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Harpco Systems is a Michigan-based consulting, training, and software practice specializing in Failure Mode and Effects Analysis (FMEA), requirements risk management, and risk-based product lifecycle management. Founded in 1987, it assists manufacturers in sectors such as automotive, medical devices, and industrial equipment to improve quality, reduce time to market, and manage design and manufacturing risks.
Customized training classes and workshops focused on Failure Mode and Effects Analysis (FMEA), requirements risk management, and usage risk assessment.
Instruction on using the Requirements Risk Assessment (RRA) methodology and Design Validation Plans to optimize customer and design requirements.
Training and workshops on utilizing Design FMEAs and Design Verification Plans to optimize product design specifications and mitigate design risk.
Instruction on creating Process Flow diagrams, performing Process FMEAs, and constructing Process Control Plans to optimize manufacturing and assembly processes.
Training on using Application FMEAs (also known as Usage Risk Assessments) and constructing Application Control Plans to manage risks from improper product usage.
Strategic risk-management training designed for management teams to oversee risk-based product lifecycle management workflows.
Provides engineering consulting for product-development and risk-management workflows.
Assists clients with new-product development and technical problem solving.
Implements failure mode and effects analysis workflows.
Applies risk-based engineering practices to product and process decisions.
Provides software tools for quality, risk, and product-lifecycle workflows.
Captures corporate best practices for product-lifecycle management.
Accelerates creation and maintenance of FMEA documentation.
Supports optimization of process controls.
Automotive · Medical Devices · Manufacturing · Industrial
Automotive · Client: Ford Motor Co.
Implemented Quality Plus software to successfully achieve Q1 and ISO 16949 certification at the Monroe BAO Plant. This involved promoting linked documentation to prevent issues during audits, ensuring operational production quality documents contained concurrent, relevant information, and creating a baseline Hot End Exhaust database linking DFMEA to operator visual aids.
Medical Devices · Client: Abbott Diagnostics
Developed a comprehensive Design Control and Risk Management program for immunodiagnostics products. This involved building the necessary infrastructure to handle product complexity and educating personnel on evaluating product design and process control.
Automotive · Client: Calsonic
Coached and improved the DFMEA process to create a knowledge base for engineers to relate requirements and specifications in a continually updated database.