Inspection Criterion--检验要求
检验方法验证的类型及基本要求
检验方法验证的类型及基本要求（一）概述方法验证的目的是证明所采用的方法达到相应的检测要求。
由于分析性质的差异，本节中所讨论的验证内容不适用微生物分析方法。
验证的内容主要包括准确度、精密度、专属性、检测限、定量限、线性、范围、粗放性和耐用性9个方面。
药典收载的方法一般比较成熟，需验证的内容与新开发的检验方法有很大差异，美国药典中明确规定其所收载的方法需做系统适应性试验，这即是美国药典对方法验证的要求。
某一方法需到底须进行哪些项目的验证，应根据实际情况而定，并不是所一的方法都必需进行以上9个方面的验证试验。
方法验证的范围，一般来说，可分为以下3种情况区别对待。
1、对于直接引用有法定依据的方法，如药典标准和部颁标准，仅做系统适应性试验即可。
但若将法定方法用于测定新药，或将某一品种的法定方法用于另一品种，就需进行系统的方法验证。
2、对于已在一实验室验证过但需在另一个实验室使用的分析方法，可采用对照试验法。
即取同一批样品，按此方法在两实验室分别进行检验，将结果进行比较（如用t检验法计算），判断是否有显著性差异。
这特别适用于大公司（包括跨国公司）的情况。
母公司完成了系统的方法验证工作，子公司实验室均可用结果对照的方法进行判断，节省了大量人力、物力。
国外称这种做法为“技术转移”（Technical transfer）。
3、其他分析方法可分为4种类型，验证要求可参见下表不同分析方法的验证要求验证项目类型类型I 类型II 类型III 类型IV定量测定限度试验准确度要求要求 * * ——精密度要求要求——要求——专属性要求要求要求 * 要求检测限————要求 * ——定量限——要求—— * ——线性要求要求—— * ——范围要求要求 * * ——注：“——”表示不坐要求；“*”表示需根据实验特性决定是否坐要求。
类型I指用于测定原料药中主要成分或制剂中活性组分（包括防腐剂）的定量分析方法。
类型II指用于测定原料药中杂质或制剂中降解产物的分析方法，包括定量分析和限度试验。
国际贸易实务 10.检验条款
第一节 商品检验 （ Inspection of the goods）
Meanings and Importance of inspection Time and Place of Inspection Commodity Inspection Institution Inspection Certificate Inspection criterion Inspection Clauses in Sales Contract
Inspection Certificate of Quality 品质检验证书 Inspection Certificate of Quantity 数量检验证书 Inspection Certificate of Weight 重量检验证书 Inspection Certificate of Value 价值检验证书 Inspection Certificate of Origin 产地检验证书 Sanitary Inspection Certificate 卫生检验证书 Veterinary Inspection Certificate 兽医检验证书 Disinfection Inspection Certificate 消毒检验证书 Inspection Certificate on Damaged Cargo 残损检验证书
1.4 Inspection Certificate 作用：
检验证书
卖方的交货证明； 通关的依据； 卖方向银行议付货款的依据； 是明确责任归属、办理索赔、理赔的依据； 是解决争议的依据； 检验证书是计算关税的依据； 计算运费、仓储等费用的依据。
思考：检验时间地点与贸易术语的搭配 D组术语、E组术语采用装运港检验合适吗？ FOB、CIF、CFR采用目的港检验合适吗？
Quality Inspection Guideline
Inspection Guidelines检验指南1. Sampling level and AQL requirement. 抽样标准和AQL要求。
1.1 Normal Inspection Level II, under ANSI/ASQC Z1.4, is the sampling plan Adopted by ProTVQuality assurance. 使用Level II抽样计划。
1.2 AQL – Critical 0 / Major2.5 / Minor 4.0.一般产品最终随机检验AQL标准是: AQL-严重0/主要1.0/次要4.0As for critical function, if the initial number is 1, another same number of samplesshould be drawn, the result will be pass if no critical function defective found.关于关键性的功能，如果第一次抽样的次品数是一，那么将第二次抽取同等的样板，如果没有关键性的功能项出现，结果为合格。
2. Terms of inspection 验货条件2.1 Inspection based on below status:and leave the factory after instruction.如果QC发现大货完成状态是”not ready”，需要打电话回办公室，在得到公司指令后离开工厂。
2.3 If factory couldn't offer a suitable environment or sufficient manpower to assist forInspection, QC needs to call back to office immediately for further instruction.如果工厂不能提供合适的验货环境或者没有足够的人手协助验货，QC要立即致电写字楼。
模型机检验标准inspection standard
一、目的(Aim:)为保证机模质量，给检查作业提供依据，为客户提供合格的产品，特制定本标准。
In order to insure the quality、give the rules to the inspection action and supply our customers with super products, we establish the standards.二、范围(Range)适用于LG公司模型机检验All the LG dummies are valid三、检验流程：（Inspection process）注：①以上工序的检验参照相应的检验标准；All the inspection process should be comply with the relative standard.②在检验过程中如某一检验标准不适用可省略其检验步骤。
Any standard is inapplicable, omitting the inspection process1．模型机整机检验标准Whole dummy inspection standard1.1、检验标准：Inspection standard:1.1.1 长、高、宽与样机相差小于1mm；Comparing the length、height、width with the real phone,△E<1mm;1.1.2 重量与样机相差±5g；Comparing the weight with the real phone,△E<=5g1.1.3 颜色与样机基本一致；(在客户确认样板与真机颜色之间可接受)Color should keep consistent with the real phone (Between the GS and the real phone isacceptable)1.1.4 手感质感与样机基本一致；(在客户确认样板与真机效果之间可接受)Touching feeling should keep consistent with the real phone (Between the GS and thereal phone is acceptable)1.1.5 整机形状、外观及配件的形状、外观与样板机基本一致。
检验规则及方法 英文
检验规则及方法英文Inspection Rules and Methods.Inspection is a crucial process in ensuring the quality, safety, and compliance of products, services, or systems.It involves the evaluation of specified requirements, standards, or specifications to determine if they are met. Effective inspection rules and methods are essential for identifying defects, preventing failures, and ensuring the reliability of products or services.1. Types of Inspection.There are several types of inspections based on the purpose, scope, and timing of the inspection:Initial Inspection: Conducted at the beginning of a process or project to establish a baseline and ensure that all requirements are met before proceeding.In-process Inspection: Performed during the production or service delivery process to monitor and control quality.Final Inspection: Carried out at the end of theprocess or project to ensure compliance with all specified requirements before release or delivery.Periodic Inspection: Conducted at regular intervals to monitor the condition and performance of equipment, systems, or structures.Random Inspection: Performed at random intervals or on a random sample to assess the overall quality and identify any potential issues.2. Inspection Rules.Inspection rules are guidelines that define thecriteria, procedures, and standards to be followed during the inspection process. They ensure consistency, repeatability, and fairness in the evaluation of productsor services. Some common inspection rules include:Sampling Rules: Define the method and criteria for selecting samples for inspection. Sampling can be either random or systematic, depending on the requirements and objectives of the inspection.Defect Classification: Defects are categorized based on their severity, impact on performance, and potential safety hazards. This classification helps in prioritizing corrective actions and ensuring that critical defects are addressed promptly.Acceptance Criteria: Define the minimum standards or specifications that a product or service must meet to be considered acceptable. These criteria are usually based on industry standards, regulations, or customer requirements.Non-Conformance Handling: Specify the procedures to be followed when a product or service fails to meet the acceptance criteria. This may include rejection, repair, rework, or retesting, depending on the nature and severity of the non-conformance.3. Inspection Methods.Inspection methods refer to the techniques, tools, and procedures used to conduct the inspection. The choice of inspection method depends on the type of product or service, the nature of the defects to be detected, and the available resources. Some common inspection methods include:Visual Inspection: Conducted by trained personnelusing their eyes to identify visible defects, damage, or discrepancies. It is widely used in various industries dueto its simplicity and cost-effectivenesss.Mechanical Inspection: Involves the use of measuring devices and tools to measure dimensions, angles, or other physical properties of products or components. This methodis essential for precision manufacturing and quality control.Electrical Testing: Used to evaluate the electrical properties of products or systems, such as voltage, current,resistance, and capacitance. It helps in identifying electrical faults and ensuring the safety and reliabilityof electrical systems.Non-Destructive Testing (NDT): Involves techniqueslike X-ray, ultrasound, magnetic particle inspection, and liquid penetrant testing to detect internal defects without damaging the product. These methods are widely used in aerospace, automotive, and other industries where product integrity is crucial.4. Importance of Inspection Rules and Methods.Inspection rules and methods play a pivotal role in ensuring the quality, safety, and reliability of products and services. They help in:Identifying Defects: Inspection rules and methods provide a structured approach to identifying defects, discrepancies, and non-conformances in products or services.Preventing Failures: Timely identification andcorrection of defects can prevent failures and ensure the smooth operation of systems and equipment.Meeting Customer Expectations: Compliance with inspection rules and methods ensures that products or services meet customer requirements and expectations, enhancing customer satisfaction.Improving Processes: Feedback from inspections can be used to identify process improvements, enhance product design, and refine manufacturing techniques.Ensuring Compliance: Inspection rules and methods ensure that products or services comply with industry standards, regulations, and safety requirements.In conclusion, inspection rules and methods are essential for ensuring the quality, safety, and reliability of products and services. They provide a structured approach to identifying defects, preventing failures, and meeting customer expectations. By adhering to these rules and using appropriate inspection methods, organizations canimprove their processes, enhance product quality, and maintain a competitive edge in the market.。
USP-化学药物质量控制分析方法验证技术指导原则
Proposed Analytical Procedure— This section should contain a complete description of the analytical procedure sufficiently detailed to enable persons “skilled in the art” to replicate it. The write-up should include all important operational parameters and specific instructions such as preparation of reagents, performance of system suitability tests, description of blanks used, precautions, and explicit formulas for calculation of test results.
TS16949来料检验作业指导书(中英文)
TS16949来料检验作业指导书Incoming_Inspection_Work_Instruction文件更改历史记录Amendment History版次Revision更改日期Change Date更改概要Description of Changes更改人Prepared by批准人Approved byPrepared by编制Reviewed by审核Approved by批准TS16949来料检验作业指导书Incoming_Inspection_Work_Instruction1.0Purpose目的The objective of this procedure is to define a standard inspection method in performing inspection and testing of components or materials.本程序目的在于定义对元件或材料进行检验/测试的标准操作方法。
Scope适用范围This procedure is applicable to all components and materials that require the relevant inspection and testing, as specified in the individual Part or Material Specification.本程序适用于所有按照元件和材料规格进行检验和测试的元件和材料。
2.0Sampling / Equipment Used 取样 / 使用设备2.1Per sampling plan stated in the Incoming Inspection Procedure: AQL：MA=0.4、MI=1.0按照来料检验程序所规定的抽样计划；AQL:MA=0.4、MI=1.0级别进行抽样.2.2Inspection Aids检验工具4.2.1 LCR Meter / LCR 测量仪4.2.2 Fluke Multimeter / Fluke 万用表4.2.3 Caliper / Plug Gauge / Pin Gauge / 游标卡尺/ 塞规/针规4.2.4 Magnifier / Microscope / 放大镜 / 显微镜3.0Reference Documents参考文件3.1 Customer’s AVL / 客户接受的供应商清单3.2 Manufacturer Part Specification / 供应商的元件规格3.3 Yamaoka AVL List / 本公司的AVL3.4 QAP-010 : Incoming Inspection Procedure / 来料检验程序3.5 SOP-QA-003 : Material Aging Control Procedure / 物料保质期控制程序4.0Inspection Criteria / 检验要点4.1MFG AVL Verification / 生产厂商确认Verify that the parts are from the authorized vendor per AVL list.根据AVL清单验证元件是否为承认厂商。
加拿大感官检验标准
CHAPTER 3, STANDARD 4FRESH AND FROZEN SCALLOP STANDARD第3章，标准4新鲜及冷冻扇贝柱标准1. INTRODUCTIONThis standard for fresh or frozen scallop meats, scallops with roe attached, and whole scallops derives its authority from the Fish Inspection Act and Regulations. It defines minimum acceptability for taint, decomposition, unwholesomeness and other requirements, other than weight, as defined in the Fish Inspection Act and Regulations and describes methods for determining that acceptability.1.导语该标准是基于鱼类检验条例和规章，针对新鲜及冷冻扇贝肉，带籽扇贝，以及整个扇贝的权威解释。
它定义了污物，腐烂，不健康以及其他要求的最小接受限值，除了重量与鱼类检验条例和规章的定义相符外，同时也描述了决定该接受限值的检验方法。
2. SCOPEThis standard applies to all fresh or frozen or previously frozen shucked-scallop meats (adductor muscle) with or without roe attached and whole scallops from any species of the family Pectinidae. Fresh or frozen scallops shall be prepared from sound, wholesome raw material processed using good manufacturing practices.Documents used to determine good manufacturing practice and compliance include:a) Recommended International Code of Practice - General Principles of Food Hygiene, CAC/RCP 1-1969 Rev. 1.b) Codex Alimentarius Sampling Plans for Prepackaged Foods (AQL 6.5) CAC/RM 42-1969.c) Recommended International Code of Practice for Fresh Fish, CAC/RCP 9-1976.d) Recommended International Code of Practice for Frozen Fish, CAC/RCP 16-1978.e) Code of Practice - General Principles of Food Hygiene for Use by the Food Industry in Canada, Health Protection Branch, Health and Welfare Canada, 1983.2.范围该标准适用于所有扇贝科中带籽或不带籽的新鲜及冷冻或事先冷冻的剥壳扇贝肉（肌肉柱）以及整个扇贝。
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2Operator isn't qualify 操作者不够资格
V 3Testing procedure isn't correct 测试程序不正确V 4haven't Calibration data at site 无校准纪录
V 5not Suitable Gauge and checking fixture 无检具
V 6
incorrect test standard or outdated QR as criteria 测试标准不正确V
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1Testing load weight isn't correct 施重不正确V
(1). BIFMA: Functional load is 225lbs;Proof load is 300lbs (2). Kmart and Target: 200lbs (3). Wal-mart:225lbs
2Drop times isn't correct 冲击次数不正确
V (1). BIFMA: Functional load 1 drop;Proof load 1 drop (2).Kmart, Wal-mart and Target: 1 drop
3Impact height isn't 6" 冲击高度
V
4Requirement level isn't correct V
(1). BIFMA: After functional load test,no loss of serviceability; After proof load test, no sudden and majoy change in the structural integrity
(2). Kmart and Target: less than 1/4" of permanent deformation
(3). Wal-mart: no majoy change in the structural integrity or component damage
5
1.1
transportation/vibration test doesn't meet 14200 times 震动次数
V 1.2transportation/vibration test, it doesn't lift to allow 1.5 mm sheet move freely under carton 纸箱没有离测试台面1。
5mm V
2.1carton drop test, the drop height isn't meet ISTA standard 摔箱高度
V 2.2
carton drop test, no make sure the most poorest corner being impacted 不是最弱角受冲击
V 3
vibration test system with a <25mm fixed controlled displacement
V 25mm fixed or controlled displacement
4after transportation/vibration or carton drop test, the
packaging have holes, tears, or openings, and the product have visible damage. 测试失败V
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before do testing, the speciments aren't clean 测试设备不干净
V
2the speciments place method isn't correct 测试方法不正确V
the speciments should be supported or suspended between 15 and 30° from the vertical
3the speciments can contact each other or any metallic material or any material capable of acting as a wick
V 4testing time isn't enough 测试时间不够
V
5after testing, handle method isn't correct V
the sepciments may be gently washed or dipped in clean running water not warmer than 38℃ to remove salt deposits from their surface.
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Inspection Criterion
Category:Regular Testing Rev# Date:2006 / Feb / 10th
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I m p a c t t e s t - E x t e n s i o n
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f l a m m a b i l i t y。