Learn what to expect from FDA QSIT and be prepared
Quality System Inspection Technique
You can also call it “surprise or routine inspection”. Sounds frightening, right? As more you are following the standard, the less you should fear. It is straightforward. But the more you know about this type of inspections, the less you will be surprised when/if it happens. Therefore let’s start with its introduction.
FDA conducts random (read unexpected) visits to medical device companies that have their product on the USA market. The office of Regulatory Affairs (ORA) is the lead office for all filed activities at the FDA exactly. You heard about saying: “Better safe than sorry”, well, they want to check if a medical company follows the compliance requirements. Because if they don’t, it could represent a potential hazard for patients with the product that they have approved.
Aim of FDA QIST
The FDA QSIT wants quickly and systematically to check the conformity of quality management systems with regulatory requirements, particularly those of the 21 CFR part 820. They usually prioritize inspections by the risk and give higher-risk devices/situations, a higher priority. Also, mandated by law, every 2 years for class II and class III device manufacturers. And of course, who else? Every medical device company that got some public complaints. Those need to be checked.
What is their methodology
If you would like to know more about inspections of quality systems, you can check it here. We will give you a brief. In general, the QSIT focuses on four main subsystems.
1. Management controls
2. Design control
3. CAPAs
4. Production and process controls
And there are two types of QSIT inspections: Level I Abbreviated and Level 2 Baseline.
It’s all about the management team providing the necessary resources to establish and maintain an effective QMS, and center-peace are managements controls.
The inspector may announce ahead of their visit, or not. For domestic manufacturers, they give heads up 5 calendar days before the inspections. And there are always a few main issues usually discussed during the inspection. They usually review:
And never forget — your records of internal quality audits will be under review as well!
It is up to you to always be prepared for the FDA to visit your facility. Make sure to sit down with your team and formulate an actual plan and be on stand by in case of an inspection visit. We advise you to even make a procedure for employees to know what to do in those cases. Finally, it’s always best practice to ensure your quality system documentation is available and up-to-date.
What are usual non-conformities and what happens if FDA finds non-conformities
USING QSIT, FDA INVESTIGATORS CAN QUICKLY EVALUATE HOW EFFECTIVELY A QUALITY SYSTEM HAS BEEN IMPLEMENTED. HOWEVER, QSIT WAS NOT DESIGNED OR INTENDED TO BE AN EXHAUSTIVE EVALUATION OF COMPLIANCE WITH ALL QUALITY SYSTEM REQUIREMENTS. SIGNIFICANT QUALITY SYSTEM DEFICIENCIES ARE LIKELY TO BE DETECTED, BUT NOT ALL DEFICIENCIES WILL BE IDENTIFIED.
After conducting an inspection, the FDA provides the classification of the inspection to reflect the compliance status based on observations noted.
Here is a list of a couple of points that appear most often.
· Failure to record appropriate case history and subject records
· Failure to protect the rights and safety of clinical trial subjects, specifically failing to obtain informed consent by 21 CFR Part 50
· Procedures for quality inspections have not been established.
· Complaints about device failures or issues with labeling or packaging were uninvestigated adequately
· Failure to document properly CAPA results
After these possible findings, you are probably going to receive 483 observations. If 483 observations are major enough and/or you do not respond accordingly, then you should expect an FDA warning letter. Don’t neglect the importance of FDA 483 observations — it’s an observation about the situation that the FDA considers important. When you get FDA 483s, you need to respond and do so within 15 business days.
How to approach problems once they were brought to your attention
Usually, the FDA selects only one product or element related to a product when they are inspecting design control. Therefore, if you keep track of which products have already been inspected by the agency, you can often predict the most likely product for the investigator to select during the next inspection.
You should ensure that the 483 response is responsive to FDA’s observations, is easy to follow, and leaves it clearly with the FDA reviewer how and what you are going to do to fix the issues. You need to provide facts and support your claims with facts and data. Make a plan of action.
For the end:
Here are the few questions you may expect from the FDA inspector:
· Has a Quality Policy been established?
· Has a quality plan been established?
· Has a management representative been appointed?
· Has management with Executive Responsibility conducted management reviews?
· Have design procedures and plans been established?
· Have design inputs or requirements for the device been identified?
· Has design validation been conducted?
· Has the software been validated?
· Have CAPA procedures been established?
· Are sources of data analyzed to identify nonconforming product and quality problems?
· Are investigations conducted to identify root causes or failures?
· Are rejects and nonconforming products handled appropriately?
· Are production employees trained and qualified?
· Is equipment adjusted, calibrated, and maintained?
DAVID O’CAEIRO — Author
