What Constitutes a Mock Audit Observation?
When the information presented to the auditor falls under the following circumstances,
- Regulatory requirements are not being met
- Products are no longer meeting safety or performance criteria
- Documentation is not accurate as compared to what is being done in practice
During the audit, when an employee’s behavior meets the following measures, it should be documented in mock audit records and flagged for a possible observation:
- There is confusion or a lack of understanding of what the auditor is requesting
- Requested information can’t produced or takes an unreasonable amount of time to obtain
- An employee provides an incorrect or incomplete response to the auditor
- An employee reacts unfavorably when pressured by the auditor
Effectively Communicating Mock Audit Conclusions
Your responsibility in communicating the results of the mock audit to the company includes the formal observations and indicators of employee performance. Unacceptable performance by personnel involved with the mock audit typically includes:
- Providing extra information or documents the auditor is not entitled to receive
- Answering questions without the necessary information
- Opening the door to new issues
- Agitated, flustered or disrespectful behavior
Monitor Corrective Action and Preventive Action (CAPA) Efforts
A risk-based approach is an effective way to prioritize the corrective and preventive actions (CAPA) that result from the mock audit..
Re-evaluating the State of Compliance
You can categorize the output of the mock audit to demonstrate that improvements have been completed to the overall state of compliance within your organization:
- Corrections that were mandatory to ensure the safety and effectiveness of the products
- Corrections that were mandatory to eliminate hazards that existed within the processes
- Corrections that were mandatory for the organization’s documentation to be truthful and to achieve data integrity
