Quality control department develop and maintained a system of quality assurance management and covers the development of documentation and techniques that ensures the satisfactory quality of product. It develop and maintained a system of quality assurance management that covers development of documentation and methods which leads to satisfactory quality of product. Quality department in any organization make ensures that organization, product, services are consistent with quality. Quality is not the responsibility of any individual or people of the quality control department. Quality department can be improved when people from all the departments or levels are loyal towards the organization and make process and better outcomes in every way. All the members should understand the customer needs and try to resolve ways to meet their needs. Leadership qualities among the members of organization should be improved. All the system which are related to quality should be maintained and managed properly. There should be good relationship between organization and supplier. There should be continuous improvement and decision based on analysis should be effective.
According to me in the case of quality assuarance there are 3 main components: 1) Focus on quality: Mans FDA not only looks at design and production of devices but also beyond the baseline by looking for the critical quality practices having more outcomes. The practices for FDA involves altering deign as per the need of customers and increasing the speed of detecting errors. Most important is FDA practices library that helps manufacturers to improve quality and design. 2) Enhance Data Transparency: FDA had wide range of quality data including information from recall, inverse reports and adverse events. The data is proposed by many strategies that supports data quality. 3) Stakeholder Engagement: FDA works with stakeholders as well as Medical Device Consortium for device compliance and quality. And it moves further the meeting goes on with stakeholders for the case of quality.
An idea to improve quality control is having a better communication environment with the group because if there is misinterpretation they will run into situation that can affect the company. People should be able to communicate their thoughts with each other because it will help them be on top their work and improve their work. Another idea would be training because there is always room for improvement, the people hired might have a lot of experience but even experience people can make a mistake, they need to refresh their mind. Organization is another important factor to improve quality control because there is a lot of documentation that they need to make, read, update, etc. which could be a problem if it is not organize. Someone might need to look into a product test document to ensure the product is working properly, the product cannot be release before being tested because it can harm people.
As people have stated before, I think a good way of improving QC/QA is to have better communication among different departments. I think in most cases, the quality department only reviews the product at the very end, right before a potential release. This can sometimes run into problems because if issues are found, then the product might have to be terminated and manufacturing would have to start from the beginning. I think there should be "quality checkpoints" where the QA does a quality check at different stages in the development of that product before doing a final check. This way, manufacturing will be able to fix problems along the way, rather than all the way at the end. Also, if mistakes are found, there should be training sessions that allow everyone involved to be aware of these potential errors.
Quality control is responsible for checking products for defects and quality. The processes of measuring, cross-checking, and comparing can get repetitive and small details might slip through the cracks. Its important for the quality control personnel to rotate and take enough breaks so that they are vigilant and fresh on the job. Too many times products that are not in spec get past quality control and there are hefty monetary losses because of that. A product that has a defect could be bought in large quantities if the defect gets passed First Article Inspection. Therefore it is important to make sure that the quality employees are able to perform their job at peak performance.
Agreed, a smooth coordination among the parties involved in the manufacture of a product will enhance product quality; but we may not forget that quality of a product is actually determined by the user. How a product does in sales matters; it reflects on the nature of the company; and above all, it impacts how the company is doing. In an earlier lecture, Prof. Simon was very insistent on the need to have a smooth communication with the customer on what they want; i.e., even before the manufacturing of a device is engaged. I believe that time dedicated to investigating with the customer when tightening the screws to obtain a high quality product will not be a waste of company time and money. This should be time well spent. We should not forget that the very life of the company depends on what the customer thinks of our product.
The traditional method that QA usually does is to develop tests after the requirements have been finalized. However this means that if any issues are found the requirements must be reviewed which can lead to significant changes especially if some requirements depend on each other. An improved method would be to develop test cases during the requirements phase. A collaborative environment would be created if the QA engineers are included in the process from the beginning of the project. This would make the process more dynamic by establishing clear communication earlier on in the project. Additionally, the engineers developing the product would be able to fix the issues at an earlier stage which can reduce the number of revisions. It is also important for the QA department to give a brief summary of common issues and how to prevent them. Ultimately, it should be understood that the QA department is not there to make everyone else's job harder.
Quality Control is the process through which department seeks to ensure that product quality is maintained or improved with either reduced errors. Improving Quality Control is essential for success at all levels. This is done by training personal, creating benchmarks for product quality and testing products, upgrade equipment where needed, create a response plan, track a mistakes.
I think the key to having exceptional and easy Quality Control is having a solid structure throughout the company. Keeping logs of what is going on in every department (R&D and manufacturing mostly) throughout everyday is important so that if something were to go wrong, a company can trace its steps back to the root cause of the problem. Also keeping up with standards and having documentation for every step of the fabrication of any medical device. Every part of the company should be informed of the goals and methods that the QA team use so that they can do their little part along the way of whatever their job is, this way when the QA team needs some sort of documentation from another part of the company, this is a five minute job to get it and not a full day or more of back and forth to find where something is.
We learned last week about the negative consequences that can face a company when they are forced to recall a product. Many times the blame is put on the FDA for allowing this product to reach commercial markets anyway with the possibility of failure or faulty operation. However, more times that not, a well operated quality control branch of product development can catch these errors and a solution can be found before the product reaches market.
When I think of a successful quality control branch I think of it being prioritized to a high degree. Many companies pay top dollar and spend all of their resources do develop new products, but don't do the same to ensure that these products are of the highest quality. This is a fatal mistake. Additionally, a successful quality control, much like any other branch, needs to have clear leadership and communication between the rest of the company.
Quality control, as a part of quality management should have better interactions with other departments. Quality check should be done at every level rather than at last. Quality control starts with process. Without good process, its impossible to achieve good quality control. It should ensure that every employees have no doubts in doing their job. The other one of improving quality control is to maintain a clean workspace and create a response plan.
One year ago, I was interning in the equipment department of a hospital as an engineer. Quality control is a part of my job. Although many companies have quality control services for hospitals, the hospital I interned still requires the engineers to do quality control for devices to minimize the risk. In this process, I learned a lot about quality control. I think there are three points that need to be paid attention to in order to improve QC department: First, to ensure the quality of testing equipment. In the quality control of medical devices, it is often necessary to input stable signals to simulate the use of devices by human body, so the performance of testing equipment must be efficient and stable. Secondly, engineers should be trained regularly in quality control. Not all engineers are familiar with the quality control process, so training engineers is also an important step. Thirdly, make plans for quality control of equipment and keep records. Quality control is not only one task, it should run through the whole life cycle of a device. Therefore, the quality control of equipment needs to make a long-term plan and record, so that hidden problems can be found as soon as possible.
First and foremost, the company should invest in properly training all quality control department members. They also need to be informed of what is expected of them by the quality assurance department and FDA. Effective and sufficient communication between the QC and QA department will also prevent grievances later on, especially since QA usually dictates the product's level of quality and durability in different settings, parameters like dimensions, material properties, and ensure compliance with FDA guidelines. QC is responsible for determining if the output matches (or is within range of) what is accepted by the QA and FDA. This would be an impossible task if all the requirements weren't expressed to QC. Defining better processes and emphasizing the importance of repeatability is also crucial. If the chosen method was fast and cheap, but difficult to replicate, QC will fail to maintain consistency when evaluating each product. This can lead to recalls in the future due to some faulty batches that weren't properly evaluated to meet FDA standard. Lastly, any obstacles or mistakes made along the way should be recorded for further improvement.
The Quality Control of an organization can be improved by making sure that there is a good communication within the the quality control department and between the quality control department and other departments. A good quality management system (QMS) is very important for the successful output from the department. Assigning a representative from a quality department to each of the departments within an organization would ensure smooth flow of the process. An equally important aspect for improving the QC department is by training the employees initially as well as later as new procedures or updates are made to any SOP's or standards or procedures. Having a good document control is very important for identification and traceability whenever needed. An effective preventive maintenance would take the department a long way.
In relation to medical devices, the role of the quality control department is significantly important as such devices can have a direct impact on a user’s health. Therefore, it is important that an effective quality management system be developed and implemented by medical device companies. As a result, it is a beneficial procedure for companies to continuously work to improve upon their quality control department. One manner in which quality control could be improved is by adopting automation to perform repetitive tasks that the quality control team was responsible for. For instance, automation could be used to measure the dimensions of a product that needs to be compared with a standard, desired value. The benefit provided if this task could be replaced by automation is that a greater number of parts could be measured and logged to provide instant statistical feedback. For instance, as measurements are made on parts, software could be used to continuously update statistical values on their dimensions such as average dimension, variance, etc. Also, as stated by others, this could be used to take measurements at a greater number of points throughout the manufacturing process rather than just at the end. The benefit of this is that it would better enable the quality control team to determine, which step of the manufacturing process is resulting in the creation of undesirable part dimensions.
