Inspections from regulatory bodies such as the Occupational Safety and Health Administration (OSHA) or the Food and Drug Administration (FDA) are a routine component of operating a compliant business. Establishing a systematic and professional approach to these site visits minimizes operational disruption and limits potential liability. A clear, well-rehearsed protocol ensures that your company maintains control over the process and manages the information flow. This preparation transforms an unexpected visit into a manageable event that ultimately strengthens your compliance framework.
Establishing an Inspection Protocol
Preparation for an inspection must begin long before an inspector arrives by developing a detailed Standard Operating Procedure (SOP). This plan should identify a single, trained management representative who will serve as the primary point of contact for the duration of the inspection, along with a designated backup. This individual must be familiar with the company’s operations and regulatory obligations, such as the workplace safety requirements outlined in OSHA 29 CFR Part 1903.
A clear communication tree must be established, detailing who the primary contact must call immediately upon an inspector’s arrival, which should include internal management and outside legal counsel. The protocol should also designate a private staging area, often called an “audit room,” for the inspector to use for document review and private discussions. This room helps contain the inspection activities and keeps the inspector away from sensitive operational areas.
Managing the Inspector’s Arrival and Credentials
The initial interaction upon an inspector’s arrival is a procedural step that determines the scope of the entire visit. The designated management representative must courteously and professionally ask to see the inspector’s official credentials and photo identification before granting access to the facility. This step is a standard practice and is not considered an obstruction of the inspection.
The representative should also request a copy of the Notice of Inspection or the inspection warrant, if one exists, to determine the precise legal authority and scope of the visit. Understanding the purpose of the inspection is necessary for controlling the process. This administrative phase ensures that the company understands the limits of the inspector’s authority before the physical tour begins.
Protocols During the Physical Walkthrough
During the physical walkthrough of the facility, the designated management representative must accompany the inspector at all times to maintain control over the process. A “buddy system” should be implemented, where a second manager or trained employee acts as a dedicated note-taker and photographer. This second person should document every area the inspector examines, every piece of equipment they look at, and every comment they make.
The company representative should take duplicate photographs or video of anything the inspector documents, ensuring the company has a matching record of the evidence gathered. Efforts must be made to limit the inspector’s movement strictly to the scope established during the opening conference. If minor, easy-to-fix violations are observed, correcting them immediately and documenting the action can reflect favorably on the company’s commitment to compliance.
Responding to Requests for Documents and Employee Interviews
Handling requests for documentation and employee interviews requires precision to ensure compliance while protecting proprietary information.
Document Handling
All requests for documents must be directed through the designated representative, who should log every item provided, including the date and time. It is a recommended practice to provide copies of requested documents rather than the originals. The goal is to provide only the specific information requested without volunteering any additional, unnecessary details.
Documents that may contain proprietary information or trade secrets, such as certain medical records or process diagrams, may require a legal review before they are handed over to the inspector. An effective strategy is to have a “backroom” support team quickly retrieve and vet documents to fulfill requests efficiently.
Employee Interviews
Employee interviews must also be managed through the designated representative, who will direct the inspector to the appropriate Subject Matter Expert (SME). Employees should be trained to answer questions factually, concisely, and without speculation, speaking only to their direct knowledge and responsibilities. While non-management employees generally have the right to a private interview, employees should be informed of their right to representation, if applicable.
Conducting the Closing Conference
The formal closing conference is a mandatory step that concludes the on-site portion of the inspection. The management team must ensure this meeting takes place, as it provides an opportunity to hear the inspector’s preliminary findings and observations. Detailed notes must be taken, recording every potential violation and the specific standard the inspector believes was violated.
During this conference, the company should seek clarification on the observations and provide any records that may demonstrate compliance or mitigate the finding. It is important to avoid arguing with the inspector or admitting fault for any alleged violations, as this conversation precedes the formal citation process. The company should request copies of all samples, evidence, or documents the inspector collected during the visit.
Addressing Citations and Follow-Up Actions
Once the inspector leaves, the company must proactively address the formal citation package, which is typically received later. For example, OSHA citations include a deadline for abatement and a period, often 15 working days, during which the employer may contest the findings or proposed penalties. Legal counsel must review the entire package to understand the full implications of the findings.
A Corrective and Preventive Action (CAPA) plan must be developed to address each noted violation. This includes immediate containment actions and systemic changes to prevent recurrence. The company must then formally respond to the regulatory agency, detailing the corrective actions taken, along with a timeline for any actions that are still pending. Documentation of these abatement efforts is necessary to demonstrate a commitment to compliance and avoid further enforcement actions.