ASQ Q2-1991 Quality Management and Quality System Elements for Laboratories - Guidelines (T48E)《质量管理及质量系统元件实验室指导方针》.pdf

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1、ANSIIASQC Q2-1991 AMERICAN NATIONAL STANDARD Quality Management and Quality System Elements for Laboratories-Guidelines - ASQC QZ 71 m OJSYO oooozoz 4 m AMERICAN SOCIETY FOR QUALITY CONTROL 310 West Wisconsin Avenue Milwaukee, Wisconsin 53203 ASdC Q2 91 0759506 0000203 b ANSVASQC Q2-1991 AMERICAN NA

2、TIONAL STANDARD Quaity Management and Quaity System Elements for Laboratories-Guidelines Sponsor: American Society for Quality Control AS-QC Q2 91 E 0759506 00002-0-4 ! Abstract AMERICAN NATIONAL STANDARD: An American National Standard implies a consensus of those substantially concerned with its sc

3、ope 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 anyone, whether he has approved the standard or not, from manufacturing, marketing,

4、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 CAUTION NOTICE: This American National Standard may be revised or withdrawn at any time.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 proc

5、edures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of approval. Purchasers of American National Standards may receive current information on all standards by calling or writing the Ame

6、rican National Standards Institute. Approved October 31, 1990 American National Standards Institute, Inc. Copyright 01991 by the AMERICAN SOCIETY FOR QUALITY CONTROL No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written p

7、ermission of the publisher. Fublished by : AMERICAN SOCIETY FOR QUALITY CONTROL 310 WEST WISCONSIN AVENUE MILWAUKEE, WISCONSIN 53203 Printed in the United States of America. 11 ASQC QZ m 075q50b oooozo5 T m Foreword Various professional and governmental, national and international bodies have develo

8、ped lists of basic elements of quaity control systems. The task force has analyzed the specific content of a considerable number of these documents. This standard is drawn largely, by intent, from ANSUASQC Q94-1987, Quality Management and Quality System Elernents- Guidelines, where that material was

9、 relevant to laboratory operations. However, a large number of suggestions and recommendations from reviewers of earlier drafts have also been incorporated. The result is a “balanced” document, outlining in sufficient detail, and with sufficient clarity, all basic elements that should be considered

10、but not necessarily adopted in the quality system of a laboratory. There is no question that as this standard is applied, modifications and additions wiil become apparent. Knowing this, the task force solicits specific comments that will aid in this standards improvement. Task force members serving

11、as writers and editors of this standard were: Chairman Thomas A. Ratliff, Jr., R the fulfillment of this quality aspect is related to the planned and efficient utilization of the technological, human, and material resources available to the laboratory. 1 1.3.2 The Customers Needs and Expectations: F

12、or the customer there is a need for confidence in the ability of the laboratory to deliver the desired quality of its services as well as the consistent maintenance of that quality. Each of the previous aspects of a quality system (see 1.1) requires the generation and communication of objective evid

13、ence in the form of information and data concerning the quality of the system and the quality of the laboratorys reported results. 1A Risks, Costs, and Benefits: lA.l General: Risk, cost, and benefit considerations have great importance for both laboratory and customer. These considerations are inhe

14、rent aspects of most products and services. The possible effects and ramifications of these considerations are given in 1.4.2 to 1.4.4. 1A.2 Risk Considerations: 1A.2.1 For the Laboratory: Consideration has to be given to risks related to deficient analytical or testing services as these lead to los

15、s of image or reputation, loss of market, complaints, claims, liability, and waste of human and fuiancial resources. 1A.2.2 For the Customer: Consideration has to be given to risks such as those pertaining to the health and safety of people, dissatisfaction with services, incorrect decisions, availa

16、bility, marketing claims, and loss of confidence. 1A.3. Cost Considerations: 1A.3.1. For the Laboratory: Consideration has to be given to costs due to marketing and operating inefficiencies, lost or damaged samples, duplicate analyses or retesting, or re- calibration of instruments. 1A.3.2. For the

17、Customer: Consideration has to be given to cost of liability, cost of the analytical or testing service, and the potential costs resulting from poor decisions based on poor results received. 1AA Benefit Considerations: lAA.l For the Laboratory: Consideration has to be given to ASQC 82 71 O757506 O00

18、0208 5 W ANSUASQC Standard Q2-1991 increased profitability, reputation, and market share, either directly to the laboratory or indirectly to its parent organization. iAA.2 For the Customer: Consideration has to be given to reduced costs, increased satisfaction, and increased confidence in the labora

19、tory. 1A.5 Conclusion: An effective quality management system should be designed to satisfy customer needs and expectations while protecting the laboratorys interests. A weil-structured quality system is a valuable management resource in the optimization and control of data quality in relation to ri

20、sk, cost, and benefit considerations. 2.0 SCOPE AND FIELD OF APPLICATION This standard describes a basic set of elements by which laboratory quality management systems can be developed and implemented. It is intended as a guideline and model for a quality system operating within an overall testing o

21、r analytical laboratory system, excluding laboratories devoted only to research. As such, it attempts to encompass quality provisions at all stages and levels of a samples total life cycle, from collection or selection through its receipt, identification, analysis or testing and reporting of results

22、, and retention or disposal. It is not limited to the specific assignment of a quality control department. The selection of appropriate elements contained in this standard and the extent to which these elements are adopted and applied by a laboratory depend upon such factors as: market served, natur

23、e of services, methods, and consumer needs. This standard is particularly relevant to laboratories performing chemical analyses and environmental testing and calibration, where statistical control methods have been effectively integrated into the analytical or testing process. Although such elements

24、 may not be appropriate for all other fields of testing, the concept of statistical control is applicable to many of these fields. The very existence of this standard can incorrectly imply that one basic quality system will suffice in a given laboratory, indeed in any situation. Experience shows tha

25、t the order of presentation (format) of subjects described here may vary from one laboratory to another depending upon factors such as regulatory requirements; the needs, customer, and field of competence of the laboratory; practices in the various methodologies used in the laboratory; and the needs

26、 of the laboratorys customers. It may be impractical for all subjects identified intheseguidelines to be contained within a single document. It is therefore acceptable to produce separate documents. However, all these documents should be cross-referenced to a single document, generally called Qualit

27、y Manual, which specifies their location and updating and control procedures. These guidelines supplement and expand upon the items relating to a quality system identified in ANSUASQC 494-1987. NOTES: 1. This standard is not intended to be used as a checklist for compliance with a set of requirement

28、s. 2. The American Society for Quality Control is in the process of developing a separate standard on the subject of service. 3. The American Society for Quality Control is also in the process of developing a new standard for quality control systems in the research and development laboratory. 4. An

29、effective quality system should readily adapt to changes brought about by new methods, new technology, and changing personnel. As a guideline, the standard should be used to structure quality control programs, or to evaluate systems, but should not be permitted to stagnate a quality system so that i

30、t ceases to meet the laboratory requirements when new measuring, operating, or quality control tools are developed. As changes come about, the quality system should be updated and documented in an appropriate quality manual. 3.0 REFERENCES a) ASTM STD E105 Standard Recommended Practice for Probabili

31、ty Sampling of Materials b) ASTM STD El22 Standard Recommended Practice for Choice of Sample Size to Estimate the Average Quality of a Lot or Process c) ASTM STD E141 Standard Recommended Practice for Acceptance of Evidence Based on the Results of Probability Sampling d) ASTM STD E177 Standard Pract

32、ice for the Use of the Terms Precision and Bias in ASM Test Methods e) ASTM STD E178 Standard Practice forDealing with Outlying Observations f) ASTM STD E994 Standard Guide for Laboratory Accredi- tation Systems g) ANSI Zl.9-1980, (MIL-STD-414-1957) Sampling Procedures and Tables for Inspection by k

33、riables for Percent Non- conforming h) ANSI 21.4-1981, (MIL-STD-105D-lW) Sampling Proce- dures and Tables for Inspection by Attributes i) ANSUASQC Standards B1-1985 and B2-1985, (ANSI 2 ASCJC CJE 91 W 0759506 0000209 7 W ANSI/ASQC Standard Q2-1991 21.1-1958 R-1975 and 21.2-1958 R-1975) Guide for Qua

34、lity Control and Control Chart Method of Analyzing Data j) ANSVASQC Cl-1985, Corrected Edition (ANSI 21.8-1971) Specijcation of General Requirements for a Quality Program k) ANSUASQC 41-1986, Generic Guidelines for Auditing of Quality Systems 1) ANSIIASQC A3-1987, Quality Systems Terminology m) ANSI

35、IASQC M1-1987, American National Standard for Calibration System n) ANSIIASQC Q90-1987, Quality Management and Quality Assurance Standards - Guidelines for Selection and Use o) ANSVASQC Q94-1987, Quality Management and Quality System Elements - Guidelines p) ANSUASQC Q4-19XX (DRAFT), Quality Control

36、 of Measurements q) Glossary and Ebles for Statistical Quality Control (ASQC 1983) r) Statistical Quality Control, 4th Ed., Grant, E.L. and Leavenworth, R.S. (McGraw-Hi1972) s) IS0 Guide 2-1983, General Terms and Their Dejnitions, Concerning Standardization, Cei.t$cation, and Testing Laboratory Accr

37、editation t) IS0 8402-1986, Quality-6cabulary u) IS0 9000-1987, Quality Management and Quality Assurance Standards - Guidelines for Selection and Use v) ISO/IEC Guide 49, Guidelines for Development of a Quality Manual for a Testing Laboratory w) Quality Control Handbook, 3rdEd., Juran, J.M. (McGraw-

38、 Hill 1974) x) MIL-STD-1235, Single andMulti-Latel Continuous Sampling Procedures and Tables for Inspection by Attributes y) Ratliff, T.A, Kelley, W.D., and Bryant, J.M. NIOSH Technical Report No. 78 Industrial Hygiene Laboratory Quality Control Manual (Rev. 3, July 1979, Cincinnati, OH) 4.0 DEFINIT

39、IONS For the purposes of this standard, the definitions given in ANSUASQC A3-1987 and the following definitions apply: 4.1 Accuracy: a) ANSVASQC A3-198, “Degree of agreement of individual measurements with an accepted reference value.” b) ASTM E177, “The degree of agreement of (such) measure- ments

40、with an accepted reference level of the property of the material measured.” c) ASTM E456, “The degree of agreement of individual or average measurements with an accepted reference value or measurement .” 4.2 Corrective Action: “When failure occurs - the process of investigation, correction, and inst

41、itution of preventive measures to preclude the recurrence of failure.” 4.3 Customer: “Ultimate consumer, user, client, beneficiary, or second party.” 4A Organization: “A company, corporation, firm, or enter- prise whether incorporated or not, public or private.” 4.5 Precision: a) ANSUASQC M1-1987, “

42、The degree of agreement among independent measurements of a quality under specified conditions.” b) ASTM E456, “Standard Terminology for Statistical Methods” Precision - the degree of mutual agreement among individual measurements. Relative to a method of test, precision is the degree of mutual agre

43、ement among individual measurements made under prescribed like conditions. The imprecision of measurement may be characterized as the standard deviation of errors of measurement. c) ASTM E177, “Standard Recommended Practice for Use of Terms Precision and Accuracy as Applied to Measurement of a Prope

44、rty of a Material.” Precision of a measurement process refers to the degree of mutual agreement between individual measurements from the process. d) ASTM E691, “Standard Practice for Conducting an Inter- laboratoq Test Program to Determine the Precision of Test Methods.” Par. 3.4.2 Numerical measure

45、s of the variability between such test results provide inverse measures of the precision of the test method. Greater variability implies smaller (that is, poorer) precision and larger imprecision. 4.6 Quaity Program: “Those elements, primary support and monitoring functions, which serve to implement

46、 the quality plan.” 4.7 Requirements of Society: “Requirements including laws, statutes, rules and regulations, codes, environmental consi- derations, health and safety factors, and conservation of energy and materials.” 4.8 Shelf Life: “That interval of elapsedtime in which a product or sample cont

47、inues to perform to specific parameters and/or undergoes no structural, physical, chemical, biological, or functional degradation or change.” 3 ASQC 02 91 D 0759506 00002LO 3 D. ANSUASQC Standard 42-1991 4.9 Source: “Origin of a sample, product, or service.” 4.10 Specialized Test: “A test method pec

48、uliar to a unique product, assembly, compound, concentration, item, etc.” 4.ll Vendor Certification: “A process used to evaluate and confirm a vendors ability to meet specifications or contractual requirements.” NOTE: The wording of the standard has been selected to convey that it is advisory. The u

49、se of the word should is intended to stress the significance and importance of the provision to the quality system, warranting very carehl consideration before omitting or significantly altering the provision. May is intended to highlight those provisions which are not essential, but, if incorporated into the quality system, would provide additional benefits to the user. However, in any specific application a document based on this standard should clearly indicate those provisions of the quality system that are obligatory, and should selectively use the word shall in s