omnexsystem spresentation

Omnex Systems ISO 9000:2000 EwQMS®

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Contents About Omnex ISO 9001:2000 and EwQMS®

Strategies for QS-9000 and TS-16949 Closer Look at The Software

Doc Pro BOSS Audit Pro MSA Pro AQuA

Why EwQMS®

About Omnex

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Driving Worldwide Business Excellence

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Core Competence

QS-9000

Service

Semiconductor

US3 Offices

CanadaPhilippines

China3 Offices

Mexico

Thailand-BangkokIndia-

Chennai

Germany-Gosheim

UK-England

ISO 9001:2000

TE Supplement

ISO/TS 16949Venezuela-

Carabobo

Brazil-San Paulo

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OMNEX Methodologies

•TS 16949•ISO 9001:2000•QS-9000•ISO-14000 Lead Auditor

Internal AuditorValue Added

QOS

APQPPAP

FMEA/Control Plan

•Team BasedTeam Based•How ToHow To •Excellence BasedExcellence Based

•Hands OnHands On

Standards

Auditing

New Product Development

Management

ToolsSPCDOE

Lean Manufacturing

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Enterprisewide Quality Management System Suite (EwQMS®)

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Document Pro(collection of all data)

Process Pro(Business Proccess)

FMEAControl Plan

Process Flow

AQuA Pro(Manufacturing

Process)

MSA Pro(Measurment

Systems)

ProcessAnalyzer

(Warranty Rework andScrap Analysis)

BOSS(Management Review

and ContinuousImprovement)

ActionsPerformance

GraphsCustomerExpectations

Audit Pro(Auditing per ISO and

QS Specifications)

CompanyDatabase

CompanyDatabase

Business SystemsManufacturing SystemsData AnalysisData Storage

Human Resources

Purchasing

SupplierDevelopment

Purchase Orders

Training PlansPersonal Objectives

EmployeeMotivation Tools

TPM(Total Productive

MaintenancePackage)

SPCStatistical Analysis

CPkPPk

PP

MTTRMTBFMaintenance

Plans

ProblemSolver

(Disciplined Problem-Solving Software)

Corrective Actions

Audit ReportsInternal Audits

FMEAControl Plan

Process Flow

PPAP

Enterprisewide Quality Management System Suite (EwQMS®)

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About AQSR

ISO 9001:2000 TS 16949 QS-9000 TE Supplement AS 9000

Improvement BasedExperiencedCustomized

a management systems registrar providing accredited third party registration/certification to the ISO 9000, QS 9000, TE Supplement, VDA 6.1 and ISO 14000 series of international standards

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Offices World Wide

OMNEXUS

3 officesMexicoChinaBrazil

ThailandIndia

OMNEX SystemsUS

IndiaAQSR

USCanadaChina

2 officesGermanyMexicoTaiwan

UKVenezuela

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Customer Awards

India FORD India Maruti Udyog

(Suzuki) TELCO CII- Governmental

Advisory Board

TISCO (Tata Steel)

United States & Canada-TS16949 RolloutVoted top five US Registrar by Quality DigestLucent-Delphi-Visteon-Magna

Latin America-Ford Mexico-Corn Products-Venezuela Automotive IndustriesTaiwan/China

Good Year DFM MotorsClarion Mitsubishi Dealerships (34)

Thailand-ISUZU Engines-Thai Bridgestone-Sony Semiconductor-AMD-3M

-NSK-Matsushita

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What Customers WantExcellenceGlobal SolutionsCustomized SolutionsHuman Interaction

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Company with a Unique Global Vision

Performance with Excellence Growing Big and Staying Small

ISO 9001:2000 and

EwQMS®

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Quality Management SystemContinual Improvement

REQUIREMENTS

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SATISFACTION

Quality Management Process ModelSource: ISO 9001:2000

February 1999

Figure 1

ResourceManagement

Measurement,Analysis,

Improvement

ProductInput Output

ManagementResponsibility

ProductRealization

QMS Process Model

How does this model work?

PLAN

PLAN CHECK/ACT

DO

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Process Model and ISO 9001:2000 Clause

Headings Quality Management System 4.0

Management Responsibility 5.0

Resource Management 6.0

Product Realization 7.0

Measurement, Analysis, Improvement8.0

ISO 9001:2000 Clauses

ISO 9001:2000 clauses are integrated and linked

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4.0 Quality Management System

4.1 General Requirements4.2 Documentation

Requirements

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Figure 1

ResourceManagement


Improvement

ProductInput Output


ProductRealization

5.0

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4.0 Quality Management System

4.1 General Requirements

4.2 Documentation Requirements

Requirements for Processes - Process Mapping, Process Flow, Monitoring (trend chart) and Continual Improvement (Teams and Improvement Proposals)- This is satisfied by Process Pro and BOSs

Documentation Requirements and Document Control is satisfied by Doc Pro.

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5.0 Management Responsibility

5.1 Management Commitment

5.2 Customer Focus5.3 Quality Policy5.4 Planning5.5 Administration 5.6 Management Review

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Figure 1

ResourceManagement


Improvement

ProductInput Output


ProductRealization

5.0

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5.0 Management Responsibility

5.3 Quality Policy - Doc Pro 5.4 Planning -

Objectives/Deployed Objectives and Improvement Proposal and Proposal Ratings - BOSS

5.5 Administration - See next page

5.6 Management Review - BOSS

5.1 Management Commitment- Evidence in Doc Pro (Quality Policy) and BOSS of their involvement in Management Review and in setting objectives and providing resources

5.2 Customer Focus - Customer Expectations gathering and evidence of meeting them - BOSS

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5.5 Administration 5.5.1 Responsibility and authority-

Organizational chart and job responsibilities - Doc Pro

5.5.2 Management Representative - evidence in BOSS and Doc Pro and other

5.5.3 Internal Communication- Web access of Management Review and Internal audits and e-mails

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6.0 Resource Management

6.1 Provision of Resources

6.2 Human resources6.3 Facilities 6.4 Work environment

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Figure 1

ResourceManagement

ResourceManagement


Improvement

ProductService

Input Output


ProductRealization

6.0

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6.0 Resource Management 6.1 Provision of Resources - Improvement Proposal

rating form, Management Review minutes, and resource planning document in Doc Pro

6.2 Human resources - Currently, can be designed in Excel. New software will be designed by 3rd quarter- 2001

6.3 Facilities - Data analysis and meeting showing no facilities problem - BOSS

6.4 Work environment - Data analysis and meeting showing no work environment problem - BOSS

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7.0 Product Realization

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Figure 1

ResourceManagement


Improvement

ProductService

Input Output


ProductRealization

7.0

7.1 Planning of Realization Processes

7.2 Customer-Related Processes

7.3 Design and/orDevelopment

7.4 Purchasing 7.5 Production and

Service Operations 7.6 Control of

Measuring and Monitoring Devices

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7.0 Product Realization 7.1 Planning of Realization

Processes - Process Map in Process Pro and documentation of processes. held in Doc Pro. Quality Plan can be held in AQuA

7.2 Customer-Related Processes- Customer expectations of product in BOSS, Requirements (Contract) Review form in Doc Pro, and custom designed intranet and database

7.3 Design and/or Development - AQuA can be used as/is or simplified to work with ISO 9001:2000

7.4 Purchasing - New software to be designed for supplier development by beginning of 3rd quarter.

7.5 Production and Service Operations- See next page

7.6 Control of Measuring and Monitoring Devices - MSA Pro; Note: the calibration module may be sufficient

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7.5 Production and Service Operations

7.5.1 Operations Control - AQuA Standardization Module with control plan

7.5.2 Validation of Processes - PPAP or equivalent and capability studies of the process. Need to integrate with SPC package

7.5.3 Identification and Traceability - Procedure in Doc Pro

7.5.4 Customer Property- Procedure in Doc Pro

7.5.5 Preservation of Product - Procedure in Doc Pro

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Prepare a Key Process Map

CleaningMarketing StampingDesign Finishing Packaging Shipping

MaintenanceEnvironmental &

SafetyCompliance

Purchasing Training

Internal AuditingCorrective &Preventive Action

Quality PlanningManagementReview

CustomerSatisfaction

QualityObjectives

DocumentControl Data Control

Support Processes

Realization Processes

QMS Processes

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8.0 Measurement, Analysis, and Improvement

8.1 General Planning

8.2 Measurement and monitoring

8.3 Control of nonconformity

8.4 Analysis of data 8.5 Improvement

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Figure 1

ResourceManagement


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ProductService

Input Output


ProductRealization

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8.0 Measurement, Analysis, and Improvement

8.1 General Planning - Evidence of measurement planning in BOSS, Process Pro and AQuA

8.2 Measurement and monitoring-

Customer Satisfaction measurement in BOSS, questionnaire in Doc Pro, Internal Audit in Audit Pro, Process and Product Measurements in BOSS.

8.3 Control of nonconformity - BOSS Datasheet and Chart and process in Doc Pro

8.4 Analysis of data - Data in BOSS and team meeting

8.5 Improvement - Data in Boss and Team Meeting including Management Review, Corrective Action (8-D) in BOSS and Aqua.

EwQMS® and

QS-9000/TS-16949

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EwQMS® and QS-9000 /TS-16949

TS-16949 is the standard of the future and is the only standard that is going to be revised to meet ISO 9001:2000 requirements

TS16949 second edition is currently slated to be completed by first or second quarter 2002

Companies currently QS-9000 or implementing TS-16949 should incorporate ISO 9001:2000 in their implementation

The Omnex Pro-Suite 2000 has already consideredthe next edition of TS-16949 and is designed to incorporate both TS-16949:99 and ISO 9001:2000

A Closer Look at the Software

Document Pro , BOSS, Audit Pro, MSA Pro

Document Pro

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Document Pro Software that documents the organization’s

Quality Management System (QMS) in one level up to eight levels. Typically it is - level one - Quality Manual, level two - Procedures, level three - Work instructions, level four - Forms and Checklists

Gateway to other Software Packages - BOSS, Process Pro, Audit Pro, MSA Pro, AQuA-Process Analyzer

Manages change of all documentation including documentation in Process Pro and AQuA

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How Document Pro Works Security - Persons signing on can see documents,

read, or request a change The user will be asked the level of documents that

they want to open - quality manual, procedure, work instruction or form/checklist

The user can select the level and it will open to a table of contents The user can double click the document of

choice The table of contents is also the master list and

shows the latest revision level of all company documents

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Navigator Bar Action will list all the actions that

the user has to take Access to levels of documents Modify personal information Create a Document Change

Request

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How Document Pro Works The open document will show all the

related documents, revision history, and personal “actions” on the left side The related documents can immediately

be accessed by selection from this screen

The revision history of the document can also be viewed

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Doc Pro - Administrator The administrator sets up all users and their

security levels Setting up documents the first time -

Users will need to request for new documentation upload New documents will follow approval process

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Change Request The Change Request has to be set

up for all new documents and for changes to documents

Change requests can be routed within the organizational hierarchy The route indicates serial and parallel

steps for a changed document.Standard routes can be set up for classes of documents

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Change Request Management

Both the administrator and the requestor can track status of change levels The software will automatically send messages as

the document moves along the route Administrator User

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BOSS Software Functionality

BOSS software allows companies to align customer expectations to key processes to improvements

Also, it facilitates data gathering and viewing of company key measurable and process measurable

It allows management of Management Reviews and improvement team meetings

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Customer Expectations to Improvement Alignment

Steering Committee of the top management in the company can be formed

Subsequent departmental committees at other levels in the company can also be formed Departments can track and improve deployed

measurables from top management These are called aggregation levels - data collection

must use forethought to their future use

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Gathering Customer Expectations Customer expectations are gathered

and entered two ways - It can be entered via table driven entries It also can be entered via post-it notes

Both the expectation and the customers are entered

The expectations can be moved to group them under an expectation category

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Benchmarking Customer expectation categories are

benchmarked against the competition and best in class companies

The benchmarking information is used to help form short and long term objectives

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Alignment Chart The expectation category and the expectations are

used to identify Result measurables that measure the

expectation category Key Processes of the expectation category. The

key processes directly impact the expectation Process measurable that measure the key

process Improving the process measurable helps to

improve the result measurable which then results in meeting customer expectations

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Improvement Proposals Improvement Proposals are formed to close the

gap between the as-is and the Goal Line The improvement Proposal identifies the projects

to be taken, benefits and costs of the program. BOSS provides automatic rating of proposals by management teams for resource allocation.

The improvement proposals can be placed in the alignment chart indicating that it is a proposal for a particular customer expectation category. In this manner, all improvements are focused on meeting customer expectations

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Data Entry and Visual Analysis

Data entry can be directly into BOSS or can be programmed by Omnex for automatic entry

Charts with constant or variable goals can be easily accessed A special feature of Boss is the link between data and

aggregation levels. The chart has a special drill down feature that allows the user to click down to the root cause. For instance Overall downtime can be clicked to Departmental downtime and then clicked to Machine downtime. Furthermore, each chart can be saved for team or Steering Committee meetings.

Departmental charts - ie aggregation levels Pareto charts and identification of problems Charts and paretos can be saved for management review

and improvement team meetings

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Management Review and Improvement Meetings

Management Review Creating Agenda and presentations Linking charts to presentations Writing meeting minutes Creating Action Plans

Improvement Teams Creating Agenda and presentations Linking charts to presentations Writing meeting minutes Creating Action Plans

Any type of meeting can be housed within BOSS

Audit Pro

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About Audit Pro Audit Pro can manage,schedule, assign and

check status of audits and corrective actions for Internal audits Third Party audits Single organizations Multiple organizations

Audit Pro can manage hundreds of audit of any number of audit programs including ISO 9000, QS-9000, ISO 14000, Housekeeping and Safety, Environmental compliance audits simultaneously for multiple or single plants.

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Audit Types and Audit Forms Audit Programs can have entities

called Audit types which are - System, Product or Process audits or Document review, pre-audit or surveillance..

The Program will allow the user to use the same or different forms for each audit program and type

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Audit Pro Assign Auditors who are then

automatically notified of the assignment via e-mail

Schedules and manages audits The audit schedule has a color code that

will indicate an audit waiting to happen (orange), audit that did not occur (red) or an audit that took place on time and paperwork submitted (green)

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Auditor Sign Up Auditors Sign On and are only authorized to

view audits assigned to them Down load forms for an audit Upload forms after the audit is complete, this

signifies the completion of an audit and changes the orange status to a green

Assign Corrective Actions (non-conformances)

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How Corrective Action Works

Three steps - write non-conformance, auditee responds, auditor closes it out

Audit Pro will track each corrective action by number and three actions as follows: Auditor attaches the corrective action - overall

audit turns from orange to green Auditee responds and auditor attaches the

replies Auditor attaches the close out

All events are controlled and monitored with event deadlines for corrective action. It will also send e-mails to all parties concerned

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Providing Access to Client/Auditee

Auditor decides what forms to provide client/auditee

Provide Customer sign on access Client/auditee down loads documents, complete

them and e-mails them back to auditor Client/auditee can view forms as authorized,

before and after an audit

MSA Pro

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MSA Pro Organizations have inspection,

testing, and lab equipment that need to be Identified and Cataloged Calibrated Measurement Uncertainty Studied Manages Gage Program

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Identification and Cataloged

Families are created Measurement instruments are assigned

to Families Measurement instruments are cataloged

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Calibration of Instruments

Calibration is conducted using internal or external labs MSA-Pro requires traceability of masters to NIST Calibration will automatically calculate bias and linearity

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Measurement System Analysis

Measurement System Analysis studies are created for families and characteristics

Each gage is attached to a family or families for Bias Linearity Stability Gage R and R

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Measurement System Analysis (MSA) Gage R& R will show the repeatability and

reproducibility of a gage Bias can be calculated when a calibration

is done or can be studied separately Multiple Bias studies will give the result for

linearity and can be graphed Stability can be studied by graphing

multiple calibrations or studied separately

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Available Reports and Graphs

Many reports and graphs are included in MSA Pro

AQuA 3

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AQuA 3 Manages Process and Quality

Documentation A process review tool A vehicle for continual

improvement

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How AQUA uses data, documents and tables

Data Relational Database, not in the

Documents Document

Document always reflects the latest changes

Table Maintains consistency

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AQuA StructurePart Family

Part A Part B Part DPart C

ProcessFlow

ControlPlan

ProcessFlow

ProcessFlow

ControlPlan

ProcessFlow

ControlPlan

ControlPlan

Format (GM,Ford etc)

Style Sheet

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How AQUA uses branching

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How AQUA links documents?

Data linkage Automatically updated data

Format linkage Documents have a uniform and

consistent appearance

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AQuA Feature List Create your own format AQuA Default format View Design & Print Design Copy an existing Part to a New Part Hiding Branches Freezing Columns

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AQuA Feature List Customize header, trailer, first

page header, first page footer, last page footer

Customize column heading in Documents

Copy, cut and paste cell contents Indenting and Outdenting

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Advanced Features Templates Process List Document Revision Control by

Using AQuAView

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Additional/Optional Modules

Standardization Module Production Part Approval Process

Module (PPAP) 8-D Reports

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Security Features User ID and Password Restricted Access to Specific Features Restricted Access to Specific

Documents Restricted Access to Parts/Part

Families and Documents Group Access Vs Individual User

Access

Why Omnex Pro-Suite

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Annual savings from ISO 9000

Savings for Companies with Sales: Greater than $200 million - $443,701 $25 million to $200 million - $109,890 less than $25 million - $53,895

Source: ISO 9000 Survey ‘99, McGraw-Hill

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Costs of ISO/QS 9000Costs for Companies with Sales:

Greater than $200 million - $299,765 $25 million to $200 million - $106,890 less than $25 million - $72,502


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Cost savings using software

Software helps in Customization - Customize programs for use Routinization - Putting into daily practice Best Practices - Improve savings by a factor of

33%


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Overall software savingsSoftware Savings for Companies with Sales

Greater than $200 million - $296,190 $25 million to $200 million - $86,970 Less than $25 million - $53,490


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Software removes reported road blocks

Road Blocks to maintaining ISO/QS 9000 Employee Resistance - Software makes it easy and

creates routinization Document Maintenance - Document Pro Training Requirement - Omnex provides software and

training Calibrating Instruments/Equipment - MSA Pro Management & Commitment - BOSS and Executive

Training from Omnex Not Following Procedure - Document Pro, Process Pro,

Audit Pro High Cost - Software saves moneySource: ISO 9000 Survey ‘99, McGraw-Hill

omnexsystem spresentation

Documents

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presentationslinking

corrective

management

process pro

msa pro

doc pro

service operations7