Non-conformance and Corrective Action Advice per ISO 9001

[Boscoeee]

Re: Non-conformance and Corrective Action Advice

I don't think it's a case of sabotage, just a case of people don't see it as important or not as important as other things they have to do. They all talk the talk and say they see how important it is but they fail to follow it up with action. They just can't see that with some short-term sacrifices they can save themselves some real hassle in the future.

I believe there is a complete lack of accountability for middle managers, if something goes wrong they blame people further down the order. The MR has raised this issue and once again everyone nods their heads in agreement but once again fail to take action. The 2nd in command is aware of the issues, but I'm not sure how aware the person at the very top is.

No one said this QMS thing would be easy, but as long as I'm in this role I'm determined to make sure it succeeds.

I applaud your passion, however the scenario you painted does not seem to support your efforts. Teamwork makes or breaks the implementation of QMS, the organization has to want control of the business systems or else it will not flourish. One of the functions as a MR is to inform Top Management as to the effectiveness of the Quality Management System, it is not his job alone to make sure it succeeds IMHO!

 

[JaneB]

Re: Non-conformance and Corrective Action Advice

I don't think it's a case of sabotage, just a case of people don't see it as important or not as important as other things they have to do. They all talk the talk and say they see how important it is but they fail to follow it up with action. ....
<snip>
No one said this QMS thing would be easy, but as long as I'm in this role I'm determined to make sure it succeeds.

Easy? Not necessarily, but it can and should be 'easier' than it obviously is at the moment.

To summarise: no, you definitely don't keep on doing audits and raising individual CAs once you've identified a system-wide problem. To do so would be a prime example of ineffective problem analysis and ineffective action.

Audit is not supposed to be responsible for finding all the problems, and audit cannot and should not (ever!) be expected to compensate for people within the system not following it, nor being accountable for this.

This is one that senior management - at the highest level needed - has to recognise the problem and address it -ie, make clear what they want and ensure it is done. It is never possible to drive this from the bottom up. Just another reason why the Standard is so clear about the need for Leadership and the role of 'top' management.

And as Sidney says, you cannot get an ISO 9001 system by dropping off various bits of the PDCA cycle - you need all of 'em.

I feel for you - I know the problem - but it has to be owned and driven by the top. Otherwise, it's a no win, doomed to failure thing.

 

[Jen Kirley]

It is an old story. Make a system, everyone nods their heads 'yes', then they go about their business. The eventually auditor comes along and plays the role of inspector. There's lots of work for the auditor because there's lots to inspect and lots to find. And it never stops because there's no alignment between what the system is asking people for and what management is asking people for.

So I was wondering: why are these documents important? What is their function? What would happen if the documentation got lost? What would happen if outdated instructions were used? Would errors be made that cost money? Have there been? What kind, how often, how costly?

Some documentation is more important than others, and failure to properly manage it can bring ghastly costs. Like here in the U.S., if we can't produce something convincing to show we're providing training, material support and documentation needed for a functioning lockout tagout program and someone gets electrocuted, we could be fined several thousand dollars per employee. But most documentation isn't as important...until you need it.

Management has some choices. Not being able to manage documentation isn't very pretty, but having an ineffective correction program is kind of serious. Something needs to be done.

So I recommend the management decide what is important, why, how to make it as trouble free to perform, and make following these processes part of people's measurable performance indicators. Alternately, sites could be celebrated when they make the biggest improvements or stay "cleanest" over time.

Of course there are risks, such as people hiding stuff. That's why we should try to make it so hard to get it wrong that we can hardly help but get it right. Then auditing can perhaps become less of a nuisance factor.

 

[Sidney Vianna]

Just like we can't inspect quality into a product, we can't audit processes into a system.

 

[JaneB]

No, one definitely can't audit processes into a system.

Lots of good advice from Jennifer.

Not being able to manage documentation isn't very pretty, but having an ineffective correction program is kind of serious. Something needs to be done.

Yes, very much so.

And making it part of people's measurable performance indicators is important. Without it, change is most unlikely to happen, because unless senior management is measuring the behaviours they want and aligning those in their management system, nothing happens. Unless you count internal auditors running around and around on a useless kind of treadmill something 'happening'. I don't.

 

[JaneB]

I don't know if this helps, but if I was in this situation as (contracted consultant acting as) internal auditor, I'd provide a clear report on the problems, the evidence of the problems, and the response required from senior management.

If it didn't change, even after I'd worked as hard as I could on educating them, then ultimately I would leave the engagement, ie, withdraw my services. Because I know all too well how much frustration there is in such a no win situation. Been there, done that, got the scars and the experience.

You don't - and can't - own this particular problem, nor can you solve it. It's up to top management.

 

[newtoiso9001]

Thanks all your replies. To be honest it's only early days for the QMS, there's be 18 years without it and only 1 with it. It's going to be a massive culture change from the very top to the very bottom.

 

[Jan T]

You keep saying that it is early days. The system is not functioning! If you allow something of this nature to go on what is to say that the rest of the processes and systems will not follow? Who is steering the ship?

Jan

 

[newtoiso9001]

Maybe a bit of a breakthrough yesterday. All managers have now been told by one of the directors that they must visit their sites during February and ensure that all the issues we keep picking up are resolved once and for all. We will therefore stop auditing for February and recommence in March, and if we still keep finding the same issues then the managers will be held accountable.

Will hopefully see improved results in March.