Identification and Traceability down to the smallest detail of the component

A

alspread

#1
I have checked through the posts and haven't found a previous response specific to my question.
I think I'm fighting one of those "perceived" or "presumed" requirements.

I interpret the standard to require traceability to the level required by the customer. That's pretty much it.
I am currently working on a conversion and I am getting some feedback that we need to control traceability down to the smallest detail of the component.

Some people believe that we need to know the source of all of the components in an assembly (i.e. where the hardware came from, circuit boards, etc.).

I say we only need to control traceability to the requirements of the customer. Traceability can include many things as noted in the standard. However, I don't see where the standard "requires" detailed traceability of all of the BOM components.

Comments? Feedback?

Where traceability is a requirement, the organization shall control the unique identification of the product and maintain
records (see 4.2.4).

NOTE Traceability requirements can include
- identification to be maintained throughout the product life,
- the ability to trace all products manufactured from the same batch of raw material, or from the same
manufacturing batch, to the destination (e.g., delivery, scrap),
- for an assembly, the ability to trace its components to the assembly and then to the next higher assembly,
and
- for a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be
retrievable.
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Re: Identification and Traceabability

As straight out requirements go, customer requirements prevail in the traceability element.

The other consideration is how traceability factors into your system's effectiveness, that is in identifying and resolving component problems (and the relative cost to do so).

So as in so many places, the degree to which controls are designed and maintained is dependent on both requirements and the controls' return on investment.
:2cents:
 
#3
Re: Identification and Traceabability

I think you are on the right track.

There is a little more to consider.

The standard says "Where traceability is a requirement . . . "

Is customer requirements the only requirements to consider? Don't forget statutory and regulatory requirements. Then don't forget "other" requirements, whatever that may mean. Certainly "other" would at least include your organization's own internal requirements.

Then also consider that it may be very beneficial to maintain traceability at the appropriate level for the top tier or end customer. It would be great to have everything in place should your customer forget to flow it down to you.
 
M

malkovics

#4
Re: Identification and Traceabability

Hello.

If we see ISO9001 standard requirement then you should keep the lot traceability and identification through the all processes, where it is possible. That's the keyword. But if your company is certified by ISO TS 16949 then "unfortunately" the should will change to shall=must. Furthermore, if you have "only" ISO 9001 standard certification but your customer requirement is full control regarding to traceability and identification (in supplier quality manual or any other quality contract with customer) then you also must keep these items.
Nevertheless, I think you should see good side of this thing (I agree with Jennifer), because if you have a customer 0km complaint or warranty (field) issue then your failure/root cause analysis will be easier with the fast and exact data collecting from your production based on your traceability/identification system.
Furthemore, if you have a problem during your production which is supplier related based on your analysis, then you can determine/block/sort (by external sorting company charged the cost to the supplier)/complaint the full suspect lots/quantity.
 
M

malkovics

#5
Re: Identification and Traceabability

ISO 9001 - 7.5.3 - Identification and traceability
ISO TS 16949 - 7.5.3 and 7.5.3.1 - supplemental
 
A

alspread

#8
Re: Identification and Traceabability down to the smallest detail of the component

Thank you for the responses.
I agree with the "value" that comes from good traceability for problem solving and the like. However, the "requirement" for traceability still seems to be customer driven and not driven by the AS9100 standard per se.

It is only the customer who would require unique identification of the product (i.e. serial numbers) or the ability to trace to the raw material source.

Obviously, configuration control is a seperate issue where one needs to know what model one has produced and the part numbers that support that model.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#9
Re: Identification and Traceabability down to the smallest detail of the component

Identifying criticality seems to be key. It seems obvious that yoiu wouldn't want the same traceability requirements for a headrest cover as yoiu would for brake components. Having the definition can help avoid the military's old requirement of Mil Std classificatoin for everything, which contributed to the $700 toilet seat debacle.
 
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