EN 9136-2018 en Aerospace series - Root cause analysis and problem solving (9S Methodology).pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Aerospace series - Root cause analysis and problem solving (9S Methodology)BS EN 9136:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9136 May 2018 ICS 03.120.10; 49.020 English Version Aerospace series - Root

2、cause analysis and problem solving (9S Methodology) Srie arospatiale - Analyse de cause racine et rsolution de problme (9S mthodologie) Luft- und Raumfahrt - Ursachenanalyse und Problemlsung (9S Methodik) This European Standard was approved by CEN on 20 November 2017. CEN members are bound to comply

3、 with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC M

4、anagement Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same

5、 status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg,

6、Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 B

7、russels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9136:2018 ENational forewordThis British Standard is the UK implementation of EN 9136:2018. The UK participation in its preparation was entrusted to Technical Committee A

8、CE/1, International and European Aerospace Policy and Processes.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application

9、. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 84429 4ICS 03.120.10; 49.020Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Co

10、mmittee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 9136:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9136 May 2018 ICS 03.120.10; 49.020 English Version Aerospace series - Root cause analysis and problem solving (9S Methodology) S

11、rie arospatiale - Analyse de cause racine et rsolution de problme (9S mthodologie) Luft- und Raumfahrt - Ursachenanalyse und Problemlsung (9S Methodik) This European Standard was approved by CEN on 20 November 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stip

12、ulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European

13、Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the

14、 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania

15、, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any fo

16、rm and by any means reserved worldwide for CEN national Members. Ref. No. EN 9136:2018 EBS EN 9136:2018EN 9136:2018 (E) 2 Contents Page European foreword . 3 Rationale . 4 Foreword 4 Introduction 5 1 Scope 6 1.1 General 6 1.2 Purpose . 6 2 Normative references 6 3 Terms and definitions . 6 4 General

17、 Process . 9 4.1 Basic Principles 9 4.1.1 Cultural Change 9 4.1.2 Effective Communication 10 4.2 When to Apply a Structured Root Cause Analysis and Problem Solving Process . 10 4.3 Process Step Description . 12 5 Process Steps . 14 5.1 Step 0 Start Immediate Containment Actions . 14 5.2 Step 1 Build

18、 the Team 16 5.3 Step 2 Define Problem . 18 5.4 Step 3 Complete and Optimize Containment Actions 20 5.5 Step 4 Identify Root Cause(s) 21 5.6 Step 5 Define and Select Permanent Corrective Actions 23 5.7 Step 6 Implement Permanent Corrective Action and Check Effectiveness 24 5.8 Step 7 Standardize and

19、 Transfer the Knowledge Across Business . 26 5.9 Step 8 Recognize and Close the Team 27 6 Information and documentation 29 6.1 Information data definition and documentation 29 6.2 Forms 30 6.3 Control of records 30 (informative) Acronym log . 31 (informative) Information data definition . 32 (inform

20、ative) Form examples 48 BS EN 9136:2018EN 9136:2018 (E) 3 European foreword This document (EN 9136:2018) has been prepared by the Aerospace and Defence Industries Association of Europe - Standardization (ASD-STAN). After enquiries and votes carried out in accordance with the rules of this Associatio

21、n, this Standard has received the approval of the National Associations and the Official Services of the member countries of ASD, prior to its presentation to CEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, a

22、t the latest by November 2018, and conflicting national standards shall be withdrawn at the latest by November 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying

23、any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Rep

24、ublic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9136:2018EN 9136:2018 (E) 4 Rationale The

25、objective of root cause analysis and problem solving is to not only reduce the number of issues (i.e. undesirable conditions, defects, failures), but to minimize their impact on quality, delivery performance, costs, and ultimately on the customer. Often big issues originate with small problems that

26、were discovered too late or were discovered, but were never resolved due to a lack of understanding the actual issue(s), incorrect analysis of the root cause, and/or ineffective actions being taken. This guidance document was created to provide a methodology for performing root cause analysis to res

27、olve a significant or recurrent issue e.g. quality, On-Time Delivery (OTD), process, documentation), as guidance within the aviation, space, and defence industry and/or when contractually invoked at any level of the supply chain. Foreword In December 1998, the aviation, space, and defence industry e

28、stablished the International Aerospace Quality Group (IAQG) with the purpose of achieving significant improvements in quality and reductions in cost throughout the value stream. This organization, with representation from aviation, space, and defence companies in the Americas, Asia-Pacific, and Euro

29、pe and sponsored by SAE International, Society of Japanese Aerospace Companies (SJAC), and AeroSpace and Defence Industries Association of Europe -Standardization (ASD-STAN), has agreed to take responsibility for the technical content of this document to promote best practices that would satisfy ass

30、ociated requirements of Aerospace Quality Management System (AQMS) standards (i.e. 9100, 9110, 9120). To assure customer satisfaction, aviation, space, and defence industry organizations must produce and continually improve safe, reliable products that meet or exceed customer and regulatory authorit

31、y requirements. This includes having processes in place to detect and eradicate significant and recurrent issues. This document standardizes methodology to perform root cause analysis and problem solving to support these efforts. The establishment of a common methodology, for use by organizations at

32、 all levels of the supply-chain should result in improved action plans and a standardized way of exchanging information between organizations and external stakeholders (e.g. suppliers, partners, customers, regulatory agencies). BS EN 9136:2018EN 9136:2018 (E) 5 Introduction This document has been de

33、veloped by the IAQG. In accordance with the continual improvement requirements defined in the 9100-series standards (see Clause 8, “Measurement, Analysis, and Improvement”), it was deemed useful to promote those industry recognized best practices for identifying the root causes of nonconformities or

34、 undesirable conditions (including potential issues and conditions) and implementing correction(s) and associated corrective/preventive actions. The process described in this document was created by comparing and mixing root cause analysis and problem solving methodologies e.g. 7 Steps, 8D, Root Cau

35、se Corrective Action (RCCA) used by main actors of aviation, space, and defence industry. Unless contractually specified, other root cause analysis processes with slightly different sequencing of activities and/or different names of process steps may be acceptable, provided that these activities mee

36、t the intent of this document and deliver the same outcomes (i.e. immediate protection, temporary fix, durable solution, systemic improvement) and provides the same level of information. Throughout this document, the words “should” and “required” indicate strong recommendations to apply and correspo

37、nd to actions that the authors of this document consider important in order to deliver robust root cause analysis. When strict application of this document is decided by an organization or is mandated by a customer, they shall be interpreted as an obligation to be complied with (i.e. interpreted as

38、“shall” and “must”). BS EN 9136:2018EN 9136:2018 (E) 6 1 Scope 1.1 General The objective of any organization, as part of continual improvement, is to reduce the number of issues (i.e. undesirable conditions, defects, failures) and to minimize their impact on quality, delivery performance, and cost.

39、This includes having processes in place to detect and eradicate significant and recurrent issues, which implies having well identified problems, a common understanding of their impact and associated root causes, and having defined and implemented adequate actions so that these problems, including si

40、milar issues will not happen again. 1.2 Purpose Propose a methodology to improve the way escapes and issues are managed, including communication between all parties e.g. engineering, Materials Review Board (MRB), manufacturing, manufacturing engineering, supplier, customer to reduce their impact, co

41、ntain them as far upstream as possible, and prevent recurrence (i.e. ensure the right measures are taken at the right location and at the right time). 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements o

42、f this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 9100, Quality Management Systems Requirements for Aviation, Space and Defence Organizations EN 9110, Quality Management

43、Systems Requirements for Aviation Maintenance Organizations EN 9120, Quality Management Systems Requirements for Aviation, Space and Defence Distributors EN ISO 9000:2015, Quality management systems Fundamentals and vocabulary (ISO 9000:2015) 3 Terms and definitions Definitions for general terms can

44、 be found in EN ISO 9000 and the IAQG Dictionary, which is located on the IAQG website. An acronym log for this document is presented in Annex A. For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at

45、the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1 apparent cause (also referred to as obvious cause, direct cause, or immediate cause) event or action that immediately results in or precedes the no

46、nconformity Note 1 to entry: This is generally NOT the root cause. BS EN 9136:2018EN 9136:2018 (E) 7 3.2 containment action to control and mitigate the impact of a problem and protect the organization and/or customer (i.e. stop the problem from getting worse), includes correction, immediate correcti

47、ve action, immediate communication, and verification that problem does not further degrade 3.3 contributing causes causes that by themselves would not cause the problem, but can increase the risk of the issue to occur. Analysis for these causes generally requires taking a closer look at the existing

48、 conditions and associated actions 3.4 correction (also referred to as Immediate Correction) action taken to eliminate a detected nonconformity SOURCE: EN ISO 9000:2005, 3.6.6, modified Note 1 to entry: A correction can be made in conjunction with a corrective action. Note 2 to entry: For product no

49、nconformity, correction might be understood as reworking the part, accepting the nonconformance through concession process, or scrapping the product. Note 3 to entry: For a system issue, it may include correcting the paper work or issuing a new purchase order. Note 4 to entry: For a delivery issue, it may include revising to air transportation instead of delivering product by truck or ship, increasing production rate, etc. 3.5 corrective action action taken to eliminate the cause of a detected nonconformity or other undesi