Do I have to write a procedure for every element in QS-9000?

J

jasone

Procedures

Hello everyone.

I am a QE who is pretty new to managing QS. My question is: Do I have to write a procedure for every element in QS or every sub-element, or just those that say "Supplier shall have a documented procedure..."

I am having a difficult time writing one for 4.1.

Thanks for the help.
Jason
 
T

tomvehoski

QS is obsolete and has been replaced by ISO/TS 16949. If you are setting up a new system I would not base it on QS any more. Get a copy of 16949 and work from that.

There are required procedures required by 16949. They are not as rigid as QS was. You do not have to write them based on the numbering of the standard. Write them to fit the way your company operates. There are several message threads here that will probably help you.

Tom
 
A

Al Dyer

Please listen to Tom, QS will be invalad by the end of the year.

Or is there a situation where you are not automotive but there is a major customer asking you to comply with QS?

It's tough enough to go from a registered QS system to TS, let alone not having QS compliancy and working your way through to go to TS.

More info please??????:) :) :)
 
R

Rick Goodson

Tom,

A follow on to your post. I would appreciate your opinion.

Can a TS procedure cover more than one TS requirement. Also, can a TS procedural requirement be covered by a flowchart? A form or chaecklist that is self-directed (does not require document instructions to complete)?
 
J

jasone

Here is the deal

OK here is my deal right now.

I just started this company this month. I have been charged with setting up the QS9000 system. It is a Japanese company and as far as I know, our customer does not require QS9000 but we are courting customers like Chrysler.

I have spoken up several times about the futility of setting up QS when it will simply be obsolete and I have gotten shot down all times (not for lack of trying). Our Japanese parent plant apparently became QS certified not too long ago and these guys think we can use most of their paperwork to become QS. Well, all I have so far is a Quality Manual that will have to be rewritten because of translation errors. Plus I have argued that procedures, work instructions and documents will all have to be written or at least controlled.

Is it possible that I could set the system up to cover both QS and TS? Will QS be grandfathered in if TS is achieved?:bonk:
 
T

tomvehoski

Rick: You can combine procedures as you like. There is not (and has never been) a requirement to address specific clauses of the standard in a particular procedure or order. There are several areas I normally combine:

Document, Data and Record Control
Corrective and Preventive Action
Product Control (old 4.7, 4.8 and 4.15)

I have fought company directives in the past to number per the standard (4.1, 4.2, etc.) so that it better fits operations and does not need to be updated to match standard revisions. I provide a cross reference chart in the policy manual (which is numbered per the standard) to link everything together. I use flowcharts for most of my procedures - there is no requirement one way or the other. I just find they are easier to understand for everyone and I can define a better process in one graphical page instead of four text.

Jasone: QS is officially dead in 2006. Some of the big 3 have already stated they want it gone by 2004 and everyone transitioned to 16949. If you implement QS you will be wasting money since you will eventually have to go through an upgrade audit for 16949. I think the required audit days for an upgrade are almost the same as a new audit, but don't have the numbers in front of me right now.

If you want ISO 9001 certification also you will have additional problems. Since QS is based on ISO 9001: 1994, which expires 12/15/03, registrars cannot issue you a 9001 certificate beyond this date. Trying to get a QS and ISO 9001: 2000 certification is tricky and confusing for the registrars since they are two different standards, not one with an "extension" of requirements.

I think you will also find that 16949 is easier to implement and a better standard. It is not as rigid as QS, requires less documentation and should help build a better quality system.

You say you are courting Chrysler - are you actually making automotive parts now? 16949 is only for automotive parts manufacturers. I believe the registrar is going to require you show that you make auto parts, or are at least bidding on the work. I am still waiting on an interpretation on my chrome plater from the registrar to determine if a motorcycle part is "automotive". They are quoting car parts which will cover them, I just like to drive registrars nuts with crazy questions.

If you are not making auto parts now, ISO 9001: 2000 will be a better fit. 16949 is built on top of it, so you can easily upgrade later. Audit day upgrade requirements from 9001 to 16949 are also lower than QS to 16949.

I suppose it would be possible to set up a 16949 system and have it audited to QS. There are some QS requirements that were dropped, so you would have to map both standards to your system. Again you would be wasting time and money since you have to upgrade eventually anyway and everyone will accept 16949 right now.

Last, unless your operations, processes and parts are almost the same as your Japanese parent you probably will not get much value from their procedures, especially with a language barrier. Some common systems, such as corrective action, may be able to be merged, and probably should be if you need to exchange information on a regular basis. If you operate autonomously you are probably better off setting up your own system. You can use theirs for guidance, but remember it may not fit what you need and there are also some "bad" systems out there you do not want to model yours after.

Tom
 

Randy

Super Moderator
tomvehoski said:

Jasone: QS is officially dead in 2006. Some of the big 3 have already stated they want it gone by 2004 and everyone transitioned to 16949. If you implement QS you will be wasting money since you will eventually have to go through an upgrade audit for 16949.

Tom

Listen to Tom Jasone.

If you haven't already done so change your approach to the leadership on this topic. Get out of the QE/QM role and get into the business subsystem management role. Revolve your discussions and arguments around the fiscal issues involved. Show cost vs returns data for doing the outdated compared to doing the new updated system. Talk $$$ with them, not procedures and all that other krap. They want to know "How much will it cost? How soon will I get it back" How much will I make/save?" , and that's it.
 
J

jasone

Ok, I tried

I don't think this is going to be the first time you guys run into someone who is being forced to use QS. My approaches did not work.

Worse than that, the President is insisting that I use all the Quality Manual and all procedures from the Japanese plant because they are under the impression from our registrar that we will be audited as a division of our Parent Company.

Well, needless to say, I am going to go ahead and try to adapt the procedures from our Japanese parent company but I am also preparing contingencies and making my own documentation as a backup so our initial audit doesnt put me in a precarious situation.

So, my question still stands: Do I need to write a procedure for every element? If so, I would really appreciate the opportunity to see someone's element 4.1 as I am not sure of the approach I should take.

Thanks again.
Jason
 
T

tomvehoski

It is possible that you will fall under a multi-site certification. If they are the parent company you would have to abide by their quality manual, more or less. How many divisions are we talking about? If there are only two, you really do not save anything by going with the corporate scheme. It will give you many more headaches since you (and your division president) may not be able to control your own system. Even if there are five or six divisions it is still probably not worth the reduced audits for the corporate scheme - loss of another divisions certificate will also result in yours being taken/suspended. You may want to point this out to your management and have them contact your registrar to get their opinion.

How are the Japanese procedures set up? Have you even been able to get them translated to review? I would really avoid writing by element. Here is my typical QS procedure setup:

1. Org. structure and authority (org chart, R&A statements)
2. Contract Review
3. Design Control (if applicable)
4. Design Changes (if applicable)
5. Document and Record Control (4.5 and 4.16)
6. Purchasing (4.6)
7. Supplier Approval (4.6)
8. Product Control (4.7, 4.8, 4.15)
9. Process Control (4.9)
10. Maintenance (4.9)
11. Receiving Inspection (4.10, 4.12)
12. In-Process Inspection (4.10, 4.12)
13. Final Inspection (4.10, 4.12)
(note 11-13 often combined depending on client)
14. Calibration (4.11)
15. Nonconforming Material (4.13)
16. Corrective and Preventive Action (4.14)
17. Internal Audits (4.17)
18. Training (4.18)
19. Servicing (4.19)
20. Statistics (4.20, 4.1.)
21. Management Review (4.1.5 - forgot above)
22. Customer Satisfaction (4.1.6 - forgot above)
23. Quality Planning (4.2 - forgot above)

If you do create a system in the above format (or similar - whatever fits the way you operate), it is pretty easy to map it to both QS and 16949. Stay away from 20 procedures called 4.1, 4.2, etc.

Tom
 
J

jasone

Tom

Thank you for your help. Now another stupid question. How do you arrange your procedures. Right now I am doing them like this:

1. Purpose
2. Responsibility
3. Requirements
4. Definitions
5. Records
6. Method (a flow chart below, describing process)
7. References
Then a revision block.

Will this work? What do your recommend?

Thanks again
Jason
 
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