1、 ASD STANDARD NORME ASD ASD NORM ASD-STAN prEN 9162:2016 Edition 2016-11 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer, 10/5 - B-1000 Brussels, Belgium - Tel +32 2 775 81 26 - Fax +32 2 775 81 31 - www.asd-stan.org ICS: Descriptors: Note Techn
2、ically equivalent writings published in all IAQG sectors ENGLISH VERSION Aerospace series Aerospace Operator Self-Verification Programs Luft- und Raumfahrt Selbstverifizierungsprogramme von Betreibern in der Luft- und Raumfahrtindustrie Srie arospatiale Programmes associs aux oprateurs dautocontrle
3、aronautique This “Aerospace Series“ Prestandard has been drawn up under the responsibility 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
4、the concerned Domain following member comments. Subsequent to the publication of 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
5、 and formal agreement of ASD-STAN, the ASD-STAN prEN will be submitted as a draft 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 gi
6、ving the EN the status of a national standard and by withdrawing any national standards 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 i
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9、rior written permission of ASD-STAN. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edition approved for publication Comments should be sent within six months after the date of publication to ASD-STAN Quality domain prEN 9162:2016 (E) 2 Contents Page Foreword 3 Rationa
10、le . 3 1 Scope 4 1.1 General 4 1.2 Application 4 2 Normative references 4 3 Terms and definitions . 4 4 General 5 5 Foundational elements . 6 6 Process application 6 6.1 Identification of processes eligible for operator self-verification application . 6 6.2 Implementation plans for measuring, monito
11、ring, managing, and continuous improvement of operator self-verification programs . 7 6.3 Training and competence of identified operators 7 6.4 Performance measures for oversight of self-verification operators and process performance 8 6.5 Structured maintenance of operator self-verification 9 7 Not
12、es 9 prEN 9162:2016 (E) 3 Foreword To continue 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 requirements. The globalization of the industry and the resulti
13、ng diversity of requirements and expectations have complicated this objective. This standard is focused on standardizing, to the extent possible, operator self-verification practices in the aviation, space, and defence industry. Establishing common requirements practices should result in improved qu
14、ality and safety, decreased costs, and elimination or reduction of organization-unique requirements. Rationale This document has been elevated from a recommended practice to a standard, and defines the actions required to implement and maintain an operator self-verification program. prEN 9162:2016 (
15、E) 4 1 Scope 1.1 General This document identifies the basic elements and provides a standard for structuring operator self-verification programs within the aviation, space, and defence industry for producers of commercial and military aircraft and weapons platforms, space vehicles, and all related h
16、ardware, software, electronics, engines, and composite components. The requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable
17、statutory or regulatory requirements, the latter shall take precedence. 1.2 Application Operator self-verification programs are applied to improve the overall efficiency and product quality of processes considered stable and capable of fulfilling all requirements, as determined by the implementing o
18、rganization. Operator self-verification programs are not stand-alone processes, but augment an existing quality management system. Its application can be made where inspection activities are currently deployed. 2 Normative references The following documents, in whole or in part, are normatively refe
19、renced in this document and are indispensable for its application. 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
20、Defense Organizations EN 9110, Quality Management Systems Requirements for Aviation Maintenance Organizations NOTE Equivalent versions (e. g., AS, EN, JISQ, SJAC, NBR) of the IAQG standards listed above are published internationally in each IAQG sector. EN ISO 9000:2005, Quality management systems F
21、undamentals and vocabulary 3 Terms and definitions For the purposes of this standard, the following terms and definitions apply: 3.1 Acceptance the establishment of a record that signifies verification that the product is compliant with all the specified requirements. In self-verification programs,
22、the organization clearly specifies the detail and extent of the approved operators acceptance authority. 3.2 Critical processes those processes that if not performed properly or improper parts/material are used could result in a failure, malfunction, or defect endangering the safe operation of the p
23、roduct involved prEN 9162:2016 (E) 5 3.3 Independent surveillance observation/review or audit of operator self-verification by an entity that is not dependent on or affiliated with the entity controlling the operator 3.4 Inspection the process of measuring, examining, testing, gauging, or otherwise
24、comparing product or material with defined requirements 3.5 Operator the term used to identify the individuals who perform the process Note 1 to entry: Self-verification qualified individuals should be referred to through terminology considered suitable by the organizations program focus, cultural,
25、and customer environment (e. g., approved operators, approved technicians). 3.6 Operator competency a means of objectively determining that identified operators have the necessary skills and knowledge to undertake the role of self-verification 3.7 Operator self-verification verification that a produ
26、ct conforms to all applicable requirements by the individual who produced the product 3.8 Surveillance the act of careful observation, monitoring, measuring, or verifying: Operators monitoring operator competence and performance to detect or prevent a noncompliance to established requirements; Produ
27、cts validation of products to detect or prevent a noncompliance to established engineering requirements; Processes verification that processes are implemented and performed, as planned. 3.9 Verification confirmation through the provision of objective evidence that specified requirements have been fu
28、lfilled 4 General 4.1 Operator self-verification places formal verification of applicable product quality requirements in the hands of a qualified, competent operator and augments existing, robust quality management systems to provide continued system and product quality improvement. Formal verifica
29、tion does not imply final verification of product. prEN 9162:2016 (E) 6 4.2 Development and implementation of an effective operator self-verification program improves the overall awareness and quality culture of the organizations manufacturing department, and promotes greater first pass quality. 4.3
30、 Integration of operator self-verification into the work process results in process and operator performance measures through regular surveillance reviews. These reviews allow the operators to control and improve the quality of the products. 4.4 Operator self-verification programs can be implemented
31、 on a selective or organization-wide basis. 4.5 Operator self-verification programs highlight operator responsibility and accountability for product quality, promote employee pride of ownership, and recognize superior performance. 5 Foundational elements In addition to a quality management system, t
32、he following elements shall be implemented and maintained to support an organizations operator self-verification program: a) Identification of processes eligible for using operator self-verification; b) Development of plans supporting operator self-verification implementation, maintenance, and conti
33、nuous improvement; c) Training and competence of identified operators; d) Development of measures for oversight of operator and process performance; e) Structured maintenance of operator self-verification. NOTE The elements of operator self-verification noted in this section are foundational in esta
34、blishing a robust program in compliance with this standard. 6 Process application A program implementation plan shall include the communication of program objectives and intent, development and deployment of associated training, establishment of process performance measures, and the methods for sust
35、aining such operations. Subordinate documentation can be developed and deployed, as deemed necessary, to provide specific or detailed direction/instructions for the work force, management, administrative personnel, program/process records and record retention, etc. 6.1 Identification of processes el
36、igible for operator self-verification application 6.1.1 When identifying potential processes for application of operator self-verification, either selectively or at an organization-wide basis, the implementing organization shall consider and select processes based on: a) The demonstrated stability o
37、f the process through such methods as first article inspection, performance results, and process generated nonconformities identified during the established process performance review period/cycle time; b) The detectability of product/process nonconformance. prEN 9162:2016 (E) 7 6.1.2 Operator self-
38、verification shall not include those processes considered by the organization, customer, and/or regulatory authorities as “critical processes”, unless adequate mitigation of risk is agreed to, in place, and proper delegation has been specified. 6.1.3 When applying a self-verification program to crit
39、ical processes, the implementing organization shall consider and select processes based on the acceptable levels of perceived risk associated with the candidate process; a defined process for risk analysis shall be used. NOTE The selection of processes is most effective when performed by a multi-dis
40、ciplined group (e. g., Manufacturing, Quality Assurance, Manufacturing Engineering, Engineering). 6.2 Implementation plans for measuring, monitoring, managing, and continuous improvement of operator self-verification programs 6.2.1 In developing and implementing plans for operator self-verification,
41、 the organization shall include the following: a) Communication overall program objectives and intent communicated to applicable customers and regulatory authorities, as required per contract, including establishment of organizational roles and responsibilities; b) Training required training and com
42、petency for self-verification operators, including identification of appropriate methods for operators to determine compliance to requirements; c) Performance Measures oversight of process and operator performance: Establishing operational baselines to assist in determining improvement resulting fro
43、m operator self-verification program implementation; Identifying potential sources of operator, process, and/or product quality errors. NOTE Performance measures of operator self-verification effectiveness reflect the results associated to product/process verification and confirmation of product/pro
44、cess conformance and nonconformance after self-verification by qualified staff. d) Sustaining Operations implementation and maintenance plans for operator self-verification processes: Selection, de-selection, and/or re-selection of self-verification operators and/or processes; Process(es) for addres
45、sing changes to associated process documentation and/or transferring inspection activities; Independent surveillance of the overall operator self-verification program shall be planned and implemented by the organization; Correcting and eliminating potential sources of operator and process errors and
46、/or improvement of program performance. 6.3 Training and competence of identified operators 6.3.1 Emphasis shall be placed on initial training courses and their content, assessment of training results, and retraining of operators (as necessary). Training course content evaluation shall be performed
47、to ensure that courses adequately address employee, management, and supervision needs prEN 9162:2016 (E) 8 with respect to technical and non-technical knowledge (e. g., human factors, documentation, data flow requirements), measurement/inspection techniques, process requirements, and the ability of
48、authorized operators to adjust, modify, or halt the process to prevent or correct product/process nonconformities. 6.3.2 In addition to initial training, refresher or re-qualification training shall be deployed in accordance with program/process requirements to ensure continued verification of emplo
49、yee knowledge and understanding of the operator self-verification program requirements. 6.3.3 Training programs for operator self-verification personnel shall include: a) In-depth training in various disciplines associated to operator self-verification activities (e. g., personnel roles and responsibilities, measurement/inspection techniques, validation of product to requirements, acceptance authority); b) Training for management to ensure thorough knowledge of operator self-verification program requirements (e. g., performance measures
