enterprise wide quality management made easy riya cao – qad bob herdoiza – cebos tony tan –...
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Enterprise Wide Quality Management Made EasyRiya Cao – QADBob Herdoiza – CEBOS Tony Tan – American RENOLIT Corp LA
Enterprise Wide Quality Management System
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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
• Introduction• Industry issues & challenges• CEBOS overview• Enterprise quality management• Customer case study• Integration• Why quality• Q & A
Agenda
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Recalls
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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
More Recalls
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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
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• 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
• 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
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Enterprise Wide Quality Management System
Industry Issues and Challenges
New product development
Demanding customer requirements
Continuing pricingand margin pressures
Global consolidationand alliances
Intense shareholder pressures
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Manufacturers
Customer compliance
Regulatory compliance
Product quality concerns
Product safety concerns
FDA Quality System Requirements
Enterprise Wide Quality Management System
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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
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• 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
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• Comply with quality standards (ISO, TS, AS, FDA, etc.)
• Automate required business processes• Integrate related quality processes and QAD
CEBOS Overview
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“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?
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• Document management• Statistical process control• Dashboards• Corrective/preventive actions/non-
conformances• Advanced product quality planning
including FMEA
Enabling Solutions
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• Enables higher customer satisfaction• Reduces product planning time• Reduces time to market• Reduces non-conformances
Driving Results
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• 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
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• 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
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• 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
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• 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
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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
Customer Case Study - Results
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• Reduce compliance risk
• Drive accountability
• Improve product quality and safety
• Optimize operational effectiveness
• Reduce waste
Why QMS
Enterprise Wide Quality Management System
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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
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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126252.htm
EAMQAD EA
QMS
PLM QAD EA
QMS
QAD EA
Management
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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 compliance
•Improved product quality and safety
•Optimize operational effectiveness
•Reduce waste
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• 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
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Riya Cao, QAD
Bob Herdoiza, Cebos
Tony Tan, Renolit
Questions & Answers
Enterprise Wide Quality Management System