I believe the quality control should work in coordination with all the other departments and the work must be assigned and it should be made sure that everyone works efficiently at personal level which is very vital. Quality check is usually done before it is send for FDA approval and if it does not matches the requirements it can be recalled and due to this lot of time and money is wasted hence the quality control group must meet with all departments regularly and ensure the rules are followed so as to their are more chances of the product being approved and hence this ensures the success of the product as quality department play a vital role in getting the product approved
I believe the improvements to the quality control department can mainly come from how accurate and precise the measurement devices are in the labs and also the QC employees themselves. I have been in a QC lab where the mechanical testing machines, which gather data from the medical device, are severely outdated and have malfunctioned numerous times all because the company is not willing to put down anymore money. This problem has led to ambiguous and misleading data which can consequently lead to device recalls based off of false assumptions that the medical device is functioning properly. Another main problem is that most employees in the QC department of large medical device companies are contractors which means they only work for 1 year (1.5 years max) for the company. This is a problem because it takes about 6 months for the employee to fully learn everything about his/her role in the QC lab and to fully understand the goals of working with each project, which leaves a solid 6 months to actually be a fully equipped 'employee' of the company. I believe this is a waste of time and resources, especially if the QC department needs to be consistent with their work and communication.
I think one of the best way to improve quality control department is through taking feedbacks form the customers which will provide the best way where the product is going wrong and where it could go better. There also needs to be a proper documentation of every process and specific guidelines which must be updated as per the situation.
Improving QC requires knowing what is wrong with QC now or how QC can be improved to achieve next level quality system. Best thing to improve QC would be to research leaders or closely related company's QC team and figure out what can you learn from them. Then have a leader in the department who knows more than anyone in the company and allow people to ask him if they have question so they avoid making mistake. keep your QC department up to date with new technologies that will improve efficiency, accuracy, and pace of work and train QA and QC department on how to use those technologies.
There are steps to follow.
1) Building an effective process. The quality control process must start by creating a checklist that covers everything. This checklist must be made by a seasoned employee rather than a new employee. Also, it should be developed together as a department meeting, so new employees also have a chance to have an impact on the checklist.
2) Keeping an organized, functional, and clean workspace. To be able to do effective quality control, everything in the environment that quality control processes will take place must be controlled. All equipment must be functional, and it must be clean enough so everyone can work.
3)Keeping the office updated and work-ready. Policies and the checklist must be kept up to date to the current techniques and methods also, and the devices must be maintenance or quality checked themselves.
4)The department head must make sure to keep the department employees are up to the task by doing weekly or monthly training exercises.
5) Lastly, everything must be documented within the department. Employee files, quality checked items, labels, maintenance, cleaning log, etc.
Improving the quality is to makes the overall idea making the process smooth and effective. There is no one reason or answer to improve quality, it is the overall process and system. The first step is to define standards ,Proper Training of employee ,Let technology help the process, Upgrading equipment and Creating a response plan.
I agree with the concept that quality control is not solely a final product testing process. The ability to merge quality control testing in-line, on-line and merge with manufacturing process controls is vital to ensure better quality with real-time communication between the various groups within an organization or between organizations if using contract manufacturing. The regulations talk of the quality unit as a separate functional group, but the concept of quality is a shared concept. Much of the recent FDA presentations have emphasize this. We need to think more about sharing quality rather than throwing over the wall. Processes need to be shared and resolving issues also be shared.
Hi everyone, Let's talk about how you can improve quality control department?
Without quality control procedures, you could face product recalls or safety hazards that lead to expensive litigation.So, tell us about your ideas on how you can do improvements on the QC dept?For example:
Leadership Qualities: An organization needs to inculcate leadership qualities among its people so that they establish unity of purpose.
Have an equipment improvement team (EIT): An EIT develops action steps for device improvements.
There are so many things we can do to improve Quality Control.
First of all, we can train employees.Ensuring quality throughout your process requires specific training for your employees. Not just the quality control officer will need education. This helps employees watch for signs of abnormalities. Additionally, cross-trained employees can look at the entire process and help develop ideas for increasing efficiency and quality control.
Secondly,Let technology help the process. we may want to install real-time sensors to track products for example.
In addition, we can upgrade equipment where needed and create a response plan. there are so many things we can do to help improve QC.
The Quality Control department in any company needs commitment in the workplace by employees. The company needs to make sure that everyone is on the same level of understanding what the mission is for the company, and how the employees can benefit from the success of the business. In order to achieve the quality that the company is aiming for, they need to ensure that they have professional leadership or well trained/experienced managers to inspect and guide employees in the department. It is in the hands of management that the work or quality is good or bad, so selecting the right people to look over the department is a key factor in the success of the company. Also, teamwork is essential and there needs to be willingness to work as a team or else each person will most likely do what they think is "right." When there is no teamwork, there is no commitment. Also, the company needs to ensure that they are paying employees fairly or else they will not perform the work as it should be, and that causes chaos in the control department. With one repeated mistake from an uncommitted employee, it will cause the company to be in danger of losing its business.
Until now, I do not work in the industry but, I believe that there are many factors that can improve the QC Department. Let's look at leadership qualities as an example. The most important of the leadership qualities is to ensure and maintain discipline among employees. Understanding the qualifications of the employees and the continuation of these qualifications are related to the person in charge at the head of the department. In addition to this, the clearness and clarity of the assigned tasks ensure that the work is completed more successfully.
Thanks!
In my opinion, one of the biggest improvements that needs to be made to most quality departments, especially at my company, is the communication between quality and manufacturing. A lot of times, quality thinks they have the final say on everything and this can lead to them to thinking they have control over other departments. I know when I write protocols for validations at my company, when quality reviews them they have plenty of comments. Some good and some that do not need to be implemented. Unfortunately, if I give pushback on these changes, it becomes a battle between departments rather than a discussion of how to handle the situation. If quality does not get what they want, they will usually continue to reject the procedure until they get what they want added. This lack of communication and lack of willingness for quality to listen to other opinions starts a lot of conflicts and wastes a lot of time. If there was a better way to get the departments to listen to suggestions and work together, it would greatly improve the production process and relieve a lot of headaches.
I absolutely love talking about quality, because I’ve worked in quality departments for some time now. Quality is very simple to me. Making sure you make product that meets customer needs and that follow specifications put in place is a very important aspect of quality. I think a way to improve quality control departments, is by ensuring everyone understands why quality is important. You can make product all you want, but if it doesn’t meet the ISO standards put in place and the specifications by the customer, then you won’t be able to make any money. I think helping everyone gain a good understanding of quality and what it entails will help quality departments. Also, making sure processes are set and updated/reviewed periodically will help quality control as well. Making sure parameters are set, and processes are monitored in a controlled format and having well defined roles and a good training system as all ways to help improve quality control.
I think communication is a big think that can be worked in the communication area. Setting up more ways to communicate effectively would help the quality control process. Like setting up meeting twice a moth to make sure records are up to standards for future audits, training modules to keep procedures fresh, and management just being more approachable for employees to ask questions.
The Quality control department can be improved in many different aspects. Of the six years I spent in quality one of the biggest improvements could be to lower the turnover rate. When I was in quality the turnover rate was high. One of the reasons I feel this was high is due to management. When you have poor management then you will always have a high turnover rate. A key factor that I think leads to this is not only poor management but poor communication as well. When an individual comes into the work force right after college in the quality department it is very important to help them understand the meaning of quality. This does not mean giving them the textbook answer but also helping them understand how significant it is to do your job correct as patients are counting on us every day.
