Department of the Army Headquarters Tobyhanna Army Depot Tobyhanna, PA 18466-5072

*TYAD Regulation No. 702-15 7 April 2011

Product Assurance ISO 9001 Quality Manual __________________________________________________________________ Applicability. This regulation applies to all organization elements of Tobyhanna Army Depot. Decentralized Printing. Activities of this installation are authorized to locally reproduce this memorandum. Publications appearing in paper form are not controlled and should be checked against the intranet prior to use. Supplementation. Supplementation of this regulation and establishment of local forms are prohibited unless prior approval is obtained from Tobyhanna Army Depot, ATTN: ELTY-MPQ, 11 Hap Arnold Boulevard, Tobyhanna, PA 18466-5072. Suggested Improvement. The proponent agency of this regulation is Tobyhanna Army Depot. Users are invited to send comments to Tobyhanna Army Depot, ATTN: ELTYMPQ, 11 Hap Arnold Boulevard, Tobyhanna, PA 18466-5072. Distribution. Tobyhanna Army Depot Publications are distributed to all organizational elements and tenant activities that have a local domain account. Activities without a local domain account may obtain copies from Records Management, Directorate of Information Management. __________________________________________________________________ FOR THE COMMANDER:

Official:

CHARLES C. GIBSON Colonel, Logistics Corps Commanding

//signed// MARY GRACE E. WASHO Publications Control Officer Directorate of Information Management *This regulation supersedes Tobyhanna Army Depot Regulation No. 702-15, 28 December 2009.

TYAD Regulation No. 702-15 NOTE: This is a CONTROLLED document, as are all system files on this server. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use.

TYAD Regulation No. 702-15 SUMMARY OF CHANGE This revision dated 7 April 2011: o Adds Summary of Change Page. o Adds commitment and continual improvement in section 5.3 Quality Policy. o Adds Production Management assesses the availability of tools and Production Engineering assesses the availability of technical data within section 6.1 Provision of Resources. o Adds reference to holding management accountable for current processes that are not monitored and process that do not currently exist within section 8.2.2 Internal Audit. o Removes reference to MD-027, Processing and Accountability of Scrap Materials from section 8.2.4 Monitoring and Measurement of Product. o Adds reference to MD-106, Control and Disposition of Nonconforming Product in Mission Directorates to section 8.2.4 and section 8.3 Control of Nonconforming Product.

TYAD Regulation No. 702-15 Contents Scope General Application Normative Reference Terms and Definitions Quality Management System General Requirements Documentation Requirements Management Responsibility Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority and Communication Management Review Resource Management Provision of Resources Human Resources Infrastructure Work Environment Product Realization Planning of Realization Processes Customer-Related Processes Design and Development Purchasing Production and Service Provision Control of Monitoring and Measuring Equipment Measurement, Analysis and Improvement General Monitoring and Measurement Control of Nonconforming Product Analysis of Data Improvement Appendix A 4 Paragraph 1 1.1 1.2 2 3 4 4.1 4.2 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5 5 5 6 9 9 9 9 10 10 11 12 12 12 13 13 13 13 14 15 17 18 19 21 21 21 23 24 24 A-1 Page 5 5 5 5 5

TYAD Regulation No. 702-15 1 Scope 1.1 - General This Quality Manual describes the policies and organization-wide processes that meet Tobyhanna Army Depot (TYAD) needs and the requirements of ISO 9001. 1.2 Application TYAD, located in Tobyhanna, Pennsylvania, is a full-service electronics maintenance facility in the Department of Defense (DOD). The Quality Management System (QMS) described in this Quality Manual applies to the repair; overhaul; power projection and logistics support in the Directorates of Command, Control, Computers/Avionics; Intelligence, Surveillance and Reconnaissance; Communication Systems; Systems Integration and Support and supporting organizations. The QMS complies with the requirements of ISO 9001. TYAD out sources functions such as calibration and supply services. Purchasing 7.4 is excluded from this QMS as TYAD does not have purchasing responsibility. Consequently, the requirements of 7.4.1 Purchasing Process and 7.4.2 Purchasing Information have been excluded. Should these situations change, appropriate systems will be developed, implemented, and maintained. Contracting now reports to the United States Army Contracting Command Aberdeen Proving Ground (C4ISR) who performs these purchasing functions. 2 Normative Reference The following referenced documents are indispensable for the application of this document: a. ISO 9000:2005, Quality Management Systems Fundamentals and Vocabulary b. ISO 9001:2008, Quality Management Systems Requirements 3 Terms and Definitions For the purposes of this document, the terms and definitions given in ISO 9000 apply. Throughout the text of this Regulation, wherever the term product occurs, it can also mean service. 4 - Quality Management System 4.1 - General Requirements 5

TYAD has established, documented, implemented and maintains the Quality Management System (QMS) described in this quality manual, and continually improves its effectiveness to TYAD Regulation No. 702-15 meet TYAD, customer, applicable statutory and regulatory, and ISO 9001 requirements. TYAD maintains required QMS approvals and any other approvals, certificates, ratings, licenses and permits required by the Communications-Electronics Command (CECOM), Department of the Army, Navy, and Air Force. TYAD has established processes needed to sustain the QMS and the criteria and methods needed to ensure that both the operation and control of these processes remain effective have been determined and documented. TYAD has identified the sequence and interaction of these processes in Appendix A, TYAD Product Realization Process. The Corporate Philosophy process and Management Reviews ensure availability of resources and information necessary to support QMS processes by providing: a. Operation and monitoring. b. Measurement and analysis. c. Implementation of actions necessary to achieve planned results and continual improvement. These processes are managed by the organization in accordance with the requirements of ISO 9001. Processes needed for the QMS refers to processes for management activities, provision of resources, product realization, and measurement. TYAD ensures that any outsourced processes that affect product conformity with requirements are in alignment with the QMS. 4.2 - Documentation Requirements 4.2.1 General The TYAD ISO Quality Manual mirrors the depot QMS that includes the quality policy, quality objectives, and references to supporting documentation as required by ISO 9001. 4.2.2 Quality Manual The ISO 9001 Quality Manual is maintained as a controlled document. It is available electronically on the depots Intranet web site to include references to documents needed by the depot to ensure effective planning, operation and control of the QMS. These references include systems and procedures for: establishing and maintaining personnel proficiency, personnel rosters, training programs, technical data, performing preliminary inspection of maintained articles (as applicable), inspecting documentation relevant to an accident for hidden damage before maintenance/repair/overhaul is performed, performing final inspection and return to service of maintained articles; and governing work performed at 6

another location. The cross reference between the standards, the Quality Manual and the referenced TYAD policies/requirements is maintained. TYAD Regulation No. 702-15 4.2.3 - Control of Documents TYAD maintains processes for reviewing, approving, and maintaining all QMS documentation to ensure that documents are current, available, and are removed when invalid or obsolete. If retained for any purpose, obsolete documents are identified to preclude their use. The following documents are available on TYADs Intranet site and are updated as needed. a. Tobyhanna Army Depot Regulation Index located under Publications, Regulations folder b. Mission Directive Index located under Mission Support - Mission Directives folder c. Standard Work/Work Instructions Index located under Mission Support Standard Work folder, Work Instruction folder. Authorized personnel review each document prior to issue, or upon modification. Change history records include the nature of the change. Internal and external documents required by the QMS, and data that supports the system, such as validation reports, design and history records, and calibration and maintenance records, are controlled and maintained in designated areas. TYAD Regulation 702-19, Development and Control of Level II and III Documentation, establishes relevant policy, responsibilities and procedural guidance. This regulation ensures that Level II and III documents are developed, approved and controlled in a uniform manner. The Technical Library controls external documentation via provisions detailed in TYAD Regulation 750-19 Configuration Management. The following is a list of documents and their controlling instructions/authority: a. Technical Manuals (TMs) Army Regulation (AR) 25-30, Department of the Army Pamphlet (DA PAM) 25-30 b. Technical Bulletins (TBs) AR 25-30, DA PAM 25-30 c. Lubrication Orders (LOs) AR 25-30, DA PAM 25-30 d. Technical Orders (Air Force) Department of the Air Force, TO 00-5-1, AF Tech Order System, Air Logistics Center e. Department of Defense (DOD) Special Processes, formerly known as Depot Maintenance Work Requirements (DMWRs) Department of the Army, CECOM f. Technical Drawings TYAD Technical Library, TYAD Regulation 750-19, Engineering Change Proposals (ECPs) g. Technical Reference Orders (TROs) D/Production Engineering, TYAD Technical Library, TYAD Regulation 750-6, Research, Issue and Control of Technical Reference Data h. Alternate Test Procedures (ATPs) D/Production Engineering, MD-090 7

i. Final Performance Check (FPCs) D/Production Engineering, MD-090 TYAD Regulation No. 702-15 j. Statement of Work (SOW) D/Production Management/D/Production Engineering, TYAD Regulation 750-15 k. Standard Work (SW) D/MP, Process Engineering Division, TYAD Regulation 702-19, WIAA011 l. Work Instructions (WI) D/MP, Research and Analysis Division, TYAD Regulation 702- 19, WIAA010 m. Mission Directives (MDs) D/MP Research and Analysis Division, TYAD Regulation 702-19, MD-000 n. Job Hazard Analysis (JHAs) D/RK, Safety Division o. Test Data Sheets MD-059 p. Preparation and Processing of TYAD Publications TYAD Memorandum 25-1 When required by contract or regulatory requirements, TYAD coordinates changes with customers and/or regulatory authorities. 4.2.4 - Control of Records TYAD follows Army Regulation 25-400-2, The Army Records Information Management System (ARIMS), and Department of the Army Pamphlet 25-403, Guide to Recordkeeping in the Army, for control of records. Records indicate conformance to requirements. Records provide evidence of information created, information received and past activity, and they are used and controlled by all organizations at TYAD. Records include letters, memorandums, completed forms, statistical and narrative reports, graphics, photographs, audio/video recordings. Types of records may be hard copy or electronic calibration, contractor, supplier, inspection, personnel, production, quality, training, etc. records. Records, whether electronic or hard copy must be identified and stored in designated areas appropriately protected against unauthorized viewing, damage from water, fire and power interruptions and in a suitable environment to minimize deterioration and prevent loss. The Directorate of Information Management (DOIM) backs up electronic files, or they are backed up on administered personal hard drives. Records are identified, stored and maintained to ensure they are readily retrievable for analysis as needed. Where required by contract or regulatory requirements, records are available for review by customers or regulatory authorities. Production records (process tags, inter-shop movement tags, inspection records, test data sheets, automatic test equipment (ATE) print outs, etc.) for systems that are complete and have been shipped may be retained in the Directorate/Work Center responsible for that system. If retained, 8

the records will be identified stored, protected and readily retrievable. Army Regulation 25-4002 defines the method for controlling any records created by and/or retained by suppliers. The TYAD Regulation No. 702-15 retention of records is determined by the regulatory authority, Army Regulation 25-400-2, the Army Records Information Management System (ARIMS) and/or customer requirements. When regulatory authority/customer requirements cannot be determined, product and QMS records will be maintained for a minimum of three years. Records may be retained beyond the specified retention period for use as reference material for investigations and studies. Personnel records are maintained indefinitely. The appropriate authority/organization handles the disposition of records as indicated in Army Regulation 25-400-2, Chapter 7, Applying Disposition Instructions. Mandatory training for recordkeeping is conducted online in the Army Civilian Training, Education and Development System (ACTEDS). 5 - Management Responsibility 5.1 - Management Commitment Top management communicates the quality policy, quality objectives, customer requirements, and statutory and regulatory requirements to the organization using the communication process as defined in the Corporate Philosophy Handbook. Top Management provides resources necessary to maintain and improve the QMS and to meet objectives. 5.2 - Customer Focus Top management ensures that customer needs, expectations and requirements are determined and fulfilled with the aim of enhancing customer satisfaction by the following; communicating the importance of meeting customer as well as any statutory and regulatory requirements, maintaining close customer contacts and feedback to TYAD, providing and supporting the QMS described in this Quality Manual. Top management ensures product conformity and on-time delivery performance are measured and appropriate action is taken if planned results are not, or will not be, achieved. 5.3 - Quality Policy The TYAD Quality Policy applies to all TYAD civilian employees, contractors and military personnel. The policy and the associated QMS documents establish the framework for setting and reviewing TYADs objectives for quality, cost and delivery performance, commitment and continual improvement of the QMS. The Quality Policy has been communicated throughout TYAD. Top management reviews the continuing appropriateness of the Quality Policy during the Management Reviews. Tobyhanna Quality Policy 9

Quality product delivered Understand customer requirements Assure best value TYAD Regulation No. 702-15 Lean environment for continual improvement Improvise methods for continual environmental stewardship Teamwork to transform customer expectations to reality Yield continuous superior products and service 5.4 - Planning 5.4.1 - Quality Objectives TYAD Corporate Philosophy identifies quality as a key focus area and top management develops specific, measurable objectives consistent with the quality policy and communicates these to all levels of the organization. These objectives include those needed to meet requirements for the product. Performance toward the objectives is monitored, evaluated, and reported to top management. The objectives are reviewed regularly and changed as necessary. 5.4.2 - Quality Management System Planning TYAD top management provides direct support to the Quality Management Division (QMD) to ensure that QMS planning described in this quality manual is carried out to meet customer requirements, the requirements of ISO 9001 and TYAD quality objectives. This support structure also ensures that integrity of the QMS is maintained when changes are planned and implemented. 5.5 - Responsibility, Authority and Communication 5.5.1 - Responsibility and Authority TYAD will ensure that responsibilities, authorities, and their interrelations are defined and communicated within the organization. Responsibilities and Authority is defined in TYAD Regulation 10-1, "Organization Missions and Functions". 5.5.2 - Management Representative Top management has appointed the Director, Productivity Improvement and Innovation as the management representative with responsibility and authority that includes: a. Ensuring processes needed for the quality management system are established, implemented and maintained, b. Reporting performance of the Quality Management System and any need for improvement to top management, c. Ensuring promotion of awareness of customer requirements throughout the organization. 10

TYAD Regulation No. 702-15 5.5.3 - Internal Communication Top management cascades information between all levels and functions of TYAD regarding the effectiveness of the QMS through the Corporate Philosophy communication process. TYAD has also implemented the Corporate Philosophy/Star Point process to effectively communicate information throughout the organization. The Public Address and Visual Information System, TYAD Intranet, the Tobyhanna Reporter (installation newspaper), periodic employee and supervisors bulletins, other available print and electronic media and the Supervisors Quarterly meetings are all used to disseminate information internally. 5.6 - Management Review 5.6.1 - General Top management reviews the complete QMS at least annually and portions of the QMS more frequently to ensure its suitability for TYAD operations, adequacy in meeting the standard requirements and effectiveness in meeting TYAD objectives. Management reviews are conducted at Primary Team meetings and the summary Management Reviews. Management reviews include assessing opportunities for improvement and the need for changes to the QMS, the Quality Policy and TYAD objectives. The Management Representative schedules management reviews, establishes agendas, and invites required management team members and employees. Records of the management reviews are maintained. 5.6.2 - Review Input Using information from various meetings as previously discussed and the associated Scorecard Reviews, the top management Prime Team regularly reviews TYAD performance and improvement opportunities. This includes, as applicable: internal and customer audit results, customer feedback, process performance and product conformity, corrective/preventive actions, follow up actions from previous scorecard reviews and management reviews, changes that could affect the QMS, changes of customer requirements that could impact TYAD, training processes, recommendations for improvement, results of audits and requests for corrective action from authorities and customers, the achievement/adequacy/effectiveness of personnel training programs and changes to authority requirement that could impact the organization. 5.6.3 - Review Output

11

Outputs from the management review process include decisions and actions for QMS improvement, as well as improvement of product and resource needs. This output is also used to develop strategic initiatives for the organization. TYAD Regulation No. 702-15 6 - Resource Management 6.1 - Provision of Resources TYAD provides all resources needed to implement, maintain and improve all QMS processes to ensure customer satisfaction is properly attained by meeting customer requirements. The QMS has processes to continually assess the availability of tools within Production Management, technical data within Production Engineering and necessary personnel to ensure the safe completion of the maintenance, repair and overhaul activities. These are explained in section 6.2.2 of this Quality Manual. 6.2 - Human Resources 6.2.1 - General TYAD and contractor personnel directly or indirectly affecting conformity to product requirements are deemed competent based on appropriate education, training, skills and experience. Certified personnel meet and maintain the applicable eligibility/personnel authority requirements. Noncertified personnel receive appropriate formal and on-the-job training and, until deemed competent, are closely supervised and certified personnel approve their work. 6.2.2 - Competence, Awareness and Training TYAD personnel and contractors who are performing services under contracts which affect the quality of products or services are selected based on their competence or qualifications to perform the work. Selection criteria for government personnel are defined and established in the Office of Personnel Management (OPM) qualifications standards that include required education, training, skills and experience. Job duties and responsibilities are outlined in detailed job descriptions specific to individual jobs. Selection and performance criteria for contractor support must be stated in an evaluation plan and performance work statement for each contract requirement. To ensure that employees are able to adequately perform their assigned responsibilities, job specific training programs are identified, implemented and recorded as prescribed in TYAD Regulation 621-2, Education and Training. For each position, the organization either provides training or employs individuals with appropriate education, background and experience. The organization evaluates the effectiveness of the training or other activities designed to meet skill requirements. TYAD makes personnel aware of the importance of their activities to the quality of the product and to the achievement of quality objectives. Appropriate records of the education, training, skills, and experience of its personnel are continually maintained.

12

TYAD Regulation No. 702-15 6.3 - Infrastructure TYAD provides and maintains the infrastructure necessary to achieve conformity to product requirements on-site or off-site. Infrastructure includes any workspace, building, equipment, hardware, software, information systems, supporting service, transport, communication and associated or related utilities. TYAD Regulation 700-7, Management of Installation Equipment prescribes policies and assigns responsibilities and procedures required for obtaining optimum utilization and maintenance management of Installation Equipment to meet mission requirements with a minimum of equipment. The Facilities Equipment Management System is used to manage trouble calls and preventative maintenance for facilities and equipment. Environmental guidance is provided within TYAD Regulation 200-5, Environmental Management System Manual. 6.4 - Work Environment Management identifies and manages those human and physical factors of the TYAD work environment required to achieve product conformity. Commanders Policy Memorandum #3, Safety and Occupational Health ensures that TYAD has an effective and comprehensive Safety and Occupational Health Program. TYAD Regulations Series 385 Safety, prescribes policies, procedures and responsibilities to protect and preserve TYAD personnel from injury and property losses. Management strives to maintain a work environment that achieves product requirements. This includes appropriate controls on temperature, humidity, lighting, cleanliness, protection from electrostatic discharge, etc. 7 - Product Realization 7.1 - Planning of Realization Processes TYAD plans and develops the processes and process documents needed for product realization in accordance with Appendix A. Typically the Directorate of Business Management initiates new product or project investigation and planning by the Directorate of Production Management for capacity and Directorate of Production Engineering for technical feasibility. Planning of the realization processes is consistent with the other requirements of the organization's QMS and is documented in a format suitable for the organization's method of operation. TYAD also identifies the need for processes and documents the processes to the extent that the processes affect quality. The need for verification, validation, monitoring, measurement and inspection activities and the criteria for acceptability are determined. The Logistics Modernization Program (LMP) is the system of record used for work loading purposes. LMP is used for planning and execution to include cost, schedule, and resource and program requirements. Records to support these activities are created and maintained. 13

TYAD Regulation No. 702-15 7.2 - Customer-Related Processes 7.2.1 - Determination of Requirements Related to the Product TYAD will determine the requirements for its products including: customer specific requirements, including delivery and post-delivery activities; product requirements not specified by the customer, but necessary for the product's intended use; statutory, regulatory and other additional requirements determined by the organization. TYAD Regulation 750-15, Statement of Work (SOW) defines the policy and responsibilities on controlling Statements of Work (SOW), in support of mission workload and Test Program Set (TPS) development and/or technical support. 7.2.2 - Review of Requirements Related to the Product TYAD reviews all requirements related to the product and the ability to fulfill customer requirements to ensure product requirements are defined, and any requirements differing from those previously expressed are resolved. Contractual requirements regarding, for example, scope of work, technical data, delivery and subcontracting work are reviewed to ensure product requirements are adequately defined, according to TYAD Regulation 11-9, Bid/No-Bid Process. The TYAD planning process also identifies and evaluates risks such as new technology and short delivery times and any statutory and regulatory requirement related to the product along with any additional TYAD requirements. All results of reviews, and actions rising from reviews, are recorded and retained. If a customer provides no documentation of requirements, the organization will confirm the requirements for the customers order prior to acceptance. Procedures for the preparation and control of technical reference orders (TROs) are described in TYAD Regulation 750-6, Research, Issue and Control of Technical Reference Data. This process is used for overhaul and repair workload. LMP operation control tickets are used for all fabrication workload to include shop travelers to identify the process operations and the order in which they occur. QMD assigns Technical Action (TA) numbers, to report component and/or Basic Issue List Item (BILI) shortages. TA numbers are assigned only when correspondence from the customer authorizing the shortages, is presented with ELTY Form 4304, Report of Component and/or Basic Issue Item (BII) Shortage. The TA Tracking system can also be utilized to manage and control requests for deviations/waivers.

14

As changes occur in product requirements, TYAD ensures that all relevant documentation is prepared and all relevant personnel are informed of the changes. TYAD Regulation No. 702-15 TYAD Regulation 750-15 describes the customer/TYAD interface process if program changes occur. Relevant documents are amended and relevant personnel are made aware of changed requirements. Contract amendment processes include provisions for disposition of out of scope defects discovered during maintenance. 7.2.3 - Customer Communication TYAD implemented all arrangements necessary to communicate effectively with customers regarding customer feedback (including complaints, product information, inquiries and contracts). TYAD provides a formal means for customers to register complaints through TYAD Regulation 702-18, Procedure for Processing Product Quality Deficiency Reports and Customer Satisfaction Claims, and TYAD Regulation 11-8, Customer Satisfaction Program, Liaison contacts, Forward Repair Activities, structured Commodity Management, etc. 7.3 - Design and Development 7.3.1 - Design and Development Planning When TYAD has design and development responsibility, the responsible personnel control and verify the product and service designs to ensure satisfaction of customer requirements. TYAD Regulation 750-21, System Engineering Management Plan (SEMP) defines the design activities and the responsibility for their implementation. Responsible personnel design and update development plans as part of the ongoing design process, including the review, verification and validation requirements. The groups that define the design input are identified and their working relationship established as part of that planning process. The specific design requirements are documented and reviewed to confirm that regulatory requirements are met and that any incomplete, conflicting or ambiguous requirements are resolved. TYAD manages the interfaces between different groups to ensure effective communication and clear assignment of responsibility. 7.3.2 - Design and Development Inputs Responsible personnel review inputs into the design process to resolve conflicting or ambiguous requirements. Input requirements will include functional, performance, applicable statutory and regulatory, and other essential requirements for the design and development process. Where appropriate, design and development inputs may include information derived from previous similar designs. 7.3.3 - Design and Development Outputs

15

Responsible personnel will document all outputs of the design and development process in a manner that enables verification of the design and development inputs. This will include meeting the input requirements and providing appropriate information for purchasing, production, and service provisions. Design and development outputs will contain or reference TYAD Regulation No. 702-15 product acceptance criteria and specify any characteristics of the product that are essential for safe and proper use. 7.3.4 - Design and Development Review At appropriate design and development stages, responsible personnel conduct systematic reviews. The purpose of each review is to evaluate the ability of the results of the design and development process to fulfill product requirements. Additionally, the review process identifies problems and proposes actions to resolve those problems. The review process includes personnel from the areas under review. The results of the review will be recorded and maintained by the organization. 7.3.5 - Design and Development Verification Design requirements are routinely checked against the outcome of the design process using predetermined acceptance criteria. The review identifies those characteristics that are important to the safe and effective functioning of the product or service. Comparisons of design requirements and their outcome are formally reviewed at appropriate stages of the design process, and verification activities, such as testing are performed. Testing the final result under defined operating conditions to ensure that it conforms to user needs and requirements ordinarily validates the resulting product or service. The organization maintains records of verification activities. 7.3.6 - Design and Development Validation Design and development validation is performed to confirm that the resulting product is capable of meeting the requirements of its intended use. Wherever applicable, validation is completed prior to the delivery or implementation of the product. Where it is impractical to perform full validation prior to delivery or implementation, partial validation is performed to the extent possible. The organization maintains records of validation activities. TYAD Regulation 702-5, Pre-Production/First Article Inspection establishes policies, prescribes responsibilities, and provides procedural guidance for First Article/First Piece inspections during repair, overhaul, fabrication, or manufacturing of an item for the first time. 7.3.7 - Control of Design and Development Changes Throughout the design process, all changes and modifications to the design will be documented, reviewed, and approved before implementation as defined in TYAD Regulation 750-19, Configuration Management. The review includes an evaluation of the effect of the changes on

16

parts and delivered product. The organization maintains records of design and development change reviews and any necessary actions.

TYAD Regulation No. 702-15 7.4 - Purchasing Materials for maintenance and manufacturing are supplied by Defense Logistics Agency (DLA), partners or contracts/purchases negotiated outside the scope of this QMS. 7.4.1 - Purchasing Process Production materials and services are acquired from three primary sources; DLA, Local Procurement and Local Manufacturing. TYAD requisitions required parts from DLA (see Section 7.5.4) for required repairs. DLA purchases from established sources of supply that have appropriate governmental approvals and TYAD requisitions the equipment and materials necessary to meet customer requirements. If equipment or required material cannot be requisitioned from DLA they are procured by Army Contracting Command (ACC) or locally manufactured by TYAD. The DLA and ACC requisitioned production material falls into the category of Government Furnished Equipment/Material and are not purchased by TYAD. (See Section 7.5.4 Customer Property for handling of DLA and ACC supplied equipment and material). Therefore, the purchasing requirements of 7.4 are excluded from this QMS. Should these circumstances change an appropriate purchasing activity will be developed. 7.4.2 - Purchasing Information D/MM requisitions needed production materials from DLA or ACC, as required. 7.4.3 - Verification of Purchased Product TYAD identifies and implements the activities needed to ensure that repair materials meet requirements. Where TYAD or its customers proposes to perform verification activities at a supplier's premises, the intended arrangements are prescribed by Federal Acquisition Regulation (FAR) Part 46 - Quality Assurance, along with the method of product release, in the purchasing information. Retail supplies are processed in accordance with TYAD Regulation 750-24, Retail Level (Below Wholesale) Receiving Process. 7.5 - Production and Service Provision 17

TYAD Regulation No. 702-15 7.5.1 - Control of Production and Service Provision TYAD carries out all production and service operations under controlled conditions. As required, these include the availability and characteristics of the product by LMP and the Technical Reference Order System (TROs); use and implementation of product information; work instructions as described in Section 4.2.3; equipment; measuring and monitoring devices as described in Section 7.6; and release per MD-094, Processing and Control of Repairable Wholesale Items and Foreign Military Sales Items for delivery and post delivery activities. 7.5.2 - Validation of Processes for Production and Service Provision TYAD validates all production and service processes where the resulting output cannot be verified by subsequent measurement and/or monitoring in accordance with TYAD Regulation 702-05. Validation demonstrates the ability of the processes to achieve planned results. TYAD defines all validation arrangements, including qualification of processes, requirements for records, qualification of equipment and personnel, revalidation, and the use of defined methodologies and procedures. Items processed through the Depots Certification Program will be in accordance with MD-056, Certification of Product Lines, Process Lines, and Work Centers. 7.5.3 - Identification and Traceability TYAD maintains product identification, required traceability and inspection/test status from receipt through all stages of production and testing to delivery. TYAD maintains the identification of the configuration of the product to identify any differences between the actual configuration and the agreed configuration via TYAD Regulations 750-06 and 750-19. Where specified traceability requirements exist and where batch identification is a part of that requirement, unique identification procedures and a record of the identification are maintained. The statuses of all products are identified with respect to defined monitoring and measurement requirements as described in MD-001, Control of Inter-Shop Movement of Materials for Processing". Where applicable, TYAD maintains suitable material identification and processing traceability for its product throughout the product realization processes. Inspection and test status of product or parts, indicating the conformance or nonconformance regarding inspection and tests preformed is accomplished in accordance with MD-064, Processing Production Inspection Results and Data Reporting, MD-055, Process Control of Materiel, MD-001, Control Of Inter-Shop Movement Of Materials for Processing and Army Materiel Command (AMC) Order Travelers.

18

Where specified traceability requirements exist and where batch identification is a part of that requirement, unique identification procedures and a record of the identification is maintained. TYAD Regulation 740-1, Management of Shelf-Life Materials establishes policy, responsibilities, and procedural guidance to ensure all materials received, stored, and used have been evaluated to determine if the material is suitable for its intended purpose, and recommends TYAD Regulation No. 702-15 procedures for optimizing shelf-life of these materials whenever possible to minimize waste disposal. Inspection stamps are issued and controlled in accordance with desktop procedure Quality Directive (QD-02), Issuance and Control of Quality Inspection Stamps, dated 9 March 2010. The stamps and are used by Quality Management and Quality Improvement Division personnel to identify tasks they perform. 7.5.4 - Customer Property TYAD receives two types of customer property: first, customer assets to be repaired, and second, materials and supplies necessary to make the necessary repairs. Based on examination of assets to be repaired or items ordered, TYAD requisitions customer property thru DLA. TYAD provides suitable means for the identification, verification, storage, and maintenance of customer property as prescribed by TYAD Regulation 735-16, Government Furnished Equipment/Material. The customer will be informed of goods that are lost, damaged, or otherwise unsuitable for use and records of such communication will be maintained. Customer owned project equipment is controlled in accordance with TYAD Regulation 735-10, Customer Owned Project Equipment (COPE). 7.5.5 - Preservation of Product TYAD provides suitable methods for the identification, handling, storage, packaging, preservation, and delivery of product as described in MD-97, Intra-Depot Movement of Materiel in Maintenance Processing. TYAD Regulation 200-1, Hazardous Material Handling, TYAD Regulation 740-1, Management of Shelf-Life Materials, review handling methods for products, including hazardous materials. Handling methods are designed to preclude mix-ups, deterioration, contamination or other damage to the product. Controlled condition and/or limited access areas are designated and used, as needed, to prevent deterioration. Packaging materials are selected and specified, as necessary, to ensure that product conformance to requirements are maintained throughout its distribution. Preservation methods, including controlled environmental conditions are planned to ensure continuing conformance to requirements during handling and storage. Distribution is arranged to protect the product during delivery to the extent under the control of TYAD. Electrostatic Discharge Precautions will be taken in accordance with TYAD-Regulation 750-32, Electrostatic Discharge Sensitive Item Control Program. 7.6 - Control of Monitoring and Measuring Equipment 19

The monitoring and measurements undertaken to provide evidence of product conformity uses Test Measurement and Diagnostic Equipment (TMDE) typically specified by customer provided technical data. To ensure they are properly performed, qualified personnel perform monitoring and measuring actions using properly maintained and calibrated equipment. TMDE complies with TYAD Regulation 702-17, Control and Use of TMDE. Monitoring and measuring TYAD Regulation No. 702-15 equipment are calibrated at the prescribed intervals, or prior to use. DA 80, US Army Calibrated Instrument or DA Label 163, US Army Limited or Special Calibration, are applied to identify calibration status. Calibration, repair and maintenance of TMDE are outsourced to the United States Army TMDE Support Center (USATSC), Tobyhanna. All calibrations are traceable to the National Institute of Standards and Technology. Evidence of standards used to calibrate all TMDE are provided to the owner(s) and documented on DA Form 7372, TMDE Calibration and Repair Data, upon completion of calibration. Records of calibration and verification are maintained. Calibration of all TMDE will be performed according to TYAD Regulation 702-17, TYAD Regulation 702-16, Operation of Special Standards (TMDE), AR 750-43; TB 750-25; TB 43180. In accordance with MD-118, TYAD maintains a register of monitoring and measuring equipment. This is accomplished with the Tool Inventory Management Application (TIMA), the D15 Database list (Depot Calibration Interval Authority), and the TMDE Integrated Materiel Management System (TIMMS) Master List. The process utilized for calibration is defined to include details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. Customer supplied equipment used to provide evidence of product conformity is controlled in accordance with MD-055 and MD-118. TYAD does not permit use of personally owned equipment. Calibration intervals specified in TB 43-180 and manufacturer recommended intervals be used as a guide. Changes to calibration intervals will be determined based upon past performance, as recorded on DA Form 7372. Users of test and measurement equipment are responsible for ensuring equipment is within the certification interval and is being used and maintained properly. Equipment that is damaged, inaccurate, or suspected of requiring repair or replacement will be reported immediately through supervisory channels to the USATSC for corrective action. TYAD Regulation 702-17 and MD-118 ensure that environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out, and that measurement equipment is recalled to a defined method when requiring calibration. D/Productivity Improvement and Innovation will designate a Calibration Coordinator. This individual will monitor the TYAD Calibration Program. Production Engineering Directorate will ensure that TMDE in the acquisition process addresses supportability to include procedures, standards, and accessories. TMDE requiring calibration that is in use must bear objective evidence that it has been calibrated within the required interval. TMDE items not being used will be placed in Calibration Before Use (CBU) status and secured. TMDE items not needing 20

calibration will be placed in Calibration Not Required (CNR) status. Criteria for CBU and CNR status are described in TB 750-25. Mission directorates will ensure timely calibration of TYAD instruments, of which each is identified in the TIMMS Master List and the Instrument Master Record File, which shows when an item is to be turned in for calibration. TYAD Regulation No. 702-15 TMDE found by USATSC to be significantly out of tolerance is reported to Productivity Improvement and Innovation Directorate on AMSAM-TMD-A Form 45, Calibration Standard Out of Tolerance Failure Report and the necessary action will be taken in accordance with TYAD Regulation 702-13, Reporting Out-Of-Tolerance. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is undertaken prior to initial use and reconfirmed as necessary. The extent and frequency of such checks is established and records maintained in accordance with TYAD Regulations 750-6 and 750-19 where necessary safeguards are in place to prevent test hardware and test software from adjustments which would invalidate the measurement result. Monitoring and measurement equipment is protected from damage and deterioration during handling, maintenance and storage. 8 - Measurement, Analysis and Improvement 8.1 - General TYAD defines plans and implements the monitoring and measurement activities needed to demonstrate product conformity and ensure conformity and continual improvements of the QMS effectiveness. This includes determination of applicable methods, including statistical techniques, and the extent of their use. 8.2 - Monitoring and Measurement 8.2.1 - Customer Satisfaction Fielding teams, customer surveys and customer feedback are tools utilized to monitor information that identifies customer perception to determine whether their requirements have been met. The information obtained will be used during the determination of activities implemented to ensure continual improvement and effectiveness of the QMS. Appropriate actions are taken to ensure that levels of Customer Satisfaction are high. Customer complaints are investigated and actions taken in accordance with TYAD Regulation 702-18, Procedure for Processing Product Quality Deficiency Reports (PQDRs) and Customer Satisfaction Claims. TYAD Regulation 11-8, Customer Satisfaction Program, establishes policy, 21

responsibilities, and procedural guidance for the customer service desk and customer satisfaction surveys.

TYAD Regulation No. 702-15 8.2.2 - Internal Audit TYAD conducts internal audits of the QMS at planned intervals to ensure that activities comply, as applicable, with the requirements of ISO 9001 and customer requirements, this quality manual and the needs of TYAD. TYAD Regulation 702-12, Audit Program defines audit responsibilities, frequency, criteria, scope and methods. Audits of specific areas and functions are scheduled based on the status and importance of the activity to be audited and the results of past audits. Audit results are treated expeditiously to prevent undue delay of corrective action. Personnel competent to audit the activity, and who do not have direct responsibility for the area being audited, carry out audits. Auditors are selected and assigned in a manner that ensures the objectivity and impartiality of the audit process. Records of the audits and their results are maintained. Audit reports are directed to management personnel having responsibility for the areas audited. Management are held accountable for any processes that are not monitored and processes that do not currently exist. Management personnel responsible for audited areas ensure that timely actions are taken to eliminate detected nonconformities and their causes. The results of the audits and corrective actions are presented at the Scorecard Review. Follow-up activities include verification of the actions taken and the reporting of verification results and/or effectiveness. 8.2.3 - Monitoring and Measurement of Processes As identified in the scorecard process and the LMP Quality Module, TYAD applies suitable methods for monitoring and measuring the performance of QMS processes, where applicable, to demonstrate their ability to achieve planned results. These methods confirm the continuing ability of each process to satisfy its intended purpose. When results are not achieved, corrective actions are taken to ensure conformity of the processes. Statistical process control is utilized where applicable to control fundamental processes. 8.2.4 - Monitoring and Measurement of Product TYAD monitors and measures characteristics of the product to verify that requirements for the product are met at appropriate stages of the product realization process. Evidence of conformity and acceptance criteria are maintained and records indicate the person(s) authorizing release of the product. All production items are either inspected or processed in accordance with the 22

Depots Certification Program (see Section 7.5.2 for Certification Program requirements). The inspection process is described in MD-064, Processing Production Inspection Results and Data Reporting. Product release and service delivery proceed when all planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and where applicable, by the customer. Depot produced nonconforming product is identified by the Mission Directorate, segregated, tagged and controlled, and deficiencies recorded. The TYAD Regulation No. 702-15 corrective action required to prevent recurrence is evaluated and documented in the corresponding LMP Quality module. When product is reworked or repaired, it is re-inspected to assure conformance with the specified requirements. Nonconforming material are processed in accordance with MD-055, MD-064 and MD-106, Control and Disposition of Nonconforming Product in Mission Directorates. Scrap will be processed according to MD-003, Recycling Process. 8.3 - Control of Nonconforming Product TYAD maintains documented procedures per TYAD Regulation 742-1, MD-64 and MD-106 to prevent the use or installation of nonconforming products during repair, overhaul and maintenance. TYAD Regulation 702-18, Procedure for Processing Product Quality Deficiency Reports and Customer Satisfaction Claims, defines how to process nonconforming product returned from a customer. These procedures provide for identification, documentation, evaluation, segregation (when practical) and disposition of nonconforming product. The procedures also provide notification to the functions concerned and records of actions taken. When nonconforming product is detected after delivery or use has started, TYAD takes action appropriate to the effects, or potential effects, of the nonconformity including providing timely reporting of the delivered nonconforming product, where appropriate. Notifications include a clear description of the nonconformity as necessary, to include items such as parts affected, customer and/or organization part numbers, quantity and date(s) delivered. Parties requiring notification of nonconforming product may include suppliers, internal organizations, customers, distributors and Authorities. When nonconforming product is identified TYAD takes actions necessary to contain the effect of the nonconformity on other processes or products, where applicable. The TYAD procedures define the responsibility and authority for the review and disposition of nonconforming product and the process for approving personnel who may make these decisions. Nonconforming product is dealt with by one or more of the following ways: a. by taking action to eliminate the detected nonconformity;
b.

by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; 23

c. by taking action to preclude its original intended use or application;

d.

by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

TYAD Regulation No. 702-15 TYAD produced nonconforming product is identified by the Mission Directorate, segregated, tagged and controlled, and deficiencies recorded. The corrective action required to prevent recurrence is evaluated and documented in the corresponding LMP Quality module. Nonconforming materiel is processed in accordance with MD-003, MD-055, MD-064 and MD106. Nonconformances are recorded in LMP. In accordance with TYAD Regulation 702-18, use of any nonconforming product will be authorized through a customers approval, supervisor and QMD review. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. Records of the nature and disposition nonconforming product are maintained. 8.4 - Analysis of Data TYAD collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the QMS and to determine where improvement can be made via reviews such as Management and Scorecard Reviews. This analysis will provide information relating to customer satisfaction, conformance to product requirements, suppliers, characteristics and trends of products and/or processes, including opportunities for preventive action. 8.5 - Improvement 8.5.1 - Continual Improvement TYAD strives to continually improve the effectiveness of the QMS through the use of the Quality Policy, quality objectives, audit results, analysis of data, corrective and preventative actions, management reviews, and through the application of Lean and Six Sigma process improvement tools. TYAD also identifies best business practices for use by TYAD to improve quality, reduce cost, and improve products. TYAD has a formal improvement program, whereby employees at any level may submit improvement ideas. The Army Ideas for Excellence Program (AIEP) is specified in AR 5-17 and the Value Engineering Program is found in AR 5-4. 8.5.2 - Corrective Action TYAD eliminates the cause of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. TYAD Regulation 702-20, Corrective and Preventive Action, defines requirements for;

24

a. Reviewing nonconformities (including customer complaints). b. Determining the causes of nonconformities. c. Evaluating the need for action to ensure that nonconformities do not recur. TYAD Regulation No. 702-15 d. Determining and implementing action needed. e. Maintaining records of the results of actions taken. f. Reviewing the effectiveness of the corrective action taken. 8.5.3 - Preventive Action TYAD maintains a documented procedure, TYAD Regulation 702-20, Corrective and Preventive Action Procedures, for implementing preventive action. Preventive actions are taken to eliminate potential causes and occurrences of nonconformities and deficiencies. TYAD Regulation 702-20 describes the preventive action procedures for: a. Reviewing potential nonconformities. b. Determining causes of those nonconformities. c. Evaluating the need for actions. d. Determining and implementing the actions required. e. Reviewing the effectiveness of the actions taken.

25

26

TYAD Regulation No. 702-15 Appendix A

Tobyhanna Army Depot Product Realization Process

Customer experiences a need Compile Design Materials , Test Procedures

Has current capability been verified ? Yes Request forwarded to D / ME No

In-Process Review with Customer

Decline work No Fabrication / Overhaul ?

Is capability obtained ? Yes Meet with customer to develop Statement of Work (SOW) Draft SOW reviewed IAW TYAD Regulation 750-15

No

Are alternatives possible ? Fabrication Overhaul

Yes

Prototype fabricated

When Required Process through repair cycle

First Article Testing and Configuration Managed No

Is SOW complete ? Yes Approved SOW to D/ME and D/MM

Ready for Inspection ?

No

Evaluate and Correct Design / Process

Yes Production Acceptance Testing

Issue Technical Reference Order (TRO) or LMP Operation Control Ticket Fail Pass/Fail ? Fail

Package and Delivery Pass

A-1