Title Procedure _ TP-7.2 Selection Verification and Validation of Methods.pdf ✅

Selection verification and validation of methods Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: TP-7.2 controlled E copy Selection verification and validation of methods TP-7.2 Approval 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 TUV Austria LABORATPRY. 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 TUV Austria LABORATPRY
Selection verification and validation of methods Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: TP-7.2 controlled E copy 1. Purpose The purpose of this document is to determine and outline necessary steps for Selection, verification, and validation of methods. 2. Scope The scope of this procedure shall cover laboratory measurement methods. 3. Definitions/abbreviations 3.1 requirement need or expectation that is stated, generally implied or obligatory 3.2 Selection 3.3 Verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents. Note 2 to entry: The activities carried out for verification are sometimes called a qualification process. Note 3 to entry: The word “verified” is used to designate the corresponding status. 3.4 Validation confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents. Note 2 to entry: The word “validated” is used to designate the corresponding status. Note 3 to entry: The use conditions for validation can be real or simulated. 4. References 4.1. ISO 9000:2015 Quality management systems — Fundamentals and vocabulary 4.2. ISO 9001:2015 Quality management systems — Requirements 4.3. ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
Selection verification and validation of methods Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: TP-7.2 controlled E copy 5. Responsibilities 5.1. Quality manager 5.2. Lab manager 5.3. Technical manager 6. Process NOTE methods = measurement procedures 6.1. Identification of Methods and/or measurement procedures 6.1.1. Lab manager and technical manager shall identify and determine methods and/ or measurement procedure for laboratory activities and customer needs 6.1.2. Lab manager and technical manager shall list methods and/or measurement procedures with updating plan each 6 months in form no TF-7.2-01 6.2. Methods selection and verification 6.2.1. Lab manager and technical manager shall ensure competency of personnel, equipment in adequate condition, environmental condition suitable to achieve testing requirements 6.2.2. Lab manager and technical manager shall verify the selected methods/measurement procedures, using one of the known verification methods such as testing sample with known results, use inter- lab comparison and intra-ab comparison, Use CRM, .... etc. 6.2.3. Lab manager and technical manager shall use statistical methods for the verification of methods and/or measurement procedures, using control charts for each method. 6.3. Deviation 6.3.1. Lab manager and technical manager shall document any deviation for method used and take corrective action according to corrective action procedure code QP-8.7 6.3.2. Lab manager shall inform customer with any deviation to test method, and ensure appropriate results shall be agreed upon with customer 6.4. Validation 6.4.1. NOTE: laboratory team does not use in house methods or non-standard methods. All methods used are standard methods 7. Process flow chart NA 8. Forms / template 8.1. Methods- Measurement procedures list form TF 7.2-01 8.2. Verification Plan form TF-7.2-02 8.3. Method verification TF-7.2-03
Selection verification and validation of methods Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: TP-7.2 controlled E copy 9. Revision history The following list provides a key-word-based overview of the changes made to this QM document over time. SN Issue No. Revision No. Date Change Training 1. 1.0 0.0 01-04-2023 Initial issue Done