Traceability

[R.B.D.B]

Are you talking about traceability of the protective cap or the product? If it is the protective cap, is it discarded by the customer or returned to you?
Unless it can affect the product in some way, why would traceability be required?

Hi Chris,

Thanks for your reply. Yes you are right. Suppose if the protective cap dislodged / found loose during transit. It leads to product damage. In this case i hope traceability required for protection cap.

 

[R.B.D.B]

I believe he is talking about the protective cap. Only way I see traceability playing into this, is if there is a potential for the cap to introduce some type of contamination, or defective cap, that would allow some sort of damage to the parts. Traceability would probably help pinpoint the origin and extent of the problem.

Hello Rich,
Thanks for your feedback. Exactly in this case, we required traceability.

 

[R.B.D.B]

Interesting this was not worded as “please suggest whether traceability is A concern in this case or not”.

Although this sounds like a classroom training test question, I would offer that traceability would not be a concern for this type of component, but FOD is a major concern. If such caps are being used as means to prevent ingress of anything that might affect product performance, FOD is the concern.

Hello Sidney,

Thanks for your reply. Yes if protection cap not in place, it may leads to product safety and also creates FOD related issue . In Both the cases, we need to have traceability to take action on particular batch of protection cap.

 

[EdenG]

Hello Eden,
Thanks for your reply. The risk may be the link with Product safety. Suppose if the protection cap may dislodged / removed during transit and leads to product damage. In this how can we trace back and find out which batch of protection cap having the problem and taking corrective action for the same. How can we manage this scenario.

If the cap is "dislodged / removed during transit" in doesn't follow there is a "batch of protection cap having a problem" but rather a case of was the cap fitted or not? It could, and most likely would be, a one off.
In this case traceability for me would only be required so far as a pre-delivery inspection of the unit (Checklist style) to confirm that it had a cap on prior to delivery, YES/NO, maybe a picture to confirm.

 

[Sidney Vianna]

we need to have traceability to take action on particular batch of protection cap.

I believe you are overthinking this. Imagine you ship a heavy part on top of a wooden crate and secure it to the crate with steel straps. Would you expect traceability of the steel strap? Or the crates? I don’t think so.

You have to always remember traceability costs money and time. It has to be justified. From what has been described so far, I would not expect such caps to have traceability.

 

[Randy]

Traceability on a protective cap? Why? What's the potential net gain?

You already said.......

After that customer will remove the protection cap and use the product.

After the cap is removed "by the customer" who really gives flip about something of little or no value that's probably tossed in the trash?

This sounds as silly as putting traceability on the paper underneath the safety cap for a bottle of aspirin or milk.

How about traceability for the wrapper on a stick of gum?

 

[Randy]

Thanks for your reply. Yes if protection cap not in place, it may leads to product safety and also creates FOD related issue . In Both the cases, we need to have traceability to take action on particular batch of protection cap.

It may be how the cap was installed and not a thing with the cap at all.

Why not this scientific solution? Tell the supplier to tape the cap on. One little piece of tape and a couple seconds of time.

 

[Bev D]

As Randy said: you are over thinking this as far as traceability goes and underthinking about how a usable level of traceability can be (and probably already is) utilized. The most stringent is a serial number on the cap itself that is recorded for the entire life of manufacturing to assembly on the bottle. Including recording the inspection data on each cap and the person or machine installing each cap and the torque value of each cap. Very expensive. The next is simple batch control that records the results of any inspections, assembly etc. of each batch of caps that is used and which assemblies (or serial number / date range) used the batch of caps.

I have had to deal with this exact situation with serial numbered medical devices that had several serial number controlled components and many components that were batch controlled. This includes caps for small bottles of biological/chemical material that are removed and tossed after use. No matter what goes wrong during (or after shipping) you must still do the hard work of getting the ‘bad caps’ and the associated bad bottles back and doing the investigation as to cause - there is NO magic in traceability other than narrowing the field of affected material and potentially reducing the field of where to investigate.

 

[Noel Gurney]

I'm more a ISO9001 person than a "AS9100, IAQG, NADCAP and Aerospace related" however I've done extensive audits of many systems of many organisations to many standards. Some things I would consider.... When you write your audit finding will it be categorised, such as "just an observation they they can choose to ignore" or some kind "noncompliance" (against a legal instrument) or a "nonconformance" (non legal instrument)? If you can't call up a part of the audit criteria in your adverse finding then I'd think about the category more.

Then as some have mentioned.. risk based thinking.

Organisational context plays a role too. It reads you are auditing "their" systems and that you are external. So what are your own real risks? Well, you're taking some risk if you choose not to mention this cap thing. So the answer is raise it and choose your category. "Consideration could be given for the organization expanding an existing documented risk assessment that demonstrates what does and what does not require traceability. For example risk relating to caps blah blah blah." This way you are encouraging them to go think about it and in some ways it's a transference of risk. They should be the experts on caps, and if you're worried that the risk can be higher than some might presume, mention something about checking their mitigating controls for "cap related risk" with their insurer.

Or if if it is noncompliance or nonconformance, just write it up and quote the clause(s) it conflicts with.

 

[R.B.D.B]

If the cap is "dislodged / removed during transit" in doesn't follow there is a "batch of protection cap having a problem" but rather a case of was the cap fitted or not? It could, and most likely would be, a one off.
In this case traceability for me would only be required so far as a pre-delivery inspection of the unit (Checklist style) to confirm that it had a cap on prior to delivery, YES/NO, maybe a picture to confirm.

Hello Eden,

Thanks for your feedback and made me to understand another perspective of the problem.