Nonconforming product documenting

Are documented procedures employed to prevent the inadvertent use or installation of nonconforming products ... 

Suspect product should be treated in the same manner as nonconforming product and quarantined until dispositioned. However, until a nonconformity can be proven, the documentation of the nonconformity merely reveals the reason for the product being suspect. 

The standard requires the supplier to provide for the documentation of nonconforming product. 

In which documents do you define the responsibility for the review and the authority for the disposition of nonconforming product ... 

A product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with a nonconforming product are defined in a documented procedure. 

The [procedures] provide for identification, documentation, evaluation, and segregation when practical, as well as disposition of nonconforming product and notification to the functions concerned. 

Nonconforming product is reviewed in accordance with documented procedures. It may be ... 

Control of nonconforming product—Requires procedures to ensure tliat product that does not conform to requirements is prevented from unintended use or installation. This includes identification, documentation, evaluation, segregation, and disposition of nonconforming product. 

Any raw material, intermediate or finished excipient found not to meet specifications must be clearly identified and segregated to prevent inadvertent use or release for sale. A record of nonconforming product should be maintained. All incidence of nonconformance should be investigated to identify the root cause. This investigation should be documented and correction made to prevent recurrence of the problem. 

Procedures should exist for the evaluation and fate of nonconforming products. Nonconforming product should be reviewed in accordance with documented procedures to determine its final outcome. The nonconforming product may be ... 

Are documented procedures employed to determine the cause of nonconformities in products, processes, and the quality system and to prevent their recurrence ... 

The original nonconformity report should indicate the nature of the nonconformity but after rework, or completion of operations, the nonconformity will have been eliminated. Where the nonconformity was accepted as is without rework, repair, or changing the specification then the actual condition is the original condition and this can be specified by the original nonconformity report. If the product has to be repaired or modified, the actual condition can be specified by the repair, salvage, or modification scheme, which is usually a separate document and can either be detailed on the nonconformity report or cross referenced to it. A lot of time can be saved if this information is readily accessible when problems arise later. 

An example of a robust process is the design, development, and operation of a nonconformance process. Regulations require an operational process to identify, document, and correct nonconformances occurring in licensed pharmaceutical manufacturing facilities for approved products. Companies spend significant human... 

Consideration is given to the control exercised at the source and documented evidence of quality conformance provided. All incoming materials are inspected or otherwise verified as to conforming to specified requirements before being released for use to production. This verification is in accordance with the quality plan or documented procedures. All incoming materials released for urgent production purposes are positively identified and recorded in order to permit immediate recall in the event of nonconformance. 

The products received from the customers are verified, stored, and maintained to prevent deterioration or loss. The conditions of handling and use of customer-supplied product are spelled out in the contract or by other documented specifications. Any customer-supplied product that becomes nonconforming is segregated from the production stream, recorded, and reported to the customer. 

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. 

Nonconformities are defined as the nonfulfilment of specified requirements in the ISO 9000 standards for quality management systems (see ISO, 1994). To avoid confusion with this definition, we will here use the term deviation instead. It covers those aspects of the accident sequence that represent a mismatch between our norms for a faultless production process and what actually happened. Nonconformities are one type of deviations, where the norm has been defined and documented. 

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