Proving the Effectiveness of Mock FDA Audits Part-1
A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.
The design and management of the mock audit can be mapped out as follows:
- Define the intent and strategy of the mock audit.
- Identify how to measure reportable data during the mock audit.
- Define what constitutes a mock audit observation, including the data and context.
- Recognize how to effectively communicate the mock audit conclusions to employees across your organization.
- Monitor corrective action and preventive action (CAPA) efforts.
- Re-evaluate the state of compliance of people, processes and products within your organization.
Mock Audit Intent and Strategy
A successful mock audit will create an accurate assessment of your employees’ performance during a regulatory agency audit that carries high stakes. When well-managed, a mock audit can result in significant improvements in both the performance level and compliance level within your organization’s employees, processes and products.
Identifying How to Measure Reportable Data
Many factors can determine how successful you are in demonstrating the compliance of your organization’s processes and products. Measuring reportable data in relation to the information presented to the auditor should include the following:
The section or topic the auditor is currently inspecting (i.e., design controls)
The corresponding regulation being audited against (i.e., FDA 21 CFR 820.30)
Applicable company processes, procedures, forms and work instructions
Identification number of the record being audited