Surviving an FDA Audit: Heuristics for Exploratory Testing

In FDA regulated industries, audits are high-stakes, fact-finding exercises required to verify compliance to regulations and an organization’s internal procedures. Although exploratory testing has emerged as a powerful test approach within regulated industries, an audit is the impact point where exploratory testing and regulatory worlds collide. Griffin Jones describes a heuristic model-Congruence, Honesty, Competence, Appropriate Process Model, Willingness, Control, and Evidence-his team used to survive an audit. You can use this model to prepare for an audit or to baseline your current practices for an improvement program. Griffin highlights the common misconceptions and traps to avoid with exploratory testing in your regulated industry. Avoid mutual misunderstandings that can trigger episodes of incongruous behavior and an unsuccessful audit. Learn how to maintain your composure during a stressful audit and leave with valuable heuristics to help you organize and present your exploratory testing results with confidence.