These are very common causes for risk management mistakes. But in essence, these mistakes are due to lack of comprehensive knowledge of risk management. Here I wanna add one more mistake that could occur in risk management, which is the overestimation or underestimation of a potential risk by misunderstanding its occurrence mechanism, possibility,…[Read more]

To run a risk management meeting, always follow the cycle of assess-evaluate-manage-measure. First thing you should do is to have quality member gather all members in the project team, because it is important to make everyone get the information of potential risks. Second thing is brainstorming the risks that could happen in the product, product…[Read more]

Design review meetings are very necessary for ensuring that the present design meets the project objectives, because without doing so, nobody would attentively look for a possible deviations that could have occurred within the design part. Besides, these meetings are helpful for facilitating the process of the design corrections if anything wrong…[Read more]

If the deviation happens, firstly we need to locate which one or multiple parts could possibly contribute to the failure of verification. This is very important and may be highly related to small decisions such as design dimensions, wrong analytical method, data collection mistake, and etc. In general, different corrections apply to different…[Read more]

For Design Development Plan (DDP), I think the two most important parts are quality management plan and scope management plan. Because the quality management plan will tell you how to evaluate the difference between the actual outcome and the desired outcome, so as to provide the right direction to apply changes and make the project back on track.…[Read more]

Verification is one of the most important steps in the design control, that it not only can address the questions of whether this is effective enough to do what potential customers want it to be, but also confirms that to what extent of adverse environment can this medical device functionally work, and will it have safety check to avoid injury to…[Read more]

The minutes in the meetings are very important because of they often specify how the team members are assigned their works and the deadlines, so that the responsibilities will be clear for the members to bear in mind. For instance, if you are gonna write about how you will make a bone implant design works, many small details should be taken…[Read more]

Design Control is a broad definition of illustrating how you monitor the design process before it goes to the FDA for auditing. There are overall 9 files that should be accomplished: Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File.
From the perspective of a company, this is a very…[Read more]

I think placebo group is the only scientific way to prove a drug is actually working on the human body. Since it is no longer a mystery that a psychological effect called “placebo effect” is proved to be statistically effective for relieving symptoms of a disease, we will never know this drug is effective because of this effect or it actually does…[Read more]

It is very important to make sure that every pharmaceutical drugs should go through the clinical trials multiple multiple times with sampling subjects more and more extensively before they are put into the market. This is because every drugs has its specific effectiveness and toxicity functions to its dose. If we don’t do clinical test, we will…[Read more]

It’s not that confusing actually, it will be easier to understand this rule when you think of this as a clinical researcher. One of the most important reasons is that there is always an overall objective you wish to confirm in the beginning, that will cause the observer-expectancy bias if you know which group is which. That means there will be…[Read more]

When designing the brand for a food company or a franchise, the color red is most commonly used because according to some researches, the color red does interact with customer’s decision by evoking more impulsive emotions and demands. Of course, appetite is the target word that the food companies want their customers to feel about their product.…[Read more]

With respect to clever uses of participation that used as a marketing strategy by some companies, I did witnessed some successful tricks that actually works for finding potential customers, and even driving them to ask for the product actively.
For instance, some small companies will run their facebook, twitter or instagram accounts by posting…[Read more]

I think one of the most important reasons why these companies never put ads on television is that they occupy the most of the market share in that area, almost monopolized in its most cutting-edge technology development that not many other companies could afford to keep up with. Just like Boeing and Airbus, they are the most known airplane…[Read more]

Sole proprietorship cannot shift its owner according to the law, the business will die with the owner. One way to do this is change the category to a Limited Liability Partnership which allows limited members to hold the company’s share. In this case, the father must sell all the shares he owns to his sons, who are also the partners, before he…[Read more]

In this course, companies including Limited Liability Company vs Corporation vs Sole Proprietorship vs partnership are classified based on the way of operating business, how many people own the business, and how the company relates to the owners. It’s all about balancing the advantages and disadvantages of doing business in a way that could do…[Read more]

S-corps, in my opinion, are those companies who only allows a few members to have a say in running business, the corporate cannot be publicly traded and have thousands of stakeholders like C-corps, but could only be taxed once, which called pass-through tax. These companies are more likely to be of small scale, family-owned, and totally runs…[Read more]

I think there should be a intermediator who can talk between and has fair amount of the knowledge on both side to help them agree to a somehow acceptable level. That being said, everyone needs to compromise for whatever the goal they need to accomplish. There is always a gap between the “radical” theoretical world and the “conservative” industrial…[Read more]

Quality control is not only a matter of saving money, actually. I think it will bring much more profitable good to the company if they did great job on quality control. First, quality control is defined with the acceptance criteria of a good before it goes to the market. This means we only need a good standard to meet that if the manufacturing…[Read more]

As mentioned in the lecture, the ways we can do for effectively monitoring product quality and collaboration between different departments is to simply make strict principles and rules to comply with. In a big company, there are a lot of departments running inside, and it’s nearly impossible to make everyone listen to a manager from one department…[Read more]