QUALITY MANUAL



QUALITY MANUAL Submitted By: PETRUS LE Reviewed By: LONG LE Approved By: LONG LE Date: 08/05/2015Table of ContentsSectionsParagraphPage0Introduction41.Purpose / Scope41.1SANMACH MFG Organizational Chart52.0References53.0Definitions / Acronyms54.0Quality Management System64.1General Requirements64.2Documentation Requirements64.2.1General64.2.2Quality Manual 74.2.3Control of Documents74.2.4Control of Quality Records85.0Management Responsibility 85.1Management Commitment85.2Customer Focus95.3Quality Policy95.4Planning 95.4.1Quality Objectives95.4.2Quality Management System Planning95.5Responsibility, Authority and Communication105.5.1Responsibility & Authority105.5.2Management Representative105.5.3Internal communication105.6Management Review 105.6.1General105.6.2Review Input115.6.3Review Output116.0Resource Management116.1General116.2Human Resources 116.2.1General116.2.2Competence Awareness Training126.3Infrastructure126.4Work Environment127.0Product / Service Realization 127.1Planning product / Service Realization127.2Customer Related Processes 137.2.1Determining of requirements related to Product /Service137.2.2Review of requirements related to Product / Service147.2.3Customer Communication147.3Design and Development (not Applicable)147.4Purchasing147.4.1Purchasing Process147.4.2Purchasing Information147.4.3Verification of purchased Product157.5Product and Service Provisions157.5.1Control of Product and Service Provisions157.5.2Validation of Processes for product and Service Provisions157.5.3Identification and Traceability167.5.4Customer Property167.5.5Preservation of Product167.6Control of Monitoring and Measuring Devices168.0Measure Analysis and Improvements 178.1General178.2Monitoring and Measuring 178.2.1Customer Satisfaction188.2.2Internal Audits188.2.3Monitoring and Measuring Processes188.2.4Monitoring and Measuring of Product188.3Control of Non Conforming Material198.4Analysis of Data198.5Improvement 208.5.1Continual Improvement208.5.2Corrective Action208.5.3Preventative Action20AppendixDocument Matrix21IntroductionL&D TECH CORP is a privately company established in 2005 and is a manufacture of Precision machined components, Weldments, Frames and Assemblies for the Semiconductor, Bio-Medical, Microwave, Military and Aero Space Industries.L&D TECH CORP has developed a quality management system to better satisfy the needs of customers and to improve management of the operations. The quality system complies with the International Standards Organization (ISO) 9001:2008(E) and the equivalent, ANSY/ASQ91.Purpose/ScopeThe purpose of this manual is to document L&D TECH CORP ’s Quality System and guide employee’s whose actions effect quality, and to outline methods employed by L&D TECH CORP to ensure that products meet specified requirements. This quality manual is divided into five (5) primary sections corresponding to quality systems clauses of ISO: 9001:2008(E) Standards. The policies are supported by procedures and work instructions located at each individual site.The Quality Manual outlines the key objectives of L&D TECH CORP and the senior management enforces the content of this manual, but the responsibility for quality belongs to each employee. The manual is an outline of Dimension’s policies and procedures are formulated to ensure that the products offered to our customers are consistent and reliable, reflecting the understanding of our customer requirements.The scope of L&D TECH CORP’s quality management system is to manufacture, procurement, and delivery of product in support of customers. L&D TECH CORP is excluded from provisions in the ISO: 9001:2008(E) 7.3 Design and development and in 7.5 in regards to service provisions.This manual also defines the delegation of authority for Quality1.1 L&D TECH CORP ’s Organizational Structure L&D TECH CORP Organization ChartReferencesISO 9001:2008(E) - Quality Management Systems RequirementL&D TECH CORP’s Quality ProceduresL&D TECH CORP’s Quality Systems Work InstructionsL&D TECH CORP’s Quality Systems FormsDefinitions/ AcronymsProduct- Results of activities or processes. A product may include hardware, processed materials or a combination of these.Quality- Total of all features and characteristics that bear on the ability to satisfy the stated and implied needs of customers.Quality Plan- Documentation set to specific quality practice, resources and sequences of activities relevant to a particular product, project or contract. Depending on its scope, the quality plan may be called an inspection plan, a validation plan, traveler, router, etc.QMS-Quality Management System: Management System to direct and control an organization with regard to qualityQAM-Quality Assurance ManualTop Management- President, Director of Operations and direct reports.QUALITY MANAGEMENT SYSTEM4.1 General RequirementsL&D TECH CORP has established a documented and maintained quality management system and continually improves its effectiveness in accordance with the requirements of ISO 9001:2008(E) Standards by managing the following processes.Identifying the processes needed for the Quality Management System and their application throughout Top Management.Determining the sequence and interaction of those processes.Determining criteria and methods needed to ensure that both the operation and control of these processes are effective.Ensuring the availability and resources and information necessary to support and monitoring of these processes.Monitoring measures and analyzes these processes.Implementing actions necessary to achieve planned results and continual improvement of these processes.L&D TECH CORP controls any and all of above processes, when outsourced. Controls of such outsourced processes are identified within the Quality Management System. Activities to control suppliers include audits, supplier improvement project, first article inspections and the monitoring of suppliers. Documentation RequirementsGeneral The Quality Management Systems documentation consists of a four level system in any form or medium and includes:Level I: A Quality Manual- Documented statement of a quality policy and quality objectives.Level II: Documented procedures required by ISO 90001:2008(E) Standards.Level III: Documented work instructions needed by top management to ensure the effective planning and control of its processes.Level IV: Records required by this policy.QMS documents are available on line on the company intranet site on the company-shared drive.4.2.2Product RealizationPurchasing, Manufacturing, Quality Assurance, ShippingContinual ImprovementC/A, P/A, Customer Feedback,Data Collection & Analysis, Internal AuditsCustomerCustomer SatisfactionManagement Responsibility, Customer related process, Contract review, QMS Planning, Resource ManagementProduct Planning, Materials, Production control, Engineering, ReceivingOutputControl of DocumentsAll Documents required by the Quality Management System are controlled. Records are special type’s documents and are controlled according to document control procedure. The document control procedure has been established to define the controls needed to: CustomerCustomer Requirements_______________________________________a) Approve documents for adequacy prior to use.b) Review, update and re-approve documents as needed.c) Ensure that changes and current revision status of documents are identified.d) Ensure that relevant versions of applicable documents are available at point of use.e) Ensure that documents remain legible and readily identifiable.f) Ensure that documents of external origin are identified and their distribution controlled, andg) Prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.4.2.4Control of Quality RecordsQuality records are established when required and maintained to provide evidence of conformity to requirements and of effective operation to the Quality Management System.Quality records required for the Quality Management System are controlled to ensure they are legible, readily identifiable and retrievable. A documented procedure has been established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition of quality records. Retention times are based on customer requirements and L&D TECH CORP’s business needs and are available upon customer request. The Master List of Quality Records details the storage location and the retention period of each group of retained records. The responsibility for these quality records may be found within the quality procedures.MANAGEMENT RESPONSIBILITY5.1 Management CommitmentTop Management demonstrates its commitment to the development and implementation of the Quality Management System and continually improving its effectiveness by:Communicating the importance of meeting customer as well as statutory regulatory requirements.Establishing the Quality PolicyEnsuring quality objectives are established.Conducting management reviews andEnsuring the availability of resources.Customer FocusL&D TECH CORP has designated a management representative to ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.Quality PolicyThe President has the responsibility to ensure that the company quality policy:Is appropriate to the mission of the operationIncludes a commitment to comply with requirements and continually improve the effectiveness of the Quality Management System.Provides the framework for establishing and the review of quality objective.Is communicated and understood within the organizationIs reviewed for continuing suitabilityL&D TECH CORP Quality Philosophy is: TOC \o "1-3" \h \z \u “To Achieve Customer Satisfaction by Meeting Customer Requirements and Continually Improving the Quality Management System Toward Meeting ‘World Class’ Performance Standards.”PlanningQuality ObjectivesTop Management ensures that the quality objectives, including those needed to meet product requirements are established at relevant functions and levels within the organization. Quality objectives are measurable and consistent with the Quality Policy. QMS PlanningTop Management ensures that:The planning of the Quality Management System is carried out in order to meet the requirements of 4.1 as well as the quality objectives, and The integrity of the Quality Management System is maintained when changes to the management system are planned and implemented.Responsibility and Authority and CommunicationResponsibility and AuthorityTop management ensures that responsibility and authority are defined and communicated within the company.Management RepresentativesThe Director of Quality Assurance is appointed, irrespective of other responsibilities, with the responsibility and authority that includes:Ensuring that processes needed for the Quality Management System are established implemented and maintained.Reporting to Top management on the performance of the Quality Management System and any need for improvement, andEnsuring the promotion of awareness of customer requirements throughout the organization.Internal CommunicationTop Management ensures that appropriate communication processes are established within the organization and that communication is accomplished regarding the effectiveness of the Quality Management System.Management ReviewGeneralTop Management reviews the Quality Management System at planned intervals, annually at a minimum, to ensure continuing suitability, adequacy, and effectiveness. The review includes assessing opportunities for improvement and the need for changes to the Quality Management System, including the quality policy and quality objectives. Records of management reviews are maintained.Review InputThe input for management review includes information on:Results of auditsCustomer feedbackProcess conformance and product conformityStatus of Preventative an Corrective actionsFollow-up actions from previous management reviewChanges that could effect the Quality Management System, andRecommendations fro improvement Review OutputThe output from the management review includes any decisions related to:Improvement of the effectiveness of the Quality Management Systems and it’s a process.Improvement of product related to customer requirements, andResource needsRESOURCE MANAGEMENT6.1 Provisions of resourcesEach top Management Team determines and provides the resources needed:Implement and maintain the Quality Management System and maintain its effectiveness, and;Enhance customer satisfaction by meeting customer requirements. Human ResourcesGeneralPersonnel performing work-affecting quality are competent on the basis of appropriate education, training, skills, and petence, Awareness, TrainingHuman resources and department management;Determine necessary competence fro personnel performing work effecting product quality.Provide training or take other actions that satisfy these needs.Evaluate the effectiveness of actions taken.Ensure that its personnel are aware of the relevance and importance of there activities and how they contribute to the achievement of the quality objectives, andMaintain appropriate records of education, training, skills, and experience. Top management ensures that training records, training courses and schedules are published.6.3 InfrastructureTop Management determines, provides and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicableBuildings, workspace and associated utilitiesProcess equipment (both hardware and software), andMaintain appropriate records of education, training skills, and experience. Work EnvironmentTop Management determines and manages the work environment needed to achieve conformity to product requirement.PRODUCT REALIZATION7.1 Planning of ProductTop Management plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the Quality Management System. In planning product realization Top Management determines the following, as appropriate:Qualities objectives and requirements for the product.The need to establish processes, documents, and provide resources specific to the product.Required verification, validation, and monitoring, inspection and test activities specific to the product and the criteria for product acceptance.Records needed to provide evidence that the realization processes and resulting product meet requirements se 4.2.4The output of this planning is in form suitable for Top Management’s method of operationCustomer Related Processes7.2.1 Determination of Requirements Related to ProductTop Management Determines; Requirements specified by the customer, including requirements for delivery and post delivery activities.Requirements not stated by the customer but necessary for specified or intended use, where known.Statutory and regulatory related to the product, andAny additional requirements determined by Top Management reviews the requirement related to the product. This review is conducted prior to Top Managements commitment to supply a product to the customer that ensures that:Product requirements are definedContract or order requirements differing from those previously expressed are Management has the ability to meet defined requirements.Records of the results of the review and actions arising as a result of the review are maintained.Where the customer provides no stated customer requirements, Top Management before acceptance confirms customer requirements. Review of requirements related to productWhere product requirements are changed, Top Management ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.Customer CommunicationTop Management determines and implements arrangements for communicating with customers in relation to:Product informationInquires, contract or order handling, including amendments, and,Customer feedback including, customer complaintsDesign and DevelopmentDesign and development does not apply to current activities taking place at SANMACH MFG is not included in the scope of registration as a product manufacture.PurchasingPurchasing ProcessesTop Management ensures that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependant upon the effect of the purchased product on subsequent product or the final product.Purchasing evaluates and selects suppliers based on their ability to supply product in accordance with Top Management requirements. Criteria for selection, evaluation and re-evaluation are established. Records as a result of the evaluation and any necessary actions arising from the evaluation are maintained.Purchasing informationPurchasing documents contain information describing the product to be purchased including where appropriate;Requirements for approval of product, procedures, processes and equipment.Requirements for qualification of personnel and;Quality management system requirementsTop Management ensures the adequacy of specified purchase requirements prior to their communication to supplier.Verification of Purchased PartsTop management establishes and implements the inspection and other activities necessary for ensuring that purchased product meets specified customer requirements.Product ProvisionsControl of Production ProvisionsTop Management plans and carries out production provisions under controlled conditions. Controlled conditions include, where applicable the following;Availability of information that describes the characteristics of the product.Availability of work instructions as necessaryUse of suitable equipmentAvailability and use of monitoring and measuring equipment.Implementation of monitoring and measuring devices.Implementation of release, delivery and post delivery activitiesValidation of Processes for Production ProvisionsTop Management validates any processes production provisions where the resulting output cannot be verified by subsequent monitoring or measurement. This includes and processes where deficiencies become apparent only after the product is in use or has been delivered.Validation demonstrates the ability of these processes to achieve planned Management establishes arrangements for these processes including, as applicable:Defined criteria for review or approval of processes.Approval of equipment and qualification of personnelUse of specific methods and procedures.Requirements for records and,RevalidationIdentification and TraceabilityWhere appropriate L&D TECH CORP identifies the product by suitable means throughout product realizationL&D TECH CORP identifies the product status with respect to monitoring and measurement requirementsWhere traceability is a requirement, L&D TECH CORP controls and records the unique identification of the product.Customer PropertyL&D TECH CORP exercises care with company property while under Sharp’s control. L&D TECH CORP identifies, verifies, protects and safeguards customer property provided for use or incorporation into the product. If any customer product is lost, damaged, or otherwise found to be unsuitable for use, this is reported to customer and records maintained.Preservation of ProductL&D TECH CORP preserves the conformity of product during internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of the product.Control of Monitoring and Measuring Devices.L&D TECH CORP determines the monitoring and measuring to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.L&D TECH CORP establishes processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.Where necessary to ensure valid results, measuring equipment is:Calibrated or verified at specific intervals, or prior to use against measurement standards traceable to international or national measurement standards; where no such standard exist, the basis used for calibration or verification are recorded.Adjust or readjust as necessaryIdentified to enable the calibration status to be determined;Safeguarded for adjustments that would invalidate the measurement result;Protected from damage or deterioration during handling, maintenance or storage.In addition L&D TECH CORP assesses and records the validity of the previous measuring results. When the equipment is found not to conform to requirements. L&D TECH CORP takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained.When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is undertaken prior to initial use and reconfirmed as necessary.MEASUREMENT, ANALYSIS AND IMPROVEMENT8.1 GeneralL&D TECH CORP plans and implements monitoring, measurement, analysis and improvement processes as needed to:Demonstrate product conformityEnsure conformity of the quality management system, andContinually improve the effectiveness of the quality management systemThis includes determination of applicable methods, including statistical techniques and the extent of their use.Monitoring and MeasurementCustomer Satisfaction As one measurement of the Quality management System L&D TECH CORP monitors information relating to customer perception as to whether Top Management has met customer requirements. The methods for obtaining and using this information are determined.Internal AuditsL&D TECH CORP conducts internal audits at planned intervals (annually) to determine whether the Quality Management System;Conformed to the planned arrangement and requirements of the ISO 9001:2008(E) Standards and the Quality Management System requirements established by the Corporation andIs effectively implemented and maintained.An audit program is planned taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits ensures objectivity an impartiality of the audit process. The Audit criteria, scope, frequency and methods are defined. Auditors do not audit their own work.The responsibility and requirements for planning and conducting audits and for reporting results and maintaining records as defined in documented procedure.The management responsibility for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and reporting of verification results.Monitoring and Measuring of Processes.L&D TECH CORP applies suitable methods of monitoring and where applicable, measurement of the Quality Management System processes. These methods at a minimum demonstrate the ability of processes to achieve a planned result. When planned results are not achieved, correction and corrective action is taken, as appropriate to ensure conformity of product.Monitoring and Measurement of ProductProducts are monitored and measured to verify characteristics of the product to ensure the requirements have been met. This carried out at appropriate stages of the product realization process in accordance with the planned arrangementsEvidence of the conformity acceptance criteria is maintained. Records indicate the persons authorizing release of product.Product release and services delivery do not proceed until the customer has satisfactorily completed the planned arrangements, unless otherwise approved by a relevant authority and where applicable.Control on Nonconforming ProductProduct, which does not conform to product requirements, is identified and controlled to prevent unintended use or delivery. The controls and related responsibility and authorities for dealing with nonconforming products are defined in a documented procedure.L&D TECH CORP deals with nonconforming product by one or more of the following ways:By taking action to eliminate the detected nonconformityBy authorizing its use, release or acceptance under concession by a relevant and where applicable, by the customer.By taking action to preclude its original intended use or application.Records of the nature of the nonconformity and any subsequent action taken, including concessions obtained are maintained. When nonconforming material product is corrected it is subjected to verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or has started, L&D TECH CORP takes action to the effects, or potential effects of the nonconformity.Analysis of DataL&D TECH CORP determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the Quality Management System, and to evaluate where continual improvement of the effectiveness of the Quality Management System can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to:Customer satisfactionConformity of product requirementsCharacteristics and trends of processes and products including opportunities for preventative action and;SuppliersImprovementContinual ImprovementL&D TECH CORP continually improves the effectiveness of the quality management through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventative actions and management review.Corrective ActionSANMACH MFG takes action to eliminate the cause of nonconformities, in order to prevent recurrence. Corrective actions taken are appropriate to the effects of the nonconformity encountered.A documented procedure is established to define requirements for:Reviewing nonconformity (including customer complaints)Determining the cause of the nonconformityEvaluating the need for action to ensure that a nonconformity do not occurDetermining and implementing action needed;Records of the results of action takenReviewing corrective action takenPreventative ActionL&D TECH CORP determines actions to eliminate the cause of potential nonconformities in order to prevent their occurrence. Preventative actions are appropriate to the effects of the potential problems.A documented procedure has been established to define requirements for:Determining potential nonconformities and their causesEvaluating the need for action to prevent occurrence of nonconformities.Determining and implementing action needed;Records of results of action taken and,Reviewing preventative action taken ................
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