The Role of the Audit Backroom
July 16, 2024 Eliza Deriso
In the life science industry, regulatory inspections can carry substantial weight and result in complications. It is important to be appropriately prepared for regulatory inspections, especially when it comes to your audit backroom, which operates behind the scenes.
Having a well-established backroom can lead to a successful inspection and decrease the stress on audit participants. It is essential that audit backroom preparation is complete before a regulatory inspection and on a continuous improvement basis.
During regulatory inspections, organizations usually utilize a “front room” and “backroom” to manage the inspection process. The front room is where direct interaction with the inspector(s) occurs, and it consists of the lead organization contact, the SMEs, a scribe (or note taker), and a regulatory specialist. The audit backroom is the operational center of a successful regulatory inspection. It operates behind the scenes and facilitates the inspection process. The audit backroom consists of quality assurance personnel, document control specialists, additional SMEs, management representatives, and compliance advisors. Responsibilities in the audit backroom should be clear, and no employee should question their role. The roles used in an audit backroom include SME preparedness, organization of audit requests, and objective evidence review.
SME Preparedness
SMEs possess a deep knowledge in a specific area relevant to the audit, usually driven by an inspection request. SME preparedness should not start with the inspection but should be part of an organization’s audit preparedness training. SMEs should receive training on the inspection process, including how auditors conduct interviews, the types of questions that may be asked, and how to respond to the inspectors. SMEs possess technical knowledge that often requires complex or technical terms. As a result, they should be prepared to explain technical aspects in layman’s terms for effective communication with the inspector(s). SMEs should also be informed and review previous audit findings related to their area of expertise.
A key to a successful inspection is a trained audit team. To prepare, organizations should practice simulated interviews to mimic an inspector’s questioning. They should understand the dos and don’ts in an inspection. Conducting mock audits or interview exercises can be beneficial for SMEs who will be supporting inspection requests.
The backroom will ensure the SME understands the audit scope, objectives of the inspection, and request(s). This is to ensure the SME is aware of what the inspector is looking for so that the team can tailor their response appropriately and not offer additional or out-of-scope information to the inspector. The backroom should work with the SME to identify the key points that need to be communicated. Additionally, it’s their responsibility to make sure SMEs are prepared to handle inquiries for which they do not have immediate answers. And, of course, the backroom should state the importance of honesty with the SME and provide support and reassurance.
