From my point of view and based on my studies, for your second question, One of the great strengths of the PDCA cycle is its effectiveness in risk management. We carefully identify potential risks during the planning phase and develop mitigation strategies. As we move through the cycle, the execution phase allows us to implement these strategies, and the checking phase involves continuous evaluation to detect deviations or unexpected risks. The iterative nature of PDCA, running through it multiple times, enables us to accumulate knowledge and refine our risk mitigation strategies based on real-world feedback.

Also, I found this:   https://doi.org/10.1155/2023/8007474 . You can check out this article related to the concept of the PDCA cycle.

The PDCA cycle varies with different specialties and the companies but the overall principle provides the framework for how problems should be addressed and mitigated. In manufacturing engineering, the Plan phase is usually carried out by process and design engineers that develop the manufacturing process by selecting the appropriate methods and tools to produce the product. In the DO phase, the production and quality control team ensure that the process and product meets the specified standards and the team executes the plans correctly. In the Check phase, quality assurance team ensures that the output meets the quality criteria which involves inspections, testing, and data analysis to ensure that the product meets required standards. In the last Act phase, the process engineering team take actions to adjust, fix, or improve the process by implementing new technologies, or making organizational changes to enhance efficiency and quality.

In the PDCA process within the field of Biomedical Engineering, employees with different specialties are often involved in all stages of the cycle. The multidisciplinary nature of Biomedical Engineering projects requires collaboration among professionals with diverse expertise, including engineers, clinicians, regulatory affairs specialists, quality assurance professionals, and others. Each stage of the PDCA cycle benefits from the input and collaboration of individuals with varied skills and knowledge.

Regarding risk identification and mitigation, the PDCA cycle inherently addresses risk management:

- Risk identification is part of the planning process. Teams assess potential risks associated with the planned changes or projects.

- During implementation, teams work to mitigate identified risks and closely monitor for unforeseen issues.

- The evaluation phase involves assessing the success of risk mitigation strategies and identifying any new risks that may have emerged.

- If risks are not adequately mitigated, adjustments are made, and additional measures are taken to address and minimize potential issues.

Employees with different specialties are involved at each stage of the PDCA cycle. The plan and the do stage often consists of engineers, scientists, and regulatory affairs specialists who create and implement the technical aspects of the projects. The check stage consists of quality management experts and data analysts who evaluate the results and ensure that they meet the standards implemented. The act stage consists of project managers, engineers, and quality improvement specialists who refine any processes or improvements to project strategies. 

The cycle also identifies and mitigates risks that arise during the process through the specialists mentioned above. These specialists make sure that any risks that arise are mitigated as per guidelines. 

Each process taken taken in the biomedical industry roughly follows the PDCA cycle, either on a larger project-based scale, or smaller continuous improvements within departments. The planning phase involves identifying problems with the current state, goal setting, and determining what actions need to be executed to achieve the ultimate goal of the cycle. This may include meeting with people to see how feasible the goal is, determining the resources and timing of the cycle, and deciding the criteria of success. The doing phase is implementing those improvements and processes determined in the planning phase. This phase lasts as long as necessary, at minimum, the amount of time needed for the criteria of success to be determined. The checking phase consists of analyzing the results of the new process and comparing it's measurement of success to that of the previous one. The acting phase takes the results from the checking phase and determines what further actions need to be done based on the results of the checking phase. The questions that need to be asked are "Was this successful?", "If it was successful, are there any new insights that could further improve the process and are those feasible right now?", and "If it was not successful, what went wrong and how can those items be addressed?". Usually, if those questions have answers that could be used to improve the process, the PDCA cycle is started over, implementing lessons learned from the first one. This would be repeated as many times as necessary until no more improvements can be made on a feasible level.

People involved in the cycle are highly dependent on the scope of the PDCA cycle. For example, a cycle limited to improvements on how information processed within a team may only require those team members to use the PDCA cycle. The previous process could have been sharing information solely via email. The problems identified may be the lack of organized information, no clear way to track the information, and inconsistency of who has access to what information. A goal could be a system that alleviates all these problems and a plan could be devised to use another software (like excel) to migrate all relevant information onto there and continue to use it for 6 months. Efficiency may be tracked in the average amount of time a team member can find a specific piece of information using the old and new system. The doing phase could be implementing new software and requiring all team members to use it. The checking phase would include the team members timing how fast they can find information from the new software versus how fast they can find information by sifting through their emails. The acting phase asking the question of how the process can be improved further may be that the software is cluttered with information, or that there is so much data that the software takes a lot of time to load. With these problems, another PDCA cycle may be instigated.

Overall, the PDCA cycle depends on its scope. As a previous poster mentioned, altering a manufacturing process would incorporate a large amount of people and would likely need a long time to resolve. On the contrary, a team-specific information network may only require those team members and a few months to resolve.

The PDCA cycle is an integral part for the process of Biomedical engineering that incorporates all employees and teams within a project. Every part of the team must plan, do, check, and act in order to get the best results in the end. Also, the PDCA does a great job in mitigating the risks associated with each type of project. The main area that contributes to this part of the PDCA cycle is verification and validation. The verification of each part of the project should be tested thoroughly to show that each input will put out a certain output. If this does not work the process must be repeated until it does. If it does work, the validation process will test again, usually with clinical trials to see if the project produces the results that came out of the verification phase of the PDCA cycle. Overall, the PDCA is vitally important for the success of each biomedical engineering project. 

The PDCA cycle is an essential aspect of successful biomedical engineering projects. While each respective department may have its own PDCA cycle, the "check" aspect can involve members of different specialties. For instance, in a pharmaceutical company, clinical trial protocols need approval before they can be enacted. When being approved, the document needs to be reviewed by various departments (not just Clinical Operations). By involving other departments in the "check" process, the risks are mitigated as experts in various specialties are actively reviewing pertinent documents. By departments "checking" within themselves and also checking with other departments, risks are mitigated. 

The Plan-Do-Check-Act (PDCA) cycle has four phases which are plan , do ,check and act. During these phases there are many specialities like biomedical engineers, clinicians, project managers, regulatory experts, and quality assurance specialists that work together to ensure the success of the project. Regarding the second question , risk management is an integral part of project management. Each step of the PDCA cycle can incorporate risk management.This means identifying potential risks before planning, implementing safeguards to reduce those risks during implementation, and routinely evaluating and updating the plan in response to feedback and risk assessments.