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 QADs 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 QADs 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-thecounter 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 - FDAs 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 3rd 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 developmen t 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/MedicalDevices/ResourcesforYou/Industry/ucm126252.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 MQ1 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/nonconformances 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 MQ1 software Modules - Documents Problem solver Audits Human resources Data collection Work manager APQP E-sync Integration from QAD to MQ1 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 Material Controls QAD EA Equipment and Facility Controls Records, Documents, Change Controls QAD EA EAM

QMS http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.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 QScan 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 [email protected] Bob Herdoiza, Cebos [email protected] Tony Tan, Renolit [email protected] 26 www.qad.com QAD Inc 27

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