Effectively managing audits is essential to any quality management program. Good audit management helps to proactively ensure quality by measuring and improving processes, procedures, and marketed services and products. In addition, supplied products and services can be audited to ensure quality adherence throughout the entire value chain.
Early detection and prevention through audit activities is the key to lowering product defects, thereby resulting in higher customer satisfaction. Many of the challenges associated with audit management center around open-ended audits and disjointed business processes. A core fundamental best practice for audit management is top-down buy-in from the organizational executive management. This level of institutional support ensures that quality is embedded into the fabric of the organization at every level.
Good audit management programs begin with a clear definition of audit processes and metrics. In compliance with current regulations, the system should be able to track progress against previous audit deficiencies and identify potential root causes on time. Integrated CAPA processes ensure that corrective actions are implemented promptly to eliminate potential root causes.
Effective audit management requires a combination of people, processes, and technology to achieve maximum results. Technology-based audit programs are in and of themselves, insufficient. The best practices summarized below highlight the essential requirements for automated audit management systems and the required processes and human resource requirements to ensure sustained compliance and reduce regulatory risk.
Figure 1 – Integrated Compliance Process Control
As shown in the figure above, CAPA is central to the audit process. Audits may reveal several issues and process deficiencies. The corrective action process ensures that these matters will be identified, tracked, and monitored in a controlled manner. All audit management systems must ensure compliance with Part 11 and include process support technologies such as reporting, analysis and trending, regulatory document management, and a documented API that supports integration with existing legacy systems such as MRP, ERP, electronic records management, and others.
Establishing a fully integrated, closed-loop system such as depicted in the figure above will ensure the information flow from one process to another. It should be clear that the integration of compliance processes such as the ones shown above will eliminate silos of information and support enterprise compliance management objectives.
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Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.