Tiêu đề ENSURING THE VALIDITY OF TEST RESULTS PROCEDURE 7.7.pdf ✅

ENSURING THE VALIDITY OF TEST RESULTS PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP 7.7 controlled E copy pg. 1 ENSURING THE VALIDITY OF TEST RESULTS PROCEDURE QP 7.7 Author Prepared by Reviewed and approved by Name Mohamed Abdelaziz Shaik aldien Function /position Quality Lead / Senior Quality Supervisor lab Manager Signature Date All rights reserved. These materials are confidential and proprietary to Conformity Assurance. No part of these materials should be reproduced, published in any form by any means (electronic or mechanical, including photocopy or any information storage or retrieval system), nor should the materials be disclosed to third parties without the express written authorization of Conformity Assurance
ENSURING THE VALIDITY OF TEST RESULTS PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP 7.7 controlled E copy pg. 2 1. purpose The purpose of this document is to determine and outline necessary steps to develop and ensure laboratroy validity of test results . 2. Scope The scope of this document is to develop methodology for ensuring validity of test results 3. Definitions/abbreviation 3.1. Test determination according to requirements for a specific intended use or application Note 1 to entry: If the result of a test shows conformity, it can be used for purposes of validation. 3.2. Inspection determination of conformity to specified requirements Note 1 to entry: If the result of an inspection shows conformity, it can be used for purposes of verification. Note 2 to entry: The result of an inspection can shows conformity or nonconformity or a degree of conformity. 3.3. Measuring equipment measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process 3.4. Review determination of the suitability, adequacy, or effectiveness of an object to achieve established objectives 3.5. Monitoring determining the status of a system, a process, a product , a service , or an activity 3.6. Measurement process to determine a value Note 1 to entry: According to ISO 3534-2, the value determined is generally the value of a quantity.
ENSURING THE VALIDITY OF TEST RESULTS PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP 7.7 controlled E copy pg. 3 3.7. Measurement process set of operations to determine the value of a quantity 3.8. Validity the quality of being logically or factually sound; soundness or cogency 4. References 4.1 ISO 9000:2015 Quality Management System – Fundamentals and Vocabulary 4.2 ISO 9001:2015 Quality Management System – Requirements 4.3 ISO IEC 17025:2017 General requirements for the competence of testing and calibration laboratories 5. Responsibilities 5.1. Technical manager 5.2. Quality manager 5.3. Lab manager 6. Process 6.1. Monitoring of the results 6.1.1.Technical manager shall monitor and record test results . He/She shall collect and gather data on monthly basis 6.1.2.Technical manager shall use suiatble statistical analsysis technique in order to analyse data and check trends tendency . for example control charts 6.1.3. Technical manager shall carry out monitoring plan for test results and data analysis . this plan shall include the following inputs : 6.1.3.1. Use of reference materials or quality control materials 6.1.3.2. Use of alternative instrumentation that has been calibrated to provide traceable results; 6.1.3.3. Functional check(s) of measuring and testing equipment; 6.1.3.4. Use of check or working standards with control charts, where applicable; 6.1.3.5. Intermediate checks on measuring equipment; 6.1.3.6. Replicate tests or calibrations using the same or different methods; 6.1.3.7. Retesting or recalibration of retained items; 6.1.3.8. Correlation of results for different characteristics of an item;
ENSURING THE VALIDITY OF TEST RESULTS PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP 7.7 controlled E copy pg. 4 6.1.3.9. Review of reported results; 6.1.3.10. Intralaboratory comparisons; 6.1.3.11. Testing of blind sample(s). 6.2. Quality control schemes utilized consists of: 6.2.1.1. Quality control samples for monitoring quality control samples for Test Method Performance (TMP) are used to monitor the performance of the test method, testing of the quality control samples should be carried out at the same conditions under which the samples being tested. 6.2.1.2. Examples of Quality Control Samples for monitoring test method performance : 6.2.1.2.1. Control positive samples; 6.2.1.2.2. Control negative samples; and 6.2.1.2.3. Reference standard e.g. Kits. 6.2.2. Quality control criteria for monitoring Test Method Performance (TMP) 6.2.2.1. Testing responsible during his/her normal testing activities will run the control positive sample i.e. sample which is predicted to give non acceptable result and run control negative sample i.e. sample which is predicted to give acceptable result or using reference standard as specified within the quality control scheme. 6.2.2.2. As predicted results achieved this will indicate test method performance. 6.2.3. Re-Testing of Retained samples (RTR) 6.2.3.1. Retained samples can be re-introduced into the workload as regular samples in order to assess laboratory performance. 6.2.3.2. Quality control criteria for Re-Testing of Retained samples (RTR) 6.2.3.3. Testing responsible will retest retained samples on periodical basis as specified within the quality control scheme with comparing the current results achieved with the previous ones. 6.2.4. Inter-Laboratory “ and/or Intra-Laboratory Comparison” (ILC) 6.2.4.1. Participation in inter laboratory comparison is considered as an important tool of quality control and as an indicator for laboratory performance.