API SPEC Q1-2013 Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry (NINTH EDITION ERTA February 20_1.pdf

1、Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas IndustryAPI SPECIFICATION Q1NINTH EDITION, JUNE 2013EFFECTIVE DATE: JUNE 1, 2014ERRATA, FEBRUARY 2014ERRATA 2, MARCH 2014Special NotesAPI publications necessarily address proble

2、ms of a general nature. With respect to particular circumstances, local,state, and federal laws and regulations should be reviewed.Neither API nor any of APIs employees, subcontractors, consultants, committees, or other assignees make any war-ranty or representation, either express or implied, with

3、respect to the accuracy, completeness, or usefulness of theinformation contained herein, or assume any liability or responsibility for any use, or the results of such use, of anyinformation or process disclosed in this publication. Neither API nor any of APIs employees, subcontractors, consul-tants,

4、 or other assignees represent that use of this publication would not infringe upon privately owned rights.Classified areas may vary depending on the location, conditions, equipment, and substances involved in any givensituation. Users of this specification should consult with the appropriate authori

5、ties having jurisdiction.Users of this specification should not rely exclusively on the information contained in this specification. Sound busi-ness, scientific, engineering, and safety judgment should be used in employing the information contained herein. APIis not undertaking to meet the duties of

6、 employers, service providers, or suppliers to warn and properly train andequip their employees, and others exposed, concerning health and safety risks and precautions, nor undertaking theirobligations to comply with authorities having jurisdiction.Information concerning safety and health risks and

7、proper precautions with respect to particular materials and condi-tions should be obtained from the employer, the service provider or supplier of that material, or the material safetydatasheet.API publications may be used by anyone desiring to do so. Every effort has been made by the Institute to as

8、sure theaccuracy and reliability of the data contained in them; however, the Institute makes no representation, warranty, orguarantee in connection with this publication and hereby expressly disclaims any liability or responsibility for loss ordamage resulting from its use or for the violation of an

9、y authorities having jurisdiction with which this publication mayconflict.API publications are published to facilitate the broad availability of proven, sound engineering and operating prac-tices. These publications are not intended to obviate the need for applying sound engineering judgment regardi

10、ngwhen and where these publications should be utilized. The formulation and publication of API publications is notintended in any way to inhibit anyone from using any other practices. Any manufacturer marking equipment or materials in conformance with the marking requirements of an API standardis so

11、lely responsible for complying with all the applicable requirements of that standard. API does not represent, war-rant, or guarantee that such products do in fact conform to the applicable API standard.All rights reserved. No part of this work may be reproduced, translated, stored in a retrieval sys

12、tem, or transmitted by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Contact the Publisher, API Publishing Services, 1220 L Street, NW, Washington, DC 20005.Copyright 2013 American Petroleum InstituteForewordNothing con

13、tained in any API publication is to be construed as granting any right, by implication or otherwise, for themanufacture, sale, or use of any method, apparatus, or product covered by letters patent. Neither should anythingcontained in the publication be construed as insuring anyone against liability

14、for infringement of letters patent.Shall: As used in a standard, “shall” denotes a minimum requirement in order to conform to the specification.Should:As used in a standard, “should” denotes a recommendation or that which is advised but not required in orderto conform to the specification.This stand

15、ard shall become effective on the date printed on the cover but may be used voluntarily from the date ofdistribution.This document was produced under API standardization procedures that ensure appropriate notification andparticipation in the developmental process and is designated as an API standard

16、. Questions concerning theinterpretation of the content of this publication or comments and questions concerning the procedures under whichthis publication was developed should be directed in writing to the Director of Standards, American PetroleumInstitute, 1220 L Street, NW, Washington, DC 20005.

17、Requests for permission to reproduce or translate all or any partof the material published herein should also be addressed to the director.Generally, API standards are reviewed and revised, reaffirmed, or withdrawn at least every five years. A one-timeextension of up to two years may be added to thi

18、s review cycle. Status of the publication can be ascertained from theAPI Standards Department, telephone (202) 682-8000. A catalog of API publications and materials is publishedannually by API, 1220 L Street, NW, Washington, DC 20005.Suggested revisions are invited and should be submitted to the Sta

19、ndards Department, API, 1220 L Street, NW,Washington, DC 20005, standardsapi.org.iiiContentsPage1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Normative References. . . . .

20、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Terms, Definitions, and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.1 Terms and Defin

21、itions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2 Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22、. . . . . . . 44 Quality Management System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44.1 Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23、 . . . . . . 44.2 Management Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54.3 Organization Capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24、. . . . . . . . . . . . . . . . . 64.4 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74.5 Control of Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25、. . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Product Realization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85.1 Contract Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

26、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85.2 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95.3 Risk Assessment and Management . .

27、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95.4 Design and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105.5 Contingency Planning . .

28、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125.6 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

29、25.7 Production and Servicing Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145.8 Control of Testing, Measuring, and Monitoring Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185.9 Product

30、Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195.10 Control of Nonconforming Product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31、 . . 205.11 Management of Change (MOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216 Quality Management System Monitoring, Measurement, Analysis, and Improvement . . . . . . . . . . . . . . 216.1 General . . . . . . . . .

32、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216.2 Monitoring, Measuring, and Improving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226.3 An

33、alysis of Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236.4 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

34、. . . . . . . . . . . . . . 236.5 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Annex A (informative) Use of API Monogram by Licensees . . . . . . . . . . . . . . . . . . . . . . . . . . .

35、 . . . . . . . . . . . . . . 26Annex B (informative) Cross-reference from API Q1, 9th Edition to API Q1, 8th Edition . . . . . . . . . . . . . . . . . . 29Annex C (informative) Cross-reference from API Q1, 8th Edition to API Q1, 9th Edition . . . . . . . . . . . . . . . . . . 40Bibliography . . . .

36、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47vIntroductionThis specification has been developed to address quality management systems for organizations that manufactureproducts or provide man

37、ufacturing-related services under a product specification for use in the petroleum and naturalgas industry. It defines the fundamental quality management system requirements for those claiming conformity to therequirements of this specification.The requirements of this specification are consistent w

38、ith those of other quality management system documents (e.g.API Q2). The requirements are structured in a way to minimize the likelihood of nonconformity. While this specificationmay include some elements of other management systems (such as those particular to environmental management,occupational

39、health and safety management, financial management, or risk management), it does not include allrequirements specific to those systems. This specification may be used either in conjunction with or independent ofother industry-specified documents.This specification can be used by internal and externa

40、l parties, including certification bodies, to assess theorganizations ability to meet customer, statutory, and regulatory requirements applicable to the product and theorganizations own requirements.This specification promotes the integration of a process approach into the application of specific se

41、ctions whendeveloping, implementing, and improving the effectiveness of a quality management system. This provides forcontinuous control over the stated requirements, as well as facilitating the overlap of processes. For an organization to function effectively, it has to determine and manage numerou

42、s linked activities. An activity thattransforms inputs into outputs can be considered a process. Process activities include determination of needsthroughout the organization, provision of resources and product realization, identification of the proper sequence ororder in a series of activities, moni

43、toring and measuring the effectiveness of the activities performed, and applyingchanges or corrections to those activities as needed. Goal of the DocumentThe goal of this specification is to provide the minimum requirements for the development of a quality managementsystem that provides for continua

44、l improvement, emphasizes defect prevention, and strives to minimize variation andwaste from manufacturing organizations. It is designed to promote reliability in the manufacturing sector of thepetroleum and natural gas industry. It is not the intent of this specification to imply uniformity in the

45、structure of qualitymanagement systems or uniformity of documentation.Applicability of API Specification Q1 and API Specification Q2 This specification establishes the API quality system requirements necessary for organizations to consistently andreliably manufacture products in accordance with API

46、or other specifications for use in the petroleum and natural gasindustry. This specification is also applicable to, and sets requirements for, all organizations desiring to acquire andmaintain a license to use the API Monogram and applies at all times within the organization when a location has been

47、licensed by the API Monogram Program. API Q1 applies to those activities that otherwise may be considered aservice (such as heat treatment, threading, or testing) if these activities or the results of these activities are identifiedas an API monogrammable product under any applicable API product spe

48、cification in the API Monogram Program.API Q2 (Specification for Quality Management System Requirements for Service Supply Organizations for thePetroleum and Natural Gas Industries) establishes the API quality system requirements necessary for service supplyorganizations to consistently and reliably

49、 provide services that meet customer, legal, and other applicablerequirements. This specification applies to service-related activities in oil and gas well construction, intervention,production, and abandonment, as well as equipment repair/maintenance. This specification does not apply to the APIMonogram Program or any product that is identified by license as eligible for marking with the API Monogram.vii1 Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry 1 Scope This specification establishes the minimum