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Varzia provides risk assessment service as a key component of a holistic, organization-wide risk management process.
As we move through stage two of the meaningful use program and with the effective date having come and gone for compliance with the new HIPAA Omnibus Mega Rule, it is critical to take a strong look at your security posture. The key areas that need to be reviewed to ensure that your practice has the best possible security posture include the technical, administrative and physical safeguards your practice has in place to protect PHI.  A thorough and comprehensive assessment of risk following NIST guidance will allow you to gain a true understanding of your security posture. Conducting and reviewing these assessments annually as part of your Risk Management Plan are not only important for meeting the regulatory requirements for Meaningful Use and HIPAA Compliance, they will assure that you are putting your practice in the most secure environment possible.
As you prepare to meet the requirements listed above, please keep the following in mind.  The more thorough you are will put your practice in a better posture.
Here are some things to keep in mind as you review your physical, administrative and technical safeguards as part of your risk assessment.
Food safety has always been an important issue, and currently it is high on the political agenda of many countries. Risk analysis has evolved over the last decade within the Codex Alimentarius Commission (CAC).
Risk analysis is now considered to be an integral part of the decision-making process of Codex. In addition to these developments in risk assessment, the 22nd Session of CAC requested FAO and the World Health Organization (WHO) to convene an international advisory body on the microbiological aspects of food safety in order to address, in particular, microbiological risk assessments. Risk assessment is one of the components of risk analysis - which can be defined as being an overall strategy for addressing risk - that also includes risk management and risk communication. The risk assessment process is a means of providing an estimate of the probability and severity of illness attributable to a particular pathogen-commodity combination.
The carrying out of an MRA, particularly quantitative MRA, is recognized as a resource-intensive task requiring a multidisciplinary approach.
As well as as a tool that can be used in the management of the risks posed by food-borne pathogens, risk assessment can also be used to justify the introduction of more stringent standards for imported foods. Information, frameworks and tools, which are applicable to microbiological risk assessment the world over can be collected or elaborated and centralised. Undertaking microbiological risk assessment at the international level enables the identification of areas which are similar or common to a particular region or even to all countries. It provides a means of addressing issues of international concern or issues of concern to a large number of countries. It enables the identification of available data on a global scale and equally important the areas where knowledge and data are lacking. This work is undertaken with the assistance of internationally recognised experts in the field with the objective of providing the highest quality information. Undertaking this work at the international level results in the provision of valuable information on particular pathogen-commodity combination for use by risk managers at both the national and international levels.
It is important to recognise that risk assessment at the international level is substantially different from risk assessment at the national level. There are also limitations to what can be undertaken at the national level due to the availability of resources.
The good news is that most products (biologics and small molecules) share similar manufacturing processes. Having spent time on more risk assessment sessions than I’d like, I sought for ways to eliminate unnecessary work, shorten meetings, while improving the outcome — Design Space planning and Control Strategy. In the email, ask the process owners to edit their sections based on the template as pre-work — (before the 1st meeting).
Below, I used the A-Mab Template from the QbD Risk Assessment Software. The first screen prompts me to modify an existing template (or create a new one).

We just saved saved 12 hours of work, 3 group meetings and 3 weeks of lead time – and no meetings so far. Assign the process owners to evaluate the relative impact between CQA and CPP of their own processes. If the process owners want paper-based template, we can print them out so they can mark the ratings with pens or pencils. So far we saved 9 unnecessary group meetings, 12 hours of individual work and a minimum of 3 weeks of waiting.
Count the number of people in the room and multiply it by the number of hours they are sitting together without saying anything (i.e. Also this is one of the primary reasons why scientists don’t like risk assessment sessions — too many (unnecessary) meetings. In the next post, Step 3 will cover the Occurrence assessment and Control Strategy to save more time and get better results. Our risk assessment process centers on an evaluation of current decision-making from key leaders, plus an analysis of the technology, personnel and procedures that are currently used in crisis situations.Our team then synthesizes these observations into a comprehensive look at disaster preparedness. There are many options available to you regarding encryption, look into the options that best meet your practices needs and financial considerations. CISSP® is a registered certification mark and (ISC)? is a service mark of the International Information Systems Security Certification Consortium, Inc. Schmidt, CEO of Preparedness, LLC is the coauthor of Business at Risk How to Assess Mitigate and Respond to Terrorist Threats. Moreover, our comprehensive TRA methodology will ensure that your application, network, and computing infrastructure are thoroughly scrutinized in order to reduce risk and exposure. Since the Uruguay Round Trade Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) entered into force in 1995, the importance of risk analysis has increased.
FAO and WHO subsequently convened a series of three expert consultations to address the three components of Risk analysis: risk assessment, risk management and risk communication. It delineated the basic terminology and principles of risk assessment and concluded that the analysis of risks associated with microbiological hazards presents unique challenges.
CAC has adopted definitions of risk analysis terms related to food safety and statements of principle relating to the role of food safety risk assessment. In response to this and as follow-up on their previous activities in the area of risk analysis, FAO and WHO convened an expert consultation in March 1999 to examine the issue of microbiological risk assessment (MRA) in an international forum. The importance of an overlap between these three elements (risk assessment, risk management and risk communication) is well recognized, but some functional separation is also necessary. The four-step process enables this to be carried out in a systematic manner, but the extent to which the steps are carried out will be dependent on the scope of the risk assessment. While MRA is becoming an important tool for assessing the risks to human health from food-borne pathogens and can be used in the elaboration of standards for food in international trade, it is not within the capacity of many, perhaps even most, countries to carry out a complete quantitative MRA.
A knowledge of MRA is therefore also important for both health and economic purposes, and there is a need to provide countries with the tools for understanding and, if possible, carrying out MRA.
This facilitates both the distribution and accessibility of the technology and related information.
At the national level in particular this should help facilitate optimal use of limited resources. It cannot consider the situation in all countries and therefore tends to be more generic in nature and cannot capture local scenarios and country to country variations e.g. Ultimately, international work is very dependant on national and regional expertise and data.
This serves as the foundation for our strategic efforts to identify gaps and implement a strategy throughout our clients’ entire organization.

Risk assessments can support a wide variety of risk-based decisions and activities by organizational officials across all tiers in the risk management hierarchy. More than ever before, there is strong consumer awareness of food quality and safety, and this continues to increase.
Furthermore, in 1999, it adopted the Principles and Guidelines for the Conduct of Microbiological Risk Assessment.
The main outcome of this expert consultation was an outline strategy and mechanism for addressing MRA at the international level.
In relation to risk assessment, such separation ensures that issues are addressed in a transparent manner using a scientific basis. This can be defined clearly by the risk manager through ongoing dialogue with the risk assessor. This need, combined with CAC's and CCFH's requests for scientific advice on MRA, has led FAO and WHO to undertake a programme of activities to address the issue of MRA at the international level.
When rating, anyone can add comments to each cell for literature review, clinical study results, RA or QA justification, etc. This is a form of waste since the process owner usually does the rating of their processes while others sit quiet until it’s their turn to rate.
New risks and challenges are emerging as a result of changes in the methods of food production at the farm and processing levels. These were developed by the Codex Committee on Food Hygiene (CCFH), which is currently developing Principles and Guidelines for the Conduct of Microbiological Risk Management. Subsequently, at its 32nd Session in November 1999, CCFH recognized that there are significant public health problems related to microbiological hazards in foods.
It identified 21 pathogen-commodity combinations of concern and prioritized these according to such criteria as the significance of the public health problem, the extent of the problem in relation to geographic distribution and international trade and the availability of data and other information with which to conduct a risk assessment. After final comments and edits have been reviewed, let’s move on to the next step since this list can easily be revisited and edited later. Consumption patterns and consumer demands regarding such issues as the variety and shelf-life of foods, as well as the preservation techniques used, are changing. CCFH suggested that FAO and WHO convene ad hoc expert consultations to provide advice on MRA, and also recommended that these consultations be conducted according to the format outlined at the 1999 expert consultation. International trade in food has also increased the risk of infectious agents being disseminated from the original point of production to locations thousands of kilometres away.
The consequence of this is that there is an increased risk to human health as well as implications for international trade in food and ultimately the food producers. As a result there has been a realisation in many countries of the need for an integrated approach to food safety. This involves looking into all parts of the food chain and linking this with the human health outcome.
However the implementation of such a holistic approach to food safety is not necessarily an easy one as it requires the expertise, interaction and collaboration of a wide range of people of many different backgrounds and professions.
The development of the risk analysis process has however provided us with a tool to make this possible.

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