Anxiety - ISO Re-registration Audit

[ASDriven]

I was hired as the Quality Manager 4 months ago at a medium sized machine shop. The previous manager retired prior to my arrival so I received no formal insight in to their QMS. In addition, the company was doing itself a big dis-service by utilizing an auditor that just didn't care and would look the other way in areas that should have been clear major findings. This went on for years.

We now have a new auditor and my concern is that it won't go so well and I'll be ousted from my position as the audit is set to occur about a month from now. While some things are being done correctly, other items are utter disasters.

I'm afraid that I won't be able to regurgitate every area of the QMS and am asking if any one has experienced this situation before. If so, how did you prepare? Could I play the "new guy" card?

**My anxiety is through the roof**

 

[contigo123]

How about acknowledging the problems by issuing non-conformances/CAPAs now so that you can show evidence of having plans in place to address the issues? I get the same anxiety, but it's better to not hide things and rather just address them up front. You would be demonstrating that you have a proactive approach as the "new guy". Also consider running an internal audit before the external audit

 

[blackholequasar]

I agree with @contigo123 - writing a CAR/NCR on known process failures is a good start.

Where does upper management stand on the issues? Are they not involved in what happens in the production floor and therefore it goes kind of unchecked? I've worked in that same situation before and we had several Major findings for ISO - so much so that it finally woke up the upper management to "hey, this isn't going to work and we will lose customers". Once you put a cost on it, they seem much more intuitive to what is going on. (Funny how that works...)

 

[yodon]

I'm afraid that I won't be able to regurgitate every area of the QMS

Nor should you! You're just the point. You don't DO everything so you shouldn't hesitate to call in the process owners for help during the audit.

Could I play the "new guy" card?

Not a good strategy, IMO. The audit is supposed to be based on facts. Whether you're new or not shouldn't have any bearing on the facts. It does show a lack of planning on management's part just to throw you into the swamp - but that should reflect on management, not you.

I like @contigo123 's suggestion of doing an internal audit. Then discuss those findings with management to see where they really stand.

I'll be ousted from my position

If that happens, it may actually be a good thing for you! If they're not behind you and committed to the system, you're probably going to be pretty miserable in the position anyway.

 

[AllTheThings]

If that happens, it may actually be a good thing for you! If they're not behind you and committed to the system, you're probably going to be pretty miserable in the position anyway.

I personally think that audit findings against some part of 5.1.1 are probably not issued nearly as much as they should be. But understandably...Upper management is in the best position to venue shop registrars if they get their hand slapped.

This may be a CYA type situation, especially with the limited time. Some internal auditing, and a gently worded gap/risk analysis (with paths to success explained) for upper management may be in order. That way, you are preparing them for potential bad news from the audit, but with a path to succeed for your organization. As long as you don't pull a 'sky is falling', and couch it in terms of risks and solutions to be addressed, pending external audit results, you shouldn't scare them with cost/impact. That puts you in the position of being proactive and prepared, rather than reactive. Good management should recognize that.

 

[ASDriven]

I deeply appreciate everyone's comments and suggestions! My head is just spinning as I think I'm trying too hard to shove a square peg in to a round hole.

@contigo123 @blackholequasar @yodon the internal audits and CARs stemming from those findings is an awesome place to start and lay the foundation down to a more well established, conforming and effective QMS.

@blackholequasar @yodon @AllTheThings - upper management is bi-polar. The company had gotten away with quite a bit and were never dinged for any of their outstanding issues so to them everything was peachy. I really hope that a risk analysis associated with the internal audit findings will make them more apt at implementing effective solutions. If not, I don't believe there's much else I can do.

I'm assuming the auditor would still give us a minor if my response, to the areas where I've started improving the procedures and processes for, was something along the lines of 'we just started to improve our existing process and procedure with final review and implementation in the next management meeting'?

 

[blackholequasar]

It depends on your auditor, to be honest. It's good to identify shortcomings of the quality system and your processes, however they may look at the historic fact that the previous auditor did not do their due diligence in investigating. You never know where it's going to go with ISO, tbh. But I'm going to try to be hopeful for you! Prepare for the worst, hope for the best, you know? It's HARD when you have a more seasoned workforce who is very laissez-faire to the importance.

In some cases, lose your certification = lose your customers.

 

[Sidney Vianna]

In addition, the company was doing itself a big dis-service by utilizing an auditor that just didn't care and would look the other way in areas that should have been clear major findings. This went on for years.

One more case that exemplifies the damage created by incompetent CB auditors and welcomed by a large portion of the registrant community. It would REALLY help your case if you could demonstrate to your management IF and WHEN such unreported major findings (as you put) have led to product returns, customer complaints, inefficiency, cost of poor quality, etc...

 

[Mike S.]

OP, I've been in your shoes. It takes awhile to get your feet on the ground and understand the culture, understand the history, and understand the current "state of the union", so to speak. Once you do, be honest with Management. Call it like you see it. As someone said, document and let them know what you see as nonconformities and what risks are involved in that.

Let them know, hey, so far I have had time to look at X, Y, and Z and this is what I found. Based on that, there likely are more areas of concern I haven't gotten to yet.

You are, or at least shouldn't be, in this alone. As someone said, don't shoulder the burden alone -- call in the process owners and Management and make sure they know they will be required to participate. Good luck!

 

[Kronos147]

I went to work for the current machine show where I am at 2 weeks before the audit.

I prepped myself by going through the manual and seeing if I could 'point' to all the stuff.

Yodon is right, the process owners should do most of the talking this time. IMO, you should use the event as your own gap analysis. What does your quality policy say? You want to continually improve? The audit will be a way for you to collect data for evidence-based decision making to determine what to address first!

Remember, the audit is about the processes, not the people. If management doesn't get that and fires you for a bad audit, collect the unemployment and find the right company!

Cheers