Despite not working in quality control, I know it's essential to stay on top of new regulatory requirements for production standards, maintain safety testing programs, and trace any product recalls to their source. Continuously monitor and improve manufacturing processes, and investigate and address any production issues before they escalate. Ensure raw materials, components, and final products meet your specifications. Your process will be more effective if you hire qualified candidates. The more confident a person is in their role and in company standards, the more likely they will be able to spot defects, abnormalities, or disruptions in the process. As a result, any defective products will not leave the facility, and any malfunctions in machinery can be caught before they cause costly shutdowns.
I work within a start-up biotechnology company that has been through two inspections as of yet with likely more in the works. Whenever something like an inspection rolls our way, the first thought that pervades our minds is the quality of our data and whether or not it is compliant with industry standards. I think that the employees of any commercial laboratory should be made aware of the importance of documentation for FDA-regulated biologics or products. If there is no documentation of steps taken by an internal or external quality assurance division, then it is unlikely that a startup can pass through an inspection unfazed. Storing procedures, compliance documentation, etc. in written format and within a computer are mandatory steps to strengthening the quality of a laboratory or biotechnology company. Having an organized methodology for record keeping and standard regulatory compliance measures would not only help in the event of an inspection, but it also strengthens the quality of the data.
Quality Control is extremely important for ensuring products are performing at their optimal level and to catch mistakes before they get on the market and in the hands of patients. Quality departments need to be improved to where the turnover rate isn’t so high. I’ve noticed that a lot of great analysts have left their positions due to poor management and low pay. If companies would invest in their Quality departments they could retain great employees, and the rate of testing that could be done would surpass their current rates. Companies wouldn’t have to train employees every week on methods when they have dependable employees who know the assays and are able to pinpoint problems before they occur.
You mentioned some valid points. There is something my department called “continuous improvement,” meaning we are always looking for new, innovative ways to improve methods and procedures that are already in place and make them better. It is a great improvement plan to have, but I feel like management needs to really analyze it twice a year to actually measure if things are improving. To your point on hiring qualified candidates, I absolutely agree with that. It honestly takes more time to train candidates who aren’t qualified because you have to teach them the basics of everything. Also, when analysts are qualified, their work is more precise with fewer errors, which leads to fewer laboratory investigations. Lab investigations ultimately slow down testing and halts the release of lots.
@wmckennedymsm-edu I do agree quality control is very crucial. It's the last defense and checks to ensure the product is ready for market. One would think that after investing so much in the development and manufacturing of a product, a company would invest in a well ran QC department. Like all other processes, companies should constantly look for ways to enhance and improve QA departments.
It is the opinion of the writer that one way quality control can be improved would be with the use of inspection stations. Introducing quality inspection on assembly lines could aid in preventing minor or major mistakes that could ultimately lead to more recalls and problems for the company overall. Additionally, another method that could be implemented to improve quality control would be to include proper working instructions. Based on the testimony of some of the writer’s acquittances who are quality assurance engineers, most of those individuals mentioned that they were not properly guided during the beginning of their time at their company. In other words, they were told to put a certain piece in a certain area and were not given proper instructions. In this case, any mistake could result in serious consequences or injuries for both the engineer and/or the person who will be using the device.
I have had a little experience in the manufacturing realm, and based of my experience I suggest that these would be the way to do so:
1.Build a Proper Process
2. Keeping a clean Workspace
3.Holding Suprise Equipment usage tests
4.Identifying Essential spare parts
5.Ensuring the managers are properly trained.
The quality control department could benefit extensively from proper training in quality control. This can include earning certifications in self-assessment and having a general understanding of statistics. Those who've attended and earned these certifications can also partake in some refresher courses in case one needs a review. Another way that the QA department can improve is to hire someone who has extensive knowledge in that field. While someone new might be a natural in their performance, they can ultimately be in charge of overseeing every meticulous process of assessment towards the product, which could be daunting. Good leadership, as well as attentiveness, would also go hand in hand with working in the QA department.
All requirements are reviewed when performing quality control for a product. During the observation of these requirements, if there are deficiencies, they are determined and if there are no deficiencies, approval is given. however, there may be requirements that go unnoticed during these checks. I think the necessity to improve this starts from the basics. If each department is aware of the requirements and complies with these requirements while performing their duties, fewer deficiencies will be revealed in the final quality control step, which will prevent unnoticed deficiencies.
As it is clearly shown in this thread, the quality control department is an essential function when dealing with medical device companies. Making sure that the products are safe to use for the end consumer and that there is no defectiveness are all critical functions that this department ensures at any given moment. One way that the QC department could be improved is to make sure the organization is always up to date. Quality control can be made up of a few or a lot of people and it is important that information does not get lost between them. Having a secure database or system where information regarding certain guidelines, laws, or regulations is properly maintained will be very useful when working with any new product. Making sure everyone on the team is up to speed with what needs to be checked and what to look out for will streamline the process and lead to fewer errors. Other improvements that can be made are trainings for the team, having a good project manager, and good communication between the different departments in the company.
I work in the industry currently and I think that management is in fact the most key component to the quality control process. I read some posts above that discuss how there are several steps to improve quality control, especially including the employees more involved in the process. While I agree with these points, I think that the most important role (from my personal experience and from the Quality control lecture discussion) is the management. There are multiple positions within the management that need to understand their respective roles and implement the proper knowledge of the projects within their co-workers and employees. QC is something that can be easily overlooked and cause large issues for the company very quickly, this is why it should be prioritized appropriately. From the projects that I have been a part of, management has always paid attention to QC and I could see the effects of this within the team knowing their roles in the process tasks relating to QC as well. Thus, good communication with the departments and employees is necessary and important, but it is essentially up to management to ensure this.
