Does TS 16949 Clause 7.5.3 require our product to have traceability?

[Helmut Jilling]

Helmut -

Are there requirements as to the retention times that these recorded lot numbers are supposed to be held? CSRs - Ford for example - talk about "Production inspection and test records (e.g. control charts, inspection and test results)" but don't specify lot number retention.

We are trying to better utilize our system and are looking for an answer to the "how long to keep lot numbers" question.

Thanks.

I am not aware of a specifci specified retention time for lot numbers. It could be that some customers have specified times, you would need to consult your customers' CSR documents.

If not, the proper time might depend on how long your product might be liable to warranty questions, or a customer might ask about specific lots?

 

[mkbagwell]

Traceability is important protect your company regardless if it is specified or not. Our QMS is certified to TS and we comply with CSRs for Ford and others for steel gears. We have developed a system to trace all products with lot numbers lot tags, and document the lot numbers and steel heat numbers all thru our system and then attached on the finished package to the customer. The steel certificate of analysis is provided with each shipment, and quantifies each chemical ingredient. This is evaluated by a QC Tech before it is unloaded from the truck. If a customer has any questions and provides the steel lot and heat numbers on the lot ticket we can trace back to the process results and steel chemical contents. I think it potentially saves a lot of headaches and maybe legal ramifications to be able to identify parts and quantities if any questions arise about the compliance of products downstream.

Yes, we do the same thing, very much similar. My question would be how long do you keep those lot numbers and their traceability. I know "through delivery" or "through shipping" is the popular CSR verbiage, TS says "throughout product realization".

I've poured over our applicable CSRs and can't find anything specific to lot number retention. Most, like Ford, on the production side, seem to have their retention priority on "Production inspection and test records (e.g. control charts, inspection and test
results)".

I think Helmut has a valid point when he asks us to look at how long our product might be liable to warranty questions or how long a customer might ask about specific lots. There's that "communication" thing again, rearing its head.

 

[bobdoering]

I sense from the initial post that if there is not a specific requirement, there is no point to implement the idea. Look, there are reasons why these ideas are put in the standards. It is not to be punitive - it is because issues have occurred over and over again, and the best practice to deal with the issues included having these ideas built into the quality system. Traceability is one such idea.

How can traceability be a benefit to the manufacturer?

If, as a customer, you sent me one bad part, I am going to ask you to 100% sort all of the suspect product. If you know the root cause was a particular lot of raw material, for example, and you can use your traceability to find the the specific product made from it, those would be the only parts you would need to sort. If you cannot determine which parts were made from the raw material, because you did not believe traceability was "required' by a standard, then you would be liable to sort all work in progress, all stock, all stock in transit and all stock at the customer. Every last piece. You may even have to recall all product, including product installed in assemblies or vehicles.

Was it worth the shortcut of not having traceability? In my experience, traceability has averted financial disaster.

 

[bobdoering]

Helmut -

Are there requirements as to the retention times that these recorded lot numbers are supposed to be held? CSRs - Ford for example - talk about "Production inspection and test records (e.g. control charts, inspection and test results)" but don't specify lot number retention.

We are trying to better utilize our system and are looking for an answer to the "how long to keep lot numbers" question.

No requirement - unless your customer specifies one. But it makes sense to maintain them for the period of time that the product may sit in your customer's stock. That depends on if they have good or crappy inventory control. With crappy inventory control, it could be years.

 

[Sorin]

Just my and a little .

With disregard of the standard used any QMS should have traceability when and where it's possible. With disregard to the customer requirements or the standard. It shall be there.

I see traceability as one of the very first bricks upon a QMS is founded/structured

 

[vanputten]

Ajit:

Where does TS 16949 state traceability is required? I say you are incorrect in stating "TS 16949 definetly requires traceability."

Traceability is a requirement for a supplier if the customer requires it. I agree that traceability is really important but it is not required per TS 16949.

 

[Gofar]

I have to agree with vanputten.

TS clause 7.5.3 starts "Where traceability is a requirement........". That requirement may come from the customer or from your own management but if it doesn't exist you don't have to do anything.

That doesn't mean its not a good idea to have some sort of traceability, of course.

 

[Sorin]

The par 7.5.3 read:

Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements.

Now on to
8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).

__________________________

What I get from this (without goint deeper) is that in order to monitor and measure the characteristic of a product I need a traceability process.
So traceability (seems to me) is an intrinsic requirement (even if not explicit enough) in TS16949.

On another note both paragraphs as identical to ISO norm and there are no aditional requirements in TS16949 (7.5.3 and 8.2.4).

 

[Gofar]

The par 7.5.3 read:

Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements.

Now on to
8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).

__________________________

What I get from this (without goint deeper) is that in order to monitor and measure the characteristic of a product I need a traceability process.
So traceability (seems to me) is an intrinsic requirement (even if not explicit enough) in TS16949.

On another note both paragraphs as identical to ISO norm and there are no aditional requirements in TS16949 (7.5.3 and 8.2.4).

I don't agree with your logic here about the requirement of TS.

Having said that, in the limited number of TS organisations I've been involved with, all had some sort of traceability system and that does seem to be normal for automotive.

My customers require and specify the extent of traceability so I've come to expect it. If they didn't, I'd probably have it for my own peace of mind.

Are there any automotive customers who don't have some sort of traceability requirement in their CSR?

 

[Sorin]

I don't agree with your logic here about the requirement of TS.

Having said that, in the limited number of TS organisations I've been involved with, all had some sort of traceability system and that does seem to be normal for automotive.

My customers require and specify the extent of traceability so I've come to expect it. If they didn't, I'd probably have it for my own peace of mind.

Are there any automotive customers who don't have some sort of traceability requirement in their CSR?

There are 2 issues here (in this topic) in regards to traceability:

1.As being part of customer requirements
2.As required or not in the standard (TS16949)

I was talking about the latter. I do not see how one can monitor a product through various stages of manufacturing without having a traceability system in place. Once again, for the purpose of the original question, I do not take in consideration customer requirements.