1 Karas Engineering AS9100 QUALITY MANAGEMENT SYSTEM MANUAL Revision D October 27, 2015
2 Statement of Commitment and Authority Commitment This Quality Management System Manual (QMSM) delineates the processes, procedures and practices that must be followed by Karas Engineering Company, Inc. in the fabrication of products and provision of services to assure conformance with the requirements of Aerospace Standard AS9100, Quality Management Systems - Requirements for Aviation, Space and Defense Organizations, revision C. Karas Engineering is committed to assuring customer satisfaction by producing safe, reliable products that meet the applicable contractual, regulatory and statutory requirements. Karas Engineering has formulated a formal Quality Policy (reference QP 5.3) and has identified Quality Objectives (reference QAP 5.4.1) that are measurable and consistent with our Quality Policy. This Quality Management System Manual (QMSM) applies to the Karas Engineering facility located at 44 Old State Street #20 in New Milford, CT All Karas Engineering personnel are responsible for delivering Quality products and services to the Aviation, Space and Defense industries as well as any other industries/customers that require compliance to AS9100/ISO Specific activities, methods, and responsibility assignments of the Quality Management System are prescribed within this manual and additional controlled implementing procedures that are developed on an as needed basis in compliance with the requirements of the AS9100 standard. These implementing documents are developed and are in place prior to performing the activities they address. Authority The Quality Management Representative has the total authority and an unlimited responsibility for assuring implementation of this Quality Management System Manual, identifying quality problems, ensuring that solutions are provided, and verifying implementation. He/She ensures the promotion of customer requirements throughout the organization. He / She has the authority to limit processing or stop work as required. He /She has the organizational freedom including sufficient independence from cost and schedule considerations with unlimited access to top management to resolve quality management issues. He / She shall keep the President advised as to the performance of the quality management system and any need for improvement. Revision Control Denny Karas President, Karas Engineering Revision A Initial Release 9/01/2009 Revision B Updated to comply with AS9100, Revision C 1/01/2012 Revision C Updated to add references to new documents; editorial changes 4/30/2014 Revision D Updated to add references to Karas Enterprise Management System (KEMS)- 10/27/15
3 AS9100 QUALITY MANAGEMENT SYSTEM REQUIREMENTS 1.0) Scope Scope of Registration: This Quality Manual describes the policies and the quality management system of the Karas Engineering organization. The quality management system described in this manual meets the requirements of the ISO 9001:2008 standard and AS 9100 Revision C standard. The scope of the quality system is defined below: Karas Engineering manufactures and machines product in accordance with customer design drawings. Karas Engineering activities are conducted at 44 Old State Road in New Milford, Ct The Quality Management System s explicit boundaries of control are defined by this Quality Manual and apply only to the activities identified above.. Sequence and Interaction of Processes: Direct processes include management planning, external and internal customer relations, control of design and fabrication documents, purchasing, and production. Indirect processes include document and records controls, management responsibility, resource management, and measurement, analysis, and improvement. These processes are described in the Quality Manual and the Quality Management System Procedures.. The following is a text explanation of the sequence and interaction of processes. They are implemented as a Plan-Do-Check-Act cycle applicable to the Leadership Team and each process. Plan The Leadership Team provides general oversight and control of internal and outsourced processes and the authorization of the Quality Manual, documents, and records required to ensure the quality management system has the structure to achieve desired objectives.
4 The Leadership Team executes the management responsibility process. This process includes: Establishment and/or review of evidence of commitment, through ongoing customer focus initiatives, quality policy and quality objective reviews, and quality management system planning; Assignment of responsibility and authority to key individuals to manage, operate, and verify all processes; Appointment of a management representative who has the responsibility and authority documented in 5.5.2a-c of the standard; Establishment of communication processes to members of the organization demonstrating the effectiveness of the quality management system; and Review of the quality management system, including outputs of the measurement, analysis, and improvement processes. As a result of output decisions made during the management responsibility process, the Leadership Team provides inputs to the resource management process to provide the necessary resources to implement, maintain, and improve the quality management system and to enhance customer satisfaction. These provisions include: Human resources (including competence, awareness, and training needs) as delivered by the Human Resources Process; Infrastructure; and Work environment. Do After the Leadership Team provides the outputs of necessary resources, they provide improvement and planning inputs to the production planning process. This includes high-level review of quality objectives and project-specific requirements to ensure production, inspection, and record-keeping processes are sufficient. The output of the planning may be a procedure, a work instruction, a project design plan, or a combination of these. Contract Specialists control the customer-related processes. Process Engineering personnel control the fabrication processes. These processes involve communicating with internal and/or external customers and suppliers to determine and review product requirements and to communicate with them during and after production in the event there are amendments to or complaints about meeting requirements.
5 Customer Specialists and Process Engineering personnel provide output of the customer-related design and development processes as inputs to the purchasing process. Purchasing personnel monitor the suppliers to ensure the supply of products and services meet applicable purchasing needs. The purchasing process includes verification of supplied products or services as they apply to purchasing agreements. Production operators use purchased products and services from the outputs of the purchasing process as inputs to the production process. Production operators: Control the production processes through the use of procedures, work instructions, proper equipment, proper monitoring and measurement, and provision of products; Identify product in such a manner that appropriate personnel can determine the completion status at any time; Exercise care with customer property (including intellectual property) while it is under the organization s control and record and report any lost, damaged, or unsuitable customer property; Preserve product information at any stage in such a manner that it retains its conformity to customer requirements; and Control monitoring and measuring devices in such a manner that monitoring and measurement can be carried out in accordance with customer requirements. The outputs of the production processes are planned to meet and/or exceed customer expectations. The results of product realization are inputs to the measurement, analysis, and improvement processes. Check All members of Karas Engineering are responsible for contributions to the measurement, analysis, and improvement processes. Contributions come from day-to-day and long range planning activities. The Leadership Team monitors the customer satisfaction process; The Management Representative coordinates the internal audit process; Quality inspection personnel execute the monitoring and measurement and nonconformance processes; The Leadership Team reviews data from the customer satisfaction process, the monitoring and measurement processes, corrective and preventive action processes, and the purchasing process to determine the effectiveness of the quality management system; and All members of Karas Engineering contribute to the improvement process (including continual improvement, corrective actions, and preventive actions).
6 Act The outputs of the measurement, analysis, and improvement processes serve as inputs to the management responsibility process as the next step in the recurring process cycle. Decisions are made at management reviews to act upon continual improvement of processes. The continual cycle of planning, doing, and checking follow as described above. The high level Plan-Do-Check-Act cycle is applicable within each process. Permissible Exclusions: Karas Engineering does not perform design and development processes and therefore considers Section 7.3 of AS9100 as a permissible exception. Karas Engineering also does not perform off site installation and post shipment support and therefore considers Section , Post-Delivery Support, as a permissible exclusion. 2.0 Normative References AS 9102, Aerospace First Article Inspection Requirement AS9103, Variation Management of Key Characteristics ISO900:2005, Quality Management Systems Fundamentals and vocabulary ISO 9001:2008, Quality Management Systems Requirements ISO 10007:1995, Configuration Management Systems ISO 10012:2003, Measurement Management Systems Requirements for Measuring Processes and Measuring Equipment ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing 3.0 Terms and Definitions 3.1 Risk An undesirable situation or circumstance that has both a likelihood of occurrence and a potentially negative consequence. 3.2 Special Requirements Those requirements identified by the customer, or determined by the organization, which have high risks of being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past
7 experience and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limits of the industry s capability, or requirements determined by the organization to be at the limits of its technical or process capabilities. 3.3 Critical Items Those items (e.g., functions, parts, software, characteristics, processes) having significant impact on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc., that require specific actions to ensure that they are managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc. 3.4 Key Characteristic An attribute or feature whose variation has a significant effect on product form, fit, function, performance, service life and producibility that requires specific actions for the purpose of controlling variation. 4.0 Quality Management System 4.1 General Requirements The quality management system has been established, documented, implemented, maintained and is continually improved in accordance with the requirements of ISO 9001:2008 and AS 9100, revision C, as well as customer and applicable statutory and regulatory Quality Management System requirements. To implement the system, the Leadership Team has completed the following activities: a) Determination of the processes needed for the quality management system and their application throughout the organization. Processes include activities that receive inputs from internal and/or external suppliers and deliver products to internal and/or external customers. b) Determination of the sequence and interaction of the processes- see QPlan 4.1 Organization Process Map for the pictorial display of the interaction of the processes. c) Determination of the criteria and methods needed to ensure that both the operation and control of these processes are effective. This involves management review, customer needs, and appropriate planning.
8 d) Allocation of the resources and information necessary to support the operation and monitoring of these processes. Resource planning and allocation evolve from day-to-day and management review activities. e) Monitoring, measurement, and analysis of these processes. The Leadership Team uses customer satisfaction information, internal audit results, inspection results, data analysis, and improvement activities to monitor measure, and analyze the processes. f) Implementation of actions necessary to achieve planned results and continual improvement of these processes- the continual improvement, corrective action, and preventive action processes are the tools used to determine if the implementation activities have met their targets. Where the organization chooses to outsource any process that affects product conformity to requirements, the organization ensures control over such processes. The type and extent of control is defined within the quality management system procedures. Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement. An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. Ensuring control over the outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced processes can be influenced by factors such as: a) The potential impact of the outsourced process on the organization s capability to provide product conforms to requirements. b) The degree to which the control of the process is shared, c) The capability of achieving the necessary control through application of the purchasing process. Purchasing (see section 7.4) controls all outsourcing activity.
9 4.2 Document Requirements General The quality management system documentation includes: Documented statements of a Quality Policy (reference QP 5.3) and Quality Objectives (reference QAP5.4.1). A Quality Manual - all of the sections of the current manual meet this documentation requirement. Documented procedures required by ISO 9001 and AS9100. The titles of these procedures are included in the Related and Support Documentation of each section of the Quality Manual and are listed in QL , List of Controlled Program Documents. Documents needed by the organization to ensure the effective planning, operation and control of processes. Other documents include work instructions in the format of text work instructions, and blank forms. Quality records required by ISO 9001 and AS9100. These include, at a minimum, all required records indicated in the standards by the parenthetical note (see 4.2.4). Quality system requirements imposed by the applicable regulatory authorities. Personnel have access to quality management system documentation and are aware of relevant procedures. Customer and/or regulatory authorities representatives have access to quality management system documentation and changes to this documentation Quality Manual This Quality Manual has been established and is maintained. It includes: The scope of the quality management system, including details of and justification for any permissible exclusion is contained in Section 1.0 of this manual. References to the documented procedures established for the quality management system are contained in the Related and Support Documents of each section of the Quality Manual as applicable. See the AS9100 Quality Management System Procedures for the text of each referenced procedure. When referencing the procedures, the relationship between AS 9100 and the procedures are clearly shown by their numbering, titles and texts. A description of the interaction between the processes of the quality management system is contained in Section 1.0 of this manual. See QPlan 4.1, Organization Process Map for a pictorial display.
10 4.2.3 Control of Documents Documents and quality records required by the quality management system are controlled. A documented procedure (QAP 4.2.3, Control of Quality Management System Documents) has been established to define the controls needed to: Approve documents for adequacy prior to issue; Review and update as necessary and re-approve documents; Ensure that changes and the current revision status of documents are identified; Ensure that relevant versions of applicable documents are available at points of use; Ensure that documents remain legible and readily identifiable; Ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled; Prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose; and, Coordinate document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements Control of Records Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records are legible, readily identifiable and retrievable. A documented procedure (QAP 4.2.4, Control of Records) has been established to define the controls needed for the records relating to: Identification; Storage; Protection; Retrieval; Retention time; Disposition; Method for controlling records that are created by and/or retained by suppliers; Availability of records for review by customer and regulatory authorities in accordance with contract or regulatory requirements.
11 Section Four Related and Support Documentation QP 4.1 Organization Process Map QFile Applicable Industry and Regulatory Requirements QAP Control of Quality Management System Documents QL Master List of Controlled Quality Management System Documents QFile Controlled Customer Generated Documents QAP Control of Quality Management System Records QFile Master List of Quality Management System Records 5.0 Management Responsibility 5.1 Management Commitment The Leadership Team has provided evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements; Establishing the quality policy; Ensuring that quality objectives are established; Conducting management reviews; and, Ensuring the availability of resources. 5.2 Customer Focus The Leadership Team has ensured that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction. (See Sections and of this manual). The Leadership Team has ensured that Product Conformity and On Time Delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved. 5.3 Quality Policy The Leadership Team has ensured that the quality policy is: Appropriate to the purpose of the organization; Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system;
12 Provides a framework for establishing and reviewing quality objectives; Communicated and understood within the organization; and Reviewed for continuing suitability. The quality policy is documented in QP 5.3, Quality Policy. 5.4 Planning Quality Objectives The Leadership Team has ensured that quality objectives, including those needed to meet requirements for product realization, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy. The quality objectives are defined in QAP 5.4.1, Quality Objectives Quality Management System Planning The Leadership Team has ensured that: The planning of the quality management system is carried out in order to meet the requirements of the general requirements of the international standard (Clause 4.1); and The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Reference QAP Control of Quality Management System Documents. 5.5 Responsibility, Authority and Communication Responsibility and Authority The Leadership Team has ensured that the responsibilities, authorities and their interrelation are defined and communicated within the organization. Reference QAP 5.5.1, Responsibility and Authority and QP 5.5.1, Organization Chart Management Representative The President has appointed a qualified individual of the organization s management as the Management Representative reference QP 5.5.1, Organizational chart. The Management Representative is responsible for establishing, implementing, and maintaining the Quality
13 Management System, and for reporting on its performance at Management Review meetings, and irrespective of other duties is responsible and accountable for: Ensuring that processes needed for the quality management system are established, implemented and maintained; Reporting to the Leadership Team on the performance of the quality management system and any need for improvement; Ensuring the promotion of awareness of customer requirements throughout the organization; and Acting as liaison with external parties on matters relating to the quality system as appropriate. The Management Representative has the organizational freedom and unrestricted access to The President of the company to resolve quality management issues Internal Communication The Leadership Team has ensured that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. Reference QAP 5.5.3, Internal Communication. 5.6 Management Review General The Leadership Team reviews the quality management system as a minimum once per year to ensure its continuing suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records of management reviews are maintained Review Input Input to Management Review includes, as minimum, information on: Results of audits; Customer feedback; Process performance and product conformity; Status of preventive and corrective actions; Follow-up actions from earlier management reviews; Planned changes that could affect the quality management system; and Recommendations for improvement.
14 5.6.3 Review Output Output from management review includes any decisions and actions related to: Improvement of the effectiveness of quality management system and its processes; Improvement of product related to customer requirements; and, Resource needs. The Management Review process is described in QAP 5.6 Management Review. Section Five Related and Support Documentation QP 5.3, Quality Policy QAP 5.4.1, Quality Objectives QF , Monthly Metrics Scorecard QF , Organizational Scorecard QAP 5.5.1, Responsibility and Authority QP 5.5.1, Organization Chart QAP 5.5.3, Internal Communication QF 5.5.3, Employee Meeting Agenda/Minutes QAP 5.6, Management Review QF 5.6, Record of Management Review Meeting
15 6.0 Resource Management 6.1 Provision of Resources Resources have been determined and provided to: Implement and maintain the quality management system and continually improve its effectiveness; and Enhance customer satisfaction by meeting customer requirements. Resources are reviewed and provided as necessary as part of management review process. The management review process is described in QAP 5.6 Management Review. 6.2 Human Resources General Personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience. The organization understands that product conformity can be affected directly or indirectly by personnel performing any task within the quality management system Competence, Training and Awareness The Leadership Team has: Determined the necessary competence for personnel performing work affecting conformity to product requirements; Where applicable, provided training or taken other action to achieve the necessary competence Evaluated the effectiveness of the actions taken; Ensured that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives; and, Maintained appropriate records of education, training, skills and experience. Competence, training and awareness processes are described in QAP 6.2 Competence, Training and Awareness.
16 6.3 Infrastructure Karas Engineering AS9100 Quality System Manual The infrastructure needed to achieve conformity to product requirements has been determined, provided and maintained. Infrastructure examples may include, but not be limited to: Buildings, workspace and associated utilities; Process equipment, both hardware and software; and, Supporting services such as transport, communication or information systems. The Leadership Team has identified and maintains the required infrastructure to achieve product conformity. Reference QL 6.3, Facilities List. 6.4 Work Environment The work environment needed to achieve conformity to product requirements has been determined and managed. Factors affecting conformity of the product include temperature, humidity, lighting, cleanliness, and protection, etc. as deemed appropriate by the Leadership Team. Reference QAP 6.4, Work Environment. Section Six Related and Support Documentation QAP 6.2, Competence, Training and Awareness QL 6.2-1, QMS Requirements Applicability Table QL 6.2-2, List of Qualified Personnel QF 6.2-1, Record of Training Reading List QF 6.2-2, Record of Training Attendance Sheet QF 6.2-3, Record of Personnel Qualification QF 6.2-4, Periodic Employee Performance Review QL 6.3, Facilities List QAP 6.4, Infrastructure and Work Environment QF 6.4-1, Request for Addition to Infrastructure QF 6.4-2, 5S Checklist
17 7.0 Product Realization 7.1 Planning of Product Realization The processes needed for product realization are planned and developed, and are consistent with the requirements of the other processes of the quality management system. In planning product realization, the following has been determined, as appropriate: a) Quality objectives and requirements for the product; (Reference Section 5.4.1); Quality objectives and requirements for the product include considerations of aspects of: product and personal safety, reliability, availability and maintainability, producibility and inspectability, suitability of parts and materials used in the product, selection and development of embedded software, and recycling or final disposal of the product at the end of its life. b) The need to establish processes, documents, and provide resources specific to the product; c) Required verification, validation, monitoring, 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 fulfill requirements; e) configuration management appropriate to the product; and, f) Identification of resources to support operation and maintenance of the product. Reference QP 7.1, Standard Quality Plan, for the product realization process activity sequence Project Management The organization plans and manages product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints, as appropriate to the organization and the product Risk Management The organization has established, implemented and maintains a process for managing risks to the achievement of applicable requirements. The process includes, as appropriate to the organization and the product: a) assignment of responsibilities for risk management, b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance), c) identification, assessment and communication of risks throughout product realization,
18 d) identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, and e) acceptance of risks remaining after implementation of mitigating actions Configuration Management The organization has established, implemented and maintains a configuration management process that includes, as appropriate to the product: a) configuration management planning, b) configuration identification, c) change control, d) configuration status accounting, and e) configuration audit Control of Work Transfers The organization has established, implemented and maintains a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another) and to verify the conformity of the work requirements. Reference QPlan 7.1, Standard Quality Plan Reference QAP 7.1.1, Project Management Reference QP , Specialized Project Plan Reference QAP 7.1.2, Risk Management Reference QAP 7.1.3, Configuration Management Reference Qlog , Industry and Regulatory Specifications Log Reference QAP 7.1.4, Control of Work Transfers 7.2 Customer Related Processes Determination of Requirements Related to Product Requirements related to the product have been determined, including: Requirements specified by the customer, including the requirements for delivery and postdelivery activity; Requirements not stated by the customer but necessary for specified use or known and intended use; Statutory and regulatory requirements applicable to the product; and, Determination of any additional requirements, which can include special requirements.
19 7.2.2 Review of Requirements Related to Product Requirements related to the product are reviewed. This review is conducted prior to committing to supply a product to customers, and ensures that: Product requirements are defined; Contract or order requirements differing from those previously expressed are resolved; The organization has the ability to meet the defined requirements; Special requirements of the product have been determined, and Risks associated with new technology, short delivery time scales, etc. have been identified. Records of the results of review and actions arising from this review are maintained. Where the customer provides no documented statement of requirements, customer requirements are confirmed before acceptance. Where product requirements are changed, it is ensured that relevant documents are amended and that relevant personnel are made aware of the changed requirements. Reference QAP 7.2.2, Customer Requirements Review and Order Entry Reference QDB , Risk Assessment Module Reference QDB , KEMS Quote Module Reference QF , Quote Sheet Reference QLog , Record of Customer Contract Review. Reference QDB , KEMS Sales Order Module Customer Communication Effective arrangements for communication with customers relating to the following are determined and implemented: Product information; Enquiries, contracts or order handling, including amendments; and, Customer feedback, including customer complaints. Reference QDB 7.2.3, Customer Complaint & Returned Product 7.3 Design and Development Karas Engineering provides precision machining services in compliance with customer supplied design drawings and is not a product design and development organization. Therefore, Karas Engineering takes a permissible exception to the requirements of this section.
20 7.4 Purchasing Purchasing Process Karas Engineering AS9100 Quality System Manual Purchasing processes are controlled to ensure purchased product conforms to specified purchase requirements. The type and extent of control is applied to suppliers and purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization is responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer. Suppliers are evaluated and selected based on their ability to supply product in accordance with requirements. Criteria for selection, evaluation and re-evaluation and any necessary actions arising from the evaluation are maintained. The organization may rely upon data from objective and external sources as a component of our supplier control process. The organization however remains responsible for verifying that purchased product meets specified purchase order requirements. The results of evaluations and necessary actions are maintained. The organization: Maintains a register of its suppliers that includes approval status ( e.g. approved, conditional and disapproved) and scope of approval (e.g. product type, process family); Periodically reviews supplier performance; the results of these reviews are used as a basis for establishing the levels of controls to be implemented; Defines the necessary actions to take when dealing with suppliers that do not meet requirements; Ensures where required that both the organization and all suppliers use customer-approved special process sources; and, defines the process, responsibilities and authority for the approval status decision, changes of the approval status and conditions for a controlled use of suppliers depending on the supplier s approval status, and determines and manages the risk when selecting and using suppliers. Reference QAP 7.4.1, Purchasing Process Reference QDB 7.4.1, Approved Suppliers
21 7.4.2 Purchasing Information Purchasing information describes the product to be purchased, including where appropriate: Requirements for approval of product, procedures, processes, and equipment; Requirements for qualification of personnel; Quality management system requirements; The identification and revision status of specifications, drawings process requirements, inspection/verification instructions and other relevant technical data; Requirements for design, test, examination inspection, verification (including production process verification), use of statistical techniques for product acceptance and related instructions for acceptance by the organization and as applicable, critical items including key characteristics; Requirements for test specimens for design approval, inspection/verification, investigation or auditing; Requirements regarding the need for the supplier to: notify the organization of nonconforming product obtain organization approval for nonconforming material disposition; notify the organization of changes in product and/or process, changes of suppliers, change of manufacturing facility location and where required, obtain organization approval, and flow down to the supply chain the applicable requirements including customer requirements, Records retention requirements, and Right of access by the organization, their customer, and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain involved in the order and to all applicable records. The adequacy of specified purchasing requirements prior to their communication to suppliers is ensured. Reference QL 7.4.2, Quality Procurement Requirements Reference QF , Request for Quote Reference QLog 7.4.2, Purchase Order Numbers Reference QDB 7.4.2, KEMS Purchase Order Module Reference QF , Purchase Order Reference QF , Supplier Waiver/Deviation Request
22 7.4.3 Verification of Purchased Product Inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements are established and implemented. The organization understands that customer verification activities performed at any level of the supply chain will not be used by the organization or their suppliers as evidence of effective control of quality and that customer verification activities do not absolve the organization of its responsibility to provide acceptable product in compliance with all requirements. Verification activities can include: Obtaining objective evidence of the conformity of the product from the supplier; Inspection and audit at the supplier s premises; Review of the required documentation; Inspection of products upon receipt; and Delegation of verification to the supplier, or supplier certification. Where purchased product is released for production use pending completion of all required verification activities, it is identified and recorded to allow for recall and replacement if it is subsequently found that the product does not meet requirements. When the organization delegate s verification activities to the supplier, the requirements for delegation are defined and a register of delegations is maintained. Where verification of purchased product is intended at suppliers premises, including customer verification of such product, the verification activity and the method of product release are stated in the purchasing information. Reference QAP 7.4.3, Verification of Purchased Product Reference QF , Record of Source Inspection/Release Form Reference QF , Record of Receipt Inspection Reference QDB , Job Card Entry Reference QLog , Record of Raw Material Test Results Reference QDB , KEMS Receiving Module 7.5 Production and Service Provision Control of Production and Service Provision Production and service operations are planned and carried out under controlled conditions, including, as applicable, the:
23 a) Availability of information that describes the characteristics of the product, this information can include drawings, parts lists, materials and process specifications,; b) Availability of work instructions, work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work instructions, process cards) and inspection documents; c) Use of suitable equipment, suitable equipment can include product specific tools (e.g., jigs, fixtures, molds) and software programs,; d) Availability and use of monitoring and measuring equipment; e) Implementation of monitoring and measurement; f) Implementation of product release, delivery and post-delivery activities; g) Accountability for all products during production (parts quantities, split orders, nonconforming product); h) Evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized; i) Provision for the prevention, detection, and removal of foreign objects; j) Monitoring and control of utilities and supplies such as water, compressed air; electricity and chemical products to the extent they affect product quality; and k) Criteria for workmanship, specified in the clearest practical way what is acceptable (for example, written standards, representative samples, illustrations). Planning shall consider, as applicable, Establishing, implementing and maintaining appropriate processes to manage critical items, including process controls where key characteristics have been identified; Identifying in-process inspection/verification points when adequate verification of conformance cannot be performed at later stages of realization; Designing, manufacturing, and using tooling to measure variable data; and, Special processes (see 7.5.2). Reference QAP 7.5.1, Control of Production and Service Provision Reference QDB , KEMS Shop Order Module Reference QF , Shop Floor Routing Reference QDB , Process Control Plan Reference QF , Process Control Chart Reference QF , Release of Finished Goods for Shipment Reference QFile , Completed First Article Inspection Reports Reference QF , WIP Rework Sheet
24 Production Process Verification The organization uses a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation and tooling are capable of producing parts and assemblies that meet requirements. This process is repeated when changes occur that invalidate the original results (e.g., engineering changes, manufacturing process changes, tooling changes). (NOTE: This activity is referred to as First Article Inspection). Karas Engineering performs first article inspection in accordance with AS9102. The methods are described in QAP , First Article Inspection, and QF , First Article Inspection Report. Reference QAP , First Article Inspection Reference QF , First Article Inspection Report Control of Production Process Changes Personnel authorized to approve changes to production process are identified. Changes affecting processes, production equipment, tools and software programs are controlled and documented. The results of changes to production processes are assessed to confirm that the desired effect is achieved without adverse effects to the product conformity. Reference QAP , Production Process Change Control Reference QF , Production Process Change Authorization Control of Production Equipment, Tools and Software Programs Production equipment, tools and software programs used to automate and control/monitor product realization processes are validated prior to release for production use and maintained. Storage requirements, including periodic preservation/condition checks, are defined for production equipment and tooling in storage. Reference QFile , CNC Programs Released Directory Reference QLog , Tooling Post-Delivery Support: Post delivery support provides as applicable for the: collection and analysis of-service data;
25 Actions to be taken including investigation and reporting when problems are detected after delivery; The control and updating of technical documentation; The approval, control and use of repair schemes; and, The controls required for off-site work (organization work undertaken at the customer s facilities). Note: Karas Engineering s current scope of work does not contain requirements for post delivery servicing of product. Processes for handling customer complaints and returned defective product are described in QDB Customer Complaint and Returned Product Validation of Processes for Production and Service Provision The organization validates processes for production 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 and has been delivered. These processes are often referred to as special processes. Validation demonstrates the ability of these processes to achieve planned results. Arrangements are established for these processes including, as applicable: Defined criteria for review and approval of the processes, including qualification and approval of special processes prior to use; Approval of equipment and qualification of personnel; Use of specific methods and procedures including control of the significant operations and parameters of special processes in accordance with documented process specifications and changes thereto; Requirements for records; and, Revalidation. Reference QAP 7.5.2, Validation of Hidden and Special Processes Identification and Traceability Product is identified by suitable means throughout production realization. The organization maintains the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration. The status of the product is identified with respect to measurement and monitoring requirements throughout product realization. When acceptance authority media is used (stamps, etc.) the organization establishes appropriate controls for the media.
26 Where traceability is a requirement, the unique identification of product is controlled and recorded. Note: Traceability requirements may include: Identification to be maintained throughout the product life; The ability to trace all products manufactured from the same batch of raw material or from the same manufacturing batch to the destination (delivery, scrap); For an assembly, the ability to trace its components to the assembly and then to the next higher assembly; and, For a product, a sequential record of its production (manufacture, assembly, inspection/verification) to be retrievable. Reference QAP 7.5.3, Identification and Traceability Reference QL 7.5.3, Raw Material Inventory Codes Customer Property Care is exercised with customer property while it is under control or being used. Customer property provided for use or incorporation into product is identified, verified, protected and safeguarded. Any customer property that is lost, damaged or otherwise found to be unsuitable for use is recorded and reported to customers. Customer property includes intellectual property and personal data. Reference QLog 7.5.4, Customer Furnished Property Preservation of Product Conformity of product during internal processing and delivery to the intended destination is preserved. This includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. Preservation of product also includes, where applicable in accordance with product specifications and/or applicable regulations, provisions for: Cleaning; Prevention, detection and removal of foreign objects; Special handling for sensitive products; Markings and labeling including safety warnings; Shelf life control and stock rotation; and, Special handling for hazardous materials. Reference QAP 7.5.5, Preservation of Product Reference QF , Packing List Reference QF , Certificate of Conformance
27 7.6 Control of Measuring and Monitoring Equipment The organization determines the monitoring and measurements to be undertaken, and the monitoring and measuring equipment needed to assure conformity of product to determined requirements. The organization maintains a register of monitoring and measuring equipment, and defines the process employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. Monitoring and measuring equipment includes, but is not limited to, test hardware, test software, automated test equipment (ATE) and plotters used to produce inspection data. It may also include personally owned and customer supplied equipment used to provide evidence of product conformity. Processes are established to ensure that monitoring and measurement can be carried out and are carried out in a manner consistent with the monitoring and measurement requirements. The organization ensures that environmental conditions are suitable for the calibrations, inspections, measurements and testing being carried out. Where necessary to ensure valid results, measuring equipment is: 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 is defined and recorded see Section 4.2.4; Adjusted or re-adjusted as necessary; Identified to enable the calibration status to be determined; Safeguarded from adjustments that would invalidate the measurement result; Protected from damage and deterioration during handling, maintenance and storage; and, A process for the recall of monitoring and measurement equipment requiring calibration or verification is established, implemented and maintained. The validity of the previous measuring results are assessed and recorded when the equipment is found not to conform to requirements. Appropriate action is taken on the equipment and any product affected. Records of the results of calibration and verification are maintained. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. Confirmation of computer software to satisfy the intended application includes its verification and configuration management. This is undertaken prior to initial use and reconfirmed as necessary. The control of monitoring and measuring devices process is described in QAP 7.6 Control of Monitoring and Measurement Devices.
28 Reference QAP 7.6, Control of Monitoring and Measurement Devices Reference QDB 7.6-1, Measuring and Monitoring Equipment Reference QF 7.6-2, Out-of-Tolerance Report Section Seven Related and Support Documentation Reference QPlan 7.1, Standard Quality Plan Reference QAP 7.1.1, Project Management Reference QP , Specialized Project Plan Reference QAP 7.1.2, Risk Management Reference QAP 7.1.3, Configuration Management Reference Qlog , Industry and Regulatory Specifications Log Reference QAP 7.1.4, Control of Work Transfers Reference QAP 7.2.2, Customer Requirements Review and Order Entry Reference QDB , KEMS Risk Assessment Module Reference QDB , KEMS Quote Module Reference QF , Quote Sheet Reference QLog , Record of Customer Contract Review. Reference QDB , KEMS Sales Order Module Reference QDB 7.2.3, Customer Complaint & Returned Product Reference QAP 7.4.1, Purchasing Process Reference QDB 7.4.1, Approved Suppliers (KEMS) Reference QL 7.4.2, Quality Procurement Requirements Reference QF , Request for Quote Reference QLog 7.4.2, Purchase Order Numbers Reference QDB 7.4.2, KEMS Purchase Order Module Reference QF , Purchase Order Reference QF , Supplier Waiver/Deviation Request Reference QAP 7.4.3, Verification of Purchased Product Reference QF , Record of Source Inspection/Release Form Reference QF , Record of Receipt Inspection Reference QDB , Job Card Entry Reference QLog , Record of Raw Material Test Results Reference QDB , KEMS Receiving Module Reference QAP 7.5.1, Control of Production and Service Provision Reference QDB , KEMS Shop Order Module Reference QF , Shop Floor Routing Reference QDB , Process Control Plan Reference QF , Process Control Chart Reference QF , Release of Finished Goods for Shipment Reference QFile , Completed First Article Inspection Reports Reference QF , WIP Rework Sheet
29 Reference QAP , First Article Inspection Reference QF , First Article Inspection Report Reference QAP , Production Process Change Control Reference QF , Production Process Change Authorization Reference QFile , CNC Programs Released Directory Reference QLog , Tooling Reference QAP 7.5.2, Validation of Hidden and Special Processes Reference QAP 7.5.3, Identification and Traceability Reference QL 7.5.3, Raw Material Inventory Codes Reference QLog 7.5.4, Customer Furnished Property Reference QAP 7.5.5, Preservation of Product Reference QF , Packing List Reference QF , Certificate of Conformance Reference QAP 7.6, Control of Monitoring and Measurement Devices Reference QDB 7.6-1, Measuring and Monitoring Equipment Reference QF 7.6-2, Out-of-Tolerance Report
30 8.0 Measurement, Analysis and Improvement 8.1 General The Leadership Team has planned and implemented the monitoring, measurement, analysis and improvement procedures needed to: Demonstrate conformity to product requirements; Ensure conformity of the quality management system; and Continually improve the effectiveness of the quality management system. This includes determination of applicable methods, including statistical techniques, and the extent of their use. According to the nature of the product and depending on the specified requirements, statistical techniques are used to support: Process control; Selection and inspection of key characteristics; Process capability measurements; Design of experiments; Matching sampling rate to the criticality of the product and process capability; and, Failure mode effect and criticality analysis. 8.2 Monitoring and Measurement Customer Satisfaction As one of the measurements of the performance of the quality system, the organization monitors information relating to customer perception as to whether customer requirements have been fulfilled. Information monitored and used for the evaluation of customer satisfaction includes (but is not limited to): product conformity, on-time delivery performance, and customer complaints and corrective action requests.
31 Karas Engineering sends out a customer satisfaction survey to all active customers at least once per calendar year. The methods for obtaining and using this information are determined and documented in QF 8.2.1, Customer Survey. The organization also monitors customer on-time delivery, customer complaints, returned product and customer corrective actions - reference QP 5.4.1, Quality Objectives, for specific customer satisfaction metrics. The organization implements plans for customer satisfaction improvement that address deficiencies identified by these evaluations and assesses the effectiveness of the results Internal Audit Periodic internal audits are conducted at planned intervals to determine whether the quality management system: Conforms to the planned arrangements, to the requirements of the standard, and to the quality management system requirements established by the organization; and, Is effectively implemented and maintained. (Note: Planned arrangements include customer contractual requirements). An audit program is planned and takes into consideration the status and importance of the procedures and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit procedure. Auditors do not audit their own work. Reference Internal Audit Schedule QF The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records, are defined in a documented procedure QAP 8.2.2, Internal Audits. Records of the audits and their results are maintained. The management responsible for the audited area ensures that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results Monitoring and Measurement of Processes Suitable methods are applied for monitoring and, where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action are taken, as appropriate, to ensure conformity of the product.
32 In the event of procedure nonconformity, the organization shall: Take appropriate action to correct the nonconforming procedure; Evaluate whether the procedure nonconformity has resulted in product nonconformity; Determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or product and, Identify and control any nonconforming product in accordance with QAP 8.3, Control of Nonconforming Product Monitoring and Measurement of Product The characteristics of the product are monitored and measured to verify that product requirements are fulfilled. This is completed at appropriate stages of the product realization procedure in accordance with planned arrangements. Measurement requirements for product or service acceptance are documented. This documentation may be part of the production documentation, but shall include: Criteria for acceptance and/or rejection; Where in the sequence measurement and testing operations are performed; Required records of measurement results (at a minimum a record of acceptance/rejection); and, Any specific measurement instruments required and any specific instructions associated with their use. When critical items, including key characteristics have been identified or are required by the customer s contract, the organization ensures that they are monitored and controlled in accordance with the established process. When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical valid principles and appropriate for use for example, matching the sampling plan to the criticality of the product and to the process capability. The plan precludes the acceptance of lots whose samples have known nonconformance. When required, the plan is submitted for customer approval. Reference QAP 8.2.4, Sampling Plans Where product is released for production use pending completion of all required measurement and monitoring activities it is identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements. Reference QF , Acceptance Tag and QF , Reject Tag and QF , MRB Hold Tag Evidence of conformity with the acceptance criteria is maintained. Records indicate the person(s) authorizing the release of product.
33 When required to demonstrate product qualification, test records provide evidence that the product meets the defined requirements. The release of product and delivery of service to the customer do not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer. The organization ensures that all documents required to accompany the product are present at delivery. Reference QAP , Measurement of Product Reference QF , Record of Production Inspection. Reference QF , Record of Final Inspection 8.3 Control of Nonconforming Material Product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in a documented procedure QAP 8.3, Control of Nonconforming Material Procedure. The term nonconforming product also includes nonconforming product returned from a customer. The organization s documented procedure defines responsibility for review and authority for the disposition of nonconforming product and the procedure for approving personnel making such decisions. Karas Engineering effectively deals with nonconforming product, as appropriate, by: 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 the customer; c) Taking action to preclude its original intended use or application, d) Taking actions appropriate to the effects, or the potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started; the organization s control of nonconforming product process provides for timely reporting of the delivery of nonconforming product. (Note: Parties requiring notification of nonconforming product include suppliers, internal organizations, customers, distributors and regulatory authorities), e) Taking actions necessary to contain the effect of the nonconformity on other products or processes. The organization does not use dispositions of use-as-is or repair unless specifically authorized by the customer, if the nonconformity results in a departure from the contract requirements.
34 Product dispositioned for scrap is conspicuously and permanently marked, or positively controlled until physically rendered unusable. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. Reference QAP 8.3, Control of Nonconforming Material Reference QLog 8.3-1, Nonconforming Material Report Log 8.4 Analysis of Data The determination of, collection, and analysis of appropriate data is completed to demonstrate the suitability and effectiveness of the quality management system, and to evaluate where continual improvement of the quality management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. Forums for the analysis of such data are: Management Review Meeting(s) of the Quality System; Monthly review of Quality Objectives measures, QP The analysis of data provides information relating to: Customer satisfaction (see Section 8.2.1); Conformance to product requirements (see Section 8.2.4); Characteristics and trends of procedures and products including opportunities for preventive action (see Sections and 8.2.4); and, Suppliers (see Section 7.4). Sources of appropriate data include: Customer Satisfaction Surveys Customer On-time Delivery measures Customer Returned Product measures Supplier On-time Delivery measures Supplier Product Quality measures Shop Floor Process Control Statistical measures Product Inspection Results Internal Audit Findings and Process measures Corrective and Preventive Action measures
35 8.5 Improvement Karas Engineering AS9100 Quality System Manual Continual Improvement The effectiveness of the quality management system is continually improved through the use of the following: Quality policy; Quality objectives; Audit results; Analysis of data; Corrective and preventive actions; and, Management review. The organization monitors the implementation of improvement activities and evaluates the effectiveness of the results. (Note: Continual improvement opportunities can result from lessons Learned, problem resolution and the benchmarking of best practices). Reference QAP for Continual Improvement process procedure Corrective Action Corrective action is taken to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the impact of the problems encountered. A documented procedure for corrective action is established defining requirements for: Reviewing nonconformities (including customer complaints); Determining the causes of nonconformities; Evaluating the need for action to ensure that nonconformities do not recur; Determining and implementing action needed; Records of the results of actions taken; Reviewing the effectiveness of the corrective action taken; Flowing down corrective action requirement to a supplier, when it is determined that the supplier is responsible for the nonconformity; Specific actions where timely and/or effective corrective actions are not achieved, and Determining if additional nonconforming product exists based on the causes of the nonconformities and taking further action where required. Reference QAP for Corrective Action process procedure.
36 8.5.3 Preventive Action Karas Engineering AS9100 Quality System Manual Preventive action is determined to eliminate the causes of potential nonconformities in order to prevent occurrence. Preventive actions are appropriate to the effects of the potential problems. A documented procedure for preventive action is established defining requirements for: Determining potential nonconformities and their causes; Evaluating the need for action to prevent occurrence of nonconformities; Determining and implementing action needed; Records of results of action taken; and, Reviewing the effectiveness of the preventive action taken. Note: Examples of preventive action opportunities include risk management, error-proofing, failure mode and effect analysis (FMEA), and information on product problems reported by external sources. Reference QAP for Preventive Action process procedure. Reference QF , Record of Preventive Action Reference QF , Failure Mode and Effects Analysis (FMEA) Reference QF , Record of Total Productive Maintenance (TPM) Section Eight Related and Support Documentation QF 8.2.1, Customer Satisfaction Survey QAP 8.2.2, Internal Audit QF , Internal Audit Schedule QF , Internal Audit Report QAP 8.2.4, Sampling Plans QAP , Measurement of Product QT , Acceptance Tag QT , Reject Tag QT , MRB Hold Tag QF , Record of Production Inspection QF , Record of Final Inspection QAP 8.3, Control of Nonconforming Material QLog 8.3-1, Nonconforming Material Report Log QF 8.3-2, Nonconforming Material Report (NCR) QF 8.3-3, Quality Alert QF 8.3-4, Nonconforming Material Containment Checklist QAP 8.5.1, Continual Improvement QF 8.5.1, Record of Continuous Improvement Project
37 QAP 8.5.2, Corrective Action QLog , Corrective/Preventive Action Request Log QF , Corrective Action Request QAP 8.5.3, Preventive Action QF , Record of Preventive Action QF , Failure Mode and Effects Analysis (FMEA) QF , Record of Total Productive Maintenance
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