Thursday, August 4, 2016

NON confirming product CFR 890.20

In manufacturing unit, there is always a confusion between non confirming product and deviation. The basic rule to differentiate both is to remember that deviation is a departure from an approved instruction or established standard where as non confirming product is always related to a product. If as a result of an event product at any stage i.e incoming, in process or finished is affected or become substandard than the product is a non confirming product. 

As per 21 CFR section 890.20

s) Control of non confirming product : Each manufacturer shall established and maintain procedure to control product that does not confirm to specified requirements. The procedure shall address the identification, documentation, evaluation, segregation and disposition of non conforming product. the evaluation of non conformance shall include a determination of the need for an investigation and notification of the persons or organisation responsible for the non conformance. 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. 

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