Raising a Major Nonconformance during an Internal Audit

Wes Bucey

Quite Involved in Discussions
#11
Ok, We got a nc from registrar 8 months ago, I audited the process during this audit and the corrective actions are not implemented, no pm schedule yet for 2014, no records for the few Preventive maintenance, they are not recording since november last year, no predictive methods in place, the metrics are not updated since 8 months ago, no records of shut down time. I'm worried about this become a Major during next surveillance audit from registrar.
I checked old registrar reports which indicates they had similar findings in the past years.
Please suggest,
Everything you do from here on depends on where you are in the food chain and whether ANYONE else agrees with you.

If you are the lead auditor, you should not wait to file the N/C in a mundane fashion. You should go to the MFWIC and say, "In my team's audit, we noticed something which needs to be addressed right now, because it will affect our registration/certification status when the registrar's auditor comes."

Then lay out the story, trying mightily to keep from blaming any individual (ultimately, the blame goes to the top dog for letting it slide!)
Then ask, "Do you want our team to write this up as a major N/C now or do you want to direct some attention to this situation and have us come back next week? This may just be something that has slipped through the cracks."

If you are NOT the lead auditor, you need to raise the issue with the lead auditor and see if you can persuade him to do the above. You will only be risking your job if you skip the chain of command. Under no condition should you write this up as a major N/C without the concurrence of the lead auditor AND his signoff.

WES'S OPINION:

Despite how drastic and dire QC JEWEL feels this situation is, it is a common occurrence in small to medium size organizations and, though once rare in large organizations, the recent "belt tightening" has made it less rare. It is probably best handled diplomatically rather than beating someone over the head with the facts. It is never smart company politics to put a boss under close scrutiny unless one has a "shield" from higher ranked bosses. Most success might be had as scripting the alert as a "timely warning" ["look what I saved us from!"] than as a threat ["do this or I'll tell."]
 
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Golfman25

Trusted Information Resource
#12
Ok, We got a nc from registrar 8 months ago, I audited the process during this audit and the corrective actions are not implemented, no pm schedule yet for 2014, no records for the few Preventive maintenance, they are not recording since november last year, no predictive methods in place, the metrics are not updated since 8 months ago, no records of shut down time. I'm worried about this become a Major during next surveillance audit from registrar.
I checked old registrar reports which indicates they had similar findings in the past years.
And Also we were warned by the auditor for potential major in this area... I'm more worried to loose the job for not clasify it as Major ;

Please suggest,
Sounds to me like your PM system is too complicated and easy to get lost in the shuffle. My suggestion is to suggest to the powers that be that they look to simplify it to make it easier to comply with. Good luck.
 
Q

qualityboi

#13
The non-conformity could be symptom of a larger problem. Has the company defined and implemented an effective corrective and preventive action process? Has the QMS developed a venue for escalation of non-conformities, product defects and returns? Short term I would ensure the issue is raised to your supervisor. Long term a good process for CAPA and escalation should be defined and implemented so there is a common ratified process that is effectively deployed to follow up for these types of findings. Lastly, think about it showing up in the Management Review as an open item when reviewing results of audits.
Some companies management try to dump QMS to one group, even worse, one person...if participation in the QMS is not enforced by top management to become part of the culture it will be a very long road for you and the company's quality journey.
 
M

mguilbert

#14
At the company I work for we have never designated findings as Minor or major. That is for external auditors in our opinion. Our job as internal auditors is to identify non-conformances and close them when the corrective action has been effective. Based on the evidence I have seen you may need to ensure all know how to determine the root cause and implement a proper corrective action. IMO a non-conformance can be issued for corrective action 8.5.2 specifically 8.5.2 f as this issue has been recurring for sometime. You may want to search this site as there are many threads and free files on PMs and give them suggestions on ways to prevent the reoccurence of the PM issues. BTW an external major should not be an issue for the audit team if the corporation takes ISO seriously. The major is not the fault of the auditors but the system itself especially if this has been brought by the external and internal auditors in the past.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#15
What does your procedure say?

When I audit, I like to ask "What do you do with a nonconformance that repeats?" The answer helps to understand the process's planning to address a complex problem (not every problem has a single cause, just as not every weed is a Dandelion) and sometimes people need more help/resources/interdepartmental cooperation.

And so, for a repeat nonconformance I would issue a Major for a repeat nonconformance; after all, if I were to come along during an ISO audit and find this, as per my CB rules I would need to issue a major. Better you than me... but for internal audits the process could be to elevate the nonconformance to the next level management, with the clear distinction that this is a repeat nonconformance. An internal procedure would need to be very specific about the definition of repeat and the escalation practice.

If your audit/NC process doesn't already have this type of capability, you (leaving out the potential issue of overly complex PM system, which isn't your problem) have two problems. Once is a repeat nonconformance, and the second is no means to get this heightened level of attention.

:2cents:
 
Q

QC JEWEL

#16
:thanks:Thanks to all of you for your replay.
I'm the lead auditor, and QC Manager is the management representative.

I had the closing meeting for this process, I invited the Process owner, QC Manager, maintenance supervisor, I told QC Manager that I need his support in the meeting due the serious of this issue, during the meeting I told them about the certification risk due repetitive problem and no effective actions in place, Manager agreed with me, and I asked to sign the non conformance report as acknowledgment, he commited to evaluate and take proper actions.
Plant Manager was not present however he asked about the meeting later and I told him the results and I also sent the results by email stating that we are risking our certification.
I expect to have the chance to review the audit results with the director and make sure he is aware of the results.
Any more comments and ideas are very welcome!
Jewel
 

John Broomfield

Staff member
Super Moderator
#17
:thanks:Thanks to all of you for your replay.
I'm the lead auditor, and QC Manager is the management representative.

I had the closing meeting for this process, I invited the Process owner, QC Manager, maintenance supervisor, I told QC Manager that I need his support in the meeting due the serious of this issue, during the meeting I told them about the certification risk due repetitive problem and no effective actions in place, Manager agreed with me, and I asked to sign the non conformance report as acknowledgment, he commited to evaluate and take proper actions.
Plant Manager was not present however he asked about the meeting later and I told him the results and I also sent the results by email stating that we are risking our certification.
I expect to have the chance to review the audit results with the director and make sure he is aware of the results.
Any more comments and ideas are very welcome!
Jewel
Jewel,

Are the nonconformities analyzed to sort the trivial many from the vital few? Are your precious corrective action resources focused on the vital few costly nonconformities while the trivial many are repeatedly corrected?

Who has accepted the responsibility for the corrective action on your process for stopping recurrence of costly nonconformity?

Does this person have sufficient authority formally delegated to them by the Chief Executive?

Or is the responsible office the CEO itself?

John
 
#18
Something which is missing here is the effect of all this poor pm going on. Sure, it "may be" a "major" and certification could be jeopardized, but seriously, what would happen? The auditor issues a major nc, you have to reply, they wait a year to come back... I can see everyone still getting 8 hours sleep a night.

I'd stop calling non-conformities major and minor - it's the wrong message IMHO. What's important isn't grading or fear of a CB auditor. What's important is what the effect of poor pm is on customers and profitability. As an auditor, did you evaluate, QC Jewel, the effect of this? Don't forget the ISO 9001 standard requires effective processes and reporting this is the most important thing you can do.

When the president of a large manufacturing company was told that the effects of processing non-conforming product costs them $8M a year, he didn't need to know about a certificate or if this is graded "major"...
 
R

Reg Morrison

#19
The auditor issues a major nc, you have to reply, they wait a year to come back...
Not in the IATF-controlled, TS world. A major NC has to be followed up and resolved much sooner than 12 months later.

A major nonconformity shall require onsite verification of the corrective action...and be completed within a maximum of ninety (90) calendar
days from the closing meeting of the site audit.
In cases where the accepted corrective action plan for a major nonconformity is found to be not effectively implemented, the audit result shall be considered failed, the IATF database shall be updated, and the certificate withdrawn (see section 8.4).
In cases where the accepted corrective action plan for a minor nonconformity is found to be not effectively implemented, a new major nonconformity shall be issued against the corrective action process (see ISO/TS 16949, section 8.5.2) and the previous minor nonconformity reissued as a major nonconformity…
 
J
#20
What does your procedure say?

When I audit, I like to ask "What do you do with a nonconformance that repeats?" The answer helps to understand the process's planning to address a complex problem
(not every problem has a single cause, just as not every weed is a Dandelion) and sometimes people need more help/resources/interdepartmental cooperation.

And so, for a repeat nonconformance I would issue a Major for a repeat nonconformance; after all, if I were to come along during an ISO audit and find this, as per my CB rules I would need to issue a major. Better you than me... but for internal audits the process could be to elevate the nonconformance to the next level management, with the clear distinction that this is a repeat nonconformance. An internal procedure would need to be very specific about the definition of repeat and the escalation practice.

If your audit/NC process doesn't already have this type of capability, you (leaving out the potential issue of overly complex PM system, which isn't your problem) have two problems. Once is a repeat nonconformance, and the second is no means to get this heightened level of attention.

:2cents:
WAIT - - YOU MEAN A DANDELION IS A WEED?????

I LIKE DANDELIONS....:tg:.....I LOOK FORWARD TO THE FIRST ONE EVERY SPRING.

JAMES
 
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