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Richard DeRisio

Quality Insider

Effective Complaint Management Can Transform Business

Quality professionals can and should contribute to the process

Published: Tuesday, April 9, 2013 - 10:49

Editor’s note: Quality Digest will host Richard DeRisio’s webinar, “Effective Strategies for Complaint Handling” on April 16, 2013, at 2 p.m. Eastern. Register here. DeRisio will also be a guest on Quality Digest Live on Friday, April 12, 2013, at 11 a.m. Pacific.

FDA’s regulation for “complaint files,” 21 CFR 820.198, is virtually unchanged since it was originally published in 1976. With all these years to perfect the content of the required forms and procedures, why is the regulation, as of this month, the most frequently cited FDA 483 Inspectional Observation? The regulation continues its run as the first or second most common FDA citation for the past several years. 

It’s all about company culture and execution. The April 16, 2013, webinar, “Effective Strategies for Complaint Handling” takes the complaint handling process from just a regulatory requirement to a strategic process for reducing risk, increasing customer confidence, and improving business performance.

In my presentations I describe the six areas where effective complaint management can reduce risk for your company. Of course, the most important area is reducing the probability that a patient or user of your product might suffer harm. Another example involves reports of emerging product problems: ineffective complaint investigations and trending can result in a failure to detect defects that lead to recalls. As a result, companies can be blindsided by a business interruption that takes them off the market for months while competitors seize their market share.

Regardless of a manufacturer’s or service provider’s business or products, complaint management is a fundamental driver for improvement. Whether it’s preserving revenue on the top line or reducing cost of poor quality at the bottom line, effective complaint management can materially affect business outcomes.

For quality professionals and departments seeking top-management recognition for contributing to business success, complaint management is a great area to optimize and publicize. And beyond the business financials aspects, there is the fundamental potential for improvements in customer satisfaction that can be truly transformational.

My background is largely in medical devices; however, the principles, procedures, and practices translate readily into any business area. Complaint management provides quality professionals an opportunity for close contact with the customer. When we are innovative and effective in harvesting what the customers are telling us, we contribute to business performance in a significant way.

Unfortunately, some companies process complaints with the primary objective of doing just enough to dodge an inspection or audit citation. There is little focus on complaint management process improvement, and amazingly, too little on the simple fix to reduce the burden of investigating complaints: simply improve product quality and make complaints go away.

A key aspect of my upcoming webinar will be the lessons learned during a transformational change at a company I was involved with that dramatically improved our responsiveness to our customers. I will discuss how we reengineered complaint management and the organizational structure to establish a lean, high-performing process that not only gave us good quality data but also provided early “sentinel” alerts to emerging quality issues. This enabled us to take rapid remedial action. We drove any complaints involving injuries or unanticipated, serious malfunctions through a fast‑paced work stream that brought about rapid failure analysis and a quick initiation of corrective actions.

I will share information on how we designed risk reduction into our products and sustained the design risk levels through continuous monitoring and reporting across the entire product life cycle.

However, you won’t be able to effect change if you don’t have data that are timely and accurate. I will provide examples of complaint metrics that are both informative and actionable as a means for continuously improving product and process quality. Metrics that provide clear information regarding ongoing product performance can serve as alerts to emerging issues so that corrections can be implemented quickly in order to minimize risk.

There are so many ways that quality professionals can contribute to creating a world-class, customer-oriented complaint management powerhouse. Members of quality organizations support complaint management in several ways, including:
• Original and updated risk assessments
• Failure investigations and analysis
• Corrective and preventive actions to reduce complaints
• Application of statistical tools to trending
• Redesign of products and processes to improve performance
• Management of complaint-handling operations

I believe that this presentation will help identify ways that you can help your company make complaint management a centerpiece for customer satisfaction and continuous improvement.


About The Author

Richard DeRisio’s picture

Richard DeRisio

Richard DeRisio is Vice President, Medical Health Services, TÜV SÜD America. Prior to joining TÜV SÜD, Richard led global and divisional clinical, quality and regulatory organizations at Abbott, Covidien, Johnson & Johnson and Pfizer, among other companies. Richard also spent ten years in the U.S. Food & Drug Administration’s Washington, DC headquarters. Richard attended Cornell University where he received a B.S. degree in chemical engineering and an M.S. degree in food science and technology.


True that

Successful firms are transforming their customer complaints into business success through the use of centralized complaints management programs like a Complaint management system. Service excellence, customer responsiveness, and customer trust are key ingredients for retaining customer loyalty in the industry today.

who's complaint manager?

Certainly quality pros' can contribute to the process; whether they should, I'm quite perplexed. Because all too often the top management echo one of the most famous french kings, that is "la qualité c'est moi !" - I 'm the quality. Statistically speaking, how many complaints are positively responded to the consumers? And how many consumers trust their suppliers' complaint handling system? Thank you.