21 CFR 820 - 820.90 nonconforming products

Original text

Expert opinion

(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.

Every nonconforming product must be separated from conforming products at point of recognition during the manufacturing process. Nonconforming is understand to not meet specified properties and requirements. The procedure to deal with nonconforming products must be in writing and implemented.

The procedure for nonconforming products should include at least the identification, the necessary documentation of such products, the evaluation, separation from conforming products and disposition.

In addition, the evaluation of nonconforming products must include a written determination of the need of an investigation and notification of the responsibles.

(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.

The written procedures must include a RACI-matrix (Responsible, Accountable, to Consult, to Inform) on who can review and decide on disposition of nonconforming products. Further, the procedure defines the review and disposition process and defines the documents and records necessary. Any decision must be justified and documented in writing.

In cases that rework is possible, written procedure must be in place to define the rework, the retesting and the reevaluation of products.

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