SZ-QS11.0.1 Change Control Procedure (PDF)

Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure SZ-QS11.0.1_Change control procedure File Name: SOP018308-2.0-SZ-QS11.0.1_Change control procedure Number: SOP01830...

Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure SZ-QS11.0.1_Change control procedure File Name: SOP018308-2.0-SZ-QS11.0.1_Change control procedure Number: SOP018308 Major Version: 2 Approval Signatures Document Approvals Allen Zhu, IT&D Manager - China Factories Task: Approval Task ([email protected]) Verdict: Approve 09-Jul-2024 07:43:05 GMT+0000 Lei Yang, EHS Supervisor Task: Approval Task ([email protected]) Verdict: Approve 09-Jul-2024 08:21:25 GMT+0000 Abel Cao, CI Manager Task: Approval Task ([email protected]) Verdict: Approve 09-Jul-2024 09:51:43 GMT+0000 Loewe Lou, Quality Compliance Manager Task: Compliance Approval ([email protected]) Verdict: Approve 09-Jul-2024 12:49:43 GMT+0000 Antoine Wang, Finance Controller Task: Approval Task ([email protected]) Verdict: Approve 10-Jul-2024 01:23:51 GMT+0000 David Luo, Operations Manager, Durex Task: Approval Task ([email protected]) Verdict: Approve 10-Jul-2024 02:43:41 GMT+0000 Stone Lin, Regional Strategic Engineering Director Task: Approval Task ([email protected]) Verdict: Approve 10-Jul-2024 02:44:00 GMT+0000 Hao Zhang, Head of Procurement,China HC Task: Approval Task ([email protected]) Verdict: Approve 10-Jul-2024 03:13:04 GMT+0000 Becky Chen, Packaging Manager, Dettol Task: Approval Task ([email protected]) Verdict: Approve 10-Jul-2024 05:28:45 GMT+0000 Hongwei Fan, Quality Manager, TC Task: Approval Task ([email protected]) Verdict: Approve 10-Jul-2024 06:09:39 GMT+0000 This copy of the document was retrieved from the system by Loewe Lou Task: Approval Task Andy on 16 Aug 2024. This Li, Engineering copy is consideredManager valid on the day of printing only. | Page: 1 Verdict: Approve ([email protected]) Status: Effective | Effective 10-Jul-2024 07:00:05Date: 15 Jul 2024 | SOP018308-2.0 GMT+0000 SZ-QS11.0.1_Change control procedure Catrina Dai, Planning & Logistics Manager Task: Approval Task ([email protected]) Verdict: Approve 10-Jul-2024 07:15:21 GMT+0000 Victor Cheng, Operations Manager Task: Approval Task ([email protected]) Verdict: Approve 11-Jul-2024 09:09:07 GMT+0000 Jessica Che, Head of HR, Taicang Task: Approval Task ([email protected]) Verdict: Approve 12-Jul-2024 09:48:58 GMT+0000 Sumate Ngamdumrongkiat, Technical Manager Task: Approval Task ([email protected]) Verdict: Approve 15-Jul-2024 09:05:26 GMT+0000 The content of this document, and any associated materials, is intended for Reckitt use only and may only be shared externally if a suitable confidentiality agreement is in place. This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 2  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang 变更控制程序 Version 版本: V2.0 QS code 体系编号：SZ-QS11.0.1 QO Code: SOP018308 Page 页码: Page 1 of 22 Change Control Procedure 变更控制程序 Role 角色 Name 姓名 Title 职位 Author Lucy Zhang Quality Compliance Engineer 作者 张露露 质量合规工程师 Document Approver Sumate Technical Manager 文件批准人 Ngamdumrongkiat 技术经理 Document Approver Becky Chen Packaging Manager 文件批准人 陈珊珊 包装经理 Document Approver Catrina Dai Planning & Logistics Manager 文件批准人 代秋月 计划物流经理 Document Approver Hao Zhang Head of Procurement 文件批准人 张昊 采购经理 Document Approver Allen Zhu IT&D Manager 文件批准人 朱文波 信息技术经理 Document Approver Andy Li Engineering Manager 文件批准人 李跃 工程经理 Document Approver Victor Cheng Operations Manager 文件批准人 程维喜 运营经理 Document Approver David Luo Operations Manager, Durex 文件批准人 骆申建 杜蕾斯运营经理 Document Approver Antoine Wang Finance Controller 文件批准人 王建 财务经理 RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 3  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 2 of 22 QO Code: SOP018308 Document Approver Lei Yang EHS Supervisor 文件批准人 杨蕾 安全主管 Document Approver Abel Cao CI Manager 文件批准人 曹旭 持续改进经理 Document Approver Jessica Che Head of HR 文件批准人 车红敏 人力资源经理 Regional Strategic Document Approver Stone Lin Engineering Director 文件批准人 林晨 中国区战略工程总监 Document Approver Zero Fan Quality Manager 文件批准人 范宏伟 质量经理 Compliance Loewe Lou Quality Compliance Manager Approver 娄伟 质量合规经理 合规批准人 RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 2 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 4  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 3 of 22 QO Code: SOP018308 1.0 Purpose 目的 This procedure document regulates change control process and relevant requirements. This will ensure that changes are controlled in such a way as to maintain product quality, safety and efficacy, that GMP and compliance to product licenses are maintained. It will also help to maintain and track the history of changes. 本程序文件规范了变更控制流程及相关要求，确保变更受到控制，以保证产品质量、安全性和 有效性、GMP 和产品生产的合规性，同时有助于保存和追溯变更历史。 2.0 Scope 范围 2.1 In Scope 包括 Planned changes that 有计划的变更: - Potentially affect patient/ consumer/ customer/ employee safety 对患者/消费者/顾客/员工的安全有潜在影响 - Potentially affect product quality or efficacy 对产品质量或功效有潜在影响 - May impact the reproducibility of a process 可能影响了工艺的重现性 - May impact compliance against external or internal requirements 可能影响对外部或内部要求的遵循 The Change Management process applies throughout the end-to-end product lifecycle, including supporting processes and services. 变更管理流程适用于整个端到端的产品生命周期，包括服务和支持流程。 Note 注： PLM does not apply to the Taicang plant. PLM 不适用于太仓工厂。 2.2 Out of the scope 不包括: The following changes to the equipment do not need to initiate changes: 设备发生以下变化时不需要发起变更：  The components begin replaced are the same make, model and manufacturer as the components they are replacing. 即将更换的部件与原部件具有相同的构造、样式和供应商；  The components have the same operating ranges, operational specifications and tolerances as the components they are replacing. 即将更换的部件与原部件具有相同的量程、规格和公差；  Does not have adjustable settings or configurations. 不可调整设置和配置的设备；  The components are made from the same materials as the components they are replacing. 即将更换的部件与原部件具有相同的材质； RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 3 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 5  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 4 of 22 QO Code: SOP018308  The components do not need certificates to indicate that they are suitable for use (certificates of materials, traceability or calibration). 部件不需要开具适用性证书、证明（材料证明、可追溯、校准证书）；  This type of change can be engineering, equipment or facilities-based that does not affect the quality of product. 不影响产品质量的工程、设备或者设施变更；  Artwork change implementation which falls within the scope of software systems such as Zen or IDM. 属于软件系统 Zen 或者 IDM 范围内的设计图纸变更。 Simple Document upgrading, refer to SZ-QS4.2.1 “Document Control Procedure”. 单纯的文件升版，参见 SZ-QS4.2.1《文件控制程序》。 Change during Project Commission & Qualification before acceptance and release, refer to “SZ- QS11.1.1-SOP001 Engineering Change Management Procedure”. 在项目调试和验证被接受之前的变更，参见 SZ-QS11.1.1-SOP001 《工程变更管理规程》。 Unplanned Changes i.e. GMP or process deviations, which shall be handled using Deviation process, refer to SZ-QS10.2.1 “Deviation and CAPA Procedure”. 计划之外的变更，如 GMP 或者工艺的偏差，应当使用偏差流程进行处理，参见 SZ-QS10.2.1 《偏差及纠正预防措施程序》。 3.0 Responsibility 职责 Role 角色 Responsibility 职责 a) Understand the principles of Change Management. 了解变更管理的原则； Reckitt employees b) Ensure changes they are coordinating are documented and managed in 利洁时员工 accordance with this procedure. 确保负责协调的变更按照本程序进行记录和管理。 a) Ensure Change Management processes within their area of responsibility comply with this procedure. 确保其职责范围内的变更管理流程符合本程序； b) Ensure personnel are trained on this procedure. 确保人员接受了本程序的培训； Senior Management c) Ensure functional / local resource are in place to manage changes 高层管理人员 effectively and to monitor and report functional / local metrics. 确保职能/本地资源能够有效管理变更，并监控和报告职能/本地指 标； d) Ensure any functional / local specific requirements are documented within functional / local procedures. 确保在职能/本地程序中记录所有特定要求。 RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 4 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 6  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 5 of 22 QO Code: SOP018308 a) Lead the overall change and coordinate all associated activity, including the assessment, implementation plan & execution. 领导整个变更并协调所有相关活动，包括评估、计划和执行； b) Ensure Change Control records are kept up to date and managed within Change Coordinators defined timelines. 变更协调员 确保变更控制记录保持为最新，并在规定的时间内进行管理； c) Clearly communicate and align on assessments, actions, and approvals with nominated individuals. 在评估、行动和批准方面与指定的个人进行有效的沟通和协调。 a) Assess impacts and risks of proposed changes. 评估变更的影响和风险； b) Represent their function / area of expertise on the change and consult within their teams as necessary. Assessors 作为与变更相关职能/专业领域的代表，并在必要时咨询其团队内 评估员 部人员； c) Ensure assessment input is robust and clear to enable effective response from the Change Coordinator. 确保评估输入有效且清晰，以使变更协调员能够做出有效响应。 a) Review changes in necessary detail, with focus relevant to the stage of the change. 对变更进行必要的详细审查，不同变更阶段的审查重点不同； b) Represent their function / area of expertise on the change and consult Approvers within their teams as necessary. 批准人 作为与变更相关职能/专业领域的代表，并在必要时咨询其团队内 部人员； c) Ensure any reasons for rejection and associated requirements are clear and justified. 确保拒绝的原因和相关要求都是明确和合理的。 a) Complete assigned actions with sufficient detail and necessary evidence. 完成指定的行动，并提供足够的详细信息和必要的证据； Action Owners b) Ensure actions are completed within agreed timelines and clearly 行动负责人 communicate and align any changes to the timelines with the Change Coordinator. 确保在商定的时间内完成行动，对完成日期的调整需要与变更协 调员进行沟通。 To make sure the right people are involved in the Change Control process, details about the Roles and Responsibilities at the change occurrence stage shall be implemented in accordance with Appendix 1 Roles & Responsibilities Matrix. RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 5 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 7  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 6 of 22 QO Code: SOP018308 为确保合适的人员参与变更控制流程，有关变更发生阶段的角色和职责的详细信息需按照附录 1 《角色和职责矩阵》执行。 4.0 Procedure 程序 4.1 Common Change Types 常见变更类型  Product launch or discontinued. 新产品上市或已上市的产品停产。  Change of raw materials / packaging materials or suppliers, such as change of raw materials / packaging materials suppliers, change of delivery conditions of raw materials / packaging materials, etc. 原材料/包装材料或其供应商发生改变，如更换原材料/包装材料供应商，原材料/包装材料 交货条件改变等。  Supplier introduction or termination. 供应商引入或退出。  Change of production formula, production process, product standard, etc. 生产配方、生产工艺、产品标准等发生改变。  Changes in equipment and facilities that may affect product quality, such as new production lines, changes in equipment parameters, etc. 可能影响产品质量的设备/设施变更，如新增生产线，设备参数改变等。  Changes in production environment and production conditions, such as changes in environmental monitoring requirements / monitoring frequency of production workshops. 生产环境、生产条件的变更，如生产车间环境监控要求/监控频率改变等。  New plant or workshop. 新建厂房或生产车间。  Other changes conforming to 2.1. 其它符合 2.1 的变更。 4.2 Process Overview 流程概览 The Change Management process begins with identifying the need for a change and preparing a change proposal. The rationale for the change proposal is reviewed and an assessment of the impacts and risks is performed by relevant subject matter experts. The action plan to implement the change is defined, including any identified actions to mitigate impacts or risks, and reviewed for approval by key stakeholders. The implementation actions are completed and finally evaluated to ensure the objectives of the change have been successfully achieved and there have been no unintended consequences due to the change. Refer to Figure 1 for an overview diagram. 变更管理流程从确定变更需求和准备提交变更开始。相关主题专家将审查提交变更的原因，并 对其影响和风险进行评估。确定实施变更的行动计划，包括所有缓解影响或风险的行动，并由 关键利益相关者审查批准。完成并最终评估实施行动，以确保成功实现变更目标，且不会产生 意外后果。请参阅图 1 以获取概览图。 RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 6 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 8  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 7 of 22 QO Code: SOP018308 Identify the Evaluate & Assessment & Approval to Implement the Need for a Approve the Planning Implement Change Change Implementation Impact & Risk Assessment Implementation Plan 识别变更需求 评估 &计划 批准实施 实施更改 评估并批准实施 影响和风险 评估 实施计划 Figure 1: End to end Change Management process flow. 如上图所示：端到端的变更管理流程。 4.3 Process 流程 4.3.1 Identifying the Need for a Change 确定变更需求 Identify the Evaluate & Assessment & Approval to Implement the Need for a Approve the Planning Implement Change Change Implementation 评估并批准实 识别变更需求 评估 &计划 批准实施 实施更改 施 i. The requirement for a change may be identified at any point in the end-to-end product lifecycle. This may include, but is not limited to, identification through innovation, continual improvement initiatives, outputs of process performance and product monitoring or as a result of Corrective/Preventive Actions, etc. 可以在产品生命周期的任何阶段确定变更需求。变更需求的识别可以但不限于通过创新， 持续改进，工艺性能和产品监控的输出或纠正/预防措施的结果等。 ii. The approach taken to manage and document a change must be appropriate to the level of risk, e.g. formal Change Control records would not be considered appropriate to manage early development experimental formulation changes, etc. Where there is uncertainty, the local Quality team shall be consulted. 管理和记录变更必须根据风险水平采用特定的方法，例如，正式的变更控制记录不适合管 理早期开发试验配方变更等。如果存在不确定性，应咨询当地质量团队。 iii. It may also be considered appropriate for certain changes to be managed through defined and robust procedure, wherein the process sufficiently incorporates the principles of Change RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 7 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 9  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 8 of 22 QO Code: SOP018308 Management (i.e. assessment, approval, and evaluation of the change – see section 5.0 Change Management). Function approvers and/or quality approvers must be added when raised changes in QO. 同时，对于某种特定的变更，可以建立明确并稳健的程序对其进行管理。此程序中需要结 合变更管理的原则（即变更的评估、批准和有效性确认–见第 5.0 章节中的“变更管 理”）在 QO 中发起变更时必须添加部门批准人和/质量批准人。 iv. Where formal Change Control records are deemed appropriate to manage the change, they shall include: 如果认为需要使用正式变更控制记录管理变更，则应包括： a. A unique identification reference for traceability. 可追溯性的唯一标识参考。 b. A clear and concise title. 清晰简洁的标题。 c. A detailed description of the current situation and the proposed change. 详细描述当前情况和提议的变更内容。 d. A rational justification for making the change, considering consequences for not implementing the change. 进行变更的合理理由，考虑不实施变更的后果。 e. Key background information necessary to understand the context of the change, such as the location(s) and/or products/materials involved, etc. 了解变更所需的关键背景信息，如所涉及的位置和/或产品/材料等。 f. A proposed date by which the change should be fully implemented, and the associated record closed. 拟定完成变更行动并关闭相关记录的日期。 g. All relevant evidence to support the change proposal. 支持变更提议的所有相关证据。 h. A nominated individual that will be responsible for coordinating the change and its associated activities. 指定负责协调变更及其相关活动的人员。 4.3.2 Assessment and Planning 评估及计划 Identify the Evaluate & Assessment & Approval to Implement the Need for a Approve the Planning Implement Change Change Implementation 评估并批准实 识别变更需求 评估 &计划 批准实施 实施更改 施 RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 8 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 10  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 9 of 22 QO Code: SOP018308 All proposed changes must be thoroughly assessed to understand the potential impacts and risks. A robust action plan must be prepared to ensure successful implementation, which also considers any requirements highlighted during the assessment. 必须彻底评估所有变更提议，以了解潜在的影响和风险。必须制定健全的行动计划，以确保成 功实施，同时考虑评估期间强调的所有要求。 4.3.2.1 Assessment of Impacts and Risks 影响和风险评估 i. Proposed changes will be assessed for any potential impacts or risks that could be associated with, or introduced because of, the change. The assessment shall consider: 将对变更提议进行评估，以确定可能与变更相关或因变更而引入的任何潜在影响或风险。 评估应考虑： a. All potentially impacted functions and systems. 所有可能受影响的功能和系统； b. Additional products, processes, or services which may be impacted. 可能受到影响的其他产品、流程或服务； c. Likely consequences of the change. 变更可能产生的后果； d. The feasibility of the change. 变更的可行性； e. Required resources and timings. 所需资源和时间； f. All possible safety, quality, compliance, and performance risks. 所有可能的安全、质量、合规和性能风险。 ii. Impact level guidance described as following: 影响水平索引如下表所示： RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 9 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 11  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 10 of 22 QO Code: SOP018308 Change impact High Medium Low 变更影响 高 中 低 Impacts registered details Potential for moderate Potential for minor 影响注册信息 impact on RB Internal impact on RB Internal Regulations & Significant impact on RB Standards. Changes that Standards or no impact. RB Internal Internal Standards. involve factory system. Changes that involve Standards Changes that involve 可能对 RB 内部标准有 individual documents. 法规& RB 内部 Global system. 一定影响，涉及工厂 可能对 RB 内部标准有 标准 对 RB 内部标准有重大影 体系的变化 很小影响或者没有影 响，涉及 Global 体系的 响，涉及个别文件的 变化 变化 Significant Impact on H&S Potential for moderate Potential for minor 对 H&S 有重大影响 impact on H&S impact on H&S or no Need to stop working 对 H&S 有一定影响 impact immediately. Only when Actions need to be 对 H&S 有很小影响或 the risk has been reduced taken to reduce the risk. 者没有影响 or eliminated can we start And prevention costs There is no need for or continue to work. a should be carefully additional control large amount of resources measured and limited, measures. The solution need to be allocated to and risk reduction with the best Health & Safety reduce risk or unlimited measures should be investment effect or 健康& 安全 resources cannot reduce implemented within a improvement measures the risk. specified time frame. without additional cost 需要立即停止工作。只 需要采取措施以降低 should be considered. 有当风险较低或完全消 风险。并需详细计算 不需要另外的控制措 除时，才能开始或继续 以限定预防成本，且 施，需考虑性价比最 工作。为降低风险需配 在规定时间期限内完 佳或不增加额外成本 备大量资源或充分的资 成降低风险的措施 的解决方案。 源投入也不能降低风 险。 Impacts registered or Impacts internal Minor impact to critical process parameter. processes. internal processes. 影响注册或者关键过程 影响内部流程 对内部流程影响很小 Product & 参数 Potential for minor No impact to product Process Impact upon product impact upon product safety, quality or 产品& 流程 safety, quality or efficacy safety, quality or efficacy. 对产品安全、质量、功 efficacy 对安全、质量、功效 效有影响 对产品安全、质量、 没有影响 功效影响很小 RB (Suzhou) Co., Ltd. 利洁时（苏州）有限公司 10 This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 12  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Author 作者: Lucy Zhang Version 版本: V2.0 变更控制程序 QS code 体系编号：SZ-QS11.0.1 Page 页码: Page 11 of 22 QO Code: SOP018308 Impacts registered or Impacts internal Minor impacts to critical specification. specification only. internal specification Specification 影响注册或者关键测试 只影响内部测试标准 only or no impact. 测试标准 标准 对内部测试标准影响 较小或者没有影响 Scope Global impact Regional impact Local impact 范围 全球影响 区域性影响 地方性影响 Requires significant spend Requires some spend No spend required Cost (>£50K) (2 years) Pharmacopoeial updates to ingredient - GR and/or LR - Change in address of specifications and analytical methods - R&D/R&D Operations existing supplier - GR and/or LR: when requested by regulatory - Sustainability team Before R&D approves the "Vendor Chain checklist" for a new ingredient - Change of raw material authority - Process improvements in TDS system, it needs to notify the relevant person in Quality manufacturing process - R&D/R&D Operations: Appropriate R&D Compliance, Procurement and Quality Control departments to confirm - Change of raw material identified changes e.g. updates to R&D the supplier's status, COA and TDS compliance. EHS registration specifications, changes to supplier address, 研发部门在TDS系统中批准新原料的 “Vendor Chain”表格前，需要通知质量合 - Change of supplier raw etc 规部门、采购部门和质量控制部门相关人员针对供应商的状态、COA和TDS的符合性 material specification - Sustainability team: Environment, human 进行确认。 - Changes to raw material rights, or sustainability delivery conditions - Process improvements: department - Change of Ingredient identifying the change Consumer Safety External Manufacturing Quality container - Change of manufacture consumable (e.g. dispensing Planning External Manufacturing Compliance bag) - Change of Ingredient Container closure system Supply Technical Procurement (if they are not the - Change of Ingredient Control Originator and/or Coordinator) of active substance - Change of Ingredient grade Procurement department should identify new suppliers based on the SKU or supplier list in change control and add them to the Packaging Material and Raw - Change of Ingredient Material assessment list. The vendor audit should be conducted by Manufacture Procurement Global Category R&D Quality - Change of Ingredient Compliance based on the results of the assessment. 采购部门应当根据变更控制中的产品类别识别新的供应商，并加入到包材和原料评 Stability 估清单中，最终根据评估的结果由质量合规相应人员进行供应商审计。 - Change to delivery conditions and/or distributor - Change to ingredient Technical Activity Manager / NPI specifications and analytical methods. Artwork Change: New Artwork - Marketing Global: Global/Area Change - Technical Activity Manager/NPI Consumer Relations (where contact - Graphics or wording change Regulatory Affairs Artwork变更：新的Artwork - Marketing Local: Local Changes details are changing) to pack, labelling or leaflet Artwork Change: Revised Artwork - LR or GR: when requested by regulatory External Manufacturing Quality (if - Graphics or wording to all R&D Artwork变更：修改Artwork authority EMO related) levels of packaging Link to 'Simplified change for Hygiene' Consumer Safety Supply Quality (for existing product; already commercialized) Packaging Procurement (if EMO related) - Change in contact details Planning Global Category R&D Quality (if - Change/New claims on GMP or Clinical Trials related) existing product Medical Science (Health GBU related) Marketing (if they are not the Originator and/or Coordinator) Packaging Changes: Changes in primary Most common: Most common: - New/Change/Discontinuation packaging or components - Procurement / PPM - Procurement / PPM Regulatory Affairs Production / Manufacturing of supplier 包装变更：主要包装或组件的变更 - Primary packaging material Packaging Changes: Changes to devices Could also be (depending on the situation): Could also be (depending on the situation): change (including resin Packaging External Manufacturing Quality 包装变更：设备变更 - Supply Quality: GMP/internal standards and - Supply Quality changes within same material) Packaging Changes: Supplier Changes for Pharmacopoeial updates to ingredient - Packaging - Packaging components primary packaging, components or devices specifications and analytical methods - GR and/or LR Supply Quality External Manufacturing Compliance material change 包装变更：主要包装、组件或设备的供应商变更 - Packaging: Packaging legislation or - R&D/R&D Operations - Device change specification updates - Sustainability team - Gadget change - GR and/or LR: when requested by regulatory - Process improvements R&D Supply Technical - Changes to delivery authority - Marketing conditions - R&D/R&D Operations: Appropriate R&D Consumer Safety EHS - Change to delivery identified changes e.g. updates to conditions and/or distributor Planning Procurement (if they are not the specifications for aerosol components, - Change to ingredient Originator and/or Coordinator) changes to device, etc. specifications and analytical - Sustainability team: Environment, human Global Category R&D Quality methods. rights, or sustainability - Primary Closure System eg - Process improvements: department Marketing tamper evident closure identifying the change - Supplier driven changes to - Marketing: Marketing led change material shelf life Sustainability Team PS - For changes in the Artwork, please consult Packaging Changes: Changes in secondary Most common: - New/Change/Discontinuation Regulatory Affairs R&D packaging packaging - Procurement / PPM of supplier 包装变更：二次包装变更 Most common: - Secondary packaging change Packaging Production / Manufacturing - Procurement / PPM Could also be (depending on the situation): - Changes to delivery Packaging Changes: Supplier Changes for - Supply Quality: conditions and/or distributor Supply Quality External Manufacturing Quality secondary packaging Could also be (depending on the situation): - Packaging PS - For changes in the 包装变更：二次包装的供应商变更 - Supply Quality: GMP/internal standards and - GR and/or LR Artwork, please consult - Sustainability tea+E6 Planning External Manufacturing Compliance "Artwork Changes" section Pharmacopoeial updates to ingredient specifications and analytical methods - Process improvements - Marketing Supply Technical - Packaging: Packaging legislation or specification updates EHS - GR and/or LR: when requested by regulatory authority Marketing - Sustainability team: Environment, human rights, or sustainability Sustainability Team - Process improvements: department identifying the change Procurement (if they are not the - Marketing: Marketing led change Originator and/or Coordinator) Packaging Changes: Changes in tertiary Most common: Most common: - New/Change/Discontinuation packaging - Procurement / PPM - Procurement / PPM Packging Production / Manufacturing of supplier 包装变更：三级包装变更 - Tertiary packaging change Packaging Changes: supplier Changes For Could also be (depending on the situation): Could also be (depending on the situation): Commercial Quality External Quality Compliance - Changes to delivery tertiary packaging - Commercial Quality - Commercial Quality conditions and/or distributor 包装变更：三级包装的供应商变更 - Packaging legislation: Packaging - Packaging legislation Planning External Manufacturing Quality - Change to delivery - Process improvements: department - Department identifying the change conditions identifying the change - Marketing led change Supply Services EHS - Marketing led change: Marketing Procurement (if they are not the Originator and/or Coordinator) Marketing Active Substance: Change in name / reference - LR or GR - GR Regulatory Affairs No change in the actual (ATC code) of the active substance R&D material, just 活性物质：活性物质名称/参考（ATC代码）的变更 Consumer Safety documentation/terminology Supply Quality change This copy of the document was retrieved from the system by Loewe Lou on 16 Aug 2024. This copy is considered valid on the day of printing only. | Page: 28  Status: Effective | Effective Date: 15 Jul 2024 | SOP018308-2.0 SZ-QS11.0.1_Change control procedure Changes Back to Main Menuto Reckitt's internal treatment of raw materials and packaging material after delivery from the external supplier 外部供应商交付后，利洁时对原材料和包装材料的内部处理发生变化 The change types listed are the most common Types of The Originator of a Change Control is the person that An appropriate Change Coordinator should be identified The Change Coordinator will be responsible for identifying the required This is not an exhaustive list, it is only Change that have been identified at RB. This is not creates the new Change Control record, i.e. the on a case by case basis, based on the purpose of the functional groups and assigning Impact Assessment items to relevant designed to provide some common intended to be an exhaustive list. requestor of the change. The request for a change change, type of activity the change is related to, the individuals from those groups. examples as guidance, to support the Where in doubt, look for a similar type of change to can come from a wide variety of sources and should functional group with responsibility for and/or greater Selection of Assessors will vary, from case to case, so the list of recommended process of selecting the most use as guidance, or reach out to your local Super User be aligned on a case by case basis. The Originator of a oversight for the activities relating to the implementation assessors is designed as guidance, a recommendation as to which groups are appropriate Type of Change. Back to Change Control is usually someone from the of the change. The Change Coordinator is the person that network for guidance. usually consulted as part of this type of change. Main Menu functional group requesting the change/identifying has overall responsibility for coordinating the Change The list of other, possible Assessors is also guidance. These lists are not Glossary the requirement for a change Type of Change Recommended Originator Recomended Change Coordinator Recommended Assessors Other, possible Assessors Examples of the Type of Change 变更类型 建议的发起人 建议的变更协调员 建议的评估员 其他，可能的评估员 变更类型的示例 Appendix 1: Roles & Responsibilites Matrix V2.0 Raw Material Changes: Shelf life changes - Supply Quality: Due to GMP/stability - Supply Quality Regulatory Affairs Packaging - Internally driven (e.g. 原材料变更：保质期变更 reasons Reckitt requirement to extend / - Supply Planning Production / Manufacturing reduce a shelf life) Raw Materials stored and handled within Supply Supply Planning : Due to stock management Supply Quality EHS - Applicable according to local Manufacturing - R&D/R&D Operations: Appropriate R&D legislation 供应制造过程中储存和处理的原材料 identified changes e.g. updates to shelf-life R&D Other Supply functions, as required of a raw material based on R&D data and Procurement knowledge. Raw Material Changes: Shelf life changes - R&D/R&D Operations - R&D/R&D Operations - Internally driven (e.g. R&D Microbiology 原材料变化：保质期变化 Reckitt requirement to extend / Raw Materials stored and handled within R&D reduce a shelf life) Facility R&D Shared Services (where available) 在研发设施内储存和处理的原材料 Raw Material Changes: Handling, Storage and/or Internally driven (one of the following): Internally driven (one of the following): - Changes in raw material Delivery Conditions - Logistics: when requested to aid - Logistics Regulatory Affairs Packaging handling, storage and/or 原材料变更：搬运、储存和/或交付条件 storage/transport - Production delivery conditions - Production: Change in manufacturing - EHS process/handling - Supply Quality Supply Planning Production / Manufacturing - EHS: Manual handling/Safety reasons - GR and/or LR - Supply Quality: Stability or GMP impact - R&D/R&D Operations (e.g. aerosols, etc) Supply Quality Engineering - GR and/or LR: when requested by regulatory authority Externally driven / supplier driven (one of the - R&D/R&D Operations: Appropriate R&D following): EHS Consumer Safety identified changes e.g. if there was a safety - Procurement concern, GMP impact or stability - Supply Quality R&D Procurement Externally driven / supplier driven (one of the following): - Procurement / PPM Commercial Quality - Supply Quality Packaging Material Changes: Handling, Storage Internally driven (one of the following): Internally driven (one of the following): - Changes in packaging material and/or Delivery Conditions - Logistics: when requested to aid - Logistics Regulatory Affairs Production / Manufacturing handling, storage and/or 包装材料变更：搬运、储存和/或交付条件 storage/transport - Production delivery conditions - Production: Change in manufacturing - EHS process/handling - Supply Quality Supply Planning Engineering - EHS: Manual handling/Safety reasons - GR and/or LR - Supply Quality: Stability or GMP impact - R&D/R&D Operations (e.g. aerosols, etc) Supply Quality Consumer Safety - GR and/or LR: when requested by regulatory authority Externally driven / supplier driven (one of the - R&D/R&D Operations: Appropriate R&D following): EHS Procurement identified changes e.g. if there was a safety - Procurement concern, GMP impact or stability - Supply Quality R&D Commercial Quality Externally driven / supplier driven (one of the following): - Procurement / PPM Packaging - Supply Quality Testing / Test Method Changes: Raw Materials - Supply Quality: Stability or GMP impact - Supply Quality Regulatory Affairs Packaging - Changes in sampling 测试/测试方法变更：原材料 - GR and/or LR: when requested by regulatory - GR and/or LR - Changes in specifications authority - R&D/R&D Operations Supply Quality Production / Manufacturing - Changes in testing frequency - R&D/R&D Operations: Appropriate R&D R&D EHS - Changes in test methods identified changes e.g. other specification or test method changes,etc Procurement Testing / Test Method Changes: Packaging - Supply Quality: Stability or GMP impact - Supply Quality Regulatory Affairs Production / Manufacturing - Changes in sampling Materials - Packaging: specification changes - Packaging - Changes in specifications 测试/测试方法变更：包装材料 - GR and/or LR: when requested by regulatory - GR and/or LR Supply Quality EHS - Changes in testing frequency authority - R&D/R&D Operations - Changes in test methods R&D