4 Best Practices for Life Science Manufacturers to Manage Risk


Managing risk for life science organizations is often seen as simply a way to achieve and maintain industry compliance, and not as a means to improving operational performance.

That’s far from the perception in other industries, where effective risk management also supports continuous improvement and competitive differentiation.

Industry leaders in risk management are committed to continuous improvement programs, which drive down risks on existing products. The reality today is that the changing nature of risks requires adopting effective strategies to properly prioritize and mitigate them.

Arguably life science manufacturers should adopt a similar approach that takes advantage of best practices from across industries.

To that end, manufacturers should focus on:

Using a single unified framework for risk management

A unified framework allows the ability to compare risks, and execute continuous improvement measures. Many possible risk models exist, such as failure modes/failure effects/causes/controls/verification, or hazards/harms/controls/consequences. A unified model allows manufacturers to assess risks consistently across regions, sites, products, and the lifecycle.

Developing a unified risk concept

During early development phases, the concept of unified risk sets the targets for product development, supplier selection, and operational monitoring. New risks can be identified at any time, but correlate back to the core risk concept.

Performing detailed risk analysis using a cross-functional team

The detailed risk analysis should result in identification of Critical Attributes/Critical Parameters as well as operational plans across the value chain. These same detailed risk analyses and plans should be executed by suppliers.

Creating design reviews that assess risk based on new, unique elements

This practice should be deployed only after manufacturers have significantly reduced risk on existing products to as low as possible. Design reviews should not focus on new, unique, and difficult elements until the residual risk of existing products is low.

To learn more how to create a performance-based risk strategy for life sciences, download the LNS research report below.


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