Nonconforming product segregating

The standard requires the supplier to provide for the segregation (when practical) of nonconforming product and that quarantine areas have visual identification. 

Segregation is another important requirement and not only for nonconforming product as specified in clause 4.13. Segregation is vital in many industries where products can only be positively identified by their containers. It is also important to prevent possible mixing or exposure to adverse conditions or cross-contamination. Examples where segregation makes sense are ... 

In the final analysis, market price and sales volume are functions of the quality standards offered and the buyer s degree of confidence that the product will conform to the standards. Maintenance of buyer s confidence requires inspection to screen out all nonconforming products, or control over variability of quality during production and distribution to a degree where few, if any, products fail to meet the standards. Screening inspection of the finished product cannot improve quality it merely serves to segregate unacceptable from acceptable product, and results in loss of production capacity and costly waste and salvage. The second consideration provides the only sound basis for quality control in frozen food production and distribution. It operates on the old principle that an ounce of prevention is worth a pound of cure. ... 

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

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 nonconforming products are identified and segregated by labels to indicate their pending disposition. 

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. 

The nonconforming customer-supplied product is segregated from the production streams recorded and reported to the customer. 

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