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 non-conformance is found. This could be in receiving inspections of the raw materials and components, on the manufacturing line, during in-process…[Read more]

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 more flexible but you may end up working more. It is a really interesting dynamic, while so many people are overworked and trying to do more with less…[Read more]

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 adhere to current regulations has a very important role. This position has a of job security because it is an ongoing process. I have been spending…[Read more]

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 certifications in my field (At my curret level a SS Black Belt is often requested). I currently work in a role supporting external and contract manufacturing…[Read more]

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 engineer one of the most valuable things when facing a product issue is to consult with someone with historic knowledge of the product. Unfortunately it…[Read more]

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 if (in this case) Conmedics had a second qualified manufacturing site for HydroSurf? I see how it is easier than choosing a different supplier, but…[Read more]

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 a project. EAC, ETC, BAC, PV, AC should also be presented. Additionally any value that is significantly below or above expected should have an…[Read more]

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, you would also need to increase cost or time so as not to sacrifice quality. If you wanted to shorten the timline of a project you would need to…[Read more]

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 note that red metrics are not bad! Red metrics just show that expectations are different than reality. You can then investigate why that gap exists.…[Read more]

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 are hard to predict and can definitely negatively affect schedule. The best we can do is try and account for those in planning phase. You might want…[Read more]

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 possible however to have a difficult project manager who may have a similar disposition to Patty. I have found that when you need to communicate a…[Read more]

In a previous Project Management course we were asked to identfy the personality styles of our team members, analyze how those styles might conflict and to come up with a set of ground rules for the project team to address those potential conflicts. What you are referring to in this post is conflict and how to resolve it. It is important for a…[Read more]

In my company, the Work Breakdown structure more closely resembles option 2. I have seen various degrees of success with this. I think one of the problems I see occur is that the people providing input into the work breakdown structur are not the people actually performing the tasks. Often the higher ups don’t necessarily know all the ins and…[Read more]

About 6 years ago the company I work for was developing a next gen drug coated coronarystent. Due to competition, sales were falling from the companies first drug coated stent. The first stent used to be a major money maker for the company as it was the first of its kind to the market. The project to develop the next gen stent had many issues…[Read more]

So first of all, regulations are rarely released by surprise. When a government entity releases a new version of a regulation they generally give a company plenty of advance notice and time to comply. What this means for the project manager is that the upcoming release of new regulations should be discussed early in the project planning process.…[Read more]

Project planning is very important and critical to the success of a project. Project plans are absolutely living documents that will be updated throughout the course of the project. One way to mitigate the issues you bring up is to have a solid project risk management process. If you can identify these risks up front during planning (staff…[Read more]