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抽样作业指导书--Sampling-Plan-for-Inspection-Instruction.doc

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抽样作业指导书 Sampling Plan for Inspection Instruction Rev. AA Ori. Date Doc No. Page Page9of 9 Record of Revision: No. Rev Originator Summaries Date CCF No. 1 2 3 4 5 6 7 8 9 10 DISTRIBUTION: Department Organization 1. Purpose 目的 This instruction serves to standardize the sampling standard applying ANSI/ASQC Z1.4 to conduct incoming materials and finish goods inspections, ensuring products meeting quality requirements. 本规程旨在规范使用ANSI/ASQC Z1.4单次抽样法对来料进行抽样检验,确保品质符合规范要求。 2. Scope 适用范围 This document is applicable to the inspection of all production materials and finished goods of *** Company Limited Plant. 本规程适用于***有限公司所有生产物料和成品的检查。 3. Responsibility职责 Quality Manager has the responsibility and authority to implement this procedure wherever sampling is required 品质经理赋予全权负责执行此流程。 4. Definition定义 AQL: Acceptable Quality Level 可接收质量水平。 Ac: Accept 接受 Re: Reject 拒收 CR: Critical 致命缺陷,会对人员造成伤害或火灾等。 MA: Major 严重缺陷,对产品有重大影响的缺陷。 MI: Minor 轻微缺陷,对产品有影响的缺陷。 5. Procedures作业程序 5.1 Inspection Levels 检查水平的规定: There are three general inspection levels (I, II & III) and four special inspection levels (S-1, S-2, S-3 & S-4). 检查水平分:一般检查水平(I、II、III)和特殊检查水平(S-1、S-2、S-3、S-4)。 Unless otherwise specified, Inspection Level II will be used. However, Inspection Level I may be specified when less discrimination is needed, or Level III may be specified for greater discrimination. Four additional special levels: S-1, S-2, S-3, and S-4, are given in the same table and may be used where relatively small sample sizes are necessary and large sampling risks can or must be tolerated.. 除非另有规定,通常采用一般检查水平 II 。当需要的判别力比较低时,可规定使用一般检查水平 I ,当需要的判别力比较高时,可规定使用一般检查水平 III 。特殊检查水平仅适用于必须使用较小的样本,而且能够或必须允许较大的误判风险。 Individual Inspection levels are designated per category of non-conforming in principle, it should be noted that inspection levels correspond with acceptance level of quality. 原则上按不合格的分类分别规定检查水平,但必须注意检查水平与合格质量水平之间的协调一致。 NOTE: In the designation of inspection levels S-1 to S-4, care must be exercised to avoid AQLs inconsistent with these inspection levels. For example, To correspond with the maximum sample size of single sampling plan for normal inspection exceeds 8 if sample size did not exceed D in S-1 level. If specified AQL =0.10, then the smaller sample sizes of single sampling plan for normal inspection is 125, therefore, S-1 shall be not to be used under AQL=0.10. 注:在规定特殊检查水平S-1至S-4时,必须注意避免检查水平同所规定的合格质量水平之间的矛盾。例如,在S-1中,样本大小字码没有超过 D,相当于正常一次抽样方案样本大小最多等于8。若规定AQL=0.10,则正常检查一次抽样方案的最小样本大小为125。因此,在规定AQL=0.10的情况下,不能规定使用特殊检查水平S-1。 5.2 Normal, Tightened and Reduced Inspection 检查严格度的确定: Generally, there are three grades for inspection –normal , tightened and reduced. Normal inspection will be used at the start of inspection unless otherwise directed by the responsible authority. 检查的严格度是指提交批所接受检查的宽严程度,通常规定为---正常检查、加严检查和放宽检查三种不同严格度的检查。除非另有规定,在检查开始时应使用正常检查。 5.3 Switching Procedures 转移规则: 5.3.1 Normal to Tightened 从正常检查到加严检查 When normal inspection is in effect, tightened inspection shall be instituted when 3 out of 5 or fewer consecutive lots or batches have been non-acceptable on original inspection. 当进行正常检查时,若在连续检查五批中有三批以上(不包括再次提交检查批)不合格,则从下一批检查转到加严检查。 5.3.2 Tightened to Normal 从加严检查到正常检查 When tightened inspection is in effect, normal inspection shall be instituted when 5 consecutive lots or batches have been considered acceptable on original inspection. 当进行加严检查时,若连续检验五批结果均(不包括再次提交检查批)合格,则从下一批检查转到正常检查。 5.3.3 Normal to Reduced 从正常检查到放宽检查 When normal inspection is in effect, reduced inspection shall be instituted providing that all of the following conditions are satisfied. a. The preceding 10 lots or batches (or more) have been on normal inspection and all have been accepted on original inspection; and b. The total number of nonconforming units (or nonconformities) in the samples from the preceding 10 lots or batches (or such other number as was used for condition “a” above) is equal to or less than the applicable limit number; and c. For Hi-tech products with at a steady rate; such as IC, resistor and capacitor; and d. Production is at a steady rate, reduced inspection is considered desirable by quality manager. 当进行正常检查时,若下列条件均满足,则从下一批转到放宽检查。 1. 连续10批或更多批(不包括再提交批)检查结果合格; 2. 在连续10或更多批所抽取的样本中不合格品(或不合格)总数小于或等于规定的界限数; 3. 对于高科技生产技术所生产出的产品,如IC,电阻,电容等; 4. 生产中未发现有严重的异常情况,品质经理同意转到放宽检查。 5.3.4 Reduced to Normal 从放宽检查到正常检查 When reduced inspection is in effect, normal inspection shall be instituted if any of the following occur on original inspection: a. A lot or batch is rejected; or b. Production becomes irregular or delayed or major abnormity ; or c. Quality manager warrant that normal inspection shall be instituted. 在进行放宽检查时,若出现下列任一情况,则从下一批转到正常检查。 1. 有一批放宽检查不合格; 2. 生产中发现严重异常情况; 3. 品质经理认为有必要回到正常检查。 5.4 Discontinuation of Inspection 检查的暂停和恢复 If the cumulative number of lots not accepted in a sequence of consecutive lots on tightened inspection reaches 5, the acceptance procedures of this standard shall be discontinued. Inspection under the provisions of this standard shall not be resumed until corrective action has been taken. a) For incoming material, inform buyer stop purchasing this material. b) After discontinuation of inspection, if supplier’s or production’s corrective action has been taken, Quality manager warrant that tightened inspection shall then be used. 加严检查开始后,若不合格批数(不包括再次提交检查批)累计到五批(不包括以前转到加严检查出现的不合格批数),则暂时停止按照本标准所进行的检查,并通知采购暂停购买该供应商的物料。 在暂停检查后,若供货方确实采取了措施,使提交检查批达到或超过所规定的质量要求,则经质量经理同意后,可恢复检查,一般应从加严检查开始。 5.5 Searches of Single Sampling Plan 一次抽样方案的检索 5.5.1 Appendix A –Sample size code letters 批量范围及抽样水平对照使用附表A。 5.5.2 Table–3 : Single sampling plans for normal inspection 检索正常检查一次抽样方案使用附表3。 5.5.3 Table–4: Single sampling plans for tightened inspection 检索加严检查一次抽样方案使用附表4。 5.5.4 Table–5 : Single sampling plans for reduced inspection 检索放宽检查一次抽样方案使用表5。 5.5.5 Searches Method检索方法 In Table I Sample size code letters, Sample sizes “n” are designated after selected code letter based on the size of batch or lot and AQL, then read out the number for judgment [Ac, Re] at the cross point of the row of sample sizes and column of specified AQL. Along the arrow and read out the first number for judgment [Ac, Re] if the cross point is a arrow, then leftward at the row of [Ac Re] direction meet sample size column to read out the correspond sample sizes “n” . Note: A. According to above method, maximum sample size be selected whatever non-conformity products or category when getting different sample size. B. AQL number for judgment [2,1] of single sampling plan can instead of judgment [0,1] of single sampling plan under customer’s agreement. 由批量范围及抽样水平对照使用表2得到的样本大小字码水平向右,在样本大小样内读出样本大小n,再从样本大小字码所在行和规定的合格质量水平所在列相交处,读出判定数组[Ac ,Re]。若在相交处是箭头,则沿着箭头方向,读出箭头所指的第一个判定数组[Ac ,Re],然后由此判定数组[Ac ,Re]所在行向左,在样本大小栏内读出相应的样本大小n。 注: A. 按上述检索方法,对不同类的不合格品或不同类的不合格得到不同的样本大小时,可以所读出的样本大小最大者所相应的抽样方案。 B. 在订货方同意的情况下,可以使用判定数组[1,2]的一次抽样方案代替判定数组[0,1]的一次抽样方案。 5.5.6 Sampling取样 The samples from each part of the lot or batch shall be selected dispersedly at random. 样板必须尽可能做到分散及随机。 5.6 Special sample size 特殊的情形 Sample size is equal or more than the lot designated sizes of code letters. If sample size equals or exceeds lot or batch size, do 100 percent inspection. 样本大小等于或大于批量的规定。 当抽样方案的样本大小等于或大于批量时,将该批量看作样本大小,抽样方案的判定数组保持不变。 6 Appendix Table 附表 Appendix 附件A: Lot size to Inspection Levels 批量范围及抽样水平对照使用表 表2批量范围及抽样水平对照使用表 批量范围 特殊检查水平 一般检查水平 S-1 S-2 S-3 S-4 I II III 1~8 A A A A A A B 9~15 A A A A A B C 16~25 A A B B B C D 26~50 A B B C C D E 51~90 B B C C C E F 91~150 B B C D D F G 151~280 B C D E E G H 281~500 B C D E F H J 501~1200 C C E F G J K 1201~3200 C D E G H K L 3201~10000 C D F G J L M 10001~ 35000 C D F H K M N 35001~150000 D E G J L N P 15000~1500000 D E G J M P Q 500001 D E H K N Q R Type WI *** Company Limited Dept.
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