An FDA inspection of a medical device company’s quality management system (QMS) can be a daunting experience. However, with proper preparation and attention to detail, you can ensure that your company is ready for the inspection. In this article, we will provide you with tips and best practices for preparing for an FDA audit of your medical device company’s QMS. What is an FDA inspection? An FDA inspection of a medical device company’s quality management system is an assessment of the company’s compliance with the Quality System Regulation and related regulations. The inspectional process is known as the "Quality System Inspection Technique" or "QSIT". The FDA executes four types of inspections, but for class I and II medical devices, it carries out routine inspections every two years using QSIT. The QSIT is an aid to teach inspectors how to inspect a medical device company so that they demonstrate compliance with Part 820 regulations. During the inspection, the FDA will review the company’s QMS documents and records. The FDA will also conduct interviews with employees to assess their knowledge of the QMS and their roles in maintaining it. The FDA will then issue a Form 483 if it finds any deviations from the regulations. The company must respond to the Form 483 within 15 business days with a corrective action plan. How is an FDA audit different from an ISO certification audit or a surveillance audit? The FDA conducts an inspection of a medical device company’s quality management system (QMS), whereas ISO conducts an audit. (Although these terms are used differently in industry in different contexts, this article will use inspector/auditor/investigator and inspection/audit interchangeably.) The two are planned and conducted differently, and their inspectors have different levels of authority. The FDA inspection is a regulatory requirement for medical device companies in the United States. The FDA inspection is conducted by an FDA investigator who has the authority to issue a Form 483 if deviations from regulations are found. To comply with the law, the company must respond to the Form 483 within 15 business days with a corrective action plan. ISO certification, on the other hand, is comparatively less intensive in nature and conducted in two stages. An ISO certification is valid for three years during which the auditor checks if everything is functioning as it should. These checks are surveillance audits. A surveillance audit is less intensive than the certification audit and is a "snapshot" in time of the auditor’s review to ensure the company is still meeting the key elements of the ISO standard. Types of FDA inspections for Medical Device QMS The FDA conducts four types of inspections for medical device companies. These are: Pre-approval inspections: These inspections are conducted before the FDA approves a new medical device. The purpose of these inspections is to ensure that the manufacturer has established and implemented a QMS that meets the requirements of the Quality System Regulation. Routine inspections: These inspections are conducted every two years for class I and II medical devices. The purpose of these inspections is to ensure that the manufacturer is maintaining a QMS that meets the requirements of the Quality System Regulation. Compliance follow-up inspections: These inspections are conducted to ensure that the manufacturer has corrected any deficiencies identified during a previous inspection. For-cause inspections: These inspections are conducted when the FDA has reason to believe that a manufacturer is not in compliance with the Quality System Regulation. During each inspection, the FDA will review the company’s QMS documentation and records. The FDA will also conduct interviews with employees to assess their knowledge of the QMS and their roles in maintaining it. The FDA will then issue a Form 483 if it finds any deviations from the regulations. The company must respond to the Form 483 within 15 business days with a corrective action plan. Four essential areas of FDA inspection readiness Have a good QMS in place Having a good QMS in place is important for an FDA inspection because it ensures that the medical device company is meeting the requirements of the Quality System Regulation. A good QMS can help the company avoid Form 483 observations and warning letters from the FDA. A good QMS can also help the company improve its product quality and reduce costs. To establish a good QMS, the company should follow these steps: Establish a quality policy and objectives. Identify the processes needed for the QMS and their application throughout the organization. Determine the sequence and interaction of these processes. Establish criteria and methods needed to ensure that both the operation and control of these processes are effective. Ensure the availability of resources and information necessary to support the operation and monitoring of these processes. Monitor, measure, and analyze these processes. Implement actions necessary to achieve planned results and continual improvement of these processes. Do regular, robust internal auditing Regular and robust internal auditing is important for an FDA inspection of a medical device company’s QMS because it helps the company identify and correct deficiencies before the FDA inspection. Internal auditing also helps the company ensure that its QMS is effective and efficient. A good internal auditing system can help the company avoid Form 483 observations and warning letters from the FDA. To establish a good internal auditing system, the company should follow these concisely stated steps: Establish an internal audit program, identify the processes to be audited, determine the frequency of audits, establish audit criteria, select auditors, conduct audits, report audit results, implement corrective actions, and follow up on corrective actions. Structure documents and records in a way that is usable and accessible Structuring documents and records in a way that is usable and accessible is important for an FDA inspection of a medical device company’s QMS because it helps the FDA investigator quickly find the information they need. A well-organized QMS can help the company avoid Form 483 observations and warning letters from the FDA. To structure documents and records in a way that is usable and accessible, the company should establish a document control procedure. This procedure should identify the documents and records needed for the QMS, and establish: Document and record formats Document and record numbering systems Document and record retention periods Document and record storage locations Document and record retrieval procedures Document and record revision procedures Train employees on the document control procedure Flesh out design controls, especially in younger companies still developing a product Fleshing out design controls is important for an FDA inspection of a medical device company’s QMS because it helps the company ensure that its product is safe and effective. Design controls help the company identify and mitigate risks associated with the product. A well-documented design control process can help the company avoid Form 483 observations and warning letters from the FDA. To flesh out design controls in preparation for an FDA inspection of the QMS, the company should establish a design control procedure. This procedure should identify and establish: Design inputs and outputs Design review procedures Design verification procedures Design validation procedures Design transfer procedures Design changes procedures Train employees on the design control procedures Take note of three FDA forms used for inspections Familiarize yourself and your staff with the three forms typically used in FDA inspections of a medical device QMS: Form 482 is used by FDA investigators to request records from a medical device company during an inspection. The form is used to document the request and the company’s response. Form 483 is used by FDA investigators to document observations made during an inspection that could lead to a regulatory action against the company. The form is issued at the conclusion of the inspection and lists the observations made by the investigator. A “clean” inspection is one that finishes without a Form 483 being issued. Minor findings or observations may be documented in other ways, including the audit report, with no Form 483 being issued. Form 484 is used by FDA investigators to document samples taken during an inspection. The form is used to document the sample taken, the location of the sample, and the analysis performed on the sample. These forms are important because they help ensure that medical device companies comply with FDA regulations. Companies that receive Form 483 observations should respond promptly and thoroughly to address the observations. Failure to respond adequately could result in further regulatory action against the company. 10 additional tips Make sure your QMS is in place, and you follow it. Use internal audits. ISO 13485 certification is good but does not demonstrate meeting the regulations. Prepare your team. Be ready to perform once the inspector arrives. Master back-room operations and organization. (e.g. How to get the requested forms to the inspector promptly and accurately) Review FDA guidelines, including the “QSIT” guide from 1999. Use other resources such as articles, podcasts, etc. Be aware of what are official requirements on the one hand, and informal resources from industry and standards bodies, on the other. Schedule the day tightly and have contacts and personnel in place. Don’t give the inspector free access to root through an archive. Instead, hand them an index to a database from which they can request records. Relax as best you can, be professional and welcoming, arrange coffee, lunch, and breaks, and confidently show the solid QMS components you’ve worked so hard to establish! Reach constant FDA inspection readiness by partnering with Pro QC If you are preparing for an FDA inspection, there are a few things you can do to ensure that your company and its QMS are ready. First, have a robust QMS in place and follow it. Second, do regular internal auditing so you discover and fix gaps before the regulators find them. Third, structure documents and records in a way that is usable and accessible. Finally, flesh out design controls. By taking these steps, you will help your organization be as prepared for an FDA inspection. About Pro QC International As a leading quality assurance company for over 40 years, Pro QC International offers a variety of services. We work with medical device manufacturers across the globe preparing for FDA inspections, ISO 13485 audits, MDSAP audits, third-party inspections, and many other services. If you have any questions or would like to request a quote, please contact us.