I was first asked to be a workshop leader for the Quality Manufacturing Conference this past June, I accepted thinking my workshop assignment would be directly related to my professional field of architecture. Instead, I was completely out of my comfort zone as I helped guide the Facility and Lifecycle Quality Management Workshops—assisted by a team of “true” experts in the field, thank goodness!
I fully expected to learn more about an area of the manufacturing process of which I had only a cursory knowledge. By the end of the two-day conference, however, I had two other unexpected learnings for which I could see parallels in my sphere of influence.
First, multiple attendees noted that a “supportive management culture” is critical to finding true root causes to errors. If the goal is to always find a person to blame, I realized, then the truth will always be difficult to find. A supportive culture allows for a team approach to discovery and learning rather than avoiding what is true to evade any repercussions. This is also a reality when dealing with facility design and construction. A collaborative and mutually supportive team always provides improved results.
My second takeaway was discovering that knowledge transfer of consequences to operators is critical. In my world, “operators” would be the equivalent of design architects and engineers, but in both spheres, these are the people on the front line of effort. Their day-to-day responsibilities can have an enormous influence on product outcome—patient safety in the biopharma world. Ensuring that potential process consequences are effectively communicated was a discussion theme that emerged repeatedly.
The Quality Manufacturing Conference was a unique experience for me. The workshop format created two days of energetic discussions while I gained a deeper understanding of what quality management entails. Many of the conference attendees I spoke to also told me they had gained new ideas and perspectives that they can incorporate in their organization’s quality approach.
Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los Angeles, one in Boston, and one in In-dianapolis.
The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.