From personal experience, signing NDAs can be nerve-wracking, especially for your first few jobs or projects. But it teaches you the importance of keeping a secret at the professional/industrial level. First, NDAs must be signed in good faith. Simple as…   Read more»

NDAs have two purposes: to protect the company that issues them, and to guarantee that they can act against the consultant/staff member should they breach that agreement. NDAs are a must when a company does not want any sensitive information…   Read more»

From personal experience, there are a variety of ways to approach such a situation, especially when you need to work with other teams or departments; you almost need to speak different languages to different employees or managers. This is coming…   Read more»

Mohammad, you provided great definitions for introducing both concepts. I’ll add to your points by explaining how these concepts really pan out in a real-world context. During my first job in the field, I worked within a smaller company. My…   Read more»

Design teams might confuse Design Controls and Project Management because they both involve overhead control. Where Design Controls focus on the design of the project and the processes within it, Project Management involves acting as keeper of the design controls,…   Read more»

FMEAs are indeed a useful tool for evaluating the types of failures a system could experience if one (or several) of its components fail. This is especially true for medical devices, which include various components/subsystems that, when under the right…   Read more»

I believe risk acceptance and its effect(s) are directly tied to the quality of the risk assessment itself, which also affects the form of a response to the hazard. When risk assessment is conducted, there is an order of precedence…   Read more»

During my time as a co-op at GAF, I have witnessed a variety of hazards that had to be mitigated, mostly within the R&D labs. Each of the labs had a variety of equipment with varying levels of risk. One…   Read more»

@shreya This is a great set of ideas to build upon for the complexities of developing & reviewing a potential product, especially regarding living documents, progress traceability & structure. I want to add my thoughts on using these methods. When…   Read more»

Both processes are necessary to ensure the product pleases two key stakeholders: the company itself and its customers. Maintaining this distinct difference between them enables specialized processes that cater to the target audience(s). Putting it together would unlikely be effective….   Read more»

Ideally, you’d imagine companies doing both. They need to fulfill regulatory requirements for the sake of remaining compliant, but they must strive to uphold product quality to maintain or improve their market share. This is especially true when considering all…   Read more»

Design teams, from my experience, tend to prioritize the most realistic aspects of a design. The end goal is to meet the customer’s requirements, yes, but at the same time, they cannot expect us to produce certain extraneous features that…   Read more»

Hi Jacob, you’ve provided a great definition of what makes an effective design input. There’s actually a mechanism that Dr. Simon discussed this week in the lecture. To turn a qualitative design goal into a quantitative result, you need to…   Read more»

Meeting minutes are a useful tool for logging significant portions of a meeting, especially when discussing subjects such as design reviews/controls. This gives professionals the ability to keep tabs on a project’s progress through crucial milestones and data, especially during…   Read more»