Enterprise Quality Management SystemsThe Future of QMS Software

Kitchner, Canada- ASQ Section

By Chad Kymal

2

Characteristics of Enterprise QMS Software

• Scope includes entire business, not just product quality– ISO 9001:2000 Functionality

• Enterprise focus and not just a site focus– Site and entity– Flexibility and Effectiveness

• Linkages• Focus on Improvement

Enterprise QMS Functionality

4

Functionality of Enterprise QMS Software

• Customer Focus – Customer expectations and Customer Satisfaction

• Business Planning (objectives setting and deployment) and Management Review

• Training/Competency/job descriptions/ employee satisfaction• Product Realization – program planning, Design tools

(DFMEA/DVP&R/Design Reviews); Process tools (Process Flow/PFMEA/Control Plan/Work Instructions); Product Realization minus ERP

• Supplier Development and Measurement System Analysis including calibration

• Measurement including customer satisfaction, internal auditing, processes and products, Analysis, and Continual Improvement Processes

5

Paradigm Shift in Requirements of Standards

• ISO 9001:1994– Do what you say

– Product Specifications

– Quality Planning for Products

– Narrow Management Review

– Measurement, Monitoring, and Improvement

• ISO 9001:2000– Process Focus

– Customer Needs and Expectations

– Business Objectives and Planning

– Expanded Management Review

– Measurement, Monitoring and Improvement

ISO 9001:1994 Focuses on the Plant; Whereas ISO 9001:2000Focuses on the entire enterprise

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Comparison of Enterprise QMS Software

EnterprisewideSoftware 1

EnterprisewideSoftware 2

Process maps no no

Process measures no no

Documents yes yes

Customer needs and expectations no no

Objectives Deployment/BusinessEntities

no no

Management review no yes

Improvement teams no no

Training/competency yes yes

Competency no no

Objectives deployment/employees no no

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Comparison of Enterprise QMS Software (cont’d)

EnterprisewideSoftware 1

EnterprisewideSoftware 2

Business process flows no no

New product development planning yes yes

Calibration yes yes

Variation no yes

Operator work instructions yes yes

Customer satisfaction no no

Audits yes yes

Data analysis no no

Improvement no no

Corrective action yes yes

Preventive/FMEA yes yes

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Minimum Functionality Requirements

• Enterprise QMS software needs to have the minimum functionality of ISO 9001:2000

• Optimally, the software should have the requirements of ISO/TS 16949:2002 for automotive suppliers

Enterprise Focus versus Site Focus

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Enterprise Focus and Not a Site Focus

• Software designed in 1980’s and 1990’s focused on one single site– Connected functions and processes in the site– Example – Lotus Notes Package X-9

• Enterprise Quality Management Systems– Unique challenge to understand how enterprises

operate– Be able to model an enterprise without radically

redesigning software

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Lotus Notes X-9 Software

• Lotus Notes based package had a table of contents for each level

• The software allowed one level to be common between all sites, i.e. the quality manual

• Did not allow sharing of procedures between sites or creating levels where procedures were shared between multiple sites

• Had to email procedures from quality manager to find out what the site had or you had to become a user in that site to find out what each site had

• Did not allow easy access to other site documentation

Performed really well if each site had unique documentation

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How Does the Enterprise Operate in Documentation?

• Common levels of documents• Shared documents between plants in levels

– Multiple levels

• Shared documents with customers• Shared documents with suppliers

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How Does the Enterprise Operate in Documentation? (cont’d)

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

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How the Enterprise Uses Performance Metrics

• Within Site– Multiple Owners of Data i.e. top management,

process management, and function management• Enterprise

– Metrics that are aggregated and disaggregated, for example- PPM data from corporate should be disaggregated to plants, departments, and also to Products

• Extended Enterprise also includes Supplier Data and Customer Data

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SalesAccountingOperations

General Management

HumanResources

Customer Satisfaction Metrics

Process Variation Outputs

Processes -

not Departments -

Drive Performance

Purchasing

Process Focus versus Department Focus

Design &Development

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Company

% Production toPlan

Plant One Plant Two

Product/Process

Unit

Product/Process

Unit

Product/Process

Unit

ProductSub-Process

Unit

ProductSub-Process

Unit

ProductSub-Process

Unit100 90 80 70

Unit Ouputs

Per

form

ance

Time

100 90 80 70

Aggregated Outputs

Per

form

ance

Time

100 90 80 70

Process Outputs

Per

form

ance

Time

CascadingObjectives

AdditivePerformance

Metrics

Data Driven - Cascade To All Levels

Key performance objectives cascade down while performance data pass upward for analysis and action.

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Enterprise Software

• Includes sites and entities– Sites are large functional organizations within one

enterprise for e.g. Plant 1, Corporate Headquarters, and R&D

– Entities are management or reporting structures within one site

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Enterprise Quality Management Systems Requirements

• One installation for the entire enterprise– All sites and entities should be held in this one

installation• Designed so that authorized personnel can see

documentation from each site, metrics from each site, or audit history from each site with a minimum of three clicks

• Enterprise functionality is available without major redesign of software

• Typically will be truly web based (W3 compliant)– One installation on a server and can be accessed on

a web browser

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Web Based Software Example

• All documents could be used and/or accessed by all the sites, ie. all documents are common

• If documentation is unique or shared then the software would have to be installed in each location

The typical site package allows all sites access to all documents or each site access to its own independent set of documents.

Linkages

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Enterprise Software Linkages

Customers, objectives, performance measurement and continual improvement

Customer expectations, company objectives, personal objectives, teams and continual improvement

Products, new product development, FMEAs, control plans and work instructions

Products, gages, and calibration and measurement systems analysis

• Process maps, process flows, process measurables and improvement

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Customer Expectations to Business Improvement Customer Expectations

Objectives

Result Measurable

Processes

Process Metrics

Continual Improvement

Teams

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Objectives Deployment and Employee Evaluations Customer Expectations

Objectives

Deployed ObjectivesFunctions/ Departments

Deployed ObjectivesPersonnel

Process Metrics

PerformanceMeasurement

Teams

Continual Improvement

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Product Linkages

Product Family Product

Program Management

Design Reviews

DFMEA

DVP&R

Characteristics

Process Flow

PFMEA

Control Plan

Work Flow

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Process Linkages

Process Map

Meetings

Business Control Plan

Process Flow

Processes

Process Measurements

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Product to Gages

Product Family

Calibration

Gage Type

Gage

Product

Performance Reports

MSA

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Enterprise Software Linkages

• These linkages connect the organization, processes, and functions

• It reduces redundant data entry• It facilitates efficiency

Another key ingredient in Enterprise QMS software is the need to exchange data between legacy systems and Enterprise QMS software.

Focus on Improvement

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Focus on Improvement

• Data availability• Data analysis• Continual Improvement

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Data Availability

• All the data is in one place– Types of data include

• Product data• Process Metric data• Process FMEA, Control Plans• Rework and customer complaints• Internal audit

– Personnel with authorization should be able to access the data with a minimum of three clicks

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Visual Data Analysis

• Visual trend analysis• Dynamic pareto analysis• Drill down analysis

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Continual Improvement

• Tracking team measurables• Meetings information centrally housed• Meeting Agenda• Running action plan• Access to tools – 8-D, CAR, Paynter• Management Review data centrally housed

33

Current Software Market- Stand alone Providers of Single Functionality

SPC SoftwareMany software

companies

AuditingMany software

companies

MSA SoftwareMany software

companies

Preventive Maintenance

Corrective Action

DocumentationMany software

companies

$3-4 Billion MarketMost Companies are under $1 million

34

Enterprise Quality Management System

SPC

SoftwareAuditing

MSA Software

Preventive Maintenance

Corrective Action

Documentation

Enterprise QMS

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Integration of ERP and an Enterprise Quality Management System

Companies need both ERP and EnterpriseQuality Management System

Enterprise Resource Planning

EnterpriseQuality

ManagementSystem

One integrated system

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Market Consolidation

• Market will consolidate to a few large players who can provide a complete Enterprise QMS

• Software quality and services will improve• Organizations will spend more on Enterprise

QMS software• Enterprise QMS software will be seen as a key

cornerstone of company strategy

Enterprise QMS Requirements

38

Minimum Functionality Requirements

• Enterprise QMS software need to have the minimum functionality of ISO 9001:2000

• Optimally, the software should have the requirements of ISO/TS 16949:2002 for automotive suppliers

39

Enterprise Quality Management Systems Requirements

• One installation for the entire enterprise– All sites and entities should be held in this one

installation• Designed so that authorized personnel can see

documentation from each site, metrics from each site, or audit history from each site with a minimum of three clicks

• Enterprise functionality is available without major redesign of software

• Typically will be truly web based (W3 compliant)– One installation on a server and can be accessed on

a web browser

40

Enterprise QMS Linkages

• Customers, objectives, performance measurement and continual improvement

• Customer expectations, company objectives, personal objectives, teams and continual improvement

• Products, new product development, FMEAs, control plans and work instructions

• Products, gages, and calibration and measurement systems analysis

• Process maps, process flows, process measurables and improvement

• Exchanges Data between Enterprise QMS and legacy systems

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Focus on Improvement

• Data availability• Data analysis• Continual Improvement