Have you established a rework procedure for your medical device?

A rework procedure consists of the corrective actions when a product has failed to meet the specifications, and it’s an integral part of any medical device production.

rework procedure for medical devices

The Code of Federal Regulations (CFR) defines rework as an action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. (21 CFR 820.3(x))

A company recently received the following observation:

….. Procedures for rework of nonconforming product have not been established.

Specifically,

a.         … devices were reworked over the last 3 years; however, the firm’s President stated there are no written procedures documenting required steps for the rework of returned devices. For example:

i.          The … component was replaced by … on the … after receiving a complaint from the customer that ….

ii.         Threaded inserts were cleaned and screws were reinstalled on the rear panel … after receiving a complaint from the customer.

b.         Specifically, the … components used to manufacture … were reworked in-house; however, the firm’s President stated there are no written procedures describing required steps for the rework of nonconforming raw materials.

According to CFR section 21 CFR 820.90(b)(2): Each manufacturer shall establish and maintain a rework procedure, 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.

For additional information pertaining to reworks, see FDA Guidance Document: Guide to Inspections of Medical Device Manufacturers, December 1997.

To view more observations pertaining to rework, refer to the following GMP Trends® Issues: 1094, 1086, 1074 and 1069

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