1、Trading Law and TechnicalFood Legal Compliance AuditIssue 3.1January 2008Contents內容Audit Details 審核概要3Audit Summary 審核小結4Product Information 產品信息51. Document Audit 文件審核1.0Quality Management System 質量管理體系62.0Complaint handling and Customer Focus 投訴處理和以客戶為中心73.0Internal Audit and Corrective Action 內審和

2、改善措施74.0Pest Control 蟲害控制 85.0Preventative Maintenance and Equipment維護保養和設備96.0 Foreign Body Controls 異物控制97.0Calibration 校準108.0Cleaning 清潔119.0Medical Screening 健康審查1210.0Water Quality 水質1211.0Environment 環境132. Site Audit 現場審核12.0Raw Materials 原料1413.0Packaging 包裝材料1514.0Process Controls 加工控制1515

3、.0Filling, Packing, Storage and Despatch充填，包裝，存放和發貨1716.0Personnel, Premises and Equipment 個人，廠房和設備1917.0Ethics道德規范21Audit Details 審核概要Tel No 電話號碼: Fax No 傳真:Product Details 產品明細Products supplied 供應的產品:Previous Audit Details 上次審核情況Date of last Hymall Legal Compliance Audit:上次審核日期：無Report seen YES /

4、NO：上次審核報告: 有 / 無： 無Key Personnel 關鍵人員Name & Job Title: 姓名和職位Present at Audit: 審核時是否在場Opening 首次會議Site現場Closing 末次會議Y YYYY YYYYNNYDetails & Sign Off 結果及簽署Reported Date 報告日期:2008、07、07Status結果:Conditional ApprovalApproval/ Conditional Approval/ RejectedSignature簽名:Score:得分 7 %A9B3C3D2E0Special Checks

5、其他檢查YesNoBusiness license 營業執照Tax license稅務登記證Hygiene license衛生許可證If applicable, QS Certificate?QS 證書（若需要）Other Certificates其他證書：_Does the Site have an Internal Audit System? 是否有內審系統YDoes the Site have a HACCP or equivalent? 是否建立HACCP 體系YProduct name & coding of LCA test 合法性評估產品名稱及批號無Audit Summary 審

6、核小結Company Profile 公司簡介:Audit Findings 審核不符合項及發現: Critical Non-conformities 關鍵不符合項:無Major Non-conformities 嚴重不符合項:1、Minor Non-conformities 一般不符合項:1注：Product information 產品信息Items項目Information信息Product name 產品名稱Specification Standard Name產品標準Ingredients 配料表Shelf life 貨架期Internal Package 內包裝Outer Pack

7、age 外包裝Storage Condition 存放條件Other information 其他信息1. Document Audit 文件審核Compliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA1.0 Quality Management System 質量管理體系A Quality Management System is in place, which is maintained and regularly reviewed.已建立了質量管理體系，并定期維護和評估Quality Policy State

8、ment exists stating intentions to produce, safe, legal, quality products.質量方針包括對產品安全，合法性和質量的承諾Quality Manual available, containing an outline of working methods and practices.建立了質量手冊，包括工作方法和操作的框架。Authorised, controlled Quality Manual.質量手冊是授權的，受控的All documents, procedures and work instructions are pr

9、operly authorised and of the correct version.所有的文件，程序和作業指導書都是現行的，授權的Organisational structure showing responsibility and management authority.組織結構可以明確各自的職責和權限Details of deputising cover for staff with responsibility for product legality, safety and quality.和產品合法性，安全性和質量有關的關鍵員工有指定的代理人Systems in place

10、to identify and manage emergent issues.有識別和管理緊急事件的體系，保留記錄Defined period of record retention. 明確記錄保留的期限Alterations to records appropriately authorised.記錄的變更必須得到授權。A VBCDECompliant 符合性 Section 章節Non Conformance and Observations審核不符合項及發現YNNA2.0 Complaint Handling and Customer Focus 投訴處理和以客戶為中心Customer

11、complaints policy and procedures in place.建立了處理客戶投訴的政策和程序Complaints recorded and analysed for trends.記錄客戶投訴并進行趨勢分析Periodic reports sent to the relevant Tesco Legou Technical Manager, where appropriate.如有必要，定期將投訴報告提供給Tesco樂購的技術經理Performance indicators established relating to customer satisfaction and

12、 communicated to appropriate staff.建立了客戶滿意度指數，并將結果傳達給相關員工Procedures in place for the management of incidents and product recall.管理風險事件的程序已建立，有產品召回程序Recall procedure tested in a manner to ensure effective operation.定期對產品召回程序進行測試，確保有效AVBCDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及

13、發現YNNA3.0 Internal Audit and Corrective Action 內審和改善措施Internal audits undertaken to ensure safety, legality and quality are maintained in accordance with the Quality Management System.定期進行內審，以確保在該質量管理體系下生產的產品是安全、合法和符合質量要求的Audits conducted by competent auditors.內審由具有資格和能力的人執行Audits scheduled and the

14、scope and frequency established.內審時間是有計劃的，其范圍和頻率已確定Records of audits retained and available.保留內審的記錄Results of audits brought to the attention of the personnel responsible for the activity audit.審核的結果應通知相關責任人Compliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA3.0 Internal Audit and Co

15、rrective Action 內審和改善措施Corrective actions and time-scales agreed taking into account the nature of the non-conformance.根據不符合項的情況，確定合理的改善措施和完成時間表Corrective actions followed up to verify completion in a timely manner.對改善措施的完成情況按時進行驗證AVBCDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及發

16、現YNNA4.0 Pest Control 蟲害控制Pest Contractor or suitably trained internal staff 由蟲害控制公司的技術人員或受過相應培訓的指定員工進行蟲害控制Site map showing the locations and type of pest control.有蟲害控制布局圖說明蟲害控制種類及位置Records of regular inspection and treatment, detailing recommendations.定期對蟲害控制的檢查和處理進行記錄，包括改進建議MSDS data for the safe

17、use, application and storage of chemicals, where appropriate. 適當時所有化學藥劑都有MSDS作為安全使用，應用及儲存參考 Site adequately proofed.現場密封良好，害蟲不易進入Drains and opening window fitted with screens to prevent pest entry. 排水溝和窗戶都有適當的紗網以防止害蟲進入Incoming raw materials thoroughly checked on arrival for absence of pest infestati

18、on, where appropriate.適當時原料驗收時會進行蟲害檢查Correctly sited permanently operational electric fly killers and/or pheromone traps.正確放置常開的滅蠅燈和/或生化信息素誘餌。AVBCDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA5.0 Preventative Maintenance and Equipment 維護保養和設備Preventative maintenance schedule

19、in place and records of maintenance retained.制定了設備的維護和保養計劃，保留記錄Maintenance, including the replacing of light fittings and glass carried out in a way that does not jeopardise product safety and legality.維護保養時，包括更換照明設施和玻璃或易碎塑料時，應采取措施把對產品潛在的危害降到最低Outside contractors and all engineers made aware and adh

20、ere to the Company Hygiene Rules.外來工作人員和所有工程技術人員都要遵守公司衛生制度Equipment positioned so as to give access under, inside and around for ease of cleaning and servicing, or properly sealed to the floor. 設備安裝的地方周圍要易于清潔，或密封AVBCDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA6.0 Foreign Bo

21、dy Controls 異物控制Documented procedure in place for the management of unplanned maintenance (breakdowns) and control records available to demonstrate the equipment was left in a clean and safe condition prior to hand back to production.建立了未計劃性的維修（如突發故障）管理程序， 記錄顯示在移交給生產部門時，設備維修后進行了清潔和安全檢查Detailed proce

22、dure in place for the handling of glass and hard clear plastic breakages in production, packing and storage areas.在原料處理，準備，加工，包裝和貯存區域，應制定詳細的書面程序處理玻璃及其他易碎物質的破碎Glass audits carried out at a frequency determined by risk assessment and records retained.根據風險評估，定期對玻璃進行檢查，保留記錄All glass and hard clear plast

23、ic items in production, packing and storage areas listed on a register.在原料處理，準備，加工，包裝和貯存區域的所有玻璃和透明硬塑料都有登記Compliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA6.0 Foreign Body Controls異物控制Glass audits to demonstrate that items are intact.檢查記錄顯示玻璃處于完整狀況Documented wood policy, detailing

24、where wood is acceptable.制定木制品政策，詳細說明什么區域可以使用木制器具Wood in production, packing and storage areas, where appropriate eliminated.在原料處理，準備，加工，包裝和貯存區域，如果可能，應排除木制品的使用ABV CDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA7.0 Calibration 校準Master list of monitoring and measuring equipmen

25、t, requiring calibration available.測量和監視設備有校準清單Measuring and monitoring equipment critical to product safety and legality checked to ensure accuracy within agreed parameters at a predetermined frequency.應定期檢查監控關鍵控制點和產品安全及合法性的測量設備的精確度，確保其在規定的范圍內Equipment calibrated to recognised National Standards wh

26、ere possible at predetermined intervals.設備的校正必須以國家認可標準頻率來進行Records of checks and calibration certificates available.保留校正記錄和證書Equipment found outside of specified limits taken out of service, replaced or sent for repair. 當發現測量和監控設備的精密度超出規定的限值范圍時，及時更換或修理ABV CDECompliant 符合性Section 章節Non Conformance an

27、d Observations審核不符合項及發現YNNA8.0 Cleaning 清潔Systems in place to minimise the accumulation of waste in production areas, and prevent the use of unfit materials.應有適當的制度使廢棄物在加工區的積聚達到最少，防止使用不適宜的原料Waste disposal meets legislative requirements.廢棄物的處置要符合法規的要求Documented Operating Procedures in place for the c

28、leaning of premises, equipment and the use of chemicals.應建立書面的設施、設備的清潔程序和化學品使用程序Cleaning schedules in place.制定清潔計劃Suitable chemical storage.化學品合理存放Cleaning practices to minimise the risk of contamination.應執行清潔規范以使污染的風險降到最低Chemical dilution and water temperature monitored, where appropriate.適當時，應監控化學

29、品的濃度和水溫Records of cleaning in accordance with schedule and procedures.記錄顯示清潔是按程序和計劃執行的Effectiveness of cleaning verified (e.g. audit)驗證清潔的有效性Food contact surface & environment swabbing進行食品接觸面和環境的涂抹測試Systems in place for the management of non-conformance.建立不合格情況的管理體系CIP cleaning monitored and recorde

30、d.自動原位清洗系統清潔應監控和記錄AVBCDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA9.0 Medical Screening 健康審查Procedures in place for the notification by employees, (including temporary employees), of any relevant infectious disease or condition with which they may be suffering, or have been

31、 in contact with.公司應建立程序，要求所有員工，包括臨時工，當患有傳染病，或其他身體不適，或有接觸過類似疾病時應通報Pre-employment health screening and Validate Healthy certificate in place.雇傭前的健康檢查，上崗前應有健康證Procedures in place for return to work after foreign travel, where appropriate.適當時，員工出國/ 省回來后上班時應有報告和審查制度Visitors and Contractors complete a he

32、alth questionnaire prior to entering production areas to check suitability to do so.來訪者和分包商在進入原料、準備、加工、包裝和儲存區域前，應填寫健康調查表vAVBCDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA10.0 Water Quality 水質Water used for cleaning, or in connection with any operation in the manufacture of p

33、roduct, where appropriate potable or suitably tested用于設備和車間的清洗，或者在食品的加工制作過程中的水源，都應符合飲用水標準The quality of water, steam or ice that comes into contact with food is regularly monitored.對直接與食品或包裝接觸的水、蒸汽、冰的質量應定期監測Schedule for water sampling, where appropriate.適當時，應定期對水進行抽樣監測Compliant 符合性Section 章節Non Conf

34、ormance and Observations審核不符合項及發現YNNA10.0 Water Quality 水質Documented procedures for water sampling, including limits and tolerance.有對水樣進行分析的程序，包括測試項目和限值Systems in place for the management of non-conformance.應建立不合格情況發生時處理方法ABVCDECompliant 符合性Section 章節Non Conformance and Observations審核不符合項及發現YNNA11.0

35、 Environment 環境Site specific Environmental policy in place, detailing responsibility for meeting legislative requirements and how this is measured.建立的具體的環境政策，有具體的責任人負責符合法律要求和監測The Quality Management system ensures Environmental matters are managed.質量管理體系應確保環境問題也包括在內No serious Environmental issues id

36、entified in any audit, which have not been effectively managed.在任何審核中，都沒有發現尚未被解決的嚴重的環境問題No Environmental issues identified on the day of audit.審核當天沒有發現環境問題ABCDVE2. Site Audit 現場審核Compliant 符合性Section 章節Non Conformance and Observations 審核不符合項及發現YNNA12.0 Raw Materials 原料Procedures in place for the che

37、cking of incoming raw materials按進貨檢驗程序進行進貨檢驗.Raw material sampling/testing in accordance with schedule.按計劃進行原料抽樣和測試System in place for the management of COA where appropriate.適當時，建立COA（檢驗分析報告）管理的體系Where required raw materials only released after testing by authorised persons.測試合格后，才可由授權人員確定放行Storage

38、 conditions adequate and clean. 存放條件符合要求，并干凈Suitable segregation of incompatible materials (e.g. raw and cooked) and materials requiring specific handling (e.g. nuts)適當的分開存放不能共存的原料（如，生熟分開）或特別處理的原料 （如，堅果）Suitable procedures in place for the management of incompatible materials.建立了不能共存原料的管理系統Stock rot

39、ation systems in place and adequate. 建立了適當的庫存周轉體系Raw materials in storage facilities are traceable from batch through to purchase orders.原料存放時，可追溯到采購批次Non-conforming materials are suitably quarantined or labelled to prevent accidental use.不合格原料應適當標識和分開存放，防止意外使用Part used raw materials returned to sto

40、res suitably protected.沒使用完的原料退回到倉庫時要保護，密封得當AVBCDECompliant 符合性Section 章節Non Conformance and Observations 審核不符合項及發現YN13.0 Packaging 包裝材料Procedures in place for the checking of incoming packaging materials 按進貨檢驗程序進行包材進貨檢驗.Packaging sampling/testing in accordance with schedule, where appropriate. 適當時，

41、按計劃進行包材的抽樣和測試Storage conditions adequate and clean.存放條件符合要求，并干凈Stock rotation systems in place and adequate.建立了適當的庫存周轉體系 Packaging suitably covered to protect from contamination.包材密封完好避免污染Obsolete or non-conforming packaging suitably quarantined or labelled to prevent accidental use.不合格包材應適當標識和分開存放，防止意外使用Part used packaging returned to stores suitably protected沒使用完的包材退回到倉庫時要保護，密封得當ABCVDECompliant 符合性Section 章節Non Conformance and Observations 審核不符合項及發現YNNA14.0 Process Controls 加工控制