For my company, to initiate a design change request, the CAD model and drawings must be updated with any changes that are being proposed. It is then reviewed and hopefully approved. If approved, our PM team creates a change request document that will list all the changes done and all product SKUs that will be affected by this change, they will also communicate these changes to the vendor. This document will be submitted to our Engineering Change Control & NPI team, for them to put into our product database. Once they process it and it’s our product database, the redesign change is complete.

Typically within the medical device company I work in, design changes are generally driven through an engineering change request. These ECRs generally have five phases where phase one is when the overall scope of the change in encompassed with the proposal as well. The submitter of the change drives the ECR and drafts the first phase and is considered the project manager of the change. Then the following phase, the PM pulls together a broader team to understand the impact from a regulatory, manufacturing, R&D, supplier and other facets of the design perspective. If there are any impacts to any of these groups, they will define deliverables that need to be completed prior to the release of the design change. Generally there are lots of approvals and discussions that go into phase 2 prior to presenting the change to the engineering design board but all facets of the medical device can be covered through this. The third phase is where the design change is presented to a board of experts which of whom will accept or deny the request. If approved, the redlines within a drawing where most designs are shown are then able to updated here in a pre-released state. All deliverables stated in phase four will also be collected here. Phase 5 is where everything is reviewed by ECR head and approved for closure. At this point the ECR is considered closed and the design change has been approved for release.

In my company I support contract manufacturing. So while we also have very similar processes to those mentioned above for internal design changes, I will go into the process when we have a design change at a contract manufacturer. Generally a change can be initiated internally or from the contract manufacturer (CM). When the CM initiates a change they send us a change notification as stipulated in our quality agreeement. That change is then evaluated internally to determine if design is impacted. It is also evaluated just like an internal change to determine impacts to regulatory, process, marketing, etc. If it is a design change we would work with the CM to develop a verification/validaton protocol, they would build samples and testing would be done either within my company or at the CM depending on where the capabilities lie. If everything passes we would update our specifications then send a copy of that spec to the CM and they would update theirs. In addition to gaining any regulatory approvals (world wide), we have to get lot break information from them to close out our change order and release the new revision. Our receiving inspection would be trained to start inspecting the new design.

At Prosidyan, the engineers redline the latest version of a document online using track changes. Before redlining, the engineer will create a DCO(document change order) with new revision and why changes are being made.The document record must be attached to a change notice document type in order to be considered as design change request. The change notice is sent to document control which approves or disproves of the changes. Once document control approves of the changes then a head from each department is obligated to sign off on the new changes. The documents is then trained for whichever department it is required for and then the document is released to be used.

At my company, the engineers also must redline the change they are making to the document. This is done online using microsoft’s track change. The newly edited document is than printed as a hard copy. If the newly edited document is checked as PMA, it is sent to someone from the headquarters of the company to approve. After it is approved, a pink sheet is attached to the old document as well as the new redlined document and sent to each department. The head of each department must sign it if he or she approves.

At Getinge, the engineers redline the latest version of the document depending on what changes need to be incorporated which can be given by various inputs of managers, personnel etc. From there, the engineer creates a change notice which contains the necessary approvers, attachments, and documents affected. The approvers attached to the change notice are those that need to approve of the change since it is within their scope. The change notice is submitted on PTC Windchill which goes to Document Services. Doc Services reviews the CN to check for any errors regarding the CN itself, attachments, approvers, documents, etc. The CN then gets routed to the approvers to approve. Any concerns that come up, the creator of the CN would have to pullback the CN address the changes and reroute. If not, the CN goes into a final review then the changes are implemented. Finally, all those who have to that document in their curriculum are trained to the new revision of the document.

For my company, we manufacture SSD for different industrial sectors as a solution. Based on customer application, it could be a hardware or a firmware modification. if it required hardware, we change the initial design, CAD schematics for PCB, connector, Pin configuration if it different from write protect to standard secure erase, flash and, microcontrollers. However, if it is a Firmware modification to meet customer requirements. a revised FM had to assign a special number. the will prepare testing and verification of changes and submitted for approval to PM. Once it is approved SOP and BOM list will be updated with the new information. Also, PM will create a PCN includes all the changes and all the products will get affected by the change.

In my company, the first step in performing a change is to submit a change request via our Windchill software. This request goes to the change administrator who either approves or reworks the change request. Once approved, a request goes out to all the managers of each department asking them to assign a person from their department to join the team performing the change. The type of change determines which departments need to be involved. The team who is selected then works together to fill out a Change Control Form (CCF) which is then presented to a Change Control Board (CCB). the CCB determines whether to approve the Change Request or rework it. Once it is a approved, a Change Notice is initiated, and an Implementation Plan (IP) is put together detailing all tasks required to be completed in order for the change to be finalized and signed off on. Once all tasks in the IP are complete, the change administrator audits the completed CCF and if everything looks good the change is finalized. The Windchill software automates the workflow of this entire process, which seems like it may might make things more efficient. However, i have found our change control process to be very burdensome.

I agree. From what I have seen in the medical industry, when a design change is necessary the steps taken depends on the stage of the project. Currently, I am working on a project that hasn't completed it's clinical trials yet, meaning it completed the regulatory submission necessary to launch to product. A change in the design was necessary during the verification stage of the project. A written justification for the change was required for the Summative reliability studies, which will be a part of the regulatory submissions for the FDA, Health Canada, and CE-mark approvals. When there is a design change for products that are already launched into the market, we have to complete an engineering change request (ECR) and an engineering change order (ECO). Since we are the legal manufacturer, the request is written and completed from the R&D/Software team while the ECO is written and completed from the Operations team as well as any suppliers that are involved in this change. Documentation, such as the project quality plan (PQP) or risk management reports, is then updated to accommodate this change.

The project manager, system analyst and the device designer all should review each proposed designs and change according to what action is needed.

The following topics should also be considered:

Design change and its cost effects.

Timeline affected due to changes.

Functional and structural change necessity.

According to aforementioned point the design change request should be considered.

One of the changes that occurs in my company is the managing of the bill of materials (BoM). Whenever a general change control is carried out, it must include a justification as to why the change is being implemented as well as the consent from all participating members via a signed approval. An example of a change control that recently occurred in my company was adding a 2.5 liter light-proof bag to a BoM designated for the manufacturing of a cell-based infusion product. The justification for initiating this change followed the discovery that cell media was photo-sensitive and would degrade in quality when exposed to light for prolonged periods, thereby compromising the quality of every affected lot. Once the change request was put into place, it required the approval of the on-site supply chain manager, the PM, all manufacturing managers, and secondary participants at the most convenient change control meeting.

Ideally, a project should contain as few changes as possible with any required changes occurring as early as possible. Since a BoM is directly related to the manufacturing process, it should be properly managed so that it sees as few revisions as possible. An online search of BoM management provides a list of guidelines to ensure that this stage of the design process runs as smoothly as possible (1). One guideline involves automating a BoM by applying a quality management software to generate and keep track of the list of supplies/materials that make up a BoM, thereby minimizing human error. Another tip is to monitor contracts with vendors to ensure that all agreements do not expire halfway through a phase, unless a supplier is performing unsatisfactory. What other proactive steps can a PM take to reduce the number revisions in a BoM? Will a change in the BoM result in the change of any other documents, perhaps the standard operating procedures (SoPs)? How is a change control board selected being that it should involve input from every department?

References
(1) Industry Star Solution website

In the company that I work in, engineers would open up something called a Change Order (CO) within a project to allow space to create changes to what ever documents need to be changed. The person would then redline the most recent revision of the document within Microsoft Word using Track Changes. Like mentioned in Dr. Simon's lecture, once the document is finished, a "Mark Up" version of the document is uploaded along with the "finished" document with all the changes. Once these are uploaded, functional groups such as quality, R&D, etc. are assigned to read over and approve the document depending on if they are impacted or are a functional group of interest. Approvals are collected in the change system (equivalent of signing the document) by each of the functional groups. Once the document has gotten all of its neccesary approvals, the document is approved, the revision number incremented and the document becomes the official current version.

This process can be very short or extremely long depending on what change is being done. If it is just a clerical change, it may be done in a week or even less. If it is something bigger such as updates to design control and the like, several weeks may be needed. It's often a balancing act between the PM and functional groups needed to approve in reviewing the document properly and sticking to timelines.

A change request at Lockheed Martin works in a very similar manner. First the person submitting the change request must log it on a special program and that program. That program will ask him a series of questions about the change like why is it being made and how important it is and if it's a flaw or an enhancement. Then that program provides the person with a change request number. The person filing the the request must send out an email to the appropriate team members that he wants to review the request and must provide that number. The appropriate people must then go onto the same program, provide the change request number and view the change. If they approve they check a box in the program. This opens up permission to the filer of the request to make that change. This is all documented on that program just in case there's any mistakes they can go back to the date of the change and see what happened.

Design change request is a formal proposal for an alteration to some product or system. In project management, a change request often arises when the client wants an addition or alteration to the agreed upon deliverables for a project. The change request form is the primary tool used for requesting, approving, and documenting changes to the project and is an important piece of the change management process.