Quality Manual: Section 4.3 - How to Maintain Document Change Control in Testing Laboratory?

4.3 Document control

4.3.1 General

The PTL has established and maintained a procedure (PTL/QSP/02) to control all documents that form part of its management systems (internally generated or from external sources), such as regulations, standards, other normative documents, test methods, as well as software, specifications, instructions, and manuals.

(documents could be policy statements, procedures, specifications, charts, textbooks, posters, notices, software, etc. These may be on various media, whether hard copy or electronic, and they may be digital, analog, photographic, or written.)

4.3.2 Document approval and issue

4.3.2.1 All documents issued to personnel in the laboratory as part of the management system are reviewed and approved for use by authorized personnel prior to the issue. A master list, identifying the current revision status and distribution of documents in the management system has been established and is readily available to preclude the use of invalid and/or obsolete documents.

4.3.2.2 The procedure (PTL/QSP/02) adopted ensures that:

a) authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;

b) documents are reviewed once a year and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements;

c) invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use.

d) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.

4.3.2.3 Management system documents generated by the laboratory are uniquely identified. Such identification shall include the date of issue and/or revision identification, page numbering, the total number of pages of a mark to signify the end of the document, and the issuing authority(ies).

Responsibility

The responsibility of the person(s)/position for review and approval of documents are defined in the procedure (PTL/QSP/02) for all level of documentation.

4.3.3 Document changes

4.3.3.1 Changes to documents are reviewed and approved by the same function that performed the original review unless specifically designated otherwise. The designated personnel have access to pertinent background information upon which to base their review and approval.

4.3.3.2 Where practicable, the altered or new text is identified in the document or the appropriate attachments by Italics.

4.3.3.3 Our laboratory's document control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedure (PTL/QSP/02) and authorities for such amendments are defined. Amendments are clearly marked, initialed and dated. A revised document is formally re-issued as soon as practicable.

4.3.3.4 A procedure (PTL/QSP/02) has been established to describe how changes in documents are maintained and controlled in computerized systems

Responsibility

The responsibility of the person(s)/position authorized to review and approve changes/amendments are defined in the procedure (PTL/QSP/02)

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You Also Like to See This:

1. PTL/QSP/01 Procedure for Customer Confidential Information and Proprietary Rights

2. PTL /QSP/02 Procedure for Document & Data Control

3. PTL /QSP/03 Procedure for Purchasing, Services and Supplies

4. PTL /QSP/04 Procedure for Service to the Customer

5. PTL /QSP/05 Procedure for Customer Complaints

6. PTL QSP/06 Procedure for Control of Non-Conforming Testing.

7. PTL /QSP/07 Procedure for Improvement

8. PTL /QSP/08 Procedure for Corrective Action

9. PTL /QSP/09 Procedure for Preventive Action

10. PTL /QSP/10 Procedure for Control of Records

11. PTL /QSP/11 Procedure for Internal Audit

12. PTL /QSP/12 Procedure for Management Review

13. PTL /QSP/13 Procedure for Training

14. PTL /QSP/14 Procedure for Housekeeping

15. PTL /QSP/15 Procedure for Estimation of Uncertainty of measurement

16. PTL /QSP/16 Procedure for Equipment

17. PTL /QSP/17 Procedure for Measurement Traceability and Calibration

18. PTL /QSP/18 Procedure for Sampling

19. PTL /QSP/19 Procedure for Handling of Test and Calibration Items

20. PTL /QSP/20 Procedure for Assuring the Quality of Test

21. PTL /QSP/21 Procedure for Reporting of Results

22. PTL/QSP/22 Procedure for use of NABL Symbol

Note: Replace DTL with PTL for Drug Testing Laboratory.

  END OF THE DOCUMENT

You may like to read these links: 

1. List of All SOPs and Documents for the Chemistry Laboratory

2. List of All SOPs and Documents for Quality Control

3. List of All SOPs and Documents For Quality Assurance Dept.

4. List of SOPs and Documents Required to Achieve NABL Accreditation 

5. List of All SOPs and Documents for Laboratory Instruments and Equipment  

6. List of SOPs and Documents for Laboratory Administration

7. STANDARD OPERATING PROCEDURE FOR ARCHIVING THE DOCUMENTS AND SUBSTANCES

8. List of SOPs for Safety In Laboratory

9. List of Items or Substances that can be Archived in the Laboratory

10. STANDARD OPERATING PROCEDURE FOR DISPOSAL OF ARCHIVED MATERIAL

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