ASQ Z1 TR1-2012 Guidelines for performing a self-assessment of a quality management system.pdf

1、Technical RepoRTAugust 27, 2012AsQ Z1 tR1 2012Guidelines for performinG a self-assessment of a quality manaGement systemRelated to ANsI/IsO/AsQ 9004:2009AsQ Z1 tR1 2012Guidelines for performinG a self-assessment of a quality manaGement systemRelated to ANsI/IsO/AsQ 9004:2009 2012 by ASQCopyright Pro

2、tection Notice for the ASQ/ANSI/ISO 9004:2009 Standard. This document is subject to copyright claims of ISO, ANSI, and ASQ. Not for resale. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASQ. All requests p

3、ertaining to the ASQ/ANSI/ISO 9004:2009 Standard should be submitted to ASQ.Note: As used in this document, the term “International Standard” refers to the American National Standard adoption of this and other International Standards.ASQ will consider requests for change and information on the submi

4、ttal of such requests regarding this Standard. All requests should be in writing to the attention of the Standards Administrator at the address below.ASQ Mission: The American Society for Quality advances individual and organizational performance excellence worldwide by providing opportunities for l

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7、nting. Every care has been taken to ensure that the file is suitable for use by our customers. In the unlikely event that a problem relating to it is found, please inform ASQ at the address below.COPYRIGHT PROTECTED DOCUMENTivCONTENTSForeward and background 1Guidelines for performing a quality manag

8、ement system self-assessment 2General 2The self-assessment process .4Performance maturity levels .4Table A Performance maturity levels .4A model for conducting a self-assessment 4Conducting a self-assessment A step-by-step model 6Table B Questions an assessor can consider in planning and conducting

9、a self-assessment to the contents of ISO 9004:2009 .7Clause 4 Managing for the sustained success of an organization .74.1 General 74.2 Sustained success 84.3 The organizations environment 84.4 Interested parties, needs and expectations .8Clause 5 Strategy and policy .85.1 General .85.2 Strategy and

10、policy formation 95.3 Strategy and policy deployment 95.4 Strategy and policy communication .9Clause 6 Resource management .96.1 General 96.2 Financial resources . 106.3 People in the organization . 106.4 Suppliers and partners 106.5 Infrastructure . 106.6 Work environment 116.7 Knowledge, informati

11、on and technology . 116.8 Natural resources 11Clause 7 Process management . 117.1 General 117.2 Process planning and control .127.3 Process responsibility and authority 12Clause 8 Monitoring, measurement, analysis and review 128.1 General .128.2 Monitoring 128.3 Measurement .138.4 Analysis. . . . .

12、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148.5 Review of information from monitoring, measurement and analysis 14Clause 9 Improvement, innovation and learning .149.1 General 149.2 Improvement 149.3 Innovation 159.4 Lear

13、ning .15Documentation of self-assessment results .15Table C Example of the recording of self-assessment results .16v(This page intentionally left blank.)1ASQ Z1 TR1 2012Guidelines for performing a self-assessment of a quality management systemForeward and backgroundPublication of this Technical Repo

14、rt registered with the American National Standards Institute (ANSI) has been approved by an accredited standards developerthe American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, USA.This document is registered as a Technical Report according to the ANSI Procedures for th

15、e Registration of Technical Reports.This document is not an American National Standard and the material contained herein is not normative in nature. Comments on the content of this document should be sent to the American Society for Quality.In 2009, the International Organization for Standardization

16、 (ISO) released a new edition of ISO 9004 titled “Managing for the sustained success of an organization A quality management approach”. The thrust of the 2009 edition of ISO 9004 goes beyond stating minimum requirements for a quality management system (QMS) and even beyond being a guideline for perf

17、ormance improvements. It was designed and developed to provide guidance on establishing, deploying and improving processes that will ensure the sustainable success of an organization. ISO 9004:2009 articulates QMS elements that should be considered to ensure the long term sustainability of an organi

18、zation.Self-assessment is described in ISO 9000:2005Quality management systems Fundamentals and vocabulary, and is emphasized as important in ISO 9004:2009. The U.S. Technical Advisory Group to ISO Technical Committee 176 (U.S. TAG to ISO/TC 176) has identified a need to improve the self-assessment

19、approach and annex included in ISO 9004:2009 to ensure it is easy to useespecially by small and medium size enterprises (SMEs). For details on the content of ISO 9004:2009 related to self-assessment see sub-clause 8.3.4 and Annex ASelf-assessment tool in ISO 9004:2009.Members of the U.S. TAG to ISO/

20、TC 176 created this Technical Report to provide users with an alternative to the ISO 9004 self-assessment text and annex. This Technical Report is intended to make it easier for small and medium-sized organizations in the USA to conduct self-assessments. ASQ Z1 TR1 20122Guidelines for performing a q

21、uality management system self-assessment GeneralSelf-assessment is a carefully considered evaluation of the effectiveness and efficiency of the organization and the maturity of the QMS that results in a perception and judgment regarding conformity of processes to requirements, the maturity level of

22、the QMS processes that will contribute to sustained success, opportunities for improvement and innovation, priorities for improvement, identification of best practices and processes that have potential for implementation in other areas of the organization, and action plans that could be considered t

23、o improve product and process efficiency and effectiveness.Self-assessment is usually performed by, or at the direction of, the organizations own management. The intent of self-assessment is to provide fact-based guidance to the organization regarding where to invest time and resources for improveme

24、nt. It also can be useful to measure progress against objectives and to assess the continuing relevance of defined objectives.Many models currently exist for the self-assessment of organizations to QMS criteria. The most widely recognized models are national and regional quality award models, also r

25、eferred to as organizational excellence models. Examples include the Baldrige National Quality Program or the EFQM Excellence model.The self-assessment approach described in this report provides a simple and easy-to-use approach to determine the maturity of a QMS and to identify the main areas for m

26、anagement to consider for improvement. It is not a substitute for internal audit of the QMS and it is not intended to conflict with or compete with the use of existing quality award or excellence models. It is a tool that can enhance the identification of improvement opportunities and the setting of

27、 priorities for the allocation of the limited human and capital resources of an organization.Specific features of the self-assessment approach described in this Technical Report are that it can be applied to the entire quality management system or to any part of the QMS or to any process, be applied

28、 to the entire organization or part of the organization, be completed quickly with internal resources, provide guidance for enhancing the QMS beyond minimum requirements,3ASQ Z1 TR1 2012 be completed by a multi-discipline team, or by one person in the organization who is supported by top management,

29、 be used as a means to develop competent assessors, provide input to improve the self-assessment process, facilitate the prioritization of opportunities for improvement and identification of best practices that can be considered for deployment elsewhere in the organization, facilitate maturing of th

30、e QMS toward world-class performance.Self-assessment can be used by an organization at several levels of sophistication. At the basic level, an organization can assess individual process maturity or the maturity of the entire QMS or any combination of processes. For example, an organization could de

31、cide to assess the maturity of only one or a small set of selected QMS processes e. g. customer-related processes or management review or analysis of data, structure the scope of the assessment to include all QMS processes required to achieve conformity with ISO 9001:2008Quality managment systems Re

32、quirements conduct a broader assessment of all processes included in ISO 9004 which goes beyond the requirements of ISO 9001, assess all or a selected set of processes required to address Baldrige or EFQM criteria.The choice of the scope of a self-assessment is limited only by the organizations crea

33、tivity, competence, availability of resources and the objectives of management. The organization has the responsibility to decide what to assess, when to assess it, who should conduct an assessment, how to conduct the assessment, how to document the results of the assessment and what to do with the

34、output of the assessment.One final note merits consideration for individuals that undertake a self-assessment of the QMS of an organization. To maximize the impact and effectiveness of a self-assessment, it should include consideration of how well the organization is applying its principles and deve

35、loping action plans to improve where necessary. This means that an assessor should look for evidence that the organization has developed and deployed a set of principles that is well thought-out and consistent with the organizations mission, vision, and business model. There should be evidence that

36、a set of principles underlie all that is done in the organization. It will not be easy for an assessor to address such an abstract concept, but uncovering disconnects amongst the vision, mission, business model and principles of an organization could be one of the most valuable outputs from a self-a

37、ssessment and a critical contributor to ensuring the sustainability of an organization. ASQ Z1 TR1 20124The self-assessment processPerformance maturity levelsThis self-assessment approach uses five levels of maturity when evaluating the process(es) or system(s) selected for the scope of the assessme

38、nt. Table A indicates a generic example on a scale ranging from 1 (no formal system) to 5 (best-in-class performance) of how a process performance level can be assigned a maturity level. Table A Performance maturity levelsMaturity level Performance level Guidance1 No formal approach No systematic ap

39、proach evident, no results, poor results or unpredictable results.2 Reactive approach Problem or correction-based systematic approach; minimum data on improvement results available.3 Stable formal system approach Systematic process-based approach, early stage of systematic improvements; consistency

40、of implementation is evident; data available to indicate conformance to objectives and improvement trends.4 Continual improvement emphasizedImprovement process in use; good results and sustained improvement trends are evident.5 Best-in-class performance Strongly integrated improvement process; best-

41、in-class benchmarked results demonstrated.A model for conducting a self-assessmentPerforming a self-assessment can be accomplished in many ways. What follows is one model that will be easy to implement, especially for smaller organizations.A self-assessment of a process or an entire system involves

42、three primary activities; 1) planning the self-assessment; 2) conducting the self-assessment and 3) reporting the self-assessment.Considerations in the planning phase include the following activities: identifying objectives for the self-assessment based on organizational needs, notifying management

43、of the function(s) to be assessed, of the date and time of the assessment, and arranging for staff participation that might be required, establishing the scope of the assessment,5ASQ Z1 TR1 2012 obtaining pertinent reference materials for review such as performance data and prior assessment or audit

44、 reports, relevant procedures, and related corrective and preventive action reports, confirming the adequacy of the knowledge, skills, and competence of the assessor to assess the assigned process or system, establishing acceptance criteria for evaluating the performance of the process(es) being ass

45、essed, preparing questions to determine the maturity of the process(es) assessed and how to evaluate improvement, ensuring issues related to integrity, confidentiality, impartiality, and bias are addressed.Considerations for conducting a self-assessment include the following activities: holding an o

46、pening meeting or communicating with key individuals in areas to be assessed, observing processes, personnel, and documentation, observing process outputs, including final product, if applicable, asking questions, conducting effective interviews, gathering objective evidence, listening carefully to

47、what is said and not said, coping when no documented procedures are available, keeping excellent notes, analyzing objective evidence, synthesizing all that is seen and heard, drawing conclusions, summarizing observations and examinations of objective evidence of conformity or process performance, ho

48、lding a closing meeting,ASQ Z1 TR1 20126 respecting the assessees, managing time, handling uncertainty, ambiguity and conflict, being cognizant of personal hygiene.Considerations for reporting a self-assessment include the following activities: documenting the purpose, scope, and the criteria used t

49、o assess process maturity, identifying assessor(s), indicating the dates and places where evidence was gathered, documenting material, objective evidence obtained, noting the names and duties of individuals interviewed, providing overall conclusions in either a report or tabular format that state the basis for conclusions related to conformity to requirements, best practices observed and opportunities for improvement relative to self-assessment objectives, ensuring that all noncon