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The world is shifting towards companies that are customer-obsessed. Gone are the days when business leaders would drive strategy meetings with the primary focus on competitor analysis. The questions decision-makers are asking these days revolve around customers.

What do customers want? What do they need? What do they like about our product? Most importantly, what are they complaining about?

If enterprises can intently listen to every customer – you can “work backward” from there to continuously improve your company’s product or service.

But how does one make sense of what several customers across the globe are saying about your offering? How do you segregate your feedback from your customers into the right buckets? Most importantly, how do you “act” on this feedback?

The only way to distil intelligence from all your customer data is by embracing the latest digital tools and data analytics technologies. Using data and AI-enabled systems and automated processes, companies can reflect internally and draw up execution plans.

Often, customer complaints – especially ones that are frequent – are caused because of a process issue. The key is to build a continuously improving quality management system that is deeply integrated with an organization’s CRM. Once the customer complaint is registered, it must feed into a Complaint Management System as part of your EQMS.

If your enterprise is equipped with the right EQMS, your complaints system will be integrated with CAPA (corrective action, preventive action) and RCA (Root Cause Analysis) Modules. This will help team members collaborate and arrive at the right solution to fix the issue at hand, and also prevent future occurrences.

In some sectors like healthcare or medical device – where regulatory requirements also play an important role – it is essential to handle complaints with agility and nimbleness. The key is to create a seamless connection between quality, regulatory and operational processes.

At ComplianceQuest, we recently completed a webinar featuring Deb Kacera, a well-known quality leader with over 20 years of experience in quality, post-market complaints, risk, and compliance in the medical device and manufacturing industries. In this blog, we share key highlights from her talk. While the points below are relevant for all sectors, they are especially relevant for quality leaders in the medical device ecosystem.

The Many Sources of Feedback

Today, customers can speak directly to the enterprise on the phone or through social media, expressing their discontent. Their one word can get amplified unless quickly addressed. Social media has changed the way customers complain, and as an enterprise it is critical to have a well-documented execution plan to handle such complaints.

In the world of medical devices, we don’t even have to wait for a customer to manually complain. Thanks to IoT-enabled devices and cloud-based data sources, it is often possible to predict issues and challenges with a product or service based on data. Using AI or NLP-based solutions, it is possible to pre-empt a customer complaint and get into “fixing” mode even before a customer complains.

For medical device quality leaders, it is also important from a quality management standpoint to build a robust, automated workflow for complaint handling. In fact, when it comes to new product approvals, regulators are carefully analyzing the complaints handling capabilities before approving a product. This is especially true if your offering includes a Software as a Medical Device (SaMD), where there are more stringent compliance requirements around complaint management.

Accelerating Responsiveness to Complaints through Smart Decisions

With an ever-present threat of litigation faced by most industries, especially life sciences, complaint handling plays a very important function not only in customer satisfaction but also in improving the product quality and the manufacturing process. It needs a solution that can automate the entire workflow from the time of receiving a complaint to risk assessment, taking appropriate action closing the loop.

The key features of ComplianceQuest’s Complaints Management Solution include:

  • AI-enabled Triage: Automatically queueing all complaints, alerting the relevant complaints coordinator/manager to review it, analyze the risk using pre-defined risk standards of the reported complaint, routing for further investigation, and evaluating the need to report to the regulatory authority. Notifications are also automatically sent to the relevant departments and personnel, and escalation mechanisms are triggered based on the severity and priority of the complaint.

  • Product History Review: The CQ Complaint Management system lists the anatomy of the finished product and cross-checks it for any non-conformance, CAPAs, inspections, etc., created in the past and the outcome. A review of the historical data (and actions) helps complaint handlers in investigating the root cause of the problem.

  • Documentation and RCA: The CQ Complaint Management Solution facilitates the documentation of several root causes and triggers the initiation of a SCAR if the problem had its origins with a supplier.

  • Collaboration: The solution is designed for teamwork and collaboration amongst all stakeholders involved in solving the problem and also designing preventive actions.

  • Integrated CAPA: This is a key value proposition of the CQ solution, where the workflow for taking corrective preventive actions is automated.

Visibility Across The Value Chain

CQ’s Compliant Management solution also enables the following:

  • Analytics and dashboards that provide data visibility without compromising on security

  • Automation of change management processes that flow through the organization

  • Risk Management to mitigate risks associated with similar complaints in the future

  • A data-driven approach to complaint management, with a deep focus on gathering customer feedback and insights, is crucial. ComplianceQuest’s solution is designed to do just that. Our customer dashboard helps track key metrics, including data on the volume of complaints, type of complaints, the root cause of similar complaints.

If you’d like to see the demo of our solutions, schedule one here: http://www.compliancequest.com/online-demo/

For a detailed list of features in ComplianceQuest’s Complaints Management Solution, visit here: http://www.compliancequest.com/complaint-management-system/

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