4.13 Control of records
Policy
The PTL is committed to maintaining, controlling, protecting, and securing records including computer records pertaining to quality and technical activities. The laboratory is also committed to maintaining confidentiality in record keeping.
Scope
It covers all technical and quality records maintained by the laboratory.
Responsibility
The quality Manager is responsible for maintaining and controlling records.
Procedure
A documented procedure (PTL/QSP/10) has been developed to control of records
4.13.1 General
4.13.1.1 The PTL has established and maintained procedure (PTL/QSP/10) for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Quality records include reports from internal audits and management reviews as well as records of corrective and preventive actions,
4.13.1.2 All records are legible, stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of records are established.
Records may be in any media, such as hard copy or electronic media.
4.13.1.3 All records are held secured and in confidence.
4.13.1.4 The PTL laboratory has a procedure (PTL/QSP/10) to protect and back up records stored electronically and to prevent unauthorized access to or amendment of these records.
4.13.2 Technical records
4.13.2.1 The laboratory retains records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records, and a copy of each test report issued, for a period as defined in the list of quality records, The records for each test contains sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test to be repeated under conditions as close as possible to the original, The records include the identity of personnel responsible for the sample checking, performance of each test and checking of results,
Technical records are accumulations of data and information which result from carrying out tests and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, worksheets, workbooks, check sheets, work notes, control graphs, external and internal test reports, calibration certificates, customers' notes, papers, and feedback.
4.13.2.2 Observations, data and calculations are recorded at the time they are made and identifiable to the specific task,
4.13.2.3 When mistakes occur in records, each mistake is crossed out, not erased, made illegible or deleted, and the correct value entered alongside, All such alterations to records are signed or initialed by the person making the correction. In the case of records stored electronically, equivalent measures are taken to avoid loss or change of original data.
The PTL testing laboratory retain records of original observations, derived data and sufficient information to be establishing an audit trial, testing record, staff records and a copy of each report or testing certificate issued, for a defined period as per the list. The records shall include the identity of personnel responsible for the sample checking, performance of each test and other checking result. The PTL testing laboratory shall protect and backup computer records. Sufficient information to allow repeat of test under identical conditions
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
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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