【中文翻译03】ISPE 良好实践指南：制药行业的知识管理

ICH Q10 [4] defines Knowledge Management as:
“Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. Sources of knowledge include, but are not limited to prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management [italics in original] activities.”

The focus of this ICH Q10 [4] definition is on documented knowledge. A more holistic definition comes from APQC 1 [9]:
“The application of a structured process to help information and knowledge flow to the right people at the right time so they can act more efficiently and effectively to find, understand, share, and use knowledge to create value.”

This definition is commonly used by KM practitioners because it embraces the two main aspects of KM: the needs of the knowledge user and the needs of managing knowledge within an organization.

A useful thought model when considering the role of KM in organizations is that of knowledge and knowledge recognition. Figure 1.1, depicts whether an organization possesses the knowledge (i.e., does the knowledge exist) versus knowledge recognition (i.e., are we aware it exists). While this may seem relatively simple at an individual level, it is much more complex at an organizational level across many people, functional areas, products, processes, etc.

• Arguably the most central role of KM begins with ensuring effective management of Box 1 in Figure 1.1, described as Facts (inclusive of tacit knowledge). We know what we know and can find this knowledge when and where needed. An example of this is applying prior knowledge at the start of development of a new product.

• Box 2 in Figure 1.1, described as Questions, represents instances where we are aware we do not have sufficient knowledge. Experimentation is directed to answer such questions and grow the body of knowledge. Risk management also plays a role in how risks associated with unknowns are managed. As these questions are answered, this knowledge should be managed effectively henceforth, including what did not work or other unanticipated learnings (in Box 1).

• Box 3 in Figure 1.1, described as Unaware, represents untapped potential and knowledge loss within an organization, such as when expertise exists in an organization to solve a problem, but the connection is never made, or knowledge is lost due to the departure of key personnel or during transfers between different teams in a product’s lifecycle. Tacit KM techniques such as lessons learned, communities of practice, tacit knowledge retention and transfer processes can play a key role in creating dialog that can lead to new insights. This knowledge should be codified and shared as appropriate (and therefore in Box 1). An effective systematic KM program within an organization’s PQS is a key administrative tool to help minimize such knowledge loss and maximize knowledge awareness.

• Box 4 in Figure 1.1, described as Exploration, represents the opportunity for ongoing learning and knowledge acquisition whether intentional (experimentation or other directed recognition efforts) or unintentional (investigations resulting from process deviations). This new knowledge may lead to new Questions and new Facts and should be managed appropriately.

Explicit Knowledge: A declarative type of knowledge that can be readily articulated (in words or images), coded, stored, and accessed.

Tacit Knowledge: A context-specific type of knowledge, acquired through personal experience or internalization that resides within people’s minds rather than any physical media or information system. Often referred to as know-how.

An important theme throughout this Guide is the emphasis on tacit knowledge. Given the regulated and document-centric nature of the pharmaceutical industry, the importance and impact of tacit knowledge is arguably underappreciated. This Guide aims to highlight this, and where appropriate, provide KM methods and tools to better recognize, capture, transfer, and apply tacit knowledge.

Explicit and tacit knowledge are explored further in Section 3.2.

Principles and additional key concepts for KM are discussed in Chapter 3.

Knowledge Management Methods and Tools: Structured and standardized solutions to facilitate effective knowledge management. Also known as KM approaches, capabilities, or practices.

Knowledge Workers: Workers who think for a living and use expertise, education, and experience to solve work problems through the creation, distribution, or application of knowledge. The pharmaceutical industry is considered a knowledge industry and as such, its workforce is comprised of knowledge workers.

Lessons Learned: The concept of Lessons Learned is often referred to as After Action Review. This Guide treats them as synonymous and will refer to the activity as Lessons Learned.