That’s a really interesting question you ask, because in real working life there isn’t a definite answer to yes or not when it comes to ethical work style. I have experienced a situation where i had a machine running during…   Read more»

I have not personally come across any ethical issues in Quality Control/Assurance but have opinions about good ethical practices in Quality. One main practice involves transparency and can be achieved through proper documentation of all activities and individuals involved. Specifically…   Read more»

I agree with Pedro to a certain degree. When it comes down to it, not following the proper quality protocols and procedures outlined would be considered unethical. However, there will always be situations in which not following these protocols, although…   Read more»

I do not see how there is actually an argument in this post about QA and ethics? It is basically unethical to not adhere to QA standards. Coming from a clinical laboratory that tests for cancer diagnostics, I do not…   Read more»

I have a related question about this too. This is a question that my friend faces with his job. He is a biomedical engineer who works as a quality control person in a medical firm. He has almost two years…   Read more»

I think some of the skills that a QC engineer must have are usually part of the important core of skills that all workers should have; attention to detail, investigational and research skills, organization and diligence, work well with different…   Read more»

I can see that may of you have favored the initials student’s post about the “Evil-Big Pharma”, well I can say that I agree to an extent. I can see how the endless circle of treating a disease opposed to…   Read more»

My coworkers and I regularly follow work instructions throughout the day and occasionally we come across issues or illogical steps within work instructions. Sometimes they are simple mistakes such as one or two steps, however other times an entire section…   Read more»

I have experienced a solution to this quality and r&d integration problem. A separate department called “Advanced Operations” assists the R&D team to formulate manufacturing & testing plans that minimize the risks associated with quality. This provides a clear plan…   Read more»

I do not work in quality assurance however I have experienced multiple audits from the quality department of my company. As explained in this week’s lecture, there are work instructions for every possible job duty in my company. Whether performing…   Read more»

Technology such as AI can be helpful in developing semi or fully automated quality inspections processes. I think it’s important to note that these new technologies also have to get validated themselves. Any new technology added to improve quality control…   Read more»

Quality Assurance is the methods used to ensure a product is suitable for the market. The methods include all of the systems, structures, reviews and evaluations used to meet product requirements. Quality Control is more focused on if the product…   Read more»

Just last week I overheard my coworkers complaining about how certain quality policies have gone too far and may be causing more damage than good. My company recently opened a new location and the manager ordered 10 new workstations for…   Read more»

As I am still new in industry, I have yet to meet someone who believes Quality is a burden; but from the perspective of a Supplier Quality Engineering Intern, if I ever do meet someone who believes this, I would…   Read more»

A Form 483 is given by the FDA when a company fails to comply with the practices set in place by their own Quality Management System (QMS) or the FDA’s standard regulations. I believe the analogy of receiving a speeding…   Read more»

Keeping up with new technology such as IoT, AI, and ML not only requires literature reviews and reading more on the emerging fields, but it may also help to hire scientists/engineers familiar in those areas. Many engineers in computational research…   Read more»

I believe the “vicious game” talked about here cannot be stopped for as long as the American culture relies more on curative medicine rather than preventative medicine. If the patient is healthy, then the doctor wouldn’t prescribe drugs, however, if…   Read more»

I do agree there is a game being played between physicians and drug companies- you go to the doctor, tell them what’s wrong, they prescribe you some pills and you hopefully feel better soon. Well, if that weren’t the case,…   Read more»

A major difference between QA and QC is that QA is more process oriented, whereas QC is more product oriented. Another distinction between the two is that QA usually requires the whole team to participate (such as following SOPs), while…   Read more»

Posted by: @maniakberk Biomedical Engineering education is an education that doesn’t teach you anything about marketable skills. Those professions are created for Electrical engineers, Computer engineers, etc. Unlike Other majors, BME is a combination of various different majors, and although…   Read more»