Take
Traceability:
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.
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.
Well, yes and no. It really depends on the product. Most companies do not add product features unless there is a requirement (design, customer, government or other).
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.
[This message has been edited by Marc Smith (edited 14 January 2000).]
