Quality System Procedure: (PTL/QSP/10) Procedure for Control of Records in Testing Laboratories

1. Purpose: To define a system in the organization for identification, collection, indexing, access, filing, storage, maintenance, and disposal of quality and technical records.

2. Scope: This procedure covers all documents affecting to the laboratory management system.

3. Responsibility: Technical Manager is responsible to implement this procedure.

4. Procedure:


 

4.1 All quality records are identifiable through a unique identification no. i.e. PTL/Dept./xx where xx is Serial No. i.e. 01, 02, 03 of the testing record. A master list of the quality record is being maintained to control the records along with the identification no. of each record for control.

4.2 Records are collected in the respective test files, these records are collected date-wise and maintained by the laboratory.

4.3 All records are indexed date-wise, discipline-wise, test-wise, etc.

4.4 All records are accessible to authorized Lab. personnel only and records are maintained in both hard copy and soft copy. Lock and keys are provided in Almirah and password is provided in computers to ensure that the record is accessible to authorized personnel only.

4.5 Format nos. and title name are provided on the front side of the file and the same is mentioned on the side. All documents are filed date-wise.

4.6 All hard copies are stored in an almirah and soft copies are in computers. An Antivirus system and password is provided in the computer to protect and preserve the data. Regular backup is being taken in the CDs as a safeguard.

4.7 Hard copies are cleaned on daily basis and kept in a file having a hard protective cover, soft copies are periodically scanned through antivirus to maintain the records. Air conditioning in Laboratory to prevent dust and moisture in order to maintain the record.

4.8 Internal Audit and Management Review Records are kept for three years and other records are kept for two years. Disposal of the records is being done by shredding/tearing the record and is being sent to the paper recycler.

5. References: Master list of Quality Records

Retention Time of records –Two Years

Internal Audit and Management Review Records – Three Years

CHANGE HISTORY

 

Sr.No.

Date of change

Revision no. of old document

Date of old document

Revision no. of Revised document

Date of Revised document

Nature of change

(addition/deletion)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                                     
END OF THE DOCUMENT

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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
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Note: Replace DTL with PTL for Drug Testing Laboratory.


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