SAE AS 13004-2017 Process Failure Mode and Effects Analysis (PFMEA) and Control Plans.pdf

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1、_ SAE Technical Standards Board Rules provide that: “This report is published by SAE to advance the state of technical and engineering sciences. The use of this report is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising there

2、from, is the sole responsibility of the user.” SAE reviews each technical report at least every five years at which time it may be revised, reaffirmed, stabilized, or cancelled. SAE invites your written comments and suggestions. Copyright 2017 SAE International All rights reserved. No part of this p

3、ublication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of SAE. TO PLACE A DOCUMENT ORDER: Tel: 877-606-7323 (inside USA and Canada) Tel: +1 724-776-497

4、0 (outside USA) Fax: 724-776-0790 Email: CustomerServicesae.org SAE WEB ADDRESS: http:/www.sae.org SAE values your input. To provide feedback on this Technical Report, please visit http:/standards.sae.org/AS13004 AEROSPACE STANDARD AS13004 Issued 2017-08 Process Failure Mode and Effects Analysis (PF

5、MEA) and Control Plans RATIONALE This standard was created to establish a common practice for effective process risk identification, assessment, mitigation, and prevention. It defines a methodology to mitigate risk using Process Flow Diagrams (PFDs), Process Failure Mode and Effects Analysis (PFMEA)

6、, and Control Plans. It is to be used by organizations throughout the life cycle of a product. FOREWORD To assure customer satisfaction, the aviation, space, and defense industry organizations have to produce and continually improve safe, reliable products that equal or exceed customer and regulator

7、y authority requirements. The globalization of the industry and the resulting diversity of regional/national requirements and expectations have complicated this objective. End-product organizations face the challenge of assuring the quality of and integration of product purchased from suppliers thro

8、ughout the world and at all levels within the supply chain. Industry suppliers face the challenge of delivering product to multiple customers having varying quality expectations and requirements. The Aerospace Engine Supplier Quality (AESQ) Committee was established as the G-22 Technical Committee u

9、nder the SAE Aerospace Council to develop, specify, maintain, and promote quality standards relating to the aerospace engine supply chain. The principles defined within this standard may be applicable to other segments of the aviation, space, and defense industries. The AESQ strategy is to create a

10、series of related quality standards for use within the aerospace engine supply chain with the intention of exceeding customer expectations through effective application of the full series of interrelated AESQ quality standards (see Appendix A). SAE INTERNATIONAL AS13004 Page 2 of 30 TABLE OF CONTENT

11、S 1. SCOPE 3 2. APPLICABLE DOCUMENTS 3 2.1 SAE Publications . 3 2.2 Other Publications . 3 3. TERMS AND DEFINITONS 4 4. REQUIREMENTS . 6 4.1 Process Risk Identification, Assessment, Mitigation, and Prevention Overview . 6 4.2 Applicability 7 4.3 Training and Competency . 7 4.4 Organizational Quality

12、 System Requirements . 7 4.5 General Requirements 7 4.6 Process Flow Diagram (PFD) . 8 4.7 Process Failure Mode and Effects Analysis (PFMEA) 9 4.8 Control Plan . 12 5. NOTES 14 5.1 Revision Indicator 14 APPENDIX A STANDARDS RELATIONSHIPS 15 APPENDIX B ASSESSMENT CHECKLIST. 16 APPENDIX C CASE STUDY -

13、 MACHINED DETAILS AND ASSEMBLY 17 APPENDIX D LINKAGES BETWEEN PFD, PFMEA, AND CONTROL PLAN 24 APPENDIX E PFMEA RANKING CRITERIA FOR SEVERITY - OCCURreNCE - DETECTION 25 APPENDIX F PROCESS FAILURE MODE AND EFFECTS ANALYSIS (PFMEA) TEMPLATE 27 APPENDIX G CONTROL PLAN TEMPLATE 28 APPENDIX H PROCESS FLO

14、W DIAGRAM (PFD) TEMPLATES 29 APPENDIX I ACRONYM LOG . 30 Figure 1 AS13004 requirements, scope, and relationships . 6 Table 1 Application guidance for AS13004 to products currently in production . 7 SAE INTERNATIONAL AS13004 Page 3 of 30 1. SCOPE This standard defines requirements for the identificat

15、ion, assessment, mitigation, and prevention of risk in the manufacturing process through the application of Process Flow Diagrams (PFDs), Process Failure Mode and Effects Analysis (PFMEA) and Control Plans throughout the life cycle of a product. This standard aligns and collaborates with the require

16、ments of AS9100, AS9102, AS9103, and AS9145. The requirements specified in this standard apply in conjunction with and are not alternative to contractual and applicable statutory and regulatory requirements. In case of conflict between the requirements of this standard and applicable statutory or re

17、gulatory requirements, the latter shall take precedence. 2. APPLICABLE DOCUMENTS The following referenced documents are important for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includi

18、ng any amendments) applies. In the event of conflict between the text of this document and references cited herein, the text of this document takes precedence. Nothing in this document, however, supersedes applicable laws and regulations unless a specific exemption has been obtained. 2.1 SAE Publica

19、tions Available from SAE International, 400 Commonwealth Drive, Warrendale, PA 15096-0001, Tel: 877-606-7323 (inside USA and Canada) or +1 724-776-4970 (outside USA), www.sae.org. AS13000 Problem Solving Requirements for Suppliers AS13002 Requirements for Developing and Qualifying Alternate Inspecti

20、on Frequency Plans AS13003 Measurement Systems Analysis Requirements for the Aero Engine Supply Chain AS9100* Quality Management Systems - Requirements for Aviation, Space, and Defense Organizations AS9101* Quality Management Systems - Audit Requirements for Aviation, Space, and Defense Organization

21、s AS9102* Aerospace First Article Inspection Requirement AS9103* Aerospace Series - Quality Management Systems - Variation Management of Key Characteristics AS9131* Aerospace Series - Quality Management Systems - Nonconformance Data Definition and Documentation AS9145* Aerospace Series - Requirement

22、s for Advanced Product Quality Planning and Production Part Approval Process NOTE: *Developed under the auspices of the IAQG and listed here as SAE International “AS” publications. Equivalent versions may be published by other standards bodies e.g., European Committee for Standardization (CEN), Japa

23、nese Standards Association/Society of Japanese Aerospace companies (JSA/SJAC). 2.2 Other Publications Copies of these documents are available online at http:/webstore.ansi.org/. ISO 9000 Quality Management Systems - Fundamentals and Vocabulary SAE INTERNATIONAL AS13004 Page 4 of 30 3. TERMS AND DEFI

24、NITONS In this Aerospace Standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. Information marked as “NOTE:” is for guidance in understanding or clarifying the

25、associated requirement. For the purpose of this standard, terms and definitions stated in ISO 9000 and the following definitions apply. An acronym log for this document is detailed within Appendix I. ALTERNATIVE PROCESSES: Alternative processes are different approved processes used to achieve the sa

26、me output (e.g., backup equipment, secondary source, alternative approved sequence). CHARACTERISTICS MATRIX: An analytical technique for displaying the relationship between process parameters and manufacturing stations. CONTAINMENT PLAN: Action to control and mitigate the impact of a nonconformity a

27、nd protect the customers operation (stop the problem from getting worse); includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degrade (refer to AS9101). CONTROL PLAN: A documented description linking manufactur

28、ing process steps to key inspection and control activities. The intent of a Control Plan is to control the design characteristics and the process variables to ensure product quality. CRITICAL ITEMS (CI): Those items (e.g., functions, parts, software, characteristics, processes) having significant ef

29、fect on the provision and use of the products and services; including safety, performance, form, fit, function, producibility, service life, etc., that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, m

30、ission critical items, key characteristics, etc. (refer to AS9100). CUSTOMER: Person or organization that could or does receive a product or a service that is intended for or required by this person or organization (refer to ISO 9000). Example: Consumer, client, end-user, retailer, receiver of produ

31、ct or service from an internal process, beneficiary, and purchaser. DESIGN CHARACTERISTICS: Those dimensional, visual, functional, mechanical, and material features or properties, which describe and constitute the design of the article, as specified by drawing or Digital Product Definition requireme

32、nts. These characteristics can be measured, inspected, tested, or verified to determine conformance to the design requirements. Dimensional features include in process locating features (e.g., target-machined or forged/cast dimensions on forgings and castings, weld/braze joint preparation necessary

33、for acceptance of finished joint). Material features or properties may include processing variables and sequences, which are specified by the drawing or Digital Product Definition (e.g., heat treat temperature, fluorescent penetrant class, ultrasonic scans, and sequence of welding and heat treat). T

34、hese provide assurance of intended characteristics that could not be otherwise defined (refer to AS9102). NOTE: For the purpose of this standard Design Characteristic is also known as Product Characteristic. DESIGN RECORDS: The records of the engineering definition/specification, which fully define

35、the product (system, part, component, or assembly), including physical or electronic/digital drawings, electronic/digital models, software, or other associated information. This includes records of authorized engineering changes not yet incorporated into the released engineering definition/specifica

36、tion. SAE INTERNATIONAL AS13004 Page 5 of 30 DESIGN RISK ANALYSIS: Analytical techniques used by the design responsible organization to identify, to the extent possible, potential failure modes related to product performance (i.e., fit, form, and function), durability, manufacturability, and cost. D

37、ETECTION CONTROL: Control to detect the cause of the failure mode or the actual failure mode after it has occurred. FAILURE MODE AND EFFECTS ANALYSIS (FMEA): A structured method for analyzing risk by ranking and documenting potential failure modes in a system, design, or process. The analysis includ

38、es: Identification of potential failures and their effects Ranking of factors (e.g., severity, frequency of occurrence, detectability of the potential failures) Identification and results of actions taken to reduce or eliminate risk The FMEA assists in the identification of CIs as well as Key Charac

39、teristics, helps prioritize action plans for mitigating risk, and serves as a repository for lessons learned. These may include: System FMEA, Interface FMEA, Design Failure Mode and Effects Analysis (DFMEA), and Process Failure Mode and Effects Analysis (PFMEA). INSPECTION PLAN/TEST PLAN: A detailed

40、 description of inspection and test activities (e.g., tolerances, methods, gauges) for features or attributes to be performed during specific manufacturing operations. KEY CHARACTERISTIC (KC): An attribute or feature whose variation has a significant effect on product fit, form, function, performanc

41、e, service life, or producibility, that requires specific actions for the purpose of controlling variation (refer to AS9100). This definition is further explained as follows: Product or system KCs are those selected geometrical, material properties, functional, and/or cosmetic features; which are me

42、asurable, and whose variation control is necessary for fulfilling customer requirements and enhancing customer satisfaction. Process KCs are those selected measurable characteristics of a process whose control is essential to manage variation of product or system KCs. Substitute KCs may be identifie

43、d when a customer defined KC is not readily measurable, within the production/maintenance setting, and other characteristics may need to be controlled to ensure conformance. NOTE: Design output can include identification of CIs that require specific actions to ensure they are adequately managed. Som

44、e CIs shall be further classified as KCs because their variation needs to be controlled. ORGANIZATION: Person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives (refer to ISO 9000). PREVENTION CONTROL: Prevention control descr

45、ibes how a cause and/or failure mode is prevented or how the rate of occurrence is reduced. It is used as input to the occurrence ranking when integrated as part of the process. PROCESS: A combination of people, material, machines, tools, environment, and methods that produce a product or service. P

46、ROCESS CHARACTERISTICS: Process variables that have a cause and effect relationship with design characteristics. Process characteristics can only be measured at the time they occur. PROCESS FLOW DIAGRAM (PFD): A representation of the sequential steps of the process which includes all operations from

47、 receipt of the material through to storage, packaging, and shipment. SAE INTERNATIONAL AS13004 Page 6 of 30 PRODUCT: Any intended output resulting from the product realization process, which in the context of this standard includes finished detailed parts, sub-assemblies, assemblies, forgings and c

48、astings (refer to AS9102). PRODUCT QUALITY ESCAPE: Any product released by an internal/external supplier or sub-tier supplier that is subsequently determined to be nonconforming to contract and/or product specification requirements (refer to AS9131). REACTION PLAN: A plan that specifies actions nece

49、ssary to avoid producing nonconforming product, operating out of control and details containment plans to be invoked when nonconforming product is detected. RISK PRIORITY NUMBER (RPN): The product of the severity, occurrence, and detection rankings and is calculated for each unique failure mode and cause combination. Example: Calculating RPN: Severity 7 X Occurrence 3 X Detection 5 = RPN 105 STANDARD REWORK: Documented