Risk Management for Acme Medical Device: Change Management and Risk Analysis

This report provides an overview of the change management process and risk management techniques for Acme Medical Device's new employee health and safety policy. It includes a detailed change management process, qualitative and quantitative risk analysis, and Monte Carlo analysis. The report concludes with next steps for implementation.

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

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Executive Summary
The organization of Acme Medical Device specializes in manufacturing medical devices since a
long time. However, two months back, there have been an accident where an employee is
reported to be seriously injured. This had been due to the introduction of a new device into the
market called the implantable insulin pumps for the patients with type 2 diabetes. The task of
managing this project had been broken down into 8 key projects on which status was being
updated about the implementation of the new IT business structure to handle the project.
However, the case study suggests that the organization lacks occupational health and safety
simulation for the employees. The following report would comprise of the overview of the entire
process followed by the change management process with identification of the changes in scope
of the project and the detailed changed management process that should be implemented. This
report would be followed by the risk management process that holds the qualitative and
quantitative technique for new risks and the Monte Carlo analysis done on the required process.
The report would thus be concluded by the next steps that should be required in the process of
risk management for the project.

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Table of Contents
Introduction......................................................................................................................................3
Background: Overview of the process.........................................................................................3
Change management....................................................................................................................4
Identification of changes in scope...........................................................................................4
Detailed change management process.....................................................................................5
Risk Management........................................................................................................................7
Qualitative and quantitative technique for new risks..............................................................7
Monte Carlo analysis...............................................................................................................8
Conclusion.......................................................................................................................................9
Next Steps..................................................................................................................................10
References......................................................................................................................................11
Appendices....................................................................................................................................14
Appendix I: Risk Register.........................................................................................................14
Appendix II: Reflection of the lessons......................................................................................15

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Introduction
The organization of Acme Medical Device had introduced a new device into the market
called the implantable insulin pumps for the patients with type 2 diabetes. The manufacturing of
the product and selling them into the market had been taken up by the company. A KPMG senior
consultant was appointed by the organization for this task to act as the Project Manager for this
purpose (Yorio, Willmer & Moore, 2015). The task of managing this project had been broken
down into 8 key projects on which status was being updated about the implementation of the new
IT business structure to handle the project. However, the case study suggests that the
organization lacks occupational health and safety simulation for the employees. The following
report would comprise of the overview of the entire process followed by the change management
process with identification of the changes in scope of the project and the detailed changed
management process that should be implemented. This report would be followed by the risk
management process that holds the qualitative and quantitative technique for new risks and the
Monte Carlo analysis done on the required process. The report would thus be concluded by the
next steps that should be required in the process of risk management for the project.
Background: Overview of the process
It has been found in the case study that there has been an incident before in the
organization where there an accident took place during the manufacturing of the latest product
(Giovannone, 2016). An employee concerned with the manufacturing process has undergone
serious injuries during the manufacturing process, however; it was reported that there has been a
fast recovery since the employee had been attending physical therapy regularly. It has also been

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reported that the employee would further join the organization after the occupational therapy in
the next one year on a part-time basis (Tong et al., 2015). This had induced the regulatory
authorities to investigate the matter after which it was found that the organization of Acme had
several lags in the occupational system in the process due to which they suggested several
measures to be taken by the organization further. The changes that were needed in the
organization were to be implemented by a change management process for the entire business
organization (Dormann et al., 2018). The requirement had mostly been a feasible occupational
system that had not been implemented by a proper process in the organization. This would
further be specified with the change management implementation process and the risk
management for the impact of these processes.
Change management
Identification of changes in scope
The most important factor before implementing a change in the organization is the
understanding and analysis of the scope of the change implemented in the organization
(Battaglia, Passetti & Frey, 2015). The process is however not a straightforward one and it set a
boundary to the change management process much before it is implemented in the system as a
new business process for the organization.
The analysis of scope for the latest business process implementation, in this case, the
employee system change happens within the organizational process so that it could be modified
and understood accordingly (Sheehan et al., 2016). It also happens to predict the changes that are
not defined in the process. According to the case study, the organization initially had no business
process system prepared for the employees to work in a certain way or make them aware of the

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hazards of not following a particular set principle. The scope is huge in this matter as the
company previously witnessed an accident where the employee had been severely injured
(Kaynak et al., 2016). Therefore, the process is expected to make the employees of the
organization much more aware of the employee systems so that they could avoid issues like this
in the future by working according to the set procedures.
Detailed change management process
The regulatory authorities have witnessed that there is a lack of a proper process in the
business process about employee system (Shea et al, 2016). This is why they have recommended
a detailed change management procedure that would include the following processes:
 Set up an occupational health and safety role in HR: The Human Resource
department works as a mediator between the employee and the management. They
need to facilitate all the parties about any business environmental change in the
organization and provide wholesome knowledge about the matter. Therefore, if the
HR department is set up with a health and safety role, they would do the needful to
pass on the information in an organized form in the organization.
 Update occupational health and safety policies: Every organization follows a set
principle about organizational system and policies that abides by the laws of the
country the organization is currently established in (Nadvi & Raj‐Reichert, 2015).
However, with changes in the business process, there must be changes in the
employee health and safety policies as well. Just like in this case as well, the
organization does not have an updated health and safety policy even after the new
manufacturing devices have been implemented due to the change in production item.

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It definitely needs to be improved in order to set a basic awareness amongst the
employees, especially the ones working for the production team.
 Provide organization-wide occupational health and safety training: It is not only
required to have the updated health and safety policy as per written terms but it is also
necessary to see that the organization be thoroughly trained with the policies in the
organization that have been implemented (Loeppke et al., 2015). As in this case, the
using of the latest and improved manufacturing devices is an alien concept for the
employees who have so far been working with the older devices. Thus, the employees
need to be trained with the use of the latest devices and also must be made aware of
the safety hazards they offer.
 Provide annual occupational health and safety refresher training: Just like any
other business process module or policy that tends to wear about from the minds of
the employees, the health and safety hazard also has the same effect (Liu et al., 2015).
Therefore, these needs to be brushed up every annual year of the business calendar so
that the employees be updated about the health and safety issues, and they also need
to be reminded that the health and safety policies are for their personal benefit, so that
they get to avoid further occurrences like the previous accident that had taken place in
the past.
 Track and report compliance: Implementing a new and updated employee health
and safety policy would require all the detailed processes as above but it is also
necessary that the processes be followed up in the end by a thorough tracking and
reporting of the entire changed process and proper reporting of it through the tracking

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(Kunyk et al., 2016). This would help in proper analysis of the task as it would be
easier to understand the root of any issue arising in the implementation process.

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Risk Management
The implementation of any new and changed process in an organization does not only
bring positive changes but also may bring about risks in the organization.
Qualitative and quantitative technique for new risks
The qualitative technique in this case would consist of the technique associated with this
project that helps in discovering the possibility that the risk of another accident that would
happen if the organization still do not have an employee health and safety policy (Idris et al.,
2015). The impact of a risk generally depends on the policy implementation according to the
resources, the knowledge transfer of the new business system to the entire workforce and the
policy implementation monitoring and reporting. This would further be analysed with the help of
the problems that currently the Acme Medical Device Company has been facing since the
introduction of the new policy in the system.
Quantitative Technique
Quantitative technique to understand the risks accompanying with this all-inclusive
project is based on the secondary data collected all through the project progression. A
quantitative risk analysis method is the identification of risks influencing a project or an
organization in the gruesome way possible (Howard, 2017). This process is quantifiable by
associating the risks along with the severity it has and the level of impact it forces upon the
project or the organization. This maintenance of data is raw and generally not used by any other
risk analysis report. Since, no project can be similar with the other; the data generated also has to
be different in comparison to other secondary data collected.

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Monte Carlo analysis
Monte Carlo Method analysis or MCM is by which understanding of a new technology is
speculated to understand any kind of risk associated with the technology in compliance with the
financial condition of the organization (Glendon, Clarke & McKenna, 2016). In the following
case, the MCM depends upon PMO, MIS, Finance, ESB, Security, and Infrastructural aspect of
Acme Medical. The MCM for this case, that is, the addition of a new employee health and safety
policy in the organization can be seen as below:
Cost
elements
Base
case
($k)
Minimu
m
Most
Likely
Maximum Minimu
m
Most
Likely
Maximum
Land 2,000 90% 100% 125% 1,800 2,000 2,500
Buildings 5,000 90% 100% 125% 4,500 5,000 6,250
Raw Mats 4,000 90% 100% 125% 3,600 4,000 5,000
Salaries 2,000 90% 100% 125% 1,800 2,000 2,500
IT 1,000 90% 100% 125% 900 1,000 1,250
Vehicles 500 90% 100% 125% 450 500 625
Marketing 1,500 90% 100% 125% 1,350 1,500 1,875
Other
general
overhead
2,500 90% 100% 125% 2,250 2,500 3,125
Total 18,500 16,650 18,500 23,125
Table 1: MCM for Cost of Implementation
(Source: Created by Author)

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Team Calculation
Estimate
Perfect Likely Outrageou
s
Comments Percentage
(%)
PMO 106.0 77.0 106.0 135.0 Testing and
roll out
risks
15
MIS 194.0 102.0 191.0 298.0 Testing
risks
between
Oracle and
Matilda
27
Finance 74.0 41.0 74.0 107.0 Testing
risks
between
new and old
Oracle
versions
10
ESB 136.0 68.0 136.0 204.0 ESB design
and testing
risks
19
Security 128.0 70.0 128.0 186.0 Server
design and
testing risks
18
Infrastruct
ure
80.0 47.0 80.0 113.0 Server
design and
testing risks
11
Total 718.0 405.0 715.0 1,043.0 100
Table 2: Overview of MCM from all the aspects
(Source: Created by the Author)
Conclusion
The following report would comprise of the overview of the entire process followed by
the change management process with identification of the changes in scope of the project and the
detailed changed management process that should be implemented. This report would be
followed by the risk management process that holds the qualitative and quantitative technique for
new risks and the Monte Carlo analysis done on the required process. The report would thus be

11RISK MANAGEMENT
concluded by the next steps that should be required in the process of risk management for the
project.
Next Steps
The following ways can be implemented make the next steps for the implementation
program of the new set of employee health and safety policy:
Updating the occupational health and safety policies should be followed by organization-
wide occupational health and safety training (Badland et al., 2014). It is not only required to have
the updated health and safety policy as per written terms but it is also necessary to see that the
organization be thoroughly trained with the policies in the organization that have been
implemented.
The new policies need to be brushed up every annual year of the business calendar so that
the employees be updated about the health and safety issues, and they also need to be reminded
that the health and safety policies are for their personal benefit, so that they get to avoid further
occurrences like the previous accident that had taken place in the past.
Implementing a new and updated employee health and safety policy would require all the
detailed processes as above but it is also necessary that the processes be followed up in the end
by a thorough tracking and reporting of the entire changed process and proper reporting of it
through the tracking.
The next steps, if taken this way, would ensure the proper implementation of the newest
system if employee health and safety policy in the organization of Acme Medical.

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References
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(2014). Urban liveability: emerging lessons from Australia for exploring the potential for
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64-73.
Battaglia, M., Passetti, E., & Frey, M. (2015). Occupational health and safety management in
municipal waste companies: A note on the Italian sector. Safety science, 72, 55-65.
Dormann, C., Owen, M., Dollard, M., & Guthier, C. (2018). Translating cross-lagged effects into
incidence rates and risk ratios: The case of psychosocial safety climate and
depression. Work & Stress, 32(3), 248-261.
Giovannone, M. (2016). Vulnerable workers: health, safety and well-being. CRC Press.
Glendon, A. I., Clarke, S., & McKenna, E. (2016). Human safety and risk management. Crc
Press.
Howard, J. (2017). Nonstandard work arrangements and worker health and safety. American
journal of industrial medicine, 60(1), 1-10.
Idris, M. A., Dollard, M. F., & Tuckey, M. R. (2015). Psychosocial safety climate as a
management tool for employee engagement and performance: A multilevel
analysis. International Journal of Stress Management, 22(2), 183.
Kaynak, R., Toklu, A. T., Elci, M., & Toklu, I. T. (2016). Effects of occupational health and
safety practices on organizational commitment, work alienation, and job performance:

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using the PLS-SEM approach. International Journal of Business and Management, 11(5),
146.
Kunyk, D., Craig-Broadwith, M., Morris, H., Diaz, R., Reisdorfer, E., & Wang, J. (2016).
Employers’ perceptions and attitudes toward the Canadian national standard on
psychological health and safety in the workplace: A qualitative study. International
journal of law and psychiatry, 44, 41-47.
Liu, X., Huang, G., Huang, H., Wang, S., Xiao, Y., & Chen, W. (2015). Safety climate, safety
behavior, and worker injuries in the Chinese manufacturing industry. Safety science, 78,
173-178.
Loeppke, R. R., Hohn, T., Baase, C., Bunn, W. B., Burton, W. N., Eisenberg, B. S., ... & Hymel,
P. A. (2015). Integrating health and safety in the workplace: how closely aligning health
and safety strategies can yield measurable benefits. Journal of occupational and
environmental medicine, 57(5), 585-597.
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.
Shea, T., De Cieri, H., Donohue, R., Cooper, B., & Sheehan, C. (2016). Leading indicators of
occupational health and safety: An employee and workplace level validation study. Safety
science, 85, 293-304.
Sheehan, C., Donohue, R., Shea, T., Cooper, B., & De Cieri, H. (2016). Leading and lagging
indicators of occupational health and safety: The moderating role of safety
leadership. Accident Analysis & Prevention, 92, 130-138.

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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.
Yorio, P. L., Willmer, D. R., & Moore, S. M. (2015). Health and safety management systems
through a multilevel and strategic management perspective: Theoretical and empirical
considerations. Safety science, 72, 221-228.

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Appendices
Appendix I: Risk Register
#ID Type of Risk Risk Statement
Risk
Level
1. Employee fall There could be occurrences of employee fall in a
manufacturing organization given the fact that
machineries may be placed in a high altitude from the
ground. There could be severe risks of employee fall due
to the lack of comprehensive fall protection measures.
This can lead to death or severe injuries.
Medium
2. Guarding of
manufacturing
devices
Heavy machineries need guarding to keep the employee
safe from being physically harmed. This needs to be
taken care of as there has been major injury incidents
before and without proper safety has a risk of happening
again.
High
3. Automated
industrial trucks
Lack of proper operational and training procedures can
lead to the injury or even death of employees while
handling an automated truck since they operate
automatically as lift trucks in the organization.
High
4. Electrical hazards Electricity and other electrical hazards are highly risky
given the fact that they are capable of claiming lives and
High

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causing serious injuries.
5. Manufacturing
machine
compatibility
Compatibility of products with machines are absolutely
necessary as not only they reduce manufacturing time
and cost but using age old machineries can cause risk of
physical harm to the employees.
Medium
6. Employee mental
health
This is another risk aspect as it is absolutely necessary
that the employees be fit from physical as well as mental
aspect. An ideal employee should be proper in physical
and mental health or else this can affect a cumulative
employee health altogether.
Low
Table 3: Risk Register
(Source: Created by Author)
Appendix II: Reflection of the lessons
As per the my reflection on the following topic can be discussed in details, it could be said 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.