Complaint Management Could Affect Adverse-Event Handling
Consumer complaints are at the heart of every product recall. Whether it's Merck's voluntary recall of the pain medication, Vioxx, or the Class I recall of counterfeit LifeScan blood glucose test strips, chances are both actions stemmed from complaints.
The reporting of side effects or adverse events is incorporated in FDA regulations. The agency operates MedWatch, a safety information and adverse-event reporting program that allows health-care professionals and the public to report serious problems associated with medical products.
While there is no denying the importance of customer complaints for life science companies, many organizations find it difficult to implement a process that will effectively manage, report, and resolve complaints. The following are some of the most common complaint-handling issues faced by FDA-regulated companies and practical tips on solving them.
1. Lack of Standard Procedure. Consumer complaints come from different sources, such as e-mail, phone, fax, and letters, or via the corporate Web site. A complaint may be reported by sales representatives and other employees who interact with the public. Complaints are often addressed by different people within an organization. Without a standard policy and a formal mechanism for gathering and processing data from different sources, complaints may languish in someone's "in" box or voice mail. Worse, complaints may get lost.
Solution: Implement a formal policy and a standard procedure for complaint management. It helps to have a department or a team that specializes in complaint handling. Under the FDA's Quality System Regulation, medical device firms must designate a complaint-handling unit, and employees who review complaints must have thorough knowledge of the product line to make an informed decision as to the severity of a complaint and whether it requires investigation. For more efficient management of complaints from multiple sources, consider automating your paper-based or partially electronic system. Under an automated system, there will be a standard electronic form that will help you capture all the necessary data and a centralized repository for storing all the information.
2. Lack of Capability to Escalate to Adverse Event. Complaints that are gathered and stored in paper files are easier to misplace or overlook. The information captured may be insufficient for the purpose of reporting to the FDA. Escalating a complaint to adverse event would require extra effort on the part of the employees who initially process complaints. All of these can result in delayed and ineffective complaint resolution.
Solution: When you switch from a paper-based complaint-handling system to an electronic system, all tasks pertaining to customer complaints will be automated, including data collection, notification, follow-up, and escalation. Choose a robust solution that provides best-practice forms and incorporates escalation to corrective/preventive action and adverse-event handling processes.
3. Inadequate Documentation. Without a formal record-keeping system and an effective tool for capturing data from complaints, documentation may be inadequate for the purpose of compliance, or in responding to a product liability lawsuit. Poor documentation of steps taken by management to resolve the complaint could serve as ammunition for the opposing party in case of litigation.
Solution: A thorough documentation of consumer complaints and adverse events and ensuing investigation is an FDA requirement. A good electronic system guides a user throughout the complaint-handling process by providing best-practice workflow and forms that require input of necessary information, and therefore, helping improve the quality of documentation. Records must include customer information, origin and details of the complaint, product information, details of investigation, CAPA, etc.
4. Lack of Customer Access. A customer may have to talk to different departments before reaching the person with the appropriate authority to act on a complaint. This is frustrating to customers, whose information may help prevent future complaints. FDA-regulated companies are likely to hear from the agency itself since consumers and health care professionals may report product-safety and quality-related complaints directly to the agency.
Solution: A company must make it as easy as possible for customers to log in complaints, either through a corporate Web site or a toll-free telephone number. Inform customers about the complaint-handling system through the Web site, account mailings, product packaging, advertising, etc. FDA-regulated companies must be able to determine which complaints need to be reported to the agency as adverse events. Choose a system that can link the different sources of complaints and also integrate the complaint-handling process with CAPA and other quality processes.
5. Lack of Management Strategy. Without the ability to track complaints and monitor resolutions, it is practically impossible for a company to formulate an effective strategy for future complaint resolution. Managers who are unable to see the ?big picture? are not equipped to fully understand customer concerns and prevent the issues that led to the complaints.
Solution: First of all, you need commitment from senior management. Through appropriate policies and procedures, management can signal to all employees that the organization is serious about product safety and customer satisfaction. In terms of tools, choose a complaint-handling software solution with advanced analytics and reporting capability. A real-time view of the quality system allows management to develop a more proactive strategy for improvement.
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