【中文翻译05】ISPE 良好实践指南：制药行业的知识管理

While the previous sections in this chapter have highlighted the expectation to manage knowledge as part of an effective PQS, effectively managing knowledge leads to a number of additional benefits with broad business impact. This section briefly introduces some of these benefits, including operational excellence and business continuity.

A key underlying concept is that the pharmaceutical industry is a knowledge industry, as characterized by its extensive use of technology and a highly educated and highly skilled workforce. Companies compete on their ability to leverage what they know to invent, develop, and manufacture highly complex products. Further, the employees of the industry are for most part knowledge workers, expected to use knowledge in their day-to-day activities rather than complete purely repetitive and transactional tasks.

As with the pursuit of operational excellence, KM can improve the efficiency and effectiveness of business operations.

Take for example the pervasive waste and inefficiency in the ability of knowledge workers to find the knowledge they seek to do their jobs. It has been reported that Fortune 500 companies lose roughly $31.5 billion (26.07 €) a year by failing to share knowledge [15, 16]. An IDC study [17] found:

• “Knowledge workers spend from 15% to 35% of their time searching for information.
• Searchers are successful in finding what they seek 50% of the time or less, according to both Web search engines and our own surveys.”
• “Only 21% of [survey] respondents said they found the information they needed 85% to 100% of the time.
• 40% of corporate users reported that they can not find the information they need to do their jobs on their intranets.”

These striking figures present a tremendous efficiency opportunity for those who can effectively remove the waste and inefficiency (and likely frustration) in finding knowledge, for which KM can play a central role. When employees have the knowledge they seek when and where they need it, informed decisions can be made in less time.

Another example of the effectiveness of KM is in the power of reflection as a means for efficiency continual improvement. Teams who pause and reflect on how they did their work and build these improvements into future work perform on average 20% better than those who do not [18]. This is the focus of KM approaches such as lessons learned (see Appendix 6), which aim to operationalize such opportunities.

A common issue is the need to retain knowledge essential for business continuity, to navigate highly complex products, and/or ensure the sustainability of product quality. Proactive measures are essential to avoid knowledge loss and the ensuing consequences.

In today’s pharmaceutical industry environment, for example, increasing numbers of novel therapies are developed in small start-up companies subsequently acquired by larger companies. This is often the point of greatest danger for knowledge loss.

During the start-up period, a typical small company may operate in a very lean manner, with relatively rudimentary Quality and KM systems in place. Once acquired, key founding personnel may depart the new entity and subsequent efforts to retain or recreate the why and what of the foundational product and process knowledge can become extremely difficult.

The strategic focus is often on the acquisition of the products and not on the knowledge about the products. In the absence of such knowledge, future understanding about the impact of changes on process or product quality can become problematic. The challenge may well be as simple as the start-up employing only fit for purpose processes with no intention, or desire, to consider the long-term commercial viability of the process. Arguably this is especially true for the highly complex therapies emerging in the industry. Research [19] shows that:
“[the] dilemma of knowledge loss [italics in original] is not specific to the biopharmaceutical sector; however, there may be a false sense of security regarding the ability to recreate such knowledge within the sector due to the traditional focus on retention of regulated data, records, and information. However, ‘know-how’ often provides the key necessary to unlock the critical knowledge from within these retained records. Without the ‘know-how’, retained data and information may never progress up the hierarchy to be converted into useful knowledge. Therefore, in the biopharmaceutical sector it is important that knowledge retention strategies should never be mistaken for record retention policies and procedures.” [19]

Another common scenario faced by the industry is the retirement of highly tenured and experienced staff, whom all too often are the singular go to person based on their experience (with product histories, relationships with suppliers, know-how for a specific process, etc.). These employee transitions pose risks to business continuity and can be addressed in a proactive manner.

There are a range of knowledge retention techniques that can be employed via KM tools and processes, including:

• Systematic Lessons Learned processes
• Formal reports at milestones that review how key knowledge about the product has evolved, e.g., technology transfer reports or Product Quality Reviews (PQRs)
• Creation of Communities of Practice, which review how results are achieved in specific areas
• Content management guidance for knowledge created in functional groups (inclusive of non-GxP technical content and business process content)
• Facilitated knowledge transfer risk assessments and interviews
  Although these concepts are straightforward, they have not been widely adopted, as discussed in the 2020 publication “Knowledge Management Implementation: A Survey of the Biopharmaceutical Industry ISPE KM Survey.” [6]