Complaints are one of the most commonly cited sections in FDA device warning letters.
“Every MDR has an associated complaint with it. So, what that means is in order to understand how to properly implement MDRs, we’ve got to understand how to properly implement complaints,” Dan O’Leary said.
Based on his own research, about a third of all device warning letters have MDR citations — with 40 percent including citations for complaint handling.
Define, Document and Implement
Manufacturers should first have a process in place that explains how a designated unit or individual in the facility is going to handle and evaluate complaints.
That is where a flow process comes in handy. It involves writing down and documenting all decisions, incorporating tools such as a flow chart that outlines each step and a well-structured form to help you in this process.
“You’re going to document the forms or database elements for complaints, and then you’re going to implement the process. And don’t forget to train the people involved and create the appropriate training records,” O’Leary advised.
Manufacturers should have protocols in place to cover all regulatory requirements, ensuring that complaint and MDR processes “interlock” with one another.
“Oftentimes problems occur when you’re transferring information from one of these systems to another. So, make sure that they hang together. Review all the procedures together to make sure that you’ve got everything covered, [that] there’s no gaps and no contradictions,” he said.
He also advised interlinking the complaint and data analysis process to avoid silos. “This means, perhaps, that your designated complaint unit is also going to handle the MDRs, so that it’s all done in a uniform way.”
Internal audit programs are the best way to ensure the robustness of your QMS, he emphasized. This involves checking all of these processes to ensure that they “are running the way that you intend that they run.”
An audit schedule should review the following elements on a regular basis: conformance to complaint, analysis, and MDR procedures; complaint investigation decisions and records; MDRs submitted on time, and records in the MDR event files.
For each of these elements, manufacturers should create a checklist based on established procedures and work instructions.
Internal quality auditors should ensure that the sample size of records isn’t too small. This runs the risk of not catching rare problems, leaving room for the FDA investigators to find them instead. “So, make sure that your sample size is large enough that you’re going to get all of the required records,” he advised. — Jennifer Lubell