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 a clinical trial study and the machine stopped for exactly 3 minutes, because this was a clinical trial i am obligated to report it and file and LDR document explaining the deviation from the SOP. while some of coworkers believed it was unnecessary to write an LDR because there was no evidence in the results that indicated any deviation , i thought it was important to report it and to be ethical
Ethics and corruption is a problem and business, and in terms of Quality Control and Quality Assurance, it is no different. Superficial language differences can create an opportunity to create an ethics problem while everything is okay on the paper. A robust code of ethics must be adapted within quality control and quality assurance departments to eliminate gray areas from the contracts and other documents to prevent corruption within the business and the industry market. A Code of ethics must include every little detail for specific procedures for quality assurance and quality control in different industries. This issue becomes more problematic in the health industry. A simple ethic violation or absence of ethics code for gray areas can create a chain reaction inpatient health that uses the medical device that has been processed form the same department. Personally, when I was working as a Quality control personal in a tissue bank, I aided in the creation of procedures and ethics code so all of our production and quality control departments would be safe from any corruption.
I have not encountered ethical issues during my experience as a quality engineer, however following ethics is very important. It's crucial to be honest and responsible when working with data and designing studies. Patient safety should always be priority when designing new products. You should also keep in mind working conditions of those that are helping process the product. When designing a process you should be conscious and keep safety a priority. When doing quality control be honest about the errors found. When receiving validation results be responsible and transparent in reporting data. It's important to always do the right thing, not just when someone is watching.
Working in a military hospital that services civilians in the city in which we are located I have seen poor quality of service due to incorrectly written consults for additional services and treatments for patients. We have a quality assurance department here and this is where these things are caught. Because our hospital is such a large organization, while we should have checks and balances, we have quality checks that review historical data to try to implement process improvements however, I believe if some of the providers would slow down and have integrity to do the right thing the first time instead of trying to create a short cuts. I would say, based on my experiences in the medical hospital industry, the risk to quality isn’t because of incompetence or neglect. The consults that get put in incorrectly are due to honestly laziness. I believe these mistakes are also mostly due to of the pressures of clinical deadlines and patient quota. These factors tend to be the stressors that the providers fall back on as excuses to validate their mistakes, however, written consult errors can be mitigated or decreased by the provider slowing down and paying attention to detail. In regards to ethics, again, it ties back into being responsible and slowing down and filling out these patient consults right the first time. IF an error occurs, then the provider should do the ethically correct thing and correct the issue.
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.
@mem42 provides a good example of the importance of conducting yourself in an ethical manner, especially amongst coworkers and throughout your realm of work. I haven't had too many relevant experiences that would cause me to question how things are being conducted ethically, but as this points out you never know how you may come off or be portrayed by others. Employees who are ethically positive, honest, hardworking, and driven by principles of fairness and decency in the workplace tend to increase the overall morale and enhance the performance of an organization. Relating ethics to QA, there should be adherence to quality assurance guidelines and standards. Often in industry you have to replicate results so not following guidelines would interfere with reproducing a high quality result.
Ethics and Quality are very related; moral attitudes and conscious awareness of standards and guidelines have to be separate from intellectual/company's agenda. As NJIT student studying ethics and/or professionals in the industry, have you come across ethical issues in Quality assurance and/or quality control or know examples of good ethical practices in Quality?
My background is in education, but in my experience in that field, I would say that I have encountered instances where there were some issues in ethical practices. In one school where I worked, students who did not necessarily earn the right to be in advanced placement courses, but were placed in those classes because it was a private school. Since parents were paying, it was common place to appease them. I took issue with it because I think it is simply wrong. People should earn the right to be in a position based on the qualifiers put in place. I also had a student to fail after being given opportunities to make up work. Even though I had made concessions to help her and was prepared to give her the zero she earned, an administrator passed her after I had already finalized my grades for the end of the school year. I spent only one year at that school because I could not bear being in a place that practiced such behavior.
QA/QC in relation to ethics can present interesting dynamics. I can go back to my college job as a cashier at Home Depot. We were asked to meet performance measures of timeliness, accuracy, sales, and service. Specific examples of ethical dilemmas with QA/QC is selling extended warranties, and credit applications. There was incentive to do those things. I saw people make false claims about credit report hits, and add extended warranties by lying about its necessity. Those decisions may meet the needs of personal gain and companies bottom line, but the expectation of quality as a service is questionable. Those are the types of decisions that are amplified when we are speaking about this topic in biotechnology. As stated it is important to adhere to high ethical standards when in the face of tight deadlines, financial gain, and notoriety.
Ethics and Quality are very related; moral attitudes and conscious awareness of standards and guidelines have to be separate from intellectual/company's agenda. As NJIT student studying ethics and/or professionals in the industry, have you come across ethical issues in Quality assurance and/or quality control or know examples of good ethical practices in Quality?
Good ethical practices include honesty, morals, and integrity. You need both of these because this shows your character. This will determine if people want to work with you, the way you treat others, the way you respond to adversity, and your attitude will affect the team. If you have no hidden agenda every one should be involved and the line of communication should always be open.
In one of my projects, which was a biomaterial, it was similar to doing a mock product that could potentially go on the market. We had an issue with sterilization, although we had to meet a deadline, the only way possible was through using a procedure which didn’t guarantee sterilization. This was an ethical issue and quality control issue my group had to deal with because our project would be hypothetically be inserted into the body, but we also had deadlines to meet. We had stayed in the lab all week endlessly, simply because we did not want to put out a non-sterile project that could if inserted into a human cause infection, or bring on other disease into the body. It’s difficult when being put under a situation like this, because you know you have to meet a deadline, and are tired, have worked ridiculous hours, but also know its not right to put out a project that could be dangerous. We had some members in the group who wanted to just meet the deadline which was understandable since it was for an overall grade and project submission but also the other members felt it wasnt right or ethical to put out a project that didn't support the goal we had set. The overall project taught my group that we had to figure out a different way to make our gel sterile along with tweak the amounts we used in order to get enough product into a syringe to be sterilized, even though it was a little more costly. It was unfortunate we were very close to being over budget as before we were under and finding the sterile solution increased the price of the product by 4% which for our small project didnt seem like much, but in perspective if this was a multi-million dollar project, the 4% cost increase would be a deal breaking in most cases. It's a very tough call to make sometimes when its such a small detail, but also this detail could cost time, millions of dollars, or peoples lives.
Good question. I would think ethics and quality control go hand to hand just based off this week's lectures. The FDA ensures the quality and safety of the medical device as it is being practice. Good ethics is heavily enforced because of the strict rules and guidelines of the FDA. I'm sure they are companies such as Johnson & Johnson who have lawyers that help them go through the loopholes legally and release medical devices into the marketplace that isn't top quality and lack safety i.e., vaginal mesh device. This type of unethical risk eventually led the company to be sued by multiple customers and the court order Johnson & Johnson them to pay well over $300 million. Yes, I understand companies demand their products to meet the deadlines and expectations, but if the product isn't up to standard and if it can potentially harm customers then companies will suffer legal consequences. It's to practice ethically from start to end.
@jad73 This is a prime example of why it is never a good idea to cut corners when it comes to business and the state of affairs because when you take short cuts in business deals it will always come back to haunt you in the long run. I believe that if the ford company would have taken an ethical stance, then the company would have gotten the defect on the car part fixed on the ford pinto, but because they wanted to make a quick profit, they scarified their company's reputation and it cost lives of the consumers in the long run. When you do things right the first time, then you won't have to repeat the same mistakes over again and waste time.
I personally have not worked in the field in the industry to see any problems, however, in the news there are many stories of companies not disclosing the risks of their products, failing to report major side effects, or just not disclosing their product did not work. For example, in 2022 Elizabeth Holmes was found guilty on 4 of 11 federal charges because she built a biomedical company based on a lie. She took millions from investors in a startup company that was going to revolutionize blood tests employing over 800 people. It turns out the whole lab was fake and staged and complaints made to the company were ignored. Any employee that questioned the QC/QA and ethics were fired. This is a very drastic example, but it is very recent showing that these problems are around now. This was disturbing to learn about because biomedical products have very real consequences to people’s safety, as this product was marketed to diabetes and their blood levels which have very real dangerous consequences if not handled correctly. Do you think besides full audits there are any other ways to look at not just start-ups but bigger well known corporations to determine when malpractice is occurring?
How One Company Scammed Silicon Valley. And How It Got Caught.
By Roger Lowenstein. New York Times May 21, 2018
Elizabeth Holmes found guilty on 4 out of 11 federal charges”
By Sarah Ashley O’Brien. CNN Business, January 4, 2022
In my opinion, this is one of the most interesting topics in the quality discussion. At the end of the day, even though every single thing including test results is documented, there is an element of word of mouth or trust that a company has in their employees to execute the tests and record the results accurately. From other posts above, I saw discussions about certain instances where not following quality protocols would be much more convenient. I believe convenience does not equate to a valid excuse for not following protocols and this should still be considered unethical. In my experience in the medical device industry, almost all the people I have worked with have followed proper protocol in terms of testing, but I have also encountered some individuals who would take an alternate route to testing because it was easier and brought along similar results, this is where the line is crossed because one exception can continue leading to more. Thus, I believe that it would be easy for employees to carry out quality related tasks in an unethical fashion to make it easy for themselves, but this should be penalized because it can easily cause a domino effect for others learning and harm the overall goal of quality.
I have not worked at my company long but from my experience I have not seen any real examples of ethical issues in the QA team. Thankfully my colleagues are very by the book with how they do things so they will make sure there is no sort of irregularity with the quality of the products and especially not the documentation. Just recently we had an issue where about a weeks worth of documents were lost due to an issue with the server and the quality team did not skip a beat to recreate all of the documents even ones that were not technically required since they were obsolete. They put in the extra effort and stuck to their ethical code to ensure that no documents were missing and that everything was properly documented.
