Product Identification and Traceability Procedure
可追溯性文件-中英文
7.5.3标识和可追溯性Identification and Traceability7.5.3.1标识和可追溯性的目的Identification and Traceability Purpose1)组织应在产品实现的全过程中，对产品及其检验试验状态进行标识，防止在服务和交付过程中不同产品或不同状态产品的混用误用；对环境管理状态进行标识，减少或避免环境影响事故的发生。
The organization shall identify the product status with respect to inspection and testing throughout the complete product realization in order to prevent the confusion and misapplication during the service and delivery by various products or different status of the products; identify the environment management status for reducing or avoidance the environmental impact accidents.2)必要时实现产品和事故的可追溯性。
When necessary to achieve the products and accidents traceability7.5.3.2标识可通过标牌、标签、刻制、卡片、分存放地点、涂漆、及各种记录等多种方式实施。
Identification can be carried into execution by placards, labels, engraving, cards, storage locations, painting, all kinds of records and other means.7.5.3.3标识的分类Identification Classification1)产品标识,包括产品的型号、规格、顾客名称、生产日期等。
原料药生产中的确认与验证 欧美GMP培训
Consequences of Inadequate Qualification and Validation: Warning Letters from the US FDA
储管理与布局 • 详细的、可追溯的所有关于制造与检测作业的记录 • 恰当地设计与维护建筑与设施
设施确认、设备确认与工具确认
• 恰当地设计与操作设备与工具
工艺验证与清洗验证
确认与验证为什么是必要的？
a、简单的回答是药监管理机构要求制药厂承担这 些义务
美国食品药品监管署（FDA）：
“…验证是为确保一个专门过程…可以持续地生产满足预设规格与质 量特征的一个产品而反复建立的书面依据。”*
*工艺验证总则指南，FDA，1987年5月
b. Regulatory Requirements of Qualification and Validation
Currently, the US FDA and the European Medicines Agency (EMEA) adhere to the International Committee on Harmonization (ICH) Guidance Q7A
United States Food and Drug Administration: “…validation is establishing documented evidence which provides a high degree of assurance that a specific process…will consistently produce a product meeting its predetermined specifications and quality characteristics.”*
产品鉴定报告流程
产品鉴定报告流程Product identification reports are an essential part of the quality control process for both manufacturers and consumers. These reports provide detailed information about the product being tested, including its components, materials, and performance characteristics. They help ensure that the product meets the necessary standardsand specifications set by regulatory bodies. For manufacturers, these reports are a way to demonstrate compliance with regulations and ensure consumer safety. For consumers, they serve as a valuable tool for making informed purchasing decisions and verifying the authenticity of a product.产品鉴定报告是制造商和消费者质量控制过程中必不可少的一部分。
这些报告提供了有关被测试产品的详细信息，包括其组成部分、材料和性能特征。
它们有助于确保产品符合监管机构设定的必要标准和规范。
对于制造商来说，这些报告是表明遵守规定并确保消费者安全的一种方式。
对于消费者来说，它们是一个有价值的工具，用于做出知情的购买决定并验证产品的真实性。
The process of obtaining a product identification report involves several steps, starting with selecting a reputable testing laboratory.Manufacturers must choose a laboratory that is accredited and has the expertise to conduct the necessary tests. Once a laboratory is selected, the manufacturer submits a sample of the product to be tested along with any relevant documentation, such as product specifications or regulatory requirements. The laboratory then conducts the required tests, which may include chemical analysis, performance testing, and quality assessments.获得产品鉴定报告的过程涉及几个步骤，从选择一家值得信赖的检测实验室开始。
产品标识和可追溯性 Product__ Identification
Prepared By:起草：Yang XiaoningRevised By:审核：Wenyi LiApproved By:批准：Dunguo PeiTQSP –Quality Management System泰纳瑞斯青岛厂质量管理体系PRODUCT IDENTIFICATIONAND TRACEABILITY产品标识和可追溯性No./编号L3 QA –011Revision/版本10Effective Date/生效日期03/12/2008Total Pages/总页数11Important NoticeThe document that you have printed might be invalid.Before imp lementation, p lease check the latest ap p licableversion posted in Computer System.重要提示：为避免使用过期文件，在实施前，必须核对计算机系统中的最新版本。
1OBJECTIVE目的The objective of this procedure is to set up a guide line to identify products and keep good productstraceability in TQSP.本程序的目的是在青岛泰纳瑞斯建立标识产品和保持良好的产品可追溯性的操作指南。
2SCOPE范围This document is applicable to the identification and status of material and product processed in TQSP.本文件适应于泰纳瑞斯青岛钢管厂生产过程中材料和产品的标识和状态。
3REFERENCE DOCUMENTS参考文件·Tenaris L2 7.01Product realization泰纳瑞斯L2 7.01产品实现·API Specification Q1 –latest Edition.API规范Q1—最新版本·API Specification 5B, 5CT.API5B, 5CT规范4DEFINITIONS AND ABBREVIATIONS定义和缩写·TQSP:Tenaris Qingdao Steel Pipe Mill泰纳瑞斯青岛钢管厂·QMS:Quality Management System质量管理体系·QA: Quality Assurance质量保证·NC: Non-conformity不合格·VERI: Verification Group of Quality 质量验证小组·WMS:Weighing, measuring and stenciling 称重、测量、打印·CSU:Cargo self-storable unit自卸单元5RESPONSIBILITY职责SC Logistics is responsible for identification of tubular material and product stored in yard,andmaintaining the integrity of identification.物流负责货场贮存区域的管材和产品的标识，并维持相关标识的完整性。
OMEGALAQ 液体温度指示剂说明书
19/03/2015EN (English)1/1SECTION 1: Identification of the substance/mixture and of the company/undertaking1.1.Product identifierProduct form Product name : Mixture: OMEGALAQ TM Liquid Temperature Lacquers 475 °F (246 °C), 488 °F (253 °C), 500 °F (260 °C)1.2.Relevant identified uses of the substance or mixture and uses advised againstUse of the substance/mixture : Temperature indicator1.3.Details of the supplier of the safety data sheetOMEGA Engineering, INC. 800 Connecticut Ave, Suite 5N01Norwalk, CT 06854 USA(800)-848-4286 or (203)-359-1660 Fax: (203)-359-7700 **************1.4.Emergency telephone numberEmergency number24-hour emergency: ChemTel U.S. : 1-800-255-3924 International: +1-813-248-0585SECTION 2: Hazards identification2.1.Classification of the substance or mixture Classification in accordance with the Globally Harmonized Standard Skin Irrit. 2H315 Eye Irrit. 2AH319 Muta. 2 H341 Carc. 1B H350 Repr. 1B H360 STOT SE 3 H335 STOT SE 3 H336 STOT RE 2H373Full text of H-phrases: see section 16 2.2Label elementsGHS-US labellingHazard pictograms (GHS-US):GHS07 GHS08Signal word (GHS-US) : DangerHazard statements (GHS-US): H315 - Causes skin irritationH319 - Causes serious eye irritation H335 - May cause respiratory irritation H336 - May cause drowsiness or dizziness H341 - Suspected of causing genetic defects H350 - May cause cancerH360 - May damage fertility or the unborn childH373 - May cause damage to organs through prolonged or repeated exposure Precautionary statements (GHS-US): P201 - Obtain special instructions before useP202 - Do not handle until all safety precautions have been read and understood P260 - Do not breathe mist, vapoursP264 - Wash hands thoroughly after handlingP271 - Use only outdoors or in a well-ventilated areaP280 - Wear eye protection, protective clothing, protective gloves P302+P352 - If on skin: Wash with plenty of wateraccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)P304+P340 - If inhaled: Remove person to fresh air and keep comfortable for breathingP305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contactlenses, if present and easy to do. Continue rinsingP308+P313 - If exposed or concerned: Get medical advice/attentionP312 - Call a doctor if you feel unwellP314 - Get medical advice/attention if you feel unwellP321 - Specific treatment (see First aid measures on this label)P332+P313 - If skin irritation occurs: Get medical advice/attentionP337+P313 - If eye irritation persists: Get medical advice/attentionP362 - Take off contaminated clothing and wash before reuseP403+P233 - Store in a well-ventilated place. Keep container tightly closedP405 - Store locked upP501 - Dispose of contents/container to hazardous or special waste collection point, inaccordance with local, regional, national and/or international regulation2.3. Other hazards2.4 Unknown acute toxicity (GHS US)1.22 percent of the mixture consists of ingredient(s) of unknown acute toxicity (Oral)1.47 percent of the mixture consists of ingredient(s) of unknown acute toxicity (Dermal)1.47 percent of the mixture consists of ingredient(s) of unknown acute toxicity (Inhalation (Dust/Mist))SECTION 3: Composition/information on ingredients3.1. SubstanceNot applicable3.2. MixtureFull text of H-phrases: see section 16SECTION 4: First aid measures4.1. Description of first aid measuresFirst-aid measures general : IF exposed or concerned: Get medical advice/attention.First-aid measures after inhalation : Remove victim to fresh air and keep at rest in a position comfortable for breathing. Call aPOISON CENTER or doctor/physician if you feel unwell.First-aid measures after skin contact : Wash with plenty of soap and water. Wash contaminated clothing before reuse. If skin irritationoccurs: Get medical advice/attention.First-aid measures after eye contact : Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy todo. Continue rinsing. If eye irritation persists: Get medical advice/attention.First-aid measures after ingestion : Drink plenty of water. Immediately call a POISON CENTER or doctor/physician. Do NOTinduce vomiting.according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)4.2. Most important symptoms and effects, both acute and delayedSymptoms/injuries : Suspected of causing genetic defects. May cause cancer. May damage fertility or the unbornchild. May cause damage to organs through prolonged or repeated exposure.Symptoms/injuries after inhalation : May cause respiratory irritation. May cause drowsiness or dizziness.Symptoms/injuries after skin contact : Causes skin irritation.Symptoms/injuries after eye contact : Causes serious eye irritation.4.3. Indication of any immediate medical attention and special treatment neededAll treatments should be based on observed signs and symptoms of distress in the patient.SECTION 5: Firefighting measures5.1. Extinguishing mediaSuitable extinguishing media : Carbon dioxide. Dry powder. Foam. Sand. Water fog.Unsuitable extinguishing media : Do not use a heavy water stream.5.2. Special hazards arising from the substance or mixtureFire hazard : Burning produces irritating, toxic and noxious fumes.Explosion hazard : Product is not explosive.Reactivity : No dangerous reactions known.5.3. Advice for firefightersFirefighting instructions : Use water spray or fog for cooling exposed containers. Exercise caution when fighting anychemical fire. Do not allow run-off from fire fighting to enter drains or water courses. Protection during firefighting : Do not enter fire area without proper protective equipment, including respiratory protection.Wear fire/flame resistant/retardant clothing. Wear a self contained breathing apparatus. SECTION 6: Accidental release measures6.1. Personal precautions, protective equipment and emergency proceduresGeneral measures : Avoid all eye and skin contact and do not breathe vapour and mist.6.1.1. For non-emergency personnelProtective equipment : Chemical goggles or safety glasses. Wear suitable protective clothing and gloves. Emergency procedures : Evacuate unnecessary personnel.6.1.2. For emergency respondersProtective equipment : Chemical goggles or safety glasses. Wear suitable protective clothing and gloves. Emergency procedures : Stop leak if safe to do so. Ventilate area.6.2. Environmental precautionsAvoid release to the environment.6.3. Methods and material for containment and cleaning upFor containment : Absorb and/or contain spill with inert material, then place in suitable container. Do not allowminor leaks or spills to accumulate on walking surfaces.Methods for cleaning up : Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Takeup in non-combustible absorbent material and shove into container for disposal.6.4. Reference to other sectionsSection 13: disposal information. Section 7: safe handling. Section 8: personal protective equipment.SECTION 7: Handling and storage7.1. Precautions for safe handlingPrecautions for safe handling : Obtain special instructions before use. Use personal protective equipment as required. Do nothandle until all safety precautions have been read and understood. Avoid breathing mist,vapours. Use only outdoors or in a well-ventilated area.Hygiene measures : Wash hands and other exposed areas with mild soap and water before eating, drinking orsmoking and when leaving work.according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)7.2. Conditions for safe storage, including any incompatibilitiesStorage conditions : Keep container tightly closed. Keep only in the original container in a cool well ventilated place. Incompatible products : Strong acids. Strong bases.Incompatible materials : Heat sources. Direct sunlight.Prohibitions on mixed storage : Incompatible materials.7.3. Specific end use(s)Temperature indicator.SECTION 8: Exposure controls/personal protection8.1. Control parameters8.2. Exposure controlsAppropriate engineering controls : Avoid creating mist or spray. Avoid splashing. Either local exhaust or general room ventilationis usually required.Personal protective equipment : Avoid all unnecessary exposure.Hand protection : Use rubber gloves.Eye protection : Chemical goggles or safety glasses.Skin and body protection : Wear suitable protective clothing. Long sleeved protective clothing.Respiratory protection : Where exposure through inhalation may occur from use, respiratory protection equipment isrecommended. Use an approved respirator equipped with oil/mist cartridges.SECTION 9: Physical and chemical properties9.1. Information on basic physical and chemical propertiesPhysical state : Liquidaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)Appearance : Opaque liquid.Colour : Variable.Odour : Solvent.Odour threshold : No data availablepH : No data availableRelative evaporation rate (butyl acetate=1) : No data availableMelting point : No data availableFreezing point : No data availableBoiling point : No data availableFlash point : None (CC)Auto-ignition temperature : No data availableDecomposition temperature : No data availableFlammability (solid, gas) : No data availableVapour pressure : No data availableRelative vapour density at 20 °C : No data availableRelative density : No data availableSolubility : No data availableLog Pow : No data availableLog Kow : No data availableViscosity, kinematic : No data availableViscosity, dynamic : No data availableExplosive properties : No data availableOxidising properties : No data availableExplosive limits : No data available9.2. Other informationVOC content : 68.6 – 70%SECTION 10: Stability and reactivity10.1. ReactivityNo dangerous reactions known.10.2. Chemical stabilityStable under normal conditions.10.3. Possibility of hazardous reactionsHazardous polymerization will not occur.10.4. Conditions to avoidDirect sunlight. Heat.10.5. Incompatible materialsStrong bases. Strong acids.10.6. Hazardous decomposition productsBurning produces irritating, toxic and noxious fumes. Carbon dioxide. Carbon monoxide. Hydrogen halide. Bromides. SECTION 11: Toxicological information11.1. Information on toxicological effectsAcute toxicity : Not classifiedaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)Skin corrosion/irritation : Causes skin irritation.Serious eye damage/irritation : Causes serious eye irritation.Respiratory or skin sensitisation : Not classifiedGerm cell mutagenicity : Suspected of causing genetic defects.Carcinogenicity : May cause cancer.Reproductive toxicity : May damage fertility or the unborn child.Specific target organ toxicity (single: May cause respiratory irritation. May cause drowsiness or dizziness. exposure)Specific target organ toxicity (repeated: May cause damage to organs through prolonged or repeated exposure. exposure)Aspiration hazard : Not classifiedPotential adverse human health effects and symptomsSymptoms/injuries after inhalation : May cause respiratory irritation. May cause drowsiness or dizziness. Symptoms/injuries after skin contact : Causes skin irritation.Symptoms/injuries after eye contact : Causes serious eye irritation.Likely routes of exposure : Skin and eye contact;InhalationSECTION 12: Ecological information12.1 Toxicityaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)12.2. Persistence and degradability12.3. Bioaccumulative potential12.4. Mobility in soilNo additional information available12.5. Other adverse effectsNo additional information availableSECTION 13: Disposal considerations13.1 Waste treatment methodsWaste treatment methods : Do not dispose in household garbage.Sewage disposal recommendations : Do not dispose of waste into sewer.Waste disposal recommendations : Dispose in a safe manner in accordance with local/national regulations. SECTION 14: Transport informationIn accordance with DOT and TDGNot considered a dangerous good for transport regulationsaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations according to Canadian Hazardous Products Regulations (HPR)Proper Shipping Name (ADR) : Not applicableTransport by seaNo additional information availableAir transportNo additional information availableSECTION 15: Regulatory information15.1. US Federal regulations15.2. International regulationsCANADAaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)15.3. US State regulationsSECTION 16: Other informationIndication of changes : Original Document.Data sources : ACGIH 2000.Canadian Centre for Occupational Health and Safety. Accessed at:ohs.ca/oshanswers/legisl/whmis_classifi.html.ESIS (European chemincal Substances Information System; accessed at:http://esis.jrc.ec.europa.eu/index.php?PGM=cla.European Chemicals Agency (ECHA) Registered Substances list. Accessed athttp://echa.europa.eu/. Krister Forsberg and S.Z. Mansdorf, "Quick Selection Guide toChemical Protective Clothing", Fifth Edition.National Fire Protection Association; Fire Protection Guide to Hazardous Materials; 10thedition.OSHA 29CFR 1910.1200 Hazard Communication Standard.REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THECOUNCIL of 16 December 2008 on classification, labelling and packaging of substances andmixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amendingRegulation (EC) No 1907/2006.TSCA Chemical Substance Inventory. Accessed at/oppt/existingchemicals/pubs/tscainventory/howto.html.according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)Abbreviations and acronyms : ACGIH (American Conference of Governement Industrial Hygienists).ATE: Acute Toxicity Estimate.CAS (Chemical Abstracts Service) number.CLP: Classification, Labelling, Packaging.EC50: Environmental Concentration associated with a response by 50% of the test population.GHS: Globally Harmonized System (of Classification and Labeling of Chemicals).LD50: Lethal Dose for 50% of the test population.OSHA: Occupational Safety & Health Administration.PBT: Persistent, Bioaccumulative, Toxic.STEL: Short Term Exposure Limits.TSCA: Toxic Substances Control Act.TWA: Time Weight Average.Other information : None.NFPA health hazard : 2 - Intense or continued exposure could cause temporaryincapacitation or possible residual injury unless promptmedical attention is given.NFPA fire hazard : 1 - Must be preheated before ignition can occur.NFPA reactivity : 0 - Normally stable, even under fire exposure conditions,and not reactive with water.Full text of H-phrases:Acute Tox. 4 (Dermal) Acute toxicity (dermal), Category 4Acute Tox. 4 (Inhalation) Acute toxicity (inhal.), Category 4Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4Aquatic Chronic 2 Hazardous to the aquatic environment — Chronic Hazard, Category 2Aquatic Chronic 3 Hazardous to the aquatic environment — Chronic Hazard, Category 3Asp. Tox. 1 Aspiration hazard, Category 1Carc. 1B Carcinogenicity, Category 1BCarc. 2 Carcinogenicity, Category 2Eye Irrit. 2A Serious eye damage/eye irritation, Category 2AFlam. Liq. 2 Flammable liquids, Category 2Muta. 2 Germ cell mutagenicity, Category 2Repr. 1B Reproductive toxicity, Category 1BRepr. 2 Reproductive toxicity, Category 2Skin Irrit. 2 Skin corrosion/irritation, Category 2STOT RE 2 Specific target organ toxicity — Repeated exposure, Category 2STOT SE 3 Specific target organ toxicity — Single exposure, Category 3, Respiratory tract irritationSTOT SE 3 Specific target organ toxicity — Single exposure, Category 3, NarcosisH225 Highly flammable liquid and vapourH302 Harmful if swallowedH304 May be fatal if swallowed and enters airwaysH312 Harmful in contact with skinH315 Causes skin irritationH319 Causes serious eye irritationH332 Harmful if inhaledH335 May cause respiratory irritationH336 May cause drowsiness or dizzinessH341 Suspected of causing genetic defectsH350 May cause cancerH351 Suspected of causing cancerH360 May damage fertility or the unborn childH361 Suspected of damaging fertility or the unborn childH373 May cause damage to organs through prolonged or repeated exposureH411 Toxic to aquatic life with long lasting effectsH412 Harmful to aquatic life with long lasting effectsSDS Prepared by: The Redstone Group, LLC6397 Emerald Pkwy.Suite 200Dublin, OH USA 43016T 614-923-7472OMEGALAQ TM Liquid Temperature Lacquers 475 °F (246 °C), 488 °F (253 °C), 500 °F (260 °C)Safety Data Sheetaccording to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulationsaccording to Canadian Hazardous Products Regulations (HPR)This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product19/03/2015 EN (English) 11/1。
准备FDA认证前检查中英文对照文档
H03.1 Product Identification and Recall_6XKhoKy0hRxF
产品回收
8
1 、制定成文的产品回收程序
• 可疑产品区分确定程序 • 回收产品的清点、处理程序 • 及时通知客户的程序 • 确定何种情况、何时通知相关国家管理部门的程序
• 列出产品回收小组每个成员的职责
9
2、 保存产品回收联系表
• 供应商联系人（供应商内部人员）：现行使用 的联系人清单已通知客户。每个联系人都有现行 的产品回收程序和联系人员名单副本。 • 二线供应商联系人（原料、配料、包装材料供 应商）：应有24小时联系电话号码
4
2、 适当地标识成品、包装品和原料，以便追踪
所有的原材料、包装品和成品都应清晰标识，以便 追踪。成品需有易读的月、日、年和批次编号，所 有原料均需标识以便追踪。
5
3、 保存所有原材料、包装材料和成品的批次识别和 追踪记录
• 保持追踪踪原物料、与食品接触的包装材料和成品 直接销售对象的所有记录。记录应包括： • 所有原材料和包装材料的与相应的成品编号相联系 的记录 • 产品出货的所有记录
追踪指定产品至第一个外部客户
17
计时
从原料批号选定开始计时至所有文件收起 4小时中止
18
产品，原料和包材的追踪
1
1、 制定所有原料、包装材料和成品的批次识别和追 踪的程序
工厂需有成文的规程，以确定如何识别和 追踪原材料和包装材料至成品批次。所有 与食品接触的包装材料都应追踪。
2
1、 制定所有原料、包装材料和成品的批次识别和 追踪的程序 (cont.)
程序包括： • 建立对生产流程每一步骤的追踪程序。包括从原料接受 到产 品出货（直接销售对象）的每一步骤。 • 有进行原料/包装材料/产品追踪的指定记录 • 每种指定记录的用途 • 每种指定记录包含的原料/产品追踪的详细信息 • 每种记录的责任人（可按工作岗位/职位区分）
FDA验厂常见问题_V2
FDA验厂常见问题注意：递交给FDA的审核文件必须翻译成英文。
Subpart B--Quality System Requirements质量体系要求Sec. 820.20 Management responsibility.管理职责1. 管理职能机构没有对供应商进行定期评审以保证质量体系达到要求问题来源：Merits Health Products Co., Ltd.2. 管理评审和质量体系程序没有形成文件（问题来源：Merits Health Products Co., Ltd.的第5点）Subpart C--Design Controls 设计控制Sec. 820.30 Design controls. 设计控制1. 厂家没有建立并保持有关设计和开发行为的计划（问题来源：Merits Health Products Co., Ltd.的第6点）2. 厂家没有充分建立并保持各种类型器械的DHF（设计历史主文档，DHF应包含或参照必要的原始记录）问题来源：Merits Health Products Co., Ltd.问题来源：Foshan R. Poon Medical Products Co., Ltd.We reviewed your firm's response and conclude that it is not adequate. While your firm provided its Design and Development Control Procedure, "Document# NLR-QP-36," your firm did not provide a systemic corrective action that would assess the design activities for all product lines. Also, your firm did not provide evidence of implementation of the procedure or training of employees on the procedure.3. 厂家没有建立和维护设计验证程序问题来源：Vega Technologies, Inc.问题来源：EMG Manufacturing Co., Ltd问题来源：Heartway Medical Products Co., Ltd4. 厂家没有建立并保持设计确认的程序（设计确认包括软件确认及适当时候的风险分析），没有遵守风险分析程序来执行分析验证。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
PMC
Packing NO / Inspection/Marking YES
PMC
QRA
Outgoing
PMC
Product tracing
All departments
QPM012 Rev.E
Contents 1. 1.1 Inspection marking when received. 料 when received from supplier. 數量 (QPM002) ( ) 數量 Mark part number, product name, spec and quantity in obvious place of package 1.2 Demo Board
After checking quantity of goods, PMC inform QRA to inspect and mark according to QPM002 Finished goods and Demo Board Inspection 2. 錄 Procedure. / Incoming inspection/marking: 錄 數量 …… 錄
QPM012 Rev.E
7. 料 7.1
Traceability Material and finished goods from subcontractor ( 利 ) 數量 There shall mark lot number, part name, quantity and date…etc.
QRA inspect and mark according to Finished Goods Inspection Procedure and record in IC Incoming Checking list. Checking list includes lot number, quantity, inspect date, date code…etc. 理 理 Received: Warehouse Management Procedure. 4. Packing: WC008001 and up According to WC008001 and up AME Customer Special Request Handling Procedure. ( WM000042) receives qualified goods according to Warehouse
理 Product Identification and Traceability Procedure
流 Flow diagram 流 Action Responsible 參 Reference Document Forms
Received NO / Inspection/Marking YES Received
3.
According to WM000042 AME Packing Procedure. 5. / Outgoing inspection/Marking 錄 錄 數量 … 錄
QRA inspect and mark goods according to Finished Goods Inspection Procedure, and record in the OQC Record. There shall be lot number, quantity, checking date, date code, customer name, shipping number…etc. 6. Outgoing Outgoing shall follow FIFO rule. WC001003A check Shipping Note WC001003A Order before product outgoing. PMC shall
Supplier
பைடு நூலகம்
QRA
Finished Goods Inspection Procedure (QPM002) 理 Warehouse Management Procedure (QPK008) Customer Special Request Handling Procedure WC008001 and up AME AME Packing Procedure 料異 (WM000042) Discrepancy Goods Material Report Inspection Procedure (QPM002) (WM002001F) Warehouse 理 Management Procedure (QPK008)
on the box for tracing when delivered. 7.2 領料 Material, semi-finished goods and finished goods A 立 令 便 量 理 PMC come into lot number for product controlling and traceability when creating work order. B (WK003002A) 領料 領料 錄 數量 …… 料 料 PMC record part number, part name, quantity 7.3 8. and date…etc. in Request Form (WK003002A) for production when request. Naming rule of lot number: Wafer 料 According to Wafer supplier’s rule. 識 識 參 B/D Reference to outgoing Reference to AME Packing Procedure, B/D and Marking & Electrical Inspection Procedure about the identification of product incoming, process, finished goods.
QPM012 Rev.E