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Complaint Management: Where Patient and Process Meet

Written by: Ken Eagleson, Senior Consultant at Process Alliance

In the fast-paced world of pharmaceuticals, product failure isn't just a setback—it can be potentially fatal for patients and carry severe legal consequences for manufacturers. Despite this, a surprising number of pharma companies still view complaint management as a separate entity from overall customer relationship management.

From a regulatory and compliance perspective, effective product complaints management is not just a good practice; it's a necessity. Immediate, real-time responses to urgent customer requests and returns are paramount in an industry where product failure can have life-altering consequences for consumers and legal ramifications for manufacturers. The call for a single, uniform, and secure platform to handle product complaints from initiation through to closure has never been more urgent.

While some pharmaceutical companies might see complaint management as a detached process, it is, in fact, an integral part of consumer management. A well-executed complaints management program goes beyond meeting regulatory requirements; it can significantly decrease customer maintenance costs, boost revenues, and enhance a company’s ability to track historical customer and product trends. This valuable data, in turn, becomes instrumental in forecasting future market, product, and customer needs.

In the complex realm of pharma, achieving effective complaints management is no small feat. The difficulty doesn't only lie in addressing customer concerns promptly but also in navigating the intricate landscape of government regulations. However, the benefits of effective complaints management are far-reaching and go beyond mere compliance. Let's delve into why it's a game-changer for pharmaceutical companies.

The Process

The pharmaceutical complaints management process is a systematic approach designed to address and resolve issues raised by customers regarding pharmaceutical products. While the specifics may vary among companies, a well-formed complaints management process typically includes the following key steps:

  1. Receiving Complaints:

    1. Channels of Communication: Complaints can be received through various channels such as customer service hotlines, email, online forms, or even social media platforms. These are then routed to specific teams (either pharmacovigilance or product complaints).

    2. Documentation: Regardless of the process, each complaint is documented thoroughly, capturing essential details such as the nature of the issue, product details, and contact information of the complainant.

  2. Initial Assessment:

    1. Categorization: Complaints are categorized based on severity and type to prioritize responses. This step helps in determining the appropriate level of urgency and attention required. Examples include if there is a Three Day Field Alert (3DFA), where a patient alleges a potential contamination or missing lot number, or leveling the product complaint (1, 2, or 3).

  3. Investigation:

    1. Root Cause Analysis: A thorough investigation is conducted to identify the root cause of the complaint. This may involve collaboration between different departments, including quality control, production, and research and development.

    2. Product Evaluation: The implicated product is often examined to assess its compliance with quality standards and specifications.

  4. Response and Resolution:

    1. Customer Communication: The customer is informed about the progress of the investigation and provided with a clear timeline for resolution.

    2. Corrective and Preventive Actions (CAPAs): Based on the findings, corrective actions are implemented to address the immediate issue, and preventive measures are devised to avoid similar problems in the future.

  5. Documentation and Reporting:

    1. Record Keeping: Every step of the complaints management process is documented for regulatory compliance and internal analysis.

    2. Regulatory Reporting: If required, reports are submitted to regulatory authorities in accordance with their guidelines.

  6. Follow-Up:

    1. Customer Follow-Up: After resolution, companies often follow up with customers to ensure their satisfaction and gather feedback on the effectiveness of the implemented solutions.

    2. Continuous Improvement: Lessons learned from the complaints are used to enhance product quality, manufacturing processes, and overall customer experience.

  7. Trend Analysis:

    1. Data Analysis: Aggregated data from complaints is analyzed to identify trends and patterns that can inform strategic decision-making and continuous improvement efforts.

    2. Feedback Loop: Insights gained from complaints are often fed back into the research and development process to improve future product iterations.

  8. Training and Communication:

    1. Employee Training: Employees involved in the complaints management process receive ongoing training to stay updated on regulations, company policies, and best practices.

    2. Communication: Internal communication ensures that relevant departments are aware of the outcomes of the complaints management process and can implement necessary changes.

Example of Complaint Management in Action By following this comprehensive process, pharmaceutical companies aim to not only meet regulatory requirements but also continuously improve their products and services based on customer feedback. The below flow chart is an example of how this process may look at an organization…

In this diagram, note that complaints have been broken into two workflows: adverse effects (AEs), which are routed to a designated pharmacovigilance team, and product complaints (PCs), which are routed to a special complaints team. Additionally, for product complaints, some companies may design a ranking system for each complaint to determine next steps for investigation. For example, a Level 1 complaint may have no SISPQ (safety, identity, strength, purity, and quality) impact, such as an aesthetic design issue, and require no further investigation. However, a complaint around usability of the product, potential contamination, or a Three-Day Field Alert (3DFA), would be tagged as Level 2 or Level 3 and would require further investigation by the company’s quality infrastructure. It is important to note here that some companies segment their processes like the flowchart above, while others may bundle all complaints together. Whatever the case may be for your company, the starting point should be the same: always consult current regulations and expectations related to your product (FDA, EU, Japan, etc.) and use them to build your process. Also, continually auditing your process is essential to maintaining control and compliance! How Can Process Alliance Help? So, why is having a robust complaint process a value to your patients and business? Beyond a cGMP requirement, a well-structured complaints process represents a commitment to both your patients and your business to provide consistent, safe, and effective regulatory approved marketed product by monitoring adverse events and product complaints. By monitoring adverse events and product complaints, you provide a regulatory agency with objective evidence that your manufacturing process is under control. Additionally, it opens an avenue for your patients to communicate and establish a healthy relationship with your company by listening to their feedback. Here are just a few ways that our experts at Process Alliance can offer support…

  • Audit your current product process, provide suggestions for process improvements, and create opportunities for more time and resources.

  • Assist in triaging/prioritizing product complaints due to a backlog—and help to lessen (or even eliminate) it.

  • Assist in the development of a robust process that deeply investigates and provides solutions for product complaints.

Ready to Optimize Complaint Management? Process Alliance is a pharmaceutical engineering consulting company committed to providing high quality results for our clients that are expanding or have been asked to update their internal processes by their customers. To learn more about how our experts can help enhance your complaint management processes, email us at, or visit our website.

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