4.0 Management requirements
4.1 Organization
4.1.1 The Pesticide Testing Laboratory (PTL) is 
part of the --------.
part of the --------.
(Lab name) incepted in the year ....... (Lab Short Name) is registered under the.................. It is engaged in providing highly reliable and cost-effective Laboratory Testing Services. PTL carries out the Pesticide and its formulations testing in different pesticides and Pesticide residue analysis in different raw agricultural commodities (Vegetables, Cereals, Pulses, Spices) and Animal feed and holds full legal responsibility for the data generated by the kind of testing work it undertakes.
4.1.2 The Pesticide Testing Laboratory (PTL) is carrying out its testing activities in accordance with the requirements of ISO/IEC 17025:2017, the needs of customers, and, regulatory authorities.
4.1.3 The management system is carried out in the laboratory's permanent facilities, no additional site is there that is away from its permanent facilities, or in associated temporary or mobile facilities.
The building and the equipment of the testing laboratory are permanently located at the (Lab Name and Address).
4.1.4 PTL is a part of (Lab Name and Address), the laboratory personnel are not involved in any other activity like commercial, marketing or finance in order to prevent the potential conflict of interest which may affect the judgment and integrity of staff and quality of work.
4.1.5 The PTL,
a) has adequate no. of managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including the implementation, maintenance and improvement of the management system, and to identify the occurrence of departures from the management system or from the procedures for performing tests, and to initiate actions to prevent or minimize such departures. The duties/responsibilities of personnel including Quality Manager and Technical Manager are defined in Annexure 1
b) has to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work. The testing personnel of PTL are not involved in any marketing activity; more-over laboratory personnel are not directly interacting with the customers to maintain quality work. To maintain confidentially, unique identification no. are provided on the samples and laboratory personnel cannot trace the customer directly by the samples provided for testing.
c) has policy & procedure (PTL/QSP/01) to ensure the protection of its customers' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results, it is ensured that under no circumstances the results of test be made known to any third party without the written consent of the customer. No reports are sent by fax without customer’s prior permission.
d) is not engaged in any activity that may diminish its trust in its independence of judgment, competence, impartiality and integrity in relation to its testing, and has a Policy & procedure (PTL/QSP/01).
e) defined the organization and management structure of the laboratory and the relationships between quality management, technical operations and support services, management structure and interrelationship of the laboratory has been defined in the organization chart (Annexure 2)
f) specified the responsibility, authority and interrelationships of all personnel who
manage, perform or verify work affecting the quality of the tests. Copies of job descriptions has been issued to all personnel to ensure that they are aware of both their responsibility and authority (Annexure 1)
g) provide adequate supervision of testing staff, including trainees, by persons familiar with methods and procedures, purpose of each test, and with the assessment of the test results;
h) has Technical Manager ,which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations; all laboratory personnel are identified by designation and shown in the list of personnel.
i) appointed a member of staff as Quality Manager who, irrespective of other duties and responsibilities has defined the responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times; the quality manager has direct access to the highest level of management (Director/Chairman) at which decisions are made on laboratory policy or resources;
j) Tech. Assistant has been appointed as deputy to Quality Manager and Technical Manager; he is competent w.r.t. Qualification and experience.
k) PTL ensures that all personnel are aware of the relevance and importance of their activities and they contribute to the achievement of the objectives of the management system by providing responsibility and authority, induction training etc.
4.1.6 Top management ensures that appropriate communication processes are established within the laboratory and the communication takes place regarding the effectiveness of the management system. Communication is done through day to day meetings, e-mail and telephone.
Ways of communication processes exists in PTL are the following:
a. Frequent meetings hold by Head of the laboratory and direct interaction with each staff member during such meetings.
b. Circulation of minutes of MRM to the relevant staff.
c. Circulars and Notices
d. Posting the information on the notice board kept at the entrance lobby.
END OF THE DOCUMENT
***********************************************************************************
You Also Like to See This:
2. PTL /QSP/02 Procedure for Document & Data Control
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
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.
END OF THE DOCUMENT
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
0 comments:
Post a Comment