Assessing the Impact of Changes to Your Validation Program

When undertaking a project to enhance your validation program, it’s crucial to have a robust method for measuring success. This is especially important as you aim to increase maturity and address organizational challenges, with a significant focus on training and personnel qualification. The Kirkpatrick model, originally designed for evaluating training programs, can be effectively adapted to assess the success of your validation program improvements.

Level 1: Reaction

This level measures how participants react to the validation program.

• Survey validation team members on their satisfaction with the validation approach
• Gather feedback on the clarity of risk-based validation concepts
• Assess perceived relevance and applicability of the new validation methodology

Level 2: Learning

This level evaluates the knowledge and skills acquired.

• Conduct assessments to measure understanding of key principles
• Test ability to perform risk assessments and develop verification strategies
• Evaluate comprehension of good engineering practices (GEP) and their integration into validation activities

Level 3: Behavior

This level examines how participants apply what they’ve learned on the job.

• Observe validation team members implementing risk-based approaches in actual projects
• Review documentation to ensure proper application of methodologies and assess the quality of user requirements, risk assessments, and verification plans. This is where I would use a rubric.
• Create some key behavior indicators, such as right-the-first time.

I use IMPACT as a tool here.

And then come up with a set of leading and lagging quality and behavioral indicators.

Leading

• Measure and report attendance at risk assessments and project team meetings
• Number of employee/team improvement suggestions implemented
• Number of good catches identified

Trended Lagging

• % RFT validation deliverables
• % RFT executions (looking at discrepancies)

Level 4: Results

This level measures the impact on the organization.

• Track reduction in validation cycle times and associated costs
• Monitor improvements in product quality and reduction in deviations
• Assess regulatory inspection outcomes and feedback on validation approach
• Evaluate overall efficiency gains in the validation process

By applying the Kirkpatrick Model to a validation program improvements we can systematically evaluate the effectiveness of their implementation and identify areas for continuous improvement.