A project is full of different priorities. I believe that one should prioritize tasks on the critical path in order to not delay the project as a whole. This way you’ll finish the project on time and the client will be happy with the results.

I appreciated the practical simulations of this course. While there was also a academic component, the practical component that allowed us to experience what happens in the industry gave great experience. I feel that I will be more of an asset to a project team after taking this course.

A good way to fight tunnel vision is to start with the big picture. Look at what the end goal is and how the particular issue is impeding that. List different ways to tackle this problem, and also bounce ideas off of other people. Lastly, taking a break and revisiting the problem later with fresh eyes helps as well.

Establishing a good relationship with a vendor starts with communication of expectations. If there are different expectations, there will be unavoidable conflict between you and the vendor. The next step, in my opinion, is paying your invoices on time. At the end of the day, the vendor has to run a business and overdue invoices puts stress on them.

My biggest motivator is a sense of purpose or “why”. This is found by knowing: (1) what the end product is, (2) how the end product will be impactful, and (3) who will be impacted. Having this overall picture of things allows me to fall back on why I started doing the work in the first place.

In my opinion, including people in the end goal does wonders for motivation. Showing people what the end product will be, explaining how it will be impactful, and showing them who it will have the impact on is a great motivation tool. By doing these three things, you give the team a sense of purpose or a “why”. When things become arduous or maybe…[Read more]

In my current line of work I am often responsible for order various parts from vendors. The first thing that I look for when selecting a vendor (assuming we already have an account & are able to order from them based on company SOPs) is the quality of the company that makes the part. Next, I look at the price of the part from 3 separate companies.…[Read more]

Before solidifying the DSD, you would want to make sure the supplier is capable of meeting the requirements. In the case of the minisim, this is what was done. An issue was discovered due to a lack of following company SOPs. If SOPs were followed, the specs would have already accounted for AquaWoah as an alternate source. This way, we would not…[Read more]

I agree with ajm73. In the current mini-sim, the two products are made from 2 separate companies. There could be a point of view that favors having 2 sources from the same company, however. You would already know the work ethic and reliability of the company in question. If you already know the quality of work the company provides, it makes people…[Read more]

The stakeholders should be involved from the beginning of the planning phase. Each stakeholder will have valuable information in the subject matter that they have expertise in. Involving them too late could result in resistance at different aspects of the project, and (depending on who the stakeholder is) can cause delays.

In my opinion, it simple falls down to profit. The project is expected to launch at a certain time and make a certain amount of money. If you spend more than you were initially budgeted for, you’ll cut into the profit margin of the product. If you spend less, you increase the margin. If the project gets too expensive, the company may even want to…[Read more]

I would start by contacting the vendor and explaining the situation. They will normally have an explanation on what’s going on with that particular lot of packaging. Being that they are the primary vendor, I’m assuming that their process capability was tested. This would give you an expected DPMO and confidence in the vendor in the first place.…[Read more]

Planning is important, and with proper planning some pitfalls can be avoided. Revising a plan when new information is discovered is recommended in an attempt to keep everything flowing as smoothly as possible. I’m not sure what would happen that caused several different people to suddenly become unavailable (it seems like an assumption was made…[Read more]

My field is regulated by The Joint Commission (TJC) and The Centers for Medicare & Medicaid Services (CMS). Every 3 years an on site audit is performed by either TJC, CMS or both. Not having our logs in order when the regulatory bodies arrive can contribute to the overall organization losing it’s accreditation. This will financially cripple the…[Read more]

I agree with ec52. Buffers are set in place to account for unexpected events. As well as with the point that the gantt chart is a living document. I would like to add that communication helps eliminate human error. The marketing department “going off and doing their own thing” could have stemmed from misinterpretation of communication to them.…[Read more]

The first thing that I would do is identify what issues are currently being faced. In this case, the product was clumping and the CMC was leaking out. With that identified, small fixes would be the next step(changing storage temperatures, etc). Simultaneously, research should be conducted in changing larger aspects of the product (carrier system,…[Read more]

I agree with ec52. When you assume you know everything, you tend to make mistakes. Consulting someone who is an expert in the area of interest can be a tremendous help with scheduling. The Subject Matter Expert will be able to give a realistic timeframe for the completion of the task, while also being aware of overworking others. It is also good…[Read more]

Maybe I worded the original post poorly. Yes, violating the current standards can be dangerous to the end user & costly to the company.

As more regulations are developed, making medical devices become more cumbersome. Because of this, medical device companies may neglect a certain area of research due to the heavy financial or time burden. Or…[Read more]