Preparation is everything.
The time to begin preparing for your next medical device manufacturing inspection is before it’s even scheduled. This is especially true if you are overdue for a routine biannual surveillance inspection of a specific device or manufacturing site. Inspections that have been delayed by the pandemic will ramp up again.
The three P’s
Inspection readiness is one part procedure, one part paperwork and one part people. It’s the third piece – the people – that is the most important when preparing for an FDA inspection. Understanding the role of everyone in the room, including the inspectors themselves, is essential for a successful experience.
Procedure: Preparing for a site visit.
FDA inspections of medical device manufacturers are conducted to evaluate compliance with certain parts of 21 CFR (Code of Federal Regulations, Title 21). Inspectors will follow the Quality System Inspection Technique (QSIT) guide to assess at least two of the following:
- Medical Device Reporting (Part 803)
- Corrections and Removal (Part 806)
- Registration and Listing (Part 807)
- Quality Systems (Part 820)
- Medical Device Tracking (Part 821)
Understanding the QSIT procedure will help you prepare your facility and equipment, as well as the essential documents including site logs. In addition, you will want to arrange a well-equipped workspace for the inspector, with enough seating to also accommodate your team members. A number of FDA inspection checklists exist online to help in your preparations.
Paperwork: Getting ahead of documentation requests.
Having a “war cart” of commonly requested documents will help keep you organized during the inspection. At a minimum, the FDA recommends having the following documentation available for review:
- Study protocols
- Protocol amendments and clarification memos
- Ethics Committee (EC)forms, approvals and reports
- Institutional Review Board (IRB) forms, approvals and reports
- Device accountability records
- Study monitoring information
- Site personnel records
- Master subject log
- Subject screening and enrollment logs
- Sponsor correspondence
- Standard operating procedures
- Informed consent documents
- Case report forms
- Clinic charts
- Subject diaries
- Laboratory reports
- Hospital records
- Adverse event filings
People: Choosing your subject matter experts
Remember that the inspectors are there to ensure the safety of consumers and healthcare providers. They are well educated, highly trained and take their work seriously. They will be both practiced and tireless in their questioning, using proven interrogation techniques to get the information they need.
Do not underestimate the importance of engaging the right people when choosing your subject matter experts (SMEs), scribes and support team members.
Clearly, your SMEs need to know the ins and outs of your manufacturing processes, systems and documentation practices. They should be experienced in the full scope of your operation, not just the production line. But even more important is how they communicate and share knowledge with third-party interests. FDA inspectors will respond best to SMEs who can:
- Make a good first impression with eye contact and a professional image.
- Be compliant and sociable, yet also authoritative and firm.
- Give precise answers and explanations with an appropriate degree of specificity.
- Speak concisely without the need to share extraneous information.
- Respond effectively under pressure, keeping to the facts without emotional reactions.
- Admit if they do not know the answer to a question and ensure follow-up.
If time allows, conduct mock inspections with your team. This will help you identify gaps and areas of increased risk. You may also wish to review case studies and explore the FDA medical devices website for the latest industry information, education and support.
Expert support is available for your inspection readiness needs. Learn how SRG can help. Contact us at USMarketing.