8D on Audit Non Conformance -- Incomplete Document

Ok. Looking for some help here. Third party audits found a few NCs based on incomplete documents. For example: 5.3 Organizational roles, responsibilities and authorities: "The process of assigning roles and responsibilities is not entirely effective." Objective Evidence: Organizational chart only identifies top management -- does not identify setup persons, operators, or inspector.

Here's the backgroud: Our QMS has at least 20 years of certification behind it (Everything from the old QS, to TS, to ISO 9001). Current cert is ISO 9001:2015 for the past 5 years -- this was the third surveillance of the second cert. So we have had a lot of eyes on it over the years -- first time anyone objected to the Org Chart. The primary way we meet 5.3 is via flow charted procedures which lay out who does what, when, etc. Auditor didn't go past the org chart and never looked at anything else.

So apparently I just can't fix the glitch and update the Org. Chart. I need to do a full 8D style response -- Immediate correction taken; Root cause analysis; corrective action plan, and Verification. I am having trouble filling out those statements. If my immediate correction is to fix the Org chart, then what is the root cause, corrective action, etc.? If my corrective action is to fix the org chart, then was is my immediate correction? Etc.

I suppose my struggle is how do I do a systemic root cause/corrective action on a process that is some percentage (90-95%?) effective and a NC based on a single document the auditor felt was incomplete. Thanks in advance for your help.

First, there's a difference between assigning roles and responsibilities and identifying them. It appears that you have identified them, and there's no requirement in the standard for an org chart, so the auditor (imo) has gone beyond his limits. This sounds like a good one to appeal. The only thing I see is that you're saying that the process isn't completely effective (90-95%). Can you explain that in more detail here? Were there actual omissions?

Do your SOP's, procedure's, instructions, flow charts and all that stuff say who's to do what, when and how? 1st and foremost where's the requirement for an org chart anyway? All an org chart really says is who gets to dump on who and who might make more money. Toss it and say R&R is contained in all our other documented stuff. Below is an Organization Chart

From TS9002:2016 5.3:

Top management should determine how to communicate the relevant roles, responsibilities and authorities. This could be through the use of relevant documented information, e.g. job descriptions, work instructions, duty statements, organization charts, manuals, procedures.

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As Jim said, this NC should be appealed.

Jim Wynne said:

First, there's a difference between assigning roles and responsibilities and identifying them. It appears that you have identified them, and there's no requirement in the standard for an org chart, so the auditor (imo) has gone beyond his limits. This sounds like a good one to appeal. The only thing I see is that you're saying that the process isn't completely effective (90-95%). Can you explain that in more detail here? Were there actual omissions?

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That's a nice catch Jim -- she only called out assigning roles and responsibilities.

So it seems the standard non-conformance language with this CB is "The process of ______________ is not entirely effective." Now, I have no idea what that really means. Is it 20% effective, 50%, or as I said 90-95% effective? Does it make a difference? If I went thru and reviewed everything related to roles and responsibilities I would find that we have both an org chart which identifies top management (and certain authorities if you remember the old QS days) as well as dozens of procedures which identify who, what, when, etc. at the operational levels. As Randy said, there isn't a requirement for an org chart, so it seems I'm just going in circles.

As for appeal, while I agree, the CB is not "appeal friendly" as far as I'm concerned. I have appealed other findings, but not this one because it should be simple "fix the glitch" and move on. Unfortunately it seems they want me to do a full autopsy on the issue which complicates things.

Golfman25 said:

As for appeal, while I agree, the CB is not "appeal friendly" as far as I'm concerned. I have appealed other findings, but not this one because it should be simple "fix the glitch" and move on. Unfortunately it seems they want me to do a full autopsy on the issue which complicates things.

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Make your correction based on what works for you with the standard you are using, file a complaint about a bogus NC and change CB's. I always ask if they have an org chart, if they say no we move on just like I detailed above, looking into the docuemnts themselves.

The only glitch is if you stated that you would have an org chart and then you can make it go down as far as you think is relevant

Golfman25 said:

As for appeal, while I agree, the CB is not "appeal friendly" as far as I'm concerned. I have appealed other findings, but not this one because it should be simple "fix the glitch" and move on. Unfortunately it seems they want me to do a full autopsy on the issue which complicates things.

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Then the thing to do is speak directly to the auditor and establish your position, and the difficulty of doing an 8D when there doesn't seem to be anything systemic going on. If you can't appeal, and I understand that position, you do need to let the auditor know that you take issue with the NC. Ideally this should be done in the closing meeting before the auditor leaves the building, but better late than never. Always remember who's paying the auditor.

Jim Wynne said:

Then the thing to do is speak directly to the auditor and establish your position,

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The time for speaking was during the audit, not after and it's a done deal at this time. I'd wager there's a KPI involved in this somehow.

Randy said:

The time for speaking was during the audit, not after and it's a done deal at this time. I'd wager there's a KPI involved in this somehow.

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I believe I said that time to bring it up was during the closing meeting, before the auditor left the building. I also said that the purpose of talking to the auditor now would be to let her know that there is disagreement, which could possibly put her on notice that similar findings in the future might not be well received.

Jim Wynne said:

Then the thing to do is speak directly to the auditor and establish your position, and the difficulty of doing an 8D when there doesn't seem to be anything systemic going on. If you can't appeal, and I understand that position, you do need to let the auditor know that you take issue with the NC. Ideally this should be done in the closing meeting before the auditor leaves the building, but better late than never. Always remember who's paying the auditor.

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Yeah, thanks. Suffice it to say that when I did question things I was eventually accused of being "combative" and difficult to work with. She thought I should be willing to accept non conformances and said I refused to acknowledge any findings where legitimate (which was hardly true). I pretty much was at my wits end when she told us we would need "training records" for every task (even the simple ones) and operators undergoing training would need 100% supervision (ie; their supervisor standing right there) until they where "trained." To say I am tired of the these people and this CB is an understatement. But I digress. Thanks.