8D on Audit Non Conformance -- Incomplete Document

Golfman25

Trusted Information Resource
Personally: I am not a great fan of 5-Whys for problem solving... but even the adherents will recognize that there is no logical rationale regarding the number "5".

Obviously: the auditor should have issued the observation in such a way that the non-conformance should be well understood (by the CA team, by the org, by the third-party).



I don't work at the company, so what follows is speculation: Is it possible that the "root cause" is that titles on an org chart do not 100% align with job duties/responsibilities, such that for any given human with a specific job title there may not be evidence which demonstrates that human is trained to execute the job responsibility?

The argument that anyone with a given job title must be trained to do the assigned work doesn't pass the red-faced test for me, because if this was true a company ought to be able to make the case that no employee has to attest they did any work by name... they could simply write down their job title.

I don't want to propose action items to address this finding, but my guess is that (1) formally documenting specific training assigned to the humans, (2) updating the WI to indicate which training is specifically necessary to to execute any given WI, would be enough to erase any doubt that someone was ever trained, or trained at the time of execution. For a small company, I wouldn't expect you need to lean that hard into a training overhaul, but it doesn't seem unreasonable to document when individuals are qualified to execute certain WI.
Thanks for the attempt. I am not sure where training is even relevant regarding assignment of roles and responsibilities. But you seem to fall into the "training = competence" camp, which it may or may not. And you're analysis would be correct if the auditor did anything more the a cursory review of an org chart to support her finding. If she found actual non-competence on the floor, or confusion as to what a person's role or responsibility was, then maybe we would have something to work with. It's the old garbage in, garbage out problem.
 

Golfman25

Trusted Information Resource
Back to the question at hand. It seems my CB wants both a correction and a corrective action. According to the Auditing Practices Group guidance (and I don't know how much weight they carry), there are times when both a correction and corrective action are not always appropriate and either/or may be sufficient on it's own. It also addresses evaluation of the need for comprehensive root cause analysis based on the nature of the findings and whether they appear to indicate a systemic failure.

If I do my correction -- add the boxes to the org chart I have part 1. The problem is when I do my root cause and 5 whys I get stopped at about why #3. Start with Problem: "assigning roles/responsibilities is not entirely effective."
Why 1: Org chart doesn't identify all roles i.e.; operators.
Why 2: Because those roles are identified in applicable procedures
Why 3: Because that is allowed by the standard (i.e.; org chart is not required).
Thus, no root cause because their is no non-conformance. This would seem a perfect application of the above guidance which indicates a correction would be all that is necessary. I am missing something. What am I missing? Thanks
So basically closing the loop here. Submitted the above, with the root cause statement that we made compliance over complicated by not having a single consolidated document. "Fixed" the org chart and added some brief "job descriptions" and bingo it was approved. Sorry, but this is the joke the whole ISO process has become.
 

Jim Wynne

Leader
Admin
So basically closing the loop here. Submitted the above, with the root cause statement that we made compliance over complicated by not having a single consolidated document. "Fixed" the org chart and added some brief "job descriptions" and bingo it was approved. Sorry, but this is the joke the whole ISO process has become.
Sometimes incompetent auditors force us to tell them what they want to hear rather than what makes sense.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Is this really true? If so it clarifies some past experiences.
Context matters. There may be a charge for processing. An auditor may receive a portion of this fee as compensation for the time taken after the audit is finished, to follow up on and close out NCs. The intent of this is to discourage softgrading.
 

Golfman25

Trusted Information Resource
Context matters. There may be a charge for processing. An auditor may receive a portion of this fee as compensation for the time taken after the audit is finished, to follow up on and close out NCs. The intent of this is to discourage softgrading.
What’s wrong with “soft grading?” It allows for nonsensical “findings”, like the one described here, to be moved along to real substantive findings. And charging me for each NC, encourages non-substantive findings and is a massive waste of time And money. Updating an org chart that has been around for 20 years and multiple auditors is entirely worthless.
 

Golfman25

Trusted Information Resource
Is this really true? If so it clarifies some past experiences.
So our contract specifies there will be a charge for each NC. Obviously requires a lot of trust between us and the auditor not to raise BS issues. What has happened twice now, we signed with a local auditor we knew and trusted, they move on, and they send us the auditor from hell. We are leaving the CB because after the fact they basically suck. Still waiting for a response on my complaint I filed months ago.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
What’s wrong with “soft grading?” It allows for nonsensical “findings”, like the one described here, to be moved along to real substantive findings. And charging me for each NC, encourages non-substantive findings and is a massive waste of time And money. Updating an org chart that has been around for 20 years and multiple auditors is entirely worthless.
Accrediting bodies frown on issuing an OFI for something that should have been a nonconformity, simply because the auditor doesn't want to spend any of his/her own time taking the effort to close them out.

If you feel you have received a non-substantial finding, dispute.

Why have an org chart if you aren't going to keep it current? I wonder if there isn't a better way to communicate that information anyway.
 

Golfman25

Trusted Information Resource
Accrediting bodies frown on issuing an OFI for something that should have been a nonconformity, simply because the auditor doesn't want to spend any of his/her own time taking the effort to close them out.

If you feel you have received a non-substantial finding, dispute.

Why have an org chart if you aren't going to keep it current? I wonder if there isn't a better way to communicate that information anyway.
It was current, just not “complete” in the eyes of the auditor. And, yes there are better ways to communicate, such as flow charted procedures, which we use. So why even write it as a NC or OFI? Changing the chart was a complete 1000% waste of time and did absolutely nothing to make us a better company. How is that justified under any standard? Point being, the standard audits should be about substantive issues, not meaningless BS, even if technically it could be considered a “non conformance.“.
 
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