Risk Management Software

Enterprise Risk Management Software

Risk Management Software developed by www.risk-management-software.com

RISK MANAGEMENT SOFTWARE www.risk-management-software.com Risk management software is a software designed primarily to limit, reduce or lower the risk and security lapses, which organizations are exposed to in their day to day activities. This software is also known as compliance management software. The software works by way of identifying potential risks of an asset, wrong decisions, security breaches etc., within the IT system and alerting an Organization on where the risk lies. Such Organization can then control the risk. They also warns Organizations of impending IT breakdown which can seriously affect its operations. Bank and non-bank financial institutions uses risk management software more than organizations in the other sectors of a free enterprise economy. They are even more careful with the lessons learned from "Rogue Trader Nick Leeson" incident. www.risk-management-software.com The type of risks that the software is designed to guard against are: The regulatory agencies in some countries (Central Banks, Deposit Insurance Corporations) make it mandatory for Bank and non-Bank Financial institutions to have this software installed. www.risk-management-software.comBasel II Accord is an International Regulation put forward by International Committee on Bank Supervision to make sure that Financial Institutions that carries Riskier Assets provide enough Capital against that risk than those with safer portfolio. It also stipulates that Financial Institutions should publish a statement of risky investment and risk management practices. * Interest rate Risk * Credit Risk * Uncertainties in Financial Market * Attacks for Organization's Adversaries or Enemies e.g. DDOS attack. * Legal Liabilities * Product Failure * Data Breach Risk etc. Below are some risk management software firms and their products: * www.risk-management-software.com"Symbiant" is a software developed by software giant, Symbiant. It is preferred by users who are interested in the reduction in cost and effort needed to manage risk. It has a standard based approach to businesses system management. The software has necessary tools put in place to promote compliance and overall performance. * ENABLON "Incident Management" is another risk management software, developed by Enablon. It is integrated with the following features: compliance management, incident management, greater operational risk control etc. * EMEX "EMEX EHS Solution" is a software developed by EMEX, another software risk management firm. It is designed to create a web based solution in the area of efficiencies and compliance and ensure they are being effectively managed. * FAST TRACK www.risk-management-software.com"Fast Track" risk management software is owned by a firm called FAST TRACK. It is known to be very effective in the area of regulatory compliance in mission critical environment e.g. ISO9001, ISO14001 etc. Risk management software like Symbiant, Calipso, Entropy, Incident management and Emex are very rich in risk management and Compliance. They are preferred by some giants that integrated financial trading system in their platform. Other risk management software e.g. Analitica, Emex EHS Solution, Entropy and A1 Tracker are also used by organizations in their quest to manage their risk. The above software products are just stated to mention but a few as there are many others within the software risk management specialization.

Audit Management Software developed by www.risk-management-software.com

Audit Management Software. www.risk-management-software.com Audit Management Software is a software designed by experts who combined knowledge of accounting & auditing with that of information system. Many audit software, otherwise known as software audit tools are very sophisticated and are designed to take care of every aspect of audit management. Audit, been a statutory requirement of an organization, can be defined as: Examination and verification of the books, records and assets of an organization, in order to express an opinion. The auditor’s opinion will be on: (1.) Whether the books and records were properly and correctly kept or not. (2.) Whether the revenue account, profit and loss account, reveal the correct trading result of an organization or not. (3.) Whether the balance sheet shows the correct position of assets and liabilities as at a certain date or not. Audit management is the responsibility of audit managers and their audit teammate in an audit firm for external audit and the responsibility of audit personnel in an internal audit situation. www.risk-management-software.comA good Audit management software or auditing software as the case may be, should have components like: inventory management or inventory software, payroll management, asset management etc. These various components are then integrated and made to work together for system auditing and to produce needed result. The advantages of using audit management software cannot be over emphasized. Audit firms that wants to comply with industry’s best practices and can afford the cost of audit management software, with associated cost of training its members of staff, normally make use of audit management software. Audit management software reduces manpower cost as an audit assignment that can take two weeks to accomplish can be completed within four days for example. It makes audit report writing process easy for auditors. It is a good innovation about the way audit work is conducted and an audit firm that uses audit management software is considered to be better and more sophisticated than others who does not automate their audit procedure. www.risk-management-software.com We shall look into whether the use of audit software is mandatory or compulsory and should be used by audit firms. The only statutory requirement in most countries of the word is audit. An organization like limited Liability Companies and Corporations must be audited every year upon presentation of its accounts to the auditors by the directors of such organization. The auditor is expected to present audit report, www.risk-management-software.com, otherwise known as management letter to the directors and the directors must present the report to shareholders in an annual general meeting. The auditor must also file annual returns for taxation purposes. The auditor is not statutorily required to use audit software in other to do his work. The use of audit software is a recent phenomenon. Many auditing firms are still using manual method to do their work. However, there are numerous advantages of using audit management software which has made its use worthwhile for audit firms. Let us now look at some audit management software as a guide for prospective users: (1.) Symbiant: This software is popular because of its ability to handle any type of Risk and audit, internal audit, external audit and third party audit. (2.) Audit Management Software Systems: This another audit management software that can be used to audit organizations like life science and regulated companies, where regular audit is necessary in order to comply with safety and quality requirement. (3.) Policy and Procedure Management: This software was designed by a company called ComplianceBridge. The software is simple and easy to use and it is very good in the area of monitoring, auditing policy compliance and reporting. (4.) ACL Analitics Exchange: This is a software owned by ACL Services. It was designed for centralized projects and control monitoring. Other audit management software are: AuditPro, AUDITworks and Compliance manager, to mention but a few. www.risk-management-software.com The use of audit management software requires training and re-training of members of staff of audit firm. The training are expected to be provided most of the time, by the company that designed each software and in some cases by consultants.

Risk and Audit Software
From only £200

Leading the way since 1999
If you are looking for Risk or Audit Management software, we have the perfect solutions. See our client list

“Having implemented Symbiant into our global business a year ago it has provided the complete solution we required to manage our risk and internal audit functions. It’s a powerful tool, very user friendly and supported by a great team. It’s a product I would certainly recommend!”

Simon Elliott – Internal Audit & Risk – The Innovation Group Ltd

Clean and powerful with all the features you need

Risk Dashboard
Risk Registers
Risk scoring, KRI and performance indicators
Audit Dashboard
Audit Dashboard
Audit Time Sheets
Action Update
Audit action tracking

How our solutions works for you

“We are very impressed with Symbiant. Its simplicity and ease of use aligned with its flexibility and extensive reporting capabilities make it a very useful tool”

Keith Mason – Internal Audit – The Institute of Chartered Accountants in England & Wales

Large or small, our Risk & Audit Software
will fit your needs now and in the future

Risk or Audit or Both?

A modular solution supplied as a complete set of tools for risk management and audit management, turn features on when you need them at no extra cost.
Risk Management Set Risk Registers, Risk Workshops, Risk Indicators, Risk Actions, Control Assessments, What if Scenarios and Incident Reporting
Audit Management Set Working Papers, Audit Planning, Action Tracking and Audit Questionnaires.

You can change or add new features and users at any time.

Risk management Software

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Risk Management Software Audit Management Software Overview Videos Contact Us

Using the latest technology you can build as you grow

We are the software developers so our solution is as up to date as it gets. Work anywhere and on any platform. Use our no hassle fully managed free hosting service (SaaS) or host on your own network.


Audit management Software

Free hosting in our UK ISO 27001 certified data center

We have been hosting our solutions for clients since 1999. Whilst you are welcome to install our software on your own servers you may find our free cloud hosting service in our fully secure UK based ISO 9001 and ISO 27001 certified data centera better and easier choice.

Audit management Software

A market leading solution you can afford.

With our free, secure hosted service you can be up and running in a few hours for as little as £200 per month on a 30 day contract.

Just select the package that suits your current requirements from the below options. All packages are scalable allowing you to add extra modules or users as required. No long term contract you can cancel with just 30 days notice.

Risk and Audit Management Software

Free trial. 30 Day contract. Cancel when you want.

All plans include a 30-day free trial

From £ 200 /month
Audit planning and Action tracking
Audit Planning, Audit Questionnaires, Action Tracking, Time Sheets, Working Papers
Includes 15 users
From £ 500 /month
Audit and Risk Management, All modules
Everything from Audit and Risk
Includes 10 users

Our Customers

Trusted by names you know, from Charities to Banks, Government to PLC
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Enterprise selects Symbiant Risk Suite
Enterprise who are the UK's largest dedicated provider of maintenance and front-line services to the public sector and utility industry have chosen Symbiant Risk Suite to manage group risk management across its 150 locations. Enterprise who have over 13,000 employees and a billion pound turnover needed a product that was easy to embed but was flexible enough to satisfy the requirements a modern risk program requires. Risk Suite ticked all the boxes.
Emerson selects Symbiant Risk Suite and Symbiant Tracker
Emerson the global manufacturing and technology company who are listed on the NYSE have selected Symbiant Risk Suite and Symbiant Tracker as their Risk Management software solution and audit action tracking solution. They particularly liked the simplicity of our solutions and the way risk suite opens an environment where people are allowed to be negative so users can give honest opinions about risks and potential issues that may be due to the failings of other employees.
Gartner make Symbiant a Cool Vendor
Gartner who are the worlds leading information technology research and advisory company were so impressed with our Software they have made us a cool vendor. They recognised how the Symbiant Risk Suite and Symbiant Tracker facilitate collaboration which is an essential part of successful risk management. They were also very impressed with our low pricing structure and how they are exceptionally good value for money by saying our software was extraordinarily inexpensive. A copy of the report can be purchased directly from Gartner
BUPA gives Symbiant Tracker the all clear
BUPA the healthcare specialist have chosen Symbiant Tracker for Audit Action Tracking. After a long and stringent evaluation, involving staff across the world it was decided that our solution was just what they were looking for.
PSS the Social Care Charity selects Symbiant Risk Suite
PSS are a charity that provides dynamic social enterprise for community social and health care services across Britain. An example of yet another charity with limited financial resources being able to benefit from our fair pricing structure.
Banque Populaire du Rwanda chooses Symbiant Tracker
The bank is one of the main commercial banks in the Republic of Rwanda. Rwanda is one of the worlds poorest countries and for one of its high street banks to select Symbiant Tracker as the audit action tracking solution is testament to the cost savings gained by our software.
Concern WorldWide chooses Symbiant Tracker
Concern WorldWide have selected Symbiant Tracker as their Audit Action Tracking solution. They needed a solution that was easy to use as well as addressing all their regulatory requirements. As well as a solution that could be accessed from any where in the world.
Europe Arab Bank selects Symbiant Tracker to replace Team Mate
Europe Arab Bank who is part of the Arab Bank Group has chosen Symbiant Tracker as their new Audit Action Tracking solution. They previously used Team Mate but found Tracker a much better product to use and better suited to their demanding requirements.
Gulf Warehousing opts for Symbiant Risk Suite
Gulf Warehousing is the a leading service provider in Qatar for 3rd Party logistics services and as such they needed a comprehensive risk management solution and found Symbiant Risk Suite ticked all the boxes.
DCC the industrial holding company selects Symbiant Tracker for the groups audit action tracking
DCC the publicly listed industrial holding company has chosen Symbiant Tracker as the groups audit action tracking software over Teammate and auto audit. They liked the purity of Tracker and how it was a powerful yet easy to implement solution.
Hollybank Trust selects Symbiant Risk Suite
Hollybank is a Yorkshire charity with a national reputation for excellence who work with some of society's most vulnerable members and we are proud that they have selected Symbiant Risk Suite to help them meet their risk management requirements
Symbiant Risk Suite is the natural choice for Save the Children
Save the Children, the world famous childrens charity has opted for Symbiant Risk Suite after the success they have had with Symbiant Tracker. Being a charity they need solutions that offer value for money and will provide internal savings and improved efficiency.
Beaufort Underwriting Agency selects Symbiant Risk Suite to help them comply with the Level 2 Measures on Solvency II
Beaufort who are part of the Munich Re group have chosen Risk Suite to form the risk management framework to support the EU Solvency II compliant internal model. Solvency II is an EU requirement for capital adequacy for insurers from 2012.
Radian Group chooses Symbiant Risk Suite as its risk management software solution.
Radian who is one of the UK's largest housing associations with an annual turnover of 100 million selected Symbiant Risk Suite to help them improve their internal risk management process.
Alberta Health Services improve efficiency with Symbiant Tracker
Alberta Health Services the Canadian government Health board have chosen Symbiant Tracker for Internal Audit Action Tracking and to improve their statutory government reporting requirements. Trackers extensive reporting capabilities were exactly what they needed to improve their current system and become compliant with government requirements. The previous spreadsheet based method had become un-manageable and very expensive to run. A perfect example of spend a little, save a lot.
MTN Africas Largest Mobile Phone Company Selects Symbiant Tracker
MTN who are Africas largest mobile network provider have selected Symbiant Tracker to improve Internal Audit Action Tracking. This is another example of how businesses in Africa are replacing in-effective make-shift solutions such as spreadsheets to improve internal controls and efficiency.
World Famous Department Store Chooses Symbiant Risk Suite
Famous for having Royal as well as some of the Worlds wealthiest people as customers this major London department store has selected Symbiant Risk Suite for the group's internal Risk Management Software solution. The company who have a reputation for quality and customer satisfaction look for the same virtues in their suppliers and the products they choose.
Yorkshire Building Society Chooses Risk Suite
After a very lengthy review process the Yorkshire Building Society have selected Symbiant Risk Suite as their new Risk Management Solution. They choose Risk Suite as it offered all the features a modern bank needs and allows them to look forward at possible future risks. This was one of the issues that caused the near collapse of the western banking system.
United National Bank Ltd selects Risk Suite
The London and Bradford based Pakistani owned United National Bank has selected Risk Suite for their Risk Management Solution.
National Bank of Malawi chooses Risk Suite
The National Bank of Malawi has purchased a license for Symbiant Risk Suite, this is a major step forward for African banks who may have learnt from the mistakes the western banks have made recently. The banks will use Risk Suite to help them meet their SOX requirements.
Scapa Group plc Chooses Risk Suite and Tracker
Scapa Group has selected Risk Suite and Tracker for their Risk Management and Internal Audit Solutions. Scapa are a manufacturer of a wide variety of standard and custom-engineered adhesive films and tape.
Symbiant Tracker Version 4 Launched
With the feedback and comments we have received from The Bank of England and other Tracker users Symbiant Tracker v4 has many new features including the ability for an issue to have many parts. This latest version of Tracker is a total re-write on previous versions and has more flexibility and functionality on previous versions. We have taken on board all users comments and created a solution to fit all industries and business models. The many to many to many relationships allows a single issue to have multiple recommendations and each recommendation to have many actions, each assigned to different assignees with different action by dates. See http://www.symtrack.com/docs for an overview.
New Version of Risk Suite Launched
From our users feedback we have added new requested features and released Risk Suite version 2. To see what is new see the overview document at http://www.symrisk.com/docs
Redrow Group PLC chooses Risk Suite
Redrow the Builders have selected Risk Suite as their Risk Management solution. Redrow previously used a top 5 accountants to manage the companies risks but decided doing it in house would save the company hundreds of thousands of pounds. They say Risk Suite will pay for itself in the first few months.
Maitland Group chooses Risk Suite
After a long tender process Maitland Group who offers Legal Advisory, Trust and Corporate Services, Asset Management and Fund Services have chosen Risk Suite. Maitland has offices throughout Europe and South Africa will be using Risk Suite to bring all the different departments Risk management under one umbrella and unify the companies risk management.
University use Risk Suite as Teaching Tool
The Cape Peninsula University of Technology in South Africa are using Risk Suite as a teaching tool to show students how risk management should be done correctly. The university supplies students for major firms in the area including, Sanlam and Old mutual insurers. Price Waterhouse Coopers, Ernst and Young as well as KPMG.
Partnership Assurance Adds Risk Suite to Tracker
Partnership Assurance who are one of the UKs leading providers of financial products who last year purchased a Symbiant Tracker license have now purchased a license for Risk Suite. They were so impressed with Tracker that Risk Suite already had the edge when they needed a Risk Management solution. They already knew our service and products were second to non.
Symbiant Tracker Version 3 Launched
With a user base of over 200 Tracker has been well received by the business community world-wide and we have had significant feedback from our clients suggesting many improvements. Symbiant Tracker v3 includes all the nice to haves and modifications our users have asked for keeping it well in front of similar products on the market.
Washington State Department of Revenues (IRS) opts for Tracker
The United States Department of Revenue in Washington have chosen Symbiant Tracker as their internal audit tacking solution. Being a US government department they have a policy to buy from US based companies. Symbiant Tracker is the first non-USA package they have ever purchased.
Nordben Life & Pension Insurance Chooses Risk Suite
Nordben Life & Pension Insurance the Guernsey based insurance company have selected Symbiant Risk Suite as their Risk Management Solution. Their accountants who are one of the big 5 recommended our solution as the best offering for value and features.
The NHS Information Centre opts for Risk Suite
Symbiant Risk Suite has been chosen has the Risk management Solution for The NHS Information Centre for Health and Social Care. They said our solutions won on price, flexibility and comprehensiveness. It wasnt a hard decision to make, Risk Suite offers much more and costs a great deal less than the other solutions. See http://www.symrisk.com
ICAEW Endorse Risk Suite and Tracker
Europes largest professional accountancy body, The Institute of Chartered Accountants in England and Wales (ICAEW) endorse Symbiant Risk Suite and Tracker. This is the first time the institute have endorsed a product which reflects the quality of the products and benefits the offer to the companies that use them. The institute will also be using the solutions for themselves.
Risk Suite General Launch
After 12 month in the field testing by various companies including KPMG LLP, Symbiant Risk Suite is launched for general release. User feedback has been substantial and the final released model meets everyones approval as a ground breaking solution. Further development will continue as new users give more feedback. See http://www.symrisk.com
Symbiant Risk Suite Launched
Symbiant Risk Suite version 1 has been released for pilots. Risk Suite has been in development for 2 years to fill the void in the risk software market for an affordable, easy to use and comprehensive risk management solution. Like Symbiant Tracker, Risk Suite is web based and includes all the elements required for companies to have a robust risk management ethos. As with Tracker the solution will evolve from user feedback. See http://www.symrisk.com
Symbiant Tracker Launched
Symbiant have launched the worlds first web based action tracking solution specifically for internal Audit. Working with guidance from KPMGs Internal Audit department Tracker allows internal audit departments to track issue actions and recommendation through to completion. The tool gives ownership of actions with action by dates and sends automated emails to the relevant parties. Auditees keep the action progress updated so IA can see the current status of issues at all times. Tracker is designed to save Internal Audit departments time chasing issues and make them a lot more effective and implementing new issues. See http://www.symtrack.com

Audit Management Solution

The Symbiant Audit Management Suite is a modular Audit and Risk Management solution. Web Based and provided as a fully managed

Audit Solution

The Symbiant Audit Management Suite is a modular Audit and Risk Management solution. Web Based and provided as a fully managed SaaS solution.
It is ready to use instantly on our secure cloud environment.
To learn more read below and watch the overview video opposite.

.Audit Action Tracking Software Overview Video

Prepare the Audit, The Team, when and where, Scope, Objectives and what questions need to be asked. The system will then notify the audit members and who is being audited and add it to planners. You can also set the system to send reminder emails closer to the audit date.
Assign questions to team members who can work off-line to carry out the audit. Auditors can attachment supporting documents,scans or images. The lead auditor can see all responses and progress in real time
When the audit is complete you can send issues that require remedial actions directly to the audit action tracker. Here you give ownership of the actions and set an action by date. Assignees can then keep you updated with progress allowing you to track to completion.
Produce professional audit reports or details on actions with just a click of the mouse, including current state of actions, performance and statistics,In fact everything for the audit committee.

Using VMware Enterprise architecture in our fully secure 27001 certified data center we provide a secure robust hosted solution. Click Here to learn more.

We are a thoroughbred web based software development company. Trading uninterrupted since 1999 we created the world's first web enabled Risk / Audit solutions back in 2002. We have a proven track record, our clients span the world and range from charities to banks, government to PLC. We are a trusted partner to some of the World's best known businesses. These businesses chose us because they need to have solutions that are reliable and fit for purpose.

Gartner are on record as stating our software is extraordinarily inexpensive. The Reason for this is simple. We are different to most suppliers in this field (Audit/Risk). Most are consultancy companies who use software as a hanger to sell people time. These companies often have investors and large sales and marketing teams who need to be paid for. This means the cost of the software has to pay for this infrastructure. It also means the offering from these companies is often quite old and out of date, they need payback before new investment can be ploughed back in. We are different, we are a software development company who work with our clients to produce the solution they want, a solution to fit their needs. This means we can provide you with the solution you want, so no need for a sales team to convince you. We have no debt or investors demanding returns. We are a cash rich private enterprise that has been successfully trading for over 14 years, therefore we can offer you the solution you are looking for at a price we think is fair but way below the industry norm.
You will not find a more advanced user friendly commercially available solution than Symbiant. At any price. We offer a 5 star solution at a 1 star price.

SaaS solution.
It is ready to use instantly on our secure cloud environment.
To learn more read below and watch the overview video opposite.

.Audit Action Tracking Software Overview Video

Prepare the Audit, The Team, when and where, Scope, Objectives and what questions need to be asked. The system will then notify the audit members and who is being audited and add it to planners. You can also set the system to send reminder emails closer to the audit date.
Assign questions to team members who can work off-line to carry out the audit. Auditors can attachment supporting documents,scans or images. The lead auditor can see all responses and progress in real time
When the audit is complete you can send issues that require remedial actions directly to the audit action tracker. Here you give ownership of the actions and set an action by date. Assignees can then keep you updated with progress allowing you to track to completion.
Produce professional audit reports or details on actions with just a click of the mouse, including current state of actions, performance and statistics,In fact everything for the audit committee.

Using VMware Enterprise architecture in our fully secure 27001 certified data center we provide a secure robust hosted solution. Click Here to learn more.

We are a thoroughbred web based software development company. Trading uninterrupted since 1999 we created the world's first web enabled Risk / Audit solutions back in 2002. We have a proven track record, our clients span the world and range from charities to banks, government to PLC. We are a trusted partner to some of the World's best known businesses. These businesses chose us because they need to have solutions that are reliable and fit for purpose.

Gartner are on record as stating our software is extraordinarily inexpensive. The Reason for this is simple. We are different to most suppliers in this field (Audit/Risk). Most are consultancy companies who use software as a hanger to sell people time. These companies often have investors and large sales and marketing teams who need to be paid for. This means the cost of the software has to pay for this infrastructure. It also means the offering from these companies is often quite old and out of date, they need payback before new investment can be ploughed back in. We are different, we are a software development company who work with our clients to produce the solution they want, a solution to fit their needs. This means we can provide you with the solution you want, so no need for a sales team to convince you. We have no debt or investors demanding returns. We are a cash rich private enterprise that has been successfully trading for over 14 years, therefore we can offer you the solution you are looking for at a price we think is fair but way below the industry norm.
You will not find a more advanced user friendly commercially available solution than Symbiant. At any price. We offer a 5 star solution at a 1 star price.

Enterprise Risk Management Software

Risk management is the systematic process of understanding, evaluating and addressing these risks to maximise the chances of objectives being achieved and ensuring organisations, individuals and communities are sustainable. Risk management also exploits the opportunities uncertainty brings, allowing organisations to be aware of new possibilities. Essentially, effective risk management requires an informed understanding of relevant risks, an assessment of their relative priority and a rigorous approach to monitoring and controlling them. To be effective, risk management must be proportionate to the size and nature of an organisation. It can range from a risk assessment for a community event up to a sizeable, integrated process for a multi-national. Enterprise risk management (ERM) refers to an integrated or holistic approach to managing risk across an organisation, using clearly articulated frameworks and processes led from board level. Risk management should be embedded in the general management of an organisation and fully integrated with other business functions such as finance, strategy, internal control, procurement, continuity planning, HR and compliance. The degree of integration will differ between organisations depending on their culture, implementation process, ways of operating and external environment. Our International Certificate and Diploma qualifications provide the comprehensive knowledge and practical skills to support those who operate in risk management. Specialist areas of risk management include expertise in insurance purchase, business continuity, health and safety and corporate governance to specialist skills and knowledge for, for example, the financial services or construction industries. As well as providing broad education in ERM we also offer specialist qualifications in a number of these specialist areas.



Symbiant Tracker is a recommendations and issues tracking database solution. It sits on a corporate intranet or the internet with our SaaS offering, and is managed by the Internal Audit department. The key feature of this tool is that, unlike many recommendations tracking tools, it is designed to be accessed and updated by the auditees, who have been assigned the recommendation in the process of agreeing the internal audit report.

Being intranet or internet based, auditees can easily be given access to the recommendations relating to them. At any point in time, the database therefore holds the latest update on the implementation of each recommendation.



Internal Audit departments main product is an audit report, or rather a series of audit reports, one for each internal audit they perform within a business each year. These reports contain recommendations relating to the weaknesses that they have found in the part of the business they were auditing.When these recommendations are implemented, the weaknesses should be resolved and any risks managed. If the recommendations are implemented it gives assurance to a company’s management that weaknesses in the operation have been addressed. If recommendations are not implemented then the internal audit effort has been a waste of time. Internal Audit usually (or should) report to the Audit Committee (sub-committee of the Board, chaired by a non-executive director) once or twice a year on how far and how well recommendations have been implemented and they usually do this by running around in the days before the Committee meeting trying to find out what has been happening. The new combined code on corporate governance (Turnbull) requires audit committees to assess the effectiveness of internal audit departments on a regular basis and one of the key things in this evaluation will be how many recommendations made have actually been implemented. Tracker gives a unique approach which is:-

  • Intranet or internet based to allow ease of aggregation and reporting

  • It puts the onus on the person to whom the action is assigned to report on where they are at with the recommendation – i.e. it introduces ownership for resolving weaknesses and raises the profile of these issues.


  • Letting auditees know of new recommendations assigned to them and alerting them when an existing action is due/overdue or updated

  • Allowing auditees to update their progress on-line which saves your time and keeps the issue progress up to date in real time

  • All parties involved in the issue can add comments or ask questions relating to an issue and all dialogue is stored with the issue so a full history can be viewed

  • Tracking issues/recommendations separately instead of having to track at the report level although you can produce a progress report at the audit report level

  • Run reports on whole range of combinations including against respondents so you can see where the sticking points are in the organisation

  • When you do need to produce a report, you can effortlessly produce precise information that is up to date and also explain any failures or missed deadlines and who was responsible

It should also be noted that companies that have to comply with the US requirement known as Sarbanes-Oxley Section 404, Turnbull and the European 8th Directive will also find Symbiant Tracker useful to track remediation issues. Why not try a risk free trial for yourself and see how Tracker can benefit you and your company.


The Symbiant Tracker is a dedicated action tracking solution specifically designed for Audits. Web Based and provided as a fully managed SaaS solution it is ready to use instantly on our secure cloud environment. If you prefer you can host it yourself on your own intranet.

With per user changes from £1 Symbiant Tracker is the most cost effective audit action tracking solution in the world. Try it free


.Audit Action Tracking Software Overview Video

If you are looking for a total audit solution to include Audit Planning Click Here


Symbiant Tracker is a unique, simple to use yet very powerful Internal Audit action tracking solution.  In simple terms Tracker allows you to give ownership of actions and track through to completion. Automated email notify and remind users of tasks and events. What is more, when you have to report to the Audit Committee, you can produce up-to-date reports in moments.

  • Specifically designed for Audit Actions
  • Attach files with responses
  • Web based Intranet or internet
  • Exceeds Bank / FSA Requirements
  • Affordable - from £1 per user
  • Allows you to keep on top of actions
  • Reduces Costs and improves efficiency
  • Link actions in a hierarchy
  • Automated emails to keep users on track
  • Full Audit Trail of all changes
  • The market leading audit action tracker
  • Configurable User Levels
  • Easy to use, quick to embed
  • Performance Statistics
  • Produces the reports you need
  • Perfected over 10 years business use
  • Advanced Features
  • Reduces your workload
  • Customisable
  • Works 24/7 all year round


Risk Management Software

SYMBIANT RISK SUITE The Symbiant Risk Management Suite is a modular Risk and Audit Management software Solution that facilitates collaborate and extends risk management across the business. Web Based and provided as a fully managed SaaS solution it is ready to use instantly on our secure cloud environment. If you prefer you can host it yourself on your own intranet. With per user changes from under £1 risk suite is the most affordable risk management solution in it's class. Try it free. WATCH THE OVERVIEW VIDEO Risk Managment Software Overview Video OUR GUARANTEE You will not find a more advanced, user friendly, commercially available solution than Symbiant. At any price. We offer a 5 star solution at a 1 star price. See our client list THE TOTAL RISK MANAGEMENT SOLUTION The Symbiant Risk Management Suite is not just a risk solution, it's an enterprise level risk and audit management solution. Modular so you can expand as needed and customisable so you can build your perfect solution. A solution that will grow and expand as required. It can be as basic as a Risk Register or as enterprising as a global corporations Risk and Audit solution. It truly is that flexible and powerful. Developed over 10 years with guidance from industry experts such as KPMG it far exceeds ANZ 4360 and ISO 31000 requirements. Symbiant is the only Risk Management Software to have been endorsed by Europe's largest professional accountancy body the ICAEW. Symbiant Risk Management Suite quite simply gives you everything you need or could want and it's getting better everyday. We are adding new features and modules all the time. We give you the solution you want and need at a price you can easily afford. QUICK POINTS TO HELP YOU CONSIDER Full Risk Management software Solution All parts of the business can collaborate Web based Intranet or internet Meets ISO 31000 for risk management Affordable - from under £1 per user easy to understand and visualise risk mapping Reduces Costs and the need for meetings Speeds up the Risk Assessment Process Automated emails to keep users updated Early identification of possible risks Questionnaires to monitor controls Risk Indicators and Assessments Ongoing identification of risks Built in risk voting Risk Vs Reward Easy to Embed Risk Mapping Flexible, Scalable and Customisable Includes Audit Management and Saas. Action Tracking Software Audit Action Tracking Software Audit Mananagement bespoke custom software compliance software enterprise risk management software audit and risk management risk management software risk software audit software for audit planning business intelligance software Risk management is the identification, assessment, and prioritization of risks (defined in ISO 31000 as the effect of uncertainty on objectives) followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events[1] 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, natural causes and disasters as well as deliberate attack from an adversary, or events of uncertain or unpredictable root-cause. Several risk management standards have been developed including the Project Management Institute, the National Institute of Standards and Technology, actuarial societies, and ISO standards.[2][3] Methods, definitions and goals vary widely according to whether the risk management method is in the context of project management, security, engineering, industrial processes, financial portfolios, actuarial assessments, or public health and safety. 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). 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.[1] For example, it has been shown that one in six IT projects becomes a 'Black Swan', with cost overruns of 200% on average, and schedule overruns of 70%.[4] Contents 1 Introduction 1.1 Method 1.2 Principles of risk management 2 Process 2.1 Establishing the context 2.2 Identification 2.3 Assessment 3 Composite Risk Index 4 Risk Options 4.1 Potential risk treatments 4.2 Create a risk management plan 4.3 Implementation 4.4 Review and evaluation of the plan 5 Limitations 6 Areas of risk management 6.1 Enterprise risk management 6.2 Medical device risk management 6.3 Risk management activities as applied to project management 6.4 Risk management for megaprojects 6.5 Risk management regarding natural disasters 6.6 Risk management of information technology 6.7 Risk management techniques in petroleum and natural gas 6.8 Risk management as applied to the pharmaceutical sector 7 Positive Risk Management 7.1 Criticisms 8 Risk management and business continuity 9 Risk communication 9.1 Seven cardinal rules for the practice of risk communication 10 See also 11 References Introduction A widely used vocabulary for risk management is defined by ISO Guide 73, "Risk management. Vocabulary."[2] 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 threats 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 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:[5] Risk management should: create 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,"[3] 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 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] - 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] - 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] - 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.[6] Common-risk checking[citation needed] - In several industries, lists with known risks are available. Each risk in the list can be checked for application to a particular situation.[7] Risk charting [8] - 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 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 article: 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] 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:[9] 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 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 hijacked. 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.[10] Hazard prevention Main article: Hazard prevention 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 mitigation. Risk reduction Risk reduction or "optimization" involves reducing the severity of the loss or the likelihood of the loss from occurring. For example, sprinklers 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. 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.[11] 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.[12] 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 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 article: 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 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 requirements for each of these components. Enterprise risk management Main article: 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 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 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 GessNet TurboAC™ risk management software. Through a 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 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.[13] Risk management is therefore particularly pertinent for megaprojects and special methods and special education have been developed for such risk management.[14] Risk management regarding natural disasters It is important to assess risk in regard to natural disasters like floods, 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.[15] There are regular conferences in Davos to deal with integral risk management. Risk management of information technology Main article: IT risk management Information technology is increasingly pervasive in modern life in every sector.[16][17][18] 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 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.[19] 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 microbiological contamination in relation to pharmaceutical products and cleanroom manufacturing environments.[20] 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,[21] or who have made a contribution emphasizing the human dimension of risk.[22][23] 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 widespread 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)[24] 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;[25] Nicholson et al. (2005) report that higher extroversion is related to greater risk tolerance;[26] McCrae and Costa (1997) link personality to tolerance of uncertainty, innovation and willingness to think outside the box;[27] Kowert, 1997) links personality to adventurousness, imagination, the search for new experiences and actively seeking out risk.[28] Building from these foundations of well validated assessment practices, more specialized assessments have been developed, including assessment of Risk Type.[29] 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, 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.[30] 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.[citation needed] 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.[citation needed] 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. 318 Reviews £200 132 Reviews £300