This procedure gives guidelines of identification, collection, indexing, filing, access, storage, maintenance and disposition of Quality control records, including label controls of under test, approved, rejected labels and calculation sheets.
Covers all the documents generated under quality system.
6.1. The records created during the operation of the Quality system, identified, as Quality records shall be legible, securely identifiable and retrievable. They may be in the form of printed modes of magnetic media.
6.2. The releasing authority shall be responsible for maintenance, storage, retrievability and disposal of Quality records.
6.3. The Quality records shall be made available for evaluation to customer or his representation in case of contractual obligation.
6.4. List of Quality records stored with their location and retention period
6.5. Quality records maintained shall be indexed appropriately and such indexing shall be recorded in a register.
6.6. The Quality records shall be kept in a suitable environment to prevent damage or loss.
6.7. UNDER TEST, APPROVED, REJECTED labels and calculations sheets should be stored in a controlled area.
SOP No xxx
Note: Enclose a list of Quality Control Record and its Retention period as ANNEXURE