Is there such a thing as a 'Special Processes' in ISO 9001:2000?

J

Jase Eyre

#1
"Special" processes and 2000

In a recent post on Welding Inspection, Tom Goetzinger replied with the following:

Originally posted by Tom Goetzinger:
Welding is normally defined as a "special process", in that it is only through destructive testing that the quality (strength) of the weld can be determined. For that reason,I would caution use regarding inspection criteria, unless it is the cosmetic aspects that you are concerned with.
I would suggest relying on the skill of your operators as opposed to inspection. We covered special processes in our procedures, indicating that those functions could only be performed by certified operators or operators in-training. Those in-training work under the direction of those certified and are allowed to perform those type of operations at which they have become proficient.
My question is this: Is there such a thing as a "Special Process" in the 2000 revision, or is this a term devised by an individual company? I can find no reference to this concept in the Standard.

In my industry (building design), the outcome of the design process likewise cannot be tested through traditional 'inspection' regimes (short of trying to knock down new buildings), but must rely on the skill of the designers. What implications does this have for compliance? How can we prove we've followed the relevant building standards short of documenting everything with checklists? Or can we rely on the fact that our designers are highly qualified, highly competant professionals?

...Or am I just confusing the issues (probable, given the day I'm having!)?

In fact, I think I'll go and have a lie down...


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JasE
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
The rule of thumb used to be if you had to do a destructive test, it was a special process (air bags and bomb fuses are examples). Welding used to be but with ultrasound, x-ray and such a weld can now be checked without destruction.

I wouldn't equate your design with a 'special process'. And no - the year 2000 version does not mention 'special processes' which, all in all, makes sense. Don't let it get you excited.
 
R

rrramirez

#3
ISO 9000:2000, 2.4.1 Note 3 gives a definition for "special process" ( A process where the conformity (2.6.1) of the resulting product (2.4.2) cannot be readily or economicaly verified is frequently referred to as a "special process".


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Senior Member ASQ (1986)
 
D

David Mullins

#4
9000:2000 DOES mention special processes.
During 9000:1994 development they tried to eliminate special processes and then got soft. The same thing has happened again in the 2000 version.
7.5.5 states "This includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered."
This exactly fits Marc's scenario of weld failure.

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Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Originally posted by David Mullins:

9000:2000 DOES mention special processes.
Yes - you are correct in what you say but then again, it does not label them special processes. So, per se, it does not mention 'special' processes. The description (and the intent I believe) is the same, I agree.

Thanks for pointing out the verbiage.
 
D

David Mullins

#6
To have a crack at the original question, I'd want proof that the structure was built to code.
I can remember many years ago a car company in Australia received several dozen steering wheels from a company that I was working for. Nothing unusual there except the 'ring' of the steering wheel would fall off after about one days use - ouch. Turned out a batch of the metal frames had been tack welded together, and skipped the full welding program due to a problem with the robot welder. They were then molded and shipped.
Lots of red faces all around! Lots of cars with lots of people running around pulling furiously on the steering wheels to see if they came off. RECALL
The "designers were highly qualified, highly competant professionals", but that didn't ensure the product met customer or Australian Design Rule (ADR) requirements.
Verification and validation of design are one thing, but in the building industry don't you still check that the construction people build to spec? Girder size, Foundations, Walls, Ties, Wiring, Plumbing?

Think I'll have a risk assessment and a little lie down too!

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J

Jase Eyre

#7
My thanks to you all for your responses to my question. I have had a lie down and feel much better for it (part of my personal 'Continual Improvement' regime).

Thank you to rrramirez for pointing out the reference to "special processes" in the revision of ISO 9000. There it was all along, right under my nose!

My chief concern in writing my original post revolved around being able to DEMONSTRATE the quality of designs outside the traditional manufacturing paradigm. I think all of your responses have helped.

First of all, the skills and competence of the designers remains (I believe) important at a foundation level (ref: 5.4.2, 6.2, 7.3.2a, 7.5.1, 7.5.5 in the 2000 std). Second, compliance with regulatory requirements (building codes etc)should be demonstrated (7.2.1c, 7.3.2b). Third, the choice of contractors (suppliers), and all communications with them, should be key factors in ensuring the designs are realised as intended: validation of service thus extends beyond the organisation (and beyond Design/Development (7.3) into Service Operations (7.5)).

Taken together, these three factors should prove sufficient, n'est pas?

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JasE
 
A

Alan Cotterell

#8
There is an Australian Standard AS 3905.12 Guide to ISO9000 for architectural and engineering design practices. During the latter stages of production of the standard an argument was put forward to the effect that if a structure was built to all the relevant Australian Standards, design validation would be unnecessary. This argument effectively puts certain liability aspects back onto the Standards organisation. My feeling is that this approach is simply another example of engineers 'covering their backsides'. Notwithstanding this some years ago there was a wage case before the Arbitration Commission in which engineers recived a loading for the extra risk they took when these sorts of responsibilities arose. (Perhaps they want to give the money back).
I suggest there is a responsibility (duty of care)to test structures (bearing in mind that each building is in some way a prototype). Perhaps wind tunnel testing of models is acceptable as a form of validation.
 
J

Jim Biz

#10
Ahhhh.....NAP? - sleep? little snooze?? (one of those things)It's possible Marc covered that in his requirements for registration page (nah - just kidding - but ya might go there to see what he did cover(GRin))
 
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