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Tools to Identify & Mitigate Risk Cheat Sheet (DRAFT) by [deleted]

This is a draft cheat sheet. It is a work in progress and is not finished yet.

Introd­uction

Data is constant, it never stops flowing and it can be overwh­elming. However, automated quality and compliance software can help make sense of it all. Gaining visibility into already available data is essential to compre­hen­sion. Unders­tanding data is the first step in calcul­ating risks, weighing out options and making important decisions.

How is this done? There are many elements to risk manage­ment. Risk management tools identify, redirect and mitigate risk throughout an organi­zation. In a fast-paced world, having a quanti­fiable and repeatable method set in place helps make risk tangible.

Decision Trees

The decision tree allows users to create a Web-based list of relevant questions that are dependent on each other. It is an effective method that quantifies results through ranking and related actions. Once a company receives an input of an adverse event, the decision tree can help determine the proper route to take. Decision trees eliminate any guesswork involved by inserting a guided set of questions that serve as a simple place to get started. It then allows users to contin­ually update previously recorded data and follow up with it

Risk Matrix:

The Risk Matrix is a simple­-to­-read method of quanti­fying risk levels. The Risk Matrix catego­rizes data and places it in its respective level on a chart. It shows if the event is minor, neglig­ible, marginal, critical or catast­rophic. From there it will also determine if the threat is frequent, probable, occasi­onal, remote or improb­able. Answers to these questions are assigned to categories that are based on a scale of one to five. Since there are many different ways to associate different levels of risk, the risk matrix helps determine the likelihood and critic­ality of occurr­ence.
 

Surveys

Risk surveys determine the type of risk on hand. It ranks unknown and uniden­tified threats and then allows users to start planning and setting distri­bution and control plans. This type of method allows users to understand what types of risk are possible and allows users to plan ahead with expect­ations.

Bowtie Model

An effective method that allows its users to build barriers to prevent events from occurring. It puts controls in place and sets recovery methods to minimize chances of impact. Bowtie Risk tools collect inform­ation on both high and low-oc­cur­rence events. In the life sciences industry, a high level of risk is a chance that cannot be taken. The Bowtie method lets users plan for risk rather than just waiting for it to occur and taking reactive measures.

Risk Register

The Risk Register monitors risk. It collects data from all processes and develops a report on it. This is extremely beneficial in the long run, especially with past events. Users are able to look up inform­ation on risks and how it was handled. This allows users to handle things better the second time around, should an event recur. The risk register gathers the data needed to back up actions and automa­tically send necessary inform­ation to regulatory agencies like the U.S. Food and Drug Admini­str­ation. It helps companies make sense of their data and determine precisely where risks are by providing necessary oversight into operations while using risk as a benchmark for achieving overall compli­ance.

Tying it All Together

Risk management tools allow users to uncover issues and determine where they hide. Risk tools hand users the necessary inform­ation to make adjust­ments and mitigate events. Risk is universal, it comes in all shapes, sizes and forms. This is why it is beneficial for quality and compliance organi­zations to speak risk. Adverse events take place even with the best of practices, so allowing software solutions to quantify risk helps users prepare. Once threats are detected, automated software helps decisi­on-­makers ensure their choices will improve the situation.

There are many different types of organi­zat­ional risk tools. It all comes down to the solution that will work best for you and your organi­zation. In our ever-e­xpa­nding, fast-paced world, technology can help you get where you need to be. Automated solutions help set clear expect­ations, enhance commun­ication and enable you to follow standards and regula­tions to achieve repeatable outcomes.