As someone who has spent over 13 years in the biotech manufacturing industry, both as an operator and managing a team of operators, I've seen firsthand the importance of roles and responsibilities in achieving a successful batch. Today, I want to dig into this topic and discuss the critical roles of 'Performer' and 'Verifier.'
The Performer and the Verifier: Two Sides of the Same Coin
In any manufacturing setting, but particularly in manufacturing therapies for sick patients, roles must be clearly defined. Lack of clear roles and role ambiguity can heighten job-related stress for the affected employee and may also lead to tension and conflicts among team members. This is what we call an error trap. Two of the most crucial manufacturing roles are that of the 'Performer' and the 'Verifier.'
The Performer: This is the individual who carries out the task. They are responsible for understanding the procedure, having the skills to execute it, and ensuring they follow the steps as outlined.
The Verifier: This person is responsible for double-checking the work done by the Performer. They ensure that the task is being completed accurately and the final outcome is achieved, while maintaining all quality standards.
Why Not Switch Roles?
You might wonder, why not let the Performer and Verifier switch roles during a task? Wouldn't that offer a fresh perspective? While it might seem like a good idea, it's fraught with risks, especially in our industry where errors can lead to the loss of life.
- Loss of Objectivity: When individuals switch roles, they may lose the objectivity required to effectively verify a task. A Performer may unconsciously overlook errors because they've done the task themselves and think they're unlikely to make a mistake.
- Skill Specialization: Each role requires a specific skill set. A Performer needs to be adept at executing tasks efficiently, while a Verifier needs to have a keen eye for detail. Switching roles can dilute these specialized skills.
- Accountability: When roles are clearly defined, it's easier to hold individuals accountable for their actions. Blurring the lines between roles can lead to a lack of accountability, making it difficult to pinpoint the source of errors.
Human Performance theories emphasize the importance of understanding human errors as a consequence rather than a cause. By clearly defining roles and responsibilities, we can create a system that is more resilient to human error. The Performer knows what they are accountable for, and the Verifier acts as a safety net, ensuring that errors are caught before they can escalate into bigger issues. This also means the Verifier should have as much or more knowledge on the task compared to the performer. Seasoned operators likely have experienced or seen the failures that can occur during the task, being better able to recognize if the performer is missing the mark.
Roles and responsibilities aren't just corporate jargon; they're the backbone of a successful, error-minimized operation. By understanding and respecting the roles of Performer and Verifier, we can create a culture that not only values quality but also understands the human element in achieving it.
Sarah Boynton, a Consultant on the Quality Executive Partners team, has extensive experience in the biopharmaceutical/cell and gene therapy space, with a particular focus on cGMP training, human performance/error prevention, downstream processing, and non-conformance investigations. Prior to joining QxP, Sarah worked for Catalent Pharma Solutions, KBI Biopharma, AstraZeneca, MedImmune, and GlaxoSmithKline.
Check out Sarah’s other recent blog: “4 Best Practices for Effective Investigation into Deviations.”