QSA 3.0 Training Matieral

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2011-10-20
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Audit ils Introduction: Introduction:
1: Quality System Requirement
1.10 Does the quality manual include the scope of the quality management system, including details of and justification for any exclusions? 品質手冊是否包插品質管理系統的所有範疇,包含任何裁剪細節? 1.11 Does the quality manual include a description of the interaction between the processes of the quality management system? 品質手冊是否包括品質管理系統的程序的相互關聯的描述? 1.12 Has the supplier defined the responsibility, authority and interrelation of all personnel who manage, perform and verify work that affects the quality of products, materials or services? (i.e. procedures, organization charts, quality manual) 供應商是否定義了所有影響產品/材料或服務的管理.執行.驗證工作的人員的權責及相互關系?(如程序, 組織圖,品質手冊) 1.13 Has the supplier provided adequate resources for in-house verification activities such as inspection, testing, monitoring and review of processes and products? 供應商是否提供了足夠的資源來支持內部相關驗證活動如檢驗,測試,監控及產品和製程的檢討. 1.14 Has the supplier appointed a management representative who has responsibility and authority for ensuring that a quality management system has been implemented and maintained? 供應商是否指定一位管理代表並授與責任及權限以確保品質管理系統被執行和維持? 1.15 Has the management representative tracked and drove the improvement on quality management system performance with record/report. 管理代表是否追蹤和推動品質管理系統執行的改善(以記錄或報表的形式)? 1.16 Has the improvement effectiveness verified (record/evidence required)? 是否有改善效果的驗證(需要記錄/證據)
品质审核系统3.0
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2011-10-20
审核结果表
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2011-10-20
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Quality System Audit Summary Report
SQE Audit Comments in following
Strong Point:
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Audit Details Introduction: Introduction:
1: Quality System Requirement
1.17 Does the supplier conduct management reviews of the suitability and effectiveness of the quality management system at appropriate intervals? (i.e. does the quality system meet customer requirements?) 是否供應商在適當的期間內實施檢討品質管理系統之適宜性和有效性的管理審查會議? (如品質 系統是否合乎顧客要求?) Does the management reviews include verification of the following input: 管理審查是否包括以下的驗證: 1.18 (a) Achievement of quality objectives 品質目標的達成狀況 1.19 (b) Results of the audits 稽核的結果 1.20 (c) Customer feedback 客戶的回饋信息 1.21 (d) Process performance and product conformity 程序的執行和產品的一致 1.22 (e) Status of preventive and corrective actions 預防與矯正 1.23 (f) Follow-up actions from previous management reviews 上次管理審查的追蹤 1.24 (g) Changes that could affect the quality management system, and 影響品質管理系統的變更 1.25 (h) Recommendations for improvement 改善建議
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Audit Details Introduction: Introduction:
1: Quality System Requirement
1.35 Are the audit criteria, scope, frequency and methods defined for the internal audit? 是否定義內部稽核的稽核標準.範圍.頻率和方法? 1.36 Are the selection of auditors and conduct of audits ensuring the objectivity and impartiality of the audit process? (e.g. auditors shall not audit their own work.) 稽核人的選擇和稽核的執行能否確保稽核過程的客觀性和公平性行(如,稽核人員不稽核自己的工作範圍)? 1.37 Is there a procedure documented the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records ? 是否有程序文件定義稽核的權責,計劃需求,執行,稽核報告,記錄的維護? 1.38 Do the follow up activities include the verification of the actions taken and the reporting of verification results ? 是否追蹤執行矯正措施的確認和驗證其有效性? 1.39 Are the audit results analyzed for improvement from a system level? 稽核結果是否被分析並從系統面進行改善? 1.40 Is there a system that identifies training requirements for all personnel affecting the quality of the product? 是否有系統對所有影響產品品質的人來鑑定其訓練需求?是否有系統對所有影響產品品質的人來鑑定其訓 練需求? 1.41 Does a system exist for determining which personnel are qualified for a job function? 是否有系統鑑定工作人員是否勝任此工作? 1.42 Is there a system to disqualify and re-qualify personnel in a job function? 是否有系統來評定人員在一項工作職責中是否喪失資格或仍具有資格? 1.43 Are accurate training records maintained? 是否有正確的訓練記錄保存?
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Audit Details Introduction: Introduction:
1: Quality System Requirement
1.25 Does the output of management reviews include any decisions and actions related to: 管理審查的輸出是否包括以下方面相關的任何決定和措施: 1.26 (a) Improvement of the effectiveness of the quality management system and its process? 品質管理系統及其過程有效性的改進? 1.27 (b) Improvement of product related to customer requirements, and 有關客戶要求有關的產品的改進 1.28 (c) Resource needs 資源需求 1.29 Are implementation of action items from management review tracked? 管理審查的矯正措施進行跟蹤驗證? 1.30 Are records maintained of these management reviews? 管理審查記錄是否被維護? 1.31 Does the supplier conduct internal audits at planned intervals? 供應商是否按計劃執行內部稽核? 1.32 Do the internal audits verify compliance with planned arrangements, ISO standards and quality management system? 內部品質稽核是否驗證品質目標,客戶/製程要求及ISO要件皆符合承諾? 1.33 Do the internal audits determine whether the quality management system is effectively implemented and maintained? (e.g., meeting the customer requirements?) 內部稽核能否確定品質管理系統是否被有效地執行和維護(如,是否滿足客戶要求) 1.34 Are the internal audits planned on the basis of the status and importance of the activity, as well as the results of previous audits? 內部品質稽核是否被安排在重要的活動及上次稽核的基礎上?
Weak Point:
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2011-10-20
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Audit Details Introduction: Introduction:
1: Quality System Requirement
1.1 Has the supplier defined and documented its corporate quality policy? 供應商是否有定義及文件化公司品質政策? 1.2 (a) Is the Quality Policy appropriate to the purpose of the organization? 品質政策同組織的目的是否適合? 1.3 (b) Does the Quality Policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system? 品質政策是否包括公司承諾和持續不斷改善品質管理系統成效? 1.4 (c) Does the Quality Policy provide a framework for establishing and reviewing quality objectives? 品質政策是否為建立和審查品質目標提供了依據? 1.5 (d) Is the Quality Policy communicated and understood within the organization? 品質政策是否在組織內得到交流和理解? 1.6 (e) Is the Quality Policy reviewed for continuing suitability? 是否審查品質政策的持續適宜性? 1.7 Are quantifiable and measurable quality objectives, including those to meet requirements for product, established at relevant functions and levels within the organization? 在組織內部相關的職責和標準方面,是否建立包括符合產品要求在內的可量化的品質目標? 1.8 Are the quality objectives consistent with the corporate quality policy? 品質目標是否和公司的品質政策相一致? 1.9 Does the quality management system documentation include a quality manual? 品質管理系統文件是否包括品質手冊?