4.4 Review of requests, tenders & contracts
1 PTL has established and maintained a documented procedure (PTL/QSP/22) for the review of requests, tenders, and contractors. The Policy and procedure for the review of the contract for testing ensure that;
a) the requirements of testing including the test method to be used are adequately defined, documented, and understood
b) the capability of the laboratory and availability of resources to meet the requirements of testing.
c) the sectional of the appropriate test methods to ensure the capability of meeting the customer requirements.
Differences between the request for testing and the contract are resolved prior to commence the testing.
While conducting the contract review, financial,
legal, and time schedule aspects are considered to conduct a review in an
effective manner.
The capability of the laboratory is assessed on the basis of physical, personnel, and information resources including the skill and expertise of the laboratory personnel required for testing. The PTL considers the result of participation in ILC and/or PT and/or the running of the trial test by using samples or items of known value in order to determine the uncertainty of measurement, the limit of detection, confidence limits, etc.
PTL accepts only written contracts provided by the customer with testing.
4.4.2 PTL maintains all the records of reviews, including any significant changes. Records maintained of pertinent discussions with a customer relating to the customer’s requirements or the results of the work during the period of execution of the contract.
4.4.3 PTL does not subcontract for any testing work. (No Subcontracting)
4.4.4 In case of any deviation from the contract the customer is informed about the deviation accordingly.
4.4.5 In case any contract needs
amendment after work has been started, the same contract review process is
repeated and amendments are communicated to the concerned personnel.
4.6 Purchasing,
services, and supplies
Policy
The PTL is
committed to Purchasing good quality material(s) and services, which
affect the quality of testing.
4.6.1 The PTL has
a policy & procedure (PTL/QSP/03) for the selection and purchasing of services
and supplies that affect the quality of the test. Procedure (PTL/QSP/03) exists
for the purchase, reception, and storage of reagents and laboratory consumable
materials relevant to the tests.
4.6.2 The PTL laboratory
ensures that purchased supplies and reagents
and consumable materials that affect
the quality of tests are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the
methods for the tests concerned. These services and supplies are used to comply with specified requirements.
Records of actions taken to check compliance are maintained.
4.6.3 Purchasing
documents for items affecting the quality of laboratory output contain data
describing the services and supplies ordered. These purchasing documents are
reviewed and approved for technical content prior to release.
The description may include type,
class, grade, precise identification, specifications, drawings,
inspection instructions, and other technical data including approval of test
results, the quality required, and the management system standard under which
they were made.
4.6.4 The laboratory evaluates
suppliers of critical consumables, supplies, and services that affect the quality
of testing and maintains records of these evaluations and lists of those
approved. The procedure for the Identification
and evaluation of critical consumables has been documented. (PTL/QSP/23)
Records
Records are maintained as per the Procedure (PTL/QSP/03)
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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