PDA Letter Article

Add Sherlock Holmes to Your Investigation Team

by Tony Cundell, PhD, Microbiological Consulting, LLC


The Role of a Microbiologist in Teams Investigating Product Failures Due to Manufacturing Issues

You have reported a microbial test failure to your site’s management following confirmation by a laboratory investigation. Now, you must assemble a cross-functional team to investigate the most likely cause of failure during manufacturing.

How can your team effectively investigate this testing failure? Consider including a microbiologist among the team members. A microbiologist increases the likelihood of a successful investigation by bringing their expertise to the investigation. Think of it as adding Sherlock Holmes to your team of investigators.