Device QMSR Fears Easing: Panel
Industry executives and FDA officials who participated in a 10/19 panel at The MedTech Conference say initial industry concerns about the new Quality Management System Regulation (QMSR) and its implementation by FDA are easing as companies get more experience with inspections under the new protocol. A Regulatory Affairs Professionals Society online post says two CDRH officials on the panel reassured conference attendees that the agency isn’t going on a fishing expedition when it requests quality system documents during an inspection. Rather, they said, FDA is working to understand how a company manages risk.
Johnson & Johnson senior director of regulatory compliance Doug Reimer said the move to QMSR was not as traumatic as industry had originally feared. He credited the relatively painless transition to the preparation the agency and industry put in before QMSR took effect in February. He noted that many companies had already been following ISO 13485 and thus FDA’s efforts to harmonize with that standard under QMSR were not completely foreign to them.
Reimer said J&J has role-played scenarios with various stakeholders, and one takeaway was to ensure they are reminded to use risk management and controls throughout the entire quality system.
He admitted to being nervous when FDA investigators first asked for audit reports, but said he has become more comfortable over time.
“I think the key part is to make sure your organization has these controls connecting all the areas of the quality system and you can demonstrate that,” Reimer said. “I think one of the challenges that you have to be ready for is when FDA or even a notified body asks you how it feeds into your risk management, how it’s connected,” Reimer said companies should become more conversant about how various parts of their processes contribute to QMSR compliance.
CDRH Office of Product Evaluation and Quality associate director for compliance and quality Keisha Thomas said FDA’s need to access records under QMSR is in the spirit of transparency and harmonization, and the agency did not intend to cause undue angst for regulated companies. She noted that under QMSR, investigators look beyond documents to ask how risk factors into corporate operations and what parameters companies use in risk-based decisions.
“What’s important to understand is we don’t come in and look at any records just for the sake of looking at them,” Thomas said. “It’s going to be in line with what we are looking at, what the inspection is unveiling in front of us. It’ll align with the questions that we’re asking, and then we’ll ask for the documentation that supports that information. One of the areas that makes this a little bit harder is because of the type of questions we’re asking. The lens in which we’re asking the questions is a little different than what we’ve traditionally done.”
FDA Office of Inspections and Investigations senior advisor Karen Masley-Joseph reaffirmed that QMSR is about patient-focused risk management throughout a product’s lifecycle and investigators’ requests for specific documents are based on the questions they are trying to answer as part of the inspection.
“The best advice is use those records to show the great decisions that you’ve made, use those records to show how effective you really have been in your system. That’s the opportunity,” she said. “It can really play to an advantage for all those companies.”
Masley-Joseph said the lack of product realization has overtaken lack of corrective action as the most typical issue raised on Form FDA-483s. She said the observations generally note a lack of one or more risk management processes throughout product realization.