Hi all,

We have our doc review tomorrow. We're going from QS9000 to ISO 9K:2K. Any tips, hints, things I should have ready to go? This is what I have so far...


Quality Manual: based on the standard, very flowery, lots of "we will" and "we do" in place of the "shalls"
Required SOPs: one for each of the six required procedures
Process SOPs: flowcharted procedures that divide our business into ten sections (ordering/CS, R&D, purchasing, processing, three separate packaging processes, QA, shipping, and management review)
Level 2 SOPs: ones that we write when we need them, haven't changed from the previous certification (except to clean up the references to now-obsolete documents)
Work Instructions: same as above
Controlled forms: same as above


Anything else that you can think of that we should have ready? Our internal audit report should be done by tomorrow - the plant manager is "auditing the audits" as we speak. I plan on printing out our CARs from 1 January on. The Key Measurables reports from each month are ready to go. Anything else? Feedback is much appreciated - I'm starting to feel nauseous...

Cheers,
-R.

Even though process maps are not required...


Do you have a description of the process interation required in 4.2.2 c)?
Can you show where you have met 4.1 a) - c)?

Process maps help to meet these requirements, but are required. So what did you do?

Even though process maps are not required...


Do you have a description of the process interation required in 4.2.2 c)?
Can you show where you have met 4.1 a) - c)?

Process maps help to meet these requirements, but are required. So what did you do?


Our Quality Manual has 9 sections - 1-8, like the standard, and a section 0 which is a little preamble about our company, what we make, history and so on. The first three sections of the standard are fluff, so I used those to outline the quality policy (Section 1), the QMS scope and roles, including a process map (Section 2), and org charts (Section 3).

Is this okay, do you think?

Our Quality Manual has 9 sections - 1-8, like the standard, and a section 0 which is a little preamble about our company, what we make, history and so on. The first three sections of the standard are fluff, so I used those to outline the quality policy (Section 1), the QMS scope and roles, including a process map (Section 2), and org charts (Section 3).

Is this okay, do you think?

If the process maps meet the requirements listed, there should be no problem.

Now another question: Does your QM and your QMS work? Is it beneficial? (okay I can never ask only one question :o ) If you answer both of those questions with a "yes", then stick to your guns and convince your auditor that this is the best system for your company (for now).

I think so. I think our docs are in good shape. At this point I'm just wondering what kind of records he wants to look at...

I think so. I think our docs are in good shape. At this point I'm just wondering what kind of records he wants to look at...

Typically, the doc review will not consider many records. the emphasis will be mostly on whether the "shalls" are addressed. I had one client that asked to see records of how the process maps were generated. He was told that the maps are the record, and they built it by a team effort, writing on a white board. He was okay with that. He mostly wanted to make sure they actually sat down and figured it out rather than using something downloaded off the web.

Sounds good Rachel. One thought however on the shall, will, do issue: We had one auditor that was touchy about using the word "will", in that it is in the future tense (i.e. some day in the future), as opposed to "shall", which implies a mandate, or "do / are / have" that imply current practice. For example, we say "All contracts are compared to the original quote" instead of saying "All contracts will be compared to the original quote"

{{auditor: "why hasn't THIS contract been compared to the quote?", you: "Oh, it WILL be"}}

Its nit-picky, I know; but auditors are sometimes a weird bunch.

Rachel,

How did it go? You have to let us know. It could have been worse it could have been on you Birthday the other day.

Greg B

but auditors are sometimes a weird bunch.
I resemble that remark.......especially true if the auditor is also a Metrology professional.......

Hershal

I resemble that remark.......especially true if the auditor is also a Metrology professional.......

Hershal

IS that allowed?! :eek:

Rachael,

I would like to know how it went as well. I am submitting our quality manual next week.

Hello all,

Thanks for the concern and good-luck wishes. I am happy to report that our document review could not have gone any better yesterday (I'm logged in on a Saturday - I officially need to get a life :o ). No non-conformances, a couple of minor things to look out for between now and our initial assessment (neither of which are directly related to documentation), and big kudos from the auditor. The auditor told me (in the presence of my boss - always a perk!) that I did an outstanding job with the documentation development, especially considering that I've only been with the company for six months. Rather nice to hear...after four months of thinking "oh crap" and worrying whether I'm going to screw it up and let the company down. Nothing like getting validation right from the horse's mouth...

Then - if Friday could have gotten any better - I got one of the coolest birthday presents from my boyfriend lastnight. It's a wall clock...but the numebrs on the face are replaced with the corresponding atomic symbols!

"It's a quarter to He right now....give me a couple of hours...I'll meet you at Be:Li."

BeSt PrEsEnT eVeR...what can I say?...he knows the way to my heart.

Have a great rest-of-the-weekend, all...thanks for all your help and advice over the last few months. It's still too soon to say...but...I might not get sacked!!

Cheers,
-R.

Rachel, :applause:

Well done. From what I have seen of your work, over the past few months, I doubted if you would have failed. It is always meticulous. They would be mad if they let you go.

Now getting to the heart of the matter. You have just celebrated a birthday and passed an audit and recieved what I assume is the world's best present, So what are you doing logging in on a Saturday????? (here am I logging in on a Sunday - Austrlian time) Anyway, again, Well done and keep up the good work.

Greg B

:applause: Congratulations Rachael. I know that you breathed a huge sigh of relief.

Congratulations Rachael. I know that you breathed a huge sigh of relief.
Yeah. I think I heard it from over here.. :lol: . Good job Rachel. :agree1: .

/Claes

Way to go, Rachel!! :applause:

Well done Rachel :applause: .......concentrate on what has to be finalized for the initial assessment........good luck......and a belated happy birthday :)

Thanks everyone! It sure does feel good to be over that hurdle...but it's not over yet. Now, to focus on the actual audit... :mg:

Well done, Rachel!

When will the audit be? (My apologies if you already said when but I missed it.)

Speaking of document reviews, I have a question for all:
When do auditors 'normally' review the documentation; e.g., procedures, master documents and records lists, etc? (Our registrar auditor already reviewed and approved our manual, and I am about ready with the rest of the documents, but the audit will not be until August-September.)

Thanks

Alex

Alex,

Thanks for the congrats! :)

I think it's just a scheduling thing. My understanding is that the doc review is usually closer to the audit than ours was. We scheduled the doc review for 7 May, the pre-assessment for 25 May, and the audit for 7-8 June (two auditors). Most of that was because of scheduling restrictions, though - we have to be through the process by 1 July (customer request), and the auditor schedules were already pretty full by the time management got around to approving the contract. :rolleyes: There's also no saying that they have to come in to do it formally, either...our auditor will let us courier our docs to him for review off-site as well. I think it's just whatever works - as long as the doc review is completed before the assessment.

Cheers!

Okay, maybe this is dumb, but...

...so the documentation is ready. The SOPs, QM and WIs are all updated and current. I know we still have to review control plans and stuff like that...that's in the works.

Question - what do I do now?
What are the things that I should be covering off to make sure that we're ready?

I have a feeling that this is one of those questions that only I can answer...

The silence is deafening.





Start looking for problem areas. You WILL find them, even if they become smaller and smaller. Auditors have a knack for zeroing in on the one thing that is deficient. Keep going through the standard with the view that you are the registrar asking how you comply. Do "dress rehearsals" so to speak. I usually do several iterations, and always find more to clean up. June will be here in no time and soon the atomic symbol clock on the wall will say, "it's time!".

Gee Rob, you make it sound like an impending doom. The atomic clock.... :lmao:

Rachel,

Just keep doing your normal reviews, audits, updates etc as they come in so you have evidence :evidence: of continuing compliance. I wouldn't go out of my way to find issues as in my experience you (I) only get flustered and may (do) alienate some people. IMHO QA should be a part of everyone's normal working lives and not stand out or make people nervous. If you are nervous about the outcome then others may be.....I sound as ominous as Rob.

Just sit back and put your feet up you've earned it. Remember a NC is not the end of the world. It is a tool used to ensure that you rectify a problem in the system it is not personal and not business or life threatening.

Greg B

So day 1 of 2 is complete - and there have been no non-conformances so far. A whole list of OFIs, but they can suggest all they want - I don't mind.

Keep your fingers crossed for me!
Cheers,
-R.

Good job Rachael. My fingers are crossed. :applause:

Just sit back and put your feet up you've earned it. Remember a NC is not the end of the world. It is a tool used to ensure that you rectify a problem in the system it is not personal and not business or life threatening. Greg B

You have a great way with words Greg. . .

Congrats Rachel. . .

So day 1 of 2 is complete - and there have been no non-conformances so far. A whole list of OFIs, but they can suggest all they want - I don't mind.

Keep your fingers crossed for me!
Cheers,
-R.
Be sure to use the OFIs as basis to start on your preventive actions. I wish we had done that from the get go where I work. Our QMS is 7 years old and we only have 3 official preventive actions. We always get dinged on that. Fortunately we have begun a new initiative to correct that.

May your audit result in a recommendation for registration.

Jaime

Audit is complete.
One minor, 6 OFIs.
Recommended for registration (!). :lmao:
Rather exciting.
Thanks for all the advice - paid off!
-R.

CONGRATULATIONS!!! :applause: It is time to celebrate now!!!:beerdive:

Super! :agree1: Congratulations Rachel :agree:

/Claes

Audit is complete.
One minor, 6 OFIs.
Recommended for registration (!). :lmao:
Rather exciting.
Thanks for all the advice - paid off!
-R.

Canadian Girls Rule. Sorry Roxane would probably say that :lmao:

Well done Rachel, :applause:
It is little wonder that you passed after veiwing your work and responses in the cove.

Greg B

Thanks everyone - I have to admit that it's a big vote of self-confidence. Being fresh out of school and fairly young, I sometimes wonder if I can hack it in the big business world...but it's pretty neat to feel myself getting my footing.

Now, next Monday I'm off to our US division to get the ball rolling down there...

It better be patio weather this weekend, because I think several de-stressing/celebratory beers are in order for me! :beerdive:

Canadian Girls Rule. Sorry Roxane would probably say that :lmao:

You took the words right out of mouth, Greg...or rather, right off of my keyboard! :D

Audit is complete.
One minor, 6 OFIs.
Recommended for registration (!).
Rather exciting.
Thanks for all the advice - paid off!

Congrats!

It better be patio weather this weekend, because I think several de-stressing/celebratory beers are in order for me!

I hear it's nice this weekend (maybe some light afternoon showers on Saturday)...the de-stressing celebration is a must after every successful external audit.