In Part One of this two-blog series, I shared 5 best practices to prepare your organization for FDA inspection success. Inspections by the FDA can lead to regulatory action and consequences such as warning letters, recalls, and consent decrees. Thus, you want to put your best foot forward to demonstrate the compliance of your Quality Management System (QMS). In this Part 2, we’ll focus on the logistics for running a smooth and efficient inspection.
1: Tone and philosophy
First and foremost, everyone interacting with the FDA should be truthful, professional, and courteous. While this may seem like common sense, it is worthwhile to emphasize. The FDA is there to protect the public good by finding the evidence that your Quality Management System is compliant, so convey that you are there to help them in that goal.
RELATED POST: Complying with FDA Design Control Requirements Using Requirements Management Principles
2: Typical Roles
In its aim to demonstrate compliance to FDA regulations, an organization is balancing 3 things: 1) Providing the investigator with requested documents, information, and subject matter experts (SMEs) in a timely manner; 2) Understanding what topics the investigator may request go to next and prepare accordingly; and 3) Keeping a record of what the investigator has examined.
To that end, here are roles to have during an inspection.
- Host – Serves as the primary interface with the investigator. This role is typically best served by your Head of Quality, as that individual understands the organization’s QMS and understands the FDA approach. If there is more than one investigator, there should be one host per investigator.
- Scribe – Takes notes on conversations with the investigator and what the investigator is examining throughout the inspection. Like the host, assign one scribe per investigator. Folks great at listening and typing quickly make for great scribes.
- Back Room lead – This person runs the Back Room, coordinating all the requests coming in, sending requests to the front room, and prepping SMEs. Even more importantly, this person is monitoring what is happening in the front room, anticipating areas of inquiry, and preparing accordingly.
- Doc Control – Whether your organization is paper based, 100% with electronic records, or a hybrid, Doc Control is key to retrieving those records in a timely manner and keeping track of what has been presented and reviewed by the investigator.
- Tech Reviewers – These folks inspect records before they head into the Front Room to ensure it’s the right document and noticing any issues that the host should be aware of before they are presented to the investigator.
- Runners – Individuals who can retrieve information and SMEs as needed.
3: Set up a Front Room and Back Room
Typically a conference room, the Front Room is where activities with the investigator(s) are centralized. Aside from the investigator, Individuals are limited the bulk of the time to the host, scribe, and SME’s.
The Back Room is where document, information, and SME preparation occurs. A large conference room works best, not too far from the Front Room.
4: Communicating between the Front Room and Back Room
Determine how information between the Front Room and Back Room will be shared. This includes document and information requests, as well as the conversations that are occurring. One way that works is a web-conference call (no audio or video) in which the scribe shares a document in which they are typing in live. This shared screen is then projected in the Back Room.
Direct chat channels between the scribe and Back Room Lead are also helpful to communicate information the Host should be aware of, like any delays in document retrieval, etc.
5: Documents/Request Management
Determine how documents and request management will occur. There will be time periods when requests are coming fast and furiously. Whether through a spreadsheet or database, it is important to keep track of what has been requested, when it has been presented to the investigator, and returning any hard copy records after the investigator is through with them.
Providing the investigator with the requests in a timely manner demonstrates that your organization’s QMS is under control and has nothing to hide. Keeping a file of everything the investigator has reviewed is key if there is any action taken by the FDA that requires formal response by your organization. It is vital to know what was specifically reviewed so it can be referenced and referred to as necessary to inform those responses.
Your organization has worked hard to build and run its Quality Management System and prepare for an FDA inspection. Implement these tips to run an efficient inspection and demonstrate your compliance to FDA regulations.
- Design Transfer: Best Practices for Translating Your Device Design into Manufacturing Specifications - June 23, 2022
- Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management - February 18, 2022
- Prepping for an FDA Inspection Part 2: Logistics - February 2, 2022