If a product has a problem in the verification and validation executed by the contracted company while a product has been passed in its own verification and validation, how do companies solve its problem in the real industry?
In the industry, I believe they would solve it in the same manner that was involved in the most recent simulation. They would take a look at all the differences between the testing conducted at the contracted company and the testing conducted at its own and start narrowing down the list by addressing one difference at a time and seeing if the issue is resolved. If they cannot succeed in getting the product to verify in both places, they may need to revisit their product and consider revising some of the materials used to see if that works. However, that comes with the added caveat that the product must first go through the companies own verification testing again every time a material is changed before it can be tested at the contracting company.
Sometimes there are discrepancies with different testing instruments, different SOP, or even different brands of reagents. These details can affect the ultimate result of the products. In order to be consistent, both companies have to make sure they are using the same reagents and the testing procedures are similar to each other so we can rely on their results. If the product is not good after that maybe it is an issue with the shipment itself. Potentially, the weather conditions were not ideal and eventually, the product started to become unstable, therefore, causing to fail in our company.
Hello,
If a product has a problem during the verification and validation executed by a contracted company, while the product has passed its own verification and validation, the company must first determine the root cause of the issue. There are a variety of reasons as to why there are discrepancies in validation, such as following different protocols or mistakes following through with the protocols. The contracted company's verification and validation process should be reviewed to identify any discrepancies in their testing methods or results compared to the internal process of the company. Once the cause of the problem has been identified, the company can work with the contracted company to address any issues and make the necessary changes to the product. This may involve additional testing, redesign, or modifications to the product. Communication between the two companies is essential during this process to ensure that both parties understand the nature and scope of the problem, and work collaboratively to find a solution. The contract between the two companies should also be reviewed to determine any specific responsibilities or obligations regarding product testing and verification. Ultimately, the goal is to ensure that the product meets the necessary standards and requirements, and that it is safe and effective for its intended use. The companies should work together to resolve the problem promptly, thoroughly, and transparently, to minimize any impact on the product's development timeline and cost.
In my experience, we have run into this problem exactly where the product was not passing our validation and verification protocols but it was passing the supplier's verification and validation protocols. In these cases, what we have done is set up a meeting with all essential personnel and walked through our protocols and then the supplier protocols to identify which ones overlap and which ones are the ones causing the issue. Once this was done, the conversation moved into what inspection tests can be done by both the supplier and the company to ensure the verification and validation of the product. Through conversing with the supplier, we were able to come to an agreement about the protocols and processes that needed to be in place. If there is any change or issue on either side for any reason, we both have controls in place to deal with and mitigate issues.
As a company, if we encounter a situation where a product has failed verification and validation executed by a contracted company, while it has passed in our own verification and validation, we will initiate a thorough investigation to identify the root cause of the discrepancy. We will work with the contracted company to address any issues on their end and may make changes to our own verification and validation process based on our findings. In some cases, we may need to re-test the product using an alternative verification and validation method or bring in a third-party expert to help resolve the issue. Our ultimate goal is to ensure that the product is safe, effective, and meets all necessary regulatory requirements before it is released to the market.
In the industry, I believe the process of finding out where the difference in results are coming from is the same as what our groups have been doing in the simulation. Companies would meticulously look at each step of the process and try to figure out what could be causing the difference in results. As some of the previous responses have stated, the difference in results could be coming from the type of equipment used, the brand of reagents used, to even the type of tests being conducted. I assume that the companies would go through all of these and see where there is a discrepancy in testing protocol. Going through these steps would ensure that the contractor company and the original company would be on the same page about the testing processes and eventually figure out what went wrong.
If a product passes at one company and not at another, I think you need to investigate the practices at both companies. If there are some missing procedures in place or faulty data, this can cause major issues when it comes to products that are already approved and out on the market. If the second companies proves that their data is more accurate, it can probably lead to pulling already existing products off the market for re-testing, which could lead to the company going bankrupt. In depth investigations need to be done as well to see how the two companies performed the testing and what could be causing the issue.
I agree with the aforementioned replies. It is important for each company to review each other's process and find not only the difference but the root cause and work together to address it. When comparing verification and validation services, there are some key project management documents that companies should consider.
First, the requirements document outlines the product requirements, including functional and non-functional requirements and etc. Both companies should have the same requirements document. Next, the test plan outlines the testing methodology. The framework for the verification and validation process is established here and should be followed by both companies as closely as possible. Not all contracted companies have the same equipment or resources. For example, there might be a significant difference in quality of testing equipment. Both companies should compare their resources for their test plans.
A real life example of a difference was the case of a radiation therapy machine in the 1980s called the Therac-25. It was designed to treat cancer patients with radiation therapy, but in use it caused several accidents that caused patients to receive massive overdoses of radiation, leading to serious injuries and death. An investigation found out that the device had a software bug that allowed the machine to deliver radiation doses much higher than intended. It turns out that the company had contracted out the software development to a third party company that had performed inadequate testing and verification of the software. When the company tested their own product, it also failed to uncover the software bug. Both companies failed to identify a critical flaw in the software with two different sets of verification and testing.
In the industry, the approach to solving the issue would likely involve analyzing the differences between the testing results obtained from the contracted company and their own testing. They would then address the differences one by one and test to see if the issue is resolved. If the problem persists, they may need to reconsider the materials used in the product. However, before any changes are made, the product must undergo verification testing again to ensure it meets the company's standards.