质量管理文件-文件控制程序 英文

ReferenceNo. Rev. date PageD o c u me n t C o nt r o lP r o c ed u r e QPM-DC001 1/11ReferenceNo. Rev. date PageD o c u me n t C o nt r o lP r o c ed u r e QPM-DC001 2/11ReferenceNo. Rev. date PageD o c u me n t C o nt r o lP r o c ed u r e QPM-DC001 3/11ReferenceNo. Rev. date PageD o c u me n t C o nt r o lP r o c ed u r e QPM-DC001 4/11ReferenceNo. Rev. date PageD o c u me n t C o nt r o lP r o c ed u r e QPM-DC001 5/115.2.5. External document coding- - → 12-3456-78912-request department code, according to Document Work Plan;3456-issueyear and month, i.e. August 2004 is represented by 0408;789-serial numberwithin a month: 001﹑002﹑003……5.3.Tabulation：5.3.1.Framework：5.3.1.1. Objective5.3.1.2. Applicable organization：dept., section5.3.1.3. Responsible organization5.3.1.4. Definition：special vocabulary5.3.1.5. Work contents：major part of the document5.3.1.6. Guidance documents5.3.1.7. Formats5.3.1.8. Appendix：charts, diagrams5.3.2. Document format：Clause, term, paragraph, item, as per Appendix 25.3.2.1.Clause to be marked with 1.、2.、3.、.... and title as a summary5.3.2.2. Term to be marked with 1.1.、1.2.、....、2.1.、2.2.、....5.3.2.3.Paragraph to be marked with 1.1.1.、1.1.2.、....、2.1.1.、2.1.2.5.3.2.4.Item to be marked with 1.1.1.1.、1.1.1.2.....5.3.2.5.Diagram：Diagrams should be coded for difference5.3.3. Document language should be easy to understand.5.3.4. Appendix code should be printed on the lower right corner of the sheet.Sheet edition and revision codes should be marked.5.3.5. Document cover page is required for summary as Appendix.5.3.6. Page No.：Page number is required for major part of the document, except appendix.5.3.7. Responsible department or drafter should gather feedbacks of relateddepartments or staff before and after document draft. Questions should beclearly stated, with reasons remarked and specific corrective proposalsdiscussed.After gathering feedbacks, responsible department should send documentdraft to authority department for review via Work Slip.Draft should include operational sheets and flow chart.5.4. Review：Review division should fulfill its duty according to rules as below, and recordconclusion on Work Slip.ReferenceNo. Rev. date PageD o c u me n t C o nt r o lP r o c ed u r e QPM-DC001 6/115.4.1. Legality5.4.2.：Validity5.4.2.1. Effective solutions to problems5.4.2.2. Solutions are not limited to current situation, but also prevention offoreseeable problems.5.4.3. Compatibility with current system5.4.4. Rationality：5.4.4.1. Execution with the highest efficiency and the lowest cost5.4.4.2. Conformity with effective operation policies.Review department should carry out detailed examination on sheet content,format, progress, and operation guidance, so as to ensure smooth flow, as well as decide issue copies and recipients.5.5. Approval：Reviewed draft should be submitted to authority for approval, according to the third clause of this process.5.6. Issue：Approved documents should be submitted to Document Control Center withDocument Request for procedures as below:5.6.1. Coding：According to Rule No.5.2. of this process5.6.2. Registry：Document Control Center should register coded documents on General List of Document Control, with issue copies.5.6.3. Issue：Document controller makes copies according to General List of DocumentControl, stamps blue Document Control Seal on each document front page,and issues the copies with countersignatures of recipients on DocumentIssue Control.5.6.4. Processes begin valid on the issue date, except another specified date.5.7. Introduction：At the beginning of practice, document producing division should explaincontents to related staff, so as for effective introduction, with demonstration of application and repetitive explanation of flow chart in combination of currentsituation.Non-scheduled lectures should be arranged upon actual necessity.5.8. Practice Review：Within three months after issue of new documents, formulating departmentshould send investigators to review practice and applicability, for the revisionreference.ReferenceNo. Rev. date PageD o c u me n t C o nt r o lP r o c ed u r e QPM-DC001 7/115.9. Evaluation：Routine practice evaluation is required according to Internal Review ControlProcess, with conclusion report on the actual practice.5.10. Revision：5.10.1. Revision is required for documents with any of the conditions as below:5.10.1.1. Rules do not comply with current operation policies or demands, and abolishment is inapplicable.5.10.1.2. Part of rules is inapplicable.5.10.1.3. Part of rules does not comply with laws.5.10.1.4. Dept. name is out dated to current system. Reduction, combination orchange of original divisions.5.10.1.5. Unclear definition of clauses, which should be exemplified duringpractice.5.10.1.6. Other necessary revision5.10.2. Revision Methods & Procedures5.10.2.1. Major content revision should follow procedure of new documents,andis to be reissued for practice.5.10.2.2. For partial revision, tabulating div. should send Document Request forreview and approval, with revision contents and reasons, whoseprogress is the same as new document.5.10.2.3. Retabulation and reissue are required for documents with four-timerevisions.5.10.2.4. Document Control Center should implement systematic control of allrevised documents.5.10.2.5. When revision, amendment, formulation or abolishment involves morethan one document, responsible div. or drafter should send all therequests for review, with the aim of successful implementation.5.11. Abolishment：5.11.1. Abolishment is required for documents with any of the conditions as below:5.11.1.1. Rules do not comply with current operation policies.5.11.1.2. Rules go against present situation.5.11.1.3. New updated rules have been issued and implemented.5.11.1.4. No reservation or application necessities.5.11.2. Abolishment processes：The same as item 5.10.2.5.。