ISO 9001 QUALITY MANUAL

Transcription

1 ISO 9001 QUALITY MANUAL Origination Date: 10/01/14 Document Identifier: AIF quality control manual Date: 10/01/14 Project: Customer review Document Status: Released Document Link: Abstract: This document describes the quality management system processes for ISO 9001.

2 REVISION LOG Issue Date Comment Author /01/14 original John Mullen DOCUMENT CHANGE RECORD Issue Item Reason for Change Page 2 of 29

3 TABLE OF CONTENTS Section 1: Welcome to (Your Company Name)... 6 Section 2: Company Vision and Governing Policies... 7 Section 3: Scope, Exclusions and Definitions Scope Exclusions Conventions... 8 Section 4: Quality Management System General Requirements Process Approach Overall Process Sequence & Interaction Documentation Overview of Documentation Quality Manual and Procedures Control of Documents Control of Records Configuration Management Section 5: Management Responsibility Management Commitment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Management Review Section 6: Resource Management Provision of Resources Human Resources General Competence, Training and Awareness Infrastructure Work Environment Corrective Maintenance Section 7: Product & Service Realization Page 3 of 29

4 7.1 Planning of Process Realization Customer-Related Processes Determination of Requirements Review of Requirements Customer Communication Design and Development - N/A Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Service Provision Control of Service Provision Process Documentation Control of Production Process Changes Control of Production Equipment & Tools Control of Work Performed by an Outside Facility Control of Service Operations Validation of Processes for Service Provision Identification and Traceability - N/A Customer Property Preservation of Product - N/A Control of Monitoring and Measuring Equipment - N/A Section 8: Measurement, Analysis, & Improvement General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Production Inspection Documentation First Article Inspection (FAI) Incoming (R&I) Inspection In-Process Inspection Final Inspection Control of Nonconformances Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action Appendix A: Company Process Cross-Reference Matrix Appendix B: Company Processes and Applicable Documents Page 4 of 29

5 Appendix C: Outsourced Processes Appendix D: Quality Objectives Appendix E: Identification of Key Realization Processes Page 5 of 29

6 Section 1: Welcome to AEROSPACE & INDUSTRIAL FASTENER The Company is a service provider of aircraft and commercial hardware The Company has provided the aerospace industry The Company has provided the commercial industry The Company has always applied high quality standards as guidelines for its processes and operations but has revised its systems to fully comply with ISO 9001:2008. The Company is dedicated to the principle of maintaining the highest levels of quality and integrity in communicating with people inside and outside of its business operation. We invite you to come see our quality system in action. To arrange a visit, contact us at: AEROSPACE & INDUSTRIAL FASTENER Ave. Stanford #109 Santa Clarita, Ca P F john@aeroindfa.com Page 6 of 29

7 Section 2: Company Vision and Governing Policies COMPANY VISION To continually improve our processes, products and services to meet our Customers' requirements, allowing us to prosper as a business and to produce a reasonable return on capital investment. QUALITY POLICY The Company is committed to providing high quality and high value products to its customers, delivering on time and continuously improving. ENVIRONMENTAL POLICY To prevent production and distribution of products or waste materials that would pose unreasonable risks to health, safety or the environment. PRACTICAL STEPS TO SUPPORT POLICIES Customer Focus: The Company shall consider the Customers needs in its every day operations and decision making and consider the impact on the Customer at all times. Workplace Excellence: The Company strives to encourage employees to strive for individual excellence in their work and in their association with other people inside and outside of the workplace. We aim to motivate employees by providing leadership, training, proper materials and facilities and a cooperative, safe environment. Empowerment: The Company managers are responsible for developing organizations and systems that accommodate the goal of achieving Customer satisfaction. Managers are to recognize and support employees charged with the responsibility of interfacing with Customers. Employees who are authorized to deal with Customers are responsible for carefully listening to Customers and fully understanding their requirements and expectations. These employees shall be as responsive as possible to those needs within the province and spirit of good business practices. Intelligent Management: Managers are directed to make decisions and guide operations based on facts, data and verifiable evidence whenever possible. Such management techniques eliminate bias and unfounded opinion wherever possible. SEE SECTION 5.1 FOR DETAILS ON THESE PRACTICAL STEPS Page 7 of 29

8 Section 3: Scope, Exclusions and Definitions 3.1 Scope The Company s quality management system applies to all employees within all functional areas of the Company s business operation. The Company s scope of business is defined as follows: Aircraft hardware distributor SIC codes: Exclusions The Company cites exclusions to 7.3 Design and Development. 3.3 Conventions Subordinate or external documentation is referenced in Bold Italics. Page 8 of 29

9 Section 4: Quality Management System 4.1 General Requirements Process Approach The Company s quality system has been fully documented and implemented and is maintained as needed to meet the requirements of our Company vision and governing policies. The Company has adopted a process-oriented method of management. This approach emphasizes the importance of: a) continuous improvement of processes based on objective measurement and analysis. b) need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness and d) understanding, meeting and integrating Customer requirements, For each process identified in use at the Company, the sequence and interaction of processes has been determined and the process controlled by way of criteria and methods specific to that process. Objectives are set for each process and then measured and monitored with appropriate data gathered and analyzed to ensure process effectiveness. During Management Review (see 5.6), process resources are discussed and allocated by management, as applicable. Corrective and preventive action is taken to ensure the processes achieve the desired results and continually improve. The following are the processes in use by the Company: Calibration (7.6) (when applicable) Configuration management (7.3 when applicable) Contract review (7.2.2) Control of nonconforming product (8.3) Control of documents (4.2.3) Control of production and service (7.5.1) Control of records (4.2.4) Corrective and preventive actions (8.5.2, 8.5.3) Internal audit (8.2.2) Management Review (5.6) Purchasing (7.4) Receiving (7.4.3) Responsibility and authority (5.5) Shipping (7.2.1, 7.5.1, when applicable) Training (6.2.2) Every process has at least one QMS Procedure that defines it in greater detail and may include a process map. These process maps define the details of each process, including owners, inputs, outputs, check stages and objectives through the use of individual process maps. The relationship between the listed processes is shown in the table in Appendix A. Outsourced processes and their controls are defined in Appendix C. Page 9 of 29

10 4.1.2 Overall Process Sequence & Interaction MANAGEMENT PROCESS MANAGEMENT Proposal Development and Contract Review INTERNAL AUDITING CORRECTIVE AND PREVENTIVE ACTION Requirements Understood? Data and Interaction Contract Released Purchasing Receiving Production Shipping Page 10 of 29

11 4.2 Documentation Overview of Documentation The Company maintains all required documentation to effectively sustain its quality management system. All Managers are responsible for the implementation of procedures and records in their areas as required by the Quality Management System. The quality system documentation is comprised of a hierarchy of documents that flow from this Quality Manual. All documents must support and enhance the primary mandates of the Corporate Vision and Governing Policies as defined in Section 2. Corporate Vision and Governing Policy Work instructions and other job specific documentation QMS Procedures Defines quality system related processes in greater detail. Quality Manual Defines overall Company policies and procedures Forms Used to record data; once complete they become records. The order of precedence of order-specific documentation is as follows unless otherwise directed by Customer or government requirements: 1. Typed provision set forth on the Contract/Purchase Order 2. Preprinted portion of the Contract/Purchase Order including the General Provisions, Statement of Work, specification/drawings attached or incorporated by reference. 3. The Company's specifications 4. Government specifications 5. Vendor/Seller specifications Quality Manual and Procedures The primary purpose of the Quality Manual and QMS Procedures is to describe and document the Quality Management System in place at the Company and to define all the processes in use within the Company. It is issued under the authority of the Operations Manager. Copies of the manual are controlled by means as described below. Uncontrolled Page 11 of 29

12 copies may be distributed to Customers as requested and shall be marked Uncontrolled. This Quality Manual has been developed by top management to define the quality system processes and policies in use at the Company. It is meant to be used by Company employees as the primary source of official Company quality policies as well as Customers that wish to verify the Company s quality management system. Additional procedures and work instructions have been developed to further clarify specific instruction for the execution of these procedures. Where subordinate documents are referenced, they are shown in bold italics. Distributed copies will be uncontrolled and not subject to revision notification unless otherwise agreed Control of Documents Documents are controlled so that information is reviewed and approved prior to release. Only the latest versions are available to users; previous versions and legacy documents are segregated and retained in a document control library for historical purposes. The controls for documents are defined in the procedure QMS-01 Document Control Control of Records Records are controlled to provide evidence of conformity to requirements. The records subject to control are defined in procedure QMS-03 Records Control Configuration Management The configuration of processes is controlled according to procedure QMS-02 Configuration Management. Section 5: Management Responsibility 5.1 Management Commitment The Company s Management is committed to the ongoing maintenance and improvement of the quality management system. To ensure this, management focuses on deploying practical steps that concretely support the Quality and Environmental Policies. CUSTOMER FOCUS: We communicate the importance of meeting Customer, regulatory and statutory requirements through employee orientation (see 6.2.2) and by providing personnel proper documentation of requirements and workmanship criteria (see ). The Proposal Development and Contract Review process, QMS-07, ensures that Customer requirements are captured and reviewed before acceptance. (see 7.2.) EMPOWERMENT: To ensure all employees are empowered to affect change and improve the Company, its processes and their own experience at the Company, all employees are granted the authority to submit requests for corrective or preventive action (see 8.5.) All employees are empowered to stop a process when nonconformities are encountered (see 8.3.). INTELLIGENT MANAGEMENT: We aim to ensure that management makes decisions based on facts, data and evidence. To do this, management has established quality objectives for all processes. (see ) The internal audit process relies on the recording of verifiable data as a means of driving corrective and preventive actions as well as improvement efforts (see 8.2.2). By conducting periodic management reviews of the quality system, management ensures the overall effectiveness of the quality system. (see 5.6.) WORKPLACE EXCELLENCE: We ensure the work environment, facilities and atmosphere are best in class by ensuring management understands and reviews resource requirements through management review (see 5.6) and through ongoing communication with employees regarding the workplace (see ) Page 12 of 29

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14 5.2 Customer Focus See 5.1 above. 5.3 Quality Policy The Quality Policy has been developed and approved by the Company s President. This policy is taught to all new employees and is audited regularly to ensure its distribution and the ongoing overall awareness of it by employees. During Management Review, the Quality Policy is reviewed for continuing suitability. The Quality Policy is defined in Section 2.0. The Quality Policy is contained inside the Quality Manual that is controlled according QMS-01 Document Control. The Quality Policy may also be issued as a stand-alone document, separately controlled. 5.4 Planning Quality Objectives Every process within the Company has at least one quality objective that governs the process. All of these objectives are derived from at least one of the key requirements of the Company Quality Policy. All objectives are subject to data gathering and the data is then reported to executive management during management review (see 5.6.) The table in Appendix D defines all the quality objectives currently in place at the Company. Quality objectives are communicated throughout the organization and are reviewed at each management review meeting. The records of management reviews include the current goals set for each objective and current standing. Additional Customer-specific goals may also be set; these will be published either in appropriate work instructions, proposal documents or in the records of management review Quality Management System Planning This quality system has been planned in advance and its documented policies and procedures are reviewed prior to implementation. Subsequent major changes that may affect the performance, quality or reliability of the process are identified, reviewed and approved and the QMS documentation updated. The QMS documentation acts as the overall quality plan for the Company. As required, specific quality processes may be developed for individual processes or technologies, which shall include the information given above. In such cases, the Operations Manager (with support from the Quality Group) shall have overall responsibility for the development of quality plans. Quality system planning and control is treated as a process (called the Management process) and is fully defined in QMS-04 Management Process. 5.5 Responsibility, Authority and Communication Responsibility and Authority The organizational chart below defines the basic management structure of the Company. In all cases, the appropriate person has been granted both the responsibility and authority for their position s duties. These are further defined in QMS- 05 Responsibilities and Authorities. All employees are empowered to request corrective or preventive action to prevent the occurrence of nonconformities relating to product, process or the Quality Management System. The Quality Manager shall oversee this effort and shall make sure that such issues are identified and recorded, that solutions are transmitted to and resolved by the proper functions and that the solutions are verified for effectiveness. Page 14 of 29

15 QUALITY MANAGER INSPECTORS RECEIVING FACILITIES MANAGER PRODUCT MANAGERS MAINTENANCE PRODUCTION MANAGER PRODUCTION SHIPPING (if req d) OPERATIONS MANAGER BUSINESS MANAGER ADMINISTRATIVE ASSISTANT CONTRACTS PURCHASING ACCOUNTING MANAGER HR ENVIRONMENTAL HEALTH & SAFETY Management Representative The Quality Manager of the Company has been assigned the role of Quality System Management Representative. The Quality Manager is responsible for ensuring the proper implementation of the Quality Management System as well as for overseeing the maintenance of the system, reporting on its effectiveness during management review and representing the Quality Management System to Customers and other concerned sources. The Quality Manager is responsible for facilitation of these policies and procedures and has the responsibility and authority to resolve matters relative to quality in processes and services from internal and external sources. Quality may suspend internal and external processes and services that do not meet requirements until appropriate corrective and preventive action is implemented on an expedited, high priority basis. The Quality Manager reports directly to the Operations Manager. Quality supervisors, inspectors and auditors report directly to the Quality Manager. In addition, the Quality Manager ensures the promotion of awareness of Customer requirements throughout the organization Internal Communication To ensure proper communication between and throughout all levels of employees within the Company, internal communication is conducted and monitored within the Management process documented in QMS-04 Management Process. Management holds periodic meetings with employees to discuss Company policies, status of quality system and Page 15 of 29

16 other information. Employees are encouraged to use the Corrective Action Request (CAR) system to submit suggestions for improvements. This system requires management to take action on quality related issues within the Company. 5.6 Management Review Management Review meetings are conducted according to the procedure within QMS-04 Management Process. This procedure defines the frequency and the required attendees. Management review inputs and outputs are also defined in this procedure. Management review meeting minutes will be posted to communicate the performance of the quality system to employees. Section 6: Resource Management 6.1 Provision of Resources During management review, the Company s management determines and provides the resources needed to implement and maintain the quality management system and continually improve its effectiveness. The processes of Management and Proposal Development and Contract Review have been developed to enhance Customer satisfaction by meeting Customer requirements and exceeding Customer expectations. All employees may also submit requests for corrective or preventive action regarding other resource needs or issues. Resource management is discussed in QMS-04 Management Process. 6.2 Human Resources General The Company s employees are selected, trained and evaluated to ensure that those personnel performing work affecting service requirements are competent on the basis of appropriate education, training, skills and experience. As required, personnel shall undergo training to develop or improve these abilities Competence, Training and Awareness All Company personnel are hired on the basis of their ability to perform acceptable work. Subsequent training is performed to ensure each employee is knowledgeable in their job function and their role within the Company. The Company has implemented a training program that: Defines the job tasks in use that impact the quality of services Determines the necessary competence for personnel in each functional area, Documents the qualification of each employee for each job task Ensures that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives Periodically reviews and re-certifies employees for operations where recertification is required or beneficial. Provides annual health and safety training to employees. Provides initial training for new employees and ongoing training for existing employees Management conducts periodic reviews of employee performance. Appropriate records of education, training, skills and experience will be maintained. The internal auditing process shall evaluate the effectiveness of training and its effect on service quality; in addition, the review of training effectiveness shall be a permanent feature of Management Review. The training program is defined in QMS-06 Training. Page 16 of 29

17 6.3 Infrastructure The Company has determined and provides the basic infrastructure needed to achieve conformity to process requirements. Infrastructure requirements are regularly reviewed during Management Review and include a review of: buildings, housekeeping and workspace; communication services, such as network connectivity, internet, intranet, etc. process equipment; utilities, including ventilation, electricity, water The Company utilizes a maintenance program that ensures the ongoing maintenance of process equipment. The Facilities Manager shall ensure the ongoing maintenance of the facilities. IT resources are overseen by the IT staff, answering to the IT Manager. For more on management s controls over infrastructure see QMS-04 Management Process. 6.4 Work Environment The Company has determined and provides the basic work environment requirements needed to achieve conformity to process requirements. The work environment is periodically reviewed during internal audits and work environmentrelated resource requirements are regularly reviewed during Management Review. For more on management s controls over the work environment see QMS-04 Management Process. 6.5 Corrective Maintenance The Company utilizes corrective maintenance and skilled maintenance personnel to ensure the ongoing performance of process equipment. No preventive maintenance action is performed unless proven to be less costly than the failure. Preventive maintenance activities are primarily condition-based. The condition of a component, measured when the equipment is in operation, governs planned and scheduled corrective maintenance. It is acceptable to operate a component to breakdown when it is the most cost-effective maintenance procedure. Correcting the problem is defined as planned and scheduled maintenance. The cost for preventive maintenance is very low because operators are trained and motivated to do some essential care and inspections. The Facilities Manager ensures the ongoing maintenance of the facilities. IT resources are overseen by the IT staff, reporting to the Facilities Manager. Section 7: Product & Service Realization 7.1 Planning of Process Realization In planning the processes for realization, management has ensured that the processes are consistent with the requirements of the other processes within the quality system. For each process, quality objectives have been established. At times additional quality objectives and measurements may be set for a given process; in such cases these shall be defined in work instructions or other controlled documents. Likewise, these instructions shall define any processes, documents or resource requirements specific to the service. Inspection, testing and other monitoring steps will also be defined in work instructions or other controlled documents. The creation, review and approval of the work order during Proposal Development and Contract Review ensures that planning of each order is fully conducted and recorded. Page 17 of 29

18 7.2 Customer-Related Processes Determination of Requirements The Company captures all requirements of the Customer as well as any applicable statutory or regulatory requirements according to QMS-07 Proposal Development & Contract Review Review of Requirements Once requirements are captured, they are reviewed to ensure that the Company has the capability to meet those requirements. This occurs before order acceptance during the Proposal Development & Contract Review process as defined in QMS-07 Proposal Development & Contract Review Customer Communication The Company treats Customer communication as an important method of gaging its success and ability to meet Customer requirements. The following communication methods are used within the Management process: Customer feedback, including Customer complaints, is recorded in the corrective action and improvement systems. See 8.5. Inquiries regarding contracts, deliverables, including amendments to active contracts are routed to the Contracts Group. Changes to active contracts are processed according to section and Questions regarding process information are routed to the appropriate Manager. Trip reports that are the result of visits to Customers are maintained and distributed as necessary. 7.3 Design and Development - N/A The Company sites exclusion to this section. (Design and Development) 7.4 Purchasing Purchasing is treated as a process within the Company s quality system. The Company accepts responsibility for the quality of products that are purchased from Suppliers including Customer designated sources. The Company does not use Customer verification as evidence of effective control of quality by the Supplier. The process is fully defined in the QMS-08 Purchasing Procedure Purchasing Process The purchasing process ensures the Company only purchases materials and services from Suppliers and Subcontractors that have undergone evaluation and approval Purchasing Information Purchase orders are used to transmit the Company s requirements to Suppliers Verification of Purchased Product Incoming materials are inspected to ensure they meet requirements before use and as a means of monitoring ongoing Supplier quality. The process is defined in the QMS-09 Receiving Procedure. Page 18 of 29

19 7.5 Service Provision Control of Service Provision The Company plans and carries out processes for process realization according to section 7.1 of this manual. In general, this includes assurances that: Monitoring and measurement equipment is controlled by way of routine maintenance and proper training use for operators and by designating unapproved equipment with proper signage to prevent use. Process documents identify all necessary work steps. Process methods are controlled by way of training and documented procedures. Processes are controlled by monitoring of process parameters where applicable and by approving processes by way of supporting documentation approval. These procedures reflect the requirements of any applicable reference standards, regulatory codes, quality plans and other documented procedures. There is effective implementation of monitoring and measurement procedures. Workmanship is controlled by way of documented procedures where the lack of such procedures would affect process quality. In-process inspection is conducted according to a work instruction to verify process quality on an ongoing basis. The Quality inspector will complete the required inspection form and by signing off is attesting that they have verified the requirements as documented in the drawing, work instruction or other reference. See also These activities are fully defined in QMS-10 Production Process Documentation Service operations are performed according to documentation developed by supervisors during the Design and Development process. The work instruction, drawings and other documents define the process and inspection steps necessary for the order. In addition, the Company may utilize drawings, bills of material, work instructions and other documents to define the necessary requirements. All such documents are reviewed before release to production. These activities are fully defined in the QMS-10 Production Control of Production Process Changes Only the Configuration Control Board may approve changes to service processes. The Company will identify and obtain Customer and/or regulatory authority approval for changes when required. The results of changes to service processes are assessed to confirm that the desired effect has been achieved without adverse effects to process quality. These activities are fully defined in the QMS-10 Production Control of Production Equipment & Tools Equipment and tools are validated prior to use and maintained and inspected periodically according to the maintenance system. The internal audit process ensures that storage conditions for equipment is adequate. See section Control of Work Performed by an Outside Facility When the Company provides subcontracts for outside processing it shall be done under the following controls: Purchase order documentation will require the Supplier to notify the Company of any process changes, any nonconformities or other issues. The outsourced service provider must be an approved, evaluated Supplier according to the requirements of section 7.4 Page 19 of 29

20 The Supplier will be subject to the Supplier Corrective Action system, as defined in section Work shall be conducted according to any specifications listed on the Company purchase order documentation Control of Service Operations The Company warrants its services against defects. For such work, all normal processes and procedures apply as if the service was not performed Validation of Processes for Service Provision The Company does not perform work operations where the resulting quality of the work cannot be ascertained Identification and Traceability - N/A The Company cites exception to this section Customer Property Where Customer property is provided to the Company for processing or use, it is suitably identified as such to prevent unintended usage and the Customer s name is indicated on the property or related paperwork. If the property is designated by the Customer for a specific use or order, the information is clearly indicated. All normal handling and protection measures are employed for Customer property as if it were owned by the Company. Damaged or missing Customer property is reported to the Customer for disposition and is processed through the nonconformance disposition system, QMS-13 Control of Nonconformances. Government and Customer property is controlled according to QMS-10 Production, specified contractual requirements and applicable property and/or facility agreements. Bailed property is controlled according to specified contractual requirements and applicable property and/or facility agreements Preservation of Product - N/A The Company sites exclusion to this section. 7.6 Control of Monitoring and Measuring Equipment - N/A The Company sites exclusion to this section. (Calibration) Section 8: Measurement, Analysis, & Improvement 8.1 General Measuring, analyzing and improvement is conducted through implemented processes that ensure the Company can demonstrate conformity to service requirements, conformity of the quality management system and continual improvement of the effectiveness of the quality management system. Where statistical techniques are used, these are defined in associated work instructions; in all cases, statistical techniques used for process acceptance requires nonconformance disposition according to QMS-13 Control of Nonconformances. Production and Quality collect data for determining the acceptability of this quality program, which may include but is not limited to: Analytical summaries Audit reports (systems, procedures, Suppliers, processes, etc.) Corrective action reports Page 20 of 29

21 Correlation of inspection results with methods and processes Graphic materials In-process inspection and test reports Nonconformance reports Organization and key personnel changes Raw inspection and test data Receiving inspection reports Source inspection reports Statistical process control reports Supplier performance, such as acceptance and rejection rates 8.2 Monitoring and Measurement Customer Satisfaction To monitor and measure Customer satisfaction, the Company collects feedback from Customers in the following methods, as applicable: Customer complaints (processed through the corrective action system) Customer-provided performance (data is gathered and analyzed) Purchasing and payment history Trip report information Internal Audit Internal quality audits are conducted to ensure ongoing compliance with requirements of the Company s policies and procedures. This is accomplished by auditing against all identified processes against requirements at least once annually. Audit requirements include those of the Company s Quality Manual as well as requirements of Customers or regulatory authorities, as applicable. The internal audit process is fully defined in QMS-11 Internal Auditing Monitoring and Measurement of Processes Process performance is measured through quality objectives and related data. The method for measuring process performance is defined in These methods demonstrate the ability of each process to achieve the planned objective Monitoring and Measurement of Production The Quality Group is responsible for examining production documentation for the purpose of identifying the criteria (inspection requirements) for approval and rejection of each work operation, its associated equipment and personnel and the results produced by the process. Production processes are inspected by the Quality Group throughout their stages of production. These inspections take place as called for on inspection instructions, travelers, Production or Quality Procedures, other quality program requirements or when there is an occurrence of some nature that indicates that a special inspection is appropriate as determined by the Quality Group. Whenever a condition exists that differs from "normal", the inspector alerts quality supervision for further investigation. The "alert" should be in the form of a Nonconformance Report or other appropriate documentation suitable for the circumstance. Inspection methods may include but are not limited to inspections by production personnel with monitoring and/or witnessing by the Quality Group and/or roving inspectors. Inspections are made using applicable inspection instructions, drawings, specifications and other appropriate reference materials. The inspection includes verification of compliance to workmanship standards and complete and correct documentation. Inspection by statistical sampling is applied, as appropriate and when specified in work Page 21 of 29

22 instructions. Statistical process control policies and procedures are subject to Customer review and approval prior to implementation Inspection Documentation Technical documentation shall provide the requirements for all processes. In all cases, this must include criteria for acceptance/rejection; where this is not clear the Quality Manager shall oversee clarification of these criteria with the Customer. Required inspection and test steps are defined in various documents depending on the nature of the order. These include the job traveler, work instructions or procedures, engineering specifications, etc. Various inspection records are used to record the results of inspections and tests along with any nonconforming measurements. The required record to use is identified in the appropriate work instruction or traveler First Article Inspection (FAI) When required by purchase order or Customer specification, a First Article Inspection (FAI) will be performed. The FAI is a thorough inspection of each attribute of the service process. The results of FAI may be used to validate production methods, processes, equipment and personnel training. The inspector conducting a first article inspection will record all results on the form of the Customer s choice; if the Customer does not have a preference then the AS9102 form (or equivalent FAIR) shall be used Incoming (R&I) Inspection See section In-Process Inspection In-process inspections are conducted during production to ensure ongoing quality of work. These may be done randomly at the discretion of the operator or management or via planned QC inspections according to a defined acceptance sampling plan; in the latter case, the sampling plan shall be statistically sound and approved by either the Customer or the Company Quality Group. Records of in-process inspections are kept on the traveler and/or production logs Final Inspection Once all operations are complete, the service process shall be examined for conformance to workmanship standards according to an accepted sampling plan. The sampling plan shall be statistically sound and approved by either the Customer or the Company Quality Group. Records of final inspections are kept on the traveler, inspection report(s) or other documentation. The specific document used is dependent on the order or type of service process. 8.3 Control of Nonconformances All services found to be nonconforming against specified requirements are identified, documented, segregated (if possible), evaluated and dispositioned on an expedited, high priority basis. This applies to incoming product (vendorsupplied) and in-process production. See QMS-13 Control of Nonconformances. 8.4 Analysis of Data The Company determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system. The data is used to evaluate where continual improvement of the effectiveness of the quality management system can be made. In addition to the quality objective data of Customer satisfaction, process conformity to requirements and trend analysis, the status and acceptability of vendors and subcontractors will be regularly reviewed during Management Review. For more on analysis of data see QMS-04 Management Process. Page 22 of 29

23 8.5 Improvement Continual Improvement It is the goal of all Company employees to continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review Corrective Action The Company has implemented and maintains a robust system for identifying and reporting nonconformities requiring corrective action. These nonconformities can be related to processes or other criteria. Such reports result in a root cause analysis by an assigned individual or team and implementation of an action plan to correct the root causes and prevent recurrence as well as follow-up activities to ensure actions taken are satisfactory. This process is defined in QMS-12 Corrective & Preventive Action Preventive Action In addition to the preventive measures taken for corrective action requests (used to prevent recurrence of an existing problem) the Corrective and Preventive Action process is used to identify potential problems to prevent them from becoming actual problems. This process is defined in QMS-12 Corrective & Preventive Action. Page 23 of 29

24 Appendix A: Company Process Cross-Reference Matrix Process Configuration Management Control of Documents Control of Records Control of Nonconformances Corrective & Preventive Action Internal Auditing Management Production Proposal Development & Contract Review Purchasing Receiving Shipping (when applicable) Applicable ISO 9001 Clauses 7.3 Configuration Management (when applicable) Control of Documents Control of Records 8.3 Control of Nonconformances Corrective Action Preventive Action Internal Audits 4.1 QMS General Requirements 4.2 Documentation Requirements 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning Responsibility and Authority Management Representative Internal Communication 5.6 Management Review 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment Configuration Management Customer Communication Control of Production & Service Provision 7.6 Control of Monitoring & Measurement Equipment (when applicable) 8.1 Measurement, Analysis & Improvement: General Customer Satisfaction Monitoring & Measurement of Processes 8.4 Analysis of Data Continual Improvement 7.1 Planning of Product Realization Production Documentation Control of Production Process Changes Control of Production Equipment Post Delivery Support Identification & Traceability Customer Property Preservation Monitoring & Measurement 8.3 Control of Nonconformances Determination of Requirements Review of Requirements Purchasing Process Purchasing Information Verification of Purchased Product Identification & Traceability Customer Property Preservation Monitoring & Measurement 8.3 Control of Nonconformances Determination of requirements related to deliverables Control of Production and Service Provision Identification & Traceability Preservation 8.3 Control of Nonconformances Page 24 of 29

25 Appendix B: Company Processes and Applicable Documents Process Applicable Company Procedures Applicable Company Records Corrective & Preventive Corrective action records (8.5.2.e) QMS-12 Corrective & Preventive Action Action Preventive action records (8.5.3.d) Internal Auditing QMS-11 Internal Auditing Internal audits (8.2.2) Management QMS-00 Quality Manual QMS-01 Document Control QMS-02 Configuration Management QMS-03 Record Control QMS-04 Management Process QMS-05 Responsibilities & Authorities QMS-06 Training Management review minutes (5.6.1) Training records (6.2.2) Calibration records (7.6) Production QMS-10 Production QMS-13 Control of Nonconformances Records of loss, damage or nonconformances (7.5.4) Records of final inspection of inspected process (8.2.4) Records of first article inspection ( ) Control of nonconformances (8.3) Proposal Development & QMS-07 Proposal Development & Contract Contract review records (7.2.2) Contract Review Review Purchasing QMS-08 Purchasing Supplier evaluation records (7.4.1) Records of loss, damage or nonconformances QMS-09 Receiving Receiving (7.5.4) QMS-13 Control of Nonconformances Control of nonconformances (8.3) (add calibration procedure QMS-15 when applicable - search catalog for QMS-15 and renumber to QMS-14) Page 25 of 29

26 Appendix C: Outsourced Processes Subcontract Services: Only approved Suppliers are used according to QMS-08 Purchasing. All service records must be accompanied by a certificate of conformance that is reviewed by QC. Services must be conducted according to specifications referenced on the Company Purchase Order. Page 26 of 29

27 Appendix D: Quality Objectives Process Quality Objective Metric Corrective & Preventive Action To ensure ongoing compliance to requirements through regular audits of the Company s processes. Nonconformance Trend Chart Design & Development N/A N/A Internal Auditing Management Production Proposal Development & Contract Review Purchasing Receiving Shipping To ensure ongoing continual improvement through the reporting and timely resolution of existing and potential nonconformities. To effectively manage the Company through review and analysis of data and continual improvement. To produce products that meet all requirements. To provide competitive and profitable quotations to win bids and to accurately process order information for internal use. To ensure purchased materials and services conform to all requirements. To ensure raw materials received meet requirements. To ensure finished products are properly delivered according to Customer requirements. Internal Audit Reports Management Review Reports Product Yield Rating Customer Satisfaction Rating Management Review Reports Subcontractor Performance Rating On-Time Delivery Rating Calibration (7.6) Configuration management, (7.3 when applicable) Contract review (7.2.2) Control of nonconformances (8.3) Control of documents (4.2.3) Control of production and service (7.5.1) Control of records (4.2.4) Corrective and preventive actions (8.5.2, 8.5.3) Internal audit (8.2.2) Management Review (5.6) Purchasing (7.4) Receiving (7.4.3) Responsibility and authority (5.5) Shipping (7.2.1, 7.5.1, 7.5.5) Training (6.2.2) Delete this table prior to release of quality manual. Calibration (7.6) Contract review (7.2.2) Control of nonconformances (8.3) Corrective action (8.5.2.e) Design change (7.3.7) when Supplier recommends improvement(s) to Customer design Design inputs (7.3.2) when Supplier recommends improvement(s) to Customer design Design review (7.3.4) when Supplier recommends improvement(s) to Customer design Design validation (7.3.6) when Supplier recommends improvement(s) to Customer design Design verification (7.3.5) when Supplier recommends improvement(s) to Customer design Internal audits (8.2.2) Loss, damage or nonconformances (7.5.4) Management review report (5.6.1) Preventive action (8.5.3.d) Realization processes and resulting product meet requirements (7.1.d) Release authority of inspected product (8.2.4) Supplier evaluation (7.4.1) Traceability (if required) (7.5.3) Training (6.2.2) Delete this table prior to release of quality manual. Application Note: Page 27 of 29

28 Exclusions to the requirements of ISO 9001 that are listed in paragraph 3.2 cannot be excluded if the business operation is required to design and develop service activities. Measurement equipment that is required to perform the service may require calibration and/or periodic verification. Products that are provided as part of the service may require preservation to protect product requirements and may require identification and traceability. Management must carefully determine the applicability of exclusions listed in if exclusions cannot be applied then the Complete ISO Design Kit is more appropriate for the QMS improvement project. Page 28 of 29

29 Appendix E: Identification of Key Realization Processes Resource Needs Business Plan and Objective Management Review Product and QMS Data Management Responsibility R e s o u r c e M a n a g e m e n t Personnel and Skills Infrastructure and Information Technology Facilities Equipment and Maintenance Resources Policies and Directions Product and QMS Data Control of NCMR s Corrective and Preventive Actions Internal Audits Customer Satisfaction A n a l y s i s a n d I m p r o v e m e n t New Product Tests and Results Calibration Customer Complaints, Customer Assessments, Product Returns Market Research Design & Development Specs, Plans, Instruc. Product Tests and Results C U S T O M E R RFQ Quote Sales Contract Requisitions Scheduling Requirements Order Processing Material Requests Materials Inventory Management Production Receiving Shipping Products Services C U S T O M E R Purchasing Products Services Purchase Orders Suppliers Billing Invoicing Invoice Payments Key Realization Processes Page 29 of 29