Knowledge Management

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Knowledge Management1,2

Knowledge management has a great future lying ahead of it. In contrast to other production factors, knowledge multiplies by use. Knowledge management can be applied in order to use knowledge in an optimal way, to further develop it and to implement it in new products, processes and business areas. Already existing quality management systems as they are used in the pharmaceutical industry are understood as precursor to knowledge management and may serve as a good starting point.

Field of Knowledge2,5

The field of knowledge consists of the following three dimensions: relevant data, relevant information and relevant knowledge. Relevant data are the basis of information. Relevant information is built from data which have been arranged in a meaningful pattern. The relevant information can be documented and is de-personalised. It can be further developed to relevant knowledge which creates the potential for taking actions and deciding.
Knowledge is interconnected and linked to persons. It can be understood as the result of staff members and information being woven into a context by personal contact and/or technology (see fig. 1).

Fig. 1: Knowledge formula.

Explicit and tacit Knowledge3,4

Knowledge is available as a function of form, time and location. A difference is made between explicit and tacit knowledge. Tacit knowledge is understood as the personal knowledge of a person. It is rooted in the actions and experiences of the individual. Tacit knowledge is difficult to formulate and it cannot be passed on to other persons easily. Explicit knowledge can be communicated. It is available in the form of media and is no longer only linked directly to persons. It can be recorded, transmitted and stored.

The transfer from tacit to explicit knowledge is understood to be the basic problem of knowledge management. If knowledge is available in the explicit form it can be used by other persons within an organisation. The organisational design and governance of knowledge creation is the task of knowledge management as can be seen in the SECI model. It divides the four forms of knowledge creation and transformation into socialisation, externalisation, internalisation, and combination. Socialisation is the direct exchange of tacit knowledge. This can take place by observing working procedures. In the case of externalisation the processing from tacit to explicit knowledge is paramount. Knowledge is documented. Internalisation is characterised by the absorption of explicit knowledge and its transformation into tacit knowledge. "Learning by doing" is a typical process for this. Combination includes the creation of explicit knowledge by combining already available explicit knowledge. Knowledge is then presented and made available in another form.

GMP meets Regulatory Affairs - Live Online Training


7/8 February 2023

GMP meets Regulatory Affairs - Live Online Training

Targets of Knowledge Management1,2,4

Knowledge management should be applied in order to use knowledge in an optimal way, to further develop it and to implement it in new products, processes and business areas. Knowledge should be increased in order to increase the company value. Knowledge management includes customers, suppliers and external knowledge holders. It comprises the tasks procurement, development, transfer, acquisition and further development of knowledge which are repeated in a sort of cycle. The cycle of knowledge is shown in fi g. 2.

Fig. 2: Cycle of knowledge.

Incentive Systems in Knowledge Management2,4

The successful building of knowledge and its use can be impeded by organisational structures as well as by remuneration and evaluation systems. Knowledge can be understood as power and kept under lock and key. There needs to be a cultural change towards the principle "to share knowledge is power". The working and incentive systems for this change can be divided into extrinsic and intrinsic systems. Whereas remuneration builds on extrinsic motivation, intrinsic motivation has great significance for the sharing and development of knowledge. Learning processes are encouraged by intrinsic motivation. Examples for intrinsic motivation are the possibility for self-realisation and acknowledgement and the chance to give meaning to life. Each member of staff holds knowledge and can be motivated by individual incentives.

Individually developed competencies can be transferred to other persons who are supposed to enhance their skills. It is clearly demonstrated to the members of staff that active participation offers advantages. The employees broaden the knowledge they already have, share it in courses and get credit. They get the opportunity to learn from each other. The progress of knowledge management is operationalised by means of measurable targets and well explained in workshops. Potentials are developed by actively integrating participants in challenging and interesting projects with which they can identify themselves. The comprehensive knowledge transfer in courses leads to a stronger interaction and acceptance among the participants.

Knowledge and incentive systems are linked to the company's success and development. The management of the company must support the strategy of knowledge management. Tasks and responsibilities should be recorded and integrated into the GMP and SOP environment. A knowledge market with supply and demand has to be created. Knowledge management is supported by efficient processes and structures.

Pharmaceutical Quality Control as a practical example1,2

Thanks to the high GMP level, the excellent process documentation and the guidance in SOP, the pharmaceutical quality control is a good basis for a successful implementation of knowledge management. Work processes are already known, documentable and transparent because of working instructions or procedures in the SOP so that in most cases, they are available independently from the persons carrying out the tasks.

The following is a suitable selection of knowledge challenges in quality control which are critical for success:

  • Laboratory:
    - Handling and solving of problems in the laboratory
    - Little analytical background and expert knowledge
    - Operational blindness
  • Members of staff :
    - Development of method and instrument specific skills
    - Loss of skills / knowledge difficult to compensate
    - Fluctuation rate
  • External training
    - Sustainable transfer of acquired skills

The costs for addressing those challenges can be assessed very well by means of the hours required. The evaluation is carried out in several steps. A strategy is defined by means of the resulting findings. Measurable targets are deduced and the responsibilities defined. Based on many years' experience the following is a non-exhaustive selection of possible steps to tackle the abovementioned challenges:

  • Instructions on the equipment
    - External training to learn the craft
    - Set up internal vocational courses
    - Participation with in-house certificates
  • Analytical Methods
    - Development of background knowledge
    - Learning objectives test and qualification certificate
  • Process understanding
    - Method validation, OOS / OOE / OOT etc.  

The establishment of knowledge management can be divided in preparatory and operative steps. Preparation includes the compilation of course materials and lectures. Operational activities cover the participation in lectures, practical training and training of background knowledge. Laboratories benefit from a reduction of laboratory tests, invalid test approaches, loss of employees and knowledge, faulty treatment of laboratory equipment, faulty handling of equipment soft ware and project delays. The working hours thus gained can be used otherwise.

Efficient Batch Record Design and Review - Live Online Training


14/15 February 2023

Efficient Batch Record Design and Review - Live Online Training


One goal of knowledge management is to create an atmosphere which gives the members of staff the opportunity to positively develop their skills in the sense of strategic knowledge goals. Achievements are rewarded by giving the reached knowledge objectives a high importance in the annual appraisal of staff . As a result of the success of their contributions the members of staff are increasingly motivated. The principle of the growing knowledge culture is shown in fi g.3.

Fig. 3: Growing knowledge culture.


Dr. Lars Lueersen
... food chemist, has an eMBA in innovation management. He has worked in the pharmaceutical industry in different positions for
15 years.

1 Lars Lueersen: Knowledge Management, PharmaLab Congress, Neuss, Germany, 2018
2 Lars Lueersen: Entwicklung, Bewertung und Weiterführung des Knowledgemanagements, Masterthesis, eMBA INO07 BFH, 2011.
3 Nonaka, Ikujirō; Takeuchi, Hirotaka: Th e Knowledge-Creating Company: How Japanese Companies Create the Dynamics of Innovation. Oxford University Press, 1995.
4 North, Klaus: Wissensorientierte Unternehmensführung: Wertschöpfung durch Wissen. Gabler Verlag, 5th edition, 2011.
5 Kraus, Pavel: Knowledge Management, eMBA INO07 BFH, 2010.

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