• Assign a cross-functional team that will establish standard operating procedures and applicable quality policies. A quality assurance person who does not participate in risk assessment should review everyone's work, as this process involves judgment calls and requires objectivity.
• The team prepares a system overview, develops a process map for the system under review, and identifies the scope of the assessment. For example, are you installing an entire line or changing a filler?
• Identify controlled or monitored functions and determine which functions could affect risk assessment parameters.
• Identify every possible risk scenario for all identified functions. Match those scenarios with their likely effect(s). For instance, if a stopper is not placed properly in a vial (a possible risk), the possible effects could include spilled product, product that's underweight/under dose, or product that appears to have been tampered with.
• Evaluate and rate each risk upon impact, likelihood of failure, and the probability of detection. The JETT Risk Management Model provides a series of rating tables to help.
• Once the team identifies the greatest risks, it proposes risk mitigation, which may include another inspection station, new alarm parameters, more sensors, and so on. [HCP]
• The team prepares a system overview, develops a process map for the system under review, and identifies the scope of the assessment. For example, are you installing an entire line or changing a filler?
• Identify controlled or monitored functions and determine which functions could affect risk assessment parameters.
• Identify every possible risk scenario for all identified functions. Match those scenarios with their likely effect(s). For instance, if a stopper is not placed properly in a vial (a possible risk), the possible effects could include spilled product, product that's underweight/under dose, or product that appears to have been tampered with.
• Evaluate and rate each risk upon impact, likelihood of failure, and the probability of detection. The JETT Risk Management Model provides a series of rating tables to help.
• Once the team identifies the greatest risks, it proposes risk mitigation, which may include another inspection station, new alarm parameters, more sensors, and so on. [HCP]
