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2. Concepts

The following concepts are essential to an understanding of quality control:

Test Specifications

Define the actual inspections or tests to be conducted. These documents hold the definition of the test measurements, whether that be qualitative or quantitative. Detailed instructions can be maintained, which get transferred to the test plan when the test is created. Furthermore testing tolerances can be maintained, which are considered when the system is determining test success or failure.

Test Plans

Forms the core of the quality system and are used to define what tests are to be conducted on which items and the sample frequency. In addition, the life cycle stage is defined on these plans. The test plan groups specifications that are to be undertaken at the same time. Many items can share the same test plan.

Test Disposition

Defines the status of the quality test and therefore the status of the item being tested. Dispositions can include the following:

  • In-process: The test has not been completed yet.

  • Released: The test has passed and the item can be released to subsequent stages.

  • Rework: Manufactured items only. The test has failed and additional work is required on that item.

  • Scrap: The test has failed and the item is required to be scrapped.

  • Quarantine: The test has failed and the item is set aside (in a non-netable location) until an authorized person can decide what next steps are needed.

Quality Tests

The execution screen which identify that a test is required. This specifies what needs testing, including the item number and lot or serial items when appropriate. Tests are generated from quality plans and may be manually created or are automatically created based on trigger events defined on the quality plan. There can be different tests generated for an item at different life cycle stages. Tests are assigned to users and completion time frames can be defined.

The Quality Test screen holds the detailed test results based on actual observation or measurements. Quantitative test specifications that have tolerances defined will automatically determine the overall status of the test based on the results entered. If a test passes or fails overall, the relevant workflow activities will be initiated and notifications generated.

The following diagram demonstrates the potential relationships between the quality documents:

Relationship of quality documents