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The QA Pharm

FDA Compliance

A Cure for Customer-Activated Tone Deafness

The best-of-the-best companies have complete transparency to customer complaints at the most senior level

Published: Thursday, October 7, 2010 - 05:30

We hear much about the importance of listening to customers and meeting their needs. Lean Six Sigma devotees say that metrics from the customer’s vantage point are at the center of their philosophy.

Many pharmaceutical companies embed their high view of the professional community and patients into company credos or mission statements. I’ve also heard of some companies that appoint team members whose sole role is to bring the “voice of the customer” into key discussions.

In the pharma industry we have built-in scientific processes that formally connect us with the patients and medical community we serve. For example, clinical research studies the patient outcome when deciding the strength, formulation, dosage form, and frequency of administration, etc.

Other technical processes such as process development, technology transfer, and validation also support the patient with well-developed and consistent processes that ensure continuous supply of quality product.

Done well, these customer-connecting processes are proactive and early in the “customer fulfillment” cycle. Put in the lingo: it’s quality by design, or intentionally meeting customer needs, which—speaking of design and intent—are what the Food and Drug Administration (FDA) regulatory requirements had in mind. Safety, efficacy, potency, purity, quality—it’s all from the patient’s perspective. Right?

Unfortunately, it’s not until the product is actually used over long periods that data are sufficiently amassed to tell us how well customer satisfaction has been achieved. There are also instances where customer feedback is nearly instantaneous that tell us that a problem got out the door, and FDA regulatory requirements tell us to listen and fix the problem.

This is where some in our industry are just plain tone deaf.

Just when I thought the prize went to a company that recently wanted to change the color specification on a cream product to “tan to slight brown on storage” in response to 30 customer complaints for discolored product, there came along another company that logged 570 customer complaints for a drug delivery patch that wouldn’t stick. Yet another company had a smoke-and-mirror complaint trend algorithm over rolling time periods that had to be met before the customer complaint was taken seriously and investigated.

Needless to say, the FDA took exception to the way these companies handled customer complaints. The agency took a warning letter to prompt each to rethink how they’re treating their customers.

The good news—there really, really is a cure for customer-activated tone deafness: Caring.

The best-of-the-best companies have complete transparency to customer complaints at the most senior level. Well-designed metrics are presented to a panel of top functional heads that includes quality, regulatory, medical, manufacturing, technical service, and marketing. Some companies have a “listening booth” where anyone in the company can hear the conversation between their 1-800-number callers and the call center. They want to actively listen to the customer and make effective decisions—because they care.

And when the serious and unexpected occurs, they own up to their responsibility and report it and recall product, if necessary. They don’t have to be told during an inspection that they failed to file a field alert—because they care.

So when it comes to our customers—patients, doctors, and nurses—let’s be sure our auditory acuity is operating at peak performance, as well as our manufacturing operations and the quality management systems that uphold them.

As the truckers say over their two-way radios, “10-4 good buddy. Got yer ears on?”


About The Author

The QA Pharm’s picture

The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).