This is the fifth in a series of blog postings in which we present a top-ten list of common errors encountered in the context of medical projects. Of course, such a ranking depends on personal observations and individual experience – and hence has a subjective outcome. Please feel invited to tell us about your perspective in the comments section!
If there were a short version of this post, it would go like this: “AFAP is the new ALARP”. But there is more to this than just two cryptic acronyms. In what follows, we will take a closer look at yet another source of infinite confusion in medical projects today.
Let’s start with simple facts: The term ALARP stands for As Low As Reasonably Practicable and is explained in Annex D of the risk management standard ISO 14971:2012. In this context, at least three warnings come to mind (sorted by increasing importance):
- The expansion of the acronym ALARP is often stated wrongly, for instance as “as low as reasonably possible” (or worse).
- The ALARP approach from Annex D is often explained wrongly. For example, some authors reduce the concept to “Risks only need to be reduced if it is economically feasible and may be ignored otherwise”, which is not what the standard states.
- None of the above really matters because Annex D of ISO 14971 does not apply in the European Union: It is overridden by stricter requirements in Annex I of the Medical Device Directive (93/42/EEC). The latter clearly states (twice) that risks must be reduced As Far As Possible. Note that this is also explained elaborately in Annex ZB of EN:ISO 14971:2012.
Nevertheless, let us clarify what the ALARP approach really implies – even if it must not be followed in the EU:
Imagine you are reevaluating a risk after some risk control option has been applied. Assume further that the evaluation has the following outcome: The residual risk is too large to be entirely negligible, but already meets the manufacturer’s criterion for risk acceptability. (In old-fashioned risk matrices, this would mean that the residual risk is neither green nor red, but yellow.) Then the residual risk is acceptable for the risk control option that reduces the risk to the lowest practicable level. (I.e., if there exists an alternative risk control option that is better than the one chosen above and that can be implemented at reasonable costs, then we choose that one instead.)
In other words, impracticable means to imply that the costs of any further reduction are way beyond the benefit in risk reduction (including the extreme case that further reduction is utterly impossible in the real world). With the as-low-as-reasonably-practicable approach, an individual risk/benefit analysis is employed to judge whether remaining risks are acceptable.
Coming up next: #5, V for Vendetta. See you there!
Top Ten Errors in Medical Projects – #7: The 100% Confusion
Top Ten Errors in Medical Projects – #8: Eager Beaver / Lazy Bum
Top Ten Errors in Medical Projects – #9: Process versus Project
Top Ten Errors in Medical Projects – #10: Clinical Something!