Risk Management in the Global Economy and outlook for 2017

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Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost becoming part of the global economy in this era of globalization; it is emerging that risks that apply to one part any one nation’s or group of nations’ economy could affect many more in a chain reaction, or domino effect.

The Judge Business School of Cambridge University, in its estimate for risk management in the global economy for 2017, has a rather bleak outlook for the global economy. The report analyzes that no fewer than 25 dozen of the world’s urban centers could face close to two dozen different kinds of major shocks of primarily an economic and also of a political and social nature.

risk-management-in-global-economy-and-outlookThis is going to likely impact these important nodal cities of the global economy to the extent that the world’s GDP is going to shrink by as much as 1.5% percent till 2019. This translates to something in the order of $ 1.2 trillion.

Factors determining risk management in the global economy in 2017The report pins down a few important factors that have contributed to the need for risk management in the global economy in 2017:

    • The world is producing more than it ever did in its history. This is because of the high level of human population, which is the highest ever recorded in history, and the economic, agricultural and industrial growth of many underdeveloped economies
    • There has been an unprecedented increase in crises and disruptions in the geopolitical, financial and technological fronts, making risk management in the global economy for 2017 an important area to be addressed by the political and financial leaders around the world

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  • The financial sector has come under greater strain in the past few years following the slowdown of 2008 than it had in the few preceding ones, making the prospect of a global meltdown any time in the future a possibility, if not a certainty
  • Added to these, risk management in the global economy for 2017, like in any other year, does face prospects that are of a natural order, such as natural disasters and wars.
Global economy will bear the brunt

risk-management-in-global-economy-and-outlookAll these factors would not have had the same impact as they are likely to have in the current scenario and in the immediate and intermediate future, if not for globalization. The world’s shift towards globalization is now certain and irreversible. The interconnected nature of the global economy has ensured that a shock in one part of the global economy is sure to cause ripples of either a minor or major nature in any other part.

Other important factors for risk management in the global economy in 2017risk-management-in-global-economy-and-outlook

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An understanding of Risk Management and Analysis for Medical Device Manufacturers

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Risk management and analysis for medical device manufacturers is an essential set of approaches to quality in the field of medical devices. Implementing these is of absolute importance and criticality to the field, as the products in this industry are high-specialty ones that deal with human lives. A small error at any stage can send the product, and with it, the reputation of the manufacturer and even the healthcare provider, into a tailspin.

From its beginnings a few decades ago as a “nice to have” feature or discipline that used to come into the picture only when there were issues; quality has grown into an indispensable element of a medical device product. A medical device product into which quality does not get intertwined at every stage, right from procurement of the raw material to the use it is put to by the consumer and beyond, is unthinkable today.

risk-management-and-analysis-for-medical-device--manufacturersThe primary driver of this metamorphosis is risk management. Risk management and analysis for medical device manufacturers has been the lynchpin among the agents of change brought about into this field. Quality has evolved as a result of the change in the import regime in the US in the seventies, when products from around the world used to deluge the US market.

the consequences of this trade policy have led to the emergence of the creation of quality approaches such as Six Sigma and kaizen among many others, and global standards, of which ISO 14971 specifically relates to Quality Management Systems and methods for medical devices. Root Cause Analysis is at the root of each of these methodologies and standards.

So, what is risk management and analysis for medical device manufacturers?

risk-management-and-analysis-for-medical-device--manufacturersIn the context of medical devices, risk management and analysis for medical device manufacturers means applying a set of processes, policies, methods and practices into their manufacturing systems in alignment with respective and relevant standards as set out by global standards such as the ISO. The aim of these standards and practices is to analyze, assess, control and monitor risk. The ISO 14971 has been revised many times and each time this is done, the latest one becomes the extant version. This and other standards and practices prescribe steps and processes that need to be implemented at all stages of the product lifecycle.

The need for risk management and analysis for medical device manufacturersThe need for risk management and analysis for medical device manufacturers is simple: To ensure that the medical device meets quality requirements and is manufactured according to standards and specifications and methods prescribed in these standards. Standards such as ISO 13485, various Quality Systems Regulations (QSRs) such as 21 CFR 820 and a few European standards work in tandem with ISO 14971. The core purpose of requiring medical devices manufacturers to meet these requirements is to ensure that safety and quality are built into a medical device from start to finish.

The time at which to carry out risk management and analysis for medical device manufacturers

risk-management-and-analysis-for-medical-device--manufacturersRisk management and analysis for medical device manufacturers is to be carried throughout the lifecycle of the medical device. A set purpose is set out at each stage of the manufacturing process. For example, medical device manufacturers are required to identify and eliminate potential hazards at the initial stage using the concepts of product optimization, and use the principles of risk elimination at all the next stages, and to use the methods prescribed during a product recall.

The ways of carrying out risk management and analysis for medical device manufacturersThe ways by which risk management and analysis for medical device manufacturers are to be exercised form an important part of quality. The ISO 14971 standard is pretty flexible in this regard, allowing the manufacturer to adapt any existing standard or approach that he thinks is best suited for his organization.

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How is Risk Management Important to Project Success?

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The answer to how risk management is important to project success is best illustrated by the fact that no project has ever succeeded without proper risk management. In other words, project management into which risk assessment has not gone in is as good as a doomed one.

Risk management’s importance to project success can never be overstated. Success at any project is unthinkable and unimaginable without proper and critical risk management. Risk management is a means by which the risks that accrue into a project are foreseen, assessed and mitigated, so that the project does not run into hitches at later stages, from where it would be all but impossible to rectify the same.

Understand what risk is, first

risk-management-important-to-project-successThe answer to the question of how risk management is important to project success has to start with a basic understanding of risk. In the context of project management, risk, as we all know, is the occurrence of a danger or an unwanted, undesired event in a project. It succeeds or is the next stage of a hazard, which is described as the potential for or the possibility of an event to cause danger.

How risk management is important to project success is to be understood from the standpoint of the fact that absolutely every activity, not only something concerning project management, has a risk. There are risks in simple and completely mundane activities such as brushing one’s teeth or putting a baby to sleep.

Diligence and thoroughness are important elements of risk management

risk-management-important-to-project-successIn order to manage a project successfully, the first step is carrying out risk management thoroughly and diligently. Risk management, if done properly, is the first and most fundamental aspect of success in a project. It is mainly about taking identifying, analyzing and mitigating risks in a business vis-à-vis its strengths and weaknesses.

It is accepted in the discipline of risk management that risks cannot be completely eliminated. However, having a sound risk management plan helps to anticipate and be prepared for risks. The ways in which this is done mainly depends on the kind of project which the organization is carrying out, and the risk manager’s ability to understand it in its fullness and implement risk mitigation strategies effectively.

Palpable benefitsRisk management’s importance to project success is illustrated by the following benefits of carrying out a Risk Analysis:

The stages of risk managementGiven the importance of risk management to project success; it is important to understand and implement risk management in its stages:

risk-management-important-to-project-successPlanning:This involves understanding the importance of risk management to project success by planning the risk management in terms of its size. It is generally true that the bigger the project from the operational, logistical and financial perspectives; the greater the risk, and vice versa.

Preparing: The next stage of risk management is to prepare for it. The right knowledge of the project in all its detail helps project managers to prepare for any exigency and for taking steps to mitigate its effects.

risk-management-important-to-project-successMeasuring the result: Judicious and farsighted project managers measure the fallout of a risk management activity by what it fetches. If a risk management activity has accrued a certain expense that cannot be justified in the light of the benefit it brought, then such a risk management action is not effective and has not understood the importance of risk management to project success.

Evaluating the impact: A risk management plan may have been planned, prepared and executed very diligently, but risk managers ask what impact such an action had on the project, and eventually, on the organization. How many resources did it consume? How much time did it take? What kind of risk did it mitigate and what was the impact of this risk, had it been allowed to continue? These are some of the questions insightful risk managers ask. This perceptiveness is a result of their sharp understanding of how work management is important to project success.

 

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Risk management methods and tools in the pharmaceutical and life sciences industries

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Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory agencies have created a number of risk management methods and tools for these industries.

A few commonly used risk management methodsIn the pharmaceutical and life sciences area, a few commonly used risk management methods and tools for organizing data and using these to help in decision-making include the following:

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A few popular risk management methods and toolsIn the field of pharmaceuticals and life sciences, these can be said to be some of the more popularly used risk management methods and tools:

Failure Mode Effects Analysis (FMEA)FMEA is a popular one among the risk management methods and tools mainly because it provides a methodology for assessing a potential failure mode for the process that goes into the manufacturing of the pharma or life sciences product and helps to analyze their possible impact on the product’s ability to perform to its required standard.

risk-in-pharmaceutical-and-life-sciences-industriesIdentification and establishment of failure modes are taken as the basis for using risk reduction techniques for eliminating, containing, reducing or controlling the possible failures. Since FMEA depends on a deep understanding of the product and the process; its main steps include dissembling complex processes into simpler and comprehensible ones. For this reason, FMEA is considered a potent risk management method and tool.

Failure, Mode, Effects, and Criticality Analysis (FMECA)Extending the concept of FMEA a little farther, the Failure, Mode, Effects, and Criticality Analysis (FMECA) takes into account the added feature of the extent of gravity of the consequences of a fault or failure, along with the possibility of their occurrence, as well as the chance of their detection. While this is the slight extension that the FMECA brings to FMEA; it is similar to it in other respects, namely:

risk-in-pharmaceutical-and-life-sciences-industriesFMECA too, like FMEA, uses identification and establishment of the process specification to identify risks and failures

FMECA too uses the method of breaking down difficult processes to easier ones to enable better understanding of the failures and risks.

Fault Tree Analysis (FTA)Fault Tree Analysis is another of the risk management methods and tools. What this tool does is that it takes up a single fault at a time for analysis, but links the chains that cause the fault. This is why it gets its name, wherein the results of the analysis are represented in a shape of a tree, in which each level of fault is described with possibilities. A sharp and incisive analytical bent of mind is required to create the FTA.

Hazard Analysis and Critical Control Points (HACCP)HACCP is yet another important one among the risk management methods and tools. It takes a systematic and proactive approach in ensuring the following in a product:

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It is considered a comprehensive risk management method and tool because it addresses all the issues relating to risk management methods and tools, applying scientific principles and methods for carrying out the following:

risk-in-pharmaceutical-and-life-sciences-industriesControlling of the risk or the negative outcomes of hazard, which could be due to any of these:

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Supporting statistical tools
risk-in-pharmaceutical-and-life-sciences-industriesWhile all the risk management methods and tools described above are a snapshot of some of the major ones, a few supporting statistical tools, too, are used to engender quality risk management. These are some of them:

 

 

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What is Accounting Fraud and How to Prevent Financial Statement Fraud

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Key Takeaway: An understanding of what is accounting fraud and how to prevent financial statement fraud is an important lesson for managements across the world, in any kind of business. In the simplest terms, accounting fraud is the practice of manipulating accounting records so that the actual financial condition is hid from the investors, the public or the other stakeholders and a false picture, which shows the company to be in a falsely healthy condition, is presented in the books.

accounting-fraud-to-prevent-financial-statement-fraudFinancial management can go haywire if the proper steps for preventing accounting fraud are not taken. Companies need to have a solid understanding of how to prevent financial statement fraud, or else their hard work and effort go down the drain, and making up for lost financial gains becomes a herculean task.

Accounting fraud is perhaps as old as accounting itself. However, with the American corporate sector having committed financial misdoings of an unprecedented scale starting from about the late 1990’s, the need for an actual congressional legislation was deemed necessary to prevent the onslaught of these financial scandals, most of which were the result of accounting frauds carried out on the financial statements of the companies that carried out these scandals.

A long list of corporate frauds 
accounting-fraud-to-prevent-financial-statement-fraudManipulating the balance sheet has been at the core of most accounting frauds that shook the American corporate sector and culminated in the enactment of the Sarbanes Oxley Act:

  • The Waste Management scandal
  • Enron
  • WorldCom
  • Tyco
  • HealthSouth
  • Freddie Mac
  • AIG
  • Lehman Brothers
  • Bernie Madoff
  • Halliburton

Accountants can manipulate their financial statements and carry out a number of fraudulent activities that can be termed as accounting fraud. These are some of the practices that are common among accounting professionals who got caught by these famous scandals:

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Internal controlsInternal controls in the form of deep and thorough scrutiny of the accounts records is the surest means for ensuring that the financial statement fraud does not take place. Staying compliant with the provisions of the SOX Act is another step in the right direction. Many companies supplement these by putting sound investigational techniques in place.

accounting-fraud-to-prevent-financial-statement-fraudCompanies can keep many checks and controls in place in the form of internal controls. They can ensure that the financial statements are vetted at various levels, starting with the accounts clerk and going all the way to the CFO. Not all types of accounts may need intervention from the CFO, but those that don’t can be handled by those in Finance who report to the CFO.

Making accounts pass through more than one sourceCrosschecking or double-checking accounts is another means of preventing financial statement fraud. The company can make a rule by which financial statements such as purchase records get checked by more than one person, with the aim of putting curbs on passing bills. When bills have to go through more than one person or level, there is a good chance of immediately detecting a fraud or a potential one. These employees can collude and cause a fraud anyway, but this is comparatively difficult, as in theory and practice, everyone through whom the bills get passed has to be involved to commit the fraud.

AuditsAudits, both internal and external, are another means of preventing financial statement fraud. When audits are carried out internally and checked by an independent, outside agency; a check is put in place, making financial statement fraud that much more difficult to commit.

Whistleblowing 
accounting-fraud-to-prevent-financial-statement-fraudWhen organizations put a good whistleblower culture in place, it can be a very strong deterrent at preventing financial statement fraud. This is not the easiest of practices to implement, but is strong one when it is implemented well. Ensuring security and protections for the whistleblowers, plus fixing rewards for their act is a means for motivating employees to take part in whistleblowing. To prevent misuse, the management can also put a system in place where wrongly called out whistleblowing results in penalties.

 

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The role of packaging in food safety and security

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The role of packaging in food safety and security is paramount. Perhaps no other factor plays the role of packaging when it comes to ensuring food safety and security. The role of packaging in food safety and security can be understood at its barest from the fact that packaging saves the product from rotting, contamination and a host of other undesirable changes.

Food being a highly decomposable item; it is prone to many effects resulting from pests, microorganisms and other contaminants. It is here that the role of packaging in food safety and security comes into play. Proper packaging not only protects food from the influence of any of these; it also helps the food to retain its moisture, shape, substance and other important characteristics. The most important attribute of the food that packaging in food safety and security plays is in helping to preserve the nutritive value of the food item.

The role of packaging in food safety and security and its importance to the world
packaging-s-role-in-food-safety-and-securityFood is the most essential need for all animals, including man. In the developed world, there is such a surplus of food that much of its gets wasted. The role of packaging in food safety and security is in ensuring that this can be minimized to a great extent. If food is properly packaged, it is possible to extend its shelf life and have it consumed after a while, instead of altogether throwing it away.

On the other hand, the role of packaging in food safety and security is equally important in many other parts of the world, there is not enough food for millions of people. When food is packaged rightly, its use can be optimized. The developed world transports food in millions of tons to the developing world. The role of packaging in food safety and security is crucial in such operations, where the quality of the food can be retained.

The role of packaging in food safety and security in the globalized world
packaging-s-role-in-food-safety-and-securityWhen food that is prepared in one part of the world gets consumed in another; the role of packaging in food safety and security acquires vital importance. This is what is happening in today’s globalized world. Food companies have their operations in almost any part of the globe that makes economic sense for them. This food is not necessarily fully consumed in the part of the world in which it is produced. Rather, it reaches out to different parts of the world. This globalized system works in the food industry just like the way it works in a garment or an automobile business.

Key points
packaging-s-role-in-food-safety-and-securityCountries of the world follow many of these regulations and conventions in addition to the many of their own. The core concept behind these regulations is that food must be safe throughout the supply chain, from the proverbial “farm to fork”. Planners and thinkers around the world work in tandem to understand the food problems the world is facing and prioritize their tasks towards ensuring that a good part of the inequities get minimized, if not outright eliminated. In ensuring this, the role of packaging in food safety and security is primary.

 

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Environmental, Health and Safety (EHS) Management and Audit

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An environmental, health and safety (EHS) management and audit program is now a prerequisite for organizations in various kinds of business. Allied to the emergence of and developing along with the concepts of worker safety and corporate social responsibility; the environmental, health and safety audit is today a major component of an organization. Organizations that need visibility and are desirous of earning a good name should make the environmental, health and safety management and audit a part of their culture.

The practice of companies auditing their environmental, health and safety (EHS) began in the 1970’s, almost contemporaneously with the enactment of OSHA. Around that time, the environmental issue was gaining ground in the corporate circles of the West with the governments and other agencies pitching in with their efforts to create greater awareness of the impact of business activities on the environment. As a result, the thinking that the top management of an organization needs to be viewing this issue more seriously started to develop and got ingrained over the years.

Cannot be glossed over
environmental-health-and-safety-management-and-auditAs a result of various legislations on the issue of environmental safety; the role of the Board of Governors became central in ensuring this aspect of the business. Environmental health and safety was no longer something that needed to be administered superficially, but in formal and designated ways, more specifically in the form of an audit. In order to incentivize corporate entities to implement environmental health and safety (EHS) management and audit; the trend started moving towards making these activities carry value addition to the organization.

Environmental health and safety management and audit is now a more formalized activity that needs to be carried out in a proper, set and well-defined manner. The processes that go into the EHS management and audit are clearly laid out in the form of standards such as the ISO 14001 standard, which is essentially an Environmental Management System (EMS) audit. To strengthen and enrich the audit activity and round it better; a few related and parallel standards such as the relevant parts of the 9000 family of standards, which deals with quality management, and 18000 series audits can be carried out with ease to supplement the environmental, health and safety audit.

Role of environmental health and safety (EHS) management and audit
environmental-health-and-safety-management-and-auditEnvironmental health and safety (EHS) management and audit have now evolved into being a practice that is coupled with and fused into many business-related activities. The practice now is to make an environmental health and safety management and audit an inseparable part of the Quality Management System. Environmental health and safety (EHS) management and audit audits are now a sure means to ensure that the organization has a reputation for corporate social responsibility by implementing this audit.

Aspects of an environmental health and safety management and auditThe aim of environmental health and safety management and audit is to instill the EHS right from the top management down to the line level employee. A properly carried out EHS management and audit system should ideally take these factors into consideration:

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