AS9100C 7.5.3 Identification and Traceability - Interpretation and Requirements

[Yffffonz]

I have a question regarding product serialization in AS9100C: 7.5.3 Identification and Traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization. [FONT=Arial,BoldItalic][FONT=Arial,BoldItalic]The organization shall maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration.[/FONT][/FONT]​

The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.​

[FONT=Arial,BoldItalic][FONT=Arial,BoldItalic]When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization shall establish appropriate controls for the media.[/FONT][/FONT]​

Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).

​

The question concerns the following comments: "Where appropriate" and "Where traceability is a requirement".​

With respect to a machine shop generating/modifying customer parts according to their supplied drawings would your recommendation be that product identification and traceability is required only when required by the customer? or does the fact that the individual parts that are being manufactured/modified have in-process inspection points and record requirements necessitate serialization of all product?​

We are trying to determine if AS9100C will require all product to be serialized, or only product that the customer requires/requests traceability.


Thank you
​

 

[howste]

Re: AS9100C 7.5.3 Identification and Traceability

Hi Yffffonz, welcome to the Cove Forums!

Traceability and/or serialization is only required if your company, your customers, or regulations require them.

 

[Marc]

<snip>The question concerns the following comments: "Where appropriate" and "Where traceability is a requirement"

These are the keys. You (your company) have (has) to determine if and when internal traceability is necessary ("Where appropriate") for what ever reason (you determine this aspect). Of course Customer Requirements ("Where traceability is a requirement") may make traceability necessary even though you might not think it is necessary.

In short, if your company has no internal reason to serialize parts, and no customer requires serialization, *and* there is no regulation (e.g. a government agency type of requirement such as an FAA requirement) requiring serialization, I would *assume* it's not an issue to you and is not required.

That said, many companies have very good internal reasons for serializing parts, sub-assemblies and/or products.

NOTE: AS9100 is not my field of expertise so replies from AS9100 people are appreciated.

 

[dsanabria]

I have a question regarding product serialization in AS9100C: 7.5.3 Identification and Traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization. [FONT=Arial,BoldItalic][FONT=Arial,BoldItalic]The organization shall maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration.[/FONT][/FONT]​

The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.​

[FONT=Arial,BoldItalic][FONT=Arial,BoldItalic]When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), the organization shall establish appropriate controls for the media.[/FONT][/FONT]​

Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).

​

The question concerns the following comments: "Where appropriate" and "Where traceability is a requirement".​

With respect to a machine shop generating/modifying customer parts according to their supplied drawings would your recommendation be that product identification and traceability is required only when required by the customer? or does the fact that the individual parts that are being manufactured/modified have in-process inspection points and record requirements necessitate serialization of all product?​

We are trying to determine if AS9100C will require all product to be serialized, or only product that the customer requires/requests traceability.


Thank you
​

Your customer should have told you that the parts are primary (critical) and that they need to have serialization or a way to identify traceability (where they came from).

You did not give us a clue of the parts and where they go on the aircraft / engine so we are limited in our answer. You PO is your legal document.

 

[Joy]

You PO is your legal document

So do you mean the conten in PO is legal requirement for the organisation?

Just consider this

Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements,the latter shall take precedence

This is not applicable for customer requirement .

 

[Jason PCSwitches]

You do not have to have every component part serialized nor the end product unless, as stated, required by contract.

You do however need to have traceability. This is accomplished by linking internal w/o's that process your component parts so you can trace it back to a batch of raw material or purchase parts, thus providing a COC and/or the base supplier.

This is important. For example if a component part of your assembly fails resulting in nonconforming product your going to want to be able to analyze the processes associated with that part to determine the cause of the failure. If that part requires several operations before it reaches it's final configuration, than you will need to trace it back threw those processes, maybe even to the raw cert.

 

[dsanabria]

So do you mean the conten in PO is legal requirement for the organisation?

Just consider this



This is not applicable for customer requirement .

Thanks for the clarification on the PO.

Purchase Order are the requirements of the customer which must be met - usually product related requirements. The PO will determine if traceability is critical i.e. serial numbers or if the parts would be handled in a specific way in order to keep traceability

 

[Marc]

The key part in thinking about this is there are, by priority:

1. Traceability Requirements (internal and external) of the product by government and/or other regulations.
2. Customer Traceability requirements (external).
3. Internal Traceability (if any) which is determined by the company its self for it's systems (internal). Some companies do produce products where 1. and 2. aren't applicable and they internally do not see a need for traceability. Whether a company is wise or not in it's decisions about traceability with respect to its internal systems is subjective.

 

[Yffffonz]

You did not give us a clue of the parts and where they go on the aircraft / engine so we are limited in our answer. You PO is your legal document.

Yes sorry. Machine shop environment where parts are machined per customers drawings along with outsourcing some secondary operations (heat treating/powercoating etc.)
I am trying to interpret 7.5.3 to determine if Identification by Batch is acceptable (all parts for a single Job have a Job Traveler with Job Router) or if part identification in 7.5.3 means having the part number attached to EVERY individual part.
With regard to traceability the responses have been very helpful with the comment that industry/gov't regulations, customer requirement & internal requirements need to be considered. I am interpreting that to mean that it should be our responsibility to query the customer to verify where their part is being used in the case that they do not mention traceability in the RFQ or P.O.?
Does anyone have a recommendation for this company model (machine shop generating parts only) with regard to part serialization? There are inprocess/final inspections done on the parts during manufacture.. so I think there should be at least an internal individual part reference to tie the individual parts to the inspection records.

 

[sipe_1]

I am running into this same issue with having to interpret this section of the standard. Our AS9100 consultant says that if you have in-process records, they should be tied to a specific part and until it leaves the door you should be able to find a part that is listed on the inspection record and confirm the results.

I'm not totally sure he is correct but without doing some research I can't argue. I think this may be a matter of personal preference and to some degree I agree with it, but in some cases it may be overkill.

Are there any un-biased auditors out there that could weigh in on this matter?