Navigating QMS Evaluation &...

© 2011 IQSJanuary 13, 2012

ASQ Meeting

“Navigating QMS Evaluation & Implementation”

Presenter: Tom WestJeff Stuart

January 10, 2012

2 © 2011 IQS1/13/2012

Agenda

1. Introduction / Current Research

2. Gap Analysis / Business Case

3. QMS Selection

4. QMS Implementation Strategies

5. Question & Answer

3 © 2011 IQS1/13/2012

IQS Company Profile • Industry Veteran

– 20+ Years in Business – 500+ Customers– 20,000 users– Installed in 15 countries

• Manufacturing Roots – Mid-west based, quality focused – Deep Manufacturing Expertise

• Hundreds of happy referenceable users • Market Focus

– Automotive– Aerospace & Defense– Life Sciences– Discrete Manufacturing

• Versatile Platform– On Premise– OnDemand

ISO 9000 TAG Expands Adoption

AS Q Supply Chain Globalization

4 © 2011 IQS1/13/2012

Research and QMS Market• Priorities for Best-In-Class Organizations

• Customer Satisfaction and Retention• Lower Cost of Quality• Using Quality as a Competitive Advantage• Need for Risk Management

• Focus Areas of Performance• New Product Introductions• Overall Equipment Effectiveness• Operating Margin• On Time and Complete Shipments

• Strategic Actions• Build-in compliance and risk control into processes• Improve operator effectiveness by delivering critical quality data from

across the enterprise

Source: Aberdeen Group May 2011

5 © 2011 IQS1/13/2012

Research and QMS Market• Technology Gaps (Best-In-Class vs Other Tier)

• The largest gap between Best-In-Class companies and Other organizations is in the area of Quality Management Systems

• 83% of Best-In-Class companies run enterprise quality systems, while only 64% of non-best-in-class use a QMS

• Effectiveness is related to Interoperability• Best-In-Class Organizations report strong integrations with the following

systems– 59% integrate with ERP (integrated record of the truth)– 48% integrate with BI (integrated transparency of reporting)– 26% integrate with PLM (integrated new product introduction)– 26% integrate with DMS (integrated document repository)

• What QMS tools differentiate Best In Class from others?


6 © 2011 IQS1/13/2012

Best In Class Differentiators

*Take Away – The biggest differentiator between Best-In-Class and Others are the tools that drive behavior (Gaps over 15%). They are NC/CAPA, EHS Mgmt, Risk Mgmt, Compliant Mgmt, Alert Systems, Change Control, and Root Cause Analysis. They simply iterate and improve faster than the rest of the pool.


7 © 2011 IQS1/13/2012

Future of Quality ManagementSingle system for…

Nonconformance/CAPAAPQPFMEA/Control PlanDocument ManagementAudit ManagementTraining ManagementSupplier PerformanceIncoming/In-Process and Final InspectionSPC Data CollectionGage Calibration Preventive MaintenanceComplaint Management

*Take Away – The future of QM systems is a web-based, cloud-architectured system with strong integrations with ERP and CRM. Managing quality across the value chain rather than as an organizational function.

8 © 2011 IQS1/13/2012

Gap Analysis / Business Case

Define Primary Business Goals– Reduce Receiving Inspection costs by 20%.– Shorten Product Launch and ECR cycle time by 40%.– Reduce reporting time by 30%.– Improve overall Product Quality.

Perform Current Systems Gap Analysis– What systems are currently being used?– What are the issues with those systems?– What capabilities are missing?– What are the costs associated with doing it in the current

system (paper, Access, Excel) and the benefits associated with an alternative solution?

9 © 2011 IQS1/13/2012

Standard QMS Benefit Categories

10 © 2011 IQS1/13/2012

Key Evaluation CriteriaKey Evaluation Criteria includes:

– Does the system address core business requirements?• Technical • Security• Application Interfaces – ERP, CRM, etc…• Configurability• Portals• Reporting / Metrics

– Is there a sufficient cost vs benefit defined?– Implementation Support / Strategy

• Time / Cost / Internal Resource Requirements– Annual Support available?

• Product Development Cycle• Technical Support

– Company History & Future Stability– References

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QMS ImplementationKeys to a Successful Implementation

– Gain Executive level commitment• Include as part of the annual MBO• Adds credibility to the project

– Create a ‘phased’ Project Plan• Allocate appropriate resources to support the project• Clearly define roles and responsibilities• Schedule weekly / monthly status meetings

– Systems migration / integration• Import legacy info or simply shut it down and start fresh• ERP Integration (master files)

– Embracing Change• Build a sense of urgency• Share the vision• Address valid concerns• Create a belief that “WE CAN DO BETTER”

12 © 2011 IQS1/13/2012

The IQS ModelThe IQS Model provides a complete framework for compliance with regulatory and industry standards, including ISO, automotive (TS), aerospace (AS), and FDA (21CFR11) requirements.

Based on business processes, not just those assigned to the quality department, has made IQS the industry standard in business performance management.

13 © 2011 IQS1/13/2012

Redefining Enterprise Quality Management

Enterprise Quality Management (EQM)

is the cradle-to-grave approach of coordinating and connecting

the people and processes used to build a product right the first time.

*Take Away – reduce risk, improve visibility into all aspects of business process and performance. Single integrated data hub allows increased visibility into total business process, providing actionable insight

14 © 2011 IQS1/13/2012

Managing Quality is not a function, but everyone’s job from the supplier to the customer.

Suppliers Customers

SupplierPerformance Management

You

EnterpriseQuality

and Compliance Management

CustomerCommunication

Management

15 © 2011 IQS1/13/2012

Information Type:

Current SolutionManaging quality across the supply chain requires the involvement and information from many, many places.

Suppliers Customers

= information in a database = information in a paper document = information in employee

• Product • Process • Customer • Supplier • Manufacturing Asset • Employee

Audit /Compliance Quality

Mfg Plant /Maintenance Mfg Plant

IT

Sales /Cust Service

EngineeringHR /Training

Mfg

Mfg

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Current Solution

Suppliers Customers

Accumulation of time/cost:



IT

Sales /Cust Service


Mfg

Mfg

1NonconformanceReported

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Current Solution

Suppliers Customers




IT

Sales /Cust Service


Mfg

Mfg

2Status?

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Current Solution

Suppliers Customers


3CorrectSpec?



IT

Sales /Cust Service


Mfg

Mfg

19 © 2011 IQS1/13/2012



IT

Sales /Cust Service


Mfg

Mfg

Current Solution

Suppliers Customers


4

Training?

20 © 2011 IQS1/13/2012

Current Solution

Suppliers Customers




IT

Sales /Cust Service


Mfg

Mfg

6

OtherComplaints?

21 © 2011 IQS1/13/2012

Current Solution

Suppliers Customers




IT

Sales /Cust Service


Mfg

Mfg

7Documented?

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Current Solution

Suppliers Customers




IT

Sales /Cust Service


Mfg

Mfg

8Calibrated?

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Current Solution

Suppliers Customers




IT

Sales /Cust Service


Mfg

Mfg 10

On-spec material?

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HR /Training Engineering Sales /

Cust Service

Mfg

Mfg ITQualityAudit /Compliance

Mfg PlantMfg Plant /Maint


IQS SolutionIQS delivers a software & service solution to provide you with

complete quality management.

Suppliers Customers

= information in a paper document = information in employee

Information Type: • Product • Process • Customer • Supplier • Manufacturing Asset • Employee


27 © 2011 IQS1/13/2012

HR /Training Engineering Sales /

Cust Service

Mfg

Mfg ITQualityAudit /Compliance

Mfg PlantMfg Plant /Maint


IQS SolutionIQS delivers a software & service solution to provide you with

complete quality management.

Suppliers Customers

= information in a paper document = information in employee

Information Type: • Product • Process • Customer • Supplier • Manufacturing Asset • Employee

1NonconformanceReported


IQS systems enable you to manage quality and costs across the value chain

2

31 © 2011 IQS1/13/2012

Contact Us• Visit our website www.iqs.com

– Sign up for our Webinar Series “Supplier Quality & APQP”– Build your own business case from your data– Investigate our EQM solution– Download whitepapers validating our results– Determine your current Enterprise Quality Management Maturity

Level and Readiness Level– Request a demonstration for your staff

• Email me at [email protected] - Tom West, Sr. Account Executive, IQS

© 2011 IQSJanuary 13, 2012

ASQ Meeting“Navigating QMS Evaluation &

Implementation”Presenter: Tom West

Jeff Stuart

Questions ?

Navigating QMS Evaluation &...

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