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