Quality Manual - Risk Analysis, Quality Assurance, ISO ...
Quality Manual
ISO/TS 16949:2002
AS9100 Rev A
ISO 9001:2000
Rev 0
Approved
Editor:
Approved:
Change history
|Edition |Date |Change |
|0 | |Approved |
Index
Change history 2
1 Introduction, objectives and methods 4
1.1 Introduction: 4
1.2 Business Objectives 6
1.3 The method: 6
2 Quality Policy 7
2.1 Goals of the Quality Policy: 7
3 Processes at XXXX 8
3.1 Sequence and Interaction of process 9
3.2 Definition of processes 10
4 Responsibility and authority 18
4.1 General manager 18
4.2 Quality Manager 18
4.3 Technical Manager 19
4.4 Sales and marketing Manager 19
4.5 Operations manager 19
4.6 Comptroller 20
Introduction, objectives and methods
1. Introduction: This Quality Manual describes the Quality management System (QMS) of XXXX. The objective of the Manual and the procedures, instructions and forms mentioned here is:
← To demonstrate the ability of XXXX to regularly supply products that are according to the requirements of Customers, Laws and Industry Standards.
← To improve the level of Customer Satisfaction by the effective implementation of the QMS including the process of continuous improvement.
← This QMS of XXXX is based on ISI/TS 16949:2002, AS9100 and ISO 9001:2000 and is written in accordance to these standards
XXXX supplies to the automotive and other industries and the scope of the standard refers to
XYZXYZ
XXXX excludes from its QMS the design of YYYYYY for the Automotive and aeronautical market as it receives drawings for the product from the OEM and thus designs the production process only.
For sales to the After Market XXXX designs material and produces YYYYYY by reverse engineering
XXXX uses outsourcing for some of its calibration, some production and tool building. These are controlled by the purchase process and monitored. When required corrective actions are requested form these suppliers. Use of these sources does not free XXXX from the responsibility to its customers.
The company “XXXX Engine YYYYYY” was founded in 1960 and went public in 1987 and is traded on the Stock Exchange.
The company operates in the Automotive and Aeronautical industries manufacturing YYYYYY for internal combustion engines. These YYYYYY are for engines used in automotives, trucks, tractors, compressors, ships and propeller aircraft.
The company employees some 120 people.
Some 97% of the production is exported on 5 continents; the majority of the YYYYYY are for the after market and the rest for the OEM’s
The main markets that XXXX sells to are: USA, South America, EU, South Africa, Australia, Turkey and other countries in Asia and Africa.
The company’s products excel in their quality and accuracy and are intended for distributors and mechanics of high performance engines for supply in all quantities and type.
The company only produces engine YYYYYY and uses production methods and control of the most advanced in the field.
The development division of XXXX is dedicated to the development and production of new materials which will increase the life of the bearing and reduce its cost. In the last 10 years XXXX has specialized in the production of YYYYYY for racing cars according to special requirements the require the development of YYYYYY with special geometry and alloys that are unique to XXXX. These YYYYYY are mainly for the North American market.
XXXX has also built the ability in house to produce and control products and thus become an approved supplier to the manufacturers of propeller driven aircraft.
2. Business Objectives
Conformance with the requirements and expectations of the customers in the levels of quality and in process control to ensure the product at least meets the specific requirements.
1. Performance of the work and supply to the customer on time
2. Customer satisfaction in the long run
3. Conformance with legal requirements
4. Supply of products and service in a fitting manner
5. Effective and efficient work whilst continually improving
6. Correct performance, first time continuously
3. The method:
1. Design and definition of the quality policy of the company:
Definition of the company’s goals in relation to quality as formally expressed by the management as described in the various procedures
2. Design and definition of the quality management of the company:
Strategic planning, resource allocation, planning, implementation and control of the quality whilst emphasizing the responsibility of the management
3. Design and definition of the QMS of the company:
Organizational structure, fields of responsibility and authority, procedures, design of processes and resources needed for the implementation of the QMS
4. Design and control of the QMS of the company:
The techniques and actions in use to fulfill the quality requirements
5. Design of Quality Assurance in the QMS of the company
Planning of the resources and methods required
Quality Policy
The company’s management will act to consolidate a system which will include all subjects connected to assuring the quality in the plant and ensure that the finished product will conform to the requirements as they appear on the order and will answer to all the customers’ expectations.
The management will act according to the organizational structure and the allocation of resources and trained and qualified staff to ensure in the best manner the quality of the product and the requirements of the customer and prevent the production and supply of non conforming products.
The management will implement an efficient and effective QMS according to the requirements of ISO/TS 16949:2002, AS91000 and ISO 9001:2000.
4. Goals of the Quality Policy:
← Customer Satisfaction by implementing the quality required and reduction of costs of poor quality
Conformance to planned timetables
← Effective and efficient management of processes which will prevent unnecessary expenses and will contribute to increased efficiency and continuous improvement
← Nurturing of the Human capital by training and education as needed.
Processes at XXXX
XXXX identifies in this manual the processes that are required to maintain the QMS and to the requirements of ISO/TS 16949:2002, AS9100 and ISO 9001:2000 in the following manner:
Customer Orientated Processes (COP’S), these are processes that have a direct connection to the customer.
Support Orientated Processes (SOP’S) internal processes needed to support the COP’S
Management Orientated Processes (MOP’S) of the system which are used as controls
These processes are based on the PDCA model and actions are planned, implemented, checked for effectiveness and corrective actions or improvements implemented
The interaction of these processes can be seen in the following table. The processes are defined to show their inputs and outputs, owner and basic documentation including references to the procedures and/or work instructions when relevant. Included is the method of monitoring and measuring the effectiveness of the process. When effectiveness is not proved then corrective actions are taken. The monitoring also allows for the collection of data for continual improvement.
XXXX operates a monitoring and analysis system based on the Quality Delivery and Cost model which measures the following:
← Not right first time
← Delivery schedule achievement
← People productivity
← Stock turns
← Overall equipment effectiveness
← Value added per person
← Floor space utilization
5. Sequence and Interaction of process
[pic]
6. Definition of processes
ProcessTypeOwnerActionsInputsOutputsDocumentationMonitoringMeasurement of effectivenessReview of customer requirementsCOPFeasibility studyCustomer requestQuotationContract reviewTime for replyNumber of ordersCredit ratingOrderOffer Definition of partProduction planningRecords
Profitability Approval of orderPart and process design APQPCOPConversion of requirements of customer to part and process that will satisfy himRequirements of partApproved processAPQP procedureTimetable
Time to approvalSpecial requirements of customer work instructionsCostCustomer timetableApproved part
PPAPCost
Zero seriesResults of feasibility and contract reviewdesign control Production planningCOP Planning of productionCustomer orders and forecastsProduction planningInternal orders Orders
production efficiencystock ordersOn time deliveryProduction of strips
Production of stripsCOPReceipt and approval of raw materialProduction planMetal strips for production of YYYYYYWork instructions
Monitoring of inputs (cost and quantities)Efficiency (ratio of outputs to inputs)
Conversion of raw material Specifications and work instructionsOutput (Gross and scrap) Control of receipt, process and materialMachinery and infrastructureFailuresRaw materialQuality records Production targetsWorkersProduction of YYYYYYCOPConversion of strips to YYYYYYProduction planParts according to customer requirementsWork instructionsMonitoring of inputs (cost and quantities)Efficiency (ratio of outputs to inputs)Specifications and work instructionsRaw materialQuality recordsOutput (Gross and scrapMachinery and infrastructure Production targetsWorkersFailuresPackaging and dispatch
Packaging and dispatchCOP Receipt and approval of packagingSupply plan agreed with customersDispatch to the customer in the packaging and on timeWork instructionsTimetable (deviations reported to sales)Conformity to program
Packaging according to customer requirementsPackaging specificationsInterim storagePackaging materials Quality records
Planning of dispatch and preparation of documentsWorkers Conformity to customer requirements DispatchMachinery and infrastructureInvoice and collectionCOP Invoice according to the agreedDelivery notesInvoicesInvoices Tracking of invoices % of collectionCollectionOrdersMoneyRecordsCustomer FeedbackCOP Treatment of customer requests RequestsReplies, comments and improvements Reviews, meetings and letters Time of reply to customer Customer satisfactionReviewsAnalysis of customer satisfactionComplaintsComments
Maintenance
SOP
Preventative maintenanceMaintenance planRepairs to machinery and infrastructureMaintenance procedureReaction time and actual timeStandard time Installation and adaptation of new equipmentReports on maintenance problemsNew equipmentMaintenance planCost of maintenanceMaintenanceMachinery and infrastructureEffective stock of replacement partsTechnical literatureRepeat problems Reduction of downtimeManagement of sparesTechnical literatureToolingSOP Manufacture and preventative maintenance of toolsProduction planProduction tools
DrawingsProduction timetableProduction timetableMaintenanceInternal ordersSupport to maintenance
Machinery and infrastructureTool records
Monitoring of sub contractors
Reduction of downtime
Technical literaturePurchasing Raw Material
Purchasing Raw MaterialSOP Stock management, order pointProduction planStock of raw material
Purchase procedureOrder monitoringAdherence to planFollow up of ordersHistorical dataApproved supplier listSize and value of stockCost of shortagePrice reviewsMaterial specificationsMaterial specificationsSupplier evaluationEffective stockPurchasing semi finished
SOP Contract with supplierCustomer ordersSemi finished goods Purchase procedureOrder monitoringAdherence to planFollow up of ordersDrawings and technical specifications
Approved supplier listApproval of first sampleCost of shortagePrice reviewsPurchase specificationsSupplier evaluationCustomer satisfactionMovement and identification on work flowSOP Loading, unloading and movement of containers between stationsWIPProtected and identified products in the correct place
Identification tagsNon conformance due to lack of preservationComplaints due to mixed partsStorage and movement equipment Non conforming product procedurePreservation of productLevel of rejections as a result of lack of preservationIdentification of status at all stagesRouting cardsStatus identificationCalibration of measuring equipmentSOP Calibration and verification of equipmentEquipmentMeasuring equipment calibrated and conforming to requirementsCalibration procedureFollow up on calibration status and usabilityCalibration timetableCalibration specificationsStorage and protection of equipmentMeasuring procedureImprovement of measuring confidenceCalibration recordsMeasurement system analysisExternal laboratory
Confidence in measuring abilityIdentification of equipmentMSATraining
SOP Identification of training needs and organizational developmentPlan for HR in business planSkilled and aware workersTraining planImplementation of training planIncrease of outputTraining aidsIncreased motivationTraining ProcedureDevelopment of training plan and training methodsInternal growth and improvement of use of informationRecords of training and qualifications
Measurement of results (outputs, waste, set up time etcImprovement of quality, reduction of non conformance’sImplementation of trainingExternal training organizations
Connection to organizational targets* Qualification and empowerment of staffIncrease of satisfaction and identification with XXXXTreatment of non conforming materialSOP Identification of non conforming materialEngineering specificationsCustomer satisfactionProcedure for control of NCMTracking of CAR'sNumber of customer complaintsQuarantine of NCMControl planSavingsTime of identification
1. Where
2. WhenTraining and qualificationsCorrective action requestsTagsDecision as to treatmentAnalysis of cause of failureCARContinuous improvement of processesCorrective actions procedureCorrective actionsMOP Decisions as to treatment of root cause to prevent reoccurrenceCustomer complaintSavings of poor quality costs
Preventative actions procedure
RecordsTracking of CAR'sNon reoccurrence of non conformance’sAudit findingsSavings of poor quality costs
Customer satisfaction
Timetable for closing CAR's
Analysis of possibility of failuresDiscovery of non conformance in processSuggestions of workersContinuous improvement of processesTracking of actionsPreventative actionsMOP Decision as to treatment
FMEASavings of poor quality costsRecords
Tracking of actionsNon occurrence of failureAudit findingsCustomer communicationsCustomer satisfactionTimetable for closing PAR's Management Review MOP Review of suitability and efficiency of QMS
Review of possibilities of improvement
Decisions for actionsInformation on efficiency and effectiveness of the plants system in relation to customer requirementsDecisions of the management to improve the quality system and its processes and products
Resources neededForm which instructs as to the inputs and outputs of the review and supporting informationMeeting every half year
Customer satisfaction
No nonconformances in auditsInternal auditsMOP Inspection of conformity to requirements of the standards, the QMS and the products
Qualified auditors
CAR's
Audit procedureAudit planContinuous improvement as a result of corrective actions
Previous audit reports
Effective implementation of the QMSAudit planRecommendations for improvement
ReportsReduction of complaints and non conformance’sResponsibility and authority
General manager
Overall responsibility for the quality of the products supplied to the customers
Communication and interpretation of the Companies policy and goals to all members of staff
Determining the quality goals and Tracking of the quality levels in the plant in relation to those determined
Appointment of multi disciplinary teams as required.
Quality Manager
Preparation of the required documentation for the QMS- preparation and approval of test and inspection criteria for all the stages of acceptance of raw material and production, design and preparation of inspection and testing forms.
Inspection and testing of raw material, material in production and final inspection.
Approval of products as acceptable or not to requirements, approval of use of suspect material and identification and Tracking of non conforming material and products. Management of the MRB and approval of decisions
Determining the needs of the plant for test and inspection equipment and the maintenance, storage and control of this equipment
Support to management and staff in the identification and solution vof problems in work processes and initiation of improvement activities to increase the quality level and prevent reoccurrence of problems
Inspection and approval of technical documents – drawings, specifications etc that are sourced from the technical office.
Recommendation as to approval or rejection of suppliers and evaluation of performance.
Coordination of multi disciplinary teams.
Management representative with the responsibility to ensure that the QMS is established, implemented and maintained and to report on the state and need for change and improvement. To promote the importance of the customer and has the authority to resolve matters relevant to quality
Customer representative with the responsibility and authority to ensure that customer requirements such as choice of critical/key characteristics, targets corrective and preventative actions are addressed.
Technical Manager
Supply of design, development and maintenance to production departments and the management
Control and maintenance of engineering drawings
Feasibility studies of requirements and technical input to contact reviews
Training for technical subjects
Sales and marketing Manager
Preparation of strategic plan for the long term and tactical plan for the short run
Appointment of agents.
Communications with customers until delivery of goods
Actions to increase sales and market awareness
Review of customer requirements, documentation of RFQ’s and orders.
Marketing input to contact reviews
Treatment and Tracking of customer complaints.
Operations manager
Coordination and management of all operations that are connected with production and delivery of goods to the Israeli ports. Prioritization, coordination and management of transport according to the instructions and the production plan
Planning of short term work requirements including mobility between departments. Authority to change processes that are in his view damaging the quality of work.
Implementation of the production processes and inspection and testing requirements in accordance with the procedures and instructions of the company
Initiation and implementation of actions to improve the quality of products including improvement of processes and updating instructions on the basis of root cause analysis
Comptroller
Management of cash flow
Management and Tracking of organizational budgets
Cost accountancy and support for other departments
Management of financial monitoring and wage calculation
Preparation of import and export documents and Tracking of collection
-----------------------
Production process controls
Non conforming product
Identification and traceability
Preservation
Document control
Record control
Process and product monitoring
Equipment and facility management
Infrastructure
Work environment
Customer property
Measuring and monitoring devices
PPAP
APQP
Shipping
Inspection and packaging
Production
Purchasing
Production planning
Review
Repeat order
RFQ
Initial order
Customer
Internal audits
Corrective and preventative actions
Implementation and maintenance of the QMS
Quality Policy and processes implemented and maintained
QMS planning
Resource management
Management review
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- iso 900 sample internal audit checklist section 5
- quality management system manual
- iso 14001 2015 gap analysis iso 9001 help
- sample iso 9001 quality manual asq
- quality manual risk analysis quality assurance iso
- audit checkliste
- internal audit plan template acqnotes
- project proposal advisera
- quality plan webs
- requirement quality