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rrent specifications and tolerances ? 所有必需的文檔資料都將反映當(dāng)前的規(guī)格和容差 7 CAR Process Highlighted Changes 糾正措施申請(qǐng)的重點(diǎn)改革 8 CAR Process Highlighted Changes (Cont’d) 糾正措施申請(qǐng)的重點(diǎn)改革(續(xù)) 9 Job Aid Introduction 工作輔助簡(jiǎn)介 ? Job Aid serves as a tool for the process user to reference activities and steps, tools and templates, and roles and responsibilities for any quality process ? 工作輔助可以作為過(guò)程用戶用來(lái)為任何質(zhì)量過(guò)程引用活動(dòng)和步驟、工具和模板、以及角色和職能的工具。 ? Each Job Aid includes the following sections: ? 每項(xiàng)工作輔助包括以下部分: – Process Highlights – 過(guò)程重點(diǎn)環(huán)節(jié) – SIPOC Diagram – SIPOC 圖表 – Record Management – 記錄管理 – Key Process Activities – 關(guān)鍵過(guò)程活動(dòng) – RACI Matrix – RACI矩陣 10 Inputs and Outputs SIPOC Diagram 輸入與輸出功率 ——SIPOC圖表 ? Job Aid will include a SIPOC Diagram, clearly defining the Supplier, Inputs, Outputs, and Customer of the overall process ? 輔助工具將包括一幅 SIPOC圖表,明確規(guī)定供應(yīng)商、輸入、輸出、以及整個(gè)過(guò)程的客戶 Refers to the receiver of the process output/ end result 指過(guò)程輸出 /最終結(jié)果的接收方 Refers to the final output/ end result of the process 指過(guò)程的最終輸出 /最終結(jié)果 SIPOC Diagram SIPOC 圖表 Supplier 供應(yīng)商 Inputs 輸入 All departments 所有部門 Product plaints (PSI, Inline Audit, PRC return center, Customer feedback, Call centers, Life Test Failure) or process nonconformance (Quality Plan Audit) 產(chǎn)品投訴(裝運(yùn)前的檢查、生產(chǎn)線稽查、 PRC退貨中心、客戶反饋、呼叫中心、壽命測(cè)試失敗)或工藝不合規(guī)(質(zhì)量方案審查) Outputs 輸出 Customers 客戶 Feedback to plained Department 給投訴部門的反饋 Initiator 發(fā)起人 Corrective Action 糾正措施 Quality 質(zhì)量部 Refers to the provider of the process or the initiator of the process 指過(guò)程的提供者或過(guò)程的發(fā)起人 Refers to the inputs provided by the process supplier to the process owner (functional area) 指由過(guò)程供應(yīng)商向過(guò)程所有者(功能區(qū))的輸入 11 ? Job Aid will include a Key Process Activities section, which clearly details each activity within the process ? 輔助工具將包括一塊關(guān)鍵過(guò)程活動(dòng)區(qū),詳細(xì)說(shuō)明過(guò)程內(nèi)的各項(xiàng)活動(dòng) Key Process Activities 關(guān)鍵過(guò)程活動(dòng) Represents the key activities of the process 代表過(guò)程中的關(guān)鍵活動(dòng) Represents necessary tools/ templates needed for key activity 代表關(guān)鍵活動(dòng)所需的必要工具 /模板 Defines each step within each key activity 規(guī)定每項(xiàng)關(guān)鍵活動(dòng)中的各個(gè)步驟 Represents owner of key activity 代表關(guān)鍵活動(dòng)的所有者 12 Roles and Responsibilities – RACI Matrix 角色與職能 ——RACI矩陣 ? Job Aid will include a RACI Matrix, clearly defining roles and responsibilities for every activity ? 輔助工具將包括一個(gè) RACI矩陣,明確規(guī)定每一項(xiàng)活動(dòng)的角色和職能 ? Responsible: The person or persons who are responsible for execution or delivery of an action item/work product ? 負(fù)責(zé)人: 負(fù)責(zé)實(shí)施或交付某項(xiàng)措施項(xiàng)目 /工作產(chǎn)品的人員 ? Accountable: The person or persons who provide the final approval or sign off of an activity or work product ? 責(zé)任人: 最終許可或簽署某項(xiàng)活動(dòng)或工作產(chǎn)品的人員 ? Consulted: The person or person who provide input or information ? 顧問(wèn): 提供輸入或信息的人員 ? Informed: The person or persons who are notified ? 知情人: 被告知的人員 13 Roles and Responsibilities – RACI Matrix 角色與職能 ——RACI矩陣 RACI MATRIX RACI矩陣 Activity 活動(dòng) Marketing 銷售部 Engineering 工程部 Quality 質(zhì)量部 Sample 樣品 Customer Seri vice 客戶服務(wù)部 Open CAR 啟動(dòng)糾正措施要求 I ** I ** A I ** Define corrective action plan 制定糾正措施方案 C C A Evaluate and plete CAR 評(píng)估并完成糾正措施要求 C A A Verify that CAR is on time 確認(rèn)糾正措施要求按時(shí)實(shí)施 C A I Determine if there is an agreement with CAR plan 確定是否與糾正措施要求的措施方案相一致 A R Verify that CAR implementation is on time 確認(rèn)糾正措施要求按時(shí)實(shí)施 C C A Determine if able to monitor sequential 3 lots 確定是否能夠?qū)B續(xù) 3批次產(chǎn)品實(shí)施監(jiān)督 A R rResponsible。 AAccountable。 Cconsulted。 IInformed r——負(fù)責(zé)人; A——責(zé)任人; C——協(xié)商人; I知情人 Represents the key activities of the process 代表過(guò)程中的關(guān)鍵活動(dòng) Represents functional areas involved in the process 代表過(guò)程中所涉及的各功能區(qū) 14 Open CAR 啟動(dòng)糾正措施申請(qǐng)