1、There are two Types of Layered Process Audits: 有兩種分層過程審核有兩種分層過程審核: Process Control Audits 過程控制審核過程控制審核 Error & Mistake Proofing Verification Audits 防錯防誤驗證審核防錯防誤驗證審核Layered Process Audits (LPA) are a system of audits performed by multiple Layered Process Audits (LPA) are a system of audits perfor

2、med by multiple levels of management. Key process characteristics are audited frequently to levels of management. Key process characteristics are audited frequently to verify process conformance. verify process conformance. 分層過程審核分層過程審核(LPA)(LPA)是一種標準化的審核是一種標準化的審核, ,在組織的所有層面上定期在組織的所有層面上定期, ,經常實施經常實施

3、, ,由多個管理由多個管理層進行的系統審核。對關鍵過程特性進行頻繁的審核以驗證過程符合性。層進行的系統審核。對關鍵過程特性進行頻繁的審核以驗證過程符合性。The purpose of Layered Process Audits is to ensure continuous conformance The purpose of Layered Process Audits is to ensure continuous conformance thereby improving process stability and first-time through capability. ther

4、eby improving process stability and first-time through capability. 分層過程審核的目的是確保持續的符合性，從而提高過程穩定性和一次通過率。分層過程審核的目的是確保持續的符合性，從而提高過程穩定性和一次通過率。LPAs assure that defined methods and work instructions are utilized, problem solving solutions are held in place, and all process issues are identified and quickly

5、 corrected.分層過程審核確保使用固定的方法和操作說明， 確保使用問題解決方案， 所有過程問題都被識別并被迅速糾正。LPA is an ongoing system of process checks that verify proper methods, settings, operator craftsmanship, error proofing devices and other inputs are in place to ensure a defect free product. 分層過程審核是一項持續的過程檢查系統， 用來驗證正確的方法、 設置、 操作員技能、防錯裝置和其

6、他輸入是否到位從而確保產品無缺陷產生。 Anybody can perform a Layered Process Audit. 任何人都能夠執行分層過程審核。 Manufacturing management must own the process and perform audits. 生產管理部門必須領導此程序并執行審核。 All managers, regardless of function, can be auditors. 所有經理，無論他的職責是什么， 都可以作為審核員。 Each management level should perform audits. 每個管理層都應

7、該執行審核。Process Control Audits shall be performed once per shift by supervisors. Plant management shall perform the audit once per week.過程控制審核過程控制審核應該在每班生產時由車間主管進行一次審核。工廠管理應該在每周執行一次審核。Error & Mistake Proofing Verification audits shall be conducted once per shift. Only qualified employees shall per

8、form Error & Mistake Proof Verification Audits. Set-up, maintenance or quality auditors are usually qualified.防錯防誤驗證審核防錯防誤驗證審核應該在每班生產執行一次。由具備資格的人員進行防錯防誤驗證審核。 建立、維護或質量審核員通常是具備資格的人員。SQAPSafety regulations 安全法規安全法規Reinforces加強加強Facilitates簡化簡化Operator training 操作員培訓操作員培訓Management/operator interfac

9、e 管理管理/操作員界面操作員界面First time through capability 一次通過率一次通過率Morale 士氣士氣Improves提高提高Build variation based on work standardization 因為工作的標準化而產生的多樣性因為工作的標準化而產生的多樣性End-of-line inspection 線尾檢驗線尾檢驗Part defects 零件缺陷零件缺陷Reduces減少減少18-0221-0224-0227-0230-0233-0236-0239-0242-0245-0248-0251-021-034-037-0310-0313-0

10、316-0319-0322-0325-0328-0331-0334-0337-0340-0343-0346-0349-0352-03Weekly 周周# of LPA Checks / Week每周每周LPA檢查次數檢查次數556065707580859095100First Time Through (%)一次通過率（一次通過率（%)KTP Now conducting 6700 Process Layered Audit ChecksKTP目前正執行6700 逐層過程審核0 Process Layered Audits 0層過程審epair Inventory修理

11、庫存FTC一次通過率Repair Inventory vs First Time Capability vs LPA對比：對比： 修理庫存修理庫存/一次通過率一次通過率/逐層過程審核逐層過程審核PROCESS過程過程ErrorProofing 防錯防錯 Process Audits 過程審核過程審核CorrectiveActions 糾正行動糾正行動PreventionActions 預防行動預防行動EmployeeWorkshops 車間職工車間職工ContinuousImprovementInputs 持續改進輸入持續改進輸入Audits are conducted regularly b

12、y all levels of supervision 各監督級定期地進行審核各監督級定期地進行審核Non-conformances are immediately addressed 立即發現（記錄）不符合處立即發現（記錄）不符合處LAYERED PROCESSAUDITS ARE PROCESSBASED, NOT PART BASED.分層過程審核是基于過程的分層過程審核是基于過程的,而不而不是基于零件的是基于零件的確定從哪里開始實施確定從哪里開始實施LPA Review 回顧: Customer Complaints, Quality Alerts 客戶抱怨，質量警告 First-Ti

13、me Through data, Scrap Reports 一次通過數據，廢品報告 Key Characteristics and Process Capability: Cpk & Gage R&R 關鍵特性和過程能力：CPK與檢具 R&R PFMEA, Process Flow Diagram, Control Plan PFMEA, 過程流程圖，控制計劃 Set-up Sheets, Work Instructions, Inspection Instructions 工藝卡片、作業指導書、檢驗指導書 Error and Mistake Proofing 防錯防

14、誤 Quality System Audits, Dock Audits, Inspection Reports 質量體系審核，貨場審核，檢驗報告 Rework instructions 返工指導書 The Area of Highest Risk should be the first area to implement the Layered Process Audit 最高風險區域最高風險區域應該是實施分層過程審核的第一個區域 This area will also be used as a Lessons Learned for implementing the Layered Pro

15、cess Audit across the entire manufacturing facility. 此區域也被用于整個制造廠學習如何實施分層審核。 Use Discretion when adding items to the checklist在向檢查表中添加項目的時候使用判斷力判斷力。 Audit items are issues that would cause Customer Dissatisfaction. 審核項目是那些導致客戶不滿客戶不滿的問題。2 X Week 每周兩次每周兩次Area Management 區域管理者區域管理者1 X Shift 每班一次每班一次Pro

16、duction Supervisor 生產主管生產主管1 X Week 每周一次每周一次Plant Manager 工廠經理工廠經理 Encourages Management Involvement 鼓勵管理層參與鼓勵管理層參與 Encourages Operator Feedback 鼓勵操作員反饋鼓勵操作員反饋 Establishes Accountability 建立責任制建立責任制EXAMPLE: LPA FREQUENCY AND STRUCTURE舉例：舉例： 分層過程審核頻率與結構分層過程審核頻率與結構123123123123123123123123123MONXXTUESXX

17、WEDXXTHURXXFRIXXSATXXMONXXTUESXXWEDXXTHURXXFRIXXSATXXPLANNEDCOMPLETEDSHIFT 1XEVERY LINE IS AUDITED ACROSS EACH SHIFT EVERY 9 DAYS IN ROTATIONSHIFT 2XPLACE A CHECK MARK IN THE ABOVE BOX FOR YOUR SHIFT FOR AUDITS COMPLETEDSHIFT 3X1 10 0PRODUCTION SUPERVISOR WEEKLY LAYERED AUDIT LINE SCHEDULE1 14 4121

18、11 149 987 75Note: Example Illustrates that 3rd Shift Not Being Audited Per the Rotation Matrix Unacceptable Condition!注意注意: 例子顯示例子顯示, 在每個循環矩陣中第三班生產中沒有進行審核在每個循環矩陣中第三班生產中沒有進行審核 不可接受不可接受的狀況的狀況!生產生產 主管周主管周LPA檢查計劃安排表檢查計劃安排表SENIO R SUPERVISO R W EEKLY LAYERED AUDIT LINE SCHEDULEQ U AR TER 1Q U AR TER 298

19、751412114109875141211410W EEK 1XW EEK 14XW EEK 2XW EEK 15XW EEK 3XW EEK 16XW EEK 4XW EEK 17XW EEK 5XW EEK 18XW EEK 6XW EEK 19XW EEK 7XW EEK 20XW EEK 8XW EEK 21XW EEK 9XW EEK 22XW EEK 10XW EEK 23XW EEK 11XW EEK 24XW EEK 12XW EEK 25XW EEK 13XW EEK 26XQ U AR TER 3Q U AR TER 498751412114109875141211410W

20、 EEK 27XW EEK 40XW EEK 28XW EEK 41XW EEK 29XW EEK 42XW EEK 30XW EEK 43XW EEK 31XW EEK 44XW EEK 32XW EEK 45XW EEK 33XW EEK 46XW EEK 34XW EEK 47XW EEK 35XW EEK 48XW EEK 36XW EEK 49XW EEK 37XW EEK 50XW EEK 38XW EEK 51XW EEK 39XW EEK 52XPLANNEDCOMPLETEDD AYSXEVER Y LIN E IS AU D ITED EVER Y 9 W EEKSPLAC

21、 E A C H EC K M AR K IN TH E AB O VE B O X FO R AU D ITS C O M PLETED每條線輪流在每9周進行一次審核. 在上面表格中, 用差號標明已經完成了審核工廠經理周工廠經理周LPA檢查計劃安排表檢查計劃安排表和日期的藍點措施并實施一個糾正行動請求.提問應該包含對操作、設備、文件等的完整說明。 Reaction to non-conformances must assure immediate response. 對不符的響應速度必須及時。). Auditors must understand LPA strategy and purpo

22、se. 審核員必須理解LPA策略和目的。 Review checklist and reactions with auditors. 和審核員共同分析檢查清單和反應計劃。 Auditors must know to respond immediately after finding a nonconformance. 審核員必須在發現一個不符合時快速作出響應。 EMPV Auditors shall be qualified to perform error and mistake proofing verification. EMPV審核員具備執行防錯防誤驗證的資格。 Perform a p

23、ractice audit where appropriate. 在適用的時候執行一次審核實踐。Once the LPA plan is approved, the Supplier shall train their Layered Process Auditors. 一旦一旦LPA計劃得到批準，供應商應該培訓自己的分層過程審核員計劃得到批準，供應商應該培訓自己的分層過程審核員 Explain why the LPA is being implemented. 解釋為什么為什么LPA在被執行。 Explain the purpose and benefits of the LPA proce

24、ss. 解釋LPA程序的目的和益處益處。 Inform workforce of LPA activity and what to expect when audits are performed in their work areas. 當在工作地點執行審核時，將LPA活動和對結果的期望 通知通知給操作工人。 Encourage workforce feedback. 鼓勵鼓勵操作工人進行反饋。 Communicate LPA results frequently. 經常對LPA的結果進行交流進行交流。 Review audit results frequently when startin

25、g process. 在啟動程序的時候經常經常對審核結果進行回顧。 Improve audit checklist based on auditor feedback. 根據審核員的反饋來改進審核檢驗表。 Management must instill discipline early in the process to complete audits on time and provide resources for immediate corrective action. 管理層必須在程序的早期時候逐漸進行灌輸，來按時完成審核并提供資 源給快速更正行動。 During early phas

26、e - Management audits will find problems, but later management audits will find improvements. 在早期- 管理層的審核將發現問題， 但是以后管理層的審核會發現（這些問題的）改進。 - Develop and apply Lessons Learned to improve audit. - 制定并運用吸取的教訓吸取的教訓來改進審核。 Corrective actions shall be documented as required by ISO/TS 更正行動應該按照ISO/TS的標準進行文件記錄. There must be a system to maintain the audit schedule and track completion. 必須有