Validation is the process of surity that you have objective evidence that are needed by the user and the use of-course. Verification is typically making sure that you are having objective evidence that matches mentioned requirements are meet. This both are done by testing, inspecting and analysing as well. Companies want effective, relevant and well-documented things for V&V and should match medical regulations as well. V&V procedures are more standardized than the past.
My question is that : After all his development what are the risks and default in V&V process?
The verification and validation process can be very lengthy, especially because of all of the detail that is required. I wouldn't necessarily say that there are risks within the V&V process itself, but potentially because of the amount of time it takes. For example, if a test failed, or if the engineers cannot figure out how to perform the specific test, and validate that method of testing, it can add on additional months to the project timeline. Pushing back the project because of delays can ultimately be risky as the medical device industry is very competitive, and ideally the device will hit the market as fast as possible.
I would say that the risk of verification and validation is not completing it in the time constraint you had originally planned or not being able to complete it at all and having a project cancelled. They are both lengthy processes as you can see in the two flow charts. On the flow chart for verification you won't know if you need to go back to almost the beginning until the end of the chart. It might be necessary to go back and revise more than once. Delays may cause issues but verification and validation are needed to ensure that the design inputs equal the output and that the inputs satisfy the user needs and what the intended use is. You want to make sure that all your testing is thorough and that each input is met so hopefully you can move on to the next step as scheduled.
Verification and validation are one of a project’s largest costs. Rework is the only cost larger than verification and validation in a project. If it is not adequately planned, not only will the schedule have to be extended but the overall cost of doing validation and verification will increase.
A lot of this can be avoided by well thought out requirements taking into account factors such as if the requirement is verifiable, what constitutes as proof of it being verified, and the primary method used to verify that requirement. Moreover, who is verifying the requirements, who where and when system validation will be done and the interfaces involved must also be planned.
This well thought out planning is necessary to avoid the company losing time, and more importantly money. The below source goes more into detail on how to perfect the planning of the V&V process and how to prevent this from happening.
Source: Thinking Ahead to Verification and Validation by Louis S. Wheatcraft
The difference between verification and validation is well explained by considering the question that each is trying to answer. Verification answers the question, "Did we make the device right?" while validation answers the question, "Did we make the right device?" Both are very important in the process of device development. The challenges that can come during verification can include parts that are out of spec. When this happens, there is usually an investigation to try and figure out why the part was not made according to the way it was said it was supposed to be made, which will cause delays to the project. Validation can be more challenging because you need to prove that you made the right device. This is done by providing evidence that the device meets all of the market requirement specifications. The risk with this is that if you cannot provide justification for why your product works the way that it should, then you will have to return back to the early stages of development and reconsider the device.
I agree with @bnb6 that I wouldn't consider there to be risks with the V&V process itself, but rather the risks if there was a problem during the verification stage or even the verification was completed successfully that the device could be properly validated. For example maybe all the specs are correct and the design outputs are equal to the design inputs, but maybe during the pilot clinical trial to validate in the a surgical device isn't what's needed to fit the patient's need of that the devices needs to do. So then maybe some tweaks would need to made in order to account for this and this could as @cdj24 mentions, add delays and could extend the time/cost of your project.
I think that the process of V& V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, it is still in the best interest of the consumer (and companies) that it is followed. For instance, according to Bryan Larson, president of Toltec Ventures LLC:
"It is extremely important to consider VV early in the design stage when developing requirement specifications for the product. For example, adding test points on circuit boards, having accessible connectors, providing data storage/retrieval capabilities, and making products modular can enhance the ability to test a product, which saves time and money. VV costs can also be reduced if previously tested materials or coatings are used for the product. Clarity, conciseness, measurability, appropriate tolerances, accuracy, and testability can all impact the final design and overall manufacturability. These specifications also provide the acceptance criteria for later V&V activities."
Therefore, if proper procedure is followed, the issue with timing should not become on that is too drastic.
I think that the process of V&V, with the many years of re-evaluating, has become a lot more streamlined than it was previously. Although it can be cumbersome and add on time if issues come up, it is still in the best interest of the consumer (and companies) that it is followed. For instance, according to Bryan Larson, president of Toltec Ventures LLC:
"It is extremely important to consider VV early in the design stage when developing requirement specifications for the product. For example, adding test points on circuit boards, having accessible connectors, providing data storage/retrieval capabilities, and making products modular can enhance the ability to test a product, which saves time and money. V&V costs can also be reduced if previously tested materials or coatings are used for the product. Clarity, conciseness, measurability, appropriate tolerances, accuracy, and testability can all impact the final design and overall manufacturability. These specifications also provide the acceptance criteria for later V&V activities."
Therefore, if proper procedure is followed, the issue with timing should not become on that is too drastic.
I don't think there are any risks involved in performing validation and verification, rather performing validation and verification reduces the overall risk of the project by ensuring quality and that the product meets all requirements and specification and fulfills its intended uses. Verification and validation are both very critical aspects of the quality side of the project and the only risks associated with verification and validation that I can think of are ensuring that the proper amount of verification and validation is performed and that there is enough time built into the schedule to perform all the necessary validation and verification needed to ensure quality of the product.
I agree with puneet as that there aren't many risks involved in performing v&v testing. The risks come into play if the requirements/specifications cannot be verified or need to be changed. If so, a design change review meeting may need to be held to assess the risk. I currently conduct validation work for a few of our products and I do not run into either process or design risk. Once again, the risk comes into play when the design or process of a product cannot be validated and would then have to be changed. The change(s) imposed will then have to be checked against hazard analysis or some FMEA to determine any effects.
As the majority stated above, I do not think there are a lot of risk and default in the Validation & Verification procedures. The V&V procedures are “...driven by the regulatory environment and international standards.” As long as the procedures are done properly, I do not see any major issues. I agree with hc255, where an issue can be that the product design does not get validated and the plan has to be changed. This would be very time consuming and costly.
You can read more information on the V&V procedures on the asme website under Validation & Verification
The risks in a failure during the verification and validation is missing details that will later become a large issue for the engineer or other department that is running the project. Also, not thinking to test an aspect of the product during the V&V can lead to failures in the distribution part of the product life cycle. Failures after distribution can lead to recall which can lead to being under the microscope from the FDA. The time it takes to add a test, while a nuisance, is significantly faster than handling the project later into the products life cycle. I think the risk in the V&V is failing to notice and prepare for a future risk.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications. Validation : The assurance that a product service, or system meets the needs of the customer and other identified stakeholders.
Verification: The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification , or imposed condition.
Validation is the process of surity that you have objective evidence that are needed by the user and the use of-course. Verification is typically making sure that you are having objective evidence that matches mentioned requirements are meet. This both are done by testing, inspecting and analysing as well. Companies want effective, relevant and well-documented things for V&V and should match medical regulations as well. V&V procedures are more standardized than the past.
My question is that : After all his development what are the risks and default in V&V process?
I think one of the risks is making the threshold too expensive for a small company to carry out.
These activities can require separate groups, design history files systems, and special change request tracking procedures that may make the monetary cost above that of a small company with a good idea.
Actually causing the to give up pursuing the implementation of a good idea
There is nothing guaranteed when it comes to design verification and validations, and especially when it comes to new product development. For sustaining projects, usually design verification should be very straight forward; since the product is already an existing product adopting the same exact specifications might be applicable without the need to come up with new specifications/acceptance criteria. Most of the times, design validation won't be needed for sustaining project depending on the changes that are happening to the product. If the changes really affect the user interface with the product and impacts the intended use then most likely design validation would be needed to validate those design changes against market requirements and to ensure that the product is safe and effective for the patients. For new project development, it is more difficult. It is hard to come up with new specifications for the product and test against them, because sometimes those specifications cannot be met after the completion of testing, that's why as mentioned in the lecture the specifications are usually not tight for new products to ensure the passing of the tests. Design Validation is now required and the team cannot really control what the results would be since it is often subjective. In both cases, the risks come from failures and justifications. The team has to be really certain before starting V&V activities in order to avoid failures. Another problem is the consistency between different documents since DV protocol, plan and reports have to be all aligned it is hard to keep track of everything and often times you tend to find mistakes. Finally, your product can be perfect and you perform a human factors study or clinical study and the feedback wouldn't be as expected since it is subjective, so the team has to always be proactive and think about answers to everything to be able to justify not perfect feedback.
