ASD-STAN PREN 9136-2016 Aerospace series - Root Cause Analysis and Problem Solving (9S Methodology).pdf

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1、ASD-STAN STANDARD NORME ASD-STAN ASD-STAN NORM ASD-STAN prEN 9136 Edition P 1 July 2016 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer 10 - 1000 Brussels - Tel. + 32 2 775 8126 - Fax. + 32 2 775 8131 - www.asd-stan.orgICS: Descriptors: ENGLISH

2、VERSION Aerospace series Root Cause Analysis and Problem Solving (9S Methodology) Luft- und Raumfahrt Ursachenanalyse und Problemlsung (9S Methodik) Srie arospatiale Analyse de cause racine et rsolution de problme (9S mthodologie) This “Aerospace Series“ Prestandard has been drawn up under the respo

3、nsibility of ASD-STAN (The AeroSpace and Defence Industries Association of Europe - Standardization). It is published for the needs of the European Aerospace Industry. It has been technically approved by the experts of the concerned Domain following member comments. Subsequent to the publication of

4、this Prestandard, the technical content shall not be changed to an extent that interchangeability is affected, physically or functionally, without re-identification of the standard. After examination and review by users and formal agreement of ASD-STAN, the ASD-STAN prEN will be submitted as a draft

5、 European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The CEN national members have then to implement the EN at national level by giving the EN the status of a national standard and by withdrawing any national sta

6、ndards conflicting with the EN. ASD-STAN Technical Committee approves that: “This document is published by ASD-STAN for the needs of the European Aerospace Industry. The use of this standard is entirely voluntary, and its applicability and suitability for any particular use, including any patent inf

7、ringement arising therefrom, is the sole responsibility of the user.” ASD-STAN reviews each standard and technical report at least every five years at which time it may be revised, reaffirmed, stabilized or cancelled. ASD-STAN invites you to send your written comments or any suggestions that may ari

8、se. All rights reserved. No parts of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of ASD-STAN. Order details: E-mail: salesasd-stan.org Web

9、 address: http:/www.asd-stan.org/ Edition approved for publication 1stJuly 2016 Comments should be sent within six months after the date of publication to ASD-STAN Quality Domain Copyright 2016 ASD-STAN prEN 9136:2016 (E) 2 White page prEN 9136:2016 (E) 3 Contents Page Rationale .5 Foreword .5 Intro

10、duction .6 1 Scope 7 1.1 General 7 1.2 Purpose .7 2 Normative references 7 3 Terms and definitions 7 4 General Process 9 4.1 Basic Principles 9 4.1.1 Cultural Change . 10 4.1.2 Effective Communication . 11 4.2 When to Apply a Structured Root Cause Analysis and Problem Solving Process 11 4.3 Process

11、Step Description . 13 5 Process Steps 14 5.1 Step 0 Start Immediate Containment Actions . 14 5.2 Step 1 Build 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 Ac

12、tions . 23 5.7 Step 6 Implement Permanent Corrective Action and Check Effectiveness . 24 5.8 Step 7 Standardize and 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

13、 30 6.3 Control of records . 31 7 NOTES 31 (informative) Acronym log . 32 Annex A(informative) Information data definition 33 Annex B(informative) Form examples 51 Annex CprEN 9136:2016 (E) 4 Figures Figure 1 Applying a structured root cause analysis and problem solving process depending on the impa

14、ct and frequency of a problem . 12 Figure 2 Root cause analysis general process mapping . 13 Figure 3 Team Composition Template (Example) . 17 Figure 4 Typical process step sequencing . 29 prEN 9136:2016 (E) 5 Rationale The objective of root cause analysis and problem solving is to not only reduce t

15、he 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 were discovered too late or were discovered, but were never resolved due t

16、o 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 resolve a significant or recurrent issue e. g., quality, On-time Delivery (OT

17、D), 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 established the International Aerospace Quality Group (IAQG) with the pur

18、pose 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 Europe and sponsored by SAE International, Society of Japanese Aerospace Com

19、panies (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 associated requirements of Aerospace Quality Management System (AQMS) stand

20、ards (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 authority requirements. This includes having processes in place to detect and

21、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 all levels of the supply-chain should result in improved action plans

22、 and a standardized way of exchanging information between organizations and external stakeholders (e. g., suppliers, partners, customers, regulatory agencies). prEN 9136:2016 (E) 6 Introduction This document has been developed by the IAQG. In accordance with the continual improvement requirements de

23、fined 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 undesirable conditions (including potential issues and conditions) and implement

24、ing 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 Cause Corrective Action (RCCA) used by main actors of aviation, space, and defence

25、 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 meet the intent of this document and deliver the same outcomes (i. e., immediate p

26、rotection, 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 correspond to actions that the authors of this document consider important in order t

27、o 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 “shall” and “must”). prEN 9136:2016 (E) 7 1 Scope 1.1 General The objective

28、 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. This includes having processes in place to detect and eradicate significant and recurr

29、ent 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 similar issues will not happen again. 1.2 Purpose Propose a methodology to improve the w

30、ay 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, contain them as far upstream as possible, and prevent recurrence (i. e., ensure the ri

31、ght measures are taken at the right location and at the right time). 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated reference

32、s, 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 Systems Aerospace Requirements for Aviation Maintenance Organizations EN 9120, Quality Manag

33、ement Systems Requirements for Aviation, Space, and Defence Distributors EN ISO 9000:2005, Quality management systems Fundamentals and vocabulary 3 Terms and definitions Definitions for general terms can be found in EN ISO 9000 and the IAQG Dictionary, which is located on the IAQG website. An acrony

34、m log for this document is presented in Appendix A. For the purposes of this document, the following terms and definitions apply. 3.1 Apparent cause (also referred to as obvious cause, direct cause, or immediate cause) the event or action that immediately results in or precedes the nonconformity Not

35、e to entry: This is generally NOT the root cause. prEN 9136:2016 (E) 8 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 corrective action, immediate communi

36、cation, 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 conditions and associated a

37、ctions 3.4 Correction (also referred to as Immediate Correction) action taken to eliminate a detected nonconformity (adapted from EN ISO 9000:2005) Note 1 to entry: A correction can be made in conjunction with a corrective action. Note 2 to entry: For product nonconformity, correction might be under

38、stood 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 transpo

39、rtation 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 undesirable situation to prevent recurrence (adapted for EN ISO 9000:2005) Note 1 to entry: A correction can be made

40、 in conjunction with a corrective action. Note 2 to entry: Corrective action may address all types of causes (i. e., apparent, contributing, root causes). 3.6 Immediate corrective action action taken to eliminate, prevent, or reduce the probability of any additional nonconformances related to the ap

41、parent cause from happening again in the short term Note to entry: These actions may be temporary and should remain in place until the root cause(s) is identified and permanent RCCA is implemented and verified to be effective. 3.7 Nonconformity non-fulfilment of a requirement (see EN ISO 9000) Note

42、to entry: It may be a nonconforming product, but may also be a late delivery, incorrect paperwork, incorrect process production or Quality Management System (QMS) related, etc. prEN 9136:2016 (E) 9 3.8 Preventive action action to eliminate the cause of a potential nonconformity or other undesirable

43、potential situation (see EN ISO 9000) Note to entry: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. 3.9 Root cause the original event(s), action(s), and/or condition(s) generating (directly or in cascade) an actual or potential undesirable

44、condition, situation, nonconformity, or failure Note to entry: There is sometimes more than one root cause associated to a single nonconformity or one root cause with multiple contributing causes. 3.10 Root cause analysis the process of identifying all the causes (root cause and contributing causes)

45、 that have or may have generated an undesirable condition, situation, nonconformity, or failure 3.11 Root Cause Corrective Action (RCCA) (also referred to as Permanent Corrective Action) action implemented to address the root cause(s) and contributing cause(s) of the undesirable condition, situation

46、, nonconformity, or failure; action taken to prevent recurrence 3.12 Root Cause Corrective Action (RCCA) Effectiveness Verification action taken to verify that the planned corrective action(s) have prevented recurrence of the identified root cause or contributing causes, and have consequently eradic

47、ated the problem Note to entry: This may include auditing, monitoring of specific metrics, or any other reporting methodologies. 3.13 Root Cause Corrective Action (RCCA) Implementation Verification action taken to verify that the planned actions were taken as scheduled Note to entry: This includes s

48、pecific actions, milestones, completion dates, and responsibilities. 4 General Process 4.1 Basic Principles a) In many instances, organizations and their suppliers do not provide adequate root cause analysis and problem solving results because: no clear criterion exists for an acceptable corrective

49、action plan; organizations are satisfied when they no longer receive defective parts; the organization continues to accept inadequate corrective action plans as priority is given to schedule versus quality; prEN 9136:2016 (E) 10 organizations (internal/external) do not have a root cause analysis mind set; people dont know or understand the process and/or have not been effectively trained. b) A robust root cause analysis and problem solving process should