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Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What?

With What?

(Materials/Equipment)

(Materials/Equipment) •

•Computerized systemComputerized system

• •FaxFax With Who? With Who? (Competence/Skills/Training) (Competence/Skills/Training) •

•Trained purchasing staff Trained purchasing staff 

•Supplier development teamsSupplier development teams

•Financial authorized personFinancial authorized person

Process

Process

Purchasing (7.4)

Purchasing (7.4)

Supplier selection/ development

Supplier selection/ development

Monitoring of supplier  Monitoring of supplier  Purchasing process Purchasing process How? How? (Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques)) •

•Purchasing procedurePurchasing procedure

•Supplier selectionSupplier selection

•Supplier performance monitoringSupplier performance monitoring

•Supplier development processSupplier development process

•E-mailE-mail

With What Key Criteria?

With What Key Criteria?

(Measurement/Assessment)

(Measurement/Assessment) •

•Cost of poor material receivingCost of poor material receiving

•Timeliness (on-time)Timeliness (on-time)

•Material/ product qualityMaterial/ product quality

•Procedure material shortageProcedure material shortage

•Premier freightPremier freight

Inputs

Inputs •

•BOMBOM

•Purchasing RequisitionPurchasing Requisition

•Customer requirementCustomer requirement

(approve-source)

(approve-source)

•Regulatory requirementRegulatory requirement

•Production scheduleProduction schedule

Output

Output •

•Contour purchased productContour purchased product

conform to spec.

conform to spec.

•On-time receivingOn-time receiving

Annex A

Annex A

(2)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What?

With What?

(Materials/Equipment)

(Materials/Equipment) •

•Material, componentMaterial, component

•Production machine/equipmentProduction machine/equipment

•Molding, pressing, assemblyMolding, pressing, assembly

•Inspection tools, gaugesInspection tools, gauges

• Assembly jigs Assembly jigs

•Component partsComponent parts

With Who?

With Who?

(Competence/Skills/Training)

(Competence/Skills/Training) •

•Trained operator Trained operator 

•QCQC

Process

Process

Defrost grill assembly

Defrost grill assembly

Inputs

Inputs •

•QMS requirementQMS requirement

•Feedback of informationFeedback of information

from service

from service

•Customer requirementCustomer requirement

•Special characteristicSpecial characteristic

•Production scheduleProduction schedule

•Delivery scheduleDelivery schedule

•Regulatory requirementRegulatory requirement

•Quality targetQuality target

Output

Output •

•Defrost grill conform toDefrost grill conform to

customer requirement/ customer requirement/ regulatory regulatory

Annex B

Annex B

(3)

With What Key Criteria?

With What Key Criteria?

(Measurement/Assessment)

(Measurement/Assessment) •

•PPMPPM

•Quality CostQuality Cost

•Delivery performanceDelivery performance

•Time for return product test/ analysisTime for return product test/ analysis

and problem solving

and problem solving

•Response timeResponse time

• •CpCp k k How? How? (Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques)) •

•Control PlanControl Plan

•Work instruction for job set uWork instruction for job set up verificationp verification

•Inspection/ Test instructionInspection/ Test instruction

•SPCSPC

•Error proofingError proofing

(4)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What?

With What?

(Materials/Equipment)

(Materials/Equipment) •

•Purchasing data basePurchasing data base

• •BOMBOM With Who? With Who? (Competence/Skills/Training) (Competence/Skills/Training) •

•Trained purchasingTrained purchasing

• •Staff Staff 

Process

Process

Purchasing Purchasing (75% component of 7.4.1) (75% component of 7.4.1)

 Are outsource from

 Are outsource from

2 suppliers

2 suppliers

How?

How?

(Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques)) •

•Supplier selection procedureSupplier selection procedure

•Supplier development methodSupplier development method

•Purchasing procedurePurchasing procedure

•Purchased product control instructionPurchased product control instruction

With What Key Criteria?

With What Key Criteria?

(Measurement/Assessment)

(Measurement/Assessment) •

•TimelinessTimeliness

•Cost of material (part)Cost of material (part)

•Quality of materials (part)Quality of materials (part)

•Quick resource for any problemQuick resource for any problem

concerned with material/part

concerned with material/part

Inputs

Inputs •

•Delivery scheduleDelivery schedule

•Supplier scheduleSupplier schedule

• Approved supplier list Approved supplier list

•Customer requirementCustomer requirement

• Approved source Approved source

•Purchase requisitionPurchase requisition

•Regulatory requirementRegulatory requirement

•Records of supplier performanceRecords of supplier performance

•Product requirement (design record)Product requirement (design record)

•Production scheduleProduction schedule

• Acceptance criteria Acceptance criteria

Output

Output •

•On-time deliveryOn-time delivery

•Conforming purchasedConforming purchased

product

product

Annex C

Annex C

(5)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What?

With What?

(Materials/ Equipment)

(Materials/ Equipment) •

•Process equipment & machineProcess equipment & machine

•Testing machineTesting machine

• •MaterialMaterial With Who? With Who? (Competence/Skills/Training) (Competence/Skills/Training) •

• APPQP team members who trained APPQP team members who trained

and skilled in applicable tool

and skilled in applicable tool

•FMEA, DOE, QFDFMEA, DOE, QFD

Process

Process

DFMEA Establishing DFMEA Establishing & updating & updating (7.1, 7.3) (7.1, 7.3) How? How? (Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques)) •

•WI, Procedure far-forgingWI, Procedure far-forging

•Testing method/destructive testing (tensile)Testing method/destructive testing (tensile)

•Poka yokePoka yoke

•DOEDOE

•Feasibility review methodFeasibility review method

•Part approved processPart approved process

With What Key Criteria?

With What Key Criteria?

(Measurement? Assessment)

(Measurement? Assessment) •

•Fail rateFail rate

•PPMPPM

•Defect rateDefect rate

Inputs

Inputs •

•Customer requirements e.g.Customer requirements e.g.

•Special characteristicSpecial characteristic

• Approval requisition Approval requisition

•Previous design projectsPrevious design projects

•Field dataField data

•Block diagramBlock diagram

•Preliminary process flow chartPreliminary process flow chart

•Material specificationMaterial specification

Output

Output

DFMEA which can prevent

DFMEA which can prevent

tensile strength failure

tensile strength failure

Annex D

Annex D

(6)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What?

With What?

(Materials/ Equipment)

(Materials/ Equipment) •

•Safety equipmentSafety equipment

•Transportation equipmentTransportation equipment

•ForkliftForklift

•Truck/tailor Truck/tailor 

•Strapping machineStrapping machine

•Finished productFinished product

•Computerize system for product pickingComputerize system for product picking

With Who?

With Who?

(Competence/Skills/Training)

(Competence/Skills/Training) •

•Trained personnelTrained personnel

•Qualified Driver Qualified Driver 

Process

Process

Delivery Control Delivery Control How? How? (Methods/ Procedures/Techniques) (Methods/ Procedures/Techniques) •

•Handling & delivery work Handling & delivery work instructor instructor 

•Labeling requirementLabeling requirement

•Packaging requirementPackaging requirement

•On-time (EDI) systemOn-time (EDI) system

•Training procedureTraining procedure

With What Key Criteria?

With What Key Criteria?

(Measurement? Assessment)

(Measurement? Assessment) •

•On-time delivery performanceOn-time delivery performance

•Error rateError rate

•Customer satisfaction scoreCustomer satisfaction score

•No customer No customer complaint/claicomplaint/claimm

•Field return reportField return report

•Premier freightPremier freight

Inputs

Inputs •

•Customer specific requirementCustomer specific requirement

•Delivery scheduleDelivery schedule

•Delivery note/ invoice/documentsDelivery note/ invoice/documents

•Storage inventory levelStorage inventory level

Output

Output •

•Conforming productConforming product

delivery on time

delivery on time

Annex E

Annex E

(7)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What? With What? (Materials/ Equipment) (Materials/ Equipment) • •CAD/CAMCAD/CAM With Who? With Who? (Competence/Skills/Training) (Competence/Skills/Training) •

•Product design skill personnelProduct design skill personnel

Process

Process

Design (7.3)

Design (7.3)

(input

(input output)output)

How?

How?

(Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques)) •

•Design procedureDesign procedure

• APQP manual APQP manual

•MathMath

With What Key Criteria?

With What Key Criteria?

(Measurement/Assessment)

(Measurement/Assessment) •

•Design error rateDesign error rate

•Drawing complianceDrawing compliance

•Product lifeProduct life

•TimelinessTimeliness

Inputs

Inputs •

•Customer requirement/SCCustomer requirement/SC

•DOEDOE

•Block DiagramBlock Diagram

•DFMEADFMEA

•Timing planTiming plan

•Regulatory requirementRegulatory requirement

•Functional & performanceFunctional & performance

requirement

requirement

•Previous similar designPrevious similar design

•Field dataField data

•Competitor analysisCompetitor analysis

•Timing planTiming plan

•Preliminary process flow chartPreliminary process flow chart

•Design goalDesign goal

Output

Output •

•Designed productDesigned product

Meet design input

Meet design input

•Design records e.g. drawingDesign records e.g. drawing

Annex F

Annex F

(8)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What? With What? (Materials/Equipment) (Materials/Equipment) • •OverheadOverhead •

•Meeting roomMeeting room

With Who? With Who?

(Competence/Skills/Training) (Competence/Skills/Training) •

•Top management &Top management &

management team management team

Process

Process

Management Review Management Review (Target 5.6) (Target 5.6) How? How? (Methods/ Procedures/ (Methods/ Procedures/ Techniques) Techniques) • •MeetingMeeting •

•VDO ConferenceVDO Conference

•Verify reportVerify report

With What Key Criteria? With What Key Criteria? (Measurement/Assessment) (Measurement/Assessment) •

•Customer satisfactionCustomer satisfaction

•Improvement trendImprovement trend

(of process/product)

(of process/product)

•Status of CAR/PARStatus of CAR/PAR

•External nonconformitiesExternal nonconformities

Inputs

Inputs

•QMS requirementQMS requirement

•Business planBusiness plan

•Process performance and analysisProcess performance and analysis

•Field failure/impactField failure/impact

•Submit resultSubmit result

•Customer feedbackCustomer feedback

•CA/PA statusCA/PA status

•Follow up action form previousFollow up action form previous

•Recommendation for improvementRecommendation for improvement

•Policy/objectPolicy/object

•Product conformitiesProduct conformities

•Yearly planYearly plan

•IQA PlanIQA Plan

•Quality poling/objective frameworkQuality poling/objective framework

identification

identification

Output Output •

•Decision & action related toDecision & action related to

•Improvement process, QMSImprovement process, QMS

•Product related customer Product related customer 

satisfaction

satisfaction

*recommendati

*recommendation for on for improvementimprovement

Annex G

(9)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What? With What? (Materials/Equipment) (Materials/Equipment) • •InternetInternet • •TelephoneTelephone •

•Customer P/OCustomer P/O

With Who? With Who?

(Competence/Skills/Training) (Competence/Skills/Training) •

•Trained staffsTrained staffs

Process

Process

Contract Review Contract Review How? How? (Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques)) •

•Contact review procedureContact review procedure

•WIWI

• APQP manual APQP manual

•Feasibility review processFeasibility review process

With What Key Criteria? With What Key Criteria? (Measurement/Assessment) (Measurement/Assessment) •

•Sale volumeSale volume

•Win in biddingWin in bidding

No. of enquiring/order?

No. of enquiring/order?

Inputs Inputs •

•Production capabilityProduction capability

•DrawingDrawing

•Customer requirementCustomer requirement

•Product requirementProduct requirement

•Regulatory requirementRegulatory requirement

•Delivery requirementDelivery requirement

Output Output •

•Getting Order Getting Order 

•Quotation issuingQuotation issuing

Annex H

(10)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What?

With What?

(Materials/Equipment)

(Materials/Equipment)

CAD/ CAM Program

CAD/ CAM Program

Computer 

Computer 

Raw material

Raw material

Strength test equipment

Strength test equipment

With Who? With Who? (Competence/Skills/Training) (Competence/Skills/Training)  APP Team  APP Team

Product design engineer 

Product design engineer 

Process design engineer 

Process design engineer 

Design & Development

Design & Development

How?

How?

(Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques))

Strength test institution

Strength test institution

 APQP Manual  APQP Manual PPAP Procedure PPAP Procedure FMEA Manual FMEA Manual Control Plan Control Plan

With What Key Criteria?

With What Key Criteria?

(Measurement/Assessment) (Measurement/Assessment) PPM PPM Scrap rate Scrap rate Cp Cpkk Inputs Inputs Customer requirement Customer requirement ECN ECN Regulatory requirement Regulatory requirement

Previous similar design

Previous similar design

Target for product quality

Target for product quality

Output

Output

Product conform to

Product conform to

strength test specification

(11)

Process: Process design & development

Process: Process design & development

Process: Process design & development

Process: Process design & development

Process owner: APQP Team

Process owner: APQP Team

Process owner: APQP Team

Process owner: APQP Team

Process Input;

Process Input;

Process Input;

Process Input;

Customer requirement

Customer requirement

ECN

ECN

Regulatory requirement

Regulatory requirement

Previous similar design

Previous similar design

(12)

Process Activities

Process Activities

Process Activities

Process Activities

Design Planning

Design Planning

Design input review

Design input review

Design output review

Design output review

Design verification

Design verification

Design validation

Design validation

Design change control

Design change control

(13)

Support Activities

Support Activities

Support Activities

Support Activities

Production; preparation of work instruction, train

Production; preparation of work instruction, train

operator 

operator 

QC; inspection, MSA

QC; inspection, MSA

Maintenance; tools equipment making/ maintenance

Maintenance; tools equipment making/ maintenance

Sale; receiving of customer requirement & feedback

Sale; receiving of customer requirement & feedback

Management; Management review

Management; Management review

Purchasing; purchasing of material

Purchasing; purchasing of material

HR; Training

HR; Training

(14)

Interface/ Linage

Interface/ Linage

Interface/ Linage

Interface/ Linage

• • Customer Customer  • • Supplier Supplier  • • HRHR • • ProductionProduction • • MaintenanceMaintenance

Process flow diagramProcess flow diagram

DrawingDrawing

Special CharacteristicSpecial Characteristic

FMEAFMEA

Control planControl plan

Working struction/ Job instructionWorking struction/ Job instruction

Product for approvalProduct for approval

Output

(15)

Measurement

Measurement

Measurement

Measurement

• •

Time

Time

• •

Correctness

Correctness

• •

Pp

Pp

k k

> 1.67

> 1.67

Reference Document/ Necessary Information

Reference Document/ Necessary Information

 APQP Procedure

 APQP Procedure

Customer requirement

Customer requirement

Regulatory requirement

Regulatory requirement

Functional requirement

Functional requirement

(16)

Material/ Equipment

Material/ Equipment

Material/ Equipment

Material/ Equipment

Computer (CAD/CAM)

Computer (CAD/CAM)

Sample part

Sample part

Jig/ Fixture

Jig/ Fixture

Production machine (press, machining, etc.)

Production machine (press, machining, etc.)

(17)

Process Audit Preparation “Turtle Diagram”

Process Audit Preparation “Turtle Diagram”

With What? (

With What? (

ท฀฀

ท฀฀

ด้

ด้

วยอะไร

วยอะไร

))

(Materials/Equipment)

(Materials/Equipment)

•Spare partSpare part

•Special purpose toolsSpecial purpose tools

•Measuring equipmentMeasuring equipment

With Who? (

With Who? (

ท฀฀

ท฀฀

โดยใคร

โดยใคร

))

(Competence/Skills/Training)

(Competence/Skills/Training)

•Trained personnel (Service)Trained personnel (Service)

Process

Process

ServicingServicing Repair  Repair  Maintenance Maintenance Service agreement (7.5.1.8) Service agreement (7.5.1.8) How? ( How? (

ท฀฀

ท฀฀

อย่

อย่

งไร

งไร

)) (Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques))

•Work instructionWork instruction

•Service ManualService Manual

With What Key Criteria?

With What Key Criteria?

( (

วั

วั

ดผลลั

ดผลลั

พธ์

พธ์

ด้

ด้

วยเกณฑ์

วยเกณฑ์

อะไร

อะไร

)) (Measurement/Assessment) (Measurement/Assessment) • •TimelinessTimeliness •

•Error rateError rate

•No returned job with some issuesNo returned job with some issues

& side effect & side effect Inputs (

Inputs (

 ใช้

 ใช้

ข้อมู

ข้อมู

ลอะไร

ลอะไร

))

•Warranty period documentWarranty period document

•Customer specificCustomer specific

requirement requirement

Output (

Output (

ผลลั

ผลลั

พธ์

พธ์

))

•Service provided withinService provided within

Warranty period Warranty period

•On-time correct serviceOn-time correct service

Conform to customer  Conform to customer  requirement

(18)

1. Process Input (what do you need?)

1. Process Input (what do you need?)

1. Process Input (what do you need?)

1. Process Input (what do you need?)

Warranty period document

Warranty period document

Customer specific requirements

Customer specific requirements

Service agreement and contract (

Service agreement and contract (

 จะเป็น

 จะเป็น

output

output

ถ้

ถ้

เป็น

เป็น

7.2

7.2

audit,

audit,

 จะเป็น

 จะเป็น

input

input

ถ้

ถ้

เป็น

เป็น

7.5 audit)

7.5 audit)

Work instruction

Work instruction

Trained personnel (skill, experience)

Trained personnel (skill, experience)

(19)

2. Process Activities

2. Process Activities

2. Process Activities

2. Process Activities

Pre-inspection/ diagnosis

Pre-inspection/ diagnosis

Repairing Service

Repairing Service

Maintenance Service

Maintenance Service

Testing

Testing

3. Support Process

3. Support Process

Contract Review

Contract Review

Feasibility Review

Feasibility Review

Training

Training

Production part/ spare part

Production part/ spare part

Tools & equipment

Tools & equipment

maintenance

maintenance

(20)

4. Linkage/ Interface

4. Linkage/ Interface

4. Linkage/ Interface

4. Linkage/ Interface

• •

Customer 

Customer 

• •

Engineering

Engineering

• •

Safety

Safety

• •

Financial

Financial

5. Process Output

5. Process Output

Service conformed to customer 

Service conformed to customer 

6. Measurement (for process efficiency &

6. Measurement (for process efficiency &

effectiveness)

effectiveness)

Timeliness (Response time)

Timeliness (Response time)

Field return rate (Returned job)

Field return rate (Returned job)

(21)

7. Audit Planning (Activities for preparation)

7. Audit Planning (Activities for preparation)

7. Audit Planning (Activities for preparation)

7. Audit Planning (Activities for preparation)

Identify Process

Identify Process

 Analyze Process

 Analyze Process

Risk Analysis (input/output) and Audit Prioritize

Risk Analysis (input/output) and Audit Prioritize

Follow up issue for previous audit

Follow up issue for previous audit

Internal and External

Internal and External

 Audit plan (Sequence/ process step,

 Audit plan (Sequence/ process step,

timing, interview partners)

timing, interview partners)

(22)

8.

8.

8.

8.

Fact verified during the audit

Fact verified during the audit

Fact verified during the audit

Fact verified during the audit

 Are those any organization service center?

 Are those any organization service center?

 Any special purposed tools

 Any special purposed tools

Who conducted diagnosis, repair, maintenance?

Who conducted diagnosis, repair, maintenance?

What are services documents?

What are services documents?

 Are spare parts appropriate provided?

 Are spare parts appropriate provided?

How is inspection/ Testing conducted

How is inspection/ Testing conducted

 Are measuring drive calibrated?

 Are measuring drive calibrated?

(23)

 Analysis of Internal Audit Process

 Analysis of Internal Audit Process

With What? (

With What? (

ท฀฀

ท฀฀

ด้

ด้

วยอะไร

วยอะไร

))

(Materials/Equipment)

(Materials/Equipment)

• Audit checklist Audit checklist

•Turtle diagramTurtle diagram

With Who? ( With Who? (

ท฀฀

ท฀฀

โดยใคร

โดยใคร

)) (Competence/Skills/Training) (Competence/Skills/Training) • •IndependenceIndependence • •TrainedTrained • •SkiSki • •ExportExport

Internal Audit

Internal Audit

(QMS Audit)

(QMS Audit)

How? ( How? (

ท฀฀

ท฀฀

อย่

อย่

งไร

งไร

)) (Methods/

(Methods/ Procedures/TechniquesProcedures/Techniques))

•Work instructionWork instruction

•Service ManualService Manual

With What Key Criteria?

With What Key Criteria?

( (

วั

วั

ดผลลั

ดผลลั

พธ์

พธ์

ด้

ด้

วยเกณฑ์

วยเกณฑ์

อะไร

อะไร

)) (Measurement/Assessment) (Measurement/Assessment) • •StrengthStrength •

•Weak point/ observationWeak point/ observation

•NonconformitiesNonconformities

•Improvement itemsImprovement items

•No. external nonconformitiesNo. external nonconformities

Inputs ( Inputs (

 ใช้

 ใช้

ข้

ข้

อมู

อมู

ลอะไร

ลอะไร

)) • •ObjectiveObjective • •FrequencyFrequency • •QMS requirementQMS requirement • •QMS StatusQMS Status •

•Customer ComplaintCustomer Complaint

•NonconformitiesNonconformities

Output (

Output (

ผลลั

ผลลั

พธ์

พธ์

))

(24)

Supporting Process (Who help)

Supporting Process (Who help)

Supporting Process (Who help)

Supporting Process (Who help)

Management Review

Management Review

• •

Training

Training

Interface/ Linkage

Interface/ Linkage

• •

 Auditee

 Auditee

Management of audit area

Management of audit area

Top Management

Top Management

Process Input

Process Input

Know QMS status

Know QMS status

(25)

Necessary Information for Audit

Necessary Information for Audit

Necessary Information for Audit

Necessary Information for Audit

Procedure, Quality Manual

Procedure, Quality Manual

Customer requirement

Customer requirement

Regulatory requirement

Regulatory requirement

 Audit Process

 Audit Process

Process Owner : QMR

Process Owner : QMR

Lead auditor 

Lead auditor 

 Auditor 

 Auditor 

(26)

Process Input

Process Input

Process Input

Process Input

• •

Objective

Objective

• •

Frequency

Frequency

• •

Status of QMS

Status of QMS

Customer Complaint

Customer Complaint

Nonconformities

Nonconformities

QMS Requirement

QMS Requirement

Material & Equipment Activities

Material & Equipment Activities

 Audit program planning

 Audit program planning

 Audit Plan/ schedule

 Audit Plan/ schedule

 Auditor team assignment

 Auditor team assignment

(27)

Process analysis

Process analysis

Checklist preparation

Checklist preparation

 Audit schedule confirmation

 Audit schedule confirmation

Follow-up issues of prior audits

Follow-up issues of prior audits

On-site audit

On-site audit

Conclusion of audit findings and audit report

Conclusion of audit findings and audit report

Follow-up audit if necessary

Follow-up audit if necessary

Material Equipment

Material Equipment

Form sheet for recording audit

Form sheet for recording audit

finding

finding

References

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