The FDA cited Reliance Mobility in a Form 483 with 13 observations after an April inspection of the company’s Columbia, Tennessee, facility.
The agency investigator found the facility had no design history files for two speech generating devices and it lacked procedures for design control. The company also lacked adequate device history records and procedures for quality audits, acceptance activities and document control.
In addition, the facility had inadequate procedures for control of labeling. For example, the procedure did not “ensure labeling is not released until a designated individual has examined the labeling for accuracy and the release, including the date and signature of the individual perfo1ming the inspection, is documented,” the agency said.
The company’s device history records for the two devices did not include the labeling for each production unit, manufacture dates, final acceptance records, or documentation of the software version downloaded into each device.
The agency also faulted the company on its complaint-handling procedure, finding that it did not properly ensure all complaints were evaluated to determine if medical device reporting was necessary or ensure that complaints received by customer support were actually logged as complaints.
The company’s procedures for reporting adverse events did not ensure completed MDRs were submitted in a timely manner or address how all information reasonably known would be submitted and it had no established CAPA procedures, the agency said.
The company also lacked procedures for control of nonconforming product or for evaluation of suppliers, contractors and consultants.
Three Practical Keys to an Effective QCU
The quality control unit must be designed in a way that enables it to see and react to issues as they arise or, better yet, preemptively. The unit must touch all of the quality systems regulated by the FDA or other regulatory bodies.
First and foremost, the QCU must be fully independent of other operations in the facility. Just like the internal audit teams, QCU staff must be independent of all quality systems so that their oversight of these systems can be unbiased. Even the perception of bias in favor of a particular process or system can render a QCU ineffective.
The second characteristic is value; that is, the QCU must be valued throughout the company, from upper management all the way down through production line staff. If the unit is not seen as valuable to the company, its operations and its products, it will not be given the resources it needs to properly oversee the quality systems throughout the corporation.
Third, the entire company must understand that responsibility for quality — the QCU’s function — is different from the responsibility for quality assurance. QA steps are taken at each stage of production. A wide range of employees and departments will have certain QA responsibilities involving personnel, training, documentation, equipment maintenance and myriad other activities and materials that go into device manufacture.
On the other hand, quality control, the QCU’s purview, refers more to an overarching philosophy. This is mirrored, for instance, in the FDA’s own Quality System Inspection technique, which focuses on key systems that are specifically designed for quality control on a corporate-wide scale, and which are supported by the various quality assurance activities that go on during day-to-day operations.
“I like to use the phrase that everybody is responsible for quality, but not everybody is responsible for quality assurance,” says Crystal Mersh, executive partner with quality control unit consultancy QxP.