Understanding FDA observation reports

With recent negative media coverage of an FDA observation report, complaint management has become a focus for many medical device companies. Two of the nine observations cited in a September 2015 report were related to the complaint system with the FDA reports stating:

1. “Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.”

2. “Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary.”

These two observations sound alike and use curiously similar language regarding receiving, reviewing, evaluating and investigating complaints. A review of these observations, in detail, is necessary to show just how serious the FDA takes customer complaints.

Fully understanding why complaints are so important to the FDA is as simple as considering the sole reason the FDA exists in the first place. Their mission statement is to be “responsible for protecting the public health.” When the FDA arrives at a facility for an inspection, typically one of the first things they look through are a manufacturer’s complaints. This is a critical part of a routine inspection. The complaint management system is one of the few communication paths a customer has to report safety issues. As part of the FDA’s responsibility to protect public health, they want to see that device manufacturers are responding to customer complaints.

Despite the FDA’s lack of detail behind these observations, a considerable amount of structure is required when establishing complaint management systems. The two observations are related but attack different parts of the quality system. The first observation cites the lack of established procedures for complaint management. The FDA doesn’t just want to see that a company is processing complaints, they want to see that the process is well-documented. The FDA is a stickler for good documentation.

Companies should take careful note of what “formally designated unit” means to the FDA. A trained team of complaint specialists must be formed to manage complaints and all the processes associated with it. For example, a team member that hasn’t been trained on the complaint process or how to identify specific safety issues in complaint language is a red flag during FDA inspections.

The second observation deals with lack of action when complaints are received. In this case, the company mentioned in the observation received reports of a possible device deficiency but failed to formally document it. Note that this doesn’t necessarily mean that they didn’t react to the complaint, but that they simply didn’t document it. There is a popular mantra in this industry: “If it wasn’t documented, it didn’t happen.” This tends to have a snowball effect, because if there had been established procedures for this, then the actions of the regulatory team would have been documented.

The odd, yet specific wording of the observations, for “receiving, reviewing, evaluating and investigating” complaints are specific for a reason. They coincide with the critical regulatory phases that the FDA wants to see while processing complaints. Best practices for these phases can be summarized:

• Receiving—Complaints must be formally received and documented with specific pieces of information.
• Reviewing—Each complaint must be reviewed to make sure that the information is complete and that it does, in fact, represent the traditional definition for a complaint. Note, not all customer communication is considered a complaint—only those alleging device deficiency are considered applicable complaints.
• Evaluating—Each complaint must be evaluated to determine whether further investigation or corrective action is necessary, and whether a significant patient safety issue has occurred. If a patient sustained an injury due to a device failure, regulatory action may be required and the incident must be reported to a governing body.
• Investigating—For complaints requiring further investigation, results of the investigation must be fully documented. Investigations must attempt to identify root cause; anything short of this can raise a red flag.

From a regulatory standpoint, these complaint actions are non-negotiable. During an FDA inspection, it would behoove companies to show documentation for each of these defined phases.

In the medical device industry, issues with complaint management are not unique. They’re often the result of the growing pains experienced by many medical device companies. More important is the response to observations. Even if the FDA didn’t exist, systematically managing complaints is simply good business practice. A robust feedback system lends itself to a stronger and more loyal customer base.