ALARP and Risk Management.
Information & Training. | Risk Management.ALARP stands for “as low as reasonably practicable”, or “as low as reasonably possible”.
ALARP is applied in risk management, where there is a trade-off between risk and benefit. In the performance of all tasks there are associated risks. Walking creates the potential risk of a trip or fall. Lifting creates the potential risk of back injury. Manufacturing a pharmaceutical product creates the potential risk of product contamination and subsequent patient injury. A medical device may not operate as intended, with the consequent potential for user harm. All business activity inherently creates risk. Clearly business needs to continue to operate, therefore the question arises as to the level of acceptable risk. Are the potential risks and resultant harms acceptable in terms of the benefits from continuing business activity. If the benefits clearly outweigh the potential risks, then it makes sense to continue activity. If the potential risks and associated harms outweigh the benefits, then it may not be acceptable to continue to engage in specific activities.
The ALARP concept seeks to establish a baseline, where the risks and benefits are measured and where risks remain, these risks are deemed acceptable in terms of the benefits being accrued.
ALARP accepts that there will always be a risk and that harm to individuals, the business, the community, etc., might arise from continuing operations. However, ALARP seeks to average out the risk and harm versus the average benefit, in order to ascertain if the risk is acceptable.
For example, consider a company that has developed of a new drug eluding stent for use in “heart by-pass” operations. This new medical device/pharmaceutical combination product may offer the benefit of increased life expectancy to patients who receive the product, however, during product development and clinical trials it was determined that one patient in 1000 will have an adverse reaction to the new stent with resultant shortened life expectancy versus a current product on the market.
The above creates a dilemma for the manufacturer of the new drug eluding stent.
Will the manufacturer hold back on releasing the new stent to market, due to the damage their product will inflict to the 1 in 1000 patients who have an adverse reaction and consequently deny the 999 other patients the opportunity for improved life expectancy, or alternatively will they release the new stent to help the 999 individuals who will experience positive effects from the product, and accept that 1 individual in 1000 will be unfortunate to have a shortened life expectancy from using their product.
Consider the above example where the positive patient benefits and negative impacts were of the order of 900 to 100 or again 800 to 200, …Clearly there are points where the risks posed are sufficiently outweighed by the benefits to allow activity to continue, despite what can be significant potential risks and resultant harms to individuals or customers, employees, shareholders, the community, the environment, etc..
ALARP seeks to create a defined measure of what is an acceptable risk / benefit ratio.
When assessing risk versus benefit, many risks will pose relatively low level of potential harm and therefore will not be a major concern.
Equally, some risks may be totally unacceptable and will therefore need to be eliminated before continuing activity, either by re-design, introduction of control measures, etc.. There will tend to be broad agreement on these higher level risks.
The region in-between, where risks and benefits are closer aligned is where there will be a need for careful consideration. It is this region where some form of pre-determined method of measurement will be of benefit.
The above can be outlined in a diagram as follows. In this diagram, by taking more risks, an organization can seek to achieve greater benefit for itself, or shareholders, or employees, or customers, etc.. However, there is a point where the benefits to not justify the risks.
Risk Measurement and Determination of Acceptability.In a Risk Management Process, the potential risks to an organization will be identified. Each of there risks will then be considered in terms of the potential harm they may cause to the various stakeholders (customers, employees, shareholders, the community, the environment, etc., …). The probability and potential severity of the risk will be assessed and given a numerical estimate. Then depending on the method of calculation applied, a risk rating number will be derived. This number, will then be compared to the pre-determined ALARP number for consideration of the risk to be acceptable or as low as reasonably practicable. Where the risk number is below the ALARP, than no action may need to be taken to further reduce the level of risk, where the risk rating is higher than the ALARP number, then product/process redesign, control identification and implementation, control monitoring etc.. will need to be implemented in order to bring the risk number below the pre-determined ALARP level.
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