An organization’s firm understanding of their annual audit scope is fundamental to successful audit planning and the effectiveness of their overall Audit Management System. It’s essential for organizations to properly plan for resourcing and audit assignments by developing an audit plan, or an operative system that will sufficiently create and manage their list of annual audits.
Preparation is key to developing a successful audit plan, and both Internal and External audits are equally vital to maintaining a cohesive overall program.
How is Your Annual Audit Plan Determined?
The benchmark for creating, managing, and updating an audit program is an organization’s understanding of the inherent risk in each of their auditees. This risk-based approach is fundamental to creating a list of annual audits, and is typically employed to identify who to audit and when.
To determine risk, organizations must create a risk assessment for each of their suppliers and internal auditees by measuring them against relevant risk parameters and then rating their risk level appropriately.
After each auditee is properly evaluated, organizations can develop a schedule that specifies the audit frequency, whether it’s once a year, or every couple of years. By associating a risk rating with each auditee, organizations can more easily develop a comprehensive and prioritized annual list that will help keep their auditors organized and moving forward.
5 Key Considerations when Managing Your Audit Plan
While determining the audit list via a risk-based approach is an important preliminary step, there are many additional factors to consider, including:
- Audit type
- Audit location
- Planned duration
- Planned start and end dates
- Skilled Auditor availability
Since some audits will naturally take longer than others, it’s important to calculate the time it will take to complete each.
Another factor that organizations must account for is the case of “For Cause” audits, which will impact the overall audit list. Although unplanned, “For Cause” audits are high priority, and therefore need to be completed within the time frame of the audit plan.
Life science organizations involved in clinical operations, clinical trial audits, or site audits will have other factors to consider as well. In addition to the trial audit, these organizations will also need to take into account the number of investigator sites that correlate to the trial itself.
To complete all audits in a timely fashion, it’s imperative for organizations to match all factors up against their internal resources, locate any gaps, and then outsource to third party auditors as necessary. If time isn’t taken into consideration, the process can cause significant stress, burdening not only your internal auditing departments, but CAPA managers, compliance personnel, and response coordinators as well.
Maintaining Your Audit Plan
Flexibility is paramount for audit planning, and organizations must ensure that their audit lists can easily adapt to changing priorities. Auditors should take a proactive approach, anticipating changes before they arise, and preparing for the possibility that some audits may need to be postponed for another quarter, or potentially another year, if non-compliance issues surface with an unexpected auditee.
Since audits can be time-consuming, resource-intensive and burdensome, planning for the list each year is just as critical as other audit operations. By creating an effective annual program for the year, an auditing team will know where, when, and how to allocate resources properly.
Audit management takes proper planning and forecasting in order to make informed decisions and devise a sound strategy for the auditing process.
By leveraging a risk-based approach, calculating audit completion times, carefully maintaining an audit list, and remaining flexible to changing priorities, organizations can help ensure successful annual audit management and support continuous improvement across their entire landscape.