ISO 9001 - Product ID & Traceability - Beyond our door?

[Janie]

4.8 Product ID & Traceability

During a discussion today, some definition questions arose. I feel that traceability must be referring to beyond our door. Others in my group feel it refers to "material lot traceability" and being able to recall product while it is still in house based on a component or ingredient failure. Seems to me like that is identification. We do plastic injectionmolding, mostly for the appliance industry, and our products have no "unique markings" either individually or as a batch or lot. Once they are unpacked out of the carton we ship them in, one is indistinguishable from any other.
Any comments to help us out?

 

[Christian Lupo]

The most simple answer to this question is "Ask your customer". Is it important to ask your customer if traceability is important. Do not assume that just because your customer doesn't say its important that it's not. By the time they tell you whats important they have also told your competitors! I also would recommend that your product be traceable after the sale, how can you do a failure investigation on returned product if you cannot tell: when it was made, by who, what shift, using which raw materials, what equipment...etc

[This message has been edited by Christian Lupo (edited 08-27-98).]

 

[Scott Knutson]

I agree with Chrisitian. If your product is returned by a customer, it would be pretty embarrassing to tell said customer that you can't solve that particular problem because you don't know who, or where it was built, the materials used, etc. Traceability solves that problem

 

[Marc]

Janie,

As a suggestion, after you hit the POST button, give things some time. I'm on ISDN and know the server responds pretty fast but it appears you're on a slow connection. It may take a minute to get back to you. If something weird is happening let me know and I'll look into it.

Back to the topic - Yeah - look at Don's response. The key word in 4.8 is APPROPRIATE. The standard states clearly:

“Where appropriate, the supplier shall establish and maintain...."

Now - the question is can you explain why and how you do and/or why you don't consider traceability necessary.

 

[Janie]

Marc, I think you're getting close to my question. I probably didn't work it well. We make things like refrigerator shelves and crisper drawers. Even if one "failed" after Suzi Homemaker purchased it, the resukt would be to simply replace. There would not be the need to recall all of the lot made during a certain time period or out of a certain material. My stance is that since our customers don't require us to be able to trace our products after they are in the field, we don't need to burden ourselves with a traceability section in our procedure. Others feel that the standard is asking us to be able to trace our products back to the lot# of material while we still have the product in house, before shipment. I see that as identification...not traceability. Whi is right or does it even matter?

 

[Marc]

You should look at this from a broad standpoint.There are several possible traceability issues.

Parts, materials and/or sub-assemblies may be serialized as may the end product. Some products nothing is traced (not necessary - no reason) like, say, tiny injection molded plastic soldiers. On the other hand a hermet connector may require lot traceability with materials traceability. All depends upon your product. And customer requirements.

An Old Traceability Thread
Another Old Traceability Thread

And Another Old Traceability Thread

Not too much in the old threads, actually.

My point in my reply, however, is basically to say look at your overall product and processes, consider industry 'standards' and customer requirements. And - consider the different possible areas where you might or might not require traceability.

 

[mchclark]

The way I keep identifcation and tracability straight is like this. If I walk out to the shop and pick up a part something tells me if its a widget or a thing-a-ma-jig. That something is the identification and is required by the standard. If then I want to know that particular part's history (who we bought the raw material from, what machine it was run on etc.) that is traceability. It is only required where appropriate, meaning you get to detrime if you need tracability or not. From what you have said here it sounds like you don't need tracability.

 

[Leslie Garon]

I agree with MCHClark. Traceability is two fold, internal and external. ISO 4.8 is concerned with external traceability for recall purposes.
Janie, this doesn't seem to apply to you so just state that traceability is not a requirement in your procedure.
As for internal traceability, it should be evident where you need it for internal problem solving purposes. Spearate Documentation it is not a specific requirement unless you want to spell it out as such (which I do not recommend). Your inventory management systems provide traceability as well as how ID and nonconforming product is handled ending with corrective and preventive action. Its all documented, you're just not making it extremely obvious.

 

[Marc]

Traceability Levels - Example

1. No traceability required.

2. Lot traceability - where each component has a lot number recorded on it and the material certs used in the lot are recorded but not traceable to the
individual components.

3. Full traceability - where each component has a number on it traceable to a material cert.

4. Serialization - where each component is serialized and has full traceability to material certs and other quality records. The assembly then includes a set-out record of each individual component's serial number.

 

[Madhu Pentamsetty]

Yes. You define your own traceability requirements based on type of product, customer requirements, and in general if it is a standard practice in your industry.

We design, manufacture, and install weighing scales to weigh trucks, trains etc. It is not an industry (weighing scale industry) practice to trace any of the materials, or components used in making the scales.

However we wrote our procedures like this
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We will provide traceability for Scales with serial numbers put on them. We do this merely to track the warranty status. If the customer calls us say 10 years from the day they were sold, we can check if it is still under warranty or not based on serial tag.

We will provide traceability for Load Cells – with serial numbers provided by our load cell sub-contractor. When we assemble the load cells into scales, we write down and keep track their serial numbers. Again we do this merely for warranty sake. A customer may have several scales, with several kinds of load cells, supplied by several kinds of load cell and scale manufacturers. If we do not keep track of the load cell serial numbers, we have no way to tell if the load cell in question was supplied by us or not.

Where it is a special customer requirement (as specified in the sales contract), steel used to make the scale will also be traced, by using a CERTIFICATE OF COMPLIANCE provided by the steel sub-contractor. This certificate is filed as a Quality Record in the Job Master File.

Where it is a customer requirement, a SCALE CALIBRATION CERTIFICATE is prepared after installation / service / calibration. This certificate which will be kept as a Quality Record, identifies the product, and the services performed. Test weights used to calibrate a scale are also traceable by referring to the WEIGHTS CERTIFICATE numbers listed on the Scale Calibration Certificate. Weights Certificate lists the identification and the calibration status of the test weights.
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Summary

Traceability is what your customer demands, or what makes business sense to you. We chose to trace our scales and load cells (that are in the scale) just to cover warranty costs. But, if a customer wants us to, we will even trace the raw steel (used in making the scale) or test weights (used to calibrate the scale).

Janie, it was not easy for me to write the above procedure. But, believe me, you, me and every body goes through the same questions. We are not certified yet, but I am willing to take it up with any auditor that might have a problem with it.

Tit Bit

After the Oklahoma bombing (using explosives made out of fertilizers) of the Federal Building, some experts suggested, that some kind of plastic particles be added to the fertilizers. These particles will remain in tact even after explosion, and provide traceability to who made it, who sold it, and when it was sold. I am not sure what happened to this idea. Talk about traceability……….ha!

Madhu