PRODUCT TESTINGAND
CERTIFICATION
Kenneth CrowDRM Associates
© 1998 DRM ASSOCIATES
TYPES OF TESTING
TECHNOLOGYDEVELOPMENT
PRODUCTDEVELOPMENT
PRODUCTIONTESTING ANDCERTIFICATION
DEVELOPMENT TESTING
RELIABILITY TESTING
ACCEPTANCETESTING
QUALIFICATION/CERTIFICATION
© 1998 DRM ASSOCIATES
CERTIFICATION TESTING
Standards SpecificationsRegulations
Certification testing to assure compliance, satisfy customers, and protect against legal liability
Legal Liability
© 1998 DRM ASSOCIATES
TYPES OF CERTIFICATION & QUALIFICATION
Automobiles Pollution Environmental Protection Agency
Safety National Highway Safety Commission
Aircraft Safety Federal Aviation Administration
Consumer Products Electrical Safety Underwriter’s Laboratories
Defense Satisfies Require- Department of Defense ments
Drugs Safety & Efficacy Food & Drug Administration
Electronic Equipment RF Emissions Federal Communication Commission
Medical Equipment Safety Food & Drug Administration
© 1998 DRM ASSOCIATES
TEST PLANNING
TESTSTRATEGY
REGULATORY ORVOLUNTARY
CERTIFICATIONREQUIREMENTS
SPECIFICATIONS
TestPlan
© 1998 DRM ASSOCIATES
TEST PROCESS
Test Plan (who, what, when)
Test Procedures (how)
Test Equipment/Instrumentation Design
Test Equipment Acquisition/Fabrication
Test Equipment Software Development
Test & Document Results
Analysis, Corrective Action, & Submittal
© 1998 DRM ASSOCIATES
TESTING TO VALIDATE ANALYSIS
Simulation & Analysisto mature product design
Physical testing to validateSimulation & Analysis
© 1998 DRM ASSOCIATES
CERTIFICATION PLANNING FOR IPD
• Understand certification & regulatory approval requirements
• Assess unique product certification and regulatory approval requirements
• Early coordination and communication with agencies and outside laboratories
• Active involvement of safety engineers, regulatory affairs department, and legal
• Early development of test plans and procedures
• Heavy simulation and analysis to reduce physical testing
• Proactive use of reliability & safety analysis - FMEA, FTA, etc.
Time-to-market& risk
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