Based on my work experience with the current company i am with, i have worked with both Quality engineers and R&D engineers/scientists. The common problem i have seen is that projects in fact due get delayed because of check ups and reviews. From what i learned is that in order to avoid having any issue with the Quality department, its best to ensure they are provided with all proper documentation and also to establish a proper protocol that way both departments are on the same page and aware on what each needs to follow to avoid inconsistencies. Many of the times i noticed that causes the most problems are when QA question a certain criteria and the proper documentation is not issued or could not be found, it's their job to verify that this was set into place. Its a collaborative effort, at the end of the day they are working for the same purpose.

I currently work as a Quality Engineer and still there exists some issues within the quality department. First and foremost, document control. Every procedural change or creation of procedure needs to adhere to document controls standards. Another issue is the lack of solid evidence to back up one's claim as to why a process exists. The procedure is that. The procedure in essence is proof. Ways to fix these issues include a more top down approach where the quality management can go forth and implement controls to ensure that to minimize time needed by the engineers and document control. Also, the specialists within document control should recognize and treat each procedure the same - that is look for the same criteria and report missing information the exact same way. However, document control is essential to the business.

Based on my past work experience, I have repeatedly encountered a hesitation/resistance to any kind of new processes from the quality department. If an engineer is coming up with a new and innovative approach to tackle a problem, the quality department resists it strongly and always tries to dissuade into going back to the old process. The part of the reason as to why they resist is because it just adds requires more resources, time and other additional burdens to amend their process in evaluating a new product. However, at times maintaining a legacy system damages the company as their competitors take an opportunity away.

My experience with the quality department at my company is very similar to reshamn’s as mentioned above in the previous posting. Some of the new processes that are currently trying to be put into place by R&D engineers are being halted by the quality team. One particular example that stands out to me was a certain process where a program and a small design change was made/ written to empty cuvettes out an instrument. This new method was greatly preferable to the original tedious way (which was removing each individual cuvette by hand) and saved about 30 minutes of qualification testing time. The early implementation of this change would have resulted in a better allocation of man hours on the floor and an increased monthly output. However, this new method was not officially implemented until 1.5 months later, during which, the quality department fought the entire way. To fix this issue, I would suggest to the quality team to try and be more flexible and do a little extra work if necessary if it’s for the greater good of the company.

I work right now at a furniture company, that does monitor arms, mechanical chairs and tables. I haven't had any problems with the quality department before. I work as a designer to special order requests based on the customer needs. Usually after the part is designed and approved by the engineering department, it goes through testings to make sure that the materials are strong and that the part will not fail. All the problems that I ran through were packaging issues, and some damages to the parts based on customers complains. If the damages of the parts are repeatable, then the engineering team has to change the design somehow to avoid any damages. At this case, we have to change all the documents that has to deal with this specific part and create a new revision in document control. For the packaging issues, we usually direct to the packaging department to redesign how it should be done.

Too much documentation: Many companies have too many documents that tend to hinder the function of QA/QC departments. Some major companies have excessive documentation that employees may become overwhelmed and possibly lose interest in the quality management system and therefore impede the expected outcome. A company that I worked for previously had so many work instructions pertaining to a given subject that some of the instructions contradicted each other.
Colleagues often think quality control belongs to the people that initiated/created it and therefore don’t actively contribute to improving the system.

When dealing with the quality department, I think one of the main issues I had was how much the result varies due to the person in the quality department you are dealing with. I know this is a problem lots of places due to even professionals having differences in opinion or a different perspective of a problem but there are some QA people who were notorious for stopping jobs when there wasn't a problem. On certain big jobs, there are QA people who watch the work being done. If they think there is a problem they have to stop the job. This is a good policy but there was some QA people who ALWAYS stopped jobs and people would just wait until back shift when someone else was the QA person and then everything would be fine. I'm not sure which person is right but I feel like this is costing the company a lot of money and for something this important, there shouldn't be such large degrees of difference in opinion. I would suggest they standardize how they approach problems or standardize how they determine there is an actual problem.

One of the issues that I experienced is how the quality organization of a company was structured. There was a quality department designated to support development (R&D) products and another quality department designated to support marketed products. The issue was that these departments were not integrated and during 'hand-off' of the product from development to commercialization there was 'loss of knowledge/expertise' about the product and this caused churn and inefficiency bringing the quality department that supports marketed products up to speed. Working in the engineering department I would get involved in answering questions which I think was unnecessary had a transition plan been established between the two quality departments detailing the information necessary and given enough time for the two departments to 'talk' to each other.

I agree with this. As an engineer that is outside the quality department, looking for continuous ways to improve processes is key for a company to continually increase efficiency and productivity. A lot of Green Belt Six Sigma/Lean projects are directed toward demonstrating some sort of increase in efficiency or savings. Quality tends to resist these changes, questions it, and in some cases refuses to go through with it for the reasons you stated of increased resources and time. Moreover, I tend to think Quality at times tends to not understand and questions the credibility of data or a specific analysis. For that reason, Quality wants to stick or revert back to old practices.

I've experienced a similar set of circumstances in my work experience. I work in the production/manufacturing department. While quality and production are within the same physical environment, their work appears very separate. Even when working on related projects, one department might be operating at a different speed than the other, with one lagging behind in terms of phases. For example, with trying to change an operation in the manufacturing side of the product, quality still needs to approve the calibration of a machine. With this lag, the manufacturing cannot progress to the next phase of the project. In order to bridge this gap, both departments should have frequent meetings to follow up when there is a common project shared between the two. Both sides should freely voice their concerns when it comes to the rate of progress, with the quality department explaining why one phase must take longer in order to be as thorough as necessary, and the manufacturing side explaining the urgency of the overall project.

I have to agree with julienneviuya. The idea that communication has to be constant is clear but also people sometimes fear consequences for being behind or not being able to do something that they will adjust the truth to make it seem like everything is going to plan. This departments begin to see themselves separate from one another losing the concept that they are both cooperating to benefit the company. Also, people fail to see the other side of the discussion with projects like this. THE production department is going to want to get projects moving and into production but the quality department is forced to make sure this all done correctly.

I also work for a medical device company and I agree with the concerns above. I would also add a challenge that we face with design control quality is that they constantly make up new rules for us to follow as per their 'style' of doing things or how they want it done. Sometime they mandate that things are done a certain way in the design change package that is not required in our procedures. It sounds small but often times, it causes us to redo work and delay project timelines.

For example, I was working on a project where I had to obsolete some part numbers. Typically we would just add quick report printout from our data management system into the design change package. For this project, QA began making us assess the report printout in our Design Output Assessments and would not approve any changes unless things were done this way. Weeks went by and management eventually convinced quality that this report printout is not a design output and is not appropriate in the assessment.

I currently work in manufacturing at a cell-therapy company, and my duties during the production process includes collaboration with the quality department in real-time as the process is occurring. This is done by taking samples of cell solutions during a cell expansion process and delivering those samples to QC for viability and sterility results. The first complication with this is waiting for the sample's results to be processed by QC, which is required for moving onto the next step but can easily be delayed if QC personal is untrained/inexperienced. Some small companies prefer hiring young employees who are fresh out of college with next to no experience, the reason being that they get paid the least and their young age is more ideal for health coverage providers. This can easily be overcome by hiring competent individuals who are familiar with working under time-sensitive processes and have more experience operating high-end analytical equipment.

Another conflict throughout the quality-manufacturing process, is that unlike commercial products, medical devices that are still undergoing clinical trials are more susceptible to having more dynamic protocols that are always being altered rather than consistent. This dependence on the trial-and-error technique can confuse many operators who must be retrained after each iteration when processing a single lot. A possible solution is to implement a more robust, repetitive protocol that allows operators to adapt to the conditions that entail each product. According to an online article on how to improve QC systems (written less than a year ago), prioritizing repeatability in a process can only lead to positive results in both the safety/efficacy of your product as well as in its documentation, making regulatory processes easier to overcome (1).

Are there any quality-improving techniques out there that can be addressed by increasing cost alone? For example, will solely investing in the use of more high-end equipment (such as a scanning electron microscope instead of an optical one) ensure better-quality results every time, or does something else need to be added?

(1) Johansson, Anna "How to Improve Quality Control in 5 Easy Steps", Innovation Enterprise (Nov. 2017)

There always seems to be a lack of communication between QA and other departments. In my department, whenever the QA department is testing for certain results, it may take a long time, Often times, moving forward with the process relies on obtaining these results, which delays the manufacturing process further. It also seems that they sometimes have unrealistic expectations when it comes to manufacturing a product. In my company, the QA department is very adamant about receiving samples at specific times. However, if there are any complications during the actual process, it may take longer to get those samples at that time. Unfortunately, they are not very understanding of this. I think if communication were improved, the relationship between QA and other departments would be better.