5.9 Assuring the quality of test results
Policy
The PTL is committed to assuring the quality of test results.
5.9.1 The PTL has quality control procedures (PTL/QSP/20) for monitoring the validity of tests undertaken. The resulting data are recorded in such a way that trends are detectable and, where practicable, statistical techniques are applied to the reviewing of the results. This monitoring is planned and reviewed and may include, but not be limited to, the following
a) regular use of certified reference materials and/or internal quality control using secondary reference materials,
b) participation in inter-laboratory comparison or proficiency-testing programs,
c) replicate tests using the same or different methods;
d) retesting of retained items;
e) correlation of results for different characteristics of an item.
5.9.2 Quality control data are analyzed and, where they are found to be outside pre-defined criteria, planned actions are taken to correct the problem and to prevent incorrect results from being reported.
Responsibility
Quality Manager is responsible for coordinating the verification practices. Technical Manager is responsible for reviewing the results and deciding the investigation and corrective action.
Proficiency testing
The PTL laboratory is followed Inter-laboratory comparison system to assure the quality of test results.
Records
The records of internal checks and ILC are maintained.
.10 Reporting the results
Policy
The PTL laboratory is
reporting the test results accurately, clearly, unambiguously and objectively
and in accordance with test method.
5.10.1 General
The results are reported in a test report, and include all the information
requested by the customer and necessary for the interpretation of the test
results and all information required by the method used.
In the case of tests performed for internal customers, or in the case of
a written agreement with the customer, the results may be reported in a
simplified way. Any information listed in 5.10.2 to 5.10.4 which is not
reported to the customer is readily available in the laboratory which carried
out the tests.
5.10.2 Test
reports
Each test report includes at least the following information, unless the
laboratory has valid reasons for not doing so:
a) a title (e.g. "Test Report');
b) the name and address of the laboratory,
and the location where the tests were carried out, if different from the
address of the laboratory;
c) unique identification of the test
report (such as the serial number), and on each page an identification in order
to ensure that the page is recognized as a part of the test report, and a clear
identification of the end of the test report,
d) the name and address of the customer;
e) identification of the method used.
f) a description of, the condition of, and
unambiguous identification of the item(s) tested;
g) the date of receipt of the test item(s) and the dates of performance of the test ;
h) reference to the sampling plan and
procedures used by the laboratory;
i) the test results with, where
appropriate, the units of measurement,
j) the name(s), function(s) and signature(s) of person(s) authorizing the test report ;
k) where relevant, a statement to the
effect that the results relate only to the items tested.
5.10.3 & 5.10.3.1 In
addition to the requirements listed in 5.10.2, test reports are, where
necessary for the interpretation of the test results, include the following:
a) deviations from, additions to, or
exclusions from the test method, and information on specific test conditions,
such as environmental conditions;
b) where relevant, a statement of
compliance/non-compliance with requirements and/or specifications;
c) where applicable, a statement on the
estimated uncertainty of measurement; information on uncertainty is needed in
test reports when it is relevant to the validity or application of the test
results, when a customers instruction so requires, or when the uncertainty
affects compliance to a specification limit;
d) where appropriate and needed, opinions
and interpretations (see 5.10.5);
e) additional information which may be
required by specific methods, customers or groups of customers.
5.10.3.2 In addition to
the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the
results of sampling have include the following, where necessary for the
interpretation of test results:
a) the
date of sampling;
b) unambiguous identification of the
substance, material or product sampled (including the name of the manufacturer,
the model or type of designation and serial numbers as appropriate);
c) the location of sampling, including any
diagrams, sketches or photographs;
d) a reference to the sampling plan and
procedures used;
e) details
of any environmental conditions during sampling that may affect the
interpretation of the test results,
f) any
standard or other specification for the sampling method or procedure, and
deviations, additions to or exclusions from the specification concerned.
5.10.4 Calibration
certificates
PTL Laboratory
is conducting tests only and hence this clause is not applicable to our
laboratory.
5.10.5 Opinions
and interpretations
PTL does not offer any opinions and
interpretations on the test report.
5.10.6 Testing and calibration results obtained from
subcontractors
No testing work is being
outsourced
5.10.7 Electronic
transmission of results
In the case of transmission of test
results by telephone, telex, facsimile or other electronic or electromagnetic
means, the requirements of this International Standard are met (PTL/QSP/21)
5.10.8 Format
of reports and certificates
The format is designed to accommodate
each type of test carried out and to minimize the possibility of
misunderstanding or misuse.
Lab has used the NABL symbol only the
test reports. The procedure has documented for use of NABL symbol. (PTL/QSP/24)
5.10.9 Amendments
to test reports
Material amendments to a test report
after issue is made only in the form of a further document, or data transfer,
which includes the statement:
"Supplement to Test Report serial number...
[or as otherwise identified]', or an equivalent form of wording.
Such amendments meet all the requirements of this
international Standard.
When it is necessary to issue a
complete new test report, this is uniquely identified and contains a reference
to the original that it replaces.
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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