Nonconforming Material Control - Gap in the Control of Non-Conforming Materials

[QE]

Dear Coves.


looking for some guidance. At work we have a gap in the control of non-confirming materials. The categories include

1. Production non-conformance.
2. Product Holds.
3. Recalled Materials

Boss wants the control over the non conforming control material system. is there any guidance from FDA to understand what will be an ideal system look like.

please advise !

 

[Ajit Basrur]

Re: Nonconfirming Material Control

The basis for non conforming materials is defined in 21 CFR Part 820.90 -

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.

 

[LexieB]

Re: Nonconfirming Material Control

Dear Coves.


looking for some guidance. At work we have a gap in the control of non-confirming materials. The categories include

1. Production non-conformance.
2. Product Holds.
3. Recalled Materials

Boss wants the control over the non conforming control material system. is there any guidance from FDA to understand what will be an ideal system look like.

please advise !

As far as I understand, you have to have a system of tracking/documenting as well as physical separation and quarantine. What I would do is keep logs on all 3 types of NC material, issue separate tags and designated quarantine areas. You also have to have set guidelines for the disposition of the NCP (especially if you are dealing with bio materials). Depending on what it is, you may need to implement procedures to autoclave and you may need to put a cap on how long its stored in quarantine.