Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify, document, review, verify, validate, and approve design changes before they are implemented. Device changes are not random. They are controlled in such a way that it create a history of the evolution of the design, which can be useful for failure investigation and for facilitating the design of future similar products. Mention some examples of device changes that must be controlled.
I believe all changes must be controlled. Whether its a change in some type of documentation or a change in a design input leading to a change in the design of the device. In order to keep an accurate record for future reference, everything from minor to major changes should be monitored.
Document control is very essential in device changes. It helps maintain a quality system or a device. An example of controlled device change is device specification which will be be usually updated with the arrival of better specification with introduction of latest tech in field. And the design control documents ensure that the systems and controls used in the finished devices meet the required specifications. They shed light on desired outcomes, clarify methods, and maintain consistent results. When utilised properly, document controls help reduce the likelihood of defects and minimise field problems.
in research and production having document control is very essential. For example, if new people were added to the team and wanted to learn more about the project and its progress, they would be able to look back and see the design history of the product and have a better understanding. Also when a product is monitored by the FDA any deviation to the design must be documented or else the company will receive a fine.
The change control process should identify everything that the change would impact and create an action plan for how to address the results of the changes. An example of an inadequately planned change is, at my company the flipping of temporary documents to permanent processing procedures caused a discrepancy in some samples made so the samples were no longer conforming to our procedures. These samples were made on the temporary documents. This was failed to be properly addressed in the change control and a planned deviation and so it resulted in an non conformance.
An example of a simpler change control I have been part of is updates to work instructions and processing forms as a result of updates to a routine validation done twice a year.
I agree with many of you regarding the importance of design control for the benefit of the not only the patient, but also the company developing the device. Documentation regarding changed in design, implementation of the device, and even new verification and validation procedures is extremely important for maintaining a meticulous DHF of the device and can be used in the case something goes wrong. Proper documentation will allow for easier verification and troubleshooting in the case that the device fails in any case.
After a device has been released it may experience common failures that lead to a recall. When a recall is issued, the manufacturer typically investigates the failure and develops a recall remediation. This may be a software update, a component replacement, or even a component repair. In any case, this remediation is an update to the original design of the device, which requires a controlled device change.
Like others have stated, it is imperative to track all changes that have been made to a product. At bare minimum, it provides a history of everything that was altered with a product and can be referenced back too if necessary. This may be due to some issue that arises with the product, or to just simply check if some design change or factor was attempted. More than this, professor had mentioned how companies sometimes refer to old documents. Old DHS documents could be such documents that are referred to. With a controlled history of all changes made, these documents can save a lot of time, effort, and money when it comes to creating new products that are like old ones.
Although I do not have much experience from industry, talking about keeping track of design changes and having a record of what has been changed makes me think of my capstone project. My team kept very detailed records of what was changed and when, and it helped on numerous occasions when we had to refer to these changes. This is on a much smaller scale than what companies must do, but even on a smaller scale, keeping track of all changes has proven to be beneficial.
When it comes to device modifications, document control is crucial. It aids in the maintenance of a high-quality system or equipment. Device specifications, for example, are a regulated device modification that is generally updated with the arrival of improved specifications and the introduction of new technology in the industry. The design control papers also guarantee that the systems and controls utilized in the completed devices fulfill the specified requirements. They explain procedures, keep findings consistent, and throw light on intended goals. Document controls, when used correctly, may help decrease the possibility of errors and field issues.
Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify, document, review, verify, validate, and approve design changes before they are implemented. Device changes are not random. They are controlled in such a way that it create a history of the evolution of the design, which can be useful for failure investigation and for facilitating the design of future similar products. Mention some examples of device changes that must be controlled.
Some device changes that must be controlled are recalls, errors in paperwork(any changes made). This is important because tracking all changes whether good or bad will help keep order. Staying on top of what is being controlled will benefit you in the end. This covers your track with errors because if everything is constantly being checked it lowers your risk.
The one thing about Quality is paper trail. Documents with a more detailed description on how the design was made, under what circumstances the products are made and all the international regulatory documentation, like design history file. A detailed description on work environment, cleanliness and hygiene and to show that products shall be identified throughout the realization process, and procedures must safeguard that returned products are separated from conforming products.
Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify, document, review, verify, validate, and approve design changes before they are implemented. Device changes are not random. They are controlled in such a way that it create a history of the evolution of the design, which can be useful for failure investigation and for facilitating the design of future similar products. Mention some examples of device changes that must be controlled.
As someone whose background comes from Mechanical Engineering, I agree that this is good practice not just for designing a medical device, but any device for that matter. For instance, a lot of times things do not work out as planned as the rough idea. Part of engineering is to encounter these issues and remedy them so they will not happen again. For instance, say the geometry in your device is causing unwanted stresses in a given area, thus leading to faster degradation of the product, it would be good practice to note that down. This way when the next line of products come in next year, you are ready.
Working in the industry, for now, a year, I have seen the importance of keeping good documentation of everything that happens especially when a product goes through an evolutionary change or in my case a process is improved. For this specific process that was being improved, it was a change in the file directory and the way the machine was making its respective output files. To do this the system had to be overhauled and extensive testing was done to make sure that the proper files were made at the end of the workflow. But to do this, every test after it was figured out was documented and recorded in the logbook which had a history of all the runs conducted on the machines. We eventually started a series of testing and validation using IOQ, OQ, and PQ methodology to eventually implement the new workflow. It had to be rigorously tested for any bugs and if the method tampered with other workflows. In doing so, a controlled Test document was released to be used in guidance for the scientist to use during the testing phase. When doing the testing, I noticed that the language of the document was written in plain English to help with transparency and was also equally detailed to make sure that the scientist knew what he or she was doing and for reproducibility purposes.
All device changes, no matter how minor or major, should be documented and controlled. If you were to do device modifications or improvements, it is a good way to keep track of design changes that did not work. Furthermore, a minor device change could a have a major impact on the device performance. If something were to go wrong with the device or if it was not able to perform as expected, it is important to have a complete and comprehensive history of all design changes in order to narrow down the cause of the issue.
