5.4 Test method and method validation
Policy
The PTL is selecting international standards.
The international standard
of the latest edition is being used for testing. Methods published in journals,
test books, and equipment manuals.
5.4.1 General
The PTL laboratory is using
appropriate methods and procedures for all tests within its scope. These
include sample preparation, handling, transport, storage, and preparation of
items to be tested, and where appropriate, an estimation of the measurement
uncertainly as well as statistical techniques for analysis of test data.
The PTL laboratory has instructions on
the use and operation of all relevant equipment, and on the handling and
preparation of items for testing, where the absence of such instructions could
affect the results of tests. All instructions, standards, manuals, and reference
data relevant to the work of the laboratory are kept up to date and made
readily available to personnel, Deviation from tests and methods occurs only if
the deviation has been documented, technically justified, authorized, and
accepted by the customer.
5.4.2 Selection of methods
The PTL laboratory is using BIS, and AOAC test methods, including methods
that meet the needs of the customer and which are appropriate for the test it
undertakes, methods published in international, regional, or national standards
are preferably being used. The laboratory ensures that it uses the latest valid
edition of a standard unless it is not appropriate or possible to do so. When
necessary, the standard is supplemented with additional details to ensure
consistent application.
When the customer does not specify the method to be used, the laboratory
selects appropriate methods that have been published either in international,
regional or national standards, or by reputable technical organizations, or in
relevant scientific texts or journals, or as specified by the manufacturer of
the equipment.
The customer is informed as to the method chosen, The laboratory confirms
that it can properly operate standard methods before introducing the tests. If
the standard method changes, the confirmation is repeated.
The laboratory informs the customer
when the method proposed by the customer is considered to be inappropriate or
out of date.
5.4.3 Laboratory-developed methods
At present no laboratory-developed
methods are being used. Test Methods are as per AOAC etc.
5.4.4 Non-standard methods
At present no Nonstandard method is being used.
5.4.5 Validation of methods
The PTL Laboratory is following Standard test
methods BIS, AOAC and hence validation of the test method is not applicable/
required.
5.4.6 Estimation of
uncertainty of measurement
5.4.6.1 The PTL laboratory
has and apply a procedure (PTL/QSP/15) to estimate the uncertainty of
measurement for all type of testing.
5.4.6.2 The PTL laboratory
has and applies a procedure (PTL/QSP/15) for estimating the uncertainty of
measurement. In certain cases, the nature of the test method may preclude
rigorous, metrological, and statistically valid, calculation of uncertainly of
measurement. In these cases, the laboratory at least attempts to identify all the
components of uncertainty and make a reasonable estimation, and ensures that
the form of reporting of the result does not give a wrong impression of the
uncertainty. Reasonable estimation is based on knowledge of the performance of
the method and on the measurement scope and makes use of previous experience and
validation data.
The estimation of uncertainty of measurement depends on factors such as:
-
the requirements of the test method;
-
the requirements of the customer;
- the existence of narrow limits on which
decisions on conformity to a specification are based
In those cases where a
well-recognized test method specifies limits to the values of the major sources
of uncertainty of measurement and specifies the form of presentation of
calculated results, the laboratory satisfied this clause by following the test
method and reporting instructions
5.4.6.3 When
estimating the uncertainty of measurement, all uncertainty components which are
of importance in the given situation are taken into account using appropriate
methods of analysis.
Sources contributing to the
uncertainty include, but are not necessarily limited to, the reference
standards and reference materials used, methods and equipment used,
environmental conditions, properties and condition of the item being tested or
calibrated, and the operator.
The predicted long-term behavior of
the tested item is not normally taken into account when estimating the
measurement uncertainty.
Wherever applicable the
laboratory has adopted a procedure to estimate the uncertainty of measurement
in carrying out all its testing and measuring equipment and materials
The PTL applies a procedure for
estimating the uncertainly of measurement for all the tests. In some cases, the
laboratory shall at least attempt to identify all the components of the uncertainty
of measurement.
5.4.7 Control of data
5.4.7.1 Calculations and data
transfers are subjected to appropriate checks in a systematic manner. The quality Manager and Technical Manager ensure that errors are avoided by cross-checks
during data transfer. A documented procedure (PTL/QSP/02) has been established
for the control of data
5.4.7.2 When computers or
automated equipment are used for the acquisition, processing, recording,
reporting, storage or retrieval of test data, the laboratory ensures that:
a) computer software, developed by the
user is documented in sufficient detail and is suitably validated as being
adequate for use,
b) procedures procedure (PTL/QSP/02) are
established and implemented for protecting the data; such procedures include,
but not be limited to, integrity and confidentiality of data entry or
collection, data storage, data transmission, and data processing,
c) computers and automated equipment are
maintained to ensure the proper functioning and are provided with the environmental
and operating conditions necessary to maintain the integrity of test and
calibration data.
Commercial off-the-shelf software (e.g. word-processing, database, and
statistical programs) in general use within their designed application range
is sufficiently validated. However, laboratory software
configuration/modifications are validated.
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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