Quality Systems Inspections Technique（QSIT） FDA QS稽核技巧 Quality Systems Inspections Technique（QSIT）

QSIT 之重點查核範圍 Quality System Regulation 1. Corrective and preventive actions 2. Design controls 3. Production and process controls 4. Management controls 5. Records/Document/Change Controls 6. Material controls, and 7. Facility and equipment controls Medical Device Reporting Regulation

QSIT查廠策略 Focus on evaluating whether the QS and subsystems have been implemented effectively. 著重品質系統、次系統之有效建立與執行 Top down approach vs. bottom up Top down: System（品質系統之全面評估） Bottom up: Nonconforming Events

管理階層 設計管制 生產與製程管制 矯正與預防措施 儀器設備管制 原物料管制 記錄、文件 與變更管制

管理階層責任

查核重點 (1) Verify that： 820.20(a), (c), (d), (e) quality policy（品質政策）, management review（管理審查）, and quality audit procedures（品質稽核程序） quality planning, and（品質規畫） quality system procedures and instructions have been defined and documented. 820.20(a), (c), (d), (e)

查核重點 (2) Has an organizational structure been established ? 是否建立組織結構？

查核重點 (3) Does the established organizational structure include provisions for: 是否明文規定下列條款： a. responsibility and authority?（權責） b. resources?（資源） 820.20 (b)(1) and (2)

查核重點 (4) Has a management representative been appointed? 820.20 (b)(3) 是否指派管理代表？ 820.20 (b)(3)

查核重點 (4b) 管理代表是否被授權與執行下列權責： 820.20(b)(3)(i) and (ii) ensuring the quality system requirements are effectively established and maintained? （確保品質系統要求有效建立與維持） reporting on the performance of the quality system to management with executive responsibility? 將品質系統執行情況向擔負決策實責之管理階層報告？ 820.20(b)(3)(i) and (ii)

查核重點 (5) Do established management review procedures ensure that management with executive responsibility reviews suitability and effectiveness at defined intervals and with sufficient frequency? 是否建立管理審查程序以確保管理階層在指定期間內審查品質系統之適切性及有效性? 820.20(c)

查核重點 (6) Do established quality audit procedures ensure that quality audits, including reaudits of deficient matters, are conducted? 是否建立品質稽核程序，以確保品質稽核及缺點之再稽核事宜之執行? 820.22

設計管制

查核重點 (1) Select a single design project 820.30(a), 820.30(c)-(j) Have design control procedures that address the requirements of the regulation been defined and documented? 法規要求之設計管制程序是否制訂並且文件化。 820.30(a), 820.30(c)-(j)

查核重點 (2) Review the design plan for the selected project, and initiate assessment of the firm's conduct of risk analysis. 審查設計規畫書，並評估公司所執行的風險分析。 820.30(b)

查核重點 (3) Were design inputs （設計輸入）established? 產品使用用途、性能特徵、風險因素、生物相容性、電磁相容性、人為因素、自願性標準以及滅菌等。 Were design outputs that are essential to the proper functioning of the device identified? 820.30 (c) (d)

查核重點 (4) Were acceptance criteria established prior to performance of verification and validation activities? 執行設計查證與確認前，是否已制訂各項允收基準？ Did verification confirm that outputs met inputs? 是否查證設計輸出符合設計輸入要求? 820.30(f), 820.30(g)

查核重點 (5) Did the design validation data show that the approved design met the predetermined user needs and intended uses? 設計確認的資料是否足以顯示認可的設計結果符合預定的使用者需求及使用用途? Are there unresolved discrepancies left from the design validation? 設計確認是否有未解決的不符合項目? 820.30(g)

查核重點 (6) If the device contains software, was the software for the device validated? 包含電腦軟體/韌體之產品是否已執行軟體/韌體確效？ Was risk analysis performed? 是否執行風險分析？ 820.30(g)

查核重點 (7) Was design validation accomplished using initial production devices or their equivalents? 是否使用最初試量產之成品或其等效產品完成設計確認? 820.30(g)

查核重點 (8) Were design changes controlled including validated or where appropriate verified? 是否執行設計變更之管制，包括變更後之查證與確認? 820.30(i)

查核重點 (9) Were design reviews conducted? 是否執行設計審查？ 820.30(e)

查核重點 (10) Was the design correctly transferred? 設計是否正確轉移？ 820.30(h)

查核重點 (11) Design History File (DHF) 820.30(j) If written procedures for maintaining the contents of the DHF, or a summary of such procedures? 是否有書面程序或摘要說明與維護醫療器材設計檔案（DHF）？ 820.30(j)

矯正及預防

查核重點 (1) Have CAPA system procedures that address the requirements of the QS regulation been defined and documented? 是否建立矯正及預防措施執行程序？ 820.100(a)

查核重點 (2) Existing Problems - Corrective Actions Were quality data sources identified? Have data from these sources been analyzed to identify existing product and quality problems that require corrective action? 是否分析品質資料，並確認產品與品質存在的問題，進而執行矯正措施？ 820.100(a)(1)

查核重點 (3) Potential Problems - Preventive Actions 820.100(a)(1) (3) Were sources of product and quality information that may show unfavorable trends identified by the firm? 經由產品及品質資訊是否顯示不利的趨勢？ Have data from these sources been analyzed to identify potential product and quality problems that may require preventive action? 上述資訊是否分析以鑑別需執行預防措施的產品及品質潛在問題？ 820.100(a)(1) (3)

查核重點 (4) Are the data received by the CAPA system complete, accurate and timely? CAPA系統的資料蒐集是否完整、精確且具時效？ 820.100(a)(1)

查核重點 (5) Are appropriate statistical analysis methods used? 是否使用適當的統計分析方法？ Are results of analyses compared across different data sources to identify and develop the extent of product and quality problems? 分析結果是否與不同的數據來源比較，以鑑別並找出其延伸的產品與品質問題？ 820.100(a)(1), 820.250

查核重點 (5) Investigating Cause 820.100(a)(2), 820.90(b) Are failure investigation procedures followed? 是否執行失效調查程序? Is failure investigation commensurate with the significance and risk of the non-conformity? 失效調查的程度與不符合的風險程度是否相當？ Is there control to prevent the distribution of non-conforming product? 是否有管制程序，預防不符合產品之放行運銷？ 820.100(a)(2), 820.90(b)

查核重點 (6) Has appropriate corrective action been taken for significant product and quality problems identified from data sources? 經獲得的數據鑑定為重大的產品及品質問題，是否採取適當的矯正措施？ 820.100(a)(3) (7)

查核重點 (7) Were corrective and preventive actions: 820.100(a)(4) effective? 矯正及預防措施是否有效？ verified or validated prior to implementation? 矯正及預防措施施行前是否經過查證及確認？ 820.100(a)(4)

查核重點 (8) Has information regarding nonconforming product, quality problems and corrective and preventive actions been properly disseminated? 不符合事項的矯正預防措施行動報告是否傳給適當部門？ Is information disseminated for management review? 矯正預防措施相關資料是否提供管理審查？ 820.100(a)(6), 820.100(a)(7)

生產與製程管制

查核重點 (1) Select a process for review. 選定一個製程審核，並辨別製程是否屬於滅菌製程？ Was sterilization the process selected? 選定一個製程審核，並辨別製程是否屬於滅菌製程？ Is the process controlled, monitored and operating according to DMR? 製程是否有管制與監測，並且根據DMR執行？ 820.70(a), 820.75(b)

查核重點 (2) Is the process operating within specified limits? （Establish using DHRs or other appropriate records） 製程是否操作於規定的範圍？（參考醫療器材歷史記錄） 820.70(a),(c),(e),(h), 820.75(b)

查核重點 (3) Has equipment been adjusted, calibrated, and maintained? 設備是否執行調整、校正與維修？ 820.70(g), 820.72

查核重點 (4) If the results of the selected process can not be fully verified, was the process validated? 如果製程結果無法完全查證，該製程是否執行製程確認？ 820.75

查核重點 (5) If the process is software controlled, is the software validated? 如果製程由軟體所控制，是否執行軟體確認？ 820.70(i)

查核重點 (6) Are personnel appropriately qualified or trained to implement processes? 製程人員是否經過適當的資格鑑定或訓練？ 820.20(b)(2), 820.70(d), 820.75(b)(1)

查核重點 (7) Is trending of the process done? 是否執行製程能力趨勢分析？ Is adequate testing done during the process? 製程中是否執行適當的測試？ If statistical sampling is done, does it follow an accepted standard? 是否統計取樣？方法是否遵循公認的標準？