As we are always being told that we undertake Risk Assessments all the time. In our personal lives and in our professional lives. Mostly, we are doing it automatically. A sub-conscious process that draws on prior knowledge, previous experience and a perceived objective. Evaluating the possible hazard(s), what the harm could be, how could it happen and what can be done to minimise, if not eradicate, the likelihood of it happening. For the most part, it’s a reflex based on an innate knowledge of the environment and the circumstances.
The challenges seem to arise when applying this – in a structured, formal way – in the workplace. Furthermore, based on feedback from a cross-section of people, it would appear an even greater challenge to apply a Risk Assessment to situations other than what is thought of as Health and Safety in the Workplace. “We know what could happen if that ladder is left there, so let’s move it”
The potential hazard to a person, or to people, is relatively straight forward to envisage, as are the mitigating actions, but it is seemingly a whole lot more abstract to consider the effect on the efficacy of a pharmaceutical product. You know what you want the end-result to be – a product to remain safe to prescribe or administer – but it’s a little harder to consider what could jeopardise it.
And there’s the catch. Risk Assessments are often undertaken as if that end-result has already been decided, and the bits before it, those troublesome what’s whys and how’s – are tailored to suit. The cart before the horse!
The main issue to consider, then, is how effective is that Risk Assessment? How truthful. How ethical? The other issue is, if you’re being inspected by the MHRA, is how do you think it will be viewed in an inspection? Because, be in no doubt, they are looking for it.
So, starting from a base-point is never easy, but being aware of the full range of operational mis-haps that can happen is always a good start. Don’t think it’ll never happen, as it probably will. And then arm yourself, through an open mind and thorough research, with the information and evidence to arrive at a satisfactory conclusion. The horse before the cart!