Preparation is key – Audit fever often begins to build in the weeks or even months leading up to the actual start of the audit. This preparation phase is crucial for the smooth conduct of the audit itself and includes, among other things, identifying potential gaps, preparing and gathering the necessary documentation, and training all relevant staff members who may need to act as spokespersons. Of particular interest here are the daily production rounds that are organized, which allow QA to have a greater presence in the production environment during the pre-audit period. The purpose of these rounds is to identify and eliminate audit-sensitive issues; ranging from housekeeping-related topics such as damage to walls, ceilings, or doors to addressing operators about their aseptic practices and gowning, rectifying uncontrolled or incomplete documentation (including logbooks), and inspecting machines and equipment.
In addition, it is advisable to conduct a trend analysis prior to the inspection to identify recurring and audit-sensitive quality incidents from recent years. This allows for a brief preparation of these topics in advance—for example, using the “5 minutes – 5 slides” principle—so that this does not have to be done amid the hustle and bustle of the audit itself.
Let the games begin – Despite weeks of thorough preparation, everyone’s nerves are on edge at the start of the audit. On the first day(s), the auditors will be given a physical tour of the organization, ranging from production departments and QC labs to warehouses, paying close attention to housekeeping, documentation, equipment, process flows, operator actions, etc. They will share their questions and comments on the spot, which may lead to requests if additional information is required; these requests must then be communicated to the back office as quickly as possible so that the relevant experts can begin preparing to address them.
Although this tour usually takes place under the guidance of management, as a QA consultant you can also play an important role here as a “sweeper.” The purpose of sweeping is to get a head start—about 10 minutes ahead of the actual audit tour—and perform a final check of the relevant areas. In addition, requests will also arise after reviewing documentation. For example, you may be asked for a list of quality incidents, as well as qualification and validation reports/protocols, batch records, complaint records, SOPs, logbooks, site master files, registration files, previous audit reports, etc. Any GMP-related document may therefore be subject to the audit. For this reason, it is important that all these documents are kept up to date at all times and that GDP forms are completed.
Backroom vs. frontroom – All requests are then collected in the backroom, from where they are forwarded to the various spokespersons. This backroom is the beating heart of the audit and aims to ensure that everything in the frontroom runs as smoothly as possible. However, it is impossible to draw up a fixed schedule in advance, since the auditor decides which requests to actually call on. It is therefore important that every spokesperson prepares their request as quickly as possible and is ready at all times to present it to the auditor in the front room. If you’re unsure or this is your first audit, it’s a good idea to have a colleague or manager review your request. Based on the feedback and questions you receive, you may identify gaps that can still be addressed before you head to the front room.
While chaos often reigns in the backroom, the front room is the very picture of calm. In addition to the auditor, there is also a host and a scribe who handle communication between the front room and the backroom. Before you begin your presentation, briefly introduce yourself and your role within the organization, after which you can proceed to explain the actual request. Although no advice can guarantee a successful review by the auditor, there are certainly some undeniable dos and don’ts:
Dos:
- Always take the time to understand the auditor’s question to avoid giving an answer that misses the point. So don’t hesitate to ask for additional information if the question asked is unclear or too general.
- Prepare thoroughly and make sure you can quickly produce all documentation. Bring hard copies of related procedures and reports, and ensure you’re already logged into the necessary software programs on your computer.
- Answer concisely but completely, without unnecessary background information or details. The more information you share with the auditor, the more follow-up questions he or she may ask.
- Communicate in a calm and confident manner. Given your thorough preparation, you are the expert on the topic at hand.
- Provide facts, not opinions or assumptions. Always base your answer on existing procedures, documentation, and processes. If you don’t know the answer, honestly state that you need to look into it further and will come back to it later.
- Assume that the auditor is not an expert on the product or process in question. Therefore, always provide sufficient background information.
Don’ts:
- Do not use language that makes you sound uncertain, such as “I think,” “normally,” etc.
- Avoid arguments with the auditor. If you disagree, you can always share your concerns with the backroom, after which further action can be taken in consultation with management.
- Do not question the accuracy of information provided by a colleague in the front room in front of the auditor. If necessary, this information can be corrected at a later time.
- Do not engage in small talk with the auditor, especially not about audit-related topics. Nothing is off the record during the audit.
- Turn off all notifications from Teams, email, and other sources so that no pop-ups appear during your presentation in the front room. Allowing the auditor to see messages sent from the back office is a recipe for disaster.
No blog or guide can come close to matching the learning curve gained through personal, hands-on audit experience, but hopefully the above explanation of the audit process and the included tips and tricks will put you on the right track for your first audit. However, please don’t hesitate to contact me or one of my colleagues at Farma Consulting & Partners for any further audit-related questions.
Author: Jonas Van Dingenen – QA Consultant
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