DiPaolo Brittany FPX 5334 1-1

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Risk Management Plan Project Name: Bausch + Lomb Project Learner Name: Brittany DiPaolo Course Name: FPX5334: Project Risk Assessment and Control Date: November 2, 2023 Table of Contents Sec$on 1 – Introduc$on to the Plan 3 ______________________________________________________________________________ 1.1 Benefits of Risk Management 3 _______________________________________________________________________________________ 1.2 Project Goals and Objec?ves 3 ________________________________________________________________________________________ 1.3 Company Background 3 _____________________________________________________________________________________________ 1.4 Risk Iden?fica?on 5 _________________________________________________________________________________________________ Sec$on 2 – Risk Scope, Components, and Value 5 ____________________________________________________________________ 2.1 Scope of the Risk Management Plan 5 __________________________________________________________________________________ 2.2 Risk Management Plan Components 5 _________________________________________________________________________________ 2.3 Expected Monetary Value 5 __________________________________________________________________________________________ 2.4 Determine the Risks 5 _______________________________________________________________________________________________ 2.5 Evaluate and Assess the Risks 6 _______________________________________________________________________________________ 2.6 Qualita?ve and Quan?ta?ve Processes 6 _______________________________________________________________________________ Sec$on 3 – Risk Analysis and Assessment 6 _________________________________________________________________________ 3.1 Major and Minor Risks 6 _____________________________________________________________________________________________ 3.2 Risk Probability 6 ___________________________________________________________________________________________________ 3.3 Risk Matrix Template 7 ______________________________________________________________________________________________ 3.4 Risk Data Quality Strategy 7 __________________________________________________________________________________________ 1
3.5 Risk Reviews 7 _____________________________________________________________________________________________________ Sec$on 4 – Correc$ve Ac$on and Monitoring 7 ______________________________________________________________________ 4.1 Risk Tolerance 7 ____________________________________________________________________________________________________ 4.2 Risk Mi?ga?on 7 ___________________________________________________________________________________________________ 4.3 Correc?ve Risk Management Strategy 7 ________________________________________________________________________________ 4.4 Correc?ve Ac?on Plan 8 _____________________________________________________________________________________________ Sec$on 5 – Postmortem Plan 8 ___________________________________________________________________________________ 5.1 Results 8 __________________________________________________________________________________________________________ 5.2 Follow Up 8 _______________________________________________________________________________________________________ Sec$on 6 – References 8 ________________________________________________________________________________________ 6.1 References 8 ______________________________________________________________________________________________________ Templates 9 __________________________________________________________________________________________________ Risk Matrix Legend Example 9 ___________________________________________________________________________________________ Risk Matrix Example 9 __________________________________________________________________________________________________ Risk Monitoring and Control Example 10 ___________________________________________________________________________________ Cita?ons 11 __________________________________________________________________________________________________________ 2
Section 1 – Introduction to the Plan 1.1 Benefits of Risk Management Effective risk management is a crucial aspect of any project, allowing for efficient handling of project risks, reduction of negative risks, and maximization of potential opportunities. By rating and scoring risks related to staffing, design, budgets, and timelines, project leaders can accurately evaluate potential issues and make informed decisions. The benefits of risk management are numerous, including the ability to rapidly forecast probable issues, avoid catastrophic events, enable growth, stay competitive, improve business processes, and enable better budgeting (Benefits of Risk Management, n.d., paras. 2-12). 1.2 Project Goals and Objectives The project goal and objectives are as follows: - A study team will evaluate the value and risks associated with a no-value-add project. - A feasibility study will be conducted, followed by a design review and evaluation of national and international regulatory compliance. The plan will then be signed off by the project team and senior management. - A realistic project timeline will be created, which will include regulatory clinical trials and filings for devices and pharmaceuticals. - The plan will encompass all pre-product launch testing and training. - The team will adhere to all standardized product development processes, ensuring compliance adherence and quality performance. - Project leaders will follow project management practices and use Microsoft Project program to ensure proper project tracking and management. 1.3 Company Background Bausch + Lomb's website describes the company's mission and vision is to help people see better and live better all over the world.Through unwavering focus rooted in innovation, quality, and craftsmanship, they continue to pursue our lifelong vision of protecting and enhancing the gift of sight through every phase of life (Bausch Lomb, n.d., para. 2). PitchBook, a financial data and software company, reports that as of 2021, Bausch + Lomb employs 12,500 individuals and generated $3,765,000 in revenue. According to PitchBook, the company is headquartered in Laval, Quebec, Canada, and is currently the fourth-largest vision care firm in the United States by sales. Bausch + Lomb is the leading consumer vision care company in India and China. Previously a subsidiary of Bausch Health, the company became a public entity in May 2022. Bausch + Lomb operates in three segments: vision care and consumer (60% of revenue), surgical (20%), and ophthalmic pharmaceuticals (20%). The company is geographically diverse, with 48% of revenue generated in the Americas, 30% in EMEA, and 22% in the Asia-Pacific region (Bausch Lomb General Info, n.d., para. 1). 3
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The process begins when a project idea is submitted to the steering team. The team is comprised of senior leadership representatives from marketing, strategy, research, development, engineering, and supply chain. Together, they review all of the ideas and select the most promising ones. In Phase 2, the project is handed over to a study team. This team investigates the project's feasibility, offering a way forward (time and budget) or recommending that the project be dropped. The study team reports back to the steering committee. If approved, the project moves on to Phase 3 - Development/Scale up and then to Phase 4 - Design/ Technology Transfer. During this time, regulatory clinical trials and filling are carried out. The project concludes with a launch at the end of Phase 5. Risks are identified and addressed throughout all stages of the cycle. 4 (Kohli, 2022)
The scope of the project and budget are overseen by the Senior Vice President and Vice Presidents of each business category. Project Directors are in charge of project processes, training, and project management tools. Project Managers determine and negotiate staffing resources and address team performance issues. Finally, project team members provide input on the project by interpreting customer requirements. 1.4 Risk Identification In order to effectively identify risks, a comprehensive approach involving both qualitative and quantitative risk analysis must be taken. The quantitative analysis aspect of risk identification involves gathering and analyzing data as well as utilizing expert judgment. It is important to note that risk analysis is an ongoing process that should be conducted throughout the project lifecycle. To ensure thoroughness, all team members should participate in risk identification, and all identified risks should be recorded in the project risk log. Section 2 – Risk Scope, Components, and Value 2.1 Scope of the Risk Management Plan Define the boundaries of the risk management plan scope. 2.2 Risk Management Plan Components Explain the components and the corresponding responsibilities that comprise the Risk Management Plan. Describe the processes included in a risk management plan. 2.3 Expected Monetary Value Apply an expected monetary value analysis to estimate the cost of a project without a risk plan. Articulate the benefits of a risk management plan. 2.4 Determine the Risks Identify sources of risk and the corresponding potential impact on project outcomes. Include evidence of at least one of these processes: Brainstorming. 5
The Delphi technique. Ishikawa diagrams. Interviewing processes. 2.5 Evaluate and Assess the Risks Define the elements of the risk breakdown structure for use in evaluating project risk. Analyze the impact of risk on project outcomes. Integrate risk analysis techniques to create a risk breakdown structure. 2.6 Qualitative and Quantitative Processes Apply qualitative and quantitative risk analysis. Include evidence of at least one of these processes: Sensitivity analysis. Expected monetary analysis. Monte Carlo simulation. Decision tree analysis.) Section 3 – Risk Analysis and Assessment 3.1 Major and Minor Risks Analyze project risk to identify major and minor risks associated with the project. How were the risks determined? Were qualitative or quantitative methods used? Was the most e ff ective method applied to determine risk?) 3.2 Risk Probability (Integrate qualitative and quantitative risk analysis techniques to identify methods for evaluating the probability of a risk event. How confident are you in the accuracy of the probabilities used? 6
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What can you do to improve the accuracy of the probability? 3.3 Risk Matrix Template Insert your completed Risk Matrix Template. See the end of this document for examples. 3.4 Risk Data Quality Strategy Define the process and tools to be used to determine the quality of data for use in assessing project risk. How reliable is the data? What is the evidence of reliability?) 3.5 Risk Reviews Define the process to be followed for risk reviews to be conducted throughout the project life cycle. Insert your completed Risk Monitoring and Control Template. See the end of this document for an example. What is being done to proactively reduce risk in the future? What is being done to communicate risks? Section 4 – Corrective Action and Monitoring 4.1 Risk Tolerance Evaluate the organizational and departmental tolerance for risk. Discuss the di ff erent risk tolerances within the organization.) 4.2 Risk Mitigation Identify risk mitigation approaches in support of the project. How will you implement the mitigation approaches? Have you identified specific triggers to initiate mitigation? 4.3 Corrective Risk Management Strategy Describe your strategy for corrective risk management. 7
Explain whether you will use auditing, strategic planning, or another type. Describe the corrective action process and responsibilities. Will you be performing a risk postmortem? If not, why not?) 4.4 Corrective Action Plan Assess corrective plan procedures in support of the project. Is your documentation available to others? Is it reviewed by the team or others? Section 5 – Postmortem Plan 5.1 Results Identify and describe how results data will be collected and reviewed to determine corrective actions. Did your postmortem results lead to any concrete changes? Explain. 5.2 Follow Up Evaluate the organization's view of risk management and approach, resulting from project outcomes. Did this project change the organization's approach and management of risk? Describe the impact of postmortem results on the organization. Recommend corrective plan procedures to e ff ectively manage risk. What recommendations would you make for future risk management projects? What resources did you use to support your assertions? Section 6 – References 6.1 References Include a minimum of two references in APA style. 8
Templates You may delete this section once you have copied the tables as directed above. Risk Matrix Legend Example If you wish, you may color code risk in addition to using the indicators of high, very high, and so forth. A usual color scheme is green, yellow, orange, red. Risk Matrix Example The risk matrix is a graphical representation of the identified risks and their evaluation in terms of probability (likelihood) of occurrence and impact on project success factors (costs, time, quality) if they should occur. The definitions of risk probability and impact levels are specific to the selected project and reflect risk appetite and thresholds. Risk #: Numerical number of risk. Risk: Provide a description of the risk (i.e. Weather impacts – storm season). Probability: Defines the likelihood that risk will occur (i.e. H, M, L). Impact: Defines the level of impact to project success factors (time, costs, quality) (i.e., H, M, L). Probability Level Criteria Code Impact Level Very High (VH) 90% Very High (VH) Catastrophic High (H) < 89% x > 80% High (H) Critical Medium (M) < 79% x > 70% Medium (M) Marginal Low (L) < 69% Low (L) No Impact Probability Level Criteria Code Impact Level 9
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Response to Risk: Avoid, mitigate, transfer and accept. Action Plan: A detailed explanation of the steps for risk mitigation(s). Person Responsible: Who will manage the mitigation strategy? Status: Status of mitigation process. Risk Monitoring and Control Example Risk # Risk Probability Impact Response to Risk Action Plan Person Responsible Status Continue Review and Action Plan Owner Time Estimate Monitoring Process [Define monitoring process of current and new risks] Review [Define stages or timeframes for specific types of review] Reporting [provide types of communication channels and deliverables] 10
Citations Kohli, S. (2022, June 29). 5 stages of the Product Development Lifecycle . Jam by Sam. https://jambysam.com/5-stages-of-the-product- development-lifecycle/ Lomb Company Profile: Stock Performance & earnings - pitchbook. (n.d.). https://pitchbook.com/profiles/company/10341-73 MSG Management Study Guide . 5 Functions of Management: Planning, Organizing, Staffing, Directing and Controlling. (n.d.). https://www.managementstudyguide.com/management_functions.htm 11