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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
In most industries, businesses run the same way. You can either stick your head in the sand and pretend that everything is going fine, or you can stand up and take the feedback-whether positive or negative-and react to it.
Guest blog by Tim Lozier.
In most industries, businesses run the same way. You can either stick your head in the sand and pretend that everything is going fine, or you can stand up and take the feedback-whether positive or negative-and react to it. This is especially true with Quality Management Systems (QMS).
In today’s dynamic and demand-driven world, businesses are challenged with speeding their product-to-market strategies to remain competitive. In the pharmaceutical industry, regulatory and compliance pressure add another dimension to the QMS. Organizations want to bring their products to market quickly, but need to ensure quality and compliance standards are met-it’s a paradox of “hurry up, but take your time doing so.”
Nevertheless, no matter how much one prepares, once product is released, post-market feedback is inevitable. You may get positive feedback, but more often than not, this post-market feedback comes in the form of complaints, which can arise from consumers, doctors, patients, vendors, and many other parties. Organizations are faced with the challenge of interpreting this feedback and turning it into opportunities.
It’s the age-old story, “We have all this data, but how do we use it?” Complaint handling systems can be very adept at collecting post-market feedback, but after the data is collected, it becomes a challenge to use the data to foster continuous improvement. You may find yourself asking:
Quite simply put, the QMS is built for continuous improvement. Companies have Corrective and Preventive Action (CAPA) systems, complaint handling systems, and change management systems to handle such quality events. But what can one do to turn post-market data into improvement in the next product? Below are a few tips.
Risk-Management Filtering: The biggest challenge facing many companies has to with sorting through the data. Complaints enter the system by the hundreds or even thousands, each with varying levels of severity. The question becomes, “How can I identify the critical adverse events from the non-critical?” The answer lies in risk assessment. By using risk methods, one can filter the critical from the non-critical based on risk levels. This enables one to effectively address those events that present the largest impact on the business. Then one can open up CAPAs based on the high risk events first.
Change Management Linked from Post-Market Events: Once a company has identified critical events and begun to correct them, how can one influence change in the product as a result? The system must be managed in a systematic way, so that R&D is able to take post-market feedback and apply it to the product. Managing the process of supplier and contract manufacturer quality is key, and it needs be done so efficiently. Change management in the QMS is ideal for this task because it includes the workflow, process automation, and integration required to enable post-market data to reach all areas of the business. By building effective change management processes, one can benchmark quality and compliance throughout the product lifecycle and reduce noncompliance as a result.
Visibility into the data: If you aren’t one of those folks with your head in the sand, you want to be able to see how you’ve improved, or where you are not improving. You need visibility into your existing data in order to influence future strategy in product quality and compliance. Without strong reporting in the QMS, you are just looking at the data. Analysis and interpretation of the data are needed. Reporting in the QMS can help to take the temperature of the compliance effort and see whether you delivering on what you’re changing in your processes.
QMS are designed to manage and track the drug development and manufacturing process. Post-market feedback is important to the health and success of that process and of a business. By streamlining the process of post-market feedback and reaching into the enterprise, one can quickly and effectively manage the continuous improvement process.