QUALITY MANUAL ELECTRODYNAMICS, INC

Transcription

1 T.K. Moore AS /24/ QUALITY MANUAL ELECTRODYNAMICS, INC 3975 McMann Road Cincinnati, OH (513)

2 T.K. Moore AS /24/ MISSION STATEMENT L-3 Electrodynamics provides engineered solutions and manufactures rugged environment input/output products for aerospace, military and government customers, who demand high-levels of customer satisfaction as measured by quality, cost, on-time delivery and exacting technical requirements. We create value by partnering with our customers and suppliers, employing a highly trained and dedicated workforce, complying with an internationally recognized QMS, and meeting established performance objectives. This ability to effectively manage our resources enables us to not only achieve the financial goals of our shareholders, but also provides a competitive advantage in our markets offering us the opportunity to grow into the future. QUALITY POLICY DO IT ONCE, DO IT RIGHT. L-3 Electrodynamics is committed to meet or exceed all of our customer s requirements and expectations, using continual improvement methods. Eric Ellis, President

3 T.K. Moore AS /24/ Table of Contents SCOPE OF BUSINESS... 5 MANAGEMENT COMMITMENT... 5 COMPANY BACKGROUND... 6 QUALITY OBJECTIVES... 9 Section 3.0 Terms and Definitions Risk Special Requirements Critical Items Key Characteristic Section 4.0 Quality Management System General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records Related Documents: Section 5.0 Management Responsibility Management Commitment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Management and Policy Deployment Review General Review Inputs Review Outputs Section 6.0 Resource Management Provision of Resources Human Resources General Competence, Awareness and Training Infrastructure Work Environment Section 7.0 Product Realization Planning of Product Realization Project Management Risk Management Configuration Management Control of Work Transfers Customer Related Processes Determination of Requirements Related to the Product Review of Requirements Related to the Product... 22

4 T.K. Moore AS /24/ Customer Communication Design and Development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Design and/or Development Verification and Validation Testing Documentation of Design and/or Development Verification and Validation Control of design and development changes Purchasing The Purchasing Process Purchasing Information Verification of Purchased Products Production and Service provision Control of Production and Service Production Process Verification Control of Production Process Changes Control of Production Equipment, Tools and Software Programs Post Delivery Support Validation of Processes Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Equipment Section 8.0 Measurement, Analysis and Improvement General Monitoring and Measurement Customer Satisfaction Internal Audits Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Non-Conforming Product Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action Attachment 1 Process Overview... 37

5 T.K. Moore AS /24/ SCOPE OF BUSINESS This quality manual and referenced procedures and forms document the QMS (QMS) of L-3 Communications Electrodynamics, Inc. (herein after referred to as L-3 EDI), a wholly owned subsidiary of L-3 Communications Holdings, Inc. (herein after referred to as L-3 Communications) located in New York, New York. L-3 EDI locations include our main facility, which primarily houses our design, manufacturing, administration activities, and machine shop operations. L-3 EDI QMS (QMS) is designed to satisfy the needs and requirements of our customers, who are generally in the military or commercial aviation, aerospace, or defense markets, and to enhance their levels of satisfaction through the effective application of this QMS, including defining processes for continual improvement and the assurance of conformity to customer, and applicable statutory, regulatory, and other stakeholder (e.g., L-3 Communications, L-3 EDI Employees) requirements and needs MANAGEMENT COMMITMENT The L-3 Electrodynamics Senior Management Team has reviewed and approved the content of this AS9100* compliant Quality Manual intended to provide our employees with a unity of purpose and a framework in which to manage our business. The manual and our registration to AS9100 provide evidence to our external customers that our company is committed to managing our business with reduced variation in processes and products and toward continual improvement throughout our operations. This manual includes the company s policies and references the six mandatory procedures implemented by EDI as required by AS9100. These and other Procedures, Flow Diagrams, Work Instructions and Forms considered necessary by EDI are managed through the document control system and are available electronically to all employees. Employees are trained on the Policies, Procedures and Work Instructions relevant to their jobs. All EDI workers (including temporary workers) understand the importance of following our documented system. Eric Ellis, President * Note: All references to AS9100 in this document are specific to the current version of the standard, as revised.

6 T.K. Moore AS /24/ COMPANY BACKGROUND L-3 Communications Electrodynamics, Inc. (L-3 EDI) roots date back to the 1940 s and Elgin Micronics, a division of Elgin National Watch Company of Elgin, Illinois, where we provided small, precision, highreliability timing instruments and fuze products in support of the war effort of World War II to the U.S. Department of Defense (DoD) and other pioneering defense companies. Up through the 1950 s and the 1960 s, as a division of General Time, we continued to provide our then-state of the art timing products to the DoD, and to NASA in support of the early days of space exploration. In 1969, the same year in which General Time merged with Talley Industries, most notably L-3 EDI designed, developed, and manufactured the Central Timing Equipment (CTE) in support of the Apollo 8 mission. The evolution of L-3 EDI s fuzing products continued into the 1970 s and through the early 1980 s with the MK339 electromechanical Safe/Arm fuze. The fuze had two selectable time delay settings that could be chosen during flight by the pilot. In the late 1970 s, L-3 EDI under FAA certificate No. 20 for contract DOT-FA78WA-4211 designed and manufactured Data Weather Mappers for the National Weather Service and the FAA. During the 1980 s and 1990 s L-3 EDI evolved into other types of solid-state electronics time-based products - Missile Electronic Safe, Arm and Fire Devices (ESAF s/esad s); and Flight Data Recorders (FDR s) / Acquisition Signal Data Computer (ASDC). In 1994, Minelco, Inc., (CAGE Code 07974), a fellow subsidiary of Talley Industries and a designer and manufacturer of fault indicator products (a.k.a. Built-In Test Equipment (BITE) Indicators) and LED indicators, was consolidated into L-3 EDI s Rolling Meadows operations from Thomaston, CT. In 1996, L-3 EDI acquired the fault indicator product line of the Airpax Division of North American Philips, Cheshire, CT (CAGE Code 82227) and followed up in 2002 with the acquisition of the Airpax (a subsidiary of VDO Control Systems) elapsed time indicator and event counter product lines. In December 1998, EDI became the third acquisition of newly formed L-3 Communications. More recently, EDI in 2008, acquired Curtis Instruments, Mount Kisko, NY (Cage Code 18583) solid state ETI product line. L-3 EDI has been developing and manufacturing high-quality and high-reliability electronic systems and electromechanical and electromagnetic products and solutions for the military and commercial aviation, aerospace, and defense markets,. Still today, most of L-3 EDI s products are based on our legacy heritage the element of time. Located in a company-owned 56,000 square-foot facility in Cincinnati, Ohio, the company has grown from a research center to a fully autonomous engineering and manufacturing operation that has been supplying primarily the aviation and defense markets with high-reliability products for over 60 years since our initial inception. L-3 EDI is fully staffed to satisfy military and commercial aviation, aerospace, and defense requirements for hardware and software quality, reliability, maintainability, producibility, testability, survivability, system safety,

7 T.K. Moore AS /24/ human performance/engineering, integrated logistics support, configuration management, data management, and qualification/environmental testing. L-3 EDI s components group core capabilities include electromagnetic and electromechanical design, custom design and test of NVIS and infrared secure light filters, mechanical packaging, quality assurance, and postdelivery support. L-3 EDI current product lines include high-reliability: Elapsed Time Indicators (ETI s), Fault / Built-In Test Equipment (BITE) Indicators, Event and Subtractive Counters, and LED s and Light Panels. These products can be readily customized by L-3 EDI as part of our value-added services offerings that we provide to meet our customer-specific applications and environmental survivability requirements. L-3 EDI products can be found in the most demanding applications:

8 T.K. Moore AS /24/ Indicators, Meters, Counters, LEDs. Light Panels Platforms Military Fixed Wing and Rotary Aircraft (A- 10, AV-8, B-1 B-52, C-130, C-135, C-141, E- 2C, F-14,F-15, F-16, F/A-18, F-11, AH-1W Super Cobra, AH-64 Apache, HH-53E, MH- 53E, SH-60F Seahawk, UH-60 Blackhawk, V- 22 Osprey) Military Ground Vehicles Commercial, and Missile Systems (Tomahawk, AMRAAM, Patriot) Shipboard Applications (Ticonderoga, Nimitz, Los Angeles, Forrestal, Seawolf, Trident) Numerous Military Electronic Equipment (Enhanced Position Location Reporting System (EPLRS); Auxiliary Power Units (APUs); Countermeasures, incl. F-15 & IED (CREW); GFI Relays; Radio; Radar, SPIDER Munition Control Units) Business and General Aviation Aircraft (Boeing 727, 737, 747, 767 & 777, Cessna Citation XL, Gulfstream G450 & G550, Hawker Beechcraft 900XP) High-Reliability, Rugged Commercial / Industry Applications (Elevators, etc.) Our customer base extends across the globe and consists of over two-thousand customers as listed in our modern Enterprise Resource Planning (ERP) system it is literally a who s who of the aviation, aerospace and defense premier contractors - and even includes direct sales to numerous agencies of the U.S. Government under approximately 4000 different National Stock Numbers (NSN s). Below is a small representative sample of some of our major customers. Major Customers BAE Boeing DRS Technologies General Atomic General Electric ITT Corp. Hamilton Sundstrand Honeywell L-3 Communications Lockheed Martin Northrop Grumman Raytheon Rockwell Collins SAAB U.S. Government Agencies Being in the aviation and defense market for as long as we have, we are no strangers to the stringent quality requirements and expectations of our customers that have evolved over time from: MIL-Q-9858, WS 6536 / MIL-STD-2000, MIL-STD-5510 / 50884, MIL-C-28809; to the current day: AS9100, J-STD-001, IPC 2220 / 6010 Series, IPC-A-600 / 610 Series, and regulatory governance facing our industry today Specialty Metals, RoHS, Import/Export, Tin Whiskers Risk Mitigation, and Suspect Unapproved Parts / Counterfeit Parts Prevention. Our product offerings are designed, manufactured, and processed to meet the most demanding and severe reliability, safety, and environmental requirements of our global aviation and defense customers, and, consequently, are either, qualified, designed, manufactured, inspected, or tested to the stringent standards and specifications.

9 T.K. Moore AS /24/ Please contact our knowledgeable Inside Sales and Application Engineering associates and they will be glad to assist you with one of our standard product offerings, or in the design and development of entirely new products or product variations as part of the value-added services we offer. QUALITY OBJECTIVES EDI Management Review is integrated into Policy Deployment, the process EDI uses to establish its goals and objectives as a company. First, a set of 3 to 5 year breakthrough objectives is established through a strategic planning process. From these, annual objectives are developed and supported by top-level improvement priorities (processes) and targets to improve (metrics), which are reviewed monthly. In addition to these cross functional objectives, sets of departmental KPIs (Key Performance Indicators) are also created and supported by action plans. Progress toward all objectives is reviewed periodically by owners and Senior Management to ensure effectiveness and continual improvement. Any missed goals are specifically discussed along with the implemented countermeasures. By using Policy Deployment, all employees, regardless of their department, are working together focused on the goals established for the company s success. Current company objectives and KPIs are available electronically to all employees.

10 T.K. Moore AS /24/ SECTION 3.0 TERMS AND DEFINITIONS For the purposes of this Quality Manual, the terms and definitions given in ISO 9000 apply. 3.1 Risk An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence. 3.2 Special Requirements Those requirements identified by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industry s capability, or requirements determined by the organization to be at the limit of its technical or process capabilities. 3.3 Critical Items Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; 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, mission critical items, key characteristics, etc. 3.4 Key Characteristic An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires specific actions for the purpose of controlling variation. Special requirements and critical items, along with key characteristics, are interrelated. Special requirements are identified when determining and reviewing requirements related to the product (see and 7.2.2). Special requirements can require the identification of critical items. Design output (see 7.3.3) can include identification of critical items that require specific actions to ensure they are adequately managed. Some critical items will be further classified as key characteristics because their variation needs to be controlled.

11 T.K. Moore AS /24/ SECTION 4.0 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements L-3 ELECTRODYNAMICS (EDI) has documented and implemented its Management System based on the AS9100 Standard. EDI manages this system toward continual improvement of its effectiveness in accordance to the standard s requirements. The system also addresses customer and applicable statutory and regulatory management system requirements. Note: Requirements within this document or reference documents may be superseded by contract or corporate policy. EDI commits to: Determination and application of the necessary processes for an effective management system Determination of the sequence and interaction of the processes Determination of the criteria and methods needed to ensure that both the operation and control of the processes are effective Ensuring the availability of resources and information necessary to support the operation and monitoring of these processes Monitoring, measuring, where applicable, and analyzing the processes Implementation of actions necessary to achieve planned results and continual improvement of these processes Managing the processes according to the requirements of AS9100 Identifying and ensuring control over any outsourced processes that may affect product conformity with requirements EDI includes management systems activities, provision of resources, product realization and measurement in our quality management system. Outsourced products and product-related services are primarily controlled through our Purchasing processes. 4.2 Documentation Requirements General EDI s documented quality management system includes: Quality Policy Statement and Quality Objectives Quality Manual Documented Procedures and records required by AS9100 Documents, including records, needed to ensure effective planning, operation and control of EDI processes Quality system requirements imposed by regulatory/statutory authorities

12 T.K. Moore AS /24/ The EDI Management Team commits to establish, implement and maintain the required procedures as well as to document them. EDI has designed its AS9100 based management system based on the Company s previously documented and effective policies and procedures. EDI makes additions and changes to our documentation over time to continue to meet the requirements of our growing company, to streamline our documentation and to avoid unnecessary complications to our processes while continuing to meet the requirements of the AS9100 Standard. EDI ensures that employees have access to quality system documentation and are aware of relevant procedures as well as their changes Quality Manual This Quality Manual was designed to comply with the AS9100 requirements and our customers needs. The manual includes: The scope of the management system References to the documented Procedures, Work Instructions and Forms throughout A description of the interaction between EDI processes (see 0 - Process Overview) Control of Documents Documents required by the EDI quality management system are controlled. EDI coordinates document changes with customers and/or regulatory/statutory authorities in accordance with contract and regulatory/statutory requirements. Records are a special type of document and are controlled according to the requirements of section QOP-05-01, QMS Document and Data Control defines the controls needed: To approve documents for adequacy prior to release To review, update and re-approve documents as necessary To ensure that changes and the current revision status of documents are identified To ensure that relevant versions of applicable documents are available at point of use To ensure that documents remain legible and readily identifiable To ensure that externally generated documents are identified and their distribution controlled To prevent unintended use of obsolete documents, and to suitably identify them if they are to be retained for any purpose Control of Records QOP Control of Quality Records define the controls needed to establish and maintain records to provide evidence of conformity to requirements and of the effective operation of the quality management system. This includes how records created and/or retained by suppliers are controlled.

13 T.K. Moore AS /24/ Required controls include: Identification of necessary records Ensuring that records remain legible, readily identifiable and retrievable Proper storage of records Security and protection from loss and destruction Retrieval from controlled storage areas Retention (including retention time and archival storage if needed) Proper disposal of records (recognizing EDI and customer confidentiality concerns and environmental consciousness) Related Documents: QOP QOP Attachment 1 Document Control and Data Control Control of Quality Records Process Overview

14 T.K. Moore AS /24/ Document Tier Tier 1 Tier 2 Tier 3 Tier 4 Quality Procedures Work Instructions Quality Records AS9100/IS09001 Satisfied Customers L-3 Electrodynamics Quality Manual Quality Manual Company Quality Policy Quality Policies Why? Committed Committed Individuals Individuals Who, What, When, Where? How? Objective Evidence Quality Quality Products Products Lean Six Sigma Continual Improvement Quality Operating Procedures QOPs Work Instructions Work Instructions (WIs) Quality Assurance (QA) Procedures Mfg Engrg (ME) Procedures Systems Products Group Operating Procedures (SPGOPs) Quality Records Completed Forms L-3 EDI QMS Documentation Hierarchy

15 T.K. Moore AS /24/ SECTION 5.0 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment The EDI Senior Management Team provides evidence of their commitment to the development and implementation of the company s management system and to continually improving its effectiveness by: Communicating, throughout EDI, the importance of meeting customer as well as statutory and regulatory requirements Establishing the Quality Policy and communicating its significance through-out EDI Establishing Quality Objectives through the Policy Deployment process Conducting Management and Policy Deployment reviews Ensuring the availability of resources 5.2 Customer Focus The EDI Senior Management Team ensures that customer requirements are determined and met with the goal of enhancing customer satisfaction (see sections and 8.2.1). They will also ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved. 5.3 Quality Policy The EDI Senior Management Team establishes the company Quality Policy. The Management Team ensures the Policy: Is appropriate to the purpose of EDI Includes commitment to comply with requirements and continually improve the effectiveness of the company s management system Provides a framework for establishing and reviewing quality objectives Is communicated, understood and implemented throughout the company Is periodically reviewed for suitability 5.4 Planning Quality Objectives The EDI Senior Management Team ensures objectives, including those needed to meet requirements for product (see section 7.1), are established at relevant functions and levels throughout EDI. Quality objectives are measurable and consistent with the quality policy. Policy Deployment (PD) is the process EDI uses to establish its goals and objectives as a company. The strategic planning process, along with VOC (Voice of the Customer) data collected throughout the year, is used to develop the First Level Policy Deployment Matrix. The matrix created by the management team is composed of four main components each linked to the element preceding it.

16 T.K. Moore AS /24/ year breakthrough objectives 2. Annual breakthrough objectives 3. Improvement priorities (processes) 4. Targets to improve (metrics) With this first or top level PD matrix, owners for each of the Improvement priorities develop their own 2 nd level PD matrix and/or the appropriate actions plans. With the matrices and action plans in place, owners define the Key Performance Indicators (KPI), which track performance at all levels of EDI. In the event a target/goal is missed, formal countermeasures are implemented to close the gap and get back on track. Matrix, action plans and KPIs are reviewed regularly by their owners, but Senior Management also conducts a formal operations review monthly where RED or missed goals are discussed along with their countermeasures. The Policy Deployment process is completed/reviewed annually on the cycle described above. All PD documentation including matrices, action plans, KPIs and training materials are kept electronically and are available to all employees. By using policy deployment all employees, regardless of their department, are working together, focusing all efforts on what s deemed important each year by Senior Management Quality Management System Planning Quality management system planning is done during the strategic planning process by top management. Policy Deployment is created annually from organizational vision by developing 3-5 year breakthrough objectives, which are translated into annual objectives. From these annual objectives, measurable business targets are established by the management and support teams. During continuous improvement events, changes to the quality system are implemented and communicated through report out presentations. This ensures that: Planning of the management system is carried out in order to meet requirements (see Section 4.1) and Quality Objectives The integrity of the system is maintained when changes to the management system are planned and implemented 5.5 Responsibility, Authority and Communication Responsibility and Authority The EDI Senior Management Team ensures that responsibilities and authorities are defined and communicated within EDI. An up to date company Organization Chart is maintained by Human Resources and is available to all employees. Departmental organizational charts are also available from Human Resources.

17 T.K. Moore AS /24/ Management Representative The Management Team appoints an official EDI Management Representative to ensure the requirements of AS9100 are maintained. That appointment, including the Responsibilities and Authorities, are communicated throughout the company. The Management Representative has the organizational freedom to resolve matters pertaining to quality. The responsibility and authority of the Management Representative includes: Ensuring that processes needed for the management system are established, implemented and maintained Reporting to management on the performance of the management system including any necessary improvements Ensuring awareness of customer requirements throughout the company Representing EDI to external parties on matters relating to the management system The organizational freedom and unrestricted access to Senior Management to resolve quality management issues Internal Communication The EDI Senior Management Team ensures that appropriate communication processes (employee newsletter, meetings, etc.) are established within EDI and that communication takes place regarding the effectiveness of the management system. 5.6 Management and Policy Deployment Review General Senior Management reviews the status of the EDI Management System during Management Reviews, which are conducted annually, at a minimum and Policy Deployment reviews, which are conducted monthly. This ensures the management system s continuing suitability, adequacy and effectiveness. These reviews include assessing opportunities for improvement and the need for changes to the management system, including the quality policy and quality objectives. This system is detailed in QOP-14-03, Continual Improvement. The Management Representative assures records of Management Review meetings, including presented material, sign in sheet, and action items are retained Review Inputs Input to management review includes: Results of audits Customer feedback Process performance and product conformity Status of corrective and preventive actions Follow-up actions from previous management reviews

18 T.K. Moore AS /24/ Changes that could affect the management system Recommendations for improvement Review Outputs Output from the management review includes any decisions and actions related to: Improvement of the effectiveness of the management system and its processes Improvement of product related to customer requirements Resource needs RELATED DOCUMENTS: QOP Continual Improvement

19 T.K. Moore AS /24/ SECTION 6.0 RESOURCE MANAGEMENT 6.1 Provision of Resources As part of its management review process, and in addition to its ongoing Program Management activities, EDI determines resource needs to meet its business objectives. These include resources needed to: Implement and maintain the management system and continually improve its effectiveness (including subcontracted personnel ) Enhance customer satisfaction by meeting customer requirements 6.2 Human Resources General Management ensures that personnel performing work affecting conformity to product requirements are competent based upon appropriate education, training, skills and experience Competence, Awareness and Training The Management Team: Determines the necessary competence for personnel performing work affecting conformity to product requirements (Job Descriptions) Where applicable, provides training or takes other actions to achieve necessary competence (Employee Personal Objectives) Evaluates the effectiveness of the actions taken (Annual Performance Reviews) Ensures that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (Annual Performance Reviews) Maintains appropriate records of education, training, skills and experience (see 4.2.4) This system is documented in QOP-18-01, Training. 6.3 Infrastructure The Management Team determines, provides and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: Building, workspace and associated utilities Process equipment (hardware and software) Supporting services (such as transport, communication, or information systems) The primary document addressing this system is QOP-09-03, Infrastructure

20 T.K. Moore AS /24/ Work Environment Senior Management determines and manages the work environment needed to achieve conformity to product requirements. Policies and procedures are developed to address factors that may affect the conformity of the product including temperature, humidity, lighting, cleanliness, protection from electrostatic discharge, etc. RELATED DOCUMENTS: QOP QOP QA-045 QOP Infrastructure Training Electrostatic Discharge Control Procedure Foreign Object Damage

21 T.K. Moore AS /24/ SECTION 7.0 PRODUCT REALIZATION 7.1 Planning of Product Realization The EDI Senior Management Team plans and develops the processes needed for product realization, which includes the following processes: Understanding Customer Requirements; Program Management including Estimating, Proposal and Contract Development; Order Processing; Scheduling; Purchasing; Product and Process Design and Development; Production Planning; Manufacturing; Inspection and Testing; Calibration; Warehousing; Shipping. Planning of product realization is consistent with the requirements of the other processes. In planning product realization, Management ensures the output of the planning is in a form suitable to the company s operating methods and determines the following: Quality objectives and requirements for the product Processes and documents, and resources specific to the product Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance Records needed to provide evidence that the product realization process and resulting product meet requirements (see 4.2.4) Resources to support operation and maintenance of the product Configuration management appropriate to the product Project Management As appropriate to the product, EDI will plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints Risk Management EDI will establish, implement and maintain processes for managing risk to the achievement of applicable requirements that includes as appropriate to the product: Assignment of responsibilities for risk management Definition of risk criteria (e.g., likelihood, consequences, risk acceptance) Identification, assessment and communication of risks throughout product realization Identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria Acceptance of risks remaining after implementation of mitigating actions Configuration Management Configuration management is established, documented and maintained appropriate to the product and the requirements of the contract per QOP-02-02, Configuration Management Plan Requirements. This will include, as appropriate to the product:

22 T.K. Moore AS /24/ Configuration management planning Configuration identification Change control Configuration status accounting Configuration audit Control of Work Transfers EDI will establish, implement and maintain a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from EDI to a supplier, from a supplier to EDI, and from one supplier to another supplier) and to verify the conformity of the work to requirements. 7.2 Customer Related Processes Determination of Requirements Related to the Product The Management Team determines: Requirements specified by the customer, including requirements for delivery and post delivery activities Requirements not stated by the customer, but necessary for specified or intended use where known Statutory and regulatory requirements applicable to the product Any additional requirements considered necessary by EDI Review of Requirements Related to the Product EDI reviews the requirements related to the product. This review is conducted prior to a EDI commitment to supply a product to the customer (e.g., submission of proposals, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures that: Product requirements are defined EDI has the ability to meet the defined requirements Contract or order requirements differing from those previously expressed are resolved Special requirements of the product are determined Risks (e.g., new technology, short delivery time scale, etc.) have been evaluated (see 7.2.1) Records of the results of the review and actions taken are maintained (see 4.2.4) Where the customer provides no documented statement of a requirement, the customer requirements are confirmed by EDI prior to acceptance of an order. Where the product requirements are changed, EDI ensures relevant documents are amended and relevant personnel are made aware of the changed requirements.

23 T.K. Moore AS /24/ Customer Communication The Senior Management Team determines and implements effective arrangements for communicating with customers in relation to: Product Information Enquiries, contracts or order handling, including amendments Customer feedback, including customer complaints 7.3 Design and Development Design and development planning EDI plans and controls the design and development its products according to Design Control QOP During the design and development planning, EDI determines: The responsibilities and authorities for design and development The design and development stages (including project organization, task sequence, mandatory steps, significant stages and method of configuration control) The review, verification and validation that are appropriate to each design and development stage Where appropriate, EDI will divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resources, responsibilities, design content, input and output data and planning constraints. EDI manages the interfaces between the different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Output from the planning stage is updated, as appropriate, as the design and development progresses. Design and development planning will consider the ability to produce, inspect, test and maintain the product. The different design and development tasks to be carried out are defined according to specified safety or functional objectives of the product in accordance with customer and/or regulatory/statutory authority requirements Design and development inputs Inputs related to product requirements are determined and records maintained (see 4.2.4). These inputs include: Functional and performance requirements Applicable statutory and regulatory requirements Information derived from previous similar designs (where applicable) Other requirements essential for design and development

24 T.K. Moore AS /24/ These inputs are reviewed for adequacy as part of the EDI design process. This review ensures the requirements are complete, unambiguous and not in conflict with each other Design and development outputs The outputs of design and development are provided in a form suitable for verification against the design and development input. The output is approved prior to release. The approval review ensures that design and development output: Meets the input requirements for design and development Provides appropriate information for purchasing and for production Contains or references product acceptance criteria Specifies essential characteristics of the product required for its safe and proper use Specifies, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items EDI will define the data required to allow the product to be identified, manufactured, inspected, used and maintained including: Drawings, part lists and specifications necessary to define the configuration and the design features of the product Information on material, processes, type of manufacturing and assembly of the product necessary to ensure the conformity of the product Design and development review At suitable stages, systematic reviews of design and development are performed according to planned arrangements (see 7.3.1): To evaluate the ability of results of design and development to meet requirements To identify any problems and propose necessary actions To authorize progression to the next stage Participants in these reviews include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of reviews and any necessary actions are maintained (see 4.2.4) Design and development verification Verification is performed according to planned arrangements (see 7.3.1) to ensure the design and development outputs meet the design and development input requirements. Design and/or development verification may include activities such as: Performing alternative calculations Comparing the new design with similar proven designs Undertaking tests and demonstrations

25 T.K. Moore AS /24/ Reviewing the design stage documents before release Records of the results of verification and any necessary actions are maintained (see 4.2.4) Design and development validation Design and development validation is performed in accordance with planned arrangements (see 7.3.1) to ensure the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Validation follows successful design and/or development verification. Validation is performed under defined operating conditions. Wherever practical, validation is completed prior to the delivery or implementation of the product. Validation is normally performed on the final product, but it can also be preformed on earlier stages prior to product completion, where appropriate. Due to the nature of EDI products, our customers often conduct final testing to validate performance as intended. Multiple validations are performed if there are different intended uses. Records of the results of validation and any necessary actions are maintained (see 4.2.4) Design and/or Development Verification and Validation Testing Any necessary testing will be planned, controlled, reviewed, and documented to ensure and prove that: Test plans or specifications identify the product being tested and the resources being used, define the test objectives and conditions, parameters to be recorded, and relevant acceptance criteria Test procedures describe the method of operation, the performance of the test and the recording of the results The correct configuration of the product is submitted for test The requirements of the test plan and the test procedures are observed The acceptance criteria are met Documentation of Design and/or Development Verification and Validation At the completion of design and/or development, EDI ensures that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all operational conditions Control of design and development changes Design and development changes are identified and records maintained (see 4.2.4). The changes are reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes includes evaluation of the effect of the changes on component parts, assemblies and product already delivered. Records are maintained regarding the results of change reviews and any necessary actions (see 4.2.4). Design and development changes shall be controlled in accordance with the configuration management process (see 7.1.3)

26 T.K. Moore AS /24/ Purchasing The Purchasing Process EDI ensures that purchased product conforms to specified purchase requirements and is responsible for the conformity of all products purchased from suppliers, including customer-designated sources. Systems are established to ensure, where required, that both EDI and all suppliers use customer-approved special process sources. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization activities or the final product. EDI maintains a register of approved suppliers that includes the scope of the approval. EDI evaluates and selects suppliers based on their ability to supply product in accordance with EDI s requirements. Criteria for selection, evaluation and re-evaluation are established. Records of Approved Vendors and the results of evaluations and any necessary actions from the evaluation are maintained by Supplier Management (See 4.2.4) In addition EDI: Maintains a register of approved suppliers that includes approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family) Defines the process, responsibilities and authority for the approval status decision, changes of the approval status and conditions for a controlled use of suppliers depending on their approval status Periodically reviews supplier performance. The results of these reviews are used as a basis for establishing the level of controls to be implemented Defines the necessary actions to take when dealing with suppliers that do not meet requirements Ensures, where required, that both EDI and all suppliers use customer approved special process sources Determines and manages the risk when selecting and using suppliers (see ) Purchasing Information EDI purchasing information describes the product to be purchased, including where appropriate: Requirements for approval of product, procedures, processes and equipment Requirements for qualification of personnel Quality management system requirements The identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data Requirements for design, test examination, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance as well as applicable critical items including key characteristics Requirements for test specimens (e.g. production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing Requirements for the supplier to: - notify EDI of nonconforming product

27 T.K. Moore AS /24/ obtain EDI approval for nonconforming product disposition - notify EDI of changes in product and/or process, changes of suppliers, change of manufacturing facility location and, where required, obtain EDI approval beforehand - flow down through the supply chain the applicable requirements in the purchasing documents, including customer requirements Records retention requirements Right of access by EDI, our customers and regulatory/statutory authorities to the applicable areas of all facilities at any level of the supply chain involved in the order and to all applicable records EDI ensures the adequacy of specified purchase requirements prior to their communication to the supplier. EDI policy QOP Purchase Order Generation applies to all activities related to procurement or lease of all services, products and components. QOP Purchase Order Generation also describes the requirements for Quality Assurance flow down. Suppliers are evaluated and selected per QOP-06-01, Supplier Selection, Approval and Monitoring Procedure Verification of Purchased Products EDI establishes and implements inspection and/or other activities necessary for ensuring that purchased product meets specified requirements (Reference QOP-10-01, Inspection and Test Verification methods include: Obtaining objective evidence of the conformity of the product from suppliers, such as accompanying documentation, certificate of conformance, test records, statistical records, and process control records Inspection and audit at the supplier's premises Review of the required documentation Inspection of products upon receipt Where purchased product is released for production use prior to completion of all required verification activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements. Where EDI utilizes test reports to verify purchased product, the data in those reports must be acceptable per applicable specifications. EDI periodically validates test reports for raw material. Where EDI or its customer intends to perform verification at the supplier s premises, EDI states the intended verification arrangements and method of product release in its purchasing information. Verification activities may include delegation of verification to the supplier, or supplier certification. Where EDI delegates verification activities to the supplier, the requirements for delegation are defined and a register of delegations maintained.

28 T.K. Moore AS /24/ Production and Service provision Control of Production and Service EDI plans and carries out production under controlled conditions as stated in QOP-10-01, Inspection and Test. EDI management ensures controlled production conditions through: The availability of information that describes the characteristics of the product The availability of work instructions, as necessary The use of suitable equipment The availability and use of monitoring and measuring equipment The implementation of monitoring and measurement The implementation of product release, delivery and post-delivery activities Accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product) Evidence that all manufacturing and inspection/verification operations have been completed as planned, or as otherwise documented and authorized Provisions for the prevention, detection, and removal of foreign objects, (QOP Foreign Object Damage) Monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product conformity Criteria for workmanship, stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations) Production Process Verification WI , First Article Inspection defines the process for the inspection, verification & documentation of a representative item from the first production run of a new part or assembly, to verify that the production processes, production documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, manufacturing process changes, tooling changes) Control of Production Process Changes Personnel authorized to approve changes to production processes are identified. EDI controls and documents changes affecting processes, production equipment and tools. This system is documented in QOP-09-01, Process Control. The results of changes affecting processes are assessed to confirm that the desired effect has been achieved without adverse effects to product conformity.

29 T.K. Moore AS /24/ Control of Production Equipment, Tools and Software Programs Production equipment, tools and software programs used to automate and control/monitor product realization processes, are validated prior to use and maintained per WI , Control of Production Equipment Programs and Software. Storage requirements, including periodic preservation/condition checks, are established for production equipment or tooling in storage Post Delivery Support Post delivery support shall provide as applicable for the: Collection and analysis of in-service data Actions to be taken, including investigation and reporting, when problems are detected after delivery Control and updating of technical documentation Approval, control and use of repair plans Controls required for off-site work performed by EDI This process is detailed in QOP-19-01, Warranty Validation of Processes EDI validates any production processes where the resulting output cannot be verified by subsequent monitoring or measurement (reference WI , Control of Production Equipment Programs and Software, and consequently, deficiencies would become apparent only after the product is in use or been delivered. These processes are frequently referred to as special processes. Validation demonstrates the ability of these processes to achieve planned results. EDI establishes arrangements for these processes including, as applicable: Defining criteria for review and approval of these special processes Approving equipment and qualifying personnel Using specific methods and procedures Keeping records (see 4.2.4) Revalidation Identification and Traceability EDI identifies the product by suitable means throughout product realization (reference QOP Product Identification and Traceability). Product status is identified with respect to monitoring and measurement requirements. EDI maintains the identification of the product configuration in order to identify the difference between the actual configuration and the agreed configuration.

30 T.K. Moore AS /24/ When used, EDI has established appropriate controls for the use of acceptance authority media (e.g., stamps, electronic signatures, passwords). Where traceability is required, EDI controls and records the unique identification of the product and maintains records (see 4.2.4). According to the level required by contract, traceability requirements can include: Identification to be maintained throughout the product life The ability to trace all the products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (e.g., delivery, scrap) of all products of the same batch For an assembly, the ability to trace the identity of its components and then to the next higher assembly A retrievable sequential record for a given product s production (manufacture, assembly, inspection/verification) Customer Property EDI exercises care with customer property while it is under the control of or being used by EDI. EDI identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product per QOP , Control of Customer Supplied Materials. If any customer property is lost, damaged or otherwise found unsuitable for use, it is reported to the customer and records are maintained (see 4.2.4). Details on notification are found in QOP-07-01, Control of Customer Supplied Materials Preservation of Product EDI preserves the product during internal processing and delivery to the intended destination per QOP Handling, Storage, Packaging, Preservation and Delivery, in order to maintain conformity to requirements. Preservation includes identification, handling, packaging, storage and protection as applicable. Preservation is in accordance with applicable product specifications, statutory and regulatory requirements. Preservation also includes provisions for: Cleaning Prevention, detection and removal of foreign objects (QOP Foreign Object Damage) Special handling for sensitive products Marking and labeling including safety warnings Shelf life control and stock rotation Special handing for hazardous materials Preservation also applies to the constituent parts of products. 7.6 Control of Monitoring and Measuring Equipment EDI determines the monitoring and measurement to be undertaken and the equipment needed to provide evidence of conformity of product to stated requirements (see 7.2.1). QOP-11-0, Control of Inspection Measuring and Test Equipment provides additional detail.

31 T.K. Moore AS /24/ EDI maintains a register of monitoring and measuring equipment, and defines the process employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. Monitoring and measuring equipment includes, but is not limited to: test hardware, test software, and automated test equipment (ATE). It also includes personally owned and customer supplied equipment used to provide evidence of product conformity. EDI establishes processes to ensure that monitoring and measurement are carried out in a manner that is consistent with monitoring and measurement requirements. EDI ensures that environmental conditions are suitable for the calibrations, inspections, measurements and testing. Where necessary to ensure valid results, measuring equipment is: Calibrated and/or verified at specific intervals or prior to use against equipment traceable to international or national measurement standards; where no such standards exist, the basis used for calibration/verification is recorded (see 4.2.4) Adjusted or re-adjusted as necessary Identified to enable the calibration status to be determined Safeguarded from adjustments that would invalidate the measurement results Protected from damage or deterioration during handling, maintenance, and storage EDI has established, implemented and maintained a process for the recall of monitoring and measuring equipment requiring calibration or verification. In the event that equipment does not to conform to requirements, EDI assesses and documents the validity of the previous measuring results. EDI takes appropriate actions on the equipment and any product affected. Records of the results of calibration and verification are maintained (see 4.2.4) Confirmation of the ability of computer software to satisfy the intended application includes its verification and configuration management to maintain its suitability for use.

32 T.K. Moore AS /24/ SECTION 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General EDI plans and implements the monitoring, measurement, analysis and improvement processes needed: To demonstrate conformity to product requirements To ensure conformity of the management system To continually improve the effectiveness of the management system This includes the determination of applicable methods, including statistical techniques and the extent of their use. According to the nature of the product and depending on the specified requirements, statistical techniques can be used to support: Design verification (e.g. reliability, maintainability, and safety) Process control Selection and inspection of key characteristics Process capability measurements Statistical process control Design of experiment Inspection Failure mode, effect and criticality analysis 8.2 Monitoring and Measurement Customer Satisfaction As one of the measurements of the performance of the management system, EDI monitors information relating to customer perception as to whether we have met their requirements. The methods and their effectiveness for obtaining and using this information are determined. Information monitored for this evaluation includes, but is not limited, to: product conformity; on time delivery performance; customer scorecards; results of customer audits, customer complaints and corrective action requests. EDI develops and implements plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results. Determination of customer satisfaction is described in QOP-03-06, Customer Satisfaction Internal Audits EDI conducts internal audits at planned intervals to determine whether the quality management system: Conforms to planned arrangements (see 7.1), to the requirements of AS9100 and to the EDI documented management system Is effectively implemented and maintained

33 T.K. Moore AS /24/ An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency are defined. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits, reporting results and establishing records are defined in QOP-17-01, Internal Quality Audits. Records of the audits and their results shall be maintained (see 4.2.4). The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformances and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results Monitoring and Measurement of Processes EDI management applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product. In the event of process nonconformity, EDI will: a. take appropriate action to correct the nonconforming process b. evaluate whether the process nonconformity has resulted in product non-conformance c. determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or products d. identify and control any nonconforming product in accordance with section Monitoring and Measurement of Product EDI monitors and measures the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria is maintained. This system is defined by QOP-02-01, Development of Quality Plans. Measurement requirements for product or service acceptance are documented. This documentation may be part of the production documentation, but must include: Criteria for acceptance and/or rejection Where in the sequence measurement and testing operations are performed Required records of the measurement results (at a minimum, indication of acceptance or rejection) Any specific measurement instruments required and any specific instructions associated with their use

34 T.K. Moore AS /24/ When critical items, including key characteristics have been identified, they are monitored and controlled in accordance with the established processes. When sampling inspection is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability). Records indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4). Where required to demonstrate product qualification, EDI ensures that records provide evidence that the product meets the defined requirements. Where product is released for production use pending completion of all required measurement and monitoring activities, it shall be identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements. Product release and delivery to the customer does not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable, by the customer. EDI ensures that documents required by the contract/order to accompany the product are present at delivery and are protected against loss and deterioration. 8.3 Control of Non-Conforming Product EDI ensures that product, which does not conform to product requirements, is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in QOP-13-01, Control of Nonconforming Product. The procedure defines the responsibilities for the review and disposition of nonconforming product as well as the process for approving personnel making these decisions. The term nonconforming product includes nonconforming product returned by a customer. Where applicable, EDI deals with nonconforming product by one or more of the following ways: By taking action to eliminate the detected nonconformity By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer By taking action to preclude its original intended use or application By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started EDI s nonconforming product control process provides for timely reporting of delivered nonconforming product By taking actions necessary to contain the effect of the nonconformity on other processes or products

35 T.K. Moore AS /24/ Dispositions of use-as-is, rework, or repair are used only after approval by an authorized representative of the organization responsible for design. Authorized representatives include personnel having delegated authority from the design organization. EDI does not use repair or use-as-is dispositions, unless specifically authorized by the customer, if the nonconformity results in a departure from the contract requirements. Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable. When nonconforming product is corrected, it is subject to re-verification to demonstrate conformity to the requirements. Records of the nature of nonconformances and any subsequent actions taken, including concessions obtained, are maintained (see 4.2.4). 8.4 Analysis of Data EDI determines, collects and analyzes appropriate data to determine the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. Analysis of data provides information relating to: Customer satisfaction (see 8.2.1) Conformance to product/customer requirements (see 8.2.4) Characteristics and trends of processes and products including opportunities for preventive action (see and 8.2.4) Suppliers (see 7.4) 8.5 Improvement Continual Improvement EDI continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, policy deployment and management review. The organization shall monitor the implementation of improvement activities and evaluate the effectiveness of the results. The structure of the continuous improvement process is defined in QOP-14-03, Continuous Improvement.

36 T.K. Moore AS /24/ Corrective Action EDI takes action to eliminate the cause(s) of nonconformances in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformances encountered. QOP Corrective and Preventive Action defines the requirements for: Reviewing non-conformances, including customer complaints Determining the causes of nonconformances Evaluating the need for action to ensure that nonconformances do not recur Determining and implementing action needed Recording the results of actions taken (see 4.2.4) Reviewing the effectiveness of corrective action taken Flow down of the corrective action requirements to a supplier, when it is determined that the supplier is responsible for the nonconformity Specific actions where timely and/or effective corrective actions are not achieved Determining if additional nonconforming product exists based on the causes of the nonconformities and taking further action when required Preventive Action EDI determines action to eliminate the causes of potential nonconformances in order to prevent their occurrence. Preventive actions are appropriate to their potential effects. QOP Corrective and Preventive Action defines the requirements for: Determining potential nonconformities and their causes Evaluating the need for action to prevent occurrence of nonconformances Determining and implementing action needed Recording the results of action taken (see 4.2.4) Reviewing the effectiveness of the preventive action taken Examples of preventive action opportunities include risk management, error proofing, failure mode and effect analysis (FMEA), and internal audits.

37 T.K. Moore AS /24/ Attachment 1 Process Overview