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

 The automotive industry has been actively auditing suppliers for more than 40 years During World War 2, US skilled workforce went off 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 and was combined in 1956 in the first Military (Mil) Specification (Std) 8959

History of Automotive Auditing

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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

History of Automotive Auditing

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Development of AUTOMOTIVE CORE TOOLS:

1. 2. 3. 4. 5.

Measurement System Analysis (MSA):1990 Statistical Process Control (SPC):1992 Production Part Approval Process (PPAP):1993 Failure Mode and Effects Analysis (FMEA):1993 Advance Product Quality Planning and Control Plans (APQP):1994

History of Automotive Auditing

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 Fords Q-101, GMs Targets for Excellence was combined to form Quality System Requirements for 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

History of Automotive Auditing

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 Global automotive industry decided to devise one standard to replace the variety of national standards Developing a single global standard under the ISO that went beyond requirements of ISO 9001:9004 was challenging US and European automotive manufacturers developed the International Automotive Task Force (IATF) to have an common standard

History of Automotive Auditing

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 At that point, ISO was resisting developing industry specific standards Given the size of the worldwide automotive industry, ISO approved the first ISO technical specification (TS) 16949 which came out in 1999 This standard was based on the QS-9000 and the German VDA 6 An oversight board was created too be a link between ISO and the IATF, which was called International Automotive Oversight Bureau (IAOB)

History of Automotive Auditing

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 In reference to ISO/TS 16949, the ISO states: The document is a common automotive quality system requirements catalog based on ISO 9001:2000, AVSQ (Italian), EAQF (French), QS9000 (US), and VDA 6.1 (German) automotive catalogs. This document, coupled with customerspecific requirements, defines quality system requirements for use in the automotive supply chain

History of Automotive Auditing

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 The ISO/TS 16949 specification is an industry-specific version of ISO 9001 ISO/TS 16949 Standard titles as Quality Management Systems Particular Requirements for the Application of ISO 9001:2008 for AUTOMOTIVE Production and Relevant Service Part Organizations ISO/TS 16949 specification adds supplemental requirements unique to the automotive industry Supplemental requirements are referred as the Automotive Core 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 of ISO 9001:2008. The sector-specific supplement requirements are outside the boxes.

ISO 9001 & ISO/TS 16949 Basics

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1. 2. 3. 4. 5.

Advance Product Quality Planning (APQP) Production Part Approval Process (PPAP) Failure Mode and Effects Analysis (FMEA) Measurement System Analysis (MSA) Statistical Process Control (SPC)

Note: Evaluating an ISO/TS 16949 QMS requires that the auditor understand the requirements of these automotive-specific requirements and how they fit within the overall structure of QMS.

Automotive Core Tools

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1. Advance Product Quality Planning (APQP) This methodology provides common guidelines for a structured approach for defining and establishing the steps needed to ensure a quality product and robust production processes. It provides a framework to pull together the other requirements and tools in ISO/TS 16949 and associated reference manuals Audit questionsnext slide

ISO/TS 16949:2009 Automotive Core Tools:

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 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?

Advance Product Quality Planning (APQP)-Audit Questions

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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 produce product consistently meeting these requirements during an actual production run at the quoted production rate Audit questionsnext slide

ISO/TS 16949:2009 Automotive Core Tools:

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 Are data available for all parts that have not 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?
Production Part Approval Process (PPAP)-Audit questions
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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 to improve current and future product and process designs Audit questionsnext slide

ISO/TS 16949:2009 Automotive Core Tools:

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 Are true cross-functional teams used (versus one person doing all the work)? Have plant-specific occurrence and detection tables been developed? If not, then the process will not work the way it is intended 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 plans and work instructions? Have there been past problems that the FMEA should have caught? What is management doing to correct it? How is the FMEA being used as a preventive tool?

Failure Mode and Effects Analysis (FMEA)-Audit questions

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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 evaluation Audit questionsnext slide

ISO/TS 16949:2009 Automotive Core Tools:

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 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?

Measurement System Analysis (MSA)-Audit 18 questions

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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

ISO/TS 16949:2009 Automotive Core Tools:

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 Do all the key processes have statistical process charts to monitor how the processes are doing? Are statistical tools appropriately used? Are the charts updated in real time and do the operators have the tools and authority to make appropriate changes as indicated by charts? Are trends, runs, patterns responded to in a timely and appropriate manner? Is everyone in the organization trained to understand and use statistical information?

Statistical Process Control (SPC) Audit questions

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Audit questions: Are the data being collected in this area important? Is there too much data collection? Have the measurements for the processes been identified and is the data correlated to the process? Have linkages between the processes and the measurements been identified and correlated? Automotive core tools (FMEA, SPC, MSA) manuals is the foundation for collecting and analyzing data. Please refer the SUPPLEMENT for Auditing the Automotive Core Tools

Auditing Statistical Data Analysis (Automotive Core Tools)

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Audit and Corrective action Quality Planning and Design Analysis and Improvement Management Responsibility Resource and support processes Process Audit Checklist 1 Area Manager/Owner Process Audit Checklist 2 Basic Production Process Process Audit Checklist 3 Basic Storage, Inventory and Preservation Note: Please find all above audit checklists with example audit questions are included in the course material

ISO/TS 16949:2009 List of Audit Checklists

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INTEGRATING ISO 9001 QMS TO ISO/TS 16949 AUTOMOTIVE

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 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 monitoring and corrective action component An improvement process

Conducting IMS
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 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

Benefits of Integrated Audits

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 QMS, Automotive controls for a process are often interdependent; evaluating one form of control provides important information on other controls For 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)

Benefits of Integrated Audits

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

Quality Management System
General Requirements

Resource Management

Documentation

Provision of resource

Human resources

Infrastructure

Work environment

Management Responsibility
Management Commitment Customer focus Quality policy
Responsibility, authority, and communication

Planning

Management review

Product and/or Service Realization

Planning for product realization

Customerrelated processes

Design and development

Purchasing

Product and service provision

Control of measurement devices

Primary Customer Value chain Customer Measurement, analysis and Improvement Customer

General

Monitoring and measurement

Control of nonconforming product

Analysis of data

Improvement

Resource and Support Processes Resource and Support Processes Document control Customer Record control

Purchasing

Training

Figure B QMS/Auto Audit Grouping

Order Generation and Quality Planning Process design and development Order generation Product design and development Product verification Production Planning Production

Production

Packaging and labelling

Storage and Distribution

Control of NCP

Customer Maintenance Tooling management Production Support Internal audits Calibration and testing

Corrective and preventive action

Customer satisfaction monitoring

Management review

QMS planning

Quality objectives

Continual improvement

Analysis of data

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Management Responsibility AIMS

Monitoring, Measurement, and Improvement

Various standards have significant areas of commonality, these can be leveraged by conducting integrated audits of these processes as following: Planning Process and Operational Controls Measurement, Analysis and Improvement Management Responsibility Resource and Common Support Processes

Areas of Commonality
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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

Areas of Difference
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Tips for Integrated QMS/Auto Audits steps: 1. It is recommended that the organization should first combine its QMS & Automotive common system 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

IMS Audits
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 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

Auditor Responsibility for IMS Audits

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Activities in service organization can be visualized by replacing the term product with service. Example: For a hospital, order generation and quality planning might become initial patient assessment and treatment planning

Production can be replaced by delivery of patient care

Production support activities can be replaced by treatment support like pharmacy operations, facilities and equipment maintenance, and nutrition planning

Integrating QMS with support services

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1. 2. 3. 4. 5.

Clause 4: Quality Management System Clause 5: Management Responsibility Clause 6: Resource Management Clause 7: Product and/or Service realization Clause 8: Measurement, analysis and improvement
Refer Figure 1 QMS/TS 16949 Model

Referring Five Primary Clauses of ISO 9001:2008

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1. 2. 3. 4. 5. 6.

Order generation and quality planning Product and / or Service realization Production / Service support Resource and support processes Monitoring, Measurement and Improvement Management Responsibility
Refer Figure 1: ISO 9001 & ISO/TS 16949 QMS Model Refer Figure 2: QMS-Automotive Audit Groupings Refer QMS, Automotive Audit Check lists Refer QMS Process Matrix Refer Supplement for Auditing Core Automotive Tools

Five Clauses Grouped into Six Audit Groupings / Operational components of QMS-Auto
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Top six witness audit issues: Readiness review incomplete by top management Not auditing to the process approach Lack of auditing either the customer specific requirements or core tool Failure to audit all shifts in operation Failure to write clear, complete findings

Audit Issues
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 As a powerful tool to measure the effectiveness of QMS, EMS, OHSAS and other management system standards Evaluates manufacturers compliance with Good Manufacturing Practice (GMP) in all aspects related production and quality control Detects any shortcomings in the implementation of GMP Recommend the necessary corrective and preventive actions

Roles of Auditor
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 Ensures quality in design, approval, monitoring and evaluation of products should comply ISO requirements Ensures quality in ISO implementation and its strategies Ensures quality in appointment, development and performance of staff and key personnel

Scope of Auditor
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 Ensures quality in obtaining and responding to the feedbacks from customers, consumers, employers, employees, government authority and other relevant institutions Includes all written quality documents, instructions and records Covering all elements of GMP including results of previous internal quality audit and any corrective and preventive actions (CAPA) taken

Scope of Auditor
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 Auditing should be seen as a positive process not a fault finding Audits need to be documented Prior to the audit date, an auditor needs to review the quality system documentation, corrective and preventive actions, and past audit findings and develop a checklist During an audit, an auditor need to see evidences that the processes are being done in accordance to procedures and policies

Audit Guidance
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 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

Audit Documentation
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 Objectives Audit scope Identification of audit team leader and members Date and place where the on-site audit activities were conducted Audit criteria and findings Conclusions

Audit Report
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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

Audit Closure
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 Integrated audits are more efficient & more effective than independent audits Additional Planning and auditor training will be needed to successfully conduct integrated audits, the long term benefits far outweigh the short term costs Fewer audits to manage Audits will be more productive, less effort to perform It will reinforce the processes and systems approach to management

Summary
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Refer Auditors ISO 19011:2002 Reference Guide Refer Cross walk ISO 19011:2011 & 2002

ISO 19011:2011 Standard for Auditor Reference

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