Process Analysis

Annex A

Process Audit Preparation “Turtle Diagram” With What? (Materials/Equipment) Computerized system Fax

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

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Inputs BOM Purchasing Requisition Customer requirement (approve-source) Regulatory requirement Production schedule •

Process

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

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

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

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

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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 •

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

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Inputs QMS requirement Feedback of information from service Customer requirement Special characteristic Production schedule Delivery schedule Regulatory requirement Quality target •

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Process Defrost grill assembly

Output Defrost grill conform to customer requirement/ regulatory •

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

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

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Annex C

Process Audit Preparation “Turtle Diagram” With What? (Materials/Equipment) Purchasing data base BOM

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

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Inputs Delivery schedule Supplier schedule  Approved supplier list Customer requirement  Approved source Purchase requisition Regulatory requirement Records of supplier performance Product requirement (design record) Production schedule  Acceptance criteria

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Process Purchasing (75% component of 7.4.1)  Are outsource from 2 suppliers

Output On-time delivery Conforming purchased product •

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How? (Methods/ Procedures/Techniques Procedures/Techniques)) Supplier selection procedure Supplier development method Purchasing procedure Purchased product control instruction •

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With What Key Criteria? (Measurement/Assessment) Timeliness Cost of material (part) Quality of materials (part) Quick resource for any problem concerned with material/part •

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Annex D

Process Audit Preparation “Turtle Diagram” With What? (Materials/ Equipment) Process equipment & machine Testing machine Material •

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

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

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Output DFMEA which can prevent tensile strength failure

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With What Key Criteria? (Measurement? Assessment) Fail rate PPM Defect rate •

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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

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

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Inputs Customer specific requirement Delivery schedule Delivery note/ invoice/documents Storage inventory level •

Process Delivery Control

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Output Conforming product delivery on time •

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

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

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Annex F

Process Audit Preparation “Turtle Diagram” Inputs Customer requirement/SC DOE Block Diagram DFMEA Timing plan Regulatory requirement Functional & performance requirement Previous similar design Field data Competitor analysis Timing plan Preliminary process flow chart Design goal •

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With What? (Materials/ Equipment) CAD/CAM •

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

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

Process

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Design (7.3) (input output)

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How? (Methods/ Procedures/Techniques Procedures/Techniques)) Design procedure  APQP manual Math •

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

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Annex G

Process Audit Preparation “Turtle Diagram” With What? (Materials/Equipment) Overhead Meeting room

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

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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 •

Process

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Management Review (Target 5.6)

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Output Decision & action related to Improvement process, QMS Product related customer  satisfaction *recommendation *recommendati on for improvement •

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

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

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Annex H

Process Audit Preparation “Turtle Diagram” With What? (Materials/Equipment) Internet Telephone Customer P/O

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

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Inputs Production capability Drawing Customer requirement Product requirement Regulatory requirement Delivery requirement •

Output Getting Order  Quotation issuing

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Process

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Contract Review

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How? (Methods/ Procedures/Techniques Procedures/Techniques)) Contact review procedure WI  APQP manual Feasibility review process •

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

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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 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

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ECN

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Regulatory requirement

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Previous similar design

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Target for product quality

Process Activities •

Design Planning

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Design input review

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Design output review

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Design verification

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Design validation

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Design change control

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PPAP

Support Activities •

Production; preparation of work instruction, train operator 

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QC; inspection, MSA

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Maintenance; tools equipment making/ maintenance

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Sale; receiving of customer requirement & feedback

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Management; Management review

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Purchasing; purchasing of material

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HR; Training

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Engineering; packing standard etc.

Interface/ Linage Output

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Customer  Supplier  HR Production Maintenance

      

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

Measurement •

Time

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Correctness

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Ppk > 1.67

Reference Document/ Necessary Information •

 APQP Procedure

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Customer requirement

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Regulatory requirement

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Functional requirement

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Company policy

Material/ Equipment

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Computer (CAD/CAM)

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Sample part

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Jig/ Fixture

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Production machine (press, machining, etc.)

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Inspection tool

Process Audit Preparation “Turtle Diagram”

ท฀ด้ ฀ ด้วยอะไร วยอะไร)

With What? ( (Materials/Equipment) Spare part Special purpose tools Measuring equipment

ท฀โดยใคร ฀ โดยใคร

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

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ผลลัพธ์ พธ์

 ใช้ข้ขอ้ มูลอะไร  ใช้ ลอะไร

Inputs ( ) Warranty period document Customer specific requirement •

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ท฀อย่ ฀ อย่งไร งไร

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Process

Servicing Repair  Maintenance Service agreement (7.5.1.8)

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

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

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

วัดผลลั ดผลลัพธ์ พธ์ด้ดวยเกณฑ์ ว้ ยเกณฑ์อะไร อะไร

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1. Process Input (what do you need?) •

Warranty period document

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Customer specific requirements

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Service agreement and contract (

 จะเป็น output ถ้เป็  จะเป็ เป็น 7.2

 จะเป็น input ถ้เป็ เป็น 7.5 audit)

audit, •

Work instruction

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Trained personnel (skill, experience)

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 Any special purposed tools or measuring equipment

2. Process Activities •

Pre-inspection/ diagnosis

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Repairing Service

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Maintenance Service

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Testing

3. Support Process •

Contract Review

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Feasibility Review

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Training

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Production part/ spare part

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Tools & equipment maintenance

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Cost estimation

4. Linkage/ Interface •

Customer 

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Engineering

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Safety

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Financial

5. Process Output •

Service conformed to customer 

6. Measurement (for process efficiency & effectiveness) •

Timeliness (Response time)

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Field return rate (Returned job)

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Error Rate

7. Audit Planning (Activities for preparation) •

Identify Process

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 Analyze Process

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Risk Analysis (input/output) and Audit Prioritize

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Follow up issue for previous audit

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Internal and External

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 Audit plan (Sequence/ process step, timing, interview partners) Create complete checklist

8. Fact verified during the audit •

 Are those any organization service center?

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 Any special purposed tools

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Who conducted diagnosis, repair, maintenance?

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What are services documents?

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 Are spare parts appropriate provided?

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How is inspection/ Testing conducted

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 Are measuring drive calibrated? How long does service taken?

 Analysis of Internal Audit Process

ท฀โดยใคร ฀ โดยใคร

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

ท฀ด้ ฀ ด้วยอะไร วยอะไร)

With What? ( (Materials/Equipment)  Audit checklist Turtle diagram

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 ใช้ข้ขอมู  ใช้ อ้ มูลอะไร ลอะไร)

Inputs ( Objective Frequency QMS requirement QMS Status Customer Complaint Nonconformities •

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ผลลัพธ์ พธ์

Internal Audit (QMS Audit)

Output ( ) Known QMS status of QMS •

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ท฀อย่ ฀ อย่งไร งไร

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

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With What Key Criteria? ( (Measurement/Assessment) Strength Weak point/ observation Nonconformities Improvement items No. external nonconformities

วัดผลลั ดผลลัพธ์ พธ์ด้ดวยเกณฑ์ ว้ ยเกณฑ์อะไร อะไร)

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Supporting Process (Who help) •

Management Review

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Training

Interface/ Linkage •

 Auditee

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Management of audit area

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Top Management

Process Input •

Know QMS status

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Improvement of QMS

Necessary Information for Audit •

Procedure, Quality Manual

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Customer requirement

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Regulatory requirement

 Audit Process Process Owner : QMR Lead auditor   Auditor 

Process Process Input •

Objective

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Frequency

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Status of QMS

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Customer Complaint

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Nonconformities

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QMS Requirement

Material & Equipment Activities •

 Audit program planning

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 Audit Plan/ schedule

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 Auditor team assignment

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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