Enterprise Wide Quality Management System Enterprise Wide Quality

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. 2

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

Enterprise Wide Quality Management System Recalls 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 4

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. 5

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) 6

Enterprise Wide Quality Management System Recent Legislation • U. S. Congress passed the Consumer Product Safety Commission Reform Act, H. R. 4040 • 3 rd party laboratory test to ensure safety standards • Searchable database on reports of safety hazards 7

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 8

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/Medical. Devices/Resourcesfor. You/Industry/ucm 126252. htm 9

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 10

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 11

Enterprise Wide Quality Management System CEBOS’ MQ 1 12

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 13

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

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

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 16

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 17

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 18

Enterprise Wide Quality Management System Customer Case Study - Solution • CEBOS MQ 1 software • Modules - Documents Problem solver Audits Human resources Data collection Work manager APQP E-sync • Integration from QAD to MQ 1 19

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 20

Enterprise Wide Quality Management System QAD & QMS Integration Framework 21

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

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 EAM Records, Documents, Change Controls QAD EA QMS http: //www. fda. gov/Medical. Devices/Resourcesfor. You/Industry/ucm 126252. htm 23

Enterprise Wide Quality Management System Metrics Affected 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 compliance • Improved product quality and safety • Optimize operational effectiveness • Reduce waste 24

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/ 25

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 26

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