I also agree the motivation the project manager has, can be effected into the other members. And I think its important for the project manager to know that the outcome of the project should be constantly made aware to the other member in the form of encouragement and direction.

There is always a benefit to retaining talent. Experience employees are very important to the furtherance of any company. This is where star player and people of ordinary characters can come in and make a difference. However, it starts being able to retain the employees in the first plane and knowing how their skills can be beneficial to the company.

Personally, I feel like if people don’t work just to make a living at a comfortable position then they are seeking some way to leverage their skills and advance them by becoming more knowledgeable and versatile. Many people end up not necessarily working in the particular field that they were educated and lead about. This is where people’s abi…[Read more]

I think that there should be a communication plan documentation that is kind of generic like an SOP, however depending on the structure of the company this may not always work. If the company is one which departments have their own kind of culture, then it may be more expedient to confirm to what ever they suggest in their training. Though I think…[Read more]

I think this is extremely important because the most important element of any project or system, is the human element. By insuring that the more suitable person for the job is selected can result in the product being nurtured in terms of knowledge, experience and excitement. Keeping seasoned employs is essential because of the expertise that they…[Read more]

I also agree that the contract should clearly say all the needs to be said about eh expectation of the interaction between the vendor and your company. Especially changes that they may make to the design of your procurement. For custom designs that are being outsourced there should be even more stringent controls around notification.

In the control phase any financial values can change based on the project dynamics. Usually the cost can be seen in the phase before the control phase and after where resources are established and assigned to a specific need. However, if in the control phase it is noticed that resources need to be readjusted, the actual cost can change. There are…[Read more]

There are usually CAPA that are open to address these failures that are managed by the department head and the quality system. If there are failures with regulatory there is not must that can be done except to deal with the consequences per the FDA or which ever regulatory branch that is associated with your device. However, with proper project…[Read more]

When keeping up with milestones, one of our greatest tool is communication. We made sure we always gave updates on our every part of the project to the project manager to always make predictions on whether or not we would not be able to meet any of our objectives. In my experience we use gantt charts for process improvement, where we would have…[Read more]

The validation check is a design step that insure that the input meets the user intent, if it does not then the design is incomplete or simply something else. I think that depending on the limitation that is preventing the user intent to be seen in the input, you wont really be compromising but saying your lacking in what’s needed to get the job done.