What makes a good GMP Auditor?
If you ask people in the GMP environment what makes a good GMP auditor, you will get a quick and comprehensive answer, because everyone knows that: They must have extensive knowledge, not only of technical processes, but also of the applicable rules and regulations; they must be able to quickly familiarise themselves with new processes and understand them; they must be independent and have the suitability of character to be an auditor; they must know and apply clever questioning techniques - ideally they should already have proof of auditor training - they must be patient enough to listen, but also persistent enough to actively steer an audit and bring things to a conclusion. And competent they must be - that above all else - c o m p e t e n t!
This is where we first encounter this term. It is used in many different areas of life and everyday situations and, depending on the perspective of its user, aims to express different things. Because of this vagueness, let us first take a look at the construct of competence from a social science perspective: What actually is competence?
In the social sciences, competence is defined as a subjective "feeling of being able to cope"1 in uncertain constellations, an ability to act even in new situations. This points us to the most important characteristic of any competence: it only becomes apparent or visible in (competent!) action.
The basis of any development of competence is knowledge, both cognitive and emotional, as well as the associated skills. The existence of this knowledge and the associated skills within a given scope of action - thus always context-dependent - can be tested and certified by qualification, i.e. by standardised testing procedures.
Technically, an auditor with the relevant qualification can offer certified proof of competence - but are they capable of comprehensive action? Especially in unknown, new situations, which an auditor will encounter again and again by virtue of their profession? Probably not. And if you have ever met highly qualified people who, despite all their qualifications, were not able to act competently, then you now know why: in order to make the transition from qualification to competence, further development processes are necessary.
Recommendation
7/8 May 2024
KPIs and Quality Metrics - Live Online Training
To better understand the structuring of such development processes, Erpenbeck and Heyse help us by replacing the rather abstract term "ability to act in open situations" with the description "ability to organise oneself" and add values, standards and rules to expand the dimensions of action.2
Fig. 1: Building block model of the concept of competence, own representation, based on Erpenbeck et al.3
Values, standards and rules are linked to existing knowledge and skills and become internalised on the path of competence development; important motivational and emotional connections are created.
The complexity of the levels of these development processes and the different dimensions that are used to form problem-solving strategies (i.e. competent action) give us clear indications that it will not be possible to manage this with one competence alone: The competent person (in this case the auditor) brings along a whole portfolio of competences in order to be able to act on their own.
Fig. 2: Competence groups according to KODE®, own illustration.4
Figure 2 shows us the four basic competences of a well-known model. Independent action, as described above, requires the interaction of different competences: Without metacognitive processing, for example, acquired knowledge cannot be applied to one's own work situation, and the best communication skills alone will not help to find solutions to problems if the necessary technical expertise is missing.
If we look a little deeper into these four categories, we find the socalled key competences as components of "being competent", some of which we encountered in a different formulation at the beginning of the article:
- Social-communicative competences, such as the ability to solve conflicts, conscientiousness, adaptability, eloquency etc.
- Professional-methodical competences, such as subject-specific knowledge, analytical thinking, knowledge orientation, objectivity, etc.
- Activity and action-related competences, such as decision-making ability, mobility, quick-wittedness, result-oriented action, etc.
- Personal competences, such as openness to change, credibility, personal responsibility, willingness to learn, etc.
Current - formal - training cannot always reflect what the future may demand of employees - how can one give answers to questions that have not (yet) been asked? Consequently, the competences that make us capable of acting are the key to successful existence in a working environment where the pace of change, not only in terms of technology, is ever increasing. Meanwhile, not only employers have discovered this for themselves in their application processes. Creators of guidelines and standards have also recognised this: In more and more sets of regulations, the formulation of "competent" personnel, to be deployed to carry out tasks, can be found explicitly; sometimes only very briefly, but sometimes described more extensively in terms of associated requirements and characteristics. As examples, we can refer to the EU GMP Guideline and DIN EN ISO 19011:2018-10.
Summary
Although knowledge is the basis of everything, it is not synonymous with competence; even a (high) qualification does not guarantee competence: competence only becomes observable in action.
Competences therefore enable and maintain our ability to act and are therefore worth constantly developing and working on; and this does not only apply to the profession of the GMP auditor, but perhaps to this profession in a very particular way due to its demanding field of work (scope of action). The education and training should therefore not only include the acquisition of knowledge, but should focus particularly on the acquisition of competences and offer scenarios in which the auditor finds opportunities for this; scenarios which offer experiential learning, always combined with direct implementation in action; which encourage and enable him to interiorise what he has learned. Exchange with others, e.g. by attending appropriate seminars, participating in workshops or conducting joint audits are important elements in building the network within which an auditor can find inspiration and develop further.
Recommendation
7/8 May 2024
Audit Trail Review for Computerised Systems in Analytical Laboratories - Live Online Training
And that, in my opinion, is how you recognise a good GMP auditor: That he can distinguish between qualification and competence and that he has both. That he recognises that the acquisition of competences does not have a fixed end in itself and that he therefore has the will and the joy of constant further development and exchange with others. That he can question his own perceptions, consider other perspectives and compare them with his available knowledge and rules. And that he has the (intrinsic) motivation to learn new things and in this learning process constantly reflects on his own attitude and the existing framing of his own way of acting and adjusts it if necessary.
I wish you all much success and joy on your way to becoming a good GMP auditor - and that you will act competently at all times!
Note: For reasons of better readability, no gender-neutral differentiation is made in the article. In the interests of equal treatment, the terms used in this article always refer to all genders.
Author:
Petra Barth
... has been working for more than 20 years as QC and QA Manager in the global pharma business. Since 2016, she has been working as an independent trainer in the field of adult education with a focus on QA and compliance training.
Source:
1 Reinmann, G./ Mandl, H. (2004): Psychologie des Wissensmanagements. S. 117.
2 Cf. homepage of KODE®. Competences open up the future.
3 Cf. Erpenbeck, J. et al. (eds.) (2017): Handbuch Kompetenzmessung. P. XVIff.
4 Cf. homepage of KODE®. What does KODE® measure?
