Risk management ALARP

It is rarely possible to completely mitigate a risk other than by somehow taking action to avoid the associated hazard in the first place. Instead, risks need to be reduced so that they become As Low As Reasonably Practical (ALARP). Remedial project actions should be specifically documented — this is sometimes referred to as the Safety Case. Remedial actions may employ hazard avoidance strategies, introduce hazard tolerant design feamres, or apply specihc project management controls, or a combination. Further information on risk management for medical devices can be found in ISO 14971. ... 

The majority of hazards will not be issues and will not typically benefit from routine weekly review by the project team. Hazards can, in the main, be seen as entities sitting in the background characterising the risk in the event than an incident was to occur. Their purpose is to focus and prioritise the development of controls during the CRM analysis and to demonstrate the practical measures that have been put in place to reduce the clinical risk to ALARP. In contrast, issues are problems which require active management - they need someone to take ownership and run with the task of fixing them. 

Realistically, it has to be concluded that the term ALARP really does not provide much help to risk management professionals and facility managers in defining what levels of risk are acceptable. It may be for this reason that the U.K. HSE chose in the year 2006 to minimize its emphasis to do with ALARP requirements from the Safety Case Regime for offshore facilities. Other major companies have also elected to move away from ALARP toward a continuous risk reduction model (Broadribb, 2008). 

Contemporary risk management follows a maturing path to the establishment, acceptance and management of a level of risk that is deemed tolerable and as low as reasonably practicable (ALARP). The recent issue of military standards [MoD 2004] describes six processes for risk management hazard identification, hazard analysis, risk estimation, risk and ALARP evaluation, risk reduction and risk acceptance. Whilst these are not the universal descriptions of the processes involved, the underlying principles are consistent with other procedures and handbooks, for example lEC 61 SOS, JSP 4S4 and Mil Stan 882D. 

ALARP demonstration is seen by many international viewers as difficult to verily and there is the perception that claims that all practicable risk reduction has been done, may be made without an appropriate effort [Bibb 2005]. Recent developments in The Medical Device Risk Management Standard (ISO 14971) indicate that the consideration of ALARP may be deleted from the new 2 edition due to the completeness question [Bibb 2005]. 

An organisation responsible for managing safety risk has to determine whether risk is already as low as reasonably practicable conversely, it has to determine whether potential risk reductions are reasonably practicable to implement. This decision can be made in different ways to match different circumstances. For example, compliance with an accepted code of practice is sometimes regarded as a good indicator of risk being ALARP or it may be that professional judgement is the best means of making a decision. 

The risks shall be reduced to the lowest practicable level the ALARP principle. The principle considers also that the complexity of any mitigation can result in an additional source of risk beeause it ean cause defects or misuse or it can imply a delay in availability, with a potentially serious impact on public health. Risk management progressively and iteratively identifies mitigation, verifies the efficacy, and assures the balance between protections and their complexity or inconvenience for design and use. 

The aim of risk management in medical devices is to ensure patients, operators and the environment are not harmed by the device. Additionally, it shall also ensure that the medical device is effective for its intended use. To this end and according to most common approaches to risk management (AAMl 2004, 2001, ISO 2000), all phases of the design and manufacturing processes shall be covered. Thus, fi om the very first stages of the project, risk is analyzed and controlled to bring it to levels ALARP (As Low As Reasonably Practicable). 

The risk management measure promoted by regulators and governments of nanomaterials is the "As Low As Reasonably Practical" (ALARP) approach (Workcover NSW, 2008 SWA, 2009a). There is a fundamental problem with this approach. ALARP is based on balancing the risk of exposure against the cost to lower the risk further to, what is commonly referred to as, a "tolerable risk." Effectively, ALARP defines risk as an economic decision—do I spend the money or not Regrettably, experience shows us, too often, that the answer is not. 

Further to this, there is increasing effort to better imderstand the risks that rail organizations face and the risk management controls that are, and / or, need to be, put in place to manage these risks. In marty operations the human component is still a key defence against incidents and accidents occurring. We carmot eliminate the human from the system. Therefore, we need to be confident that our frontline personnel are equipped with the skills, knowledge and attributes required to be able to perform the required tasks safely. More specifically, we need to train our personnel such that we reduce the likelihood and consequences of human error to As Low As Reasonably Practicable (ALARP). 

Central to the safety case is the hazard control and risk manag ent process, ensuring that risks are well managed. ALARP is used to determine how far you should go to control the hazard. The safety case process is very thorough and highly labor intensive and, if you are not careful, could become overly bureaucratic. It is just a snapshot in time of the safety of the system, so that means that it must be maintained to still be relevant. This is where bureauCTacy can take over if not careful. 

Applicable hazards are managed to closure or are conditionally closed and managed tiirough restrictions. The Safety risk is ALARP and tolerable ... 

Risk management, criteria for accepting risk (e.g. ALARP)... 

For this, the risk was considered to have been controlled to a level as low as is reasonably practicable (ALARP) and as such this output is not a shortfall . However, in the hght of the accident, the risk will have to be le-evaluated, and this is done in the Risk Management Action section of the accident investigation. 

Another difficulty with the use of ALARP is that the term is defined by those who will not be exposed to the risk, i.e., the managers, consultants, and engineers who work safely in offices located a long way from the facility being analyzed. Were the workers at the site be allowed to define ALARP, it is more than likely that they would come up with a much lower value. 

The notion of de minimis risk is similar to that of ALARP. A risk threshold is deemed to exist for all activities. Any activity whose risk falls below that threshold value can be ignored— no action needs to be taken to manage this de minimis risk. The term is borrowed from common law, where it is used in the expression of the doctrine de minimis non curat lex, or, the law does not concern itself with trifles. In other words, there is no need to worry about low-risk simations. Once more, however, an inherent circularity becomes apparent for a risk to be de minimis it must be low, but no prescriptive guidance as to the meaning of the word low is provided. 

There are a number of recognized principles for managing risks and achieve target values for tolerable risks of accidents with injuries or casualties within the railway industry. Typically, different countries have recognized different principles. Thus, MEM is mainly practiced in Germany, ALARP in the UK, and GAMAB/GAME in France. The principles are shortly described below. 

A safety management risk assessment techniqne that is used to define and control the hazards associated with a process, job, or procedure. The Job Safety Analysis ensures that the hazards involved in each step of a task are reduced to as low as reasonably practical (ALARP). The assessment starts with a summary of the entire job process. The job is broken into smaller steps and listed in a tabular form. The hazards for each step are then identified and listed. This is repeated for each step in the process and a method of safe work is identified. It may be also called a Job Hazard Analysis (JHA). See also As Low As Reasonabfy Practical (ALARP). 

ZlO-2005 tersely states its purpose in Section 1.2 as follows The primary purpose of this standard is to provide a management tool to reduce the risk of occupational injuries, illnesses, and fatalities. This question logically follows. What risk reduction level is to be achieved This chapter Establishes that achieving a zero risk level is unattainable Discusses the great variations in cultural and situational aspects of risk acceptance and Combines the elements of risk (probability and severity) with ALARP (as low as reasonably practicable) to arrive at a definition of acceptable risk, the operational goal. 

As we proceeded with our studies, we found that developing a distinct, perhaps statistical, universally applicable definition of acceptable risk that did not contain general and judgmentally interpretive terms is not possible. But, with a studied understanding of risk, and risk taking, and the concept of As Low as Reasonably Practicable (ALARP), I dare to offer a practical definition of acceptable risk that can be effectively applied when dealing with workplace hazards, risks, and deficiencies in safety and health management systems. 

ALARP is a sound concept. It promotes a management review that should result in achieving acceptable risk levels. Practical economic and risk trade-offs are frequent and necessary in the benefit/cost deliberations that take place when determining whether the costs to reduce risks further can be justified by the resulting decrement in risk. ... 

The scale of risk evaluation provides for the definition of an ALARP zone. For a risk to be ALARP, it must be possible to demonstrate that the risk is not able to be eliminated, but that it can be managed in some technical or procedural way. This is one of the requirements of ISO 14971 however, the ALARP management approach does not permit to stop the search by the manufacturer of solutions that can eliminate or reduce the risk to an acceptable zone. 

For risk index unacceptable or in the ALARP zone, describe the management action implemented to eliminate or reduce the risk index. 

Petroleum Institute (API) developed their Recommended Practice 75 (RP 75), which recommended that offshore facilities develop a Safety and Environmental Management Program (SEMP). Like a safety case, RP 75 is mostly nonprescrip-tive. However, it makes extensive reference to industry standards (mostly from the American Petroleum Institute), and so it is perceived as being considerably more prescriptive then the safety case approach. Nor does RP 75 require that a formal assessment of acceptable risk (ALARP) be determined. 

Management has to decide if the calculated level of risk is acceptable, and, if it is not, what actions need to be taken to reduce it. Some Safety Management Systems—in particular many Safety Cases—are built around the concept of a numerical value for an ALARP (As Low as Reasonably Practicable) value, as already discussed. If the risk lies above or below the predetermined ALARP value then corrective actions must be taken. 

Some Safety Case reports contain an as low as reasonably practicable (ALARP) demonstration section that shows how the identified major hazards have been managed such that the associated level of risk is acceptable. The vexed topics of ALARP and acceptable risk are discussed in Chapter 1. 

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