Detailed Risk Management Report: Analyzing Acme Medical Device's Risks

This report provides a comprehensive risk management analysis for Acme Medical Device, a medical device manufacturer facing challenges related to outdated machinery, employee safety, and production issues with a new product. The report, prepared by a consultant, addresses the need for change management and the implementation of an employee health and safety policy. It details the identification of changes in scope, change management processes including the establishment of an occupational health and safety role, policy updates, employee engagement procedures, refresher training, and the introduction of new manufacturing devices. Furthermore, the report explores risk management methodologies, including qualitative and quantitative techniques, and Monte Carlo analysis. The analysis highlights the importance of addressing these issues to improve employee well-being, production efficiency, and overall organizational performance. The report also includes appendices with a risk register and a reflection on the lessons learned.

Running head: RISK MANAGEMENT
Risk Management
Name of the Student
Name of the University
Author Note

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Executive Summary
Acme Medical Device is an organization that has the specialization in the manufacturing
industry, mostly manufacturing devices used in medical industries over a long period of time.
The company has recently introduced a latest product that is quite new in the market, known as
the implantable insulin pumps, that is used for the patients who have been diagnosed with Type 2
diabetes. The organization had been in vogue since a long time and hence, the machineries that it
uses have become out-dated and mostly causes many issues with the company. One such issue
had occurred when an employee had been injured during the production. Although the incident
did not turn out to be fatal, and the employee is recovering soon, but it had brought up the issue
that the organization lacks an Employee Health and Safety policy. In addition to this the incident
and several other incompetence had made the employees to lessen in the company, mostly due to
disinterest of working further. It had also been found that the discomfort the employees have
been facing in the company is due to the production issues that had cropped up during the
manufacturing of the newly introduced device. The project of managing the production and
bringing up the Employee Health and Safety policy had been entrusted upon a consultant by
breaking it into 8 key projects which would evaluate the new IT structure for the business that
handles the project. Therefore, this will be evaluated in the required steps as the evaluator
methodologies suggest.

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Table of Contents
Introduction......................................................................................................................................3
Background: Overview of the process.........................................................................................4
Change management....................................................................................................................5
Identification of changes in scope...........................................................................................5
Detailed change management process.....................................................................................6
Risk Management........................................................................................................................9
Qualitative and quantitative technique for new risks..............................................................9
Monte Carlo analysis.............................................................................................................10
Conclusion.....................................................................................................................................10
Next Steps......................................................................................................................................11
References......................................................................................................................................13
Appendices....................................................................................................................................16
Appendix I: Risk Register.........................................................................................................16
Appendix II: Reflection on the lessons......................................................................................17

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Introduction
Acme Medical Device is an organization that mostly manufactures medical devices and
has been in vogue since a long time. It has lately introduced a new change in the organization by
the Inception of manufacturing a new device called the implantable insulin pumps for the
patients who have been diagnosed with type 2 diabetes. The company has taken up the
manufacturing of the product and introducing them into the market by selling. However, there
have been issues in the company regarding the manufacturing of the product and other incidents
as well. They have been a report of a freak accident that happened some 2 months back in the
organization during the manufacturing of the product where an employee was severely injured
although it was not fatal at all. The organization has appointed at KPMG senior consultant who
would take up the job of handling the entire project for the organization and evaluate the
company's business process. The task of handling the project has been separated into 8 key
projects which needs status updating of the entire implementation process of a new business
process and also an employee health and security policy that has been found to be absent in the
organizational process. Thus, this report would include an overview of the entire business case
study which would later be complemented by a Change Management process that has been
identified because of the changes in the scope the project has (Pereira et al., 2014). Thus, there
will be an implementation of the entire Change Management process and it would be followed
by a Risk Management process holding the qualitative and quantitative methodologies of the
risks that have been there in the organization along with the Monte Carlo analysis been done on
the same process. Therefore, the report would conclude here following the next steps that should

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be recommended to be implied in the process that has implemented the new risk management
process.
Background: Overview of the process
The case study has been suggesting the idea that the Acme Medical Device Company has
been introducing a new medical device that is preferably suited for the patients who have been
diagnosed with type 2 diabetes and with that newly implemented manufacturing project there
have been many discomforts in the organization. Firstly, there has been a report of an incident 2
months back during the manufacturing of the latest product where an employee has been put
under serious injuries while the manufacturing process where going on. Although there have
been no reports that it was a fatal accident and it has been informed that the employee has been
recovering fast and attending physical therapy on a regular basis (Farrell & Gallagher, 2015).
Again, there has also been information about the employee about the joining the organization
after going through in occupational therapy for a year and then joining with the organization
working as a part time employee. After this incident although there have been reports of many
employees leaving the organization. KPMG consultant has been ask to go through the entire
project and the accident at his little orchid after which it was found that the organization has
several gaps that needed to be taken care of further (Glendon, Clarke & McKenna, 2016). The
regulatory authority is also investigated the matter and reached a conclusion that there has to be
fully addressed by arranging for a change management implementation process as well as a risk
management for having a proper impact on this processes (Arnold & Yildiz, 2015). In addition,
the consultant was asked to put forward an employee health and safety policy which have been
absent in the organization so far causing the above-mentioned accident.

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Change management
The organization of acme medical device specifically needed a change in the
organizational structure as well as the business process. The first and foremost feasibility correct
way by which the change could be implemented in the organization is the identification of the
changes. It is seemingly necessary that the consultant understands the need of the change in the
organization as well as in the business process (Creswell & Creswell, 2017). Report about the
manufacturing devices and the absence of a proper employee health and security policy only
impacted more on the matter that the organization needed a change. This would further be
described in details with the identification of the changes in scope management as well as the
detail Change management process as implied by the consultant.
Identification of changes in scope
Before implementing any kind of change in an organization it is essentially needed that
the scope of implementing that change is understood and analysis have been made for the
organization. The entire process is also not a straightforward one and there has been a set of
boundaries that circles a Change management process even before it is being implemented in the
system for a new business process being introduced in the organization.
There have been many incidences in the organization that have taken place is one after
another. This included a freak accident happening during the time of manufacturing a latest
device and as a result the employees departing one by one (Guadix et al., 2015). In addition to
this there has been reports of low productivity in the manufacturing of the insulin measuring
devices for type 2 diabetes. The latter problem husband identified as repercussion of the age old
machinery is that the company has been using for a long time. With analysis of the score that the

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latest business process implementation for modifying and absent employee health and safety
policy happens to predict that there have been changes in the organization that has not been
defined. The organization at its point of inception did not have a business system that process the
employees for working in the organization with a certain way. This makes them unaware of the
fact that there might be hazards if a particular set principle is not being followed (Hill, 2017).
This is identification of youth scope for the above incident since the company had previously
gone through a freak accident due to which they had been severe injuries involving an employee.
Detailed change management process
There has been an identification by the regulatory authority that there is lack of a proper
business process and employee engagement in the entire system of the organization (Howard,
2017). This is another reason that the authorities have recommended for a detailed Change
management process including the below mentioned procedures that would be helpful for the
organization in applying the changes feasibly:
 Set up an occupational health and safety role in HR: An HR or Human Resource
Department forms a bridge in the gap between the employee and the management of the
higher authorities. It is required that the HR department informs all the parties in the
organization or the hierarchical structure starting right at the top and ending to the bottom
about all the business environmental changes that has been happening and provide
wholesome knowledge of the entire matter (Kagermann, 2015). It is thus, unknown fact
that if the Human Resource Department has been set up properly with the health and
safety rule it would be their expertise to implement the entire documented form of the
information for an employee to take up health and safety policy and pass on the entire
information within the organization in a particular set principal organized form.

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 Update occupational health and safety policies: It is a norm of every organization to
follow a set principal regarding the organizational system and policies complied with the
laws of the country the organization has been established in. The changes in the business
process however brings in changes in the policies set before as well. Here in this case is
well there is no updated health and safety policy or rather it is absent although there has
been introduction of a new production item in the manufacturing department (Kroese et
al., 2014). Therefore, this definitely needs to be look forward to for setting up a basic
awareness between the employees especially who are working in the production team.
 Make an employee engagement procedure: Just having an updated health and safety
policy for the employees as a documented manner is not the only way occupational health
can be established in an organization. Each employee needs to be made aware of the
consequences if this occupational health and safety policies and not followed. In addition
to this all the employees of the organization are to be thoroughly trained with the written
terms in the policies that the organization have implemented. In this matter the using of
the new and improved manufacturing devices has been a concept that the older
employees in the company are not fully aware of (Lieder & Rashid, 2016). Therefore the
employees has to be given a proper training with time to time by using latest devices with
every change that has been implemented in terms of devices and they must be made
aware of all the safety hazards that the new installations had to offer.
 Provide annual occupational health and safety refresher training: All the business
processes that an employee goes through during the orientation module normally things
to wear as the time passes. The health and safety hazards and the policies to curb them
also belong to the same scenario. Thus, these policies needs to be brush up once every

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year in the business calendar so that it could be and updated health and safety policy for
the employees that they might be able to keep in mind so that none of the accidents that
have been there before in the organization occur again (Modarres, Kaminskiy &
Krivtsov, 2016). This would also work as their personal benefit because they would not
face any obligation regarding serious injuries that had been an incident taken place in the
past.
 Introduce latest manufacturing devices into the company: It has also been reported
that the manufacturing devices that acme medical device company uses is age old and
have been in nuisance the company has its inception back in time. Therefore it needs to
be approved by the higher authorities that latest manufacturing devices needs to be
installed in the company to support higher productivity in lesser time (Nadvi & Raj‐
Reichert, 2015). The health hazards that the company has faced earlier can also be
avoided since incompatibility of production and manufacturing devices can cause serious
accidental issues.
 Monitoring and reporting of the compliances: All the Change Management processes
that has been stated above about the new and updated health and safety policy of the
installation of latest devices cannot be completed as a detailed process if it is not
followed up in the end everyday through a basic tracking and reporting (Zou, Isa &
Rahman, 2017). It is only by the process of tracking and reporting that the working of the
Change Management processes can be evaluated (Nardi, 2018). Only through this
process a proper analysis of the task can be made which would be easier for the
compliances, the authorities and the entire organization to understand the exact root of
any issue that might arise in the implementation process.

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Risk Management
It can be found that when a new process is applied on any organization by replacing the
old ones it can bring about positive changes but it may also have some perilous repercussions
that has the potential of bring about further risks in the organization (Pot, Totterdill & Dhondt,
2016). For this case scenario this will be evaluated with the qualitative and quantitative
techniques for new risks and Monte Carlo analysis for the following case:
Qualitative and quantitative technique for new risks
A qualitative technique is a process that consists of several techniques that have been
associated with a project in search of the possibility of risk. In this project the discovering of the
possibility would be the risk of another accident that may happen in the organization if they do
not have an employee health and safety policy yet. This impact of a risk normally has its
dependency on the policy implementation networks according to the resources (Sadgrove, 2016).
This is followed by the knowledge transfer of the change business plan to the entire workforce
and also the implementation of the policy going through a regular monitoring and reporting. The
qualitative analysis would further redone that the acme medical device company has been facing
currently with the introduction of the latest business process policies regarding employee health
in the system (Tong et al., 2015). A qualitative analysis is made up on assumptions, therefore it
works similarly in this case as well.
A quantitative technique can be defined as the understanding of the risk that accompany
with a project with the implementation of a new system or replacement of a traditional business
process. This is based upon a secondary data that has been collected with the course of time the
project has progressed further. In this case the quantitative risk analysis method has been the risk

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identification that influences this project for Acne medical device company in the most gruesome
way possible. It has been quantified with associated risks and the severity it has and the level of
impact that the risk forces on the organization or the project propagation (Stark, 2015). The data
obtained is absolutely because it is not used by another risk analysis report as no project is
similar with the other.
Monte Carlo analysis
MCM or the Monte Carlo method of simulation is a process with which a new
technology is speculated in understood for any kind of risk that might arise with the technology
that has been in accordance to the financial condition of the organization (Taylor, Bogdan &
DeVault, 2015). In this particular case the Monte Carlo simulation has been dependent upon the
PMO, MIS, ESB, Security and Infrastructure for the organization. The details MCM analysis is
attached as an MS Excel sheet.
Conclusion
Therefore, it can be finally said as a conclusion that the Acme Medical Company needed to
implement many changes in their business process, and these would be handled by the KPMG
consultants after the issues have been identified properly. This identification process had been
represented through an overview of the entire business case study which was later complemented
with a Change Management process that has been identified because of the changes in the scope
the project has. Thus, there has been an implementation of the entire Change management
process and it had been followed by a risk management process holding the qualitative and
quantitative methodologies of the risks that have been there in the organization along with the
Monte Carlo analysis been done on the same process. Therefore, the report concludes following

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the next steps that should be recommended to be implied in the process that has implemented the
new risk management process.
Next Steps
It is required that the HR department facilitates all the parties in the organization or the
hierarchical structure starting right at the top and ending to the bottom about all the business
environmental changes that has been happening and provide wholesome knowledge of the entire
matter.
It is definitely required to be looking forward to setting up a basic awareness between the
employees especially who are working in the production team. Each employee needs to be made
aware of the consequences if this occupational health and safety policies and not followed. In
addition to this all the employees of the organization are to be thoroughly trained with the written
terms in the policies that the organization have implemented.
These health and safety policies needs to be brush up once every year in the business calendar so
that it could be and updated health and safety policy for the employees that they might be able to
keep in mind so that none of the accidents that have been there before in the organization occur
again. It is needed to be approved by the higher authorities that latest manufacturing devices
needs to be installed in the company to support higher productivity in lesser time. The health
hazards that the company has faced earlier can also be avoided since incompatibility of
production and manufacturing devices can cause serious accidental issues. However, it is only by
the process of tracking and reporting that the working of the Change Management processes can
be evaluated.

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References
Arnold, U., & Yildiz, Ö. (2015). Economic risk analysis of decentralized renewable energy
infrastructures–A Monte Carlo Simulation approach. Renewable Energy, 77, 227-239.
Creswell, J. W., & Creswell, J. D. (2017). Research design: Qualitative, quantitative, and mixed
methods approaches. Sage publications.
da Silva Pereira, E. J., Pinho, J. T., Galhardo, M. A. B., & Macêdo, W. N. (2014). Methodology
of risk analysis by Monte Carlo Method applied to power generation with renewable
energy. Renewable Energy, 69, 347-355.
Farrell, M., & Gallagher, R. (2015). The valuation implications of enterprise risk management
maturity. Journal of Risk and Insurance, 82(3), 625-657.
Glendon, A. I., Clarke, S., & McKenna, E. (2016). Human safety and risk management. Crc
Press.
Guadix, J., Carrillo-Castrillo, J., Onieva, L., & Lucena, D. (2015). Strategies for psychosocial
risk management in manufacturing. Journal of Business Research, 68(7), 1475-1480.
Hill, T. (2017). Manufacturing strategy: the strategic management of the manufacturing
function. Macmillan International Higher Education.
Howard, J. (2017). Nonstandard work arrangements and worker health and safety. American
journal of industrial medicine, 60(1), 1-10.

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Kagermann, H. (2015). Change through digitization—Value creation in the age of Industry 4.0.
In Management of permanent change (pp. 23-45). Springer Gabler, Wiesbaden.
Kroese, D. P., Brereton, T., Taimre, T., & Botev, Z. I. (2014). Why the Monte Carlo method is
so important today. Wiley Interdisciplinary Reviews: Computational Statistics, 6(6), 386-
392.
Lieder, M., & Rashid, A. (2016). Towards circular economy implementation: a comprehensive
review in context of manufacturing industry. Journal of Cleaner Production, 115, 36-51.
Modarres, M., Kaminskiy, M. P., & Krivtsov, V. (2016). Reliability engineering and risk
analysis: a practical guide. CRC press.
Nadvi, K., & Raj‐Reichert, G. (2015). Governing health and safety at lower tiers of the computer
industry global value chain. Regulation & Governance, 9(3), 243-258.
Nardi, P. M. (2018). Doing survey research: A guide to quantitative methods. Routledge.
Pot, F., Totterdill, P., & Dhondt, S. (2016). Workplace innovation: European policy and
theoretical foundation. World Review of Entrepreneurship, Management and Sustainable
Development, 12(1), 13-32.
Sadgrove, K. (2016). The complete guide to business risk management. Routledge.
Stark, J. (2015). Product lifecycle management. In Product Lifecycle Management (Volume
1) (pp. 1-29). Springer, Cham.
Taylor, S. J., Bogdan, R., & DeVault, M. (2015). Introduction to qualitative research methods: A
guidebook and resource. John Wiley & Sons.

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Tong, D. Y. K., Rasiah, D., Tong, X. F., & Lai, K. P. (2015). Leadership empowerment
behaviour on safety officer and safety teamwork in manufacturing industry. Safety
science, 72, 190-198.
Zou, X., Isa, C. R., & Rahman, M. (2017). Valuation of enterprise risk management in the
manufacturing industry. Total Quality Management & Business Excellence, 1-22.

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Appendices
Appendix I: Risk Register
#ID Type of Risk Risk Statement
Risk
Level
1. Employee fall This has an ability of fatally injuring the employees. Medium
2. Guarding of
manufacturing devices
This also has a property of severely injuring
employees.
High
3. Automated industrial
trucks
This can lead to the death of employees on a high
level, otherwise can cause severe injuries.
High
4. Electrical hazards These are capable of claiming lives as well as
creating severe burns and other injuries.
High
5. Manufacturing
machine compatibility
Incompatibility of machineries cause physical harm
to employees and also reduces the production by
value of time.
Medium
6. Employee mental
health
An ideal employee should be proper in physical and
mental health or else this can affect a cumulative
employee health altogether.
Low

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Appendix II: Reflection on the lessons
My reflection on the following topic would describe that the lesson had made me identify the
major risks that are associated with the manufacturing industry imposed due to the absence of a
proper employee health and safety policy. The lesson has also made me understand the different
aspects that needs to be understood when there is a need in the same organization to replace the
traditional business process of having no employee health and safety policy to implementing a
new one. I have learned about the wholesome idea of implementing a new business process and
the things that need to be kept in mind while doing so. This has provided me with a broader
knowledge of Project Management skills while managing risks of new business policy
implementation in an industry.