Verification means to check if the inputs and outputs are equal to each other and to verify each output with a verification protocol. To an extent, it is a rigid rule that Verification takes place during the execution phase of the project. The reason is that it would become costly if verification occurred at other processes because design control processes have definite and discrete phases that are established by the “Review Meetings” at the end of each phase. So once the DID and DSD in the planning and initiating phases are set and approved in the review meetings, the executing phases start. Otherwise, if a partially made DSD is reviewed, and verification starts in parallel, there will be a lot of time wasting occurring in having multiple review meetings. Thus, it is important to establish and finalize the DID and DSD in the planning stage first and then move onto the execution phase, so a bigger picture of what is wrong with the entire project can be seen better. For instance, like in last week’s simulation, a certain verification protocol did not meet the design specification document (DSD) requirements. So, the first way to remedy this problem is to change the verification protocol. Then, if the verification protocol still does not meet the requirements, the team may have to change the DSD at last resort. This way the company is not losing so much money.
However, this does not mean that project management processes have to happen in a rigid manner. A project can have multiple parts to it that are in different phases. For instance, one part of the project is developing labels for a hydrophobic solution and the other part is designing the hydrophobic solution. The company can have the planning and executing phases occur at the same time. The label project can be in the planning stage, while the hydrophobic solution aspect of the project can be in the execution phase. Who knows, Murphy’s law can cause trouble with the hydrophobic solution that the company has to re-evaluate the planning stage for the solution.
Thus, for design control phases, it is better to have a rigid rule that verification takes place during the execution phase. For the PM process, the phases can overlap.

Verification tasks can be designed during the Planning process of project management. For example, if the project will need clinical trials for design verification then anticipating and formulating them in the Planning process would ease the remainder of the development processes. Also, Verification can be done after Design Input of the Planning process; we can evaluate and verify that all the requirements for the design have been met. In fact, waiting to this during the Validation/Executing process would be both costly in time and money because, if a requirement is missed, a change in the design must be made and we would have to return to Planning and start at its very beginning again. Performing Verification after Design Input would also ferret out any suspicious and incompatible requirements. In the Initiating process Verification can be used to compare the design proposal to similar existing designs and their analyze success. Essentially, Verification used before the Executing process is for establishing a well-founded design. During the Executing process, Verification is more active because tests are performed and analyzed assessing whether or not the device was rightly designed. For this reason, Verification is often thought to be alongside the Executing process of project management. Verification after the Executing process can be used for quality assurance purposes. For example, assessing whether the design packaged right (Closing process) or any extraneous difficulties such as, does the device need to be sterilized or must special disposal procedures be done (Monitoring and Controlling process)? Therefore, Verification is very flexible and can (should) flow into every Process.

References:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm#_Toc382720784

The Execution Phase of any project plan is to make sure all the activities of the project that were planned are carried out in an effective and efficient way.The verification test designed for the execution phase depends heavily on the plans developed in the Planning Phase. Though the rule of following the verification design protocol in the execution phase only is rigid but there is already enough work to do in the Execution Phase of the project, so flowing it in other processes requires ways to be reinvented to deal with other challenges such as risk, change in requests, training and resource issues. Thus, it becomes impractical and undesirable to flow it in the other processes when the project manager has to support and monitor the execution of other important project plans such as the Communications Plan, the Risk Plan and Procurement Plan.

I think Verification can occur anytime during a project. I do not have any industry experience but theoretically speaking Verification can occur at any point. It can also occur during the research phase where making a change in your project is a lot easier versus the execution phase where it would require a lot more changes in your timeline and paperwork. So to sum it all, it is not a rigid rule it can occur into other processes. And the advantage of this is, that one can use this verification process according to their project. Not every project is the same and not every project requires the same set of procedures.

Just to add to everyone else, verification is not always as described theoretically. From speaking with individuals working in the field, every company has a different set of rules or loops to full-fill certain GMP or GCP.

Shachi, you bring up a good point. However, though it may delay other processes it is essential to, at the very least, carry on project development with verification in mind. Even though the official verification step comes later during the execution phase, unofficial verification tests should be carried out i order to ensure the appropriate desired result of the product or its components. At the cost of time, this will avoid failure down the line and may begin the preparation of full verification later on in the development process.

In my opinion, I believe verification can occur at any phase during a project. It all depends on the kind of project and especially in medical devices, verification is a must step after each operation during manufacturing. Verification can also occur after the project manager creates the Bill of Materials (BOM) and checks to make sure all the parts/ assembly parts have been ordered to manufacture the device. All in all, it is not a rigid rule and verification can occur at any time during the project. It can be in the beginning after planning or in the end, right before shipping the device to the customer.

Yeah, Even I am also in the view that verification can takes place at any time in a project. It's not that verification takes place only during the execution phase. Even after the project completion it is very important to look up the verification since there may be any problem in the product. Even the change in any small outcome of the project may lead to the total change in the product benefits. Verification in in the execution phase alone is not a wise decision. For every manufacturer the product package also plays a role. So I say that the verification can takes place at any time.

Verification is about building something correctly. Verification process determines if the product is correctly built or not as described in procedure manuals and if all quality assurance and quality control activities are being performed as they are supposed to be. Verification process checks that the product is being developed with all specifications appropriately while meeting all documented specifications or not. It is an objective process where product specifications and all quality requirements are documented well enough so that they could be measured and analyzed. It is about evaluating the process and product in development. It is performed to build a product in the right way. Document reviews and inspection are examples of the verification process activities. I think verification can be done in any phase of the project even though it is usually done in execution phase. Verification in every phase will assist if any change is required or not in any phase. So any major changes can be prevented and it will also save the resources and cost of the project.

While project processes and design controls are not directly related, it is pretty standard that verification will be achieved through the executing phase of the large-scale project. Since verification will certainly be done through a series of testing protocols, it is conceivable that the writing of the protocols could be done in the planning phase. Laying out how the design inputs and outputs can be compared definitely takes careful planning to achieve success in this step. Verification itself can even be considered an entire project itself and will be one of the most extensive parts of the design control process.

It is a common theme that different phases of product development can flow into one another. This is the same case with design verification. However,due to the nature of design verification being to check that inputs=outputs, this does not mean that verification tests can just be done for no reason excessively prematurely. It is necessary to ensure that the specific area of of development is completed to a point where the verification test can be performed and no further changes will take place after a successful pass. In cases where one part of the design is held up and another is fully completed, in order to minimize delay, there could be cause to perform early verification tests.

Design verification means confirming by objective evidence (i.e. testing) that the design outputs meet design inputs. Design Verification is one of the most important activities in the development phase of a medical device. It is a rigid rule as there are predecessor and successor activities that happen prior and after design verification. For example, in order for design verification to occur the design needs to be finalized (“freeze”) and equipment in place to manufacture it. Only then the medical device can be manufactured and tested. Design Validation ensures the design meets user needs and intended use. Just as Design Verification it is a critical activity and can only happen after the design has passed design verification. There is a process to the design controls that works to minimize design flaws which ultimately benefits the end user and the company.

The diagram explaining the relationship between PM processes and design controls (from the Initiating and Planning lecture) indicates that design controls can easily exist in more than one PM process. Design input, output, and planning for example, are shown to come into effect at the end of project initiation and remain active until the beginning of the execution phase. Likewise, design verification and validation is initiated during the execution phase and concludes in the closing phase, which makes sense in terms of being able to make changes to the inputs if the outputs from the execution phase do not match. For example, if an implantable device does not display any immediate adverse effects, it may pass onto the closing phase followed by market where any long-term toxic effects will become more apparent and therefore must be validated. This ability for design controls to flow into multiple PM processes can therefore allow faulty devices to be revised in a way that minimizes risk, such as by applying new labels, changing vendors, changing packaging standards, etc.

Although most projects are designed to allow revisions in the face of unexpected/untimely events, it is usually very costly, inefficient, and ideally avoided. Is there a PM process that prepares corrective action protocols in case any project deviations arise. Are there any design controls present during this phase that can facilitate the revision process? What if verification was only limited to the execution phase, how might that impact a project for a Class I device compared to a Class III?

Verification is a process which checks that a device or a product satisfies all the regulations or specification requirements i.e. if the input matches the expected output. As agreed by most above verification can take place at different stages of the project cycle. Verification may mostly be carried out mostly in the planning phase, development phase and the execution phase. As the project cycle goes on the verification in phase is looked upon. In the planning phase focus is on creating verification tests. Based on verification tests detailed task lists are created. Here most of the verification process is carried out. In case of medical devices verification has to be carried out starting from the planning phase to the execution and manufacturing phase to check if the requirements have been met.

Verification is a process to check if the input is equal to the output and every input has to have an output.
Verification phase has to be in the execution phase since by that time most of the basics are covered such as the DID and DSD and any change will have to be approved unless it changes the overall purpose of the device we are manufacturing. There is no rigid rule that it should be done in the execution phase itself but since most things are sorted out in the execution phase, and before going to the next stage we need to verify that whatever work has been done is correct as per our requirement verification is done.