Failure to Close Out an Internal Audit Finding

[SteelWoman]

I have a strange issue/question... I recently did a special audit of one of our dept's because the mgmt. of that dept isn't known for his "follow through" abilities and I was leery of how well his dept. was conforming to his procedures. The audit resulted in 10 findings, one of them "major." The dept. mgr was given nearly 2 months to resolve the findings/fix the problems, but on a scheduled re-check this week it was REAL clear he had not done what was required. I'm concerned about what to do next, having never been in this situation before (!) and also concerned about it's potential impact during our next surveillance audit. I have ZERO management support for disciplining or removing this dept. manager... the suggestion so far has been to just give him ANOTHER deadline, but I have no confidence that will do it. I know I'll need to write up an additional finding about his failure to meet the deadlines, but then what? Any thoughts/suggestions?

[E Wall]

I'm not sure how you could possibly close out the audit finding if the problems still exists. IMHO that should never be allowed to happen.

I've had similar experiences and if you want to help your system...document! document! document! that you are doing everything possible (and keep communicating/updating both the supervisor and the manager). Try to work with the person responsible...sit down together and make a plan (if possible). Make sure the issue is brought up at Mgmt Rev. If you still get no help, wait until your surveillance audit.

Our problem was they were taking waaaaay to long to fix very *simple* things (some very low quality impact - others high). Some folks I was able to 'partner with' so to speak and helped guide them through taking 'correct' steps to resolve the problem in a timely manner, but that didn't work with all. Finally I sent weekly open RCA logs to all involved (originator/recipient) and both the QA Manager and the Plant Manager. Brought it up and pressed for a resolution plan from the plant mgr at the next Mgmt Rev mtg (really need to take on that pit bull persona in there). Of course things continued as they were. Surveillance audit time rolls around. during the review the auditor wanted to know what steps had been taken to have the open items addressed and i was able to show him all the documentation, including the mgmt rev mtg minutes - where the Plant mgr made a bold "Get it done by X or else!" and wanted to know what he did when his deadline passed. He said he spoke with the supervisor and let him know "that it needs to be done" but was still aware it was open. He got a very polite (and it sooo helps having info come from outside the organization sometimes) "I'm dissapointed to see that the system isn't being supported as stronlgy as in the past" and then the auditor wrote up a NCN. Since then we've overhauled the process (literally...step-by-step, paint by number type instructions including form with #'s that matched instruction sheet) made set timelines depending on quality impact, and every Friday I still issue out the weekly 'RCA Open Log'.

[Marc]

A 'Key' here is ensuring your corrective action system has a defined escalation path. If it finally reaches management review and they don't do anything, you've done your job. Let the registrar auditors take it from there.

[goose]

Following Marc's comments we follow the escalation path.

If no response (at least a plan) submitted within 60 days report is issued to monthly Quality Steering Comittee chaired by QA and Plant Manager. Usually this is is effective in getting response for root cause and corrective action.

We have sent a few pesky issues to Quarterly Management Reviews. If items not resolved it's a "hit against Management Review.

Our Registrar auditors like this approach of the Internal Audits being proactive.

[SteelWoman]

Good replies - thanks! Actually I am well known for my "bulldog" tendencies, and also for my documentation... I have hard copies of every email I've sent (which are MULTIPLE) regarding this problem. Today is the actual deadline for him to have finished these items, and I have been babysitting him for 2 months... it is very clear to all involved that the ONLY way these will get closed is to literally DO them myselves, which would involve me doing the guy's managerial job FOR him.. .which frankly I just don't have the TIME to do. So I think today's additional finding will go against upper management, not this dept. per se, for their failure to support the quality system's continued effectiveness. That will, hopefully, get the attention of the uppermost brass. We'll see..... I've already warned my managers that this places our certification in possible jeopardy for a major non-con at our next surveillance audit... wait and see, I guess, at this point.

THANKS all!

[SteelMaiden]

As stated in the earlier posts....sometimes you just have to do what you have to do. Document, document and document every point of contact that you have had with this dept. about the nonconformances. Explain to them (and document it) that if they do not meet the deadlines, the registrar will find it and issue a BIG finding, perhaps even pull your certification.
If your registrar is a good partner to you they should be able to sit your managers down and "lecture" them if it comes up at your surveillance.

Good luck!

[Raffy]

Hi,
As Kevin Mader always say, Document, document and document. We often ask how do we close an audit. After audit, there must be a follow-up audit, to verify the effectiveness of the corrective action the concerned department had taken. During that time, if you found out that the corrective action is indeed effective. Then, its time for you to close the said audit. That is, if you have a provision on your form whether the audit would be closed or not.
Hope this helps,
Raffy

[Jim Biz]

I have a thought on this that might be worth pondering --

In our system - we have an esclation path somewhat as Marc has described - we do an audit - then schedule a follow-up - (usually 30 days) close or determine that a secondary follow-up will be needed.

At the time of the second follow-up (60 - 90 days depending upon the complexity of the issue) seldom does the problem/issue exist in it's origional form - a "partial" implementation or a change in practices can muddy the waters so to speak...

At that point we have "closed the origional finding" & re-issued corrective action updating the planned steps to address "what is left - to clear up the matter.

Given the above example we have closed the origonal finding - without complete effective actions but brought the remainder of the issue back to the top of the list.

Regards
Jim