RISK MANAGEMENT

• Risk - uncertainty about possible damage, injury, or loss
• Risk denotes potential negative impact on an asset or some characteristic value that may arise from some present process or future events
• Risk is unavoidable.
• Risk threatens the ability of an individual or organization to achieve its goals.
• Risk - potential for harm or financial loss
• The level of risk reflects:

  1. likelihood of unwanted event
  2. potential consequences of the unwanted event
• Safety risk - the risk of an accident or crime that impacts your health or quality of life
• Health risk - risk of negative health outcomes, e.g. disease
• Property risk - risk to your property, e.g. fire, theft, flood
• Dread risk - risk that people particularly fear, such as the risk of an airplane crash
• Passive risk - the risk of doing nothing (inactivity)
• What to do about risks?

  Eliminate, Minimize, Shift, Absorb risks
• Risk management - all about planning for what might go wrong if x happens; planning y as a reaction when something goes wrong
• Risk management plan - a key project management process that enables a company/project managers see ahead to potential risks and reduce their negative impact
• Risk management plan is a set of health product vigilance activities and interventions to identify, characterize, prevent, or minimize risks to health products, and the assessment of the effectiveness of those interventions
• Risk management steps

  1. Set your goals
  2. Identify risks
  3. Evaluating or analyzing risks
  4. Choosing methods of managing the risks
  5. Carrying out these methods
  6. Reviewing the results
• FDA Circular No. 2018-013


  Guidelines Framework for RMP for Establishments
• Section A - Introduction

  Internal Environment

  Risk Management Approach

  Risk Management Objective

  Data Lock Point
• Internal Environment - brief description of the company, vision, mission, organizational structure, officers, contact info of responsible officers
• Risk Management Approach - brief description of the establishment's management processes, personnel involved, the periodic reporting, and monthly procedures to be performed
• Risk management objective - ensure safety, efficacy, and quality of the drug products the establishment engages with in order to protect public health
• Key Result Area - outlines the outcome within the position for which the employee is responsible
• A strategic result that you should aim to achieve

  Key Result Area
• A metric to determine the progress within a KRA

  Key Performance Indicator
• Key Performance Indicator - metric to determine the effectiveness of a certain area
• KRA describes the scope of a job role and comes before KPI
• KPIs are created based on KRAs
• Structure of KRA

  1. entire job description
  2. results
• KPIs do not tell a story. Many KPIs can be aligned to a KRA.
• Timeline of KRA and KPI

  KRA - long term goals

  KPI - can change from month to month
• Data Lock Point - timeframe to which the RMP is expected to be valid
• Section B - Risk Identification

  1. Risk Universe
  2. Risk Assessment
  3. Summary Risk Register
  4. Unknown Risks
• Risk Universe - contains all identified risks
• Risk Assessment - risks are described based on their (1) significance and (2) likelihood of occurence
• Summary risk register (tabulated) contains risks described based on their (1) priority risks, (2) specific objectives under which priority risks belong, and (3) naming convention for each priority risk
• Unknown risks - planned activities must be set by the establishment to identify them
• Section C - Risk Minimization

  1. Routine Risk Minimization
  2. Additional Risk Minimization
  3. Justification for Identified Risks w/o Minimization Activities
• Routine Risk Minimization - planned activities conducted by the drug establishment regularly to minimize risks
• Additional Risk Minimization - planned activities conducted the drug establishment when routine risk minimization activities are not sufficient to manage a risk
• Section D - Risk Communication

  1. Internal Communication
  2. Communication to FDA
  3. Communication to Consumers and Healthcare Professionals
  4. Communication to Other Stakeholders