ICH Q10 knowledge management
Posted: 3 September 2019 | Christian Rack (Qualified Person - B. Braun Gruppe) | No comments yet
The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to improve your company’s knowledge management and break down the barriers to knowledge sharing.
THERE IS an important saying that states: “Information damages only the person who does not have it.” Despite this, or maybe because of it, structured knowledge sharing leaves room for improvement in many companies. From the two enablers in the ICH Q10 guidelines – risk and knowledge management – knowledge management plays a secondary role. In contrast to risk management, according to ICH Q9, there is no clear guidance about what a structured knowledge management process should look like.1 For various reasons, people tend not to share the knowledge they have; for example, due to scattered physical locations and the usage of knowledge as power.2 Hoarding of knowledge is, if not otherwise organised, beneficial for its owner and risky for the organisation.3 However, effective knowledge management is seen as a competitive advantage and fundamental for generating new ideas.4
Effective knowledge management requires an interplay of areas: people, processes, content and technology.5 People must be willing to share their knowledge and this works best if it is supported by a corresponding corporate culture, rewards system and is assigned key roles.6 Processes describe the workflow from knowledge acquisition to knowledge sharing and application.7 Content describes the knowledge sources that should be made available. These could be internal, explicit or tacit knowledge.8 The active screening of external knowledge is often not directly associated with knowledge management, but rather with the term regulatory intelligence.9 The last area covers technological aspects including the taxonomy, visualisation tools or document management.10
The World Health Organization (WHO) defines knowledge management as a set of principles, tools and practices that enable people to create knowledge and to share, translate and apply what they know to create value and improve effectiveness.11 Knowledge is not the same as data or information. According to the data, information, knowledge and wisdom (DIKW) model, the foundation of knowledge is data, which is a discrete series of facts about events. Data is raw in format, not organised in any way and provides no further information regarding patterns, structure or context.12 Data becomes information when it is contextualised, categorised, calculated or condensed. Information becomes knowledge when it is combined with experiences, ideas, insights and judgements, and it is used as a basis for decision‑making or taking an action. According to the model, wisdom comes after knowledge. Wisdom means to extrapolate knowledge by understanding underlying principles.13
Effective knowledge management requires an interplay of areas: people, processes, content and technology”
There has been no study or information about the spread of formal knowledge management within the pharmaceutical industry. However, general studies show that 40 percent of companies consider their level of knowledge sharing to be five or below on a scale of one to 10.14 In another study, 60 percent found it ‘difficult’, ‘very difficult’ or ‘nearly impossible’ to obtain information vital to their job from their colleagues.15 The same study revealed that the average on-boarding takes 6.5 months, due to learning the details of their job and seeking information on their own. Considering that 42 percent of the knowledge is unique to the job owner and the increasing retirement rates of the baby boomer generation, it is not surprising that the companies in the Fortune 500 lose annually around $31.5 billion due to a lack of knowledge sharing.16
ICH Q10’s knowledge management is focused on product knowledge created along the product lifecycle.1 However, independent of the type of knowledge that is shared, the foundation is a knowledge-sharing culture.17 The biggest impact on that culture is the immediate supervisor.18,19 The role of this manager is therefore to foster knowledge sharing and to break down the barriers to knowledge sharing. “Breaking silos” is a typical phrase that describes a desire to access knowledge that is normally not available outside the immediate environment. Yet people are only willing to share their knowledge when they feel they get something in return.20 So, where to start? How can a manager create and cultivate a culture that changes a passive attitude into an active attitude when it comes to knowledge sharing? The following are five proven actions that every manager can take directly without first creating a formal knowledge management environment.
1) Training sharing
One day of external training costs around €1,000, which does not include the travelling costs or the downtime of the employee. Normally, the seminar documentation disappears in a cupboard of the employee and in the best case, some highlights are shared among several direct peers. The shift aims to make a clear statement that everyone who attends external training must file the information in a defined folder and give a five‑minute lecture with two slides for the whole group. The presentation should include answers to the following questions:
- What did I learn from the seminar?
- Which ideas/techniques should we consider for our group/department?
This sharing works best for scientific or technical trainings. It is difficult for more personal or management trainings such as ‘conflict conversation’ and should therefore not be applied to those trainings.
2) Accelerated on-boarding
The standard on-boarding programme includes a combination of reading standard operating procedures (SOPs), meeting key persons and attending trainings. Some trainings are prerequisites for accessing databases, software or a building; other trainings are independent. Some trainings are organised frequently; others only once in a while.
A new employee might find it hard to distinguish between important or urgent trainings and less important ones, which could lead to delays, when seldom trainings or trainings with a long forerun are not organised before the employee enters. The on-boarding time could be shortened considerably by optimising the process along the critical path of trainings; and the shorter the on-boarding, the earlier new employees can be beneficial to the company.
Alongside the optimised on-boarding training list, a designated mentor can further help to improve the on-boarding process.
3) SOP input list
The role of this manager is therefore to foster knowledge sharing and to break down the barriers to knowledge sharing”
Several practices lead to poor SOPs. Sometimes, SOPs are released under pressure in betastatus, shortly before an inspection takes place. Sometimes the author and the user are different persons and the major focus of the SOP is good manufacturing practice (GMP) compliance rather than practicability. However, the problem is that while people give their input to the SOP shortly after the release, shortly after the approval loop there is usually little motivation to create a newer version.
A SOP input list could solve this issue. In a simple excel list, every employee can write his input for this SOP, including the date and his/her name. With each review cycle, the author must either consider the comments or actively explain to the comment giver why the comment will be not considered.
4) Job aids
Much practical knowledge does not fit into a SOP: how to filter for information in systems applications and products (SAP); how to book a certain room; or how to ship a parcel overseas. Often, this requires knowledge that is only used occasionally; but when this information is needed, it can take hours and several calls to figure out. This knowledge should be transferred by writing it down in an informal way and saving it in a shared and known folder.
5) Technology scouting
It is highly likely that there isn’t a single person working in the pharmaceutical industry who feels that he reads enough and is up to date with all industry trends discussed in draft guidelines, USP forums, Pharmeuropa, to name just a few. Some companies have regulatory intelligence departments,9 which are located in regulatory affairs and therefore mostly deal with information relevant to the regulatory affairs department. But the same problem applies to technical developments for production and the analytical departments: how can we be aware of everything that is upcoming and relevant? Technology scouting describes the systematic identification, collection, interpretation and utilisation of trends.21 Following this approach, a department internal approach would be to assign one topic of interest to each member of the department for interpretation and present the outcome in a group or department meeting. The topics could be taken from headlines from the diverse amount of newsletters or websites. The basic questions are: does it affect or could it help our department? Would it make sense to dig deeper into this topic?
The roll out of a formal knowledge management solution is, despite its beneficial ROI, a time- and cost-intensive project.22 However, it is possible to start on a low level with some minor actions and when people feel that knowledge sharing is not a one-way street, a positive culture towards knowledge sharing could be shaped.
About the author
Christian Rack is an industrial pharmacist with more than 10 years of experience in QA, QC, pharmaceutical development and as a Qualified Person in GMP/ cGMP environments. These include dealing with solid, liquid and sterile dosage forms and investigational medicinal products within various types of pharmaceutical companies from CMOs and generic manufacturers to originators.
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- Leonard D. 2014. “How to Prevent Experts from Hoarding Knowledge”, HBR. December 18, https://hbr.org, https://hbr.org/2014/12/how-to-prevent-experts-from-hoarding-knowledge (accessed 2018 Dec 30).
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