Non-Conforming Product

Medical Device Manufacturer should have a system and instructions to identify, document, evaluate and disposition of nonconforming products. Nonconforming products are very expensive to handle and should be prevented its occurrence in the first place.

The system and instruction should applies to all purchased, in-house manufactured materials, components, subassemblies and finished products. The system should also have a form called Product Nonconformity Report Template to record the detail of the nonconformity product and its disposition.

Let us talk about identification, documentation, evaluation, disposition, Advisory Note and Recall for nonconforming products.

Identification: All associates in the company especially QC inspectors and production personnel are responsible for identifying nonconforming products in the course of their inspection and process monitoring activities.

Documentation: When a nonconformity is identified, it should be documented in detail in Nonconformity Report form. Only certain personnel can initiate this form like QC inspectors and Quality Assurance. All other personnel report identified nonconformities to QA.

Disposition: The nonconformity report form should document, the identity of the device in question, department, area, operation where nonconformity occurred. The report should also describes objective facts detailing the nature of the nonconformity. The nonconforming product shall be labeled ‘rejected’ and quarantined until QA decides its disposition- reworked, accepted as-is and scrapped.

Advisory Notices and Recall: When nonconforming product is detected after delivery to the customers, customers should be notified expeditiously and be instructed on how to mitigate or avoid the effects, or potential effects, of the nonconformity. If the product need to be recalled, the sponsor should instruct them how to send back the product in question.

Reference	Criteria
21 CFR 820.90(a)	Has the company established and maintained procedures to control product that does not conform to specified requirements?
21 CFR 820.90(a)	Do the procedures address the identification, documentation, evaluation, segregation, and disposition of a nonconforming product?
21 CFR 820.90(a)	Does the evaluation of nonconformance include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance?
21 CFR 820.90(a)	Have evaluations and investigations been documented?
21 CFR 820.90(b)(1)	Has the company established and maintained procedures that define the responsibility for review and the authority for the disposition of the nonconforming product?
21 CFR 820.90(b)(1)	Do the procedures set forth the review and disposition process?
21 CFR 820.90(b)(1)	Is the disposition of nonconforming product documented?
21 CFR 820.90(b)(1)	Does documentation include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use?
21 CFR 820.90(b)(2)	Has the company established and maintained procedures for rework, including retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications?
21 CFR 820.90(b)(2)	Are rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, documented in the device history record (DHR)?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.