02
2 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. Safe Harbor Statement Enterprise Wide Quality Management System<br>
04
Recalls 4 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 Enterprise Wide Quality Management System<br>
05
More Recalls 5 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. Mattel Does Damage Control After New Recall Toyota Recall 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. Jan 26, 2011 Enterprise Wide Quality Management System<br>
06
6 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) Compliance Enterprise Wide Quality Management System<br>
07
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 Recent Legislation 7 Enterprise Wide Quality Management System<br>
08
Industry Issues and Challenges New product development Demanding customer requirements Continuing pricing and margin pressures Global consolidation and alliances Intense shareholder pressures Enterprise Wide Quality Management System 8 Manufacturers Customer compliance
Regulatory compliance Product quality concerns Product safety concerns<br>
09
FDA Quality System Requirements Enterprise Wide Quality Management System 9 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm Corrective and preventative actions Records, documents, change controls Equipment and facility controls Production and process controls Material controls Design controls Management<br>
10
10 Software company
Seventeenth year
Hundreds of deployments - thousands of users
Currently supporting 12 languages
Serve vertical markets of QAD
Registered to ISO 9001:2008 CEBOS Overview Enterprise Wide Quality Management System<br>
11
11 Comply with quality standards (ISO, TS, AS, FDA, etc.)
Automate required business processes
Integrate related quality processes and QAD CEBOS Overview Enterprise Wide Quality Management System<br>
12
CEBOS’ MQ1 Enterprise Wide Quality Management System 12<br>
13
13 “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 Why Important? Enterprise Wide Quality Management System<br>
14
14 Document management
Statistical process control
Dashboards
Corrective/preventive actions/non-conformances
Advanced product quality planning including FMEA Enabling Solutions Enterprise Wide Quality Management System<br>
15
15 Enables higher customer satisfaction
Reduces product planning time
Reduces time to market
Reduces non-conformances Driving Results Enterprise Wide Quality Management System<br>
16
16 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 Customer Case Study - American RENOLIT Enterprise Wide Quality Management System<br>
17
17 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 Customer Case Study - Business Problem Enterprise Wide Quality Management System<br>
18
18 Document control
Corrective/preventive action (CAPA) management
Employee training tracking
Audit management
Project management
Shop floor inspection management
APQP documentation management Customer Case Study - Specific Areas Targeted Enterprise Wide Quality Management System<br>
19
19 CEBOS MQ1 software
Modules
Documents
Problem solver
Audits
Human resources
Data collection
Work manager
APQP
E-sync
Integration from QAD to MQ1 Customer Case Study - Solution Enterprise Wide Quality Management System<br>
20
20 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 Customer Case Study - Results Enterprise Wide Quality Management System<br>
21
21 QAD & QMS Integration Framework Enterprise Wide Quality Management System<br>
22
22 Reduce compliance risk
Drive accountability
Improve product quality and safety
Optimize operational effectiveness
Reduce waste Why QMS Enterprise Wide Quality Management System 2008<br>
23
Corrective and Preventative Actions Records, Documents, Change Controls Equipment and Facility Controls Production and Process Controls Material Controls Design Controls Meeting FDA QS Requirements Life Science Compliance 23 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm EAM QAD EA QMS PLM QAD EA QMS QAD EA Management<br>
24
24 Metrics Affected Enterprise Wide Quality Management System<br>
25
25 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/ Next Steps Enterprise Wide Quality Management System<br>
26
26 Riya Cao, QAD
zrc@qad.com
Bob Herdoiza, Cebos
bob.herdoiza@cebos.com
Tony Tan, Renolit
tony.tan@renolit.com Questions & Answers Enterprise Wide Quality Management System<br>
27
www.qad.com
© QAD Inc 27<br>
