Enterprise Wide Quality Management System
Enterprise Wide Quality Management Made Easy
Riya Cao – QAD
Bob Herdoiza – CEBOS
Tony Tan – American RENOLIT Corp LA
Enterprise Wide Quality Management System
Safe Harbor Statement
The following is intended to outline QAD’s general
product direction. It is intended for information
purposes only, and may not be incorporated into
any contract. It is not a commitment to deliver
any material, code, functional capabilities, and
should not be relied upon in making purchasing
decisions. The development, release, and timing
of any features or functional capabilities
described for QAD’s products remains at the sole
discretion of QAD.
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Enterprise Wide Quality Management System
Agenda
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Introduction
Industry issues & challenges
CEBOS overview
Enterprise quality management
Customer case study
Integration
Why quality
Q&A
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Enterprise Wide Quality Management System
Recalls
Johnson & Johnson issued a
massive recall Friday of over-thecounter drugs including Tylenol,
Motrin and St. Joseph's aspirin
because of a moldy smell that has
made people sick.
Jan 15, 2010
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Enterprise Wide Quality Management System
More Recalls
Mattel Does Damage Control
After New Recall
Aug 15, 2007
…a world-wide recall Aug. 1 of about
1.5 million Mattel toys believed to
contain lead contamination,
including items featuring such popular
characters as Elmo and Big Bird.
Toyota Recall
Jan 26, 2011
Toyota Motor Corp said it would recall
more than 1.7 million vehicles worldwide,
bringing total recalls to nearly 16 million
since late 2009 and dealing a blow to its
efforts to restore its reputation for quality.
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Enterprise Wide Quality Management System
Compliance
• Industry standards
- TS 16949
- ISO 9000
- ISO 13485
• Regulatory
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FDA 21 CFR Part 210 & 211
FDA 21 CFR Part 820
FDA’s Quality System Inspection Technique (QSIT)
FDA Bioterrorism Act of 2002
Hazard Analysis and Critical Control Point (HAACP)
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Enterprise Wide Quality Management System
Recent Legislation
• U.S. Congress passed the Consumer Product
Safety Commission Reform Act, H.R.4040
• 3rd party laboratory test to ensure safety
standards
• Searchable database on reports of safety
hazards
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Enterprise Wide Quality Management System
Industry Issues and Challenges
New product
development
Product quality
concerns
Product safety
concerns
Continuing pricing
and margin pressures
Demanding customer
requirements
Manufacturers
Global consolidation
and alliances
Intense shareholder
pressures
Customer compliance
Regulatory compliance
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Enterprise Wide Quality Management System
FDA Quality System Requirements
Corrective and
preventative
actions
Production and
process controls
Design controls
Management
Equipment and
facility controls
Material controls
Records,
documents,
change controls
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
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Enterprise Wide Quality Management System
CEBOS Overview
• Software company
• Seventeenth year
• Hundreds of deployments - thousands of
users
• Currently supporting 12 languages
• Serve vertical markets of QAD
• Registered to ISO 9001:2008
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Enterprise Wide Quality Management System
CEBOS Overview
• Comply with quality standards (ISO, TS, AS, FDA, etc.)
• Automate required business processes
• Integrate related quality processes and QAD
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Enterprise Wide Quality Management System
CEBOS’ MQ1
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Enterprise Wide Quality Management System
Why Important?
“To achieve Best-in-Class performance, companies must…
implement Quality Management Systems at an enterprise
wide level…“ --Aberdeen Group August 2008
• Best in class manufacturers consistently
demonstrate:
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Solid visibility and control across the organization
Minimal scrap, rework, and returned materials
Good communication across the organization
Standardized processes
Operational metrics tied to financial metrics
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Enterprise Wide Quality Management System
Enabling Solutions
Document management
Statistical process control
Dashboards
Corrective/preventive actions/nonconformances
• Advanced product quality planning
including FMEA
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Enterprise Wide Quality Management System
Driving Results
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Enables higher customer satisfaction
Reduces product planning time
Reduces time to market
Reduces non-conformances
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Enterprise Wide Quality Management System
Customer Case Study - American RENOLIT
• Manufacturer of plastic films
• International company with over 4,000
employees spanning 30 manufacturing and
sales locations globally
• Los Angeles site is one of the facilities that
manufactures film for the medical industry
• Some applications of our film go into blood
bags, IV, dialysis, nutritional, cardiovascular,
biotech, collection and urological drain
bags
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Enterprise Wide Quality Management System
Customer Case Study - Business Problem
• Stand alone non-integrated systems
• Excel spreadsheets primary automation tool
• Unable to view trends across the
organization
• Correct information was often difficult to
locate
• User and IT management high
• Inconsistent processes / not standardized
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Enterprise Wide Quality Management System
Customer Case Study - Specific Areas Targeted
• Document control
• Corrective/preventive action (CAPA)
management
• Employee training tracking
• Audit management
• Project management
• Shop floor inspection management
• APQP documentation management
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Enterprise Wide Quality Management System
Customer Case Study - Solution
• CEBOS MQ1 software
• Modules
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Documents
Problem solver
Audits
Human resources
Data collection
Work manager
APQP
E-sync
• Integration from QAD to MQ1
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Enterprise Wide Quality Management System
Customer Case Study - Results
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Central data repository for all locations
Improved data for business decisions
Analysis capabilities across the organization
Consistent / standardized processes
Streamlined processes
Flexible reporting and process configuration
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Enterprise Wide Quality Management System
QAD & QMS Integration Framework
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Enterprise Wide Quality Management System
Why QMS
• Reduce
compliance risk
• Drive accountability
• Improve product
quality and safety
• Optimize
operational
effectiveness
• Reduce waste
2008
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Life Science Compliance
Meeting FDA QS Requirements
QMS
Corrective and
Preventative
Actions
PLM
QAD EA
Production and
Process Controls
Design Controls
Management
Equipment and
Facility Controls
Material Controls
QAD EA
Records,
Documents,
Change Controls
QAD EA
EAM
QMS
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
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Enterprise Wide Quality Management System
Metrics Affected
Process
Integration
Benefit
•Real time inventory control driven by quality
events
•Improved compliance
•Automation
•Eliminate user errors
•Data integrity
Enterprise Quality
Management
Value
•Eliminate double entries
•Improve efficiency
•Closed-loop quality management
•Improved compliance
•Compliant to FDA QS
•Improved product
quality and safety
•Paperless quality processes & records
•Enterprise wide quality accountability
•Optimize operational
effectiveness
•Reduce waste
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Enterprise Wide Quality Management System
Next Steps
• Ask your account manager to arrange an
Integration Q−Scan
• Stop by the CEBOS booth in the EXPO
center for a demo
• Review and download information on the
QAD Life Sciences website
http://www.qad.com/erp/Life-Sciences/
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Enterprise Wide Quality Management System
Questions & Answers
Riya Cao, QAD
zrc@qad.com
Bob Herdoiza, Cebos
bob.herdoiza@cebos.com
Tony Tan, Renolit
tony.tan@renolit.com
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www.qad.com
© QAD Inc
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