Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

Issue link: https://www.e-digitaleditions.com/i/1302985

Contents of this Issue

Navigation

Page 65 of 75

66 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Quality: Viewpoint professional looking print-out that would probably 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 accurate. 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 specification, of course the cost of rework or scrap will appear in your cost center report. But what about the cost of: • Purchasing agents trying to locate replacement raw materials to 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) er- rors corrected so we could ship product? Add to that the compliance and legal liability risk. Everyone was horrified. I had accomplished my purpose. Not only had we identified the problem and its scope, but forcing ev- eryone 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 investiga- tions and corrective actions. The depression that was seeping into the management staff was palpable. Finding a solution I tried giving pep talks to the troops. Guess what. I'm no Winston Churchill. The operators and mainte- nance 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 environment, I'd guess that you're no Churchill either. 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 charismatic 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 culture (1), and the in- dustry 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 organi- zation that continually views quality as a primary goal. It is the pattern—the emotional scenery—of human habits, beliefs, commitments, awareness, and behavior concerning quality" (3). The problem with this definition is that "beliefs", "commitments", and "awareness" are blurry concepts. What manager knows how to directly change the "be- liefs", "commitments", and "awareness" of their em- ployees? I needed a definition of quality culture that could be connected with actions that could be taken by management. I concluded that "habits" and "behaviors" would have to do; they were measurable.

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - October 2020 - PharmTech - Regulatory Sourcebook - October