5.1 General
5.1.1 Many factors determine the correctness of the tests performed by PTL, these factors include contributions from:
- human factors
- accommodation and environmental conditions
- test methods and method validation
- equipment
- measurement traceability
- sampling
- the handling of test items
5.1.2 The extent to which the factors contribute to the total uncertainty of measurement differs considerably between the type of tests, the PTL considers these factors in developing test methods and procedures, in the training and qualification of personnel, and in the selection of the equipment it uses.
5.2 Personnel
Policy
5.2.1 The PTL laboratory
management ensures the competence of all who operate specific equipment,
perform tests, evaluate results, and sign test reports, When using staff who
are undergoing training, appropriate supervision is provided. Personnel
performing specific tasks are qualified on the basis of appropriate education,
training, experience, and/or demonstrated skills, as required.
The personnel responsible for the
opinions and interpretation included in test reports, is, in addition to the
appropriate qualifications, training, experience and satisfactory knowledge of
the testing carried out, also have:
-
relevant
knowledge of the technology used for the manufacturing of the items, materials,
products, etc. tested, or the way they are used or intended to be used, and of
the defects or degradations which may occur during or in service
-
knowledge of
the general requirements expressed in the legislation and standards, and
-
an
understanding of the significance of deviations found with regard to the normal
use of the items, materials, products, etc. concerned
5.2.2 The
management of the laboratory has formulated the goals with respect to the
education, training and skills of the laboratory personnel; the laboratory has
a policy and procedure (PTL/QSP/13) for identifying training needs and
providing training of personnel. The training program is relevant to the
present and anticipated tasks of the laboratory. The effectiveness of the
training actions taken is evaluated.
5.2.3 The student
is not used in testing work. Only competent laboratory personnel are used for
testing work and they work in accordance with the laboratory's management
system.
5.2.4 The PTL has
maintained current job descriptions for managerial, technical, and key support
personnel involved in tests. (Annexure
1)
Job descriptions are defined in many ways. As a
minimum, the following has been defined:
a) Name
b) Qualification
c)
Training
attended
d) Management duties
e) Expertise
f) Responsibilities
g) Further expertise/training required
5.2.5 The
Management has authorized specific personnel to perform particular types of
tests, to issue test reports, give opinions and interpretations, and operate particular types of equipment. The PTL laboratory has maintained
records of the relevant authorization(s), competence, educational and
professional qualifications, training, skills, and experience of all technical
personnel. This information is readily available and shall include the date on
which authorization and/or competence has been confirmed.
Requirements for all the personnel
working in the laboratory are identified by the Quality Manager in consultation
with the concerned head looking at the requirement of work, that qualified & competent
personnel are taken. PTL testing Laboratory ensures the competency of the staff
based on educational qualification, experience & training to operate
specific instruments. Detail of the staff is recorded in the personnel file.
A review of training progress &
effectiveness is part of the regular management review meetings. A formal evaluation of training effectiveness is carried out by trainers and submitted to
Director/Chairman.
In the case of special testing work
the staff are specially trained and tested for the work being done by them. All
training records are maintained. The methodology involved in identifying
training needs and providing training to relevant personnel.
Records
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.
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