SOP Title: Archival of Documents and Records
- Objective:
To lay down procedure for archival of documents and records to ensure controlled accessibility, traceability and preservation.
- Scope:
This procedure is applicable to archival of documents and records of all departments at the site.
- Responsibility:
All Departments: To ensure that the documents/records produced within the department are reviewed for correctness and submitted to QA Department for archival.
QA Department: To review the documents/records submitted, logging and archival in the Document Room in safe and secure manner.
- Accountability:
QA Department
- Procedure:
5.1 Definitions:
Archival: Archival is a systematic approach to collects, organize, preserve, maintain control over, and provide restricted access to records/documents.
5.2 Procedure:
5.2.1 | Document/record submission for archival | |
5.2.1.1 | All the completed records and documents shall be submitted to the QA Departments for archival. | |
5.2.1.2 | Before submission, the records shall be reviewed for correct data entry and completion and a list of records submitted shall be given to the QA Department. | |
5.2.1.3 | QA person shall verify the records and update the current list of document/ records in Annexure. | |
5.2.2 | Archival of the documents and records | |
5.2.2.1 | The records/documents shall be stored in the dedicated racks provided separately for each department in the Document Room. | |
5.2.2.2 | A list of Document/records stored in the Document Room shall be prepared and kept updated for each department as per Annexure. | |
5.2.2.3 | The Document Archival Room shall be kept under the custody of QA Department and the necessary arrangement shall be provided to ensure proper segregation, security, protection from any damage and cleanliness of the room. | |
5.2.2.4 | The racks in the Document Archival Room shall be properly labelled and identified with the necessary information to indicate at least Department Name, Rack No., Block No. etc. | |
5.2.2.5 | Document Archival Room shall be provided with lock and key facility and the key shall be with QA Department. | |
5.2.2.6 | Archival Room shall be monitored routinely for cleanliness and maintenance of documents and records. | |
5.2.3 | Document/record issuance | |
5.2.3.1 | Documents/records from the Archival Room shall be issued to the concerned person (whenever required) for justified reason and the issuance record shall be maintained as specified in Annexure. | |
5.2.3.2 | The issued document/record shall be retrieved within minimum time frame, verified and restored in its dedicated racks. | |
5.2.3.3 | No person shall be allowed to enter the Document Archival Room without permission from QA Department. |
- Abbreviation:
Abbreviation | Expansion |
QA | Quality Assurance |
QAD | Quality Assurance Department |
SOP | Standard Operating Procedure |
*Note – Ready to use SOP available in “DOWNLOAD” Section.