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1、ANSUASQ 21.13-1999 AMERICAN NATIONAL STANDARD Qualty Guidelines for Research Approved as an American National Standard by: ANSI Accredited Standards Committee 2 1 on Quality Assurance American Society for Quality, Secretariat Copyright American Society for Quality Provided by IHS under license with
2、ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 12:03:07 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSI/ASQ Z1.13-1999 AMERICAN NATIONAL STANDARD Quality Guidelines for Research Approved as an American National Standard by: ANSI Acc
3、redited Standards Committee Z1 on Quality Assurance American Society for Quality, Secretariat An American National Standard Approved on February 20, 1998 American National Standards: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An
4、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 or she has approved the standard or not, from manufacturing, purchasing, or using produc
5、ts, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the American Nation
6、al Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five 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 I
7、nstitute. Comments concerning this standard are welcome and will be considered in future standards development and revision. They should be sent to the Standards Administrator, American Society for Quality, 61 1 E. Wisconsin Avenue, Milwaukee, Wisconsin 53202. Copyright American Society for Quality
8、Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 12:03:07 MDTNo reproduction or networking permitted without license from IHS -,-,- O 1999 by ASQ Copyright Protection Notice for the ANSI/ASQ Z 1.13- 1999 Standard. This standard is
9、 subject to copyright claims of 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 pertaining to the ANSI/ASQ Z1.13-1999 standard should be submitted to ASQ. ASQ Mission:
10、The American Society for Quality advances individual and organiza- tional performance excellence worldwide by providing opportunities for learning, quality improvement, and knowledge exchange. 109 8 7 6 5 4 3 2 1 Printed in the United States of America Published by: American Societv for Quaiitv Qual
11、ity Press 611 East Wisconsin Avenue Milwaukee, Wisconsin 53201 -3005 Web site http:/www.asq.org Standards Group on QEDS web site 800-248-1946 http:/standardsgroup.asq.org Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Berni
12、e Not for Resale, 04/18/2007 12:03:07 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSIIASQ 21.13-1999 Contents Page Foreword v Introduction vii 1 Scope and field of application . i 1.2 Field of application . 1 1.1 Scope . 1 2 References . 1 3 Definitions . . . . . . . .
13、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3.1 External customer . 1 3.2 Internal customer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3.3 Principal investigator . 1 3.4 Peerreview 1 3.5 R
14、esearch plan . 1 3.6 Stakeholder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 4 The management of basic and applied research projects 3 4.1 Responsibility for the research . . . . . . . . . . . . . . . . . . . . . .
15、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4.2 Planning the research . 2 4.2.1 Technical Approach . - 4.2.2 Schedule and Deliverables - 4.2.3 Facilities and Requirements . 3 4.3 Performing and documenting the research 3 4.4 Assessing the performance of the research . . . . . . . . .
16、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4.5 Transferring the results of the research 4 3 3 5 Institutional quality management program 4 5.1 Planning 4 5.2 Leadership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5.3 Suppor
17、t for the performance of research . 4 5.3.1 Human Resources 4 5.3.2 Material Resources . 4 5.3.3 Research Environment . 5 5.4 Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.4.1 Research Reviews 5 5.4.2 Su
18、pport Activities 5 5.4.3 Management Activities 5 5.4.4 Personnel Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.4.5 Data Utilization . 5 5.5 Quality improvement . 5 5.5.1 Principles . . . . . . . . . . . . . . . . . . . . . . . . .
19、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5.5.2 Quality Improvement Goals . 5 5.5.3 Training . 5 . 111 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 12:03:07
20、 MDTNo reproduction or networking permitted without license from IHS -,-,- STD-ASQ 21.L3-ENGL 1777 - 075750b 0002700 300 Foreword The purpose of this document is to provide guidance for the development and implementation of a quality man- agement system to scientists and managers involved in basic a
21、nd applied research. Historically, quality management system guidance for researchers has been limited or nonexistent. This document will provide the scientists and technical managers with information that has been difficult to locate. Documents that have been written in the past on quality systems
22、for research have been written more with an intent of adapting hardware and compliance-ori- ented quality assurance regulations to basic and applied research. The guidance in those documents has been too cumbersome or not applicable to the work of the researcher. The guidance in this document is con
23、cise and uses familiar scientific and technical terminology in order to translate quality management concepts into a document that is usable by the scientist and technical manager. V Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User
24、=Wing, Bernie Not for Resale, 04/18/2007 12:03:07 MDTNo reproduction or networking permitted without license from IHS -,-,- STD=ASQ ZL-13-ENGL 1977 075750b 0002701 247 = Introduction This document is intended to provide guidelines for the development of quality management systems at basic and applie
25、d research laboratories. It is written primarily for scientists and technical managers and purposely uses sci- entific and technical terminology in an attempt to translate the concepts of quality management into language that is more familiar to scientists and technical personnel. It is intended tha
26、t this document will normally be adopted in its present form, but on occasion it may need to be tailored for specific types of research activities or because of contractual requirements. vii Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/11111110
27、01, User=Wing, Bernie Not for Resale, 04/18/2007 12:03:07 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSVASQ Z1.13- 1999 1 SCOPE AND FIELD OF APPLICATION 1.1 Scope This document can be used in the development of a quality system for basic and applied research. That is
28、where the output is knowledge, information, data, or proof-of-concept, but not product or service design or development. This includes fields like the biologi- cal, physical, and applied sciences, which use meth- ods such as field investigation, laboratory experimentation, computer modeling, and the
29、ory for- mulation. 3.2 Internal customer An organization or person inside the research institu- tion organizational structure that is provided a prod- uct or service from some other organization or person in the laboratory. 3.3 Principal investigator An individual who has primary responsibility for
30、per- forming or overseeing the research. In some instances, the principal investigator is also referred to as the project manager for the research project. 3.4 Peer review One of the Primary mhanisms for assuring quality in science. Within a scientific community, peers are define,d as those persons
31、who constitute the competent professional group whose role it is to define what quality research results are within that particular dis- While this document presents an overall quality sys- tem for all aspects of research institution activities, it attempts to focus the application of quality system
32、s on the main output of research institutions-the research results. 1.2 Fieid of application This document can be used as a quality system model in situations where -The development of a quality system for a basic and applied research environment is desired. -A baseline is required for evaluating a
33、laboratorys organizational capabilities for managing and perform- ing basic and applied research. 2 REFERENCES cipline. Technical peers are individuals who typically meet all of the following criteria -They have an equal or greater level of academic education in the same technical discipline in whic
34、h the work is performed or in a closely related field, or have equivalent work experience and technical activity in a related discipline. -They have demonstrated evidence of proposing and solving engineering, experimental, or theoretical prob- lems that are recognized as valid by that community of t
35、echnical peers. ANSI/ISO/ASQC A8402- 1994, “Quality Systems Terminology.” -They have contributed to the body of knowledge within a technical discipline such as publishing - research results in the proceedings of Scientific meet- ings or in journals. ANSI/ISO/ASQC 49004- 1 - 1994, “Quality Manage- me
36、nt and Quality System Elements-Guidelines. DOE Standard DOE-ER-STD-600 1-92, “Implemen- 3.5 Research plan tation Guide for Quality Assurance Programs for Basic and Applied Research, U.S. Department of Energy, Washington, D.C., June 1992. 3 DEFINITIONS 3.1 External customer proposal. An organization
37、or person outside the research insti- tution organizational structure who funds the research activities and for whom the outcome and associated peripherals of that research are provided. As defined below. stakeholders are not external CUS- tomers. A document that describes the management systems use
38、d for the planning, performing, documenting, assessing, and transferring of research results in basic and applied research institutions. While this docu- ment uses the words research plan, it may also be referred to as a research proposal or an experimental 3S An organization or person with an inter
39、est or share in the research performed at the laboratory and with something to lose or gain depending on the quality of the research. Stakeholders might include a scientific 1 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing,
40、Bernie Not for Resale, 04/18/2007 12:03:07 MDTNo reproduction or networking permitted without license from IHS -,-,- - - - -.- - - - _- - . . - - . _ -. - - STD-ASP ZL.13-ENGL 1999 m 075950b 0002703 OLT D ANSIIASQ 21.13-1999 community, the editors of a peer-reviewed journal, future generations who b
41、enefit from the knowledge produced, or the technological process and products that emerge from the research. Stakeholders are not customers of the research in the same way as those who provide funding. 4 THE MANAGEMENT OF BASIC AND APPLIED RESEARCH PROJECTS The research organization should require s
42、cientists to develop a research plan or research proposal that describes the conduct of the research. Research plans may define an entire program of research in which multiple scientists perform studies in a particular sci- entific field. For very large and complex experiments, a research plan may b
43、e generated for each experiment. Any changes to the established management systems (or any other requirements) should be specified in the research plan. This guidelines document should be used by the research organization to develop research plans, and by the funding agency or primary external custo
44、mer to review those plans. The sections below describe what should be included or referenced in a typical research plan. When research is performed in an organization that has implemented an institution-wide QA program, redundancy and duplica- tion in terms of developing the elements of a research p
45、ian should be avoided. The objective should be to ensure that the elements described in this guideline are covered either (1) by including a description of these elements in a research plan as described below, or (2) by including a reference in the research plan as to how the element is satisfied by
46、 a higher-level institutional QA program. The research organization should be committed to rnan- aging its technical work in accordance with accepted principles of project management and should ensure that all in-house and subcontracted research projects meet the requirements defined in research pla
47、ns with respect to the quality of scientific results, cost and schedule, and environmental, safety, and health concerns. 4.1 Responsibility for the research The research plan should identify (I) a principal inves- tigator (or project manager) who is responsible for the research and (2) the funding a
48、gency or the primary external customer of that research. The principal investigator may delegate work to others who are qualified to do the research. 4.2 Planning the research 4.2.1 Technical Approach The principal investigator should provide a written description of the research project. To an extent com- mensurate with the type of research (exploratory research, fundamental studies, institutional projects, etc.), the principal investigator should describe the research to be performed and the possible research results, hypotheses, and calculated predictions that m