2012
Always On: 24/7 Quality
by Elena Acri-Kalbach
"Mommy, why is the lot code smeared on the bottom of this bottle?” asked my 7-year-old son, Gabriel. That’s right—I go shopping with a 7-year-old who knows what a lot code is.
“Gabe, perhaps there was a problem on the packaging line that caused the smeared but legible lot code,” I replied. “And no, Mommy’s work didn’t produce that product. Look at the lot coding, son.”
As you can guess from that exchange, a trip to the local pharmacy or supermarket is not a quick one. I am a vice president of quality assurance and regulatory affairs at Accupac Inc., a contract manufacturer of over-the-counter and cosmetic liquids. And I can’t seem to turn my job off after walking out of the office doors.
I started my career at Wyeth, working in environmental monitoring. It was my first job after graduating with a bachelor’s degree in microbiology. Although I worked second shift, I was glad to have a steady income and full benefits at a large pharmaceutical company. It was the perfect job for someone with a type A personality (although I tried to disguise it as a type B). My favorite part was being the microbiology police and having the authority to shut down the filling room if needed.
I enjoyed the black and white environment of Class 100 life, learning and applying my current good manufacturing practices (cGMPs). Unfortunately, cGMPs were not taught in college. As a matter of fact, many of the positions I was looking at as a microbiologist required cGMP experience. At the time, I didn’t realize four little letters could mean so much.
I eventually left Wyeth for SmithKline Beecham (now Glaxo-SmithKline) and another microbiologist role, then into the wonderful world of quality assurance in the biopharmaceutical manufacturing division. It was a welcomed change from the laboratory, and I was still able to apply the cGMP principles I learned along the way. I became obsessed (an understatement) with auditing. You name it, I wanted to audit it. Internal audits, vendor audits, service provider audits—there was no end to the fun.
I started working toward a master’s degree in quality assurance and regulatory affairs, and the first class I took was called Quality Audit. I just couldn’t get enough information on the various methods and techniques of auditing. ASQ’s Quality Audit Handbook was my exciting bedtime reading, with the goal of taking the certified quality auditor exam. I took the exam and passed. A few years later, I took and passed ASQ’s certified manager of quality/organizational excellence. Hooray!
Ultimately, I wanted everyone to share my zeal for fact finding and improving the quality systems we had in place. I can’t say everyone had the same passion, especially the operations/production department. Actually, the raw material vendors I visited weren’t too happy after I left either. But really, I’m just trying to help!
Fast forward to Accupac. Since the beginning of my career, I have been in a contract manufacturing environment. Typically, the number of customers was small, and corporate policy prevailed. However, at Accupac, we have about 12 different customers, some of them large pharmaceutical companies.
As far as quality systems are concerned, we operate under one umbrella but occasionally are challenged to mold our systems to a specific customer’s corporate requirements. Typically, it’s not that difficult a conversation to have, and many times I am able to see a different point of view on how to apply cGMPs. It is constantly a learning experience that, as a quality sponge, I am more than eager to soak up.
As a mother, I strive to have my children understand what I do when I’m at the office for the day (and sometimes evenings as well). I firmly believe it will help them develop a healthy appreciation for the importance of a strong work ethic. When my kids and I are at the store, I’ll walk down the aisle and point to products that “Mommy’s work” produced.
My daughter, Lanie, is too young to pick up on the game I have with my son. That is, the game of on-the-shelf quality. He looks at numerous products, sometimes taking quite a while, and tries to find things wrong. We’ve been doing this for about two years, and, for a 7-year-old, the types of defects he finds absolutely amaze me.
You don’t have to work in quality to appreciate good products on the shelves. Just ask my son. When he is old enough, maybe he can spend his summers as a quality control inspector and have the same passion sparked. His mom would be so proud to see her son follow in her footsteps.
ELENA ACRI-KALBACH is a vice president, quality assurance and regulatory affairs for Accupac Inc. in Mainland, PA. She has a master’s degree in quality assurance and regulatory affairs from Temple University in Fort Washington, PA. Acri-Kalbach is a senior member of ASQ and is a certified quality auditor and manager of quality/organizational excellence.
