Global Supplier Management Procedure SOP012135 PDF

Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE GLOBAL SUPPLIER MANAGEMENT PROCEDURE File Name: SOP012135-3.0-GLOBAL SUPPLIER MANAGEMENT PROCEDURE Number: SOP012135 Major Version:...

Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE GLOBAL SUPPLIER MANAGEMENT PROCEDURE File Name: SOP012135-3.0-GLOBAL SUPPLIER MANAGEMENT PROCEDURE Number: SOP012135 Major Version: 3 Approval Signatures Document Approvals Amanda Baila, Global Supply Chain Quality Director Task: Approval Task ([email protected]) Verdict: Approve 15-Feb-2024 14:32:56 GMT+0000 Conall Burns, Director of Quality Management Systems Task: Compliance Approval ([email protected]) Verdict: Approve 15-Feb-2024 15:54:48 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 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 1  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 1 of 15 Global Supplier Management Procedure SOP012135 Note: version 3.0 is a minor revision with a reduced approval. The planned periodic review date of the last major version shall be retained. 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. 1 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 2  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 2 of 15 1.0 Purpose The purpose of this procedure is to establish a common risk-based approach to the end-to-end supplier management process within Reckitt. This facilitates proper identification and approval of suppliers and their goods or contract services provided, continuous improvement in performance and ensures the safety, well-being and protection of the consumer for all Reckitt Business Units. 2.0 Scope This procedure applies to all suppliers of all Reckitt Business Units for: Qualification of new and/or additional supplier sites/facilities Qualification of new and/or additional goods – raw materials, packaging materials (components and resin), devices (technical and medical), semi-finished goods and finished products manufactured by Reckitt’s 3rd party (e.g., External Manufacturing Organisation - EMO) Qualification of new and/or additional contracted services – including but not limited to, for example contract cleaning activities impacting GMP areas, embellishment, consumer relations and vigilance, contract laboratories, calibration services, pest control, contract warehousing and distribution centres, transportation providers and consultants, design and artwork agencies, technical service providers (e.g., equipment passivation), services providers that perform activities for different functions within Reckitt (e.g., Regulatory - performing registrations on behalf of Reckitt, translations, regulatory consultancy, provision of e-Learning modules or training) This procedure does not apply to: Suppliers of all categories of non-production spend (except embellishment which is included under ‘Contracted Services’ above) – refer to RB PACT Policy 020 Global Supplier Selection for further details Suppliers of Clinical goods and contracted services – refer to Assessing, Selecting and Contracting with Vendors SOP018694 for further details IS vendors and products (IS systems) – refer to Vendor Selection and Management Policy and Procedure (GLOIT- 5.1-POL001 & GLOIT-G5.1-SOP001 respectively) for further details. 3.0 Process overview The below figure illustrates the end-to-end high-level process for Supplier Management. This process is structured around the identification and controlled approval of suppliers followed by their on-going management and, for key suppliers their strategic relationship. When a supplier relationship with Reckitt is no longer beneficial the supplier exit/delisting stage will be implemented. Figure 1: Supplier Management Process 2 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 3  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 3 of 15 4.0 Common Annotations 1 Quality - includes Supply Quality, R&D Quality and Commercial Quality teams, where applicable. 2 Technical - includes R&D, Supply Technical and Packaging where applicable. 3 Risk - described in this document relates to the Technical or Quality risks associated with the supplier and their goods or services supplied. It does not apply to Commercial risk unless specifically indicated. 4 Confidentiality/Non-Disclosure Agreements (NDAs) - may be arranged with suppliers by other than Procurement functions e.g., R&D or Quality, as appropriate. Ariba MyContract is the platform where the latest version of NDA template is available and completed forms are stored. 5 Supplier Quality Questionnaire – used to gather and assess information regarding vendor’s QMS. For examples of approved Reckitt Supplier Quality Questionnaires that may be used refer to section 9.0 for references. 6 Vendor Quality Manuals – used to communicate relevant Reckitt quality requirements for different type of vendors. For relevant Quality Manual refer to section 8.0 for references. 7 Monitoring Assurance - supplier assurance monitoring may include, but is not limited to, supplier scorecard review, supplier non-conformances, supplier batch failures, CAPA responses, cost and service level performance. 5.0 Procedure Please note below requirements are listed in alphabetical order. General requirements: Accountability: The individual and their function who initiated the project are accountable for ensuring its progress and completion. Certificate & Testing: Suppliers shall provide a valid Certificate of Analysis/ Conformance/ Manufacture, where applicable with each shipment of goods/ services. The format must be agreed with Reckitt (preferably in the Technical/ Quality Agreement or other contract) prior to commercial orders being placed. Any trial work and testing required for approval must be documented, stored, be traceable and appropriate to the level of risk. Any transportation or storage constraints required to maintain the quality of the goods prior to their use must be stipulated in an agreed contract. Change Management: Change Management shall be used to control the introduction of new suppliers to Reckitt and/or changes to suppliers or their goods/ contract provided. The responsibility for raising the change control form is with the function leading the change. For new suppliers, change management is conducted in accordance with relevant Technology Transfer (TT) process (Technology Transfer Policy POL000147, Global Technology Transfer Procedure – Health SOP010090, Technology Transfer Procedure SOP015560 for Hygiene, Global Technology Transfer Procedure SOP024503 for Nutrition). For changes to existing suppliers/goods/contracted services the change control form will be raised at the initiation of the project. Principles of the change management are detailed in the Global Change Management Procedure SOP012093. Commercial Units: Supply Services assume procurement responsibilities for commercial units. Not all stages and/or activities may be required but where applicable shall follow this procedure. Contracts & Agreements: There shall be written, agreed contracts or purchase orders in place between Reckitt and the Supplier detailing Reckitt minimum requirements, terms and conditions (Procurement responsibility). Consistency of the goods and services provided by the supplier shall be ensured by clearly communicated and documented relevant quality requirements and responsibilities. The requirement for a ‘Reckitt – Supplier’ Technical/Quality Agreement will be determined in accordance with local procedures. This for example may take the form of an agreed and signed specification (R&D responsibility, including Packaging where applicable), signed Supplier Quality Questionnaire5, Supplier Expectation Manual or more formal agreement (Quality responsibility). Technical Manual is required for all Reckitt products classifications manufactured by EMO. Where Reckitt owns the product, a Full Technical Manual shall be provided with all Reckitt internal documentation. Where products are branded by Reckitt and owned by manufacturer (legal Entity), minimum of CPBOM must be provided. Technical Manual template example can be found in EQC Technical Manual Process SOP003390. More detailed local templates can be used where applicable. Local requirements: Additional requirements to this procedure may be included in local procedures where specific Regulatory or Quality demands shall be met. Minimum Requirement: All potential new suppliers to Reckitt and any existing suppliers with a new manufacturing facility, goods and contract services shall be subject to Procurement, Quality1 and Technical2 risk- 3 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 4  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 4 of 15 based Assessments. Approval is given when all identified risks have been mitigated or reduced to an acceptable level by each function. Refer to Global Product Compliance Risk Management Procedure SOP012862. o Where suppliers either do not supply the requested information, or the information provided/ risk- based assessment does not meet Reckitt requirements, then this must be immediately escalated to Procurement to assist in resolution. New suppliers: All potential new suppliers to Reckitt shall be subject to a risk-based assessment and be approved by Reckitt Procurement, Sustainability (as per details in Supplier Selection and Management SOP009284), Quality1 and Technical2 prior to the ordering of goods or contracted services for commercial use. They may however be used for trial or development work following assessment and approval by Quality 1 in accordance with local procedures prior to formal approval. The process for the approval and ongoing assurance of suppliers must meet requirements of this procedure. Regulatory and Safety: R&D and Technical must ensure that Regulatory and Safety consultation and alignment is completed at each stage to ensure that regulatory and safety requirements are identified, considered and completed. All supplier approvals shall comply with local and market Regulatory requirements. Risk-based3: All Reckitt facilities must have a documented risk-based process for selecting, approving, assuring and discontinuing suppliers that meet the requirements of this procedure. The level of effort required to select, approve, assure and discontinue/delist suppliers must be appropriate to the level of risk associated with the supplier and their goods/contracted services provided. Refer to section 6.0 for further details. Site Quality Audit: Where the risk-based assessments determine that Quality site audits are required, these shall be conducted in accordance with the Global Auditing Process SOP007070. Auditors performing these audits shall be qualified in accordance with the Lead Auditor Qualification and Competency Assessment Procedure SOP005289. Additionally, Sustainability criteria as per Appendix 3 Human Rights Quality Aide Memoire of Global Auditing Process SOP007070 shall also be considered during the Quality audit. Any findings shall be captured in the audit report (Appendix 5 of Global Auditing Process SOP007070) and be escalated to Sustainability team via email [email protected]. A list of approved suppliers for each site shall be kept and maintained by the site Quality 1 teams. Supplier Balance Scorecard: Globally coordinated tool, required for an on-going supplier monitoring. The criteria including definition of number of suppliers to be selected and which suppliers are to be monitored (by factory/location) is to be agreed between participating in the activity functions based on supplier past performance, risk assessment of goods supplied and availability of Reckitt resources. For details see Supplier Balance Scorecards SOP SOP014275. Supplier Quality Performance: Locally coordinated tool, required for an on-going supplier monitoring. It should include numbers of received non-conforming good or services, adequacy of documentation received with each delivery (for example Certificate of Analysis or Conformance, as required) and a risk-based review on the period of re-assessment for the supplier. Technology Transfer (TT): For approval of goods or for site-to-site transfers of goods, the applicable process as per Technology Transfer Policy - Health POL000147 and Global Technology Transfer Procedure – Health SOP010090, Technology Transfer Procedure SOP015560 for Hygiene, Global Technology Transfer Procedure SOP024503 for Nutrition shall be followed. Quality ensures throughout the goods-approval process that the required elements of the TT process have been completed and approved. Vendor Governance Variance Form –Tool allowing variance application. Refer to Vendor Governance Variance Form R075314 for more details. Tables Notes: The following procedure sections have ‘Responsibility Tables’ and ‘Functional Breakdown of Activity’ tables. These simplify and structure the activities required by whom and in which order The ‘order’ column within the ‘Functional Breakdown of Activity’ table applies across functions, e.g., activity #3 for Procurement would start at the same time as activity #3 for R&D 4 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 5  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 5 of 15 5.1 Supplier pre-selection The purpose of the Supplier Pre-Selection Stage is to identify potential suppliers who have adequate capability and capacity to provide the goods or contracted services to meet Reckitt requirements. Any function may engage with procurement at this stage depending on the project scope. By the end of this stage the preferred supplier(s) to choose to perform further Development work with will have been confirmed. Responsibility Table High Level Sub-Level Technical Activities to be Completed Proc. Qual. CAS Process Process Supp. R&D Pack. Issue (draft) specification or technical guidance and the technical compliance questionnaire for the goods to be procured, for example REACh, raw Technical material questionnaires, TSE statements, R R R Evaluation GMO, INCI listing, Proposition 65 statements, Latex statements Issue and approve Confidentiality Agreements4 with supplier Issue Supplier Quality Questionnaire5 Pre-Selection Quality Issue and approve Confidentiality R Evaluation Agreements4 with supplier Corporate Refer to Supplier Selection and Affairs & R R Management SOP009284 for details Sustainability Issue and approve Confidentiality Agreements4 and share Vendor Quality Commercial Manual6 with supplier R Evaluation Agree tendering, contractual arrangements Functional Breakdown of Activity Function Order Detailed Activities to be Completed 1 Complete supplier Confidentiality/ Non-Disclosure Agreements4 with supplier before pre- selection starts 2 Initiate tendering process for the identification of prospective suppliers 3 Send out i. Supplier Agreements to supplier for their review and evaluate response Procurement (includes Corporate Responsibility requirements. EVP Supply approval is required to share documents with EMOs when dealing with a Powerbrand) and ii. General Packaging Specification to supplier (where applicable) and iii. Relevant Vendor Quality Manual6 as per Supplier Selection and Management SOP009284 1 Complete supplier Confidentiality/ Non-Disclosure Agreements4 with supplier before pre- selection starts 3 Supplier Quality Questionnaire5 sent to prospective supplier shortlist to establish the level Quality1 of quality compliance with Reckitt requirements 3 Issue supplier Technical/ Quality Agreement (where applicable) to the supplier for completion. This must agree roles and responsibilities 4 Risk assessment initiated to determine requirements for supplier approval 1 Must involve Procurement from the initial stage of supplier identification to ensure provision of (draft) specification or technical guidance and alignment with the Reckitt sourcing strategy R&D 1 Complete supplier Confidentiality/ Non-Disclosure Agreements4 with supplier before pre- selection starts 5 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 6  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 6 of 15 3 Issue questionnaire(s) relating to goods to be supplied to Safety and Regulatory to ensure compliance, for example REACh, raw material (attribute) questionnaires (e.g., Raw Material Questionnaire (RMQ) Template SD002536), TSE statements, GMO, INCI listing, Proposition 65 statements, Latex statements and request supplier’s specification for goods Lead the TT process for Reckitt products and ensures that the management of any goods is 5 transitioned successfully to Supply in accordance with the relevant TT requirements Technical 5 Review goods information and specifications provided by supplier Supply 1 Must involve Procurement from the initial stages of supplier identification to ensure Packaging alignment with the Reckitt sourcing strategy 3 Issues Packaging Material Questionnaire R056208 (recommended as best practice) Corporate 3 Refer to Supplier Selection and Management SOP009284 for details Affairs & Sustainability NOTE: Procurement are responsible for the overall management and approval of the supplier relationship. For provision of goods or services impacting Clinical and Consumer Trials or a claims study, R&D must ensure that suppliers are identified and assessed in accordance with the specific R&D procedures. 5.2 Development The purpose of the Supplier Development stage is to review responses provided by the potential suppliers, to determine and carry out thorough risk assessment the actions required to approve the supplier and/or their goods and services. By the end of this stage the information and actions required for the supplier and/or their goods to be approved by each function will have been completed. Responsibility Table High Level Sub-Level Technical Activities to be Completed Proc. Qual. CAS Process Process Supp. R&D Pack. Evaluate technical compliance questionnaire(s) (where applicable) response for goods Commence technical due diligence with supplier. For the projects with 3rd party Intellectual Property (IP) follow details of Technical Global Technical Due Diligence Review R R R Evaluation Procedure SOP008528 Commence TT process Engage applicable Fragrance Manager for the assessment of relevant volatile material Development with measurable vapor pressure (e.g., Ethanol). Follow local processes for details Evaluate Supplier Quality Questionnaire5 Quality and Vendor Quality Manual6 self- R Evaluation assessment response Corporate Refer to Supplier Selection and Affairs & R Management SOP009284 for details Sustainability Issue and sign Confidentiality Agreements4 Commercial Agree tendering, pricing and contractual R Evaluation Carry out credit checks 6 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 7  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 7 of 15 Functional Breakdown of Activity Function Order Detailed Activities to be Completed 1 Evaluate supplier’s response to Supplier Agreements Procurement 1 Supplier response to Supplier Quality Questionnaire5 and Reckitt Vendor Quality Manual6 self-assessment evaluated to establish the level of quality compliance with Reckitt requirements 1 Supplier response to Technical/ Quality Agreement (where applicable) evaluated to Quality1 establish the level of quality compliance with Reckitt requirements Risk assessment completed to determine requirements for supplier approval, e.g., Site 2 Quality Audit Initiate completion of actions required for supplier approval 3 1 Supplier response to goods compliance questionnaire evaluated to establish the level of quality compliance with Reckitt requirements 1 Fragrance Manager response to volatile material assessment evaluation and relevant actions identification 3 Must identify all critical parameters of the goods specifications (excluding packaging materials) and perform due diligence with the supplier (may require Quality and/or R&D Technical Supply support) 3 Consultation with Regulatory and Safety required (where applicable) to develop the regulatory strategy and manage any safety concerns 4 Lead the TT process for Reckitt products stages 1 and 2, ensuring that the management of any goods is transitioned successfully to Supply in accordance with relevant TT requirements 4 Leads the TT process for the receiving Reckitt Supply site to ensure the successful Technical Supply transition of goods, incorporating safety requirements and performing all trial work in conjunction with R&D 1 Packaging team will send out and agree item-level packaging specifications and agree GPS with the supplier. See details in Project Golden: Packaging Documentation Guidelines for Creation – Review – Approval SOP015505 Must identify all critical parameters of the packaging specifications and perform due 3 diligence with the supplier (may require Quality and/or Technical Supply support) Packaging Consultation with Regulatory and Safety required (where applicable) to develop the regulatory strategy and manage any safety concerns 3 Determines through risk assessment, and leads, following the TT process any trials required to provide technical assurance of supplier capability to deliver the packaging 4 materials specification Corporate 1&2 Refer to Supplier Selection and Management SOP009284 for details Affairs & Sustainability 5.3 Approval The purpose of the Supplier Approval Stage is to review the information and activities completed during the Development stage in accordance with the risk assessment and provide approval. If the information or actions required are not deemed to be complete this must be communicated by the functional approver and acted upon to ensure that the Reckitt requirements are met. By the end of this stage the supplier will be approved for the goods/ service described in the project. Procurement may instruct the local Planning or Supply Services teams to place orders with the suppliers for the approved goods or services. 7 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 8  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 8 of 15 Responsibility Table High Level Sub-Level Technical Activities to be Completed Proc. Qual. CAS Process Process Supp. R&D Pack. Approve technical specification for Technical goods R R R Approval Confirm and approve technical capability of supplier Complete all actions required from risk assessment for quality approval of supplier Quality Approval Approve supplier Quality Agreement R Approval (where applicable) Perform verification testing of supplier goods (where applicable) Corporate Refer to Supplier Selection and Affairs & R Management SOP009284 for details Sustainability Commercial Complete Commercial Agreements R Approval and overall supplier approval Functional Breakdown of Activity Function Order Detailed Activities to be Completed 1 Sign-off Supplier Agreement and complete commercial requirements for supplier approval Procurement 3 Ensures quality and technical approvals, of goods and services, are received before instructing Supply Planning/ Supply Services to place commercial order with the supplier 1 Approve applicable supplier Technical/ Quality Agreements Quality1 2 Ensures risk assessment and requirements for supplier Quality approval completed, including, where applicable, signed Vendor Governance Variance Form R075314 1 Lead the identification, performance and documentation of all trial work and testing to provide technical assurance of a supplier’s capability to deliver to the specification. Refer to relevant TT requirements 1 Agree and approve technical specifications and test methods for goods (excluding R&D packaging materials) with the supplier. These must be published in advance of placing supplier orders 2 Approve supplier for the goods/services described in the project (consulting with Regulatory and Safety teams) and ensure addition of supplier to the goods specification 1 Approve supplier goods from a site Technical and Safety perspective Supply 1 Completion of trial work for the receiving Reckitt Supply site to ensure the successful Technical transition of goods with R&D. Refer to relevant TT requirements 1 Lead the identification, performance evaluation and documentation of all trial work and testing to assure supplier capability and to deliver to the packaging material specification. Refer to relevant TT requirements 1 Packaging teams finalise, agree and sign-off the MPS, GPS and packaging material Packaging specification and test methods with the supplier. The signed packaging material specification must be stored in a safe, secure location, and published in advance of placing supplier orders. See details in Project Golden: Packaging Documentation Guidelines for Creation – Review – Approval SOP015505 8 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 9  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 9 of 15 Corporate 1&2 Refer to Supplier Selection and Management SOP009284 for details Affairs & Sustainability NOTE: Supplier Agreements, Technical/ Quality Agreements and results from supplier audits will be stored centrally, for example on the Ariba system. Where supplier sites are required to be used (for example they are the only supplier for a given goods/service) and these are determined to be high risk (red) then the escalation process in the Global Product Compliance Risk Management Procedure SOP012862, Global Product Development – Health SOP009878, Product Development Standards Hygiene SOP010657 shall be followed where applicable. Where existing supplier sites are determined to be high risk (for example following a quality audit), then this must be escalated via the Critical Events and Product Recall Procedure – All Products SOP007700. 5.4.1 Assurance The purpose of the Supplier Assurance stage is to monitor on-going supplier performance, ensuring Reckitt requirements are met. This stage ends only when a supplier and/or their goods/services have been de-listed or discontinued. Different tools are used for the assurance purposes like Supplier Balance Scorecard with input provided by Procurement, Quality, R&D/NPI, Commercial and Supply Planning/Services for selected supplier (For details see Supplier Balance Scorecards SOP SOP014275) or Supplier Quality Performance. Responsibility Table High Level Sub-Level Technical Activities to be Completed Proc. Qual. CAS Process Process Supp. R&D Pack. Monitor selected supplier’s performance via scorecard Perform routine supplier re- Performance assessments R Monitoring Review any existing Vendor Governance Variance Form as per Assurance Vendor Governance Variance Form R075314 Coordinate selected supplier’s Commercial performance monitoring via scorecard Performance R Drive actions on escalated supplier Monitoring performance feedback Functional Breakdown of Activity Function Order Detailed Activities to be Completed 1 Review and update Supplier Agreements as required 1 Coordinate performance monitoring against supplier scorecard for selected suppliers Support Reckitt functions to close out requests for information and documents with Procurement 3 the supplier Receive and drive action on escalated supplier performance feedback provided by other functions 1 Monitor Supplier Quality Performance and provide feedback to both the supplier and local Procurement team 1 Review and update Technical/ Quality agreements and/or existing Vendor Governance Quality1 Variance Form as per Vendor Governance Variance Form R075314 as required Perform periodic risk-based Quality reassessment of suppliers 2 9 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 10  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 10 of 15 1 Update and agree goods specifications with suppliers (excluding packaging material) as R&D required through Change Management Supply N/A Not applicable Technical Packaging 1 Update the packaging material specification as required through Change Management 2 Periodic risk-based supplier re-assessment of suppliers based on previous audit result and risk level 2 Ensure that following an Audit, a corrective action plan is submitted by the site and all findings closed off Corporate Affairs & 2 Copackers and selected raw and pack materials Suppliers are required to re-new Sustainability membership for the Supplier Environmental Performance Programme (SEPP) annually Twice a year for selected suppliers, Sustainability will populate the Procurement 2 Supplier Balanced Scorecard which will cover Human Rights and Environmental Metrics along with ensuring social responsibility clause is embedded in contract 5.4.2 Strategic Supplier Relationship The purpose of the Strategic Supplier Relationship stage is to identify opportunities for improvement with key suppliers (for example supply chain initiatives, quality improvements, cost efficiencies), develop and agree the business case and plan before implementing the actions. At the end of this stage the action plan will be completed and tracked. Partnership provides further development to drive and improve supplier quality by selecting and developing reliable, compliant supplier partners to maintain high quality and low costs through: Develop new and strategic suppliers for NPDs, cost savings and business continuity Develop CAPA plans to resolve major quality issues Drive continuous improvement. Responsibility Table High Level Sub-Level Technical Activities to be Completed Proc. Qual. CAS Process Process Supp. R&D Pack. Identify, assess, implement, and track R R Reckitt Led or improvement. Provide CAPA guidance Partnership Supplier Led E/NPD initiatives, cost savings, business R R R R R R continuity Functional Breakdown of Activity Function Order Detailed Activities to be Completed 1 Coordinate selection of key suppliers for improvement (quality, service, cost) Develop improvement business case and plan and alignment of Global/Local Procurement 2 Procurement Coordinate and track improvement implementation for impact and adjust 3 accordingly 1 Identify opportunities for supplier improvement with Procurement (e.g., Provides CAPA guidance following audit or non-conformance) Quality1 2 Provides inputs to develop improvement business case and plan 3 Track improvement implementation for impact and adjust accordingly 1 Identify opportunities for supplier improvement with Procurement R&D 2 Develop improvement business case and plan 3 Track improvement implementation for impact and adjust accordingly 1 Identify opportunities for supplier improvement with Procurement Supply Technical 2 Develop improvement business case and plan 10 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 11  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 11 of 15 3 Track improvement implementation for impact and adjust accordingly 1 Identify opportunities for supplier improvement with Procurement Packaging 2 Develop improvement business case and plan 3 Track improvement implementation for impact and adjust accordingly 1 Identify opportunities for supplier improvement with Procurement Corporate Affairs 2 Develop improvement business case and plan & Sustainability 3 Track improvement implementation for impact and adjust accordingly Please note, each function is responsible for owning their improvement plans. 5.5 Supplier Exit and Delisting The purpose of the Supplier Delisting stage is to remove a supplier as a provider of goods or services that are no longer required by Reckitt or that the supplier no longer provides. This may initiate the pre-selection stage where an alternative source is not already approved. By the end of this stage the goods may be brought from the alternative supply source where applicable. If no purchase has been made from the supplier within 2 years (high risk) or 3 years (medium/low risk) since they were initially approved and there is a still a requirement to use their goods, then re-qualification shall be performed using risk- management principles (see section 6.0 for details). Goods cannot be procured until re-qualification is complete. The purpose of the Supplier Exit stage is to remove a supplier as an approved source of good(s)/service(s) via Change Control. This may relate to specific goods/services provided by the supplier only. Reasons for this could be following a deterioration in Quality or Commercial Performance, Regulatory or Ethical non-compliance of supplier or their goods to Reckitt requirements. By the end of this stage the supplier will no longer be approved to supply the specified goods/services to Reckitt. Once exit is complete the supplier may only re-supply the goods/services to Reckitt once the supplier approval process has been completed. This may also initiate the pre-selection stage where no alternative source is already approved. Responsibility Table High Level Sub-Level Technical Activities to be Completed Proc. Qual. CAS Process Process Supp. R&D Pack. Identification of supplier/goods/services Removal from to delist Exit Reckitt R R R R R R Carry out change Control with cross- directory functional team Identify and initiate alternative supplier Delisting Dual sourcing R pre-selection process Functional Breakdown of Activity Function Order Detailed Activities to be Completed 1 Identify dual sourcing opportunities for pre-selection process 2 Local procurement to raise change control to manage supplier exit / delisting Lead Business Continuity Planning for supplier exit (supported by Supply / Supply Services Procurement 2 and other functions as required) Make final decision on supplier exit / delisting 3 Update procurement systems to reflect exit/delisting 4 1 Identification of supplier/goods/services to exit and notify procurement Quality1 4 Support Business Contingency Plan (BCP) / CC and update quality systems to reflect exit/delisting 1 Identification of supplier/goods/services to exit and notify Procurement R&D 4 Support BCP / CC and update quality systems to reflect exit/delisting Technical2 1 Identification of supplier/goods/services to exit and notify Procurement 11 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 12  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 12 of 15 4 Support BCP / CC and update quality systems to reflect exit/delisting 1 Identification of supplier/goods/services to exit and notify Procurement Packaging 4 Support BCP / CC and update quality systems to reflect exit/delisting Corporate 1 Identification of supplier/goods/services to exit and notify Procurement Affairs & 4 Support BCP / CC and update quality systems to reflect exit/delisting Sustainability N.B. Records of supplier exit / delisting, and reasons as to why, should be maintained by Procurement to ensure the supplier approval process is followed prior to re-approval 6.0 Risk Management The below figure provides guidance for the risk assessment process and areas that should be considered as a minimum. The level of control applied to supplier management should be proportionate to the level of risk to the product, business and consumer/user. These guidelines are not exhaustive and shall not be substitute for local regulations and requirements. Refer to the Global Product Compliance Risk Management Procedure SOP012862 for further details. Figure 2: Supplier Risk Management Criteria The Figure 2 provides guidance on the Technical and/or Quality risk assessment process. The R&D / Quality / Packaging teams, as appropriate should determine the risks on a case-by-case basis. Commercial risks are not included. The output from the risk assessment will determine the requirements for ongoing supplier assurance. In principle, low risk suppliers will require less governance from Reckitt whilst high risk suppliers will require greater focus for assurance. 12 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 13  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 13 of 15 Figure 3: Supplier Assurance Criteria The above figure provides guidance for the minimum requirements for supplier assurance. These guidelines are not exhaustive and shall not be substitute for local regulations and requirements. 7.0 Abbreviations BCP – Business Contingency Plan CAPA – Correction Action and Preventative Action CAS – Corporate Affairs and Sustainability CC – Change Control CPBOM – Customer Product Bill Of Material EMO – External Manufacturing Organisation – an external contract manufacturer which performs specified production or service activities for Reckitt E/NPD – Existing or New Product Development EVP – Executive Vice President GPS – Group Packaging Specification GxP – Refers to a series of good practices where the letter ‘x’ is substituted for others, for example Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc IP – Intellectual Property MPS – Master Packaging Specification NDA – Non-Disclosure Agreement NPI – New Product Implementation Pack. – Packaging Technology PCR – Post Consumer Recycling PLM - Product Lifecycle Management – The system within which specifications, BOMs and MOMs are managed (e.g., TDS or Optiva) Proc. – Procurement Function QAG – Quality Agreement QMS – Quality Management System Qual. – Quality Function R&D – Category Research and Development or Research & Development Operations 13 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 14  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 14 of 15 SEPP – Supplier Environmental Performance Programme SLA – Service Level Agreement Supp – Supply Technical Tech. – Technical TT – Technology Transfer 8.0 References External: Eudralex Volume 4 European Medicines Agency Guideline on Good Pharmacovigilance Practices 21 Code of Federal Regulations parts World Health Organisation Good Manufacturing Practices Main Principles ISO 9001:2015 Quality Management Systems ISO 13485:2016 Medical Devices ICH Quality Guidelines Cosmetic Product Regulations (EC) No. 1223/2009 Medical Device Directive 93/42/EC & Medical Device Regulation 2017/745 (MDR) Internal: Reckitt Vendor Quality Manuals: ▪ QM000038 External Manufacturing Organisation Quality Manual – Health ▪ QM000039 External Manufacturing Organisation Quality Manual – Hygiene ▪ QM000040 Global Supplier Quality Manual - Packaging Suppliers ▪ QM000041 Global Supplier Quality Manual - Raw Material Suppliers ▪ QM000042 Supplier Quality Manual IFCN Nutrition ▪ QM000044 Supplier Quality Manual – Adult Nutrition ▪ QM000045 Supplier Quality Manual – Packaging Nutrition ▪ SOP024685 EMO Quality Manual – IFCN ▪ SOP024685 EMO Quality Manual – Adult Nutrition R075314 Vendor Governance Variance Form SOP011485 Paper and Board Certification Requirements SOP007070 Global Auditing Process SOP010090 Global Technology Transfer Procedure – Health SOP008528 Global Technical Due Diligence Review Procedure SOP011310 Embellishment Management Procedure – Hygiene POL000060 Global Embellishment Procedure – Health SOP007135 Global Company Quality/Technical Agreements Procedure SOP014275 Supplier Balance Scorecards SOP POL000074 Global Consumer Relations Policy SOP009284 Supplier Selection and Management SOP007700 Critical Events and Product Recall Procedure – All Products POL000120 Global Distribution Policy SOP005289 Lead Auditor Qualification and Competency Assessment Procedure SOP014198 Qualification of Materials, Formulations and Products SD002536 Raw Materials Questionnaire SOP POL000147 Global Technology Transfer Policy – Health SOP012093 Global Change Management Procedure SOP012862 Global Product Compliance Risk Management Procedure SOP009878 Global Product Development – Health SOP010657 Product Development Standards Hygiene SOP003938 Global Consumer Relations - Contact Handling Procedure SOP015560 Technology Transfer Procedure for Hygiene SOP008572 Guidance for Planning and Conducting Virtual Audits SOP015505 Project Golden: Packaging Documentation Guidelines for Creation Review Approval R056208 Packaging Material Questionnaire SOP018694 Assessing, Selecting and Contracting with Vendors SOP003390 EQC Technical Manual Process 14 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 15  Status: Effective | Effective Date: 16 Feb 2024 | SOP012135-3.0 GLOBAL SUPPLIER MANAGEMENT PROCEDURE Global Supplier Management Date: February 2024 Author: M. Garlinska Procedure Version: 3.0 SOP012135 Page: Page 15 of 15 SOP024503 Global Technology Transfer Procedure SOP024662 Guidelines for Assessing Raw Material and Packaging Component Suppliers SOP024693 Management of Raw Material Attribute Questionnaire GLOIT-5.1-POL001 Vendor Selection and Management Policy GLOIT-G5.1-SOP001 Outsourcing Management 9.0 Supporting documents 9.1 SD018844 - Global Supplier Management Process Guideline 9.2 SD018845 - Supplier Quality Questionnaire Template A 9.3 SD018846 - Supplier Quality Questionnaire Template B 9.4 SD018847 - Global Supplier Quality Management Tools 10.0 Version control record Version Effective Date Author Updates Minor revision with focus on: Reckitt Vendor Quality Manuals and Governance Variance Form incorporation. QualityOne documents reference update. Moving document previously listed as appendixes into Monika Support Document format. 3.0 February 2024 Garlinska Addition of new Support Document - SD018847 Global Supplier Quality Management Tools. Removal of references for D8391720 and GRD2.PD.SOP.02 as documents are not available. Addition of reference of Paper and Board Certification Requirements SOP011485. For previous version history, please refer to the Document History revision reason on QualityOne – document code SOP012135 (D8333716). Thank you very much for reading this document, if you have any comments or wish to leave feedback about this document please email: [email protected]. For an overview of the Global QMS, refer to Reckitt Quality Manual (POL000103). 15 This copy of the document was retrieved from the system by Loewe Lou on 11 Sep 2024. This copy is considered valid on the day of printing only. | Page: 16