Have company documents ready for the FDA auditor.
The FDA, or Food and Drug Administration, is an agency within the U.S. Department of Health and Human Services. This agency monitors companies in food and drug-related industries and ensures these companies are complying with FDA laws and regulations. One of the ways this is accomplished is through a Food and Drug Administration Audit, also known as an inspection. Preparing your company well in advance will help you pass the FDA audit.
Instructions
1. Create an information booklet about your company for the FDA auditor. The booklet should include an overview of your company, any organizational charts or demographics, your corporate matrix, all of your company's recent field actions and any recent company complaints.
2. Choose which employees will interact with the auditor. You should have one employee designated as the primary facilitator, as well as employees from your management team, control room staff, if applicable, and experts within your company who deal with specific concepts or processes.
3. Prepare your employees. Each employee needs to be prepared to answer questions they may be asked by the FDA auditor. Some common questions from FDA auditors are about company policies, job descriptions and duties, training procedures and possible errors within company systems. Be sure all employees you choose are fully up to date on all these topics. If an employee can't answer a question asked by the auditor, instruct them to admit they don't know but assure the auditor that they will get the information as soon as possible.
4. Prepare your facility for inspection. FDA auditors will inspect products, labeling, materials and equipment as well as any documentation related to these areas. Be sure you have documentation ready and that your facility is clean, functioning properly and ready for the inspection.
5. Schedule your best workers for the day of the inspection. The FDA auditor will only be speaking with certain employees, but he will examine the quality of each of your procedures and systems and observing general workers as they complete job tasks. Be sure problem employees and newer workers are not on duty when the inspector arrives, if possible.
Tags: your company, asked auditor, Drug Administration, employees will, Food Drug, Food Drug Administration, possible Prepare
