Omne xsales

T R A I N I N GT R A I N I N G

S O F T W A R ES O F T W A R E

B u i l d i n g S u c c e s s W o r l d w i d e

Quality Management System Implementation

Copyright 2001, Omnex, Inc. 2

Omnex Introduction

• Consulting and Client Site Training in Quality and Management Systems Development and Implementation:

• ISO 9001:2000 Quality Management systems• ISO/QS 9000; ISO/TS 16949 (Automotive)

• ISO 14000 Environmental Management Systems

• QOS/BOS/Balanced Scorecard• Product and Service Development and Introduction• Business Process Re-Engineering• Productivity & Performance Enhancement• IT Systems/Business Process Integration

Copyright 2001, Omnex, Inc. 3

Omnex Introduction

• Capabilities– Recognized Worldwide Experts in ISO 9000 & 14000, QS-9000

and QOS– Effective Strategic Business Approach to Implementations – Specialized Client Site Training– Performance Improvement systems and methodologies– International Resources with Multi-language and Global Service

Delivery Capabilities

• Bias Toward Action

Copyright 2001, Omnex, Inc. 4

Omnex Approach

Copyright 2001, Omnex, Inc. 5

Omnex Approach

• Conduct Discovery Analysis and Develop Plan• Establish Cross Functional Team & Objectives• Assist in Selecting Registrar, Plan Registration Process• Create an Operating System• Define and Document Key Business Processes• Define and Document Key Business Process Controls• Establish Effective Data Management• Initiate Effective Management Review• Drive Continuous Improvement

Copyright 2001, Omnex, Inc. 6

Strategic Value of Omnex Approach

• Easy to Implement

• Easy to Understand and Use

• Easy to Maintain

• Maximize Value, Minimize Paperwork

• Supports Analysis for Continuous Improvement

Copyright 2001, Omnex, Inc. 7

Conduct Discovery Analysis

– Understand existing systems– Understand existing processes and activities– Understand functional organizational structure– Map to system objectives– Align with current system and ISO 9001:2000

• Develop Implementation Plan

Copyright 2001, Omnex, Inc. 8

HumanResources

ProductionPurchasing Accounting Sales

General Management

Technical

Functional "Chimneys"

ProcessMeasurables

Activity-based Causation

Process OutputsCorrelate withOrganizationalPerformanceCharacteristics

KeyPerformance

Indicators

FinancialPerformance

CustomerSatisfaction

Key ProcessCapabiliy

Learning &Growth

Need for Cross Functional Team, Objectives, Process Definition

Copyright 2001, Omnex, Inc. 9

Quality Management System Strategy

Copyright 2001, Omnex, Inc. 10

ISO 9001:2000

• Defines a business using a Process Model • Requirements organized in five categories

– Quality Management System Requirements– Management Responsibility– Resource Management– Process Management– Measurement, Analysis and Improvement

• Changes– More business-based terminology and process model– Definition of “Quality”: Requirements focus on “Customer Satisfaction,”

not “conformance to specification”– Formally mandates continuous improvement– Expanded emphasis on management responsibility and resource

assurance

Copyright 2001, Omnex, Inc. 11

ISO 9001:2000 Process Model

Product

realization

InputProduct/ Service

(and/or service)

Requirements

Resource management

Measurement, analysis, improvement

Management responsibility

Customer

Customer

Satisfaction

QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT

Output

Quality Management System

Copyright 2001, Omnex, Inc. 12

New Requirements in ISO 9001:2000

• Voice of the Customer-Expectations & Requirments• Quantifiable Objectives• Internal Communications• Infrastructure• Work Environment• Customer Communications• Measurement and Monitoring• Customer Satisfaction• Continual Improvement

Copyright 2001, Omnex, Inc. 13

ISO 9001:2000 Business Plan

5.2Customer

Expectations

7.2 CustomerRequirements

5.4 QualityPolicy

5.5.1Objectives

5.5.1DeployedObjectives

Department Function Process

QualityPlanning

Process A Process CProcess B

QualityPlan

5.5.2/7.1Processes

BusinessPlan

Copyright 2001, Omnex, Inc. 14

Understand Primary Business Processes

• Product and Service Realization– Marketing

– Sales

– Purchasing

– Design

– Production/Distribution

– Delivery

• Planning– Quality Planning

– Analysis of Data

– Improvement

• Management– Strategic Planning

– Resource Planning

– Performance Monitoring

• Measurement(Accounting)– Documentation

– Analysis

– Maintain Records

• Human Resources– Staffing

– Training

Copyright 2001, Omnex, Inc. 15

Utilize Flow Charts for Documentation

LOGO Number: SOP-01

Responsibility Flow Remarks

Approval: President

Revision Date: 12/1/98

Title: Management Review

Department: Management

Purpose: To define the procedure for conducting management reviews.

Scope: This procedure applies to all management meetings.

President

President

President

Recorder

Recorder

Refer to QOS Implementation andImprovement, 4th Edition dated3/26/96 for instructions from"prepare agenda..." to write &distributes minutes".

Page: 1 of 1

Elements:

Internal AuditReport

KeyMeasurables

Prepare agenda &circulate toattendees

Action Plans

Conduct Meeting

Actionagreedupon?

Action Plans

Assign action item

Write, distribute &file minutes of

meeting

Update action plans

Done

Agenda

CA Requests

CA Reports

Refer forCA ?

Yes

Yes

No

CA Request

Action Plans

Minutes

No

Copyright 2001, Omnex, Inc. 16

Define Key Business Process Controls

• Identify Performance Characteristics (Values)• Conduct a Business Process Analysis (FMEA)• Develop an Improvement Plan• Implement a Control Plan• Generate Data for Continuous Improvement

Copyright 2001, Omnex, Inc. 17

APQP/AQP

Verifyand

Validate

ProcessFlow

4.3 Contract ReviewCustomer

Requirements(ex: specifications, designperformance specification)

Associate PCswith Operational Steps

ProcessFMEA

IdentifyProcess

Characteristics(sources/causes

of variation) 8-D

Action Plan

IdentifyRoot Cause

ControlPlan

WorkInstructions

QS-9000Procedures

SPCProcess

Measurables------------------

SystemicCausation

StrategicProcess

Improvements

IdentifyProduct Characteristics

OP10

OP20

OP30

QOS

DynamicProcessControl

Implement ControlStrategy

ImplementProcess

Improvements

Employ Dynamic Process Control

Copyright 2001, Omnex, Inc. 18

Implementation Process

Copyright 2001, Omnex, Inc. 19

Organizing for ISO 9000 Implementation

• Management Team– Develops Operating System in Management Responsibility– Develops & Deploys Policy and Objectives– Conducts Management Review

• Steering Committee– Lead by Management Representative– Cross functional– Appoint by virtue of authority, position and expertise– Champions for process teams

• Process Teams– Cross functional– Subject matter & process experts– Develop all documentation

Copyright 2001, Omnex, Inc. 20

Implementation Structure

A rg oS teerin g C om m ittee

C ard in a lS teerin g C om m ittee

L on d onS teerin g C om m ittee

P ort C o lb ernS teerin g C om m ittee

S tock tonS teerin g C om m ittee

W in s ton S a lemS teerin g C om m ittee

M u lti-P lan tP rocess Team

M u lti-P lan tP rocess Team

M u lti-P lan tP rocess Team

C ross F u n c tion a lS teerin g C om m ittee

C ross F u n c tion a lM an ag em en t Team

Example

Copyright 2001, Omnex, Inc. 21

Implementation Steps

• Conduct Discovery Analysis• Develop Implementation Plan

– Timing– Roles and Responsibilities– Status Assessment & Program Management– Identify key indicators for improvement

• Form Steering Committee(s)• Train and Orient Committee(s)• Select & Orient Registrar

Copyright 2001, Omnex, Inc. 22

Implementation Steps• Form Key Process Teams• Train teams in methodologies for business processes• Implement Approaches and methodologies• Map and Document Key Processes• Form Process Level Teams• Map and Document Processes and Activities• Develop Level III Documentation• Implement Procedures, Work & Process Instructions

Copyright 2001, Omnex, Inc. 23

Implementation Steps

• Train Internal Audit Teams• Establish Management Review Process• Conduct Internal Audits concurrently with

Implementation Process• Establish Corrective & Preventive Action• Conduct Pre-Audit Finishing Process• Registration Audit

Copyright 2001, Omnex, Inc. 24

Effective Management Review Process

• Meet Regularly• Maintain Discipline• Drive System Implementation Process• Focus on Strategically Critical Continuous

Improvement• Utilize Data

– Achieve and Maintain Shared Level of Understanding– Support Effective Decision Making

• Take Action

Copyright 2001, Omnex, Inc. 25

Benefits of Omnex Approach

• Defined and Shared Responsibilities • Documents Your Business Processes• Easier to Implement and Maintain• Drives Performance Improvement• Focuses on Value• Relevant and Sustainable

Copyright 2001, Omnex, Inc. 26

Typical Obstacles and Solutions

• Lack of Management Commitment

• No Defined Plan

• NVA Documentation/ Frequent Rewrites

• Lack of Understanding of Requirements

• Organization by Elements

Address Early with Defined Objectives (Relevance)

Plan Your Work, Work Your Plan

Facilitate Documentation

Training

Organization by Key Processes & Activities

Copyright 2001, Omnex, Inc. 27

Need for Top Management Commitment

• If top management is not involved:– There will be documents which do not reflect actual

practices– Managers will give only “lip service” to policy and its

implementation—system will lack relevance– ISO will be seen as a “paperwork monster” (generating

enormous costs without benefit) that lessens value– There will be a lack of clear, quantifiable

improvement

Copyright 2001, Omnex, Inc. 28

Role of Omnex Consultants

• Provide Objective Voice• Contribute Technical Expertise• Maintain Focus and Discipline• Expand the Vision of the Organization • Provide Perspective from Other Successful Efforts• Analyze and Identify Opportunities with Credibility• Provide Disciplined Program Management• Provide Dedicated Resources

Copyright 2001, Omnex, Inc. 29

Global Presence & Alliances

• Omnex, Inc.– Training Development

& Publishing– Software Development

• AQuA®

• BOSs®

• AQSR, International

• International Offices– Brazil– Canada– Germany (J-V)– Mexico– India– Peoples Republic of

China– Taiwan– Thailand– Venezuela

Copyright 2001, Omnex, Inc. 30

Recent Domestic Clients

• Corrigan Moving Systems• Defiance Engineering &

Testing• Delphi Automotive • EASi-Meg Engineering• Engineering Technology• Ford Customer Service

Division• Ford Human Resources

Service Center• Ford Warranty Specialists

General Motors Information Systems and Services

Giffels Arch. & Engr. Hendrickson

International Lucent Technologies Mobil Oil Petro Canada Siebe Automotive NA Teleflex Visteon