Knowledge management is one of your organisations most valuable assets and is integral to your organisational culture. This is particularly important for pharmaceutical, biotech and medical device companies where knowledge is the critical foundation for achieving success. All R&D, manufacturing, engineering, clinical and regulatory work is completed by skilled professionals with extensive knowledge. Consequently, managing that knowledge is crucial. It is even argued that being effective at knowledge management provides the competitive advantage over rivals.

 

What is knowledge management?

Firstly, knowledge is made up of information and includes everything in your organisation such as systems, processes, people, documents and technology. Essentially everything that makes up the inner workings of an organisation. The management part lays out the plan or process for capturing this information, using it and then distributing it to employees.

Knowledge management has many definitions and meanings however one of the most relevant for pharmaceutical, biotech and medical device companies is as follows:

“Knowledge Management is the process of creating, using, sharing and maintaining knowledge.”

(Davenport, 1994)

Breaking this definition down further:

Creating – New knowledge creation is integral in any organisation, through learning, coaching, shadowing. This element is critical in an industry that is continually evolving with new regulations, technology and innovations. New knowledge must be acquired to remain competitive.

Using/applying – A critical element is making sure the environment is set up to allow people to use their knowledge/experience.

Sharing – How is knowledge transferred to others? Is there a process for transferring knowledge throughout the team, department or organisation? ~How well do you distribute information? How well do you learn from experienced employees?

Maintaining – It is critical to have systems and processes in place to ensure knowledge within an organisation is maintained. These include software, filing systems, refresher training etc. As mentioned, it is important the knowledge available to people is the latest and accessible.

A simplistic way of looking at knowledge management is to remember a time when you joined a new company. You know nothing on day one. You do not even know where the toilet is. But 6 months later you know enough to perform your job comfortably. This is because by this point you know how to find information, use systems, use software. You know who to talk to and you know what technology is available and how to use it. Companies that are good at creating, using, sharing and maintaining knowledge can onboard a new person quickly. They have the environment and the culture that enables a new starter to understand their role and tasks quickly.  

There are two main types of knowledge to consider that should be mentioned. The first is explicit knowledge. This is knowledge and information that can be easily articulated, codified, stored, accessed and taught. Explicit knowledge aligns perfectly with our definition of knowledge management as it is knowledge that is easy to capture and share. Examples of explicit knowledge include writing down and following SOPs, setting up an experiment, watching ‘how to’ videos. These are all knowledge that can be captured, documented and distributed.

The second type is tacit knowledge. This is knowledge gained through experience and is very difficult to document and share. This is the type of knowledge, that if managed correctly, will provide your organisation with a competitive advantage. The biggest challenge with tacit knowledge is being able to transfer it to others as it is difficult to share or communicate. Examples of tacit knowledge include leadership, sales skills, applying a regulation or guideline, interpreting out of specification. It is knowledge that is developed over time through experience.

 

Why is it important?

Being competent at knowledge management is only going to support compliance activities such as during an audit. In fact, knowledge management plays an integral role in your quality management processes whether you follow GMP ICH guidelines or ISO 13485. Being able to demonstrate to regulators or notified bodies that you encourage knowledge development, knowledge sharing, and knowledge maintenance can only be positive.

In addition to regulatory benefits there are a multitude of other benefits that come with being good at knowledge management and are listed below:

Fast access to knowledge and information – In order to be agile and dynamic organisations must have information that is accessible quickly when it is needed. This helps with onboarding, succession plans and carrying out complex tasks.

Increased collaboration and innovation – With an environment for learning and sharing knowledge a positive outcome is innovation and new ideas that will only drive your organisation forwards.

Improved quality of information and data – Along with fast information it is important that the information is accurate and of a good quality. Having knowledge management systems and processes in place will drive good quality information.

Improved organisational agility – Life science organisations must be able to adapt to their environment with changes in regulations and innovations. Being competent at knowledge management will help your employees/team change quicker, when needed.

An improved organisational culture – This is a tool to achieve good knowledge management (which will be discussed). But equally being good at knowledge management also contributes to the overall culture or your organisation. Having an environment that encourages knowledge management such as training, mentoring and systems in place will facilitate a positive culture. This will ultimately reduce staff turnover and help you recruit the best talent which inevitably leads to better knowledge retention and knowledge/information transfer.

 

How to implement it

Managing knowledge within a pharmaceutical, biotech and medical device company is difficult, especially when the organisation is large or growing fast. As previously discussed, creating a pharmaceutical or medical device involves significant knowledge in range of areas from R&D to manufacturing. A whole range of regulations must be interpreted and applied to a product at all stages of development. This requires skilful and knowledgeable employees applying tacit knowledge on a regular basis. If done successfully you will maintain a competitive advantage.

Below are some simple takeaway tools that can be used to support knowledge management of tacit knowledge. They can be applied to a whole organisation, department or small team.

Organisational culture – As mentioned previously, organisational culture and knowledge management go hand in hand. By creating an environment and culture that promotes knowledge acquisition, application and maintenance you will be good at managing knowledge. But how do you do this? From a human resource perspective there a range of practices that can be implemented. Firstly, you want to promote from within to keep knowledge within the business. Secondly, it is useful to create career plans for your team, merging their aspirations with your business goals. Then create development plans identifying gaps in their skills and knowledge and a plan to remedy those gaps.  To do this, all levels of management must fully back the approach and have the training to support career and personal development. Another tool to change behaviours is to incentivise through bonuses, rewards and praise.  With a good culture in place, you will be better placed to attract and retain top talent. By retaining your best staff, you prevent tacit knowledge from leaving the business.

Mentoring, coaching and shadowing – This is a very cost-effective method for transferring knowledge within an organisation. A good approach is to pair junior employees with more experienced professionals to encourage tacit knowledge transfer. Coaching is used to help someone achieve their goals, with the more experienced person sharing their approach/opinion. Mentoring is when a more experienced person shares their advice to a junior member of staff. Finally, shadowing is when someone follows another professional completing a task and is a good method for learning new skills and knowledge.

Learning and development – A key component of knowledge management it is acquiring and maintaining knowledge. Learning and development activities such as training courses are a very good tool to develop new skills and learn new knowledge from an experienced teacher. There are several ways to develop new skills through learning and development such as in-person classroom training, live online training, practical courses, on-demand training and e-learning modules. Each method has its pros and cons and should be selected based on your aims and objectives.

It is also important not to treat training as a one-off event by adopting a continuous learning approach. Be sure to have a plan in place to apply your new skills in the workplace.

Social networking – A good tool to support tacit knowledge transfer is to encourage team networking. This can be done in several formal and informal ways. For example, creating an environment that enables social interactions such as a coffee area or lounge area. This supports long term professional relationships which in turn enables the flow of knowledge. A formal or organised approach would be to organise town halls or team days.

A great example of social networking is working lunches whereby someone shares a positive outcome, task or project they have experienced. This is all done over a free lunch which incentivises people to attend. The person can deliver a short presentation in an informal environment where others can learn and ask questions.

 

Summary

Knowledge management is something you should be thinking about, especially in life sciences. Organisations that manage knowledge/information effectively are better placed to drive innovation, improve organisational culture, be more agile and can access information quickly (great for onboarding). They will also have the added benefit of supporting your compliance activities, demonstrating competence to regulators.

The toughest type of knowledge to manage is tacit which is gained through experiences and is hard to document and share. Tools such as mentoring, shadowing and encouraging social networking are great methods to improve the flow of tacti knowledge from person to person.

 

  

Written by Alexander Pearce

Alex is a Director at Educo Life Sciences and has extensive experience of designing technical training programmes for the pharmaceutical, biotech and medical devices industry. He has developed both classroom and online training to support the development of life science professionals.