CAPA in QA
CAPA, or Corrective Action Preventive Action, is more than just a response mechanism — it's the engine of continuous improvement in the world of Quality Assurance (QA). It is the structured process where all quality signals converge: deviations, complaints, inspection findings, or risks that exceed the acceptance threshold. A CAPA defines a concrete action plan based on root cause analysis, aimed at improvement, with a specified due date and a designated responsible.
In essence, action is the catalyst for improvement. A lack of action inevitably leads to decline. CAPA ensures that quality issues, whether current or potential, are addressed, leaving no room for ambiguity or inertia.
Corrective Action
A corrective action is a reactive measure taken after the occurrence of a nonconformity, defect, or other undesirable situation. Its primary purpose is to prevent recurrence. This form of action ensures that past issues do not repeat, creating a feedback loop for continuous improvement.
Preventive Action
A preventive action is proactive, designed to identify and mitigate potential issues before they occur. This is often driven by risk assessments, trend analyses, or findings from internal self-inspections. By anticipating problems and taking early measures, preventive actions strengthen the robustness of a QA system and reduce the likelihood of future deviations.
CAPA in Statistics
Cohen’s kappa (also known the inter-rater reliability) is a fundamental concept in statistics. It is the degree to which two independent observers reach the same conclusion.
In our context, this applies to the alignment between your organization’s interpretation of the law (with our help) and that of regulatory bodies such as the FAMHP (Federal Agency for Medicines and Health Products).
Through inspection experience, we understand how authorities perceive industry standards. This often goes beyond the written law or guidelines; it's about how these are interpreted and where consensus lies across the industry. While legislation forms the foundation, the FAMHP evaluates how this legislation is implemented and whether your interpretation aligns with theirs.
Our goal at CAPA is to maximize inter-rater reliability between clients and regulators — ensuring that your interpretation of the law holds up under inspection, while doing so in the most economically efficient manner possible.
However, it’s not just about high inter-rater reliability; it’s about adopting an analytical, statistically sound approach. Important decisions should never be based on gut feeling alone. Even if luck is temporarily on your side, decisions made without relying on data will, in the long run, lead to suboptimal outcomes.