Enterprise Wide Quality Management Made Easy Riya

Transcript:Enterprise Wide Quality Management Made Easy Riya:
Enterprise Wide Quality Management Made Easy Riya Cao – QAD Bob Herdoiza – CEBOS Tony Tan – American RENOLIT Corp LA Enterprise Wide Quality Management System 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 Introduction Industry issues & challenges CEBOS overview Enterprise quality management Customer case study Integration Why quality Q & A Agenda Enterprise Wide Quality Management System 3 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 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 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 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 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 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