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Revision Date: 2013-05-08 Approved By: Director, Mythical True Value Metrology Date: 2013-05-08
This document is authenticated in whole by verification of the above digital signature, using the signer's public key.
This is a complete re-issue of the manual with all previous changes incorporated, therefore there are no revision marks. This version replaces all prior issues.
This manual is the property of Mythical True Value Metrology. It must not be reproduced in whole or in part or otherwise disclosed without prior written consent from Mythical True Value Metrology. The official controlled copy of this manual is the digitally signed PDF document on the Mythical True Value Metrology network 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.
This document is controlled as a single entity, as any change however slight, even a single character to any part of the document by definition changes the entire document. For this reason, as well as the fact that the concept of page varies with the publication format, page-level revision is not practiced with this or any other Mythical True Value Metrology document.
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5.6 Management Review.....................................................................................................24 5.6.1 General ..............................................................................................................24 5.6.2 Review Input......................................................................................................24 5.6.3 Review Output...................................................................................................24 6. RESOURCE MANAGEMENT................................................................................................24 6.1 Provision of Resources..................................................................................................24 6.2 Human Resources..........................................................................................................25 6.2.1 Assignment of Personnel....................................................................................25 6.2.2 Competence, Awareness, and Training..............................................................25 6.3 Infrastructure.................................................................................................................25 6.4 Work Environment .......................................................................................................26 7. SERVICE REALIZATION.......................................................................................................26 7.1 Planning of Service Realization ...................................................................................26 7.2 Customer-Related Processes..........................................................................................27 7.2.1 Determination of Requirements Related to the Equipment...............................27 7.2.2 Review of Requirements Related to the Product...............................................27 7.2.3 Customer Communication.................................................................................28 7.3 DESIGN AND DEVELOPMENT................................................................................28 7.4 PURCHASING..............................................................................................................28 7.4.1 Purchasing Process.............................................................................................29 7.4.2 Purchasing Information......................................................................................30 7.4.3 Verification of Purchased Product......................................................................30 7.5 CALIBRATION AND SERVICE PROVISION...........................................................31 7.5.1 Control of Production and Service Provision....................................................31 7.5.2 Validation of Processes for Calibration Provision.............................................31 7.5.3 Identification and Traceability...........................................................................32 Identification................................................................................................................32 Traceability..................................................................................................................32 Inspection and Test Status............................................................................................32 7.5.4 Customer Property.............................................................................................33 7.5.5 Preservation of Product......................................................................................33 7.6 Control of Monitoring and Measuring Devices.............................................................33 7.6.1 Substitution of Test and Measurement Equipment Used as Measurement Standards.34 8. MEASUREMENT, ANALYSIS & IMPROVEMENT.............................................................34 8.1 General..........................................................................................................................34 8.2 Monitoring and Measurement ......................................................................................35 8.2.1 Customer Satisfaction........................................................................................35 8.2.2 Internal Audit.....................................................................................................35 8.2.3 Monitoring and Measurement of Processes.......................................................36 8.2.4 Monitoring and Measurement of Product..........................................................36 8.3 Control of Nonconforming Product...............................................................................36 8.4 Analysis of Data ...........................................................................................................37 8.5 Improvement..................................................................................................................37 8.5.1 Continual Improvement.....................................................................................37
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All printed copies, and all electronic copies and versions except the one accessible on the Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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2. INTRODUCTION
This Quality Manual demonstrates and documents Mythical True Value Metrologys commitment to maintaining a high-level of quality and strong customer service within an environment that has safety as a first priority, is focused on the customers, and fosters continual improvement. Since the philosophy of Mythical True Value Metrology is that Quality is an integral part of the entire business operation, hereafter this Quality Manual will be referred to as the Business Operating Manual. The organization is in the process of implementing that change. As part of the implementation, the term Quality Management System is also being changed to Business Management System.
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With the exception of ISO/IEC 17025, these are not auditable standards and are used solely for guidance. ISO/IEC 17025 is currently used only for guidance as it is part of the laboratory's continual improvement process to become accredited to that standard at a future date.
NCSL PDF
QMS
RSA
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equipment and testing equipment. The department performs, or arranges for, the calibration of all such equipment owned by or used by Mythical Airlines in all operating stations, as well as that of other aviation customers as arranged by contract. The department was created in 1995 and has been registered to ISO 9001 since August 2001. The departments vision is to be the leading metrology facility in the airline industry and provide strong support toward continually building a superior Mythical Airlines team.
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Exclusions: ISO 9001 clause 7.3 Design and Development. Mitigated: ISO 9001 clause 7.4 Purchasing.
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Level 2 documents are referenced in this Business Operating Manual but are not part of it.
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Receiving Process Evaluation Process Calibration Process Repair Process Process for control of Outside Services Out-Processing Process
(QP 4101) (QP 4102) (QP 4103) (QP 4104) (QP 4105) (QP 4106)
Support Processes: Mythical True Value Metrology Support Processes describe all other business requirements that are necessary to manage and control resources, and to conduct business in an orderly manner. The support processes are implemented and managed in accordance with the applicable requirements of the International Standard. They include: Quality Management (Business Operating Manual) Document Management (QP 4230, QP 4240) Facility and Equipment Management (QP 6300, QP 6400) Information Technology Management (QP 6301) Measurement Standards (QP 7600) Human Resources (QP 6220) The sequence and interaction of the Core and Support Business Processes are described in section 5.4.2 QMS Planning and QP 4100. The criteria and methods required to ensure the effective operation and control of these processes are defined and documented. The entire QMS documentation and other key information necessary to support the operation and monitoring of the department business processes are available to all department employees, and other parties requiring access, on the Laboratory network. Appropriate levels and types of monitoring and measurement of core and supplemental processes have been determined and are documented in relevant policies and procedures. The QMS includes policies and procedures for implementation of actions required to achieved planned results, and for continual improvement of the business processes.
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includes other documents and records required by the organization to ensure the effective operation and control of the business processes. The degree of documentation is consistent with: the methods used, the complexity and interaction of the business processes, and skills needed and training required by the personnel involved in carrying out these activities. An outline of the department QMS documentation is shown in Figure 1.
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Figure 1: Documentation The QMS is maintained, updated, and continually improved as the department seeks better business practices. Mythical True Value Metrology employees have been trained on: which procedures apply to them, how to access those procedures, how to apply them to their job function, and how to report related results.
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The Business Operating Manual is a controlled document subject to the requirements of section 4.2.3 Control of Documents.
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When practical, the changes are highlighted in the document and/or on attachments. 4.2.3.3 Obsolete Documents Electronically maintained documents are promptly removed from active files when they become obsolete. They may be maintained for the document retention period, in file areas not accessible to general users. After a revision issue, obsolete hard copy documents are promptly removed from points of issue and use. The obsolete master document is archived and may be retained for legal and/or knowledge preservation purposes. The obsolete point of use copy is destroyed. NOTE: Due to the nature of work performed by Mythical True Value Metrology (calibration and repair of precision tools, inspection, measuring and test equipment) there may be multiple versions of Level 3 documents for a given manufacturer/model of equipment. This is an acceptable situation because: it is due to version changes during production by the manufacturer of the equipment being calibrated and is outside the control of Mythical True Value Metrology; and the metrology technicians are responsible for selecting the correct document version based on the specific version or serial number of the item being calibrated. These documents are also exempt from the requirement to destroy old copies, unless and until it can be demonstrated that there will never again be a requirement to calibrate or repair that specific instrument from any current or potential future customer. The primary reason for this exemption is that some of the workload items may be several decades beyond their manufacturer's support life and the data owned by Mythical True Value Metrology may well be the only data available anywhere. 4.2.3.4 Documents of External Origin Due to the nature of the organization as a department of a large corporation, there are a number of documents of external origin that we must use and follow but which are controlled elsewhere. Access to and use of these documents is in accordance with applicable Mythical Airlines policies. Mythical True Value Metrology is also subject to various government regulations. When there is a need to refer to any of these regulations, access is gained through the Mythical Airlines system or the regulatory agency system. Our presumption is that the link from that site goes to the most current edition of the regulation. Any other copies of these regulations are not authorized for use. These and other situations are further documented in QP 4230.
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5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
The top management of Mythical True Value Metrology is committed to the development and improvement of an effective Quality Management System. This commitment is demonstrated by: Communicating to the organization the importance of meeting all customer, regulatory, and legal requirements. (Section 5.5.3 Internal Communications.) Establishing the Mythical True Value Metrology Quality Policy for total commitment to excellence and the associated quality objectives. The Quality Policy and the Quality Objectives are published and displayed on the Laboratory network sign-in page and the office notice board. (Sections 5.3 Quality Policy and 5.4.1 Quality Objectives.) Conducting Management Reviews. (Section 5.6 Management Review.) Identifying and acquisition of controls, processes, equipment, fixtures, resources, and skills need to achieve the required quality. The associated quality management activities are described in Section 6 Resource Management.
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verbal and written communications, as well as periodic visits to their facilities to better understand their individual processes. It is the responsibility of all personnel that interface with customers to access stated or implied needs and bring them to the attention of top management so that they may be addressed. To continually improve, the department also monitors, measures, and analyzes customer satisfaction throughout the business cycle. The department also meets all of its other obligations including regulatory and legal requirements. This is further described in Section 7.2.1 Determination of Requirements Related to the Equipment.
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implemented by means of documentation, and training about the Business Management System to meet the requirements of the Standard. The Policy is maintained through Business Management Systems audits and corrective and preventive action, and reviewed for continuing suitability through periodic Management Reviews. Further, this Quality Policy is supported by the quality objectives listed in this Business Operating Manual. (Section 5.4.1 Quality Objectives).
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Figure 2: Core & Support Business Processes Each core and support business process has a process owner who has the prime responsibility for ensuring that the process: achieves its objectives, and is under continual review for improvement. The business processes, their associated procedures, and the business process owners are shown in the Business Process and Responsibility Matrix. Each of the core business processes and support processes is linked to a specific Level 2 quality procedure. The Quality Plan describes the overall plan for quality assurance. The quality plan consists of the core business processes and their interactions, the support processes and their interactions, the Business Process and Responsibility matrix, and appropriate outputs of management review, such as supporting resources.
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The Quality Plan is assessed for on-going suitability and effectiveness during management review meetings.
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The Management Representative also acts as the liaison between the department and other third parties on matters concerning the department Business Management System. The Metrology Engineering and Support Manager is the Deputy Management Representative.
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All printed copies, and all electronic copies and versions except the one accessible on the Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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All printed copies, and all electronic copies and versions except the one accessible on the Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.
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6. RESOURCE MANAGEMENT
6.1 Provision of Resources
Top management of Mythical True Value Metrology determines and provides, in a timely manner, the resources needed: to implement, maintain and improve the effective operations of the QMS processes, and to enhance customer satisfaction by meeting requirements.
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These resources are assessed and reviewed on a periodic basis consistent with annual and strategic business planning activities.
6.3 Infrastructure
Top management of Mythical True Value Metrology identifies, provides and maintains the facilities and infrastructure it needs to achieve service quality, including: workspace and associated facilities, including utilities; process equipment, hardware and software; supporting services such as telephone, computer networks, etc.
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QP 6300 and QP 6301 have been established to further describe and implement the above policies.
7. SERVICE REALIZATION
NOTE: The product of Mythical True Value Metrology is the service of providing calibration of tools, precision measuring equipment, and testing equipment.
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Clarify standards of acceptability, including those that contain a subjective element. Identify quality records that are necessary to provide confidence of conformity of the processes and results, and the records are maintained as described in documented procedures.
Quality Procedure QP 7100 describes the planning for service delivery and refers to other Mythical True Value Metrology quality procedures involved in the process.
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Requirements are adequately defined and documented. Differences between the standard requirements and those in the request are resolved. Mythical True Value Metrology has the capability and capacity to meet these requirements.
If a change to the standard requirements is identified by the laboratory or requested by the customer, the department documents such statements of or changes to requirements. The department ensures that relevant documentation is amended and relevant personnel are made aware of the changed requirements.
7.4 PURCHASING
Purchasing of outside materials, supplies, and services is not a burdensome requirement for Mythical True Value Metrology. In most cases, Mythical Airlines is considered the supplier of all purchasing services. All purchases of capital items, high volume consumables, items or services requiring a purchase order, contracted services, and so on are largely handled by other Mythical Airlines departments and are under the control of Mythical Airlines policies and procedures and therefore outside the scope of this QMS. Much of the purchasing process uses Mythical Airlines requirements, controls and staff, which are outside the scope and controls of the Mythical True Value Metrology QMS.
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Suppliers that may be used with a purchase order or through the electronic business-tobusiness system are controlled by the Mythical Airlines corporate purchasing and accounting departments, which are outside the scope of this QMS. Some materials and supplies are obtained from the Mythical Airlines stock system. Support processes are supplied and controlled by other Mythical Airlines departments.
Mythical True Value Metrology directly purchases some materials, supplies, and services from other companies by using Mythical Airlines corporate purchase card. Almost all such purchases are infrequent or non-recurring retail purchases of very small quantities of cataloged or other commercial off-the-shelf products. All purchases must follow the policies and procedures of Mythical Airlines, which are outside the scope of this QMS. Mythical True Value Metrology maintains a local list of active outside (non-Mythical Airlines) suppliers and the materials or services they provide, but suppliers are primarily managed at the corporate level and must be listed in the corporate enterprise management system database. Mythical Airlines provides for the inspection and auditing of suppliers, when a need is determined, according to Mythical Airlines policy. In this respect Mythical Airlines is a supplier of this service to Mythical True Value Metrology. Mythical True Value Metrology, where practical, verifies purchased material, supplies, and services before use or redistribution.
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7.5 CALIBRATION AND SERVICE PROVISION 7.5.1 Control of Production and Service Provision
Mythical True Value Metrology identifies and plans calibration processes that directly affect quality to ensure that these processes are carried out under controlled conditions. The plan is modified, if necessary, based on review of new customer requirements. These plans are executed under controlled conditions. Controlled conditions include the following: The availability of information that specifies the product/calibration characteristics. Use of documented work instructions defining the manner of calibration, where the absence of such instructions could adversely affect quality. Use of suitable calibration equipment in a suitable work environment. Compliance with reference standards, codes, control plans, and/or documented procedures and work instructions. Calibration personnel have access to appropriate product specifications information and control measures at each stage of the process. Monitoring and control of suitable product characteristics and process parameters, and the availability and use of measuring and monitoring devices. The approval of process and equipment as required. Criteria for workmanship are stipulated in the clearest practical terms using written standards, representative samples, or illustrations, as appropriate. Suitable maintenance of equipment to ensure continuing process capability. The implementation of defined processes for release, delivery, and any applicable postdelivery activities.
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Validation demonstrates the ability of the processes to achieve planned results. Mythical True Value Metrology defines arrangements for validation, including the following, as applicable: qualification of processes; qualification of equipment and personnel; use of defined methodologies and procedures; requirements for records; re-validation.
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are protected from damage and deterioration during handling, maintenance, and storage; calibration results are recorded; have the validity of previous results re-assessed if measuring and monitoring devices are subsequently found to be out of calibration, and corrective action taken.
Where software is used to control measuring and monitoring of specified requirements, it is validated prior to initial use. Once the software has been verified to function as intended (as part of the receiving inspection process), then no further tests are required unless a version upgrade is installed or a skilled operator has reason to suspect a problem. Quality Procedure QP 7600 provides additional guidance on control of measurement standards and implements this policy.
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Mythical True Value Metrology ensures that service provided which does not meet requirements is identified, controlled where possible to prevent unintended use or delivery to the customer, and corrected if it has been delivered. This policy is implemented in QP 8300. This procedure includes provisions for: identification, documentation, evaluation, segregation (where practical), disposition of nonconforming service, and for notification of the functions concerned; assigning responsibility for the review and the authority for disposition of nonconforming service; correction of nonconforming service and re-verification/calibration of the affected equipment after correction to demonstrate conformity (if necessary); handling of nonconforming service when it is detected after delivery to the customer.
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determining the causes of nonconformity; evaluating of the need for actions to ensure that nonconformities do not recur; determining and implementing the corrective actions needed; recording results of action taken; review and evaluation of corrective action taken to assess its effectiveness.
- - - [END] - - -
Graeme C. Payne
ASQ Senior Member, CQA, CCT, CQE, CQT GK Systems, Inc. 4440 Weston Drive SW, Suite B Lilburn GA 30047-3181 USA http://www.gksystems.biz This EXAMPLE manual is a representative item for use as a training aid only. Any resemblance to any real corporation, organization, policies or procedures is not All printed copies, and all electronic copies and versions except the one accessible on the intentional and is purely coincidental. Mythical True Value Metrology server, are considered uncontrolled copies used for reference only.