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preparing for fda inspection

FDA Inspection

Intro

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.

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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.

Closing

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.

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This is part one of a two-part series. Part two is available here.

FDA Inspection

FDA inspections can be daunting, especially for an organization that is expecting its first one. In part one of a two-blog series, here are five best practices to prepare your organization for success:

1: Understand why the FDA will perform an inspection

The first step in preparing for a successful FDA inspection is understanding why your facility and Quality System (QS) are being inspected. Whether it’s a pre-approval inspection, a biennial audit, or for‑cause, knowing where the FDA will be focusing will help you focus on how to prepare.

2: Learn what an FDA Investigation is like

Another key understanding is that an FDA inspection is not just another audit. The inspection is not the same as an ISO 13485 certification audit, internal audit, or supplier audit. While not all FDA investigators are identical, in general, FDA inspections are much more rigorous and intense in nature.

Thus, educating yourself and your organization on what to expect during an FDA inspection is important. Many resources are available at the FDA’s website, including guides for medical device manufacturers and their Quality System Inspection Technique (QSIT). Another aspect to know is an inspection will assess compliance to 21 CFR 820 (the Quality System), as well as other parts, including 803 (MDR), 821 (Tracking), 806 (Corrections and Removals), and 807 (Registration and Listing).

RELATED POST: The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

3: Identify Subject Matter Experts (SMEs) for processes and devices

Identify subject matter experts (SMEs) for QS processes and devices. These individuals should be knowledgeable with the subject matter, as well as able to communicate well with the investigator. While your organization’s records should speak for themselves, having an individual who can guide an investigator as necessary makes the inspection run more smoothly and efficiently.

4: Perform an assessment and address gaps

For an organization preparing for its first FDA inspection, review your Quality System procedures and records, with increased attention to the areas relevant to the anticipated focus of the inspection.

Many organizations also design their Quality Systems for ISO 13485 compliance, and while ISO 13485 and the FDA Quality Systems Regulations (QSR) are similar, there are some differences. Note, the FDA has indicated that harmonizing and modernizing the Quality System Regulation (QSR) with ISO 13485 is an active initiative. Until then, ensure your Quality System covers all aspects required by the FDA. One available tool that maps the FDA 21 CFR to ISO 13485:2016 is AAMI TIR102:2019.

Also audit your recent Quality Systems records for 2 reasons, 1) identify any issues for compliance to your organization’s procedures, and 2) familiarize yourself with any issues so they can be reviewed clearly by the SME if those topics come up in the investigation.  Use a reputable auditor that is familiar with FDA inspections and how investigators are trained. Involve your SMEs so they are prepared as well.

Records to review include those associated with the particular device of focus. For example, in a Pre-Market Approval (PMA) inspection, ensure an SME can walk an investigator through the Design History File of the device to demonstrate the design controls were adequately met. Before the FDA arrives is a good time to ensure that there is evidence that all design inputs are verified and all user needs and all intended uses have been validated.

Ensure that your firm is registered and that your device listings are up to date.

RELATED POST: Complying with FDA Design Control Requirements Using Requirements Management Principles

5: Perform mock inspection(s)

Mock inspections serve a number of purposes when preparing for an FDA inspection. They allow individuals that may be involved, including SMEs, an opportunity to practice, can identify areas of concern that can be addressed before the FDA arrives, and give your organization an opportunity to practice the logistics of hosting an FDA inspection.

Again, use an experienced auditor familiar with FDA inspections and the mindset of FDA investigators. 

As with any large endeavor, preparation is key. These best practices provide you with the path and resources to educate and prepare your organization for an FDA inspection.

Visit part two of this blog series for best practices and tips regarding the logistics of running a smooth and efficient inspection.

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