Issue link: https://www.e-digitaleditions.com/i/1300450
www.biopharminternational.com October 2020 BioPharm International eBook 51 said that we were going to estimate it right there. Everyone groaned. They knew we'd be there forever. "No," I said, "We don't need to be com- pletely accurate in order to get this done. What we will do, though, is to include all the costs, whether they show up on a cost report, or not." Normally these kinds of cost anal- yses would be done with accoun- tants. They would pore over every last decimal point, then present management with a professional looking print-out that would proba- bly get filed somewhere. Our "cost analysis" wasn't very accurate. We did it in small groups in a conference room. Some gathered at the whiteboard; some hunched over scraps of paper. It didn't take nearly as long as everyone feared. That was the good news. The bad news was that it didn't need to be very accu- rate. It told a gruesome story. What we found out was that the visible costs were just the tip of the iceberg. The real costs don't show up as identifiable lines on a cost report. If a batch fails a specifica- tion, of course the cost of rework or scrap will appear in your cost center report. But what about the cost of the following activities: • Purchasing agents trying to locate replacement raw materi- als so you can rush through a new batch? • Sales reps placating customers whose shipments are delayed. • Sales reps trying to find new customers because your old ones finally gave up on you? • Logistics trying to deal with all the 'just-in-case' inventory that you have to store because your manufacturing process is so unreliable? • Chasing down batch records to get blanks and other good documentation practice (GDP) errors corrected so we could ship product? Add the compliance and legal lia- bility risk. Everyone was horrified. I had accomplished my purpose. Not only had we identified the problem and its scope, but forc- ing everyone to crank the numbers had convinced all of us that our problem was widespread, and deep. In other words, there would be no quick fix. The problem was our culture. The enemy was us. What this exercise had done, though, was unify us. If we did nothing, nothing would ever change. And, there was enough money at stake to justify a substantial effort. How to fix it? It was clear that for me to harp on the supervisors to supervise more closely would never work. They were already up to their necks in investigations and corrective actions. The depression that was seeping into the manage- ment staff was palpable. FINDING A SOLUTION I tried giving pep talks to the troops. Guess what. I'm no Winston Churchill. The operators and main- tenance techs were all mystified why the plant manager would stand in front of everyone and make such a fool out of himself. If you're a manager in a pharmaceutical envi- ronment, I'd guess that you're no Churchill either. I realized that I needed to find a solution to our culture problem that makes use of my skill set, which lies more in the realm of analytical administration than being a charis- matic leader. The first task I set for myself was to figure out what culture is and define it in a useful way. FDA has focused on quality cul- t ure (1), and the industr y has responded (2). But, we are still trying to understand how to create a strong quality culture in the real world. In Juran's Quality Handbook, Frank Gryna defined quality culture as, "A culture throughout the organization that continually views quality as a Regulatory Sourcebook Quality: Viewpoint For years, FDA has urged biopharmaceutical manu- facturing firms to adopt advanced manufacturing pro- cesses and proposed the use of quality metrics to doc- ument quality practices to improve quality and reduce regulatory oversight. To date, pharma companies have resisted quality metrics and quality ranking programs, citing the need to protect proprietary information. The COVID-19 pandemic and subsequent travel restrictions prompted FDA to rely on past inspection reports, product recall information, customer complaints, sample testing, and social media to assess compliance. The pandemic has also opened discussion about increasing domestic production of medical products and reducing the regulatory burden on companies through real-time assessments of drug quality. An article, "Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?" examines recent strategy proposals by FDA to promote modern manufacturing systems with a focus on data demonstrating quality achievements. It also examines FDA efforts to advance quality metrics initiatives, soliciting industry input, and visiting manufacturing facilities to see how quality metrics are used within the companies to measure quality. Read the article on www.BioPharmInternational.com. —The editors of BioPharm International Pandemic-Inspired Quality Metrics Requirements?