A February inspection of Bishop, Calif.-based NeuroField found the firm failed to report device failures for its neurofeedback devices, and it didn’t properly control products according to specifications, the FDA said.
The agency inspector identified 23 instances where customers reported functional or structural failures, but the events were processed as routine service repairs and not evaluated for MDR reportability.
The inspector also observed four instances where incoming in-process materials failed to meet specifications, but they were not documented, evaluated or segregated as noconforming materials.
“Some of these failed materials/components, as documented in your device history record were repaired and used in building finished devices,” the Form 483 said.
In addition, the firm had no established quality policy and it could not provide inspection and testing records for the NeuroField X3000 Plus, and the software for the device was not validated.
Read the NeuroField Form 483 here: www.fdanews.com/05-08-18-neurofieldinc483.pdf.
Process Validation Tips
The fifth most cited problem that FDA encounters during inspections is process validation. Process validation is conducted on production equipment and is intended to confirm what you already know about how that equipment works. Validation is specific to the equipment, process, and production and should identify and control critical raw material and process parameters. The firm must complete this before the final design transfer and it should be a part of the design history file or DHF.
So where does this go wrong?
Often, firms will not have a validation master plan. This plan is essential to good project management. It ensures validation of processes. It sets priorities, establishes roles and responsibilities, and creates oversight, as well as schedules, timelines and budgets. The validation master plan also identifies qualified resources and methods for handling deviations; describes procedures, methods, forms, and implementation strategies and documentation. The master plan should also contain continuous improvement components—monitoring, tracking, trending, and revalidation.
The process validation master plan should include: product design/development; process development; facility qualification; utility qualification; test methods validation; cleaning validation; procedures, methods, and forms; qualified personnel and training; roles and responsibilities; and budgets, timelines and schedules.
FDA also frequently sees misconceptions between verification and validation. The following logic tree can help clear up mistakes:
Yet another pitfall is not identifying the worst case conditions in the operational qualification stage. The process parameters should be challenged to assure that they will result in a product that meets all defined requirements under the anticipated conditions of manufacturing.
Look at worst case testing. The operational qualifications will define the process limits or inputs to ensure that the output of the process meets pre-defined requirements, even at worst case conditions.
Excerpted from the FDAnews management report: Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps.