Traceability System to trace Failed Product for Corrective Action

[Moncia]

Re: traceability

they have been in business for 30 years now
but the whole ISO is on me, I have to figure it all out on my own, and I am still learning.
We had been issued SCARs before, and I thought just to do root cause analysis you have to trace the problem back to the root

 

[Marc]

Re: traceability

I think the question is (correct me if I'm wrong), "How to implement a traceability system" rather than whether it is actually required by ISO 9001. We all know there are companies where traceability isn't required. But we also know that traceability provides a valuable part of an effective nonconformance system.

 

[Coury Ferguson]

Re: traceability

That's what I am trying to figure out. I think it is, and have to convince my bosses we need it. We are private label company. we put customers' labels on our products which then are sold to their end user, so I think it is required
and if yes, how it is addresses at your companies

The requirements of traceability is specified on the Contract/Purchase Orders. Most of the product that they built had Serial Numbers, which was required by the Contracts/Purchase Orders, which met the requirements.

If your Company has the requirements of traceability specified in Contracts/Purchase Order, then traceability will be required. If not, don't put effort in any procedures. Just make sure that you exclude the requirements. This is my opinion.

Sorry about spelling your name incorrectly earlier.

 

[Colin]

Re: traceability

I think the question is (correct me if I'm wrong), "How to implement a traceability system" rather than whether it is actually required by ISO 9001. We all know there are companies where traceability isn't required. But we also know that traceability provides a valuable part of an effective nonconformance system.

I think I understood the original question - I was trying to establish whether it was a requirement for this specific case - given that they have managed without it so far and the CB didn't seem to see it as a problem.

If we can establish whether it is required, we can offer help to do so but if not required then why worry about it?

 

[Moncia]

Re: traceability

7.5.3 Identification and Traceability


I.W. Tremont has established and documented procedures for product identification from receiving through all stages of production, and until shipment is picked up. The main product monitoring system in place is a physical identification of labels with assigned lot numbers, which in turn are recorded in the computer data base. Additionally, physical location of the material within the production area is an indicator of the material/product status. Furthermore, VP of Operations ensures that all incoming materials, in process and final products are properly identified and their status is correctly tracked and displayed. (See WI 9.4)

That's what we have in QM, and I wrote thist thing, so either we need to revised it, if it is not required by industry, or implement true traceablility on the production. As of now, we have none

 

[Moncia]

Re: traceability

and that's where I assumed it is required, even for the getting Corrective action done

 

[Colin]

Re: traceability

7.5.3 Identification and Traceability


I.W. Tremont has established and documented procedures for product identification from receiving through all stages of production, and until shipment is picked up. The main product monitoring system in place is a physical identification of labels with assigned lot numbers, which in turn are recorded in the computer data base. Additionally, physical location of the material within the production area is an indicator of the material/product status. Furthermore, VP of Operations ensures that all incoming materials, in process and final products are properly identified and their status is correctly tracked and displayed. (See WI 9.4)

That's what we have in QM, and I wrote thist thing, so either we need to revised it, if it is not required by industry, or implement true traceablility on the production. As of now, we have none

I agree - either make a statement to exclude it or, if it is required by yourselves or your customers, implement a system to provide it.

 

[Moncia]

OK, I just spoke to a VP of Operations, and he said, 2 customers do require it in their POs. However, he has been keeping track of the original lot number of the material that is die cut. It is stamped on the traveler and inputed into the computer. So we obviously are doing it.
But my argument with them is that if we get complaint, and I have to do corrective action with root cause analysis, I cannot trace that failed box to a particular person who worked on it
I can only trace it to the process, like the problem was die cutting, but we have 3 die cutters and there is no way as of now to tell, which one of them actually did cut it, THAT'S MY PROBLEM, purelly from ISO stand

 

[Colin]

OK, I just spoke to a VP of Operations, and he said, 2 customers do require it in their POs. However, he has been keeping track of the original lot number of the material that is die cut. It is stamped on the traveler and inputed into the computer. So we obviously are doing it.
But my argument with them is that if we get complaint, and I have to do corrective action with root cause analysis, I cannot trace that failed box to a particular person who worked on it
I can only trace it to the process, like the problem was die cutting, but we have 3 die cutters and there is no way as of now to tell, which one of them actually did cut it, THAT'S MY PROBLEM, purelly from ISO stand

Good auditing Moncia! Could you include something on the traveller to include the specific machine used and if required, the operator?

 

[Moncia]

Re: traceability

You did not
My name, by the way is Monika - nice to meet you guys
Moncia is just my nickname