As technology improved, so has the ability to manufacture goods. I know from my experience, this improvement has constituted to an increase in areas of inspection or in other words inspection techniques have become more strict and controlled. All aspects…   Read more»

Based on the provided information, I agree with the assessments above, I believe that a change order would be needed and this change should be addressed with R&D and Quality. In addition, a risk assessment on the device should be…   Read more»

I have never personally done a design change from an initial design standpoint, but I have made Engineering Change Orders on documentations post the design change. Essentially these change orders have to be approved by R&D, Quality, and the effected…   Read more»

An example of risk that I have personally worked with was the creating of SOP’s for in process checking, the SOP that was created ensured proper inspection of the manufactured product. We had to ensure that all operators were trained…   Read more»

In my opinion, I feel that Research and Development is probably your highest investment, you want to ensure that the product you are developing meets specific standards and criteria’s, a project after designed can undergo trials, where they fail or…   Read more»

As you mentioned, recalls may be detrimental to the reputation of a company. Particularly the possibility of litigation. Below I attached a link to an article about a lawsuit that is currently happening with Merck.

http://www.investopedia.com/news/mercks-zostavax-drug-hit-lawsuits-mrk-gsk/

I completely agree, to be in business you have to have an the knowledge of industry and most importantly the ability to speak and negotiate with potential buyers. I know I personally deal with a particular vendor and he goes…   Read more»

I agree with the comments above, it is difficult to point at which role would be the most critical for a project manager. If I were to take a guess, I assume that creating the story behind the product line….   Read more»

I have heard from fellow coworkers of projects being “killed” because of a shift within the market or money is shifted to another project due to unforseen circumstances. In this instance, the project is not fully killed but just put…   Read more»

I personally never had experience dealing with recalls, but I assume that are some costly side effects from a recalls such as tainting of the company brand to potential litigation if the recall is based on causing harm to individuals….   Read more»

From my experience the quality assurance team performs tests on everything that comes in for product to ensure that the material meets it’s specifications. They also test materials from vendors, and ensure that the vendor material meet our specifications. From…   Read more»

As a PM, these types of scenarios should be anticipated with proper communication between all team members. As a result the project manager as the responsibility to organize and communicate between team members, it is important to have weekly updates…   Read more»

Ussually when looking at vendors the company has a list of approved suppliers that would ease the purchasing aspect because prior business has already been initiated,and buying from an approved supplier means that you know what type of quality of…   Read more»

Hi Fady, when we say severe failure, are there critical components within the equipment that broke down or is the product itself being produced or being check incorrectly? I would say that we should treat this as a preventative maintenance…   Read more»

Well it depends, setbacks and delays often occur, but my question is, since this component is critical, does Arugalo Medical have a list of approved suppliers for this component and is this company the only supplier? Lastly, wouldn’t it be…   Read more»

That a good question and it could be slightly trivial to answer. I believe that the original validation would not expire, but lets says there is a gap between the validation such as let’s say that you just did an…   Read more»

I don’t think missing a major milestone can particular effect future success of a product/project, delays should be anticipated and addressed in a timely fashion. Usually project managers incorporate potential delays/setbacks within their timelines, because they do happen. Now is…   Read more»

I agree the comments above, with the support of Dr. Simon’s courses I feel that his courses provide a real world approach and look within industry. There have been countless of times were I refer back to my lecture notes…   Read more»

I agree with the comments above, I believe that the biggest difference would be dealing with the diverse regulations. From my previous experience within a cosmetic standpoint, I was working on a reform on an overseas product, both the overseas…   Read more»

I had a similar experience, but with the purchase of a 2 identical pieces of equipment, but they were being placed at two different locations. We had to validate each piece of equipment, but with regards to our Test method…   Read more»