In this scenario the type of change control which should have occurred is the ECO (engineering change order). This is when you make changes to the project after it has completed the design controls and project processes. The managers should have held design review meetings after each design control phase. Within the design review meetings the group of engineers and leads should have submitted a design change request when they were reviewing the specifications of the Mylan EpiPen and EpiPen Jr. Design Review Meetings and Design Change Requests are within the monitoring and controlling phases of the project process. However, the modifications which result in a recall can put the project back into the planning phase. Since the DDP is a living document it must be updated to include the new changes.

I agree with bb254, that an Engineering Change Order may be necessary, especially since the design controls have been finished for this project. In that ECO, it would most likely call for a change for that defective part causing the device's failure to activate. Most likely there would be a change in the specification, since you're changing one input in order to affect the output. In this case, that changed part would be the input resulting in a more accurate output of the device's ability to function. It will be necessary to revisit the Planning Phase as this calls for a change in some aspect of the design because of the ECO. Primarily the Executing Phase of the Project process may be affected since Design Verification will need to be conducted once more in order to ensure that this part is not defective. Risk Management and the Monitoring & Control Process really looks manages this recall because the purpose is to either mitigate or eliminate this risk.

I agree with the previous two comments, things like that I didn't have any knowledge about until this course, it is very important in cases like this to understand which type of change must occur and how that will affect the entire project. As bb254 mentioned, going back to the planning phase will be a necessity and that will put everything else into change regarding the failed part of the device. It is necessary to know the consequences of a simple change in the DDP and how it will affect the entire device cycle.

Recalls are a very interesting topic, nice post. Recalls are done, not by the company that designs and develops the product, but by the manufacturer or distributor. When these parties find that the medical device violates an FDA law (e.g. efficacy or failure to perform what it was designed for) they initiate a recall. How did this device slip through the Monitoring and Control processes, rigorous Verification and Validation, and FDA inspection? This proves that the PM processes and Design Control though effective at ensuring quality products are not infallible. Then can they be improved to a point where recalls never happen? As the posts above have said, the recall identifies a change that needs to be made to the device, a ECO must be issued and the Planning process must be revisited. Then the company must ensure the FDA that the problem has been fixed and no more laws will be violated. This would require some very convincing Verification and Validation data. Once ensured the FDA will retract the recall.
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm

Based on the provided information, I agree with the assessments above, I believe that a change order would be needed and this change should be addressed with R&D and Quality. In addition, a risk assessment on the device should be conducted for different variable of risk to the patient. Since the change is on a finished product, there could be a potential recall on the product to effect the new changes.

I think depending on the severity of the reason for recall, a number of scenarios could occur. For a situation where the risk to the consumer is small to moderate, as is with this EpiPen recall, the previous responses are the way to go: pushing an ECO and following through on the process. However, is risk is high enough and/or if consumers make enough bad press, like with the Samsung Galaxy Note S7 hubbub, I imagine a simple ECO won't do. If this is the case, a company may end up redoing the entire project from the start since such glaring issues weren't avoided the first time around. Whether the company decides to keep the same product is ultimately up to them. Supposedly the Galaxy Note 7 is coming back under the same name, so at least Samsung feels like the name hasn't been completely ruined.

This is a very interesting post. I wonder that what might be the cause for the device failure. Because the device failure is after the market approval which means, initially there was no risk because of using this product. So it means that some change in the material of the device or something would have called this issue. On reading this post I remember a food product which got banned due to the trace of lead content elevation which would have led to severe health issues. So finally it was found that the source of water from which they were manufacturing turned to have higher lead levels which is the major reason for this issue. So this even created an awareness even the source of the element should be taken into consideration. So there may be any changes due to the source of the elements also.

As had been mentioned above, an engineering change order (ECO) will be required since the device design controls portion of the process has already been completed. Since the device now requires a recall, the design review process will likely need to be reopened in the monitoring and controlling phase, but it could go all the way back to the initiating phase. The failure of the device can have many causes, but most likely should have been caught during the verification and validation process.

I agree with most of the participants regarding product recall due to a device failure. Product recall is the worst thing that can happen to a medical device company. It can affect the business assets, the people involved and the end client. In this particular situation, change control procedures should have been followed by the company. It is required by ISO 13485 that the medical device company to have the change control procedure such as an Engineering Change Notice (ECN). It is used to make changes in the process after design control has been completed and almost ready for productions. After the 1st prototype lot, there should be a design review meeting to discuss any failures. Mylan should’ve had a meeting with the engineers and the design review team to review the manufacturing process and specification of EpiPen and EpiPen Jr. All in all, product recall can really put the project back to as early as planning and can really hurt the company financially.

At the point of an FDA recall, yes I agree that a change notice must be had to fix the issue as soon as possible to make the product acceptable and safe for public use. As it was already on the market, it is more likely that there was an issue with the manufactoring of the EpiPen since devices like these are often monitored and tested very carefully. So while yes the project manager should worry about fixing the product, I believe it is more important for the project manager should focus on getting ahead of the bad press and focus on public relations. They should be working with the person speaking for the company to assure them and the public that the issue is being dealt with with the full attention that it deserves. Since the company would be under heavy scrutiny, it is in the best interest to turn into the skid and try to make a positive out of the situation to have the product come back better and safer or at the very least, keeping up their reputation for an opportunity to do better next time.

I concur with the class mats, things like that I didn't have any information about until this course, it is vital in cases like this to comprehend which sort of progress must happen and how that will influence the whole venture. As betty specified, backpedaling to the arranging stage will be a need and that will put everything else into change with respect to the flopped some portion of the gadget. It is important to know the outcomes of a straightforward change in the DDP and how it will influence the whole gadget cycle.