As a QC Scientist for many years, I believe that having a general sense of organization is necessary.  Knowing how to set up your experiment can help save time as your not having to stop in the middle of your process to collect reagents, etc.  Also, paying attention to detail is very important.  That helps with the precision and accuracy of pipetting and analyzing in an experiment.  I've seen many assays fail because the scientist lacked the precision required to have the assay run as expected.  Staying focused on the task is also very important. For example, if you are working on an assay using 96-well plate & a well is missed because of a lack of focus, then the entire assay must be repeated which adds more time to your day and more cost because you have to use more materials and reagents.  Overtime, as you gain more experience in what you're doing, you will get better organized.

@pjf22 I agree with you, organizational skills are paramount and essential to QC. It's a very meticulous set of checks and balances traversing each end of the production operations to ensure everything is done decently and in order. Those skills if performed daily limit the temptation to cut corners by missing steps. It demands honesty and integrity in the quality of work performed. Basically, it allows for processes to run smoother. As my mom used to say often, "if you do it right the first time you don't have to do it over."

I have limited experience in Quality Control via delegated tasks within my laboratory job. Whenever I run an assay I have to document a plethora of different activities that I perform in order to ensure that the test is valid. These activities I mentioned include decontamination of the BSL hoods under which the assay is conducted, for starters this needs to be documented in a log to keep track of our decontaminations. I also have to log whenever I grab reagents from the freezer. Other quality control task include logs of patient samples being accurate, so the technicians such as myself cross check how they were input into the system through scanning them. There are other, arguably more important steps under the quality assurance umbrella such as standards of procedure being followed, tracking what training each technician has received, and credentials of employees being in alignment with the task they are asked to perform. Documentation is plentiful but necessary within a biotechnology company, let alone within an industry laboratory.

First of all, for defect detection, the quality control department should be as knowledgeable as the team that designed the product so that it can detect errors. I think another important skill is knowing the product qualifications well. A finished product may be performing its function but not satisfiying the requirements. In this case, the task of quality department will be to ensure that the production process is redeveloped according to the requirements.

As others have said here as well, I do not have experience working in a quality control team but using the information we learned this week and general knowledge of the biomedical device industry, it is definitely very important for anyone on that team to be organized. As stated in the prompt, QC is responsible for making sure that the final product does not contain defects or any other kind of issue. Understanding what a possible issue might be will be a challenge in the beginning, as there are many different things to look for. Being organized and knowing exactly what kind of problems occur and managing a team in order to resolve these problems are all aspects that need a good sense of organization. The final product may be very complicated, and many different factors may need to be considered in order to determine if it is fully functional. The more complex that it becomes, the greater the need for organization and a deeper understanding of the issue at hand.

I agree with as934's assertion of need for investigative tools and mindset. I have used similar frameworks, including FMEA & 5 Why's analysis in my previous job. AVParker's description of the need for organizational tools is similar to the experience I had in my job.

Something I wish I did a better job of doing when I was in industry is working with other managers (production, supply chain / fulfillment, marketing) articulate the need for improved quality control. When other managers are incentivized to "maximize their metrics", it becomes very easy for them to sacrifice product quality, especially when the product remains within specifications. 

I don't have direct QC experience in the industry but in my time so far, I have seen some concepts on how the overall QC process works. As discussed in the lectures, there are not multiple processes in Quality that management has to control, but there are also multiple documents such as the quality procedures or work instructions that need to be properly organized. In my experience, I believe that most companies have an overall database with this vital and confidential documents that all members of the organization with relevant permissions would have access to. As you can tell from the descriptions, documentation and organization are some extremely important skills that management needs to possess, not only for assigning the proper tasks and keeping track of these but also for managing all quality documents effectively. 

To be any kind of Quality person I know from experience you need to have organizational skills but you most of all need patience. I am a very impatient person but the quality engineers I work with have the aforementioned skills in abundance. Just the other day I finished adding to a test plan and I was submitting it to our quality engineer to read and she went  through the entire 100 page document line by line just in case when I was adding to it I accidentally changed something that I did not disclose. All props to her because I definitely lack that level of commitment and patience to be a quality engineer. As for organizational skills our quality server that houses all of our documents is very well maintained by the Quality team but again this may just be their personality but I feel like it helps to be well organized.

I haven't worked in either quality control or quality assurance. But I have thought of this question before because I do work in R&D and I have always wondered how the Quality department makes sure that everything we’ve tested pasts all the tests. But I would assume that a QC person manages a team by breaking everyone up into different areas that focus on different aspects of the quality process so every area has ample focus. I also think they would ensure the quality of the product by having multiple check points throughout the process to make sure nothing is slipping through the cracks.

I am currently working at a cell and gene therapy company. Recently, there was an incident that resulted in failure of a process and sterility tests. After doing a root cause analysis, upper management determined that Quality Assurance needed to observe the processes. Personnel from the QA team watched the cell processing team and advised the team on improvements that could be implemented to ensure the sterility of the operations. As a result, the cell processes were successful and sterility tests were passed. In my opinion, observing the role of Quality Assurance revealed the importance of having a quality system unit. There were a few oppositions to have Quality Assurance in the processing labs. However, I believe it served that operations well and should be done again in the future, especially as an internal audit. 

Quality management is the planning stage where quality standards are agreed upon, responsible parties are assigned, specs are decided, meetings are planned, and metrics are defined to determine how well the project meets the outlined specifications.  quality management is the canopy of an umbrella, quality control is the handle—they’re different parts of the same process—quality management dictates all quality assurance methods (like the spokes of the umbrella)

I think the most important skills for QC is like knowing how to manage your time and work. You would be surprised, but it keeps very complicated the more tasks you get. I would suggest also learning minicab too, it will help with data analysis. You should also get really familiar with word and track changes. These are skills that are heavily used in QC. 

One of the key qualities a QC must have is attention to detail when it comes to evaluating the product in order to meet every QA requirement. However, in my opinion, QC performance is greatly influenced by the work done by the QA team in determining the structure and assessments necessary for a product to be safe and meet any FDA and regulatory requirements. If the QA work is understandable and accurate, then it will be easier for a QC engineer to perform better on the job. Another important skill a QC can have is investigative skills. This ability is necessary to identify the reasons for failures that may occur in medical devices.

A quality control engineer must have extensive knowledge of the product, the theories that make the product work, and the specifications of the product and its components. For example, in the case of a non conforming material, the engineer must investigate why the component failed and what the root cause is. An issue I have seen in the industry is that engineers resort to not determining root cause. Stating that a root cause is undetermined or unknown is not helpful. I am not sure if it is even a valid statement. Every failure has a root cause. Most likely, if the root cause is unknown, then there must be ongoing research to see why the component failed. Is it a supplier issue, is it the environment or the component in the product, or the design of the component itself? A quality control engineer must have a tenacious nature in researching and looking for answers. They must work cross functionally with research and development, manufacturing technicians, and suppliers. This type of engineer must also have the courage to suggest change in the design of the product or component if necessary. 

QC plays an important role in making sure that processes and products meet their respective standards. I think planning the workflow can save a significant amount of time. For instance,  when working on an experimental task or assays where collecting an important chemical compound, planning where the equipment is set beforehand saves so much time and interruptions. Secondly, I think detailing and accuracy are other important aspects as one small error can lead to the failure of the whole process which could potentially lead to a waste of time and money. With these aspects QC processes can work better, reducing errors and making production steps are completed efficiently and consistently