FAMILY DOLLAR验厂咨询-质量管理标准及良好生产规范和产品控制及制程控制相关要求概述
1.QUALTY MANAGEMENT STANDARD質量管理標準
1.1The Compamy shal have a Qualty Mament Svslem establitshed, documented, imple mented, maintained and where appropriale, improved公司腹常建立一個文件化的質量管理系統,酸系統腹被青施及維持,並在適當的情况下于以改善Organizational Structure, Res ponsibility and Management Authority組織結構·责任及管理權
The Campany shalhave an arganisaonalsiuclure ,which deary ensures job fucion,responsibly and repoting relaionships af hose saf whose aciies afect produt saely,legaly and qualy
are clearly defined and documented.
公司須有組械架構·以確保相關人員(當其工作對產品的安全性,法律要求和質量有直接影譽時)的職能、责任、及相應的會報渠道被清楚地文件化。
1.2 Supplier Approval and Performance Monitoring豁可供廛商及其供貨表現黠察
The Compamy shall operate procedures for approval and the monitoring of its suppliers.公司須有既定程序對共供應商進行可及供貨表現監察
1.3 Product ldentification and Traceability產品的標粱及可追蹤性
The Compamy shall have a system with the ability to trace materials from raw material source to finished product and vice-versa.公司須具有能夠追查材料從原材料至成品(及反之亦然)的系統·
1.4 Management ofincidents and Product Recall事故處理及牵品回收
The Compamy shal have efective conrol of inddents and productrecal proedures in onder to ensure thatallpolenialrisks to he poductqually,saelyand lenalty are controled公司组具備有效事故和南品回收之控制程序,以確保所有射產品質量,安全性和合法性的潜在風險得以控制。
1.5lComplaint Handling投訴處理
The Compamy shall have a system for the management of product complaints and their investigation公司須具有處理產品投断和调查的系統·
1.6 Corrective Action改善行動
The Coampany shalensure sysems exis! b imwesigale the cause ofsignifcar non conbmmly against slanands,specfcaiansand proedures, whichare ilicalto produc saley,legalyand qualyand coreciive action taken.常發現產品规格、标凖、及生座程序上出現嚴重不符(而酸等不符合項目將影響到產品安全性、合法性及品質方面)的時候,公司要有有關系杭對酸等不符合項目,进行原因分析及探取相酶的改善行動。
1.7Training
人员培副
The Compary shall ensure that all employees are adequately trained, instructed and supervised commensurate with their activity.公司腹確保所有昌工從事其有期工作前,必提供有足的培副、指及督:
1.8 Procedures
系统程序文件
The Company shal have. and aerale in accordance wi wilen delaled wrocadures, insiucions, and relerence documents to cover alproeses cilcalto podur salely.leally and ualy公司组確保所有射產品安全、合法性和質量相關的重要工字,均有相關的程序文件、工作指導及参考文件,提供予操作人員作依。
1.9 Document Control交件控制
The Company shal ensure hat alldoauments, records and data cifcalto the management of product safety,legalty and qualiy are in place and efecively controled公司須確保所有對產品安全、合法性和量相關的重要文件、配錄和资料,予以常及有效地控制。
1.10 Record Kee ping配綠控制
The Com pary shall maintain records to demonstr ate the effective control of product safety, legality and quality.公司组確保所有射產品安全、合法性和量相的重要配,予以常保存及作有效地控制
GOOD MANUFACTURING PRACTICE (GMP)良好生產规範The Company shal apply Good Manufa cluring Pracice so as to prevent conlamination and enabie the production of safe and legal products公司應實施良好生產规範,以防止產品受污染及能夠生產安全和合法的產品。2.1Building Exterior AND interior建策物的内、外要求
All grounds within the sile shall be finished and maintained to an appropriate standard.工廠範面内的地面須完整和保持一定標準·
2.2LayoutProduct Flow生產佈局/流程
Premises and plant shall be designed, constructed and maintained to control the risk of product contamination and damage生座場所和車間應予以骰計,建造和保餐,以控制產品受污染和害的險·
2.3 Lighting照明設備
The fabricaion ofthe fa cities including the lighting shall be suiable for the iniended purpose with due regard lo the riskof product contaminafion and damage.對於照明設備的構建,除了切合预期的目的外,並適常考虚到產品受污染和損害的風險·2.4 Equipment and Maintenance股慵及維修保餐
Equipment shal be suitabiy designed for the intended purpose and shall be used so as to minimise the risk of contamination and damage of produc..殴備的酸計須恰當以符合预期的目的和使用要求,而以减低牵品受污染及害的風險
2.5iCleaning整深
Appropriate standards of cleaning shall be maintained at all times.廖時翅保持適當的清潔標準·
2.6 Health and Personal Hygiene健康及個人衡生
Appropriate standards of hygiene and housekeeping shall be maintained at all times.廖時鹩保持滴當的衡生和内移管理標凖·
2.7 Pest Control岛害控制
The Compamy shall be responsible for minimising the risk of pest infestation on the site.公司有责任確保生產範面内的蛊害骚援風險被减致最低2.8 Glass Control Program玻璃控制程序
Appropriate faciities and procedures shall be in place to control the risk ofglass or other physical contamination or damage of product.須有適當的酸施和程序来控制由玻璃或其他物置污染或捐壊產品的風險2.9Chemical Residue Control剩除化學品控制Appropriate facilities and procedures shallbe in place to conirol the risk of chemical contamina fion or damage of product组有適常的酸施和程序来控制牵品受化婴品污染或措的風險
PRODUCT CONTRO!
產品控制
The Campamy shall be able to demonstrale effective product conirdl is undertaken公司須能筠證明有效地進行產品控制Hazard and Risk Assessment System (HRAS)危害及屈險酐估系統
The Company shal have a Hazard and Risk Managemen systemin pace to ensure hata heazards to consumer saety and product inegriy are ientied and appropriate controls eslabished公司组设有危害和風險管理系統,以確保所有危害消费者安全及產品完整性的險被别,並予以常的控制。
3.2Specifications and Codes of Practice規格與業務守則
The Compamy shal ensure that approprale speciicalions or Codes of praclice exist for, - raw malerials (inc. packaging malerials) -inlemmediate/semi processed products (whereappropriale)對於所使用的原材料(包括包装材料)、成品、牛成品、或牛加工品(如適用),公司須確保有適當的規格或業務守則存在·
3.3 Product Analysis /Testing
奎品分析/测試The Compamy shal undertake or subconrac analyses or testing, chical to conim producl saely, legayand qualy, using appropnale procdures, a cities and siandards公司應使用適當的程序、設施和標準來進行產品的安全性、合法性和質量上分析或测試·相關的分析或测試亦可交由其他外部器可機構软行。
3.4 Segregation and Stock Rotation
隔離和存貨周轉
Procedures shall be in place to prevent the cross contamination of raw materials, packaging and finished products.组有滴常的程序,以防止原材料,包装和成品受到交叉污染"
3.5 Foreign Body Contamination吴物污染
The Company shall ensure al necessary steps are taken to identily, avoid, eliminate or minimise the risks ofmetal or other foreign body contamina fion.公司須確保所有必須的步骤來盛别、避免、排除或诚低由金局或其他物所引起的污染風險·
3.6 Product Release產品的放行
The Compamy shall ensure that product is not released unless all release procedures have been followed.公司須確保所有既定的及必須的放行程序已被行,否则,相的牵品批次不可被放行。3.7 Control of Non-Conforming Product不合格品控制The Compamy shall ensure all out of specification product is clearty identifed, labelled and quarantined.公司组確保所有不合格品被清楚鐵別·鐵和隔雕PROCESS CONTROL製程控制
The campany shall be able lo demonstrate effective contral ofal operations undertaken公司腐能筠担明其所有生產活動是被有效控制
4.1 Control of Operat io ns生畜活助控制
hhere conrol ofthe raw materis,inemedale or fiished produ,poceses anl/0r emironmentis requred to ensure produt salety,legalty and quty,there shal be adequale conrol monilorngand record keeping. Vhere parameters such as rawContoland fnalgovemm product safety, quality and legality these shall be controlled, monitored andre cord ed.當有關的原材料、牛成品、成品、或生產境控制是用以確保、法律性和品質上的要求時,相關的控制需要被规管、察、及記錄常相關原材料品竹·製程控制、及成品檢验的各項參動將會影舞最终產品的安全件,法律件和品質時,相题的会數蛋要抽規,些察、及記钱。
4.2 incoming Raw Materials Control原材料控制
4.3in-Process Control AND Process inspection生產遏程控制及鬟程檢查
4.4Final inspection最終產品檢查
4.5 Labelling and Packing標簇及包裝
4.6 Reference Samples卷考樣辦
The Company shall ensure that reference samples, or component samples are held and are avaiable for appropriae personnel or referal.公司鏖確保参考樣辦或組件樣辦被保存及可供適當昌工参考(使用)4.7Calibration and Control of Measuring and Monitoring Devices涮量及梭洄儀器的校险及控制
The Company sha iderily measuring equpmen used to monlor cica conlrol points andprodurlsafety an legalty. The identhied measumg equipment sha be calbraed, to a recognised nationastandard. Where a trace able calibralion is not possible, the Company shalldemonstrale the basis by which standardisation is caried oul.公司應鐵別用於验测重要控制點和南品安全件和合法性的酒量發備·並以器可的國家標凖,對两量设備进行校验·當校凖不可被追湖時,公司應组明所使用的校验基碰標凖。