Attend PACK EXPO – this year’s can’t-miss event in Chicago, Oct 23-26.
Discover solutions from 2,000+ exhibitors to advance your operations and network with colleagues at PACK EXPO International.
REGISTER TODAY

Risk assessment: A step-by-step process

Interphex New York presenters Gary Lynch of Eli Lilly & Co. and Terry Petro of Bosch Packaging Technology recommended beginning with the finished product in mind, including risk assessment of packaging and labeling. Here are the key steps:

• 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]
Where the Entire Industry Meets
Discover solutions from 2,000+ exhibitors to advance your operations and network with colleagues at PACK EXPO International, Oct 23-26.
REGISTER TODAY
Where the Entire Industry Meets
Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Take Quiz
Test Your Supply Chain Smarts