If we do not implement knowledge management in the pharmaceutical industry, do we still meet GMP requirements? Who is expected to bear the responsibility for knowledge management? Are authorities already calling for established processes? What is the best way to meet the requirements of ICH Q 8-11?
These questions were the subject of a workshop on quality risk management (QRM) and knowledge management (KM) that was held on 19-20 May in Bethesda (USA). The PDA PCMO Task Force on Knowledge Management in Manufacturing initiated this event, which most likely marks the start of global dialogue in this field.
For the first time, representatives of the pharmaceutical industry presenting their latest concepts were joined by participants from NASA (1), und APQC (2), who in turn contributed their experiences for a cross-industry discussion. The spectrum of topics ranged from IT tools to managing change processes within an organisation.
The first session was devoted to the principles of knowledge management. The knowledge pyramid was used to explain how to advance from data to knowledge.
It is also vitally important to distinguish between explicit and implicit knowledge. The knowledge depots of organisations can only store explicit knowledge. Therefore, it is imperative to pursue the question of how to retrieve implicit knowledge from the depths of the subconscious and convert it to explicit knowledge, making it available to fellow employees within the company.
(1) National Aeronautics and Space Administration
(2) American Productivity and Quality Center
The practical examples were contributed by David Reifsnyder, Genentech, and Joe Brennan and Paige Kane, Pfizer. Not only did they present technical IT solutions in these examples. The integration into a lifecycle model was also demonstrated. Mastery of the global supply chain has been a major driver of implementation at Pfizer. Here it is especially important to support changes and improve flexibility within the company.
Pfizer introduced an IT tool based on SharePoint that is primarily intended to improve communication among employees. However, this is not in any way meant to replace established document management systems in the quality sector. That would be impossible anyway since the system has not been validated. It was intentionally established outside of the Quality Department, even though it does access quality and GMP documents for informational purposes.
It is important here as well to stress that this system is intended to support the conversion of implicit to explicit knowledge. Quick access to information from different sources should also be available for problem solving.
Edward Hoffmann of NASA and Cindy Hubert from the APQC made a very important contribution (3) in their presentation of a clear picture of other branches of industry. They placed their emphasis squarely on the process of cultural change instead of dealing in any way with IT systems.
(3) the American Productivity and Quality Center
As CKO (Chief Knowledge Officer), Edward Hoffmann is Head of Knowledge Management at NASA. It is important to him that the significance of knowledge management not be deemed a function of the size of his department. Instead, he sees himself as a service provider within the agency to foster current projects by sharing existing knowledge and experience. He stressed the fact that his department is made up of only a few people, even though it supports a work force of 17,000. Moreover, initiating knowledge management is not a matter of resources, but rather it depends on the willpower within the organisation to create a culture of shared knowledge.
In her capacity as consultant, Cindy Hubert has accompanied many businesses implementing knowledge management. She, too, placed heavy emphasis on the aspect of changing behaviour patterns in employees. She introduced a model with which it is possible to define the maturity level of knowledge management within the company.
As a non-profit organisation the APQC makes know-how available particularly to member organisations, including some pharmaceutical companies. To establish knowledge management in a company on a long-term basis, it is advisable to abandon the notion that implementing an IT tool alone would serve the purpose. Ms. Hubert also stressed the fact that staff members would only go along if they could expect short-term improvements for themselves. In a nutshell: “What`s in it for me?”
Anyone unable to answer this question will have a hard time with implementation, says Cindy Hubert.
In the final session Tor Graberg of the Swedish GMP supervisory authority and Stephan Rönninger, Amgen, explained the requirements of the authorities and the ICH. The ICH triggered the debate on knowledge management with publication of the ICH Q10 in 2008. As a representative of the EFPIA and ICH, Stephan Rönninger talked about these requirements and expectations. Taking risk management in ICH Q9 as an example, he showed that risk management would be hard to implement without the structures of knowledge management.
Tor Graberg made it clear that the terms trust, collaboration and communication are inseparably intertwined with knowledge management. It is not new requirements or standard procedures that the authorities wish to set up. What they do want, however, is to heighten awareness of the fact that the pharmaceutical industry will not master future challenges without appropriate knowledge management.
Since the event was conceived as a workshop, six discussion groups were worked into the agenda. In many hours of work they developed a fundamental understanding based on the talks presented. The topics ranged from IT tools to following organisational changes in companies. The necessity of cultural change and raising levels of awareness became apparent in the course of many discussions. It was a very open exchange and the participants returned to their various companies with a great deal of knowledge to share with their fellow employees.
The workshop as a whole was a great success and the Task Force Knowledge Management in Manufacturing Organisations gained much insight that will be useful for upcoming work. It will be exciting to see how this subject continues to develop.
Maas & Peither AG, GMP Publishing