SECTION 16 QUALITY RECORDS
GENERAL POLICY
Quality records demonstrate achievement of the required quality and effective operation of the quality system. The records are identified, indexed, and stored in a suitable environment to minimize deterioration. Records are stored by the Document Control department. Retention periods for quality records are defined.
PROCEDURAL POLICIES
1. General
1.1 Quality records provide the evidence that product designs meet their design input requirements, that finished products conform to the design output requirements, and that the quality system is operated in accordance with documented procedures and that it is effective.
2. Establishment of Records
2.1 Records are usually established by the personnel directly involved with the task, operation, or activity whose results need to be recorded.
2.2 Records identify the product, person, or event to which they pertain; provide the relevant facts and data; and are signed and dated by the person who established the record.
2.3 Specific record formats are usually prescribed by the procedures that call for their establishment. These can be forms, reports, minutes of meetings, sign-offs or stamps placed on other documents, and so forth. Records can also be established and maintained in electronic media (computer files or databases).
3. Indexing and Storage
3.1 Records are indexed and grouped to facilitate their retrieval. Binders, drawers, cabinets, etc., containing records are clearly labeled with identification of their content. Records may not be stored in private desk drawers or other obscure locations that are not generally known.
3.2 The activities of identification, collection, indexing, filing, storage, maintenance and disposition of quality records are governed by General Process Specification G9023, Quality Records.
4. Storage Location and Retention Periods
4.1 Records are stored and maintained by Document Control. General Process Specification G9023, Quality Records, stipulates the storage locations for all types of records required by the quality system.
4.2 Retention periods for records are determined by the department that establishes them or by Document Control. The retention period is determined on the basis of contractual obligations, warranty periods, useful life of products, legal considerations, etc. General Process Specification G9023, Quality Records, stipulates the retention periods for all types of records required by the quality system.
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