1、ANSUASQ 21.13-1999 AMERICAN NATIONAL STANDARD Qualty Guidelines for Research Approved as an American National Standard by: ANSI Accredited Standards Committee 21 on Quality Assurance American Society for Quality, Secretariat ANSI/ASQ Z1.13-1999 AMERICAN NATIONAL STANDARD Quality Guidelines for Resea
2、rch Approved as an American National Standard by: ANSI Accredited 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
3、substantially concerned 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 anyone, whether he or she has approved the standa
4、rd or not, from manufacturing, 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 edition. Caution Notice: This American National Standard may be revised or wi
5、thdrawn 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 than five years from the date of publication. Purchasers of American National Standards may receive current information on all standar
6、ds by calling or writing the American National Standards Institute. 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
7、, Wisconsin 53202. O 1999 by ASQ Copyright Protection Notice for the ANSI/ASQ Z 1.13- 1999 Standard. This standard is 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 per
8、mission of ASQ. All requests pertaining to the ANSI/ASQ Z1.13-1999 standard should be submitted to ASQ. ASQ Mission: The American Society for Quality advances individual and organiza- tional performance excellence worldwide by providing opportunities for learning, quality improvement, and knowledge
9、exchange. 109 8 76 543 2 1 Printed in the United States of America Published by: American Societv for Quaiitv Quality 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 ANSIIASQ 21.13-
10、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 . 1 3.1 External customer . 1 3.2 Internal customer 1 3.3 Principal investigator . 1 3.4 Peerreview 1 3.5 Research plan . 1 3.6 Stakeholder 1
11、4 The management of basic and applied research projects 3 4.1 Responsibility for the research 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 performan
12、ce of the research 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 Support 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
13、5.4.1 Research Reviews 5 5.4.2 Support 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 5 5.5.2 Quality Improvement Goals . 5 5.5.3 Training . 5 . 111 STD-ASQ 21.L3-ENGL 1777 - 075750b 0002700 300 Forewor
14、d 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 and applied research. Historically, quality management system guidance for researchers has been limited or nonexistent. This docu
15、ment 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 for research have been written more with an intent of adapting hardware and compliance-ori- ented quality assurance regulations
16、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 concise and uses familiar scientific and technical terminology in order to translate quality management concepts into a document th
17、at is usable by the scientist and technical manager. V 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 applied research laboratories. It is written primarily for scientists and t
18、echnical 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 that this document will normally be adopted in its present form, but on
19、occasion it may need to be tailored for specific types of research activities or because of contractual requirements. vii 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 where the
20、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 theory for- m
21、ulation. 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 per- formi
22、ng 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 who consti
23、tute 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 systems on the m
24、ain 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 laboratory
25、s 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 which the work
26、 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 technical p
27、eers. 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- ment and Qua
28、lity 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 or person
29、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 used for the
30、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 interest or sha
31、re 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 - - - -.- - - - _- - . . - - . _ -. - - STD-ASP ZL.13-ENGL 1999 m 075950b 0002703 OLT D ANSIIASQ 21.13-1999 community, the editors of
32、a peer-reviewed journal, future generations who benefit 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 PR
33、OJECTS The research organization should require scientists 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 lar
34、ge and complex experiments, a research plan may be 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, an
35、d by the funding agency or primary external customer 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
36、 terms of developing the elements of a research pian 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 re
37、search plan as to how the element is satisfied by 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 proje
38、cts meet the requirements defined in research plans 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 r
39、esponsible for the research and (2) the funding agency 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 writte
40、n 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 calculate
41、d predictions that may or may not be corroborated by the actual data accumulated by experiments. The principal investigator should describe the purpose of the experimental work and identify the criteria that can be used for assessing the degree of success of the work, given input from stakeholders a
42、nd customers. The principal investigator should provide a brief his- torical overview of the research, including publica- tions that describe previous experiments or theories that have led to the research described in the research plan. The principal investigator should describe any unusual or poten
43、tially problematic techniques and experimen- tal methodology that will be employed in the perfor- mance of the research and how these will be handled. The principal investigator should describe any relation- ships, interrelationships, or dependencies that the experimental work has to other known pro
44、jects or areas of research. When it is known that similar work will be performed elsewhere, this should be stated with a brief explanation of how the work is coordinated or the rea- son it is necessary that it be competitive. 4.2.2 Schedule and Deliverables The principal investigator should identify
45、 the proposed duration (term) of the research as well as identify the resource planning for (1) support and technical (or research) staff, graduate students, and postdoctoral researchers, (2) operating expenses, (3) equipment including computer programs, and (4) special training requirements. The pr
46、incipal investigator should describe any sched- uled milestones and deliverables for the research, including construction and fabrication of items and development of software if appropriate. scheduled evaluations. and the presentation of nonproprietary 2 ANSUASQ 21.13-1999 research results at scient
47、ific meetings or publication of the results in preferred professional journals. 4.2.3 Facilities and Requirements The principal investigator should describe any facility and schedule requirements needed to carry out the research. Consideration should be given to the follow- ing elements -If the perf
48、ormance of the research will require the use of permanent laboratory facilities, briefly describe the required use, location, gross square footage, and impact on the laboratorys utility services for each year the research will be performed. -Identify whether major modification will be needed to exis
49、ting laboratory facilities in order to perform the research. -If the performance of the research will require the acquisition of leased space, briefly describe the required use, estimated square footage, and the impact on that space for each year the research will be per- formed. -If the research requires that experiments be per- formed in the field (outdoors), briefly describe the required use, location, and environmental impact of the research. -If the research requires that samples be taken, include or reference a description of the means for col- lecting, safeguarding
