Hi Dhairya, that is actually a good question. From my point of view, these is how I would do in case of a low or high severity.
1) Hazards that fall into a low severity risk, are considered generally
acceptable and will not require further analysis. Additional mitigation can be done but is optional for hazards that fall into low severity…[Read more]

Hi Dhairya, that is actually a good question. From my point of view, these is how I would do in case of a low or high severity.
1) Hazards that fall into a low severity risk, are considered generally
acceptable and will not require further analysis. Additional mitigation can be done but is optional for hazards that fall into low severity…[Read more]

I agree that meeting minutes are important, since they capture the essential information of a meeting (decisions and assigned actions). They keep team members on track by reminding them of their role in a project and clearly define what happened in a group session. It also needs to be written off and sent to anyone who attended the meeting for…[Read more]

Even though the FDA does not have hard rules for human factors, only guidelines (as per the link given by Luisa).The FDA expects manufacturers to engage in human factors for risk management and it is very important. The human factors focus for risk management is the use-related errors. Risk management of use-related errors deals with the…[Read more]

Now that we were able to identify most of the design transfer challenges, I believe that it will be a good idea to ask ourselves how can we avoid design transfer failures due to the challenges listed above.
One of the tips for a successful design transfer is to:
– Hire more project managers
– Implement a technical solution to manage tasks,…[Read more]

Hi, thank you for sharing with us the steps needed for a Gantt chart, it will be really useful towards the upcoming project. I would like to add somethings to your comment.
First, I was thought that if any assignments that needed to be done were missed, the team members must come up with a “contingency plan” in order to be able to complete the…[Read more]

Hi, thank you for sharing with us the steps needed for a Gantt chart, it will be really useful towards the upcoming project. I would like to add somethings to your comment.
First, I was thought that if any assignments that needed to be done were missed, the team members must come up with a “contingency plan” in order to be able to complete the…[Read more]