Effectively handling customer complaints, while not the most popular in the pantheon of business processes, is an essential component of successful FDA compliance programs. Many drug manufacturers treat complaint management programs as a nuisance, or ignore the issue entirely. This attitude usually results in those firms getting trapped into a cycle of solving the same problem over and over. The FDA places great emphasis on managing customer complaints. The reality is, knowing the techniques of running an effective complaint management program can result in real bottom line benefits to your business.
Why Managing Complaints Improves Your Business
Those familiar with FDA inspection techniques are aware that agency inspectors usually attach great value to running an effective complaint management process. What is less well known is why. Studies on customer complaints show that typically less than 15 percent of problems get reported in the form of complaints to the manufacturer. While the complaint reporting percentage is likely to be higher with pharmaceuticals, it still holds that a single or small handful of complaints may indicate a much larger problem just below the surface.
Over 100 years of experience has taught the FDA that large problems often initially surface as a few isolated complaints. Many times the magnitude of a problem is not discovered until those initial isolated complaints are investigated. Therefore, the FDA believes that timely and thorough investigation and resolution of drug product complaints enhances the safety of drug products in commercial distribution, and is a key component of the agency’s mission of ensuring the safety of the drug supply chain in the US.
To the FDA a complaint is an opportunity for the manufacturer to learn something new about its product or processes. That potential knowledge can then be used to make the product more effective, safer, or to make the process more efficient. Each complaint represents an individual opportunity to identify and solve a potential problem, and to prevent the same problem from re-occurring in the future. Firms who lack effective complaint handling processes often deal with the same problems repeatedly, which is inefficient from a business operations standpoint. More troubling, however, is that under the right conditions, small chronic problems can blossom into full-blown major crisis.
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