Specification 06-09-0005, REV. 15-5 9001 QUALITY MANUAL

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Specification 06-09-0005, REV. 15-5 9001 QUALITY MANUAL

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9001 QUALITY MANUAL
Specification 06-09-0005, REV.
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9001 QUALITY MANUAL
Specification 06-09-0005, REV.
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9001 QUALITY MANUAL
QUALITY SYSTEM DESIGN, DEVELOPMENT, PRODUCTION, SERVICING
INTRODUCTION
This policy defines organization policies Linear Technology Corporation (LTC) assures conformance requirements during design, development, production, testing, inspection shipment products. sets general quality policies, procedures practices LTC.
DEFINITIONS
purpose this quality manual, definitions given 8402 shall apply. Below list acronyms used LTC: GAUGE OCAP TECN TQMS VCAR Customer Material Return Customer Source Inspection De-Ionized Discrepant Material Report Design Rules Check Engineering Change Notice End-of-Line Failure Analysis Gauge Repeatability Reproducibility Government Source Inspection Inspection Failure Report Incoming Quality Control Material Procurement Specifications Material Review Board Measurement System Evaluation Out-of-Control Action Plan Purchase Order Process Preventive) Action Team Pattern Generation Quality Assurance Quality Assurance Policy Quality Audit Report Quality Control Teams Return Material Authorization Released Product Listing Special Standard Operating Procedure Statistical Process Control Stop/Start Sheet Temporary Engineering Change Notice Mark Layout Total Quality Management System Vendor Corrective Action Request
SCOPE
requirements specified this Quality Manual designed prevent detect nonconformances during design, development, production, testing inspection.
FIELD APPLICATION
Quality Program specified herein designed ensure 100% customer satisfaction ensuring product conformance achieve maintain highest level product quality reliability ensure program continuous improvement. This manual applies manufacturing locations military commercial products manufactured LTC.
REFERENCES
8402 9000 9001 Quality Vocabulary Quality Management Quality Assurance Standards: Guidelines Selection Quality Systems: Models Quality Assurance Design/Development, Production, Installation Servicing Quality Systems: Model Quality Assurance Production Installation. Quality Management Quality System Elements Guidelines Guidelines Auditing Quality Systems, Part Guidelines Auditing Quality Systems, Part Guidelines Auditing Quality Systems, Part Quality Assurance Requirements Measuring
9002 9004 10011-1 10011-2 10013-3 10012-1
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QUALITY SYSTEM REQUIREMENT
LTC's Total Quality Management System (TQMS) encompasses concept strategic quality planning management ensure program continuous quality reliability improvement. quality system designed meet requirements 9001 MIL-STD-883 MIL-STD-976 MIL-M-38510 (Class Class MIL-I-38535, Appendix MIL-I-45208 MIL-STD-45662 MIL-Q-9858 ANSI/NCSL Z540-1-1994 commercial customers goal defect-free products pledges that products shall manufactured accordance with applicable specifications specific customer requirements.
MANAGEMENT RESPONSIBILITY
LTC's management with executive responsibility shall ensure that Quality policy understood, implemented, maintained levels organization.
4.1.1 Quality Policy
Policy Statement front this manual.
4.1.2 Organizational Chart
current organizational chart showing senior management organizational reporting structure available upon request from secretary Vice President Finance.
Organizational Chart
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4.1.2.1 Responsibility Authority
employees this organization have authority initiate action prevent occurrence product, process, quality system nonconformity notifying appropriate support management personnel. Inspectors have responsibility identify record product process problems Stop/Start Inspection Failure Report. employee organization organizational freedom authority initiate, recommend, provide solutions relating product, process quality system nonconformances. Engineering, Quality Assurance management have responsibility verify implementation solutions. employee factory that running process location responsibility suspend operation event out-of-control process control further processing accordance with associated Out-of-Control Action Plan (OCAP) issuing Stop/Start. Quality Assurance, Engineering, Production Control Customer Service have responsibility suspend control further processing delivery nonconforming product until deficiency unsatisfactory condition been corrected. This done issuance Stop/ Start Inspection Failure Report (IFR) ECN/TECN specification ship-hold. multidisciplinary approach used decision-making manage concept development through production shipping.
4.1.3 Management Review
Quality Reliability Manager shall assure that effectiveness quality system reviewed reported shown below: Annual strategic quality planning goal setting drive continuous quality reliability improvement programs. This meeting held beginning each fiscal year with department heads participating. resulting goals reviewed approved management. Quarterly management review company performance Corporate Quality goals. performance goals summarized Quality Assurance manager distributed department heads. Semiannual reviews distributed President Vice Presidents. Quality systems audit results shall reviewed annually each period middle upper management determine adequacy compliance documented quality system. Upper management includes President/CEO. Quarterly reports critical process nodes Manager. Monthly reports management including President COO, report detailed results trend analysis monitors gates. real-time basis, following reviews and/or actions performed: Quality system audit results shall reviewed determine effectiveness quality system. Failure analysis, root cause identification, corrective action. Customer request corrective action. Process/Preventive Action Teams (PATs) findings recommendations. Review nonconforming material/product reports. Quality Manual and/or procedures shall revised when necessary reflect decisions management reviews. Records reviews shall maintained evaluation, required.
4.1.2.2 Verification Resources Personnel
verification activities requirements shall documented appropriate standard operating procedures (SOP) detailed specifications include inspection, test, monitoring design, production, product. Design reviews audits quality system, processes, and/or product shall carried personnel independent those having responsibility work being performed. verification personnel required trained certified training certification program (spec 06-09-0002 05-06-0007), records training maintained. Adequate resources shall identified assigned areas management, performance work verification activities, including internal quality audits.
4.1.2.3 Management Representative
Manager Quality Assurance Reliability authority responsibility ensuring that requirements this Quality Manual implemented maintained.
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QUALITY SYSTEM 4.2.1 General
quality system consists Quality Manual, quality procedures inspection, surveillance, monitoring ensure that products conform customer requirements.
REFERENCES
Spec Number Title 06-03-5000 06-03-5001 06-04-0011 00-01-1006 08-07-1001 05-03-8082 06-03-7050 Customer Specification Review Internal Specification Procedure Design Flowchart SOP: Engineering Change Notice Calibration Program Requirements Assembly Workmanship Standards Record Keeping
4.2.2 Quality System Procedures
Documented implemented procedures consistent with requirements 9001 stated quality policy shall form part quality system.
4.2.3 Quality Planning
system designed meet requirements 9001, other requirements outlined Section 4.0. quality planning process covers processes from incoming inspection through shipping. Quality planning includes: preparation quality plans accordance with specific requirements. identification acquisition controls, processes, inspection equipment, fixtures, total production resources skills that needed achieve required quality. Ensuring compatibility design, production process installation, servicing, inspection test procedures, applicable documentation. updating, necessary quality control; inspection, testing techniques, including development instrumentation. identification measurement requirement involving capability that exceeds known state sufficient time needed capability developed. identification suitable verification required test, inspection gates. clarification standards acceptability features requirements, including those which contain subjective element (i.e., workmanship standards). identification preparation quality records. (For records, Section 4.16.)
CONTRACT REVIEW 4.3.1 General
Documented procedures shall implemented maintained performance contract review coordination these activities.
4.3.2 Review
Prior acceptance contract order, shall reviewed accordance with referenced specifications herein, resolving issues, determining capability organization meet customer requirements. differences identified during contract review will documented defined "SL" (Specified Lot) special flow specifications below. cannot agree portion contract, waiver agreement must approved end-customer before product delivered. (For records, Section 4.16.)
REFERENCES
Spec Number Title 06-03-5000 06-03-5001 Current Rev. Customer Specification (Special Lot) Specification Procedure Device Catalogs, Data Book, Supplements
DESIGN CONTROL 4.4.1 General
produces broad line standard, high performance linear integrated circuits which defined marketing catalogs data books. Design criteria manufacturing capabilities have been established support these products. (For records, Section 4.16.)
4.4.2 Design Development Planning
Spec 06-04-0011 provides guideline flowchart from design conception product qualification RPL. Since manufactures primarily standard products, opposed custom products, there need establish milestone
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charts customer. Design verification activities planned assigned qualified personnel equipped with adequate resources.
4.4.9 Design Documentation
identification, documentation, appropriate review approval changes modifications accomplished ECNs Mask Sequence Specification, 02-01-xxxx Design changes controlled LTC-supplied designs bills material subcontractors. (For records, Section 4.16.)
REFERENCES (Company proprietary)
Spec Number Title 80-01-xxxx 80-02-xxxx 02-01-xxxx 02-02-1000 02-02-1002 05-01-xxxx 06-04-0001 06-04-0011 09-01-0001 CMOS Design Rules Bipolar Design Rules Mask Sequence Specifications Milpitas Product Documentation Requirements Product Release Procedure Assembly Bonding Diagram Bill Materials Quality Assurance/Reliability Assurance Qualification Requirements Design Flowchart Released Product Listing/Top Mark Content Layout Procedure
4.4.3 Organizational Technical Interfaces
design review meeting held weekly with engineering management review status, document progress, technical requirements each design.
4.4.4 Design Input
Inputs design typically come from review customer's requirements, contract review, marketing research identify features which should incorporated into product. primary goal provide customers with designs that reduce their component board level costs, while providing leading edge technology. manufactures primarily standard (non-custom) products. Based above inputs, final design concept developed in-house.
4.4.5 Design Output
design output, integrated circuit, defined described data sheet, which released when product qualified. Product characterization qualification conducted verify conformance data sheet requirements. data sheet specifies product performance limits well other pertinent information pertaining product, e.g., design considerations that critical safe proper functioning product, regulatory requirements, etc.
DOCUMENT DATA CONTROL 4.5.1 General
Documented implemented procedures shall govern control documents data relating quality system.
4.4.6 Design Review
Design shall plan, conduct design reviews which documented, assigned competent personnel representing applicable functions.
4.5.2 Document Data Approval Issue
Pertinent issues appropriate documents available locations where operations essential effective functioning quality system. initiation change documentation required procurement, manufacturing, inspection materials product controlled Document Control department ensure review approval authorized personnel prior issue. Data associated with this Quality System shall maintained documented Section 4.16, Control Quality Records. Document Control group responsible maintenance, control, reproduction, distribution historical archiving LTC's product procedural documentation. Document Control services internal areas which Document Control Books (DCBs) located, internal specifications listed following page:
4.4.7 Design Verification
Design verification shall establish that product meets data sheet requirements. Since products designed proprietary products (defined LTC), change final data sheet match characterization results prior release. This further ensures that design input matches design output.
4.4.8 Design Validation
Design validation shall performed prior release ensure that product conforms design requirements accordance with Quality Assurance Reliability Assurance Qualification requirements, 06-04-0001.
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REFERENCES
Spec Number Title 00-01-0010 00-01-0005 00-01-1006 00-01-1008 00-01-3100 00-01-0001 00-01-0003 00-01-3111 Specification Master Plan Temporary Engineering Change Notice Procedure Standard Operating Procedure (SOP): Engineering Change Notice SOP: Specification Format Organization Approval Matrix Standard Operating Procedure: Document Control Distribution Level Specifications Locations Report
PURCHASING 4.6.1 General
Purchasing shall ensure that material purchased from suppliers subcontractors conformance specified requirements. Records qualified suppliers shall maintained.
4.6.1.1 Supplier Responsibility
responsibility supplier provide maintain quality system which will assure compliance with requirements applicable material procurement specification, 01-xx-xxxx specifications listed below.
REFERENCES
Spec Number Title 06-09-0003 01-xx-xxxx 09-01-0004 09-01-0008 06-01-0011 06-09-0018 06-01-0006 06-01-0007 01-xx-xxxx Purchasing Procedure Material Procurement Specification Qualified Vendor Listing Procedure Approved Subcontractor Listing Vendor Corrective Action SOP: Inventory Control Incoming Inspection, General Incoming Inspection, Subcontracted Materials Applicable Drawing Stores Item Numbers
4.5.3 Document Data Changes
Document Control shall promptly post route ECNs (Engineering Change Notices) TECNs (Temporary Engineering Change Notices) appropriate locations when approval complete. information shall contain, minimum, affected document number, description change, effective date duration, affected documentation, justification change, documentation material disposition, distribution, approval signatures. Previous revision history available from Document Control department. Additional justification background information shall provided originator upon request designated signatory. Document Control maintains Master Spec Listing which includes revision letter, effectivity date, specification number, product number (when applicable), title. 00-01-0001, SOP: Document Control. When change made, LTC's standard practice generate TECN specification process. Each time TECN generated, revision changes spec copies reissued required Level Level Document Control Book locations within factory satellite locations called document footer.
REFERENCES
Spec Number Title 00-01-1006 00-01-3100 00-01-1008 00-01-0005 00-01-0001 SOP: Engineering Change Notice Approval Matrix SOP: Specification Format Organization Temporary Engineering Change Notice SOP: Document Control
4.6.2 Assessment Subcontractors
Selection sources qualified will made upon supplier's ability conform agreed upon requirements quality, cost, delivery, based upon previous performance. exercises tight control over critical subcontractors prevent field reliability problems. effectiveness these controls continually assessed through on-site engineering surveillances, incoming inspection results, reliability monitor results, subcontractor-supplied data. This defined Specification 06-01-0020. Previously qualified suppliers continue used long they demonstrate capability meet conditions requirements. Suppliers subcontractors granted approval after qualification testing inspection materials purchased under preliminary approval status. monthly record approved suppliers' subcontractors' history maintained updated after completion inspections disposition lots.
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Suppliers subcontractors that consistently demonstrate exceptionally high acceptance rates will become candidates participation Preferred Vendor Program. Determination suitability will based following: Consistently high acceptance rate through Incoming Inspection. field-related problems. Recommendation LTC's Preferred Vendor Board after reviewing survey results from vendor. Willingness part supplier provide periodic statistical data critical nodes/parameters that have been identified. Suppliers subcontractors that qualify partnership program will placed reduced surveillance schedule, they will awarded greater share business.
REFERENCES
Spec Number Title 06-09-0003 01-xx-xxxx 09-01-0004 06-01-0007 09-01-0008 06-01-0020 06-06-0001 06-04-0002 06-05-7001 06-09-0008 Purchasing Procedure Material Procurement Specifications Approved Vendor List Incoming Inspection, Subcontracted Material Approved Subcontractor Listing Survey Audit Qualification Disqualification Procedures Statistical Process Control (SPC) Reliability Audit Program Failure Analysis Program Preferred Vendor Program
Type Indirect material consists material other than direct that directly used manufacture product. Type Indirect material consists material directly used manufacture product. Type Engineering evaluations consist material specifically purchased evaluations purposes which Engineering will inspect. Type material used direct material, will stored area where Type material stored. Type material upgraded Type having requester complete "Request Enter Part into Stores" having perform incoming inspection material. purchase order reviewed approved management originating department. Additionally, Quality Assurance reviews approves Purchase Orders Type material.
REFERENCES
Spec Number Title 06-09-0003 01-xx-xxxx Purchasing Procedure Material Procurement Specifications
4.6.4 Verification Purchased Products
When specified contract, purchaser his/her representative shall afforded right verify source upon receipt that purchased product conforms specific requirements. Verification purchaser shall absolve supplier/subcontractor his/her responsibility provide acceptable products, shall preclude subsequent rejection. When purchaser his/her representative elects carry verification subcontractor's plant, such verification shall used supplier subcontractor evidence effective controls quality supplier/ subcontractor.
4.6.3 Purchasing Data
purchase order shall list stock number, description part, designate material Type applicable. purchase order shall also state drawing number part number current revision level, quantity needed, applicable material procurement spec. revision (for Type materials only), required delivery date(s) negotiated price. shall also include inspection, test, packaging requirements, applicable. Type parts materials shall purchased from original equipment manufacturers, approved vendors subcontractors, authorized distributors. Below list categories: Type Direct material that distinct value-added identity finished product.
CONTROL CUSTOMER-SUPPLIED PRODUCT
currently LTC's practice include purchasersupplied materials products. Therefore, this clause 9001 does apply. event that should agree contractually accept/use purchaser-supplied product, will document procedures verify, store, maintain such product. Verification supplier does absolve customer responsibility provide acceptable product.
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PRODUCT IDENTIFICATION TRACEABILITY
Inventory identification traceability shall controlled through assignment product numbers, numbers, numbers, serial numbers, date codes back mark codes appropriate. card traveler must, minimum, specify number number, operation, device type stock number, quantity in/out quantity inspected/rejected (for inspection points). Runcards travelers accompany material through factory until reaches Boxstock. Offshore subcontracted material shall identified general back mark codes. device back mark code used provide complete traceability test traveler, assembly traveler, wafer traveler, materials used. Where space allows, complete backside mark code imprinted, follows: (For records, Section 4.16.)
C/AA/BBB/XX/YY, where: Denotes Plant Origin: Country Origin (COO) Denotes Device Type Denotes Assembly Number Denotes Year Denotes Seal Week
Documented work instructions necessary equipment facilities shall available approved processes that affect quality product. responsibility each organization that handles product monitor control processes. Each organization responsibility establishing requirements approval processes equipment. Standards workmanship shall defined each area either documents called "workmanship standards" "standard operating procedures," physical examples product that conforms requirement. responsibility each department assure equipment suitably maintained. Only certified personnel perform qualified processes. records, Section 4.16.
REFERENCES
Spec Number Title 00-01-1008 06-02-XXXX 06-08-XXXX 06-09-XXXX 05-03-8082 08-07-1001 06-09-0002 06-03-7050 08-07-1003 08-07-0656 SOP: Specification Format Organization Quality Process Monitor Specs Procedures, Quality Audit Procedures, Standard Operating Assembly Workmanship Standards Calibration Program Requirements Operator Training Certification Program Record Keeping Maintenance P.M. Special Facilities Safety Guidelines Procedures
REFERENCES
Spec Number Title 05-03-4601 Country Origin Backside Mark Standard Military Drawings MIL-M-38510 Slash Sheet Drawings DESC Drawing Slash Sheet Drawings MIL-STD-883 Compliant Data Sheets, Data Book
4.9.2 Special Processes
Statistical Process Control (SPC) implemented critical processes throughout manufacturing flow. products shipped 100% tested inspected several times. products fully characterized qualified before release. LTC's Reliability program designed continually assess performance devices field. above controls work together ensure that processing deficiencies become apparent before product delivered customer. Therefore, does have "special processes." specifications listed following page.
PROCESS CONTROL 4.9.1 General
Processes which directly affect quality products services delivered shall carried under controlled conditions. Controlled conditions include production plan well appropriate controls material, production servicing equipment, processes procedures, computer software, personnel, associated supplies, facilities, environment.
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REFERENCES
Spec Number Title 00-01-1006 06-03-5001 06-06-0001 06-04-0002 06-04-0011 06-04-0012 06-04-0001 xx-xx-xxxx xx-xx-xxxx SOP: Engineering Change Notice (Special Lot) Specification Procedure Statistical Process Control (SPC) Reliability Audit Program Reliability Monitor Program (Quick Reaction Reliability) Program Quality Assurance/Reliability Assurance Qualification Requirements Applicable Standard Operating Procedures (Also, Specifications referenced 4.10.2 apply 4.9.)
Lots which pass criteria specified shall considered acceptable. logs, travelers, boxes stamped with accept-date stamp prior releasing appropriate location. fails criteria, rejected inspection failure report (IFR) initiated. reject samples must segregated attached IFR. responsible Manufacturing Engineer must review disposition rejects complete form. applicable Package Engineers shall responsible notifying supplier rejections following corrective action Discrepant Material Reports (DMR).
REFERENCES
Spec Number 06-09-0003 06-01-0006 06-01-0007 06-01-0011 06-02-0020 01-xx-xxxx 06-08-0013 08-07-1001 Title Purchasing Procedure Incoming Inspection, General Incoming Inspection, Sub-Material Vendor Corrective Action Inspection Failure Report (IFR) Procedure Material Procurement Specifications Control Age/Temperature Sensitive Materials Calibration Program Requirements
4.10 INSPECTION TESTING 4.10.1 General
final inspection testing shall performed accordance with referenced procedures verify acceptance specified requirements.
4.10.2 Receiving Inspection Testing
Receiving/Production Control shall responsible segregating incoming material until completion inspection routing subcontracted assembly lots inspection.
4.10.2.1
accordance with LTC's Quality Assurance procedures, Type Type purchased materials shall subjected Incoming Inspection. Type Direct material that distinct value-added identity finished product. Type Indirect material consists material other than direct that directly used manufacture product.
4.10.3 In-Process Inspection Testing
shall: Inspect, test identify product required quality plan documented procedures. Establish product conformance specified requirements process monitoring control methods. Section 4.20 specifics. Hold product until required inspections tests have been completed necessary reports have been received verified except when product released under positive recall procedures. Section 4.10.1. Release under positive recall procedures shall preclude activities outlined Section 4.10.2A. Identify nonconforming products. specifications listed following page.
4.10.2.2
Lots released further processing prior completion incoming inspection. However, must completed within hours hours, depending upon type material that released. sample fails, notifies Production Control works together recapture lot, provided that ensures that affected lot(s) shipped prior completion inspection.
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REFERENCES (Representative)
Inspection Hold Monitors 06-02-0002 06-02-0004 06-02-0008 06-02-0012 06-02-0017 06-02-0022 06-02-5001 06-02-7036 06-08-0002 06-08-0003 06-08-0004 06-08-0005 06-08-0015 06-09-0018 06-09-0019 06-09-9001 06-09-9003 Test 06-02-0006 06-02-0011 06-02-0019 06-02-0031 06-03-0011 06-03-0012 06-03-7001 06-03-7003 06-03-7004 06-03-7006 06-03-7007 06-03-7008 06-03-7009 06-03-7011 06-03-7012 06-03-7016 06-03-7017 06-03-7018 06-03-7019 06-03-7025 06-03-7026 06-03-7027 06-03-7032 06-03-7033 06-03-7034 06-03-7063 06-03-7064 06-03-7065 06-03-7067 06-04-0001 06-08-0006 Records 06-03-7050 06-03-7051 06-03-5000 06-03-5001 06-03-7068 09-01-0002 09-01-0004 09-01-0005 09-01-0008 06-02-0001 06-02-0020 06-02-0003 06-02-0005 06-02-0007 06-02-0009 06-02-0014 06-02-7002 06-02-7003 06-02-7004 06-02-7070 06-03-7028 06-03-7029 06-03-7030 06-03-7031 06-03-7035 06-03-7036 06-03-7038 06-03-7061 06-03-7062 06-03-7066 06-06-0001 06-08-0014 08-07-1001
REFERENCES
Spec Number Title 06-02-0014 06-02-0013 06-02-7002 06-02-7003 04-04-XXXX Outgoing Electrical Test 883, STANDARD MIL, Commercial Devices External Visual Inspection Post Pack Inspection Shipbench Inspection Final Test Set-Up Specifications
4.10.5 Inspection Test Records
Records that product passed required inspections tests defined Quality plan must maintained. These include records from: Test, Visual/Mechanical, Postpack, Boxstock, Shipbench, Flows. Specific procedures defining acceptance criteria inspection test records found referring specifications listed below, applicable travelers. Records shall identify inspection authority responsible release product, shall clearly show acceptance failure required inspections tests (reference Section 4.12). Nonconforming material shall identified, segregated, dispositioned accordance with Section 4.13 referenced procedures. Section 4.16 specifics.
REFERENCES
Spec Number Title 06-03-7050 00-01-1006 Record Keeping SOP: Engineering Change Notice
4.10.4 Final Inspection Testing
products will undergo final test according applicable test procedure, will inspected completeness specified requirements, appearance against applicable workmanship standards, associated data documentation available authorized. Electrical test visual/mechanical acceptance shall precede transfer Finished Goods inventory area. Finished Goods inventory consists only products formally released product listing (RPL). Additionally, impossible ship product that RPL, computer will print shipper. Inspection product prior shipment shall assure compliance contractual requirements described referenced procedures applicable "SL" special flow requirements. government shall allowed access subcontractor facilities verify acceptability, when contractually required.
4.10.6 Test Software Control
Test software shall approved before Test Engineering. Test software shall stored controlled access "server," from which only most current approved software shall used test product. document-controlled Test Program Book contains released (04-12-xxxx) test program listings, including program name latest revision each device type Wafer Sort, Final Test, tests. Revisions used recorded test flow traveler, which also serves test specification. Changes test procedures only made after been approved signed off. Major changes software defined spec 06-04-0007) only made after been approved signed off.
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Whenever possible, equipment accuracy parameter tolerance shall least 10:1 ratio. However, when 10:1 accuracy possible, electrical quality guaranteed guard banding test limits against published data sheet. Guard bands combination published test equipment specifications techniques. This ensures that parametric readings outside device specifications deleted, resulting faulty unit being rejected. Additionally, final sampling plan guarantees acceptance quality limits inside published data sheet parameters.
REFERENCES
Spec Number Title 00-01-1006 04-04-6300 04-01-xxxx 04-13-xxxx 04-21-xxxx 04-12-xxxx 04-14-xxxx 04-25-xxxx 06-04-0007 06-04-0009 SOP: Engineering Change Notice Test Area Standard Product Test Flows Product Test Flows DESC Drawing Test Flows Test Program List Product Test Program Index DESC Drawing Test Programs Customer Notification Major Changes Datasheet Change Control
4.11 CONTROL INSPECTION, MEASURING, TEST EQUIPMENT
measuring test equipment shall controlled, calibrated, maintained prior release during production, installation, servicing demonstrate conformance product specified requirements. Subcontractors vendors shall demonstrate conformance intent MILSTD-45662. unique identification must provided equipment tools requiring calibration. This will included calibration recall list which includes department number, equipment type date. re-calibration frequency must determined recorded. calibration inspection, measuring test equipment, including torque tools, shall checked before equipment dropped otherwise subjected impact). uses outside calibration laboratories services provided original equipment manufacturer. Prior contractual agreement, outside calibration labs used calibrate LTC's test measurement equipment must audited MIL-STD-45662
Specification 06-09-0005, REV.
08-07-1001 "Calibration Program" requirements. outside calibration system controls must comply with MIL-STD-45662 requirements. Outside calibration labs shall responsible maintaining complete accurate list instruments equipment from under service agreement. list shall identify instruments serviced means coded symbols identify service performed recall period. outside shall furnish data sheets certification each calibration performed. Criteria established review equipment determine calibration required. following conditions met, calibration will required. Equipment performs particular function, required that other calibrated equipment used with equipment initial setup. performance equipment monitored through calibrated equipment. Equipment used indication only. Equipment where calibration meaning cannot performed. Equipment will identified with sticker stating, "calibration required." equipment calibrated directly original manufacturers shall accepted they meet following requirements: Calibrates equipment accordance with established written calibration procedures. Records out-of-spec conditions with before after values. Supplies original calibration data paperwork which satisfy these requirements: appropriate inspection, measuring, test equipment selected provide required accuracy measurements made. equipment used measurements made shall defined detailed procedures travelers. Calibration adjustment performed required individual calibration procedure and/or manufacturer's specifications. Primary, secondary, working standards traceable National Institute Standards Technology (NIST) natural physical constants.
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Where test hardware test software used, correlation units tested ensure equipment been running properly. Correlation units frequency defined applicable procedures. Correlation wafer/units also used verify setups test programs operators experiencing large number rejects. general, test hardware, software, techniques considered proprietary LTC. Such information released except non-disclosure agreement authorization Chief Operating Officer. However, resolve correlation difficulties with customers, provide serialized data logged devices. Procedures describing verification calibrated equipment listed below: accuracy, precision, capability inspection measurement equipment must sufficient provide meaningful results. Equipment selected based manufacturers' guaranteed operating specifications tolerances. During initial inspection/test development, correlation studies conducted verify desired results. critical inspections where control chart used, Measurement System Evaluation (MSE) Gauge Repeatability Reproducibility (Gauge conducted ensure capability. Every user responsible checking calibration status calibrated tool piece equipment before used responsible that used calibration required before use. This done verifying data calibration sticker and/or defined applicable detailed procedure. Records recall notices shall also maintained along with calibration certificates conformance applicable equipment history file. history file shall kept each piece calibrated equipment. file shall consist calibration data sheets, calibration certificate conformance, out-of-tolerance evaluation forms applicable). test maintenance group shall responsible maintaining calibration data sheets equipment under their calibration program, with copy going history file. Records shall kept minimum period years longer, required customer contract). event that piece equipment found calibration, consideration given review previous work completed with equipment since previous calibration. out-of-calibration condition that determined adversely affect product quality reliability will require rectification, customer notification possible recall product. Calibration procedures shall have specified temperature humidity specific environmental conditions listed various equipment calibration specifications. Areas where operations sensitive surrounding environment shall specified, monitored, controlled. Upon receipt before use, equipment inspected damage verification that appropriate calibration stickers have been affixed equipment. Production tooling used inspection media shall controlled checked accuracy intervals, according calibration procedures. deemed necessary verify acceptability, government customer representatives shall allowed access personnel calibrated equipment. advanced metrology requirement (exceeding known state-of-the-art technology) identified during contract review shall addressed Test Engineering reported spec review form.
REFERENCES
Spec Number 08-07-1001 Title Calibration Program Requirements MIL-STD-45662 Calibration Systems Requirements
04-05-xxxx
02-05-xxxx 08-07-1003 06-06-0001 06-08-0002 08-07-xxxx
Applicable Test Preventive Maintenance (PM) Calibration Procedures
Applicable Fabrication P.M. Calibration Procedures Maintenance P.M. Specification Statistical Process Control (SPC) Controlled Environment Surveillance Applicable Facilities P.M. Procedures
4.12 INSPECTION TEST STATUS
Inspection stamps serve identify inspector accepted made authorized disposition material product. Trained certified inspectors shall issued inspection stamps which used indicate completion acceptance testing. Inspection stamp design unique LTC.
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Each inspection area shall segregate inventory according inspection status implement positive controls segregate accepted materials from rejected material. Manufacturing travelers shall accompany material. traveler shall show least those manufacturing steps from last quality gate function and/or manufacturing operations which describe work operations being inspected. travelers shall indicate completion manufacturing operations operator initials number, date quantity out. identification inspection test status shall maintained defined procedures referenced herein); throughout production product ensure that only product that passed required inspections tests shipped. Each gate inspection shall include verification that specified manufacturing inspection steps have been completed. Only accepted material which passes Final Inspection allowed Boxstock area. containers identified with stamp label box. Only product which fully qualified Released Products List (RPL) shipped from Boxstock.
REFERENCES
Spec Number 06-02-0001 06-02-1000 06-06-0002 06-02-0020 06-02-7003 06-02-7002 06-02-0003 06-02-0007 06-02-0009 06-02-0014 09-01-0002 Title Quality Assurance Inspection, Wafer Sort Quality Control Checkpoints Inspection Stamp Control Inspection Failure Report Boxstock Inspection Post-Pack Inspection Optical Inspection Optical Inspection Group-A Electrical Test Outgoing Electrical Test 883, STANDARD MIL, Commercial Released Product Listing 06-09-0018 06-09-0019 06-09-0022 02-04-1102 06-02-3000
nonconformance shall recorded corrected before product moved next step process, with notification functions concerned. processes, work operations, quality records, service reports, customer complaints analyzed detect eliminate potential causes nonconforming product.
4.13.2 Review Disposition Nonconforming Material
Where nonconformance detected process, product shall scrapped, reworked, returned preceding step correction. dispositions materials specified #06-01-0006. rework shall performed approved procedures results shall recorded appropriate rework traveler. Reworked product shall re-inspected/re-screened accordance with documented procedures. does perform repair shippable product. responsibility review authority disposition nonconforming product materials described following procedures:
REFERENCES
Spec Number 06-02-0020 06-01-0006 06-01-xxxx 06-02-xxxx 06-03-xxxx Title Inspection Failure Report Incoming Inspection, General Applicable Incoming Inspection Procedures Applicable Inspections Monitoring Procedures Applicable Inspection Test Operational Procedures SOP: Inventory Control Engineering Alert: Minimum Yield Requirements Nonconforming Material Control Procedure Stop/Start Procedure
4.13 CONTROL NONCONFORMING PRODUCT 4.13.1 General
Nonconforming material shall identified segregated prevent unauthorized accidental use. Where nonconformance detected during verification step,
4.14 CORRECTIVE PREVENTIVE ACTION 4.14.1 General
Prevention procedures corrective action procedures ensure that product conforms established specification quality standards vital parts LTC's continuous quality improvement program.
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intent identify root cause nonconformance correction prevention recurrence. This applies manufacturing support operations responsible manufacture product, shall apply (but limited to): Design, Purchasing, Manufacturing, Testing, Final Packaging Shipment, Customer Material Returns Failure Analysis. Emphasis shall placed identifying root cause prevention recurrence nonconformance. This include containment, interim corrective action, final corrective action, subsequent audits ensure that required corrective action measures place effective preventing recurrence nonconformances. response time goals are: Containment within hours. Verification within hours. Root cause corrective action identification plan within days. Discrepancies found during incoming inspection material lots documented Discrepant Material Report (DMR) group. Once rejection determined valid, Group required generate Vendor Corrective Action Request (VCAR). Upon receipt completed VCAR from supplier, Quality Engineering shall determine corrective action sufficient prevent recurrence problem. supplier does provide effective corrective action, supplier disqualified. Discrepancies found during in-process outgoing inspection documented Inspection Failure Report (IFR) Stop/Start Production in-process inspection performed production group. Stop/Start reviewed appropriate Engineering group determine disposition appropriate corrective action. IFRs summarized monthly trend report department. report issued responsible Production Engineering groups review with emphasis placed eliminating recurring problems. Other activities which identify need initiating corrective action are: calibration (out tolerance) failures from inspection step (IFR) results from reliability monitoring results from quality measurement analysis corrective action reports chart OCAPs findings from process audits quality system audits management reviews quality system quality trends customer feedback vendor ratings audits failure analysis When quality problems undesirable trends occur, Quality Control Team (QCT) responsible initiating meeting series meetings establish Process Action Team (PAT) identify define corrective action measures. These meetings held until problems resolved when quality levels improved acceptable level. responsibility taking appropriate preventive corrective action shared among Production, Quality Assurance, Reliability, Engineering groups. Representation PATs should reflect this shared responsibility preventive/corrective action. above groups responsible ensuring that corrective actions effective. changes procedures which result from corrective action documented through Engineering Change Notice (ECN) procedure recorded Document Control department. customer failure analysis reports distributed management, including president chief operating officer.
REFERENCES
Spec Number 06-02-0020 06-01-0011 02-04-1102 06-02-3000 06-05-7001 06-06-0001 06-08-0014 06-06-0003 06-09-0020 Title Inspection Failure Report (IFR) Procedure Vendor Corrective Action Stop/Start Procedure Customer Material Return Processing Procedure Failure Analysis Program Statistical Process Control Quality Audit Procedure Team Problem-Solving Corrective Preventive Action Program
06-01-0006 06-09-0003 Material Review Board (MRB) Procedures
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4.14.2 Corrective Action
procedures corrective action shall include: effective handling customer complaints reports product nonconformities; investigation cause nonconformities relating product, process, quality system, recording results investigation (see 4.16); determination corrective action needed eliminate cause nonconformities; application controls ensure that corrective action taken that effective.
4.15.2 Handling
production parts, supplies, components shall handled manner that will prevent damage deterioration. Handling requirements further defined following:
REFERENCES
Spec Number 06-09-0015 06-09-9001 06-08-0005 06-09-0018 04-04-6300 05-03-7903 06-01-0006 06-01-0007 06-09-0001 Title Prevent Product Mixing Electrostatic Discharge Control Requirements Environment Requirements Processing Storage SOP: Inventory Control Test Area Mark Pack Incoming Inspection, General Incoming Inspection, Subcontracted Material Quality Assurance Policy
4.14.3 Preventive Action
procedures preventive action shall include: appropriate sources information such processes work operations which affect product quality, audit results, quality records, service reports, customer complaints detect, analyze, eliminate potential causes nonconformities; determination steps needed deal with problems requiring preventive action; initiation preventive action application controls ensure that effective; confirmation that relevant information actions taken submitted management review (see 4.1.3).
4.15.3 Storage
materials processed shall stored manner that will minimize possibility incurring damage deterioration. During scheduled quality system audit, samples stock shall checked damage deterioration packaging. Access Stores, Boxstock, Dispatch areas shall limited authorized personnel. condition product stock shall assessed appropriate intervals detection deterioration. Procedures receipt, dispatch, storage material referenced following specifications:
REFERENCES
Spec Number 06-07-0001 06-07-0002 06-08-0005 06-09-0004 06-09-0018 06-09-9001 09-07-0003 06-04-0011 06-08-0013 Title Dispatch Procedure Boxstock Procedure Environment Requirements Processing Storage SOP: Stores SOP: Inventory Control Electrostatic Discharge Control Requirement Special Flows Reliability Monitor Program (Boxstock Audit) Control Age/Temperature Sensitive Materials
4.15 HANDLING, STORAGE, PACKAGING, DELIVERY 4.15.1 General
Documented procedures define system preservation, segregation, handling items government-owned property throughout entire manufacturing inspection flow through storage shipping. Precautions shall taken protect material from abuse, misuse, damage, deterioration, unauthorized use.
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4.15.4 Packaging
materials shall packaged manner that will minimize possibility incurring damage deterioration during storage handling. Procedures defining further requirements packaging found referencing procedures following specs:
REFERENCES
Spec Number 05-03-2000 05-03-2003 05-03-4601 05-03-4604 05-03-7899 05-03-7900 05-03-7901 05-03-7903 06-01-0026 06-01-0010 06-02-7002 06-07-0002 06-08-0013 06-09-9001 09-01-0005 09-07-0003 Title Wafer Pack Break Plate Back/Side Mark Mark Pack Incoming Procedure Pack Partial Finish Product Singapore Pack Pack Mark Pack Incoming Inspection Sensitive Material Incoming Inspection Anti-Static/Conductive Packaging Material Post-Pack Inspection Boxstock Procedure Control Age/Temperature Sensitive Materials Electrostatic Discharge Control Requirements Mark Layout Listing (TML) Special Flows
Specific procedures defining details these processes listed below:
REFERENCES
Spec Number 06-07-0002 06-02-7003 06-09-9001 Title Boxstock Procedure Shipbench Inspection Electrostatic Discharge Control Requirements
4.16 CONTROL QUALITY RECORDS
Quality records shall retained such manner retrievable. These records document conformance specifications effective operation quality system. records used substantiate controls military/ aerospace, high reliability, MIL-M-38510 MIL-STD-883 product shall retained minimum five years. commercial products covered customer purchase order record retention requirements, records manufacturing, quality assurance, support groups retained period shown below. quality records shall legible traceable product involved. Quality records shall stored maintained that they readily retrievable facilities that provide suitable environment minimize deterioration, damage, loss. Where contractually agreed upon, quality records shall made available evaluation customer customer's representative agreed period. following procedures contain additional requirements regarding record keeping:
REFERENCES
Spec Number 06-03-7050 06-03-7051 Title Record Keeping Electronic Archiving Operating Procedure
4.15.5 Preservation
(Does apply)
4.15.6 Delivery
Unless specified contract, Customer Service department responsible selection carriers arrangement shipments. final boxing shipping finished products responsibility shipping department ensure protection product quality after final inspection during transit final destination.
Specification 06-09-0005, REV.
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4.16.1 Quality Records Matrix
following table (Quality Records Matrix) identifies types quality record, where record kept, method storage, position function responsible minimum retention period.
Quality Records Matrix
Quality Record Quality System Review Report Design Verification Contract Review Inspection Records Failure Analysis Reports Initial Documentation/Subsequent Changes Design Material Processing, Qualification Test Change Records Specification (Documents, Applicable Forms) Calibration In-Process Monitor Inspection Logs Control Charts Stop/Start Sheets/ IFRs 38510, 883, Customer Rel, Wafer Assembly, Screening Qualification, Quality Inspection Records (including printouts, read/record data) Commercial Travellers, Wafer Sort Summaries, Final Electrical Screening, Inspection Records, Mark Pack Travellers Commercial Assembly, Qualification Quality Inspection Records, (including printouts, read/record data) Procurement Documents Inspection Stamp Control Records Quality Audit Reports (QARs), Audit Logs (two years), Vendor/Sub-Contractor Audits, Customer Audits, Quality Deficiency Records (QDRs) generated DESC DCMC, Distributor Audit Reports Operator Training/ Certification Control Charts (SPC) MIL-SPEC Library Results, Problem Analysis Preferred Vendor Records Location Engineering Cust. Spec. Review QA/IQC QA/Rel. QA/Hi Rel. Method File File File Elect. File Elect. File/Data Base Elect. File/Data Base Responsible P.E./D. Engr. QA/IQC QA/Rel. QA/Hi Rel. Period Min. Years Life Product Years Min. Years Min. Years Min. Years
Doc. Control QA/Test Maint. QA/IQC Rel/JAN Prog/QA
File/Data Base File/Data Base Elect. File Elect. File
Doc. Control QA/Test Maint. QA/IQC Rel/Jan Prog/QA
Life Document Life Equipment Min. Years Min. Years
QA/Manufacturing
Manufacturing/ File/QA Elect. File Elect. File/File
Wafer Fab, Test, Mark Pack
Min. Years
Min. Year
Purchasing Doc. Control Audit
File/Data Base File File
Purchasing Doc. Control Audit
Min. Years Min. Years Min. Years
Personnel/ Applicable Trainer Applicable Area Dept.
File Elect. File File File File
Personnel Applicable Trainer Area Supervisor
Active File, Active File, Min. Years Life Document Min. Years
Specification 06-09-0005, REV.
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4.17 INTERNAL QUALITY AUDITS
Internal audits quality system shall conducted according schedule established Corporate Quality Audit department. schedule shall ensure that areas operating under quality system described this quality manual audited least once year. results these audits shall documented communicated management area being audited. Management will ensure that corrective actions taken resolve audit findings. (See Section 4.16). Quality system audit results shall reviewed determine adequacy compliance documented quality system. corporate auditor will follow-up until corrective action implemented. (See Section 4.16). results internal quality audits shall part input management review activities. (See Section 4.1.3). audit process detailed following procedures:
REFERENCES
Spec Number 06-08-0014 06-08-0015 06-01-0020 Title Quality Audit MIL-M-38510 Quality Audit Checklist Vendor Survey/Audit Qualification/Disqualification Procedure Approved Subcontractor Listing Approved Vendor Listing Record Keeping Electronic Archiving Operating Procedure
Personnel performing specific assigned tasks shall qualified basis appropriate education, training and/ experience, required. Training records shall maintained each functional supervisor, copy sent Human Resources. Records shall indicate: Employee Name, Date Hire, Badge Number, Department Number, Supervisor, Spec Trained (Title Spec Number), number training hours, Initials Trainer, Operator's Initials, Date Certified. (See Section 4.16). shall responsibility quality systems audit department monitor training certification records ensure compliance with documented requirements.
REFERENCES
Spec Number 06-09-0002 05-06-0007 06-09-0007 06-09-9001 06-08-0005 08-07-0028 06-03-7050 xx-xx-xxxx Title Operator Training Certification Program Operator Training Certification Program Safety Policy (Required 06-09-0002) Control Procedure Environmental Requirements Processing Storage Wafer Smock Procedure Record Keeping Procedure Applicable Specifications Training Specifications Work Area
09-01-0008 09-01-0004 06-03-7050 06-03-7051
4.19 SERVICING (FAILURE ANALYSIS)
Failure analysis devices returned from customers only service which provided LTC. Failure analysis joint responsibility Reliability group, Product Engineering, Design Engineering. Outside analytical labs utilized special areas which require capabilities beyond scope in-house equipment. Procedures identification, handling, analysis reject defective devices shall documented. This information will conveyed customer government representative formal Failure Analysis Report accordance with established industry standards including, limited MIL-M-38510, MIL-I-38535 Appendix MIL-Q-9858. summary report failure analysis activity findings shall prepared submitted management quarterly basis, more frequently, necessary.
4.18 TRAINING
Each department shall establish training requirements jobs that effect quality product shipped customers. Individual departments shall maintain records indicate that person satisfactorily completed appropriate training his/her assigned job. responsibility each functional manager insure that his/her personnel receive proper training. employees trained motivated provide excellence workmanship throughout manufacturing process provide service customers which standard which other companies judged.
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REFERENCES
Spec Number 06-05-7001 MIL-I-38535 MIL-Q-9858 Title Failure Analysis Program General Spec Microcircuits Quality Program Requirement
4.20 STATISTICAL TECHNIQUES 4.20.1 Identification Need
Statistical Process Control (SPC) program place improve process capability, reduce process variations, provide continuous improvement, provide robust designs along with statistical sampling plans used integral part inspection testing. program applicable manufacturing processes, operations which statistical sampling control acceptance purposes, designs that deemed critical. Statistical techniques employed analyze process data identify root causes process variation that process modified achieve: Continuous reduction variability around desired target; Consistency over time; Conformance requirements. program comprises following elements: structure: Steering Committee (Corporate level), Quality Control Teams (area facilitators/ management), Process Action Teams (PATs). Employee training: Basic SPC, Advanced SPC, Design Experiments, Team Organization. Establishment documentation Critical Nodes manufacturing/related processes flow charts Control Plan Detail tables. LTC's Self-Audit program program. Application manufacturing, inspection, calibration, maintenance, preventive maintenance, environmental control, document control, purchasing materials, service data, other areas need arises. Formation Process Action Teams (PATs) composed representation from manufacturing, engineering, maintenance, (and applicable, quality engineering) with objective applying solve problems, improve process capabilities reduce process variation.
Specification 06-09-0005, REV.
Reports shall established measure progress made terms improved process capabilities indexes) quality improvements. Statistical Sampling procedures employed those operations requiring 100% inspection which destructive nature. Goal setting continuous quality improvement. Specific statistical methods applications available include, limited following: Design Experiments/factorial analysis Analysis variance/factorial analysis Safety evaluation/risk analysis Tests significance Quality control charts/Cum-Sum techniques Statistical sampling inspection
4.20.2 Procedures
Documented procedures shall implemented maintained controlling application identified statistical techniques.
REFERENCES
Spec Number MIL-STD-105 06-06-0001 06-06-0003 Title Sampling Procedures Tables Inspection Attributes Statistical Process Control (SPC) Procedure Team Problem Solving
4.21 QUALITY COST
Quality cost data, cost scrap, rework, prevention defective material primary concern LTC. Quality cost data shall collected, analyzed, used improve effectiveness, efficiency, control waste. This data form yield reports scrap reports, which compared their respective specified goals. overall operating expenses Quality Assurance Department forecast budgeted annual basis. cost department operation broken down into specific categories. Each category reviewed monthly basis assess actual cost versus planned cost. yield, scrap, cost data considered Confidential, only reviewed with customers upon express, written permission LTC's Chief Operating Officer.
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APPENDIX A-RELIABILITY ASSURANCE
Reliability Assurance group shall made professional individuals with training experience environmental stress testing, failure analysis techniques, reliability calculations, reliability predictions integrated circuits. activities Reliability Assurance group shall focus measurements product reliability, well identification timely elimination design processing deficiencies which limit otherwise compromise product reliability. Reliability Assurance shall exercise full authority over qualification products, processes, materials, manufacturing locations. Reliability Assurance group shall prepare implement written program plans detailed procedures covering, minimum, these areas: Wafer Fabrication Reliability Monitor Program Quick Reaction Reliability Audit Program Long-Term Reliability Audit Program Product/Process/Material Qualification Program Major Change Qualification Assembly Subcontractor Qualification Failure Analysis Corrective Action Program Achieving extremely failure rates during product life field demands that integrated circuit manufacturer audit reliability performance outgoing products. Product reliability audits responsibility Reliability group, with immediate responsibility program implementation, performance, reporting assigned Manager Quality Reliability Assurance. summary data file shall maintained product families. This summary shall include, minimum, device type tested, package type, assembly location, manufacturing date code, actual test condition used, sample size, duration test, number failures observed. Management shall apprised immediately audit results which indicate that failure rate goals being that significant degradation performance evident.
PRODUCT QUALIFICATION PROGRAM
products will released without acceptable reliability data defined Reliability Quality Assurance responsible engineering groups. Before major design process change considered qualified, sufficient test data shall collected demonstrate that processes used conform applicable government, industry, customer, internal specifications. finished devices must capable passing tests required applicable government, industry, customer specifications. major change defined significant departure from existing approved process/design, agreed Reliability Assurance Manufacturing, Design documented LTC's 06-04-0001 06-04-0006 Qualification Specifications. Similarity materials design previously qualified products shall considered sufficient purposes product process change qualification. Similarity data supplemented with test data product question those areas where similarity does justify blanket qualification product change approval. Life test data device within product family used generically qualify other devices within same product family, providing devices encapsulated packages made from same materials sealed using same sealing process. purposes qualification, product family includes microcircuit chips equivalent complexity function made same wafer area using same process. Qualification requirements shall established documented products processes. Documentation shall include tests, test conditions, pass/fail criteria which must before product process considered fully qualified. Qualification tests shall include environmental tests mechanical tests specified 06-04-0001 spec, shall necessarily limited these tests where device service conditions known more severe than test conditions standard qualification. Qualification requirements MIL-STD-883, (standard military device), MIL-M-38510 devices shall Method 5005 MIL-STD-883, minimum.
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Major changes MIL-M-38510 devices shall defined MIL-M-38510 qualification requirements specified MIL-M-38510. Qualification test reports shall retained minimum period five years.
REFERENCES
Spec Number 06-04-0001 06-04-0006 06-04-0011 06-04-0012 Title Quality Assurance/Reliability Assurance Qualification Requirements Qualification Changes 38510 Products Reliability Monitor Program (Quick Reaction Reliability) Program
APPENDIX B-MAJOR CHANGE NOTIFICATION
major change definitions requirements MILM-38510 military products, LTC's major change requirements commercial products, specific customer change requirements shall fully documented Quality Assurance group. responsible Engineering group and/or Quality Assurance group responsible initiating major change processed through Document Control group. Appropriate qualification test data justifying major change shall support ECN. Quality Assurance Reliability manager responsible maintaining database customers require major change notification. Quality Assurance Reliability manager responsible ensuring that major change implemented until customers have major change notification requirements notified have approved major change. Quality Assurance Reliability manager responsible sending customer appropriate qualification test data justifying major change maintaining record customer major change notifications.
REFERENCES
Spec Number 06-04-0007 06-04-0006 Title Customer Notification Major Changes Qualification Changes 38510 Products
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APPENDIX C-ENVIRONMENTAL CONTROL
Facilities Maintenance departments responsible control following items support manufacture integrated circuits: Temperature humidity control Controlled filtered hoods Airborne particle control De-ionized (DI) water Gases Clean shall responsibility Facilities Engineering Maintenance departments establish maintain necessary equipment controls provide services listed above. shall responsibility Facilities Engineering Maintenance departments define document requirements such facilities based requirements various product groups. shall responsibility Quality Assurance Systems Quality Audit departments monitor quality these services listed above. Quality Reliability Assurance department shall perform periodic surveillance environmental controls. Surveillance inspection records shall maintained Quality Assurance shall include minimum monthly report hood/area temperature, humidity particle count, water bacteria count resistivity. Surveillance inspection records shall maintained minimum five years, MIL-M-38510.
REFERENCES
Spec Number 06-08-0002 06-08-0004 06-01-0016 01-07-0001 06-01-0005 01-65-0001 Title Controlled Environment Surveillance Deionized Water Monitor Incoming Inspection: Gases MPS: Gases Incoming Inspection: Chemicals MPS: Chemicals
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APPENDIX D-MILITARY STANDARD CROSS REFERENCE MATRIX
06-09-0005 Section Number Quality System Element Preface 4.1.2 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 4.21 Appendix Appendix Appendix Quality Policy Organizational Chart Management Responsibility Quality System Contract Review Design Control Document Data Control Purchasing Control Customer Supplied Product Product Identification Traceability Process Control Inspection Testing Control Inspection, Measuring, Test Equipment Inspection Test Status Control Nonconforming Product Corrective Preventive Action Handling, Storage, Packaging, Delivery Control Quality Records Internal Quality Audits Training Servicing (Failure Analysis) Statistical Techniques Quality Cost Reliability Assurance Major Change Notification Environmental Control 9001 1994 4.1.1 4.1.2 4.1.2.1-4.1.3 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 4.18 4.19 4.20 MIL-Q-9858 3.3, 5.1, 5.2, 6.1-6.3, 4.2-4.5 MIL-I-45208 3.2.1, 3.2.4 3.11.2, 3.11.3 MIL-I-38535 Appendix 30.1.3.1 30.1 30.1, 30.1.3 30.1.1.1 30.1.1.6 30.1.1.8, 30.1.2.4 30.1.1.1 30.1.1.12, 30.1.2 30.1.1.4, 30.1.2.6 MIL-STD-45662 4.1, 5.5, 5.11 5.2, 5.10 5.2, 5.10 5.6, 5.12
3.1, 3.10-3.12 30.1.1.3, 30.1.1.5, 30.1.1.6, 30.1.1.12 3.2.3 3.2.2 30.1.1.9, 30.1.2.5 30.1.2.2 30.1.1.10 30.1.1.11 30.1.1.14 30.1.2, 30.1.2.2 40.3.1 30.1.1.2, 30.1.2.1 30.1.1.10, 30.1.2.3 30.1.1.3 30.1.2.4 30.1.1.7
Specification 06-09-0005, REV.
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Specification 06-09-0005, REV. 15-5 9001 QUALITY MANUAL

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