QUALITY MANAGEMENT SYSTEM MANUAL ISO 9001:2008

Transcription

1 QUALITY MANAGEMENT SYSTEM MANUAL ISO 9001:2008 Revision: 9 Issue Date: 28 April 2014 CONTROLLED COPY Number: Issued to: UNCONTROLLED COPY A.M.S. Electronics, Inc. 113 Pillow Street, Butler, PA (724) fax (724)

2 TABLE OF CONTENTS SECTION: Manual Page Cover Page 1 Table of Contents 2 Quality Management System Approval 3 Revision History 4 Forward / Introduction 4 Quality Policy Statement 5 1 Scope 5 2 Normative Reference 5 3 Terms and Definitions 5 4 Quality Management System General requirements Documentation requirements 6 5 Management Responsibility Management commitment Customer focus Quality policy Planning Responsibility, authority, and communication Management review 14 6 Resource Management Provision of resources Human resources Infrastructure Work environment 17 7 Product Realization Planning and validation of product realization Customer-related processes Design and development Purchasing Production provision Control of monitoring and measuring devices 22 8 Measurement, Analysis and Improvement 23 Attachments: 8.1 General Monitoring and measurement Control of nonconforming product Analysis of data Improvement 25 A.M.S. Organizational Chart Attachment 1 27 A.M.S. Quality Policy Attachment 2 28 A.M.S. Process Diagram Attachment 3 29 Quality Manual.doc Page 2 of 29 Revision: 28 April 2014

3 QUALITY MANAGEMENT SYSTEM APPROVAL The following A.M.S. Electronics, Inc. management personnel have endorsed this Quality Program: PRESIDENT and CEO DATE: QUALITY ASSURANCE MANAGER DATE: PURCHASING MANAGER DATE: PRODUCTION MANAGER DATE: SALES MANAGER DATE: ENGINEERING DATE: ACCOUNTING DATE: Quality Manual.doc Page 3 of 29 Revision: 28 April 2014

4 REVISION Level REVISION HISTORY DESCRIPTION OF CHANGE OR ISSUE Effective Date 0 Original Release 20 Feb Clarified QP 8-3, Control of Nonconforming Product. 24 Mar Updated Scope to exclude Service, expand information on Design and Development (QP-7-3) and add all relevant Quality Procedures to their appropriate sections. Updated A.M.S. Organizational Chart. Updated Table of Contents to reflect Attachments 1-3. Updated sections 4.1, 4.2.1, 4.2.3, 4.2.4, 5.5.2, 6.2.1, 6.2.2, 6.3, 7.1, 7.2.1, 7.5.5, 7.6, 8.2.2, 8.2.4, and to meet the ISO9001:2008 requirements. 19 Jun Nov May Revised Organizational Chart 23 July The Quality Policy (attachment 2) and QMS Process Flow and Interaction (attachment 3) and required Biennial Review. The Organizational Chart was also reviewed and revised to keep all attachment document dates the same. Revised QP 7-1 name to Planning and Validation of Product Realization in section March Revised the wording of the Quality Policy (attachment 2) and removed the acronym. 14 May Biennial Review of Quality Manual 08 May Biennial Review of Quality Manual / Made slight modifications to the Organization Chart with the addition of a Sales Manager. 28 April 2014 FORWARD / INTRODUCTION A.M.S. Electronics Incorporated (A.M.S.) is a contract manufacturer of electronic assemblies, wiring harnesses, and custom cables for industrial and consumer-end markets. Our manufacturing processes are to satisfy the customer s need for electronic assemblies at the best possible value for the dollar. A.M.S. is committed to the strategic supply of top quality electronic assemblies and cabling products and to providing excellent customer service to the industry. A well integrated leadership team and highly experienced workforce, working together toward continuous improvement in products and processes, makes A.M.S. a desirable place of employment and a responsible neighbor for the surrounding community. Personnel of A.M.S. fully endorse and support the quality management system described in this manual. Employees are directed to maintain the integrity of the QMS and report any unresolved quality issues or discrepant conditions before such matters can compromise product quality, customer satisfaction, or the quality management system. Personnel are encouraged to seek improvements in their daily work processes. Quality Manual.doc Page 4 of 29 Revision: 28 April 2014

5 QUALITY POLICY STATEMENT A.M.S. Electronics, Inc. is dedicated to complete customer satisfaction. We manufacture the highest quality electronic assemblies at the best possible value. We are committed to continuous improvement and our quality system is frequently monitored to ensure its effectiveness. At A.M.S., we start and finish with QUALITY. 1 SCOPE The Quality Management System that has been established, documented, and implemented by A.M.S. is described in this manual. This manual addresses the requirements of ISO 9001:2008; including Design and excluding Service. Sequencing and numbering of this document parallels the corresponding paragraphs of ISO NORMATIVE REFERENCE The following normative reference documents have been utilized in the development of our quality management system. ISO 9000:2000 Quality management systems Fundamentals and vocabulary ISO 9001:2001 Quality management systems Requirements ISO 9001:2008 Quality management systems Requirements (Update) ISO 9004:2000 Quality management systems Guidelines for performance improvements 3 TERMS AND DEFINITIONS The terms and definitions provided in ISO 9000 and ISO 9001 have been adopted as standard definitions. Terms or definitions unique to A.M.S. are defined in individual Quality Procedures (QP s). Quality Manual.doc Page 5 of 29 Revision: 28 April 2014

6 4 QUALITY MANAGEMENT SYSTEM 4.1 GENERAL REQUIREMENTS A.M.S. has established, documented, and implemented a quality management system (QMS) that is continuously evaluated for potential process improvements in accordance with the requirements of ISO 9001:2008. Through our quality management system we: determined the processes needed for the quality management system and their application throughout the organization, determined the sequence and the interaction between these processes, determined the criteria and methods to ensure that the operation and control of our processes are effective by: ensuring the availability of resources and information necessary to support the operation and monitoring of these processes, monitoring, measuring (where applicable), and analyzing these processes, and implementing actions necessary to achieve planned results and continual improvement of these processes. Outsourced processes that affect product conformity are identified, defined, and controlled through our Quality Management System. Outsourced processes are performed outside the facility by A.M.S. employees using the same established standards, processes, and product requirements as those performed in-house. A.M.S. has defined, documented, and controlled these outsourced processes using the established standards applicable to conform to customer requirements. These processes are managed in accordance with the requirements of ISO 9001: DOCUMENTATION REQUIREMENTS General The A.M.S. quality management system is supported by documentation that consists of the following: Quality Policy statement developed by top management that provides the overall intentions and directions of A.M.S. related to quality awareness and objectives. Quality Manual establishes the requirements and guidelines for our entire quality management system. Quality Procedures (QP s) directly support and provide additional detail for the cross-functional requirements of this quality management system. Quality Records provide the objective evidence determined by A.M.S. to be necessary to record the results or activities performed. Quality Manual.doc Page 6 of 29 Revision: 28 April 2014

7 Assembly Instructions (AI s) identify how to perform specific operations or tasks necessary to produce product and/or control processes Quality Manual This QMS Manual serves as the basis for all quality program guidelines and requirements; it additionally defines the scope of the quality management system. QMS Manual revisions are summarized at the beginning of this document. When a revision to individual section of the manual is required, the entire manual is revised to the next revision level. Customer or supplier representatives will be provided an uncontrolled version of this manual upon request. Controlled versions of this document may be obtained through the Quality Manager. A distribution log is maintained to indicate those individuals in possession of a controlled copy of this Manual. Where controlled copies are issued, this log indicates the manual holder name and assignment of a unique manual number. The principle activities of the order/production process are depicted in the process flow diagram displayed as Figure 1. Primary management activities are illustrated in the process flow diagram in Figure 2. Quality Manual.doc Page 7 of 29 Revision: 28 April 2014

8 Figure 1 Order/Production Process A-M-S- Electronics, Increceives customer inquiry or purchase order Customer evaluates AMS quotation quotation Purchasing processes customer inquiry per QP or order per QP order Production schedules production per QP Purchasing orders materials per QP Purchased Customer supplied material or Purchased material? Customer Supplied Kit received and forwarded to Stockroom yes Stockroom inspects incoming material per QP and readies kit for Production Stockroom releases kit to Production per QP Stockroom inspects incoming material per QP and readies kit for Production Production Personnel produce product per QP 7-5-1, applicable Process Control Card QC stations performs in-process inspections per QP Final QC performs final inspection per QP and releases for shipment Packer prepares product for delivery per QP Quality Manual.doc Page 8 of 29 Revision: 28 April 2014

9 Figure 2 Management Process Perform quality planning per QP Provide training per QP Implement, measure, and maintain records per QP Evaluate customer satisfaction per QP Perform internal audits of the QMS per QP Control documents and data per QP and QP Control monitoring and measurement devices per QP 7-6 Control nonconformances per QP 8-3 Review and analyze data Implement corrective and/or preventive actions per QP and QP Perform management review per QP Encourage continual improvement of QMS Quality Manual.doc Page 9 of 29 Revision: 28 April 2014

10 4.2.3 Control of Documents A.M.S. has established, implemented, and maintains a documented procedure to control the documents indicated in this QMS Manual. Documents are controlled by unique revision level to ensure processes and products conform to established requirements. The Quality Manager has the primary responsibility to maintain the quality management system documents confirming that: documents are reviewed to ensure they are adequate for their intended use and approved prior to release, documents are reviewed, updated, and re-approved as necessary, document changes and current revision levels of documents are identified, the relevant versions of documents are available at the point of use and/or are directly accessible to affected personnel, all documents are maintained such that they remain legible and are readily identifiable, documents of external origin that are determined to be necessary for the planning and operation of the Quality Management System are identified and their distribution controlled, and obsolete documents are promptly removed from the point of use and suitably identified to prevent unintended use if retained for reference or knowledge preservation purposes. A.M.S. procedures QP 4-2-3, titled Document Control; QP , titled Documents of External Origin; and QP ; titled Outsourced Processes define our document control practices for documents of both internal and external origin Control of Records A.M.S. establishes, maintains, and controls records to provide evidence of conformity to requirements and the effective operation of the Quality Management System. Records are maintained in a manner to assure that they remain legible, readily identifiable, and retrievable. A.M.S. procedure QP 4-2-4, titled Control of Records, defines the controls needed for the identification, storage, protection, retrieval, retention time, and disposition of records. Record retention practices will satisfy all applicable regulatory and customer requirements. Supporting Procedures: QP QP QP Document Control Documents of External Origin Control of Records Quality Manual.doc Page 10 of 29 Revision: 28 April 2014

11 5 MANAGEMENT RESPONSIBILITY 5.1 MANAGEMENT COMMITMENT A.M.S. has implemented a quality management system that is continuously monitored and maintained for effectiveness and improvement opportunities in accordance with the requirements of ISO 9001:2008. Customer, statutory or regulatory requirements are communicated to the organization to assure customer satisfaction. Through the Quality Policy and other established quality objectives, top management of A.M.S. is committed to continually improve our processes and the effectiveness of the quality management system. Regular management reviews are conducted to evaluate the quality management system and ensure the availability of appropriate resources. 5.2 CUSTOMER FOCUS Through documented procedures, top management ensures that customer requirements are met and that enhancement of customer satisfaction is at the forefront of all of our operations. 5.3 QUALITY POLICY Top management has established and maintains a Quality Policy that defines and documents company objectives and commitment to quality. It is appropriate to the purpose of the organization and identifies our commitment to comply with customer requirements and continually improve the effectiveness of our quality management system. This Quality Policy provides the framework for establishing and reviewing our quality objectives, and is reviewed for continued effectiveness and suitability as an inclusive part of our management review process. The Quality Policy, as included in the introductory section of this manual, is communicated to new employees as an inclusive part of the orientation process, posted throughout the facility, and periodically reviewed to ensure understanding by all employees. 5.4 PLANNING Quality Objectives Top management of A.M.S. ensures that quality objectives, including those needed to meet product requirements, are established, measured, and reviewed for effectiveness by the relevant functions and levels within our organization. These objectives are measurable and consistent with our Quality Policy. Quality Manual.doc Page 11 of 29 Revision: 28 April 2014

12 5.4.2 Quality Management System Planning Top management ensures that the quality management system is planned and carried out in order to meet the general QMS requirements of ISO 9001:2008 and our quality objectives. QP 5-4-2, titled Quality Management System Planning lays out the procedure for this process. Integrity of the quality management system is maintained when planned changes are made and implemented. 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION Responsibility and Authority Top management ensures that responsibilities and authority is defined and communicated through the company. An organizational structure has been established and maintained to identify the interrelation of personnel who manage, perform, and verify work affecting product quality. This structure is defined through the organizational chart (see below). The following summary descriptions, and specific responsibilities defined in the Quality Procedures describe the responsibilities and authorities. Organizational Chart Engineering Angelo DiMichele President Accounting Administrative Assistant Order Coordinator Quality Manager HR Manager Purchasing Manager Production Manager Sales Manager QC Training Receiving SMT Quote Development QC Inspector IT Stockroom TH QC Inspector Personnel Purchasing Cable/Harness/EM QC Inspector Test Technician Shipper Maintenance The President has primary responsibility for promoting efforts to make A.M.S. a growth oriented company that will achieve a position of sustained profitability over the long term. The President is additionally responsible to position A.M.S. to meet the increased cash requirements necessary to support expected increases in sales. Directs the A.M.S. staff to Quality Manual.doc Page 12 of 29 Revision: 28 April 2014

13 capture and deliver the best practices of continuous improvement in a way that blends operational issues with human resource considerations. The Production Manager has primary responsibility for planning, directing, and establishing production priorities for products in keeping with effective operations and cost factors. Additionally, the Production Manager is responsible for scheduling maintenance on all production equipment, and facilities maintenance. The Purchasing Manager has the primary responsibility for developing material & labor quotations for jobs; maintaining the Approved Suppliers List and maintaining Stockroom inventory at levels required by Production needs. The Quality Manager ensures that the quality management system is relevant to A.M.S. customers and is aligned with applicable industry standards. The Quality Manager also functions as the Management Representative and serves as the company liaison with external parties on matters relating to the quality management system and product quality. The Sales Manager is responsible for developing, promoting and maintaining the company s sales goals through good customer service, quality relations with new/existing accounts and providing sales coverage. The Accounting Manager oversee the general accounting function including accounts payable, accounts receivable, general ledger, payroll, cost accounting, credit and collections, month-end and year-end closings, and financial statement preparation. Also aids in the collection of data and final presentation of business plans for potential new business ventures. Engineering has primary responsibility for planning, directing and coordinating activities concerned with design, construction, and modification of product designs. Any Employee managing, performing or verifying work affecting quality has the authority and organizational freedom to initiate action to prevent occurrence of potential nonconforming conditions. These same people are assigned responsibility and authority to identify and document quality related problems, stop work and control continued processing when quality related problems exist. Individual Quality Procedures detail specific responsibilities and authorities for individuals involved in the process activity Quality Management Representative A.M.S. top management has designated the organization s Quality Manager as the Management Representative with responsibility to: ensure that the quality management system processes are established, implemented and maintained, report to top management on the performance of the quality management system and any need for improvement, and promote an awareness of customer requirements throughout the organization. Quality Manual.doc Page 13 of 29 Revision: 28 April 2014

14 5.5.3 Internal Communication Top management ensures that communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. Typical communication tools include: personal discussions, bulletin board postings, employee meetings, or other communication tools appropriate to the information transmitted. 5.6 MANAGEMENT REVIEW General Top management members perform reviews of the quality management system in accordance with QP 5-6-1, titled Management Review, at planned intervals to assess its suitability, adequacy, and effectiveness. Reviews include the assessment of improvement opportunities and required changes to the QMS including the Quality Policy and quality objectives. Management reviews include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Records of the management review process are maintained to provide, as a minimum, evidence of the achievement of the quality objectives specified in the business plan and customer satisfaction with A.M.S. products Review Input Top management members provide input related to internal and external audits, customer feedback, process and product conformance, preventive and corrective actions, the status of actions from previous management reviews, any changes that could affect the quality management system, and recommendations for improvement Review Output Output of the management review process include decisions and actions directed toward improving the effectiveness of the quality management system, including its processes, product, and resource needs. Supporting Procedures: QP QP Quality Management System Planning Management Review Quality Manual.doc Page 14 of 29 Revision: 28 April 2014

15 6 RESOURCE MANAGEMENT 6.1 PROVISION OF RESOURCES Resource requirements of the company are identified, planned, acquired, and provided by the management of our organization. Resource needs are re-evaluated whenever business needs or conditions change. Sound resource management includes the assignment of trained and qualified personnel, adequate facilities, tools and equipment, and appropriate systems for completion of quality work, implementation, maintenance, and improvement of the Quality Management System. Management provides the resources necessary to meet customer requirements and enhance customer satisfaction. 6.2 HUMAN RESOURCES General A.M.S. Electronics, Inc. believes that employee training is a key element in supporting the needs of our customers along with the goals and objectives of our Quality Policy. We strive to create an environment that promotes the effective identification and use of training as a quality enhancement tool. A documented procedure, QP 6-2-2, titled Competence, Awareness, and Training, has been established, implemented, and maintained to identify training needs and for ensuring that personnel performing work affecting quality and conformity to product requirements are competent on the basis of appropriate education, training, skills, and experience Competence, Awareness, and Training A.M.S. management is responsible to: determine the necessary competence for personnel performing work affecting conformity to product requirements, where applicable, A.M.S. will provide training or take other actions to achieve the necessary level of competence required, evaluate the effectiveness of training or other actions taken, ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and maintain appropriate records of education, training, skills and experience. Quality Manual.doc Page 15 of 29 Revision: 28 April 2014

16 6.3 INFRASTRUCTURE A.M.S. management monitors technological advancements and customer expectations to determine infrastructure needs. Infrastructure needs are addressed and maintained to achieve product conformance. QP 6-3, titled Infrastructure and Work Environment governs these activities. These include: buildings, workspace and associated utilities, process equipment, including hardware and software, supporting services, including transportation, communication, and informational systems needs. Lean manufacturing principles (e.g. material travel and handling methods, workspace design and floor space optimization, one-piece flow, etc.) are considered during planning efforts for facility additions or modifications. Routine maintenance (e.g. cleaning, oiling, filter changes, etc.) is performed as needed to ensure continuing process capability, capacities and production of products that meet customer quality requirements. QP 6-3-1, titled Equipment and Facilities Maintenance, defines the generation and implementation of the preventive maintenance schedule. 6.4 WORK ENVIRONMENT A.M.S. management personnel evaluate product requirements in order to determine and manage the work environment factors necessary to achieve product conformance. Facilities are maintained in a state of order, cleanliness and repair consistent with the product and manufacturing process needs. Product integrity and means to minimize potential risks to employees are appropriately addressed, especially in the design and development process and in manufacturing process activities. The management of A.M.S. Electronics, Inc. provides adequate resources to maintain a suitable production and working environment under controlled conditions. It is the responsibility of each employee to assist in the maintenance of this environment by correcting and/or reporting any adverse conditions or situations to their supervisor. Supporting Procedures: QP QP 6-3 QP Competence, Awareness, and Training Infrastructure and Work Environment Equipment and Facilities Maintenance Quality Manual.doc Page 16 of 29 Revision: 28 April 2014

17 7 PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALIZATION A.M.S. identifies and develops the processes required for product realization. Product realization, validation, and planning is laid out in QP 7-1, titled Planning and Validation of Product Realization, and is consistent with the requirements of other quality management system processes, and considers the following as appropriate: quality objectives and requirements for the product, processes, documents, and provide resources specific to the product, product specific verification, validation, monitoring, measurement, inspection and test activities along with product acceptance criteria, and records required to provide evidence that the realization processes and resulting product meet established requirements. The primary output of the product realization planning process is the Assembly Instructions (A.M.S. form #PR-01) that identifies the production and testing requirements necessary to manufacture the product. 7.2 CUSTOMER RELATED PROCESSES A.M.S. maintains effective arrangements for communicating with customers in relation to product information, inquiries, contracts or order handling, including amendments, customer feedback, and complaints. Product information is typically communicated to the customer through product specific literature and an Internet website, Determination of Requirements Related to the Product A.M.S. personnel determine: customer requirements, including delivery, requirements not identified by the customer but necessary for intended use, where known, statutory and regulatory requirements applicable to the product and safety or environmental regulations as applicable to the acquisition, storage, handling, recycling and elimination or disposal of materials, and any additional product or process requirements considered necessary by A.M.S Review of Requirements Related to the Product Prior to commitment to supply product (e.g. quotation submittal, order/contract acceptance, and/or order/contract changes), customer requirements related to the product are reviewed to ensure that: product requirements are defined, contract or order requirements differing from those previously expressed are resolved, and A.M.S. has the ability to meet the defined requirements. Quality Manual.doc Page 17 of 29 Revision: 28 April 2014

18 Product requirement review is addressed in procedure QP 7-2-1, titled Quotation/Proposal Processing, and QP 7-2-2, titled Order Review Process. Customers traditionally reference applicable specifications, or other documented statements of product quality in written orders; however, if requirements are received verbally, customer requirements are confirmed prior to acceptance. Records of the results of the review and actions arising are maintained. Where product or order requirements are changed, A.M.S. ensures that relevant documents are amended and affected personnel are notified of the changes. 7.3 DESIGN AND DEVELOPMENT A.M.S. produces products to Customer and/or Industry specification. When requested by the Customer, A.M.S. can provide engineering services for the development, revision, or recreation of outdated products. All engineering activities are governed by QP 7-3, titled Design and Development. Our procedure insures that the customer s requirements are met by requiring customer approval throughout the stages of development, and during any subsequent revision process. 7.4 PURCHASING Purchasing Process Selection of suppliers and their performance is integral to our own performance and our customers satisfaction. A.M.S. ensures that purchased product and services conform to specified purchase requirements. The type and extent of supplier control exercised is based on the nature or complexity of the work required and the impact of the suppliers work on subsequent product realization or the final product. Suppliers are evaluated and selected based on their ability to supply product in accordance with A.M.S. Purchase Order requirements. Supplier monitoring and reevaluation is performed to assess continuing capabilities. Records of supplier evaluations and any actions arising from the evaluations are maintained. Purchased products or materials used in the product conform to applicable regulatory requirements. Customer designated supply sources are used when specified by contract; however, this does not relieve A.M.S. of the responsibility to ensure the quality of purchased products. QP 7-4-1, titled Supplier Evaluation, Selection, and Monitoring is used to insure the suppliers used by A.M.S. can comply with requirements imposed by us as well as our customers. Quality Manual.doc Page 18 of 29 Revision: 28 April 2014

19 7.4.2 Purchasing Information Purchase Orders that are issued to suppliers contain all information necessary to clearly communicate the requirements of the desired product or service. This includes: any requirement for approval of product, procedures, processes and equipment, any qualification requirement of personnel, and any quality management system requirement. Purchase Orders are reviewed for adequacy prior to communication and issue to the supplier. A documented procedure QP titled Purchasing Information, defines the process to assure clear communication of purchase requirements Verification of Purchased Product QP 7-4-3, titled Verification of Purchased Product defines the process of purchased products being verified against Purchase Order requirements, and Subsequent confirmation of product acceptability during processing. If, in any instance, A.M.S. or its customer elects to perform inspection at a supplier facility, the verification arrangements and product release criteria are identified in the Purchase Order. 7.5 PRODUCTION AND SERVICE PROVISION A.M.S. Electronics claims exemption from ISO Service Provision. Any nonconformances detected by the customer are handled in accordance with QP , titled Customer Concerns and Returns. All rework is done at our facility. A Return Material Authorization (RMA) will be issued to the customer and A.M.S. will bear the cost of freight and labor for the rework of the material to the customer s standard Control of Production Provision A.M.S. plans and produces product under controlled conditions. These conditions are addressed in QP 7-5-1, titled Control of Production Provisions, and include as applicable: the availability of information that describes the characteristics of the product, the availability of assembly instructions as necessary, the use of appropriate equipment for the product, the availability and use of monitoring and measuring devices along with their application at appropriate steps in the process, and the implementation of release and delivery activities. As appropriate to supplement employee training and experience, Assembly Instructions (AI s) are prepared for the operation of processes that impact product quality and are accessible at the work stations. These documents are then used to control the product realization process. Quality Manual.doc Page 19 of 29 Revision: 28 April 2014

20 Production is order driven and scheduled to meet customer order requirements. A system is in place to readily determine the status of production information and order status Validation of Processes for Production Provision Processes for production provision are validated to demonstrate their ability to achieve planned results. A.M.S. has established arrangements for these processes that include the following activities: defined criteria for review and approval of the processes, approval of equipment and qualification of personnel, identification and use of specific methods and procedures, requirements for records, and allowance for revalidation of processes Identification and Traceability A.M.S. has established and maintains controls to coordinate identification of product through physical marking, Assembly Instruction information, or other means. Product status with respect to monitoring and measurement requirements is readily identifiable throughout all processes. Methods used to facilitate identification and traceability is indicated in QP 7-5-3, Product Identification and Traceability Customer Property When customer property is provided for tooling, use, or incorporation into the product, it is handled with appropriate care, identified, verified, and suitably protected while in A.M.S. control. In the event customer property is lost, damaged, or otherwise unsuitable, we will document the incident through the use of Nonconformance Report, report it to the customer, and maintain records. Quality Procedure QP 7-5-4, titled Customer Property, defines control methods for customer-owned materials Preservation of Product A.M.S. has established and maintains suitable preservation practices as defined in QP titled Preservation of Product/Shipping, in order to preserve and protect the product during all internal and external processing, and delivery to the customer. This includes preservation of identification, proper handling practices, appropriate packaging, storage and protection where applicable. Preservation practices apply equally to the constituent parts of the product. Quality Manual.doc Page 20 of 29 Revision: 28 April 2014

21 7.6 CONTROL OF MONITORING AND MEASURING DEVICES A.M.S. has determined the monitoring and measurement actions to be undertaken to verify product conformance to the applicable requirements. Appropriate monitoring and measuring equipment have been acquired, and are maintained, in accordance with QP 7-6, Control Monitoring and Measurement Devices. Monitoring and measurements are established and carried out at various stages of the processes and are consistent with requirements of the process or product specification. Monitoring and measurement equipment is maintained to ensure results of measurements are valid. Measuring equipment is: calibrated or verified at specified intervals, or prior to use, against standards traceable to national or international standards (if no such standard exists, the basis used for calibration or verification is recorded), adjusted or re-adjusted as necessary to ensure continued accuracy, is identified in order to determine its calibration status, safeguarded against adjustments that would invalidate the measurement result, and handled, maintained, and stored in an appropriate manner to ensure accuracy and prevention from damage or deterioration. If equipment is determined to be out of calibration, records of measurements obtained using the device are reviewed for impact on product and appropriate action is taken. Calibration and verification records are maintained for monitoring and measuring equipment. If computer software is used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed as necessary. External sources for calibration are required to meet the requirements of ISO-17025, ANSI/NCSL Z-540, or equivalent quality management system standard. Supporting Procedures: QP 7-1 QP QP QP 7-3 QP QP QP QP QP QP QP QP 7-6 QP Planning and Validation of Product Realization Processes Quotation/Proposal Processing Order Review Process Design and Development Supplier Evaluation, Selection, and Monitoring Purchasing Information Verification of Purchased Product Control of Production Provisions Product Identification and Traceability Customer Property Preservation of Product/Shipping Control of Monitoring and Measurement Devices Customer Concerns and Returns Quality Manual.doc Page 21 of 29 Revision: 28 April 2014

22 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 GENERAL A.M.S. has planned and implemented monitoring, measurement, analysis, and improvement processes necessary to: demonstrate product conformance, ensure conformity of the Quality Management System, and continually improve the effectiveness of the Quality Management System. An inclusive part of the production planning process is the application of monitoring, measurement, and analysis methods and the extent of their use. Statistical techniques are utilized to monitor and report Quality Management System conformance, progress toward accomplishment of established performance goals, and indicate possible process improvement opportunities. 8.2 MONITORING AND MEASUREMENT Customer Satisfaction The evaluation of customer satisfaction is one of the measures utilized by A.M.S. Electronics, Inc. to assess Quality Management System performance. A.M.S. monitors information obtained from customers regarding their perception of product quality through formal and informal data collection methods. The primary tool to evaluate customer satisfaction is a periodic survey submitted to customers. Analysis of customer submitted supplier quality rating data, customer complaints or returns, and consideration of customer order practices are also used to evaluate customer satisfaction. Quality Procedure QP 8-2-1, titled Customer Satisfaction, defines A.M.S. s approach to evaluating customer satisfaction; and QP , titled Customer Concerns and Returns insures customer feedback surrounding nonconformances are addressed promptly and a satisfactory resolution is achieved Internal Audit A.M.S. conducts internal audits at planned intervals to confirm the Quality Management System conforms to planned processes, ISO 9001:2008, and additional requirements identified in this document. The internal auditing program also assures that the Quality Management System is effectively implemented and maintained. Audits are scheduled annually on the basis of status and importance of the activities to be audited and previous audit results. A complete audit of the Quality Management System (all quality management related processes, activities, and shifts) occurs annually as a minimum. Audit frequencies are appropriately increased in response to internal/external nonconformities or customer complaints. Audits of manufacturing processes are performed to confirm their effectiveness. Audits are conducted in accordance with QP 8-2-2, titled Internal Quality Audits, which identifies the audit criteria, scope, and the methods used. Additionally, this procedure Quality Manual.doc Page 22 of 29 Revision: 28 April 2014

23 identifies the responsibility and requirements for planning, conducting, reporting, and maintaining the results of audits. The documentation of auditor training, audit pre-planning, audits conducted, and final audit results are recorded and maintained on the following forms: QA-12 QA-26 QA-27 QA-28 QA-29 Audit Checklist / Report Internal Audit Schedule Analysis Annual Audit Overview Auditor Evaluation Audit Finding Auditor selection is conducted to ensure objectivity and impartiality. Auditors do not audit their own work. Auditors are formally trained and qualified to perform audits against the requirements of the ISO 9001 standard. Management of the audited area is responsible for making any necessary corrections or performing the necessary Corrective Actions without undue delay to eliminate reported nonconformities and their causes. Follow-up activities are performed to verify that actions have been taken to address audit findings. Verification results are reported as an integral part of the audit process Monitoring and Measurement of Processes A.M.S. has established suitable methods to monitor and measure the processes of the Quality Management System. These methods, as defined in QP 8-2-3, titled Monitoring and measurement of Processes, demonstrate the ability to achieve planned results. When planned results are not obtained, process corrections and corrective measures are taken, as appropriate to ensure the integrity of the product Monitoring and Measurement of Product Suitable methods have been established to measure and monitor product conformance at appropriate stages of manufacture to confirm compliance with product requirements. Quality Procedures QP 8-2-4, titled Product Monitoring and Measurement, and QP 7-5-1, titled Control of Production Provisions, defines how A.M.S. determine product acceptance. Records of product conformance to established acceptance criteria are maintained for each product and indicate the authorized inspection personnel. Only authorized inspection personnel can release product for delivery to the customer. Release of product is dependent on satisfactory completion and verification that conformance to applicable acceptance criteria has been met. Authorization to release nonconforming product may only be obtained from the customer. Quality Manual.doc Page 23 of 29 Revision: 28 April 2014

24 8.3 CONTROL OF NONCONFORMING PRODUCT A.M.S. has established and maintains a documented instruction QP 8-3, titled Control of Nonconforming Product, to identify and control nonconforming materials or product in order to prevent its unintended use or delivery. Responsibilities and authorities involved with the control of nonconforming product are defined in the instruction. A.M.S. addresses nonconforming product through one or more of the following methods: taking action to eliminate the detected nonconformance authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer, and implementing appropriate actions to preclude its original intended use or application (this is handled through a process of marking the nonconforming units with tags or rework arrows indicating the deficiency, and segregating the nonconforming units from all others to prevent further processing). Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. Repaired or reworked discrepancies are re-inspected for conformance to acceptance criteria. Instructions for the rework or repair of nonconforming product, including re-inspection, are accessible and utilized by Production personnel. All employees have the responsibility to inform management/supervisory personnel of suspect or known discrepant materials upon discovery. When nonconforming product is detected after delivery, A.M.S. will promptly notify affected customers and take actions appropriate to the actual or potential effects of the nonconformance. 8.4 ANALYSIS OF DATA A.M.S. determines, collects, and analyzes appropriate data to demonstrate the suitability and effectiveness of the Quality Management System and determine where continual improvement practices can be utilized. Analysis includes data generated as result of internal monitoring and measurement along with that from other relevant sources. The analysis of data is performed per QP 5-6-1, titled Management Review, and provides information related to: customer satisfaction, conformance to product requirements, characteristics and trends of processes and products including opportunities for preventive action, and suppliers. A primary element of the data analysis process is to detect trends in product quality and operational performance when compared to process and product objectives. Appropriate actions are taken to facilitate progress toward company objectives. Quality Manual.doc Page 24 of 29 Revision: 28 April 2014

25 8.5 IMPROVEMENT Continual Improvement A.M.S. continually improves the effectiveness of the Quality Management System through the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. Process improvements directed toward manufacturing processes focus on control and reduction of variation in product characteristics and manufacturing process parameters Corrective Action Corrective measures are taken in accordance with an established procedure to eliminate internally and externally identified nonconformances. Corrective actions are taken to eliminate the causes of nonconformities in order to prevent recurrence and are commensurate to the effects of the nonconformities including potential risks and costs. A.M.S. procedure QP 8-5-2, titled Corrective Action, identifies the requirements for: reviewing nonconformances, including customer complaints, determining the causes of nonconformances, evaluating the need for action to prevent recurrence, determining and implementing required actions, recording the results of actions taken, and reviewing the effectiveness of the corrective actions taken. Product rejected by the customer is formally analyzed to determine the root cause of the nonconformity. This testing and/or analysis are performed as timely as possible while assuring thorough review and investigation. Corrective actions, appropriate to the identified risks, are taken to prevent recurrence. Records of the analysis and resulting actions are maintained and available upon request. When applicable, the corrective actions and implemented controls for a specific nonconformance are applied to similar processes and/or products Preventive Action A.M.S. has established a documented procedure, QP 8-5-3, titled Preventive Action, to determine the actions necessary to eliminate the cause and occurrence of a potential nonconformance. Preventive actions taken are commensurate to the effects of potential problems. The preventive action system is designed to eliminate potential causes of nonconformities by analyzing information from internal quality audits, customer Quality Manual.doc Page 25 of 29 Revision: 28 April 2014

26 complaints, corrective actions, quality objectives, process controls and nonconformance reports. Additionally, preventive measures are identified as a result of employee suggestions, review of quality reports, process improvement efforts, quality audits, and customer or supplier input. Preventive actions are undertaken to improve processes, products, and supplier performance; control and reduce costs; ensure customer satisfaction; and, improve safety. A.M.S. procedure identifies the requirements for: determination of potential nonconformities and their causes, evaluation of the need for action to prevent occurrence of a nonconformance, determination and implementation of actions needed, recording the results of actions taken, and reviewing preventive actions taken. Supporting Procedures: QP QP QP QP QP QP 8-3 QP QP Management Review Control of Production Provisions Customer Satisfaction Customer Concerns and Returns Internal Quality Audits Control of Nonconforming Product Corrective Action Preventive Action Quality Manual.doc Page 26 of 29 Revision: 28 April 2014

27 Organizational Chart Engineering Angelo DiMichele President Accounting Administrative Assistant Order Coordinator Quality Manager HR Manager Purchasing Manager Production Manager Sales Manager QC Training Receiving SMT Quote Development QC Inspector IT Stockroom TH QC Inspector Personnel Purchasing Cable/Harness/EM QC Inspector Test Technician Shipper Maintenance Angelo DiMichele, President Attachment 1 Quality Manual.doc Page 27 of 29 Revision: 28 April 2014

28 Quality Manual.doc Page 28 of 29 Revision: 28 April 2014 Attachment 2

29 Production Planning and Purchasing Production and Inspection Shipment Quality Management System ` Process Flow and Interaction Attachment 3 Verify purchased product per QP Order materials per QP Receive customer inquiry Prepare and deliver product per QP Customer evaluates AMS quotation Perform final inspection per QP Produce product per applicable Customer s Instructions and QP Raw materials available? Perform production planning per QP 7-1 Quotation and Customer Order Entry Process customer inquiry per QP Customer Feedback Evaluate customer satisfaction per QP Postwave Wave Prewave Electro- Mechanical Surface Mount Kit Preparation Select and monitor suppliers per QP Validate process per QP yes Perform 1 st article and inprocess inspections per QP Final QC Testing Postwave QC Prewave QC SMT QC Automatic Optical Insp. Operator Visual Customer Receive customer order Process customer order per QP Respond to customer returns per QP no Design product per QP 7-3 QP 8-3 Control of Nonconforming Product QP 7-6 Control of Monitoring and Measurement Devices QP 6-3 Infrastructure and Work Environment -- QP Equipment and Facilities Maintenance QP Customer Property QP Quality Records QP Document Control; QP Documents of External Origin no QP Internal Quality Audits QP Corrective Action and QP Preventive Action QP Product Identification and Traceability QP Competence, Awareness, and Training QP 5-4 Quality Management System Planning and QP Management Review yes Design and Development required? Attachment 3 Quality Manual.doc Page 29 of 29 Revision: 28 April 2014