Change Management And Risk Management For Acme Medical Device

Overview of the Project

As with all projects, requests for change almost certainly occurs. In this case study assignment, there is a key change that you need to formally consider in your assignment that may impact the Consultant’s Report and Summary. Are there risks and issues related to this change?

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.

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 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 Process

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 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. 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 (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.

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.

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.

Risk Management Process

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.

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)	Minimum	Most Likely	Maximum	Minimum	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)

Team	Calculation Estimate	Perfect	Likely	Outrageous	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
Infrastructure	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 concluded by the next steps that should be required in the process of risk management for the project.

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.

Quantitative and Qualitative Techniques for Risk Assessment

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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