Concerned about health and safety on the job?

OSHA 1

Are you one of those concerned about health and safety on the job? You’re not alone. Across the length and breadth of the US, the millions of workers who are employed in the various sectors, be it manufacturing or services, or technological or agricultural, are prone to injury at the workplace. Not one kind of job or working condition or employment or workplace is free from the potential to cause injuries or illnesses. This is why there is every reason to be concerned about health and safety on the job.

Concerned-about-Health-and-Safety-on-the-JobYet, there are a good number of security safeguards that have been put in place in the form of legislations from the Occupational Safety and Health Administration (OSHA). OSHA has been primarily enacted with the purpose of giving employees rights to a safe workplace. Why every employee needs to be concerned about health and safety on the job is best answered by these disconcerting statistics:

Concerned-about-Health-and-Safety-on-the-Job

OSHA is about dispelling concerns about health and safety on the jobConsidering the damage that concerns about health and safety on the job can cause to the workforce as well as to the economy, the US legislated OSHA way back in December 1970. The main intention of this historic piece of legislation was to ensure safety of workers at the workplace not just through suggestions, but through actionable steps.

Concerned-about-Health-and-Safety-on-the-JobThe hallmark of this legislation is that it empowers employees to demand a safe workplace. If an employer is seen to be violating the provisions of OSHA or if the employee feels that there is some form of potential danger to her physical wellbeing at the workplace; she has the right to complain to OSHA without fear of being retaliated against.

A host of rights to assuage concerns about health and safety on the jobAmong the main features of OSHA is that it requires the employer to publish employee rights about their safety at the workplace. This enables them to allay concerns about health and safety on the job, as they have a ready reference to which they can go back in case of a doubt about the implementation aspects of any provision of OSHA. Employees who are concerned about health and safety on the job have the following rights:

Concerned-about-Health-and-Safety-on-the-Job

Click to Continue Reading

Risk Management in the Global Economy and outlook for 2017

Risk Management in the Global Economy and outlook for 2017.gif

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

risk-management-in-global-economy-and-outlook

  • 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

Click to Continue Reading

An understanding of Risk Management and Analysis for Medical Device Manufacturers

Risk Management and Analysis1.jpg

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.

Click to Continue Reading

Benefits of Risk Management in all Industries

Benefits of risk management in all industries3

The benefits of risk management can be felt across all industries. Risk management is a process that needs to be applied if the risks have to be mitigated and contained, if not fully eliminated. The benefits of risk management in all industries came into greater focus following the financial debacle of 2008.

Firstly, why does an organization need to implement risk management strategies? Simple: Risks can offset the potential benefits and convert them into drawbacks. The benefits of risk management in all industries always outweigh the drawbacks of non-implementation of risk management strategies. In addition to helping the upper management get a better idea of the state of affairs of the company, benefits of risk management in all industries also help to reduce the financial burden for the organization and to meet regulatory requirements.

benefits-of-risk-managementIt needs to be understood that risk management is a set of processes that need to be implemented extremely stringently and diligently at every possible stage. Risk management is a journey, not a destination. For the benefits of risk management in all industries to be felt thoroughly, it is important to understand that it is intuitive.

Each industry has its unique risksRisk management is not a standard set of processes or exercises that can be applied into every industry. For example, the benefits of risk management in the finance sector could be different from those of the manufacturing industry. Likewise, the benefits of risk management in all industries in the life sciences sector could be way different from the risk management that is implemented in say, human resources.

benefits-of-risk-managementYet, even though the dynamics of risk management are different across all industries and are unique to each of them; the benefits of risk management in all industries are there to be felt and experienced.

Look out for the sleeping monstersEven though risk management is implemented in accordance with its own set principles or standards; there is still a possibly that some risk that was not obvious at an earlier stage could spring an unpleasant surprise later. This makes the benefits of risk management in all industries all the more worthy of consideration.

If the benefits of risk management in all industries need to be felt; the most important quality for risk managers is to inculcate the ability to see what is called the “unknown unknowns”. In simple terms, this is a phase used to describe the ability to foresee beyond the known factors.

benefits-of-risk-management

The ability to see beyond the obviousA few factors could become manifest in clear ways, but it is the obscure and latent ones that need greater attention. It is not always possible for even the most farsighted business risk manager to sometimes grasp the dormant risks that could crop up out of nowhere and pose a threat to the business. Developing this ability helps to realize the full benefits of risk management in all industries, because this is a quality of risk management that is common across all industries.

benefits-of-risk-managementIn order to realize the benefits of risk management in all industries fully, risk managers need to be on their guard all the time. This is obvious and goes without saying, but in the light of the fact that some risks can become enormous and uncontrollable at later stages, it is best for risk managers to understand ways of deriving the benefits of risk management in all industries.

 

Click to Continue Reading

Ways of managing risk in construction projects

Ways of managing risk in construction projects 1

The ways of managing risk in construction projects need to be drilled down into the systems that are used in construction projects. Managing risk in construction projects entails not just ensuring the physical safety of the workers involved in the construction project, but goes much beyond.

Projects that are executed on time and in compliance with safety regulations go a long way in contributing to the creation and building of infrastructure projects that are vital to an economy and for ensuring the smooth movement of goods and services and the overall conduct of life for people in the country. On the other hand, delays and cost overruns in construction projects, which are a direct result of not managing risk in construction projects, set the project backwards, leading to higher cost on the project, added labor costs and delays in implementing infrastructure.

Inherent risks in construction projectsA proper grasp of the inherent risk is often the first means to managing risk in construction projects. Some of the risk factors in construction include:

managing-risk-in-construction-projects

Implementing risk management in construction projectsIn line with risk management principles laid out in many other industries; managing risk in construction projects also involves taking a few steps and implementing processes and safety standards.

It is important to note that like in many other industries, when managing risk in construction projects, one has to take the important factor of variables into consideration. That is, risk factors keep changing over the duration of the project, meaning that risk factors are hardly ever static.

The process of managing risk in construction projectsLike in most other industries in which systematic application of risk management principles is called for; managing risk in construction projects also requires professionals in this industry to do the same. The steps start with:

Risk assessmentBeing the foremost among the means of managing risk in construction projects; risk assessment is a comprehensive set of steps which starts with understanding the hazards. Hazards, as we know, are all pervasive in the construction industry, and are the precursors to a risk. While a hazard is the possibility of an adverse event; a risk is the actual occurrence of that event. So, managing risk in construction projects involves looking at the issue from the hazard stage.

It involves the following:

Risk assessment:
managing-risk-in-construction-projects

Project controls:
managing-risk-in-construction-projects
Risk mitigation

managing-risk-in-construction-projectsViewed from the overall perspective of ensuring safety and quality and also in view of the importance of the industry to the economy; managing risk in construction projects is a major exercise that needs to be handled with care and precision.

 

Click to Continue Reading

How is Risk Management Important to Project Success?

Risk Management Important.gif

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.

 

Click to Continue Reading

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

pharmaceutical and life sciences34

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:

pharmaceutical and life sciences3

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:

risk-in-pharmaceutical-and-life-sciences-industries

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:

risk-in-pharmaceutical-and-life-sciences-industries
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:

 

 

Click to Continue Reading