This report evaluates the risk management process for Acme Medical Device Company, which has introduced a new product and faced issues in the manufacturing process. It includes a change management process and qualitative and quantitative techniques for new risks.
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Running head: RISK MANAGEMENT Risk Management Name of the Student Name of the University Author Note
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1RISK MANAGEMENT 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.
2RISK MANAGEMENT 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
3RISK MANAGEMENT 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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4RISK MANAGEMENT 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.
5RISK MANAGEMENT Change management Theorganizationofacmemedicaldevicespecificallyneededachangeinthe 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
6RISK MANAGEMENT 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 informsall 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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7RISK MANAGEMENT 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 thenewandimprovedmanufacturingdeviceshasbeenaconceptthattheolder 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
8RISK MANAGEMENT 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 havebeentherebeforeintheorganizationoccuragain(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.
9RISK MANAGEMENT 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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10RISK MANAGEMENT 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
11RISK MANAGEMENT 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.
12RISK MANAGEMENT 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).Manufacturingstrategy:thestrategicmanagementofthemanufacturing 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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13RISK MANAGEMENT Kagermann, H. (2015). Change through digitization—Value creation in the age of Industry 4.0. InManagement 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. InProduct 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.
14RISK MANAGEMENT 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.
15RISK MANAGEMENT Appendices Appendix I: Risk Register #IDType of RiskRisk Statement Risk Level 1.Employee fallThis has an ability of fatally injuring the employees.Medium 2.Guardingof manufacturing devices Thisalsohasapropertyofseverelyinjuring employees. High 3.Automatedindustrial trucks This can lead to the death of employees on a high level, otherwise can cause severe injuries. High 4.Electrical hazardsThesearecapableofclaiminglivesaswellas 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.Employeemental 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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16RISK MANAGEMENT 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 knowledgeofProjectManagementskillswhilemanagingrisksofnewbusinesspolicy implementation in an industry.