Process Analysis

Annex A

Process Audit Preparation “Turtle Diagram”

With What? (Materials/Equipment) •Computerized system •Fax Inputs •BOM •Purchasing Requisition •Customer requirement (approve-source) •Regulatory requirement •Production schedule

With Who? (Competence/Skills/Training) •Trained purchasing staff •Supplier development teams •Financial authorized person

Process

Purchasing (7.4) Supplier selection/ development Monitoring of supplier Purchasing process

How? (Methods/ Procedures/Techniques) •Purchasing procedure •Supplier selection •Supplier performance monitoring •Supplier development process •E-mail

Output •Contour purchased product conform to spec. •On-time receiving

With What Key Criteria? (Measurement/Assessment) •Cost of poor material receiving •Timeliness (on-time) •Material/ product quality •Procedure material shortage •Premier freight

Annex B

Process Audit Preparation “Turtle Diagram”

With What? (Materials/Equipment) •Material, component •Production machine/equipment •Molding, pressing, assembly •Inspection tools, gauges •Assembly jigs •Component parts Inputs •QMS requirement •Feedback of information from service •Customer requirement •Special characteristic •Production schedule •Delivery schedule •Regulatory requirement •Quality target

With Who? (Competence/Skills/Training) •Trained operator •QC

Process

Defrost grill assembly

Output •Defrost grill conform to customer requirement/ regulatory

How? (Methods/ Procedures/Techniques) •Control Plan •Work instruction for job set up verification •Inspection/ Test instruction •SPC •Error proofing •Procedure of stamping, molding

With What Key Criteria? (Measurement/Assessment) •PPM •Quality Cost •Delivery performance •Time for return product test/ analysis and problem solving •Response time •Cpk

Annex C

Process Audit Preparation “Turtle Diagram”

With What? (Materials/Equipment) •Purchasing data base •BOM

With Who? (Competence/Skills/Training) •Trained purchasing •Staff

Inputs •Delivery schedule •Supplier schedule •Approved supplier list •Customer requirement Process Output •Approved source Purchasing •On-time delivery •Purchase requisition (75% component of 7.4.1) •Conforming purchased •Regulatory requirement Are outsource from product •Records of supplier performance 2 suppliers •Product requirement (design record) •Production schedule •Acceptance criteria With What Key Criteria? (Measurement/Assessment) How? •Timeliness (Methods/ Procedures/Techniques) •Cost of material (part) •Supplier selection procedure •Quality of materials (part) •Supplier development method •Quick resource for any problem •Purchasing procedure concerned with material/part •Purchased product control instruction

Annex D

Process Audit Preparation “Turtle Diagram”

With What? (Materials/ Equipment) •Process equipment & machine •Testing machine •Material

With Who? (Competence/Skills/Training) •APPQP team members who trained and skilled in applicable tool •FMEA, DOE, QFD

Inputs •Customer requirements e.g. •Special characteristic •Approval requisition Process •Previous design projects DFMEA Establishing •Field data & updating •Block diagram (7.1, 7.3) •Preliminary process flow chart •Material specification How? (Methods/ Procedures/Techniques) •WI, Procedure far-forging •Testing method/destructive testing (tensile) •Poka yoke •DOE •Feasibility review method •Part approved process

Output DFMEA which can prevent tensile strength failure With What Key Criteria? (Measurement? Assessment) •Fail rate •PPM •Defect rate

Annex E

Process Audit Preparation “Turtle Diagram”

With What? (Materials/ Equipment) •Safety equipment •Transportation equipment •Forklift •Truck/tailor •Strapping machine •Finished product •Computerize system for product picking Inputs •Customer specific requirement •Delivery schedule •Delivery note/ invoice/documents •Storage inventory level

How? (Methods/ Procedures/Techniques) •Handling & delivery work instructor •Labeling requirement •Packaging requirement •On-time (EDI) system •Training procedure

With Who? (Competence/Skills/Training) •Trained personnel •Qualified Driver

Process

Delivery Control

Output •Conforming product delivery on time

With What Key Criteria? (Measurement? Assessment) •On-time delivery performance •Error rate •Customer satisfaction score •No customer complaint/claim •Field return report •Premier freight

Annex F

Process Audit Preparation “Turtle Diagram”

Inputs With What? •Customer requirement/SC (Materials/ Equipment) •DOE •CAD/CAM •Block Diagram •DFMEA •Timing plan •Regulatory requirement •Functional & performance Process requirement Design (7.3) •Previous similar design (input  output) •Field data •Competitor analysis •Timing plan •Preliminary process flow chart •Design goal How? (Methods/ Procedures/Techniques) •Design procedure •APQP manual •Math

With Who? (Competence/Skills/Training) •Product design skill personnel

Output •Designed product Meet design input •Design records e.g. drawing

With What Key Criteria? (Measurement/Assessment) •Design error rate •Drawing compliance •Product life •Timeliness

Annex G

Process Audit Preparation “Turtle Diagram”

With What? (Materials/Equipment) •Overhead •Meeting room Inputs •QMS requirement •Business plan •Process performance and analysis •Field failure/impact •Submit result •Customer feedback •CA/PA status •Follow up action form previous •Recommendation for improvement •Policy/object •Product conformities •Yearly plan •IQA Plan •Quality poling/objective framework identification

With Who? (Competence/Skills/Training) •Top management & management team

Output • & action related to Management Review •Decision Improvement process, QMS (Target 5.6) •Product related customer satisfaction *recommendation for improvement

Process

How? (Methods/ Procedures/ Techniques) •Meeting •VDO Conference •Verify report

With What Key Criteria? (Measurement/Assessment) •Customer satisfaction •Improvement trend (of process/product) •Status of CAR/PAR •External nonconformities

Annex H

Process Audit Preparation “Turtle Diagram”

With What? (Materials/Equipment) •Internet •Telephone •Customer P/O

Inputs •Production capability •Drawing •Customer requirement •Product requirement •Regulatory requirement •Delivery requirement How? (Methods/ Procedures/Techniques) •Contact review procedure •WI •APQP manual •Feasibility review process

With Who? (Competence/Skills/Training) •Trained staffs

Process

Contract Review

Output •Getting Order •Quotation issuing With What Key Criteria? (Measurement/Assessment) •Sale volume •Win in bidding No. of enquiring/order?

Process Audit Preparation “Turtle Diagram”

With What? (Materials/Equipment) CAD/ CAM Program Computer Raw material Strength test equipment Inputs Customer requirement ECN Regulatory requirement Previous similar design Target for product quality

With Who? (Competence/Skills/Training) APP Team Product design engineer Process design engineer

Design & Development

How? (Methods/ Procedures/Techniques) Strength test institution APQP Manual PPAP Procedure FMEA Manual Control Plan

Output Product conform to strength test specification

With What Key Criteria? (Measurement/Assessment) PPM Scrap rate Cpk

Process: Process design & development Process owner: APQP Team Process Input; • • • • •

Customer requirement ECN Regulatory requirement Previous similar design Target for product quality

Process Activities • • • • • • •

Design Planning Design input review Design output review Design verification Design validation Design change control PPAP

Support Activities • • • • • • • •

Production; preparation of work instruction, train operator QC; inspection, MSA Maintenance; tools equipment making/ maintenance Sale; receiving of customer requirement & feedback Management; Management review Purchasing; purchasing of material HR; Training Engineering; packing standard etc.

Interface/ Linage Output • • • • •

Customer Supplier HR Production Maintenance

 Process flow diagram  Drawing  Special Characteristic  FMEA  Control plan  Working struction/ Job instruction  Product for approval

Measurement • Time • Correctness • Ppk > 1.67

Reference Document/ Necessary Information • • • • •

APQP Procedure Customer requirement Regulatory requirement Functional requirement Company policy

Material/ Equipment • • • • •

Computer (CAD/CAM) Sample part Jig/ Fixture Production machine (press, machining, etc.) Inspection tool

Process Audit Preparation “Turtle Diagram”

With What? (ทำำด้วยอะไร) (Materials/Equipment) •Spare part •Special purpose tools •Measuring equipment Inputs (ใช้ข้อมูลอะไร) •Warranty period document •Customer specific requirement

With Who? (ทำำโดยใคร) (Competence/Skills/Training) •Trained personnel (Service)

Process Servicing

Repair Maintenance Service agreement (7.5.1.8)

How? (ทำำอย่ำงไร) (Methods/ Procedures/Techniques) •Work instruction •Service Manual

Output (ผลลัพธ์) •Service provided within Warranty period •On-time correct service Conform to customer requirement

With What Key Criteria? (วัดผลลัพธ์ดว้ ยเกณฑ์อะไร) (Measurement/Assessment) •Timeliness •Error rate •No returned job with some issues & side effect

1. Process Input (what do you need?) • Warranty period document • Customer specific requirements • Service agreement and contract (จะเป็ น output ถ้ำเป็ น 7.2 audit, จะเป็ น input ถ้ำเป็ น 7.5 audit) • Work instruction • Trained personnel (skill, experience) • Any special purposed tools or measuring equipment

• • • •

2. Process Activities Pre-inspection/ diagnosis Repairing Service Maintenance Service Testing

3. Support Process • • • • • •

Contract Review Feasibility Review Training Production part/ spare part Tools & equipment maintenance Cost estimation

• • • •

Customer Engineering Safety Financial

4. Linkage/ Interface

5. Process Output

• Service conformed to customer

6. Measurement (for process efficiency & effectiveness) • Timeliness (Response time) • Field return rate (Returned job) • Error Rate

7. Audit Planning (Activities for preparation)

• Identify Process

• Analyze Process • Risk Analysis (input/output) and Audit Prioritize • Follow up issue for previous audit • Internal and External • Audit plan (Sequence/ process step, timing, interview partners) • Create complete checklist

8. Fact verified during the audit • • • • • • • •

Are those any organization service center? Any special purposed tools Who conducted diagnosis, repair, maintenance? What are services documents? Are spare parts appropriate provided? How is inspection/ Testing conducted Are measuring drive calibrated? How long does service taken?

Analysis of Internal Audit Process

With Who? (ทำำโดยใคร) (Competence/Skills/Training) •Independence •Trained •Ski •Export

With What? (ทำำด้วยอะไร) (Materials/Equipment) •Audit checklist •Turtle diagram Inputs (ใช้ข้อมูลอะไร) •Objective •Frequency •QMS requirement •QMS Status •Customer Complaint •Nonconformities

How? (ทำำอย่ำงไร) (Methods/ Procedures/Techniques) •Work instruction •Service Manual

Internal Audit (QMS Audit)

Output (ผลลัพธ์) •Known QMS status of QMS With What Key Criteria? (วัดผลลัพธ์ดว้ ยเกณฑ์อะไร) (Measurement/Assessment) •Strength •Weak point/ observation •Nonconformities •Improvement items •No. external nonconformities

Supporting Process (Who help) • Management Review • Training

Interface/ Linkage

• Auditee • Management of audit area • Top Management

Process Input

• Know QMS status • Improvement of QMS

Necessary Information for Audit • Procedure, Quality Manual • Customer requirement • Regulatory requirement

Audit Process Process Owner : QMR Lead auditor Auditor

• • • • • •

Process Input Objective Frequency Status of QMS Customer Complaint Nonconformities QMS Requirement

Material & Equipment Activities • • • •

Audit program planning Audit Plan/ schedule Auditor team assignment Document review

Process analysis Checklist preparation Audit schedule confirmation Follow-up issues of prior audits On-site audit Conclusion of audit findings and audit report Follow-up audit if necessary

Material Equipment Form sheet for recording audit finding Reference manual/ requirement