Nonconforming product evaluating

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

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

Quality assurance functions primarily to monitor the fact that the quality function is being performed. Its role in PV is readily associated with its main functions. For example, it performs the tests that demonstrate the product s content uniformity. It may also perform the statistical evaluation of the test results to show that the process is reproducible. Quality assurance initiates the action to dispose of nonconforming product. It implements the inspection criteria and sets the specifications for product approval or rejection. It analyzes the product complaints to learn how effective its test program has been in preventing reject-able product from reaching the marketplace. 

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. 

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 ... 

Step 5. The MRC must evaluate each completed and prospective action to determine whether a new chemical substance required to be on the TSCA Inventory was formed during the manufacture of the nonconforming commercial product, is in the nonconforming commercial product, or will result from the reworking of the nonconforming commercial product. The MRC must also evaluate whether a chemical substance subject to a Significant New Use Rule (SNUR) or any other restriction is a component of the nonconforming product The Liaison must provide the MRC with information needed to complete such evaluation. 

A key aspect of statistical quality control is evaluating the ability of a production process to meet or exceed preset specifications. This is called process capability. Simply setting up control charts to monitor whether a process is in control does not guarantee a high process capability. To produce an acceptable product, the process must be capable and in control before production begins. The process capability refers to the ability of the process to produce an output characterized by key product quality features that are within the imposed specification limits. This determines the level of nonconformities produced by the process. 

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