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Quality Policy Manual
World-class quality customer support Siliconix' products only enabled effective quality systems. quality system must encompass industry, national, international standards effective must include involvement support management. Siliconix, continuous maintenance quality system under full ownership organization. this charter, quality responsibility employees Siliconix. Employees have responsibility ensure that requirements this quality system implemented, maintained, improved upon.
King Owyang President
Edward Tefankjian Corporate Quality Vice President
Vishay Siliconix 2201 Laurelwood Road, Santa Clara, 95054-1595 Tel: (408) 988-8000 FAX: (408) 567-8950
Table Contents Introduction Process Approach Quality Policy 1.1. 1.2. 3.1. 5.1. 5.2. 5.3. 6.1. 6.2. 6.3. 6.4. 6.5. 6.6. 7.1. 7.2. 7.3. 7.4. 8.1. 8.2. 8.3. 8.4. 8.5. 8.6. 9.1. 9.2. 9.3. 9.4. 9.5. SCOPE General.3 Application.3 Document (Normative) Reference.3 Terms Definitions.3 Terms definitions automotive industry Responsibility Authority Quality Management System General Requirements Outsourced Processes Documentation Requirements.5 Management Responsibility Management Commitment.7 Customer Focus Quality Policy.7 Planning Responsibility, Authority Communication.8 Management Review.9 Resource Management Provision Resources Human Resources.10 Infrastructure Work Environment.11 Product Realization.11 Planning Product Realization Customer-Related Processes Design Development.13 Purchasing Production Service Provision Control Monitoring Measuring Devices Measurement, Analysis Improvement General.22 Monitoring Measurement Control Nonconforming Product.25 Analysis Data Improvement
Appendix
Quality Policy Manual Vishay Siliconix
Introduction Siliconix international manufacturer semiconductor products. Products include power MOSFETS, power Integrated Circuits (IC's) analog signal processing devices. Siliconix headquartered Santa Clara, California part Vishay Intertechnology, Inc. headquartered Malvern, Pennsylvania. This Quality Policy Manual applies Siliconix employees worldwide. These quality systems specifications implemented accordance with latest revision 16949, QS-9000 Semi-conductor Supplement, United States Military Standards MIL-PRF-38535 MIL-PRF-19500. Siliconix President Quality Vice-President will approve major revisions this manual. Minor revisions, which materially change content this manual compromise underlying policies, require only approval Quality Manager Director. Only controlled copies this manual will updated. Document Management maintains distribution list controlled copies this manual. Process Approach Siliconix uses process approach (Figure i.e., application system process within company, together with identification interaction these processes, their management. Siliconix uses methodology known "Plan-Do-Check-Act" (PDCA) applied processes. PDCA briefly described follows: PLAN: CHECK: ACT: Establish objectives processes necessary deliver results accordance with customer requirements companies' policies. Implement processes. Monitor measure processes product against policies, objectives, requirements product report results. Tack actions continually improve process performance.
Quality Policy goal exceed quality expectations customers. This commitment starts with management extends through entire organization. achieved through innovation, technical excellence, continuous improvement.
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Quality Policy Manual Vishay Siliconix
Continual Improvement Continual Improvement Quality Management System Quality Management System
Management Management Responsibility Responsibility Customers Customers Resource Resource Management Management Measurement, Measurement, Analysis Analysis Improvement Improvement
Customers Customers
Satisfaction
Requirements
Input
Product Product Realization Realization
Product Product
Output
Value-AddingActivities InformationFlow
Figure Model Siliconix Process-Based Management System
Management Management
Business Plan Goal Setting Resource Review Business Plan Goal Setting Resource Review
CUSTOMER
STAKEHOLDER
Analysis Data Internal Audits Monitor Measure
Customer Feedback
SUPPLIER
INDUSTRY LEADER
Market Development
Product Process Design Verification Validation
Wafer Fabrication
Assembly Test
Shipping
Supporting Functions
Engineering Calibration Maintenance Quality Purchasing Finance EH&S Facilities
Figure Customer Orientated Processes (COPS) Vishay Siliconix (SCLA)
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CUSTOMER
Sales
Order Entry
Planning
Warehouse
Quality Policy Manual Vishay Siliconix
SCOPE 1.1. General
Quality Policy Manual details requirements Quality Management System demonstrating Siliconix': Ability consistently provide product that meets customer, Government, in-house applicable regulatory requirements. enhance customer satisfaction through effective application system, including processes continual improvement system assurance conformity customer requirements. 1.2. Application
This Quality Policy Manual applies Siliconix facilities regulatory requirements. Document (Normative) Reference Siliconix uses most recent edition said regulatory requirements including IASG Sanctioned Interpretations. Terms Definitions NOTE: Supply chain vocabulary: supplier Siliconix customer
following terms definitions apply. 3.1. Terms definitions automotive industry 3.1.1. Control Plan
Documented description systems processes required controlling product. 3.1.2. Design Responsible Organization
Organization with authority establish new, change existing, product specification. Note: This responsibility includes testing verification design performance within customer's specified application. 3.1.3. Error Proofing
Product manufacturing process design development prevent manufacture nonconforming products. 3.1.4. Laboratory
Facility inspection, test calibration that include, limited chemical, metallurgical, dimensional, physical, electrical reliability testing.
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3.1.5. Laboratory Scope
Controlled document containing specific test, evaluations calibrations that laboratory qualified perform, list equipment which uses perform above, list methods standards which performs above. 3.1.6. Manufacturing
Process making fabricating production materials, production service parts, assemblies, heating treating, welding, painting, plating other finishing services. 3.1.7. Predictive Maintenance
Activities based process data aimed avoidance maintenance problems prediction likely failure modes. 3.1.8. Preventative Maintenance
Planned action eliminate causes equipment failure unscheduled interruptions production, output manufacturing process design. 3.1.9. Premium Freight
Extra costs charges incurred additional contracted delivery. Note: This caused method, quantity, unscheduled late deliveries, etc. 3.1.10. Remote Location
location that supports sites which non-production processes occur. 3.1.11. Site
location where value-added manufacturing processes occur. 3.1.12. Special Characteristics
Product characteristics manufacturing process parameters which affect safety compliance with regulations, fit, function, performance subsequent processing product. Responsibility Authority
responsibility, authority, role personnel manage, perform verify work affecting product quality defined organizational charts descriptions. Each manager responsible implementing required quality systems their respective area. employees have responsibility authority bring management's attention areas concern ideas addressing issues relevant quality. Each employee responsibility ensure effective efficient quality system. Siliconix quality system foundation business system. Improvements Siliconix quality system linked business plan objectives. Improving quality system results improved business performance. goals business better achieved when foundation system improved. Each employee accountable this ongoing improvement process.
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Quality Policy Manual Vishay Siliconix
Quality Organization interfaces with functional organizations locations establish quality reliability goals standards. This interface helps ensure measurement performance, analysis information, progress against goals. Quality Management System 5.1. General Requirements
Siliconix established, documented, implemented, maintains manages Quality Management System continually improves effectiveness accordance with requirements ISO/TS1 16949:2002, applicable regulatory, customer house requirements. Siliconix: Identifies processes needed Quality Management System their application throughout Siliconix. Determines sequence interaction processes. Determines criteria methods needed ensure that both operation control these processes effective. Ensures availability resources information necessary support operation monitoring these processes. Monitors, measures, analyses these processes. Implements actions necessary achieve planned results continual improvement these processes. 5.2. Outsourced Processes
Siliconix ensures control over processes that affect product conformity with requirements outsourced processes, identifies these processes within Quality Management System. processes needed include processes management activities, provisions resources, product realization measurement. Ensuring control over outsourced processes shall absolve Siliconix responsibility conformity customer requirements. 5.3. Documentation Requirements 5.3.1. General
quality management system documentation includes: statement Quality Policy Quality Objectives. Quality Manual. Documented procedures required ISO/TS16949 which includes: Documentation Control Record Control iii. Training Competence Internal Audits Control Non-Conforming Product Corrective Actions vii. Preventive Actions Documents needed Siliconix ensure effective planning, operation control processes. Records required Siliconix provide evidence conformity requirements effective operation quality management system.
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Quality Policy Manual Vishay Siliconix
major quality system elements (Documents Appendix that support Quality Management System, including this Quality Policy Manual, follows: Management Responsibility Quality Systems Contract Review Design Control Document Data Control Purchasing Control Customer Supplied Material (Para. 7.5.4) Product Identification Traceability Process Control Inspection Testing Control Inspection, Measuring Test Equipment Inspection Test Status Control Nonconforming Material Corrective Preventative Action Handling, Packaging, Preservation Delivery Control Quality Records Internal Quality Audits Training Customer Satisfaction Statistical Techniques 5.3.2. Quality Manual
Siliconix shall establish maintain Quality Manual that includes: Quality Management System scope, including details justification exclusions. Reference documented procedures established quality management system. description interaction between processes quality management system. 5.3.3. Control Documents
Documents required Quality Management System controlled include, limited following requirements: Approved documents adequacy prior issue, Reviewing updating documents necessary, Ensuring that changes current revision status documents identified, Ensuring that relevant versions applicable documents available points use, Ensuring that documents remain legible readily identifiable, Ensuring that documents external origin identified their distribution controlled, Preventing unintended obsolete documents, applying suitable identification them they retained purpose. 5.3.3.1. Engineering Specifications
Engineering specifications have timely reviews, exceeding working weeks) distributed implemented based customer-required schedule. Dates which each change implemented production maintained.
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5.3.4. Control Records Records established maintained provide evidence conformity requirements effective operation Quality Management System. Records legible, readily identifiable retrievable. documented procedure established define controls needed identification, storage, protection, retrieval, retention time disposition records including customer-specified records. 5.3.4.1. Records Retention
control records satisfies regulatory customer requirements. Management Responsibility 6.1. Management Commitment
management provides evidence commitment development implementation Quality Management System continually improves effectiveness Communicating Siliconix employees, quarterly meetings, importance meeting customer well statutory regulatory requirements. Establishing quality policy. Ensuring that quality objectives established. Conducting management reviews. Ensuring availability resources. 6.1.1. Process efficiency
management reviews product realization processes support processes assure their effectiveness efficiency. 6.2. Customer Focus
management ensures that customer requirements determined with enhancing customer satisfaction. 6.3. Quality Policy
management ensures that Quality Policy: appropriate purpose Siliconix Includes commitment comply with requirements continually improve effectiveness quality management system. Provides framework establishing reviewing quality objectives. communicated understood within organization. reviewed continuing suitability. 6.4. Planning 6.4.1. Quality Objectives
management ensures that quality objectives, including those needed meet requirements product established relevant functions levels within Siliconix. quality objectives measurable consistent with quality policy. 6.4.1.1.
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Quality Supplemental Objectives
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Quality Policy Manual Vishay Siliconix
management defines quality objectives measurements, achievable within defined time period that included business plan used deploy quality policy. 6.4.2. Quality Management System Planning
management ensures that: planning Quality Management System carried order meet requirements detailed paragraph well stated quality objectives. integrity Quality Management System maintained when changes Quality Management System planned implemented. 6.5. Responsibility, Authority Communication
management ensures that responsibilities authorities defined communicated within Siliconix. 6.5.1. Responsibility Quality
Managers with responsibility authority corrective action promptly informed products processes that conform requirements. Personnel responsible product quality have authority stop production correct quality problems. Production operations across shifts staffed with personnel charge delegated responsibility for, ensuring product quality. 6.5.2. Management Representative
management appointed Quality who, irrespective other responsibilities, responsibility authority that includes: Ensuring that processes needed Quality Management System established, implemented, maintained. Reporting management performance Quality Management System need improvement. Ensuring promotion awareness customer requirements throughout Siliconix. Note: responsibility management representative includes liaison with external parties matters relating Quality Management System. 6.5.2.1. Customer representative
management designated employees with responsibility authority ensure that customer requirements addressed. 6.5.3. Internal Communication
management ensured that appropriate communication processes established within Siliconix that communication takes place regarding effectiveness Quality Management System.
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6.6. Management Review 6.6.1. General
management reviews Siliconix' Quality Management System, planned intervals, ensure continuing suitability, adequacy effectiveness. This review includes assessing opportunities improvement need changes Quality Management System, including quality policy quality objectives. Records from management review maintained. 6.6.1.1. Quality Management System Performance
These reviews include requirements Quality Management System performance trends essential part continual improvement process. Part management review monitoring quality objectives, regular reporting evaluation cost poor quality. These results recorded provide, minimum, evidence achievement quality objectives specified business plan. Customer satisfaction with product supplied. 6.6.2. Review Input
input management review includes information Results audits. Customer feedback. Process performance product conformity. Status preventive corrective actions. Follow-up actions from previous management reviews. Changes that could affect Quality Management System, recommendations improvements. Analysis actual potential field-failures their impact quality, safety environment. 6.6.3. Review Output
output from management review includes decisions actions related Improvement effectiveness Quality Management System processes. Improvement product related customer requirements. Resource needs. Resource Management 7.1. Provision Resources
Siliconix determines provides resources needed: implement maintain Quality Management System continually improve effectiveness, enhance customer satisfaction meeting customer requirements.
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7.2. Human Resources 7.2.1. General
Personnel performing work affecting product quality competent basis appropriate education, training, skills experience. 7.2.2. Competence, Awareness Training
Siliconix: Determines necessary competence personnel performing work affecting product quality. Provides training take other actions satisfy these needs. Evaluates effectiveness actions taken. Ensures that personnel aware relevance importance their activities they contribute achievement quality objectives. Maintains appropriate records education, training, skills experience. 7.2.2.1. Product Design Skills
Siliconix ensures that personnel with product design responsibility competent achieve design requirements skilled applicable tools techniques. Applicable tools techniques identified. 7.2.2.2. Training
Siliconix establishes maintains documented procedures identifying training needs achieving competence Manufacturing Test personnel performing activities affecting product quality. Manufacturing Test personnel performing specific assigned tasks qualified, required, with particular attention satisfaction customer requirements. 7.2.2.3. Training
Siliconix provides on-the-job training Manufacturing Test personnel modified affecting product quality, including contract agency personnel. Personnel whose work affect quality informed about consequences customer nonconformity quality requirements. 7.2.2.4. Employee Motivation Empowerment
Siliconix process motivate employees achieve quality objectives, make continual improvements, create environment promote innovation. process includes promotion quality technological awareness throughout whole organization. Siliconix process measure extent which personnel aware relevance importance their activities they contribute achievement quality objectives. 7.3. Infrastructure
Siliconix determines, provides maintains infrastructure needed achieve conformity product requirements. Infrastructure includes, applicable:
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Quality Policy Manual Vishay Siliconix
Buildings, workspace associated utilities. Process equipment (both hardware software). Supporting services (such transport communication). 7.3.1. Plant, Facility Equipment Planning
Siliconix uses multidisciplinary approach developing plant, facility equipment plans. Plant layouts optimize material travel, handling value-added floor space, facilitates synchronous material flow. Methods have been developed implemented evaluate monitor effectiveness existing operations. Note: These requirements focus lean manufacturing principles link effectiveness Quality Management System. 7.3.2. Contingency Plans
Siliconix prepared contingency plans satisfy customer requirements event emergency such utility interruptions, labor shortages, equipment failure field returns. 7.4. Work Environment
Siliconix determines manages work environment needed achieve conformity product requirements. 7.4.1. Personnel Safety Achieve Product Quality
Product safety means minimize potential risks employees addressed Siliconix, especially design development process manufacturing process activities. 7.4.2. Cleanliness Premises
Siliconix maintains premises state order, cleanliness repair consistent with product manufacturing process needs. Product Realization 8.1. Planning Product Realization
Siliconix plans develops processes needed product realization. Planning product realization consistent with requirements other processes Quality Management System. planning product realization, Siliconix determines following, appropriate: Quality objectives requirements product. need establish processes, documents, provide resources specific product. Required verification, validation, monitoring, inspection test activities specific product criteria product acceptance. Records needed provide evidence that realization processes resulting product meet requirements. Customer requirements references technical specifications included. output this planning form suitable Siliconix methods operation.
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Quality Policy Manual Vishay Siliconix
8.1.1. Acceptance Criteria
Acceptance criteria defined Siliconix and, where required, approved customer. attribute data sampling, acceptance level zero defects. 8.1.2. Confidentiality
Siliconix ensures confidentiality customer-contracted products projects under development, related product information. 8.1.3. Change Control
Siliconix process control react changes that impact product realization. effects change, including those changes caused supplier, assessed, verification validation activities defined, ensure compliance with customer requirements. Changes validated before implementation. proprietary designs, impact form, function (including performance and/or durability) reviewed with customer that effects properly evaluated. When required customer, additional verification/identification requirements, such those required product introduction will met. Note: product realization change affecting customer requirements including product manufacturing process changes requires notification agreement from, customer. 8.2. Customer-Related Processes 8.2.1. Determination Requirements Related Product
Siliconix determines: Requirements specified customer, including requirements delivery post-delivery activities. When known, requirements stated customer necessary specified intended use. Statutory regulatory requirements related product. additional requirements determined Siliconix. Post-delivery activities include after-sales product service provided Part customer contract purchase order. Including recycling, environmental impact characteristics. Identified result Siliconix' knowledge product manufacturing Processes. Note: compliance item includes applicable government, safety, environmental regulations, applied acquisition, storage, handling, recycling, elimination disposal materials. Siliconix demonstrates conformity customer requirements designation, documentation control special characteristics. 8.2.2. Review Requirements Related Product
Siliconix reviews requirements related product. This review conducted prior Siliconix' commitment supply product customer (e.g. submission tenders,
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acceptance contracts orders, acceptance changes contracts orders) ensure that: Product requirements defined. Contract order requirements differing from those previously expressed resolved. Siliconix ability meet defined requirements. Records results review actions arising from review maintained. Where customer provides documented statement requirements, customer requirements confirmed Siliconix, before acceptance. Where product requirements changed, Siliconix ensures that relevant documents amended that relevant personnel made aware changed requirements. Note: some situations, such internet sales, formal review impractical each order. Instead review will cover relevant product information such catalogs advertising material. 8.2.2.1. Review Requirements Related Product
Waiving requirement stated 7.2.2 formal review requires customer authorization. 8.2.2.2 Organization manufacturing feasibility Siliconix investigates, confirms documents manufacturing feasibility proposed products contract review process, including risk analysis. 8.2.3. Customer communication
Siliconix determines implements effective arrangements communicating with customers relation Product information. Inquiries, contracts order handling, including amendments. Customer feedback, including customer complaints. Necessary information, including data, customer-specified language format (e.g. computer-aided design data, electronic data exchange). 8.3. Design Development
Note: requirements include product manufacturing process design development, focus error prevention rather than detection. 8.3.1. Design Development Planning
Siliconix plans controls design development product. During design development planning, Siliconix determines: design development stages, review, verification validation that appropriate each design development stage. responsibilities authorities design development.
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Quality Policy Manual Vishay Siliconix
Siliconix manages interfaces between different groups involved design development ensure effective communication clear assignment responsibility. Planning output updated, appropriate, design development progresses. Siliconix uses multidisciplinary approach prepare product realization including; Development/finalization monitoring special characteristics. Development review FMEAs, including actions reduce potential risks. Development review control plans. Note: multidisciplinary approach typically includes Siliconix' design, manufacturing, engineering, quality, production other appropriate personnel. 8.3.2. Design Development Inputs
Inputs relating product requirements determined records maintained. These inputs include: Functional performance requirements. Applicable statutory regulatory requirements. Where applicable, information derived from previous similar designs. Other requirements essential design development. These inputs reviewed adequacy. Requirements complete conflict with each other. 8.3.2.1. Product Design Input
Siliconix identifies, documents reviews product design inputs requirements, including following: Customer requirements (contract review) such special characteristics, identification, traceability packaging. information: Siliconix process deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, other relevant sources, current future projects similar nature. Targets product quality, life, reliability, durability, maintainability, timing cost. 8.3.2.2. Manufacturing Process Design Input
Siliconix identifies, documents reviews manufacturing process design input requirements, including: Product design output data. Targets productivity, process capability cost. Customers' requirements, any. Experience from previous developments. Note: manufacturing process design includes error-proofing methods degree appropriate magnitude problems commensurate with risks encountered.
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8.3.2.3. Special Characteristics Siliconix identifies special characteristics: Including special characteristics control plan. Compiling with customer-specified definitions symbols. Identifying process control documents including drawings, FMEAs, control plans, operator instructions with customer's special characteristic Symbol Siliconix' equivalent symbol notating include those Process steps that affect special characteristics. 8.3.3. Design Development Outputs
outputs design development provide form that enables verification against design development input then approved prior release. Design development outputs: Meet input requirements design development. Provide appropriate information purchasing, production service provision. Contain reference product acceptance criteria. Specify characteristics product that essential safe proper use. 8.3.3.1. Product Design Outputs
product design output expressed terms that verified validated against product design input requirements. product design output includes: Design FMEA, reliability results. Product special characteristics specifications. Product error proofing, appropriate. Product definition including drawings mathematically based data. Product design reviews results. Diagnostic guidelines where applicable. 8.3.3.2. Manufacturing Process Design Output
manufacturing process design output expressed terms that verified against manufacturing process design input requirements validated. manufacturing process design output includes: 8.3.4. Specifications drawings. Manufacturing process flow chart/layout. Manufacturing process FMEAs. Control plan. Work instructions. Process approval acceptance criteria. Data quality, reliability, maintainability measurability. Results error-proofing activities, appropriate. Methods rapid detection feedback product/manufacturing process nonconformities.
Design Development Review
suitable stages, systematic reviews design development performed accordance with planned arrangements: evaluate ability results design development meet requirements. identify problems propose necessary actions.
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Participants such reviews include representatives functions concerned with design development stage(s) being reviewed. Records results reviews necessary actions maintained. 8.3.4.1. Monitoring
Measurements specified stages design development defined, analyzed reported with summary results input management review. 8.3.5. Design Development Verification
Verification performed accordance with planned arrangements ensure that design development outputs have design development input requirements. Records results verification necessary actions maintained. 8.3.6. Design Development Validation
Design development validation performed accordance with planned arrangements ensure that resulting product capable meeting requirements specified application intended use, where known. Wherever practicable, validation completed prior delivery implementation product. Records results validation necessary actions maintained. 8.3.6.1. Design Development Validation Supplemental
Design development validation performed accordance with customer requirements including program timing. 8.3.6.2. Prototype Program
When required customer, Siliconix incorporates prototype program control plan. Siliconix uses, wherever possible, same suppliers, tooling manufacturing processes will used production. performance-testing activities monitored timely completion conformity requirements. While services outsourced, Siliconix responsible outsourced services, including technical leadership. 8.3.6.3. Product Approval Process
Siliconix conforms product manufacturing process approval procedure recognized customer. product manufacturing process approval procedure also applies suppliers. 8.3.7. Control Design Development Changes
Design development changes identified records maintained. changes reviewed, verified validated, appropriate, approved before implementation. review design development changes includes evaluation effect changes
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constituent parts product already delivered. Records results review changes necessary actions maintained. 8.4. Purchasing 8.4.1. Purchasing Process
Siliconix ensures that purchased product conforms specified purchase requirements. type extent control applied supplier purchased product dependent upon effect purchased product subsequent product realization final product. Siliconix evaluates selects suppliers based their ability supply products accordance with Siliconix' requirements. criteria selection, evaluation re-evaluation suppliers established, records results evaluations necessary actions arising from evaluation maintained. 8.4.1.1. Regulatory conformity
purchased products materials used product, conforms applicable regulatory requirements. 8.4.1.2. Supplier Quality Management System Development
Siliconix performs supplier Quality Management System development audits with goal supplier conformity. Conformity with 9001:2000 first step achieving this goal. automotive customers unless otherwise specified customer, suppliers Siliconix third-party registered 9001:2000 accredited thirdparty certification body. 8.4.1.3. Customer-Approved Sources
Where specified contract (e.g. customer engineering drawing, specification), Siliconix purchases products, materials services from approved sources. customer-designated sources, including tool/gauge suppliers, does relieve Siliconix responsibility ensuring quality purchased products. 8.4.2. Purchasing Information
Purchasing information describes product purchased, including where appropriate: Requirements approval product, procedures, processes equipment. Requirements qualification personnel. Quality Management System requirements. Siliconix ensures adequacy specified purchase requirements prior their communication supplier.
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8.4.3. Incoming Product Quality Siliconix established implemented inspection other activities necessary ensuring that purchased product meets specified purchase requirements. When Siliconix customer intends perform verification supplier's premises, Siliconix states intended verification arrangements method product release purchasing information. Siliconix process assure quality purchased product utilizing more following methods: Receipt, evaluation statistical data. Receiving inspection and/or testing such sampling based performance. Second third party assessments audits supplier sites, when coupled with records acceptable delivered product quality. Part evaluation designated laboratory. Another method agreed with customer. 8.4.3.1. Supplier Monitoring
Supplier performance monitored through following indicators: Delivered product quality. Customer disruptions including field returns. Delivery schedule performance. Special status customer notifications related quality delivery issues. Siliconix promotes supplier monitoring performance their manufacturing processes. 8.5. Production Service Provision 8.5.1. Control Production Service Provision
Siliconix plans carries production service provision under controlled conditions. Controlled conditions include, applicable: availability information that describes characteristics product. availability work instructions, necessary. suitable equipment. availability monitoring measuring devices. implementation monitoring measurement. implementation release, delivery post-delivery activities. 8.5.1.1. Control Plan
Siliconix has: Developed control plans system, subsystem, component and/or material level product supplied, including those processes producing parts. Control plan pre-launch production that takes into account design FMEA manufacturing process FMEA outputs. control plan: Lists controls used manufacturing process control. Includes methods monitoring control exercised over special characteristics defined both customer Siliconix. Includes customer-required information.
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Initiates specified reaction plan when process becomes unstable statistically capable. Control plans reviewed updated when change occurs affecting product, manufacturing process, measurement, logistics, supply sources FMEA. 8.5.1.2. Work Instructions
Siliconix prepares documented work instructions Manufacturing Test personnel having responsibilities operation processes that impact product quality. These instructions accessible work station. These instructions derived from sources such quality plan, control plan product realization process. 8.5.1.3. Verification Set-Ups
set-ups verified whenever performed, such initial job, material changeover change. Work instructions available set-up personnel. Siliconix uses statistical methods verification where applicable. 8.5.1.4. Preventive Predictive Maintenance
Siliconix identifies process equipment provides resources machine/equipment maintenance develops effective planned total preventive maintenance system. This system includes: Planned maintenance activities. Packaging preservation equipment, tooling gauging. Availability replacement parts manufacturing equipment. Documenting, evaluating improving maintenance objectives. Siliconix utilizes predictive maintenance methods continually improve effectiveness efficiency production equipment. 8.5.1.5. Management production Tooling
Siliconix provides resources tool gauge design, fabrication verification activities. Siliconix establishes implements system production tooling management including:
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Maintenance repair facilities personnel. Storage recovery. Set-up. Tool-change programs perishable tools. Tool design modification documentation, including engineering change level. Tool modification revision documentation. Tool identification, defining status, such production, repair disposal.
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Quality Policy Manual Vishay Siliconix
Siliconix implemented system monitor these activities work outsourced. 8.5.1.6. Production Scheduling
Production scheduled order meet customer requirements, such Just-inTime supported information system that permits access production information stages process order driven. 8.5.1.7. Feedback Information from Service
process communication information service concerns manufacturing, engineering design activities established maintained. 8.5.1.8. Service Agreement with Customer
When there service agreement with customer, Siliconix verifies effectiveness Siliconix application centers. special-purpose tools measurement equipment. training application personnel. 8.5.2. Validation Processes Production Service Provision
Siliconix validates processes production service provision where resulting output cannot verified subsequent monitoring measurement. This includes processes where deficiencies become apparent only after product service been delivered. Validation demonstrates ability these processes achieve planned results. Siliconix established arrangements these processes including: Defined criteria review approval processes. Approval equipment qualification personnel. specific methods procedures. Requirements records. Revalidation. 8.5.3. Identification Traceability
Siliconix identifies product suitable means throughout product realization. Product status identified with respect monitoring measurement requirements. Where traceability requirement, Siliconix controls, records maintains unique identification product. Inspection test status indicated location product production flow unless inherently obvious, such material automated transfer process. 8.5.4. Customer Property
Siliconix exercises care with customer property while under Siliconix' control being used Siliconix. Siliconix identifies, verify, protects safeguards customer property provided incorporation into product. customer property lost, damaged otherwise found unsuitable use, this reported customer records maintained.
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Note: Customer property include intellectual property. 8.5.4.1. Customer-Owned Production Tooling
Customer-owned tools, manufacturing, test, inspection tooling equipment permanently marked that ownership each item visible, determined. 8.5.5. Preservation Product
Siliconix preserves conformity product during internal processing delivery intended destination. This preservation includes identification, handling, packaging, storage protection. Preservation also applies constituent parts product. 8.5.5.1. Storage Inventory
order detect deterioration, condition product stock assessed appropriate planned intervals. Siliconix uses inventory management system optimize inventory turns over time assure stock rotation, such "first-in-first-out" (FIFO). Obsolete product controlled similar manner nonconforming product. 8.6. Control Monitoring Measuring Devices
Siliconix determines monitoring measurement undertaken monitoring measuring devices needed provide evidence conformity product determined requirements. Siliconix establish processes ensure that monitoring measurement carried carried manner that consistent with monitoring measurement requirements. Where necessary ensure valid results, measuring equipment Calibrated verified specified intervals, prior use, against measurement standards traceable international national measurement standards; where such standards exist, basis used calibration verification recorded. Adjusted re-adjusted necessary. Identified enable calibration status determined. Safeguarded from adjustments that would invalidate measurement result. Protected from damage deterioration during handling, maintenance storage. addition, Siliconix assessed recorded validity previous measuring results when equipment found conform requirements. Appropriate actions taken equipment product affected. Records results calibration verification maintained. When used monitoring measurement specified requirements, ability computer software satisfy intended application confirmed. This undertaken prior initial reconfirmed necessary. 8.6.1. Measurement System Analysis
Statistical studies conducted analyze variation present results each type measuring test equipment system. This applies measurement systems referenced control plan. analytical methods acceptance criteria used conforms those customer reference manuals measurement systems analysis.
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8.6.2. Calibration/Verification Records
Records calibration/verification activity gauges, measuring test equipment, needed provide evidence conformity product determined requirements, including employee customer owned equipment include: Equipment identification, including measurement standard against which equipment calibrated. Revisions following engineering changes. out-of-specification readings received calibration/verification, assessment impact out-of specification condition. Statements conformity specification after calibration/verification, Notification customer suspect product material been shipped. 8.6.3. Laboratory Requirements 8.6.3.1. Internal Laboratory
Siliconix' internal laboratory facility defined scope that includes capability perform required inspection, test calibration services. This laboratory scope included Quality Management System documentation. laboratory specifies implements, minimum, technical requirements for: Adequacy laboratory procedures. Competency laboratory personnel. Testing product. Capability perform these services correctly, traceable relevant process stand (such ASTM, etc.). Review related records. Note: Accreditation ISO/IEC 17025 national equivalent used demonstrate supplier in-house laboratory conformity this requirement mandatory. 8.6.3.2. External Laboratory
External/commercial/independent laboratory facilities used inspection, test calibration services Siliconix defined laboratory scope that includes capability perform required inspection, test calibration, either: Evidence that external laboratory acceptable customer laboratory accredited ISO/IEC 17025 national equivalent. Measurement, Analysis Improvement 9.1. General
Siliconix plans implements monitoring, measurement, analysis improvement processes needed: demonstrate conformity product. ensure conformity Quality Management System. continually improve effectiveness Quality Management System. This determined applicable methods, including statistical techniques, extent their use.
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9.1.1. Identification Statistical Tools
Appropriate statistical tools each process determined during advance quality planning included control plan. 9.1.2. Knowledge Basic Statistical Concepts
Basic statistical concepts, such variation, control (stability), process capability overadjustment understood utilized throughout Siliconix. 9.2. Monitoring Measurement 9.2.1. Customer Satisfaction
measurements performance Quality Management System, Siliconix monitors information relating customer perception whether company meets customer requirements. method obtaining using this information determined. 9.2.1.1. Customer Satisfaction Supplemental
Customer satisfaction with Siliconix monitored through continual evaluation performance realization processes. Performance indicators based objective data include, limited Delivered part quality performance. Customer disruptions including field returns. Delivery schedule performance. Customer notifications related quality delivery issues. Siliconix monitors performance manufacturing processes demonstrate compliance with customer requirements product quality efficiency process. 9.2.2. Internal Audit
Siliconix conducts internal audits periodically determine whether Quality Management System: Internal, customer, military international standard. effectively implemented maintained. audit program planed, taking into consideration status importance processes areas audited, well results previous audits. audit criteria, scope, frequency methods defined. Selection auditors conduct audits ensure objectivity impartiality audit process. Auditors audit their work. responsibilities requirements planning conducting audits, reporting results maintaining records defined documented procedure. management responsible area being audited ensures that actions taken without undue delay eliminate detected nonconformities their causes. Follow-up activities include verification action taken reporting verification results.
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Quality Policy Manual Vishay Siliconix
9.2.2.1. Quality Management System Audit Siliconix audits Quality Management System verify compliance with this specification. 9.2.2.2. Manufacturing Process Audit
Siliconix audits each manufacturing process determine effectiveness. 9.2.2.3. Product Audit
Siliconix audits products appropriate stages production delivery verify conformity specified requirements, such product dimensions, functionality, packaging labeling, defined frequency. 9.2.2.4. Internal Audit Plans
Internal audits cover quality management related processes, activities shifts, scheduled according annual plan. When internal/external nonconformities customer complaints occur, audit frequency appropriately increased. Note: Specific checklists used each audit. 9.2.2.5. Internal Auditor Qualification
Siliconix uses internal auditors qualified audit. 9.2.3. Monitoring Measurement Processes
Siliconix applies suitable methods monitoring and, where applicable, measurement Quality Management System processes. These methods demonstrate ability processes achieve planned results. When planned results achieved, correction corrective action taken, appropriate, ensure conformity product. 9.2.3.1. Monitoring Measurement Manufacturing Processes
Siliconix performs process studies manufacturing (including manufacturing sequencing) processes verify process capability provide additional input process control. results process studies documented with specifications, where applicable, means production, measurement test, maintenance instructions. These documents include objectives manufacturing process capability, reliability, maintainability availability, well acceptance criteria. Siliconix maintains manufacturing process capability performance specified customer part approval process requirements. Siliconix ensures that control plan process flow diagram implemented, including adherence specified: Measurement techniques. Sampling plans. Acceptance criteria. Reaction plans when acceptance criteria met. Significant process events, such tool change machine repair, recorded.
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Quality Policy Manual Vishay Siliconix
Siliconix initiates reaction plan from control plan characteristics that either statistically capable unstable. These reaction plans include containment product 100% inspection appropriate. corrective action plan then completed Siliconix, indicating specific timing assigned responsibilities assure that process becomes stable capable. plans reviewed with approved customer, when required. Siliconix maintains records effective dates process changes. 9.2.4. Monitoring Measurement Product
Siliconix monitors measures characteristics product verify that product requirements have been met. This carried appropriate stages product realization process accordance with planned arrangements. Evidence conformity with acceptance criteria maintained. Records indicate person(s) authorizing release product. Product release service delivery does proceed until planned arrangements have been satisfactorily completed where applicable customer. Note: When selecting product parameters monitor compliance specified internal external requirements, Siliconix determines types product characteristics, leading types measurement, suitable measurement means, capability skills required. 9.2.4.1. Layout Inspection Functional Testing
layout inspection functional verification applicable customer engineering material performance standards performed each product specified control plans. Results available customer review. 9.2.4.2. Appearance Items
Siliconix manufacturing parts designated customer "appearance items", provide: Appropriate resources including lighting evaluation. Masters color, grain, gloss, metallic brilliance, texture, distinctness image (DOI), appropriate. Maintenance control appearance masters evaluation equipment. Verification that personnel making appearance evaluations competent qualified 9.3. Control Nonconforming Product
Siliconix ensures that product which does conform product requirements identified controlled prevent unintended delivery. controls related responsibilities authorities dealing with nonconforming product defined documented procedure. Siliconix deals with nonconforming product more following ways: taking action eliminate detected nonconformity. authorizing use, release acceptance under concession relevant authority and, where applicable, customer. taking action preclude original intended application.
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Quality Policy Manual Vishay Siliconix
Records nature nonconformities subsequent actions taken, including concessions obtained maintained. When nonconforming product corrected subject re-verification demonstrate conformity requirements. When nonconforming product detected after delivery started, actions appropriate effects, potential effects, nonconformity used. 9.3.1. Control Nonconforming Product Supplemental
Product with unidentified suspect status classified nonconforming product. 9.3.2. Control Reworked Product
Instructions rework, including re-inspection requirements, accessible utilized appropriate personnel. 9.3.3. Customer Information
Customers informed promptly event that nonconforming product been shipped. 9.3.4. Customer Waiver
Siliconix obtains customer concession deviation permit prior further processing whenever product manufacturing process different from that which currently approved. record expiration date quantity authorized maintained. Siliconix also ensures compliance with original superseding specifications requirements when authorization expires. Material shipped authorization properly identified each shipping container. purchased product, Siliconix agrees with requests from suppliers before submission customers. 9.4. Analysis Data
Siliconix determines, collect analyze appropriate data demonstrate suitability effectiveness Quality Management System evaluate where continual improvement effectiveness Quality Management System made. This includes data generated result monitoring measurement from other relevant sources. analysis data provides information relating Customer satisfaction. Conformity product requirements. Characteristics trends processes products including opportunities preventive action. Suppliers. 9.4.1. Analysis Data
Trends quality operational performance compared with progress toward objectives lead action support following: Development priorities prompt solutions customer-related problems. Determination customer-related trends correlation status review, decisionmaking longer term planning.
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Quality Policy Manual Vishay Siliconix
information system timely reporting product information arising from usage. Note: Data compared with those competitors and/or appropriate benchmarks. 9.5. Improvement 9.5.1. Continual Improvement
Siliconix continually improves effectiveness Quality Management System through quality policy, quality objectives, audit results, analysis data, corrective preventive actions management review. 9.5.1.1. Continual Improvement Company
Siliconix defines processes continual improvement. 9.5.1.2. Manufacturing Process Improvement
Manufacturing process improvements continually focus upon control reduction variation product characteristics manufacturing process parameters. Note: continual improvement implemented once manufacturing processes capable stable, product characteristics predictable meet customer requirements. 9.5.2. Corrective Action
Siliconix takes action eliminate cause nonconformities order prevent recurrence. Corrective actions appropriate effects nonconformities encountered. documented procedure established define requirements for: Reviewing nonconformities (including customer complaints). Determining causes nonconformities. Evaluating need action ensure that nonconformities recur. Determining implementing action needed. Records results action taken. Reviewing corrective action taken. 9.5.2.1. Problem Solving
Siliconix defined process problem solving leading root cause identification elimination. customer-prescribed problem-solving format exists, Siliconix uses prescribed format. 9.5.2.2. Error-Proofing
Siliconix uses error-proofing methods their corrective action process.
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Quality Policy Manual Vishay Siliconix
9.5.2.3. Corrective Action Impact Siliconix applies other similar processes products corrective action, controls implemented, eliminate cause non-conformity. 9.5.2.4. Rejected Product Test/Analysis
Siliconix analyzes parts rejected customer's manufacturing plants, engineering facilities. Siliconix minimizes cycle time this process. Records these analyses kept made available upon request. Siliconix performs analysis initiates corrective action prevent recurrence. Note: Cycle time related rejected product analysis consistent with determination root cause, corrective action monitoring effectiveness implementation. 9.5.3. Preventive Action
Siliconix determines actions eliminate causes potential nonconformities order prevent their occurrence. Preventive actions appropriate effects potential problems. documented procedure established define requirements for: Determining potential nonconformities their causes. Evaluating need action prevent occurrence nonconformities. Determining implementing action needed. Records results action taken. Reviewing preventive action taken.
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Appendix Cross Reference Documents Major Quality System Elements Quality Policy Manual Elements Management Responsibility Quality System Contract Review Product Appro Design Control Document Data Control Purchasing Control Customer-Supplied Prod Product Identification Traceability Process Control Applicable Procedures/ Specifications COPS-0001 COPS-0001 SYST-0004 PPAP-0001 1910, 1930 QA-1-0043 DCTL-0004 DCTL-1004 COPS-0011 0501, 0522 COPS-0001 0501 PROMIS INVC-0022 PROMIS 0501 INVC-0016 PROMIS 8804 0501 0554 COPS-0014, GENL-0002, 0554 QSYS-0814 QSYS-0002 COPS-0013 ESDS-0004 INVC-0019 RCRD-0001 AUDI-1000 TRNG-0000 COPS-0001 CISP-0005 MIL-PRF-38535 A4.8.1.3 G3.2 A4.8.1.3.1 A4.8.1.3 A4.8.1.1.1 H3.2 A4.8.1.1.8 G3.4 A4.8.1.2.4 A4.8.1.1.8 A4.8.1.3.3 A4.8.1.1.3 A4.8.1.2.7 A4.8.1.2.8 A4.8.1.1.12 A4.8.1.2.6 A4.8.1.1.4 A4.8.1.1.5 A4.8.1.1.6 A4.5, A4.8 A4.8.1.1.3 A4.8.1.1.4 A4.8.1.1.5 A4.7 A4.3.6 A4.8.1.1.9 A4.8.1.2.5 A4.7 A4.8.1.1.12 A4.5.8 A4.8.1.1.10 A4.8.1.1.11 A4.8.1.1.12 A4.4.2.8 A4.8.1.2 A4.9 A4.8.1.1.2 A4.8.1.2.1 H3.2.4.3 H3.2.2.1 MIL-PRF-19500 D3.1 D3.2 D3.3 D3.4 D3.5 D3.6 D3.8 D3.9 TS16949 CLAUSES
10.0
Inspection Testing Control Inspection, Measuring, Test Equipment, Tooling Inspection Test Status Control Nonconforming Product Corrective Preventive Action Handling, Storage, Packaging, Preservation Delivery Control Quality Records Internal Quality Audits Training Servicing Statistical Techniques
D3.10
11.0 12.0 13.0 14.0 15.0 16.0 17.0 18.0 19.0 20.0
D3.11 D3.12 D3.13 D3.14 D3.15 D3.16 D3.17 D3.18 D3.20
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Document Number: 73315 02-Feb-05
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