P&G验厂咨询-宝洁供应商品質验厂保証关键要素
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发布时间: 2025-05-22
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| 1 | Leadership.領導階層 Leadership demonstrates a commitment to the establishment and maintenance of a quality culture within each site and the organization as a whole. They set clear operating standards for site activities and ensure that these standards are communicated to individuals and reinforced through personal example, defined responsibility and clear accountability. Leadership ensures that the organization is designed and developed to deliver the consumer and customer expectations in terms of product and package development, execution and delivery. 領導階層應該制定一個可供每個部門以及整個組織遵守的質量文化的承諾書。他們為每個部門的活動給出明確的操作標準並保証這些標準每個個體都以身作則地去遵守，以做到權責分明。領導階層需要確保該組織是由有設計能力的員工根據產品和包裝的發展，執行，發送來發布消費者滿意的高質量產品。 |
| 1.1 | Leadership ensures that the organization is designed, staffed and capable of delivering intended quality products, data and results. Leadership is accountable for quality results and quality assurance systems. 領導階層需要確保該組織是有設計能力的員工來發布高質量的產品，數據以及結果。領導階層需要對質量結果和質量保障系統負責。 |
| 1.1.1 | Leadership considers physical design, product complexity, process capability, initiative load and organization capability in the design of the system and organization to deliver key element requirements. The leadership ensures that there are enough qualified individuals available to perform the required tasks for specific operations.領導階層應該將結構設計，產品復雜性，加工能力，主動承擔性，組織能力綜合考慮來發布重要標準。領導階層應該確保有足夠有資格的人員來履行特殊標準要求的任務。 |
| 1.1.2 | The tasks and responsibilities are defined, documented and clearly communicated to affected individuals. 任務和職責應該明確，有文件記錄並讓每個相關的人員都清楚自己的任務和職責。 |
| 1.1.3 | There will be a Quality Assurance function with a defined leader that has the final responsibility for product/material release decisions and for the review and approval of Quality Assurance Systems. QA will be independent from the manufacturing, research/development and logistics operations. 需要有一個質量保証的職能部門以及一個 對物料/產品放行以及對產品質量保証系統進行審核批準的最終負責人。QA應該獨立於其他職能部門，如生產，研發及後勤物流。 |
| 1.1.4 | Leadership assures that Quality responsibilities are clearly communicated and allocated to trained and qualified individuals.領導階層應該確保質量責任能夠清楚地落實到相關受過專業培訓有資格的人員身上。 |
| 1.1.5 | The leadership team is structured so that QA can influence the direction and decisions of the organization. 領導階層的結構設置應該讓 QA能夠影響整個組織的行動方向和決定。 |
| 1.1.6 | Leadership understands, develops and supports proactive quality management, and leads by personal example.領導階層應該了解支持質量管理並以身作則。 |
| 1.1.7 | Leadership ensures that operations comply with relevant product, Company, certification and regulatory requirements.領導階層應確保操作與相關產品，証書和規章要求相符合。 |
| 1.1.8 | Leadership encourages simplification, standardization and reapplication of benchmark systems across the site.領導階層應該鼓勵標準系統的簡化，標準化以及再運用。 |
| 1.1.9 | Leadership is personally involved in the quality program, fully aware of results and system effectiveness, supports resolution of quality issues and provides resources. (For ISO certification, there must be documented management reviews.)領導階層應該親自參與質量管理體系，充分意識到結果和系統的有效性，支持質量問題的改善解決並提供必要的資源，（對於ISO証書，必須有管理審查之類的文件記錄。） |
| 1.1.10 | Leadership ensures that organization, department and individual responsibilities and actions for delivering a quality product are clearly defined. 領導階層應該確保組織，部門，個人對每個高質量產品的發送各司其責。 |
| 1.1.11 | Leadership has responsibility to influence other functions and companies to ensure site deficiencies are resolved.領導階層有責任去影響其他職能部門和公司來確保各方面的缺陷得以解決。 |
| 1.1.12 | Leadership has responsibility to ensure that initiatives and changes to current operations maintain compliance with technical standards, Company and regulatory requirements. See Policy 1 and SOP 1 for compliance to Company requirements.領導階層有責任確保對當前操作的變更需與技術標準，公司規章要求相符合。請參考Policy 1& SOP 1. |
| 1.2 | Leadership uses a written statement to establish a commitment to quality and continuous improvement (e.g. mission and vision, OGSM’s). They define, in measurable terms, the quality objectives, together with the means and methods to achieve these goals.領導階層應該以書面的形式建立一份 質量及不斷改進的承諾書（任務，版本...）,並且以可衡量的固定條款來規定質量目標以及達到這些目標的方法措施。 |
| 1.2.1 | There is a clearly defined process for communication of quality objectives to ensure individuals understand their role in meeting these objectives and the development of quality systems. The individual line organizations are responsible for the implementation and effectiveness of the quality systems.需要有一個權責明確的程序來確保每個人都清楚自己對於質量達標以及質量系統完善方面所承擔的職責。每個人都對質量系統的實施和有效性負責。 |
| 1.2.2 | Leadership ensures that Quality Assurance gaps are acted on promptly, responsibilities are defined, investigation extends down to the root cause, and corrections are both preventative and systemic to avoid repeated or similar problems.領導階層應確保質量問題很快得到處理，質量問題責任明確，質量問題的調查應該追溯到根本原因，改善措施應該包括預防措施以避免類似問題重復發生。 |
| 1.3 | Systems, sponsored by leadership, are in place to reward/recognize improvements to the quality assurance systems or quality results.應該建立一個由領導階層讚助的系統來獎勵那些對改善質量保障系統或質量結果做出貢獻的人員或團體。 |
| 1.3.1 | Individuals are rewarded for their contribution to QA and held accountable for their quality responsibilities.如果個人對自己所負責的質量問題有突出貢獻應該予以獎勵。 |
| 1.3.2 | These systems encourage broad participation and continual improvement.這些系統可以鼓勵員工廣泛的參與以及產品質量的持續改進。 |
| 2 | Training. 培訓 Training and qualification is an investment in both the individual and the business. The development of the knowledge and skills of the workforce is a critical part of continuous improvement and helps reduce error and waste. 培訓和資格認定應該作為對個人和公司的一筆投資。勞動力的知識和技能的改進是促進持續改善，幫助減少錯誤損失的一個重要因素。 |
| 2.1 | A training plan is prepared for those individuals in roles affecting product design, quality or data that ensures their ability to carry out their assigned tasks. 應該制定一份培訓計劃來培訓和產品設計，質量或數據相關的人員確保他們有能力完成各自的工作。 |
| 2.1.1 | Roles have a clear definition of the skills and knowledge required, including QA specific training as required for the role.各個工位應該要求有相應的技能和知識才可以上崗，包括QA方面的特殊培訓。 |
| 2.1.2 | There is a defined program for new employees and transferees that states Company expectations and provides an introduction to the workplace. This program includes an introduction to principles of QA and all applicable regulations. 對於新員工和新調任者，應該建立一份明確的文件讓他們了解他們的工作場所以及公司對他們工作的期望值 。這份文件應包括對QA工作原則和所有其他應用規章制度的介紹。 |
| 2.1.3 | Personnel, including new employees, transferees, managers, temporaries and on-site contractor personnel, have a training plan that ensures individuals gain the required skills and knowledge of tasks including QA systems, associated with their role (e.g. policies, SOPs, regulations).應該對所有人員包括新進員工，調任者，經理，臨時工和現場承包人制定一個 相應的培訓計劃，使他們具備在各自工作中所要求的知識和技能，包括QA系統。 |
| 2.1.4 | As part of their training, personnel are made aware of quality defects/failures/losses/risks which may occur from the improper performance of their specific jobs.作為培訓的一部分，應該讓所有員工了解在各自不同的特殊工作如果由於不恰當操作可能會引起的質量缺陷和風險。 |
| 2.2 | Training courses have designated owners and defined qualification processes. 培訓課程應該有指定的人員或機構進行培訓並有明確的資格審查過程。 |
| 2.2.1 | Owners are responsible to ensure that course content is documented, relevant, sufficient and effective. 培訓人有責任確保培訓內容與參加培訓人員的工作相關，培訓內容充分有效並有文件記錄。 |
| 2.2.2 | Training courses remain consistent with current policies, procedures and regulatory requirements.培訓內容應始終與當前政策，程序和各種規章制度的要求一致。 |
| 2.2.3 | Trainers are knowledgeable in the subject being trained. Trainers are designated by way of qualification, proven expertise or education.對於培訓項目，培訓人在這方面應該知識淵博。培訓人應該經過資格審查，確定其具備相關專業技能和教育背景。 |
| 2.2.4 | There is a defined qualification process that is relevant to the topic being trained (e.g. on-the-job assessment or written tests for manual tasks.)應該有一個與培訓主題相關的資格審查過程，如在職評估或手工任務的書面測驗。 |
| 2.2.5 | Courses have individuals authorized to perform qualifications. These individuals are experienced and designated.培訓課程應由經驗豐富的指定授權人員進行資格審查。 |
| 2.3 | There is a system capable of demonstrating the current level of training and qualification in the organization.組織中需要有一個完善的系統來展示當前培訓以及資格審查的狀態水平。 |
| 2.3.1 | There is a tracking system to assure individuals are qualified to perform tasks and to identify training gaps for resolution, whether individual, organizational or instructional in nature . 應該有一個追蹤系統來確保個人亦能力完成各自的任務並 |
| 2.3.2 | Training records contain enough detail (e.g. subject, trainer and trainee names, dates of training and results of qualification) to identify qualified operators to perform tasks. 培訓記錄應盡可能詳細，包括培訓課題，培訓人，參加培訓人員姓名，培訓數據以及資格審查結果，這樣有利於挑選合格的人員完成相關的工作。 |
| 2.3.3 | Records of training and qualification are maintained for the full employment time of employees and archived after employment ends. 培訓記錄以及資格審查過程應該在員工在職期間一直維持存檔。 |
| 2.3.4 | Trained and qualified personnel can perform tasks independently. Unqualified personnel are supervised by someone experienced and qualified in the task.受過培訓的合格人員可以獨立完成任務，而不合格人員應該在有經驗的合格人員的監督下完成任務。 |
| 2.3.5 | A system is in place that ensures personnel maintain their qualification status (e.g. assessment and follow-up refresher training or periodic requalification) to include relevant QA skills and topics應該有一個系統來確保個人的資格審查狀況得以維持（評估及後續的進修培訓，定期的資格審查），其中也包括相關的QA技能課題。 |
| 3 | Buildings, Facilities, Equipment Design and Installation. 建築，設施，設備設計及安裝 Buildings, facilities, equipment, and computer systems are designed, constructed and installed to perform their required function if they are to develop or deliver quality products, free from contamination or adulteration and in compliance with all regulations. The design and installation facilitates efficient business operations, and minimizes the risks of errors in the operation/initiative/project. QA reviews the designs. 建築，設施，設備和計算機系統如果是用於開發高質量的產品，它們就應該設計安裝到位使其具備應有的功能，並且應使其遠離污染及摻假來符合所有的規章制度。這些設計安裝應有助於推動公司的有效運作，將運作中的錯誤引起的風險降到最低。QA 來審核這些設計。 |
| 3.1 | There is a system to ensure QA input to the design process.需要建立一個系統確保將質量保障輸入到設計過程。 |
| 3.1.1 | The project leader is accountable for ensuring that QA requirements are met (such as design requirements and objectives being defined, evidence of requirements, standards and objectives being met, reviews including QA and additional qualified resources). 項目組長對於QA的所有要求是否達到負責。（如設計要求和目標定義明確，這些標準目標是否達到，審核包括 QA和其他有資格的部門。 |
| 3.1.2 | Where specific design standards exist, these are followed with deviations explained and documented as part of the design records.在特殊明確的設計標準存在時，如果需要變動設計標準需要有變動理由和相關的變更設計記錄。 |
| 3.1.3 | The final approval process for equipment, data systems or facility projects affecting product design, quality or data includes approval from QA as well as a qualified resource with expertise in the area affected.對影響產品設計，質量/數據的設備，數據系統或設施項目的最終批準過程需要QA和其他相關部門的審核通過。 |
| 3.2 | The flow of personnel, materials and processes is logical and efficient.人員，物料以及各個過程的流程應該合理有效。 |
| 3.2.1 | There is a logical flow of materials through the operation. Where design does not eliminate the possibility of errors, there is a system in place to minimize the risk of material mix-up.應該保証操作過程中的物料流通合理。如果設計無法消除可能的錯誤，就應該有一個系統來將物料混淆的風險降到最低。 |
| 3.2.2 | The facilities and equipment are designed, constructed and located to suit the functions, products and processes for which they are intended and to prevent risk of errors such as contamination, mix-ups or adulteration. 機器設備設計安裝應該使其具備相應的功能，可以防止污染，混淆，摻假之類的錯誤帶來的風險。 |
| 3.2.3 | There is space for storage of ingredients, packing materials, in-process materials, bulk product, information, and finished products. Facilities are designed, monitored and controlled to provide the necessary conditions.應有足夠的空間儲存原料，包裝材料，制程物料，半成品，信息及成品。相關設施設計，監測應該得到控制以提供必要的條件。 |
| 3.2.4 | The water systems are designed, constructed and maintained to deliver water consistently meeting the approved specification or standard at the point of use. The design includes sampling points that can be used to prove that the water quality meets the specification or standard.水源系統應該設計維護合理以滿足通用標準的用水要求，設計應包括水質達到特定的標準。 |
| 3.2.5 | útility systems (e.g. steam, HVAC, compressed air, etc.) are designed, constructed and maintained to deliver outputs consistent with product and operational requirements公共系統（蒸氣，暖風，壓縮空氣系統等）應該設計維護好以滿足產品和操作要求。 |
| 3.2.6 | Pilot or learning plants are designed with 1) sampling/data collection points and 2) a known scale up factor to assure consistency with the full-scale operations. |
| 3.2.7 | Approved paths for personnel and truck traffic are designed to prevent interference with the sensitive operational areas.允許人員和貨物的流動通道 應該設計合理防止敏感操作區域受到幹擾。 |
| 3.2.8 | The facility is designed with sufficient space and segregation to minimize the risk of mix-ups, inadvertent shipment and contamination.應該設計有足夠的空間和隔離區域來將物料混淆，裝運疏忽以及污染的風險減到最低。 |
| 3.2.9 | Break areas, washrooms, hand wash stations and locker rooms are adequate for the staffing and type of operation. 應有足夠的休息室，洗手間，衣帽間供員工使用。 |
| 3.2.10 | Access to facility is controlled (e.g. fence, electronic controls, locked doors). Access to sensitive areas or operations is further restricted (as required by regulation/policy or as needed to prevent tampering, adulteration, contamination and theft).設施準入應該加以控制（如防護圍牆，電子控制，密室）。而對於敏感區域以及操作的準入更應該加強控制（如法規政策要求和防止污染，摻假，偷盜所需要的那樣） |
| 3.3 | There is separation of different parts of the operation to prevent cross-contamination and mix-ups between areas.不同操作中的零部件應該分開放置以避免交叉污染和混淆。 |
| 3.3.1 | The design of the premises allows for the separation of different functions as required to prevent contamination and mix-up (e.g. storage, making, packing, testing, maintenance, employee breakroom & washroom facilities)不同功能區域的隔離設計應該可以防止污染和混淆。(倉庫，產線，包裝，測試，維護，員工休息室和洗手間等區域） |
| 3.3.2 | Areas provide separation of different products and operations. Equipment is spaced to avoid congestion, allow for a logical flow of materials and prevent cross contamination, product or packaging mix-ups. 不同產品和操作區域應有隔離空間，這樣可以避免擁堵保証物料的流通，防止交叉污染和產品，包裝的混淆。 |
| 3.3.3 | Space is provided around and beneath equipment to allow efficient operation, maintenance, housekeeping, cleaning and sanitization. 設備周圍應有足夠的空間可以供操作有效進行，設備得到維護清掃保持衛生。 |
| 3.3.4 | The design includes protection for the product stream from contamination or adulteration.設計理念應包括使產品受到保護以免被污染或摻假。 |
| 3.3.5 | In the case of the manufacture or use of sensitizing, toxic or biological materials, the area layout, material/personnel flow and airflows to and from areas/equipment must be controlled to prevent contamination to all other areas. 如有涉及到光敏處理，有毒或生化物料的使用生產，應保証這些物料的放置區域的布局合理以防止對其他區域的污染。 |
| 3.3.6 | Where separate sampling facilities are required, the facility design minimizes the risks of contamination of the material being sampled or contamination of the sample. 取樣設備的設計也要按要求隔離，這樣可以將取樣的物料以及樣品可能受到的污染降到最低。 |
| 3.3.7 | Space and equipment are provided for cleaning, sanitization and storage of ancillary containers, tools, hoses and mobile equipment. 應該提供足夠的空間和設備來做好清潔工作以及其他輔助工具，軟管，移動設備的存儲。 |
| 3.3.8 | Where the nature of the work can be impacted by the surroundings (e.g. laboratories, sensory test areas, data centers, etc.) facility and equipment design includes defined segregation/isolation measures, proven to minimize the effect of the surroundings on the work.環境會對工作的性質產生影響（如實驗室，感官測試區域，數據中心等），所以各種設施設備的設計應有明確的隔離措施來將環境對工作的不良影響降到最低。 |
| 3.3.9 | Break, smoking, washing and toilet facilities are easily accessible but separated from the operational areas. 休息間，吸煙區，洗手間等設施應該盡可能的方便員工但也應與工作區域隔開。 |
| 3.4 | Buildings, facilities and equipment are designed for ease of cleaning and where required, sanitization.房子，設備機器應設計安排在合理的地方便於清潔維護。 |
| 3.4.1 | The principles of clean design are used in specifying and constructing new and modified facilities or equipment. Businesses will set design standards and have QA approval.清潔設計的原則應用於列明以及構建新設備的過程中，公司制定這些設計標準並要讓QA通過。 |
| 3.4.2 | For existing facilities where clean design has not been addressed, controls to prevent contamination are in place. An action plan is created to get the facility upgraded to the standards defined by the business.對現有的設施若還沒有制定清潔設計標準，防止污染的控制措施應該有。應該建立一個行動計劃使這些設施升級以達到公司標準。 |
| 3.4.3 | The materials used in the construction of facilities are durable, easily cleanable and do not become a source of contamination.用於設施建設的材料應該持久耐用，容易清理，不會污染環境。 |
| 3.4.4 | Surfaces are easily cleanable and constructed so as to minimize trapping of dirt or residual product. Joints between the floor and the wall are smooth and cleanable. Ceilings are free of objectionable clutter and accessible for cleaning. 設施表面應易於清掃，設計合理以減少臟物和殘留物的產生。地板和牆結合的地方平滑易於清掃。天花板也要易於清理使其遠離臟物。 |
| 3.4.5 | Surfaces coming into contact with the product are constructed of materials which are known to be non-reactive, non-additive, and non-absorptive to the product. External finishes of equipment minimize risks of contamination.與 產品表面接觸的材料應該無電抗性，無添加劑，無吸引力。設備的外觀顏色應將對產品的污染風險降到最低。 |
| 3.4.6 | Lighting and ventilation systems are designed and located to allow ease of cleaning and to prevent contamination resulting from failure of the system (e.g. shatterproof light bulbs, appropriate mesh screens or filters).照明和通風系統應該設計安裝合理便於打掃清潔以防止系統失靈帶來的污染（如電燈泡...） |
| 3.5 | The buildings, equipment and facilities are designed to provide protection from the environment (e.g. pests, dust, etc) and provide the internal conditions required. 房子，設備機器應設計安排妥當以便可以抵御外界環境的侵害（有害物，灰塵等…）並且可以提供所需要的內部條件。 |
| 3.5.1 | Points of entry into the building are designed to prevent the entry of environmental contamination and pests. The design and operation of the loading docks protects the facility, materials, processes and finished products from the environment and pests during loading and unloading. Openings and screens in walls and doors for ventilation purposes must be designed and located such that they exclude pests and do not allow contamination of the process.建築設計合理以防止外界環境污染和害蟲侵害，裝運碼頭的設計操作應確保設施，物料，成品在裝載卸載的過程中免受外界環境和害蟲侵害。門牆上通風的孔也應設計布置合理防止外界環境和害蟲侵害。 |
| 3.5.2 | Sites where product is manufactured or where materials, intermediates and finished product are stored, must be able to demonstrate effective barriers and/or control systems to prevent pest entry or harborage (e.g. cleared zone of approx. 1 meter around the building, sealed building). 產線，物料，半成品，成品的存儲場所必須有防護牆，這樣可以阻止害蟲侵擾。 |
| 3.5.3 | Ventilation systems comply with the requirements of the product, package or operation. 通風系統的設置應該考慮產品，包裝以及操作的要求並與之符合。 |
| 3.5.4 | Tank connections are designed to be protected from contamination and inadvertent misconnection (e.g. hoses with caps, off-the-ground storage).管道連接的設計合理以抵御侵害。 |
| 3.5.5 | Where the control of environmental factors (for example temperature, ventilation and humidity) is critical to the quality of product or data, there is a system to monitor and control these conditions where they are not assured by design. Where room conditions are affected by employee access (such as in the case of certain laboratories, sample retention rooms and stability rooms), access is restricted to assure the necessary conditions are maintained.因環境因素（如溫度，通風性，濕度）的控制對產品質量或數據準確性非常重要，所以應有一個 系統來監測這些因素。因人員流動對室內條件有影響，所以應對人員流動有一個限制來確保實驗室，樣品室的必要條件得以保障。 |
| 3.6 | Data centers, infrastructure, facilities, and equipment used for computer systems are designed and constructed to ensure proper system development, testing and deployment, good systems management, compliance with applicable laws and compliance with Company Policies and Guidelines on System Development/Security (e.g. Auditnet IT CSA Matrix).用於計算機操作的數據中心，基礎構造以及設備應該設計合理確保適當的系統發展，試驗及部署。良好的系統管理要符合相關的法律以及公司的政策和指導方針。 |
| 3.6.1 | Users are properly involved in the planning, development, testing and acceptance of the system.系統使用者應該參與系統地策劃，發展，測試和系統最後被採用的整個過程中。 |
| 3.6.2 | Where government regulations require user authentication, computer system designs incorporate functionalities and records necessary to comply.若政府法規對用戶証明有要求，計算機系統設計的功能一體化和相關記錄應與法規相符合。 |
| 3.6.3 | The design of information and control systems includes an analysis of user and process needs including data storage capacities, data handling rates, numbers of concurrent users and required hardware capacities (process capabilities, memory, disk sizes and types, etc.)信息和控制系統的設計應包括用戶和過程需求的分析，如對數據存儲能力，數據處理率，當前用戶數量，所需硬件容量（處理能力，存儲器，磁盤大小及類型等） |
| 3.6.4 | Information and control systems handling critical or sensitive data must have protected access control. The level of access must be defined for each individual.對重要敏感數據的處理，必須有一個控制準入系統保護信息和控制系統，而這些要讓每個使用者都清楚了解。 |
| 3.7 | Normal operating standards are maintained during construction and modification to facilities, equipment and utilities.正常的操作標準在機器設備的構建及修正中應該得到維護。 |
| 3.7.1 | The change control system ensures that temporary modifications of the facility are documented and approved by QA.控制系統的變更應確保設施暫時的更改有文件記錄並得到QA的批準。 |
| 3.7.2 | Temporary modifications are constructed and checked frequently to prevent contamination or adulteration to the product.暫時的變更也要經常檢查防止產品受到污染或被摻假。 |
| 3.7.3 | Sampling devices, data monitoring systems and sensors are designed, constructed and installed to ensure data integrity and avoid product contamination & adulteration.取樣設備，數據監測系統的設計安裝要確保數據的完整性，避免產品受到污染或被摻假。 |
| 3.7.4 | Systems ensure that necessary precautions are taken to protect the operation during modifications, alterations, installations, or excavation/site clearance of facilities, equipment and utilities (e.g. physical separation or shutdown of operation).應該有一個系統來確保在設備設施的更改，安裝或清潔的過程中，有必要的防御措施來保障其操作的安全性。（如自然分隔操作中斷） |
| 4 | Technical Standards & Product Design.技術標準&產品設計 Technical standards are approved and in place to define relevant requirements for the life cycle of products throughout the supply chain including development, receiving, making, packing and shipping. This key element covers both written and physical standards.在產品供應鏈中（開發，接收，生產，包裝，運輸過程）應有技術標準來規定產品的使用壽命。這個重要技術標準應包括書面標準及物量標準。 |
| 4.1 | Product Design & Development follows an established work process with reviews planned at established intervals (e.g. phases, gates, etc.) that include QA and other qualified resources. 產品的設計開發需要遵循一套已制定的工作流程，中間不時地會有預計的審核（各階段等…）包括QA及其他有資格的部門。 |
| 4.1.1 | Design and Development Controls ensure that 設計和開發控制應確保 -Design input requirements are defined and evaluated for completeness. Requirements are based on the consideration of customer and consumer needs (to include complaints, returns, warranty repairs, quality incidents, etc) as well as supply chain capabilities. 設計輸入要求應詳細列明力求完整。這些要求應考慮客戶需求（包括客訴，退貨，保修， 質量事件等）和產品供應能力。 -Activities are planned to ensure key steps are defined and accomplished in the proper sequence.活動計劃可以 確保重要步驟得以完成。 -Development tools are applied as relevent (e.g. Design of Experiments, Transformation flowsheets, Quality Evolution Charts, FMECA, Risk Prioritization, Fault Tree Analysis). Risks are identified for intended use and foreseeable misuse.開發工具的應用可以識別誤用的風險。 -Product Design verification is completed to establish the adequacy of product design in meeting defined internal requirements such as defect rates, reliability, capacity, productivity, scrap, rework, material utilization, cost and special testing as relevant.產品設計驗証過程完善，保障產品設計能滿足內部要求，如缺陷率，可靠性，產能，報廢率，返工率，物料利用率，成本及相關的特殊測試。 -Product Design validation is completed to establish the adequacy of product design in meeting defined customer/consumer performance requirements and objectives (such as stability, compatibility, durability, reliability, effectiveness, preference, 產品設計確認過程完善，保障產品設計在實際的測試條件下能滿足客戶要求（如穩定性，兼容性，耐久性，可靠性,有效性,重量/尺寸等) case weight/dimensions, as relevent) when used as intended based on testing under actual conditions (e.g. as made, as packed, as shipped, as used) or simulated use. -Conclusions are based on reproducible, accurate testing and documented. 結論的得出應建立在可重復的精確測試上並有文件記錄。 -Key Decisions are made with the concurrence of the accountable functions along with their documented rationale or basis. 重大決定必須經過相關責任單位的同意並有文件記錄。 |
| 4.1.2 | Product design changes are controlled to ensure the adequacy (e.g. integrity, durability, compatibility, sufficiency, performance, accuracy) of design is maintained.控制產品設計適當性（完整性，耐久性，兼容性，充足性，準確性，性能）的設計變更應有記錄維持。 |
| 4.1.3 | Products designed externally use the same design criteria as products designed internally (e.g. Connect & Development, etc.). 產品的外觀設計與內在設計使用同樣的標準。 |
| 4.1.4 | Promotional items and gifts are selected according to an established process that ensure the design fits with P&G brand equity, meets legal requirements for the market intended and is compatible with the intended method of delivering product to the consumer (e.g. co-packing, distribution channel). 促銷產品和贈品的選擇應根據一個已確定的過程來保障設計符合寶潔公司的品牌理念，滿足特定市場的合法要求，並與產品到達消費者手上的方式一致。 |
| 4.1.5 | Expiration or "best before" dates and labeled storage condition statements are based on a stability-testing program. For drugs, stability data must be generated prior to market introduction.產品的過期時間和貯存條件必須在經過測試後列明。對於藥物之類的，在進入市場前更因如此。 |
| 4.2 | Written and approved Technical Standards define the requirements of material supply, production, customization and distribution to consistently deliver the product design.審核批準的書面技術標準應該規定原材料供應，生產，訂制以及分配需始終符合產品設計的要求. |
| 4.2.1 | There is a process to accurately translate product design into Technical Standards. Technical standards, which include formulas, materials, drawings, packaging standards and other specifications, are based on documented research and testing that is consumer/customer/process relevant and meets regulatory requirements. The basis for final technical standards will be documented (e.g. QEC, PCS, manufacturing standard, basis document, readiness reports, transformation flowsheets, compatibility/stability report). 需要有一個過程可以準確地將產品設計轉換成技術標準。技術標準（如公式，原料，圖紙，包裝標準和其他規范）應該建立在有文件記錄的研究和測試基礎上。最終確定的技術標準的根據應有文件記錄。（如QEC, PCS，生產標準，基礎文件，可讀性報告，轉化流程圖，兼容性/穩定性報告） |
| 4.2.2 | Standards are linked/cross-referenced, as necessary, to achieve document traceability, eliminate confusion and ensure compliance with all defined requirements and local regulations.技術標準之間應相互聯系，必要時可以使文件間實現可追溯性，消除混亂，保証其與所有相關要求法規相符合。 |
| 4.2.3 | Technical Standards are used to define internal process, material and product requirements which will ensure the consistent meeting of consumer/customer needs, process requirements and regulatory compliance (e.g. production standards are complete and accurate with no gaps or TBDs-to be determined). 技術標準用以約束內部過程，物料及產品使之始終滿足客戶需求並與相關法規符合。 |
| 4.2.4 | Technical Standards are written, approved (also by QA where required), and effectively deployed for raw and packaging materials, formulas, test methods, packaging procedures, making instructions and other specification or procedure necessary to make and ship product. There is a system to verify the accuracy of the information transferred from technical standards into site operating systems (e.g. control systems, reporting systems, SAP, RTCIS, etc).經 QA批準的技術標準應在原料，包裝物料，測試方法，包裝程序，制作說明書和其他規范方面有效的運用。應有一個 系統來確認技術標準轉換成操作系統的信息準確度。 |
| 4.2.5 | Standards control the stages of the product life cycle consistent with development of product knowledge. Production (including experimental production) will not commence without approved standards being available at the production site. Research is documented (e.g. lab notebooks, make & place, SMART) with controls consistent with the stage of development and consumer exposure.技術標準應使產品使用的各階段與產品發展趨勢相一致。沒有批準的技術標準生產就不能開始。產品研究也要與產品發展趨勢和消費趨勢相一致。 |
| 4.2.6 | The current, approved version of technical standards is in use. There is a system in place to control creation, review, approval and distribution of technical standards and ensure the distribution is consistent with corporate policy on the control of restricted and highly restricted information. This system controls changes, is validated and assures the most current, approved standard is delivered for use.當前使用的最新技術標準應是經過批準的。應有一個系統來管控技術標準的產生，審核，批準和發行並保証發行的標準符合公司政策，這個系統控制標準的變化使當前使用的技術標準是最新的，也是經過批準的。 |
| 4.2.7 | Technical standards (e.g. formula cards, process standards, packing standards, etc.) identify reportable process/product/package parameters (variables and attributes) and their specification targets/limits/criteria. This may include product/package testing or correlated process measures (critical quality-related process factors) considered part of quality control. The basis for these reportables is documented and linked to customer/consumer/regulatory requirements. 技術標準（如公式卡，制程標準，包裝標準等）可識別值得報告的過程，產品，包裝參數及它們的規范目標、限制、標準。這可能包括產品包裝測試或與質量控制相關的過程因素。這些東西都有文件記錄並與客戶需求及相關法規相符合。 |
| 4.2.8 | Any deviations from current standards must be documented and approved in compliance with P&G policy.對當前技術標準的任何改動都必須有文件記錄並經過批準，與公司政策相符合。 |
| 4.3 | Formula cards or equivalent technical standards which fully define the product are used to define the manufacture of intermediate, bulk and finished product.全面定義產品的公式卡片或同等的質量標準應該用於判定供應商是中間商，零售商還是成品生產商。 |
| 4.3.1 | There will be no manufacture (including EO or CQV) without approved product standards and all other relevant technical standards.沒有經過批準的產品技術標準就不能進行生產。 |
| 4.3.2 | These standards will fully comply with business unit requirements in format and content.這些標準無論在形式還是內容上都應完全符合公司的整體要求。 |
| 4.4 | Raw and packaging material specifications are used in the purchase, acceptance, storage and use of materials.原材料以及包裝規格應該用於材料的採購，接受，儲存和使用。 |
| 4.4.1 | Raw and packaging material specifications and standards will include relevant information as required to make consistent quality product including regulatory and functional characteristics as well as relevant storage, handling requirements. These must identify the specific parameters and criteria required to accept the materials for use.原料，包裝材料規格和標準應包括能夠始終生產高質量產品的相關信息。這些必須可以識別特殊參數以及特定標準，保証物料可以使用。 |
| 4.4.2 | There is a system to link specifications to approved production locations (not just Company name, distributor, broker, etc.) for all raw and packaging materials.對於所有的原料，包裝材料，應有一個 系統來使其規格與生產地點有聯系。（不僅僅是公司名稱，發行商…) |
| 4.5 | Artwork is approved and controlled as a technical standard. 包材應該按照技術標準核準控制。 |
| 4.5.1 | Labels and printed primary & secondary packaging materials (e.g. containing regulated content) must have a unique IPMS GCAS number as part of the printed text to allow for accurate identification.標貼以及一級，二級包裝材料需有一個通用的IPMS GCAS 數字印刷文本，這樣可以準確的進行識別。 |
| 4.5.2 | A process is in place to assure labeling for new products or changes in labeling for existing products is reviewed and approved as part of artwork approval. Artwork is reviewed prior to approval (e.g. color, registration, GTIN code (e.g. UPC, EAN), misalignment, text content accuracy). Approval must be specific to each country of sale.需要有一個 系統來審核批準所有的包裝材料，如新產品的標簽和現有產品的標簽變動。包裝物料經過批準前需經過審核。（如顏色， GTIN 碼）。產品銷售到不同的國家，批準程序應有所不同。 |
| 4.5.3 | There is a process in place to assure that the approved piece of art is linked to the correct product/package combination by its IPMS GCAS code. 應有一個程序來確保經過批準的包材可以通過IPMS GCAS 碼與找到正確的產品。 |
| 4.6 | Test methods are defined in technical standards for material/process/product/package characteristics/parameters.原材料，過程，產品，包裝特征/參數的測試方法應該按照技術標準來規定。 |
| 4.6.1 | Test methods are validated for intended use. They provide sufficient detail and clarity to assure they can be consistently executed. Where supplier, contractor or Compendial test methods are specified in technical standards, the method is documented and available. Alternative test methods are validated, available on site, proven to be equivalent and identified in a technical standard.測試方法在使用前經過驗証。測試方法應提供足夠的細節來確保他們被始終如一地執行。供應商，承包商的測試方法也應在技術標準中詳細列明，這些方法應有文件記錄。測試方法的改變必須經過現場驗証並被証明是同等有效的。 |
| 4.6.2 | Minimum sampling instructions and plans are documented. Sampling plans are based on valid statistical and scientific rationale to ensure adequacy for intended use and consistent with demonstrated capability of the process. Sampling plans include normal operating events (e.g. startups, changeovers, splices and lot changes).即使是最小的取樣指示計劃都要有文件記錄。取樣計劃必須建立在有效的科學統計原理基礎上，確保取樣的頻率並使之與整個過程的承受力相符合。取樣計劃包括普通的操作事件。 |
| 4.6.3 | Quality acceptance criteria for defect classification are controlled and clearly defined by specification descriptions, drawings, physical examples or photographs. Grading systems are fully described to differentiate grades. Target-Acceptable-Marginal-Unacceptable (TAMU) is one example of such a system. 缺陷分類的質量接受標準應按照規格描述，圖紙或圖片來進行控制。等級系統應充分利用。達標接受否則不接受可以作為一個 例子。 |
| 4.7 | Other standards and specifications used in the operation are controlled and linked. 操作中的其他標準規格也應該相互關聯並且按照技術標準核準控制。 |
| 4.7.1 | Relevant information on the warehousing, storage, handling, shipping and loading of products and materials will be contained in approved technical standards. 有關倉庫，產品物料的處理，運輸，裝載的相關信息應包含在經過批準的技術標準中。 |
| 4.7.2 | Manufacturing/process standards will contain sufficient process-related information to ensure consistent product quality (e.g. storage conditions, process parameters and limits, sampling requirements, control strategies, rework/reblend/recycle operations, etc.). 生產制程標準應包含足夠的制程信息來確保產品的質量。（存儲條件，過程參數/限制，取樣要求，控制策略，返工，循環操作等） |
| 4.7.3 | Packaging, assembly, customization, and manipulation operations will use approved packing standards. Packing standards and other relevant standards (e.g. manufacturing or process standards, approved supplier lists, test methods etc.) will contain sufficient information to ensure consistent quality packages. Packing standards will define all components which make up the final pack including product and any promotional items.包裝，裝配，訂制，操作應採用經過批準的包裝標準。包裝標準和其他相關標準應包含足夠的信息來確保包裝質量。包裝標準涉及包裝最終完成所需要的所有零部件。 |
| 4.7.4 | Quality acceptance criteria contains quality characteristics and acceptance criteria for making operations, in-process control checks, stability testing, receipt of bulk product, release for packing/shipping, etc. Sampling instructions are included for each section.質量接受標準包含在操作，制程控制檢驗，穩定性測試，散裝產品接收，包裝物料放行方面所涉及到的質量特性和接受標準。每個操作過程中都包含取樣指示。 |
| 4.7.5 | There is a system to approve the countries in which products and formulas may be made, sold or distributed (e.g. Approved Country-of-Sale matrix). 哪些國家可以生產，銷售產品，應有一個 系統來 審核批準。 |
| 4.7.6 | Physical reference standards (e.g. odor) must be controlled, identified, approved and available at the point of use, prior to the start of manufacture.產品生產前必須有一些參考標準來控制，識別，批準產品的使用。 |
| 5 | Written Procedures. 書面程序 Written procedures are in place for Quality Assurance systems and for processes that impact production, product development, artwork development and quality capability. In order to achieve consistency of product quality, work processes are reproducible. The key to achieving this reproducibility is well written and faithfully followed procedures. Systems are in place to ensure that only up-to-date procedures are in use.應建立影響生產，產品，包材的發展和質量的質量保證體系的書面程序。為了實現產品質量的一致性，工作流程是具備可重複性的。實現這種可重複性的關鍵是書面程序寫得很好並忠實地遵循程序。應有一個系統確保只有最新的程序在使用。 |
| 5.1 | A formalized system is in place to create, approve, distribute and periodically review SOPs - Standard Operating Procedures.應該建立一個正式的系統來創立，批準，發布並定期審核標準操作指導書。 |
| 5.1.1 | SOPs are written for mandatory work processes required by regulations, certifications, Company policy, business unit requirements or to assure quality.標準作業指導書應按照相關法規，証書，公司政策要求來編寫以確保質量。 |
| 5.1.2 | SOPs are consistent with regulations, Company policies-SOPs and technical standards. They provide guidance as necessary to correctly and reproducibly perform the required actions.標準作業指導書應與法規，公司政策和技術標準相符。他們為正確可重復地完成任務提供指導。 |
| 5.1.3 | SOPs present in the operational areas are in the local language of the work force and there are procedures that specify the format and content requirements and, where necessary, the process for translation from/to English. 操作區域的標準作業指導書應該是勞動者的母語，這樣他們可以明白操作步驟及要求，必要時可以翻譯成英語。 |
| 5.1.4 | Procedures are clear, unambiguous and reflect current practice. Where possible, SOPs describe or reference a complete system since many procedures rely on other procedures to be effective. Where procedures require records (e.g. line clearance, OOS, C&S, material acceptance), the record will be attached or referenced to the procedure to aid change control. 程序明確，毫不含糊並反映目前的做法。在可能的情況下，標準作業程序說明或參考一個完整的系統，因為許多程序依賴於其他程序是有效的。凡程序要求的記錄（如線清除， OOS狀態，C&S ，材料驗收） ，該記錄將附在或引用的程序，以幫助更改控制。 |
| 5.1.5 | Secondary procedures (e.g. One Point Lessons -OPL, Job Aids, Work Instructions) are approved by QA and included in change control systems when they contain information included in technical standards or SOPs or other quality critical content. 次要程序（例如，一點經驗教訓，工作輔助工具，工作說明）需經過QA批准，並列入改變控制系統中當它們包含的信息包括在技術標準或標準作業程序或其他質量的關鍵內容。 |
| 5.1.6 | SOPs must be approved by QA and controlled to ensure that only the effective version is in use. Any deviation from a written procedure will be recorded and justified. Quality Assurance approves any planned exception to a written procedure in advance.標準作業程序必須經QA批準和控制，以確保只有有效的版本在使用。任何偏離的書面程序，將記錄並說明理由。QA需提前批准書面程序以外任何例外情況 。 |
| 5.1.7 | Official copies (either electronic or hard copy) of SOPs are readily available to the people who need them.正式副本（無論是電子或硬拷貝）的標準作業程序，當需要它們時必須在那裡。 |
| 5.1.8 | SOP distribution and deployment systems have identified owners and include a controlled procedure to assure that official up-to-date copies are used. Systems ensure people using new and revised SOPs read them and training is provided, if necessary, as part of the SOP deployment process.標準作業程序分配和部署系統已確定所有者，包括控制程序，以確保官方最新副本在使用。系統確保人們使用新修訂的標準作業程序並提供培訓，如有必要，作為標準作業程序的部署過程。 |
| 5.1.9 | There is a system to define the review of SOPs to assure they are current. A master set of current and historical SOPs is securely maintained and used as the basis for change control and distribution. 有一個系統來確定審查標準作業程序，以確保它們是最新的。當前和以前的標準作業程序得到安全維護和使用為變更控制和分配基礎。 |
| 5.1.10 | New and modified SOPs are approved and trained prior to implementation.新增和修改的標準作業程序在實施前要經過批準，員工也受過這培訓。 |
| 6 | Validation and Change Control.驗證和變化控制 Validation is establishing documented evidence that a specific process will consistently produce a product or result meeting its pre-determined expectations, specifications and quality attributes. This includes manufacturing processes along with sub-processes such as 1) equipment, 2) cleaning and sanitization processes or methods, 3) control and information systems and software applications, 4) utilities such as water systems and 5) analytical instruments and methods. Validation consists of a master plan that defines processes and sub-processes requiring validation and properly approved protocols and reports for each validation. Change control systems ensure existing processes remain validated, and all changes are fully deployed through affected systems. 驗證是建立有記錄證據表明，特定的進程將不斷生產的產品達到預先確定的規格和質量屬性。這包括製造工藝與子過程，如1 ）設備， 2 ）清洗和消毒工藝或方法，規格和質量屬性，3 ）控制和信息系統及應用軟件， 4 ）實用程序，如供水系統和5 ）的分析手段和方法。屬性。驗證包括一個總體規劃，定義流程和子進程，需要確認和妥善批准議定書和報告的每個驗證。變更控制系統確保現有的程序仍然有效，所有的變化全面部署在受影響的系統中。 |
| 6.1 | Master plans are in place (e.g. site, project, initiative, system) that include written procedures for validation, and an index of required validations and references to validation documentation. 確認文件所需要的書面程序以及要求的確認索引，參考資料應該包括在確認文件的總體規劃中。 |
| 6.1.1 | Validation is done according to written plans, procedures and protocols. 驗證是根據書面計劃，程序和議定書完成的。 |
| 6.1.2 | Validations include the following elements, or their equivalent, as required: 認證包括以下內容，或相等的內容，要求如下： - a static check to establish documented evidence that equipment and systems are constructed and installed to meet the design intent靜態檢查，以確定證據的設備和系統的構造及安裝，以滿足設計意圖。 - dynamic checks to establish documented evidence that process equipment and systems operate as intended throughout expected operational ranges動態檢查，以確定該進程的文件證據，設備和系統運作在整個預期操作範圍內。 - documented evidence of the effectiveness and reproducibility of processes under actual production conditions. Where required by business units, validation or verification includes the demonstration of process capability, homogeneity or product stability. 證據的有效性和可重複性的過程實際生產條件。凡要求的業務單位，審定或核查包括演示過程能力，產品同質性或穩定性。 -evidence of operating condition at the time of validation in compliance with approved process standard (e.g. manufacturing standard, PCS, Centerline, etc.). 驗證符合標準的批准過程操作條件下的證據（例如製造標準，個人電腦，中線等） 。 |
| 6.1.3 | A list of equipment, processes, systems, and methods requiring validation is maintained, indicating the type of validation, status and tracking the completion of items vs. the plan. Examples of systems requiring validation are process water systems, making, packing, cleaning, sanitization, storage systems, test methods, inventory control, equipment, process control and data systems used to make product release decisions. This list is regularly reviewed.清單設備，工藝，系統和方法，需要保持驗證，表明驗證的類型，現狀和跟踪完成項目與計劃。實例系統需要驗證過程水系統，製作，包裝，清洗，消毒，儲存系統，測試方法，庫存控制，設備，過程控制和數據系統用來製造產品放行的決定。這份清單要定期審查。 |
| 6.1.4 | QA approves master plans and the individual protocols and reports. QA批准總體規劃，個人議定書和報告。 |
| 6.1.5 | Validations are conducted in either a Concurrent or Prospective manner. Retrospective validations are not acceptable. Older validations must be reviewed to ensure they are current and compliant to applicable regulations, Company policies and SOPs.驗證以並行或預期的方式進行。回顧性驗證是不能接受的。舊的認證必須進行審查，以確保它們是當前和符合適用的法規，公司的政策和標準作業程序。 |
| 6.1.6 | Critical parameters, sampling requirements and success criteria are established and documented in the validation protocol. These are based on, but not limited to, information contained in technical standards and initiative/project documents (such as product readiness reports). 關鍵參數，取樣的要求和成功標準建立和記錄在驗證議定書裡面。這些是基礎，但不僅限於其中所包含的技術標準和項目文件（如產品準備報告） 。 |
| 6.1.7 | Initiative delivery processes validate new or significantly changed processes, equipment, test methods and systems. 最初交付進程驗證新的或顯著變化過程，設備，測試方法和系統。 |
| 6.1.8 | New designs, processes or systems are approved for ongoing production based on a review and approval of validation data /results.新的設計，流程或系統應通過批準，這樣可以為正在進行的生產服務 。 |
| 6.1.9 | Where allowed by regulations, and when included in the approved protocol, product resulting from validation runs that meets specifications can be released for shipment. Special conditions for releasing product not produced by a validated process, such as additional sampling, positive release or co-release with R&D, are defined in the approved protocol.法規允許的情況下，當包括在批准議定書，產品經過驗證符合規格可出貨。特殊條件所產生的未經過審定的產品，如額外的採樣，積極釋放或共同發布的研發，應包括在批准議定書。 |
| 6.1.10 | Experimental Orders (E.O.) can be considered as part of the validation process providing they are conducted in a way that provides data necessary to validate changes to processes, equipment, test methods and systems before the changes are made permanent. Modifications to the process during the E.O. will negate the validation and require re-validation.實驗訂單可被視為部分驗證過程提供它們進行的方式，提供必要數據，以驗證修改過程，設備，測試方法和制度在變化被視為永久性前。E.O.修改過程將否定驗證並要求重新驗證。 |
| 6.1.11 | Cleaning and sanitization procedures are validated to ensure that they can consistently clean and sanitize the equipment/facilities to predetermined chemical or microbiological standards. For drug products and where required, removal of product by chemical assay for active ingredients or other hardest to remove component is necessary. For experimental operations, verification through testing of cleaning & sanitization is an acceptable alternative to full validation.清潔和消毒程序審定，以確保他們能夠始終如一的清潔和消毒設備/設施，以預先確定的化學或微生物標準。藥物產品在必要時，通過化學分析，活性成分或其他方法清除產品的有害部分是必要的。實驗操作，通過試驗驗證的清潔和消毒是可以接受的替代方案充分驗證。 |
| 6.1.12 | Test methods are validated before use against specific success criteria that are related to the intended use and requirements of the method. 試驗方法對使用與具體的成功標準相悖時，在使用前要經過驗證。 |
| 6.1.13 | Test Methods not requiring validation include:測試方法不需要的驗證包括 - Compendial methods, as long as the method is used for the specified purpose and is verified under actual conditions of use at each site. 概略方法，只要該方法是用於指定用途並在實際情況通過驗證都可以使用。 - Test methods where accuracy is primarily dependent on the calibration of the measuring device such as direct measurements of dimensions. 試驗方法的準確性，主要是依賴於校準的測量設備，如直接測量方面。 - Test methods that are simple observations, e.g. appearance, odor, color.測試方法通過簡單的觀察，例如：外觀，氣味，顏色 - Exploratory test methods used in early phases of product development (prior to consumer testing) when they are not a primary source of data to guide a development project.在早期階段的產品開發探索試驗中使用的方法（事先向消費者測試），當他們沒有一個主要的數據來源以指導開發項目。 The rationale for not validating a test method will be documented.沒有驗證測試方法的理由將被記錄在案。 |
| 6.2 | Approved validation plans, procedures, protocols and reports are consistent with the nature and scope of the project, detailing the specific success criteria and summarizing data that support the conclusions.批準通過的確認計劃，程序，協議以及報告應該與項目的本質范圍相一致，將特殊的成功標準詳細化並總結數據來支持最終的結論。 |
| 6.2.1 | Validation documentation includes the following types of records: 驗證文件包括下列類型的記錄： Instructions – documents that define expectations, such as planning documents, protocols, policies and SOPs.說明-文件確定的預期效果，如規劃文件，協議，政策和標準作業程序。 Events – documents that record or report events, such as test results, audit observations and equipment logs. 活動-文件，記錄或報告的活動，如測試結果，審計意見和設備的記錄。 Reviews – documents that analyze, evaluate or review, such as data summaries, qualification task reports, investigation reports and calculated results. 評審-文件，分析，評估或審查，如數據摘要，資格任務的報告，調查報告和計算結果。 Information – documents containing supportive information such as flowcharts, as-wired diagrams and glossaries.信息-文件，其中包含支持性信息，如流程圖，作為有線圖表和術語表。 |
| 6.2.2 | Validation follows an approved written protocol, including success criteria, the rationale for the sampling plans and the statistical techniques used to analyze the data. Protocols are written and approved prior to the validation.驗證遵循如下核准的書面協議，其中包括成功的標準，依據的抽樣計劃和統計方法來分析資料。書面議定書批准之前要經過驗證。 |
| 6.2.3 | Data from validation studies is fully and accurately documented and evaluated using relevant statistical techniques (e.g. comparative statistics such as T and F testing), including those that did not meet the success criteria.數據驗證的研究是全面，準確地記錄和評價，使用有關的統計技術（如比較統計數字如T和F檢驗） ，包括那些沒有達到成功的標準。 |
| 6.2.4 | Validation considers events and conditions that will be part of the ongoing operation of the process (e.g. changeovers, startups, splices, hopper fills, centerline ranges, material variants, cleaning & sanitization, recycle, rework, allowable equipment wear/buildup, seasonal changes, utility variations, etc.) that can affect product quality. Events and conditions that are included in validation must be documented for use in change control.審定認為事件和條件，將是目前的操作過程（如轉換，啟動， 接合，漏斗填滿，中線範圍，材料的變種，清潔和消毒，回收，再加工，允許設備磨損/建設，季節變化，公用設施變化等） ，可能會影響產品質量。包含在驗證中的事件和條件必須記載用於變更控制。 |
| 6.2.5 | A final summary report is written for each validation. This report includes the raw data, conclusions drawn from the data, a discussion of the results versus the acceptance criteria and recommendations. The validation report includes the process conditions used during the run and provides evidence of the effectiveness of the Process Control Strategy.最後的總結報告是針對每個驗證的。本報告包括原始數據，從數據得出的結論，討論的結果與接受的標準和建議。審定報告包括運行過程中使用的工藝條件，並提供證據的有效性，過程控制策略。 |
| 6.2.6 | Validation documents are kept as long as the process, analytical method, product, production system and/or procedure exists or according to the specific product/regulatory requirements or until it is changed and revalidated.驗證文件存放至它改變和重新生效，只要這個過程，分析方法，產品，生產系統和/或程序的存在。 |
| 6.3 | Change control systems exist to ensure existing processes remain validated, and changes are fully deployed through affected systems.改變當前的控制系統確保現在的過程依然有效， 變化必須在相關的系統裡充分實施。 |
| 6.3.1 | There is a documented change control procedure that specifies the process to be used and the approvals required (including QA), when changes to current products, systems, processes and procedures are required.應有一個 記載的變更控制程序，指定該進程使用和審批要求（包括質量）時，改變目前的產品，系統，流程和程序是必需的。 |
| 6.3.2 | The impact of changes to materials, product, processes, and personnel is evaluated by competent individuals prior to the implementation of the change. 材料，產品，流程和人員變化帶來的影響應在變化實施前進行評估。 |
| 6.3.3 | If the change is not consistent with the existing validation, a documented revalidation is conducted before the change can be implemented. The extent of revalidation needed is determined as part of the change control process. 如果改變不符合現有的審定，有文件證明的是前進行重新的變化能夠得到執行。重新確定部分的程度由部分變更控制過程決定。 |
| 6.3.4 | Change control procedures identify when testing to verify that the change does not affect an existing validation is required.修改控制程序確定測試時，驗證該變化不會影響現有的驗證是必要的。 |
| 6.3.5 | The review process together with decisions and revalidation requirements are documented.審查過程，決定和重新確認要求記錄在案。 |
| 6.3.6 | Changes are deployed through all affected systems (e.g. training, procedures, records, technical standards, process control strategies, etc.).變化部署在所有受影響的系統中（如培訓，程序，記錄，技術標準，過程控制戰略，等等） 。 |
| 6.4 | Computer system validation encompasses the entire system development life cycle from initiation through development, testing and production use to decommissioning which includes the operation of the hardware, software applications, data integrity, access, security and error detection. The systems used for storage, retrieval and back-up of data are validated for data transcription and data integrity.計算機系統確認包含整個系統發展的生命周期，從開始發展，測試，生產運用到發展結束，其中包括硬件，軟件應用，數據整合，數據接入，數據安全和錯誤偵察。這個系統用於數據記錄以及數據完整的儲存，修復和備份。 |
| 6.4.1 | Computer Validation protocols include performance testing of the following (as applicable) against defined success criteria: 計算機驗證協議包括性能測試如下（如適用）對界定成功的標準 - hardware and software functional capability硬件和軟件功能 - data integrity and security數據完整性和安全性 - error detection capabilities錯誤檢測能力 - information transfer systems completeness and accuracy 信息傳輸系統的完整性和準確性 - load capability and data volume 負載能力和數據量 - data back-up systems數據備份系統 - adherence of custom software to system design and source-coding standards加入自定義的軟件系統設計和源編碼標準 - error trapping designed to react to new or reconfigured hardware or software錯誤捕捉旨在應對新的或重新配置的硬件或軟件 - removal of "dead" code lines消除“死”代碼線 - names for sections of code or modules are consistent, logical and as defined by design SOP章節名稱或模塊的代碼是一致的，符合邏輯和所定義的標準作業程序 - security procedures in place to protect the data安全程序來保護數據 - passwords allow specified levels of access to the system密碼允許指定級別的訪問權限系統 - operations within the system are logged and data is available listing identity of operator, date & time of log-on, and files changed操作系統內的記錄和數據可記錄操作者，日期和時間的登錄和文件變化 - program files are accessible only to specified computer system administrators程序文件都可以只對特定的計算機系統管理員 - archived data files are protected from change (i.e., read only)存檔數據文件受到保護，不會變化（即只讀 - designated person(s) responsible for system control and security issue and record all passwords指定的人（縣） ，負責系統的控制和安全問題，並記錄所有的密碼 - access and input to databases should be strictly controlled獲取和輸入數據庫應嚴格控制 |
| 6.4.2 | A structural and functional analysis of a computer system to identify components and interrelations are performed to define the limits or boundaries of the system for validation, determine validation priorities and ensure validation of the entire system.結構和功能分析的計算機系統，對確定成分和相互執行界限的系統進行驗證，確定優先事項，並確保驗證驗證整個系統。 |
| 6.4.3 | The information transfer systems are validated to ensure that the information transcription is complete and accurate. Load capability and data volume analysis is carried out to confirm that storage disks and data buffers are large enough and transfer systems efficient enough to cope with the volume and rate of flow of information.信息傳輸系統的驗證，以確保信息的轉錄是完整和準確的。對負載能力和數據量進行分析，以確認和數據存儲的磁盤緩衝區足夠大並具備高效率的轉讓系統，來足以應付的大流量的信息流通。 |
| 6.4.4 | It is the responsibility of the users to establish the validity of software purchased off-the-shelf from a third party. Set up and operation of commercial software, including equations and macros used within, are validated for the intended use when used for purposes related to product quality.用戶有責任建立從第三方購買現貨軟件的合法系統。建立操作商業軟件，包括方程和宏內使用，使用相關質量產品的打算得到驗證。 |
| 7 | Housekeeping, Pest Control, Sanitization & Maintenance. 內務管理，蟲害控制，消毒和維護 Systems are in place to ensure areas within the site and external surroundings have a clean and orderly appearance, to avoid attracting pests, and to prevent contamination or mix-up of products and materials. Cleaning, sanitization, and maintenance of the equipment and premises is conducted to ensure product quality is maintained.應有一個系統，以確保地區內的網站和外部環境有一個清潔，有序的外觀，以避免吸引害蟲，並防止污染或混淆的產品和材料。清洗，消毒和維修設備以確保產品質量保持不變。 |
| 7.1 | General expectations are established for ownership and documentation of the results of included systems.對於所有系統的所有權和文件的結果應該有一個 預定的期望值. |
| 7.1.1 | Designated personnel are responsible for ensuring that housekeeping, pest control, cleaning/sanitization and maintenance are properly executed. 指定人員負責確保內務管理，蟲害控制，清潔/消毒和維修得到妥善執行。 |
| 7.1.2 | Regular documented inspections of the condition of the facility, grounds and equipment are carried out and preventive measures employed.條件設施，場地和設備的定期檢查需要記錄，預防性措施也要實施。 |
| 7.1.3 | Records are maintained to document in sufficient detail that necessary tasks have been performed.維持記錄文件以提供充足的詳細資料，必要的任務已經完成。 |
| 7.1.4 | Written procedures are in place to define system requirements.應有一個 書面程序來確定系統需求。 |
| 7.2 | Housekeeping systems and standards are in place to ensure areas have a clean and orderly appearance, and to minimize the risk of product contamination or mix-up.清潔系統以及標準應該建立以確保整個區域清潔有序，將產品交叉污染及混亂的風險降到最低。 |
| 7.2.1 | All parts of the premises are included in routine cleaning schedules and are maintained in a clean and orderly condition ( “a place for everything and everything in its place”). 所有地區都在例行清潔時間表，並保持清潔和有秩序的條件（ “一個地方的一切，一切都在自己的位置” ） |
| 7.2.2 | Spills are quickly and effectively removed to minimize the risk of further contamination of the premises or product. 洩漏事件迅速，有效地清除，以盡量減少進一步污染的場地或產品的風險。 |
| 7.2.3 | Sites will provide suitable washroom facilities. Hand wash reminder signs are posted in washrooms. 應提供合適的洗手間設施。洗手提醒標誌張貼在洗手間。 |
| 7.2.4 | Systems are in place to ensure ancillary equipment (e.g. scoops, buckets, and other portable containers) are maintained, cleaned and stored in a way that prevents contamination.應有一個系統以確保附屬設備（如鏟子，水桶，和其他的便攜式容器）的維護，清潔和儲存的方式要可以防止污染。 |
| 7.2.5 | Cleaning processes and materials are not a source of contamination. Cleaning equipment is maintained in good condition and is stored clean and dry after use.清洗工藝和材料的來源，沒有污染。清洗設備保持在良好的條件和儲存清潔乾燥後使用。 |
| 7.2.6 | Materials and equipment stored within the building are inspected and cleaned to reduce the potential of environmental contaminants.材料和設備存放在建築物內進行檢查和清理，以減少潛在的環境污染物。 |
| 7.2.7 | Areas have designated waste containers that are emptied and cleaned on a regular basis. If they contain materials that are a contamination risk (e.g. pest attractants, dust, etc.) they are covered. The refuse containers are located away from sensitive operations.有指定廢物容器排空廢物並定期清洗。如果這些場所有污染風險材料（如害蟲引誘物，灰塵等） ，它們就應有廢物容器並定期清洗。垃圾容器應位於遠離敏感區域的地方。 |
| 7.2.8 | Raw and packing material shipping containers can be used for waste disposal only if limited to single-use, all original labels are completely removed or obliterated, the container is cleaned and is clearly labeled as waste. Primary and secondary product containers (e.g. bottles, cartons, bags) or their shipping container cannot be used for any other purpose than intended. 原料和包裝材料的集裝箱可用於廢物處置僅限於單一的使用，所有原來的標籤是完全取消或抹殺，集裝箱清洗，並明確地標記為垃圾。初級和中級產品的容器（如玻璃瓶，紙箱，包裝袋）或其集裝箱不能用於任何其他目的。 |
| 7.2.9 | Scrap and obsolete materials are disposed of to minimize the risk of contamination, inadvertent use and misuse.廢料和廢棄材料的處置，以盡量減少無意中使用和濫用帶來污染的風險。 |
| 7.2.10 | Production, storage and other critical areas have standards that defines eating, drinking, and smoking restrictions to prevent the potential for product contamination. 生產，儲存和其他關鍵領域的標準，界定飲食，吸煙和限制，以防止潛在的產品污染。 |
| 7.3 | Equipment cleaning & required sanitization is performed to prevent product contamination.設備清潔以及必須的衛生應該做到位以防止產品污染。 |
| 7.3.1 | Production equipment has written, validated cleaning and sanitization procedures, detailing the concentration of cleaning and sanitization agents, method and duration of application and the frequency of application.生產設備書面確認清潔和消毒程序，詳細介紹了集中清理和衛生處理劑，方法和時間的應用和應用的頻率。 |
| 7.3.2 | Product contact surfaces are kept in a clean condition. For products susceptible to microbial contamination, equipment is sanitized before use. 產品接觸表面保持清潔的狀況。產品容易受到微生物污染，設備的消毒後才能使用。 |
| 7.3.3 | Cleaning and sanitization agents are reviewed and approved as effective for the intended use. Such chemicals are reviewed through a chemical clearance system to ensure they are safe for use at the particular location. Procedures for use, including verification of removal of cleaning and sanitizing agents, are documented in an SOP.清洗和消毒代理應經過審核並批准，能夠發揮有效的預定作用。這類化學品通過化學清關系統進行審查，以確保他們可以在特定的位置安全地使用。程序的使用，包括核查拆除清潔和消毒代理，都記錄在一個SOP中。 |
| 7.3.4 | Chemicals and cleaning materials are shown to be compatible with the equipment or surfaces to be cleaned, safe to use and not react with the product to prevent effective cleaning.化學品和清潔材料性質必須對設備或表面的清潔無害，使用安全並對產品沒有反應，以達到有效的清洗。 |
| 7.3.5 | Cleaning agents are properly labeled, isolated and stored under the required conditions and used within their shelf life.清潔劑得到妥善標記，隔離和儲存，在其有效期內使用。 |
| 7.3.6 | Chemicals are stored in a way that prevents improper use or inadvertent contact with the product stream. 化學品儲存的方式，避免使用不當或無意接觸。 |
| 7.3.7 | Sanitizers are rotated, as necessary, to prevent microbial adaptation.輪換消毒方式，如有必要，以防止微生物適應一直以來的方式。 |
| 7.3.8 | Cleaned equipment is dried prior to storage. Cleaned hoses are hung off the floor in a manner that allows remaining liquid to drain. Utensils, containers and other equipment are drained and dried before use and are stored to prevent contamination before re-use.清洗設備，存儲之前保持其乾燥。清洗軟管遠離地板讓剩餘的液體流幹。用具，容器和其他設備，在再重新使用前乾燥儲存以防止污染。 |
| 7.3.9 | Utensils and cleaning implements such as scrapers and brushes are approved for product contact. There is a system to clearly distinguish them from non-product-contact utensils.用具和清潔工具，如刮刀和刷子與產品接觸要經過批准。應有一個 系統來明確區分開來非產品可接觸的器皿。 |
| 7.3.10 | Where necessary to protect product, tissues or cloths used in the cleaning process are lint-free. Cleaning cloths are either disposed of or returned for washing when they become too soiled for use or at the end of the cleaning operation.需要保護的產品，紡織品或布所用的清潔過程是無紡布。清潔布洗滌用得過於髒或清理行動完成，清潔布應處理掉。 |
| 7.4 | Pest control systems are in place to prevent, control and monitor pest activity. 有害物控制系統應該建立防止，控制，監督有害活動。 |
| 7.4.1 | Local pest control system includes the following:當地蟲害控制系統包括以下內容： - A documented control procedure.有文件記錄的控制程序 - A plan of the site showing the locations of all pest control devices. These types devices are specified, located and installed in an effective manner.有一個 計劃顯示所有位置安裝蟲害控制裝置，這些類型的設備已指定，在一個有效的方式下安裝。 - Data on the use and operation of pesticides and control devices.數據的使用和殺蟲劑的運作和控制設備 - Details of the inspection and maintenance of all control devices.所有控制裝置的詳細檢查和維修 - Review of inspection data highlighting the risk areas of infestation.檢驗數據審查突出容易受侵擾的風險領域 - Recommendations for facility improvements to minimize infestation risks and prevent repeat infestation.建議改善設施，盡量減少蟲災風險和防止重複侵擾 - Timetable or plan for inspection and treatment. Inspections are documented to determine potential high-risk areas for proper follow-up.時間表或計劃的檢查和治療。檢查記錄，以確定潛在的高風險地區進行適當的後續行動。 |
| 7.4.2 | When licensed pest control contractors are used, the contracting site is responsible for monitoring the work of the contractor and the effectiveness of the program. Contractor reports include what was found and what actions were taken. The contracting site ensures that action is taken on all recommendations and actions implemented are documented.當使用持牌的蟲害控制承包商，承包商負責監測工作和程序的有效性。承包者報告包含發現什麼和採取什麼行動。承包商保證採取行動，對所有建議和行動實施都有文件記錄。 |
| 7.4.3 | The storage, consumption and disposal of food is managed to minimize the potential for contamination of product and attracting of pests.儲存，消費和處置食品的管理，盡量減少產品受污染的和吸引害蟲潛在的風險。 |
| 7.4.4 | Pest control devices are used in a way that do not attract pests into the facility.蟲害控制設備使用的方式應不能使其吸引害蟲。 |
| 7.4.5 | All pesticides have regulatory approval for their intended use and method of application. Preventive measures are employed to prevent contamination of products. Exterior doors (including dock doors) are not left open unless they are protected by effective insect/pest control devices (such as screens or other methods proven to provide a barrier to insect/pest entry).對於所有農藥其預定用途和方法的應用都應得到管理部門的批准。應採取預防措施來防止產品污染。外門（包括站台門）不能打開，除非有有效的昆蟲/蟲害控制設備保護它們（如屏幕或其他方式可以為昆蟲/病蟲害進入設置一個阻礙） 。 |
| 7.4.6 | Incoming and outgoing trucks and incoming materials are inspected to be sure they are free of pests. If pests are found, the truck is rejected or delivery is refused.進出的車輛和來料應進行檢查以確保他們都沒有攜帶害蟲。如果發現他們有攜帶害蟲，車輛和來料都不能進來。 |
| 7.4.7 | The UV bulbs in insect traps are replaced at least annually, preferably at the beginning of the insect season.易滋生昆蟲的紫外線燈泡至少每年更換一次，最好是在昆蟲開始泛濫的季節。 |
| 7.4.8 | Pest control devices are protected from damage. They are inspected regularly to determine the types of pests being caught and to ensure they still work.蟲害控制設備應受到保護免遭損壞。應對這些控制設備定期進行檢查，以確定捕捉害蟲的類，並確保設備仍然工作。 |
| 7.5 | Systems are in place for both planned and non-planned maintenance of facilities and equipment. These systems ensure facilities and equipment conditions necessary to achieve product quality requirements and system validations are maintained, and that product contamination is prevented.應該有系統來對機器設備進行有計劃或臨時的維護。這些系統可以確保機器設備性能良好來生產出高質量的產品。系統確認也應當得到維護，這樣產品污染就可以避免。 |
| 7.5.1 | Preventive maintenance procedures are written and require routine documented inspection and corrective actions of the facility, grounds and equipment. 預防性維護程序應有書面記錄，並要求定期更新設施，場地和設備的檢查和改正措施的記錄。 |
| 7.5.2 | Equipment leaks are permanently repaired and/ or contained in a way that prevents product contamination.設備漏水應一次性修好，防止產品受到污染。 |
| 7.5.3 | The use of temporary repair materials (i.e. tape, silicone sealant, wood) on equipment is not allowed. Repair materials used are compatible with the products manufactured or stored at the facility.使用臨時修補材料（如磁帶，矽酮密封膠，木材）修理設備是不允許的。使用的修復材料要符合產品的製造或貯存條件。 |
| 7.5.4 | There is a written procedure that specifies the equipment to be calibrated, frequency of calibration, calibration methods, tolerances/accuracy to be achieved and necessary documentation to be maintained. Calibration must cover the operating range of the equipment with an external reference and at a frequency appropriate to assure reliability and accuracy. Single point checks or equipment with internal checks can be used for routine verification. 應有一個書面程序，指定設備進行校準，校準頻率，校準方法，公差/準確性並將必要的文件予以保留 。校準應包括設備與外部的操作範圍並以適當的頻率進行以確保校準的可靠性和準確性。單點檢查或設備內部檢查可用於例行核查. |
| 7.5.5 | The weights and measures used for calibration are traceable to official government standards.用於校準的度量衡可追踪至官方標準。 |
| 7.5.6 | There is a system in place for approval and management of lubricants. The system defines where each can be used, which lubricants must be "food grade", and how lubricants are to be labeled and stored. Food grade lubricants are used in equipment where the lubricant could possibly come in contact with the product through leaks or spills. If non-food grade lubricants are also used, the two grades must be clearly distinguishable to prevent mix-ups.有一個系統對潤滑劑進行審批和管理。該制度規定，哪裡可以使用潤滑油，哪種潤滑油必須是“食品級” 的，以及如何將潤滑油標記和儲存。用於設備中的食品級潤滑油可通過泄漏接觸到產品。如果非食品級潤滑油也被使用，這兩種必須明確區分，以防止混淆。 |
| 7.5.7 | Equipment maintenance is performed according to established procedures and schedules. Maintenance work is documented. Records include the date the work was performed, who performed it, what was done and components replaced or materials used.設備維修完成需按照既定程序和時間表。維修工作應有文件記錄。記錄包括完成工作日期，誰執行它，做過什麼和零部件更換的零件或使用的材料。 |
| 7.5.8 | There are change control processes for approval of product-contact items such as adhesives, gaskets and hoses. Product contact materials cannot be substituted during maintenance without change control. 有變更控制流程審批可接觸產品的物品，如粘合劑，墊圈和軟管。在維修期間，如沒有變更控制，可接觸產品的物品不能隨意改變。 |
| 7.5.9 | There is a written procedure for returning equipment to service following maintenance, including removal of tools and parts and completion of cleaning/ sanitization. Where required these are verified by a second party.有一個書面程序可將設備退回得到下列維修服務，包括清除工具和零件和完成清潔/消毒。如有需要可讓第二方驗証。 |
| 7.5.10 | Maintenance activities are performed in a way that protects production and storage areas from contamination.維修活動應以一種適當的方式進行以保護生產和儲存的地區不會受到污染。 |
| 7.5.11 | Facilities are properly maintained. This includes:設施應得到適當的維修，包括： - Walls, roofs and ceilings are kept clean and free from leaks and chipped or peeling paint. 牆壁，屋頂和天花板都保持清潔，無漏水或剝離塗料 - A perimeter around the buildings is kept free of vegetation to discourage the presence of pests (excluding appropriately designed office areas). 周邊建築物保持無植被狀態，阻止害蟲侵擾（不包括設計恰當的辦公區） 。 - Grounds and roadways are properly maintained to prevent standing water. 地面和道路得到妥善保養，以防止積水 - Cracks/crevices/penetrations are sealed.裂紋/裂縫/穿透應密封好。 |
| 8 | Materials. 材料 Materials includes ingredients and components used to make, pack or ship products to customers and consumers whether purchased from other sites (typically suppliers providing raw ingredients, packing components or promotional items) or produced by internal operations (such as gas, steam, water, certain chemicals, etc). Materials must be controlled during research, qualification, receipt, storage, manufacture, transportation and disposal.材料包括用於製造的原料和部件，給客戶和消費者包裝的產品，不管這些東西是否從其他地方購買（通常是提供原料，包裝部件或促銷品供應商） ，或內部生產的（如煤氣，蒸汽，水，某些化學品等） 。材料必須在研究，資格審查，接收，儲存，生產，運輸和處置過程中加以控制。 |
| 8.1 | Materials used in research (e.g. experimentation, trial, studies or testing) are of acceptable quality with known characteristics so that learnings can be properly captured and results reproduced. Appropriate levels of materials evaluation/testing are adopted as they progress through the development process.用於研究，實驗，測試的材料應該具備出色的質量這樣可以得到最好的結果。材料評估的合適標準應該在其發展過程中逐步被採用。 |
| 8.1.1 | The identity of materials is clearly established so that learnings can be properly captured and reproduced. When a specification is available, there is testing data confirming the material complies with the requirements of the specification. When no specification exists, material characteristics (as typical for similar materials) are defined via test data. Test data may be sourced internally, or via contract lab or supplier analysis. 材料的性質應區分清楚這樣便於後續使用。當定規范存在時，必須有測試數據確保材料符合相關的規格要求。當沒有規范時，材料性質要通過測試數據來定義。測試數據可能來自內部，或與之簽定合同的實驗室或供應商的分析。 |
| 8.1.2 | Materials used in research are controlled to avoid contamination, expiration, or wrong use via proper containers, labels, storage, handling and dispensing practices. 研究中使用的材料應得到控制，以避免污染，過期或通過固有的集裝箱，標簽，儲存，處理和分配做法而導致錯誤使用。 |
| 8.1.3 | Research conducted is traceable via records to specific materials used (e.g. quantities, lot number, test data, specification, material name, etc)進行的研究可通過記錄追溯具體使用的材料（如數量，批號，測試數據，規格，材料名稱，等等） |
| 8.1.4 | R&D facilities that make, pack or ship products for consumer use comply with requirements of manufacturing facilities in the proper receipt, handling, storage, use and disposal of materials.製造，包裝或運輸產品的研發設施，要符合生產設施的適當接收，處理，儲存，使用和材料處置的要求。 |
| 8.2 | Material from each supplier location is properly evaluated under controlled conditions prior to use under normal process controls. The rigor of evaluation and approval is relative to the stage of use and pertinent regulation. 每個供應商的原材料在正常的過程控制下使用前都必須在控制條件下做適當的評估。評估以及批準通過的嚴格性與材料的使用階段和相關規章制度有關。 |
| 8.2.1 | Material Suppliers must be selected, qualified and approved using an established procedure for each supplier producing location. This includes defining materials needing qualification or those that can be excluded. Once qualified, significant changes to these materials, their supply chain or their application (e.g. suppliers, facilities, process conditions, material characteristics, ingredients, containers, labels, transportation, distributors and repackers, etc.) are evaluated and re-qualified prior to on-going use under normal controls. 材料供應商必須對每一個供應商按照既定程序進行選擇，確定合格才可以批准使用。這包括確定哪些材料合格或哪些可以被排除在外。一旦合格，對這些材料，他們的供應鏈或其應用（如供應商，設施，工藝條件，材料特性，材料，容器，標籤，運輸，分銷商和repackers等）要進行重大修改，在正常使用前都必須進行評估和重新認証是否合格。 |
| 8.2.2 | Materials for use in ongoing production are received from approved supplier-producing locations and used only for their intended use. Supplier location approval is documented. Approval is based on successful qualification demonstrating performance meeting success criteria. 正在進行生產所使用的材料來自被批準合格的供應商，這些材料僅用於其預定用途。供應商所在地批准有文件記錄。批准是基於成功的資格證明，証明其性能達到成功標準。 |
| 8.2.3 | Materials used as ingredients or packaging components in ongoing production are purchased according to an approved specification, with supplier agreement to comply. Supplier agreements are documented and updated with each change to the specification. 用作原料或包裝組件的材料是從經過批準的合格供應商那購買的，與供應商共同遵守的協議應有文件記錄並隨規格的改變而進行更新。 |
| 8.2.4 | Where supplier COA (e.g. Certificate of Analysis) is used in ongoing production as part of acceptance testing, the suppliers’ analysis data is verified (and periodically reverified) as equivalent to in-house testing. Suppliers requiring verification are defined along with the process of verification. The supplier COA provides evidence of full compliance to the specific version of the approved specification. 如果供應商的COA （如分析證書）在目前生產中使用並作為驗收測試的一部分，該供應商的分析數據驗證（並定期重新驗証 ）等同於內部測試。供應商要求的核查和核查進程一起列明。供應商的分析證書為批準通過的規格提供証據。 |
| 8.2.5 | All new packaging materials will have its artwork and barcode checked upon receipt versus the approved standard (e.g. e-Padex, CSS). 所有新的包裝材料都應有包材信息和條碼來檢查是否符合核定的標準，這樣才可以接收。（如電子Padex ，CSS ） 。 |
| 8.3 | There is a system in place to ensure suppliers consistently manufacture materials compliant to specifications and as qualified. Prior to receipt, materials are contained, labeled, handled, stored, distributed and shipped in a manner that avoids damage, mix-up, misuse, contamination or other forms of alteration (such as intentional tampering) to materials after their manufacture.需要建立一個 系統來確保供應商始終生產符合規格的原材料。在接收供應商的原材料之前，應確保原材料包裝，標簽，儲存，分發，運輸都以安全的方式進行以避免損壞，混淆，錯用，污染以及其他形式的破壞。 |
| 8.3.1 | There is a program to assess and improve quality assurance at supplier sites. This program defines which suppliers are included and the improvement objectives.應有一個計劃來評估和完善供應商的質量保證體系。這個計劃包括哪些供應商需要評估以及改進目標。 |
| 8.3.2 | The receiving location has evidence of quality assurance by the supplier for materials used as product ingredients or packaging components. Where issues are found on receipt, the receiving site will have a complaint system to ask suppliers to investigate, correct and prevent future occurrences. 接收地點有供應商提供的證據，証明作為產品成分或包裝組件的材料是有質量保證的。接收發現問題時，接收站點應有一個投訴制度，要求供應商進行調查，糾正和防止今後類似問題再次發生。 |
| 8.3.3 | Materials used as product ingredients or packaging components in ongoing production are labeled or accompanied by documentation defining the material's identity, the material reference code (e.g. GCAS-Global Code Allocation System) and a unique lot or batch number. 作為產品成分或包裝組件的材料應進行標記或以文件的方式定義材料性質，材料參考代碼（如GCAS全球代碼分配系統）和一個獨特的批號。 |
| 8.3.4 | Receiving practices confirm that materials containers and modes of shipment are such materials arrive fit for use. Reused containers (e.g. drums, trucks, tank cars, etc.) need to be properly cleaned prior to reuse. Containers or shipments are made tamper-proof or evident where possible. Truck inspections are documented (e.g. cleanliness, odor, damage, open roof).接收通常做法會確認材料放置的容器和運輸方式保障材料到達後適合使用。需重複使用的容器（如鼓，卡車，罐車等） ，再次使用之前需要得到適當的清理。容器或出貨如果可能應標識清楚以防止被隨意擺弄。卡車檢查應有文件記錄記錄（如清潔，無味，損壞） |
| 8.3.5 | Delivery vehicles are unloaded at defined locations, designed for the purpose. The locations are designed to protect material from environmental damage during unloading.運載工具按照其用途設計，在指定地點卸貨。卸貨地點的設計應考慮卸貨時，可以保護材料不受外界環境損壞。 |
| 8.4 | Systems are in place that ensure materials produced or processed internally consistently meet specifications and production standards. 需要建立一個 系統確保內部生產加工的材料始終達到規格以及生產標準。 |
| 8.4.1 | Materials produced or processed on site that become ingredients or contact products/packages (such as water, gases, steam, compressed air, etc.) are properly controlled:成為成份或接觸類產品/包裝的生產或加工的材料，（如供水，氣體，蒸汽，壓縮空氣等） 應得到適當控制： - As required by standards, testing provides evidence of compliance. 如標準要求，測試需提供符合証明。 - Steam production uses food-grade, approved additives or materials that are not carried over into the steam.蒸汽生產使用不結轉到蒸汽的食品級材料，批准添加劑。 - Compressed air, nitrogen, or other gases are free from contaminants such as water, oil, other gases and microbes and is supplied under pressures that prevent back flow into the gas system. 壓縮空氣，氮氣，或其他氣體供給不受污染，例如水，石油，其他氣體和細菌，這樣以防止其回流入氣體系統。 - Treated process water is handled as a starting material and accepted based on evidence of full compliance to specifications at the point of use. 處理過程中水作為起始原料接受，但需證據其完全符合使用規格。 |
| 8.4.2 | If processing aids are used as described in Policy 35, they are authorized in technical standards.如果加工輔助工具的使用如政策35描述的那樣，它們在技術標準中應經過授權的。 |
| 8.5 | Materials are controlled at receipt or prior to use to ensure they are the correct identity and quality. Off-quality, mislabeled, mixed, contaminated, altered or unapproved materials are blocked from use. Quality Incidents associated with off quality materials that are released for use are investigated and reported.原材料接收使用之前需要把好控制關以確保原材料來源和質量可靠。質量不達標，標簽貼錯混亂，被污染摻假或未通過批準的原材料不可以使用。對於原材料發生的質量方面的問題要進行調查並上報。 |
| 8.5.1 | Written procedures are in place detailing the requirements to receive, release, block and reject materials. The quality of the materials is verified before being released for use. Records provide evidence that procedures are being followed. QA is responsible for the release of any material.應有一個 書面程序詳細說明接收，放行，阻止和拒絕材料的要求。在允許使用前，材料的質量需驗証合格。程序被遵守需有文件記錄証明。QA對材料的放行負責。 |
| 8.5.2 | Unique, tamper evident seals, where used, are checked on receipt. Trucks and containers are inspected for evidence of potential tampering or contamination before and during the off-loading process. Container seals are intact on receipt. Containers opened for the purpose of receipt sampling are marked and re-closed.接收單上需要有獨特明顯的印章。卡車和集裝箱進行檢查，以確定在整個卸載過程中是否有潛在的故意破壞或污染。接收單上要有集裝箱印章。集裝箱開放是因接收樣品後需要做標記，然後標記完後需重新封閉。 |
| 8.5.3 | Materials received are clean, undamaged and clearly identified with labels (or attached documentation) showing the material reference code. Only approved materials from approved supplier locations (as defined on the material specification or approved supplier list) are received for use in routine production. Materials are tested, inspected or checked to confirm identity. When labels or printed materials are received, they are checked versus the fully approved artwork or specification to be sure they are correct (e.g. e-Padex standard). Materials are used only for their intended purpose.接收的材料應清潔，無損和有明確的標籤（或所附文件）顯示材料參考代碼。只有來自經過核准供應商的經批准的材料（定義的材料規格或核准供應商名單）才可以接收用於日常生產。材料要經過測試，檢查或檢查，以確認其性質。當接收標籤或印刷材料時，應檢查其是否符合認可的包材規范規範，以確保它們是正確的（如電子Padex標準）。材料僅用於預定的用途。 |
| 8.5.4 | Test data must provide evidence that each lot of the material meets the specification. Where supplier certificates of analysis (CoA) are used to provide evidence of compliance to specifications, the test values or data contained are confirmed to meet reportable specification limits and/or release criteria prior to use of the material. The use of "typical analysis", “certificates of conformity” or “certificates of guarantee” (where supplier data is not provided) does not provide sufficient evidence of quality for a material. This requirement applies at a minimum to all ingredients or primary/secondary packaging components (including the container protecting and identifying the consumer purchased unit and other materials where reportable items are defined in the specification). 測試數據必須提供証據証明每批材料都達到標準規格。如果供應商的分析證書是用來提供符合規格的證據，測試值或數據應得到確認，以滿足報告的規格限制或在材料使用前發行標準。“典型分析” ， “合格證書”或“保證證書”的使用 （如供應商沒有提供數據）不提供足夠的證據證明材料的質量。這一規定最低限度可適用於所有成分或初級/中級包裝元件（包括集裝箱，並確定了保護/識別消費者的購買單位和在定義規格中的其他材料） 。 |
| 8.5.5 | Procedures are used to control the quality of material samples for acceptance testing:使用程序控制材料樣品的質量以進行接收測試： - Sampling is done in an environment using equipment, containers and procedures that avoid contamination of the samples and the material being sampled. 取樣需在這樣的環境中完成，在這樣的環境裡，使用的設備，容器和程序，可以避免樣本和取樣材料受到污染。 - Samples are traceable to individual deliveries and containers sampled. 樣本可追踪至個人交付和取樣的集裝箱。 - Sample labels indicate the material name, lot or control number, sample location, date and name of person collecting. 樣本標簽說明材料名稱，批次或控制單號，採樣地點，日期和收集人的名字。 - Testing follows procedures that provide supporting evidence that the material is properly identified, not contaminated and fully compliant with specifications. 測試遵循如下程序，提供支持性證據表明該物質是經過確定，沒有污染，完全符合規範。 - Test results supporting release decisions or rejections are recorded. 測試結果支持或拒絕放行決定都應有文件記錄。 |
| 8.5.6 | Where required, a sample of each delivery of incoming materials is retained. 如有需要，每一個來料交付樣本應保留。 |
| 8.6 | Materials are controlled in storage and handling to prevent damage, contamination, infestation and the inadvertent use of expired, rejected, blocked, remnant or wrong materials.原材料在儲存處理方面要加強控制防止損壞，污染，侵害以及無意使用了過期，不合格，殘留及錯誤的原材料。 |
| 8.6.1 | Each delivery (and where defined, supplier batch or lot) of raw materials, packaging components and labels is assigned a unique reference or control number upon receipt that is traceable to suppliers lot or batch number. For drugs, multiple receipts of the same manufacturer's lot must be assigned separate reference numbers.原材料，元器件和包裝標簽的每次交付都分配一個獨特的參考或控制單號，這些單號可以追溯到供應商的批號。對於藥物，同一供應商的多次交付必須有他們單獨的參考或控制單號。 |
| 8.6.2 | There is a system in place to track lot numbers of bulk materials. If multiple deliveries are unloaded into one storage tank, it is possible to track the deliveries to the final product.應有一個系統來跟踪散裝材料的批號。如果有多個交付卸載到一個存儲箱，交付踪運到最終產品是有可能的。 |
| 8.6.3 | Material status (including remnant, expired, damaged, out-of-specification, rejected, etc.) is controlled to avoid improper use. Control may depend on physical segregation, labeling and/or status control by a validated computer system. Materials of different release status are not stored in the same inventory location. Obsolete and rejected material are disposed of in a timely manner to prevent inadvertent use.物料狀況（包括殘留，過期，損壞，失去規範，拒絕等）應合理控制以避免不恰當地使用。通過審定的計算機系統相，控制可能依賴物理隔離，標識和/或狀態控制。不同材料應存儲在不同的地方。陳舊，報廢的材料應及時處置，防止意外使用。 |
| 8.6.4 | Materials are stored in compliance with current standards, stacked so that damage or contamination does not occur and located away from walls (e.g. adequate for inspection and cleaning). 材料都按照現行標準儲存，遠離牆壁防止損壞或污染（如適當的檢查和清潔） 。 |
| 8.6.5 | Any hazardous chemicals, including toxic substances, biological actives, and flammable or reactive materials or controlled substances are stored in facilities suitable for this purpose so that access and risk are controlled.任何危險化學品，包括有毒物質，生物活性，和易燃或易發生反應材料都應控制其存儲設施以便風險得到控制。 |
| 8.6.6 | Materials are used within an age control strategy (e.g. FIFO) to reduce the possibility of materials expiring before use, minimize storage damage/contamination and to increase the consistency of material characteristics into the process. Partially used containers or pallets of material (such as created with each changeover) are protected from contamination/damage and used first at the next opportunity. 材料應有年齡範圍內的控制策略（例如先進先出） ，以減少材料使用前過期的可能性，最大限度地減少儲存損失/污染和提高材料特性的一致性。存放材料的部分容器或托盤（如建立相互轉換）應保護其不會受污染/損害，下次可以首先使用。 |
| 8.6.7 | Material, which has passed its re-test date, is either re-sampled and re-analyzed prior to use (according to established procedures and standards) or disposed. Material past its expired date is properly disposed of. For chemicals and reblend product that have no expiry or re-test date defined by the supplier or within technical standards, a re-test date will be assigned to ensure that the material/reblend meets the relevant specification and has not become contaminated or adulterated.需要再次測試的材料在使用前應（根據既定程序和標準）重新取樣分析。過期的物料應進行適當的處理。對於沒有過期的或需要再測試的化學品和混合產品，應安排一個重新測試的如期以確保材料符合有關規範，沒有受到污染或摻假。 |
| 8.6.8 | Materials are stored in a manner to prevent contamination and degradation. Materials are covered when there is a risk of contamination. If materials become contaminated in the warehouse, they are immediately blocked to avoid inadvertent use. 材料存儲方式得當保護其不會受到污染。當有被污染的風險時，材料應被遮蓋。如果倉庫裡的材料受到污染，他們應被立即封鎖以避免無意中使用。 |
| 8.6.9 | Labels and other printed packaging materials are stored in a manner (e.g. physical separation such as separate inventory locations), that maintains their integrity and prevents mix-up. When required, labels and other printed packing materials are stored in separate controlled areas. Printed material returned from packing lines are checked for condition and identity before being put back into storage. 標簽以及其他印刷包裝材料存儲方式得當（物理分離，如單獨存貨地點）以維持他們的完整性，防止混淆。如有需要，標簽以及其他印刷包裝材料應存儲在不同的區域。包裝線退回的印刷材料在存儲前要進行檢查。 |
| 8.6.10 | Access to material storage areas is controlled to the appropriate level for the category of products produced (e.g. regulated) and type of materials stored (e.g. labels, coupons, hygienic).存儲材料領域的進入應得到控制，並將產品劃分適當的級別（如監管）和存儲材料的類型（如標籤，優惠券，衛生） |
| 8.6.11 | Unloading hoses are stored off the floor, capped, and where required, drained and dried. Hoses are of minimum length to prevent material degradation and facilitate cleaning. Unloading stations are clearly identified to prevent mix-up and controlled to prevent unauthorized transfer. Where required, hoses should be cleaned after use and sanitized before use.卸貨軟管存放在地板下面，如有要求應將液體排幹。軟管長度應盡可能的短，以防止退化便於清潔。卸載站是明確劃分，以防止混淆並控制得當防止擅自轉讓。 |
| 8.6.12 | For drugs, all raw materials and critical packaging components are reconciled and reconciliation documented. This reconciliation is within narrow preset limits, beyond which, investigation is initiated. Limits are based on historical data. Some level of reconciliation to identify losses and as a secondary check on dispensing/inventory systems that lose accuracy over time, is good practice for other business units that may not have a regulatory requirement. 對於藥物，所有原材料和關鍵包裝的零部件都應有和解文件記錄。這一和解是在較窄的預設限制內，超出該限制就要開始調查。限制是根據以前的數據建立的。某種程度的和解，以確定損失，並作為次要檢查分配/庫存系統會隨著時間的推移失去準確性，對於其他業務部門是良好的做法。 |
| 8.6.13 | The status of materials is verified before use to ensure that blocked or rejected material is not used. All materials deemed unsuitable for use (e.g. rejected or scrap) must be physically labeled as such to prevent inadvertent use.材料使用前應對其狀況進行確認保証報廢的材料不被使用。所有被認為不適合使用的物料必須貼上標簽以防止誤用。 |
| 8.6.14 | Different materials are not stored on the same pallet unless physically separated (such as in separate containers, each labeled) and adequate to prevent mix-ups and cross contamination.不同的物料應存儲在不同的區域，除非他們已經被自然分離（用不同的集裝箱存儲並有貼標簽），這樣可以防止混淆和交叉污染。 |
| 8.7 | Unused proprietary materials (e.g. non-commodity materials…particularly those providing equity performance, look, taste or smell in finished product/package) which can be misused to “reverse-engineer”, copy or enable the unapproved sale of expired, developmental, off-quality or counterfeit products must be disposed of in compliance with Policy 11. 沒有使用過的私人物料（非商品原料...特別是那些在性能，外在，氣味方面都與成品相似的物料），而且這些物料可能被誤用，復制並可以使過期，有質量問題的假冒偽劣產品被銷售，所以這些物料 必須按照第11條政策進行處理。 |
| 8.7.1 | Unused proprietary material must be controlled to prevent diversion/product counterfeiting. Controls may include:未使用的專有材料必須加以控制，防止非法轉移/假冒產品。控制可包括： - Returned to the supplier for proper destruction, allowable rework or recovery prior to disposal. 適當的破壞，返回供應商，處置之前允許返工或回收。 - Alternately, the receiving site can render such materials unusable or dispose of these materials on site (even if contractors are used on site for this purpose). 另外，接收站點可以歸還或處置這種不能使用的材料 。 - Proprietary materials may not be sold or turned over (by supplier or receiving site resources) to off-site disposal subcontractors without being rendered unusable either on-site or under witness, when required to meet Company policy. 專有的材料不得出售或移交（由供應商或接收站點） ，禁止沒有在現場或在他人見証下歸還這種不能使用的材料，必要時需要滿足公司的政策。 - Contracts with suppliers must enforce this requirement for the proper handling of proprietary materials and related equipment such as printing plates. 合同供應商必須執行這一要求，妥善處理有關專利的材料和設備，如印刷板。 - The use of “certified” disposal subcontractors or the availability of reconciliation documentation does not satisfy this requirement.處置分包商“認證”使用或和解文件不需要滿足這一要求。 |
| 9 | Making Operation. 運行操作。 Making operations convert approved starting materials into products using specified procedures, standards, equipment and personnel. This concept also applies to research organizations through their pilot operations or experimental orders, etc.運行操作將經過批准的起始原料轉換成產品使用指定的程序，標準，設備和人員。這一概念也適用於通過其試點運行或實驗命令運作的研究組織。 |
| 9.1 | Conditions of the making area are controlled and maintained to produce the designed product free of contamination and adulteration.制造區域的條件應該嚴格控制維護以確保生產沒有污染摻假的合格產品. |
| 9.1.1 | The major equipment used in the making process is clearly identified and its use documented.制造過程中使用的主要設備是經過清楚地認証，其用途有文件記錄。 |
| 9.1.2 | Proper conditions (e.g. temperature, humidity, microbial, and dust control systems) are defined, maintained, and monitored in the manufacturing environment. 生產環境裡的 適當的條件（如溫度，濕度，微生物，和灰塵控制系統）應詳細列明，維護和監測。 |
| 9.1.3 | Separate facilities or environmental control systems are needed for products such as antibiotics, live vaccines/ bacterial preparations and toxic/potent actives. 對於產品，如抗生素，活疫苗/細菌製劑和有毒成分，單獨的設施或環境控制系統是必需的。 |
| 9.2 | The Making Operations produce the specified product compliant with technical standards and regulations.制造部門生產的產品應該符合技術標準及慣例。 |
| 9.2.1 | Operator standards (e.g. hygiene, attire, jewelry, pockets, tools, health, etc) are appropriate for QA/GMP requirements for the products being produced. Personnel should be healthy to perform their assigned duties. Where required by regulation, Regular medical examination must be conducted for all production personnel involved with manufacturing processes. 操作標準（如衛生，服裝，珠寶，口袋裡，工具，衛生等） ，符合的QA / GMP要求對產品的生產。人員健康可以完成各自的任務。凡有規定，必須對所有參與生產過程的生產人員進行定期醫療檢查。 |
| 9.2.2 | Before the making operations commence:在生產過程開始前： - Changeover or line clearance procedures are employed to remove material, lock out valves, remove paperwork, etc. that could result in adulteration, mis-formulation or use of wrong components.清除程序的改變可以採用清除材料，鎖定保險閥，刪除文件等，但這可能導致摻假，誤制訂或使用錯誤。 - Any product made during changeover that does not comply with specifications is segregated and promptly dispositioned.不符合規范的任何產品轉換應隔離並及時轉換位置。 - The production equipment is configured to produce the correct product.生產設備配置好，可以生產正確的產品。 - Required cleaning and sanitization is completed at the correct time. 需要在正確的時間完成清洗和消毒。 - Only materials, including bulk materials, may be used that have been identified, approved, dispensed and labeled. 隻有經過確認，批準，分配和標記的材料（包括散裝材料）才可以使用。 - The materials are dispensed to the accuracy described in technical standards. The dispensed materials are labeled and controlled to prevent mix-ups or contamination.材料按照技術標準分配準確。分配的材料應被標記並加以控制防止混淆污染。 - Proper routing of materials (such as from tank farms) are confirmed to prevent mix-up.材料安排恰當防止混淆。 |
| 9.2.3 | While making the finished product:在制作成品時： - Materials used in the process are controlled and documented. 制作過程中使用的物料是經過控制才可以使用的並有文件記錄。 - Operations comply with the technical standards, regulations, written procedures and validated conditions.操作符合技術標準，法規，書面程序和其他驗証條件。 - There are procedures in place to handle deviations in the making process.有一個程序來完成制作過程中的異常處理 - Actions including deviations are documented and verified.異常處理應有文件記錄並經過確認。 - Centerlines are followed to ensure that the intended finished product design/performance is met. 遵循一定的核心標準以確保所有成品設計性能達到標準。 - Analytical, micro and retained samples are taken and tested as specified in technical standards.分析，微型和保留樣本的方法被採取並按照所規定的技術標準進行測試。 - Process control strategies are being used (e.g. machine controls, procedures, maintenance).應使用制程控制策略。（如機器控制，程序，維修） |
| 9.2.4 | All documentation is completed during each step of the manufacturing process. The records provide evidence of compliance to operating procedures that control and alter the product (e.g. material dispensing and addition, batch records, process control, maintenance, line clearance).在生產的每個階段都要有完整的文件記錄。這些記錄可以提供証據証明生產符合操作程序（物料分配，批次記錄，過程控制，維修，線清理） For drugs – significant steps in the process require double signatures and the yield reconciliation of each lot is checked and recorded.對於藥物，制程中的重要步驟要求則應更加嚴格，每批都要檢查並作記錄。 |
| 9.2.5 | Materials, intermediates and product are not used for purposes other than their approved usage.材料，半成品和產品不被用於其他用途。 |
| 9.3 | Rework, reprocess, reclaim, repair, recycle, resale and blend operations are controlled according to technical standards.返工，再加工，收回，修理，循環利用，轉售以及各種混合操作應該按照技術標準加以控制。 |
| 9.3.1 | Products to be reworked, recycled, reprocessed, resold, repaired, reclaimed or blended are identified and handled to minimize contamination, adulteration, mix-up and degradation of the products.產品被返工，回收，再轉售，修復，再生或混合應得到確認和處理，盡量減少產品污染，摻假，混合行動和退化。 |
| 9.3.2 | Lot traceability is maintained and documented throughout the recycle process.整個回收過程中，批次追溯應系統應得到維護並有文件記錄。 |
| 9.3.3 | Technical standards authorize these operations (rework, reprocess, reclaim, repair, recycle, resale and blend) before they are conducted. 行動實施前，需要有技術標準授權這些行動（返工，重新處理，回收，維修，回收，轉賣和混合） 。 |
| 9.3.4 | Products produced from these operations (rework, reprocess, reclaim, repair, recycle, resale and blend) are only released if they meet all approved technical standards.這些操作（返工，重新處理，回收，維修，回收，轉賣和混合）產生的產品，隻有當他們達到規定的技術標準才可以放行。 |
| 10 | Packing Operation. 包裝操作 All packaging, customization and manipulation operations consistently convert the specified materials into quality finished product packages using approved standards, procedures and equipment. Finished products are labeled and coded. 所有的包材，據定制和處理轉變成成品包裝材料需批準標準，程序，設備.成品應有標簽和條碼. |
| 10.1 | Conditions of the packing area are controlled and maintained to produce the designed product free of contamination, adulteration, mix-up, mispack or mislabel.包裝區域的條件應該嚴格控制維護以確保生產的是沒有污染、摻假、混雜包裝，沒有貼錯標簽的合格產品. |
| 10.1.1 | The major equipment used in the packing process is clearly identified and its use documented.主要的生產包材的機器有文件資料明確的標示身份和用途。 |
| 10.1.2 | Proper conditions (e.g. temperature, humidity, microbial, and dust control systems) are defined, maintained, and monitored in the manufacturing environment. 在工廠環境中紙的狀況（如溫度，濕度，微生物潮濕灰塵管控系統）需詳細說明，維護和監測 |
| 10.1.3 | Separate facilities or environmental control systems are needed for products such as antibiotics live vaccines/ bacterial preparations and toxic/potent actives.對一些如抗生素存活的疫苗或有中毒可能的產品需必要有分開的工具或環境管控系統 |
| 10.2 | The Packing Operations produce the specified product (including package, bundle, case, pallet, promotional item secondary pack, customization, etc.) compliant with technical standards and regulations.包裝公司生產的指定產品包材（包括包裝，綁帶，箱了，貨盤，以及促銷產品的次級包裝，專用等）需要符合技術標準及安規。 |
| 10.2.1 | Operator standards (e.g. hygiene, attire, jewelry, pockets, tools, health, etc) are appropriate for QA/GMP requirements for the products being produced. Personnel should be healthy to perform their assigned duties. Where required by regulation, regular medical examination must be conducted for all production personnel involved with packaging operations. 生產產品的操作人員標準（如衛生，服裝，裝飾，口袋，工具，健康等）都需符合QA/GMP要求,人員健康的完成要求的任務，按規則要求，正常需體檢所有包裝生產人員。 |
| 10.2.2 | Before the packing operations commence:在包裝開始之前 - Changeover procedures are employed to assure only correct materials for the operation to be conducted remain in the area.確証隻有正確的物料用於操作當生產轉接時。 - Any product made during changeover that does not comply with specifications is segregated and promptly dispositioned調整轉接生產的不合格產品需隔離處置 - The equipment, control systems and software are correctly configured/set-up (e.g. code dating, online printing, fill weight, check weighers, bar code scanners, vision systems, reject zones, metal detectors).設備，控制系統和軟件需正確配置(條碼日期標注，在線打印，填寫重量，台称，條碼掃描器，可視系統，不良區，金屬探測器） - Required cleaning and sanitization is completed. 完成清潔和衛生工作 - The materials must be issued to the accuracy described in technical standards. 按技術標準要求材料需準確組織。 |
| 10.2.3 | While packing the finished product:當包裝成品時 - Materials used in the process are controlled. 所用材料需管控 - Operations comply with the technical standards, regulations, written procedures and validated conditions.操作符合技術標準，安規，書面程序和確認的條件 - There are procedures in place to handle deviations in the packing process.有程序的處理包裝過程中的偏差物、 - Actions including deviations are documented and verified.行動包驗証偏差 - Centerlines are followed to ensure that the intended finished product design/performance is met. 遵循中心線保証印成品是符合設計要求的 - Required tests (such as fill weight, count, sheet size) are done in compliance with all Company and regulatory requirements of the intended markets.所需測試（所填的重量,數量，尺寸)都符合公司和銷售市場安規要求 - Analytical, micro and retained samples must be taken and tested as specified in Technical Standards.分析的，保留的樣品按技術標準測試。 - Product and materials removed (e.g. during line checks) or fallen from the line are returned to the line only when allowed by the site procedures, standards and regulatory requirements. 產品和物料移除(在線檢查過程）或從線上跌落的隻有按現場程序，標準和安規要求才可退回線上 - Process control strategies are being used (e.g. machine controls, procedures, maintenance). |
| 10.2.4 | During the packing process required documentation is completed. 包裝過程要求文件資料完成 - The records required provide evidence of compliance to operating procedures that control or alter the product and ensure traceability (e.g. material issue and use, packing records, process control, maintenance, line clearance, weight checks, lot codes, etc.)記錄証明是符合操作程序以保証可追溯性（材料問題和使用，包裝記錄，制程管控，維護，線條清除，重量檢查，批號條碼等) - For drugs – significant steps in the process require double signatures and documentation of yield reconciliation.對於藥品-制程中關鍵步驟需雙倍簽名和依從文件。 - Palletizing complies with approved technical standards for the markets where the product will be shipped. Unit loads with more than one lot code, where necessary, are recorded to maintain lot traceability. 站板貨需符合技術標準出貨地銷售要求,保持記錄的可追溯性 |
| 10.2.5 | Packaging materials and products are not used for purposes other than their approved usage. Test product should never be packed in any current packaging material, unless authority and clearances (e.g., QA, product reco, PS&RA, patent, experimental order) have been obtained to ship and sell this product. 包材和成品隻能用於批準的用途，測試樣品不能像出貨品一樣包裝好除得到相關授權可出貨及銷售這些樣品. |
| 10.3 | Rework, reprocess, reclaim, repair, recycle, resale and blend operations are controlled according to technical standards. 返工，再加工，收回，修理，回收利用，轉售以及各種混合操作應該按照技術標準加以控制。 |
| 10.3.1 | Product to be reworked, recycled, reprocessed, resold, repaired, reclaimed or blended are identified and handled to minimize contamination, adulteration, mix-up and degradation of the product.返工，再加工，收回，修理，回收利用，轉售以及各種混合的產品需區分處理以達到污染最少，減少摻雜，混合和產品的退化。 |
| 10.3.2 | Lot traceability is maintained and documented throughout the recycle process.通過回收程序維護和查找批次的可追溯性 |
| 10.3.3 | Technical Standards authorize these operations (rework, reprocess, reclaim, repair, recycle, resale and blend) before they are conducted. 經技術標準授權才能進行以下這些操作(返工，再加工，收回，修理，回收利用，轉售以及各種混合) |
| 10.3.4 | Product produced from these operations (rework, reprocess, reclaim, repair, recycle, resale and blend) are only released if they meet all approved technical standards.從這些操作中生產的產品(返工，再加工，收回，修理，回收利用，轉售以及各種混合)隻有全部符合技術標準才可以放行 |
| 10.4 | Finished products are correctly identified with lot codes and where required, expiration/use-by dates as defined in technical standards.成品應該用次條碼正確地進行標識，過期使用應按技術標準應詳細說明。 |
| 10.4.1 | Lot codes are permanent, legible and identify when and where a product was produced. This lot code is traceable back to components and manufacturing details of the product.批次條碼是永久的,清晰的辨別何時何地生產的產品，可往回追溯到成份和生產的詳細資料. |
| 10.4.2 | Product coding format, placement and content meets P&G and regulatory requirements of the intended markets.產品條碼格式，放置和內容需符合寶潔和銷售地安規要求 |
| 10.4.3 | Pre-coded packing materials and labels are controlled to ensure that they match the lot number of the product being packaged. Excess pre-coded materials remaining after packing is completed are destroyed. 先印條碼的包材需管控保証與所包產品批號條碼相符，包裝完成多出的印有條碼的材料應消毀. |
| 11 | Storage & Handling of Finished Product. 存儲和成品操作 Warehouses and distribution centers have systems that identify the inventory in stock, show where the product has been sent and maintain the product in good condition in storage and in transit to the customers.倉庫和發貨中心有系統識別倉庫中的成品 ,並能顯示產品所發地和保持儲存狀態好能發給客戶. |
| 11.1 | Receiving operations identify and inspect incoming goods.接收部門應該要識別檢驗外面進來的產品。 |
| 11.1.1 | Delivery vehicles are unloaded at defined locations, designed for the purpose. The locations are designed to protect product from environmental damage (e.g. infestation, dirt, water or other contamination) during unloading.發貨工具在指定地卸貨,指定區是為了保護產品在卸貨過程中不受環境損壞（如害蟲，污垢，水淹或其它污染) |
| 11.1.2 | Incoming deliveries are inspected for correctness of quantity, item code, seal number ( if relevant), lot number and general condition before being put into a stock location. Damaged product is removed and isolated. The inspection and any damages/discrepancies is documented as part of the receiving record.在放入指定倉庫區需來料檢查數量是否正確，品名代碼，封條或相關,批號或一般情況.已破損的需移開隔離放，任憑破損和差異需做文件作為收貨記錄、 |
| 11.1.3 | There is a system for verifying the accuracy of incoming shipment documentation and that unloading checks are accurate and reliable.應有系統確認來貨文件資料 和卸貨檢查準確可靠 |
| 11.1.4 | Trucks and containers are unloaded promptly after arrival. Container yards or drop-lots are not used as overflow warehouses.卡車和貨櫃一到就應卸貨，當倉庫范圍都滿貨其它剛不能進入。 |
| 11.1.5 | When receiving unpalletized loads, the delivery is separated by product code and by lot and then palletized. Pallet patterns and standards for wooden pallets are obtained from the technical standards.收到的不是整站板貨物時，貨物單獨按產品條碼批次放並放成站板形. |
| 11.2 | The Stock Location system is designed to segregate product as required while allowing easy and rapid retrieval for shipment.有需要設計倉庫定位系統隔離產品允許很容易快速出貨 |
| 11.2.1 | There is a defined location control strategy that includes separation of incompatible goods and allows easy and rapid retrieval of stock for shipment. Where required by local regulations, drug products are stored in a separate, secure area.應有套詳細定義區域管控策略包括分隔性質相反的貨物並可很易快速出貨隻需區部調整，藥物產品單獨存儲在安全區域。 |
| 11.2.2 | Product stocks are stored on pallets. Shelf storage can be used for small quantities of product. Product is not stored in direct contact with the floor or walls of the warehouse.存貨用站板形式存儲，量小的產品可用貨架形式存儲，產品不能直接接觸倉庫的地面或牆面 |
| 11.2.3 | Where multiple items are stored in the same location/shelf/row, such as small quantities, residuals or slow movers, the inventory control system is capable of distinguishing between the different items and pallets. 當多種產品存放在一個區或一個貨架或一排時，像數量小的，出貨剩余的，出貨慢的貨物，存貨管控系統有能力區分這些不同的貨物和站板。 |
| 11.2.4 | Where multiple item codes are stored on the same pallet, they are physically separated.當一個站板放有很多種類條碼的貨物時，需自然隔開放、 |
| 11.2.5 | Items or pallets in a single location are of the same control status, unless the item selection and product status system is validated as capable of preventing use of unapproved materials.貨物或站板放在同一管控區域,除非用選擇和產品狀況系統有很效才能防止用錯料。 |
| 11.3 | There is a damage control strategy to ensure that only good product is shipped to the trade.應該具備一套破損品控制策略來保証隻有品質合格的產品才可以裝運交貨。 |
| 11.3.1 | Damaged product that poses a contamination risk to other stock, either by leakage or odor transfer, is physically removed from storage to a suitably controlled area.已破損的物料很容易對其它存貨造成污染,不管是液體的泄露還是氣味的泄露,所以自然的應放到其它合適場所管控。 |
| 11.3.2 | Product spills and leaks are cleaned away as soon as they are identified to prevent the spread of contamination. 一旦發現產品溢出和泄露應馬上清理以便污染擴大 |
| 11.3.3 | There is a system for inspection of storage areas to identify and replace broken or damaged pallets. If stock is re-palletized in the warehouse, the original pallet pattern is followed including number of layers, lack of overhang and correct pallet wrapping.應有套對倉庫存貨檢驗體制以確認或替代破損品或站板上的貨，替代重按原站板形放入倉庫時應保証是照原來的站板放上相同層的貨量等。 |
| 11.3.4 | Palletized loads are adequately secured to prevent product damage during storage and movement. 用站板式裝貨可按全的防止產品存儲和移動的破損。 |
| 11.3.5 | Picking operations involving the selection of individual items or small packs placed into a larger shipper case include inert packaging material to prevent movement of the units in transport.條選操作是有關選擇單種或小包貨物放到大到的出貨箱中，包選擇包裝插入材料以防止運輸過程產品的晃動 |
| 11.3.6 | Stacking of palletized loads is controlled:站板形貨物堆放的管控 - Clearance between stacks is maintained to allow for easy retrieval of pallets without damaging adjacent stock. 堆之間清除維護經便很易取貨而不損壞臨近貨物 - Pallets are stacked only when specified in the Individual Packing Standard for the product concerned.有關特別說明單個包裝標準隻能按裝板形堆放 - Maximum stack heights defined by Packing Standards are observed.按包裝標準留心堆放的最大高度。 |
| 11.3.7 | Products are stored within the temperature and humidity limits specified by standards. Records are kept to show the temperature/humidity comply with the standards. There is a documented strategy for the actions to be taken if conditions in the warehouse go outside these limits. 產品應放在按標準規定的溫度和濕度倉庫中，記錄下相關的溫度和濕度,如產生溫濕度在條件之外應採購相應的文件規定措施 |
| 11.3.8 | For markets with extremes of temperature or humidity, insulated or temperature controlled delivery vehicles are used as necessary and as defined within approved Technical Standards.如市場溫濕度極高,在技術標準內運輸過程中運用隔熱和可控制溫度的運輸工具是必要的， |
| 11.3.9 | The warehouses have systems in place to prevent the accumulation of strong odors, noxious/reactive gases, dirt and dust, e.g.倉庫應有系統防止強氣味，有害或反應強烈的氣味混合在一起。 - The ventilation systems remove/dissipate odors, including perfumes. 有通風系統驅散氣味，包香水 - Fumes from truck motors or battery-charging areas are filtered/extracted to prevent product contamination. 卡車尾氣和充電區域氣味需過濾以防止產品污染 - Diesel or gasoline powered vehicles are not permitted inside warehouses. - LPG or other liquid gas powered vehicles are well maintained and fitted with an appropriate catalytic converter. Three-way converters (Nitrogen Oxides, Carbon Monoxide & Hydrocarbons) are required for all sites storing paper products; two way converters (CO,HC) are acceptable for other locations. |
| 11.4 | An Inventory Management system controls the release status, order of shipment and expiry of products in the warehouse.應該有套存貨管理系統來管控倉庫裡的產品放行狀態，裝運秩序以及過期的產品。 |
| 11.4.1 | The status control system prevents the shipment of product not yet released, e.g. quarantine, quality inspection, blocked and reject stock. Control may depend on physical segregation, labeling or status control by a validated computer system.狀況管控系統防止出貨不能放行的產品如需品質檢驗的，退回的貨，管控依自然隔離，標簽或有效的電腦控制系統. |
| 11.4.2 | An inventory control strategy is used to define the order of shipment of product and the systems required to prevent shipment of over-aged stock.一套存貨管控策略用於詳細定義訂單產品出貨,並運用於防止出存期過長的產品。 |
| 11.4.3 | The age control system is designed to allow shipment of newer stock where required by regulation in the receiving market or if shipping to another regional DC.存貨貨期管控系統允許出新進存貨按市場要求。 |
| 11.4.4 | When shipping both full, manufactured unit loads and picked pallets, the age control system can manage full unit loads separately from part pallets and the picking operation.存貨貨期管控系統能全面管理從貨盤上分別單個裝載和挑選操作 |
| 11.4.5 | Products have defined time periods (e.g. stop ship date), prior to the expiry date, when shipments must stop to ensure that customers always receive fresh product. The age of stock in the warehouse is checked on a regular basis to ensure that product is shipped to distribution channels consistent with remaining shelf life. 產品早就定了時間周期（如停出貨期）先於過期日. |
| 11.4.6 | Stock that has passed its stop-ship limit is not shipped to customers or donated without a specific action plan agreed between the GBU QA and MDO QA, compliant to P&G Policy.產品過了停止出貨期就不允許出給客人或損贈. |
| 11.4.7 | Stock that has expired is destroyed as required by P&G policy on product disposal. It is not permissible to donate or divert expired stock for consumer use.按寶潔政策存貨過期就要消毀,不允許捐贈或轉多給消費者使用. |
| 11.4.8 | The accuracy of the inventory management system is verified by an independent, documented count on a defined schedule.存貨管理系統的精確性經定期時間的文件核對檢驗。 |
| 11.5 | Products are picked for shipment using clearly defined instructions.慶有明確的詳細說明挑選裝運的產品 |
| 11.5.1 | Picklists or transfer orders are prepared for each customer order. Picklists specify the items to be picked and their locations in the warehouse in enough detail to prevent accidental mis-picking of product.要挑選或轉移的貨需先準備,產品分類和詳細說明所在倉庫區域以免發生錯選 |
| 11.5.2 | Product can be picked as full pallets or as individual items depending on business requirements. If individual items are co-mingled onto a single pallet, picking procedures include:按業務需求，要選擇的貨有選整板或選個別的.如選的貨是個別混合到一個站板上的，挑選程序包括 - A requirement to inspect the pallet base prior to use and reject defective pallets.驗貨 - A clear definition of the maximum height and weight of the full pallet.有明確的站板的最大高度 - A requirement to maintain the correct orientation of units and shippers. - A definition of order of pick (e.g. heavy items to the bottom of the pallet, liquids below non-liquids). - A requirement to separate incompatible products (e.g. perfumed F&HC not to be co-picked with Iams or Paper). - Any customer-specific requirements, e.g. layer pallets, tie sheets etc. |
| 11.5.3 | Case-pick operators and fork-lift truck drivers are responsible for ensuring that product is picked and taken to the delivery vehicle without damage:挑選操作員或是叉車司機在搬運貨物到運輸車中保証不要損壞產品 - Picked items and unit loads are inspected for damage. Defective items are not to be shipped and are replaced.不良品不替換不可發貨 - All picked pallets are wrapped prior to shipment as defined in P&G Pallet Standards. 按寶潔站板標準選好要出貨的貨需示先全部包裝好 |
| 11.5.4 | During picking operations, the product code and lot number are checked as part of the picking process. If lot numbers are pre-printed on the picklist, any discrepancies in lots picked are noted and the stock controller informed for amendment of the Inventory. If the lot numbers are not pre-printed, then they are written onto the picklist, which is archived for use in any potential recall.在挑選過程，應檢查產品的批號和條碼,如批號是示有印在貨物上則有任何差異記下並通知存貨部修正,如批號沒有先印在貨物上則需書面記下挑選物以方便如發生後續召回。 |
| 11.5.6 | The accuracy of the picked order is verified either prior to or during loading operations. 訂單挑選的精確性取決於先前工作或是裝貨過程。 |
| 11.6 | Products are loaded into delivery vehicles in a way that prevents damage during loading and transportation.應該確保產品在裝到運輸工具上以一種安全的方式進行避免在裝載和運輸過程中受到損壞。 |
| 11.6.1 | Delivery vehicles are checked for design, structural integrity, cleanliness, pest infestation, dryness and absence of strong odors. These inspections are documented. Vehicles not meeting the acceptance criteria are rejected and the hauler notified. Where required, certificates of cleanliness will be supplied by the hauler.運輸工具裝運時應進行整體，清潔，害蟲，幹燥和無強氣味檢查。檢查需歸檔，不符標準的運輸工具不能使用,如有必要要求運輸公司提供清潔証明。 |
| 11.6.2 | Product is loaded into the vehicle in a way that prevents product movement during transport. Dunnage, straps and temporary bulkheads are used as required to prevent damage.用安全的方式裝載產品到運輸工具中以防止運輸過程產品晃動，可用木屑，綁帶，照時防水用品可用於保護以免產品破損。 |
| 11.6.3 | Loose items are not placed on top of palletized loads.散件不能置於貨盤頂部 |
| 11.6.4 | Non-palletized or “dead-piled” shipments are arranged with the cases all at one level or with the stack height reducing to the rear of the truck. Stack heights do not exceed that defined in the packing standard for the SKU or that printed on the shipper無堆成板形的出貨應用箱子放於一個水平位置或是高度從卡車前減少到後。 |
| 11.6.5 | Delivery vehicles are secured/sealed, to prevent tampering, adulteration or loss.發貨運輸工具需封條，以防止損壞，摻雜和損失。 |
| 11.7 | Customer refusals and products returned from the trade are controlled.客戶拒絕的產品以及退貨品應該加以控制。 |
| 11.7.1 | Untouched loads refused by a customer on arrival and returned to our warehouse unopened are inspected on receipt for transport damage. If the delivery vehicle has been unloaded en-route or at the customer, or the return has been delayed, or if there is any question as to its storage history meeting standards, then the load is treated as a trade return except where prohibited by local regulations.未開的被退的產品運輸回倉庫一到需檢查是否有運輸破損，如在客人處卸貨了或延誤退貨了，或未按存儲時間標準的貨物，整批視為商業退貨除非當地安規禁止。 |
| 11.7.2 | Trade returns require a greater degree of control than customer refusals. Stock is inspected on receipt and returned to inventory only if all of the following criteria are met:商業退貨比客人退貨需更好的管控，一旦收到退貨應馬上按以下標準驗收。 - Returned in the original shippers, unopened, undamaged and with no customer-applied labels or markings that cannot be removed without damage.原樣退回，未開封，未破損，未有不能要損壞貨物才能移除的客人標簽或商標, - The product is still a current and on-going SKU. Products from special promotions may not be suitable for return to inventory within its ship-by date. - Product is in a clean and saleable condition, with a known history of storage conditions while out of our control. 產品是清潔和可銷售的情況。 |
| 11.7.3 | If the condition of the product or its storage and shipping conditions casts doubt on its quality, the product is destroyed, unless there is a documented examination or other testing to show the product complies with standards. P&G QA will approve dispositions of stock. If the reason for the return implicates other product or systems, suitable investigations are performed.若產品狀況或存儲和運輸條件引起對產品質量的懷疑，則產品被消毀,除非有檢測資料証明產品符合標準 |
| 11.7.4 | The handling of customer refusals and trade returns for registered products complies with the requirements of the local regulatory body.處理消費者退貨或是商業退貨應按地當安規機構要求執行。 |
| 11.7.6 | Returns, whether good stock or defective, are recorded in the inventory control system without compromising the age control system.退回的不管是良品還是不良品都需記錄到存貨管控系統. |
| 11.7.7 | All returned clinical supplies must be reconciled. 所有退回品都需依從 |
| 11.8 | Reclaim operations performed in a warehouse are controlled.倉庫裡的回收操作應該加以控制。 |
| 11.8.1 | Reclaim operations to recover damaged customer units are performed in a defined area of the warehouse that is separated from normal operations either by physical distance or a wall. The area meets applicable design standards and is kept clean and tidy.回收修理客人損壞的貨物應在離正常倉庫操作一定距離或用牆離開的倉庫區域，並按要求保持清潔整齊 |
| 11.8.2 | Primary packages are not opened in the warehouse areas. Secondary packing or customization operations occur in the warehouse only with the approval of QA.主要包裝不能在倉庫打開，第二道包材操作需經QA允許才能在倉庫操作。 |
| 11.8.3 | Area/line clearances are performed and documented between reclaim operations for different SKUs. |
| 11.8.4 | Product details, including the lot code, are transferred to the new case. Each case contains only one production lot or control number.產品明細包批號條碼，都需轉到新箱子中，每箱隻能放一個生產批號產品並控制數量 |
| 11.8.5 | Reclaim operations are in compliance with the relevant technical standards. 回收修理操作需符合相關技術標準 |
| 11.8.6 | Branded and pre-printed shippers are used only for the products described in the artwork. It is not permissible to use branded items for the storage of papers, components, waste product or other similar items.打有品牌的和示先印好收貨人的包材隻能於用產品，不允許用打有品牌的材料用於儲存紙類，部件或廢品相關類產品。 |
| 12 | Laboratory Control. 實驗室管控 Professional laboratory operations are critical to the successful control of Manufacturing and R&D activities. Any part of the operation where starting material, in process or product measurements are performed to assure product quality is considered to be a Laboratory. Laboratories must have adequate facilities, instrumentation, analytical methods, procedures, record keeping, and competent and qualified personnel. This ensures that product quality and R&D decisions are based upon sound data, and delivers results which assure product quality, reduce process variability, and meet regulatory requirements.專業的實驗室操作是生產控制和研發活動的關鍵，實驗室必須有合適的設施，設備， 分析方法，程序，記錄保留和有能力有資格的人員，這些好的資料是保証產品質量和減少產品變異並符合安規要求. |
| 12.1 | Laboratory personnel are sufficient in number, trained and qualified and capable to perform testing with accurate and consistent results. 實驗室應該有足夠數量的工作人員，這些人員有受過專業培訓並有資格及能力來進行實驗測試以獲得準確一致的結果。 |
| 12.1.1 | Personnel that perform analytical, microbiological and sensory functions possess the technical mastery (education and/or experience) needed to assure that quality results and capability of the people are maintained.執行分析，支配技術撐握程度（教育或經驗）的生物學和感官功能需擔保產品品質. |
| 12.1.2 | Laboratories have a documented process to qualify analysts and maintain their qualification. 實驗室有文件程序培養分析師 和維護他們的資歷。 |
| 12.1.3 | Quantitative assessment tools (e.g. precision ratio, method accuracy, method precision, etc.) are used in assessing capability of analysts on methods used. These data are recorded, tracked and assessed using accepted statistical techniques.有定量的評估工具（如精密度比率，方法準確性，方法精確性等）用來評估分析師運用方法的能力，這些資料需記錄，可追溯，評估用可接受的統計技術。 |
| 12.2 | Laboratory equipment used to generate data is qualified, calibrated and maintained.用於產生數據的實驗設備應該精確並經校準和維護的。 |
| 12.2.1 | Test methods define required laboratory equipment and reagents. 測試方式需詳細說明需要實驗室設備和試劑 |
| 12.2.2 | Data from unvalidated methods/lab equipment cannot be used as the basis for the release decisions.沒有得到確認的方法和設備不能用於決定發放的根據 |
| 12.2.3 | Laboratory equipment is qualified under an approved protocol and report. New equipment, or changes to existing equipment is qualified prior to use. 實驗室設備是經過協議和報告批準有資格的，有資格的人員才能使用新的設備和變更目前設備 |
| 12.2.4 | This qualification is the responsibility of the individual laboratory and is outlined in a documented protocol. Equipment used in multiple locations is qualified in each laboratory or point of use. |
| 12.2.5 | There is a written procedure in place and followed detailing the calibration of all laboratory equipment. It details the calibration frequency, responsibility, specific limits and standards to be used and requires that equipment outside of acceptable limits be temporarily taken out of operation, serviced and recalibrated before being used again. It may be necessary to perform routine checks between calibrations on some equipment (e.g. bench top scales) to ensure equipment continues to operate properly.應有書面文件規定實驗室所有設備需校準，詳細說明校正的頻率，責任人，特別限度和標準運用。在使用前一定要校準，所有有必要執行例行查核一些設備如（台秤）以保証設備能繼續正確運用。 |
| 12.2.6 | Calibration results and actions taken when calibration limits are not met are documented for each piece of equipment, including the name of the person who performed the calibration.校準結果不符文件資料的每台設備都要採取措施,包括記錄執行校準的責任人。 |
| 12.2.7 | Standards used for calibration (e.g. weights, measures, thermometers) are traceable to the recognized reference standard (e.g. national, international).校準標準使用（重量，尺寸，溫度計)都是經過公認的參考標準(如國內的，同際的） |
| 12.2.8 | Instruments and equipment are tagged or accompanied by a visible indication showing when last calibrated, and when next calibration is due. 工具，設備需標上標簽清楚的寫明上次校準時間和下次需樣準時間 |
| 12.2.9 | The calibration and working range of use for each instrument or piece of equipment is clearly visible for analyst reference. 每件工具和每個設備的刻度和使用范圍清晰給分析人員可參考使用。 |
| 12.2.10 | Laboratory equipment is maintained according to the manufacturer's specification at a minimum.實驗室設備的維最少按制造商的規格書 |
| 12.2.11 | There are records for each piece of equipment showing all maintenance, repairs and replacements, calibrations results and responsible persons.每台機器都需有維護，修理，替換，校準結果和負責人的記錄 |
| 12.2.12 | The cleaning and storage of equipment (including glassware) is controlled by written procedures.設備（含玻璃器具類）的清潔和存儲需由書面文件程序指示管控 |
| 12.3 | Laboratory methods are validated, site verified and are followed exactly.實驗方法需經証實，實驗地點應該是經過確認的，應嚴格照遵循。 |
| 12.3.1 | Where methods are specified in a product registration document and where product categories have established global or regional methods, these are strictly followed.當方法特別指出用於一種產品的注冊文件資料，產品分類需建立的全球或區域方法，都需嚴格遵循. |
| 12.3.2 | Testing in plant laboratories are carried out according to approved, validated methods. R&D or the originator of the method has the responsibility for validation.在工廠實驗室進行的實驗需按批準的，有經過証明的方法，研發或是方法原創者有責任確認 |
| 12.3.3 | Exploratory test methods used in early phases of R&D (prior to consumer testing) are not required to be fully validated. Clinical studies also require validated methods.在研發早期的探測測試階段無需完全証實,臨床研究需要經過驗証的方法 |
| 12.3.4 | Compendial methods do not require validation, but are site verified under actual conditions of usage.概论方式不無驗証,但可在有實際使用時証實 |
| 12.3.5 | Plant and R&D laboratories conduct a formal verification of the method to establish documented evidence that the plant is able to achieve results consistent with those achieved in R&D. This is done prior to or concurrent with use for the release of materials or products, and normally occurs with the assistance of R&D/TSO when the method is transferred to the plant.工廠和實驗室執行正式的方法驗証需建立文件証據以便工廠能完成與研發所完成的一致結果， |
| 12.3.6 | Current, approved, applicable methods and procedures are readily available in the laboratory prior to manufacture or EOs. These are rigorously followed.當前的，經批準的，可運用的方法和程序在實驗室易找到,需嚴格遵循. |
| 12.3.7 | Superseded methods are archived to maintain traceability of analysis over the life of the relevant products or to meet regulatory record retention requirements, whichever is longer.替代的方法存檔維護其分析追溯性超過相關產品壽命或需按符合安規記錄保技力要求,看哪個時間更長 |
| 12.4 | Sensory evaluations are conducted in the correct environment, by adequately trained individuals, following approved methods and using known standards.感官評價應該由經過充分培訓的人員遵循認可的方法和運用已知的標準在正確的環境下進行。 |
| 12.4.1 | Sensory testing is described in a written and approved procedure.感官測試應在書面經認可的書面文件中描述. |
| 12.4.2 | There is a system in place for creating, approving and maintaining standard sensory samples and solutions that is documented and consistent between relevant R&D and PS sites. R&D/TSO is responsible for supplying initial standard samples to the plants. 應有套體制實時的創造，批準和維護標準感官樣品，在研發和PS站點有解決方法的文件資料。研發/TSO負責提供開始的標準樣品給工廠。 |
| 12.4.3 | Standard samples and solutions are clearly identified with contents, date of preparation, name of person who prepared the standard, appropriate reference and expiration date.標準樣品和解決方案很明確的標明內容，準備日期，準備標準的人員，參考和有效期。 |
| 12.4.4 | Sensory standards are stored under conditions that minimize degradation. 感官標準存儲在退化最小的條件下。 |
| 12.4.5 | There is a selection process designed to evaluate the sensitivity of the individual for the parameter to be tested, including requirements for periodic requalification.應有選技一套工藝流程設計以評估測試參數的個別敏感性，包括定時重新限定。 |
| 12.4.6 | Panelists undergo a documented training and qualification process and a system exists to ensure they remain qualified and calibrated over time.陪同人員經過培訓和申請資格過程，系統存在以保証超過一定時間他們仍然是有資格的. |
| 12.4.7 | Members of a sensory evaluation panel are physically able to perform as expected during the panel test; e.g. odor panelists with colds or nasal congestion are excluded |
| 12.4.8 | Sensory testing is performed in a segregated area free from taints, odors and other conflicting sensory impressions.感官測試隔離無污染，無氣味區域測試。 |
| 12.5 | Laboratory reagents and media used in generating data are controlled and standardized.實驗室試劑和媒介用於產生實驗數據需控制和標準化 |
| 12.5.1 | The methods of standardization are included in the test method or derived from approved compendia.標準化的方法包含在測試方法中或來自經過認可的概略 |
| 12.5.2 | Reagents, chemicals standards, stock solutions and media are prepared according to manufacturers’ or approved procedures. 試劑，化學規格，存儲解決方法和媒介按廠商或經過批準的程序準備。 |
| 12.5.3 | The true concentration of active material is determined for reagents and standard solutions intended for use in quantitative analysis. Commercially prepared standard solutions from qualified suppliers can be accepted and used based on the supplier's COA, but must be verified periodically after opening.活性物質濃度決定用於試劑的定量分析，商業要求從有資歷的供應商準備或是按供應商的CQA準備。打開以後需定期確認 |
| 12.5.4 | Microbiological media is labeled with its identification, date of preparation/receipt, date opened, expiration date and the name of the preparer.生物媒介需標出品名，準備/接收打開日期,有效期和準備人員。 |
| 12.5.5 | Microbiological media is positively and negatively controlled prior to or concurrent with its use in testing.在使用前或使用當中應能很好的管控生物媒介。 |
| 12.5.6 | The determination and control of expiration dates is outlined in a written procedure (or follow manufacturers' recommendations) and regular checks are carried out to ensure that no expired materials are in use.要保証沒有過期的材料被用到，有書面程序文件（或按生產商薦意）並定期檢查 |
| 12.5.7 | Laboratory reagents are stored under conditions that prevent degradation. Regular checks are made of chemicals, reagents and media to ensure they remain suitable for use.實驗試劑被存儲到能防止退化的條件下，定期檢查化學物，試劑和媒介給保工業化它們仍然可用 |
| 12.6 | Laboratory results are recorded as work is conducted and the records retained.實驗結果應該記錄備案。 |
| 12.6.1 | Analytical and microbiological test results are documented (in permanent ink when written by hand), together with a reference to the method, relevant calculations and the original data from laboratory equipment, such as printouts. Data is entered directly into the official record, and not to another place for later transcription.分析和生物測試結果應歸檔記錄（如手寫剛用永久墨水）與來自實驗室設備中的參考方式,相關計算方法和原始數據一起保留。像打印出來的，做為資料正式記錄起來,不能隨後抄. |
| 12.6.2 | The minimum information recorded as part of lab records includes:至少經下記錄信息是實驗室記錄的一部份 - The sample identification number or name.樣品身份名稱 - Batch number and where needed, the manufacturer and/or supplier.批號或哪裡生產，生產廠家或供應商 - Reference to the relevant specifications and methods.參考的相關規格書和方法 - Test results including observations and calculations and a copy of any relevant certificates of analysis.測試結果包含觀察方法和計算方法和一份相關分析証明拷貝 - Dates of testing and the identity of the analyst and where required, the identity of the person verifying the testing and calculations. 測試數據和分析人員身份，確認測試和計算人員 - Identification of the specific pieces of equipment used.所用設備種類 - Where labs are responsible to determine specification conformance, clarity on whether the material or product met specifications.是否材料或產品符合規格書 |
| 12.6.3 | Laboratory analysts enter their calculations and test results in bound notebooks with pre-numbered pages or other recording system incorporating controls assuring records' integrity and security against loss. 實驗分析人員把他們的計算和測試結果寫入筆記本或其它記錄系統合並管控以保証記錄的真實性和安全性以免損失。 |
| 12.6.4 | Analyses are recorded in a manner that permits trend analysis of the results. |
| 12.7 | The accuracy and precision of the data provided by the laboratory is verified over time and the results of these on-going checks is documented.實驗產生的數據的精確度和精密度應該經過反復認証，並且每次現場的檢驗結果都應有文件記錄。 |
| 12.7.1 | There is a system to minimize the variability in laboratory results through different analysts, equipment or environment, track method performance and identify causes of excessive variability. 有套體制保証將實驗結果變化降到最小,通過不同分析人員，設備或環境,追蹤方法和辨認超過可變性原因、 |
| 12.7.2 | There is an on-going program to verify the accuracy and precision of the data provided between laboratories (within a site or site-to-site), such as co-op programs, check standards, etc.應有套向前進行的程序確認實驗室（一個站點或站到站）提供的數據精確,像CO-OP程序和檢查標準等。 |
| 12.7.3 | If the results of these on-going verifications indicate that analyses are not accurate or precise, then investigation is conducted and improvement plans carried out.若向前進行的程序指出分析不正確或精確，需採購調查和改善計劃。 |
| 12.8 | Out-of-specification results are investigated and acted on.不符合標準規格的實驗結果應該進行調查並採取措施。 |
| 12.8.1 | The laboratory has a written procedure for handling out-of-specification results including documentation requirements. For product categories that have established global or regional procedures, these are followed. 實驗室應有套書面的程序處理不符規格的結果 |
| 12.8.2 | Retesting is acceptable when the investigation indicates that analyst error caused the out-of-specification result or when the review is inconclusive. Retesting/resampling is only permitted as defined in the approved procedures/standards.調查顯示由於分析人員錯誤造成的出現不符規格的結果可接受重測，但重測或重抽樣需經批準程序或標準允許。 |
| 12.8.3 | The results of the investigation are reviewed and approved by a second qualified person before action is taken. 在採取行動前 調查結果核查和批準由第二批有資格人員 |
| 12.8.4 | The final disposition of the product and the reasons for that disposition is recorded.需記錄最終的部署 |
| 13 | Process Control. 制程控制 Effective Process Control enables us to consistently deliver high quality products at the lowest possible cost. Effective daily management systems must be established to control processes to defined & validated conditions to deliver consistent product quality. 有效的制程控制促使盡用可能低成本生產出高品質的產品，必須建立有效的日常管理體制控制生產一致品質產品確實的條件 |
| 13.1 | There is an established process to develop & define the process to consistently deliver the product design. 應有套建立的程序去開發和定義制程一如既往的傳送產品設計. |
| 13.1.1 | Process design requirements are established based on product design, consumer needs and production requirements. These requirements are documented including control parameters/limits.制程設計需求應按產品的設計要求，消費者需要和生產需要建立,這些要求包控制參數和限度值需歸檔 |
| 13.1.2 | A structured approach is followed to define, document and deliver robust processes and methods for producing and testing the product and package. This approach uses approved methodologies, scientific and statistically based experimental techniques to establish the optimum process conditions and their allowable ranges.需跟隨已形成的方案來議定，歸檔，傳送制程和生產產品方法和產品包裝測試,這方案用方法學，基於實驗驗証的技術科學統計建立最優的制程條件和允許的范圍. |
| 13.1.3 | The impact of processing time and scale factors on product are considered during development in pilot facilities.影響產品制程時間和規模的因素需要產品開發試產時考慮。 |
| 13.1.4 | Product Development and production organizations are jointly responsible for defining the final, full scale process conditions and control strategy that yields desired production and product quality results.產品開發和生產公司需對最終的，總體的制程條件和管控策略以期想要的產量和產品品質。 |
| 13.1.5 | Relationship between process control parameters and finished product/package characteristics are quantified and documented. 制程管控參數體現在成品/包裝特點上. |
| 13.1.6 | Critical process parameters (e.g. optimum set-up conditions, centerlines and target process conditions such as cleaning/lubrication/maintenance) are defined for all products. 關鍵的制程參數（如最優設置條件，中心線，目標制程條件像清潔/維護）需給所有產品定義 |
| 13.1.7 | Control points to be monitored, trigger points for intervention, adjustments to be made, their expected impact and the allowable range of these adjustments are documented. Control parameters (e.g. limits) consider the impact from equipment, process conditions, raw and packing materials and plant utilities/environmental factors. Process operating/control strategies and trouble-shooting techniques for problem situations are documented. These indicate potential actions and clearly detail the extent of adjustment. 監控控制點，幹預關鍵點，如需調整剛預期的影響和允許范圍需有文件資料証明。控制參數（限度）需考慮設備，制程條件，原料和包裝材料和工廠設施/環境因素. |
| 13.1.8 | Process control verification/validation follows a written protocol, which ensures representative conditions (equipment, materials, people, environment, specifications and duration). Valid test methods, statistical data, success criteria and review/approval of results. Process control parameters are verified as effective as described in the validation/readiness reports. 制程控制確認需照書面方案，保証主要條件（設備,材料，人員，環境，規格書和為期時間）.有效的測試方式，統計數據,成功標準和核查批準結果。制程控制的參數像在的已有的報告中確認的一樣有效。 |
| 13.2 | There is a documented process to transfer and implement the completed process control strategy into the daily operation. This is a joint responsibility of R&D and PS. The format and content of process control strategy/plan documentation follows business unit requirements.應有套成文件的程序用於轉達和貫徹執行日常運作中完整的制程控制策略, R&D and PS. 有連帶的責任,制程控制策略/計劃的內容和形式按業務單位要求來。 |
| 13.2.1 | There is a process to ensure that the plant systems are suitable to implement the process control strategy and deliver the intended result. 應有一套程序保証工廠系統適合貫徹制程策略和交付已有的結果 |
| 13.2.2 | Operating personnel are trained to understand these parameters and their relationship to finished product quality, what to monitor, when and how to investigate abnormal variation.應操作人員理解參數與成品的關系，監控什麼，何時和怎麼調查不正常的變化。 |
| 13.2.3 | Details are developed to integrate and systematize the specific control of equipment, buildings, utilities, environment (e.g. Q factors) into the manufacturing site.詳細資料應形成集中和系統化特別管控制造場所的設備，建築，設施和環境 |
| 13.2.4 | Technical understanding developed during the site specific transfers are documented and included in transfer process, logic diagrams and transformation flow sheets as provided.技術上理解形成,特別轉移需歸檔並包含轉移進程，圖表，轉移流程表。 |
| 13.3 | The Process Control Strategy is fully executed. The process is in control and the product is consistent as designed. Process parameters are monitored and control responses are implemented..制程控制策略完全執行到位，能控制到產品與設計的一致.監控制程的參數和控制已執行的反應。 |
| 13.3.1 | Process adjustments are made by qualified personnel in accordance with the defined process control strategy and these adjustments are recorded. There are sufficient process documentation and troubleshooting guides to correct process problems. 隻有資格的人才可按制程控制策略調整制程制程並做調整 記錄，這些充足的制程文件和問題解決導向可糾正制程問題。 |
| 13.3.2 | Measures of process control and product consistency are established (e.g. center line compliance, Cr/Tz, Cpk, Q factors). Data analysis tools are applied (e.g. control charts, decision trees, histograms, Pareto charts, six sigma).建立 制程控制和產品密度量度,可應用數據分析工具（控制圖表,策測圖表，柱狀圖等） |
| 13.3.3 | The effectiveness of the control strategy is verified or validated (see KE6). Results monitoring and trend analysis are in place. Near misses, quality alerts and quality variances are reported, investigated and corrected and these actions documented and tracked (see KE18). 証實控制策略的有效性，適當的做結果監測和趨勢分析，報告，調查和糾正近乎失敗,品質預警和品質編印,這些行動需歸樓和追溯. |
| 13.3.4 | Changes to the Process Control Strategy need to go through the Change Control system (see KE 6).變化制程控制策略需全面檢查變化控制體制. |
| 14 | In Process & Finished Product Release & Control. Only products meeting technical standards are released. In order to protect the consumer from off-quality products, traceability is maintained through the manufacturing and shipping process so that products may be retrieved from the market efficiently and accurately.加工和成品放行和控制。隻有符合技術標準的產品才可放行，為了保護消費者不買到不符標準備的產品，所有的生產出貨過程都需是可追溯的，以便發生品質問題時準確有效的找回。 |
| 14.1 | A system is defined for the release of all products.應有套體制放行所有的產品 |
| 14.1.1 | Testing, sampling and limits used in release decisions for intermediates and finished products are defined by R&D in technical standards (e.g. specifications, process/manufacturing/warehousing standards, formula cards, packing standards). R&D and QA concur with the release of finished product until responsibility for release is formally transferred to QA (via a pre-agreed protocol). 測試，抽樣 和界定運用於半成品和成品放行決定,產品按工程標準所做的（標準包規格書,加工/制作/倉儲標準,包裝標準）,研發和QA同意產品放行直到產品正式移交給其部門（按原訂的協議）. |
| 14.1.2 | Products intended for consumer studies must also comply with the following:供消費者學習使用的贈品需符合以下條件 - PS & RA clearance of materials, components, labels and products involved.產品相關PS和RA物料成份標貼清除. - Patent/legal clearance for the use of any proprietary materials, designs or technology.有關產品專利和使用材料，設計和技術的清除。 - Laboratory and test records are accurate and complete.實驗和測試記錄需精確和完整的。 |
| 14.2 | The intermediate product release system ensures that only intermediates meeting release criteria are available for use. 半成品放行體制保証隻有半成品會議放行標準可以放行. |
| 14.2.1 | Making and packing processes manage in-process release by means of the documented Process Control strategies (see KE13). 制作和包裝過程管理加工中的放行通過有文件資料可用的制程管控策略。 |
| 14.2.2 | Where regulations and standards allow, intermediate products can be moved to the next stage of the process before testing is complete, so long as the process is validated and the finished product is not released until the results of testing are available, all materials are shown to be in specification and the lot is released by QA.隻要安規和標準允許，半成品可以在完全檢測完成前流入下一步加工,隻要加工是有效的，並且成品隻有在檢測結果出來才可以放行，所有的物料符合規格書,QA才可以放行一批。 |
| 14.3 | The finished product release system ensures that only product meeting release criteria is available for shipment.成品的放行體制保証隻有產品會議放行標準才可放行出貨。 |
| 14.3.1 | Finished product can be released for shipment when all raw & packing materials, intermediates and finished product analyses meet specification, all production/packing standards are met and relevant quality records are complete and checked. Where required by regulations, yield accounting is complete and the results within the allowable variance.產品在如此情形時才可以放行出貨，所有物料包裝,半成品，成品分析符合規格書，符合所有生產和包裝標準並且相關品質記錄完成和檢查過，按規則要求，產量入賬完成並且結果在允許的偏差范圍。 |
| 14.3.2 | QA organizations define positive finished product release strategies for each product such that product does not ship to customers without evidence of meeting release criteria. Strategies may be either continuous or lot.QA部詳細給每個產品定義正確的成品放行策略,如有沒有証據証明產品符合放行標準則不可以出貨。策略包持續的或是批次的。 Continuous: Release of the product is based upon continual evaluation of data generated from the Process Control systems and in-process sampling indicating compliance to Technical Standards. If the values are out of specification, product is not released.持續的:貨物放行基於加工管控體制產生的數據不斷的評估和制程中抽樣顯示符合技術標準.如數值在規格書這外，則不能放行。 Lot Release: Product lots are quarantined and not released until results of analysis/process control data are available and approved by QA.批次放行:整批隔離檢查直到分析結果和制程中數據出來並且經QA批準才可放行。 |
| 14.3.3 | Release processes include a review of manufacturing records for completeness. The review also includes a check for deviations from standard.放行過程包括核查生產記錄，核查偏差標準。 |
| 14.4 | There is a system that ensures that product for export meets the requirements of the importing market.應有套體制保証出品產符合進口市場要求。 |
| 14.4.1 | The importing organization will ensure that local market requirements and regulations are communicated to the exporting organization and that shipment is allowed in technical standards. This information includes, as a minimum:進口公司需保証把當地市場要求和安規與出口公司有詳細的溝通並且所出貨是符合技術標準的。這些信息應包括,至少以下幾點: - Unit load structure and labeling.成品的負荷結構並標上標簽. - Container loading and identification.貨櫃裝貨並標明 - Permissible remaining shelf life.允許保存的保質期 - Regulatory requirements on product coding and labeling.安規要求的條碼和標簽 - Language and coding requirements for both product and load labels.產品和裝貨所需語言和條碼要求 - Required documentation and permits.需要的文件資料和通行証。 |
| 14.4.2 | The exporting organization ensures that product loads meet the import requirements prior to releasing the shipment.出口公司保証產品裝裝符合進口國要求才可放行出貨。 |
| 14.4.3 | The importing organization or its designated agent ensures that the shipment is in compliance on arrival at the importing country. The exporting organization is responsible for all aspects of cross-border direct-customer shipments and deviation investigation.進口公司或其代理保証進口的貨物交對進口地點，出口公司負責跨境所有直接客人貨物的出貨和偏差的調查。 |
| 14.4.4 | Land shipments involving transit across other countries comply with all relevant regulations in these geographies.跨國陸路運輸的貨物需符合相關地區的安規。 |
| 14.5 | There is a system to ensure release, reprocessing or rework of intermediates and finished product is controlled and authorized.應有套體制保証半成品和成品的放行，回收或返工管控和授權。 |
| 14.5.1 | Intermediates and finished products not meeting requirements in relevant technical standards are prevented from being used or shipped.與相關技術標準不符的半成品和成品應禁止使用和發貨。 |
| 14.5.2 | The reason for the deviation is investigated and documented in a deviation report.偏差原因調查歸檔到偏差報告文件資料中。 |
| 14.5.3 | The release or rework of off-quality product is approved by QA. 需QA批準放行或返工次品。 |
| 14.5.4 | There is a technical standard covering each occasion an intermediate or finished product is reworked. 需有技術標準覆蓋每一批返工的半成品和成品 |
| 14.5.5 | The frequency of rework included in technical standards (e.g. recycle streams), is monitored as part of the process control strategy. If rework becomes more frequent, the manufacturing process is investigated to identify deviations from the original validation.返工次數包括在技術標準內，並作為制程控制策略的一部份，如返工變的很頻繁，則要確認生產過程控制策略的有效性。 |
| 14.5.6 | Test product not intended to be shipped as part of regular production must be carefully controlled (e.g. packed in blank packages and cases, not normal printed stock).測試產品若要用作出貨的一部份則要小心管控（如包在白盒中，而不是正常的印刷盒存儲) |
| 14.6 | Inventory control systems are capable of preventing the accidental shipment of unreleased or off-standard product and intermediates.倉庫管控體制有能力預防處理突發事件沒能放行的出貨或是沒達標的成品和半成品. |
| 14.6.1 | The inventory control strategy includes processes (e.g. electronic control or manual labeling) for identifying and isolating product that is not shippable. Rejected materials are individually labeled with their identity, quantity and reason for rejection. 倉儲管控策略包這些過程(電子管控或手工標示）以區分和隔離不能出的貨，不合格材料需單獨標示出品名，數量和不合格原因. |
| 14.6.2 | Where an approved, validated, computer-based system is used, items under quality inspection, blocked or reject status are not separated from good stock as long as the validation has proven the following points:有經過批準，有效的電腦系統管控的倉庫,不合格品，封鎖的或判退的貨不從良品倉庫中分開隻要確認以下幾點有效可行： - The system and strategy have steps that prevent accidental miss-shipment such as: use of bar-code readers, visual placards or chaining-off racks or areas containing the suspect material.有步驟的體制和策略阻止亂發貨的事件如:讀卡器讀條碼，在不合格區張貼標示和圍上。 - The authority to release product is clearly defined and restricted to specified roles/positions in the organization.可放行的貨物清楚的標示並且限制在公司特別指定的位置。 - Any items that pose a safety risk or could further damage adjacent stock by leakage or odor transfer is removed from normal storage areas.任何會形成安全隱患的或產生進一步損害其它存儲物的泄露或氣味散發都需移離正常儲存區。 |
| 14.6.3 | Where either manual or computer systems do not meet the requirements above, non-shippable items are physically isolated from good stock.或是手工或是電腦系統管控的不能符合以上要求的體制，不合格的貨物都需從良品倉隔離。 |
| 14.6.4 | Unreleased product can be shipped between P&G-controlled sites only when the producing site retains control over unreleased product in both locations (such as shipping a quarantined product to a distribution center) and allowed by regulation. This procedure is described in a SOP.不能放行的貨物隻能在寶潔公司內部轉移，而按安規要求生產廠保持對此批物貨的二個地方的管控（從隔離區到分發中心）,這個程序在SOP中有描述. |
| 14.7 | There are systems to maintain traceability of material and products that allow accurate and rapid recall.應有套體制以維護材料和產品的可追溯性，可準確快速召回. |
| 14.7.1 | Recall of product from the trade, including customer warehouses requires high-level agreement. Retrievals of product have the agreement of the MDO, GBU and R&D senior managers responsible for the region as well as the Vice President of WQA.從市場中召回產品包從客人倉庫中需高級協議，需區域高級主管和WQA副總的同意。 |
| 14.7.2 | Production lot codes for all products are recorded in the inventory control system and there is the capability to track to all customer orders. The system is capable of tracking back to the starting materials and systems used to manufacture the product.生產的批號應已記錄在倉儲管理系統中並且可追溯到客人訂單，這系統並且還可以追溯到開始用物料及生產體制。 |
| 14.7.3 | Shipping locations maintain the capability to generate a complete customer list within 48 hours showing where a particular production lot was shipped. The customer list accounts for the full quantity of the product available for shipment with an accuracy of +/- 2%. Local regulations may require stricter limits.當一批特別的貨已發送發貨區必須可在48小時內能產生完整的客戶清單資料,全部可出貨的數量準確達隻有+/- 2%偏差，當地安規可能有更嚴格的限制。 |
| 14.7.4 | This traceability system is tested as needed (e.g. mock retrieval, annual minimum) to ensure system effectiveness against success criteria. The results of this test must be documented to include: 這些可追溯的系統測試是必須的，來保証系統的效性和成功的標準一致.測試結果必須歸檔包括 - Raw/pack material to FP product traceability.原料和包裝物料的可追溯性。 - Total amount produced, shipped and located. 總量生產，發貨和放置。 - Elapsed time to complete data collection (e.g. mock or actual).完成數據收集 - Count of stock remaining in the warehouse.倉庫存貨量清點 |
| 14.7.5 | There is a product retrieval plan based upon Company requirements that includes:按公司要求產品的撤回計劃包以下： - A clear definition of responsibilities, including a named coordinator for the retrieval process.清楚的責任定義，包協助撤回的人員。 - The steps needed to raise the customer list in the required time.有需要時間產生客人清單資料 - A list of organizations and individuals who will need to be involved with the process.涉入到的公司和個人清單。 - A definition of who is notified and involved.詳細定義誰需通知 |
| 14.7.6 | Product returned as part of a retrieval is clearly identified and physically isolated from normal stock.退回的貨作為撤回的一部份應明確標示和與正常存儲隔離存放 |
| 14.8 | There is a system to ensure that rejected or excess (not fully consumed within the supply chain) products and intermediates are made unusable to prevent inadvertent use or misuse.應有套體制保証退貨的或是多余的（在供應鏈中沒被完全消耗）成品或是半成品不能誤用或是亂用。 |
| 14.8.1 | Products and intermediates no longer required by the business are made unusable or donated as defined in Company policy 11.公司政策詳細說明產品和半成品不再用的不能亂用或損贈 |
| 15 | Records. 記錄 Records include data, reports and other information as required to support quality decisions and conclusions. Thorough documentation is good science and makes good business sense, and for some businesses, there are specific legal requirements. Records enable us to investigate complaints, spot trends, protect intellectual property, make product improvements, establish traceability for research and manufacturing, and to retrieve products should that ever be necessary. Accuracy, completeness, timeliness and availability for analysis & conclusions are critical parameters for a useful records system. For development and initiative decisions relative to product and package design, R&D is accountable for these records and reports even if acquired or delegated to PS or Contractors.記錄包數據，報告和其它其關支持品質決定的信息和結論，全部的文件資料的整理歸檔是科科的並且讓業務更有意義，有些生意有些特別法律的要求。記錄可是我們的調查投訴，調查趨勢，保護知識產權，改善產品，為研究和制造建立可追溯性.找回產品變得需要,有用的記錄系統是由精確，完整，合時和有效的分析總結生要的參數，, |
| 15.1 | Records contain a full and accurate account of work performed and are generated as work is being performed. 記錄應包括完整和和準確的工作執行情況和正在繼續執行的工作。 |
| 15.1.1 | Paper records are filled out in ink, legible and signed or initialed, as required, by the person completing the record. When used, electronic records systems provide security and integrity of records equivalent to paper.紙質記錄需用墨水填寫，清晰的並且記錄人員簽上名或大寫，當使用時，電子檔記錄與紙記錄的應是一樣安全完整的。 |
| 15.1.2 | Records provide traceability of materials and reproducibility of activities. The information must be sufficient to reconstruct the critical events/aspects of manufacturing, testing, distribution or development operation. 記錄提供了材料的可追溯性和活動的再現性，這些信息由於生產，測試，分發和開發操作的各個方面和重要事件構成。 |
| 15.1.3 | The correct method for correcting entries is to draw a single line through the error, initial, date and enter the correct data and explanation for the correction as close as possible to the original. The use of correcting fluid or any other method of obliterating the error is not permitted. 改正隻能在錯語處線標出，然後在離原文最近的地方寫上正確的內容，不能用塗改液. |
| 15.1.4 | Where required, electronic records retain a transaction audit trail to show modification information.當需要,電子檔記錄保留一個事務審核索引以找修改信息. |
| 15.1.5 | The records stored in computer files are complete, accurate, secure and retrievable. 存在電腦中的文件是完整的，精確的，安全的並且可找回的。 |
| 15.1.6 | Where we elect to maintain regulatory records in an electronic format, systems comply with the applicable regulations and Company policy.當維護存的電子檔和系統中安規記錄時應按安規和公司要求維護 |
| 15.2 | Records are durable (able to be stored as long as required) and easily retrievable within their defined retention periods. As electronic technology changes, access to existing records is maintained where required.記錄保持需持久(要求存多久就能存多久）能按時期很好的分類並容易查找。隨著電子技術變革，能維護目前存在的記錄檔案到要求的地方。 |
| 15.2.1 | The required records (electronic or paper) are kept secured, consistent with their asset classification. 要求的記錄（電子檔或紙質）需安全保存，和他們的分類 一致. |
| 15.2.2 | Storage conditions ensure that records will not deteriorate or become corrupted over time. 存儲條件保証所有記錄長時間 不會變質 |
| 15.2.3 | Records must be accessible in a timely manner. Where required by regulation, there must be a system to make R&D records available to manufacturing sites.記錄需合時易取，按安規要求，在生產工廠有研發記錄可用。 |
| 15.2.4 | There is a written procedure for backing up and restoring computer or other electronic records.有書面程序備份和存儲電腦中或其它電子記錄. |
| 15.2.5 | Records are retained for a period defined by procedure or policy in compliance with relevant regulations.符合安規文件的程序要求記錄須保存一定時間 |
| 15.2.6 | Information required by regulations is documented and retrievable within required time frames.安規需要的文件資料已歸檔好並且在一定時間內可找回 |
| 15.2.7 | For any document related to QA/Product/Process/Procedure/Development, printing on the back side of previous or expired documents (such as for the purpose of cost savings) is not allowed.相關QA/產品/制程/程序/開發的文件資料.不可以在打印在用過一面的文件紙上（即使為節約）也不不允許的. |
| 15.3 | Data & reports defined for product launch initiatives are accumulated and retained supporting each specific product/market combination. 存儲產品投放數據的詳細資料需累積和保留以做每種產品資料和市場結合的支持資料。 |
| 15.3.1 | Where product registration is required, all documentation pertinent to the registration is retained.產品注冊需要,所有相關產品注冊的文件需保留. |
| 15.3.2 | Documentation used to prepare and support patent applications and claim support is retained.專利申請文件資料需保留. |
| 15.3.3 | Product Development documents all key steps and decisions made during the product/package development and initiative process along with supporting data and rationale, based on consumer/customer acceptance, performance, regulatory compliance, stability, compatibility and other relevant success criteria. 在產品開發和包裝設計制作等所有關鍵步驟和決定相關文件資料和有關客戶/消費者接收，執行符合安規的基本原理需保留. |
| 15.3.4 | Records show that product made for consumer testing/use or for use in establishing product stability/shelf life was produced in compliance with approved technical standards, Company and regulatory guidelines. 記錄應可以顯示為消費產品使用做過測試以確保產品的穩定性/保質期並符合經批準的技術標準和安規要求。 |
| 15.3.5 | Written procedures define the records required prior to launch of an initiative. This documentation demonstrates compliance with quality assurance, regulatory, consumer and customer acceptance requirements.書面程序規定記錄在產品開始投放市場之前就開始,這些文件可証明產品是符合質保,安規，消費者和客戶能接受的。 |
| 15.4 | There is system for R&D and PS technical delegates to capture learnings such as consumer/customer understanding, technology identification and market knowledge.應有一個給研發和技術代表了解消費者或客戶,技術和市場知識的學習體制. |
| 15.4.1 | Development records (primary records such as lab notebooks and secondary records such as technical reports) are accurate, complete and detailed to ensure learnings are maintained and allow work to be repeated, if necessary, or continued at a later date, such as:開發記錄（主要是實驗筆記和次要的記錄像技術報告）必須準確，完整並保留好以防需再現可再現工作，若將來要用時可能繼續之前的工作。像: - Key consumer habits & practices, demographics, potential market size, key unmet consumer needs. 關鍵的消費者購買習慣，消費人群數量，潛在市場大小和需求。 - Potential product technologies under development.開發不全時潛在的產品技術含量 - Technical testing methods and data.技術測試方式和數據 - Consumer test methods and data.消費者測試方式和數據 - Accelerated stability protocols and reports.加快產品穩定性草案和報告。 - Real-time stability test data generated using the representative process, product and packaging. 用典型的制程方法，產品和包裝實時穩定性測試數據 - Records supporting patent applications and substantiation.專利申請記錄資料 - Risk assessments.風險評估 - Failure analysis and return assessments.失敗分析和退貨評估 |
| 15.4.2 | Required technical reports supporting product design and quality related decisions are defined and retained. 支持產品設計和品質決定的需求技術報告需詳細定義和保留 - Market segment and brand equity reports.品牌分割市場報告 - New initiatives plans (e.g. pipeline).新啟動計劃 - Claims Support reports and data.申請支持報告和數據 - Franchise/business-building evaluations.專賣業務建立評估 - Independent institute testing and external endorsements.獨立資格的測試和外面背書 - Decisions and any mitigation plans to reduce risk.減少風險的決定計劃 - Decisions and mitigation plans regarding failures and return levels.有關失敗和退回水平的決定計劃 |
| 15.4.3 | Development work conducted externally by strategic partners, contractors etc. is controlled and documented to ensure that products meet Company standards and regulations. Records are developed and maintained similar to internal R&D records to achieve traceability, reproducibility and freedom to practice. 外面的戰略合作伙伴,供應商等開發的工作也需管控，保証有件資料証明產品是符合公司標準和安規，所做記錄也應和公司內部開記錄類似有可追溯性，效率性. |
| 15.4.4 | External partners conducting development work are to be qualified and checked periodically to confirm that their systems are capable of meeting Company standards and regulatory requirement.外面合作伙伴執行開發工作的需有資格的並需定期查核其體制是有能力符合公司標準和安規要求的。 |
| 15.5 | R&D (in conjunction with PS&RA and ER) accumulates, correlates and files all data required to be available to be communicated to the public domain.研發（與PS&RA and ER同力合作）積累，聯接和歸檔所有的需求資料到公用盤以方便公司人員溝通 . |
| 15.5.1 | The product information files are compiled, when required, and contain data required and are retrievable on request within 48 hours.產品信息文件需匯編，當有需要時，保留的資料在48小時內可取回 |
| 15.5.2 | Product composition and ingredient information required by external authorities is compiled, controlled and kept available by R&D (in conjunction with PS&RA). Information is retrievable within the time specified by the regulatory authorities in the country of sale.外面權威機構需要的產品的組成和成份信息需匯編，管控，並且由研發（與PS&RA同力合作）保存,當銷售地安規機構有需要時可在規定時間內取回 |
| 15.5.3 | Product information provided to the public domain goes through review (e.g. PS&RA, legal, external relations). 提供到公共盤的信息資料需重新核查. |
| 16 | Self Improvement Program.自我改善程序. The Self-Improvement Program (SIP) is the primary mechanism used to deliver the company's quality expectations. It is a tool used to evaluate sufficiency and confirm effectiveness of activities and systems related to quality. The SIP is needed to help ensure compliance with regulatory, Company and site-specific requirements. The SIP helps to identify opportunities for continuous improvement and prevents problems. A well functioning SIP identifies and corrects deficiencies in a systemic and timely manner. 自我改善程序（簡寫SIP）是一個公司到達產品品質預期主要的機制。這是評估和確認與品質相關體制和活動有效性的工具。SIP需要幫忙確保符合安規，公司和作業現場特別要求。SIP也幫忙確認機會給繼續改善和預防問題。一個功能非常有效的SIP能區分和改進系統和方式的不足。 For highly regulated businesses, i.e. those operating under GMP regulations, and especially those operations exporting P&G products to multiple countries having differing GMP requirements, the requirements contained in this SIP may be insufficient to ensure regulatory compliance and must be augmented by further evaluations specific to compliance with applicable regulations.高安規要求業務中，如在GMP安規管制下，尤其是出口寶潔公司產品到有各種不同GMP安規要求的國家,包括在SIP中的要求也許不能保証安規符合，必須增加更進一步的評估細節以符合各類應用安規. |
| 16.1 | There will be an organized self-assessment and improvement program which covers all areas of the site related to QA and Technical Standards.應有套有組織的自我評估和改善程序能覆蓋到與QA和技術標準有關的所有方面。 |
| 16.1.1 | Leadership actively participates in the Self Improvement Program.領導層應活躍於參加自我改善程序。 |
| 16.1.2 | There is a designated System Owner. 需指派體制的責任人。 |
| 16.1.3 | The auditing team includes expertise in the practice of auditing, effective system design, quality assurance, specific applicable regulatory requirements and the system or process being audited. 審核組應包在實踐審核中有專業知識，有效體制設計，品質保証，安規種類應用要求和需審核體制和加工過程的人員， |
| 16.1.4 | The SIP is defined by a written procedure.SIP應以書面程序定義 |
| 16.1.5 | All required systems are thoroughly assessed at a frequency as necessary to sustain capability, no less frequently than annually. 所有體制需經常全面評估以保持其實際能力,最少一年一次。 |
| 16.1.6 | SIP at sites handling products regulated by GMP regulations will include evaluation of the compliance of the site’s systems, operations and procedures against each requirement of all GMP regulations applicable to the site’s products. Sites must understand all GMP regulations for countries in which the products are manufactured, distributed or sold and comply with them. SIP工廠操作產品由GMP安規管控，包評估符合工廠體制，操作，程序符合GMP安規應用工廠產品的要求，工廠需理解生產,分發和銷售的產品需符合當地GMP安規要求。 |
| 16.2 | The Self Improvement Program will be fully documented, be site-wide, and follow an agreed schedule. The audit needs to be led by qualified individuals within the organization. Individuals should not be assigned to independently audit their own work or area of responsibility.SIP有完備的文件資料証明，寬大場所並按約定時間跟蹤，由公司內部有資格人員引導審核.內部審核人員不能單獨審核該人員所負責的工作或工作區。 |
| 16.2.1 | The total site audit team includes a cross section of the organization to cover the technical, operational and managerial aspects of the site.總的現場審核組應交叉包技術，操作和管理各方面人員。 |
| 16.2.2 | The established audit schedule is followed.應跟蹤建立的審核時間 |
| 16.2.3 | The system assessment (key elements for P&G) is in-depth and factual (not just a simple or general checklist).這個評估體制要深入（是寶潔公司的關鍵要素）和切實（不隻是簡單的一張檢查表） |
| 16.2.4 | A report is written upon conclusion of the assessment. Repeat observations are highlighted within the SIP audits.需按評估結論寫書面報告，在SIP審核中重復觀察結果突出。 |
| 16.3 | There will be evidence of self-initiated, systemic improvements stemming from internal observations and supported by site leadership. 從內部觀測報告或是工廠領導層支持中獲得自我主動，系統地改善事物的証明。 |
| 16.3.1 | Observations are investigated to determine root causes. Systemic solutions based on the deficiencies are identified and included on the action plans. Temporary corrective actions may be necessary until permanent solutions can be implemented. Corrective actions are verified to be effective. The action plans include designated owners and a completion date. 觀測報告決定根源,據不足的系統的解決方案應確認包含在行執行計劃中，在永久改善方案可以貫執行前採購臨時改善對策是必要的,.改善行動証明有效，這些改善計劃包括指定責任人和完成時間。 |
| 16.3.2 | Results, development of solutions and action plans are reviewed with leadership.結果，解決方案的形成和行動改善計劃需讓上層核查. |
| 16.3.3 | Sites will track the completion of all identified corrective actions. The expectation is that the sites will have the identified corrective actions completed in a reasonable time period. 工廠需追蹤完成所有的確認改善行動,並且需在合理的時間內完成 |
| 16.3.4 | Improvement plans can be a combination of the SIP, quality incident program, defect elimination and other quality systems. 改善計劃與SIP，品質事件程序，不良清除和其它品質體制結合運用. |
| 17 | Consumer and Customer Learning and Response. 消費者和客戶學習和回應 Consumer and customer contacts are a significant source of information concerning the design and perceived performance of our products. It is essential that information received, particularly in the complaint system, is recorded accurately and acted upon appropriately, especially health and safety related complaints. 消費者和客人間的聯系相當重要，是有關設計和產品業執行認知的信息來源,這是基本的信息收集，特別在客戶抱怨系統中,應精確的記錄和適時的處理，尤其有關健康和安全的投訴。 |
| 17.1 | There is a system in place to receive, investigate, document and follow-up on all verbal and written consumer and customer comments (e.g. inquiries, complaints or testimonials). Consumers and customers who contact us are handled promptly and in a professional manner. 應有一套體制適時接收，調查，歸檔和追蹤消費者和客人所有口頭，書面的評價（如詢問，抱怨或是感謝）.此工作人員需用專業方式快速處理. |
| 17.1.1 | The system includes:這套體制包括: - Defined initial points of contact.詳細說明最初聯系的幾點： - The information to be requested depends on the nature of the contact (complaint, inquiry, testimonial etc.). 這些信息應按要求依聯系性質分類（ 投訴，詢問，証書資料等。） - Training and qualification of the persons responsible for recording consumer comments to receive, record, respond to routine inquiries and classify the nature and severity of complaints. 培訓相關有資格人員負責客人反饋的接收，記錄，回應詢問和嚴重的抱怨，並且按性質分類. - Consumer relations personnel are fully briefed on product technology, positioning, claims and all other relevant facts prior to launch. Briefing extends to all advisers likely to handle calls in all countries where product is marketed.客服相關人員需全面簡要了解產品的技術，配置，投入市場相關的主要事項，能像顧問一樣掌握來電所詢的銷售到各國的產品簡要信息。 -Expected timeliness for the completion of the investigation.預期適時完成調查。 |
| 17.1.2 | The functional responsibilities of all organizations dealing with consumer comments is defined.處理客人反饋的所有組織功能作用需詳細定義. |
| 17.1.3 | The system is able to respond rapidly to cases involving a serious product failure, adverse reaction, potential tampering etc. (according to the nature and severity of complaint). The system defines when the regulatory and medical departments and senior management must be informed (again according to the complaint level). 這套體制能迅速回應有關產品嚴重不良，有害反應,潛在損害的事件.(按性質和抱怨的嚴重程度大小處理）也要詳細定義安規和醫療設備部和高級主管人員要被通知到（ 也是依照抱怨程度水平處理）. |
| 17.1.4 | The procedure for documenting and responding to complaints complies with regulations.照規則處理歸檔和回應投訴 |
| 17.1.5 | The procedure details when outside regulatory authorities are required to be notified.當外面的權威安規有需要通知到時詳細說明程序。 |
| 17.1.6 | There is a system to gather customer and consumer feedback (e.g. complaints, return levels, damage and defect levels) such as from retailers, warranty repair services, industrial customers using our products as their ingredients or components, professional services and original equipment manufacturers as relevant. The data is utilized to verify and improve the design of products, packages, services and supply chains.有套體制集中客人和消費者的反饋(如投訴,退回標準,損壞和不良標準）像從零售商，保修期服務，做工業成份或部件用的工業客戶，專業服務，原始設備制造相關地方。利用這些數據証明和改善產品設計，包裝，服務和供應鏈. |
| 17.2 | There is a system in place to evaluate the nature and severity of consumer and customer complaints, determine the extent of investigation and follow-up actions to be taken. For complaints related to Drug & Medical Devices products, Quality Assurance will assess and document the need for further investigation.應有一套體制，適當的評估消費者和客人投訴性質的嚴重性,決定展開調查和採取下一步跟蹤行動,對於藥品和醫療設備產品和相關投訴，品質保証需評估和証需更進一步調查的必要. |
| 17.2.1 | Samples returned are investigated according to established procedures.退回的樣品需按照已建立的程序調查。 |
| 17.2.2 | A full investigation includes, as necessary:完整的調查包含也是必要的: - The involvement of personnel from the affected departments. 涉及的人員來自受影響商場。 - Root cause analysis.根原分析 - Analysis and/or testing of the complaint sample and a comparison of the results with the product specifications.分析和測試投訴退回的產品比照產品規格書分析。 - Inspection of production documentation relevant to the complaint to identify material or process errors. 檢查與投訴相關的產品文件確認為物料或是加工過失。 - Inspection and/or testing of retained samples, if lot number is known.需保留檢查和測試樣品，若批次號已知。 - A written report of investigation results, findings and conclusions.需有書面的調查報告，查原和結論. |
| 17.2.3 | There is a person designated to follow through on action plans.需指派人員跟蹤整個行動計劃. |
| 17.2.4. | An action plan is developed based on the results of complaint incidence tracking and outcomes of investigations. Where required by regulation or certification, the action plan conforms to CAPA-Corrective and Preventative Actions, such as to include documented evidence that the actions taken were systemic and verified to be effective.根據投訴事件追蹤和調查結果形成行動計劃，按安規和証書需要，行動計劃符合CAPA-改進和預防行動，像包文件資料証據表明行動是系統化和有效的。 |
| 17.2.5 | Action plans are reviewed with QA, Product Supply, Product Development and PS&RA and Legal, if required. 若有需要，行動計劃需與QA，產品供應，產品開發和PS,RA和法律部門一起核查。 |
| 17.2.6 | The final report is a confidential document and is available at the source location (the producing site).最終的報告是機密文件需在生產場所能找到。 |
| 17.2.7 | There is a procedure defined for handling unexpected, serious issues arising in the market (tampering, threats of bio-terrorism etc.).有一套程序詳細詳細處理銷售市場發生的無法預料的，嚴重的問題,(損害的，公開恐嚇威協) |
| 17.3 | There is a system to eliminate sources of consumer/customer dissatisfaction with significant business impact. 應有一套消除對業務重大影響的消費者/客戶不滿意的體制. |
| 17.3.1 | There is a system to identify emerging, serious or repeating issues.應有體制辨認問題的浮現，嚴重和重復。 |
| 17.3.2 | The system includes a review of data and development of action plans to address the issues identified. 這套體制包數據的核查和致力於辨認問題的行動計劃的形成 |
| 17.3.3 | There are procedures in place to track, understand and address sources of consumer inquiries.有程序追溯，了解和致力於消費者詢問的來源。 |
| 17.3.4 | Complaints are utilized to identify consumer and customer issues that may arise after product launch.投訴需整合利用以區別產品投入市場引起的消費者和客人的問題 |
| 17.3.5 | Consumer contact verbatims are available to R&D and Customer Services as a resource for consumer learnings, product availability, etc.消費者聯系應給研發和客服部當做消費者知識和產品實用性的資源。 |
| 18 | Quality System Results Tracking and Improvement. 品質系統原由追溯和改進. Measurement and tracking of results is key to ongoing improvement. We know how our systems are performing so that we can set priorities for improvement efforts. Operations establish results tracking systems for their key Quality Assurance Systems to have an accurate picture of the current state and to identify needs for improvement. These measures include relevant sources of information, including available external (downstream customer/consumer) and internal measures of Quality Assurance.措施方法和追蹤起因是進一步改善的關鍵，我們知道體制是怎麼樣運作的就能為改善方面優先設置.公司設立起因追蹤系統是品質體制的關鍵,這能讓對改善有個對目前情況清晰明確的圖片和確認需要，這些方法包相關的信息來源，包外面（分銷商或是端消費者）和內在品質保証方案. |
| 18.1 | While the measures of PS, R&D & MDO operations may differ, each operation establishes both internal and external measures of quality for the purpose of maintenance, continuous improvement and initiative success. Internal measures are needed to achieve control and enable improvement. External (such as feedback from downstream customers, shelf quality defects, etc.) measures are needed to both validate internal measures and prioritize improvement efforts. 各部門的措施方法也許各公司不一樣，但每個公司都為維護，繼續改善和積極成功而建立內外品質措施，內部措施需要完成管控和促使改進，外部措施（如分銷商的反饋，貨架品質不良報告反饋等），這措施都有效以証實內部措施和優化改進方案。 |
| 18.1.1 | External and internal quality measures and action plans are tracked and routinely reviewed by leadership. 內部和外部的品質措施和行動計劃需可追溯和按程序讓上司核準. |
| 18.1.2 | The frequency of determining these measures and the use of historical data ensures that trends and special causes are identified promptly. 決定這些措施使用和歷史數據的運用能保証更快分清趨勢和查出特別原因. |
| 18.1.3 | Leadership sets goals to focus improvement against specific measures.上司需設立目標用特別措施注重改善 |
| 18.1.4 | There are periodic management reviews of product quality, quality system effectiveness and action plans. Business units will define the required frequency, process, participants and content. Where required by regulation or certification (such as required for ISO9001 or Medical Device regulations), these are scheduled and documented as required. 需定期性的管理檢查產品品質,品質系統的有效性和執行計劃,業務單位必須詳細定義需要審核的次數，過程，參與者和內容.按規則或証書要求（如按ISQ9001或是醫療設備規定）,按要求必須定時及備有詳細文件資料証明。 |
| 18.1.5 | Where required by regulation in the country of sale, annual product reviews are completed. 按銷售地安規要求，每年產品的檢查審核需完全。 |
| 18.2 | Operations have measures of Quality Assurance Capability to identify and correct risk areas that have the potential to create future incidents, defects, complaints, damage, retrieval or regulatory action. 公司應有質保能力來辨別和改正那些有潛在制造深遠事件，過失，抱怨，損壞和需要修補或調整行動的風險區域 . |
| 18.2.1 | QAC ratings from audits are tracked by the site along with the QAC ratings of any contractors, joint ventures and licensees the site is responsible for auditing.審核QAC等級需在工廠和任何供應商，合資公司和許可方使用場所可查和追溯. |
| 18.2.2 | Deficiencies identified by internal or external audits are corrected promptly in a systemic fashion to avoid repeated occurrences. Action plans for corrections are supported with measures that track progress (e.g.% compliance with scheduled audits, % actions completed on time, number of repeat observations and individual Key Element ratings). Action plans are reviewed with leadership to ensure on-going effectiveness of the QAC improvement program.內外部審核的不足確認需及時在系統格式中糾正以免重復發生,措施及進程是改進執行計劃的支持資料（如有百分之多少符合按時審核，有百分之多少是按時執行，重復觀測的數量，和單個關鍵元素級別）.執行計劃需上司核準以保証進行中的QAC改善規劃的有效性。 |
| 18.3 | Operations have measures of quality system failure, e.g. quality incidents, significant quality incidents, quality alerts, non-conformities or near misses. These highlight to leadership those failures found and corrected internally as well as those affecting downstream operations or customers. The key objective is to avoid failure recurrence.公司應有品質體系失敗的衡量標準,例如多少品質事件,重大品質事件,品質預警,不符和近期過失。這些著重區和那些影響分銷商操作或客戶操作的應讓管理層在內部發現和糾正，關鍵的目標是避免錯誤重發生. |
| 18.3.1 | Quality Incidents, their severity (e.g. SQI, QI or Quality Alert, frequency and cost) are tracked and reported. The site will establish procedures and records that include品質事件,它的嚴重性(如，SQI，QI和品質警報，發生頻率和成本費用）可追溯和報告,工廠應建立程序和記錄包括： 1. The use of criteria and/or appropriate statistical methodology to analyze available data (such as audit reports, defects, service records, complaints, returns, operational data) to identify non-conformities (e.g. system failures).標準的運用和/或適合的統計學方法來分析現有的數據（像審核報告，不良，服務記錄,抱怨，退貨，操作數據）以識別不符項（系統故障）. 2. The investigation of root causes and the planning of corrective and preventative actions.根本原因調查和改善和預防執行計劃 3. The verification of the effectiveness of corrective and preventative actions taken.改善，預防的有效性確認。 |
| 18.3.2 | Quality Incidents are thoroughly investigated by knowledgeable operating and QA personnel to identify root causes and drive systemic corrective action that prevent recurrence. Temporary corrective actions may be necessary until permanent solutions can be implemented.品質事件需收知識豐富的操作人員和QA人員查找原因，促使系統性改善以預防再次發生，可暫用臨時改善計劃直到永久對策可貫徹執行. |
| 18.3.3 | Where required by business unit, Quality Alerts (also known as near misses or damage tracking) are also tracked as an early indicator of quality incidents. 應業務單位要求,品質警報（以接近失誤或是損失追溯而知名）作為品質事件的初期指示器也可追塑。 |
| 18.4 | Operations measure and report process capability and defect levels promptly to ensure 1) timely control of manufacturing operations and 2) the use of quality criteria in initiatives.操作措施和報告生產能力和及時控制不良水平以保証及時控制生產運作和品質標準的積極應用。 |
| 18.4.1 | Making, converting and packing operations measure their process capability, where required by Company or business unit. This is done for reportable variables using statistics such as Cr, Tz and Cpk. Process Capability is also a measure used in evaluating initiative and project success.按公司或是業務單位要求生產制作，加工和包裝操作衡量加工能力，這些可用像Cr,Tz,Cpk 統計數據以報告變化清況，加工能力是用於評估項目成功的方法， |
| 18.4.2 | Making, converting and packing operations measure their defect level in ppm for all reportable parameters where required by Company or business unit. The defect level reported by line operations is independently verified periodically to ensure that underreporting does not occur. The defect level in ppm is a measure used in initiative and project success criteria.按公司或是業務單位要求生產制作，加工和包裝操作衡量不良水平用百分比數據做所有報告.操作線上不良率單獨報告需定時核對以保証沒有發生少報，百分比不良率是衡量項目好和成功的標準. |
| 18.4.3 | Business units are responsible to periodically measure and report quality of consumer units on store shelves (e.g. shelf quality, trade survey).業務單位需負責定期報告客人現貨品質情況（如現貨品質,交易調查） |
| 18.5 | Business units have measures of their customer/consumers’ satisfaction with key products/services. 業務單位應有客戶或消費者對其主要產品或服務滿意度的調查方法 |
| 18.5.1 | Customer and consumer satisfaction is tracked with methods such as surveys, questionnaires, studies, complaint tracking or interviews. Action is taken to reduce areas of dissatisfaction and loss.應用客戶和消費者滿意度調查追溯方法如各種調查,問卷調查，學習,抱怨追溯和投訴接見，採取減少不滿和損失。 |
| 18.6 | Operations or business units have a measure of the total cost of quality related losses (e.g. rework, reblend, quality incident costs, scrap product, expired product, reliability, etc.). 公司或業務單位應套方法計算總的質量相關損失總成本（如返工，混合區分工作 ，質量事情成本，產品報廢，產品過期，可靠性等損失) |
| 18.6.1 | Where required by business units, there is a program to measure and track quality related losses. There are plans in place to reduce these losses.按業務單位要求，需有套程序來計算和追溯品質相關損失,以便適時減少損失。 |
| 19 | Accountability for Contractors. 承包商的責任義務: This KE applies to P&G operations that manage contractors, or contractors that manage sub-contractors. Procter & Gamble's quality expectations of contractors are no different from P&G sites, including the expectation for continual improvement. This element may also include providers of quality critical services and data. Contractors may develop, prototype, make, package, label, manipulate, analyze, warehouse or distribute products, provide data management services or any combination of these. 這是KE運用管理寶潔公司的承包商,包是轉包商,寶潔公司對供應商的品質預期與其自己工廠的質量預期是一樣的，包括不斷的改進期望.這些元素包提供品質評定服務和維護資料,供應商需開發，打樣，生產制作，包裝，貼標簽,熟練操作，分析，分發儲存產品，提供資料管理服務或任何與之聯系的服務。 |
| 19.1 | There is a defined and documented system for selection of contractors. 應有詳細和備有文件資料証明的系統供選擇承包商. |
| 19.1.1 | The selection system defines contractor operations to be visited and approved by QA before contracts are finalized. A qualified auditor or other approved P&G representative determines if the contractor meets Company requirements. 下訂單前，供選擇的系統詳細說明廠商是經過QA訪問確認過的，並且是有資格的審核員和經寶潔公司批準的代表才能決定廠商是否符合其要求。 |
| 19.1.2 | Before a new contract is established with an existing contractor, the contractor is evaluated to determine the strength of their quality systems and their ability to meet P&G's requirements for the new initiative. The evaluations are documented and may include a re-audit of the site (e.g. if the contract involves introduction of a new and/or more highly regulated product/technology to the site).在與現合作廠商簽一份新合同前，需經評估廠商是否已加強品質制體和能力以符合寶法新的執行要求，評估需備詳細文件証明資料，包括對工廠現場的再評（如，若合同涉及到新的或是更高管制產品或技術向工廠介紹內容）。 |
| 19.2 | There is a defined and documented system for on-going management of contractors..進行中的承包商用詳細和備有文件資料的系統管理。 |
| 19.2.1 | Each contractor has designated QA and business contacts responsible to monitor the performance and compliance of the contactor with regulatory and Company policies and requirements.每個供應商需指派QA和業務聯系人負責監控合同的執行情況需符合寶潔公司要求. |
| 19.2.2 | The contractor management system ensures that current technical standards are deployed at contractors in a timely manner. No deviations or changes are allowed unless documented concurrence from the responsible P&G QA contact has been received at the contractor site.供應廠商管理系統需保証目前的技術標準在廠商處及時被運用，不許有背離或是變更除非有收到相關寶潔QA的書面文件証明資料. |
| 19.2.3 | There is a documented release strategy. Delegation of final release authority to the contractor is approved by P&G QA and documented. Such delegation follows an established procedure that includes contractor performance requirements to be maintained. 應有文件發放的策略,最終發放權委托需由經寶潔公司QA和文件管制批準，這樣的委批需照已建立的程序(包括維護供應商執行需求） |
| 19.2.4 | On-going evaluation includes periodic re-assessments of contractors according to Company requirements. 持續進行的評估包按要求對供應商定期性的再評估 |
| 19.2.5 | For contractors working for multiple P&G business units, separate concurrence for changes or deviations affecting shared materials, test methods etc. or systems is obtained from each/all of the respective P&G QA contacts.生產幾種產品的供應商，單個發生的偏離或是變更影響共用物料，測試方式或系統個別聯系寶潔QA. |
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