A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist with questions to ask about processes and documents can help ensure a well-planned, systematic, and consistent approach to quality audits.
If the best way for an organization to survive an auditor’s visit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.
As part of maintaining a constant state of audit readiness, consider audit checklist questions a well-trained auditor would ask.
For example, a checklist for a computer system validation (CSV) audit may specifically ask if you have a traceability matrix when what the auditor wants to know is how you know you’ve tested everything.
The checklist may specifically ask if you have screenshots for your testing, or the question may be broadly what evidence you have of actual results.
Another question may be whether there are mechanisms in place to initiate revalidation when program changes, such as sequence of program steps, are made.
The auditor’s checklist may include a question about whether your organization has a defined, documented CSV policy.
The audit checklist questions may be specific and presume to know how the organization would accomplish the desired goal, or the questions may be less presumptuous, more open-ended, and designed to promote follow-up questions, which you should then be able to answer more specifically.
Ultimately, to know what questions to expect, it helps to be familiar with relevant regulatory agencies’ audit and inspection processes. The U.S. Food and Drug Administration’s (FDA) Compliance Program Guidance Manual provides some idea of what the agency's personnel are looking for during inspections.
An FDA auditor will often ask follow-up questions to their audit checklist entries for a more complete picture or to determine whether something is actually a finding. General follow-up questions may include:
Employees must be versed in responding to auditors, answering only what is asked and getting clarification if needed. If you don’t know the answer to a question, don’t guess. “I don’t know, but I'll find out for you” is an acceptable response.
A robust and well-organized audit program and plan can aid significantly in an organization’s preparedness for audits and inspections.
As your organization develops and refines its audit plan, it is important to keep audit checklists up to date. As regulations change, standard industry practices evolve, and new guidances are introduced, auditors will revise audit checklists. The checklists will also be updated to accommodate advancements in technology and to reflect any recent citations, warning letters, or issues found during audits but not covered by the current checklist. New questions may be added, and existing questions may be removed.
Just as auditors revise their checklists, an organization should also update their own audit plan and checklists to keep up with changes in the industry.
An audit checklist can be one of many effective tools for audit planning, including helping employees understand and anticipate what questions an auditor would ask in the case of an audit, and ultimately for maintaining a constant state of audit readiness.
Enjoying this blog? Learn More.
21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?Download Now
Support for the Internet Explorer browser will end on June 15, 2022 and some site features may be unavailable. For the best experience, we recommend using a modern web browser such as Google Chrome, Mozilla Firefox or Microsoft Edge.