Project and Product Risk Management Implementation.

Aims

Implement and product Risk Management Implementation

Role

Lead Implementor and Internal Quality Consultant

Key Points

• Develop an intuitive approach to project risk management compliant with the requirements of ISO 9001 and ISO 13485.
• Develop robust FMEA (failure mode effect analysis) for product risk assessment compliant with ISO 13485.

Successes

• The process implemented in three weeks used self-calculating spreadsheets with lookup tables and conditional formatting and rolled out across departments, including software and hardware.

Skills

• Excel lookup tables and conditional formatting Risk Management.
• Failure mode effect analysis (FMEA)

Tools used

• Excel.