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PRODUCT TESTING AND CERTIFICATION Kenneth Crow DRM Associates TYPES OF TESTING DEVELOPMENT TESTING RELIABILITY TESTING QUALIFICATION/ CERTIFICATION ACCEPTANCE TESTING TECHNOLOGY DEVELOPMENT © 1998 DRM ASSOCIATES PRODUCT DEVELOPMENT TESTING AND CERTIFICATION PRODUCTION CERTIFICATION TESTING Regulations Standards Specifications Legal Liability Certification testing to assure compliance, satisfy customers, and protect against 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 Requirements Department of Defense Drugs Safety & Efficacy Food & Drug Administration Electronic Equipment RF Emissions Federal Communication Commission Medical Equipment Safety Food & Drug Administration © 1998 DRM ASSOCIATES TEST PLANNING TEST STRATEGY SPECIFICATIONS Test Plan © 1998 DRM ASSOCIATES REGULATORY OR VOLUNTARY CERTIFICATION REQUIREMENTS 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 & Analysis to mature product design © 1998 DRM ASSOCIATES Physical testing to validate Simulation & Analysis CERTIFICATION PLANNING FOR IPD • Understand certification & regulatory approval requirements • Assess unique product certification and regulatory approval requirements Time-to-market & risk • 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. © 1998 DRM ASSOCIATES