Developing a Risk Management Plan for Acme Medical Device Co.

This report provides a comprehensive analysis of risk management at Acme Medical Device Company, focusing on their insulin pump manufacturing and sales project. It details the application of both qualitative and quantitative analysis techniques to identify, evaluate, and mitigate potential risks. The report reviews the company's background, discusses risk management methodologies, and presents findings from employee surveys. Key areas of concern include manufacturing process inefficiencies, technology integration challenges, and the need for robust data security measures. The report concludes with recommendations aimed at improving risk management practices and ensuring the successful implementation of the insulin pump project. Desklib offers access to this and other solved assignments for students.

Running head: RISK MANAGEMENT
Risk management
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Executive Summary
Risk management utilizes several tools in order to provide realistic solutions. In the preset study,
Acme Medical Device Company faced issues in the going projects for manufacturing and selling
insulin pumps. In this perspective, it becomes important to develop risk management plan so that
the issues can be mitigated easily. In order to develop risk management technique, quantitative
and qualitative analysis has been so that the risks can be mitigated efficiently.

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Table of Contents
Background..........................................................................................................................3
Risk management technique................................................................................................5
Qualitative research approach..............................................................................................5
Quantitative analysis............................................................................................................8
Conclusion.........................................................................................................................13
References..........................................................................................................................14
Appendices........................................................................................................................16
Appendix I: Risk Register.................................................................................................16
Appendix II: Supplemental Information............................................................................16

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Background
Risk management is referred as identification, evaluation as well as taking economic
control of several business risks. However, some risks are easy for prediction and other are
completely not predictable as well as out of control. The enhancement in technology becomes
vital in medical field. Thus, with every passing time, the medical world has embraced the
improvements that the technology has provided in the particular industry. Accordingly, the Acme
Medical Device Organization has decided upon the process of manufacturing as well as selling
insulin pumps (Bessis 2015). It would be helpful to make implantable for providing advantages
to the patients that are diagnosed with the type 2 diabetes. The particular pumps include a
concise structure. It is useful for the products and helpful for the process (Hopkin 2018). The
comprehensive automation would take up various issues regarding implementation for settling
the place in the industry. The risks related to the issues require to be managed properly. It is
needed that the whole situation is analyzed throughout as well as developed into presentation of
a report. In this perspective, summary of a detailed consultant report regarding the status of IT
risks. It requires to be developed as an outcome. Hence, the following report has the detailed
analysis of the situation from the opinion of the consultant. In the study, background of the case
study organization is discussed. The steps are required to follow in the study and the documents
are reviewed, quantitative as well as qualitative analysis technique are discussed.
In addition, qualitative as well as quantitative analysis of the risks as well as issues for
the projects is discussed in the study. The outcomes of analysis are obtained and
recommendations are provided for Acme Medical Device Company, which would be helpful to
manage the risks for the organization. Carrying out risk management procedure involves several

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steps, which are helpful to provide several chances. These are unconsciously achieved before
applying any proper methodologies. Apart from these, the steps including management of the
risks utilize for producing feasible solution (Larson and Gray 2015). The procedures for
management of the risks in the organizational process can be explained as followed. However,
the physical factors are involved in the particular context. The process is justified with the
procedure of monitoring as well as reviewing the tasks. Hence, identification of the risks
involved with Acme Medical Device Organization with monitoring as well as reviewing the
process.
On the other hand, evaluating the risks is another important aspect. In order to evaluate
the risks required for managing the consequences of an event. It should be achieved with the
analysis of the risks through assessment of the procedures that is able for managing the
procedures of business (Bromiley et al. 2015). The analysis of the results is low. However, if the
risks are identified for moderating the process and it should be carried out with maximum
caution and need to be aborted. On the other hand, the risks are the obstacles for Acme Medical
Device Organization.
After finding out the risks, it is required to control the risks. A controlled process affects
on business of the organization through various procedures (Agca et al. 2016). In addition, it is
required to eliminate the risks that are eliminated from the system in extreme situation. It is
achieved through simplifying the risk processes that are eliminated from the procedure. In
addition, it is important proper actions through simplification of the process and manage
effective plan in the process.

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Risk management technique
Technical life cycle is important element in order to manage risks in any types of
projects. In order to evaluate the risks involved with the project in Acme Medical Device
Organization, it is required to select effective methods. The methods are usually expected
inspecting the risks and analyse them properly. The methods for evaluation of the risks are
important to find the right ways. On the other hand, the risk factors related to the technology
used in Acme Medical Device Organization. In this perspective, quantitative and qualitative
analysis would assist to find the right ways for the organization. In the current organization, the
qualitative approach would include extensive research on qualitative analysis that is dependent
on management of expertise (Wynne 2016). However, qualitative analysis would be helpful to
ensure the process that makes the approach for extensive research approach. The quantitative
research depends on the process of understanding the market scenario. Hence, it is important to
make understanding behavioural impact of the technology that is implanted on workforce,
business and the customers that would be analyzed by statistical modelling. The quantitative
research depends on making comprehension of the impact of latest technology. In addition, the
research can be described as followed.
Qualitative research approach
Qualitative research approach would be helpful to generate effective outcome in the
research. Acme Medical Device Organization is presently experiencing several types of
manufacturing issues. In the organization, frequently bringing new as well as enhanced products
to the consumers needs important manual reconfiguration in manufacturing machinery as well as
outdated system of manufacturing. Lifecycle of the products are shortened for competition as

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well as new products (Aven 2016). The outcomes are required for manufacturing equipment. In
addition, the downtime required for the equipments need to manufacture properly and obsolete
way. A risk management matrix is one of the tools that assists in determining the risks that are
required for developing the risk responded. The first step of the process is developing a RAM
that is able to define the rating scales and its impact. In qualitative analysis, probability is
measured utilizing relative scale. In the matrix, the process that is highly not possible to occur. In
addition, several situations happen in exceptional situations, which are denoted as very low. On
the other hand, infrequent occurrence in the past projects can be denoted as low. The moderate
level of occurring the risk when there is possibility for occurrence. The high level of occurring
the process in pat projects. However, there is high possibility of occurring the projects when the
previous projects as well as conditions exist for it in order to occur on the project.
Using RAM, the risk management of Acme Medical Device Organization can be
achieved. For an instance, low likelihood of occurring the project may have mean of risk event
that is not likely occurring within the next deployment. The impact scale of the project could
consist of making different consideration like opportunity, politically as well as impact on the
employee.
Using RAM as well as ranting scales, the likelihood of the risk events occurring in the
risk level. It will provide information that is required to prioritize in the projects. In addition,
qualitative risk evaluation can be helpful to determine whether there is any particular type of
categories of the risk. It requires special attention on the risk management (Ho et al. 2015).
However, it can be used for duration of the process and whether any categories of the risks
would need special attention for the risk event that requires to be handled properly. On the
contrary, the most challenging aspect of performing qualitative risk is providing definition of the

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rating scales. However, the duration of the projects are required to manage properly and timely.
In the present case study, there are several issues like unplanned downtime and planned
maintenance downtime needs 12-18 hrs in a month. In this perspective, manufacturing
information system provides reports that are generated through multiple systems. It needs
important manual data mining in order to provide effective decision-making information. On the
other hand, the manufacturing information system reports produced through several systems and
important manual data mining for providing useful decision-making system.
In these situations, it is required for analyzing the risks in Acme Medical Device
Organization. The matrix and RAM are useful, through which a business case can be developed
for the completely implantable insulin pump program (Cole et al. 2017). The strategy is the use
of 3D printing technology for customizing implantable devices to the requirements of patients.
On the other hand, doctors for customizing the devices can do the use of HL7 universal medical
interface standards, connection with Acme systems. The risks can be categorized under the
category. In addition, specifications of the patients are received from manufacturers as well as
physicians. Hence, qualitative analysis would be helpful for the organization in order to manage
the risks in the organization. In addition, with the help of qualitative analysis, several
information like background information, business objectives and program plan can be obtained
that can be helpful to analyze the existing risks in Acme Medical Device Organization and
provide effective outcomes. On the other hand, evaluation of market, financial assessment and
risks assessment can be helpful.
Apart from these, the program manager has an important program management structure
that helps to analyze the key projects. Program management is helpful to manage the complexity
as well as interdependency of the activities, deliverables and milestones that requires setting a

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program that assists for the program and making better coordination effect. Moreover, it is
required for sales and marketing that is developed on the existing base of the client. Management
of clinical traits is important that results implantable device trails (Hillson and Murray-Webster
2017). Optimizing manufacturing in Acme Medical Device Organization is one of the key
aspects that help to make important information system of manufacturing need to be considered
in the process. However, it is required to upgrade information system for managing as well as
controlling the systems are complied with stringent patient data with the security standards,
controlling as well as managing the business systems.
Quantitative analysis
In order to make quantitative analysis for the project of the organization, it is required to
select sample for the research. The sample for the research is the respondents selected from the
organization. The employees are considered sample for the research. In the research, 55
employees are selected for the research. They are asked closed ended questions regarding the
risks while conducting the project. The obtained data are helpful to analyze the research and
gain expected results.
 How long you are working in Acme Medical Device Organization?
Options Response % Respondents Total no of
respondents
Less than 6 months 18.18% 10 55
6 months- 1 year 27.27% 15 55
1 year- 2 years 36.36% 20 55
2 years- 5 years 18.18% 10 55

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More than 5 years 18.18% 10 55
Findings and analysis
From the above table, it can be clearly stated that most of the employees working in
Acme Medical Device Organization are working since 1year to 2 years. However, same
numbers (18.18%) of people working in the company are working less than 6 months, 2 to 5
years, or more than 5 years.
Hence, it is required to take the opinion of the employees and take suitable actions so that
the risks can be mitigated easily and timely. How far do you agree that risk management is one of the most important aspects for
project development?
Options Response % Respondents Total no of
respondents
Strongly agree 27.27% 15 55
Agree 50.90% 28 55
Neutral 3.63% 2 55
Disagree 9.09% 5 55
Strongly disagree 9.09% 5 55
Findings and analysis

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In the survey, most of the respondents are agreed that that risk management is one of the
most important aspects for project development. However, 9.09% respondents are strongly
disagreed on the matter. Hence, the management of Acme Medical Device Organization needs to
emphasize on implementing effective risk management technique.
 What are the risks involved with the project?
Options Response % Respondents Total no of
respondents
Pressure for
frequently brining
new products
21.81% 12 55
Shortening of
product life cycle
and competition of
new products
32.72% 18 55
Planning for
downtime
maintenance
18.18% 10 55
Unplanned
downtime
18.18% 10 55
Manufacturing
system produced by
several systems
9.09% 5 55
Findings and analysis

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From the above table, it can be mentioned that most of the respondents in the survey
think that shortening of the product life cycle as well as competition of new products is one of
the major issues found in the process. However, issues like pressure for frequently brining new
products, planning for downtime maintenance, unplanned downtime and manufacturing system
produced by several systems are required to evaluate so that risks can be avoided or mitigated
properly.
 What are the techniques helpful to mitigate the risks involved with the project of the
organization?
Options Response % Respondents Total no of
respondents
Systematic upgrade
path
30.90% 17 55
Consolidating
manufacturing
system
23.63% 13 55
Consolidating
financial systems
9.09% 5 55
Updating the
network
infrastructure
18.18% 10 55