5.7 Sampling
5.7.1 The PTL has a
sampling plan and procedure (PTL/QSP/18) for sampling. This procedure includes
the selection, sampling plan, withdrawal, and preparation of a sample to yield the required information. The sampling plan and procedure are available at the
location where sampling is undertaken. Sampling plans are based on statistical
methods.
5.7.2 Where the customer
requires deviations, additions, or exclusions from the documented sampling
procedure, these are recorded in detail with the appropriate sampling data and
are included in all documents containing test results, and are communicated to
the appropriate personnel.
5.7.3 The PTL has a procedure (PTL/QSP/18) for recording relevant data and operations relating to
sampling that forms part of the testing that is undertaken. These records
include the sampling procedure used, the identification of the sampler,
environmental conditions (if relevant), and diagrams or other equivalent means
to identify the sampling location as necessary and, if appropriate, the
statistics the sampling procedures are based upon.
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5.8 Handling of test and
calibration items
Policy
The PTL is handling test items to
protect the integrity of test.
5.8.1 The PTL has procedure
(PTL/QSP/19) for the transportation, receipt, handling, protection, storage,
retention and/or disposal of test items, including all provisions necessary to
protect the integrity of the test item, and to protect the interests of the
laboratory and the customer.
5.8.2 The PTL laboratory
has a system for identifying test items. The identification is retained
throughout the life of the item in the laboratory. The system is designed and
operated so as to ensure that items cannot be confused physically or when
referred to in records or other documents.
5.8.3 Upon receipt of the test item, abnormalities or
departures from normal or specified conditions, as described in the test method,
are recorded.
When there
is doubt as to the suitability of an item for test or when an item does not
confirm to the description provided or the test required is not specified in
sufficient detail, the laboratory consult the customer for further instructions
before proceeding and record the discussion.
5.8.4 The
laboratory has procedures (PTL/QSP/19) and appropriate facilities for avoiding
deterioration, loss or damage to the test item during storage, handling and
preparation. Handling instructions provided with the item shall be followed.
When items
have to be stored under specified environmental conditions, these conditions are
maintained, monitored and recorded. Where a test item or a portion of an item
is to be held secure, the laboratory has arrangements for storage and security
that protect the condition and integrity of the secured items or portions
concerned.
Records
Record of handling of test items are maintained, for each
item following information is recorded:
a) Laboratory Identification no.
b) Name of the customer
c) Date of receipt
d) Sample description
e) Condition of receipt
f) Date of test/measurement completed
g) Sample disposal date
h) Identity of assigned analyst
Retention time of test records is min. two year. For
internal audit and MRM records is min. three years.
END OF THE DOCUMENT
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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