The procedure should be something that tells the auditor, in short, the basic rules for the plant. Ours includes check in procedure which is regulatory person provides ID and credentials, plant movement rules, which are escorted at all times, and employee engagement rules, no pictures of plant personnel, discussions with plant personnel are at the discretion of the personnel, etc. And any other rules you want such as any pictures or samples taken, your company takes a duplicate sample or picture.
The other things people are saying are all great advice, but you wouldn't want to put in your procedure 'tell them only what they ask and give them only what they ask for' as it seems deceptive (even though it is great advice!)
Another thing, just for fun, I like to put prompts into Chat GPT. Here's the response to my prompt: "Write a procedure for dealing with a regulatory agent showing up at my business" and here's what it came up with: (this could be a good starting point)
Procedure for Handling a Regulatory Inspector Visit
Purpose:
The purpose of this procedure is to establish a structured process for handling a regulatory inspector's visit to your business. This procedure ensures that all necessary steps are taken to facilitate a smooth and compliant inspection process while maintaining a cooperative and professional relationship with the inspector.
Procedure:
1. Designate a Regulatory Inspection Coordinator:
- Assign a knowledgeable individual within your organization as the Regulatory Inspection Coordinator.
- The Coordinator will serve as the main point of contact for the regulatory inspector and coordinate all activities related to the inspection.
2. Pre-Inspection Preparation:
- Review and familiarize yourself with the applicable regulations, permits, and requirements relevant to your business.
- Conduct internal audits to identify and address any potential compliance gaps.
- Ensure that all required documentation, records, permits, and licenses are readily accessible and up to date.
3. Notification of Inspector's Arrival:
- Upon receiving notification of the regulatory inspector's visit, promptly notify the designated Regulatory Inspection Coordinator.
- The Coordinator will confirm the date, time, and purpose of the inspection and communicate it to the appropriate personnel.
4. Coordinate Inspection Logistics:
- Arrange a suitable meeting area or office space where the inspector can conduct the inspection and review documents.
- Provide necessary facilities, such as access to restrooms, designated parking areas, or safety equipment as required.
5. Greet and Accompany the Inspector:
- Warmly welcome the regulatory inspector upon their arrival.
- Introduce the designated Regulatory Inspection Coordinator as the main contact person and accompany the inspector throughout the visit.
6. Opening Meeting:
- Conduct an opening meeting with the regulatory inspector to establish rapport and clarify the scope and objectives of the inspection.
- Provide an overview of your business operations and processes, emphasizing your commitment to compliance and cooperation.
7. Document Review and Information Sharing:
- Provide the inspector with requested documents, records, and any other relevant information promptly.
- Answer any questions or concerns the inspector may have, providing accurate and transparent information.
8. Facility Tour:
- Accompany the inspector during the facility tour, highlighting areas and processes relevant to the inspection scope.
- Address any questions or observations raised by the inspector and provide additional information or clarifications as needed.
9. Interacting with the Inspector:
- Maintain a professional and cooperative demeanor throughout the inspection process.
- Answer questions honestly and to the best of your knowledge, seeking clarification or guidance from appropriate personnel if necessary.
10. Taking Notes:
- Designate a staff member to take detailed notes during the inspection, documenting areas inspected, discussions, and any findings or recommendations made by the inspector.
- These notes will serve as valuable records for follow-up actions and future reference.
11. Closing Meeting:
- Conduct a closing meeting with the regulatory inspector to summarize the inspection findings, observations, and any identified non-compliance issues.
- Discuss timelines and expectations for addressing any non-compliance issues, if applicable.
- Express gratitude for the inspector's time and insights.
12. Post-Inspection Actions:
- Review the inspection findings and develop a corrective action plan to address any identified non-compliance issues.
- Communicate the action plan to relevant personnel and assign responsibilities for implementation.
- Monitor progress and ensure timely completion of corrective actions.
13. Follow-up Communication:
- Maintain open lines of communication with the regulatory inspector following the inspection.
- Provide updates on the implementation of corrective actions and any other relevant changes or improvements made.
14. Continuous Improvement:
- Conduct internal assessments and audits to address any recurring compliance issues and improve overall regulatory readiness.
- Use inspection findings as opportunities to enhance compliance practices, employee training, and operational procedures.
By following this procedure, we demonstrate our commitment
to compliance, transparency, and cooperation during regulatory inspections, fostering a positive relationship with regulatory authorities.
Signed by:
[Authorized Representative's Name]
[Date]
Note: This procedure is intended as a template. Please review and modify it to align with your organization's specific requirements, applicable regulations, and the nature of the regulatory inspections you may undergo.
