Failure to Close Out an Internal Audit Finding

S

SteelWoman

#1
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?
 
Elsmar Forum Sponsor

E Wall

Just Me!
Super Moderator
#2
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

Hunkered Down for the Duration
Staff member
Admin
#3
Escalation Path

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.
 
G

goose

#4
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.
 
S

SteelWoman

#5
thanks

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

Super Moderator
Super Moderator
#6
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

Quite Involved in Discussions
#7
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
 
J

Jim Biz

#8
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
 
S

SteelWoman

#9
Closing out

Good responses all around... to update you, the original findings were NOT closed out due to uncooperative dept manager... I extended the deadlines at the request of MY manager (who also manages the problematic manager), and the guy managed to come in under the wire (barely) with some semblance of resolutions. I'm going to attempt to confirm effectiveness this week. But I have, to cover everything, printed out a BOOK of emails about the problems I've had here, and done 99% of my communications with the dept manager only by email so I have documentation. I DO plan to enlist the help of my registrar's auditor when he is here in a few months, and ask him to sit down with my management team about it. I'll probably get in hot water for doing that (one of my manager's says "it won't be a problem unless you make it a problem!") - but for my own integrity and, more importantly, the integrity of this quality system, I need to get the message across (with the help of the registrar) that this is serious stuff... not to be trivialized as, "Oh well... the guy sure tried hard, didn't he."

Thanks for your postings... very helpful, and I particularly liked the suggestion of involving the registrar, if only for a talk with my management team. Our registrar is quite cooperative with such things and I do think that will be effective.
 
A

Al Dyer

#10
SteelWoman,

Stick to your guns with your morals and attitude, reputation is the best thing you can have in our career choices.

I once did this when I issued a corrective action to the Vice-President for not holding monthly management meetings. I kept documentation and informed my boss, the General Manager, of the lack of response. He said to make a decision and he would back me up.

After about 3 requests for at least a response I let the subject go and informed the G.M. and gave him a "copy" of all my documentation.

During the surv. audit it came time for management review. I asked the V.P. if he would like to sit in with him and the auditor. As we had two auditors he said no Al, you can go with the other auditor.

After about an hour the lead auditor and I met for a time out. He was laughing so hard I thought he was going to have a stroke.

The V.P. had hand written meeting minutes with no sign-ins or no outcomes, and he had mis-dated them and forgot we had a formal sign-in sheet, agenda, and outcome measurements.

Although he could have written me up under 4.17, he decided to give a major to the V.P. for management review.

Of course as the M.R. I had to sign-off on the write-ups and the V.P. went ballistic.

I did have a good G.M. who stood behind me and backed up my actions, he threatened to fire the both of us. We lasted another two years going through the same crap and the company is now a proud holder of a QS-9000 certificate from Perry Johnson.:D
 
Thread starter Similar threads Forum Replies Date
silentmonkey How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Root Cause Failure Analysis - Not following Customer packaging Specification Problem Solving, Root Cause Fault and Failure Analysis 9
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Kaizen Events - Factors Affecting Failure Lean in Manufacturing and Service Industries 13
C Failure nets - Same level effects FMEA and Control Plans 0
C Failure mode at 0h, vs. 1 year vs. 5 year... FMEA and Control Plans 8
R How to properly use Survival Analysis to predict time to machine failure Reliability Analysis - Predictions, Testing and Standards 0
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
M Informational US FDA – Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples Medical Device and FDA Regulations and Standards News 0
C Detection Action for Failure Effects - AIAG 4th Edition Layout FMEA and Control Plans 5
Marc NASA Says Oregon Company Metals Fraud Caused $700 Million Satellite Failure - 2019 World News 16
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
N PFMEA repetitive failure modes in subsecuent stations. FMEA and Control Plans 1
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
J How to look up Failure Modes on FDA website FMEA and Control Plans 4
P Electronic component failure analysis turnaround time Reliability Analysis - Predictions, Testing and Standards 0
C Design for Assembly in DFMEA - Failure Effect of Sub-System(s) FMEA and Control Plans 5
Marc Server RAM Failure - 7 Dec 2018 Forum News and General Information 3
K Spot weld - Peel test failure Manufacturing and Related Processes 3
C Electrical Power Plant Supply failure in PFMEAs FMEA and Control Plans 10
kisxena Memo to File - Failure to Validate Supply Chain Security Management Systems 1
Y IEC 62304 Section 4.3(a) - 100% probability of failure IEC 62304 - Medical Device Software Life Cycle Processes 3
S FMEA column column ''therblig motion'' for a given potential failure FMEA and Control Plans 12
J What does "factional and failure dependencies“ mean? FMEA and Control Plans 1
N PFMEA Potential Failure Mode for Weight FMEA and Control Plans 5
P Root Cause for a Process Validation Batch Failure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Infusion Pump Power Failure Alarm IEC 60601-2-24 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Determining Effect of Failure without a DFMEA (Design FMEA) FMEA and Control Plans 1
R Will multi-time flashovers constitute a failure of Hi-Pot test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
P IATF 16949 - 10.2.5 Warranty and 10.2.6 Field failure IATF 16949 - Automotive Quality Systems Standard 1
J Medical Device Failure Effects - Where to draw the line? FMEA and Control Plans 8
kedarg6500 Potential Effects of Failure(s) FMEA and Control Plans 23
Marc Definition PFH - Probability of dangerous failure per hour Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition PFD - Probability of failure on demand Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
C Squeeze in one more - Rate of failure Statistical Analysis Tools, Techniques and SPC 6
L First Time Completing a 5 Why/RootCause Failure Analysis Nonconformance and Corrective Action 8
Z Failure Mode Identification in PFMEA according to AIAG FMEA Rev.4 FMEA and Control Plans 6
B IPCD Sterility test failure during MPQ (EO sterilization validation) ISO 13485:2016 - Medical Device Quality Management Systems 2
A Failure Mode from Operator "Components Fallen but Loaded" FMEA and Control Plans 3
D Is Failure to achieve a Goal a Major Non-Conformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Population failure rate based on attribute data Statistical Analysis Tools, Techniques and SPC 4
P UFMEA - Use Failure Mode Effects Analysis FMEA and Control Plans 7
Sean Kelley Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
alonFAI Component Failure (Relay) during ICT Testing after Surface Mount Assembly Manufacturing and Related Processes 5
J Thread Gauge Calibration Failure for Pitch Diameter being too large General Measurement Device and Calibration Topics 3
J Should failure mode caused by Fixture problem be into PFMEA? FMEA and Control Plans 2
T Weibull analysis of life time test of 8 electric motors until failure Reliability Analysis - Predictions, Testing and Standards 9
Q Corrective Action - Product failure during testing Nonconformance and Corrective Action 7

Similar threads

Top Bottom