IMS-QMS & Automotive

8/12/2019 IMS-QMS & Automotive

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Integrated Management System (IMS)- ISO

9001:2008 QMS & ISO / TS 16949:2009

Automotive Lead Auditor Course

Akshar Institute of Management Studies (AIMS)

2009-13 copyrights reserved


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History of Automotive Auditing

The automotive industry has been actively

auditing suppliers for more than 40 years

During World War 2, US skilled workforce wentoff for fight. Loss of skilled work force in

manufacturing component industry occurred.Many techniques were developed for quality

parts, a practice of auditing was developed andwas combined in 1956 in the first Military (Mil)

Specification (Std) 8959

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The automotive industry came under the mil-Std 8959A

and also wanted to monitor suppliers

Ford and GM started officially auditing suppliers in 1964

with the release of their standards Q-101 and Supplier

Performance and Evaluation Report (SPEAR), respectively

In Europe, British Standard (BS) 5750 became a national

standard for auditing of suppliers. It was this standard the

International Organization for Standardization (ISO) used

as the first draft of ISO 9001:1987

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Development of AUTOMOTIVE CORE TOOLS:

1. Measurement System Analysis (MSA):1990

2. Statistical Process Control (SPC):1992

3. Production Part Approval Process (PPAP):1993

4. Failure Mode and Effects Analysis (FMEA):1993

5. Advance Product Quality Planning and Control Plans

(APQP):1994

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Fords Q-101, GMs Targets for Excellence was

combined to form Quality System Requirementsfor internal OEM in 1994

It was renamed as QS-9000 and released in 1994.It used the same auditing scheme as ISO

9001:1994 and registrars began auditing

suppliers to new automotive standard

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Global automotive industry decided to devise onestandard to replace the variety of nationalstandards

Developing a single global standard under theISO that went beyond requirements of ISO9001:9004 was challenging

US and European automotive manufacturersdeveloped the International Automotive TaskForce (IATF) to have an common standard

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In reference to ISO/TS 16949, the ISO states:The document is a common automotive qualitysystem requirements catalog based on ISO9001:2000, AVSQ (Italian), EAQF (French), QS-9000 (US), and VDA 6.1 (German) automotivecatalogs. This document, coupled with customer-

specific requirements, defines quality systemrequirements for use in the automotive supplychain

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ISO 9001 & ISO/TS 16949 Basics

The ISO/TS 16949 specification is an industry-specificversion of ISO 9001

ISO/TS 16949 Standard titles as Quality ManagementSystemsParticular Requirements for the Application ofISO 9001:2008 for AUTOMOTIVE Production andRelevant Service Part Organizations

ISO/TS 16949 specification adds supplemental

requirements unique to the automotive industry

Supplemental requirements are referred as the AutomotiveCore Tools

Both the Standards are well Integrated to conduct IMS

Please note while referring ISO/TS 16949 Standard : The boxed text is the original text ofISO 9001:2008. The sector-specific supplement requirements are outside the boxes.

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ISO/TS 16949:2009

Automotive Core Tools:

1. Advance Product Quality Planning (APQP)

This methodology provides common guidelines for astructured approach for defining and establishing thesteps needed to ensure a quality product and robust

production processes.

It provides a framework to pull together the otherrequirements and tools in ISO/TS 16949 and associatedreference manuals

Audit questionsnext slide

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Advance Product Quality Planning

(APQP)-Audit Questions

Has the organization developed an APQP process specific

to the needs of this plant? If not, how do they know they

have successfully completed the APQP process?

Are true cross-functional teams used (versus one person

doing all the work)?

Is the process functional with data being updated

regularly?

Does the top management include data from APQP as an

input to the management review process?

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ISO/TS 16949:2009


2. Production Part Approval Process (PPAP)

This methodology defines generic requirements for

production part approval.

It is used to determine if all customer engineering design

record and specification requirements are properly

understood and the process has the potential to produceproduct consistently meeting these requirements during an

actual production run at the quoted production rate


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Production Part Approval Process

(PPAP)-Audit questions

Are data available for all parts that havenot received formal tool scrap

authorization from the customer?

Are data in a retrievable format? Are sample/master parts available and in a

state as to prevent possible damage?

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ISO/TS 16949:2009


3. Failure Mode and Effects Analysis (FMEA)

This provides general guidelines for preparing a FMEA

of products and processes, including the application

techniques used to conduct the analysis.

It provides guidance on how to use the FMEA toimprove current and future product and process designs


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Failure Mode and Effects Analysis

(FMEA)-Audit questions

Are true cross-functional teams used (versus one person doingall the work)?

Have plant-specific occurrence and detection tables beendeveloped? If not, then the process will not work the way it isintended to!

Are design FMEAs available?

Have all process FMEAs been completed and are they current?

Have data from the FMEA been filtered down to control plansand work instructions?

Have there been past problems that the FMEA should havecaught? What is management doing to correct it?

How is the FMEA being used as a preventive tool?

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ISO/TS 16949:2009


4. Measurement System Analysis (MSA)

This methodology provides an introduction to MSA,

along with guidance on how to conduct measurement

system studies to ensure the quality of data used for

product and product evaluationAudit questionsnext slide

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Measurement System Analysis (MSA)-Audit

questions

Have families of gages been identified?

Are master parts available for each part for the gauging

requirements? Is at least one stability study being done for each family? What

about bias and linearity study?

Does the GR&R include a full graphical analysis as outlined in

the manual? What is being done to study the measurement error in your

plant?

Are any data available to demonstrate continual improvement of

the gauging system?

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ISO/TS 16949:2009


5. Statistical Process Control (SPC)

This methodology provides an introduction to SPC and

presents general guidelines for the selection and application

of statistical techniques to monitor, analyze, and improve

production and supporting processes

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Statistical Process Control (SPC)

Audit questions

Do all the key processes have statistical process charts to

monitor how the processes are doing? Are statistical toolsappropriately used?

Are the charts updated in real time and do the operators havethe tools and authority to make appropriate changes as indicated

by charts?

Are trends, runs, patterns responded to in a timely andappropriate manner?

Is everyone in the organization trained to understand and usestatistical information?

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Auditing Statistical Data Analysis

(Automotive Core Tools)

Audit questions:

Are the data being collected in this area important? Is there toomuch data collection?

Have the measurements for the processes been identified and is thedata correlated to the process?

Have linkages between the processes and the measurements beenidentified and correlated?

Automotive core tools (FMEA, SPC, MSA) manuals is thefoundation for collecting and analyzing data.

Please refer the SUPPLEMENT for Auditing the AutomotiveCore Tools

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INTEGRATING ISO 9001 QMS

TO ISO/TS 16949 AUTOMOTIVE

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Conducting IMS

Common components of the ISO 9001 and ISO/TS

16949 provides an opportunity to conduct IMS

Common components include:

A planning component An operational component

A moni toring and corrective action component

An improvement process

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Benefits of IntegratedAudits

Reinforces the concept of an IMS

It also reinforces the transition from managing functional

elements to managing processes and systems of processes

Auditors can evaluate a holistic process of product and

process planning rather than auditing quality planning,

environment planning, or health and safety system

planning

It provides more efficient audits; auditors can evaluate the

process once, which includes all controls (QMS &

Automotive) relating to that process instead of analyzing

all separately

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Benefits of IntegratedAudits

QMS, Automotive controls for a process are often

interdependent; evaluating one form of control provides

important information on other controlsFor example:

Quality system controls designed to minimize scrap and rework may

directly impact on the organizations ability to reduces its volume of

oily scrap steel and the conserve natural resources.

Evaluating quality and environmental controls at the same time allows

evaluation of these interdependencies & provides for a more effective

audit.

(Refer Figure A. IMS Structure on next slide)

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Figure A. ISO 9001 & ISO/TS 16949 IMS Structure

Customer Customer

Quality Management System Resource Management

General

Requirements

DocumentationProvision of

resource

Human

resourcesInfrastructure

Work

environment

Management Responsibility

Management

Commitment

Customer

focus

Quality

policyPlanning

Responsibility,

authority, and

communication

Management

review

Product and/or Service Realization

Planning for

product

realization

Customer-

related

processes

Design and

developmentPurchasing

Product and

service

provision

Control of

measurement

devices

Primary Customer Value chain

Measurement, analysis and Improvement

GeneralMonitoring

and

measurement

Control of

nonconforming

product

Analysis

of dataImprovement

Resource and Support Processes


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Resource and Support Processes

Monitoring, Measurement, and Improvement

Document

control

Record

controlPurchasing Training

Order Generation and Quality Planning

Process design

and development

Product design

and development

Order

generation

Production

Production

Planning

Production Packaging

and

Storage and

Distribution

Product

verification

Control of

NCP

Customer

Production Support

Maintenance Tooling

management

Calibration

and testingCorrective and

preventive action

Internal

audits

Analysis

of data

Customer

satisfaction

monitoring

Continual

improvement


Management review

QMS

planning

Quality

objectives

Customer

pp

Figure B QMS/Auto Audit Grouping


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Areas of Commonality

Various standards have significant areas of commonality,

these can be leveraged by conducting integrated audits ofthese processes as following:

Planning

Process and Operational Controls Measurement, Analysis and Improvement


Resource and Common Support Processes

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Areas of Difference

Despite the many commonalities between the three

management system standards, some areas requires focused

reviews, the most notable are as follows:

Product design skills

Design and Development Validation-supplement

Prototype program

Product approval process Regulatory conformity

Supplier quality management system development

Customer-approved sources

Laboratory requirements etc

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IMS Audits

Tips for I ntegrated QMS/Auto Audits steps:

1. It is recommended that the organization should first

combine its QMS & Automotive commonsystem audits

2. Then, integrate the Automobile core tools audits into to

its Quality Management System (QMS) audits

Such an audit program will be focused on auditing

processes versus programs or elements and will result in

the most efficient, effective audits

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Auditor Responsibility for IMS Audits

Auditor should be aware of the current status of the

standards

Auditor should be aware of the top management using the

Policies to manage the organization effectively

ISO certificates that are issued by registrars are site

specific

Process identification

Customer identification

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Integrating QMS with support services

Activities in service organization can be visualized byreplacing the termproductwithservice.

Example:

For a hospital, order generationand quality planningmight become initialpatient assessmentand treatment

planning

Production can be replaced by delivery of patient care

Production supportactivities can be replaced by treatmentsupportlike pharmacy operations, facilities and equipment

maintenance, and nutrition planning

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Referring Five Primary Clauses of ISO

9001:2008

1. Clause 4: Quality Management System

2. Clause 5: Management Responsibility3. Clause 6: Resource Management

4. Clause 7: Product and/or Service realization

5. Clause 8: Measurement, analysis andimprovement

Refer Figure 1 QMS/TS 16949 Model

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Five Clauses Grouped into Six AuditGroupings / Operational components of

QMS-Auto

1. Order generation and quality planning

2. Product and / or Service realization

3. Production / Service support

4. Resource and support processes5. Monitoring, Measurement and Improvement

6. Management Responsibility

Refer Figure 1: ISO 9001 & ISO/TS 16949 QMS ModelRefer Figure 2: QMS-Automotive Audit Groupings

Refer QMS, Automotive Audit Check lists

Refer QMS Process Matrix

Refer Supplement for Auditing Core Automotive Tools

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Audit Issues

Top six witness audit issues:

Readiness review incomplete by topmanagement

Not auditing to the process approach

Lack of auditing either the customerspecific requirements or core tool

Failure to audit all shifts in operation

Failure to write clear, complete findings

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Roles of Auditor

As a powerful tool to measure the effectiveness ofQMS, EMS, OHSAS and other management

system standards Evaluates manufacturers compliance with Good

Manufacturing Practice (GMP) in all aspectsrelated production and quality control

Detects any shortcomings in the implementationof GMP

Recommend the necessary corrective andpreventive actions

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Scope of Auditor

Ensures quality in design, approval,

monitoring and evaluation of products shouldcomply ISO requirements

Ensures quality in ISO implementation and

its strategies Ensures quality in appointment, development

and performance of staff and key personnel

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Scope of Auditor ...contd

Ensures quality in obtaining and responding tothe feedbacks from customers, consumers,

employers, employees, government authority andother relevant institutions

Includes all written quality documents,instructions and records

Covering all elements of GMP including resultsof previous internal quality audit and anycorrective and preventive actions (CAPA) taken

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Audit Guidance

Auditing should be seen as a positive process not afault finding

Audits need to be documented Prior to the audit date, an auditor needs to review

the quality system documentation, corrective andpreventive actions, and past audit findings and

develop a checklist

During an audit, an auditor need to see evidencesthat the processes are being done in accordance to

procedures and policies

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Audit Documentation

Audit plan

- should be sent to auditee prior to audit activity- findings from the last audit should be also mentioned

Audit note should include

- an audit questionnaire

- all records and comments during the audit

Audit report is an

- official document to report the audit findings

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Audit Report

Objectives

Audit scope

Identification of audit team leader andmembers

Date and place where the on-site auditactivities were conducted

Audit criteria and findings

Conclusions

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Audit Closure

Follow-up and closing of loop:

Receive a satisfactory response from auditee and

their commitment to correct for any deficiency Ensure Corrective actions / Preventive actions

(CAPA) identify the root cause and they are

satisfactory, accomplished and documented

Timeframe for CAPA is being followed

Verify and track CAPA by scheduling a follow-up

audit

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Documents

IMS-QMS & Automotive