T/BIOT 01-2023 Active Group standards

T/BIOT 01-2023 Product Traceability Evaluation Methodology

Publish Date: 2023-12-11 Implement Date: 2023-12-11 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/BIOT 01-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Terminology (principles and coordination and cooperation)

Publish Date: 2023-12-11

Implement Date: 2023-12-11

Scope

Scope: This document specifies the breadth, depth, and accuracy of the product traceability process and its accounting methods, and uses these to evaluate and grade the effectiveness of enterprises in maintaining the traceability characteristics of their products. This document applies to the evaluation of traceability characteristics of traceable products, as well as to enterprises' self-evaluations of traceable products; Main technical content: 5.2.1 Traceability Breadth Enterprises shall, in accordance with the requirements of relevant compliance obligations, determine the key traceability links within their quality management system and adopt the "one step forward, one step back" principle to establish external traceability unit requirements with suppliers and/or supply chains. Table 1: Evaluation Elements of Traceability Breadth Evaluation Object Evaluation Elements (including but not limited to) Evaluation Requirements Traceability Breadth Order; a) The accuracy and completeness of the definition of traceability units related to compliance business; b) The clarity of the identification of key production process traceability units related to product functionality, safety, and quality claims (where applicable); c) Compliance with the enterprise's product traceability objectives. Materials (including raw materials; intermediate products; waste and finished products); Responsible entities; Release process; Supplier information; Supply chain management information. 5.2.2 Traceability Depth Enterprises shall, in accordance with the requirements of relevant compliance obligations, determine the internal traceability information within their quality management system and adopt the "one step forward, one step back" principle to establish external traceability information requirements with suppliers and/or supply chains. Table 1: Evaluation Content of Traceable Products - Traceability Depth Evaluation Elements (including but not l