IECQ OPERATIONAL DOCUMENT

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1 IECQ OD 3403 Edition IECQ OPERATIONAL DOCUMENT IEC Quality Assessment System for Electronic Components (IECQ System) Assessment Procedures for acceptance of Candidate Electronic Component Management Plan (ECMP) Subject Matter Experts (SME s) in the IECQ ECMP Scheme IECQ OD 3403:2017 (E)

2 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2017 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. IEC Central Office 3, rue de Varembé CH-1211 Geneva 20 Switzerland Web: About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Catalogue of IEC publications: The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee, ). It also gives information on projects, withdrawn and replaced publications. IEC Just Published: Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available on-line and also by . Electropedia: The world's leading online dictionary of electronic and electrical terms containing more than terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary online. Customer Service Centre: If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service Centre FAQ or contact us: csc@iec.ch Tel.: Fax:

3 IECQ OD 3403 Edition IECQ OPERATIONAL DOCUMENT IEC Quality Assessment System for Electronic Components (IECQ System) Assessment Procedures for acceptance of Candidate Electronic Component Management Plan (ECMP) Subject Matter Experts (SME s) in the IECQ ECMP Scheme INTERNATIONAL ELECTROTECHNICAL COMMISSION

4 IECQ OD 3403 Edition 2.1 IEC:2017(E) 1 CONTENTS INTRODUCTION Flow Chart of SME Credentialing Process Subject Matter Expert Roles and Responsibilities Requirements for Subject Matter Expert Education Requirements SME Experience Knowledge Details Component Selection Component Application Component Qualification Continuous Component Quality Assurance Component Dependability Component Compatibility with the Equipment Manufacturing Process Component Data Configuration Control Experience gained: Impartiality Registration Periodic verification of SME credentials Witness Assessment... 7 Annex A (normative) Subject Matter Expert Appraisal Form... 8

5 2 IECQ OD 3403 Edition 2.1 IEC:2017(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION IECQ Operational Document 3403 Assessment Procedures for acceptance of Candidate Electronic Component Management Plan (ECMP) Subject Matter Experts (SME s) in the IECQ ECMP Scheme INTRODUCTION This Operational Document (OD) sets out the application, assessment and surveillance process for individuals seeking to be accepted and maintain acceptance as IECQ Subject Matter Experts (SME s). The requirements of this OD are supplementary to the IECQ Basic Rules, IECQ 01 and Rules of Procedures, IECQ 03-1 and IECQ Applicant Submits Application to the IECQ Secretariat Application Reviewed by IECQ Avionics WG Upon Successfully Review by WG, Applicant Approved as an IECQ SME Maintenanc e of Credentials Further information concerning these procedures or any other aspect of the IECQ Scheme, may be obtained at: Document History Date Summary Version 1. Original Issue Version 1.1 Expansion of obligations of SME s in Section Edition 2.0 a) Flowchart Revised to add candidate participation in witness assessment per OD 704. b) Annex A - Subject Matter Expert witness assessment form deleted Updated document number to align with IECQ ADHP Scheme previous OD 703 new OD 3403 IECQ Secretariat c/o IEC Sydney Office The Executive Centre, Australia Square, Level George Street, Sydney, NSW 2000 Australia info@iecq.org Tel: I Fx:

6 IECQ OD 3403 Edition 2.1 IEC:2017(E) 3 1 Flow Chart of SME Credentialing Process SME CRITERIA AND CERTIFICATION PROCESS SEQUENCE Yes 1-IECQ establishes need for additional SME's Candidate partcipates in Witness Assessment per OD 704 Pass? 2-IECQ issues formal notification soliciting applications for the SME position. Pass? Not Selected 5a. Candidate notified of decision End Selected Or 3-Potential SME applies for position, using form included in OD Annex A (Appendix) 5b. Candidate notified of decision 6. Candidate attends SME training course or demonstrates equivalence 7. Candidate takes exam. No 4-IECQ evaluates applications and notifies candidates of decision Pass? No 8a. Candidate notified of decision End Yes No 8b. Candidate notified of decision 9. IECQ decides to interview candiate? Yes 10b. Candidate notified of decision 11. Candidate interviewed No 12a. Candidate added to IECQ registration list of SME's Yes Pass? No 12b. Candidate notified of decision End 13, Candidate sent letter and Certificate 14. New SME participates in one (1) ECMP assessment (See experience gained, item d) 15. Probationary status removed 16. SME furnishes periodic evidence (2 year intervals) to IECQ of compliance with ongoing requirements. (per Annex B)? 17. SME maintains certification and continues participating in ECMP assessments Yes

7 4 IECQ OD 3403 Edition 2.1 IEC:2017(E) 2 Subject Matter Expert Roles and Responsibilities This Section applies to all ECMP SME s that have been accepted into the IECQ Scheme. The role of the subject matter expert is to provide to the assessment and audit team, the necessary expertise, knowledge, and experience regarding the selection, qualification and management of electronic components, including the associated processes for implementation, for use in commercial avionics/defense industry equipment. Other relevant industries could include telecommunications, military, aerospace, biomedical and automotive. The SME must also provide the necessary technical input on any questionable issues involving the subject matter. The SME shall at all times act in a professional and impartial manner respecting the confidence of the organisations the SME have assessed. In order to allow open access to the ECMP records the organization being audited may require the SME to sign a non disclosure agreement. Should an SME believe that there is a potential for a conflict of interest or a possibility for confidentially to have been breached, the SME shall immediately notify the IECQ Certification Body for whom they have been engaged. 3 Requirements for Subject Matter Expert 3.1 Education Requirements A relevant engineering or science degree (i.e. Physics, Electrical, electronic) and 10 years industrial experience selecting, qualifying and applying electronic components for defense and commercial avionics industry or 15 years equivalent experience. Other relevant industries may include telecommunications, military, aerospace, biomedical and automotive. 3.2 SME Experience Knowledge Details The SME shall demonstrate significant experience in the areas of: Component Selection Component Application Component Qualification Component Quality Assurance Component Dependability Component Compatibility with the equipment manufacturing Process Component Data Configuration Management Component Selection Minimum detailed knowledge shall include: a) Knowledge of qualification testing methods for electronic components including relevant industry standards and understanding how to read and approve qualification test reports

8 IECQ OD 3403 Edition 2.1 IEC:2017(E) 5 b) Understanding how Systems Engineering design requirements are translated into hardware requirements, product design and component requirements. c) Understand activities associated with hardware design reviews. d) Experience managing component selection processes including review of data sheets, managing cross functional teams responsible for selecting electronic components for commercial avionics/defense programs Component Application EMC a) Understand purpose of EMC/EMI testing and impact on electronic components b) Knowledge of EMC/EMI industry test methods/industry standards and understanding how to read and approve EMC/EMI test data Stress Analysis and Derating Understand Electronic Component Application/Derating criteria (i.e. Semiconductor Junction Temperatures, voltage/power derating, various electrical/thermal parameters of components) Thermal Analysis Understand the thermal impact on electronic components caused by heat generation during system operation, coolant availability and the environmental ambient conditions Mechanical Analysis Understand the mechanical analysis process and the influences of temperature cycling and dynamics (primarily vibration and shock) on electronic component interconnection interfaces, leads, solder joints, ribbon and wire bonds Testing. Testability and Maintainability a) Understand the concepts of maintainability and testability. b) Experience generating and/or evaluation program test plans for components and assemblies Avionics radiation environment Understand the methods and technology to comply with radiation requirements Component Qualification Understand how electronic component manufacturers can be qualified Understand the processes used to qualify electronic component manufacturers. a) Understand quality management systems and the assessment of them. b) Understand the types of alternative processes that can be used to qualify electronic component suppliers Understand the methods by which electronic component process management systems can be approved, such as third party certification and alternative processes Understand the concept of component qualification demonstration. a) Understand the types of qualification data that can be used to qualify electronic components and be familiar with the appropriate use of such data to qualify components. b) Understand how third party and customer-supplied data can be used to qualify electronic components

9 6 IECQ OD 3403 Edition 2.1 IEC:2017(E) c) Understand the concept of similarity as it relates to electronic components and how it may be used to qualify such components. d) Understand the concept of equipment manufacturer validation and how it can be used for electronic component qualification Understand the processes that can be used to qualify components from non-qualified suppliers Understand the processes used to qualify electronic distributors Continuous Component Quality Assurance Understand the general quality assurance requirements for key quality assurance processes and be able to assess them for adequacy Understand the requirements for an electronic component manufacturer s quality assurance system and be able to asses both the system and the data Understand the concept and implementation of in-house continuous monitoring for quality assurance of electronic components Understand and be familiar with the processes used for tracking and monitoring design and manufacturing process change data used by electronic component manufacturers Component Dependability Understand the concept of electronic component reliability assessment, its application and the use of reliability analyses and derived requirements for component specification Understand the concept of component availability and the associated risk assessment and procedures Understand the concept of component obsolescence and the procedures and measures used to mitigate the associated risks Component Compatibility with the Equipment Manufacturing Process Understand the processes used for component shipping, handling and storage, equipment manufacturing, assembly, repair and rework and the compatibility of the components to those processes Component Data Understand the types and uses of data used to qualify electronic component and be able to asses their relevance and applicability to the manufacturing process using the components and the system requirements Configuration Control Understand the configuration control methods used by electronic component suppliers and their uses, such as alternative sources, equipment change documentation, customer notification and approvals, and the focal organization. 3.3 Experience gained: a) Either: Minimum of 15 years experience gained with a user, certifier of high reliability electronic components. Experience gained in the defence and commercial avionics industry is preferred. Other relevant industries could include telecommunications, military, aerospace, biomedical and automotive. b) or: A relevant engineering degree and 10 years industrial experience as detailed in (a).

10 IECQ OD 3403 Edition 2.1 IEC:2017(E) 7 c) A SME shall not be considered fully accredited until they have participated in 1 witnessed ECMP assessment. A SME shall perform at least two ECMP assessments every 24 months to remain accredited. Until accredited the SME shall accompany another accredited SME on any assessments. 3.4 Impartiality It is important that Avionics OEM s are able to provide open access to ECMP records. The employer or other background of the SME may inhibit this. Details of the SME s background shall be available, to enable the applicant requesting an ECMP audit to confirm the commercial acceptability of the SME. 3.5 Registration A register of accredited ECMP SME s and their commercial allegiance shall be maintained by the IECQ Secretariat. 4 Periodic verification of SME credentials An IECQ appointed SME shall furnish evidence of compliance with the requirements for continuing certification in accordance with clause 3 at 2 year intervals. This evidence shall be furnished to IECQ Secretariat Info@iecq.org 5 Witness Assessment Witness Assessments shall be recorded on IECQ PRD-XXX and submitted to the IECQ Secretariat Info@iecq.org

11 8 IECQ OD 3403 Edition 2.1 IEC:2017(E) Annex A (normative) Subject Matter Expert Appraisal Form As part of the SME selection process, it will be necessary for the prospective SME to submit his qualifications to the IECQ for evaluation. To maintain uniformity in this process, the Subject Matter Expert Appraisal Form in Annex A shall be used. Note 1: In addition to a high degree of technical expertise, it is also necessary that the SME be accomplished in communicating with other members of the audit team and the employees of the company being audited. At the discretion of the IECQ representatives reviewing the SME applicant s background and credentials, it may be necessary to have at least a telecom interview with the applicant to access their communication skills. Note 2: If there is inadequate room allowed on the Annex A form to allow the candidate to completely describe their qualifications, either change the form format to Landscape, or attach additional pages.

12 IECQ OD 3403 Edition 2.1 IEC:2017(E) 9 Record of Applicant Details Candidate Name: Postal Address: (either home or employer depending on status and how you wish to be contacted) Telephone: Notice required Availability: Geographic limitations Language Skills 1 = Totally Fluent 2 = Formal qualification/not fluent 3 = Conversation Level Level Level Level Security Clearance (EG: ITAR, UKMoD, USDoD) Personal o Details Indemnity Employer o Other o Details

13 10 IECQ OD 3403 Edition 2.1 IEC:2017(E) SME Experience as Required by IECQ OD 703 Requirement 3.2 The SME shall demonstrate Significant experience of: SME Candidate Submission a Component Management/specification of passive, active and electromechanical components to an expert level The SME shall demonstrate a clear understanding of all applicable component families and offer evaluation and judgements on those component types where expertise cannot be clearly demonstrated by the facility being audited Clear knowledge and involvement in the development and use of industry, national and international standards are required This experience shall include current knowledge of the technical and business changes occurring in the component industry and the effect of these changes on the avionics industry b Component testing experience on passive, active or electromechanical components to an expert level Practical experience of the application of environmental and parametric testing is required: component qualification, screening, highly accelerated stress testing, etc. c d Electronics Dependability: particularly with respect to reliability testing and trend and statistical analyses. This shall include but not be restricted to an appreciation of the following techniques; PiQ, Arrhenius, coffin- Manson, Miners CDI, knowledge of avionics redundancy/reliability shall be required for both single channel and multiple channel avionics systems Avionics (or similar) systems design techniques, including the approaches

14 IECQ OD 3403 Edition 2.1 IEC:2017(E) 11 SME Experience as Required by IECQ OD 703 e f g h Requirement utilized to implement required system safety requirements Manufacturing engineering including the applicable avionics (or similar) system manufacturing skills necessary to evaluate the effects of the assembly techniques used on system reliability and longevity Mechanical packaging of avionics (or similar) systems to allow assessment of the requirements which involve mechanical factors such as EMC, mechanical analysis, durability, etc. OEM plan development/assessment skills derived from practical and hands on experiences developing and/or implementing and/or evaluating the standards, and assisting OEM s in developing their own unique ECMP plans Assessment skills are not required to the same level as the lead Assessor, however assessment training shall have been undertaken, in addition to experience of undertaking product certification assessments, i. e.: rather than management system assessments SME Candidate Submission 3.3 Experience gained a Either: Minimum of 15 years experience gained with a user, manufacturer or certifier of high reliability electronic components. Experience gained in the defence and commercial avionics industry is preferred. Other suitable industries include telecommunications, military, aerospace, biomedical and automotive. Or: A relevant engineering degree and 10 years industrial experience as detail in (a) above.

15 12 IECQ OD 3403 Edition 2.1 IEC:2017(E) SME Experience as Required by IECQ OD 703 Requirement b Minimum of 5 years direct participation in industry standards generating organization, this activity is allowed to be concurrent with the a) activity SME Candidate Submission c On-going education: Attendance at a minimum of 3 relevant conference/industry standards meeting in any 24 month period is required to maintain status as an SME. d A SME shall not be considered fully accredited until they have participated in at 3 ECMP Until that time, the unaccredited SME shall accompany another accredited SME or unaccredited SME on the assignment. A SME shall perform at least two ECMP assessments every 24 months to remain accredited. 3.4 Impartiality It is important that Avionics OEM s are able to provide open access to the ECMP records. The employer or other background of the SME may inhibit this. -- End --

16 INTERNATIONAL ELECTROTECHNICAL COMMISSION 3, rue de Varembé PO Box 131 CH-1211 Geneva 20 Switzerland Tel: Fax: info@iec.ch