Identifying Raw Material Part Numbers - Product Identification and Traceability

I have an "opinion" question. I know what my opinion is, I just want to see what the consensus is.

My company is a contract manufacturer in the medical device industry. I started the QMS here 5 years ago, then I left for 2 1/2 years, and now I'm back. In the 2 1/2 years that I was gone, there were 8 QA managers monkeying around with my QMS, and now is has fallen to pieces. I have been back for 5 months now, and have gotten most of it reassembled. My last big hurdle is product identification and traceability (mostly identification).

Before I left, we had a "formula" for identifying raw material part numbers. All part numbers were in the same format, and you would look at either the raw material on the shelf or the part number in the inventory control system, and know exactly what the other was. However, after I left, a few things happened, such as:

• New computer system. They didn't migrate old data from the old system. They did everything from scratch again.
• Purchased two different product lines from other contract manufacturers
• New Purchasing/Inventory Control Manager

First, when they went to the new computer system, they didn't keep the same raw material numbering system. They just started using the vendor part number and the roll width for rollstocks that we purchase. For instance, we buy 1525 material at 5" widths, the part number is 1525-5". OK, this is fine. However, for some materials, they don't use this approach. For example, we have part numbers in our system such as: Blue Foam, Shield Box, Yellow Vinyl, etc.

Secondly, with the two product lines that they purchased from other contract manufacturers, they adopted the existing part numbering structure from both of those companies, so I have part numbers that don't "mean" anything, and to us are just "random numbers".

Now, how in the am I supposed to write a product identification procedure that defines all of these methods of coming up with part numbers?

Re: Product Identification and Traceability

This is a challenge I don't envy.
I'd say you have to consolidate the part numbering system is you're going to track all parts with the same systems.
That might mean tearing it down and starting again.
Consolidate where possible.

Will upper mgt put up the resources to handle such a project?
I guess aside for editing part #s you'll have to edit BOMs too.

eesh.

Re: Product Identification and Traceability

ontheopenroad said:

I have an "opinion" question. I know what my opinion is, I just want to see what the consensus is. ...


Now, how in the am I supposed to write a product identification procedure that defines all of these methods of coming up with part numbers?

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I might be a rookie on medical devices but for 9001:2000 what requires you to talk about the specifics (down to the individual part # scheme) when covering ID and Traceability? We have no documented procedure for this, just a statement in the QM that we ID, and where contracturally required, we also record & retain lot info for traceability. We have labels for our products that signify "Passed QC Lab testing"; this covers measurement status requirements. Maybe we're stone simple in our products but maybe also you have chosen to become very micro-focused with your system. Your choice, but not an ISO 9K requirement

Re: Product Identification and Traceability

fuzzy said:

I might be a rookie on medical devices but for 9001:2000 what requires you to talk about the specifics (down to the individual part # scheme) when covering ID and Traceability? We have no documented procedure for this, just a statement in the QM that we ID, and where contracturally required, we also record & retain lot info for traceability. We have labels for our products that signify "Passed QC Lab testing"; this covers measurement status requirements. Maybe we're stone simple in our products but maybe also you have chosen to become very micro-focused with your system. Your choice, but not an ISO 9K requirement

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Fuzzy,

I certainly concur with your statement, and I may be trying to overcomplicate issues simply because "I've always done it that way . . ." However, with medical devices and FDA regs (QSR), I do have to have a documented procedure for ID & T. Probably, my biggest issue is not the numbering per se, as I can simply make my procedure say that our software system does not allow for duplication of part numbers, and thus each ID is unique. However, we are not currently labeling inventory as it comes in the door, so my rolls of "blue foam" do not have labels identifying it as "blue foam". Now, I can fairly easily look at the roll and say, "Hey, that's blue foam." But does that meet the letter of the reg?

Re: Product Identification and Traceability

ontheopenroad said:

... However, we are not currently labeling inventory as it comes in the door, so my rolls of "blue foam" do not have labels identifying it as "blue foam". Now, I can fairly easily look at the roll and say, "Hey, that's blue foam." But does that meet the letter of the reg?

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So a procedure is not really the issue, is it? Operational discipline to follow requirements seems to be the root cause here...welcome to my world; been there, done that, everyday for three years. Sounds like a process in need of a metric. Then you can subject it to hourly / daily / monthly audit until the results come within whatever goal you choose on your metric. # of products ID'd correctly / # of products audited. : I believe that metrics (with commitment & consequences) drive behavior. Good Luck behind the wheel...

Re: Product Identification and Traceability

ontheopenroad said:

Fuzzy,
However, we are not currently labeling inventory as it comes in the door, so my rolls of "blue foam" do not have labels identifying it as "blue foam". Now, I can fairly easily look at the roll and say, "Hey, that's blue foam." But does that meet the letter of the reg?

Click to expand...

Isn't it a supplier requirement to make their product per your specifications, including labelling or packaging?

B.G. Wiehle
(in the automotive industry)

Re: Product Identification and Traceability

If you have been away for two and a half years and the company is still there, maybe their "new" system aint so bad at all