Starting QS9000

[Marc]

[email protected] wrote:

--> My company is considering becoming qs9000 as one of your possible
--> customers want this. I have a few questions I hope you can answer:
-->
--> 1) Can you pass a QS9000 audit if you have some minors found during
--> the audit.

Yes - but you do have to 'fix' the minors.

--> 2) Can I get just a section of the plant certified ( some machines,
--> one team of people) while the rest run to our ISO9002 and AS9000
--> system?

Technically you can limit the scope of the registration.

--> 3) Do I have to go back into my files and do AQP, FMEA, PFMEA ect
--> for jobs already run and shipped through the years? Do I have to do
--> this for jobs in stock we have no orders for?

You start doing them when you 'officially' start the system. You do not go back and do stuff that is out of production. But - if it's in production you have to have a control plan, process FMEA & flow diagram.

--> 4)Do I indeed have to get everything calibrated within the shop
--> (personal equipment, Maintenance equipment) If only company owned
--> equipment is ever used for product acceptance.

Nope - but everything has to be inventoried.

 

[Tom Goetzinger]

IMHO, I don't agree with "but everything has to be inventoried".
In our environment, only certain measuring devices have to be calibrated and only those that do appear on our Master Calibration lists. Our procedure supports this, and it has not been objected to.
You have to do what makes good sense and is of value to your business. Just be prepared to defend your decision; you must have considered the options and it is wise to have evidence of what you decided. Management Review minutes are one place this can be done.

 

[Marc]

So far my experience (including minor citations) has been that every instrument has to be identified (this does not mean everything has to be calibrated) and in the calibration database. Who is the registrar who accepted your scenario and what are the words in your procedure that supports this?

 

[Andy Bassett]

I must admit that i also understood that all test equipment has to be included in the register (within reason of course), and the registration companies that i have worked with have wanted to see that the equipment is identified with a simple sticker when it is not calibrated.

ie 'Not for production use'
'Not Calibrated'

Regards

------------------
Andy B

 

[Tom Goetzinger]

Our registrar is NSF International Strategic Registrations, Ltd.
We specify in our procedures that all measurements used to determine final product quality must be made using calibrated devices and that only those devices will be added to our device list.
We are QS 9000-TE, and maybe that is the difference. While listing all devices is a common approach, I don't see the standard as requiring it, and I don't see where it does a business any good to maintain records on those devices which are not calibrated. Does not seem to add value. Our auditor agreed, after a through review of our methods and results.

 

[barb butrym]

they do need to be identified......and listing is a way of doing that...but not required. I have used, in a few instances, a dye penetrant/ink/paint of a certain color to indicate all personal property (or even company owned, not calibrated)...and of course the status is identified as cal not required...and no acceptance is made using equipment with the marking..or you can choose to verify prior to use

 

[Elberth Ardila Tabera]

IMHO, I don't agree with "but everything has to be inventoried".

In our environment, only certain measuring devices have to be calibrated and only those that do appear on our Master Calibration lists. Our procedure supports this, and it has not been objected to.

You have to do what makes good sense and is of value to your business. Just be prepared to defend your decision; you must have considered the options and it is wise to have evidence of what you decided. Management Review minutes are one place this can be done.

[This message has been edited by Marc Smith (edited 09 February 2000).]

 

[Tom Goetzinger]

Marc,
Why the big concern of who the registrar is? Plain and simple, the standard does not require all measuring devices to be identified, only those that "can affect product quality" (4.11.2.b), and I won't get into the discussion of "if it doesn't affect quality, why are you measuring it" discussion.
Just because it is a common practice to inventory and identify all measuring devices does not make it required. If you have received minor citations for not having them all identified, perhaps the reasoning behind the decision was not adequately documented.

 

[Marc]

I hear what you are saying, however the expectations of registrars I have 'experienced' in my implementations have expected all equipment to be identified and accounted for in a listing. Now I hear you saying "...show me where it says that..." but that does not always work.

I ask which registrar it is because I want to be able to say DNV (or whichever) allows this. There has been an evolution in interpretations of the requirements since the 1987 release, and since the '94 revision as well, as you well know, and I want to be sure this is a common 'ruling'.

As a weird example, I have seen registrars get upset if your quality manual does not address something - sometimes it's just a detail of a list. You tell them "...we didn't write about it because we don't do it..." - depending upon the registrar you may or may not be written up. Now let's face it - nowhere is it written that even if you don't do servicing you have to have a statement to that effect in writing in your quality manual and/or procedure. And common sense (mine, of course) tells me that to write it is - well, why can't the mgmt rep just say "...we don't do servicing..." and let it go at that.

So yes - when I find a registrar is accepting an interpretation I haven't seen accepted before I want to know which registrar it is and I want to be sure I have my facts streight.

 

[Marc]

Elberth Ardila Tabera: Who is your registrar?