PM

Project Management

RM

Risk Management

QARA

Quality Assurance and
Regulatory Affairs

BA

Business Analysis

KM

Knowledge Management
BPA
Business Process Management

Risk Management

Risk management is one of the key tools required for evaluating consumer safety whilst using a company’s products or services.  A robust risk management process will ensue that the customer needs are defined, the product or service is designed to meet those needs and a process is applied that is consistently capable of producing the defined requirements .  Risk management begins at concept phase of the product or service life cycle and is  a key activity applied to product portfolio generation  and strategic decision making.

Based on Technical and International standards for risk management (Failure Mode and Effects Analysis, ISO 14971, ISO 31000, etc), Avanti Europe’s leadership team have many years of both practical and theoretical  experience in  the facilitation of risk management workshops (Human Factors engineering; Task Analysis; Hazard Assessment; user FMEA, design FMEA, process FMEA and warehousing FMEA).  We have facilitated and trained risk management teams within multi million US Dollar projects, where the identification of potential consumer and business risks have changed and redefined company strategies.  The use of a robust risk management activities will prevent errors both in product and process design and Avanti Europe’s team can assist in the development of a bespoke risk management strategy.

Expertise includes, but is not limited to:

  • Failure Mode and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Hazard Analysis and Critical Control Points (HACCP)
  • Medical device risk management (ISO 14971)
  • Combination products risk management (ISO 14971 and ICH Q9)
  • Pharmaceutical risk management (ICH Q9)
  • Enterprise risk management and public sector (ISO 31000)
  • Information technology risk management (ISO/IEC 27005)
  • Developing and implementing bespoke risk management procedures and processes
  • Customer-specific training (in-house or as e-Learning)