Those who possess knowledge have traditionally been respected in society. We know who these fonts of knowledge were because they were well-respected people—great authors, outstanding teachers and valued mentors.
But we need to understand the nature of the knowledge held by these leaders. Is it just an accumulation of data? No! Allow me to use two books about Hawaii as an example. Fodor’s series of travel guides includes a book on Hawaii that is an accumulation of data that many tourists find useful—listings of restaurants, hotels, maps and sights of interest. James A. Michener wrote a novel on Hawaii that is a true book of knowledge, beginning with how the Hawaiian Islands were formed, describing how the culture evolved and the impact of significant events in the life of its people. This novel was regarded as enhancing business and travel to Hawaii.
The PDA Task Force on Knowledge Management is developing a technical report to define data, information and knowledge, and discuss the role of knowledge in our industry. Knowledge management, after all, is one of the key enablers of ICH Q10 (the other being Quality Risk Management, or QRM). Knowledge management is an enhancement of the culmination of all data that we, as an industry, are very good at collecting. When we add context to the data it becomes knowledge.
The 2014 PDA Knowledge Management Workshop held last May was a key part of the effort. The workshop served as a means to learn what others in the industry are doing about this enabler. In addition, we reached beyond the pharma/biopharma industry to gain insight from NASA and the American Productivity & Quality Center, or APQC.
Naturally, knowledge management goes hand-in-hand with QRM, as Stephan Rönninger, PhD, Head External Relations Europe, Amgen, explained at the workshop. Without knowledge of your process, a risk assessment cannot provide a basis for decision making. Decision makers in a site look to various departments within their organization for information. They look to the accountants for financial data. They look to the quality group to see how they are performing. Finally, they look to their operations people to tell them whether or not they’re meeting customers’ needs. These are very basic knowledge needs; however, management might benefit from better visibility of what constitutes the processes and systems, and how they are directly controlled. They do not deserve to be caught unaware when a drug shortage occurs, for example, because a batch is rejected. Knowledge management used as a tool gives management the ability to understand and disseminate information needed to carry out responsibilities properly.
Other presenters at the workshop provided additional keen insights on not only what knowledge is, but also its value when gathered properly.
Keynote Presenter, Justin Neway, PhD, Vice President and Chief Science Officer, ADQM Solutions, Dassault, described the Knowledge Pyramid, where there is an abundance of data at the base of the pyramid, which has the least value. As it becomes information, it gains value and you can act on it, and then finally it becomes knowledge.
For knowledge to be effective, it is important to accumulate it, make it accessible, and disseminate it at every teachable moment. It is the level of knowledge gained, not the volume of data, that is important. Process Knowledge consists of two major parts—Process Reliability and Process Robustness. Individual users need to have self-service, no obstacle access to the data they need. Reconcile self-service with the teachable moment to involve tacit knowledge. Multiple systems store data differently. Consequently, an additional tool is needed to integrate and contextualize the data.
David Reifsnyder, PhD, Head of Biologics Process Validation, Global Biologics, Genentech, discussed the platform approach process based on knowledge management in place at Genentech. The basis for the platform is a Product History File, which contains the registration information, QRM, Development Report, Annual Product Quality Review among others. This approach uses viral validation as an example since it follows the same manufacturing process including types of resin and washing steps.
Eda Ross-Montgomery, PhD, Senior Director, Technical Steward, Shire Pharmaceutical, described how knowledge management is regarded as a journey, not a destination. This is important to consider when working with a CMO. Her company treats CMOs as if part of the company.
DSM Greenville, now part of Patheon, is one of those CMOs for Shire. The Monthly Product Technical Dashboard is uniform across the Shire network, including reports on CMOs. A Monitoring Plan, uniform for each platform, is used to collect information.
Paige Kane, Director, PGS Knowledge Management at Pfizer, said that there is more knowledge within our organization than we could buy. Pfizer utilizes its KM Portal, which preserves, manages and exploits all available Product and Process Knowledge. Within the portals are structures, called Pillars, that:
- Connect people to people
- Connect people to content
- Retain knowledge
- Transform data
The tool used is commercially available. To be used throughout the organization, a tool must be seen as to have a value—“What’s in it for me?,” as well as being user friendly.
For a nonpharma perspective, Edward Hoffman, PhD, Chief Knowledge Officer and APPEL Director at NASA asked, “What is the catalyst for major change?” His answer: “A crisis.” The number one issue for knowledge management is the difficulty in finding the documents needed. The value belongs to those who can “find” answers. He asked if success is considered networking on finding solutions, that begs the question, is learning occurring? Hoffman explained that NASA’s solution entailed establishing a community, operated on a federated model as a people-centric organization. The website for this community is km.nasa.gov.
Knowledge management entails finding the right information and applying it at the right time to form a solution, shared Cindy Hubert, Executive Director, APQC, who also recommended managing explicit knowledge differently from tacit knowledge.
“We really don’t manage knowledge,” she said. “We manage the flow.”
Providing a European perspective, Tor Graberg, Chief Pharmaceutical Inspector, Swedish Product Agency, and former PIC/S President, outlined three key points: trust, collaboration and communication. He recommended always using the ICH Q10 definition of knowledge management (see EU-GMP Part III). An effective knowledge management process maintains the state of control and facilitates continuous improvement. As an inspector, he is often asked how will knowledge management be inspected? His usual response is that inspectors are not looking to examine the formal system, however, they do expect that knowledge from different processes and systems will be appropriately used.
The task force will continue its work, anticipating that our next deliverable will be a detailed proceeding from this workshop to make the learnings sustainable. Look for those proceeding to come mid-year in 2015 and be published in the PDA Journal of Pharmaceutical Science and Technology!
The author would like to thank Stephan Rönninger of Amgen for his assistance in preparing this article.
About the Author
Chris Smalley, PhD, is responsible for innovative processes and biotechnology implementation and validation and single-use systems worldwide in the vaccine and pharmaceutical businesses at Merck.