Traceability

[R.B.D.B]

Hello everyone,

Happy new year to all members. I have one clarification. In one of my audits, i observed that protective caps used in their product, and it is used to protect the part from damage and dust till the receipt at customer place. After that customer will remove the protection cap and use the product. After that there is no use of protection cap. But they didn't maintain the traceability since these items are packaging material. Please suggest whether traceability is the concern in this case or not.

 

[EdenG]

Hi R.B.D.B

I'm by no means an auditor but if there is no use of the protection cap after removal and presumably it is disposed of, what use is traceability in this instance? We maintain traceability for critical characteristics / components. Why do we need traceability? To have a track of something through it's lifecycle, perhaps in-case of failure or some breach of contract - Does that apply here?

Why do you feel it needs traceability and what is the risk?

 

[ChrisM]

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?

 

[Bev D]

As an auditor - where is the “shall”? What is the stated requirement for traceability?
As someone who cares about Quality what happens if the cap is missing or damaged during shipment? What kind of contamination can occur and what is the effect?
How much traceability are you talking about? Does the product have a serial number? Does the cap have a batch number (or serial number) that the manufacturer records? (Tying the cap to the product). Are you thinking the Customer needs to record the product to cap link before they throw it away? Why? What good does that do?

As an auditor you must think about what the written requirement is - without adding interpretations that aren’t there and as someone who cares about quality you must really think about what the ‘requirement’ or ‘action’ is intended to do and can actually do.

 

[Rich Shippy]

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.

 

[Sidney Vianna]

Please suggest whether traceability is the concern in this case or not.

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.

 

[Bev D]

FOD?

It would be a lot more helpful if the OP could give us more specific regarding the situation…we are once again left to speculate.
Since I’m feeling a bit silly this morning: what if the cap is made of radioactive material? Or if it was a cap to a bottle of radioactive material? Surely there would have to be some traceability that the cap was properly disposed of? Or maybe it’s made of lead to prevent the radioactive material from leaking out of the bottle?

 

[Rich Shippy]

Foreign Object Damage/Debris. (FOD)

 

[Ed Panek]

What risks exist to the product requiring the use of a protective cap that dont exist after first use? Is it a shipping concern?

 

[R.B.D.B]

Hi R.B.D.B

I'm by no means an auditor but if there is no use of the protection cap after removal and presumably it is disposed of, what use is traceability in this instance? We maintain traceability for critical characteristics / components. Why do we need traceability? To have a track of something through it's lifecycle, perhaps in-case of failure or some breach of contract - Does that apply here?

Why do you feel it needs traceability and what is the risk?

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.