Quality of Process or Quality Process?

You're reading too much into this, Jennifer. The operator loads parts into two work holders (chucks) and another part between, closes a door and presses "start" and when the cycle is complete, removes the finished assembly. That's all. Totally controlled by the machine to set parameters. Training required? Minimal. No variation to reduce on the influence the operator. EOS.

CB auditor didn't do anything to evaluate, just recorded the missing record. EOS. And the QMS is in effective... Ba! Humbug!

 

Given the minimalist set of data (you didn't answer my questions) and the fact I wasn't there, all I can do is read into it.

It really is simple. Auditors don't get to decide if a task requires competency verification. The organization is responsible to do that. If the task really is as simple as you describe, then the process is also simple.

(1) Define the requirement and persons to fulfill the requirement.
a) Operator inserts a chunk of material into the chuck.
b) Operator presses the "GO" button.
c) Operator removes the part.

(2) Verify the person can satisfactorily perform the above steps.

(3) Retain documented information/record of (2).

Steps 1-3 are a process. A record of (2) verification of (1) could not be produced when requested at time of audit. That indicates the process is not fully effective - key word is "fully."

I have tried to explain that IATF has an acceptance theshold (zero defects, as it were) you don't seem to agree with. That group is not likely to tolerate your claim that there is no skill in this operator's process position. He is, unless you describe otherwise, operating a machine that produces automotive parts.

If you want to advise the client to dispute the NC, feel free. Please let us know how that goes. I am interested, truly.

 

Not at all! Where's the "effect"? This is what drives management nuts and why the whole certification process is viewed with distain. Auditors say/write something is "ineffective", but what they actually report through evidence is compliance - only. "There's no record" is a simple compliance statement.

Management get measured on effectiveness every day. Measured against a plan. They understand effective and ineffective. They don't understand that a missing record is being called ineffective. Why not? Because it's a simple compliance issue.

For something to be "effective" or ineffective" there MUST be a result - the "effect" if you like. This is, frankly, auditing "101". However, for various reasons; fear of arguing with the auditor, retribution, whatever, no-one pushes back.

 

There is a requirement for an output of a process in order to determine it's effective. In this case, a record. Auditors don't get to pick and choose when to apply this expectation, especially those who audit to regulated industries, - that is, IATF, etc. The requirements we audit to are straightforward and sometimes unforgiving in our perception. We cannot alter that.

By all means, feel free to dispute the action request. I am very interested in how that would turn out.

 

If you are saying that the output of the training process is a record of training, then I give up this discussion. The output of training is a (hopefully, if the training's "effective") competent person! To simply look at a(ny) process and say the output is a record is to miss the whole point of the process! Actually, in this case the auditor is a consultant, so there'll be no appealing it. But since this person is also an IATF auditor, I can't help but feel bad for their clients if that's the type of thing being reported!

 

The output is a competent person, and the evidence to verify the fact. They aren't mutually exclusive.

I can't comment on the auditor being a consultant, as I am not able to confirm he/she consulted for this firm within the defined period that accrediting bodies allow. In either case, the ability to appeal applies.

I reiterate that you should advise your client to dispute the action request if it is not valid. I really would like to hear how that turns out.

 

There is no information regarding what clause the NC was written to.

A record is required by the standard as evidence that someone in the organization has determined competency. In this case, that apparently was a training record.

Andy has not described why the record was missing. All we know is the auditor noted the missing record as nonconformance. No other evidence of the CNC Operator's qualification was provided by the OP. Andy has described the CB documentation as including terminology such as "not effective" so that may or may not have been the auditor's opinion.

Auditors perform in part to expectations set out by CBs' internal procedures, ABs, and in this case IATF. We do not know what the CB's procedures say or what the AB has issued to this CB as nonconformances in the past, but I can offer that IATF is strict in its requirements and auditors I have known did not find themselves permitted to make judgment calls in cases like this. A record was required and was not available at time of audit. That is all.