C=0 Sampling Plans
AQL-抽样表之运用
E.采用II级检验水平(INSPECTION LEVEL II)。
F.由A-E之条件,由(6-1)样本代字表查出其代字为〝J〞,再由表(6-2)单次正常检验表查得:
‧样本大小(亦即要抽验的产品数量):80PCS
‧抽验箱数须至少为总箱数的开根号值,例如:总箱数为200箱,抽验箱数至少需15箱。
4.1.5允收与拒收之判定:
4.1.5.1单次抽样时,若样本中不良品为d个则:
d≦Ac允收注:Ac为允收不良数
d≧Re拒收注:Re为拒收不良数
(正常或加严检验Rc=Ac+1)
4.1.5.2双次抽样时,若第一次抽样d1个不良品,第二次抽样有d2个不良品时:
第一次抽样不良品有d1个
d1≦Ac1允收
d2≧Re1拒收
3.2.2中低价值产品—家私类及家品类(个别产品成本价人民币50元至200元之间的),AQL值设定为:Critical =0, Major=2.5,Minor=4.0
3.2.3较低价值产品—家私类及家品类(个别产品成本价人民币50元以下的),AQL值设定为:Critical =0, Major=4.0,Minor=6.5
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LTPD
A GENERAL EXCEL SOLUTION FOR LTPD TYPESAMPLING PLANSDavid C. Trindade, Sun Microsystems, and David J. Meade, AMDDavid C. Trindade, Sun Microsystems, 901 San Antonio Road, MS UCUP03-706, Palo Alto, CA 94303KEY WORDS: Acceptance sampling, sample size, EXCEL add-in, risk probabilityAbstractIn this paper we discuss a fairly common problem in lot acceptance sampling. Suppose a company qualification or lot acceptance plan calls for a large sample size n with a non-zero acceptance number c. For example, a plan may call for accepting a lot on three or less failures out of 300 sample units. Because the sample units are costly, the manufacturer wants to reduce the acceptance number and consequently the sample size while holding the rejectable quality percent defective p value constant at a specified consumer's risk (e.g., 10% probability of acceptance). Thus, an LTPD sampling plan is desired. However, typical tables available in the literature cover only a limited number of p values for a few risk probabilities. For the general situation of any desired p value at any probability of acceptance, what are the sample sizes n corresponding to various c values? We describe methods for obtaining solutions via EXCEL and present a simple add-in for the calculations. IntroductionThere are several ways to categorize a single-sampling lot acceptance plan for fraction non-conforming product. See discussion in Western Electric handbook on acceptance sampling [1]. In particular, plans that have a low probability of acceptance (say, 10%) for a specified quality level are called LTPD or Lot Tolerance Percent Defective plans. This quality level is considered the highest percent defective (that is, the poorest quality) that can be tolerated in a small percentage of the product. The Dodge-Romig [2] Sampling Inspection Tables define LTPD as “an allowable percent defective which may be considered as the borderline of distinction between a satisfactory lot and an unsatisfactory one.” An alternate name for the LTPD is the rejectable quality level or RQL.For our purposes, we will consider a random sample of a lot from a process or from a large lot for which the sample is less than 10% of the lot size (Type B sampling). In this manner, we can apply the binomial distribution exactly instead of the more complicated hypergeometric distribution (Type A). For a discussion of the differences between Type A and B sampling see Duncan [3] or Montgomery [4].The probability of acceptance of the poorest quality LTPD that can be tolerated in an individual lot is often referred to as the “consumer’s risk.” A value of 10% for the consumer’s risk is commonly referenced in LTPD plans. Many product qualification plans are based on LTPD considerations in order to assure consumer protection against individual lots of poor quality. However, a common problem is the need to adjust the sample lot size and corresponding acceptance number based on time, money, or resource considerations while holding the consumer’s risk constant at a specified quality level. Because of this objective, many tables are available (see [2], [5] or [6]) to assist in the proper selection of sample sizes and acceptance numbers. A difficulty with utilizing these tables is the restriction to only the values specified in the tables. Other authors have provided graphical solutions to handle more general requirements. See Tobias and Trindade [7]. Further details on LTPD schemes can be found in Schilling [8]. We present below a general EXCEL solution that handles any specified LTPD at any probability of acceptance.The following example is based on the problem (solved graphically) in Tobias and Trindade [7]Example 1: Consider the case where a given sampling plan calls for a lot to be accepted on three or less failures out of 300 sampled units. Because of the cost associated with each individual unit, we need to construct a sampling plan that will allow the lot to be rejected on just one failure. One important requirement of the new plan is that the LTPD and the probability of acceptance be equivalent to that of the original plan. In this example, we will set the probability of acceptance equal to 10%.Step 1: Begin by creating in a spreadsheet a table like the one shown in Figure 1, specifying the sample size n, the acceptance number c, and the probability of acceptance (10% for LTPD plans). We are interested in determining the percent defective at the specified probability of acceptance, that is, the LTPD.Step 2: The binomial cumulative distribution function gives the probability of realizing up to c rejects in a sample of size n . To determine the percent defective value that makes the binomial CDF equal to the probability of acceptance value, we use an identity between the binomial CDF F (x ) and the Beta CDF G (p ) for integer valued shape parameters. (See Bury [9], page 346.) The relationship is:F (x ; p, n ) = 1 – G(p ; x + 1, n – x ).We use the EXCEL BETAINV function to calculate the LTPD for the original plan, as illustrated in cell B10. The LTPD calculated in this example is 0.02213, as shown in Figure 2. The general format of the BETAINV isBETAINV(1-prob of acceptance, c + 1, n – c).Figure 1: Illustration of how the Excel worksheet should be set up prior to solving for a solution to the original samplingplan.where c=3, n=300, and prob of acceptance = 0.1.Step 3: Create a second table with two columns. The first column should contain a list of possible samplesizes in descending order if a lower acceptance number is desired or in ascending order for a higher c .set up prior to solving for the alternative sample size.The second column should contain the EXCEL BINOMDIST function (binomial CDF) for each sample size, LTPD, acceptance number combination, as shown in Figure 3 (column F). Our goal is to find the smallest value of n that yields a BINOMDIST function value less than or equal to the probability of acceptance, 10%. From Figure 4 we can easily see that the appropriate sample size is 175. This is the smallest possible sample size for which the BINOMDIST function is less than or equal to 0.10. The format of the BINOMDIST function isBINOMDIST(acceptance number, sample size, LTPD, 1)The final “1” instructs Excel to calculate the cumulative distribution function.Figure 4: Illustration of solving for the correct value of n.The new sampling plan calls for rejection of any lot where more than 1 unit fails out of a sample of 175 units. The probability of accepting any given lot at an incoming percent defective value equal to the LTPD is 10%.Automated Analysis ToolsThe process of finding an alternative LTPD sampling plan can be made simple through the use of visual basic macros. The example below introduces a user-friendly Excel macro that performs LTPD sampling plan calculations. We will use the data from the previous example where c= 3, n= 300, and probability of acceptance = 10%.Step 1: Execute t he macro and select “Find alternative sampling plan.” See Figure 5.Step 2: Enter the information for the original sampling plan. Then, enter a new acceptance number for the alternative sampling plan. Finally, enter the worksheet cell address where output table should be placed. Figure 6 illustrates typical input.box.Step 3:Click the “OK” button. The final analysis table is show in Figure 7. The routine also provides the approximate AQL to accept 95% of the lots.The program also provides the capability for: 1. solving for the LTPD for a given sampling plan; 2. solving for the sample size for a specified LTPD and acceptance number. The execution of these routines are self-evident from the dialog boxes. output table. The sample size for the alternative sampling plan is 175 (reference cell C10).Program AvailabilityThe EXCEL LTPD add-in, written in Visual Basic by David Meade, is available for free downloading from the website /LTPD.html. References[1] Western Electric Company (1956), Statistical Quality Control Handbook, Delmar Printing Company, Charlotte, NC[2] Dodge, H.F., and H.G. Romig (1959) Sampling Inspection Tables, Single and Double Sampling, 2nd ed., John Wiley and Sons, New York[3] Duncan, A.J (1986) Quality Control and Industrial Statistics, 5th ed., Irwin, Homewood, IL[4] Montgomery, D.C. (1991) Introduction to Statistical Quality Control, 2nd ed,, John Wiley and Sons, New York[5] MIL-STD-105D (1963) Sampling Procedures and Tables for Inspection by Attributes, U.S. Government Printing Office[6] MIL-S-19500G (1963) General Specification for Semiconductor Devices, U.S. Government Printing Office[7] Tobias, P.A. and D.C. Trindade (1995) Applied Reliability, 2nd ed., Kluwer Academic Publishers, Boston, MA[8] Schilling, E.G. (1982) Acceptance Sampling in Quality Control, Marcel Dekker, New York[9] Bury, K.V. (1975) Statistical Models in Applied Science, John Wiley and Sons, New York。
C=0 Sample plan
10.0 2 2 4 3 4 5 6 7 8 9 9 9 9 9 9
150000 125D 500000 125D over
125D 1200
※ Indicates entine lot must be inspected . NOTE : The Acceptance Number in all cases is ZERO . ※ 表示有關批次須要全檢 注意:所有情況下,接受數是 " 零 "
0.65 ※ ※ ※ ※ ※ ※ 200 200 200 200 200 300 476 476 556
0.10 0.15 0.25 1.0 0.4 0.65 SAMPLE SIZE ( 樣本數 ) ※ ※ ※ ※ ※ 125 125 125 125 125 192 294 294 345 435 ※ ※ ※ ※ 80 80 80 80 80 120 189 189 218 270 300 ※ ※ ※ ※ 50 50 50 50 75 116 116 135 170 200 2444 ※ ※ ※ 32 32 32 32 48 73 73 86 108 123 156 189 ※ ※ 20 20 20 20 20 47 47 53 68 77 96 119 143 ※ 13 13 13 13 13 20 29 34 42 50 60 74 90 102
allproblemareacallednonconformancenonconformingunit713whenonemorenonconformancedoesdotnecessarilymeanrejectioninspectoronlyacceptszerononconformacessamplewithholdlotforcesmanagementpersonnel程序71planstheory計劃是參照超几何分布hypergeometricdistribution而成目的是將計算的精准度提高最重要的就是零缺陷的哲學milstdlose的理論演化而成其中最特別者是沒有分開主要major与次要minor缺陷
【教学设计新部编版】《简单线性规划》(数学北师大版必修5)
教师学科教案[ 20 – 20 学年度第__学期]任教学科:_____________任教年级:_____________任教老师:_____________xx市实验学校《简单线性规划》◆教学目标【知识与能力目标】1.了解线性规划的意义及线性约束条件、线性目标函数、可行解、可行域、最优解等概念;2.能根据条件建立线性目标函数;3.了解线性规划问题的图解法,并会用图解法求线性目标函数的最大值、最小值.【过程与方法目标】1.能根据条件建立线性目标函数;2.了解线性规划问题的图解法,并会用图解法求线性目标函数的最大值、最小值.【情感态度价值观目标】了解线性规划的意义及线性约束条件、线性目标函数、可行解、可行域、最优解等概念;◆教学重难点【教学重点】线性规划问题的图解法;【教学难点】寻求线性规划问题的最优解.在现实生产、生活中,经常会遇到资源利用、人力调配、生产安排等问题。
1、下面我们就来看有关与生产安排的一个问题:引例:某工厂有A 、B 两种配件生产甲、乙两种产品,每生产一件甲产品使用4个A 配件耗时1h,每生产一件乙产品使用4个B 配件耗时2h ,该厂每天最多可从配件厂获得16个A 配件和12个B 配件,按每天8h 计算,该厂所有可能的日生产安排是什么? (1)用不等式组表示问题中的限制条件:设甲、乙两种产品分别生产x 、y 件,又已知条件可得二元一次不等式组:2841641200x y x y x y +≤⎧⎪≤⎪⎪≤⎨⎪≥⎪≥⎪⎩ (1)(2)画出不等式组所表示的平面区域:如图,图中的阴影部分的整点(坐标为整数的点)就代表所有可能的日生产安排。
(3)提出新问题:进一步,若生产一件甲产品获利2万元,生产一件乙产品获利3万元,采用哪种生产安排利润最大? (4)尝试解答:设生产甲产品x 件,乙产品y 件时,工厂获得的利润为z ,则y x z 32+=,这样,上述问题就转化为:当y x ,满足不等式(1)并且为非负整数时,z 的最大值是多少?◆教学过程把y x z 32+=变形为233z y x =-+,这是斜率为23-,在y轴上的截距为3z 的直线。
品质术语英文
品质术语英文Quality Glossary AAcademic Quality Improvement Project (AQIP): A forum forinstitutions to review each other'saction projects.Acceptable quality level (AQL): In a continuing series of lots, a quality level that, for the purpose of sampling inspection, is the limit of satisfactory process average.Acceptance number: The maximum number of defects or defectives allowable in a sampling lot for the lot to be acceptable.Acceptance sampling: Inspection of a sample from a lot to decide whether to accept that lot. There are two types: attributes sampling and variables sampling. In attributes sampling, thepresence or absence of a characteristic is noted in each of theunits inspected. In variables sampling,the numerical magnitude of a characteristic is measured and recorded for each inspected unit; thisinvolves reference to a continuous scale of some kind.Acceptance sampling plan: A specific plan that indicates the sampling sizes and associated acceptance or nonacceptance criteria to be used. In attributes sampling, for example, there aresingle, double, multiple, sequential, chain and skip-lot sampling plans. In variables sampling, thereare single, double and sequential sampling plans. (For detailed descriptions of these plans, see thestandard ANSI/ISO/ASQ A3534-2, Statistics—Vocabulary and Symbols—Statistical QualityControl.)Accreditation: Certification by a duly recognized body of the facilities, capability, objectivity,competence and integrity of an agency, service, or operational group or individual to provide thespecific service or operation needed.Accuracy: The characteristic of a measurement that tells how close an observed value is to a truevalue.Action plan: A specific method or process to achieve the results called for by one or moreobjectives. May be a simpler version of a project plan.Activity network diagram: An arrow diagram used in planning and managing processes and projects.Advanced Product Quality Planning (APQP): Segment of QS-9000 process that uses tools tooffer the opportunity to get ahead of problems and solve them before the problems affect thecustomer.Affinity diagram: A management tool used to organize information (usually gathered during abrainstorming activity).Alignment: The actions taken to ensure a process or activity supports the organization's strategy,goals and objectives.American Association for Laboratory Accreditation (A2LA): An organization that formally recognizes another organization's competency to perform specific tests, types of tests orcalibrations.American Customer Satisfaction Index (ACSI): Released for the first time in October 1994, an economic indicator and cross industry measure of the satisfaction of U.S. household customers withthe quality of the goods and services available to them—both those goods and services produced within the United States and those provided as imports from foreign firms that have substantialmarket shares or dollar sales. The ACSI is co-sponsored by the University of Michigan BusinessSchool, ASQ and the CFI Group.American National Standards Institute (ANSI): ANSI is a private, nonprofit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system.It is the United States' member body in the International Organization for Standardization, knownas ISO.American Society for Nondestructive Testing (ASNT): The world'slargest technical society for nondestructive testing (NDT) professionals.American Society for Quality (ASQ): A professional, not-for-profit association that develops, promotes and applies quality related information and technology for the private sector, government and academia. The Society serves more than 108,000 individuals and1,100 corporate members inthe United States and 108 other countries.American Society for Quality Control (ASQC): Name of the Societyfrom 1946 through the middle of 1997; then changed to ASQ.American Society for Testing and Materials (ASTM): Not-for-profit organization that provides a forum for the development and publicationof voluntary consensus standards for materials,products, systems and services.American Society for Training and Development (ASTD): A membership organization providing materials, education and support related to workplace learning and performance.American standard code for information interchange (ASCII): Basic computer charactersaccepted by all American machines and many foreign ones.Analysis of means (ANOM): A statistical procedure fortroubleshooting industrial processes andanalyzing the results of experimental designs with factors at fixed levels. It provides a graphicaldisplay of data. Ellis R. Ott developed the procedure in 1967because he observed thatnonstatisticians had difficulty understanding analysis of variance. Analysis of means is easier forquality practitioners to use because it is an extension of thecontrol chart. In 1973, Edward G.Schilling further extended the concept, enabling analysis of meansto be used with non-normaldistributions and attributes data where the normal approximation tothe binomial distribution doesnot apply. This is referred to as analysis of means for treatment effects.Analysis of variance (ANOVA): A basic statistical technique for analyzing experimental data. Itsubdivides the total variation of a data set into meaningful component parts associated with specificsources of variation in order to test a hypothesis on the parametersof the model or to estimatevariance components. There are three models: fixed, random and mixed.Appraisal cost: The cost involved in ensuring an organization is continually striving to conform to customers' quality requirements.Arrow diagram: A planning tool to diagram a sequence of events or activities (nodes) and the interconnectivity of such nodes. It is usedfor scheduling and especially for determining the critical path through nodes.AS9100: An international quality management standard for the aerospace industry published bythe Society of Automotive Engineers; also published by other organizations worldwide, as EN9100 inEurope and JIS Q 9100 in Japan. The standard is controlled by the International Aerospace QualityGroup (see listing).Assessment: A systematic process of collecting and analyzing data to determine the current,historical or projected status of an organization.Assignable cause: A name for the source of variation in a processthat is not due to chance and therefore can be identified and eliminated. Also called "special cause."Association for Quality and Participation (AQP): Affiliate organization of the American Societyfor Quality (ASQ) dedicated to improving workplaces through quality and participation practices.Attribute data: Go/no-go information. The control charts based on attribute data includepercent chart, number of affected units chart, count chart, countper unit chart, quality score chartand demerit chart.Attributes, method of: Measurement of quality by the method of attributes consists of noting the presence (or absence) of some characteristic (attribute) in each of the units under consideration and counting how many units do (or do not) possess it. Example: go/no-go gauging of a dimension.Audit: The inspection and examination of a process or quality system to ensure compliance torequirements. An audit can apply to an entire organization or may be specific to a function, processor production step.Automotive Industry Action Group (AIAG): The originator and sole source of the QS-9000series of standards. ASQ's Automotive Division maintains a liaisonto this group.Availability: The ability of a product to be in a state to performits designated function under statedconditions at a given time.Average chart: A control chart in which the subgroup average, X-bar, is used to evaluate the stability of the process level.Average outgoing quality (AOQ): The expected average quality levelof outgoing product for agiven value of incoming product quality.Average outgoing quality limit (AOQL): The maximum average outgoing quality over allpossible levels of incoming quality for a given acceptance sampling plan and disposal specification.Average run lengths (ARL): On a control chart, the number of subgroups expected to be inspected before a shift in magnitude takes place.Average sample number (ASN): The average number of sample units inspected per lot inreaching decisions to accept or reject.Average total inspection (ATI): The average number of units inspected per lot, including all unitsin rejected lots (applicable when the procedure calls for 100% inspection of rejected lots).BBaldrige Award: See "Malcolm Baldrige National Quality Award."Baseline measurement: The beginning point, based on an evaluation of the output over a period of time, used to determine the process parameters prior to any improvement effort; the basisagainst which change is measured.Benchmarking: An improvement process in which a company measures its performance againstthat of best in class companies, determines how those companies achieved their performance levelsand uses the information to improve its own performance. The subjects that can be benchmarkedinclude strategies, operations, processes and procedures.Benefit-cost analysis: An examination of the relationship between the monetary cost of implementing an improvement and the monetary value of the benefits achieved by theimprovement, both within the same time period.Best practice: A superior method or innovative practice that contributes to the improvedperformance of an organization, usually recognized as "best" by other peer organizations.Big Q, Little Q: A term used to contrast the difference between managing for quality in all businessprocesses and products (big Q) and managing for quality in a limited capacity—traditionally only infactory products and processes (little q).Black Belt (BB): Full-time team leader responsible for implementing process improvementprojects—define, measure, analyze, improve and control (DMAIC) or define, measure, analyze,design and verify (DMADV)—within the business to drive up customer satisfaction levels and business productivity.Blemish: An imperfection severe enough to be noticed but that should not cause any realimpairment with respect to intended normal or reasonably foreseeable use (see also "defect,""imperfectio38n" and "nonconformity").Block diagram: A diagram that shows the operation,interrelationships and interdependencies ofcomponents in a system. Boxes, or blocks (hence the name), represent the components; connectinglines between the blocks represent interfaces. There are two types of block diagrams: a functionalblock diagram, which shows a system's subsystems and lower level products and theirinterrelationships and which interfaces with other systems; and a reliability block diagram, which issimilar to the functional block diagram except that it is modified to emphasize those aspectsinfluencing reliability.Board of Standards Review (BSR): An American National Standards Institute board responsible for the approval and withdrawal of American National Standards.Body of knowledge (BOK): The prescribed aggregation of knowledge in a particular area an individual is expected to have mastered to be considered or certified as a practitioner.Bottom line: The essential or salient point; the primary or most important consideration. Also, theline at the bottom of a financial report that shows the net profit or loss.Box, George E.P.: A native of England, Box began his career during World War II with the BritishArmy Engineers, where he learned statistics. He studied at University College, became head of thestatistical techniques research section at Imperial Chemical Industrials and obtained a doctorate. Hemoved to the United States and was a founder of Technometrics, published by ASQ and theAmerican Statistical Association. A professor at the University of Wisconsin, Box is an HonoraryMember of ASQ.Brainstorming: A technique teams use to generate ideas on a particular subject. Each person inthe team is asked to think creatively and write down as many ideas as possible. The ideas are notdiscussed or reviewed until after the brainstorming session.Breakthrough improvement: A dynamic, decisive movement to a new, higher level of performance.Brumbaugh, Martin A. (deceased): The founder and first editor of Industrial Quality Controlmagazine. A former professor of statistics at the University of Buffalo, Brumbaugh publishedregularly on applied statistics. Brumbaugh was instrumental in getting two separate qualityorganizations—the Federated Societies and the Society for Quality Control—merged into onenational organization: ASQ (then ASQC). Brumbaugh was an ASQ Honorary Member.BS 7799: British commerce, government and industry stakeholders wrote BS 7799 to addressinformation security management issues, including fraud, industrial espionage and physical disaster.May become ISO standard.Business process reengineering (BPR): The concentration on the improvement of businessprocesses that will deliver outputs that will achieve results meeting the firm's objectives, prioritiesand mission.CC chart: See "count chart."Calibration: The comparison of a measurement instrument or system of unverified accuracy to ameasurement instrument or system of known accuracy to detect any variation from the requiredperformance specification.Capability maturity model: A framework that describes the key elements of an effective software process. It's an evolutionary improvement path from an immature process to a mature, disciplined process. The CMM covers practices for planning, engineering and managing software developmentand maintenance. When followed, these key practices improve theability of organizations to meetgoals for cost, schedule, functionality and product quality.Cascading: The continuing flow of the quality message down to, not through, the next level ofsupervision until it reaches all workers. Same concept as "deploying."Cause: An identified reason for the presence of a defect or problem.Cause and effect diagram: A tool for analyzing process dispersion.It is also referred to as the"Ishikawa diagram," because Kaoru Ishikawa developed it, and the "fishbone diagram," because thecomplete diagram resembles a fish skeleton. The diagram illustrates the main causes and subcausesleading to an effect (symptom). The cause and effect diagram is one of the "seven tools of quality."(See listing).Centerline: A line on a graph that represents the overall average (mean) operating level of theprocess.Central tendency: The tendency of data gathered from a process to cluster toward a middle valuesomewhere between the high and low values of measurement.Certification: The result of meeting the established criteria set by an accrediting or certificategranting organization.Certified mechanical inspector (CMI): An ASQ certification.Certified quality auditor (CQA): An ASQ certification. Certified quality auditor (CQA)-biomedical: An ASQ certification. Certified qualityauditor (CQA)-hazard analysis and critical control point (HACCP): An ASQ certification.Certified quality engineer (CQE): An ASQ certification. Certified quality improvement associate (CQIA): An ASQ certification.Certified quality manager: An ASQ certification.Certified quality technician (CQT): An ASQ certification. Certified reliability engineer (CRE): An ASQ certification. Certified Six Sigma Black Belt (CSSBB): An ASQ certification. Certified software quality engineer (CSQE): An ASQ certification. Chain reaction: A chain of events described by W. Edwards Deming: improve quality, decrease costs, improve productivity, increase market with better quality and lower price, stay in business,provide jobs and provide more jobs.Chain sampling plan: In acceptance sampling, a plan in which the criteria for acceptance andrejection apply to the cumulative sampling results for the current lot and one or more immediatelypreceding lots.Champion: A business leader or senior manager who ensures that resources are available for training and projects, and who is involved in project tollgate reviews; also an executive whosupports and addresses Six Sigma organizational issues.Change agent: An individual from within or outside an organization who facilitates change within the organization. May or may not be the initiator of the change effort.Characteristic: The factors, elements or measures that define and differentiate a process, function, product, service or other entity.Chart: A tool for organizing, summarizing and depicting data in graphic form.Charter: A written commitment approved by management stating the scope of authority for animprovement project or team.Checklist: A tool used to ensure all important steps or actions in an operation have been taken.Checklists contain items important or relevant to an issue or situation. Checklists are often confusedwith check sheets (see individual entry).Check sheet: A simple data recording device. The check sheet is custom designed by the user, which allows him or her to readilyinterpret the results. The check sheet is one of the "seven tools of quality." (See listing). Check sheets are often confused with checklists (see individual entry).Classification of defects: The listing of possible defects of a unit, classified according to theirseriousness. Note: Commonly used classifications: class A, class B, class C, class D; or critical,major, minor and incidental; or critical, major and minor.Definitions of these classifications requirecareful preparation and tailoring to the product(s) being sampled to enable accurate assignment ofa defect to the proper classification. A separate acceptancesampling plan is generally applied toeach class of defects.Closed-loop corrective action (CLCA): A sophisticated engineering system designed todocument, verify and diagnose failures, recommend and initiate corrective action, provide follow-upand maintain comprehensive statistical records.Code of conduct: Expectations of behavior mutually agreed on by a team. Collier, Simon (deceased): An ASQ president who led the Society during a critical growth periodin 1952-53. His term was marked by numerous milestone events, including a membership increaseof 22% and the formation of 11 new sections and the first divisions. Collier, an ASQ HonoraryMember, was a chemist who began his career at the National Bureau of Standards (now the NationalInstitute of Standards and Technology). Later he worked at Johns-Manville Corp., where heproduced a quality training film used by more than 300 companies.Common causes: Causes of variation that are inherent in a process over time. They affect every outcome of the process and everyone working in the process (see also "special causes").Company culture: A system of values, beliefs and behaviors inherent in a company. To optimize business performance, top management must define and create the necessary culture.Complaint tracking: Collecting data, disseminating data to appropriate persons for resolution, monitoring complaint resolution progress and communicating results.Compliance: The state of an organization that meets prescribed specifications, contract terms,regulations or standards.Computer aided design (CAD): Software used by architects, engineers, drafters and artists tocreate precision drawings or technical illustrations. CAD softwarecan be used to createtwo-dimensional (2-D) drawings or three-dimensional (3-D) models.Computer aided engineering (CAE): A broad term used by theelectronic design automationindustry for the use of computers to design, analyze and manufacture products and processes. CAEincludes CAD (see listing) and computer aided manufacturing (CAM), which is the use of computersfor managing manufacturing processes.Concurrent engineering (CE): A way to reduce cost, improve quality and shrink cycle time bysimplifying a product's system of life cycle tasks during the early concept stages.Conflict resolution: The management of a conflict situation toarrive at a resolution satisfactory to all parties.Conformance: An affirmative indication or judgment that a product or service has met the requirements of a relevant specification, contractor regulation.Conformitè Europeënne Mark (CE Mark): Conformity European Union mark. The EuropeanUnion created the CE Mark to regulate the goods sold within its borders. The mark represents amanufacturer's declaration products comply with the EU's New Approach Directives. Thesedirectives apply to any country that sells products within the EU.Consensus: A state in which all the members of a group support an action or decision, even if someof them don't fully agree with it.Consultant: An individual who has experience and expertise in applying tools and techniques toresolve process problems and who can advise and facilitate an organization's improvement efforts.Consumer: The external customer to whom a product or service is ultimately delivered; Also calledend user.Consumer's risk: Pertains to sampling and the potential risk that bad product will be accepted and shipped to the consumer.Continuous flow production: Means that items are produced and moved from one processingstep to the next one piece at a time. Each process makes only the one piece that the next processneeds, and the transfer batch size is one.Continuous improvement (CI): Sometimes called continual improvement. The ongoing improvement of products, services or processes through incremental and breakthroughimprovements.Continuous quality improvement (CQI): A philosophy and attitude for analyzing capabilities andprocesses and improving them repeatedly to achieve the objective of customer satisfaction.Continuous sampling plan: In acceptance sampling, a plan, intended for application to a continuous flow of individual units of product, that involves acceptance and rejection on a unit byunit basis and employs alternate periods of 100% inspection and sampling, the relative amount of100% inspection depending on the quality of submitted product. Continuous sampling plans usuallyrequire that each t period of 100% inspection be continued until a specified number, i, ofconsecutively inspected units are found clear of defects. Note: For single level continuous samplingplans, a single d sampling rate (for example, inspect 1 unit in 5 or 1 unit in 10) is used duringsampling. For multilevel continuous sampling plans, two or more sampling rates may be used: Therate at any time depends on the quality of submitted product.Control chart: A chart with upper and lower control limits on which values of some statisticalmeasure for a series of samples or subgroups are plotted. The chart frequently shows a central lineto help detect a trend of plotted values toward either control limit.Control limits: The natural boundaries of a process within specified confidence levels, expressed asthe upper control limit (UCL) and the lower control limit (LCL).Control plan (CP): A document that describes the required characteristics for the quality of aproduct or service, including measures and control methods.Coordinate measuring machine (CMM): A device that dimensionally measures 3-D products,tools and components with an accuracy approaching 0.0001 in.Corrective action: The implementation of solutions resulting in the reduction or elimination of anidentified problem.Corrective action recommendation (CAR): The full cycle corrective action tool that offers easeand simplicity for employee involvement in the correctiveaction/process improvement cycle.Correlation (statistical): A measure of the relationship between two data sets of variables. Cost of poor quality (COPQ): The costsassociated with providing poor quality products or services. There arefour categories of costs: internal failure costs (costs associated with defectsfound before the customer receives the product or service), external failure costs (costs associatedwith defects found after the customer receives the product or service), appraisal costs (costsincurred to determine the degree of conformance to quality requirements) and prevention costs(costs incurred to keep failure and appraisal costs to a minimum).Cost of quality (COQ): A term coined by Philip Crosby referring tothe cost of poor quality. Count chart: A control chart for evaluatingthe stability of a process in terms of the count of events of a given classification occurring in a sample.Count per unit chart: A control chart for evaluating the stabilityof a process in terms of theaverage count of events of a given classification per unit occurringin a sample.C: The ratio of tolerance to six sigma, or the USL (upperspecification limit) minus the LSL (lower pspecification limit) divided by six sigma. It is sometimes referredto as the engineering tolerancedivided by the natural tolerance and is only a measure of dispersion.C index: Equals the lesser of the USL minus the mean divided bythree sigma (or the mean) minus pkthe LSL divided by three sigma. The greater the Cpk value, the better.Critical processes: Processes that present serious potential dangers to human life, health and theenvironment or that risk the loss of very large sums of money or customers.Crosby, Philip (deceased): The founder and chairman of the board of Career IV, an executive management consulting firm. Crosby also founded Philip Crosby Associates Inc. and the QualityCollege. He wrote many books including Quality Is Free, Quality Without Tears, Let's Talk Quality,and Leading: The Art of Becoming an Executive. Crosby, whooriginated the zero defects concept,was an ASQ Honorary Member and past president.Cross functional: A term used to describe a process or an activity that crosses the boundarybetween functions. A cross functional team consists of individuals from more than oneorganizational unit or function.Cross pilot: See "scatter diagram."Cultural resistance: A form of resistance based on opposition to the possible social andorganizational consequences associated with change.Culture change: A major shift in the attitudes, norms, sentiments, beliefs, values, operatingprinciples and behavior of an organization.Culture, organizational: A common set of values, beliefs, attitudes, perceptions and acceptedbehaviors shared by individuals within an organization.Cumulative sum control chart (CUSUM): A control chart on which the plotted value is the cumulative sum of deviations of successive samples from a target value. The ordinate of eachplotted point represents the algebraic sum of the previous ordinate and the most recent deviationsfrom the target.Current good manufacturing practices (CGMP): Regulations enforced by the U.S. Food andDrug Administration for food and chemical manufacturers and packagers.Customer: See "external customer" and "internal customer."Customer delight: The result of delivering a product or service that exceeds customerexpectations.Customer relationship management (CRM): A strategy used to learn more about customers'needs and behaviors to develop stronger relationships with them. It brings together information。
QCSamplingPlan
学习改变命运,知 识创造未来
QCSamplingPlan
学习改变命运,知 识创造未来
QCSamplingPlan
检查水准
检查水准确定了批量和样本大小之间的关系. 如果批量大,样本数也随之增大.但不是按比例 增大,对大批量样本所占的比例要比小批量中 样本所占的比例小.
学习改变命运,知 识创造未来
QCSamplingPlan
检查水准(Inspection Level)
4.连续生产型抽样检查
对大量连续生产的产品进行的抽样检查,例如 ,每“X”个小时抽取“X”.根据对比样本进行检 查的结果,来判定前“X”个小时或数小时所生 产产品的品质状况.
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QCSamplingPlan
AQL(Acceptable Quality Level )
w AQL 是对过程平均不合格率规定的,认为满 意的最大值.可以将它看作可接收的过程平 均不合格率和不可接收之间的界限.换句话说: 若正在生产的产品大多数批的平均品质至少 象AQL一样的好,生产过程可以认为是满意的.
QCSamplingPlan
学习改变命运,知 识创造未来
2021年2月21日星期日
基本概念和用语
w 群体与样本
群体
群体是提供被做为检查的对象,或者称采取出 施的对象.通常称为批(LOT).批的大小常以“N” 表示.
样本
样本是指从群体中(或批中),抽取的部分个题. 抽取的样本数量常以“n”表示.
学习改变命运,知 识创造未来
学习改变命运,知 识创造未来
QCSamplingPlan
抽样方案的特性函数
接受概率(%) 1.000.8750Fra bibliotek75 0.625
运筹学基础(中文版第10版)哈姆迪塔哈课后习题答案解析
运筹学基础(中文版第10版)哈姆迪塔哈课后习题答案解析第一章线性规划模型1.1 线性规划的基本概念1.请解释线性规划模型的基本要素以及线性规划模型的一般形式。
答:- 线性规划模型的基本要素包括决策变量、目标函数、约束条件。
- 线性规划模型的一般形式如下:Max/Min Z = c₁x₁ + c₂x₂ + ... + cₙxₙSubject to:a₁₁x₁ + a₁₂x₂ + ... + a₁ₙxₙ ≤ b₁a₂₁x₁ + a₂₂x₂ + ... + a₂ₙxₙ ≤ b₂...aₙ₁x₁ + aₙ₂x₂ + ... + aₙₙxₙ ≤ bₙx₁, x₂, ..., xₙ ≥ 01.2 线性规划模型的几何解释1.请说明线性规划模型的几何解释。
答:线性规划模型在几何上可以表示为一个多维空间中的凸多面体(可行域),目标函数为该多面体上的一条直线,通过不同的目标函数系数向量c,可以得到相应的最优解点。
通过多面体的边界和顶点,可以确定最优解点的位置。
如果可行域是无限大的,则最优解点可以在其中的任何位置。
1.3 线性规划模型求解方法1.简要说明线性规划模型的两种求解方法。
答:线性规划模型可以通过以下两种方法进行求解: - 图形法:根据可行域的几何特征,通过图形方法确定最优解点的位置。
- 单纯形法:通过迭代计算,逐步靠近最优解点。
单纯形法是一种高效的求解线性规划问题的方法。
第二章单变量线性规划2.1 单变量线性规划模型1.请给出单变量线性规划模型的一般形式。
答:Max/Min Z = cxSubject to:ax ≤ bx ≥ 02.2 图形解法及其应用1.请解释图形解法在单变量线性规划中的应用。
答:图形解法可以直观地帮助我们确定单变量线性规划模型的最优解。
通过绘制目标函数和约束条件的图像,可以确定最优解点的位置。
对于单变量线性规划模型,图形解法特别简单,只需要绘制一条直线和一条水平线,求解它们的交点即可得到最优解点的位置。
抽样检查标准AQL
A-R 3-4 3-5 3-6 5-8
A-R 5-6 5-6 5-8
A-R 7-8 7-8
A-R
A-R
A-R
A-R
A B C D E F G H J K L M N P Q
B C D E F G H J K L M N P Q R
A B C D E F G H J K L M N P Q
2 2 2 3 5 8 13 20 32 50 80 125 200 315 500 800 0-1 0-2 0-1 0-2 1-3 0-1 0-2 1-3 1-4 0-1 0-2 1-3 1-4 2-5 0-1 0-2 1-3 1-4 2-5 3-6 0-1 0-2 1-3 1-4 2-5 3-6 5-8 0-1 0-1 0-2 0-1 0-1 0-2 0-2 0-2 1-3 1-4 2-5 3-6 5-8 1-3 1-4 2-5 3-6 5-8 1-3 1-4 2-5 3-6 5-8 0-1 0-2 1-3 1-4 2-5 3-6 5-8 0-1 0-1
A-R 3-4 5-6 7-8
A-R 5-6 7-8
A-R 7-8
A-R
A-R
A-R
A-R
A B C D E F G H J K L M N P Q
B C D E F G H J K L M N P Q R
A B C D E F G H J K L M N P Q
2 3 5 8 13 20 32 50 80 125 200 315 500 800 1250 2000 0-1 1-2 0-1 1-2 2-3 0-1 1-2 2-3 3-4 0-1 1-2 2-3 3-4 5-6 0-1 1-2 2-3 3-4 5-6 7-8 0-1 1-2 2-3 3-4 5-6 7-8 0-1 0-1 1-2 0-1 0-1 1-2 1-2 1-2 2-3 3-4 5-6 7-8 2-3 3-4 5-6 7-8 2-3 3-4 5-6 7-8 0-1 1-2 2-3 3-4 5-6 7-8 0-1 0-1
sampling plan
NOTICE OF NOT MEASUREMENT CHANGE SENSITIVEMIL-STD-690CNOTICE 16 December 1999DEPARTMENT OF DEFENSESTANDARD PRACTICEFAILURE RATE SAMPLING PLANS AND PROCEDURESTO ALL HOLDERS OF MIL-STD-690C:1. THE FOLLOWING PAGES OF MIL-STD-690C HAVE BEEN REVISED AND SUPERSEDE THE PAGES LISTED:NEW PAGE DATE SUPERSEDED PAGE DATE 126 March 19931Reprinted without change2 6 December 19992 6 December 19993 6 December 19993 6 December 19993a 6 December 1999New page426 March 19934Reprinted without change2. RETAIN THIS NOTICE AND INSERT BEFORE TABLE OF CONTENTS.3. Holders of MIL-STD-690C will verify that page changes and additions indicated above have been entered. This notice page will be retained as a check sheet. This issuance, together with appended pages, is a separate publication. Each notice is to be retained by stocking points until the standard is completely revised or canceled.Custodians:Preparing activity:Army – CR DLA – CCNavy – ECAir Force – 11(Project RELI-0092) AMSC N/A AREA RELI DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.1. SCOPE1.1 Purpose. This standard provides procedures for failure rate (FR) qualification, sampling plans for establishing and maintaining FR levels at selected confidence levels, and lot conformance inspection procedures associated with FR testing for the purpose of direct reference in appropriate military electronic parts established reliability (ER) specifications. Figures and tables throughout this standard are based on exponential distribution. Weibull distribution will be acceptable in certain components such as capacitors. Use of Weibull distribution for any component must be approved by the qualifying activity. This standard also provides guidance to specification writes in the use of this standard (see appendix) and reference material for users of ER parts.1.2 Application. This standard is applicable for reference in electronic parts ER specification when the following conditions exist:a. Electronic parts are essentially the same design and are manufactured under essentiallycontinuous production; the production process is established and controlled in accordance withMIL-STD-790.b. The part design and manufacturing processes produce a product whose failure rate canreasonably be assumed to be constant with time over its intended life (i.e., an exponentialdistribution of failures per unit time).c. The qualifying activity administers this standard to provide the consumer with assurance that thequalified FR level is being maintained by a given manufacturer, since these procedures inthemselves are not sufficient to assure the qualified FR level.1.3 Method of reference. This standard can be referenced in ER specifications by specifying the following procedures:a. Procedure I, “Qualification at the initial FR level” (see 5.1).b. Procedure II, “Extension of qualification to lower FR levels” (see 5.2).c. Procedure III, “Maintenance of FR level qualification” (see 5.3).d. Procedure IV, “Lot conformance FR inspection” (when specified ) (see 5.4).REPRINTED WITHOUT CHANGE.12. APPLICABLE DOCUMENTS2.1 Government documents.2.1.1 Specifications, standards, and handbooks. The following specifications, standards, and handbooks form a part of this document to the extent specified herein. Unless otherwise specified, the issues of these documents are those listed in the issue of the Department of Defense Index of Specifications and Standards (DODISS) and supplement thereto, cited in the solicitation.STANDARDSDEPARTMENT OF DEFENSEMIL-STD-790-Standard Practice for Established Reliability and High Reliability QualifiedProducts List (QPL) Systems for Electrical, Electronic and Fiber Optic PartsSpecifications.(Unless otherwise indicated, copies of the above specification, standards and handbooks are available from the Defense Automated Printing Service, Bldg. 4D (DPM-DODSSP), 700 Robbins Avenue, Philadelphia, PA 19111-5094.)2.2 Order of precedence. In the event of a conflict between the text of this document and the references cited herein, the text of this document takes precedence. Nothing in this document, however, supersedes applicable laws and regulations unless a specific exemption has been obtained. SUPERSEDES PAGE 2 OF MIL-STD-690C.23. DEFINITIONS3.1 Reliability terms. The definitions of reliability terms used herein are as follows:a.Burn-in (pre-conditioning). The operation of an item under stress to stabilize its characteristics.b.Confidence level. This term denotes the probability of disqualifying a product when the true failurerate of the product is at the failure rate specified for qualification.c.Corrective action. A documented design, process, procedure, or materials change implementedand validated to correct the cause of failure or design deficiency.d.Derating. (1) Using an item in such a way that applied stresses are below rated values.(2) The lowering of the rating of an item in one stress field to allow an increase inanother stress field.e.Established reliability. A quantitative maximum failure rate demonstrated under controlledconditions specified in a Department of Defense specification and usually expressed as percent failures per thousand hours of test.f.Failure. The event, or inoperable state, in which any item or part of an item does not, or would not,perform as previously specified.g.Failure analysis. Subsequent to a failure, the logical systematic examination of an item, itsconstruction, application, and documentation to identify the failure made and determine the failure mechanism and its basic course.h.Failure rate (FR) level. This term denotes the maximum percentage of failures (per 1,000 unithours) based on a specified confidence level.i.Failure rate (FR) test. This term denotes the test required to accumulate data from which a failurerate is calculated and is used synonymously with the standard specification term “life test”.j.Higher FR level. This term is a relative term describing a FR level associated with a higher number of failures per unit time.k.Inspection lot. A group of electronic parts offered for inspection at one time and in combinations authorized by the applicable ER specifications.l.Lower FR level. This term is a relative term describing a FR level associated with fewer number of failures per unit time.m.Mean time to failure (MTTF). A basic measure of reliability for non-repairable items: The total number of life units of an item divided by the total number of failures within that population, duringa particular measurement interval under stated conditions.SUPERSEDES PAGE 3 OF NOTICE 1 TO MIL-STD-690C.3n.Predicted. That which is expected at some future time, postulated on analysis of past experience and tests.o.Qualifying activity. The military activity or its agent delegated to administer the qualification program.p.Reliability.(1) The duration or probability of failure free performance under stated conditions.(2) The probability that an item can perform its intended function for a specified intervalunder stated conditions. (For non-redundant items this is equivalent to definition(1). For redundant items this is equivalent to definition of mission reliability).q. Screening. A process for inspecting items to remove those that are unsatisfactory or those likely to exhibit early failure. Inspection includes visual examination, physical dimension measurement and functional performance measurement under specified environmental conditions.r. Test, acceptance. A test conducted under specified conditions by, or on behalf of, the Government, using delivered or deliverable items, in order to determine the item’s compliance with specified requirements. (Includes acceptance of first production units.)s. Test measurement and diagnostic equipment (TMDE). Any system or device used to evaluate the condition of an item to identify or isolate any actual or potential failures.u. Test qualification (design approval). A test conducted under specified conditions, by, or on behalf of the Government, using items representative of the production configuration, in order todetermine compliance with item design requirements as a basis for production approval. (alsoknown as a “Demonstration.”)v. True failure rate. This term describes the failure rate that would be measured if all units of a controlled process were, in fact, tested. A “controlled process” is one in which RF variation about it, is due to chance causes.w. Truncation. Truncation is a “cutoff” point for life test data, that establishes a precise point in time in which the manufacturer can choose the elimination of previous extended life test data when:(1) A life test failure has occurred and the manufacture has determined the cause andimplemented corrective action acceptable to the qualifying activity.(2) The manufacturer seeks an extension of failure rate on the basis of new designimprovements, occurring after a life test failure or failures.The truncation point is not a random event. There must exist a clear distinction between the “old”less reliable and the “new” improved design (see 5.5).NEW PAGE3a4. GENERAL REQUIREMENTS4.1 FR levels.a. FR levels are related to operation of the part at the stress level specified by the applicable ERspecification.b. Provisions are made for FR levels ranging from 1.0 to 0.001 percent per 1,000 component parthours. In the event the existing FR level of a current product is higher than 1.0 percent, anadditional level (level “L”) shall be added which will represent the state of the art for the part.c. Although the failure is expressed in percent per 1,000 hours (%/1,000 hr) throughout this standard,sampling plans and statistical tables may be used for FR levels expressed either in terms ofpercent per 1,000 cycles, operations, or in terms of duty cycle and stress level.d. Where a FR level is required for periods other than 1,000 hours, an appropriate conversion factormay be applied.Example: 1%/10,000 hours is equivalent to 0.1%/1,000 hours, or when specifying %/10,000hours, the unit-hour requirement is to be multiplied by 10.e. Tables are provided to show the relationship between true failure rates and selected confidence.4.1.1 FR level determination. Determination of FR levels shall be based upon data from all FR tests. Data shall be accumulated from:a. The qualification FR sample. The specification designates the number of sample units to beinspected, number of permissible failures, duration of FR test, and other criteria that may apply.b. Inspection lots which have been submitted for FR conformance inspection during any qualificationperiod or interval. Data accumulated shall meet the specification requirement referenced in4.1.1a.c. Samples subjected to extended FR tests. The data shall be added at the specified time ofmeasurement and not at the end of the FR test.4.1.2 Qualification approval for higher FR levels. Qualification approval granted on one of the lower FR levels shall include approval for all of the higher established FR levels. For example: Qualification approval for “R” shall include approval for levels “P”, “M”, and “L” (if “L” is designated in the ER specification).4.1.3 Supplying to higher ER levels. Parts qualified and marked (color coded or part numbered) to lower failure rate levels are substitutable for higher failure rate level parts with procuring activity approval.A manufacturer may supply to all higher FR levels than that to which he is qualified, and may elect to use the sample size associated with the FR level to be supplied on orders or contracts. Election by the manufacturer to apply this option does not negate the requirement to maintain qualification in accordance with procedure III (see 5.3).4.1.4 FR marking. All parts shall be marked with the FR level to which they are qualified, except when the contract or purchase order specifies higher FR marking under the substitution criteria of 4.1.3. REPRINTED WITHOUT CHANGE4。
ISO 2859-1 VS Zero Defect Sampling Scheme for sharing
5 consecutive lots accepted
Supplier improves quality
Example : 1√,2√,3×,4√,5×, 6√,7X, 8×,9√,10×,11×,12√,13×,Discontinue inspection , 14√,15×,16√,17√,18√, 19√,20√,21√,
Sampling Scheme for Lot-by-Lot Inspection by Attributes AQL VS Zero Defect ISO 2859-1 VS MIL-STD-1916(Attributes)
Created by: Jane
- INTERNAL -
Content
Purpose of ISO2859-1 ISO 2959-1 Sampling Scheme Introduction
Question: How about change AQL to 0.025% ? Follow the arrow till you meet the Ac & Re numbers, then take the sample size the same line with Ac & Re numbers as the solution.
• Level –II shall be used unless otherwise specified. • IL keep unchanged when switching rules implemented. • Avoid AQL inconsistent with the IL when designated S-1 to S-4.
Acceptance Quality Limit (AQL)
品管(QCC)圈推行讲解
品管圈(QCC)推行资料三、執行:訓練主管人員、訓練輔導人員、全面宣導、逐步成立小組、登記與追蹤執行情形。
四、評估:圈會記錄的指導與鼓勵、活動成果報告、成果發表之評價與鼓勵、確認推行效果。
五、修正:推動小組、圈長、輔導員等之檢討與改善,檢討修訂實施辦法、階段之改正措施。
參、實施步驟:一、組圈:自行組小組、取圈名、訂圈徽。
二、選舉圈長:由圈員自行推選一位圈長。
三、界定問題:將工作環境所有問題陳列。
四、選擇活動主題:選擇適當的推行主題。
五、設定目標:制訂預計達成的改善目標。
六、現況分析與對策之研擬:研擬改善案。
七、嘗試與實施對策:實際推行改善方案。
八、確認效果:評量是否達成預定的目標。
九、標準化:作業流程、方法予以標準化。
十、自我評量:自我衡量活動小組的效益。
十一、活動成果發表:實施成果正式發表會。
肆、品管工具:一、特性要因圖:是一種分析原因或對策的一種圖形,主要是將結果(特性)與原因(要因)或期望的效果與對策之間,利用箭頭連結成一個圖形,此圖形又稱為「魚骨圖」、「石川圖」、「因果圖」。
魚骨圖範例: RMA 修復量問題分析二、查檢表:是一種設計用來收集資料的制式表單,在查檢時採用簡單的記號填記於表單內,俾便進行資料之整理、分析,或作為核對、檢查之用。
三、柏拉圖:是將所蒐集之數據依原因或結果分類所繪畫而成的累積曲線分配圖,主要找出影響問題最嚴重的因素,俾便作為採取改善措施的參考,又可稱為ABC圖。
柏拉圖–最大問題再分析–順序比例–比較前後之間的變化–找題目(訂目標用)–找原因–下對策–效果之表現–報告或記錄用四、直方圖:是將收集的計量型數據測定值或資料之全距分為幾個相等的區間作為橫軸,並將各區間內測定值所出現的次數累積而成的面積,用柱子排起來,以瞭解數據的分配(集中與分散)情形,又可稱為柱狀圖或次數分配圖。
五、散佈圖:是將蒐集成對的兩組數據,以點來顯示兩個變數之間相關情形的一種圖形,主要目的在探討兩個變數之間的相關性。
抽样计划
抽样计划表-Table II-B Single sampling plans for tightened inspection (master table)
Q&A
Questions :
1.在公司内部有没有采用随机抽样? 2.公司所有的产品是否都按ANSI/ASQC Z1.4:2003,Single Sampling Plan for normal or tightened inspection (General Inspection LEVEL II. AQL=0.65) 来进行抽样的? 3. 利用ANSI/ASQC Z1.4:2003,Single Sampling Plan for tightened inspection (General Inspection LEVEL II. AQL=0.65) 进行抽样与其正常的抽样有什么区别? 4.抽样检验的作用在那里?
抽样计划表-Table II-A Single sampling plans for normal inspection (master table)
抽样计划表-Table II-B Single sampling plans for tightened inspection (master table) Q&A
同样在2003年,针对国际标准ISO2859-1:1999发生的新的变化,中国 对GB2828-87进行了修订,等同采用ISO2859-1:1999作为国家标准, 代号为GB/T2828.1-2003。
抽样计划表-Table I-Sample size code letters
抽样计划表-Table II-A Single sampling plans for normal inspection (master table)
LTPD_sampling
LTPD - Lot Tolerance Percent DefectiveAcceptance sampling is an important aspect of statistical quality control. It originated back in World War II when the military had to determine which batches of ammunition to accept and which ones to reject. They knew that they couldn't test every bullet to determine if it will do its job in the field. On the other hand, they had to be confident that the bullets they're getting will not fail when their lives are already on the line. Acceptance sampling was the answer - testing a few representative bullets from the lot so they'll know how the rest of the bullets will perform.Acceptance sampling is a compromise between not doing any inspection at all and 100% inspection. The scheme by which representative samples will be selected from a population and tested to determine whether the lot is acceptable or not is known as an acceptance plan or sampling plan. There are two major classifications of acceptance plans: based on attributes ("go, no-go") and based on variables. Sampling plans can be single, double or multiple. A single sampling plan for attributes consists of a sample of size n and an acceptance number c. The procedure operates as follows: select n items at random from the lot. If the number of defectives in the sample set is less than c, the lot is accepted. Otherwise, the lot is rejected.In order to measure the performance of an acceptance or sampling plan, the Operating Characteristic (OC) curve is used. This curve plots the probability of accepting the lot (Y-axis) versus the lot fraction or percent defectives.LTPD - Lot Tolerance Percent DefectiveThe LTPD of a sampling plan is the level of quality routinely rejected by the sampling plan. It is generally defined as the percent defective (number of defectives per hundred units X 100%) that the sampling plan will reject 90% of the time. In other words, this is also the percent defective that will be accepted by the sampling plan at most 10% of the time. This means that lots at or worse than the LTPD are rejected at least 90% of the time and accepted at most 10% of the time.The LTPD can be determined using the operating characteristic (OC) curve by finding that quality level on the bottom axis that corresponds to a probability of acceptance of 0.10 (10%) on the left axis.Associated with the LTPD is a confidence statement one can make. If the lot fails the sampling plan, one can state with 90% confidence that the quality level of the lot is worse than the LTPD (i.e., the defective rate of the lot > LTPD). On the other hand, if a lot passes the sampling plan, then one can state with 90% confidence that its quality level is equal to or better than the LTPD.The LTPD of the sampling plan describes what the sampling plan will reject, but it is also important to know what the sampling plan will accept. Information on what the sampling plan will accept is provided by the AQL of the sampling plan.The acceptable quality level or AQL of a sampling plan is a measure of the level of quality routinely accepted by that sampling plan. It is defined as the percent defective (defectives per hundred units X 100%) that the sampling plan will accept 95% of the time. This means lots at or better than the AQL are accepted at least 95% of the time and rejected at most 5% of the time.The AQL can be determined using the operating characteristic (OC) curve by finding that quality level on the bottom axis that corresponds to a probability of acceptance of 0.95 (95%) on the left axis. Associated with the AQL is a confidence statement one can make. If the lot passes the sampling plan, one can state with 95% confidence that the quality level of the lot is equal to or better than the AQL (i.e., the defective rate of the lot < AQL). On the other hand, if the lot fails the sampling plan, one can state with 95% confidence that the quality level of the lot is worse than the AQL.The AQL describes what the sampling plan will accept, but it is also important to know what the sampling plan will reject. Information on what the sampling plan will reject is provided by the LTPD of the sampling plan.Table 1: Single Sampling Plans Indexed by AQL and LTPD。
水环境监测中心检验流程
水环境监测中心检验流程1.取样前需要确保采样瓶已清洗并干燥。
Before sampling, make sure that the sampling bottle has been cleaned and dried.2.钳子和采样瓶都需要用90%乙醇进行消毒。
Both the pliers and the sampling bottle need to be disinfected with 90% ethanol.3.在采样点选择时,应避开排放口和其他可能受到污染的地方。
When choosing the sampling point, avoid discharge outlets and other potentially contaminated areas.4.从水中采集样本时,确保尽可能减少空气的混入。
When collecting samples from water, make sure to minimize the introduction of air as much as possible.5.在采样过程中要尽量避免直接接触水体,使用采样瓶进行采集。
During the sampling process, try to avoid direct contact with the water, and use a sampling bottle for collection.6.清洗采样瓶时使用无氯漂白水和反复冲洗,确保瓶内干净。
When cleaning the sampling bottle, use chlorine-free bleach and rinse repeatedly to ensure the interior of thebottle is clean.7.采集的样本需在规定时间内送至实验室进行检测。
The collected samples should be sent to the laboratoryfor testing within the specified time.8.在实验室检测前,样本需要进行适当的保存和保存记录。
sampling plan ANSI ASQ Z14 2008
AMERICAN SOCIETY FOR QUALITY 600NORTH PLANKINTON AVENUE MILWAUKEE,WISCONSIN53203AMERICAN NATIONAL STANDARDSAMPLING PROCEDURES AND TABLES FOR INSPECTIONBY ATTRIBUTESAMERICAN NATIONAL STANDARDSampling Procedures and Tables for Inspectionby Attributes--`,,```,,,,````-`-`,,`,,`,`,,`---Prepared byThe Statistics Subcommittee of the AccreditedStandards Committee Z1on Quality,Environment,Dependability and StatisticsSecretariatAmerican Society for QualityAbstractSampling Procedures and Tables for Inspection by Attributes is an acceptance sampling system to be used with switching rules on a continuing stream of lots for AQL specified.It provides tightened,normal,and reduced plans to be applied for attributes inspection for percent nonconforming or nonconformities per100units.AMERICAN NATIONAL STANDARD:An American national Standard implies a consensus of those substantially con-cerned with its scope and provisions.An American National Standard is intended as a guide to aid the manufacturer,the consumer,and the general public.The existence of an American National Standard does not in any respect preclude any-one,whether he has approved the standard or not,from manufacturing,marketing,purchasing,or using products,processes, or procedures not conforming to the standard.American National Standards are subject to periodic review and users are cautioned to obtain the latest editions.CAUTION NOTICE:This American National Standard may be revised or withdrawn at any time.The procedures of the American National Standards Institute require that action be taken to reaffirm,revise,or withdraw this standard no later thanfive years from the date of publication.Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute.Published byAMERICAN SOCIETY FOR QUALITY600NORTH PLANKINTONMILWAUKEE,WISCONSIN53203©2008by the AMERICAN SOCIETY FOR QUALITYNo part of this publication may be reproduced in any form,in an electronic retrieval system or otherwise,without the prior written permission of the publisher.Printed in the United States of America--`,,```,,,,````-`-`,,`,,`,`,,`---Foreword(This foreword is not a part of the American National Standard—Sampling Procedures and Tables for Inspection byAttributes,Z1.4-2008)This standard is a reaffirmation of ANSI/ASQCZ1.4-2003,“Sampling Procedures and Tables for Inspection by Attributes.”Suggestions for improvement of this standard are welcomed.Send your comments to the sponsor,ASQ Standards,600North Plankinton Avenue,Milwaukee,WI53203.iii(This page intentionally left blank) --`,,```,,,,````-`-`,,`,,`,`,,`---Table of ContentsParagraph Page1.SCOPE (1)2.DEFINITIONS AND TERMINOLOGY (1)3.PERCENT NONCONFORMING AND NONCONFORMITIES PERHUNDRED UNITS (2)4.ACCEPTANCE QUALITY LIMIT(AQL) (2)5.SUBMISSION OF PRODUCT (3)6.ACCEPTANCE AND NON-ACCEPTANCE (3)7.DRAWING OF SAMPLES (4)8.NORMAL,TIGHTENED,AND REDUCED INSPECTION (4)9.SAMPLING PLANS (5)10.DETERMINATION OF ACCEPTABILITY (6)11.SUPPLEMENTARY INFORMATION (6)TablesTable I Sample Size Code Letters (10)Table II-A Single Sampling Plans for Normal Inspection(Master Table) (11)Table II-B Single Sampling Plans for Tightened Inspection(Master Table) (12)Table II-C Single Sampling Plans for Reduced Inspection(Master Table) (13)Table III-A Doubling Sampling Plans for Normal Inspection(Master Table) (14)Table III-B Doubling Sampling Plans for Tightened Inspection(Master Table) (15)Table III-C Doubling Sampling Plans for Reduced Inspection(Master Table) (16)Table IV-A Multiple Sampling Plans for Normal Inspection(Master Table) (17)Table IV-B Multiple Sampling Plans for Tightened Inspection(Master Table) (19)Table IV-C Multiple Sampling Plans for Reduced Inspection(Master Table) (21)Table V-A Factors for Determining Approximate Values for Average Outgoing Quality Limits for Normal Inspection(Single Sampling) (23)Table V-B Factors for Determining Approximate Values for Average Outgoing Quality Limits for Tightened Inspection(Single Sampling) (24)Table VI-A Limiting Quality(in percent nonconforming)for Which Pa =10Percent(for Normal Inspection,Single Sampling) (25)Table VI-B Limiting Quality(in nonconformities per hundred units)for Which Pa =10Percent(for Normal Inspection,Single Sampling) (26)Table VII-A Limiting Quality(in percent nonconforming)for Which Pa =5Percent(for Normal Inspection,Single Sampling) (27)Table VII-B Limiting Quality(in nonconformities per hundred units)for Which Pa =5Percent(for Normal Inspection,Single Sampling) (28)Table VIII Limit Numbers for Reduced Inspection (29)Table IX Average Sample Size Curves for Double and Multiple Sampling Plans(normal and tightened inspection) (30)Table X-A Sample Size Code Letter A—Individual Plans (31)Table X-B Sample Size Code Letter B—Individual Plans (33)Table X-C Sample Size Code Letter C—Individual Plans (35)ANSI/ASQ Z1.4-2008vviTable X-D Sample Size Code Letter D—Individual Plans ............................................37Table X-E Sample Size Code Letter E—Individual Plans ............................................39Table X-F Sample Size Code Letter F—Individual Plans ............................................41Table X-G Sample Size Code Letter G—Individual Plans ............................................43Table X-H Sample Size Code Letter H—Individual Plans ............................................45Table X-J Sample Size Code Letter J—Individual Plans.............................................47Table X-K Sample Size Code Letter K—Individual Plans ............................................49Table X-L Sample Size Code Letter L—Individual Plans ............................................51Table X-M Sample Size Code Letter M—Individual Plans............................................53Table X-N Sample Size Code Letter N—Individual Plans ............................................55Table X-P Sample Size Code Letter P—Individual Plans ............................................57Table X-Q Sample Size Code Letter Q—Individual Plans ............................................59Table X-R Sample Size Code Letter R—Individual Plans ............................................61Table X-S Sample Size Code Letter S—Individual Plans ............................................63Table XIAverage Outgoing Quality Limit Factors for ANSI-Z1.4Scheme Performance(Single Sampling) (64)Table XII Limiting Quality for ANSI-Z1.4Scheme Performance for WhichP a =10Percent (Single Sampling) (65)Table XIII Limiting Quality for ANSI-Z1.4Scheme Performance for WhichP a =5Percent (Single Sampling) (66)Table XIV Average Sample Size Tables for ANSI-Z1.4Scheme Performance (Single Sampling).............67Table XV-A Sample Size Code Letter A—Scheme Performance ........................................71Table XV-B Sample Size Code Letter B—Scheme Performance ........................................72Table XV-C Sample Size Code Letter C—Scheme Performance ........................................73Table XV-D Sample Size Code Letter D—Scheme Performance ........................................74Table XV-E Sample Size Code Letter E—Scheme Performance ........................................75Table XV-F Sample Size Code Letter F—Scheme Performance.........................................76Table XV-G Sample Size Code Letter G—Scheme Performance ........................................77Table XV-H Sample Size Code Letter H—Scheme Performance ........................................78Table XV-J Sample Size Code Letter J—Scheme Performance.........................................79Table XV-K Sample Size Code Letter K—Scheme Performance ........................................80Table XV-L Sample Size Code Letter L—Scheme Performance ........................................81Table XV-M Sample Size Code Letter M—Scheme Performance........................................82Table XV-N Sample Size Code Letter N—Scheme Performance ........................................83Table XV-P Sample Size Code Letter P—Scheme Performance.........................................84Table XV-Q Sample Size Code Letter Q—Scheme Performance ........................................85Table XV-R Sample Size Code Letter R—Scheme Performance ........................................86INDEX OF TERMS WITH SPECIAL MEANINGS.. (87)ANSI/ASQ Z1.4-2008--`,,```,,,,````-`-`,,`,,`,`,,`---1.SCOPE1.1PURPOSE.This publication establishes sampling plans and procedures for inspection by attributes.When specified by the responsible authority,this publication shall be referenced in the specification,contract,inspection instructions,or other documents and the provisions set forth herein shall govern.The“responsible authority”shall be designated in one of the above documents,as agreed to by the purchaser and seller or producer and user.1.2APPLICATION.Sampling plans designated in this publication are applicable,but not limited,to inspection of the following:a.End items.ponents and raw materials.c.Operations.d.Materials in process.e.Supplies in storage.f.Maintenance operations.g.Data or records.h.Administrative procedures.These plans are intended primarily to be used for a continu-ing series of lots or batches.The plans may also be used for the inspection of isolated lots or batches,but,in this latter case,the user is cautioned to consult the operating charac-teristic curves tofind a plan which will yield the desired pro-tection(see11.6).1.3INSPECTION.Inspection is the process of measur-ing,examining,testing,or otherwise comparing the unit of product(see1.5)with the requirements.1.4INSPECTION BY ATTRIBUTES.Inspection by attributes is inspection whereby either the unit of product is classified simply as conforming or nonconforming,or the number of nonconformities in the unit of products is counted,with respect to a given requirement or set of requirements.1.5UNIT OF PRODUCT.The unit of product is the unit inspected in order to determine its classification as con-forming or nonconforming or to count the number of non-conformities.It may be a single article,a pair,a set,a length, an area,an operation,a volume,a component of an end product,or the end product itself.The unit of product may or may not be the same as the unit of purchase,supply,pro-duction,or shipment.2.DEFINITIONS AND TERMINOLOGYThe definitions and terminology employed in this standard are in accord with ANSI/ASQ A3534-2-2006(Terms, Symbols,and Definitions for Acceptance Sampling).The following two definitions are particularly important in applying the standard.DEFECT:A departure of a quality characteristic from its intended level or state that occurs with a sever-ity sufficient to cause an associated product orservice not to satisfy intended normal,or foresee-able,usage requirements.NONCONFORMITY:A departure of a quality charac-teristic from its intended level or state that occurswith severity sufficient to cause an associatedproduct or service not to meet a specificationrequirement.These acceptance sampling plans for attributes are given in terms of the percent or proportion of product in a lot or batch that depart from some requirement.The general terminol-ogy used within the document will be given in terms of per-cent of nonconforming units or number of nonconformities, since these terms are likely to constitute the most widely used criteria for acceptance sampling.In the use of this standard it is helpful to distinguish between:a.an individual sampling plan—a specific plan thatstates the sample size or sizes to be used,and theassociated acceptance criteria.SAMPLING PROCEDURES AND TABLES FOR INSPECTION BY ATTRIBUTESANSI/ASQ Z1.4-2008--`,,```,,,,````-`-`,,`,,`,`,,`---requirements of the specific situation.An AQL for a group of nonconformities may be designated in addition to AQLs for individual nonconformities,or subgroups,within that group.AQL values of10.0or less may be expressed either in percent nonconforming or in nonconformities per hun-dred units;those over10.0shall be expressed in nonconfor-mities per hundred units only.4.6PREFERRED AQLs.The values of AQLs given in these tables are known as preferred AQLs.If,for any prod-uct,an AQL be designated other than a preferred AQL,these tables are not applicable.5.SUBMISSION OF PRODUCT5.1LOT OR BA TCH.The term lot or batch shall mean “inspection lot”or“inspection batch,”i.e.,a collection of units of product from which a sample is to be drawn and inspected to determine conformance with the acceptability criteria,and may differ from a collection of units designated as a lot or batch for other purposes(e.g.,production,shipment,etc.). 5.2FORMATION OF LOTS OR BATCHES.The prod-uct shall be assembled into identifiable lots,sublots,batches, or in such other manner as may be prescribed(see5.4).Each lot or batch shall,as far as is practicable,consist of units of product of a single type,grade,class,size,and composition, manufactured under essentially the same conditions,and at essentially the same time.5.3LOT OR BATCH SIZE.The lot or batch size is the number of units of product in a lot or batch.5.4PRESENTATION OF LOTS OR BATCHES.The formation of the lots or batches,lot or batch size,and the manner in which each lot or batch is to be presented and identified by the supplier shall be designated or approved by the responsible authority.As necessary,the supplier shall provide adequate and suitable storage space for each lot or batch,equipment needed for proper identification and pres-entation,and personnel for all handling of product required for drawing of samples.6.ACCEPTANCE AND NON-ACCEPTANCE6.1ACCEPTABILITY OF LOTS OR BATCHES. Acceptability of a lot or batch will be determined by the use of a sampling plan or plans associated with the designated AQL or AQLs.In the use of this standard a statement that a lot is acceptable means simply that sample results satisfy the standard’s acceptance criteria.The acceptance of a lot is not intended to provide information about lot quality.If a stream of lots froma given process is inspected under an acceptance sampling scheme such as provided in this standard,some lots will be accepted and others will not.If all incoming lots are assumedto be at the same process average and if the nonconforming items that are discovered and replaced by conforming items during sample inspection are ignored,it will be found that both the set of accepted lots and the set of non-accepted lotswill have the same long run average quality as the originalset of lots submitted for inspection.Inspection of incominglots whose quality levels vary around afixed long run aver-age quality level will divide the lots into a set of accepted lotsand a set of non-accepted lots,but it will be found that the long run average quality of the accepted lots is only slightly better than the long run average quality of the non-accepted lots.Replacement of the nonconforming items that are dis-covered during sample inspection does not alter thisfinding because the samples are a small fraction of the lots.The purpose of this standard is,through the economic and psychological pressure of lot non-acceptance,to induce a supplier to maintain a process average at least as good as the specified AQL while at the same time providing an upperlimit on the consideration of the consumer’s risk of accept-ing occasional poor lots.The standard is not intended as a procedure for estimating lot quality or for segregating lots.In acceptance sampling,when sample data do not meet the acceptance criteria,it is often stated that the lot is to be “rejected.”In this connection,the words“to reject”generallyare used.Rejection in an acceptance sampling sense means to decide that a batch,lot or quantity of product,material,or service has not been shown to satisfy the acceptance criteria based on the information obtained from the sample(s).In acceptance sampling,the words“to reject”generally are used to mean“to not accept”without direct implication of product usability.Lots which are“rejected”may be scrapped,sorted(with or without nonconforming units being replaced),reworked,re-evaluated against more spe-cific usability criteria,held for additional information,etc. Since the common language usage of“reject”often resultsin an inference of unsafe or unusable product,it is recom-mended that“not accept”be understood rather than“reject”in the use of this standard.The word“non-acceptance”is used here for“rejection”when it refers to the result of following the procedure. Forms of the word“reject”are retained when they refer to actions the customer may take,as in“rejection number.”ANSI/ASQ Z1.4-2008--`,,```,,,,````-`-`,,`,,`,`,,`---6.2NONCONFORMING UNITS.The right is reserved to reject any unit of product found nonconforming during inspection whether that unit of product forms a part of a sample or not,and whether the lot or batch as a whole is accepted or rejected.Rejected units may be repaired or cor-rected and resubmitted for inspection with the approval of,and in the manner specified by,the responsible authority.6.3SPECIAL RESERV ATION FOR DESIGNATED NONCONFORMITIES.Since most acceptance sampling involves evaluation of more than one quality characteristic,and since these may differ in importance in terms of quality and/or economic effects,it is often desirable to classify the types of nonconformity according to agreed upon groupings.Specific assignment of types of nonconformities to each class is a function of agreement on specific sampling appli-cations.In general,the function of such classification is to permit the use of a set of sampling plans having a common sample size,but different acceptance numbers for each class having a different AQL,such as in Tables II,III,and IV .The supplier may be required at the discretion of the respon-sible authority to inspect every unit of the lot or batch for designated classes of nonconformities.The right is reserved to inspect every unit submitted by the supplier for specified nonconformities,and to reject the lot or batch immediately,when a nonconformity of this class is found.The right is reserved also to sample,for specified classes of nonconfor-mities,lots or batches submitted by the supplier and to reject any lot or batch if a sample drawn therefrom is found to con-tain one or more of these nonconformities.6.4RESUBMITTED LOTS OR BATCHES.Lots or batches found unacceptable shall be resubmitted for rein-spection only after all units are re-examined or re-tested and all nonconforming units are removed or nonconformities corrected.The responsible authority shall determine whether normal or tightened inspection shall be used on reinspection and whether reinspection shall include all types or classes of nonconformities or only the particular types or classes of nonconformities which caused initial rejection.7.DRA WING OF SAMPLES7.1SAMPLE.A sample consists of one or more units of product drawn from a lot or batch,the units of the sample being selected at random without regard to their quality.The number of units of product in the sample is the sample size.7.2SAMPLING.When appropriate,the number of units in the sample shall be selected in proportion to the size of sublots or subbatches,or parts of the lot or batch,identified by some rational criterion.In so doing,the units from each part of the lot or batch shall be selected at random,as defined in ANSI/ASQ A3534-2-2006.7.3TIME OF SAMPLING.Samples may be drawn after all the units comprising the lot or batch have been produced,or samples may be drawn during production of the lot or batch.7.4DOUBLE OR MULTIPLE SAMPLING.Where dou-ble or multiple sampling is to be used,each sample shall be selected over the entire lot or batch.8.NORMAL,TIGHTENED AND REDUCED INSPECTION8.1INITIATION OF INSPECTION.Normal inspection will be used at the start of inspection unless otherwise directed by the responsible authority.8.2CONTINUATION OF INSPECTION.Normal,tight-ened or reduced inspection shall continue unchanged on successive lots or batches except where the switching pro-cedures given below require change.8.3SWITCHING PROCEDURES.8.3.1NORMAL TO TIGHTENED.When normal inspection is in effect,tightened inspection shall be insti-tuted when 2out of 5or fewer consecutive lots or batches have been non-acceptable on original inspection (i.e.,ignor-ing resubmitted lots or batches for this procedure).8.3.2TIGHTENED TO NORMAL.When tightened inspection is in effect,normal inspection shall be instituted when 5consecutive lots or batches have been considered acceptable on original inspection.8.3.3NORMAL TO REDUCED.When normal inspection is in effect,reduced inspection shall be instituted providing that all of the following conditions are satisfied.a.The preceding 10lots or batches (or more,as indi-cated by the note to Table VIII)have been on nor-mal inspection and all have been accepted on original inspection;andANSI/ASQ Z1.4-2008--`,,```,,,,````-`-`,,`,,`,`,,`---b.The total number of nonconforming units(or non-conformities)in the samples from the preceding10lots or batches(or such other number as was usedfor condition“a”above)is equal to or less than theapplicable limit number given in Table VIII(see8.5).If double or multiple sampling is in use,allsamples inspected should be included,not“first”samples only;andc.Production is at a steady rate;andd.Reduced inspection is considered desirable by theresponsible authority.8.3.4REDUCED TO NORMAL.When reduced inspec-tion is in effect,normal inspection shall be instituted if any of the following occur on original inspection:a.A lot or batch is rejected;orb.A lot or batch is considered acceptable under theprocedures for reduced inspection given in10.1.4;orc.Production becomes irregular or delayed;ord.Other conditions warrant that normal inspectionshall be instituted.8.4DISCONTINUATION OF INSPECTION.If the cumulative number of lots not accepted in a sequence of con-secutive lots on tightened inspection reaches5,the accept-ance procedures of this standard shall be discontinued. Inspection under the provisions of this standard shall not be resumed until corrective action has been taken.Tightened inspection shall then be used as if8.3.1had been invoked.8.5LIMIT NUMBERS FOR REDUCED INSPECTION. When agreed upon by responsible authority for both parties to the inspection,that is,the supplier and the end item cus-tomer,the requirements of8.3.3b may be dropped.This action will have little effect on the operating properties of the scheme.8.6SWITCHING SEQUENCE.A schematic diagram describing the sequence of application of the switching rules is shown in Figure1.9.SAMPLING PLANS9.1SAMPLING PLAN.A sampling plan indicates the number of units of product from each lot or batch which are to be inspected(sample size or series of sample sizes)andthe criteria for determining the acceptability of the lot or batch(acceptance and rejection numbers).9.2INSPECTION LEVEL.The inspection level deter-mines the relationship between the lot or batch size and the sample size.The inspection level to be used for any partic-ular requirement will be prescribed by the responsible authority.Three inspection levels:I,II and III are given in Table I for general use.Unless otherwise specified, Inspection Level II will be used.However,Inspection LevelI 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 givenin the same table and may be used where relatively small sample sizes are necessary and large sampling risks can or must be tolerated.NOTE:In the designation of inspection levels S-1to S-4, care must be exercised to avoid AQLs inconsistent with these inspection levels.9.3CODE LETTERS.Sample sizes are designated by code letters.Table I shall be used tofind the applicable code letter for the particular lot or batch size and the prescribed inspection level.9.4OBTAINING SAMPLING PLAN.The AQL and the code letter shall be used to obtain the sampling plan from Tables II,III,or IV.When no sampling plan is available for a given combination of AQL and code letter,the tables directthe user to a different letter.The sample size to be used is given by the new code letter,not by the original letter.If this procedure leads to different sample sizes for different classesof nonconformities,the code letter corresponding to the largest sample size derived may be used for all classes of nonconformities when designated or approved by the respon-sible authority.As an alternative to a single sampling planwith an acceptance number of0,the plan with an acceptance number of1with its correspondingly larger sample size fora designated AQL(where available),may be used when des-ignated or approved by the responsible authority.9.5TYPES OF SAMPLING PLANS.Three types of sam-pling plans:Single,Double and Multiple,are given in TablesII,III,and IV,respectively.When several types of plans are available for a given AQL and code letter,any one may be used.A decision as to type of plan,either single,double,or multiple,when available for a given AQL and code letter,will usually be based upon the comparison between theANSI/ASQ Z1.4-2008--`,,```,,,,````-`-`,,`,,`,`,,`---administrative difficulty and the average sample sizes of the available plans.The average sample size of multiple plans is less than for double(except in the case corresponding to sin-gle acceptance number1)and both of these are always less than a single sample size(see Table IX).Usually the admin-istrative difficulty for single sampling and the cost per unit of the sample are less than for double or multiple.10.DETERMINATION OF ACCEPTABILITY10.1PERCENT NONCONFORMING INSPECTION. To determine acceptability of a lot or batch under percent non-conforming inspection,the applicable sampling plan shall be used in accordance with10.1.1,10.1.2,10.1.3and10.1.4. 10.1.1SINGLE SAMPLING PLAN.The number of sam-ple units inspected shall be equal to the sample size given by the plan.If the number of nonconforming units found in the sample is equal to or less than the acceptance number,the lot or batch shall be considered acceptable.If the number of nonconforming units is equal to or greater than the rejection number,the lot or batch shall be considered not acceptable.10.1.2DOUBLE SAMPLE PLAN.The number of sample unitsfirst inspected shall be equal to thefirst sample size given by the plan.If the number of nonconforming units found in thefirst sample is equal to or less than thefirst acceptable number,the lot or batch shall be considered acceptable.If the number of nonconforming units found in thefirst sample is equal to or greater than thefirst rejection number,the lot or batch shall be considered not acceptable. If the number of nonconforming units found in thefirst sam-ple is between thefirst acceptance and rejection numbers,a second sample of the size given by the plan shall be inspected.The number of nonconforming units found in the first and second samples shall be accumulated.If the cumu-lative number of nonconforming units is equal to or less than the second acceptance number,the lot or batch shall be con-sidered acceptable.If the cumulative number of noncon-forming units is equal to or greater than the second rejection number,the lot or batch shall be considered not acceptable.10.1.3MULTIPLE SAMPLE PLAN.Under multiple sampling,the procedure shall be similar to that specified in 10.1.2,except that the number of successive samples required to reach a decision might be more than two. 10.1.4SPECIAL PROCEDURE FOR REDUCED INSPECTION.Under reduced inspection,the sampling procedure may terminate without making a decision.In these circumstances,the lot or batch will be considered acceptable,but normal inspection will be reinstated starting with the next lot or batch(see8.3.4(b)).10.2NONCONFORMITIES PER HUNDRED UNITS INSPECTION.To determine the acceptability of a lot or batch under Nonconformities per Hundred Units inspection, the procedure specified for Percent Nonconforming inspec-tion above shall be used,except that the word“nonconfor-mities”shall be substituted for“nonconforming units.”11.SUPPLEMENTARY INFORMATION11.1OPERATING CHARACTERISTIC CURVES. Operating characteristic curves and other measures of per-formance presented in this standard are of two types.Those for the individual plans that represent the elements of the schemes are presented in Tables V,VI,VII,IX,and X. Analogous curves and other measures of overall scheme per-formance when the switching rules are used are given in Tables XI,XII,XIII,XIV,and XV.Scheme performance is defined as the composite proportion of lots accepted at a stated percent nonconforming when the switching rules are applied.The term scheme performance is used here in a very restrictive sense.It refers to how the ANSI Z1.4scheme of switching rules would operate at a given process level under the assumption that the process stays at that level even after switching to tightened inspection or discontinuation of inspection.This gives a conservative“worst case”description of the performance of the scheme for use as a baseline in the sense that if the psychological and economic pressures asso-ciated with the switching rules are considered,the protection of the scheme may be somewhat better than that shown. Operating characteristic curves are given in Table X for individual sampling plans for normal and tightened inspec-tion.The operating characteristic curve for unqualified acceptance under reduced inspection can be found by using the AQL index of the normal plan with the sample size(s) and acceptance number(s)of the reduced plan.The curves shown are for single sampling;curves for double and multi-ple sampling are matched as closely as practicable.The O.C. curves shown for AQLs greater than10.0are based on the Poisson distribution and apply for nonconformities per hun-dred units inspection;those for AQLs of10.0or less and sample sizes of80or less are based on the binomial distri-bution and apply for percent nonconforming inspection; those for AQLs of10.0or less and sample sizes larger than 80are based on the Poisson distribution and apply either for nonconformities per hundred units inspection,or for percentANSI/ASQ Z1.4-2008。
品质知识
1.验收抽样计划(acceptance sampling plans):为了避免错误的拒绝一个良好的货批或错误的接受一批不良的货批,因此利用统计方法设计抽样计划。
若以数据的性质来分类,可分为计量值抽样计划(variable sampling plans)和计数值抽样计划(attributes sampling plans)。
若以抽样的方式来分类,可分为单次抽样(single sampling)、双次抽样(double sampling)、多次抽样(multiple sampling)与逐次抽样(sequential sampling)。
2.亲和图(affinity diagrams):亲和图是品管新七大手法之一。
用来收集事实、看法和意见,并且将它们组织化。
制作步骤如下:1.选定题目 2.收集叙述性的语言数据3.将叙述性数据记录于卡片上4.将步骤3之卡片分组5.给予各组卡片一个适当的标题6.绘制亲和图7.将结果发表。
此图是由矩形盒与椭圆形所构成,内容为各项事实、看法或意见。
归于同一组之矩形盒可以用椭圆形加以包围,并且加上标题。
3.Alpha风险(Alpha risk):在进行假设检定时,指虚无假设(H0)为真时,做出拒绝虚无假设之错误机率,一般以α表示之,也称型I误差(Type I error)。
在质量管理之验收抽样计划中,α则称为生产者风险,亦即代表一个优良之货批被拒收之机率。
4.箭头图(arrow diagram):箭头图是用来规划作业和事件之前后顺序的工具。
此图可以表达作业的时间和先后顺序,图中包含了节点、实线箭头、虚线箭头。
箭头图可当作制作质量计划时,委派责任及制定时间表之工具。
其主要处理的项目有处理质量规划中之人员(who)、地点(where)、及时间(when)等要素。
5.可归属原因(assignable causes):所有制程之产出均自然出现某种程度的变异。
此变异的产生若对于制程具显著之影响,我们通常可以辨认其变异之主要来源,找出其变异的特定原因。
EU GMP 指南附件8:起始物料和包装材料的取样(中英文)
EU GMP 指南附件8:起始物料和包装材料的取样(中英文)Annex 8 附件8SAMPLING OF STARTING AND PACKAGING MATERIALS起始物料和包装材料的取样Principle 原则Sampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions on the whole cannot be based on tests which have been carried out on nonrepresentative samples. Correct sampling is thus an essential part of a system of Quality Assurance.取样是一个重要的操作,取样中,每批仅有小部分被取出。
如果对不具有代表性的样品进行检测,则不能得出有效结论。
因而正确的取样方法是质量保证体系的必要因素。
Note 注Sampling is dealt with in Chapter 6 of the Guide, items 6.11. to 6.14. This annex gives additional guidance on the sampling of starting and packaging materials.取样在指南第6章第6.11至6.14项。
本附件针对起始物料和包装物料给出一些额外的指南。
Personnel 人员1. Personnel who take samples should receive initial and on-going regular training in the disciplines relevant to correct sampling. This training should include:取样人员应接受与正确取样操作相关的初始培训和周期性继续再培训,该培训应包括:—sampling plans,—取样计划—written sampling procedures,—书面取样程序—the techniques and equipment for sampling,—取样技术和取样工具—the risks of cross-contamination,—交叉污染风险—the precautions to be taken with regard to unstable and/or sterile substances,—对不稳定和/或无菌物料采取的预防措施—the importance of considering the visual appearance of materials, containers and labels,—考察物料、包材和标签的外观的重要性—the importance of recording any unexpected or unusual circumstances.—记录非预期或异常情况的重要性Starting materials 起始物料2. The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled.为保证起始物料一个完整批准的鉴别,一般需要对每个包装进行单独取样,独立检测鉴别项。
英语字典
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Quirky Quality DictionaryAAcademic Quality Improvement Project (AQIP): A forum for institutions to review each other's action projects. Acceptable quality level (AQL): In a continuing series of lots, a quality level that, for the purpose of sampling inspection, is the limit of satisfactory process average. Acceptance number: The maximum number of defects or defectives allowable in a sampling lot for the lot to be acceptable.Acceptance sampling: Inspection of a sample from a lot to decide whether to accept that lot. There are two types: attributes sampling and variables sampling. In attributes sampling, the presence or absence of a characteristic is noted in each of the units inspected. In variables sampling, the numerical magnitude of a characteristic is measured and recorded for each inspected unit; this involves reference to a continuous scale of some kind. Acceptance sampling plan: A specific plan that indicates the sampling sizes and associated acceptance or nonacceptance criteria to be used. In attributes sampling, for example, there are single, double, multiple, sequential, chain and skip-lot sampling plans. In variables sampling,there are single, double and sequential sampling plans. (For detailed descriptions of these plans, see the standard ANSI/ISO/ASQ A3534-2, Statistics—Vocabulary and Symbols—Statistical Quality Control.)Accreditation: Certification by a duly recognized body of the facilities, capability, objectivity, competence and integrity of an agency, service, or operational group or individual to provide the specific service or operation needed.Accuracy: The characteristic of a measurement that tells how close an observed value is to a true value.Action plan: A specific method or process to achieve the results called for by one or more objectives. May be a simpler version of a project plan.Activity network diagram: An arrow diagram used in planning and managing processes and projects. Advanced Product Quality Planning (APQP): Segment of QS-9000 process that uses tools to offer the opportunity to get ahead of problems and solve them before the problems affect the customer.Affinity diagram: A management tool used to organize information (usually gathered during a brainstorming activity).Alignment: The actions taken to ensure a process or activity supports the organization's strategy, goals and objectives.American Association for Laboratory Accreditation (A2LA): An organization that formally recognizes another organization's competency to perform specific tests, types of tests or calibrations.American Customer Satisfaction Index (ACSI): Released for the first time in October 1994, an economic indicator and cross industry measure of the satisfaction of U.S. household customers with the quality of the goods and services available to them—both those goods and services produced within the United States and those provided as imports from foreign firms that have substantial market shares or dollar sales. The ACSI is co-sponsored by the University of Michigan Business School, ASQ and the CFI Group.American National Standards Institute (ANSI): ANSI is a private, nonprofit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. It is the United States' member body in the International Organization for Standardization, known as ISO.American Society for Nondestructive Testing (ASNT): The world's largest technical society for nondestructive testing (NDT) professionals.American Society for Quality (ASQ): A professional, not-for-profit association that develops, promotes and applies quality related information and technology for the private sector, government and academia. The Society serves more than 108,000 individuals and 1,100 corporate members in the United States and 108 other countries. American Society for Quality Control (ASQC): Name of the Society from 1946 through the middle of 1997; then changed to ASQ.American Society for Testing and Materials (ASTM): Not-for-profit organization that provides a forum for the development and publication of voluntary consensus standards for materials, products, systems and services. American Society for Training and Development (ASTD): A membership organization providing materials, education and support related to workplace learning and performance.American standard code for information interchange (ASCII): Basic computer characters accepted by all American machines and many foreign ones.Analysis of means (ANOM): A statistical procedure for troubleshooting industrial processes and analyzing the results of experimental designs with factors at fixed levels. It provides a graphical display of data. Ellis R. Ott developed the procedure in 1967 because he observed that nonstatisticians had difficulty understanding analysis of variance. Analysis of means is easier for quality practitioners to use because it is an extension of the control chart. In 1973, Edward G. Schilling further extended the concept, enabling analysis of means to be used withnon-normal distributions and attributes data where the normal approximation to the binomial distribution does not apply. This is referred to as analysis of means for treatment effects.Analysis of variance (ANOVA): A basic statistical technique for analyzing experimental data. It subdivides the total variation of a data set into meaningful component parts associated with specific sources of variation in order to test a hypothesis on the parameters of the model or to estimate variance components. There are three models: fixed, random and mixed.Appraisal cost: The cost involved in ensuring an organization is continually striving to conform to customers' quality requirements.Arrow diagram: A planning tool to diagram a sequence of events or activities (nodes) and the interconnectivity of such nodes. It is used for scheduling and especially for determining the critical path through nodes.AS9100: An international quality management standard for the aerospace industry published by the Society of Automotive Engineers; also published by other organizations worldwide, as EN9100 in Europe and JIS Q 9100 in Japan. The standard is controlled by the International Aerospace Quality Group (see listing). Assessment: A systematic process of collecting and analyzing data to determine the current, historical or projected status of an organization.Assignable cause: A name for the source of variation in a process that is not due to chance and therefore can be identified and eliminated. Also called "special cause." Association for Quality and Participation (AQP): Affiliate organization of the American Society for Quality (ASQ) dedicated to improving workplaces through quality and participation practices.Attribute data: Go/no-go information. The control charts based on attribute data include percent chart, number of affected units chart, count chart, count per unit chart, quality score chart and demerit chart.Attributes, method of: Measurement of quality by the method of attributes consists of noting the presence (or absence) of some characteristic (attribute) in each of the units under consideration and counting how many units do (or do not) possess it. Example: go/no-go gauging of a dimension.Audit: The inspection and examination of a process or quality system to ensure compliance to requirements. An audit can apply to an entire organization or may be specific to a function, process or production step.Automotive Industry Action Group (AIAG): The originator and sole source of the QS-9000 series of standards. ASQ's Automotive Division maintains a liaison to this group.Availability: The ability of a product to be in a state to perform its designated function under stated conditions at a given time.Average chart: A control chart in which the subgroup average, X-bar, is used to evaluate the stability of the process level.Average outgoing quality (AOQ): The expected average quality level of outgoing product for a given value of incoming product quality.Average outgoing quality limit (AOQL): The maximum average outgoing quality over all possible levels of incoming quality for a given acceptance sampling plan and disposal specification.Average run lengths (ARL): On a control chart, the number of subgroups expected to be inspected before a shift in magnitude takes place.Average sample number (ASN): The average number of sample units inspected per lot in reaching decisions to accept or reject.Average total inspection (ATI): The average number of units inspected per lot, including all units in rejected lots (applicable when the procedure calls for 100% inspection of rejected lots).Return to topBBaldrige Award: See "Malcolm Baldrige National Quality Award."Baseline measurement: The beginning point, based on an evaluation of the output over a period of time, used to determine the process parameters prior to any improvement effort; the basis against which change is measured.Benchmarking: An improvement process in which a company measures its performance against that of best in class companies, determines how those companies achieved their performance levels and uses the information to improve its own performance. The subjects that can be benchmarked include strategies, operations, processes and procedures.Benefit-cost analysis: An examination of the relationship between the monetary cost of implementing an improvement and the monetary value of the benefits achieved by the improvement, both within the same time period.Best practice: A superior method or innovative practice that contributes to the improved performance of an organization, usually recognized as "best" by other peer organizations.Big Q, Little Q: A term used to contrast the difference between managing for quality in all business processes and products (big Q) and managing for quality in a limited capacity—traditionally only in factory products and processes (little q).Black Belt (BB): Full-time team leader responsible for implementing process improvement projects—define, measure, analyze, improve and control (DMAIC) or define,measure, analyze, design and verify (DMADV)—within the business to drive up customer satisfaction levels and business productivity.Blemish: An imperfection severe enough to be noticed but that should not cause any real impairment with respect to intended normal or reasonably foreseeable use (see also "defect," "imperfection" and "nonconformity").Block diagram: A diagram that shows the operation, interrelationships and interdependencies of components in a system. Boxes, or blocks (hence the name), represent the components; connecting lines between the blocks represent interfaces. There are two types of block diagrams: a functional block diagram, which shows a system's subsystems and lower level products and their interrelationships and which interfaces with other systems; and a reliability block diagram, which is similar to the functional block diagram except that it is modified to emphasize those aspects influencing reliability.Board of Standards Review (BSR): An American National Standards Institute board responsible for the approval and withdrawal of American National Standards. Body of knowledge (BOK): The prescribed aggregation of knowledge in a particular area an individual is expectedto have mastered to be considered or certified as a practitioner.Bottom line: The essential or salient point; the primary or most important consideration. Also, the line at the bottom of a financial report that shows the net profit or loss. Box, George E.P.: A native of England, Box began his career during World War II with the British Army Engineers, where he learned statistics. He studied at University College, became head of the statistical techniques research section at Imperial Chemical Industrials and obtained a doctorate. He moved to the United States and was a founder of Technometrics, published by ASQ and the American Statistical Association. A professor at the University of Wisconsin, Box is an Honorary Member of ASQ.Brainstorming: A technique teams use to generate ideas on a particular subject. Each person in the team is asked to think creatively and write down as many ideas as possible. The ideas are not discussed or reviewed until after the brainstorming session.Breakthrough improvement: A dynamic, decisive movement to a new, higher level of performance. Brumbaugh, Martin A. (deceased): The founder and first editor of Industrial Quality Control magazine. A formerprofessor of statistics at the University of Buffalo, Brumbaugh published regularly on applied statistics. Brumbaugh was instrumental in getting two separate quality organizations—the Federated Societies and the Society for Quality Control—merged into one national organization: ASQ (then ASQC). Brumbaugh was an ASQ Honorary Member.BS 7799: British commerce, government and industry stakeholders wrote BS 7799 to address information security management issues, including fraud, industrial espionage and physical disaster. May become ISO standard.Business process reengineering (BPR): The concentration on the improvement of business processes that will deliver outputs that will achieve results meeting the firm's objectives, priorities and mission.Return to topCC chart: See "count chart."Calibration: The comparison of a measurement instrument or system of unverified accuracy to a measurement instrument or system of known accuracy to detect any variation from the required performance specification.Capability maturity model: A framework that describes the key elements of an effective software process. It's an evolutionary improvement path from an immature process to a mature, disciplined process. The CMM covers practices for planning, engineering and managing software development and maintenance. When followed, these key practices improve the ability of organizations to meet goals for cost, schedule, functionality and product quality. Cascading: The continuing flow of the quality message down to, not through, the next level of supervision until it reaches all workers. Same concept as "deploying." Cause: An identified reason for the presence of a defect or problem.Cause and effect diagram: A tool for analyzing process dispersion. It is also referred to as the "Ishikawa diagram," because Kaoru Ishikawa developed it, and the "fishbone diagram," because the complete diagram resembles a fish skeleton. The diagram illustrates the main causes and subcauses leading to an effect (symptom). The cause and effect diagram is one of the "seven tools of quality." (See listing).Centerline: A line on a graph that represents the overall average (mean) operating level of the process.Central tendency: The tendency of data gathered from a process to cluster toward a middle value somewhere between the high and low values of measurement. Certification: The result of meeting the established criteria set by an accrediting or certificate granting organization.Certified mechanical inspector (CMI): An ASQ certification.Certified quality auditor (CQA): An ASQ certification. Certified quality auditor (CQA)-biomedical: An ASQ certification.Certified quality auditor (CQA)-hazard analysis and critical control point (HACCP): An ASQ certification. Certified quality engineer (CQE): An ASQ certification. Certified quality improvement associate (CQIA): An ASQ certification.Certified quality manager: An ASQ certification. Certified quality technician (CQT): An ASQ certification. Certified reliability engineer (CRE): An ASQ certification.Certified Six Sigma Black Belt (CSSBB): An ASQ certification.Certified software quality engineer (CSQE): An ASQ certification.Chain reaction: A chain of events described by W. Edwards Deming: improve quality, decrease costs, improve productivity, increase market with better quality and lower price, stay in business, provide jobs and provide more jobs. Chain sampling plan: In acceptance sampling, a plan in which the criteria for acceptance and rejection apply to the cumulative sampling results for the current lot and one or more immediately preceding lots.Champion: A business leader or senior manager who ensures that resources are available for training and projects, and who is involved in project tollgate reviews; also an executive who supports and addresses Six Sigma organizational issues.Change agent: An individual from within or outside an organization who facilitates change within the organization. May or may not be the initiator of the change effort. Characteristic: The factors, elements or measures that define and differentiate a process, function, product, service or other entity.Chart: A tool for organizing, summarizing and depicting data in graphic form.Charter: A written commitment approved by management stating the scope of authority for an improvement project or team.Checklist: A tool used to ensure all important steps or actions in an operation have been taken. Checklists contain items important or relevant to an issue or situation. Checklists are often confused with check sheets (see individual entry).Check sheet: A simple data recording device. The check sheet is custom designed by the user, which allows him or her to readily interpret the results. The check sheet is one of the "seven tools of quality." (See listing). Check sheets are often confused with checklists (see individual entry). Classification of defects: The listing of possible defects of a unit, classified according to their seriousness. Note: Commonly used classifications: class A, class B, class C, class D; or critical, major, minor and incidental; or critical, major and minor. Definitions of these classifications require careful preparation and tailoring to the product(s) being sampled to enable accurate assignment of a defect to the proper classification. A separate acceptance sampling plan is generally applied to each class of defects.Closed-loop corrective action (CLCA): A sophisticated engineering system designed to document, verify and diagnose failures, recommend and initiate corrective action, provide follow-up and maintain comprehensive statistical records.Code of conduct: Expectations of behavior mutually agreed on by a team.Collier, Simon (deceased): An ASQ president who led the Society during a critical growth period in 1952-53. His term was marked by numerous milestone events, including a membership increase of 22% and the formation of 11 new sections and the first divisions. Collier, an ASQ Honorary Member, was a chemist who began his career at the National Bureau of Standards (now the National Institute of Standards and Technology). Later he worked atJohns-Manville Corp., where he produced a quality training film used by more than 300 companies.Common causes: Causes of variation that are inherent in a process over time. They affect every outcome of the process and everyone working in the process (see also "special causes").Company culture: A system of values, beliefs and behaviors inherent in a company. To optimize business performance, top management must define and create the necessary culture.Complaint tracking: Collecting data, disseminating data to appropriate persons for resolution, monitoring complaint resolution progress and communicating results.Compliance: The state of an organization that meets prescribed specifications, contract terms, regulations or standards.Computer aided design (CAD): Software used by architects, engineers, drafters and artists to create precision drawings or technical illustrations. CAD software can be used to create two-dimensional (2-D) drawings or three-dimensional (3-D) models.Computer aided engineering (CAE): A broad term used by the electronic design automation industry for the use of computers to design, analyze and manufacture products and processes. CAE includes CAD (see listing) and computer aided manufacturing (CAM), which is the use of computers for managing manufacturing processes. Concurrent engineering (CE): A way to reduce cost, improve quality and shrink cycle time by simplifying a product's system of life cycle tasks during the early concept stages.Conflict resolution: The management of a conflict situation to arrive at a resolution satisfactory to all parties. Conformance: An affirmative indication or judgment that a product or service has met the requirements of a relevant specification, contract or regulation.Conformitè Europeënne Mark (CE Mark): Conformity European Union mark. The European Union created the CE Mark to regulate the goods sold within its borders. The mark represents a manufacturer's declaration products comply with the EU's New Approach Directives. These directives apply to any country that sells products within the EU.Consensus: A state in which all the members of a group support an action or decision, even if some of them don't fully agree with it.Consultant: An individual who has experience and expertise in applying tools and techniques to resolve process problems and who can advise and facilitate an organization's improvement efforts.Consumer: The external customer to whom a product or service is ultimately delivered; Also called end user. Consumer's risk: Pertains to sampling and the potential risk that bad product will be accepted and shipped to the consumer.Continuous flow production: Means that items are produced and moved from one processing step to the next one piece at a time. Each process makes only the one piece that the next process needs, and the transfer batch size is one.Continuous improvement (CI): Sometimes called continual improvement. The ongoing improvement of products, services or processes through incremental and breakthrough improvements.Continuous quality improvement (CQI): A philosophy and attitude for analyzing capabilities and processes and improving them repeatedly to achieve the objective of customer satisfaction.Continuous sampling plan: In acceptance sampling, a plan, intended for application to a continuous flow of individual units of product, that involves acceptance and rejection on a unit by unit basis and employs alternate periods of 100% inspection and sampling, the relative amount of 100% inspection depending on the quality of submitted product. Continuous sampling plans usually require that each t period of 100% inspection be continued until a specified number, i, of consecutively inspected units are found clear of defects. Note: For single level continuous sampling plans, a single d sampling rate (for example, inspect 1 unit in 5 or 1 unit in 10) is used during sampling. For multilevel continuous sampling plans, two or more sampling rates may be used: The rate at any time depends on the quality of submitted product.Control chart: A chart with upper and lower control limits on which values of some statistical measure for a series of samples or subgroups are plotted. The chart frequently shows a central line to help detect a trend of plotted values toward either control limit.Control limits: The natural boundaries of a process within specified confidence levels, expressed as the upper control limit (UCL) and the lower control limit (LCL).Control plan (CP): A document that describes the required characteristics for the quality of a product or service, including measures and control methods. Coordinate measuring machine (CMM): A device that dimensionally measures 3-D products, tools and components with an accuracy approaching 0.0001 in. Corrective action: The implementation of solutions resulting in the reduction or elimination of an identified problem.Corrective action recommendation (CAR): The full cycle corrective action tool that offers ease and simplicity for employee involvement in the corrective action/process improvement cycle.Correlation (statistical): A measure of the relationship between two data sets of variables.Cost of poor quality (COPQ): The costs associated with providing poor quality products or services. There are four categories of costs: internal failure costs (costs associated with defects found before the customer receives the product or service), external failure costs (costs associated with defects found after the customer receives the product or service), appraisal costs (costs incurred to determine the degree of conformance to quality requirements) and prevention costs (costs incurred to keep failure and appraisal costs to a minimum).Cost of quality (COQ): A term coined by Philip Crosby referring to the cost of poor quality.Count chart: A control chart for evaluating the stability of a process in terms of the count of events of a given classification occurring in a sample.Count per unit chart: A control chart for evaluating the stability of a process in terms of the average count of events of a given classification per unit occurring in a sample.C p: The ratio of tolerance to six sigma, or the USL (upper specification limit) minus the LSL (lower specification limit) divided by six sigma. It is sometimes referred to as the engineering tolerance divided by the natural tolerance and is only a measure of dispersion.C pk index: Equals the lesser of the USL minus the mean divided by three sigma (or the mean) minus the LSL divided by three sigma. The greater the C pk value, the better. Critical processes: Processes that present serious potential dangers to human life, health and the environment or that risk the loss of very large sums of money or customers.Crosby, Philip (deceased): The founder and chairman of the board of Career IV, an executive management consulting firm. Crosby also founded Philip Crosby Associates Inc. and the Quality College. He wrote many books including Quality Is Free, Quality Without Tears, Let's Talk Quality, and Leading: The Art of Becoming an Executive. Crosby, who originated the zero defects concept, was an ASQ Honorary Member and past president.Cross functional: A term used to describe a process or an activity that crosses the boundary between functions. A cross functional team consists of individuals from more than one organizational unit or function.Cross pilot: See "scatter diagram."Cultural resistance: A form of resistance based on opposition to the possible social and organizational consequences associated with change.Culture change: A major shift in the attitudes, norms, sentiments, beliefs, values, operating principles and behavior of an organization.Culture, organizational: A common set of values, beliefs, attitudes, perceptions and accepted behaviors shared by individuals within an organization.Cumulative sum control chart (CUSUM): A control chart on which the plotted value is the cumulative sum of deviations of successive samples from a target value. The ordinate of each plotted point represents the algebraic sum of the previous ordinate and the most recent deviations from the target.Current good manufacturing practices (CGMP): Regulations enforced by the U.S. Food and Drug Administration for food and chemical manufacturers and packagers.Customer: See "external customer" and "internal customer."Customer delight: The result of delivering a product or service that exceeds customer expectations.Customer relationship management (CRM): A strategy used to learn more about customers' needs and behaviors to develop stronger relationships with them. It brings together information about customers, sales, marketing。