checking and verification training in progress document

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ISO/TS 16949:2009Internal Audit TrainingAutomotive Process Approach Auditing

ISO/TS 16949Internal Audit Training

TRAININGIN

PROGRESS

Participant:…………………………..Trainer:………………………………..Date:…………………………………..

Checking and Verification

Document stating resultsachieved or providing evidence of activities

performed.

aqc :Centre for Knowledge and Skills Enhancement

This training module consists of more than

85 slides of information and workshop practices.

Attached samples of the materials and records

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Course Objectives

> To able to conduct an effective audit using process approach method.> To avoid necessary delay in an audit.> To achieve the ability of writing a good nonconformance report.> To sharpen the skills in interviewing the auditee.> How to see the system weaknesses using gap analysis.>To able to plan and prepare checklist for an audit.> Able to determine what is customer oriented process.> Able to determine what is support process.> Able to determine what is management process.> Using automotive process “turtle” diagram approach auditing

1. Course Objective2. Internal Audit Clause 8.2.23. Quality Management System

Requirements.

ISO/TS 16949Internal Audit TrainingAutomotive Process Approach Auditing

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Internal Audit Clause 8.2.2

ISO 19001:2008

> Conduct internal audit at planned intervals.> System is effectively implemented and maintained.> Plan according to status and importance of the processes.> Auditors shall not audit their own work.> Responsibilities for conducting, reporting and maintaining records.> Take prompt actions without delay.> Follow-up activities include verification of actions.

ISO/TS 16949:2009

> Quality Management System Audit.> Manufacturing Process Audit.> Product Audit.> Internal Audits Plan, processes, activities and shifts.> Internal Auditor Qualification. Education, Work Experience, Training, Audit

Experience.

1. Course Objective2. Internal Audit Clause 8.2.23. Quality Management System

Requirements.


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1.0 Automotive Audit Introduction1. Automotive Audit Introduction2. Automotive Industry Specific 3. Customer Oriented Process4. Support Process5. Management Process 6. Risk Analysis (Turtle Diagram)7. Process Audit Approach8. Nonconformance Analysis

The IATF has mandated an automotive process-based approach to QMS development and implementation, with a greater emphasis on meeting customer's needs. Organizations must clearly stress the important elements of Customer Oriented Processes (COP's), including:

>Process ownership, ……….. definition, customer-focused process objectives, controls, ………… and interaction

>Process …………………………… for process improvement

>Process effectiveness in meeting ……………………………………………………………………….


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2.0 Automotive Industry (IATF) Specific RequirementProcess Categorization

1. Automotive Audit Introduction2. Automotive Industry Specific 3. Customer Oriented Process4. Support Process5. Management Process 6. Risk Analysis (Turtle Diagram)7. Process Audit Approach8. Nonconformance Analysis

What is a process?

An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.

A process can be as "small" as a task someone has to do, such as entering data into a computer. A somewhat larger process would involve several people within a certain department to complete something, such as putting together and implementing a new marketing campaign. A process can also span several departments who all have to work together for a common goal, such as developing, producing and releasing a new product or service.


INPUT Process OUTPUT RESULTS

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2.0 Automotive Industry (IATF) Specific RequirementProcess Categorization

1. Automotive Audit Introduction2. Automotive Industry Specific 3. Customer Oriented Process4. Support Process5. Management Process 6. Risk Analysis (Turtle Diagram)7. Process Audit Approach8. Nonconformance Analysis >

> Identify support process.> …………………...process.

> process owner identify.> > > > process monitored, analysed and improved.>


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2.0 Automotive Industry (IATF) Specific RequirementProcess Approach Chart, Octopus Diagram


AutomotiveManufacturing

Plant

Input: Customer has an order

Output: Customer receive the order.

1. You need to identify all the activitiesrelated to receiving customer order.

2. You need to identify all the activities (support process) need to be done that will ensure the customer receive the order.

Input: Customer has acomplaint.

Output: Customer receive correctiveaction on its complaint.


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3.0 Customer Oriented Process (COP)

3.1 market analysis of customer requirements,tender/quotation and order request.> customer representative (5.5.2.1)> >

3.2 product and process design.> apqp (7.1,7.1.1) > acceptance criteria (7.1.2)> > engineering spec (4.2.3.1)>> design planning (7.3.1)> > design Input (incl.special characteristics, all of 7.3.2)> > design review & monitoring (7.3.4,7.3.4.1)> > control plan (7.3.3.2/7.5.1.1)> product design skills if applicable (6.2.2.1)



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4.0 Support Process

> calibration/laboratory control (7.6,7.6.2)> preventive and predictive maintenance (7.5.1.4)> > purchasing (7.4.1,7.4.2,7.4.3)> > infrastructure and work environment (6.3,6.3.1,6.3.2,6.4)> > > > records control (4.2.4)

5.0 Management Process

> internal audits (8.2.2)> > > data analysis (8.4,8.4.1)>



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6.0 Risk Analysis (Turtle Diagram)

> identify, study and reduce risk related to the process.

With what?Materials/Equipments.

With who?Personal involved.

InputWhat should we receive.

OutputWhat should we deliver.

How many?Performance Indicator.

How to do?Methods, Procedures

Techniques.

Process



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7.0 Process Audit Approach

identify what is the customer oriented process: owner identify.: : is documented.: : : is records maintained.

> Identify all the support process.: : output.: : : : with what.

> identify the management process.: approval. : :

Customer Requirements & Order Request

Tooling Facility ManagementPurchasing

TrainingDocument ControlRecords Control

Inspection/VerificationInfrastructure

Management ReviewInternal Audit

Preventive ActionData Analysis

Continual Improvement



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7.0 Process Audit Approach Work Sheet

Customer Oriented Process:……………………………….

Identify Support Process:

> ………………………………… > ……………………………..> ………………………………… > ……………………………..> ………………………………… > ………………………………> ………………………………… > ………………………………> ………………………………… > ………………………………

Identify Management Process> ………………………………… > ……………………………..> ………………………………… > ……………………………..> ………………………………… > ………………………………> ………………………………… > ………………………………> ………………………………… > ………………………………

Production



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7.0 Process Audit Approach Work Sheet


Customer OrientedProcess

Support Process

ManagementProcess

Department MeasurementIndicator


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4. Quality Management System

4.1 General Requirements4.2 Documentation Requirements

5. Management Responsibility

5.1 Management Commitment5.2 Documentation Requirements5.3 Quality Policy5.4 Planning5.5 Responsibility, Authority and Communication5.6 Management Review

6. Resource Management

6.1 provision of Resources6.2 Human Resources6.3 Infrastructure6.4 Work Environment

7. Product Realization

7.1 Planning of Product Realization7.2 Customer-related Processes7.3 Design and Development7.4 Purchasing7.5 Production and Service Provision7.6 Control of Monitoring and Measuring Devices

8. Measurement, Analysis and Improvement

8.1 General8.2 Monitoring and Measurement8.3 Control of Nonconforming Product8.4 Analysis of Data8.5 Improvement

Quality Management System : Requirements

1. Scope : 1.1 General1.2 Application

2. Normative Reference3. Terms and Definitions4. Quality Management System5. Management Responsibility6. Resource Management7.Product Realization8. Measurement, Analysis and

Improvement


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4. Quality Management System

4.1 General Requirements4.2 Documentation Requirements




Improvement

Choose one clause and list what is the audit process approach requirements.


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5. Management Responsibility

5.1 Management Commitment5.2 Documentation Requirements5.3 Quality Policy5.4 Planning5.5 Responsibility, Authority and Communication5.6 Management Review




ImprovementChoose one clause and list what is the audit process approach requirements.


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2.0 Overview

> document originated by International Automotive Task Force (IATF)> IATF consists of automotive OEMS and industry associations.> copyright by ANFIA, CCFA/FIEV, SMMT and VDA.

-Associazione Nazionale Fra Industrie Autombilistiche (ANFIA/Italy)-Comite’des Constructeurs Francais d’Automobiles (CCFA/France)-Society of Motor Manufacturers and Traders (SMMT/UK)-Verband der Automobilindustrie-Qualitata Management Center (VDA-QMC/Germany)

> copyright by vehicle manufacturers DaimlerChrysler, Ford Motor Company, General Motors.

> www.iaob.org> www.vda-qmc.de> www.anfia.it> www.smmt.co.uk> www.iatf-france.com

1. Overview2. Audit Process 3. Audit Days


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2.0 Audit Process

> Stage 1 audit-Readiness Review- description of processes showing the sequence and interaction including

key indicators and performance trends for the previous 12 months minimum.- evidence of all the requirements of ISO/TS 16949:2002 are addressed.- quality manual.- internal audit and management review planning and results from previous

twelve months.- list of qualified internal auditors.- list of customer specific requirements.- customer satisfaction and complaints status, including performance.

> Stage 2 Site Audit- use automotive process approach.

(octopus and turtle diagram)- audit all ISO/TS 16949:2002 clauses, all processes to be audited.- review effectiveness of the implementation.- description of all nonconformities findings.- report to organization within 15 days after end of site audit.- corrective action must be verified and closed within 90 days if the end of the - site audit.

1. Overview2. Audit Process 3. Audit Days


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CAR 4 : ISO/TS 16949 Clause 7.3.6.3

Describe the Clause Title: ………………………………………………………..

Preliminary process capability studies was found not performed for several important product dimensions as indicated in customer’s assembly drawing XYZ 123

8.0 Nonconformance Analysis

Work Sheet : Corrective Taken to Prevent Prevent Recurrence

1. Nonconformance


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CAR 5 : ISO/TS 16949 Clause 7.5.1.4

Describe the Clause Title: ………………………………………………………..

There was no appropriate predictive maintenance methods defined with condition-based monitoring/analysis data recorded, as required.

8.0 Nonconformance Analysis

Work Sheet : Corrective Taken to Prevent Prevent Recurrence

1. Nonconformance


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TRAININGEND


aqc publication : tel:04-8902212 fax:04-8982212 email:[email protected] h/p:0124890690

ISO/TS 16949Internal Audit Training

Checking and Verification

Document stating resultsachieved or providing evidence of activities

performed.

MANUFACTURING PROCESS AUDIT CHECKLIST

OTHER OBSERVATIONS

1. Review the safety measures implemented in the shop (Display / instructions / implementation).

2. Review and evaluate the cleanliness of premises and work environment.

9. Review the target and actual quality performance of the process.

12. Review Tool History Card for verification of tool life and tool history.

13. Review status of routine / periodic maintenance of equipments.

SUMMARY OF FINDINGS (COMPLAINCES & DISCREPENCIES)

SIGNATURE WITH DATE RESPONSE TO ACTION REQUEST RAISED

DISPOSITION ACTION:

ROOT CAUSE:

CORRECTIVE ACTION:

TARGET & RESPONSIBILITY: SIGNATURE WITH DATE (ACTION BY)

SIGNATURE WITH DATE (VERIFIED BY)

MANUFACTURING PROCESS AUDIT CHECKLIST

PROCESS / OPERATION NAME: DATE:

PART NAME: PART NO:

OME NO: OPERATION NO:

AUDITOR: AUDITEE:

EQUIPMENT DETAILS:

TARGET ACTUAL REMARKS

SETUP TIME

CYCLE TIME

SL. NO.

SL. NO. ACTUAL

MANUFACTURING PROCESS OBJECTIVES Vs. ACTUAL Cpk / Ppk VALUE

SL. NO. PRODUCT CHARACTERUSTICS SAMPLE SIZE TARGET ACTUAL

REMARKS

TOOLS MACHINE REMARKS MAINTENANCE OBJECTIVES

TARGET ACTUAL TARGET ACTUAL

ESTIMATED DATA FOR QUALITY, RELIABILITY, MAINTAINABILITY AND

MEASURABILITY

CUSTOMER: ___________________________________________

DATE: _________________________________________

PART NAME: ___________________________________________

PART NO & REV NO: _________________________________________

SL. NO. DESCRIPTION ESTIMATED DATA

1.

QUALITY (IN PROCESS REJECTIONS)

5000-PPM

2. RELIABILITY (MEAN TIME BETWEEN FAILURES)

3.

A.40 T Hitchii (Blanking Operation) 10 Hours

B. 40T Senju (Piercing & Shaving Operation) 10 Hours

4. MEASURABILITY (GAGE REPETABILITY & REPRODUCABILITY)

B. Receiver gauge

TEAM MEMBERS SIGNATURE:

1. 3. 5.

2. 4. 6.

PART DESCRIPTION / NAME : AUDIT DATE :

PART NUMBER (CUSTOMER) : AUDITED BY :

PRODUCT CODE / MODEL : SIFT/TIME :

FINDINGS /EVIDENCES STATUS NCR

1.0 Specification and Drawingsa)b) c) Customer Speificd) Applicable Standardse)

1.1a) Documentation

b)

c)

2.0 Packing Controla)b)

c)d)

3.0 Outgoing Inspectiona) Outgoing/Final Inspection Record

b) Sampling & Checking Method

c) Function Check

4.0 Layout Inspectiona) b) Inspection Resultsc) Record Keeping

5.0 Inprocess Inspectiona) Appearance Inspection & Record

b)

c)

d)

e) Function Test & Others Test

6.0a)b)

c) Material Request & Control Record

7.0 Incoming Inspectiona)

b)

8.0a)

b)

c)d)

PRODUCT AUDIT CHECKLIST

ACTIVITIES

Date of Audit: Area (Department):

Auditor: Signature

Audittee: Signature

Name of Process: Kind of Process Customer Oriented ProcessSupport ProcessManagement Process

Evidence for Process (Tick) Requirements for Processes

Process Owner? Yes No what ? (material, equipment)Documented Owner? Yes No who? (capabilities, qualification)Links Established? Yes No how? (methods, techniques)Is Monitored? Yes No measurement? (objectives, performance)Records Available? Yes No

Name of Supporting Process: Name of the Measurement Indicators:

Name of Documents: ISO/TS 16949 Related Clauses:

Findings: (Written statements of what you have observed or verified)

Conformance? Yes No

Opportunities for Improvement (OFI)

PROCESS APPROACH AUDIT EVIDENCE

Auditor: Date:

Auditee: Department/ Section : of

With What, Equipments, Emails, Microsoft

Availability of the support infrastructure. Confirmation is done through email as records. Customer XYZ order is tracked through Excel. OK

NC

R

OFI

With Who, Training, Knowledge, Skills

OK NCR OFI

OK NCR OFI

How? Instructions, Procedures, Methods

Approval is done for all received orders. Review done by the clerk and tracking on customer delivery date is executed timely.

OK NCR OFI

Inputs: OK NCR OFI

Outputs Copy is given to accounts department for billing. One copy kept in the store. OK NCR OFI

Automotive Process Approach Audit Report

Audit Criteria. Clause/ Ref Process Name Process Suport

Items Audit Evidence Collected Audit Findings

Page

Clause 7.5.1.6, 7.2.1, 7.2.2, 7.2.2.1, 7.2.3

Order Request and Production Planning (Customer Oriented Process (COP)

Microsoft Excel, UBS System, Email, Fax Machine, Telephone

SOP-004-Contract Review, SOP 006-Purchasing, SOP 007-Production Control

Customer acknowledgement of Delivery Order.