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Design Verification Ethics

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During the slides on design verification, it was mentioned that for verification it is advantageous to catch the issue in the design before the verification protocol and report have been initiated. Catching a problem during the verification phase would require one to go back and make revisions to the Design Inputs (DID) or the (DSD) which will require more time to record appropriately. Are you aware of any companies which encourage employees to instead of recording everything legitimately with each revision included in the verification report, these unsuccessful instances where simply neglected in order to save time? What do you believe of are the ethics associated with this?

Topic starter Posted : 30/10/2021 6:58 pm
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I am not personally aware of any companies that openly promote this, but there are definitely cases of negligence that, when caught in an audit, result in a CAPA (corrective action preventative action) that requires a lot more resources, time, and money to correct. In terms of ethical considerations, lack of reporting of unsuccessful verification or correction to outputs can in worst case lead to serious patient harm and in the best case lead to internal audits that require NC or CAPA  

Posted : 31/10/2021 3:49 pm
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I am not aware of any company that does this and if they did I'm sure it would be held close to the vest. While this strategy may work in the short term to avoid displaying the failures of a product, lies like these can eventually evolve into something greater if the failures come up again but there is no history of it ever happening. Even more so if a regulatory agency reviews this failure and begins to question how it was not caught during the verification process. The ethical issues of this practice are apparent and doing so puts people at unnecessary and careless risk when the product reaches them. 

Posted : 31/10/2021 6:38 pm
Eminent Member Registered

I personally haven't encountered this type of scenario. However, avoiding any step during the verification process puts a huge risk to the patients and customers. Some of the steps can only be identified by certain personnel and not others. Therefore, it is their responsibility to review any unusual outcome because no ne else may recognize this. If it requires extra time, steps and efforts it must be done in an accurate manner. 

This post was modified 7 months ago by Tamanna
Posted : 31/10/2021 9:46 pm
Sheila Sarathy

I believe that would depend on if the company is working on something with high demand and urgency. For instance, I work for a laboratory that has a pcr lab that processes covid19 samples. With the height of the pandemic and pcr employees being in high demand, a lot of credentials for the employees can be overlooked with the intention of being able to process the most amount of samples. They can also be known to cut corner in the sole effort to get the most covid results out as soon as possible. 

Posted : 31/10/2021 10:34 pm
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The company I currently work for does not let any sort of failures go through. Since I work at a medical device company, the product affects patient care and health which in turn, if product fails, can be a big legal issue as well as bad publicity for a company. Overall, integrity is a big factor that I've seen always shine through where quality will not let a product launch if there is a failure that is not justifiable during V&V. I would say that there are companies, big and small, that would try to push a small issue or a known risk into the market ( Hopefully, many of those learn that hiding issues is not fruitful and will always come back to create issues for a company. 

Posted : 01/11/2021 7:08 pm
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There are serious legal repercussions for companies who do not report negligence for the sake of time. This would result in poor patient care and could possibly lead to death. Patient care should be the top priority, especially for medical companies. Lack of proper reporting could not only cause patient harm but if discovered, could ruin the company's reputation. Companies who advise their employees to not report everything to save time and money would, later on, face a bigger problem. Small issues could easily pile up and if these problems arise, then the internal investigation would show negligence.

Posted : 03/11/2021 12:30 am
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I have not come across any company that does this. Especially for medical device companies or pharma companies I think it’s illegal and ethically wrong for them to do that because it goes against all the regulations and laws regarding product design an product release. The company is required to record all data and steps so that if anything goes wrong in the future, they can back track it. There will be serious consequences legally when this occurs as well as a lot of patients will get seriously harmed because of the lack of care of this company.

Posted : 03/11/2021 11:29 am
Rifath Hasan

"Human factor" plays a crucial role in design verification ethics. Along with verification and validation, there's a term called Human Factor which means, evaluating a device’s user interface to confirm that the device can be used safely and effectively by the intended users in the intended use environment. To get approval from US FDA, human factors validation test is required with V&V. Manufacturers usually bring a market-ready device to a human factors validation study. Since manufacturers come to human factors consultants at this late stage, it is possible to have some potential flaws remaining in the design. At this point, an ethical question is raised. The easiest way for manufacturers to avoid such conflict is to thoroughly understand the benefits of human factors and include them from the beginning of device production. 

Posted : 06/11/2021 11:55 pm
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Much like our peers, I am not aware of any companies that do this. I think this is an extremely dangerous thing to do especially in the field of medical devices. While it can be frustrating and annoying to have to go back and revise paperwork because of one issue, it is better than having to face legal repercussions in the case that the device fails and has fatal consequences. Yes revisions can be tedious, but they are important to ensure the device is functioning as intended. Catching an issue in the design can also even help catch many other issues as well. I have found that after catching one issue and brining it up, a number of other issues are also present. By pointing out these issues, you are saving time and money in the long run. It is extremely timely and expensive to be involved in a lengthy court battle than it is to make revisions and improvements. While the oath "do no harm" applies to physicians, a similar one should also apply to engineers as well in terms of ethics.   

Posted : 07/11/2021 12:41 am
Eminent Member Registered

I feel as though many companies are guilty of this to some extent. Maybe they need the product out now for revenue and they feel they can fix what they missed in an update or they feel as though the problems they were having are not serious. I believe this is isn't really an ethical problem as its obviously wrong. The interest should be in helping the public an devices or drugs or anything that gets sent off due to false paperwork and checks could be very dangerous and harmful

Posted : 09/04/2022 9:54 pm
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I do not know of any companies that outrightly say that their employees should do such things, but I would not be surprised if a company did this to cut corners. I think many companies, in order to get a product out in a timely manner, would be above not looking over their documentation, which is a serious ethical issue. You never know how serious the mistake is that you may have chosen to ignore out of convenience, so it better to look through everything with scrutiny so that you many not have a future lawsuit on your hands.

Posted : 09/04/2022 10:37 pm