Auditing strategy

[SeanN]

Yes, I've gathered that it's been advised against.

It's more culturally that I'm struggling with, than technical Quality Problems.

Because the NCR's are in the hundreds it's nearly impossible to tackle- I've posted previously on this forum about it separately. It's a very bad sticky plaster that I'm managing, we've always just had enough in place to pass audit but not a robust QMS. We're coming up to audit and I'm just trying to pick up the pieces from previous years, just at least for this years audit. It's a tough job but someone has to do it and it's a pick your battle situation.

Culturally, it's more just about change management and managing people. I can look in all areas of the QMS and see issues, it's just about picking one problem and seeing it through until it's fixed.

N.galt, I've read many interesting and thoughtful posts in this thread. In your case, it's probably about both culture (change management and managing people, as you mentioned) and technical (ISO9001 is more general than AS9100). I am rather junior in QA here in the US (as a new and soft chapter in life, under circumstances), but pretty senior in business management as CxO in several countries for 21 years. My personal tips:
- Have two "books", one for yourself and one for "outsiders".
- For yourself, be very sincere to yourself and your management, carefully list and plan for what should be done for your QMS.
- For outsiders, very well prepare to handle possible questions/concerns/ etc. the immediate goal is to pass the audit. Try to make "majors" look "moderates" or "minors".
- Nothing else.
- If you pass the audit, you will have some break to implement your plan (who do what and when and how, and how much etc.). If you cannot convince your management about your CAPA plan (because they don't see the necessity, as you already pass it, why putting more resources?), get tips from a management forum and start plan B for your career (with 1 more star in your CV, passing the 9001 audit).
- If you fail the audit, it's unfortunate for your company, but a good opportunity for you to carry out your plan. Very likely that your management will accept your plan.
At the end of the day, I guess you are the one who can sit on a "very bad sticky plaster" for too long. So, the "CAPA" plan should be your ultimate goal, not the audit.
Good luck!

 

[Sidney Vianna]

My personal tips:
- Have two "books", one for yourself and one for "outsiders".
- For yourself, be very sincere to yourself and your management, carefully list and plan for what should be done for your QMS.
- For outsiders, very well prepare to handle possible questions/concerns/ etc. the immediate goal is to pass the audit. Try to make "majors" look "moderates" or "minors".
- Nothing else.

Really? In a world where the biggest challenge for quality professionals is the fact that most don’t understand that a high-performing, sustainable and welcomed QMS is only achieved when it is properly, seamlessly and invisibly embedded in the organization business processes, you advise someone to have “2 books”? A façade one for external consumption and another one to tell it like it is?

No wonder the quality function is so disregarded in most organizations. It is perceived as a hindrance rather than an asset.

 

[Randy]

Really? In a world where the biggest challenge for quality professionals is the fact that most don’t understand that a high-performing, sustainable and welcomed QMS is only achieved when it is properly, seamlessly and invisibly embedded in the organization business processes, you advise someone to have “2 books”? A façade one for external consumption and another one to tell it like it is?

No wonder the quality function is so disregarded in most organizations. It is perceived as a hindrance rather than an asset.

Probably why one is and will most likely stay "junior"

Really 2 sets of books? In a previous life I was a criminal investigator with a specialty in "White Collar Crime". Never, ever have I've seen 2 sets of "cooked books" work. Oh yeah, if you've got any SOX requirements or existing/pending customer/consumer litigation, not only the books are cooked, but probably someone's "Goose" as well.

 

[SeanN]

Really? In a world where the biggest challenge for quality professionals is the fact that most don’t understand that a high-performing, sustainable and welcomed QMS is only achieved when it is properly, seamlessly and invisibly embedded in the organization business processes, you advise someone to have “2 books”? A façade one for external consumption and another one to tell it like it is?

No wonder the quality function is so disregarded in most organizations. It is perceived as a hindrance rather than an asset.

Sidney, I meant two "notebooks". Two plans to handle the situation. When I say "Try to make "majors" look "moderates" or "minors"", it's totally possible when assessors see our readiness and willingness. Apologies if I was not clear enough.
Life is not always easy and straightforward. Read the second half of my post. The ultimate goal is a real QMS as most quality professionals want to be in. How to get there is an art you need to learn over time. In some cases, you are hired to pass an audit (at least that's their expectation/assignment to you). If you don't, you may have no chance to present your "high-performing, sustainable". Be realistic.

 

[SeanN]

Probably why one is and will most likely stay "junior"

Really 2 sets of books? In a previous life I was a criminal investigator with a specialty in "White Collar Crime". Never, ever have I've seen 2 sets of "cooked books" work. Oh yeah, if you've got any SOX requirements or existing/pending customer/consumer litigation, not only the books are cooked, but probably someone's "Goose" as well.

Randy, no "cooked books" by any means. One who has to "cook" things to create a new approach to a problem is questionably "senior" - smile. N.galt is in front of a real challenge and I assume he is not expecting someone reading a textbook for him now.

 

[Randy]

The ultimate goal is a real QMS as most quality professionals want to be in.

The ultimate goal be to be honest with a strong code of personal ethics in all things.

When I say "Try to make "majors" look "moderates" or "minors"", it's totally possible when assessors see our readiness and willingness.

I care not one thing about readiness & willingness because they aren't part of the audit equation when I audit.......Guess what, that's all I do, audit, certification type audits as do a couple others here. I can mention your "readiness & willingness" in a summary section or somewhere like that, but in 20 or so years I haven't seen that in any of the multiple standards I do......Nope, nada, no where.

Wanna get a head start? Get rid of that major, minor, 3 bags full fluff you document and record whether it's broke or not, that's it.... Broke-Fix it, Not broke-Move on and leave it alone. Call the bad stuff what you want, doesn't matter, and nobody really cares, I sure don't and I've probably seen about as much as there is as has Sidney and a few others.

You start playing silly "A" games and it's be like messing with very high voltage or a really mean dog........You'll get bit.

We've strayed way off path from what the OP was asking and saying, so I'll apologize for that, conversations have a way of flowing and that's a dynamic some here seem to fail to appreciate.

 

[ChrisM]

In my opinion:
You should be defending your QMS to the hilt against the auditor(s). It's "your" system and demonstrating numerous flaws in it to anyone outside your organisation is almost like writing your own death sentence. Get through the audit then produce an internal report highlighting issues that would have caused serious issues if the audit had flagged them up; see what sort of response and commitment you get from the Senior Management before considering what you need to do next.

 

[SeanN]

In my opinion:
You should be defending your QMS to the hilt against the auditor(s). It's "your" system and demonstrating numerous flaws in it to anyone outside your organisation is almost like writing your own death sentence. Get through the audit then produce an internal report highlighting issues that would have caused serious issues if the audit had flagged them up; see what sort of response and commitment you get from the Senior Management before considering what you need to do next.

ChrisM, I am with you on most points.
One of the benefits of being in a forum like this is that you see (have seen?) perspectives from 3 different groups: auditors, auditees, hired business management. Sometimes opinions are too extreme, and the intensity of the conversation is unnecessarily elevated, but we can indeed learn something from everyone (like, what usually called, "worse-case scenarios").
People may opt to be "super" auditors, but if they do not understand auditees and managements, I doubt that they can really go far. In my opinion, a successful and resilient QMS is when the 3 above groups have buy-in attitude and truly understand others' perspectives and needs (and then they can support each other).

 

[Golfman25]

ChrisM, I am with you on most points.
One of the benefits of being in a forum like this is that you see (have seen?) perspectives from 3 different groups: auditors, auditees, hired business management. Sometimes opinions are too extreme, and the intensity of the conversation is unnecessarily elevated, but we can indeed learn something from everyone (like, what usually called, "worse-case scenarios").
People may opt to be "super" auditors, but if they do not understand auditees and managements, I doubt that they can really go far. In my opinion, a successful and resilient QMS is when the 3 above groups have buy-in attitude and truly understand others' perspectives and needs (and then they can support each other).

Good point. And the biggest issue I see from quality types is failure to understand management. So "management doesn't care," they get frustrated and act like the world is ending. Management may have a much bigger perspective of the organization.

 

[ChrisM]

... and the higher up the business Management structure you progress, the more the focus is on the financial effects on the organization.
Ask for £100,000 or $100,000 for a project to make a quality improvement and almost certainly it will be dismissed outright. Support it with a brief report detailing how this spend will save twice or three times this amount within, say, a year and the spend will almost certainly get approved