What if your favorite company pertains to a cryptocurrency? Can I discuss my evaluation on that?

Interesting that you say “some auditors have the mindset that they must issue an observation or a finding before leaving a plant.” I believe ALL auditors have this mindset no matter how good your quality system is. From what I have seen, auditors will question everything and listen very closely to what people in regulatory and quality say so they…[Read more]

I agree with this. As an engineer that is outside the quality department, looking for continuous ways to improve processes is key for a company to continually increase efficiency and productivity. A lot of Green Belt Six Sigma/Lean projects are directed toward demonstrating some sort of increase in efficiency or savings. Quality tends to resist…[Read more]

With more and more companies wanting to adapt a lean culture to reduce downtime, increase efficiency, and reduce waste improving Quality and Manufacturing practices is key. I believe one of the first aspects in improving Quality in general is getting everybody on board to buy in to this culture. By doing this, most departments will be open…[Read more]

I believe it comes off as a burden because Quality are the people who tend to reject or question every detail of a report or analysis.

You want to get product that moves out the door in a timely matter. Quality Control, most of the time, requires 100% inspection of a lot or doing First Article Inspections on a certain amount of product. These…[Read more]

Going on a tangent as well – I understand the idea of simplicity that technology adds. But to turn an app into a medical device that is used by doctors to make decisions seems foolish. I’m for the idea of “mobile apps that pose minimal risk to patients and consumers” mainly for things like monitoring or tracking. But I don’t think a phone was…[Read more]

The Tylenol Recall in 1982 was what started the idea of recalling products off shelves. Johnson and Johnson had to deal with this issue and James Burke, the CEO at the time, was commended for the way he handled the entire issue. The issue arose when several people died due to cyanide-laced Tylenol capsules. As a result, he recalled all the…[Read more]

After the brain is frozen and transported, I assume to a customer, would the customer try to use the brain, realize it doesn’t work, and then go back to you? I assume after that you do an investigation to see why it failed afterward?

I would like to know the answer to this as well.

Interesting. Did they go back and re-do the protocol and initiate the the trails again after realizing the diminished interleukin levels? If they conducted it again, what happened afterwards?

The main motivating factor, in terms of animal studies, is conducting the study on these animals and seeing what the results are. The results will demonstrate if the research for the university is worth pursuing and these type of studies help identify for professors and doctors in the school if they should continue some of their research…[Read more]

Generally speaking, research in industry is investigate and completed “faster” usually because they have the resources in terms of money and experienced people. It also depends what type of research that the company is conducting. In terms of medical device manufacturing, people in Product Development and R&D ideally want to get it done quick but…[Read more]

It depends.

If you are missing milestones that need to be accomplished that are highly critical to compliance and basically keeping the customer/patient safe, then I would be able to accept missing it.
These are the type of situations that can easy be explained and accepted. Therefore, I agree with your statement.

If you are missing…[Read more]

Most of the projects that I have worked on, which have had a big scope and long timelines, has followed a format in which one person is the Project Manager and underneath the project manager are a bunch of Project Leads from different departments. The Project Manager usually has a high overview of the details of what is going on within the…[Read more]

The regulatory aspect of project management for medical devices is a very obvious difference. I think another big difference between project management for medical devices vs building construction involves the tighter and stricter deadlines. For medical devices, meeting deadlines is critical because it can potentially lead to discontinuation of…[Read more]

Planning phase and executing phase are by far the most important phases in product lifecycle management.

During the planning phase it is imperative to get all stakeholders involved in developing a timeline, budget, resource allocation, and solidified sequence of steps to make the project successful. Ideally one would want the planning phase to…[Read more]