Monday, 7 July 2014

QMS ESSENTIALS (Part IV)





This article is the fourth installment of a six-part series (I, II & III) on common business challenges and the quality management system (QMS) tools (e.g., corrective action, document control) that can help alleviate those challenges. In this article we'll discuss something that affects all industries at some point or another—the complaint.


The Challenge: Manual Processes Drain Efficiency

Incoming complaints often signal that the time for a change has come. Oftentimes when companies address complaints an Excel spreadsheet is used for manually entering and updating relevant data and tracking these complaints. However, this method is prone to human error that can cause the following results:
  • Double entry of data. Without automation you may find yourself having to input the same data more than once, which is time-consuming and inefficient.
  • Lack of visibility. Manual spreadsheets make it more difficult to derive trends from complaints that are received in separate departments, simply because you don’t have access to all of the information.
  • Recurring adverse events. Without visibility and access to all information regarding adverse events, you lose the ability to be proactive in helping to stop adverse events before they occur. You also increase the chance of post-market incidents.
  • Prioritization of adverse events. Oftentimes adverse event information is prioritized by the date you receive the information. The key is discerning which events are the most critical. Without some systematic measure to categorize and prioritize these events, you may be missing key, high-risk events. Leveraging risk-based tools, you can build quantitative measures to filter events by their risk. That way, you are addressing the most high-risk events first and taking action on systemic issues that have an impact on the business.

The result of the above is excessive waste and hard-to-manage complaints. Eventually, you will take up excessive time and resources and will be left with information in separate silos due to disparate processes that have hindered communication. Over time, this could lead to an overload of adverse events that become more difficult to manage, resulting in a more time-consuming process for handling complaints.


The Answer: An Automated Approach

There are software solutions that automate customer feedback and enable you to address complaints quickly and effectively while simplifying the related processes such as reporting and corrective action. An automated process for handling incoming complaints increases visibility into the trends in adverse events so you can more easily uncover systemic issues from one site to the next throughout your enterprise, regardless of location. You will also have greater visibility into other processes associated with complaint handling.

In addition, complaints must be handled in compliance with regulatory guidelines. If your process records complaints including all of the information about the customers and products, you will ensure that complaints are managed by level of severity, not just in the order in which they were received.

What does all of this mean for your organization?

It means greater control over the outcome of adverse events from discovery, to correction, and finally, resolution. You will reduce the time it takes to resolve these adverse events, which will reduce the chances of having to resolve post market issues later. You will also help prevent adverse events from recurring. And the need for double entry of data will be completely eliminated, resulting in a faster and more intuitive process for your organization.

You will also benefit from risk histories that will be applied to each product, resulting in a risk portfolio for all products. This can be viewed in a report that will show you which products pose too much of a risk, or need to be redesigned or even recalled. Using this report you can also identify trends across departments, which will provide insight into any systemic issues that you would not be able to see otherwise, providing you with the knowledge needed to proactively mitigate these unforeseen risks.


The Real-World Example

In this example, a life science organization faced the challenge of adapting quality and compliance processes within its global operation while maintaining compliance. The company lacked visibility due to its siloed and manual business processes that required a lot of time and resources to manage.

By switching to an automated complaint-handling process, this company was able to build commonality into its processes and integrate where necessary. In addition, they were able to filter adverse events by risk using a risk matrix tied to a decision tool. This allowed them to prioritize events by risk, and not by due date. As a result this company has experienced time savings, a faster corrective action process, fewer recurring mistakes, and greater visibility into events that occur across their global enterprise. They have reduced the chances of post market events and have greatly increased productivity. In fact, integrating all processes has enabled this company to reduce the time it takes them to manage complaints by more than 90 percent.

Sources: Quality Insider, Verse Solutions.



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