another auditor however who hated being questioned.

This auditor had a problem with our team (me in particular) for contesting several of his "findings" during the first year audit / TS - IATF transition. He was trying to write us up based on "best practices", claiming he could write us up for anything if he put it under ISO 9001:2015 4.4.1... each time we pushed back, his attitude and demeanor would get more aggressive. He wouldn't allow us to debate anymore at one point and blurted out: "I'm writing the NCs and that's the way it is, if you don't like it you can file an appeal!"
 
This auditor had a problem with our team (me in particular) for contesting several of his "findings" during the first year audit / TS - IATF transition. He was trying to write us up based on "best practices", claiming he could write us up for anything if he put it under ISO 9001:2015 4.4.1... each time we pushed back, his attitude and demeanor would get more aggressive. He wouldn't allow us to debate anymore at one point and blurted out: "I'm writing the NCs and that's the way it is, if you don't like it you can file an appeal!"
If you don't like it you have the right to kick his A&& out of the building and file a complaint! I'm a 3rd party guy, that's all I do and have done for nearly a quarter century and I'm telling you from my side of the table attitudes like that are bull&hit! And oh yeah, "write you up for anything?" That's another big pile of Horse&hit....
:horse:
 
I mean where do we start with this?

1) An audit that claims to be auditing the current process on the grounds of continual improvement is sampling records from 2+ years ago
2) a) The claim that the job sheet should have been ticked. Should it? Is there evidence that supports this?
b) Unless you have a procedure somewhere that states 'all job sheets must have all sections ticked' then this isn't even a nonconformity
3) Logging 'explanation needed' rather than actually going out to find the explanation in the course of the audit.
4) Recommendations given alongside audit findings. Auditors should not try to act as consultants. No good can ever come out of this
5) Increasing the sample size once they believed there was a problem. ISO 19011 (auditing QMSs) recommends not doing this. I'd suggest getting hold of a copy of the internal audit procedure that these people are supposed to be compliant to and seeing if it calls out ISO 19011 as good practice. They've contravened it in so many ways, including not verifying information, not sticking to an agreed sampling plan
6) a) NCs are normally linked to the risk of customers (internal or external) receiving non-conforming goods. Stock systems carry zero risk (OK, stuff might be out of stock and therefore late, but this is normally addressed with communications) and audit findings should reflect this. The scope of your process is carrying out tooling repairs, not managing elaborate stock systems.
b) An interesting thought occurs that - unless you run a very special toolroom - then you likely have a preponderance of grease, cutting fluids and other such substances, which might act as some mitigation against paperwork being filled in promptly. I've worked in chemical processing - in aerospace moreover - and it was absolutely understood by both auditors and employees that it is better to preserve the paperwork than splash nickel sulfate all over it.
7) Not covering the NCs with you before the end of the audit to ensure you understood them and agreed with their findings. Another ISO 19011 requirement.
8) Writing up minor stock issues against multiple clauses of ISO 9001. If you were really non-compliant to all those clauses then this should have been a major finding for a breakdown of system.
9) Drawing unwarranted assumptions in their NCs: "Ineffective communication between the tooling team and procurement team has led to
incomplete or missing records."
How do they know this? It's your job to do the root-cause analysis, not theirs. This record could have been down to dozens of possible reasons, and if it's the one from 2022 then I guarantee they didn't try to find all the personnel who were working on it at the time. The NC should be a statement of evidential fact, not a half-assed root cause.

If anyone had tried to stick me with this audit report, I would have declined to accept it. And if they hadn't held a closing meeting in order for me to have the chance to decline it, then I would have complained directly to their superior(s).
 
There is a HUGE difference between an internal and external audit. While some of the precepts are similar, an internal audit can and should also identify concerns beyond conformance to requirements. Many of the constraints imposed onto external audits, primarily third party audits should definitely be rethought during (well executed) internal audits.
 
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