1 Eagle Machining, Inc. Quality Management System
2 1 of Antoine Drive Bldg D, Houston, Texas BUSINESS OPERATING MANUAL (QUALITY MANUAL) Revision Date: 08/01/2014 Approved By: Joseph Vu Date: 08/01/2014 This manual is the property of Eagle Machining, Inc. (). It must not be reproduced in whole or in part or otherwise disclosed without prior written consent from Eagle Machining, Inc. and may be used interchangeably in this manual or quality management system. The official controlled copy of this manual is the signed PDF document on the Eagle Machining, Inc. server and visible to all authorized users. All printed copies, and all electronic copies and versions except the ones described above, are considered uncontrolled copies used for reference only.
3 2 of Complies with International Standard ANSI/ISO/ASQ Q9001:2008 Clause Number Title 0 Table of Contents TOC Scope General Application Normative References Normative Reference Terms and Definitions Terms and Definitions Quality Management System General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records Document Structure Management Responsibility Management Commitment Customer Focus Quality Policy Planning Quality Objectives QMS Planning Responsibility, Authority and Communications Responsibility and Authority Management Representative Internal Communication Management Review General Input Output Resource Management Provision of Resources Human Resources General Competence, Training and Awareness Infrastructure Work Environment 6.0
4 3 of Clause Number Title Product Realization Planning of Product Realization Customer-Related Processes Determination of Requirements Related to Product Review of Requirements Related to Product Customer Communication Design and Development (7.3)(Exclusion taken) Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Validation of Production and Service Provision)(Exclusion taken) Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Devices Measurement, Analysis and Improvement General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring & Measurement of Processes Monitoring and Measurement of Product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action 8.0
5 4 of 1. SCOPE 1.1 General This Quality Management System (QMS) manual establishes the basis of the Eagle Machining, Inc. Quality Management System. This Quality Manual demonstrates and documents Eagle Machining, Inc. commitment to maintaining a high-level of quality and strong customer service within an environment that has safety as a first priority. Since the philosophy of Eagle Machining, Inc. is that quality is an integral part of the entire business operation. This Quality Manual may be referred to as the Business Operating Manual and can be used interchangeably throughout the QMS. It is focused on customer satisfaction and establishes the requirements for management of the processes that are essential to the implementation and continual improvement of the QMS. Our QMS complies with all applicable requirements contained in ISO 9001:2008 and encompasses all operations at this facility. This Business Operating Manual specifies requirements by which the Quality Management System demonstrates ability to: Consistently provide product that meets customer and applicable regulatory requirements, Enhance customer satisfaction through the effective application of the Quality Management System, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. 1.2 Application This Scope applies to the Eagle Machining, Inc. facility located at Antoine Dr, Bldg D, Houston, TX Eagle Machining, Inc. provides precision machining for machined parts. This Business Operating Manual is intended to demonstrate conformance to: ANSI/ISO/ASQ Q American National Standard: Quality Management System requirements. This standard is the United States legal equivalent of the ISO 9001:2008 international standard. These two reference numbers may be used interchangeably in this manual and the quality management system. The reference to the year is not used. Reference to this conformance standard also implies reference to all guidance standards contained therein.
6 5 of 1.3 Other Relevant Standards ANSI/ISO/ASQ Q Quality Management Systems Fundamentals & Vocabulary ANSI/ISO/ASQ Q Managing for the sustained success of an organization A quality management approach In addition to the conformance and compliance standards, may from time to time use other standards documents as guidance in its operations and Quality Management System. These may include but are not limited to current editions of the following: ANSI/NCSL Z540.3 American National Standard Requirements for the calibration of measuring and testing equipment ISO Measurement management systems Requirements for measurement processes and measuring equipment ISO/IEC General requirements for the competence of testing and calibration laboratories Abbreviations, Acronyms and Definitions ANSI ASQ FAA IEC ISO Metrology NCSLI PDF QMS American National Standards Institute American Society for Quality Federal Aviation Administration (the USA regulatory agency for aviation and aerospace operations.) International Electrotechnical Commission International Organization for Standardization The science and practice of precision measurement, specifically the various disciplines of calibration required by customers National Conference of Standards LaboratoriesInternational Portable Document Format, a file system extension used to designate a document that conforms to the requirements of international standard ISO , Document management Portable document format Part 1: PDF 1.7 Quality Management System. 1.4 Services offered The product of Eagle Machining, Inc. is the service of providing Precision Machining for machined parts. The Company s vision is to become the leading Precision Machiningfacility in the worldwide industrial & commercial markets and provide strong support toward continually building a superior Machine Shop team.
7 6 of 1.5 Purpose of This Manual Eagle Machining, Inc. s overall commitment to quality in work practice and customer service is defined through its Core and Support Business Processes. Through each of these business processes, the Business Management System is aligned with the goals and strategic direction of the organization. The Business Management system as described in this Business Operating Manual defines the company s commitment: by demonstrating its ability to consistently provide quality service that meets customer and applicable regulatory requirements, by addressing customer satisfaction through the effective application of the system, including the processes for continual improvement and the prevention of nonconformity, through employee empowerment, especially for innovative action to improve the company s performance, and through orderly change management that will maintain a high level of service in technologically complex and fast-paced environments, both to accommodate technological change and for continual improvement of technical skill and capability Business Operating Manual This Level 1 Business Operating Manual and its subsidiary documents describe the Quality Management System of Machining Inc. It provides an overview of the quality policies and key requirements for the company. It is the source of reference for all matters dealing with quality. It is available for inspection by our customers, potential customers, third party quality auditors, and regulatory agencies Subsidiary Level 2 Documents There are several Level 2 quality documents that include information on: Organizational structure Responsibilities and authorities, including Management Representativeappointment business processes including core and support processes Core Business Processes define the departments sequence of processes and subprocesses required to achieve contracted requirements and address applicable requirements of clause 7 of ISO 9001, and regulatory requirements. Support Business Processes address infrastructure requirements such as those described by clauses 5, 6 and 8 of ISO 9001, and regulatory requirements.
8 7 of Computer Network The computer network is an important piece of the QMS. This network contains the documents and applications that define the management controls by which the department demonstrates conformance to its QMS. It also demonstrates the effectiveness of the QMS towards attainment of the company s management objectives. This network contains at least the following documents and records: The Business Operating Manual, Required Procedures, and other instructions and forms that implement the policies in the Business Operating Manual. Internal Auditing Information: including audit schedule, audit checklists that detail the department management controls, plus conformance criteria; conformance responsibility; and objective evidence criteria for each control. These controls are further described in the corresponding level 2 quality procedures. Audit findings that assess compliance and effectiveness and needs for improvement Corrective and preventive activities for continual improvement Summaries of Management Review meetings, including action items and their current status of accomplishments. Other support documents as needed to supplement this information Permissible Exclusions and Mitigation Eagle Machining, Inc. does not provide design or development activity for customers. Therefore, clause 7.3 of the ISO 9001 standard is not applicable and is excluded. Eagle Machining, Inc. does not perform servicing or produce products that that readily lend themselves to any type of servicing by the manufacturer. Therefore, Clause service provision is excluded. These exclusions shall not affect Eagle Machining, Inc. s ability or responsibility to provide products that meet all customer requirements, including any statutory and regulatory requirements Distribution, Review and Revision The Business Operating Manual is maintained on the network as a read-only document and is available to all Department employees and to other interested and authorized parties. All copies printed from the network are not valid 24 hours after printing as stated in the Footer of each page and are uncontrolled. Electronic copies, other than the one visible on the company internal network, are uncontrolled. The Business Operating Manual will be reviewed by management and revised as required. After management review, the Business Operating Manual is updated (if needed) by incorporating all approved changes. The Management Representative may approve minor changes and updates to the Business Management System. (Minor changes include, for
9 8 of 2. NORMATIVE REFERENCES example, spelling corrections, punctuation corrections where the sense of the sentence is not changed, or maintaining hyperlinks and references to other documents on the network.) The revision date is updated, and the document is re-approved and released as a new issue in its entirety. The revision data on the cover refers to the entire document. Procedures for quality policies and procedures documents within the QMS are covered in section Control of Documents, and implemented by QP 423. Eagle Machining, Inc. has established, documented and implemented an effective QMS as a means of ensuring that its machining activities conform to specified requirements, to foster an environment of continual improvement with an eventual goal of achieving its position as the leading ISO 9001 precision machiningorganization in the community. REFERENCE DOCUMENTS ISO 9001:2008 Clause 1 ANSI/ISO/ASQ Q Quality Management System Requirements ANSI/ISO/ASQ Q Quality Management Systems Fundamentals & Vocabulary ANSI/ISO/ASQ Q Managing for the sustained success of an organization A quality management approach 2.1 Normative Reference This establishes the Eagle Machining, Inc. Quality Management System (QMS) as the Normative Reference. Eagle Machining, Inc. Quality Policy Manual contains the requirements and supporting documentation, which demonstrates conformance to the ISO 9001:2008 QMS. The Business Operating Manual is a controlled document and acts as a normative document for the rest of the system. 3.0 TERMS AND DEFINITIONS 3.1 Glossary, definitions of terms.
10 9 of 4. REFERENCE DOCUMENTS ISO 9001:2008 Clause 4 Quality Procedure QP423, Control of Documents Quality Procedure QP424, Control of Records Quality System Manual Clause 5.3, Quality System Manual Clause 5.4.1, Quality System Manual Clause 6.1, Quality System Manual Clause Quality Management System-General Eagle Machining, Inc. has established, documented and implemented a Quality Management System as a means of ensuring that products conform to specified requirements. The outline structure of the documentation covering the Quality Management System requirements is defined in this Quality System Manual. This Quality System Manual includes or references the documented procedures that form the quality system and provides direction to continually improve its effectiveness in accordance with the requirements of ISO 9001:2008. The Quality Management System is maintained by: a) identifying the processes needed for its QMS and their application throughout the organization, b) determining the sequence and interaction of these processes, c) determiningthe criteria and methods needed to ensure that both the operation and control of these processes are effective, as contained in Quality Procedures and Work Instructions. d) ensuringthe availability of resources and information necessary to support the operation and monitoring of these processes per QMS Clause 6. e) monitoring, measuring and analyzing these processes, and f) implementing actions necessary to achieve planned results and continual improvement of these processes. The QMS processes are managed in accordance with the requirements of ISO 9001:2008. Processes that are outsourced, which affect product conformity with these requirements, are identified and management ensures control over such processes through the approval of suppliers, supplier qualification, supplier audits, source and incoming inspection. 4.2 Documentation Requirements General The Quality Management System documentation includes; a) documented statements of a quality policy and quality objectives, per Quality System Manual Clause 5.3 and 5.4.1,
11 10 of b) this Quality System Manual (see below), c) the documented procedures and work instructions referenced within each Clause of this Manual, where required by the ISO 9001:2008, d) documents needed to ensure the effectiveness of; e) planning, operation and control of the processes, and f) records required by the ISO 9001:2008 (see below) Quality System Manual The Quality System Manual provides an overall description of the scope of the Quality Management System, the general quality system, quality objectives and documented procedures (referenced by this manual), and a description of the interaction between the processes of the Quality Management System. It is the source of reference for all matters dealing with quality. It is available for inspection by our customers, potential customers, third party quality auditors and regulatory agencies. The Quality System Manual is maintained on the network as a read-only document and is available to all employees and to other interested and authorized parties. All copies printed from the network are reference copies and are uncontrolled. Electronic copies other than the one visible on the internal network are uncontrolled. This established and maintained Quality System Manual includes; a) the scope of the QMS as defined in Clause 1 as it applies to Eagle Machining, Inc., b) This Eagle Machining, Inc. facility does not perform design and development, therefore exclusion is taken to Clause 7.3, Design and Development. Eagle Machining, Inc. does not perform servicing or produce products that that readily lend themselves to any type of servicing by the manufacturer. Therefore, Clause 7.5 service provision is excluded. c) the requirements of the QMS as it applies to products d) inclusion or reference to the documented procedures and work instructions established for the QMS, and e) a description of the interactions between the processes of the Quality Management System (below).
12 11 of C U S T O M E R R E Q U I R E M E N T S Continual Improvement of the Quality Management System Resource Management Input Management Responsibility Product Realization Measurement Analysis & Improvement The Process-Based Quality Management System Output Product C U S T O M E R S A T I S F A C T I O N
13 12 of PROCESS INTERACTION FOR Eagle Machining, Inc. TOP MANAGEMENT HUMAN RESOURCES / TRAINING MANUFACTURING / PRODUCTION QUALITY CONTROL SALES / MARKETING / CUSTOMER SERVICE MATERIALS MACHINING FINAL INSPECTION REWORK / REPAIR PURCHASING SUPPLIERS* Receiving, Inventory,Shipping, Delivery CUSTOMER*
14 13 of Control of Documents Documents required by the QMS are prepared, reviewed, approved, distributed and controlled by appropriate functions within the organization, which are defined in Quality Procedure QP423 Control of Documents. Records are a special type of document and are controlled IAW Procedure QP424 Control of Records. This procedure defines the controls needed; a) for approval of documents for adequacy prior to issue, b) for review and update as necessary and re-approval of documents, c) for ensuring changes and the current revision status of documents are identified, d) for ensuring that relevant versions of applicable documents are available at points of use, e) for ensuring that documents remain legible and readily identifiable, f) for ensuring that documents of external origin are identified and their distribution is controlled, and g) for preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose. Internal quality audits ensure that quality documentation remains compatible with processes in use, and remains compliant with applicable requirements Control of Records Records have been established and are maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. Records are maintained legible, readily identifiable and retrievable. Procedure QP424, Control of Records, defines the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records may be in the form of any type of media, such as hard copy or electronic media. Records are made available for evaluation by the customer or his representative for an agreed period, where agreed contractually.
15 14 of 4.3 Documentation Structure The diagram below outlines the structure of the Eagle Machining, Inc. Quality Management System: Quality M anagement System (QM S) Quality Policy Manual Department Specific Procedures Level 1 Level 2 Systems Operations Processes W ork Instructions Required Records Level 3 Level 4 Level 1 Quality Policy Manual A description of the Eagle Machining, Inc. Quality Management System method of establishing, implementing, and maintaining a QMS that meets the requirements of the ISO 9001:2008 Standard. Level 2 Quality Procedures Department Specific Operating Procedures stating the requirements Level 3 Department specific work instructions that provide detailed instructions for work in support of the Department Procedures. Level 4 Records required by the Quality Management System or Operating Procedures or Work Instructions. RESPONSIBILITIES Top management is responsible for ensuring that issues of appropriate documents are available for use and are periodically reviewed for removal of all obsolete issues. The establishment of the Quality Management System is the responsibility of top management. Top Management is responsible for the Quality System Manual and for the overall control of documents.
16 15 of 5. MANAGEMENT RESPONSIBILITY REFERENCE DOCUMENTS ISO 9001:2008 Clause 5 Quality System Manual Clause 6 Quality System Manual Clause 7.2.1, Quality System Manual Clause 8.2.1, Quality System Manual Clause 7.1, Quality System Manual Clause 4.1, Quality System Manual Clause 4.2.4, Quality Procedure, Internal Quality System Audits, QP822 Quality Procedure, Corrective Action System, QP852 Quality Procedure, Preventive Action System, QP Management Commitment Management provides evidence of its commitment to the development and implementation of the Quality Management System and to continually improving its effectiveness by; a) communicating to all employees the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy (see 5.3 below), and ensuring that this policy is understood by all employees, c) ensuring that the quality objectives (see below) are established and reviewed for continuing suitability and adequacy and, when necessary, the need for change, d) conducting management reviews (see 5.6 below), and e) ensuring the availability of resources, per QSM Clause Customer Focus Management ensures that customer requirements are determined, per QSM Clause These requirements are met with the aim of enhancing the satisfaction of our customer, per QSM Clause Quality Policy Eagle Machining, Inc. is committed to providing products and services that meet customer requirements. We monitor our process performance and review our quality objectives for continual improvement of our quality management system. Management ensures that the Quality Policy a) is communicated and understood within the organization, and b) is reviewed for continuing suitability.
17 16 of Our Quality Policy means that we will provide our customers with products and services that meet their requirements while continually improving the Quality Management System to enhance customer satisfaction. 5.4 Planning Quality Objectives It is the responsibility of Top Management to ensure that quality objectives, including those needed to meet product requirements (see 7.1 a) are established at relevant functions and levels within the organization. These objectives are measurable and consistent with the quality policy. The overall quality objectives are as follows: a) to comply with customer contract requirements, b) to establish, monitor and measure internally set quality goals, c) continual Improvement of the Quality Management System, based on our internal and external customer feedback and other internal management system mechanisms, QMS Planning Eagle Machining, Inc. management ensures that: a) the planning of the Quality Management System is carried out in order to meet the requirements given per 4.1 as well as the quality objectives, b) the integrity of the QMS is maintained when changes to the QMS are planned and implemented. 5.5 Responsibility, Authority and Communications Responsibility and Authority The responsibilities and authorities of all employees within the organization are defined and communicated by top management. Our management with responsibility and authority for corrective action is promptly informed of products or processes that do not conform to requirements Management Representative The Quality Manager is the Management Representative who, irrespective of other responsibilities, has responsibility and authority that includes: a) ensuring that processes needed for the QMS are established, implemented, and maintained, b) reporting on the performance of the QMS, including any need for improvement, and c) ensuring the promotion and awareness of customer requirements throughout the organization.
18 17 of Internal Communication Management has established communication processes within the facility that ensure communication takes place regarding the effectiveness of the QMS. 5.6 Management Review General Eagle Machining, Inc. top management conducts reviews as needed, or as a minimum, annual reviews of the quality management system 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 objectives. In addition, the quality management system is reviewed for its effectiveness in ensuring that the structure of the quality management system and the resources provided are adequate to meet requirements. The results of each review are maintained per QP424 Control of Records. Follow-up actions are communicated to employees by top management Management Review Input Inputs to the management review include information on a) Results of audits QP822, b) Customer feedback, c) Process performance and product conformity to requirements, d) Status of corrective action QP852 and preventive actions QP853, e) Follow-up actions from previous management reviews, f) planned changes that could affect the QMS, g) Recommendations for improvement Management Review Output The outputs from the review include all decisions and actions related to a) Improvement of the effectiveness of the QMS and its processes b) Improvement of product related to customer requirements, and c) Resource needs
19 18 of 6. RESOURCE MANAGEMENT REFERENCE DOCUMENTS ISO 9001:2008 Clause 6 Quality Policy Manual Clause 4.3, Quality Policy Manual Clause 7.1, Quality Policy Manual Clause Competence, Training and Awareness. 6.1 Provision of Resources Top management determines and provides the resources needed to implement and maintain the QMS and continually improve its effectiveness and to enhance customer satisfaction by meeting customer requirements. The manager of each department identifies the requirements and provides adequate resources for the efficient and effective accomplishment of all tasks and responsibilities assigned within that organization. This includes trained personnel and qualified personnel for the performance of work and verification activities. 6.2 Human Resources Human Resources Department has processes for identifying the training needs and provides for the training of all personnel performing activities affecting quality. Personnel performing work affecting product quality are determined to be competent on the basis of appropriate education, training, skills and experience and are provided access to relevant work instructions Competence, Training and Awareness In order to ensure continual improvement and customer satisfaction, the Eagle Machining, Inc. management: a) determines the necessary competence for personnel performing work affecting product quality, including verification of experience, education, and training, b) provides training or takes other actions to satisfy these needs, c) evaluates the effectiveness of the actions taken, d) ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, e) maintains appropriate records of education, training, skills and experience.
20 19 of 6.3 Infrastructure Management determines, provides and maintains the infrastructure needed to achieve product conformance to product requirements. The infrastructure includes, as applicable, a) buildings, workspace and associated utilities, b) process equipment (hardware and software), c) supporting services (such as transport or communication), 6.4 Work Environment Management determines and manages the work environment needed to achieve conformity to product requirements. 7. PRODUCT REALIZATION REFERENCE DOCUMENTS ISO 9001:2008, Clause 7 Quality System Manual Clause 4.1, Quality System Manual Clause 4.3, Quality Procedure, Control of Records, QP424 Quality Procedure, Purchasing, QP 74 Form 72, COP 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 as defined in QSM Clause 4.1, in planning product realization management determines the following: a) Product requirements and quality objectives, 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 meet the requirements QSM Clause
21 20 of 7.2 Customer-Related Processes Determination of requirements related to the product Eagle Machining, Inc. determines the requirements specified by the customer, including the requirements for delivery and post-delivery activities. Requirements not stated by the customer but necessary for specified use or intended use are reviewed and resolved prior to the delivery of the product. Any statutory or regulatory requirements are determined and acted upon by BestMachine Shopas well as any company-specific requirements. Before acceptance, the Sales Department reviews contracts, at a minimum, for pricing, quantities, and ship-dates. Appropriate departments are consulted as necessary during the Contract Review.(Ref. Form 72 COP) Review of requirements related to the product The requirements related to the product are reviewed prior to the commitment to supply the product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensure that; a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) Eagle Machining, Inc. has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review are maintained as part of the Contract File per Clause Where the customer provides no documented statement of requirement, the customer requirements are confirmed before acceptance. Where product requirements are changed, relevant documents are modified and relevant personnel are made aware of the changed requirements Customer Communication Eagle Machining, Inc. determines and implements effective arrangements for communicating with customers in relation to product information, inquiries, contracts or order handling, including amendments, customer feedback, including customer complaints. Eagle Machining, Inc. accomplishes customer product communications through assignment of personnel as the customer contact. Additional customer contact may be from feedback that relates to product issues after acceptance by the customer Purchasing Process(QP74) The purchasing process ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. Suppliers are evaluated and selected based on their ability to supply product in accordance
22 21 of with our requirements. Eagle Machining, Inc. has a documented procedure to ensure that purchased products conform to specified requirements. Criteria for selection, evaluation and re-evaluation of suppliers are established. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained in accordance with QPM Clause 4.2.4, Control of Records Purchasing Information Purchasing information describes the product to be purchased including requirements for approval of product, procedures, processes, and equipment as appropriate. The adequacy of specified purchase requirements is ensured through verification prior to their communication to the supplier. Purchasing documents contain information clearly describing the product ordered, including, where applicable: a) the type, class, style, grade, or other precise identification b) the title or other positive identification, and applicable issue of specifications, drawings, process requirements, inspection instructions, and other relevant data, including requirements for approval or qualification of product, procedures, process equipment and personnel. c) the title, number, and issue of the quality system standard to be applied Verification of Purchased Product (7.4.3) Inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements are established and implemented. When Eagle Machining, Inc., our Customers or the Customer's representative, intends to perform verification at the supplier s premises the right to verify shall be afforded by the supplier. Where Eagle Machining, Inc. verifies purchased product at the supplier s premises, Eagle Machining, Inc. specifies verification arrangements and the method of product release in the purchasing documents.
23 22 of 7.5 Production and Service Provision Control of Production and Service Provision Production and service provision are planned and carried out under controlled conditions which include; a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post-delivery activities Eagle Machining, Inc. does not perform servicing or produce products that that readily lend themselves to any type of servicing by the manufacturer. Therefore, Clause service provision is excluded Identification and Traceability Product is identified by suitable means throughout product realization where appropriate. This includes identification of product status with respect to monitoring and measurement requirements. Where traceability is a requirement, controls and records of the unique identification of the product are maintained Customer Property Care is exercised with customer property while it is under the control of, or being used by Eagle Machining, Inc. Processes are in place to identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this situation is reported to the customer and records maintained.
24 23 of Preservation of Product The conformity of product is preserved during internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection of all tangible aspects of our product. Preservation also applies to the constituent parts of the product. The customer specifies the requirements for handling, packaging, storage, preservation and delivery. 7.6 Control of Monitoring and Measuring Equipment The monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements have been determined. Procedures have been established to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment is; a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration or verification is recorded, b) adjusted or re-adjusted as necessary, c) identified to enable the calibration status to be determined, d) safeguarded from adjustments that would invalidate the measurement result, e) protected from damage and deterioration during handling, maintenance and storage. In addition, the validity of the previous measuring results are assessed and recorded when the equipment is found not to conform to requirements, and appropriate action is taken on the equipment and any product affected. Records of the results of calibration and verification are maintained IAW Clause When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed prior to initial use and reconfirmed as necessary. 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT REFERENCE DOCUMENTS ISO 9001:2008 Clause 8.0 Quality Policy Manual Clause 7.1, Quality Policy Manual Clause 4.2.4, Quality Procedure, Control of Nonconforming Product, QP83 Quality Procedure, Corrective Action, QP852 Quality Procedure, Internal Audit, QP822 Quality Procedure, Preventive Action,QP853
25 24 of 8.1 General The monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of the product and to ensure conformity of the Quality Management System are planned and implemented. 8.2 Monitoring and Measurement Ensuring conformity of the product to requirements is demonstrated by: a) Nonconformance analysis related to the Control of Nonconforming Product QP83, b) Product audits, c) Applying Lessons Learned, d) Warranty analysis, e) Inspection, Internal and external audits, nonconformance, corrective and preventive actions and customer feedback results are used to continually improve the effectiveness of the Quality Management System. This includes the determination of applicable methods, including statistical techniques, and the extent of their use Customer Satisfaction As one of the measurements of the performance of the Quality Management System, information relating to customer perception as to whether the organization has met customer requirements is monitored. The methods for obtaining this information have been determined and include: a) Customer Complaints, b) Acceptance by the Customer Representative prior to shipment, c) Direct customer contact via meetings, telephone and , d) Spare parts speed of delivery information, e) Warranty issues, Customer feedback may result in changes to the specifications or configuration as contracted with the customer.
26 25 of Internal Audit Internal audits are conducted at planned intervals to determine whether the Quality Management System a) Conforms to the planned arrangements per QPM Clause 7.1 to the QMS requirements established within this Manual, and b) is effectively implemented and maintained. Internal quality audits are planned and scheduled on the basis of the status and importance of the processes and areas, including the results of previous audits. Auditors do not audit their own work. The audit criteria, scope, frequency and methods are defined in documented procedures, per QP822, including their planning and implementation. Selection of auditors and the conduct of audits ensure objectivity and impartiality of the audit process. The results of the audits are recorded and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area make timely corrective actions on the deficiencies found during the audits. Follow-up activities include the verification of the actions taken and the reporting of verification results. Records are maintained in accordance with QPM Monitoring and Measurement of Processes Suitable methods for monitoring and, where applicable, measurement of the QMS processes are applied within the operations to demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product Monitoring and Measurement of Product The characteristics of the product are monitored and measured to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements, per QPM Clause 7.1. The required inspection and testing, and the records to be established, are documented in the quality procedures. Evidence of conformity with the acceptance criteria is maintained. These records indicate the person(s) authorizing release of product. Product release and delivery do not proceed until all the planned arrangements have been satisfactorily completed, per QPM Clause 7.1 unless otherwise approved by a relevant authority, and where applicable, by the customer. 8.3 Control of Nonconforming Product Product, which 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 QP83. a) by taking action to eliminate the detected nonconformity (reworked to meet specified requirements),
27 26 of b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application (isolated, scrapped or returned to vendor). Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. When nonconforming product is corrected, it is subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, action is taken which is appropriate to the effects, or potential effects, of the nonconformity. 8.4 Analysis of Data Appropriate data is determined, collected and analyzed to demonstrate the suitability and effectiveness of the Quality Management System and to evaluate where continual improvement of that effectiveness can be made. Data generated as a result of monitoring and measurement or from other relevant sources aids the fulfillment of the analysis requirements through the trending of the data. The types of data include, but are not limited to: a) customer satisfaction, b) conformance to product requirements, c) characteristics and trends of processes and products including opportunities for preventive action, and d) suppliers. 8.5 Improvement Continual Improvement The effectiveness of its Quality Management System is continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review Corrective Action Action, which is appropriate to the magnitude of the problem and commensurate with the risks encountered, is taken to eliminate the cause of nonconformities in order to prevent recurrence. The root cause of the problem is identified and an action plan is developed to correct the problem and eliminate any recurrence The Corrective Action and Preventive Action procedures are separate Quality System Procedures that make a clear distinction between corrective action and preventive action and their inter-relationship. Procedure QP852 defines requirements for: a) reviewing nonconformities (including customer complaints), b) determining the causes of non-conformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken, and f) reviewing corrective action taken.
28 27 of Any changes to the documented procedures resulting from corrective action is implemented and recorded, following the Corrective Action Procedure QP Preventive Action Action, which is appropriate to the effects of the potential problem, is taken to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. The specifics are outlined by procedure QP853 which defines requirements for: a) Determining potential nonconformities and their causes, b) Evaluating the need for action to prevent occurrence of nonconformities, c) Determining and implementing action needed, d) Records of results of action taken, per QPM Clause 7.1 and, e) Reviewing preventive action taken. RESPONSIBILITIES Any employee, supplier or customer may initiate a preventive action request. The Quality Manager is responsible for ensuring that causes of problems and adverse trends are thoroughly investigated and that effective preventive actions are taken and reporting on the timeliness of the actions. Eagle Machining, Inc. maintains records, which provide objective evidence that the product has been inspected and/or tested. These records show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria.