Bernard Jee, Product Manager, Pilgrim Quality Solutions

Nobody likes to hear complaints. When we do, our basic human instinct is to withdraw into our shell and stop listening. Unfortunately, in Life Sciences, ignoring a Complaint can be a matter of life and death. And within any industry, the most expensive defect is a complaint from your customer. For this reason, ongoing communication flow is critical.

Once a product has left your warehouse and lands in the hands of your customer, there is no way to get it back into your own hands unless you conduct a massive, expensive, and brand-tarnishing recall. But this worst case scenario can be avoided with a solid feedback system that delivers critical input from your customer and allows you to respond to that input. This system is often referred to as a Complaint Management system. But notice I used the term ‘feedback’ instead. The word “complaint” carries a strong connotation and a negative tone, but “feedback,” while sometimes negative, is frequently neutral or even positive in content.

All feedback is good feedback when it comes to quality

Consider your own organization. The engineers and designers have logged hours and hours of research and testing to produce a product that they believe is the best and is critical to human health. Lab technicians have conducted required testing and clinical trials, and the regulatory bodies have approved your product. But the real test of how well your product performs is conducted at the hands of your customers, where it is frequently used daily. Feedback, whether positive or negative, is inevitable.

The ultimate definition of quality is whether a product meets customer needs. Therefore, it is to your benefit to make the feedback process as straightforward as possible. Treat each customer complaint as a measure of how well your company is doing in terms of overall quality.

Complaint data is empowering data

Let’s trace the journey of a common medical device. How an engineer designs a product to be used can be different than how a surgeon would use the device. A surgeon may hold the device in a particular manner which the engineer never theorized. It is natural then, when a surgeon uses the device, they will not like a certain area of the product because it doesn’t work the way they want it to, and hence, will initiate feedback to you on a perceived design flaw.

This brings up a number of questions:

• How do you capture this feedback?
• How do you determine if it is valid feedback?
• How does this compare with feedback you’ve received from others?
• When do you know it’s time to make a change to the product?

You will have to run through all possible scenarios. An overwhelming task. How do you even know where to begin?

Captured findings drive continuous improvement

You need a feedback handling system that will guide you in capturing all the data you need. Yes, you may have your process, procedure, and paper-based forms to do this, but are you capturing meaningful data? Data is the most valuable tool these days — it separates fact from fiction. It provides information that you can actually act upon, and not just what you think you should act upon.

Data captured by your Quality Management System (QMS) such as failure modes and root causes can be merged with data from other systems such as your CRM, or your ERP can alert you to trends occurring in a particular region for a particular product. These alerts can help you take early action to curb something major from happening going forward. Or they can allow you to rest assured that action need not be taken for a low-risk or low-volume trend.

A consistent method of case intake, determination/assessment, and investigation is critical in achieving this. With older, paper-based systems, risks of corrupt data are high. Paper-based forms can be lost, and data captured in those forms has to be manually transposed to electronic format to create a chart, for example using Microsoft Excel.

Reliable business intelligence supports regulatory compliance

Data that is stored in a database can be extracted through automation and analyzed by a business intelligence software tool at or near real time, providing you with insight to make important business decisions at critical junctures. Of course, whether manual or electronic, the validity of data can always be challenged; however, with a trusted QMS and business intelligence platform, challenges can be easily defended.

To help you with harvesting the massive amount of data, you will need a powerful QMS solution such as Pilgrim’s SmartSolve^® with built-in analytical capabilities from TIBCO Spotfire®, which provides feedback on the captured meaningful data. You know the saying: Garbage in. Garbage out. A lot of systems will help you capture the customer complaint and fulfill regulatory obligations, but be sure to identify a comprehensive system that will help you capture meaningful data, fulfill regulatory obligations, and harvest your data to maintain the health of your brand.

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