QMS has not been maintained. How do we stay certified to ISO 9001?

[Frankie11]

Hi everyone,

I was hired a few months back as the QHSE Manager for a medium-sized manufacturing company with 5 factory/sales offices in various states. The company is certified under one ISO 9001 certificate. I was warned as early on as my first interview that most of the branches were no longer maintaining their QMS to the standard.

I have begun visiting the various branches and performing gap analysis for each one. In some cases, it's a complete omnishambles: they have stopped documenting non-conformances and customer complaints/feedback, management reviews and internal audits haven't been done since 2011 etc etc.

I am sending back reports to the branch manager and the CEO and I am also providing branch managers with an Action Plan for them to implement. If all goes to plan, they will be back up and running by March when we have our surveillance audit.

I am worried about how to address the huge gap in documentation (in some cases from 2011) up to now. Will the auditors be satisfied with seeing the gap analysis and completed action plan? Is there anything else I should do to save our certification?

Many thanks in advance,
Frankie.

 

[JulieChisholm]

You should have this formally documented as an internal audit if you can, and issue CAPAs for the non-conformances. In our last ISO audit, anything that I had already identified and was in an audit report, they down-graded from a non-conformance to an observation. A gap analysis is great, but I doubt you have a procedure that requires each department to respond to the observations and present an action plan with a system to monitor closure to each observation. I'm sure it seems overwhelming if there are that many issues, but the ISO auditors are interested in assuring there is someone in the Quality role that understands the standard, and there is an action plan in place that is place and that will get the company back into a reasonable state of compliance. I don't know which body you are using, or your industry.

This is just my personal experience and good luck. I'm a bit in your position as well.

-Julie

 

[Frankie11]

Thanks Julie,

I was hoping to avoid issuing formal CARs at this stage. I want to make the process of getting the system back up and running as painless as possible but I can see the benefit in doing this. And it will be good practice for my newly appointed QA reps...

I have in fact put together a procedure of sorts for how the non-conformances are to be actioned, reviewed and closed out. I think now I will formalise this document and get the CEO to sign off on it.

 

[Sidney Vianna]

most of the branches were no longer maintaining their QMS to the standard.

they have stopped documenting non-conformances and customer complaints/feedback, management reviews and internal audits haven't been done since 2011 etc etc.

Are you focusing on the right problem? It seems to me that loss of certification is secondary to the apparent system breakdown.

Actually, suspension or revocation of the certificate could be a bless in disguise, don't you think? It might be what top management (and the rest of the organization) needs to take ownership of the system.

 

[AndyN]

I want to make the process of getting the system back up and running as painless as possible but I can see the benefit in doing this. And it will be good practice for my newly appointed QA reps...

Why? Remember the saying "no pain, no gain"? The fact is life is full of consequences and the extra work required is because they didn't do the minimal work earlier, needed to maintain the system. You should make it painful, otherwise they won't get to understand...

 

[JulieChisholm]

For an organization that strayed that far out of compliance, the entire experiece is going to be painful no matter what. The OP is just trying to "get it done" which is what any Quality manager should do. I consider myself a service organization and not the other way around. Now most people at my company jump through hoops now to meet what I consider are the requirements. They had to experience growing pains, but I certainly didn't want to contribute to that or not mitigate any of it if I could. And everything then got done that much quicker!

 

[Tara Monson]

I agree with Julie. In order to show you want to maintain certification, you need to make your QMS work for YOU. If your branches are not abiding by the QMS, it is still your job to abide by it. Write up an internal audit report complete with associated CARs to show that you take this seriously.

In my experiences, giving other the "chance to fix problems" before writing up CARs has never proven to be effective. They have more "important" things going on.

Document Document Document.

If you don't want to avoid the work of issuing CARs, that not only shows your new QA techs that you do not take the QMS seriously, it also shows the CB that you are not following your QMS and the standard.

I'm interested to hear how this turns out! Keep us updated!

 

[claireyvb]

Hi,

I have come across this in the past and mitigated with good effect.

Like you I conducted a gap analysis to see where the system was at. Following that I explained the likely outcome of audit and future business implications resulting from the lack of adherence to the QMS to management. Following that I created an 'Integrity Statement' or 'QMS Structure Statement' explaining what has happened, what had been done to assess the situation, what plans were being implemented to correct this (it included SMART objectives) and most importantly I got the Management Representative to sign up to it.

In our case the auditors were 'happy' (I use that loosely) to see that we had identified the issue and that something was being done about it. Obviously we signed ourselves up to delivering on those objectives and I expect the auditor to be 'crawling' all over these objectives at next visit.

I hope this helps!
Claire

 

[db]

I had this happen to a client a few years back. What saved them was a couple things. The gap analysis and the concentrated effort to get things back working again (not just answering the NC's). The other thing was the response of top management. When the new QM came on board and saw how messed up things were, she went to top management. He confirmed that he knew things were not right because of the increase in scrap, customer complaints and other types of data. They held a Management Review meeting and she showed how the increase in pain the organization was feeling was directly related to the breakdown in the QMS.

The pain is what got them to start taking the QMS seriously. There were still issues during the recertification audit, but the survived the entire process and their system is much more robust as a result.

 

[Mikishots]

Thanks Julie,

I was hoping to avoid issuing formal CARs at this stage. I want to make the process of getting the system back up and running as painless as possible but I can see the benefit in doing this. And it will be good practice for my newly appointed QA reps...

I have in fact put together a procedure of sorts for how the non-conformances are to be actioned, reviewed and closed out. I think now I will formalise this document and get the CEO to sign off on it.

If you have any expectations of the CBs accepting your analysis and allowing you to continue, you will need to show that you understand not only analysis and containment, but correction as well. You MUST issue CARs if you find that the QMS is not effective. This falls squarely in 4.1 (c) and (f).