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Design Controls

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 AJY6
(@ajy6)
Posts: 82
Estimable Member
Topic starter
 

If you were making a product, how would you make sure the product is always high quality and fully functional? What are some ways you can minimize low-quality products? Also, when should design controls be implemented when creating a product?

This topic was modified 1 year ago by AJY6
 
Posted : 02/11/2022 1:31 pm
(@devdesai)
Posts: 79
Trusted Member
 

Design controls play an important role in ensuring that the product is high quality and fully functional. Having detailed inputs that take into account all aspects of the device and its function will make sure that the device is high quality. Doing proper and extensive verification and validation testing will make sure that the device is fully functional. Furthermore, all products have limitations which is why it is important to have a factor of safety and properly inform the customers on safety protocol and requirements. Low-quality products can be minimized by having a detailed quality control system. This will prevent inferior product from making it to market. Design controls should always be implemented when creating a product, especially a medical device. Design controls are crucial because they define a process that ensures that the intended uses, user needs, and specifications are met by the device. Not using design control system can lead to faulty or low quality devices and products being sold on the market. 

 
Posted : 06/11/2022 6:36 pm
(@jbdoddo1)
Posts: 39
Eminent Member
 

I agree with DevDesai, and would add that there are many different forms of design controls that are performed through the product's life cycle. Initial stages are dominated by the project proposal and design development plan, with reviews of the design development plan and design input document to ensure they remain within the scope of the project proposal. During the development and prototyping phase, the design input document and design specification document are checked for continuity. Finally, during production the design specification document is continuously verified through product QC / QA testing to ensure it meets the tolerances of the specification document. All of this needs to be thoroughly documented through a form of change management and documentation known as the design history file. Adherence to these controls best ensures that the customer is receiving a product that executes the manufacturer's original intention of the product.

 
Posted : 06/11/2022 7:08 pm
(@hmara)
Posts: 76
Trusted Member
 

In order to ensure a high quality product; all projects would need to be properly documented and researched. Standards should be followed in order to ensure ease of reading and ease in finding documentation later. Documentation should provide ample room for revisions and modifications. The project manager should ensure that standards are adhered to. To ensure that the product is high quality; the teams shall take input from all sectors of the company, document their work adequately, and go through extensive revision processes. Most of these issues are addressed in ISO 13485 and 21 CFR 820.30; following these regulatory commission's rules will ensure that a product is robust and well made.

 
Posted : 06/11/2022 11:07 pm
(@ag2265)
Posts: 70
Trusted Member
 

I agree with @DevDesai and how you need to have strong Design Controls as they help build and guide your project. I think that it is also crucial to ensure that the various steps you may have in your design control system that they are fully thought out and detailed so that the group that is conducting the process can seamlessly traverse the system and produce a quality product. From personal experience, I recall creating comparison matrices during my Capstone Project with my team to base decisions on materials chosen to designs implemented. We would compare and contrast materials based upon their overall scores from a set criteria that all the materials were judged upon. Additionally, certain criteria were more important than others, therefore a weighted scoring system was implemented as well. By conducting this process in our design input step, we were able to efficiently and effectively select the materials that we would be using for the design of the product. Furthermore, this method was used multiple times after when regarding various structural design decisions. Following the selections of how we were going to build our product, we also needed to make sure that a quality product was being built so we had made checkpoints for us throughout the process. If a checkpoint was not met then we would discuss what went wrong and revised the design so that all checkpoints were met. Design controls are extremely important in the design, development, and building phases of the product as these are the most flexible stages of a product life cycle. The moment that the product is put on market and considered defective, there is no going back and one is likely to lose most if not all their money.

 
Posted : 06/11/2022 11:55 pm
(@sandra-raju)
Posts: 38
Eminent Member
 

As mentioned in the earlier lectures by Dr. Simon, planning is a really important step in ensuring that the product being developed is comes out the best it can the first time around. If you do not think through all the different aspects of the product, how those aspects will be achieved, as well as the potential problems that could arise, then you'll likely have to do multitudes more work to fix what you've already started. A good foundation is key. An important part of this planning process as well as in the development stage, is Design Controls, as mentioned by @devdesai earlier in this thread. Design controls allow for a set of boundaries and rules that the product needs to pass before moving on to the next step. Being very detailed at this stage allows for thorough checks of the product during the development and testing stage. Extensive verification also goes a long way in ensuring that there aren't any flaws in the design of the product and that it is the best possible version it can be. 

 
Posted : 07/11/2022 12:07 am
 AJY6
(@ajy6)
Posts: 82
Estimable Member
Topic starter
 

To ensure a product is always high quality, one should make checkpoints between the manufacturing stages of the device to see if everything is up to standards. Some ways you can minimize low-quality products is to make sure all products are up to par while creating the device. For example, if one sees flaws like not straight edges or bad soldering work, one should take it off the line and try to fix it. However, if the device cannot be repaired, it should be placed for scraps. Design controls should be implemented into the product in the initial phases because design controls ensure all the products are of high quality and fully functional. If design controls are not implemented into the product it will lead to a low success rate because the product will not be checked and can cause severe injuries if it is a medical device. 

 

 
Posted : 09/11/2022 1:33 pm
(@knd26)
Posts: 78
Estimable Member
 

I agree with what was said, that proper documentation, and a good quality control department are keys to having high-quality products on the market. One of the most important aspects of having good products to me is to have good employees working, that care about their job and what they are doing. If diligent people are hired, they would be less inclined to take the easy way and let different shortcomings fall through the cracks. It would also be important to have all the right people in the company that know what they are looking for to screen the product; to have many different scientists, engineers, and employees check over the product at the right stage because everyone brings new expertise and perspective to the project. The more people you have looking at and using the project the more you can vet through before the product hits the market. This would be especially important early in the project to make fewer paperwork changes.

I would personally want many people to look at the product each time a major design is changed, to get different perspectives as to whether it was a good change or still needs work. Is this something that happens in industry, or does it just keep going through the channels of design control until someone sees a problem?

 
Posted : 11/11/2022 9:48 am
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