Nonconforming product review

The standard requires the supplier to define the responsibility for review and authority for the disposition of nonconforming product. 

The standard requires the supplier to review nonconforming product in accordance with documented procedures and advises that it may be ... 

Nonconforming product is reviewed by authorized personnel to make disposition and request corrective action. The product is resubmitted through the regular inspection channels for acceptance, if approved for release because of rework or a use as is with waiver disposition. 

Customer Complaints. A failure in a company s quaUty system often shows up in the form of a customer complaint. These reports of nonconformances, whether for product or service deficiencies, are typically received by the sales or customer service organization and then channeled to QA. Quahty assurance often tracks the progress and coordinates the complaint investigation. Once completed, it is QA that reviews the report of the investigation and corrective action for thoroughness and efficacy. QuaUty assurance then either passes the information along to the sales or customer service organization or contacts the customer direcdy. 

Don t work to instructions unless provided in the quality system procedures, product specification, production plan or in approved change notices or remedial action instructions or by the nonconformity review board. 

Corrective and preventive action (CAPA) is the term commonly used to describe the subsystem of a comprehensive quality system that deals with the systematic investigation, understanding, and response to quality issues including nonconformities. A corrective or preventive action may be initiated based on review and analysis of quality data from a variety of sources including adverse experiences, product complaints, quality audits, FDA inspections, third-party inspections, nonconforming materials reports, process control information, trend analyses, and other sources. 

The product requirements are reviewed before the contract or tender is accepted. Product requirements are defined and communicated to the personnel responsible for the quality production. The unresolved and ambiguous issues are resolved and documented. The changes made in the product specifications are approved before execution of the order. Provisions are made for removing absolute drawings, procedures, work instructions, and specifications from all work areas to ensure that they are correctly authorized versions. Provisions are made for emergency changes necessary to prevent the production of nonconforming material. 

If nonconformances or deviations to the project plan or IQ protocol are encountered during the software IQ testing, these must be documented, analyzed, resolved, reviewed, and approved. The resolution process must indicate what additional actions must be taken to provide a conforming product (e.g., return the program to development for error analysis and correction, and re-execute the test script after correction the nonconformance was due to an inaccuracy in the test script, review and update the test script, etc.). After the successful resolution of the nonconformance has been obtained, the original test, the nonconformance information, and the retest must all be retained, approved, and reviewed by the appropriate personal. 

Minor The nonconformance cannot immediately impact the process, product or safety. The corrective action is to be reviewed at the next scheduled follow-up audit. 

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