Non conformance product identification and traceability

#1
Hi, so I am looking for clarification on the traceability and identification with a non-conformance product.

My question is that if the decision has been made to dispose off a nonconformance product. Is it correct to assign the same Batch code to the remanufacture of the product?

One of the arguments I got is the nonconformance quantity can be traceable with the disposition evidence and the remanufactured batch will be traceable with new lot codes from the raw materials.

My understanding of a batch code should be a unique identification number, especially if is liked to a nonconformance product.

21 CFR Sec. 820.90 Nonconforming product.

(a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.
(b) Nonconformity review and disposition. (1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.
(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.

Thanks so much for your help!
 
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yodon

Staff member
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#2
Was hoping someone would jump in with more experience but maybe this gets the discussion going at least.

First, I'm not completely sure what you're asking. In the first sentence, you mention "dispose" (which I take to be scrap) but subsequently you talk about rework. So I'm assuming you're taking all or part of a lot / batch that is nonconforming and doing rework to bring the items into spec. Is that correct? Assuming I'm at least not too far off base, I'll give my thoughts.

Bear in mind, the main reason for traceability is for recall or communications (let's say "postmarket actions"). The more detailed the traceability information maintained, the smaller the scope of your postmarket actions, should any need to be taken.

Reworked items, IMO, should be considered when collecting data for traceability. If you can absolutely guarantee that the rework cannot introduce unique issues that lead to field failures then maybe there's no need to take any extra measures to enable traceability to reworked items. If there is a possibility, though, you may want to enable traceability in the event that postmarket actions need to be taken on just the reworked items. How you do that; e.g., through some unique batch identifier or a different lot code is up to you.

If you do set up something, be sure you don't do something whereby you lose track of any traceability common between the conforming items in the original batch and the reworked items. In other words, if there's something common between the original conforming and reworked set (e.g., materials), you want to be sure that traceability picks up both.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
My response is more general, and I'm not familiar with 21 CFR Sec. 820.90.

In automotive I worked with airbag components and assembly over a few years in the late 1990's.

Components had to be traceably by batch/lot. For QS-9000 the component supplier had to be able to provide details of what companies received each batch/lot within 24 hours. The auditors chose a batch/lot number and monitored as the company pulled the records, etc., so it was verified that they could, in fact, do this. The auditors worked in shifts and were there over the 24 hour period. If I remember the certification body was LRQA. Components were not serialized, but were marked to identify batch/lot.

As for assembled airbags it was pretty much the same in that the assembly facility had 24 hours to identify every auto assembly plant and parts supplier who received each serialized airbag.

There wasn't much 'rework' because few parts and no assembled airbags could be reworked in any way.

Yodon has pretty much covered everything better than me, so I'll leave it at that.
 
#4
Hi Yordon

Thanks for your reply to my post. I know it sounds a bit confusing. I mentioned the term remanufactured which my colleagues explained is different to rework.

Remanufacture: manufactured again form scratch (new raw materials) for my point of view this is manufacturing, but the organization used this term because the batch identification remains the same.

You answered my question with the following statement.
In other words, if there's something common between the original conforming and reworked set (e.g., materials), you want to be sure that traceability picks up both.
 
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