While I haven't been witness to any exceptional quality practices, I remember reading about how the auto industry handles mechanical defects in some of their parts. Apparently, if a defect is discovered (usually through an injury or malfunction report) the data gets collected by the company. Once the issue is determined to be a manufacturing defect, the companies will assess the number of individuals that are affected. They then do a risk analysis, weighing the cost of doing nothing, providing a recall or notifying possible car owners about the issue. If the analysis shows that it would be less expensive to do nothing or just wait for injuries to occur and pay the cost of compensation, they may take that option. I found this practice to be disturbing, as it indicates an informed decision to put the product users' health at risk. Whether this is still true or not, I am not entirely sure, but I feel that a practice like this would be a good example of an ethical issue in QA and/or QC.

When I was searching some articles I came across this article related to quality and ethics. It might not be related to this. But I just thought sharing this would be a good one.
Ethics is the foundation of quality. Ethics is the foundation for the defining dimensions of quality care.
I think only if the ethics is followed quality will be achieved. It is technically interrelated to each other.

http://www.ache.org/ABT_ACHE/EthicsToolkit/JA08_Ethics_Nelson_Gardent.pdf

Although I have not been exposed to a major ethical issue regarding quality control, I still know that it occurs, especially when it deals with hospital equipment. When I was shadowing a phlebotomist (a person who draws blood from patients) for my training period, I saw him drop a needle on the ground. Although the cap was still on, my first instinct would be to throw away the needle and use a fresh one. Instead, he picked it up and told me if no one saw it, you can still use it. I was shocked to hear him say that. I knew that I would not follow that teaching, but it goes to show that not everyone follows the quality assurance and quality control procedures. Although it is a small scaled quality issue, it is still an issue, especially since these medical "equipments" are being used on patients almost daily. It should be imperative to teach existing and new staff members the benefits of following quality controls and assurance policies.

Based on my experiences in the industry, the risk to quality isn’t because of incompetence or neglect. I believe it is mostly because of the pressures from project deadlines and teams not incorporating all relevant departments in project planning. For example, I was recently working on a design change project to help the software team deploy new computer workstations into production. The software team did the software validation and pulled me into do the design change end of things. The software manager did not consider the potential impact to process validations in project planning and didn’t understand the magnitude of work that was required to assess all possible impact. It was almost like I was being strong armed every day to commit to unrealistic deadlines and was even asked “Is there any way we can cut corners because this is a paperwork exercise?” I believe the manager should have been aware of his limited knowledge of the design change process and pulled in the process validation team early on to discuss a strategy so we did not have to feel so much pressure or be faces with the idea of “speed vs quality.”

Echoing on what dh239 posted; This is what happened in the Ford Pinto case. The company knew that there was a flaw in the design and they did the risk analysis and calculated the amount that would be needed to change the part that was defective. It would cost them a little over $10 to make the change for each car and they thought that because they followed, or are within, the guidelines by the NHTSA in safety standards at that time; they believed that they do not have to make the change in the flawed design and released the car. Even though the design was within the guidelines, at that time, Ford should've done the change because lives were lost by the faulty designed vehicle. This example clearly ties ethics and quality assurance/control as well as the governing regulatory agencies involved.

Quality in business always battles with ethics due to the increasing cost associated with ethical devices. Oftentimes, when you hear about an ethical scandal, such as the famous Ford Pinto, it comes down to cost analysis. Many managers already dislike the cost associated wit ha QA department and are not inclined to allocate more money to strengthening that department. Stricter quality controls necessitate more tests/positions which means more spending for the company. As a result, companies agree to lower quality control and thus less safe devices.

I haven't witnessed anything exceptional, but in my other classes, we had a lecture about ethics and we discussed about different situations. As for my personal experience, I think that when you work in the industry you must display your boss/manager your ethics. Even if we don't try, they still evaluate you without you knowing. I happen to have a co-worker who sometimes made odd comments, or behaved somewhat non-serious. Our manager was very flexible, outgoing and easy going, which made it easier to have conversations with him. However, when it came to business duties, my coworker was not considered "mature" enough to take on the lead. His work ethic wasn't coming across the right way. The devil is in the details, therefore, we should be careful as to how we come across ethically.

I currently intern as a quality engineer, and in my department I do see how values, morals, and ethics pay a huge role in driving us to produce better outcomes. For example, in my company, many people always express how the fact that our products are directly inserted into patients battling between life and death and are in most cases the last chances they have to live, a tremendous responsibility and motivation to make sure that our products are the best they can be. So although, time and money can ask us to compromise, the thought of a life at risk, overweighs all these other limiting factors and makes us produce a device of ultimate quality.

A personal experience of mine, that ended up with a good result, was when I was a young teenager. Flat screen televisions had been becoming more commonplace so they were reasonably affordable. I saved up my money and bought a fairly good one at the time. A couple years had gone by with no incidents on my end, but one day I got a letter in the mail informing me that my model television had been recalled due to instances of the speakers catching fire, which is not something that usually ends well when it is in a home. I got a decent amount of cash at the end of it and was able to use it plus a little of my money to buy a new flat screen. I'm glad that my television hadn't caught fire and glad that the company worked to fix the problem.

A more serious situation, which did not involve me, was a story I remember hearing about dealing with a metal hip implant made by the company DePuy Orthopedics, who was owned by Johnson & Johnson. There is a storied history behind it, but the short version is that the hip was shown to release tiny metal fragments into the blood due to the design involving metal-on-metal contact. Whats more is that it was strongly believed from evidence that the company knew that there were flaws in the design but decided to push forward with manufacturing and distribution for a couple years after getting market approval. The whole time the company denied any hazardous effects from the design and instead blamed it on things like improper implantation and instead waited until sales declined before discontinuing it. The end result was a payout by Johnson & Johnson to the sum of $2.5 billion for those affected by it. And this implant was able to make it into the system due to how easy it was for them to get 510(k) clearance by using similar devices at the time as credence, despite the fact that their very minor design difference that ended up causing huge problems.

According to me, ethics and quality are interrelated especially when it comes down to medical devices. The products developed must of the highest quality because if a malfunction occurs at a critical stage, it could be fatal to somebody's life. When the ethics followed are right, quality controls and quality assurance protocols will automatically be accurate and efficient. When companies do not follow these ethical practices, they are ready to compromise on the quality of their products as long as their expenditure and investment reduce. This just makes ethics and quality directly related especially in the healthcare industry.

I agree, ethics and QA are related and you can see this in any type of environment. One of things a always notice, the drive force for people to follow the rules (QA system) comes from fear "what happen if someone catch me" not from love to do the right thing and help others. From my experience (Outside the US) in the healthcare system, there is a QA system ----> people know about it-----> people follow it only when they hear there is an inspection or audit, if that is not connected to ethics, i am not sure what does.

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 see the point in not adhering to policy, protocols, and maintaining quality control. Yes, it can be related to a speed limit; do people actually follow it? Well, in the medical device industry, or clinical laboratory field, there following policy and adhering to protocol is the easiest thing to do. If something is proven to work and produce high quality results, why deviate from it. It would be unethical to not follow guidelines that can cause impose harm to people that are seeking the service or medical device. Of course, adhering and following rules is not for everyone, this is why we have a legal system and every company has a QA/QC department. 

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 unethical, would be much more convenient. Pedro had mentioned speed and I think this is a great example. Ethically speaking, every single quality measure that needs to be taken should be taken. This typically is very time consuming and can be difficult with upcoming deadlines. In other situations, some people break procedure for convenience. Someone else had posted before about a doctor who dropped a capped needle and then still moved forward to use it, which is a prime example of breaking procedure for convenience. All in all, I agree with Pedro that not following procedures and standards set for quality purposes should be considered unethical.

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 in a manufacturing line, I see the importance of documentation, especially when there are people handling and building product. Because human error may occur at times, it is important that all employees understand how to communicate any deviations to standard operating procedures so that corrective action can be implemented.