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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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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Trends that will shape Supply Chain and Logistics in 2017

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Trends that will shape Supply Chain and Logistics in 2017 is an interesting topic to think about. Though most of the trends are a takeoff from the previous years, unless something really disrupting happens out of the blue at some point of time in the year; the signals are strong that the trends that emerged in the previous few years are set to solidify and get reinforced.

What are the trends that will shape supply chain and logistics in 2017?

For a sector that is dependent heavily on infrastructure for its working; there has been little of path breaking significance in terms of what has been added to the existing infrastructure in any country of significance in the world, at least not to the extent that it can impact the industry in a significant way. The Chinese hobbyhorse, the One Belt One Road (OBOR) initiative, is not slated for completion in this year. The completion of this grand project could spell a major change for the shape supply chain and logistics, but nothing of such drastic significance is set to take place in 2017.

trends-will-shape-supply-chain-and-logistics-2017In the other “happening” countries – for the supply chain and logistics industry that is – 2017 is not likely to see a signal shift. But the developments that have been happening over the past few years are likely to gather pace. Technology is one area in which the change is to be expected. While again, technology itself may not really be new till this point of time in this year; a few trends have been emerging, promising to make some impact on the shape supply chain and logistics industry in 2017.

Big Data as a driver of changeBig Data is the word on everyone’s lips. How can one expect an industry that is so completely data driven as logistics and supply chain to be insulated from its influence?

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Transition to m-commerceA notable development that is expected in the supply chain and logistics in 2017 is the evolution of ecommerce into m-commerce. This again, is nothing new or defining for 2017, but the year is likely to see a continuation of the trend set earlier.

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People all over the world are finding it much easier to shop with the help of their mobile devices, and are adapting to this medium, albeit at different levels and speed. The explosion in the number of smartphones being purchased globally has added impetus to m-commerce.

Try-ons as a new trendA new feature of online shopping is the try-on option that consumers are now being given. Online shoppers are given the option of choosing 4-5 varieties of their chosen product. All these pieces are delivered with the order, and the consumer can try out each of them and select the one that she thinks suits her best. The idea is to replicate the actual shopping to the extent possible.

trends-will-shape-supply-chain-and-logistics-2017This trend has its challenges, for sure, because the cost of making it work could be unimaginably high. As with any new trend, it is going to be some time before the economies of scale of such huge logistical operations start kicking in. Yet, this is a very tangible factor that is sure to count among the supply chain and logistics trends of 2017.

 

 

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Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need for global supply chain regulatory compliance.

Global supply chain regulatory compliance has now become something on which organizations cannot compromise. Any shipment of any item that reaches foreign shores can get rejected if it has not met global supply chain regulatory compliance. Such a consignment could even get labeled as counterfeit. This explains the importance and need for global supply chain regulatory compliance. Being in global supply chain regulatory compliance means adhering to even the local laws of the foreign country into which goods and products are exported.

Governments have become more stringent 

global-supply-chain-regulatory-complianceAs a result of these trade and technological developments; governments all around the world without exception are jumping on the bandwagon to formulate laws that apply to the supply chain industry. For most governments, global supply chain regulatory compliance is a must. They are becoming extremely strict in enforcing these laws and are handing out severe punishments to businesses and organizations that are lax in enforcing global supply chain regulatory compliance. Most countries are legislating laws regarding global supply chains almost exclusively, in a way that other political acts are framed. This has pushed the need for global supply chain regulatory compliance further.

Other related developmentsAs technologies advance in the global supply chain, many developments in auxiliary and supplementary fields have hastened global the push for supply chain regulatory compliance requirements. For example, heavy paperwork, which used to be hallmark of most merchandising businesses, has made way for automation. Global supply chain regulatory compliance has to take factors such as these into consideration.

global-supply-chain-regulatory-complianceOther developments in allied areas such as intellectual property rights have gone on to strengthen the role of global supply chain regulatory compliance. As countries demand greater protection for their intellectual property products, they use global supply chain regulatory compliance as an instrument to enforce these, when these products concern exports.

In addition, there could also be other critically important issues in global supply chain regulatory compliance that may not be related to any of these, but can play a decisive role in disrupting global businesses. Think of natural disasters such as the Fukushima earthquake or the many natural disruptions such as hurricanes in South and North America. These could throw businesses out of gear. Global supply chain regulatory compliance is a kind of insulation against the uncertainties caused by events such as these.

In other words, global supply chain regulatory compliance should leave no stone unturned. There is no scope for compromise of any kind in implementing global supply chain regulatory compliance provisions.

Items that go into global supply chain regulatory complianceMeeting global supply chain regulatory compliance requirements means having to take care of a number of ingredients. Some of these are:

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Upcoming crucial global supply chain regulatory compliance regulation in the USSeveral legislations aimed at bringing about global supply chain regulatory compliance are in place. However, at this point of time, a really crucial global supply chain compliance regulation that could play a major role in the US in the coming years is the Automated Commercial Environment (ACE).

global-supply-chain-regulatory-complianceIn a nutshell, this U.S. Customs and Border Protection (CBP)-mandated regulation aims to bring in place a single portal which will make information on imported goods flow electronically from the businesses themselves right to the respective departments or agencies that require and handle them. The ACE is aimed at making import and export related work paperless, while also seeking to become a major facilitator of trade.

 

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Why Trade Compliance and Logistics Must Work Together

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Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.

Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.

Need to grapple with multiple laws

why-trade-compliance-and-logistics-must-work-togetherThere is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.

Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.

A way out of the complexity

why-trade-compliance-and-logistics-must-work-togetherFor many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.

Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation 

why-trade-compliance-and-logistics-must-work-togetherAnother important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.

Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

 

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What is logistics and supply chain management?

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed.

Logistics and supply chain management is emerging as a major area of business because of the evolution and growth of globalization. Many products and goods are produced in one country and consumed in another situated thousands of miles away. The right logistics and supply chain management helps to deliver the goods and products to the right person, at the right time, at the right place and in the right condition. Lack of proper logistics and supply chain management is a recipe for disaster.

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What is logistics and supply chain management?

 

Among the lay people, there is a tendency to use the two words synonymously and interchangeably. In trade, however, there are major differences between the two. Logistics is just a part of the supply chain. In simple, general and broad terms, one can understand the difference between logistics and supply chain in the following ways:

Logistics is a part of supply chain, meaning that it is a set of activities that are carried out within an organization. Supply chain, on the other hand, is the full set of activities that are carried out from start to finish, i.e., from the time it departs the organization that it is leaving till the time it reaches its logical destination. In this process, supply chain management involves the coordination and collaboration of many entities. In this sense, supply chain is a whole set of activities, of which logistics is only a part.

Another way of understanding logistics and supply chain management 

logistic-and-supply-chain-managementAnother way of understanding logistics and supply chain management is this:

Logistics can be understood as being a discipline in which the following activities are involved:

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On the other hand, supply chain management can be said to include more extended activities, which include:

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Logistics and its extended activitiesLogistics often is described in terms of inbound and outbound logistics. Simply put, inbound logistics is the movement of raw materials and goods that are bought by and transported into a company. When these are processed and finished and shipped to customers; they become part of outbound logistics.

Logistics and supply chain management in a broader contextWhen one tries to get an understanding of logistics and supply chain management at a higher or broader level in the way logistics has been described above; supply chain management can be understood as consisting of these elements:

logistic-and-supply-chain-managementA sound supply chain system seeks to create value for the organization by building and utilizing logistics infrastructure. Logistics and supply chain management become meaningful when the organization synergizes demand with supply, stock and supply and inventory management

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