Traceability

[R.B.D.B]

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.

Hello Sidney,

Thanks for your feedback.

 

[R.B.D.B]

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.

Hello Noel Gurney,

Thanks for your guidance in this subject.

 

[R.B.D.B]

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.

Hello Bev,

Thank you for your feedback.