A step-by-step path to effective product complaint management

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Pharmaceutical Technology Europe PTE

Product failure can be potentially fatal to a customer and have severe implications for manufacturers; however, many pharma companies still believe that complaint management is not related to the overall management of customer relationships.

Product complaints management is essential from a regulatory and compliance perspective. Immediate and real-time response to urgent customer requests and returns is critical; product failure can be fatal for customers and have severe legal implications for manufacturers. Hence, there is a need for a single, uniform and secure platform to manage product complaints right from initiation through to closure.

Many pharmaceutical companies view complaint management as a process not related to the overall management of customer relationships, but complaints management is an integral part of consumer management. A properly executed complaints management programme can decrease customer maintenance costs, increase revenues, and improve a company’s ability to track historical customer and product trends, which is useful to forecast future market, product and customer needs.

In pharma, effective complaints management is hard to achieve and it can also be difficult to ensure compliance with government regulations. However, effective complaints management is effective for many reasons:• Insufficient product complaint handling was and is still one of the top FDA findings in 483 published warning letters.• Regulatory and competitive pressures are forcing organizations to change their product complaint management strategy.• The dynamic and stringent regulatory landscape is making it mandatory for organizations to track, record, and report all complaints with respect to product quality and safety; and to take appropriate follow-up actions to prevent reoccurrence of such incidents.•


A step-by-step solution
Some of the salient features of good complaint management solutions are:

  • Functionality breadth and depth:
  • web-based application integrated with workflow
  • escalation management
  • single complaint with multiple processing (parent-child notifications)
  • reminders
  • reports
  • complaint closure form
  • multiple language capability
  • document management system integrated to record all attachments & reports with individual complaint
  • electronic signatures
  • integration with sales and distribution processes
  • integration with adverse event handling processes.
  • Standardized and automated. The system needs to be centralized, integrated and standardized to report the event or problem to the regulatory authorities in the required time (typically 15-30 days). The system should not have integration overheads and heavy manual operations.
  • Safety and security. The solution will interface with multiple systems in sales, customer relationship, production, material management, design, and drug development and regulatory requirements. It would have huge data flows, which are mission critical and can create loopholes into information security. The architecture of the solution should ensure complete data security.

Performance of solution. The technical solution needs to contain multiple integration points, workflows and data elements. The solution should encompass clear business rules, SOPs and workflows in a simple architectural form. The solution should have an efficient and easy to use notification engine, as well as a high-performance reporting engine.

Exploring the solution further
The following functionalities should be covered at various stages of the complaint management process:

  • Receipt. Functionality to consolidate different channels of complaint receipt such as web form, email, fax, telephone, sales team escalation and so on into one uniform platform. Customers should have either a web portal to log complaints online or a toll free number to submit complaints.
  • Data and complaint management. The solution should automatically capture critical information related to a product complaint. The solution should also include online tracking of product complaints from receipt through to final sign-off. It should include storage, archival and retrieval of all the product compliant-related documents. Data upload is an important requirement of the receipt functionality where investigational data pertaining to the complaint can be uploaded during the complaint life cycle.
  • Routing and escalation. Automatic routing of complaints depending upon the severity and type of complaint for further investigations. For example, quality problems to quality control and production or safety problems to drug safety. This ensures automatic escalation of the non-completed actions in the workflow. The solution should include automated trigger for internal corrective and preventive action.
  • Task management. Automatic task management features for compliant processing.
  • Processing and reporting. Collaborative framework to manage compliant processing across various cross-functional departments such as production, R&D, quality control, drug safety and so on. The solution should also include an option to view compliant summaries, in-process complaints, investigation outcome and perform trend analysis as per type, product and department.
  • User management. The functionality to track users and their actions involved in the complaint processing.

The solution should provide an integrated approach to the complaint management where it can interact with various stakeholders, such as manufacturers, patients, doctors and regulatory authorities. The core functionality should be integrated with call center processes, product life cycle processes and peripheral applications that provide functionalities not covered by ERP. The below diagram illustrates the solution.

How the solution solves the problem
A robust complaint management solution should provide both processes and technology for gathering, classifying and preserving product information in order to anticipate, diagnose and resolve product-related problems. It should offer direct access to specific product details that allow quick problem resolution, and a web-based entry and status reporting system for customer service. Triggers can alert quality personnel to critical or recurring customer reports for specified products; such alerts are invaluable for enabling quick defect-correction and customer notification before a problem becomes widespread.

The solution should be driven by specific ROI levers including reduced warranty costs, mitigation of regulatory fines, reduced refund/return error owing to accurate information and reduced cost of compliance. The solution should also result in reduced costs of compliance through minimum time and costs of processing complaints, uniform compliance and high-quality content among all partners.

With this solution, companies can look forward to the following benefits:

  • standardized, consistent and complete global complaint handling process and data collection
  • increased data consistency and enhanced reporting capability
  • increased customer loyalty through improved response time
  • increased security with Part 11 compliance
  • all complaints captured in one single database
  • complaint data consistency
  • standardized process can be rolled out globally, within short time frame.

Complaints management is a complex and critical problem. As regulatory and market pressures continue to mount upon pharma companies, industry leaders will need to develop effective solutions or face the high costs inherent in failed technology implementations, FDA censure and weak customer relationships. The preferred alternative is a customer-focused complaints management solution that works.