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  • Marie Salova

Would Socrates have made a good Validation Engineer?

On the face of it, the two fields of validation and philosophy may seem quite far apart on practical terms. However, conceptually, there is considerable overlap given a shared focus on rationalism (making the right distinctions), logical interpretation (making the right inferences) and moral reasoning (making the right value-based decisions).  Although the linkages between the two disciplines is often over-looked, they are in fact continuous and integral. Science, after all, began as the “philosophy of nature”. Most of the Greek philosophers were also mathematicians and what is statistics? As well as a favourite tool for validation, it is also essentially a science of estimates and probability.


This begs the question, can some of the tools of philosophy be valuably applied in the field of validation?


Let’s briefly explore here some of those included in our soft skills training of validation professionals; namely those of (i) Decorum, (ii) Rhetoric, (iii) Heuristics, (iv) Logic and (v) Hermeneutics.


(i)                    Decorum


As a multi-faceted socio-cognitive process, effective validation depends on building constructive working relationships with all stakeholders. Decorum might seem an old-fashioned virtue but it’s actually very apt in the pharma industry where discretion is highly valued. While T.A.C.T. (temperature, agitation, chemicals, time) is primarily a concern for cleaning validation, all STEM professionals need exercise of tact in their social interaction. Cicero posited that decorum should be applied to both actions and speech. For validation, good manners and professional etiquette go a long way to open (and keep open) many doors.


(ii)                 Rhetoric


By definition, rhetoric is persuasive. It has also long been identified as vital in engineering, defined as “the development of an explanatory framework that identifies and validates a particular solution to a problem as the best” (Robinson) although this reference to “validation” is not meant here in the regulatory sense but more so, infers demonstrability. Validation often presents us with compound problems to solve. This necessitates the need both for analogical precepts and that we explain clearly their relevance. Such rational argumentation is a vital tool to “justify the weights given to qualitatively different criteria” (Robinson).


(iii)               Logic


One requirement of rational argumentation is that of “logical coherence”. To convince an auditor or regulator of our risk-based decisions, we must provide a clear documentation trail but also a weight of evidence to our causal inferences (Swain & van Amelsvoort). These writers set out useful standards for this “weight of evidence” in the following : strength, consistency, specificity, temporality, exposure-intensity (e.g. dose-response), plausibility, coherence, experimental evidence and again, analogy.


However, validation professionals realise only too well that everything has its limits. This includes, albeit counterintuitively, logic itself yet there is a duty to  ensure that premises supports their conclusion in every technical report.


(iv)               Heuristics


Philosophers emphasise the importance of heuristics in constructing scientific theory and evaluative judgements. Subjectivity is a key feature in interpreting legislation - each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm (ICH Q9). Hence, the onus is on validation professionals to be aware of the rationale behind their assumptions and decisions. Critical thinking training based on a heuristics-and-bias approach is fast becoming de rigour both for QA and validation professionals and rightly so. As manufacturing settings become more complex, so must the cognitive approach to risk management increase commensurately in it’s sophistication.


(v)                  Hermeneutics


It’s from the field of humanities that the art of interpretation, critique and synthesis has evolved.

Although hermeneutics is the branch of interpretation generally associated with biblical texts, it is also worth considering in light of validation placing as it does an emphasis on contextual judgement. Clearly, there is an overlap at the regulatory intersection with guidelines tending not to be overly-prescriptive. There is one noticeable parallel between validation and hermeneutics and that is the shared quality of “having conversations with the past” (Caputo) i.e. understanding preceding assumptions (captured with respect to validation in protocols). However interestingly, hermeneutics encourages us to conserve (as opposed to “preserve”) the original intent by “making wise use of it”. It advises against “literal loyalty” to rules and regulations, termed as a “disservice” to tradition. Instead, it suggests that tradition be allowed to “renew itself” and prioritises the contextualising of each guideline with reference to others.  For validation professionals, these infer a holistic and risk-based approach with Kant perhaps offering the useful moral guidance – “live your life as every act was to become a universal law”.


Conclusion


If you’re currently working in a validation role but view philosophy as “all Greek” to you, then hopefully you will reflect. Given our rich European intellectual heritage in philosophy, with tendrils already into science and engineering, it’s certainly worth serious consideration.


Thus, the answer to our title question about Socrates is “Yes” and for this reason not just validation but all STEM professionals should receive training in Socratic dialogue. Read future posts for more on this subject.

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