July 23, 2025
Quality audits are a cornerstone of compliance in FDA and ISO-regulated environments, ensuring that procedures, records, and activities align with stringent regulatory standards. These systematic examinations verify that quality systems meet the requirements of regulations like 21 CFR Part 211 and 21 CFR Part 820, and ISO standards such as ISO 9001 and ISO 13485. By conducting thorough quality audits, companies demonstrate control, mitigate risks, and maintain product safety and efficacy.
Importance of Quality Audits
Quality audits are mandated by regulatory bodies like the FDA and ISO to ensure product quality and safety. These audits extend to suppliers, holding them accountable for their contributions to the supply chain. A robust quality audit process not only ensures compliance but also drives continuous improvement by identifying gaps and implementing corrective actions.
5 Key Factors Leading to Quality Audit Complications
Despite their importance, quality audits can fail if critical elements are not addressed. Below are five key reasons why quality audits may not succeed and how to address them for better compliance.
1. Inadequate Documentation
Documentation is the backbone of quality audits. In regulated environments, the adage “if it’s not documented, it didn’t happen” holds true. Incomplete or inaccurate documentation, often found in manual or spreadsheet-based systems, leads to audit findings. An Enterprise Quality Management System (EQMS) streamlines documentation by automating routing, review, and approvals, ensuring a centralized, searchable repository for all records.
2. Weak CAPA and Nonconformance Processes
Corrective and Preventive Action (CAPA) and nonconformance processes are essential for addressing deviations. Deficiencies in these areas are frequent causes of FDA Form 483 observations. An EQMS automates CAPA workflows, standardizes data, and links nonconformances to corrective actions, ensuring auditors see a controlled, well-documented process from start to finish.
3. Ineffective Internal Audit Programs
Internal audits are critical for ensuring compliance with regulations and policies. Poorly designed audit procedures or inadequate auditor training can lead to missed gaps and noncompliance. Implementing a repeatable internal audit program supported by an EQMS ensures consistent execution, real-time visibility, and comprehensive audit trails.
4. Insufficient Training Management
Training records are often a focal point during quality audits. When working with manual training systems, it can be a struggle to maintain up-to-date records and verify competency. An EQMS automates training tasks, tracks completion, and provides evidence of role-based training, ensuring compliance with evolving regulatory standards.
5. Lack of Risk-Based Approach
Taking a risk-based approach in quality management is incredibly important. This approach involves taking proactive steps in identifying, assessing, and controlling potential hazards that could impact the quality of your product or service. Without proper risk assessments, for example, organizations may overlook high-risk areas, leading to negative audit findings. An EQMS facilitates risk prioritization, enabling proactive mitigation and demonstrating a commitment to quality during audits.
Conclusion
Quality audits are vital for maintaining compliance in FDA and ISO environments. By addressing common pitfalls like poor documentation, weak CAPA processes, ineffective internal audits, insufficient training, and lack of risk assessments, companies can achieve audit readiness. Implementing an EQMS integrates quality processes, provides clear evidence of control, and supports continuous improvement, ensuring successful quality audits and regulatory compliance.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
