1. Enterprise Wide Quality Management Made Easy
Enterprise Wide Quality Management System
Enterprise Wide Quality Management Made Easy
Riya Cao – QAD
Bob Herdoiza – CEBOS
Tony Tan – American RENOLIT Corp LA 1

2. 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.

3. Agenda Introduction Industry issues & challenges CEBOS overview
Enterprise Wide Quality Management System
Agenda
Introduction
Industry issues & challenges
CEBOS overview
Enterprise quality management
Customer case study
Integration
Why quality
Q & A

4. Recalls Enterprise Wide Quality Management System
Johnson & Johnson issued a massive recall Friday of over-the- counter drugs including Tylenol, Motrin and St. Joseph's aspirin because of a moldy smell that has made people sick.
Jan 15, 2010

5. More Recalls Enterprise Wide Quality Management System
Mattel Does Damage Control After New Recall
Toyota Recall
Aug 15, 2007
Jan 26, 2011
…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 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.

6. Compliance Industry standards Regulatory TS 16949 ISO 9000 ISO 13485
Enterprise Wide Quality Management System
Compliance
Industry standards
TS 16949
ISO 9000
ISO 13485
Regulatory
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)

7. 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

8. Industry Issues and Challenges
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

9. FDA Quality System Requirements
Enterprise Wide Quality Management System
FDA Quality System Requirements
Corrective and preventative actions
Design controls
Production and process controls
Management
Material controls
Equipment and facility controls
Records, documents, change controls

10. CEBOS Overview Software company Seventeenth year
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

11. CEBOS Overview Comply with quality standards (ISO, TS, AS, FDA, etc.)
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

12. Enterprise Wide Quality Management System
CEBOS’ MQ1

13. Why Important? Best in class manufacturers consistently demonstrate:
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:
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

14. Enabling Solutions Document management Statistical process control
Enterprise Wide Quality Management System
Enabling Solutions
Document management
Statistical process control
Dashboards
Corrective/preventive actions/non-conformances
Advanced product quality planning including FMEA

15. Driving Results Enables higher customer satisfaction
Enterprise Wide Quality Management System
Driving Results
Enables higher customer satisfaction
Reduces product planning time
Reduces time to market
Reduces non-conformances

16. Customer Case Study - American RENOLIT
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

17. Customer Case Study - Business Problem
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

18. Customer Case Study - Specific Areas Targeted
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

19. Customer Case Study - Solution
Enterprise Wide Quality Management System
Customer Case Study - Solution
CEBOS MQ1 software
Modules
Documents
Problem solver
Audits
Human resources
Data collection
Work manager
APQP
E-sync
Integration from QAD to MQ1

20. Customer Case Study - Results
Enterprise Wide Quality Management System
Customer Case Study - Results
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

21. QAD & QMS Integration Framework
Enterprise Wide Quality Management System
QAD & QMS Integration Framework

22. Why QMS Reduce compliance risk Drive accountability
Enterprise Wide Quality Management System
Why QMS
Reduce compliance risk
Drive accountability
Improve product quality and safety
Optimize operational effectiveness
Reduce waste
2008

23. Meeting FDA QS Requirements
Life Science Compliance
Meeting FDA QS Requirements
QMS
Corrective and Preventative Actions
PLM
QAD EA
Design Controls
Production and Process Controls
Management
Material Controls
Equipment and Facility Controls
QAD EA
EAM
Records, Documents, Change Controls
QAD EA
QMS

24. Metrics Affected Enterprise Wide Quality Management System Process
Benefit
Value
Integration
Real time inventory control driven by quality events
Automation
Data integrity
Improved compliance
Eliminate double entries
Eliminate user errors
Improve efficiency
Enterprise Quality Management
Closed-loop quality management
Compliant to FDA QS
Paperless quality processes & records
Enterprise wide quality accountability
Improved product quality and safety
Optimize operational effectiveness
Reduce waste

25. Next Steps Ask your account manager to arrange an Integration Q−Scan
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

26. Enterprise Wide Quality Management System
Questions & Answers
Riya Cao, QAD Bob Herdoiza, Cebos Tony Tan, Renolit

27.
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