The participant will be able to identify the risks present in any process, use basic risk analysis tools to determine the best control strategy and will understand the importance of integrating controls as part of the quality management system.

Participant’s Profile

Top management, process owners, and all personal responsible for the planning and implementation of the quality management systems processes.


Introduction to risk analysis.

  • Terms and definitions.

Pertinent interested parties.

  • Interested parties vs. Needs and expectations.
  • Mendelow matrix.
  • Relevant requirements of the interested parties.

Process context. 

  • SWOT Analysis.
  • Context and actions.

Process approach.

  • Process approach diagram.

Failure Modes determination.

  • Process outputs.
  • Lessons learned.
  • Continuity of supply.

Effects determination.

  • What if?
  • Severity ranking.

Causes determination.

  • Cause and effect diagram.
  • 5 Whys
  • Occurrence ranking.

Risk level estimation.

  • RPN. Risk Priority Number.

Actions to address risks.

  • Preventive actions.
  • Actions to mitigate effects.
  • Contingency plans.

Monitoring and measurement.

  • Effectiveness of corrective actions.
  • Reevaluation of new risk level.

Standardization of controls in the QMS.