Change Control Process 变更控制流程

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变更控制管理流程

变更控制管理流程

变更控制管理流程背景在业务和项目管理中,变更是一种常见的现象。

为了确保变更能够被有效地管理和控制,变更控制管理流程被引入。

本文将介绍一个标准的变更控制管理流程,以帮助组织和团队在实施变更时更加高效和有序。

目标- 确保所有变更都被审查、评估和批准,以避免未经授权或未经评估的变更对业务或项目带来风险和问题。

- 确定变更的影响范围和风险,在变更实施前进行充分的准备工作,以降低不必要的风险和影响。

- 提供透明和可追踪的变更控制过程,便于审计和追踪变更历史。

- 促进有效的沟通和协作,在变更实施过程中各方能够及时获得相关信息和决策。

流程步骤1. 变更请求- 发起人提交变更请求,并提供详细的变更描述和理由。

- 变更请求应包括所涉及的业务或项目范围、影响和风险评估。

2. 变更评估- 变更评估小组(Change Assessment Group)对变更请求进行评估。

- 评估包括变更的商业影响、技术可行性和资源需求。

- 评估结果将用于确定变更是否应被批准、拒绝或需要进一步的审查。

3. 变更批准- 变更委员会(Change Control Board)对变更请求进行审议和决策。

- 变更委员会由相关利益相关方组成,包括业务代表、项目经理、技术专家等。

- 变更委员会根据评估结果和变更的优先级等因素,决定是否批准变更。

- 批准的变更将进入下一步骤,否则将结束变更流程。

4. 变更计划- 变更计划包括变更的详细实施计划、资源分配和沟通计划等。

- 变更计划应充分考虑风险管理和变更影响管理。

5. 变更实施- 根据变更计划进行变更实施。

- 变更实施过程中需确保变更的正确性和可追溯性。

- 变更实施后,进行验证和确认,确保变更的预期效果和质量。

6. 变更关闭- 在变更实施后进行变更关闭。

- 特定文件和记录将被归档和存档,便于审计和追踪。

总结变更控制管理流程提供了一种系统化、透明和可控的方式来管理和处理业务和项目中的变更。

通过严格遵循这个流程,组织和团队可以更有效地处理变更,并减少变更可能带来的风险和问题。

工程变更流程(中英文)

工程变更流程(中英文)

实施变更 Implement the changing
跟踪变更 实施情 况 Follow up the result of changing implementation
生产部/品管 部/采购及 相关 部门
Production Dept. /QA Dept.
/Purchasing Dept. and related Dept.
8.0 9.0 /
确定变更 实施计 划 Define the changing implement
plan
变更小组/技 术部/ 开发 部 Changing Team
/Technical Dept. /Engineering Dept.
变更验证 Changing validation
变更小组/品 管部/ 生产 部 Changing team /QA Dept.
工程变更控制程序 Engineering Change Control Procedure
4. 流程 Flow 步骤 Ste p
流程 Flow
1.0
变更需求 的来源 和提出
The source and provide of the
changing requirement
2.0
评审变更 需求
Review the requirement of
/Engineering Dept. /Customer
下发变更 通知 Send the notice of changing
开发部/ 技术 部 Engineering Dept. /Technical Dept.

发放记录 〔设计变 更通知 单〕 〔过程变 更通知 单〕
Send Records Design Changing Report Process Changing Report

药品变更控制的流程

药品变更控制的流程

药品变更控制的流程英文回答:Process for Drug Change Control.Introduction.Drug change control is a critical process in the pharmaceutical industry that ensures the safety andefficacy of drugs throughout their lifecycle. It involves managing any changes made to a drug's formulation, manufacturing process, or labeling. A robust drug change control process helps prevent medication errors, adverse drug events, and regulatory non-compliance.Key Steps in the Drug Change Control Process.1. Initiation: A change request is initiated when a need for a change is identified. The request should include a detailed description of the proposed change, itsrationale, and potential impact.2. Assessment: A review team assesses the proposed change to determine its potential risks and benefits. The team may include representatives from quality assurance, regulatory affairs, and clinical development.3. Approval: If the change is deemed necessary and safe, it is approved by the appropriate authorities. This may include management, regulatory agencies, and ethics committees.4. Implementation: The change is implemented accordingto a predefined plan. This may involve updating manufacturing processes, label specifications, or clinical protocols.5. Monitoring: The implemented change is closely monitored to assess its impact on the drug's safety and efficacy. Regular reviews and risk assessments are conducted.6. Documentation: All aspects of the drug changecontrol process are documented meticulously. This includes the change request, assessment report, approval records, and monitoring data.Regulatory Requirements for Drug Change Control.Regulatory agencies such as the FDA and EMA have established guidelines for drug change control. These guidelines ensure that changes to drugs are made in a safe and controlled manner. Key regulatory requirements include:Prior approval: Certain types of changes, such as those affecting the drug's safety or efficacy, requireprior approval from regulatory authorities.Documentation: Comprehensive documentation is required at each stage of the change control process.Risk assessment: A thorough risk assessment must be conducted to identify and mitigate potential risks associated with the change.Monitoring: Post-implementation monitoring isessential to assess the impact of the change on the drug's safety and efficacy.Best Practices for Effective Drug Change Control.Establish a Clear Change Control Policy: Define the scope, responsibilities, and procedures for drug change control within the organization.Appoint a Change Control Committee: Form a multidisciplinary team responsible for reviewing and approving change requests.Use a Risk-Based Approach: Prioritize change requests based on their potential risks and benefits.Communicate Effectively: Ensure timely and effective communication among all stakeholders involved in the change control process.Continuously Improve: Regularly review and update the drug change control process to enhance its effectiveness.中文回答:药物变更控制流程。

软件配置管理

软件配置管理

软件配置管理1、简介软件配置管理,贯穿于整个软件生命周期,它为软件研发提供了一套管理办法和活动原则。

软件配置管理无论是对于软件企业管理人员还是研发人员都有着重要的意义。

软件配置管理可以提炼为三个方面的内容:●VersionControl-版本控制●ChangeControl-变更控制●ProcessSupport-过程支持关键活动包括:配置项、工作空间管理、版本控制、变更控制、状态报告、配置审计等。

2、软件配置管理技术软件配置管理是一组活动,是设计用来标识变更的工作产品、建立它们之间的关系、定义管理这些工作产品不同版本、控制变更以及审计和报告所发生的变更。

每一个涉及到软件工程过程的人员均在某种程度上和SCM相关联。

一般情况下需要专门的SCM小组或专门的技术人员来管理和支持。

下面通过依次介绍配置管理过程中的主要活动来描述配置管理过程。

2.1识别配置项在项目开发过程中,程序、数据和文档都可以作为配置管理的对象,下面以图的形式来列举可能的配置项,如图2-1所示,由图可以看出配置项之间是组合关系或者相互关系。

图2-1可能的配置项2.2基于配置项版本控制版本控制是将规程和工具相结合来管理在软件工程过程中所创建的配置对象的不同版本,通过“属性元组”等其它技术来控制完整版本中的“变体”,采用不同的工具不同的技术,版本控制的机制会有一些不同。

2.3变更控制变更在软件开发过程中是不可避免的,但过于频繁的变更也会对项目的开发产生负面的影响,如影响项目的进度、浪费人力物力,因此需要对变更进行控制。

变更控制可以依照如下的步骤来进行:(1)提交变更请求;(2)审核变更请求;(3)分配和确定任务;(4)提取变更项;(5)执行变更;(6)审核变更;(7)更新配置管理库。

整个变更控制的产物主要是变更请求单、变更报告单、工程变更单或变更确认单等。

2.4配置审计配置审计一般包括两种,一种是正式的技术评审,另一种是软件配置审计。

在正式的技术评审中,将关注已经被修改的配置项的正确性,配置项的评估配置项,以确定它与其他一致性、遗漏及潜在的副作用。

变更控制流程英语作文

变更控制流程英语作文

变更控制流程英语作文Title: Implementing Change Control Processes。

In today's dynamic business environment, change is inevitable. Whether it's due to technological advancements, market demands, or internal reorganizations, organizations must adapt to stay competitive. Implementing effective change control processes is crucial to manage these transitions smoothly and minimize disruptions. In this essay, we will explore the importance of change control processes and outline steps to implement them successfully.Firstly, let's discuss why change control processes are essential. These processes provide a structured approach to manage changes within an organization. They help in assessing the impact of proposed changes, identifying potential risks, and ensuring proper communication among stakeholders. By establishing clear procedures for requesting, reviewing, approving, and implementing changes, organizations can maintain stability while fosteringinnovation.The implementation of change control processes involves several key steps:1. Assessment of Current Processes: Before implementing any changes, it's essential to evaluate the existing processes. This includes identifying strengths, weaknesses, and areas for improvement. Gathering feedback from stakeholders across various departments can provide valuable insights into the effectiveness of current procedures.2. Defining Change Categories: Not all changes are equal. It's essential to categorize changes based on their impact and urgency. For example, minor changes may only require approval from a department head, while major changes may need endorsement from the executive team. By classifying changes into different categories, organizations can streamline the approval process and allocate resources more efficiently.3. Establishing Change Review Board: A change review board (CRB) plays a crucial role in overseeing the change control process. This board typically consists of representatives from different departments or functional areas. Its primary responsibility is to review change requests, assess their impact, and make informed decisions about their implementation. Having a diverse CRB ensures that changes are evaluated from various perspectives, minimizing the risk of oversight.4. Documentation and Communication: Clear documentation is essential throughout the change control process. This includes documenting change requests, approvals, implementation plans, and post-implementation reviews. Additionally, effective communication is key to ensuring that all stakeholders are informed about upcoming changes and their potential impact on operations. Utilizing communication channels such as emails, meetings, and intranet portals can help disseminate information efficiently.5. Training and Education: Implementing change controlprocesses requires buy-in from employees at all levels of the organization. Providing training and education on the new procedures is essential to ensure widespread adoption. This training should not only cover the technical aspects of the process but also emphasize the rationale behind it and its benefits to the organization as a whole.6. Continuous Monitoring and Improvement: Change control processes should not be static. Continuous monitoring and evaluation are necessary to identify bottlenecks, address issues, and incorporate lessons learned from past changes. Regular reviews of the change control process enable organizations to adapt to evolving needs and optimize their change management capabilities.In conclusion, implementing effective change control processes is essential for organizations to navigate through periods of transition successfully. By following the steps outlined above, organizations can establish structured procedures for managing changes, minimize disruptions, and foster a culture of adaptability and innovation. While the process may require initialinvestment in terms of time and resources, the long-term benefits far outweigh the costs. Embracing change control processes is not just about managing change; it's about empowering organizations to thrive in an ever-changing world.。

变更控制Change control WHO

变更控制Change control WHO

13
PRINCIPLES OF CHANGE CONTROL
• Change control is not department-specific, but encompasses the whole company.
The change control • monitors all types of changes, which can influence the process or product quality and • states the measures necessary for implementing the change or • decides that a change should not be implemented.
8
LIFE CYCLE
CHANGES AND APR
OOS
Deviations Audits Complaints
Changes in materials
Improvement (equipment, systems, procedures, etc.)
Root Cause Analysis CAPA proposal Risk assessupferman, Industry Pharmacist
Alain Kupferman
Pharmacist (ULB, Brussels, Belgium) Industry Pharmacist (Qualified Person)
比利时
Alain Kupferman
11
The task of change control
PRINCIPLES OF CHANGE CONTROL
• In the WHO-GMP guideline glossary there is the definition of the term “change control”:

Change control变更控制

Change control变更控制

Pharmaceutical Services Corporation 美国医药服务有限公司Change Control变更控制Topics题目•What is change?什么是变更?•What is change control?什么是变更控制?•Why do we need change control?为什么需要变更控制?•What should be covered by change control?变更控制应包括什么?•What are the requirements of the change control process?变更控制过程的要求是什么?Definition定义•What is change?什么是变更?•To alter, to become different改变,变得不同•Changes can be either planned or unplanned 变更可能是有计划的,也可能是没有计划的What is Change Control?什么是变更控制?• A formal system for evaluating all changes that may affect the quality, safety and efficacy of the product一个正式的系统,用于评价所有可能影响产品质量、安全和效力的变更。

Why?为什么?•It is a regulatory requirement法规要求•It is a way in which the correct personnel can be made aware of impending changes能够使合适的人员知道即将发生变更的一种途径•It is a way of identifying the work needed to support a change识别为支持变更所需要进行的工作的一种途径•It prevents constant trivial “evolutionary”change 防止不断的没有价值的“进化”变更•Raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware), processing steps, labeling and packaging materials, and computer software原料、标准、分析方法、厂房、支持系统、设备(包括计算机硬件)、工艺步骤、标签、包装材料和计算机软件•Must include:必须包括:–Identification of changes subject to change control 确认需要经过变更控制进行的变更–Documentation of proposed changes提议变更的文件–Evaluation by Quality质量部的评估–Work required to support change支持变更所需要进行的工作–Record of changes变更记录–Audits of Change Control system变更控制系统的审计EU GMP•The basic requirements of GMP are that:GMP的基本要求是–(ii) critical steps of manufacturing processes and significant changes to the process are validated要对生产工艺的关键步骤和工艺的重要变更进行验证•Regular periodic or rolling quality reviews of all licensed medicinal products should be conducted and should include:对所有注册药品要进行定期或周而复始的质量审核,其包括:–A review of all changes carried out to the processes or analytical methods对所有工艺或分析方法进行的变更要进行审核FDA Oral Solid Dosage guidanceFDA口服固体制剂指南•As with other dosage forms, it is important for the firm to carefully control how changes are made in the production of topical products. Firms should be able to support changes which represent departures from approved and validated manufacturing processes.同其他制剂一样,企业认真地控制外用药产品生产的变更是十分重要的。

TS-2018 06 工程变更控制程序

TS-2018 06 工程变更控制程序

1.0PURPOSE目的This procedure defined the processes of ECN and the responsibilities of related departments to assure ECN effective execution and control and avoid the risks of product quality generated by ECN.本程序定义了工程变更的流程及工程变更过程中相关部门的职责,确保工程变更过程有效地实施和控制,避免工程变更中产生产品质量风险。

2.0SCOPE范围This procedure is applicable for the ECN control of silicon, ingot, casting, wafer, cell and module of Changzhou Trina Solar Energy Co., Ltd.本程序适用于常州天合光能从硅料到单晶、多晶、硅片、电池和组件ECN的控制。

3.0DEFINITION 定义3.1ME: Manufacturing Engineering 制造工程3.2TECN: Temporary Engineering Change Notice 临时工程变更通知单3.3ECN: Engineering Change Notice工程变更通知单3.4ECCB: Engineering Change Control Board 工程变更管控平台Before engineering change formally initiated, Manufacturing engineering, Quality, Process, Production, TD and other relevant departments should participate in and assess engineering change proposal preliminarily.由制造工程、质量、工艺、生产、技术等有关部门参与的,在工程变更正式发起前对工程变更提案进行初步评估。

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Change Control ProcessPurposeThe purpose of this document is to provide the project manager, sponsors, steering committee members and all other stakeholders with the standard process for managing changes on the [project name] project.Related DocumentsThe scope of the [project name] has been defined in the approved Project Charter dated [date]. The work breakdown of the project and the timeline are detailed in the approved project plan dated [date].Purpose and ObjectivesThe purpose of this change management procedure is to manage change requests so that approved changes will be controlled, ensuring the project remains on schedule, within budget and provides the agreed deliverables.The primary objectives of change management are to:∙manage each change request from initiation through to closure;∙process change requests based upon direction from the appropriate authority;∙communicate the impact of changes to appropriate personnel; and∙allow small changes to be managed with a minimum of overhead.ScopeThe Change Management Process is the mechanism used to initiate, record, assess, approve and resolve project changes. Project changes are needed when it is deemed necessary to change the scope, time or cost of one or more previously approved project deliverables. Most changes will affect the budget and/or schedule of the project. PolicyThe use of the formal change management procedure will be required when any changes are discovered or requested which impact previously reviewed, approved and published project deliverables.The documentation and tracking of all change requests will be managed using the defined procedure and facilitated by the use of the change management log.A multi-tiered approach will be used to approve change requests:∙The Project Manager will make decisions to analyze and decisions to proceed with changes if the changes do not impact scope, budget or schedule or result in an increase in risk for the project.∙Changes which do impact scope, budget or schedule will be forwarded to the Steering Committee for review. The Steering Committee will advise the Project Sponsor.∙Where the [functional owner] has the resources to absorb the impact of the change, the Project Sponsor will make the final decision, based upon the information provided by the Project Manager and the input of the Steering Committee. The Project Sponsor, the [advisor], and [advisor] will discuss requests that may result in a significant change in scope, schedule, and budget, i.e. the impact of the change cannot be covered by [functional owner] resources. This group will advise the Steering Committee.∙The Steering Committee will make the final decision based upon the information providedDecision Matrixs c op e ch a n g ei n c r e a s e b u d g e tn o t i nc r e a s e b ud g eti n c r e a s e r i s kn o t i nc r e a s e r i s ki n c r e a s e s c h e d u l en o t i nc r e a s e s c h ed u le Decision by Project ManagerN N Y N Y N Y Vet with Steering CommitteeY Y N Y N Y N Decision by Project SponsorY Y Y Y Y Y Y Vet with [advisor names]Y Y n/a Y n/a Y n/a Decision by Steering CommitteeYYYYYYYT h e i m p a c t o f t h e c h a n g e m a y b e a b s o r b e d b y [f u n c t i o n a l o w n e r ]T h e i m p a c t o f t h e c h a n g e c a n n o t b e a b s o r b e d b y [f u n c t i o n a l o w n e r ]The following is a general guideline for the change management process. Most changes will require a subset of the steps listed.ProceduresEach request will be tracked from the time of presentation through: 1. Identify (identify and document the required change)2. Validate (verify the change is valid and requires management)3. Analyze (analyze and record schedule, cost and effort impact of change)4. Control (decide whether to execute the change)5. Action (execute decision, including revision to project plans if necessary)6. Close (verify that action is complete and close change request)Identify Change Request ActionResponsibility1. Identify and record the issue (in [location]). Project Manager or Team LeadValidate Change RequestAction Responsibility2. Identify member of the management team as the issue owner.3. Validate change request with project team members as appropriate.4. Assess and evaluate change for necessity to project.5. Update change request with target date for completion of analysis.Project ManagerAnalyze ImpactAction Responsibility6. Triage w/ consultation of the Project Sponsor7. Meet contract requirements for responding to Change Requests.8. Assign resources to review the impact of the change request.9. Direct activity to assess the scope, cost and schedule impact of thechange.10. Update change request with impact analysis and estimates in terms ofscope, cost, schedule and effort impacts.11. Update change request with target date for decision.Project ManagerControl Change RequestAction Responsibility12. Meet Sigma contract requirements for responding to Change Requests.13. Determine required approvals and assign priority to the change request.14. If changes impact scope, budget or schedule place request on agenda fornext Steering Committee meeting.15. If changes do not impact scope, budget or schedule decide whether toproceed with the change.Project Manager16. Review and discuss analysis of change request.17. Develop recommendation for the Project Sponsor.Steering Committee18. Decide whether to proceed with the change.19. If impact of change cannot be absorbed by [functional owner], schedulediscussion with [advisor names].Project Sponsor20. Review and discuss analysis of change request.21. If change request should be escalated to Steering Committee, placerequest on agenda for next meeting (or email if request is urgent).22. Develop recommendation for the Steering Committee.Project Sponsor, [advisor names]23. Review and discuss analysis of change request.24. Decide whether to proceed with the change.Steering Committee25. Generate approval signature sheets for each outstanding change request.26. Update status of change request with control decision.Project SponsorAction Change RequestAction Responsibility27. Negotiate contract changes.28. Execute contract changes. Project Manager, Project Sponsor, Technology Acquisition Manager29. Incorporate change request into appropriate plans and work plan.30. Update work plan baseline for agreed changes.Project ManagerClose Change RequestAction Responsibility31. Close change request..32. Communicate work plan change to project team.33. Monitor and report progress against project plan.34. Confirm all updates have been recorded and file all Change RequestDocuments.Project Manager。

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