QUALITY MANAGEMENT SYSTEM ANSI/ISO/ASQ Q Quality Manual

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1 QUALITY MANAGEMENT SYSTEM ANSI/ISO/ASQ Q Quality Manual

2 Quality Manual Quality Manual KAYA Associates, Inc. 101 Quality Circle Suite 120 Huntsville, AL Phone: Fax: KAYA Technical Services 135 Crestview Court Nicholasville, KY Phone: Fax: KAYA Fabrication Shop 7222 Peppermill Pkwy. North Charleston, SC Phone: Fax: KAYA Associates, Inc. P.O. Box Fort Greely, AK Phone: Page 1 of 2

3 Quality Manual Introduction... 3 Quality Management System Requirements Scope General Application Normative References Terms and Definitions Quality Management System General Requirements Supplemental Documentation Requirements General Quality Manual Control of Documents Control of Records Management Responsibility Management Commitment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority, and Communication Responsibility and Authority Responsibility for Quality Management Representative Internal Communication Management Review General Review Input Review Output Resource Management Provisions of Resources Human Resources General Competence, Training, and Awareness TABLE OF CONTENTS 6.3 Infrastructure Work environment Administration Areas Maintenance and Fabrication Shop Areas Product Realization Planning of Product Realization Customer-Related Processes Determination of Requirements Related to the Product Review of Requirements Related to the Product Customer Communication Design and Development Design and Development Planning Design and Development Inputs Design and Development Outputs Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes Purchasing Purchasing Process Customer Approved Sources Subcontracted Processes Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Work Instructions Validation of Processes for Production and Service Provision Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Equipment Page 2 of 2

4 Quality Manual 8 Measurement, Analysis, and Improvement General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Action Control of Reworked Product Customer Information Preventive Action FIGURES 4-1 Process Flow Chart QM Document Distribution List KAYA Quality Policy Statement Organizational Chart Record of Management Review TABLES 5-1 KAYA Quality Planning Table (Example) KAYA Supplier Quality Report (Example) Monitoring and Measurement Analysis Table (Example) Page 3 of 2

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6 INTRODUCTION KAYA Associates, Inc. (KAYA) is a Small Business Administration (SBA)-certified 8(a) Small Disadvantaged Business (SDB) headquartered in Huntsville, Alabama. KAYA provides facilities planning and engineering, installation management, environmental services, fabrication services, and Air Traffic Control support to the Department of Defense (DoD), other Government agencies, and commercial customers. We augment these competencies with the use of Geographic Information Systems (GIS), interactive mapping tools, project-specific applications development, and website development. KAYA has over 220 employees with offices in Alabama, South Carolina, and Kentucky. Our employees are located at ten customer sites across the United States. Our management team consists of a group of seasoned professionals who average over 20 years of experience to both the private and governmental sectors. We have received numerous client and peer recognition letters and certificates for superior performance. We have an approved accounting system and maintain a Top Secret facility security clearance. KAYA is an ESRI authorized Business Partner for GIS applications. More information concerning KAYA can be found at KAYA developed and implemented a Quality Management System (QMS) to demonstrate our ability to consistently provide product that meets customer and applicable regulatory requirements, and to address customer satisfaction through the effective application of the system, including continual improvement and the prevention of nonconformities. The quality system complies with the ANSI/ISO/ASQ Q9001:2008. The QMS is divided into eight sections modeled on the sectional organization of the ISO International Standard. Sections are further subdivided into clauses representing main quality system processes and elements. Each clause begins with a general policy statement expressing the commitment to implement basic requirements and principles for the pertinent quality system process or element. The general policy statement is followed by more specific procedural policies outlining how the general policy is implemented, and referencing applicable operational and documented procedures. The purpose of this manual is to define the quality system and describe the interaction between the processes of the system, to define authorities and responsibilities of the management personnel involved in the system, and to provide procedural policies for the implementation of all the processes of the QMS. Another purpose of this manual is to present the QMS to our customers and other external interested parties, and to inform them what specific controls are implemented at KAYA to ensure quality. Page 3 of 29

7 QUALITY MANAGEMENT SYSTEM REQUIREMENTS 1 SCOPE 1.1 General The Quality Management System (QMS) defined in this manual is provided to demonstrate our company s commitment to conform to sound Quality Management processes offered by KAYA Associates, Inc. (KAYA). This QMS additionally demonstrates our ability to consistently provide customer service that meets customer and applicable regulatory requirements and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. This manual is designed in compliance with ISO 9001:2008 and establishes the requirement, authority, and responsibility for each department to improve and document a formal QMS in the form of departmental manuals and processes. 1.2 Application Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. 2 NORMATIVE REFERENCES The following referenced documents are indispensable for the application of this manual. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality Management Systems Fundamentals and Vocabulary ISO 9001:2008, Quality Management Systems Requirements 3 TERMS AND DEFINITIONS For purposes of this manual, the terms and definitions given in ISO 9000 apply. Throughout the text of this manual, wherever the term product occurs, it can also mean service. Page 4 of 29

8 4 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements KAYA has established, documented, implemented, and maintains a QMS and continually improves its effectiveness in accordance with the requirements of ISO 9001:2008. KAYA has: a) determined the processes needed for the QMS and our application throughout the company (see Section 1.2), b) determined the sequence and interaction of these processes, c) determined criteria and methods needed to ensure that both the operation and control of the processes are effective, d) ensured the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitored, measured where applicable, and analyzed these processes, and f) implemented actions necessary to achieve planned results and continual improvement of these processes. These processes are managed by KAYA in accordance with the requirements of ISO 9001:2008. Where KAYA chooses to outsource any process that affects product conformity to requirements, the organization will ensure control over such processes. The type and extent of control to be applied to these outsources processes will be defined within the QMS Supplemental Process Approach The QMS is designed as a system of interrelated processes. The process approach is also applied to the auditing of the system. All main processes are defined as Customer-Oriented Processes (COPs), Support-Oriented Processes (SOPs), and Management-Oriented Processes (MOPs), and are organized into a Plan Do Check Act loop. COPs, by definition, are the processes that are directly linked to an external customer by an input and output. These COPs are demonstrated by a flowchart listing each step of the process (see Figure 4-1). Included in the flowchart is a listing of records that support the process, as well as the measurable used to determine if the process is effective. KAYA has generated the following list of COPs: Request for Work Product Production Delivery Customer Feedback Page 5 of 29

9 4.2 Documentation Requirements General The QMS documentation includes: Figure 4-1. Process Flow Chart a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures and records required by ISO 9001:2008, and d) documents, including records, determined by KAYA to be necessary to ensure the effective planning, operation, and control of our processes. Page 6 of 29

10 4.2.2 Quality Manual KAYA has established and maintains a quality manual that includes: a) the scope of the QMS, including details of and justification for any exclusions (see Section 1.2), b) the documented procedures established for the QMS, or reference to them, and c) a description of the interaction between the processes of the QMS Control of Documents Documents required by the QMS will be controlled. Records are a special type of document and shall be controlled according to the requirements given in Section A documented procedure will be established to define the controls needed: a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by KAYA to be necessary for the planning and operation of the QMS are identified and their distribution controlled (see Figure 4-2), and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. Figure 4-2. QM Document Distribution List Page 7 of 29

11 4.2.4 Control of Records Records established to provide evidence of conformity to requirements and of the effective operation of the QMS will be controlled. KAYA will establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. Records will remain legible, readily identifiable, and retrievable. 5 MANAGEMENT RESPONSIBILITY 5.1 Management Commitment Top management will provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness by: a) communicating to the company the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.2 Customer Focus Top management will ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see Sections and 8.2.1). 5.3 Quality Policy Top management will ensure that the quality policy: a) is appropriate to KAYA s purpose, b) includes a commitment to comply with requirements and continually improve the effectiveness of the QMS, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. Figure 5-1 provides KAYA s overall Quality Policy Statement. 5.4 Planning Quality Objectives Top management will ensure that quality objectives, including those needed to meet requirements for product (see Section 7.1 a), are established at relevant functions and levels within KAYA. The quality objectives will be measurable and consistent with the quality policy. Page 8 of 29

12 Figure 5-1. KAYA Quality Policy Statement Page 9 of 29

13 5.4.2 Quality Management System Planning Top management will ensure that: a) the planning of the QMS is carried out in order to meet the requirements given in Section 4.1, as well as the quality objectives, and b) the integrity of the QMS is maintained when changes to the QMS are planned and implemented. Table 5-1 is an example of a KAYA Quality Planning Table. Table 5-1. KAYA Quality Planning Table (Example) Page 10 of 29

14 5.5 Responsibility, Authority, and Communication Responsibility and Authority Top management will ensure that responsibilities and authorities are defined and communicated within KAYA. Interrelation of all personnel who manage, perform, and verify work affecting quality is identified in the Organizational Chart (Figure 5-2), and in operational procedures and other documents defining these activities. Top management ensures that personnel have sufficient independence and authority to perform these tasks, in particular, internal auditors and personnel responsible for monitoring experience from the post-production stage and reporting adverse events. All departments and functions in the company are responsible for implementing, maintaining, and improving the quality system. Authorities and responsibilities for specific processes of the QMS are defined: throughout this quality manual and in every operational procedure where the specific quality system process or activity is documented; in Quality System Processes as Process Owners, and in job descriptions Responsibility for Quality The managers throughout the process have the responsibility and authority to: initiate action to prevent the occurrence of occupational, process, and quality system nonconformance, identify and record occupational, process, and quality system problems, initiate, recommend, or provide solutions, verify the implementation of solutions, and represent the needs of the customer in internal functions in addressing TS requirements. In cases that affect quality, the managers hold the authority to perform the actions listed above and ensure communications between departments. Figure 5-2 shows the interrelation of personnel who manage, perform, and verify work affecting quality. Page 11 of 29

15 Figure 5-2. Organizational Chart Management Representative Top management will appoint a member of KAYA s management who, irrespective of other responsibilities, will have responsibility and authority that includes: a) ensuring that processes needed for the QMS are established, implemented, and maintained, b) reporting to top management on the performance of the QMS and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout KAYA Internal Communication Top management will ensure that appropriate communication processes are established within KAYA and that communication takes place regarding the effectiveness of the QMS. Page 12 of 29

16 5.6 Management Review General Top management will review KAYA s QMS twice a year, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. This review will include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives. Records from management reviews will be maintained (see Section 4.2.4) through a Record of Management Review Review Input The input to management review will include information on: a) results of internal and third party audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the QMS, and g) recommendations for improvement Review Output The output from the management review will include any decisions and actions related to: a) improvement of the effectiveness of the QMS and its processes, b) improvement of product related to customer requirements, and c) resource needs. A Record of Management Review will be maintained during the Management Review. Included on the Record of Management Review will be any decisions and actions related to improving the effectiveness of the QMS and its processes, improvement of product related to customer requirements, and any resource needs. Figure 5-3 is an example of the Record of Management Review maintained by KAYA. Page 13 of 29

17 6 RESOURCE MANAGEMENT 6.1 Provisions of Resources Figure 5-3. Record of Management Review (Example) KAYA will determine and provide the resources needed: a) to implement and maintain the QMS and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources General Personnel performing work affecting conformity to product requirements will be competent on the basis of appropriate education, training, skills, and experience. Page 14 of 29

18 6.2.2 Competence, Training, and Awareness KAYA will: a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, c) evaluate the effectiveness of the actions taken, d) ensure that our personnel are aware of relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills, and experience (see Section 4.2.4). 6.3 Infrastructure KAYA will determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace, and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport, communication, or information systems). 6.4 Work environment KAYA will determine and manage the work environment needed to achieve conformity to product requirements Administration Areas A suitable working environment will be defined as: Fire evacuation routes will be clear from items blocking a straight path to an emergency exit. Lighting in working areas will be sufficient to read the front page of a newspaper. Rest rooms should have sufficient ventilation and be sanitary with all lavatory items in good working order. Desk areas will be clean and will be maintained in an orderly manner. Fire extinguishers will be easily accessible, tracked, and inspected on a monthly basis Maintenance and Fabrication Shop Areas A suitable working environment will be defined as: Aisles will be free from intrusion enough to efficiently move product from the fabrication areas to the warehouse finished goods inventory. Fire evacuation routes will be clear from items blocking a straight path to an emergency exit. Lighting in working areas will be sufficient to read the front page of a newspaper. Page 15 of 29

19 Lighting in inspection areas will be sufficient to read the classified ads of a newspaper. Inspection areas are those areas where inspection is performed by cast and trim operators, leak test and machining personnel, and inspection personnel. Rest rooms should have sufficient ventilation and be sanitary with all lavatory items in good working order. Fabrication debris and scrap will be cleaned up broom clean at the end of each working shift. Equipment which has not been used in 1 year is not in work areas. Maintenance debris and ongoing projects are either cleaned up or clearly marked. Noise levels will not exceed 100 db in work areas, or protective equipment will be worn. Air quality in work areas will comply with state and federal OSHA requirements, or protective equipment will be worn. Hazardous materials will be maintained and stored in a controlled area, and will comply with state and federal OSHA requirements. Fire extinguishers will be easily accessible, tracked, and inspected on a monthly basis. 7 PRODUCT REALIZATION 7.1 Planning of Product Realization KAYA will plan and develop the processes needed for product realization. Planning of product realization will be consistent with the requirements of the other processes of the QMS (see Section 4.1). In planning product realization, KAYA will determine the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes and documents, and to provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see Section 4.2.4). The output of this planning will be in a form suitable for the organization s method of operations. 7.2 Customer-Related Processes Determination of Requirements Related to the Product KAYA will determine: a) requirements specified by the customer, including the requirements for delivery and postdelivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by KAYA. Page 16 of 29

20 7.2.2 Review of Requirements Related to the Product KAYA will review the requirements related to the product. This review will be conducted prior to KAYA s commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contacts or orders, acceptance of changes to contracts or orders) and will ensure that: a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) KAYA has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review will be maintained (see Section 4.2.4). Where the customer provides no documented statement of requirement, the customer requirements will be confirmed by KAYA before acceptance. Where product requirements are changed, KAYA will ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements Customer Communication KAYA will determine and implement effective arrangements for communicating with customers in relation to: a) product information, b) inquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints. 7.3 Design and Development Design and Development Planning KAYA will plan and control the design and development of product. During the design and development planning, KAYA will determine: a) the design and development stages, b) the review, verification, and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. KAYA will manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output will be updated, as appropriate, as the design and development stages progress Design and Development Inputs Inputs relating to product requirements will be determined and records maintained (see Section 4.2.4). These inputs will include: a) functional and performance requirements, b) applicable statutory and regulatory requirements, Page 17 of 29

21 c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. The inputs will be reviewed for adequacy. Requirements will be complete, unambiguous, and not in conflict with each other Design and Development Outputs The outputs of design and development will be in a form suitable for verification against the design and development input and will be approved prior to release. Design and development will: a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production, and service provision, c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use Design and Development Review At suitable stages, systematic reviews of design and development will be performed in accordance with planned arrangements (see Section 7.3.1): a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Participants in such reviews will include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions will be maintained (see Section 4.2.4) Design and Development Verification Verification will be performed in accordance with planned arrangements (see Section 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions will be maintained (see Section 4.2.4) Design and Development Validation Design and development validation will be performed in accordance with planned arrangements (see Section 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practical, validation will be completed prior to delivery or implementation of the product. Records of the results of validation and any necessary actions will be maintained (see Section 4.2.4) Control of Design and Development Changes Design and development changes will be identified and records maintained. The changes will be reviewed, verified and validated, as appropriate, and approved before implementation. The review of Page 18 of 29

22 design and development changes will include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions will be maintained (see Section 4.2.4). 7.4 Purchasing Purchasing Process KAYA will ensure that purchased product conforms to specified purchased requirements. The type and extent of control applied to the supplier and the purchased product will depend on the effect of the purchased product on subsequent product realization or the final product. KAYA will evaluate and select suppliers based on their ability to supply product in accordance with our requirements. Criteria for selection, evaluation and re-evaluation will be established. Records of the results of the evaluations and any necessary actions arising from the evaluation will be maintained (see Section 4.2.4). Quality performance of suppliers is monitored. Suppliers showing inadequate performance may be asked to implement corrective actions. If the requested corrective actions are not implemented and there is no improvement, the supplier is downgraded to the REJECTED rating and is removed from the Approved Supplier List. Records of suppler monitoring and reevaluations are maintained. A vendor list is maintained and vendors are evaluated annually: NOT APPROVED Vendors who are not qualified due to major nonconformities or other problems, or if effective corrective action has not been taken. Purchasing may choose not to purchase products or services from these suppliers. APPROVED Vendors who are approved for the purchase of functional items. KAYA may remove vendors from the APPROVED list if there is a problem and effective corrective action has not been taken. Records of the approved vendors and their current status are maintained. The type and extent of controls exercised over the vendor depend on the type material/service purchased. For functional materials currently purchased from approved vendors, the satisfactory capability and performance and completion of a survey form is sufficient. Table 7-1 is an example of the Supplier Quality Report maintained by KAYA. Page 19 of 29

23 Table 7-1. KAYA Supplier Quality Report (Example) Customer Approved Sources When specified in the contract, materials will be purchased from the customer s approved vendor list (if the customer has an approved vendor list for a material, unlisted vendors may supply materials for that customer s product only after they have been added to the customer s approved vendor list by the customer.) Subcontracted Processes When processes that affect product conformity are outsourced, special controls are implemented to ensure that these processes meet specified requirements. Such controls may include, when applicable: Evaluation and pre-qualification of suppliers Page 20 of 29

24 Assessment of supplier realization processes and quality system Flow-down of production part approval (PPAP) requirements Monitoring of supplier quality performance Requirements for process control, inspection, testing, or other records demonstrating product conformity Containment and verification of the supplied product (used only as a temporary measure in conjunction with supplier corrective actions) Ensuring control over outsourced processes does not absolve KAYA of the responsibility of conforming to all customer requirements Purchasing Information Purchasing information will describe the product to be purchased, including, where appropriate, a) requirements for approval of product, procedures, processes, and equipment, b) requirements for qualification of personnel, and c) QMS requirements. KAYA will ensure the adequacy of specified purchase requirements prior to our communication with the supplier Verification of Purchased Product KAYA will establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchased requirements. When KAYA or our customer intends to perform verification at the supplier s premises, KAYA will state the intended verification arrangements and method of product release in the purchasing information. 7.5 Production and Service Provision Control of Production and Service Provision KAYA will plan and carry out production and service provision under controlled conditions. Controlled conditions will include, as applicable: a) availability of information that describes the characteristics of the product, b) availability of work instructions, as necessary, c) use of suitable equipment, d) availability and use of monitoring and measuring equipment, e) implementation of monitoring and measurement, and f) implementation of product release, delivery, and post-delivery activities Work Instructions Work instructions are established for operators of processes that impact product quality. Work instructions include job set-up instructions, process instructions, control plans, rework instructions, inspection and test instructions, instructions for monitoring of manufacturing processes, laboratory testing and calibration instructions. Page 21 of 29

25 These processes are controlled with the implementation of the following: Documented Procedures defining the requirements of production, workmanship criteria, compliance to standards, quality plans, and methods of control and monitoring these procedures will be described as: General Work Instructions Operator Part Number Instructions (these instructions will be accessible for use at the work station) Part Number Control Plan Visual Aids Digital Handwork Samples Compliance to Standards Control Plans and procedures are enforced daily by management and verified by Quality Auditors and scheduled Internal Audits performed. Customer Special Characteristics will be designated, documented and controlled per customer requirements as defined Quality Planning Process, and the Control Plan. Compliance will be documented and available to customers, per the Quality Planning Process Validation of Processes for Production and Service Provision KAYA will validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Validation will demonstrate the ability of these processes to achieve planned results. KAYA will establish arrangements for these processes including, as applicable, a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see Section 4.2.4), and e) revalidation Identification and Traceability Where appropriate, KAYA will identify the product by suitable means throughout product realization. KAYA will identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, KAYA will control the unique identification of the product and maintain records (see Section 4.2.4). Products are identified throughout all stages of production, to include purchased materials and components, customer-owned products, parts and subassemblies during production, and the finished Page 22 of 29

26 products. Product identification shall consist of one or more of the following identification methods (as required or allowed by the customer) during production, delivery, and installation: KAYA Associates, Inc. Customer trademark Part number Part name Cavity number Revision level Date code Anyone removing products from normal production flow or finished inventory due to real or suspected deficiencies will identify the status of the containers involved. Inspection and test status of products is identified to prevent non-conforming product, or product with unknown inspection status, to be used or dispatched. The identification may be in the form of stickers or tags, sign-offs in the work order, or placement of products in designated locations, such as quarantines (for non-conforming product) or staging areas (for further processing of conforming product) Customer Property KAYA will exercise care with customer property while it is under our control or being used by KAYA. KAYA will identify, verify, protect, and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged, or otherwise found to be unsuitable for use, KAYA will report this to the customer and maintain records (see Section 4.2.4) Preservation of Product KAYA will preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation will include identification, handling, packaging, storage, and protection. Preservation will also apply to the constituent parts of a product. 7.6 Control of Monitoring and Measuring Equipment KAYA will determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determine requirements. KAYA will establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment will: a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification will be recorded (see Section 4.2.4); b) be adjusted or re-adjusted as necessary; c) have identification in order to determine its calibration status; Page 23 of 29

27 d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance, and storage. In addition, KAYA will assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. KAYA will take appropriate action on the equipment and any product affected. Records of the results of calibration and verification will be maintained (see Section 4.2.4). When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application will be confirmed. This will be undertaken prior to initial use and reconfirmed as necessary. 8 MEASUREMENT, ANALYSIS, AND IMPROVEMENT 8.1 General KAYA will plan and implement the monitoring, measurement, analysis, and improvement processes needed to: a) demonstrate conformity to product requirements, b) ensure conformity of the QMS, and c) continually improve the effectiveness of the QMS. This will include determination of applicable methods, including statistical techniques, and the extent of their use. 8.2 Monitoring and Measurement Customer Satisfaction As one of the measurements of performance of the QMS, KAYA will monitor information relating to customer perception as to whether KAYA has met customer requirements. The methods for obtaining and using this information will be determined. Customer complaints are received in various ways: , verbal, fax, or through the customer feedback survey located at: Customer complaints are responded to immediately per the Customer complaint flow chart and/or the method specified by the customer. Page 24 of 29

28 8.2.2 Internal Audit KAYA will conduct internal audits at planned intervals to determine whether the QMS: a) conforms to the planned arrangements (see Section 7.1), to the requirements of ISO 9001:2008 and to the QMS requirements established by KAYA, and b) is effectively implemented and maintained. An audit program will be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods will be defined. The selection of auditors and conduct of audits will ensure objectivity and impartiality of the audit process. Auditors will not audit their own work. A documented procedure will be established to define the responsibilities and requirements for planning and conducting audits, establishing records, and reporting results. Records of the audits and their results will be maintained (see Section 4.2.4). The management responsible for the area being audited will ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities will include the verification of the actions taken and the reporting of verification results (see Section 8.5.2) Monitoring and Measurement of Processes KAYA will apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods will demonstrate the ability of the processes to achieve planned results. When planned results not achieved, correction and corrective action will be taken, as appropriate Monitoring and Measurement of Product KAYA will monitor and measure the characteristics of the product to verify that product requirements have been met. This will be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see Section 7.1). Evidence of conformity with the acceptance criteria will be maintained. Records will indicate the person(s) authorizing release of product for delivery to the customer (see Section 4.2.4). The release of product and delivery of service to the customer will not proceed until the planned arrangements (see Section 7.1) have been satisfactory completed, unless otherwise approved by relevant authority and, where applicable, by the customer. 8.3 Control of Nonconforming Product KAYA will ensure that product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure will be established to define the controls and related responsibilities and authorities for dealing with nonconforming product. Where applicable, KAYA will deal with nonconforming product by one or more of the following ways: Page 25 of 29

29 a) taking action to eliminate the detected nonconformity; b) authorizing its use, release, or acceptance under concession by a relevant authority and, where applicable, by customer; c) taking action to preclude its original intended use or application; d) taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. When nonconforming product is corrected, it will be subject to re-verification to demonstrate conformity to the requirements. Records of the nature of the nonconformities and any subsequent actions taken, including concessions obtained, will be maintained (see Section 4.2.4). 8.4 Analysis of Data KAYA will determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made. This will include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data will provide information relating to a) customer satisfaction (see Section 8.2.1), b) conformity to product requirements (see Section 8.2.4), c) characteristics and trends of processes and products, including opportunities for preventive action (see Sections and 8.2.4), and d) suppliers (see Section 7.4). Table 8-1 is an example of a Monitoring and Measurement Analysis Table. 8.5 Improvement Continual Improvement KAYA will continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. Page 26 of 29

30 Table 8-1. Monitoring and Measurement Analysis Table (Example) Page 27 of 29

31 8.5.2 Corrective Action KAYA will take action to eliminate the causes of nonconformities to prevent recurrence. Corrective actions will be appropriate to the effects of the nonconformities encountered. A documented procedure will be established to define requirements for: a) reviewing nonconformities (including customer complaints), b) determine the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see Section 4.2.4), and f) reviewing the effectiveness of the corrective action taken Control of Reworked Product Rework instructions will be provided to perform any rework operations. These rework instructions will be accessible and utilized by the appropriate personnel in the rework area. Repaired or reworked product will be re-inspected in accordance with the control plan or documented procedures Customer Information If it is believed that non-conforming product has been shipped to the customer, the customer will be notified immediately and arrangements made to replace or rework the product Preventive Action KAYA will determine actions to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive actions will be appropriate to the effects of potential problems. A documented procedure will be established to define requirements for: a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken (see Section 4.2.4), and e) reviewing the effectiveness of the preventive action taken. Page 28 of 29

32 9 Revision History Revision Date (MO/YR) Description Reviewed By Approved By 1 01/11 Updated Quality Policy Signature Block Pete Berdovich Robert Dunn 2 03/11 Updated Office Addresses and Phone Numbers Pete Berdovich Robert Dunn 3 04/11 Updated Organization Chart, # of employees, assigned Pete Berdovich Robert Dunn QC # 4 03/12 Updated Quality Policy Signature Block, Org Chart and Distribution List Pete Berdovich Robert Dunn Page 29 of 29

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