Why All The Questions?
The Reality Check
You’re absolutely right. In the end, we follow documented procedures, not memory. Every critical task has an SOP, every process has a work instruction, and every decision references approved documentation. So why do interviewers ask so many questions that seem to test memorization?
Testing Judgment, Not Memory
They’re not looking for perfect recall. They’re evaluating whether you understand when to follow procedures, which procedure applies, and why it exists. Can you recognize a deviation when you see one? Do you know when to escalate? That’s judgment, not memorization.
Assessing Your Foundation
In GMP environments, procedures are your safety net—but you need to understand the underlying principles. When something unexpected happens (and it will), you need the conceptual foundation to make sound decisions while you reference the procedure. Knowledge plus procedure equals competence.
Evaluating Problem-Solving Approach
Questions reveal how you think through problems. Do you consider patient safety first? Do you think about data integrity? Do you understand regulatory implications? Your thought process matters as much as the final answer, because procedures can’t cover every scenario.
Verifying Regulatory Awareness
Understanding why a procedure exists (the regulatory basis) helps you execute it correctly and recognize when something is wrong. If you don’t know that 21 CFR Part 11 requires audit trails, you might not notice when they’re not working properly—even if the SOP says to check them.
Checking Communication Skills
Can you articulate complex compliance concepts clearly? During an FDA inspection, you need to explain procedures confidently without sounding robotic. Interviewers want to know you can represent the company professionally under pressure.
“Follow the procedure, but understand the principle.” Procedures tell you WHAT to do. Understanding tells you WHY. Together, they create a competent professional who can maintain compliance even when faced with the unexpected.
When addressing interview concerns or questioning the process, maintain professionalism. Instead of “Why are you asking me things I don’t need to memorize?”—try “I understand we follow documented procedures in actual practice. Could you help me understand how this knowledge applies to the role?” Don’t be rude. Your attitude matters as much as your answers.