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GB/T 24737.8-2009Guide for technological management - Part 8: Process verification (English PDF)

工艺管理导则 第8部分:工艺验证

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

November 30, 2009

Implementation date

September 1, 2010

Scope

GB/T 24737.8-2009 is the English-translated version of 工艺管理导则 第8部分:工艺验证.

GB/T 24737.8-2009 is Part 8 of GB/T 24737 and specifies the scope of process validation, its basic task, the main content of the verification and the validation procedure.

Clause 1 applies it to the process validation of mechanical products and states no exclusions; the part has no normative references clause, clause 2 being the scope of process validation itself, which calls for validation by small-batch trial production when new products go into mass production, after the prototype trial appraisal and before mass production.

Clause 3 gives the basic task as assessing, through that small-batch trial production, whether the process design is reasonable and adaptable, so that mass production holds product quality stable, keeps cost low and complies with safety and environmental protection requirements.

Clause 4 lists what the verification has to cover: whether the process route and the process requirements for key and important parts are reasonable and feasible, whether the choice of equipment and process equipment can meet the technical requirements, whether the test means meet the requirements, whether the assembly and assembly line methods can ensure the technical requirements, and whether the process meets labour safety and green manufacturing requirements.

Clause 5 sets out the programme in three steps: drawing up a verification implementation plan covering the major verification projects, the technology to be proven, the organizational measures, the schedule and the budget; the preparation beforehand, in which the plan is issued, the process documents and the information needed are prepared, the necessary technology, equipment and materials are provided and the test and pre-production preparations are made; and the execution of the verification, which must follow the pre-production process documents strictly, with the process and tooling designers tracking and visiting the production site to find and solve problems in good time and to record them, their causes and the measures taken in detail, and with the operators' rationalization proposals actively taken up.

The draft breaks off inside that third step. The foreword states that GB/T 24737 is divided into nine parts, that Appendix A of this part is informative, and that the part falls under the national technical committee on technical product documentation (SAC/TC146). It was issued on 2009-11-30 and has applied since 2010-09-01.

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Document preview — GB/T 24737.8-2009

National Standard of the People's Republic of China

ICS
25.020
Classification
J 30

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Foreword
  • 1 Scope
  • 2 Scope of the validation process
  • 4 Verify the contents of the main
  • 5 Process Validation Program

Foreword

GB/T 24737 "technological management" is divided into nine sections.

--- Part 1. General;

--- Part 2. Product craft work program;

--- Part 3. Product Structure Process review;

--- Part 4. Process design;

--- Part 5. Process Planning;

--- Part 6. process optimization and technology assessment;

--- Part 7. Process Quota;

--- Part 8. Process Validation;

--- Part 9. production site process management.

This section GB/T Part of 824,737.

Appendix A of this section is an informative annex.

This part of the National Technical product documentation Standardization Technical Committee (SAC/TC146) and focal points.

1 Scope

This section GB/T 24737 specifies the scope of the validation process, the basic tasks, the main content verification and validation procedures.

This section applies to process validation of mechanical products.

2 Scope of the validation process

If students mass production of new products, after the prototype trial identification before mass production, process validation should be carried out by a small group of trial.

3 Basic task of process validation

By a small group of trial production and reasonable assessment process design, adaptability, to ensure product quality and stability in mass production, low cost, and Compliance with safety and environmental protection requirements.

4 Verify the contents of the main

Routing technology and process requirements --- key member and an important member is reasonable and feasible;

--- The choice of equipment and process equipment whether it can meet the technical requirements;

--- Test means meets the requirements;

--- Assembly and assembly line methods can ensure technical requirements;

--- Process Meets labor safety, green manufacturing requirements.

5 Process Validation Program

5.1 Verify the implementation plan developed

Content Verification implementation plan should include. verification major project, proven technology, organizational measures, schedule, budget and so on.

5.2 Preparation before verification

Before verifying all relevant departments should verify implementation plan to do the following preparations.

--- Issued a verification plan;

--- To prepare the verification process documents and related information required;

--- Provide all the necessary technology and equipment;

--- Prepare all the materials required for authentication;

--- Do test preparation;

--- Do pre-production preparation.

5.3 To perform verification

Must be in strict accordance with the requirements of pre-production process documents 5.3.1 verification.

5.3.2 verification process, the relevant processes and tooling design must often track visits to the production site, identify problems in a timely manner Solve and cause of the problem and measures to resolve detailed records.

5.3.3 verification process, the process of production personnel should listen carefully to the operator's rationalization proposals, to help improve technology, tooling recommendations to Actively adopt.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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