API TR 18TR1-2015 Guidance on Changes to API Q1 Ninth Edition (FIRST EDITION).pdf

1、Guidance on Changes to API Q1, Ninth EditionAPI TECHNICAL REPORT 18TR1FIRST EDITION, JUNE 2015Special NotesAPI publications necessarily address problems of a general nature. With respect to particular circumstances, local,state, and federal laws and regulations should be reviewed.Neither API nor any

2、 of APIs employees, subcontractors, consultants, committees, or other assignees make anywarranty or representation, either express or implied, with respect to the accuracy, completeness, or usefulness of theinformation contained herein, or assume any liability or responsibility for any use, or the r

3、esults of such use, of anyinformation or process disclosed in this publication. Neither API nor any of APIs employees, subcontractors,consultants, or other assignees represent that use of this publication would not infringe upon privately owned rights.API publications may be used by anyone desiring

4、to do so. Every effort has been made by the Institute to assure 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

5、 ordamage resulting from its use or for the violation of any authorities having jurisdiction with which this publication mayconflict.API publications are published to facilitate the broad availability of proven, sound engineering and operatingpractices. These publications are not intended to obviate

6、 the need for applying sound engineering judgmentregarding when and where these publications should be utilized. The formulation and publication of API publicationsis not intended in any way to inhibit anyone from using any other practices.Any manufacturer marking equipment or materials in conforman

7、ce with the marking requirements of an API standardis solely responsible for complying with all the applicable requirements of that standard. API does not represent,warrant, or guarantee that such products do in fact conform to the applicable API standard.Classified areas may vary depending on the l

8、ocation, conditions, equipment, and substances involved in any givensituation. Users of this Technical Report should consult with the appropriate authorities having jurisdiction.All rights reserved. No part of this work may be reproduced, translated, stored in a retrieval system, or transmitted by a

9、ny 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 2015 American Petroleum InstituteForewordNothing contained in any API public

10、ation 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 for infringement of lett

11、ers 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. Suggested revisions are invited

12、and should be submitted to the Standards Department, API, 1220 L Street, NW,Washington, DC 20005, standardsapi.org.iiiContentsPage1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13、. 12 Normative References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Terms, Definitions, Acronyms, and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14、. . 13.1 Terms and Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2 Acronyms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15、. . . . . . . . . . . . 14 Changes from Previous Edition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2vvi1 Guidance on Changes to API Q1, Ninth Edition 1 Scope This document is written for experienced quality professionals

16、seeking to implement the new requirements of API Q1, Ninth Edition (Q1, 9th) and to gain a deeper understanding of the requirements with an overall view to improving their quality management system (QMS) and conformance to Q1, 9th. While Q1, 9th was created independently of ISO 9001:2008, the specif

17、ication continues to satisfy those requirements and the supplemental requirements in API Q1, Eighth Edition (Q1, 8th). The formatting of Q1, 9th was revised to align with API Q2, First Edition and to follow a chronological order in the production and delivery of the product. 2 Normative References T

18、he following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. API Specification Q1, Specification for Quality Pr

19、ograms for the Petroleum, Petrochemical and Natural Gas Industry, Eighth Edition API Specification Q1, Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry, Ninth Edition API Specification Q2, Specification for Quality Ma

20、nagement System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industry 3 Terms, Definitions, Acronyms, and Abbreviations 3.1 Terms and Definitions For the purposes of this document, the terms and definitions given in API Q1 apply. 3.2 Acronyms and Abbreviations DAC

21、design acceptance criteria KPI key performance indicator MOC management of change Q1, 8th API Specification Q1, Eighth Edition Q1, 9th API Specification Q1, Ninth Edition QMS quality management system 2 API TECHNICAL REPORT 18TR1 4 Changes from Previous Edition 1 Scope Intent of Section The intent o

22、f this section is to outline the areas to which the specification applies. Changes from Previous Edition Q1, 8th included provisions for service supply organizations, which are now covered by API Q2. Added 5.8 to the list as an excludable section. 3 Terms, Definitions, and Abbreviations Intent of Se

23、ction The intent of this section is to specify terms and definitions in addition to those given in ISO 9000. Changes from Previous Edition Q1, 9th eliminated 2 terms, added 12 new terms, expanded on 2 terms, and renamed 1 term. Abbreviations were added to Q1, 9th that were not present in Q1, 8th. El

24、iminated the following Q1, 8th terms: 3.1.9 field nonconformity, 3.1.11 tender. Added the following terms to Q1, 9th: 3.1.4 collection, 3.1.5 compliance, 3.1.6 critical, 3.1.11 first article, 3.1.12 key performance indicator (KPI), 3.1.13 legal requirement, 3.1.14 management noun, 3.1.16 outsource o

25、utsourced activity, 3.1.17 preventive maintenance, 3.1.19 risk, 3.1.20 service, 3.1.21 servicing. GUIDANCE ON CHANGES TO API Q1, NINTH EDITION 3 Expanded the following terms: 3.1.9 design validation was modified to include a note that provides examples of design validation that were previously in Q1

26、, 8th, 7.3.6; 3.1.10 design verification was modified to include a note that provides examples of design verification that were previously in Q1, 8th, 7.3.5. Renamed the following term: in Q1, 8th, 3.1.4 control feature was renamed 3.1.18 procedure. 4 Quality Management System Requirements This sect

27、ion consolidated requirements from Sections 4, 5, and 6 of Q1, 8th. 4.1 Quality Management System 4.1.1 General Intent of Section The intent of this section is to establish requirements related to the QMS. Changes from Previous Edition Added the terms “at all times” and “for all products and servici

28、ng provided for use in the petroleum and natural gas industry.” 4.1.2 Quality Policy Intent of Section The intent of this section is to establish requirements related to the quality policy. Changes from Previous Edition Added the requirement for the quality policy to be communicated, understood, imp

29、lemented, and maintained at all relevant functions and levels within the organization. 4.1.3 Quality Objectives Intent of Section The intent of this section is to establish requirements related to the quality objectives. Changes from Previous Edition Changed the responsibility for establishing quali

30、ty objectives from top management to management with approval from top management. Expanded the requirement for quality objectives to include customer requirements. 4 API TECHNICAL REPORT 18TR1 4.1.4 Planning Intent of Section The intent of this section is to establish requirements related to planni

31、ng for the QMS. Changes from Previous Edition Changed responsibility for QMS planning from top management to management. 4.1.5 Communication 4.1.5.1 Internal Intent of Section The intent of this section is to establish requirements related to internal communication for the QMS. Changes from Previous

32、 Edition Changed the responsibility for internal communication from top management to management. Added requirement 4.1.5.1 b) results of analysis of data need to be communicated at relevant levels. 4.1.5.2 External Intent of Section The intent of this section is to establish requirements related to

33、 external communication for the QMS. Changes from Previous Edition Added requirement 4.1.5.2 d) information required by product quality plans is to be provided when required by contract 4.2 Management Responsibility Some of the responsibilities that were assigned to top management in Q1, 8th have be

34、en assigned to management in Q1, 9th. 4.2.1 General Intent of Section The intent of this section is to establish responsibilities for top management and management in an organization. Changes from Previous Edition Added the use of KPIs for data analysis. 4.2.2 Responsibility and Authority Intent of

35、Section The intent of this section is to establish the responsibility, authority, and accountability of personnel within the scope of the QMS. GUIDANCE ON CHANGES TO API Q1, NINTH EDITION 5 Changes from Previous Edition Expanded the requirement for ensuring that responsibility and authority are defi

36、ned and communicated to include accountability. The application of this requirement is now specified to be personnel within the QMS. Added the requirement for documentation. 4.2.3 Management Representative Intent of Section The intent of this section is to establish responsibilities and authorities

37、for the management representative. Changes from Previous Edition Added requirement 4.2.3 c) management representative is to ensure that actions are taken to reduce the likelihood of the occurrence of nonconformities. Added the requirement for top management to maintain a management representative. 4

38、.3 Organization Capability 4.3.1 Provision of Resources Intent of Section The intent of this section is to establish responsibility for appropriate resource allocation to implement, maintain, and improve the effectiveness of the QMS. Changes from Previous Edition Removed the word “continually” from

39、the requirement to improve the effectiveness of the QMS Q1, 8th, 6.1 a). Removed the requirement to provide the resources needed to enhance customer satisfaction by meeting customer requirements Q1, 8th, 6.1 b). 4.3.2 Human Resources 4.3.2.1 General Intent of Section The intent of this section is to

40、 establish the requirement for a procedure defining personnel competency and identifying training requirements and other actions necessary to achieve personnel competency. Changes from Previous Edition Separated personnel competence from training and awareness. Added the requirement for a documented

41、 procedure defining personnel competence. 6 API TECHNICAL REPORT 18TR1 4.3.2.2 Personnel Competence Intent of Section The intent of this section is to establish the requirements for personnel competence and the associated records. Changes from Previous Edition Added the requirement for personnel to

42、be competent to meet customer requirements. Added the requirement to maintain records of the determination of personnel competence. 4.3.2.3 Training and Awareness Intent of Section The intent of this section is to establish requirements for QMS and job training. Changes from Previous Edition Added r

43、equirement 4.3.2.3 b) customer-specified training and/or customer-provided training (when required). Added requirement 4.3.2.3 c) identification of training content to the requirement to identify training frequency. 4.3.3 Work Environment Intent of Section The intent of this section is to establish

44、the requirements for an organization to identify and manage the conditions of the work environment needed to achieve conformity of product. Changes from Previous Edition Merged the requirements for infrastructure and work environment into one section, “Work Environment.” Incorporated the note that w

45、as in Q1, 8th into this section to expand the work environment requirements to achieve conformity to the manufacture of the product. Expanded 4.3.3 b) to include maintenance of process equipment. 4.4 Documentation Requirements 4.4.1 General Intent of Section The intent of this section is to establis

46、h the minimum documentation requirements for an organizations QMS. Changes from Previous Edition Included the quality manual section under general instead of a separate section. Added requirement 4.4.1 b), Item 3) identification of processes that require validation. GUIDANCE ON CHANGES TO API Q1, NI

47、NTH EDITION 7 Expanded requirement 4.4.1 d) to include compliance with specified requirements. Added requirement 4.4.1 e) identification of legal and other applicable requirements. 4.4.2 Procedures Intent of Section The intent of this section is to establish the requirement that procedures be docume

48、nted and maintained. Changes from Previous Edition This is a new section. 4.4.3 Control of Documents Intent of Section The intent of this section is to establish the requirements for document control. Changes from Previous Edition Removed the requirement for a master list or equivalent. Removed the

49、requirement for document changes to be reviewed and approved by the original function. Added translations and updates. Specified “documents” to be controlled as procedures, forms, and work instructions. Included identification and distribution requirements to the documented procedure. 4.4.4 Use of External Documents in Production Realization Intent of Section The intent of the section is to establish the requirement for control of external documents used in product realizat