Quality Risk Management Tools

quality-risk-management-2PTM Consulting gained wide knowledge and skill implementation on Quality Risk Management tools, needed for the practical and scientific approach to data organization and decision-making, by providing documented, consistent and communicative methods throughout drug product and medical product development and manufacturing.

PTM Consulting supports pharmaceutical and medical companies in the implementation of the decision-making Quality Risk Management process for both the systemic level and specific projects in the efficient and effective usage of the following tools, also suitable for Quality by Design, Lean Manufacturing and Six Sigma programs.

The main Quality Risk Management tools used by PTM Consulting follow:

  • FMEA (Failure Mode and Effect Analysis)
  • FTA (Fault Tree Analysis)
  • Ishikawa or Fishbone Diagram
  • CAPA (Corrective Action and Preventive Action)
  • HAZOP (HAZard OPerability analysis)
  • HACCP (Hazard Analysis Critical Control Points)
  • PHA (Preliminary Hazard Analysis)