Question: Write a Compliance Risk Management plan Matrix for a Pharmaceutical Company in relations to FDA and FCPA. Taking into consideration the below: This spreadsheet provides
Write a Compliance Risk Management plan Matrix for a Pharmaceutical Company in relations to FDA and FCPA. Taking into consideration the below:
This spreadsheet provides you with a format for the compliance risk management plan, which you can either create for your own organisation, or you may use the fictional case study provided on the Online Campus. Remember to only use the fictional case study provided if you have chosen not to use your own organisation or another organisation you are familiar with
Part of the ongoing project requires you to create a risk matrix for your risk management plan, for which you will need to complete columns ABCDEFand G of the Compliance risk management plantab You will need to use the Risk matrixand Risk rating scalestabs in order to do this. Follow these steps to complete the relevant sections:
Consider the context of the organisation: Before completing the spreadsheet consider the context of the organisation; for example, where the organisation is based, the industry it is inthe size, products and services, frameworks, culture, and regulations that would impact the operations of the organisation.
Identify relevant legislative acts: Conduct your own research and identify one or two acts or regulations that are relevant to the industry and nature of services of the organisation. For example, if you were creating a compliance risk management plan for a PHARMACEUTICAL company the FDA and FCPA would apply to the organisation.
Decide on relevant chapters or extracts from the chosen legislation: Legislation is separated into chapters, and each chapter is often divided according to the theme it attempts to address. Read the contents page of the legislation carefully to determine which chapter would be relevant to your organisation or the case study. For this ongoing project, you are required to identify at least extracts from the chosen legislation, but you may include more. Each extract should be considered a compliance obligation and included in its own row in the spreadsheet. Add the extracts or chapters from these acts to the tab called Compliance risk management planunder the heading Regulatory provisionColumn A
Highlight areas of concern or compliance obligations: Provide an interpretation of each extract in the Interpretation of sectioncolumn Column BTo do this, find phrases or statements that you think could be classified as compliance obligations. Remember that all stakeholders will have an understanding of law text. Therefore, you should provide a simple interpretation of the text you have highlighted, and this interpretation can also be seen as the compliance obligation that needs to be fulfilled. You should be aware of any phrases that are ambiguous or unclear, or phrases that are prescriptive. You may choose to add the legislative shorthand, such as Article of the GDPR; however, inserting the actual extract will make it easier for you to analyse.
Identify the risk drivers: Remember that risks and risk drivers are a pivotal part of your risk management plan, as they will inform the nature of your risk rating scales. Therefore, it is advised that you populate this section of your compliance risk management plan with as much detail as possible. This section is split into two columns called Risk driversColumn Cand ConsequencesColumn D
Create impact and likelihood scales: Navigate to the second tab in the spreadsheet, the Risk rating scalestab This sheet contains generic risk impact and risk likelihood scales. Alter the scales in the sheet to better suit the context of your chosen organisation. There is a generic risk matrix in the third sheet called Risk matrixthat you should use when editing the scales.
Assign risk ratings: Navigate back to the first tab, the Compliance risk management planand assign an impact Column Eand likelihood Column Frating for each extract. If you click on the cell a little arrow will appear and you can choose a risk number and a likelihood letter. The combination you choose will automatically reflect in Column GYou will notice that this automation is linked to the risk matrix.
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