体系文件修改 System document modification

gaowenhua

体系文件修改是质量管理体系（QMS）、环境管理体系（EMS）、职业健康安全管理体系（OHSMS）等运行过程中的常规且关键的活动。任何不规范的修改都可能导致体系失效、不符合法规要求或在审核中被开具不符合项。



System document modification is a routine and critical activity in the operation of quality management systems (QMS), environmental management systems (EMS), occupational health and safety management systems (OHSMS), and other processes. Any non-standard modifications may result in system failure, non-compliance with regulatory requirements, or issuance of non conformities during audits.

gaowenhua

为什么要修改体系文件？

• 法规/标准更新：如ISO标准换版、行业法规变化（如KGMP、FDA要求）。
• 组织变更：公司架构调整、部门职责变化、新并购或拆分。
• 流程优化：发现现有流程效率低下或存在漏洞，需要改进。
• 外部审核发现：认证机构或客户审核提出的整改要求。
• 内部审核/管理评审发现：内审或管理评审识别出的改进机会。
• 技术/设备更新：引入新工艺、新设备或新软件系统。
• 客户要求变化：客户对产品或服务提出新的质量要求。
  

Why do we need to modify the system documents?
Regulatory/standard updates: such as ISO standard updates, industry regulatory changes (such as KGMP, FDA requirements).
Organizational changes: company restructuring, changes in departmental responsibilities, new mergers and acquisitions, or spin offs.
Process optimization: Identified low efficiency or loopholes in existing processes that need improvement.
External audit findings: Rectification requirements proposed by certification bodies or clients during audits.
Internal audit/management review findings: Improvement opportunities identified by internal audit or management review.
Technology/Equipment Update: Introducing new processes, equipment, or software systems.
Customer requirements change: Customers propose new quality requirements for products or services.

gaowenhua

体系文件修改的基本原则

• 受控性：所有文件修改必须在受控程序下进行，确保可追溯。
• 审批权限：修改必须由授权人员审批，通常“谁编制，谁修改；谁批准，谁再批准”。
• 版本/修订状态管理：必须清晰标识文件的版本号（Version）和修订状态（Revision），避免使用过期文件。
• 及时性：文件修改后应及时发布，确保相关人员使用最新版本。
• 培训到位：文件修改涉及流程或职责变化时，必须对相关人员进行培训。
• 记录完整：保留所有修改记录，包括修改原因、内容、审批、分发和培训记录。
  

Basic principles for modifying system documents
Controlled: All document modifications must be carried out under controlled procedures to ensure traceability.
Approval authority: Modifications must be approved by authorized personnel, usually "whoever prepares, who modifies; whoever approves, who re approves".
Version/Revision Status Management: It is necessary to clearly identify the version number (Version) and revision status (Revision) of the file to avoid using expired files.
Timeliness: After the document is modified, it should be released in a timely manner to ensure that relevant personnel use the latest version.
Training in place: When document modifications involve changes in processes or responsibilities, relevant personnel must be trained.
Complete records: Keep all modification records, including modification reasons, content, approval, distribution, and training records.

gaowenhua

体系文件修改的标准流程（PDCA循环）🔹 阶段1：提出修改申请（Plan）

• 填写《文件修改申请单》（Document Revision Request Form）

  • 申请人：任何发现文件问题或改进机会的员工。
  • 内容：
    • 文件名称、编号、当前版本/修订号。
    • 修改原因（必须清晰说明，如：法规更新、流程优化、纠正措施等）。
    • 建议修改内容（可附修改稿或说明）。
    • 可能影响的其他文件或流程。
      
  • 提交：提交给文件原编制部门或质量管理部门（QA）。
    

• 评估与审批

  
  
  • 文件责任部门：评估修改的必要性、可行性和影响范围。
  • 跨部门评审（如需要）：涉及多部门的修改，应组织相关部门会签。
  • 最终审批：由原文件的批准人或其授权人审批《修改申请单》。
  • 结果：批准、驳回或要求补充信息。
    

Standard Process for Modifying System Documents (PDCA Cycle)
🔹  Stage 1: Submit a modification request (Plan)
Fill out the Document Revision Request Form
Applicant: Any employee who discovers document issues or opportunities for improvement.
Content:
File name, number, current version/revision number.
Reason for modification (must be clearly stated, such as regulatory updates, process optimization, corrective measures, etc.).
Suggest modifying the content (with a revised draft or explanation attached).
Other documents or processes that may be affected.
Submission: Submit to the department that originally prepared the document or the Quality Management Department (QA).
Evaluation and Approval
Document responsibility department: Evaluate the necessity, feasibility, and scope of impact of modifications.
Cross departmental review (if necessary): For modifications involving multiple departments, relevant departments should be organized to sign off.
Final approval: The "Amendment Application Form" shall be approved by the approver or authorized person of the original document.
Result: Approval, rejection, or request for additional information.

gaowenhua

执行修改（Do）
指定修改人
通常由原文件编制人或熟悉该流程的技术人员进行修改。
进行修改
在受控的电子文档或纸质副本上进行修改。
使用“修订模式”（如Word的修订功能）或“颜色标记”清晰标出所有修改处。
禁止直接在现行有效文件上涂改。
更新文件元数据
版本号/修订号：按公司《文件控制程序》规则更新。
小修订（如错别字、格式调整）：Rev. 0 → Rev. 1
大修订（如结构、流程重大变更）：Version 1 → Version 2
修订日期：更新为本次修改的生效日期。
修订说明（可选但推荐）：在文件首页或修订记录页简要说明本次修改内容。

Execute modifications (Do)
Designated modifier
Usually, modifications are made by the original document preparer or technical personnel familiar with the process.
Make modifications
Make modifications on controlled electronic documents or paper copies.
Use 'revision mode' (such as Word's revision function) or 'color coded' to clearly mark all modifications.
It is prohibited to directly alter current valid documents.
Update file metadata
Version/Revision Number: Updated according to the company's Document Control Procedure rules.
Minor revisions (such as typos and formatting adjustments): Rev. 0 → Rev. 1
Major revisions (such as significant changes in structure and processes): Version 1 → Version 2
Revision Date: Updated to the effective date of this revision.
Revision description (optional but recommended): Briefly explain the content of this revision on the first page or revision record page of the document.

gaowenhua

执行修改（Do）
指定修改人
通常由原文件编制人或熟悉该流程的技术人员进行修改。
进行修改
在受控的电子文档或纸质副本上进行修改。
使用“修订模式”（如Word的修订功能）或“颜色标记”清晰标出所有修改处。
禁止直接在现行有效文件上涂改。
更新文件元数据
版本号/修订号：按公司《文件控制程序》规则更新。
小修订（如错别字、格式调整）：Rev. 0 → Rev. 1
大修订（如结构、流程重大变更）：Version 1 → Version 2
修订日期：更新为本次修改的生效日期。
修订说明（可选但推荐）：在文件首页或修订记录页简要说明本次修改内容。


Execute modifications (Do)
Designated modifier
Usually, modifications are made by the original document preparer or technical personnel familiar with the process.
Make modifications
Make modifications on controlled electronic documents or paper copies.
Use 'revision mode' (such as Word's revision function) or 'color coded' to clearly mark all modifications.
It is prohibited to directly alter current valid documents.
Update file metadata
Version/Revision Number: Updated according to the company's Document Control Procedure rules.
Minor revisions (such as typos and formatting adjustments): Rev. 0 → Rev. 1
Major revisions (such as significant changes in structure and processes): Version 1 → Version 2
Revision Date: Updated to the effective date of this revision.
Revision description (optional but recommended): Briefly explain the content of this revision on the first page or revision record page of the document.

gaowenhua

执行修改（Do）
指定修改人
通常由原文件编制人或熟悉该流程的技术人员进行修改。
进行修改
在受控的电子文档或纸质副本上进行修改。
使用“修订模式”（如Word的修订功能）或“颜色标记”清晰标出所有修改处。
禁止直接在现行有效文件上涂改。
更新文件元数据
版本号/修订号：按公司《文件控制程序》规则更新。
小修订（如错别字、格式调整）：Rev. 0 → Rev. 1
大修订（如结构、流程重大变更）：Version 1 → Version 2
修订日期：更新为本次修改的生效日期。
修订说明（可选但推荐）：在文件首页或修订记录页简要说明本次修改内容。


Execute modifications (Do)
Designated modifier
Usually, modifications are made by the original document preparer or technical personnel familiar with the process.
Make modifications
Make modifications on controlled electronic documents or paper copies.
Use 'revision mode' (such as Word's revision function) or 'color coded' to clearly mark all modifications.
It is prohibited to directly alter current valid documents.
Update file metadata
Version/Revision Number: Updated according to the company's Document Control Procedure rules.
Minor revisions (such as typos and formatting adjustments): Rev. 0 → Rev. 1
Major revisions (such as significant changes in structure and processes): Version 1 → Version 2
Revision Date: Updated to the effective date of this revision.
Revision description (optional but recommended): Briefly explain the content of this revision on the first page or revision record page of the document.

gaowenhua

发布与实施（Act）

• 文件分发与回收

  • 发布：通过公司文件管理系统（如SharePoint、文档服务器）或邮件将新版本文件发布给所有受影响的部门和人员。
  • 回收：收回所有旧版本的纸质文件，并加盖“作废”章或销毁。确保现场不使用过期文件。
  • 电子文件：在系统中将旧版本设为“历史版本”或“已作废”，新版本设为“现行有效”。
    

• 培训与沟通

  • 组织对相关员工进行培训，重点讲解修改内容、原因和新操作要求。
  • 保留培训记录（签到表、培训材料、考核记录）。
    

• 更新关联文件

  • 检查并更新所有受此次修改影响的其他文件，如：
    • 相关的作业指导书（WI）
    • 记录表格（表单）
    • 培训教材
    • 内部审核检查表
      
    
    

• 记录存档

  
  
  • 将以下记录归档保存（通常至少保存6年或按法规要求）：
    
    • 《文件修改申请单》
    • 修改审批记录
    • 旧版本文件（存档）
    • 新版本文件
    • 分发/回收记录
    • 培训记录
      

Publication and Implementation (Act)
File distribution and recycling
Release: Publish the new version of the file to all affected departments and personnel through the company's file management system (such as SharePoint, document server) or email.
Recycling: Retrieve all old versions of paper documents and stamp them with a "void" seal or destroy them. Ensure that expired documents are not used on site.
Electronic files: Set the old version as "historical version" or "obsolete" in the system, and set the new version as "currently valid".
Training and Communication
Organize training for relevant employees, focusing on explaining the modification content, reasons, and new operational requirements.
Keep training records (attendance sheet, training materials, assessment records).
Update associated files
Check and update all other files affected by this modification, such as:
Related Homework Instructions (WI)
Record Form (Form)
training materials
Internal Audit Checklist
Record archiving
Archive and preserve the following records (usually for at least 6 years or as required by regulations):
Document Modification Application Form
Modify approval records
Old version files (archive)
New version file
Distribution/Recycling Records
Training Record

gaowenhua

文件类型修改要点
质量手册重大修改需管理层批准，可能涉及方针、目标、组织架构变更。
程序文件（SOP）修改需谨慎，直接影响操作流程。必须进行充分评审和培训。
作业指导书（WI）通常由一线技术人员修改，需确保与SOP一致，图文并茂。
记录表格修改表单格式或内容时，需评估对历史数据可比性的影响。
外来文件（如法规、标准）公司内部不直接修改，而是通过《法规标准跟踪程序》识别变化，并据此修改内部文件



Key points for modifying file types
Major modifications to the quality manual require approval from management and may involve changes in policies, objectives, and organizational structure.
Caution should be exercised when modifying program files (SOP) as it directly affects the operational process. Adequate evaluation and training must be conducted.
The work instruction manual (WI) is usually modified by front-line technical personnel, ensuring consistency with SOP and accompanied by illustrations and text.
When modifying the format or content of a record table, it is necessary to evaluate the impact on the comparability of historical data.
External documents (such as regulations and standards) are not directly modified within the company. Instead, changes are identified through the 'Regulations and Standards Tracking Procedure' and internal documents are modified accordingly

whping

谢谢分享