ISO 9001:2000 Implementation – Increasing Value and Reducing Lead Time

- Removing Implementation Roadblocks

Chad Kymal, CEO Omnex

© Omnex All rights reserved

Speaker Biography

Chad Kymal is a widely sought international trainer and consultant whose broad experience includes TQM, setup reduction, technology assessment and inventory analysis, statistical process control, and quality function deployment. He has co-authored or championed most of Omnex's quality training courses. He is on the Malcolm Baldrige Board of Examiners and is an RAB certified Lead Auditor.

He has a Bachelor’s degree Mechanical Engineering from General Motors Institute, a Master's degree in Industrial and Operations Engineering from the University of Michigan, and an MBA from the University of Michigan.

Kymal founded Omnex, Inc., a business/quality management solution provider that offers training to semi-conductor, automotive, manufacturing, and service industries. Omnex has worked with Ford Motor Company, Lucent Technologies, Philips Semiconductor, Magna, and most of the Fortune 500 companies worldwide. Omnex provides over 50 training courses in subject areas ranging from APQP to Six Sigma and has 15 offices worldwide.

Chad is also the founder of AQSR, one of the top five rated Quality System registrars in the US as rated by Quality Digest. Chad and AQSR specialize in providing auditing services in ISO 9000, QS-9000, TE Supplement, TS 16949, VDA 6*, AS-9000 and the ISO 14001 series of international standards.

He also founded Omnex Systems, which provides Omnex's industry-leading Advance Product Quality Planning Software, AQuA®, which is being used by several leading companies in the industry. Currently, Omnex Systems is offering the Enterprise-wide Quality Management System (EwQMS™) Suite, which features AQuA, Audit Pro, Boss, Document Pro, MSA Pro, HR Pro, Process Analyzer, Process Pro, and TPM Pro.

Chad has recently published a book on ISO 9001:2000 auditing for Paton Press, and is working on a book for ISO/TS 16949:2002 auditing. Chad led the Omnex team that helped Ford Motor Company rewrite the QOS methodology. He helped write the QS-9000 requirements and did the first worldwide witness audit for the same.

Chad Kymal worked closely with the Automotive Electronic Council (AEC) to develop the Semiconductor Supplement. He has also helped Visteon and Delphi in developing their customer specific requirement.

Chad was named Executive Director of SAC. He is currently leading SAC to develop a second party/third party auditing process for the semiconductor supply chain. He is also helping SAC remove waste and redundancy in quality system requirements auditing in the semiconductor supply chain.

Agenda

• ISO 9001:2000 Requirements and Deadlines• ISO 9001:2000 Roadblocks and Preventing

them• Transitioning from ISO 9001:1994 – Key

Differences• Creating Value from ISO 9001:2000

Implementation• Creating the culture change and the savings

quickly

About Omnex

• Consulting– Omnex provides leading Quality Management and

Performance Enhancement consulting and training to an extensive array of both service and manufacturing sectors.

• Training– Omnex is the leading provider of quality-focused training to the

manufacturing and service industries.

• Software– Omnex Systems LLC specializes in developing management

improvement software to cater to the needs of a variety of quality management systems.

About Omnex

Offices Worldwide– Brazil– Canada– China– India– Korea– Mexico– Taiwan

– Saudi Arabia– Germany– Thailand– UK– Venezuela

Omnex Systems

EwQMS Suite of Integrated Modules

Agenda

• ISO 9001:2000 Requirements and Deadlines• ISO 9001:2000 Roadblocks and Prevention• Transitioning from ISO 9001:1994 – Key

Differences• Creating Value from ISO 9001:2000

Implementations• Creating the culture change and the savings

quickly

ISO 9001:2000 Requirements and Deadlines

ISO 9001:2000 Process Model

ISO 9000 Series of Standards

Terms and Definitions

Guidance

QMS Requirements

ISO 9000:2000

ISO 9001:2000

ISO 9004:2000

ISO 9001:2000 Registration Process

• Documentation Review

• Onsite Audit

• Corrective Action

• Certificate Issuance

• Surveillance

Steps to ISO 9001:2000 Implementation

Activity Jan Feb Mar Apr

Conduct Discovery Analysis and Assessment

Develop Plan and Strategy Present Executive OverviewForm Team and Initiate ProjectTrain TeamCreate Documentation Plan and Facilitate RolloutFormulate Implementation PlanTrain Internal AuditorsConduct Internal Audit

Conduct Corrective ActionConduct Registeration Audit

ISO 9001:2000 Deadlines

• Organizations need to get registered by Dec.31, 2003 to retain their ISO Certification

• Organizations not upgraded to ISO 9001:2000 will lose their ISO certification

• ANSI/RAB and registrars will not continue to support ISO 9001:1994 past the deadline

ISO 9001:2000 Roadblocks and Prevention

Roadblocks and Problems

• Top Management commitment and involvement• ISO 9001:2000 Implementation seen as a Quality Department

effort• Goal of Implementation is passing the audit• No Plan or leadership for the implementation. • Providing Customer Focus/Measuring Customer Satisfaction• Over documentation• Understanding steps for Process Focus• Implementing a process for continual improvement• Objectives deployment and Business Review• Poor internal audits

Transitioning from ISO 9001:1994 - Key Differences

Transitioning from ISO 9001:1994 - Key Differences

• Process Focus and business process measurement

• Documentation of Procedures

• Customer Focus

• Objectives Deployment

• Management Review

Transitioning from ISO 9001:1994 - Key Differences (cont’d)

• Resources Planning and including Competency

• Customer Satisfaction

• Analysis of Data

• Continual Improvement

Providing Value In ISO 9001:2000 Implementations

Getting Value from Your Implementation

• Set Objectives for your ISO/TS 16949:2002 Implementations– Find crucial senior management problems to work

on – SAVE Money with the implementation

• For example:– Setting business objectives and a management process– Implement Six Sigma or Lean as a part of the continual

improvement process – Save Money– Process and documentation Commonization– Improved Problem solving with lead time and cost savings

target

• Become Process focused –process map, process list, BMS control plans, and alignment charts

Getting Value from Your Implementation (cont’d)

• Use the alignment methodology to become customer focused

• Train your implementation team and Auditors– Use the idea of a BMS and not a QMS

• Use software which has prescribed Best In Class Methods. Use it to optimize the implementation and make it easy. Use web based software– Documentation– Customer Focus and Continual Improvement– New Product Development (FMEAs?)– Process Mapping and Process Flows

• Get your top management involved in the implementation

Creating the culture change and the savings quickly

ISO 9001:2000 Implementation Plan

• Form Overall Objectives and Strategy • Form Team and Train Team • Form ISO and Software Implementation Plan• Develop Documentation• Implement Software Modules – Documentation,

Process Focus, Customer Focus• Train Auditors and Conduct Audit –implement Audit Pro

ISO 9001:2000 Implementation Plan

• Form Overall Objectives and Strategy – Month 1 • Form Team and Train Team – Month 1• Form ISO and Software Implementation Plan – Month 1• Develop Documentation – Month 2• Implement Software Modules – Documentation,

Process Focus, Customer Focus – Month 2 to 4• Train Auditors and Conduct Audit –implement Audit Pro

– Month 5

Month 1

• Conduct Discovery Analysis and formulate overall objectives and strategy for ISO 9001:2000

• Form ISO and Software Implementation Plan • Conduct Executive Overview for Senior Management• Form Team and Train Team

Month 2 – Develop Documentation

• Required Procedures – Most can be reused from ISO 9001:1994 system– Document Control– Records Control– Internal Audit– Non Conforming Product– Corrective Action– Preventive Action

• Review documentation from current system and decide which to keep

• Identify additional value added documentation

Keep documentation to a minimum. Use softwareTo implement and provide evidence of a process

Month 2 to 4 – Implement Software Modules

4.1, 4.2 building the process model, review of process metrics

and managing process variation.

4.2 document management.

5.1 - 5.4, 6.1 managing customer expectations, customer satisfaction,

continual improvement, and data analysis. 5.5 6.2, 6.4 human performance management functions, competency,

training management and satisfaction surveys 6.3 preventive and reactive maintenance. 7.1 project management. 7.1, 7.3 APQP, PPAP processes

7.4, 7.5 document management.

7.5 preventive and reactive maintenance.

7.4, 8.2.2 internal and external audit function with a focus on

process improvement. 7.6, 8.4 calibration and measurement systems analyses. 8.2.1 human performance management functions, competency, training management and satisfaction surveys

8.2.3, 8.4, 8.5 managing customer expectations, customer satisfaction,

continual improvement, and data analysis. 8.5.2, 8.5.3 document management.

Process Pro

Document ProBOSS

HR Pro

TPM Pro Project Planner AQuA Pr Document ProTPM Pro Audit Pro

MSA Pro HR Pro

BOSS

Document Pro

Process Focus - Process Pro

The process flow shows the linkages between each step within the process. You can then click to see the processflow definition.

Business Management System Control Plan – Example A

Business Management System Control Plan

Organization_______________________________________ Product Description ______________________________________

General Manager___________________________________ Issue/Rev Date __________________________________________

Process ActivityCustomer Req/Expectation

Key Process? Measurement Responsibility

Acceptance Criteria 2002

Review Frequency Control Methods

Comments/ Reaction

Q1,Q2,Q3,Q4

EXAMPLES

Business Fulfillment On time delivery Yes % On-time in FAB Logistics 94,95,96,96% 4/yrPareto chart, Cont Imp Targets

Corrective action after 3 consecutive

% On-time to customer

Production Control 100% 4/yr Pareto chart

C/A is more than 15% off target

Complaint Response Quality 10 days 4/yr Pareto chart Continue to monitorValid Complaints Quality 10 per qtr 4/yr Pareto chart Continue to monitor

Competitive No Time to market Design/Dev 52 weeks Weekly Proj Rev minutes R, Y, G reactionBusiness Creation Innovation No Patents Filed Design 20 per year Monthly Line item Continue to monitor

Customer Focus and Continual Improvement -

BOSS

It all starts with the customer

Quality is what the customer says it is!

Multiple customers and multiple expectations categories.

You can then align customer quality expectations with company driven process improvement activities.

EwQMS helps you measure key processes.

OFI’s can trigger improvement proposals so the team can make adjustments to the process.

If results indicate further analysis, team meetings can be held to determine OFI’s.

Data for process measurables is kept within the EwQMSsystem for analysis and continuous improvement activities.

Excel data can also be imported using Data Exchanger, an EwQMS tool giving you total flexibility in data collection.

You can then use the EwQMS report generator to report detailed information on a variety of process metrics.

EwQMS drill down functionality allows management to quickly find the root cause of process variation.

Again, EwQMS visual management tools allow easy interpretation of metrics data.

Improvement proposals can be documented and tracked against results.

Documentation – Document Pro

CustomerDocumentation

SupplierDocumentation

1

2

3

BMS Manual

Common

Specific

Common

Specific

4Common

Specific

Additional Levels- Reference Documents- Marketing Information- Uncontrolled documents- CAD Drawings- Business Metrics- PPAP- Customer Specific Information- Measurement Systems- Audit Information

The Document Management Process

Spans multiple sites, groups and levels.

No limited file types; graphics, audio, video

Action items with email support

Automated routing and escalation

Records management

Document draft functionality

User defined login default

On line revision history and reference documents

EwQMS module hot links

Customer complaint and concern management

Month 5 – Train Auditors and Conduct Audit

• Train Internal Auditors• Conduct Internal Audit using Audit Pro• Use Audit Pro to follow up on Corrective Actions

Audit Pro

The Auditing Process

Scheduling of Audits

Auditor selection criteria ( i.e. qualifications)

Auditor calendar and date verification

Managing Audits

Visual audit status

Audit query and report capability

Visual CAR status

Reminders and escalation functionality

Custom email messages

Sharing across the Enterprise

Audit information

Auditee information

Auditors

Conduct Registration Audit

• Conduct Registration Audit• Track and record – overall objectives accomplished• Provide Senior Management Presentation