1、AECMA STANDARD NORME AECMA AECMA NORM prEN 9162 Edition P 1 May 2005 PUBLISHED BY THE EUROPEAN ASSOCIATION OF AEROSPACE INDUSTRIES - STANDARDIZATION Gulledelle 94 - B-1200 Brussels - Tel. + 32 2 775 8110 - Fax. + 32 2 775 8111 - www.aecma-stan.orgICS: Descriptors: ENGLISH VERSION Aerospace series Op
2、erator self-verification programs Srie arospatiale Programme dauto-vrification par loprateur Luft- und Raumfahrt Selbstprfungsprogramm fr Bedienungspersonal This “Aerospace Series“ Prestandard has been drawn up under the responsibility of AECMA-STAN (The European Association of Aerospace Industries
3、- 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 this Prestandard, the technical content shall not be changed to an extent that int
4、erchangeability is affected, physically or functionally, without re-identification of the standard. After examination and review by users and formal agreement of AECMA-STAN, it will be submitted as a draft European Standard (prEN) to CEN (European Committee for Standardization) for formal vote and t
5、ransformation 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 standards conflicting with the EN. Edition approved for publication 31 May 2005 Comments should be
6、 sent within six months after the date of publication to AECMA-STAN Quality Domain Copyright 2005 by AECMA-STAN Page 2 prEN 9162:2005Foreword This standard was reviewed by the Domain Technical Coordinator of AECMA-STANs Quality Domain. After inquiries and votes carried out in accordance with the rul
7、es of AECMA-STAN defined in AECMA-STANs General Process Manual, this standard has received approval for Publication. To continue to assure customer satisfaction, aerospace industry organizations must produce and continually improve safe, reliable products that meet or exceed customer and regulatory
8、requirements. The globalization of the aerospace industry and the resulting diversity of requirements and expectations have complicated this objective. This document is focussed on standardizing, to the extent possible, Operator self-verification practices in the aerospace industry. Establishing com
9、mon aerospace practices should result in improved quality and safety, decreased costs, and elimination or reduction of organization-unique requirements. Contents Page 1 Scope 3 2 Normative references. 3 3 Terms and definitions 3 4 General 5 5 Basic required elements. 5 6 Application . 6 6.1 General
10、6 6.2 Identification of processes eligible for using Operator Self-Verification . 6 6.3 Development of plans for Operator Self-Verification implementation, maintenance and continuous improvement. 6 6.4 Training and competence of identified operators. 7 6.5 Development of metrics for oversight of ope
11、rator and process performance. 8 6.6 Structured maintenance of processes . 8 Bibliography. 9 Page 3 prEN 9162:20051 Scope The focus of Operator Self-Verification is on traditional manufacturing operations, and applications can be made wherever traditional inspection is employed. The practices recomm
12、ended in this document are intended to identify the basic elements and provide a “guideline” for structuring Operator Self-Verification programs within the aerospace industry; applicable to producers of commercial and military aircraft and weapons platforms, space vehicles, and all related hardware,
13、 software, electronics, engines and composite components. Operator Self-Verification programs are applied to improve the overall efficiency and product quality of processes considered mature, as judged by the implementing organization. Operator Self-Verification programs are not stand-alone processe
14、s, but augment existing quality management systems. The identified program elements are for voluntary implementation by the organization, and are not intended for contractual flow-down unless otherwise stipulated through contractual agreement. Purpose: To provide the recommended elements for Operato
15、r Self-Verification processes within the aerospace industry. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (
16、including any amendments) applies. ISO 9000:2000, Quality management systems Fundamentals and vocabulary. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 acceptance the establishment of a record that signifies verification that the product is
17、 compliant with all the specified requirements In Self Verification programs the organization should clearly specify the detail and extent of the approved operators or team members acceptance authority. 3.2 critical processes those processes that if not performed properly or if improper parts or mat
18、erial are used could result in a failure, malfunction or defect endangering the safe operation of the product involved 3.3 escaped defect a defect discovered by someone other than the operator; provided the operator was given the training, instructions, and tools necessary to perform the verificatio
19、n task 3.4 independent surveillance the entity performing the close observation/review or audit of Operator Self-Verification should not be dependent on or affiliated with the entity controlling the Operator Page 4 prEN 9162:20053.5 multi tasking the use of more than one source to perform independen
20、t performance evaluations of an Operator Self-Verification process 3.6 objective evidence unbiased, factual data supporting the existence or verity of something Objective evidence may be obtained through observation, measurement, test, or other means. 3.7 operator the term used to identify the indiv
21、iduals or teams who physically perform the process Self Verification qualified individuals or teams should be referred to through terminology considered suitable by the organizations program focus, cultural and customer environment. (i.e. “Approved Operators”, “Approved Technicians”, “Certified/Appr
22、oved Process Team Members” etc.) 3.8 operator competency a means of objectively determining that identified operators or team members, have the necessary skills and knowledge to undertake the role of self-verification 3.9 operator self-verification placement of the formal verification of applicable
23、requirements in the hands of the qualified and competent operator 3.10 organization as used in this text, the term refers to the implementing “organization” as defined in ISO 9000:2000 3.11 periodic operator review points, at periods of time established by the organization, at which an operator is t
24、o be assessed to determine whether re-training or initial training is required 3.12 quality management system a set of interrelated elements established with policies and objectives to direct and control an organization with regards to quality 3.13 random surveillance a point selected for an unannou
25、nced, independent close observation/review to assess the individual Operator Self-Verification Process 3.14 regular metric data review an established point at which an operator and/or process is to be assessed via control metrics to determine quality of performance, where Operator Self-Verification
26、is in place 3.15 should indicates a recommended action, content or path, but not mandatory application 3.16 stable and under control process a process which has operated within the established control metric criteria for an acceptable period of time, as established by the organization, and all assig
27、nable nonconformity causes have been eliminated via corrective action Page 5 prEN 9162:20053.17 surveillance the act of close observation or review of an activity, operation or process 3.18 verification confirmation through the provision of objective evidence that specified requirements have been fu
28、lfilled 3.19 traditional inspection the inspection of products or processes by individuals whose sole function is the inspection of parts, assemblies or processes 4 General Operator Self-Verification places formal verification of applicable requirements in the hands of the qualified and competent op
29、erator, and augments existing, robust quality management systems to provide continued system and product quality improvement. Development and implementation of an effective Operator Self-Verification program affects the overall awareness and operating culture of the organization, and promotes reduct
30、ion in traditional inspections. Integration of Operator Self-Verification into the work process, establishes process and operator performance metrics, and through regular surveillance reviews, allows the operators to control and improve the quality of the products. Operator Self-Verification program
31、s can be implemented on a selective or organizational wide basis and can reduce the cost of quality, improve defect prevention and detection, improve efficiency and productivity, eliminate waste, and require operator accountability. Operator Self-Verification enriches employees through promoting act
32、ive involvement in the manufacture and improvement of products. It also promotes streamlining of product and process flows by eliminating the need to move the product to a traditional inspector, or an inspector to the product, enhances the potential for product improvement through in depth review by
33、 various disciplines, and thus potentially provides improved quality and greater customer satisfaction. Operator Self-Verification programs should highlight the responsibility/accountability for product quality, promote employee pride of ownership, recognize superior performance, and provide operato
34、rs with enhanced ability to control process performance. 5 Basic required elements In addition to an existing quality management system, the following items are deemed essential in implementing and maintaining an Operator Self Verification program: Documention of Operator Self-Verification candidate
35、 processes; Development of plans for Operator Self-Verification program implementation; Documented training and competency of Self-Verification operators; Evaluation of human performance limitations; Development of metrics for oversight of process and operator performance; Documented implementation
36、and maintenance plans for Self-Verification processes. Page 6 prEN 9162:20056 Application 6.1 General The basic elements of Operator Self-Verification are essential in establishing a robust program in compliance with this practice. However, the details of these elements are left to the discretion of
37、 the implementing organization based on evaluation of their needs. Effective and continued communication with the customer and/or regulatory authority representatives, as well as with company personnel that will be affected by the program, is essential and vital in deploying self-verification progra
38、ms. Effective, two-way communication builds the necessary broad base of employee understanding, participation, involvement and commitment; promotes customer acceptance and satisfaction with the program and its results; and avoids unnecessary remedial activities, change costs and delays in implementi
39、ng the program. Effective program implementation also requires the development of a broad based plan with provisions to inform all personnel involved of the programs objectives and intent, formalize actions required, ensure management commitment, and establish the timetable for goal completion. In a
40、ddition to the plan, the organization should establish and formally document the process for operator self verification program implementation and operation. The documentation should provide program philosophy and operational perspective to company and customer personnel. Subordinate documentation c
41、an be developed and deployed, as deemed necessary, to provide specific or detailed direction and instructions for the work force, management, administrative personnel, program/process records and record retention, etc. 6.2 Identification of processes eligible for using Operator Self-Verification Whe
42、n identifying potential processes for Operator Self-Verification, either selectively or on an organizational wide basis, the implementing organization should consider and select processes based on: acceptable levels of perceived risk associated with the candidate process and the reduction or elimina
43、tion of traditional inspection (formal or informal processes for risk analysis may be used); demonstrated stability and maturity of the process through such methods as first article performance results and process generated non-conformities within the established process performance review period/cy
44、cle time. Operator Self-Verification should not include those processes considered by the organization, customer, or regulatory authorities as “critical processes” (those that mandate traditional inspection for review and acceptance), unless adequate mitigation of risk is agreed to and in place, and
45、 proper delegation has been specified. The selection process is most effective when performed by multi-disciplined groups. The combined efforts of the various disciplines such as Manufacturing, Quality Assurance, Manufacturing Engineering, Engineering and others offers a more diverse overview of can
46、didate processes. 6.3 Development of plans for Operator Self-Verification implementation, maintenance and continuous improvement In developing the plans for implementation of Operator Self-Verification, the organization should consider the various logistical needs of program implementation, such as
47、training and retraining requirements, oversight documentation and control system requirements, management review and performance metrics, methods for data integration and feedback to allow for effective operator control and improvement of process performance. At a minimum consider: Requirements for
48、comprehensive training programs; Establishing operational baselines to assist in determining improvement resulting from Operator Self-Verification program implementation; Possible changes to documentation for transferring of inspection activities; Appropriate methods for operators to determine proce
49、ss compliance to requirements and to regulate the process to maintain that compliance; Page 7 prEN 9162:2005 Independent surveillance of Self-Verification operators, products and processes; A review of all contributing elements to ensure provision of defect free sources and environment for the Self-Verification Operator; Documented alternative courses of action for self verification operators and processes found to be operating outside quality metric criteria (examples: suspension of qualification, retraining, requalification or restart actions). Dev
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