posted 14 January 2000 03:43 AM               

They are trying to escape from a lot of requirements, ie Parts marking, Traceability, Inspection etc by saying that if the customers does not want it they do not do it.

It is true that that they are operating in a price sensitive industry, but what do you think? could they escape a lot of the ISO requirements using the defence that the customer does not want it (and the subsequent cost) but still become ISO certified.

Regards

posted 14 January 2000 05:55 AM               

But i can well imagine a scenario where something goes wrong, the customers asks which products have this particular defect, the manufacturer replies that he does not have sufficient traceability systems to say exactly which ones have this problem, and the customer replies in disgust that he thought the manufacturer had a QMS.

All in all i think ill play this one by ear.

Regards

posted 14 January 2000 08:03 AM               

If I injection mold toy soldiers I will probably not have any traceability. What for? What will it gain me? You could argue that the toy soldier is a total lack of traceability. You might argue that you track only bulk materials and that there is no need to track beyond that (no lot number on each soldier, for example).

On the other hand, if I injection mold covers for automotive air bags I will at least indicate manufacturing date (or lot number or other traceable indicator) - aspects such as several tear strip dimensions are critical safety features. If problems are identified we can implement containment.

These are just examples of two traceability situations. Each product and situation has to be considered on its own. ISO does not require traceability. Key words are in bold:

From ISO9001:2000:
--> ...7.5.2 Identification and traceability
-->
--> The organization shall identify, where appropriate, the product by
--> suitable means throughout production and service operations. The
--> organization shall identify the status of the product with respect
--> to measurement and monitoring requirements. The organization shall
--> control and record the unique identification of the product, where
--> traceability is a requirement (see 5.5.7).

From ISO9001:1994
--> ...4.8 Product identification and traceability
-->
--> Where appropriate, the supplier shall establish and maintain
--> documented procedures for identifying the product by suitable means
--> from receipt and during all stages of production, delivery and
--> installation.
-->
--> Where and to the extent that traceability is a specified
--> requirement, the supplier shall establish and maintain documented
--> procedures for unique identification of individual product or
--> batches. This identification shall be recorded (see 4.16).

It's a question of being ready to explain why (if / why not) and to what extent traceability is applicable to your product.

As an outsider I could argue that you would want each toy soldier identified for traceabilioty to batch (minimum) because you (as manufacturer) might get a batch of plastic which is (for some far fetched reason) poisonous (or some such reason). But then it goes on down to traceabiliy to lots shipped and could go further. We can all come up with 'what if' scenarios, but let's face it - the company has to come up with a reasoned answer for what it does and does not do.

quote:

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I suppose its all a question of degree. I think there is a little game going on here whereby something is not been done because the customer has not asked for it.

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I wouldn't say that traceability is a necessary element of a QMS. Typically you do see some level of traceability (particularly bulk material / lot traceability) - but, as in the toy soldier example, how far? Probably not very.

Hope this helps and doesn't confuse.

posted 16 January 2000 05:41 PM               

Its just that at the moment this company has 4 product lines for 2-3 customers, and they have zero incoming inspection, zero in process inspection, zero tracability, and an occassional final inspection which is not recorded in anyway, all becuase they say'the customer has not asked for it'.

If this is all possible, it will be the first time i have come across a company that wishes to be certified, but doesnt really aply any of the ISO elements.

I find myself writing in the manuals,'...becuase company xxxx is a small company reacting to company demands xxxxxx is only done if requested by the customer...' what else can i say? i cannot describe how they might do tracability becuase they simply arent doing it.

Regards

posted 20 January 2000 04:37 PM               

The products are Routers or other small similar electronic assemblies.

Does anybody have an experience about how much inspection and traceability you would expect to have for such products.

posted 20 January 2000 06:03 PM               

The reason I say this is that an auditor will certinaly question all of these "do not have to do's", if not out loud, certianly in his/her own mind.

What better than a letter from the customer to put your "claims" to doubt.

posted 20 January 2000 07:30 PM               

quote:

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Originally posted by Andy Bassett:
I agree with everything that has been said, i go along with all the business about where appropiate etc.

I find myself writing in the manuals,'...becuase company xxxx is a small company reacting to company demands xxxxxx is only done if requested by the customer...' what else can i say? i cannot describe how they might do tracability becuase they simply arent doing it.

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Make sure you don't 'set yourself up'. I've left several clients over the years because their management was screwed. I remember a plant manager telling me HE didn't have to do management review! Don't get in a position where you know they're doomed to failure and when they do you get the blame. I am very up front about what is necessary. I do not minimize that requirements are requirements.

In so far as they elect assys do they do a functional before they ship? This is all addressed in how their quality planning system is designed. I would look closely at quality planning.