Glossary Term: Quality Management


A test that measures the physical and/or chemical properties of a substance.

Expiration Date

Date or time window during which an item or lot is required to be used for its intended purpose.

Hold Reason

User-defined code has specifying the reason a lot has been marked as unusable.

Item Attributes

Characteristics of an item or lot listed in the test specification record are then assayed and test results are recorded.

Lot Source

Historical records of the composition of a lot.

QC Action

User-Defined or system-defined message displayed for Expired or out-of-specification lots to be identified and handled accordingly.

QC Grade

This is a certain quality grade of an item that identifies its particular composition. Used to separate one lot from other production lots. Defined in the required specifications record for …

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QC Status

An item’s QC status reflects its current usability. A QC status of unusable does not prevent an item from being sold or used for production; rather, the inventory status must …

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The outcome of a QC test performed on a lot wasn’t what you had hoped for. The results may not be the expected results (as defined in the test specification) …

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