I’ve had experience with design control during my undergrad capstone. I got my B.S. in mechatronics engineering and the capstone had to be electronic with other guidelines. We didn’t do the specified documentation presented in this lecture but our report…   Read more»

I’ve been through a process validation before as an Engineering intern. Process validation is the gathering and assessment of data from the process design stage through production to produce scientific proof that a process is capable of consistently providing high-quality…   Read more»

I think the required documentation for design control is most important. Revised design control documentation serves as a valuable source of truth for the project.  Recording everything in one document helps you to organize your thoughts, makes it easier to…   Read more»

Risk control should form part of the company`s broader health and safety plan providing a method to identify, control, and reduce the risks present in the workplace. The control of workplace risk is a practical, evidence-driven process; employers assess the…   Read more»

One factor is the likelihood that the patient will receive one or more benefits — using the information supplied, it is occasionally feasible to forecast which patients would benefit. It’s also feasible that various patient subgroups will get different results,…   Read more»

Internal risk includes personnel management concerns such as labor shortages or low morale, as well as technology difficulties such as outdated software. External risks include economic slowdowns, which result in lower revenue, as well as political dangers from trade wars,…   Read more»

If I were to create a medical device firm, I believe I would do so as a project-based company at first. PBOs are more concerned with project outcomes than with organizational structure. In compared to other organizations, I feel this…   Read more»

  In a functional organization, projects that exist within a single functional division generate no organizational issues. But projects that extend across functional divisions are demanding to manage. This is because the project manager has no direct functional authority and…   Read more»

I work for Coca-Cola which is now operating in more than 200 countries and producing nearly 500 brands. From a legal and management standpoint, the Coca-Cola company is not a single organization, and the Company does not own or control…   Read more»

Only certain human differences impact my outlook on another people in the workplace. It’s not looks nor demographic backgrounds. However, what the person possesses in character, life experience and knowledge make me view and work with others differently. In the…   Read more»