ks629

Forum Replies Created

RE: Why do people work?

I agree in general with the results of the survey, it makes sense. I think the more interesting question to ask is why do people leave the job they are in? I am in a company right now where a lot of...

In forum Project Management Application: Clinical Trial

7 years ago
RE: How to make good relation with vendors

Having a good relationship with supplier is extremely important. I have worked in Supplier Quality for the last 7 years. I think what @ap962 posted is a great start but one of the most important thing...

In forum Project Management Application: Clinical Trial

7 years ago
RE: What it an NCMR

I always like to give my suppliers the benefit of the doubt, I wouldn't assume it's an ethics issue. An NCMR is a Non-Conforming Material Report and it would be opened for anytime a material related...

In forum Project Management Application: Clinical Trial

7 years ago
RE: Overworked Americans vs. Motivation

I agree that Americans tend to be overworked. It really does come down to company culture though. I have worked in a bunch of companies and some of them its strictly 8-5 and others the schedule is mo...

In forum Project Management Application: Clinical Trial

7 years ago
RE: Clinical Project Team Roles

I would choose to be in the Regulatory group because it is an exciting and ever changing environment. Due to constant changes in the world wide regulations the group that is making sure the trials ad...

In forum Project Management Application: Clinical Trial

7 years ago
RE: Six Sigma Green Belt Certificate

I have a Six Sigma Green Belt from my former employer. I also have a Certified Quality Auditor and Certified Quality Engineer. I work as a quality engineer and those are the most requested certificat...

In forum Project Management Application: Clinical Trial

7 years ago
RE: Importance of Human Resource Management

I work in a company that has recently experienced high turnover and I can tell you from experience that losing talent and knowledge is a huge problem in the medical device field. As a quality enginee...

In forum Project Management Knowledge Areas

7 years ago
RE: Single Source/Dual Source

I guess my question to you all is how would selecting a different coating from the same supplier reduce sourcing risk? What is the major sourcing risk that is being reduced? Would it be acceptable i...

In forum Project Management Knowledge Areas

7 years ago
Single Source/Dual Source

In the Mini-Sim, there is a requirement that a second source be selected for product coating due to it being a critical component. The second source selected is AquaWoah which comes from the same sup...

In forum Project Management Knowledge Areas

7 years ago
RE: Be wary of EV and statistics calculated with it

I disagree with this a bit. It's true earned value could be skewed, but it should also not be used by itself. It should be presented along with other values to get a complete picture of the health of...

In forum Project Management Process and Medical Device Development

7 years ago
RE: Which of the following project would you say is better and why

In project management there is a concept known as the triple constraint. The three constraints are cost, time, and scope. The idea being if you want to for example broaden the scope of the project, ...

In forum Project Management Process and Medical Device Development

7 years ago
Design Transfer

Design Transfer is the process of handing off the new product from the design team to the manufacturing/base business team. In my company the design team (along with the manufacturing team) will cont...

In forum Project Management Process and Medical Device Development

7 years ago
RE: Monitoring & Controlling Techniques

As a quality engineer, I have always been a huge fan of Metrics. I believe metrics can be a great way to identify problem areas and where you may need to reallocate resources. It is important to not...

In forum Project Management Process and Medical Device Development

7 years ago
RE: Factors affect schedule variance (SV)

Today has me considering how much weather can negatively affect schedule. This month we have had 5 snow days. Last fall our site in Miami was closed for a week due to a hurricane. Forces of nature a...

In forum Project Management Process and Medical Device Development

7 years ago
RE: PM: Timeline, Risk, Social Approaches

In this project simulation, Patty wasn't the project manager but she was a significant stakeholder and team member. The project manager's job is to mediate between these two personalities. It is poss...

In forum Project Management Process and Medical Device Development

7 years ago
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