"जोखिम व्यवस्थापन" का संशोधनहरू बिचको अन्तर

कुनै सम्पादन सारांश छैन
कुनै सम्पादन सारांश छैन
पङ्क्ति १:
== परिभाषा ==
{{अनुवाद}}
जोखिम व्यवस्थापन भन्नाले संस्थाको सञ्चालक समिति, व्यवस्थापन तथा कर्मचारीहरुले लागु यस्तो प्रक्रियालाई जनाउँदछ, जस अनुसार संस्थाको उद्देश्य प्राप्ती हुने निश्चितताको लागी संस्थाको रणनीति तयार गर्दा तथा संगठन भरी भएका संस्थालाई प्रभाव पार्ने कारोवारहरु पत्ता लगाई त्यसबाट हुने जोखिमलाई संस्थाले बहन गर्न सक्ने जोखिमको तहसम्म व्यवस्थापन गर्दछ ।
{{refimprove|date=January 2014}}
[[File:ISS impact risk.jpg|thumb|320px|Example of '''risk management''': A NASA model showing areas at high risk from impact for the [[International Space Station]].]]
'''Risk management''' is the identification, assessment, and prioritization of [[risk]]s (defined in [[ISO 31000]] as ''the effect of uncertainty on objectives'', whether positive or negative) followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events<ref name="Risk Management pg. 46">{{cite book|first=Douglas|last=Hubbard|title=The Failure of Risk Management: Why It's Broken and How to Fix It|page=46|publisher=John Wiley & Sons|year=2009}}</ref> or to maximize the realization of opportunities. Risks can come from uncertainty in financial markets, threats from project failures (at any phase in design, development, production, or sustainment life-cycles), legal liabilities, credit risk, accidents, [[Act of God|natural causes and disasters]] as well as deliberate attack from an adversary, or events of uncertain or unpredictable [[Root cause|root-cause]]. Several risk management [[Technical standard|standards]] have been developed including the [[Project Management Institute]], the [[National Institute of Standards and Technology]], actuarial societies, and ISO standards.<ref name=voc>{{cite book | author=ISO/IEC Guide 73:2009 | title= Risk management — Vocabulary | publisher=International Organization for Standardization | year=2009 | url=http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=44651}}</ref><ref name=iso>{{cite book | author=ISO/DIS 31000 | title= Risk management — Principles and guidelines on implementation | publisher=[[International Organization for Standardization]] | year=2009 | url=http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=43170}}</ref> Methods, definitions and goals vary widely according to whether the risk management method is in the context of project management, security, [[Risk analysis (engineering)|engineering]], industrial processes, financial portfolios, actuarial assessments, or public health and safety.
 
== सन्दर्भ सामाग्रीहरु ==
The strategies to manage threats (uncertainties with negative consequences) typically include transferring the threat to another party, avoiding the threat, reducing the negative effect or probability of the threat, or even accepting some or all of the potential or actual consequences of a particular threat, and the opposites for opportunities (uncertain future states with benefits).
{{reflist}}
 
[[श्रेणी:जोखिम व्यवस्थापन]]
Certain aspects of many of the risk management standards have come under criticism for having no measurable improvement on risk, whether the confidence in estimates and decisions seem to increase.<ref name="Risk Management pg. 46"/>
 
{{TOC limit|3}}
 
==Introduction==
 
A widely used vocabulary for risk management is defined by ISO Guide 73, "Risk management. Vocabulary."<ref name=voc/>
 
In ideal risk management, a prioritization process is followed whereby the risks with the greatest loss (or impact) and the greatest [[probability]] of occurring are handled first, and risks with lower probability of occurrence and lower loss are handled in descending order. In practice the process of assessing overall risk can be difficult, and balancing resources used to mitigate between risks with a high probability of occurrence but lower loss versus a risk with high loss but lower probability of occurrence can often be mishandled.
 
: Intangible risk management identifies a new type of a risk that has a 100% probability of occurring but is ignored by the organization due to a lack of identification ability. For example, when deficient knowledge is applied to a situation, a [[knowledge]] risk materializes. Relationship risk appears when ineffective collaboration occurs. Process-engagement risk may be an issue when ineffective operational procedures are applied. These risks directly reduce the productivity of knowledge workers, decrease cost-effectiveness, profitability, service, quality, reputation, brand value, and earnings quality. Intangible risk management allows risk management to create immediate value from the identification and reduction of risks that reduce productivity.
 
Risk management also faces difficulties in allocating resources. This is the idea of [[opportunity cost]]. Resources spent on risk management could have been spent on more profitable activities. Again, ideal risk management minimizes spending (or manpower or other resources) and also minimizes the negative effects of risks.
 
===Method===
For the most part, these methods consist of the following elements, performed, more or less, in the following order.
 
# identify, characterize [[threat]]s
# assess the [[vulnerability]] of critical assets to specific threats
# determine the [[risk]] (i.e. the expected likelihood and consequences of specific types of attacks on specific assets)
# identify ways to reduce those risks
# [[:wikt:prioritize|prioritize]] risk reduction measures based on a strategy
 
===Principles of risk management===
The [[International Organization for Standardization]] (ISO) identifies the following principles of risk management:<ref name="iso3100">{{Cite news |title=Committee Draft of ISO 31000 Risk management |publisher=[[International Organization for Standardization]] |url=http://www.nsai.ie/uploads/file/N047_Committee_Draft_of_ISO_31000.pdf |format=PDF|publication-date = 2007-06-15}}</ref>
 
Risk management should:
* create [[value (economics)|value]] – resources expended to mitigate risk should be less than the consequence of inaction, or (as in [[value engineering]]), the gain should exceed the pain
* be an integral part of organizational processes
* be part of decision making process
* explicitly address uncertainty and assumptions
* be systematic and structured process
* be based on the best available information
* be tailorable
* take human factors into account
* be transparent and inclusive
* be dynamic, iterative and responsive to change
* be capable of continual improvement and enhancement
* be continually or periodically re-assessed
 
==Process==
According to the standard [[ISO 31000]] "Risk management – Principles and guidelines on implementation,"<ref name=iso /> the process of risk management consists of several steps as follows:
 
===Establishing the context===
This involves:
 
#identification of risk in a selected domain of interest
#planning the remainder of the process
#mapping out the following:
#*the social scope of risk management
#*the identity and objectives of [[Project stakeholder|stakeholders]]
#*the basis upon which risks will be evaluated, constraints.
#defining a framework for the activity and an agenda for identification
#developing an analysis of risks involved in the process
#mitigation or solution of risks using available technological, human and organizational resources.
 
===Identification===
After establishing the context, the next step in the process of managing risk is to identify potential risks. Risks are about events that, when triggered, cause problems or benefits. Hence, risk identification can start with the source of our problems and those of our competitors (benefit), or with the problem itself.
* Source analysis{{Citation needed|date=March 2009}} - Risk sources may be internal or external to the system that is the target of risk management (use mitigation instead of management since by its own definition risk deals with factors of decision-making that cannot be managed).
Examples of risk sources are: stakeholders of a project, employees of a company or the weather over an airport.
* Problem analysis{{Citation needed|date=March 2009}} - Risks are related to identified threats. For example: the threat of losing money, the threat of abuse of confidential information or the threat of human errors, accidents and casualties. The threats may exist with various entities, most important with shareholders, customers and legislative bodies such as the government.
When either source or problem is known, the events that a source may trigger or the events that can lead to a problem can be investigated. For example: stakeholders withdrawing during a project may endanger funding of the project; confidential information may be stolen by employees even within a closed network; lightning striking an aircraft during takeoff may make all people on board immediate casualties.
 
The chosen method of identifying risks may depend on culture, industry practice and compliance. The identification methods are formed by templates or the development of templates for identifying source, problem or event. Common risk identification methods are:
* Objectives-based risk identification {{Citation needed|date=March 2009}} - Organizations and project teams have objectives. Any event that may endanger achieving an objective partly or completely is identified as risk.
* Scenario-based risk identification - In [[scenario analysis]] different scenarios are created. The scenarios may be the alternative ways to achieve an objective, or an analysis of the interaction of forces in, for example, a market or battle. Any event that triggers an undesired scenario alternative is identified as risk – see [[Futures Studies]] for methodology used by [[Futurists]].
* Taxonomy-based risk identification - The taxonomy in taxonomy-based risk identification is a breakdown of possible risk sources. Based on the taxonomy and knowledge of best practices, a questionnaire is compiled. The answers to the questions reveal risks.<ref>[http://www.sei.cmu.edu/library/abstracts/reports/93tr006.cfm CMU/SEI-93-TR-6 Taxonomy-based risk identification in software industry]. Sei.cmu.edu. Retrieved on 2012-04-17.</ref>
* Common-risk checking {{citation needed|date=June 2013}} - In several industries, lists with known risks are available. Each risk in the list can be checked for application to a particular situation.<ref>[http://cve.mitre.org Common Vulnerability and Exposures list]. Cve.mitre.org. Retrieved on 2012-04-17.</ref>
* Risk charting <ref>{{cite book|last=Crockford|first=Neil|title=An Introduction to Risk Management|location=Cambridge, UK|publisher=Woodhead-Faulkner|edition=2|year=1986|page=18|isbn=0-85941-332-2}}</ref> - This method combines the above approaches by listing resources at risk, threats to those resources, modifying factors which may increase or decrease the risk and consequences it is wished to avoid. Creating a [[Risk Matrix|matrix]] under these headings enables a variety of approaches. One can begin with resources and consider the threats they are exposed to and the consequences of each. Alternatively one can start with the threats and examine which resources they would affect, or one can begin with the consequences and determine which combination of threats and resources would be involved to bring them about.
 
===Assessment===
{{Main| risk assessment}}
Once risks have been identified, they must then be assessed as to their potential severity of impact (generally a negative impact, such as damage or loss) and to the probability of occurrence. These quantities can be either simple to measure, in the case of the value of a lost building, or impossible to know for sure in the case of the probability of an unlikely event occurring. Therefore, in the assessment process it is critical to make the best educated decisions in order to properly prioritize the implementation of the [[risk management plan]].
 
Even a short-term positive improvement can have long-term negative impacts. Take the "turnpike" example. A highway is widened to allow more traffic. More traffic capacity leads to greater development in the areas surrounding the improved traffic capacity. Over time, traffic thereby increases to fill available capacity. Turnpikes thereby need to be expanded in a seemingly endless cycles. There are many other engineering examples where expanded capacity (to do any function) is soon filled by increased demand. Since expansion comes at a cost, the resulting growth could become unsustainable without forecasting and management.
 
The fundamental difficulty in risk assessment is determining the rate of occurrence since statistical information is not available on all kinds of past incidents. Furthermore, evaluating the severity of the consequences (impact) is often quite difficult for intangible assets. Asset valuation is another question that needs to be addressed. Thus, best educated opinions and available statistics are the primary sources of information. Nevertheless, risk assessment should produce such information for the management of the organization that the primary risks are easy to understand and that the risk management decisions may be prioritized. Thus, there have been several theories and attempts to quantify risks. Numerous different risk formulae exist, but perhaps the most widely accepted formula for risk quantification is:
 
: Rate (or probability) of occurrence multiplied by the impact of the event equals risk magnitude
 
==Composite Risk Index==
The above formula can also be re-written in terms of a Composite Risk Index, as follows:
 
'''Composite Risk Index = Impact of Risk event x Probability of Occurrence'''
 
The impact of the risk event is commonly assessed on a scale of 1 to 5, where 1 and 5 represent the minimum and maximum possible impact of an occurrence of a risk (usually in terms of financial losses). However, the 1 to 5 scale can be arbitrary and need not be on a linear scale.
 
The probability of occurrence is likewise commonly assessed on a scale from 1 to 5, where 1 represents a very low probability of the risk event actually occurring while 5 represents a very high probability of occurrence. This axis may be expressed in either mathematical terms (event occurs once a year, once in ten years, once in 100 years etc.) or may be expressed in "plain english" (event has occurred here very often; event has been known to occur here; event has been known to occur in the industry etc.). Again, the 1 to 5 scale can be arbitrary or non-linear depending on decisions by subject-matter experts.
 
The Composite Index thus can take values ranging (typically) from 1 through 25, and this range is usually arbitrarily divided into three sub-ranges. The overall risk assessment is then Low, Medium or High, depending on the sub-range containing the calculated value of the Composite Index. For instance, the three sub-ranges could be defined as 1 to 8, 9 to 16 and 17 to 25.
 
Note that the probability of risk occurrence is difficult to estimate, since the past data on frequencies are not readily available, as mentioned above. After all, probability does not imply certainty.
 
Likewise, the impact of the risk is not easy to estimate since it is often difficult to estimate the potential loss in the event of risk occurrence.
 
Further, both the above factors can change in magnitude depending on the adequacy of risk avoidance and prevention measures taken and due to changes in the external business environment. Hence it is absolutely necessary to periodically re-assess risks and intensify/relax mitigation measures, or as necessary.
Changes in procedures, technology, schedules, budgets, market conditions, political environment, or other factors typically require re-assessment of risks.
 
==Risk Options==
Risk mitigation measures are usually formulated according to one or more of the following major risk options, which are:
 
#Design a new business process with adequate built-in risk control and containment measures from the start.
#Periodically re-assess risks that are accepted in ongoing processes as a normal feature of business operations and modify mitigation measures.
#Transfer risks to an external agency (e.g. an insurance company)
#Avoid risks altogether (e.g. by closing down a particular high-risk business area)
 
Later research{{Citation needed|date=March 2009}} has shown that the financial benefits of risk management are less dependent on the formula used but are more dependent on the frequency and how risk assessment is performed.
 
In business it is imperative to be able to present the findings of risk assessments in financial, market, or schedule terms. Robert Courtney Jr. (IBM, 1970) proposed a formula for presenting risks in financial terms. The Courtney formula was accepted as the official risk analysis method for the US governmental agencies. The formula proposes calculation of ALE (annualised loss expectancy) and compares the expected loss value to the security control implementation costs ([[cost-benefit analysis]]).
 
===Potential risk treatments===
Once risks have been identified and assessed, all techniques to manage the risk fall into one or more of these four major categories:<ref>{{cite book |last=Dorfman|first=Mark S. |title=Introduction to Risk Management and Insurance|edition=9 |publisher=Prentice Hall |location=Englewood Cliffs, N.J |year=2007 |pages= |isbn=0-13-224227-3 |oclc= |doi= |accessdate=}}</ref>
 
* Avoidance (eliminate, withdraw from or not become involved)
* Reduction (optimize – mitigate)
* Sharing (transfer – outsource or insure)
* Retention (accept and budget)
 
Ideal use of these strategies may not be possible. Some of them may involve trade-offs that are not acceptable to the organization or person making the risk management decisions. Another source, from the US Department of Defense (see link), [[Defense Acquisition University]], calls these categories ACAT, for Avoid, Control, Accept, or Transfer. This use of the ACAT acronym is reminiscent of another ACAT (for Acquisition Category) used in US Defense industry procurements, in which Risk Management figures prominently in decision making and planning.
 
====Risk avoidance====
This includes not performing an activity that could carry risk. An example would be not buying a [[Real property|property]] or business in order to not take on the [[legal liability]] that comes with it. Another would be not flying in order not to take the risk that the [[airplane]] were to be [[Aircraft hijacking|hijack]]ed. Avoidance may seem the answer to all risks, but avoiding risks also means losing out on the potential gain that accepting (retaining) the risk may have allowed. Not entering a business to avoid the risk of loss also avoids the possibility of earning profits. Increasing risk regulation in hospitals has led to avoidance of treating higher risk conditions, in favour of patients presenting with lower risk.<ref>{{cite journal|last=McGivern|first=Gerry|coauthors=Fischer, Michael D.|title=Reactivity and reactions to regulatory transparency in medicine, psychotherapy and counselling|journal=Social Science & Medicine|date=1 February 2012|volume=74|issue=3|pages=289–296|doi=10.1016/j.socscimed.2011.09.035}}</ref>
 
==== Hazard prevention ====
{{Main|Hazard prevention}}
[[Hazard (risk)|Hazard]] prevention refers to the prevention of risks in an emergency. The first and most effective stage of hazard prevention is the elimination of hazards. If this takes too long, is too costly, or is otherwise impractical, the second stage is [[Disaster mitigation#Mitigation|mitigation]].
 
====Risk reduction====
Risk reduction or "optimization" involves reducing the severity of the loss or the likelihood of the loss from occurring. For example, [[Fire sprinkler|sprinkler]]s are designed to put out a [[fire]] to reduce the risk of loss by fire. This method may cause a greater loss by water damage and therefore may not be suitable. [[Halomethane|Halon]] fire suppression systems may mitigate that risk, but the cost may be prohibitive as a [[strategy]].
 
Acknowledging that risks can be positive or negative, optimizing risks means finding a balance between negative risk and the benefit of the operation or activity; and between risk reduction and effort applied. By an offshore drilling contractor effectively applying HSE Management in its organization, it can optimize risk to achieve levels of residual risk that are tolerable.<ref>IADC HSE Case Guidelines for MODUs 3.2, section 4.7</ref>
 
Modern software development methodologies reduce risk by developing and delivering software incrementally. Early methodologies suffered from the fact that they only delivered software in the final phase of development; any problems encountered in earlier phases meant costly rework and often jeopardized the whole project. By developing in iterations, software projects can limit effort wasted to a single iteration.
 
[[Outsourcing]] could be an example of risk reduction if the outsourcer can demonstrate higher capability at managing or reducing risks.<ref>{{cite journal|last=Roehrig|first=P|year=2006|url=http://www.btquarterly.com/?mc=bet-governance&page=ss-viewresearch|title=Bet On Governance To Manage Outsourcing Risk|journal=Business Trends Quarterly}}</ref> For example, a company may outsource only its software development, the manufacturing of hard goods, or customer support needs to another company, while handling the business management itself. This way, the company can concentrate more on business development without having to worry as much about the manufacturing process, managing the development team, or finding a physical location for a call center.
 
====Risk sharing====
Briefly defined as "sharing with another party the burden of loss or the benefit of gain, from a risk, and the measures to reduce a risk."
 
The term of 'risk transfer' is often used in place of risk sharing in the mistaken belief that you can transfer a risk to a third party through insurance or outsourcing. In practice if the insurance company or contractor go bankrupt or end up in court, the original risk is likely to still revert to the first party. As such in the terminology of practitioners and scholars alike, the purchase of an insurance contract is often described as a "transfer of risk." However, technically speaking, the buyer of the contract generally retains [[legal risk|legal responsibility]] for the losses "transferred", meaning that insurance may be described more accurately as a post-event compensatory mechanism. For example, a personal injuries insurance policy does not transfer the risk of a car accident to the insurance company. The risk still lies with the policy holder namely the person who has been in the accident. The insurance policy simply provides that if an accident (the event) occurs involving the policy holder then some compensation may be payable to the policy holder that is commensurate to the suffering/damage.
 
Some ways of managing risk fall into multiple categories. Risk retention pools are technically retaining the risk for the group, but spreading it over the whole group involves transfer among individual members of the group. This is different from traditional [[insurance]], in that no premium is exchanged between members of the group up front, but instead losses are assessed to all members of the group.
 
====Risk retention====
Involves accepting the loss, or benefit of gain, from a risk when it occurs. True [[self insurance]] falls in this category. Risk retention is a viable strategy for small risks where the cost of insuring against the risk would be greater over time than the total losses sustained. All risks that are not avoided or transferred are retained by default. This includes risks that are so large or catastrophic that they either cannot be insured against or the premiums would be infeasible. [[War]] is an example since most property and risks are not insured against war, so the loss attributed by war is retained by the insured. Also any amounts of potential loss (risk) over the amount insured is retained risk. This may also be acceptable if the chance of a very large loss is small or if the cost to insure for greater coverage amounts is so great it would hinder the goals of the organization too much.
 
===Create a risk management plan===
{{main|Risk management plan}}
 
Select appropriate controls or countermeasures to measure each risk. Risk mitigation needs to be approved by the appropriate level of management. For instance, a risk concerning the image of the organization should have top management decision behind it whereas IT management would have the authority to decide on computer virus risks.
 
The risk management plan should propose applicable and effective security controls for managing the risks. For example, an observed high risk of computer viruses could be mitigated by acquiring and implementing antivirus software. A good risk management plan should contain a schedule for control implementation and responsible persons for those actions.
 
According to [[ISO/IEC 27001]], the stage immediately after completion of the [[risk assessment]] phase consists of preparing a Risk Treatment Plan, which should document the decisions about how each of the identified risks should be handled. Mitigation of risks often means selection of [[security controls]], which should be documented in a Statement of Applicability, which identifies which particular control objectives and controls from the
standard have been selected, and why.
 
===Implementation===
Implementation follows all of the planned methods for mitigating the effect of the risks. Purchase insurance policies for the risks that have been decided to be transferred to an insurer, avoid all risks that can be avoided without sacrificing the entity's goals, reduce others, and retain the rest.
 
===Review and evaluation of the plan===
Initial risk management plans will never be perfect. Practice, experience, and actual loss results will necessitate changes in the plan and contribute information to allow possible different decisions to be made in dealing with the risks being faced.
 
[[Risk analysis (business)|Risk analysis]] results and management plans should be updated periodically. There are two primary reasons for this:
# to evaluate whether the previously selected security controls are still applicable and effective
# to evaluate the possible risk level changes in the business environment. For example, information risks are a good example of rapidly changing business environment.
 
==Limitations==
 
Prioritizing the ''risk management processes'' too highly could keep an organization from ever completing a project or even getting started. This is especially true if other work is suspended until the risk management process is considered complete.
 
It is also important to keep in mind the distinction between risk and [[uncertainty]]. Risk can be measured by impacts x probability.
 
If risks are improperly assessed and prioritized, time can be wasted in dealing with risk of losses that are not likely to occur. Spending too much time assessing and managing unlikely risks can divert resources that could be used more profitably. Unlikely events do occur but if the risk is unlikely enough to occur it may be better to simply retain the risk and deal with the result if the loss does in fact occur. Qualitative risk assessment is subjective and lacks consistency. The primary justification for a formal risk assessment process is legal and bureaucratic.
 
==Areas of risk management==
As applied to [[corporate finance]], ''risk management'' is the technique for measuring, monitoring and controlling the financial or [[operational risk]] on a firm's [[balance sheet]]. See [[value at risk]].
 
The [[Basel II]] framework breaks risks into [[market risk]] (price risk), [[credit risk]] and operational risk and also specifies methods for calculating [[capital requirement]]s for each of these components.
 
===Enterprise risk management===
{{Main|Enterprise Risk Management}}
In enterprise risk management, a risk is defined as a possible event or circumstance that can have negative influences on the enterprise in question. Its impact can be on the very existence, the resources (human and capital), the products and services, or the customers of the enterprise, as well as external impacts on society, markets, or the environment. In a financial institution, enterprise risk management is normally thought of as the combination of credit risk, [[interest rate risk]] or [[asset liability management]], liquidity risk, market risk, and operational risk.
 
In the more general case, every probable risk can have a pre-formulated plan to deal with its possible consequences (to ensure ''contingency'' if the risk becomes a ''liability'').
 
From the information above and the average cost per employee over time, or [[cost accrual ratio]], a project manager can estimate:
 
* the cost associated with the risk if it arises, estimated by multiplying employee costs per unit time by the estimated time lost (''cost impact'', ''C'' where ''C = cost accrual ratio * S'').
* the probable increase in time associated with a risk (''schedule variance due to risk'', ''Rs'' where Rs = P * S):
** Sorting on this value puts the highest risks to the schedule first. This is intended to cause the greatest risks to the project to be attempted first so that risk is minimized as quickly as possible.
** This is slightly misleading as ''schedule variances'' with a large P and small S and vice versa are not equivalent. (The risk of the [[RMS Titanic|RMS ''Titanic'']] sinking vs. the passengers' meals being served at slightly the wrong time).
* the probable increase in cost associated with a risk (''cost variance due to risk'', ''Rc'' where Rc = P*C = P*CAR*S = P*S*CAR)
** sorting on this value puts the highest risks to the budget first.
** see concerns about ''schedule variance'' as this is a function of it, as illustrated in the equation above.
 
Risk in a [[project]] or [[business process|process]] can be due either to [[Special Cause Variation]] or [[Common Cause Variation]] and requires appropriate treatment. That is to re-iterate the concern about extremal cases not being equivalent in the list immediately above.
 
===Medical device risk management===
For medical devices, risk management is a process for identifying, evaluating and mitigating risks associated with harm to people and damage to property or the environment. Risk management is an integral part of medical device design and development, production processes and evaluation of field experience, and is applicable to all types of medical devices. The evidence of its application is required by most regulatory bodies such as FDA. The management of risks for medical devices is described by the International Organization for Standardization (ISO) in ISO 14971:2007, Medical Devices—The application of risk management to medical devices, a product safety standard. The standard provides a process framework and associated requirements for management responsibilities, risk analysis and evaluation, risk controls and lifecycle risk management.
 
The European version of the risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN 14971:2012 are identical to ISO 14971:2007. The only difference is an Annex that refers to the new MDD and AIMDD.
 
Typical risk analysis and evaluation techniques adopted by the medical device industry include hazard analysis, fault tree analysis (FTA), failure mode and effect analysis (FMEA), hazard and operability study (HAZOP), and risk traceability analysis for ensuring risk controls are implemented and effective (i.e. tracking risks identified to product requirements, design specifications, verification and validation results etc.)
 
FTA analysis requires diagram editors such as Microsoft Visio. FMEA analysis can be done using Microsoft Excel. There are also integrated medical device risk management solutions, such as [http://www.gessnet.com/#!products/cog4 GessNet TurboAC™ risk management software].
 
Through a [http://www.fda.gov/medicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm206153.htm draft guidance], FDA has introduced another method named "Safety Assurance Case" for medical device safety assurance analysis. The safety assurance case is structured argument reasoning about systems appropriate for scientists and engineers, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is safe for a given application in a given environment. With the guidance, a safety assurance case is expected for safety critical devices (e.g. infusion devices) as part of the pre-market clearance submission, e.g. 510(k). In 2013, FDA introduced another draft guidance expecting medical device manufacturers to submit cybersecurity risk analysis information. Here is a [http://www.gessnet.com/#!background/c1sfr brief background] of FDA's move on related topics.
 
===Risk management activities as applied to project management===
In [[project management]], risk management includes the following activities:
* Planning how risk will be managed in the particular project. Plans should include risk management tasks, responsibilities, activities and budget.
* Assigning a risk officer – a team member other than a project manager who is responsible for foreseeing potential project problems. Typical characteristic of risk officer is a healthy skepticism.
* Maintaining live project risk database. Each risk should have the following attributes: opening date, title, short description, probability and importance. Optionally a risk may have an assigned person responsible for its resolution and a date by which the risk must be resolved.
* Creating anonymous risk reporting channel. Each team member should have the possibility to report risks that he/she foresees in the project.
* Preparing mitigation plans for risks that are chosen to be mitigated. The purpose of the mitigation plan is to describe how this particular risk will be handled – what, when, by whom and how will it be done to avoid it or minimize consequences if it becomes a liability.
* Summarizing planned and faced risks, effectiveness of mitigation activities, and effort spent for the risk management.
 
===Risk management for megaprojects===
[[Megaprojects]] (sometimes also called "major programs") are extremely large-scale investment projects, typically costing more than US$1 billion per project. Megaprojects include bridges, tunnels, highways, railways, airports, seaports, power plants, dams, wastewater projects, coastal flood protection schemes, oil and natural gas extraction projects, public buildings, information technology systems, aerospace projects, and defence systems. Megaprojects have been shown to be particularly risky in terms of finance, safety, and social and environmental impacts.<ref name="Megaprojects and Risk">{{cite book|first=Bent|last=Flyvbjerg|title=Megaprojects and Risk: An Anatomy of Ambition|publisher=Cambridge University Press. ISBN 0521804205|year=2003}}</ref> Risk management is therefore particularly pertinent for megaprojects and special methods and special education have been developed for such risk management.<ref>[[Oxford BT Centre for Major Programme Management]]</ref>
 
===Risk management regarding natural disasters===
It is important to assess risk in regard to natural disasters like [[Flood risk assessment|floods]], [[seismic hazard|earthquakes]], and so on. Outcomes of natural disaster risk assessment are valuable when considering future repair costs, business interruption losses and other downtime, effects on the environment, insurance costs, and the proposed costs of reducing the risk.<ref>{{cite book|title=Acceptable Risk Processes: Lifelines and Natural Hazards|year=2002|publisher=ASCE, TCLEE|location=Reston, VA|isbn=9780784406236|url=http://www.asce.org/Product.aspx?id=2147485887&productid=5260|editor=Craig Taylor and Erik VanMarcke}}</ref> There are regular [[International Disaster and Risk Conference|conferences in Davos]] to deal with integral risk management.
 
===Risk management of information technology===
{{Main|IT risk management}}
[[Information technology]] is increasingly pervasive in modern life in every sector.<ref>
{{cite book |last1= Cortada|first1= James W.|title= The Digital Hand: How Computers Changed the Work of American Manufacturing, Transportation, and Retail Industries |date=2003-12-04 |year= |publisher= Oxford University Press|location=USA|isbn= 0-19-516588-8|page= 512}}
</ref><ref>
{{cite book |last1= Cortada|first1= James W.|title= The Digital Hand: Volume II: How Computers Changed the Work of American Financial, Telecommunications, Media, and Entertainment Industries |date=2005-11-03|publisher= Oxford University Press|location=USA|isbn= 978-0-19-516587-6 }}
</ref><ref>
{{cite book |last1= Cortada|first1= James W.|title= The Digital Hand, Vol 3: How Computers Changed the Work of American Public Sector Industries |date=2007-11-06 |year= |publisher= Oxford University Press|location=USA|isbn= 978-0-19-516586-9|page= 496}}
</ref>
 
[[IT risk]] is a risk related to information technology. This is a relatively new term due to an increasing awareness that [[information security]] is simply one facet of a multitude of risks that are relevant to IT and the real world processes it supports.
 
A number of [[IT risk management#Risk management methodology|methodologies]] have been developed to deal with this kind of risk.
 
[[ISACA]]'s ''[[Risk IT]]'' framework ties IT risk to [[enterprise risk management]].
 
===Risk management techniques in petroleum and natural gas===
For the offshore oil and gas industry, operational risk management is regulated by the [[safety case]] regime in many countries. Hazard identification and risk assessment tools and techniques are described in the international standard ISO 17776:2000, and organisations such as the IADC (International Association of Drilling Contractors) publish guidelines for HSE Case development which are based on the ISO standard. Further, diagrammatic representations of hazardous events are often expected by governmental regulators as part of risk management in safety case submissions; these are known as '''bow-tie''' diagrams. The technique is also used by organisations and regulators in mining, aviation, health, defence, industrial and finance.<ref name="bowtiexp.com.au">[http://www.bowtiexp.com.au/bowtiexp.asp#aboutBowTies RPS HSE & Risk Management]. BowtieXP. Retrieved on 2012-04-17.</ref>
 
===Risk management as applied to the pharmaceutical sector===
The principles and tools for quality risk management are increasingly being applied to different aspects of pharmaceutical quality systems. These aspects include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products). Risk management is also applied to the assessment of [http://www.pharmamanufacturing.com/articles/2011/126.html microbiological contamination] in relation to pharmaceutical products and cleanroom manufacturing environments.<ref name=Sandle>{{cite book | author = Saghee M, Sandle T, Tidswell E (editors) | title = Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices | edition = 1st | publisher = Business Horizons | year = 2011 | isbn = 978-8190646741}}</ref>
 
== Positive Risk Management ==
 
Positive Risk Management is an approach that recognizes the importance of the human factor and of individual differences in propensity for risk taking. It draws from the work of a number of academics and professionals who have expressed concerns about scientific rigor of the wider risk management debate,<ref>John Adams, RISK, Routledge 1995</ref> or who have made a contribution emphasizing the human dimension of risk.<ref>{{cite book|author1=David Hillson|author2=Ruth Murray-Webster|title=Understanding and Managing Risk Attitude|url=http://books.google.com/books?id=VeMdki1LYEUC|accessdate=17 April 2012|date=30 March 2007|publisher=Gower Publishing, Ltd.|isbn=978-0-566-08798-1}}</ref><ref>{{cite book|author=David Cooper|title=Leadership Risk: A Guide for Private Equity and Strategic Investors|url=http://books.google.com/books?id=6hoEbrk3xzcC|accessdate=17 April 2012|date=25 May 2010|publisher=John Wiley & Sons|isbn=978-0-470-03264-0}}</ref>
 
Firstly, it recognizes that any object or situation can be rendered hazardous by the involvement of someone with an inappropriate disposition towards risk; whether too risk taking or too risk averse.
 
Secondly, it recognizes that risk is an inevitable and ever present element throughout life: from conception through to the point at the end of life when we finally lose our personal battle with life threatening risk.
 
Thirdly, it recognizes that every individual has a particular orientation towards risk; while at one extreme people may by nature be timid, anxious and fearful, others will be adventurous, impulsive and almost oblivious to danger. These differences are evident in the way we drive our cars, in our diets, in our relationships, in our careers.
 
Finally, Positive Risk Management recognizes that risk taking is essential to all enterprise, creativity, heroism, education, scientific advance – in fact to any activity and all the initiatives that have contributed to our evolutionary success and civilization. It is worth noting how many enjoyable activities involve fear and willingly embrace risk taking.
 
Within the entire Risk Management literature (and this section of Wikipedia) you will find little or no reference to the human part of the risk equation other than what might be implied by the term 'compliant'. This illustrates the narrow focus that is a hall mark of much current risk management practice. This situation arises from the basic premises of traditional risk management and the practices associated with health and safety within the working environment. There is a basic logic to the idea that any accident must reflect some kind of oversight or situational predisposition that, if identified, can be rectified. But, largely due to an almost institutionalised neglect of the human factor, this situationally focused paradigm has grown tendrils that reach into every corner of modern life and into situations where the unintended negative consequences threaten to outweigh the benefits.
 
Positive Risk Management views both risk taking and risk aversion as complementary and of equal value and importance within the appropriate context. As such, it is seen as complementary to the traditional risk management paradigm. It introduces a much needed balance to risk management practices and puts greater onus on management skills and decision making. It is the dynamic approach of the football manager who appreciates the offensive and defensive talents within the available pool of players. Every organisation has roles better suited to risk takers and roles better suited to the risk averse. The task of management is to ensure that the right people are placed in each job.
 
Positive Risk Management relies on the ability to identify individual differences in propensity for risk taking. The science in this area has been developing rapidly over the past decade within the domain of personality assessment. Once an area of almost tribal allegiance to different schools of thought, today there is wide spread consensus about the structure of personality assessment and its status within the framework of the cross disciplinary progress being made in our understanding of Human Nature. The Five Factor Model (FFM)<ref>{{cite journal|doi=10.1146/annurev.ps.41.020190.002221|title=Personality Structure: Emergence of the Five-Factor Model|year=1990|last1=Digman|first1=J M|journal=Annual Review of Psychology|volume=41|page=417}}</ref> of personality has been shown to have relevance across many different cultures, to remain consistent over adult working life and to be significantly heritable. Within this framework there are many strands which have a clear relationship to risk tolerance and risk taking. For example, Eysenck (1973) reports that personality influences whether we focus on what might go wrong or on potential benefits;<ref>Eysenck M. W. (1992) Anxiety and The Cognitive Perspective. Hillsdale: Lawrence Erlbaum Associates</ref> Nicholson et al. (2005) report that higher extroversion is related to greater risk tolerance;<ref>{{cite journal|author=Nicholson, N., Soane, E., Fenton-O'Creevy, M., & Willman, P.|year=2005|title= Personality and domain specific risk taking|doi=10.1080/1366987032000123856|journal= Journal of Risk Research|pages= 157–176|volume= 8|issue=2}}</ref> McCrae and Costa (1997) link personality to tolerance of uncertainty, innovation and willingness to think outside the box;<ref>McCrae, R., & Costa, P.T. (1997) Conceptions and correlates of Openness to Experience. In J. Johnson, R Hogan and S. Briggs (Eds.) Handbook of Personality Psychology. London: Academic Press.</ref> Kowert, 1997) links personality to adventurousness, imagination, the search for new experiences and actively seeking out risk.<ref>{{cite journal|author=Kowert, P.A., & Hermann, M.G. |year=1997|title= Who takes risks? Daring and caution in foreign policy making|jstor=174466|doi=10.1177/0022002797041005001 |journal= Journal od Conflict Resolution|volume= 411|pages= 611–37|issue=5}}</ref> Building from these foundations of well validated assessment practices, more specialized assessments have been developed, including assessment of Risk Type.<ref>Geoff Trickey (2011), Risk Types. OP Matters No 14 February 2012 The British Psychological Society</ref>
 
===Criticisms===
 
However, researchers at the [[University of Oxford]] and [[King's College London]] found that the notion of complementarity may be a concept that does not work in practice. In a four-year organizational study of risk management in a leading healthcare organization, [http://oxford.academia.edu/MichaelFischer Fischer & Ferlie] ( 2013) found major contradictions between rules-based risk management required by managers, and ethics-based self-regulation favoured by staff and clients. This produced tensions that led neither to complementarity nor to hybrid forms, but produced instead a heated and intractable conflict which escalated, resulting in crisis and organizational collapse.<ref>{{cite journal|last=Fischer|first=Michael Daniel|coauthors=Ferlie, Ewan|title=Resisting hybridisation between modes of clinical risk management: Contradiction, contest, and the production of intractable conflict|journal=Accounting, Organizations and Society|date=1 January 2013|volume=38|issue=1|pages=30–49|doi=10.1016/j.aos.2012.11.002|accessdate=22 February 2013}}</ref>
 
The graveyard of former greats is littered with examples where the balance of risk went seriously awry; the ENRON and RBS stories have become iconic references in the pantheon of corporate governance and corporate mortality. Eastman Kodak might be a nominee for the opposite pole – the corporately risk averse.
 
==Risk management and business continuity==
Risk management is simply a practice of systematically selecting cost-effective approaches for minimising the effect of threat realization to the organization. All risks can never be fully avoided or mitigated simply because of financial and practical limitations. Therefore, all organizations have to accept some level of residual risks.{{fact|date=January 2014}}
 
Whereas risk management tends to be preemptive, [[business continuity planning]] (BCP) was invented to deal with the consequences of realised residual risks. The necessity to have BCP in place arises because even very unlikely events will occur if given enough time. Risk management and BCP are often mistakenly seen as rivals or overlapping practices. In fact, these processes are so tightly tied together that such separation seems artificial. For example, the risk management process creates important inputs for the BCP (e.g., assets, impact assessments, cost estimates). Risk management also proposes applicable controls for the observed risks. Therefore, risk management covers several areas that are vital for the BCP process. However, the BCP process goes beyond risk management's preemptive approach and assumes that the disaster '''will''' happen at some point.{{fact|date=January 2014}}
 
==Risk communication==
Risk communication is a complex cross-disciplinary academic field. Problems for risk communicators involve how to reach the intended audience, to make the risk comprehensible and relatable to other risks, how to pay appropriate respect to the audience's values related to the risk, how to predict the audience's response to the communication, etc. A main goal of risk communication is to improve collective and individual decision making. Risk communication is somewhat related to [[crisis communication]].
 
===Seven cardinal rules for the practice of risk communication===
(as expressed by the [[United States Environmental Protection Agency|U.S. Environmental Protection Agency]] and several of the field's founders<ref>{{cite book|title=Seven Cardinal Rules of Risk Communication|first=Vincent T.|last=Covello|first2= Frederick H.|last2=Allen.|publisher=U.S. Environmental Protection Agency|location=Washington, DC|date=April 1988|id= OPA-87-020}}</ref>)
 
*Accept and involve the public/other consumers as legitimate partners (e.g. stakeholders).
*Plan carefully and evaluate your efforts with a focus on your strengths, weaknesses, opportunities, and threats (SWOT).
*Listen to the stakeholders specific concerns.
*Be honest, frank, and open.
*Coordinate and collaborate with other credible sources.
*Meet the needs of the media.
*Speak clearly and with compassion.
 
==See also==
{{div col|cols=3}}
* [[Airmic]]
* [[Chief risk officer]]
* [[Environmental Risk Management Authority]]
* [[Event chain methodology]]
* [[Financial risk management]]
* [[Fuel price risk management]]
* [[Global Association of Risk Professionals]]
* [[Hazard and operability study]]
* [[International Risk Governance Council]]
* [[International Swaps and Derivatives Association]]
* [[ISO 31000]]
* [[List of finance topics]]
* [[List of project management topics]]
* [[Loss-control consultant]]
* [[Managerial risk accounting]]
* [[Operational risk management]]
* [[Optimism bias]]
* [[Precautionary principle]]
* [[Process Safety Management]]
* [[Professional Risk Managers' International Association]]
* [[Public Entity Risk Institute]]
* [[Reference class forecasting]]
* [[RiskAoA]]
* [[Risk assessment]]
* [[Risk governance]]
* [[Risk homeostasis]]
* [[Risk Management Agency]]
* [[Risk Management Authority]]
* [[Risk Management Information Systems]]
* [[Risk Management Programme]]
* [[Risk management tools]]
* [[Risk register]]
* [[Roy's safety-first criterion]]
* [[Society for Risk Analysis]]
* [[RiskLab]]
* [[Social risk management]]
* [[Social vulnerability]]
* [[Substantial equivalence]]
* [[Supply Chain Risk Management]]
* [[Vulnerability assessment]]
* [[Global Risk Forum GRF Davos]]
{{div col end}}
 
==References==
{{Reflist|35em}}
 
==Further reading==
* Airmic / Alarm / IRM (2010) "A structured approach to Enterprise Risk Management (ERM) and the requirements of ISO 31000" http://www.theirm.org/documents/SARM_FINAL.pdf
* {{cite journal | author = Alberts, Christopher | coauthors = Audrey Dorofee, Lisa Marino | title = Mission Diagnostic Protocol, Version 1.0: A Risk-Based Approach for Assessing the Potential for Success | publisher = [[Software Engineering Institute]] | date = March 2008 | url = http://www.sei.cmu.edu/library/abstracts/reports/08tr005.cfm | accessdate = 2008-05-26}}
* {{cite book |author= Alexander, Carol and Sheedy, Elizabeth |title=The Professional Risk Managers' Handbook: A Comprehensive Guide to Current Theory and Best Practices |publisher=PRMIA Publications |location= |year=2005 |pages= |isbn=0-9766097-0-3 |oclc= |doi= |accessdate=}}
*{{cite journal | author = Altemeyer, Lynn | title = An Assessment of Texas State Government: Implementation of Enterprise Risk Management, Applied Research Project | publisher = Texas State University | year = 2004 | url = http://ecommons.txstate.edu/arp/14/}}
* {{cite book |last=Borodzicz|first=Edward |title=Risk, Crisis and Security Management |publisher=Wiley |location=New York |year=2005 |pages= |isbn=0-470-86704-3 |oclc= |doi= |accessdate=}}
* {{cite book |last=Gorrod|first=Martin |title=Risk Management Systems : Technology Trends (Finance and Capital Markets) |publisher=Palgrave Macmillan |location=Basingstoke |year=2004 |pages= |isbn=1-4039-1617-9}}
* Hopkin, Paul "Fundamentals of Risk Management 2nd Edition" Kogan-Page (2012) ISBN 978-0-7494-6539-1
* {{cite journal| last = Hutto | first = John | title = Risk Management in Law Enforcement, Applied Research Project | year = 2009 | publisher = Texas State University | url = http://ecommons.txstate.edu/arp/301/}}
* {{cite book |author= Institute of Risk Management/AIRMIC/ALARM|title=A Risk Management Standard |publisher=[[Institute of Risk Management]]|location=London |year=2002 |pages= |isbn= |url = http://www.theirm.org/publications/PUstandard.html}}
* {{cite report |first= John|last=Moteff|title=Risk Management and Critical Infrastructure Protection: Assessing, Integrating, and Managing Threats, Vulnerabilities and Consequences |publisher=Congressional Research Service|location=Washington DC |year=2005 |pages= |isbn= |url = http://opencrs.com/document/RL32561/2005-02-04}}
*{{cite book |author=Morgan, Granger, and Henrion, Max |title=Uncertainty: A Guide to Dealing with Uncertainty in Quantitative Risk and Policy Analysis|publisher=Cambridge University Press |year=1992 |isbn=0-5214274-4-4 }}
*{{cite book|author= National Institute for Occupational Safety and Health|title=System Safety and Risk Management: A Guide for Engineering Educators|location=Cincinnati, OH|year=1998|url=http://www.cdc.gov/niosh/topics/SHAPE/pdfs/safriskengineer.pdf}}
*{{cite book |author=Nederpelt, Peter van |title=Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk.|publisher=MicroData |year=2012 |isbn=978-1-291-037-35-7 }}
* {{cite book | last = Stoneburner | first = Gary | coauthors = Goguen, Alice and Feringa, Alexis | title = Risk Management Guide for Information Technology Systems | publisher = National Institute of Standards and Technology | month = July | year = 2002 | location = Gaithersburg, MD | url = http://csrc.nist.gov/publications/nistpubs/800-30/sp800-30.pdf|format=PDF}}
* {{cite book | author = United States Environmental Protection Agency | authorlink = United States Environmental Protection Agency | title = General Risk Management Program Guidance | publisher = United State Environmental Protection Agency | month = April | year = 2004 | url = http://www.epa.gov/OEM/content/rmp/rmp_guidance.htm#General}}
* {{cite journal | last = Ward | first = Dan | coauthors = Quaid, Chris | title = The Pursuit of Courage, Judgment and Luck | journal = Defense AT&L | pages = 28–30 | publisher = Defense Acquisition University | date = March/April 2007 | url = http://www.dau.mil/pubs/dam/03_04_2007/war_ma07.pdf | accessdate = 2008-05-26|format=PDF |archiveurl = http://web.archive.org/web/20080408205443/http://www.dau.mil/pubs/dam/03_04_2007/war_ma07.pdf |archivedate = 2008-04-08}}
 
{{Occupational safety and health|state=expanded}}
 
{{DEFAULTSORT:Risk Management}}
[[Category:Risk management| ]]
[[Category:Risk]]
[[Category:Actuarial science]]
[[Category:Management]]
[[Category:Project management]]
[[Category:Risk analysis|Risk analysis]]
[[Category:Security]]
[[Category:Communication studies]]