Quality Management Systems – Risk Management – Risk Assessment and Control

Course Title: Quality Management Systems – Risk Management – Risk Assessment and Control

Course Facilitator: Merle Kock

Course Duration: 1 Day (8 Hours)

Course Summary

This module provides participants with the skills & tools to develop and implement a systematic process for the assessment, control, communication & review of risks to the business as well as understand risks and mitigation via robust controls & methods as outlined below:

• The recognition of risks prior to potential events impacting the healthcare system will enable improved efficiency.
• Through the identification of hazards, evaluation of its risk, and the implementation of methods to avert the incident, potential harmful situations can be minimized.
• Upon identification of the risks, participants will also be taught to evaluate the risks which require interventions and those which are low risk.
• The importance of a risk plan will be discussed, for improved operations as well as legal purposes. The assessment will encompass all the teachings of the course to enable application in the real world of healthcare for improved risk management under the guidance of the facilitator.

The Purpose of risk management is to manage risk in three stages:

• Identifying underlining risks/ hazards in Healthcare Sector/Pharma Environment.
• Logically determining the risk of harm to the protection of patients.
• Considering what could be done to eliminate the reduce that risk.

Course Goals and Objectives

The Goal of the session will be to define the formal risk management process comprising the identification, analysis, planning, tracking, controlling and communication of the risk factors associated with your company/division with special focus on your business sector.

Course Training Objectives – to ensure the effective implementation of an effective Risk Management System are outlined below:

• Implementation/Evaluation of the overall Enterprise Risk Management (ERM) system at a company level.
• Understanding of the principles of a FMEA (Failure Modes & Effects Analysis) Risk Management Model in line with Best Practices – incorporating risk scoring that includes the following:
• Severity of the risk
• Detectability of the risk
• Likelihood of the risk occurring

Overall Assessment Brief

Individuals/Groups to submit the risk assessments to the course facilitator for evaluation.

Evaluation will be based on the following metric:

• The ability to conduct a cross functional risk assessment using the FMEA model highlighting the severity, detectability, and likelihood of occurrence of the risks identified.
• The ability to develop mitigating factors together with an action plan.