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The intended audience for this document is all project Teams, Project Managers, Engineering, construction, integration Managers and Radio frequency Subject Matter Experts. Risks will affect the project negatively and will have a potential impact on the project and the organization. The main purpose of this is to identify all the potential risks and mitigate them throughout this project. This document will also detail the approach, steps that needed to be taken and document the concern areas of the project and also provide a detailed plan of action and monitor the risk events. During the documentation of the risk the very first step is to decrease the possibility of the risk to occur if the risk is unavoidable them prepare the contingency plan and identify all the events that potentially occur before or after the risk is identified. Performing a mitigation might come with some cost and this might exceed the actual planned cost emergency courses of action executed before the risk happening are pre-emptive activities planned to diminish the effect or to reduce the chances of occurring risk completely. Alternate courses of action actualized after a risk happens can typically just diminish the effect. Identifying and reporting potential risks to the result of a task is only the initial step. It is similarly critical to screen all tasks at regular intervals by the project teams and gave an account of those during status report.

This document will also plan the required tools, procedures, process and mitigation steps that will be used to control the risks that has potential consequences against the project.

6.2 Risk Identification

A risk is any event that could prevent the project from progressing as planned, or from successful completion. Risks can be identified from a number of different sources. Some may be quite obvious and will be identified prior to project kickoff. Others will be identified during the project lifecycle, and a risk can be identified by anyone associated with the project. Some risk will be inherent to the project itself, while others will be the result of external influences that are completely outside the control of the project team. The Insert Project Name Here Project Manager has overall responsibility for managing project risk. Project team members may be assigned specific areas of responsibility for reporting to the project manager. Throughout all phases of the project, a specific topic of discussion will be risk identification. The intent is to instruct the project team in the need for risk awareness, identification, documentation and communication.

Risk awareness requires that every project team member be aware of what constitutes a risk to the project and being sensitive to specific events or factors that could potentially impact the project in a positive or negative way. Risk identification consists of determining which risks are likely to affect the project and documenting the characteristics of each. Risk communication involves bringing risk factors or events to the attention of the project manager and project team.

Methods for Risk Identification

At any time during the project, any risk factors or events should be brought to the attention of the Insert Project Name Here project manager using Email or some other form of written communication to document the item. The project manager is responsible for logging the risk to the Risk Register. Notification of a new risk should include the following Risk Register elements:

· Description of the risk factor or event, e.g. conflicting project or operational initiatives that place demands on project resources, unexpected study outcomes, delays, etc.

· Probability that the event will occur. For example, a 50% chance that the vendor will not have an animal colony that meets the criteria available.

· Schedule Impact. The number of hours, days, week, or months that a risk factor could impact the schedule. As an example, the animals require an additional 3 months to meet age requirements.

· Scope Impact. The impact the risk will have on the envisioned accomplishments of the project. Delayed animal delivery may result in a reduction in the number of studies that can be completed within the contract period of performance.

· Quality Impact. A risk event may result in a reduction in the quality of work or products that are developed. As an example, lack of funding caused by cost overruns may result in the reduction of the study size and impact statistical empowerment

· Cost Impact. The impact the risk event, if it occurs is likely to have on the project budget.

Document Reviews

In order to identify any risk, initially all the documents related to the project must be diligently reviewed and evaluated to gather issues or gaps within the processes which may generate uncertainty and impact the project outcome.

Brain Storming

In this process, all of the participants which includes but is not limited to, the Team, the Project Manager and the Project Sponsor will be encouraged to think and consider all options to gather information about the risk. Also, there would be no discrimination, criticism, or judgement of any kind which routes to negativity. Best approach is to have Nominal Group Techniques. Having this technique would enable the facilitator to let the participants to write down the ideas on the sticky notes and then later speak out their idea and stick it to the wall. Also, in this process each participant will have the ability to take notes and think independently. It also encourages everyone to participate during this session as ideas can be anonymized.

6.3 Risk Analysis

Risk Analysis is to a way to identify the potential risk. It is a process to manage and prepare to deal with the risk. Risk analysis is based on the prioritization of the possible impact that might happen, and the probability of threat you may face. Risk Analysis occurs when you plan the project to help you identify the possible problems. And it occurs when the plan and outside environment are changing where risk is more likely to happen. There are two types of risk analysis which are Qualitative Analysis and Quantitative Analysis.

The difference between the two methods is that Qualitative Risk describe the descriptive situation about the risk while Quantitative focus on the numerical scale.

Since Qualitative Risk analysis prioritize the risk with probability rank, so each risk can be rate by the likelihood of risk impact occur. Probability starting from 0% to 100%. The following chart define the rating for each percentage of likelihood. The impact scale is organizationally defined (for example, a one to five scale, with five being the highest impact on project objectives – such as budget, schedule, or quality).

6.4 Risk Monitoring Plan

Based on trigger events that have been documented during the risk analysis and mitigation processes, the project team or project managers will have the authority to enact contingency plans as deemed appropriate. Day to day risk mitigation activities will be enacted and directed by the project managers.

Contingency plans that once approved and initiated will be added to the project work plan and be tracked and reported along with all of the other project activities.

The process of controlling the risk induced in the project includes various methods; one of the methods is by implementing acceptance criteria for monitoring the intake of complaints and initiating a response when the complaints go above the acceptance criteria.

The Risk reporting process includes the different ways of reporting failures/risks induced by the product to the product manager, team members or upper management. This risk reporting helps in alerting other teams and department within the company and outside to keep tracks of other things being affected because of this failure. The risk reporting is also done to applicable regulatory bodies to keep the regulatory body informed that this risk is being induced by the product, but the benefit of the product overplays the risk induced. We also notify the regulatory body that we as a company are accepting the risk induced by the product and have implemented measures to reduce the risk as low as possible. These failures/risks are continuously monitored by the team members to make sure that the product is not inducing any new risks.