How to Prepare for an FDA Inspection Audits by third parties don’t have to be stressful events. The level of preparation within your organization will make a significant difference in your level of success. Below are some helpful hints and techniques that will enable your organization to perform smoothly during an FDA inspection. Organizational Culture Let’s start by considering where your organization is now in terms of readiness. Is being audited an opportunity to tell your story? Is it thought within your organization that “all of this quality stuff is in the way of doing business?” It must be understood that the single most important element for a successful audit outcome is the existing quality culture within your company. Substantial compliance to quality systems can only be derived from the diligent execution of all requirements defined within the Quality Management System as a matter of doing business, each and every day. What you are doing in an audit is communicating and demonstrating how you run your business within the framework of your Quality Management System. How well you do this makes a difference. Audit Procedure In order to execute a third party audit, you need to first prepare by defining how you want the audit to be executed within a Third Party Audit Procedure. The procedure should, at a minimum, define: 1. How to Receive Inspectors •Verify Credentials •Communications to Executive Staff & Employees •Opening Presentation 2. Duties of key individuals •Receptionist •Audit Support Team Members 3. Audit Room & Control Room Set-up 4. Conducting Tours Improving Quality and Compliance www.pathwise.com 866.580.PATH 5. Daily Audit Summaries The Information Book Prepare an Information Book for the Auditor containing standard information that will be needed during the audit. The book should contain: 1. Company Overview 2. Organizational Charts 3. Facility Demographics a. Headcount b. Facility diagram 4. Documentation a. Site / Corporate SOP Matrix 5. Recent Field Actions (make sure you have information that spans the scope of their inspection) 6. CAPA & Complaints information for past six months to one year Employee Preparation Next, identify “who” within your organization will participate in the audit and in what way will they participate. It is important to understand that you only get one chance to “tell the story”. At a minimum you should identify the: 1. Facilitators – The primary host(s) for the auditor and are responsible for the oversight of all facets of audit execution. 2. Scribes & Runners Improving Quality and Compliance www.pathwise.com 866.580.PATH 3. Subject Matter Experts - Individuals who are focused on specific processes each and every day. They are specially trained and prepared for audit situations. 4. Control Room Staff 5. Employees 6. Management Team Employee preparation is essential. Each and every employee does not need to know the details of the execution and goings on within the audit, but they do have to be prepared and know they play a role within the audit. Employees should be prepared to answer key questions such as: 1. What is the Quality Policy? – Ensure each employee understands and can speak to what the policy means to them – Use the Quality Policy Training 2. How do you know what’s required of you in your job? – As defined within my job description, – As I have been trained to do – By following approved procedures and work Instructions – Know how to access procedures and work instructions – Bring up errors in procedures and instructions now 3. Is your training current? – Ensure your training in TRS and LMS is current – If there are gaps, complete the training now and maintain it! 4. What if I don’t know the answer? – “I am not sure but I will get the information for you.” Improving Quality and Compliance www.pathwise.com 866.580.PATH These basic steps of preparation should be defined, implemented and practiced for successful execution during an audit. Practice makes perfect! Inspection Procedure Prior to inspection day, it is important to understand what the third party can and will look at while on site. The FDA, in particular, is somewhat prescriptive in what information they can and cannot access. The FDA has authority to inspect all equipment, materials, products, labeling, and surrounding documentation including but not limited to SOPs, clinical study and quality systems documentation. They do not have the authority to inspect certain documentation such as personnel data, financial statements, R&D records, audits and management reviews. Understanding how the auditor will determine the compliance and effectiveness of your Quality System can also help you prepare your staff in advance. The Auditor will plan to examine the system from either the “bottom up” or from the “top down” as depicted below: The QSIT inspection approach is a "top-down" approach where the auditor will be looking at the firm's "systems" for addressing quality before they actually look at specific quality problems. In the "top-down" approach, they will "touch bottom" in each of the subsystems by sampling records, rather than working their way from records review backwards towards procedures. What will they be looking for? Improving Quality and Compliance www.pathwise.com 866.580.PATH  Verification that your CAPA system procedures have been defined and documented.  To determine if appropriate nonconformance sources of product and quality problems have been identified.  To determine if these sources of product and quality information are trended and if any unfavorable trends have been identified.  To challenge the quality data information system and verify that the data received by the CAPA system are complete, accurate and timely.  Verification that appropriate statistical methods are employed to detect recurring quality problems.  Timelines for approval and execution follow a logical sequence.  To determine if failure investigation procedures are followed.  To determine if appropriate actions have been taken for significant product and quality problems identified from nonconformance data sources.  To determine if corrective and preventive actions were effective and verified or validated prior to implementation.  Verification that corrective and preventive actions for product and quality problems were implemented and documented.  To determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including to Management Review.  Objective evidence that Executive Management is engaged. Conclusion A successful outcome from a third party audit is dependent upon many factors and preparation is key. While the material offered in this article will help provide insight into third party audits, it is not all encompassing. If you would like additional information or help in specific areas of preparation or remediation, please do not hesitate to contact us. Improving Quality and Compliance www.pathwise.com 866.580.PATH