Site inspections regularly check and verify your organization’s regulatory compliance, safety standards, and more. The FDA, EHS, and the EPA may do inspections and audits virtually or in the field. The FDA tries to inspect each licensed firm every two years or less. To successfully navigate inspections, you should have a dedicated Inspection Team. The purpose of this team is to conduct mock inspections, manage the inspection process, and ensure the readiness of the site, staff, and documents.
To address the breadth of compliance inspections, several different areas of expertise and people from various departments should participate on the Inspection Team. First, make a well-defined role and set of responsibilities for each person. Training and testing each Inspection Team member on their responsibilities reduces the risk of errors and improves confidence.
Members of the Inspection Team include:
- Inspection Leader
- Inspection Room Leader
- Subject Matter Experts
- Scribes
- Hosts
- Document Request Coordinator
- Document Runners
- Administrative Personnel
How to Choose Your Team
Key characteristics include performing well under pressure, easily answering questions, and concisely, confidently, and intelligently. The members must be well-versed in the Standard Operating Procedures (SOPs). This entails knowing the content, purpose, and how and when to use the SOPs. A document manager for audits, such as ACE Inspection, could improve your efficiency and success in meeting Inspector requests. The Inspection Team should comprise of representatives from:
- Quality Assurance
- Regulatory Affairs
- Manufacturing
- Quality Control
- Material Management
- Scientists and Technical Manufacturing Experts
The Purpose of the Inspection Team
The Inspection Team will also develop the documents and review SOPs beforehand. To prepare for an inquiry, you must also go through a mock inspection, which the Inspection Team can perform. This simulates the stress of the actual process, assesses gaps in knowledge, prepares responses, points out inefficient methods, and builds confidence. With good preparation, you can focus on making an excellent first impression.
Consultants
Consultants are helpful for gap analysis, identifying risks, and even preparing a readiness plan for your Inspection Team. Furthermore, consultants can help you write responses and follow-up reports after an inspection. Great consultants can work within your budget and your needs through services tailored just for you.
PSC Biotech and PSC Software offer solutions for inspection day preparation and management. For more information on our consulting expertise, contact sales@biotech.com, and for ACE Inspection software, email info@pscsoftware.com.
