It is an absolute necessity to improve the relationship of QC with other company departments. It is in fact in those other departments best interest to ensure a healthy relationship with their QC. The quality department usually runs deep within the structure of the organization. There should be a great emphasis on the integration of various departments together, such as quality and R&D. Member of the Quality department should always strive toward attending R&D meetings. Perhaps, this is allowed them to catch potential flaw with compliance to the regulation before the newly evolved ideas discussed during those meetings are actually born, ideally, there is also an individual from the quality team present to identify potential compliance issues before they develop a faulty idea. Furthermore, all departments should promote communication among themselves. In addition, the quality department should also be flexible and open to suggestion and interpretation. As Dr. Simon mentioned, some regulations are subjected to interpretation, so abiding by them on a flexible term should sometime being considered when both parties (perhaps quality and R&D) seems to both correct in their respective opinion.
I touched on this topic in a different post. The relationship between QA and other departments like R&D and manufacturing is essential to keeping order and communication in the the process of developing and mass producing any kind of device, including medical devices. If the quality team notices something is wrong with a device, they need to be able to go back through the documentation of any process that affected the device and find what went wrong where. Therefore, every team must be included in the QA process. The records that every team makes must be detailed enough for the QA team to be able to get meaningful and useful information out of it, otherwise it'll take more time and money to get the information they need, which is annoying for everyone involved.
This question goes back to the first and maybe most important thing we learned about in this class. Communication is key. Proper communication between R&D and QA/QC can allow both sides to understand what the other wants from them, and ensure that there is minimal delays in the development process. Most of the cause for bad relationships between the departments stems from the fact that the Quality Control division has a large amount of control over all other aspects of product development, including R&D. Their job is to oversee, and ensure procedures are met to develop a high quality product. If R&D is skipping steps, doing something improperly, or not meeting requirements in terms of product quality, they will likely face delays and hardships from QA/QC. However, if there is a clear line of communication between R&D and QA/QC, than many of these problems can be remedied before they even start by having both sides know what is expected of them.
From the lecture as we saw that major work of quality department is to oversee if all other department have abide to procedure which are set by regulatory boards in order to get certified and if a department doesn't abide to any procedure to make sure that department do abide to the procedure. This leads to having bad relation with other department. What are the ways we can think of to overcome such shortcoming and make sure procedures are also followed.
For example relation between R&D and Quality.
Unfortunately, QC is often viewed as a "road block" in the device development process. A lot of the time, individuals in R&D are getting pressure from other groups to move as fast as possible, so they may feel it's okay to cut corners in some areas to move the process along faster. However, it's QC's job to make sure procedures are being followed, so when they push back and say things need to be re-done the right way, R&D may not like that because that will take more time and effort. I think it's important for QC not to just say R&D needs to re-do something "because the procedure says so", but also offer some perspective as to WHY the procedure says that. In other words, if the QC individual approved the work of the R&D individual that cut corners, what effects would that have down the line? Is it an error in documentation, in which other individuals in the future would not be able to find the proper rationales to explain why design decisions were made (like in an audit situation)? Would cutting corners in this instance lead to the device failing in the field, potentially harming the user? If the QC individual is able to provide this perspective, it would allow the R&D individual understand why they need to re-do something.
The quality department is the department responsible for making sure that the other departments in the company are in compliance with the standards which can be that of the company, FDA, ISO standards etc. If the department does not adhere to these standards then there is a loss of time, money and efforts put in by any of the departments. To overcome these issues there should be a representative from each of the various departments reporting to the quality department to make sure that they are on the right track at every step of the process. The quality department by itself could elect a person to follow up with a particular department at a given time to ensure smooth flow of the process. Meetings should be held periodically to ensure that both the departments are following the requirements and are in compliance with the standards and to address any issues and solve them in a timely manner. The other departments should have an understanding that the quality department is making sure that all the departments are following the standards for the better good of the company and save time and energy of the people involved by making sure everything is in place. Each department could also have a quality team which is specialized and dedicated to their particular department and then this will be reviewed by the main quality department.
The Quality Department oversees if the standards laid down are been followed or not as there would be a lot of loss of time, money and effort if that happens and the project would be delayed even further.
Companies have a separate department or a person from Quality who will take care of the Quality standards of that particular department so the overall Quality department will be in touch with the sub Quality departments and make sure that the departments follow the regulations.
Sometimes there are few changes that need to be done but its important to understand that it is so that the end product is put into the market without flaws.
In my experience, inter-department relationships are best maintained by good communication. The quality signature on a Change Notice can often be the hardest to get, so a strategy that I use is to inform the quality representative of my intended changes and get them on board as soon as possible, or get their feedback and address their concerns as soon as possible. For bigger projects it is important to have cross functional team meetings to align members from all departments and inform them of any upcoming items or tasks which will be presented to them soon by the R&D team. Communication is the key to cooperation between all departments, not just R&D and Quality, in understanding the compliance guidelines set by QA.
The quality department should work in co-ordination with all the departments by regular inspections and checks while developing the product. For example the R & D is concerned on developing the product and are more research oriented than regulatory hence the quality department should collaborate rate with them efficiently and have regular meetings and then ensure that they are following the guidelines they must work in harmony and not be very specific and make the other department understand that why the regulation by their department is needed to get approval from FDA
In relation to this, I believe the best way to overcome such shortcomings is to have a representative voice from each department provide their inputs on any revisions or additions that the quality assurance department intends to make. Aside from the non-negotiable regulation or standards required by organizations such as the FDA, additional standards should be made in a manner that would not create any major hurdles for the departments affected. An example of this is if the quality assurance department required four times as many products to be measured for dimensions than before while the number of available employees to do this remained consistent. As a result, it is important that while creating new or revised standards, the quality assurance must take into consideration factors pertaining to the departments that would be responsible for abiding by them. Overall this can be done effectively by having good working relations and communication with the various departments, so as to receive feedback from them. Ultimately, this will allow for improvement in quality as the required standards and processes created are those that the various departments can abide by in a reasonable manner.
In order to prevent unnecessary tension from forming between the quality dept. and other departments, there should be a clear form and frequency of communication established at the beginning of the project. To avoid any confusion later on, the regulatory requirements will be recorded and each department can sign the document once the agreements are made. There should be weekly meetings with all the departments in attendance to update everyone on what they've accomplished, any changes that need to be made, and any delays. The regulatory department should also confront any department that starts to stray from the regulatory guidelines as soon as possible, especially the R&D team. The R&D team may see the regulatory dept. as an annoying hurdle at first, but the regulatory dept. will help minimize wasted time (from running speedy but poor trials that must be discarded in the end, for example) and avoid recalls.
With any conflicts within groups, the key thing is communication. To explain in detail, both parties should at the beginning of the conversation make sure they understand each other's party and that both departments exist for a valid reason. And ultimately, by collaborating with each department they are able to develop products that are very safe and at the same time effective. For example, you know that your parents are the majority of the time correct when they warn you not to do such actions. I think it goes in line for department collaborations as well. Quality should make sure that R and D are developing according to standards that way the product is safe and in addition the product will take less time to be approved by the FDA. And the Quality team should make sure that when they suggest a correction towards things that the R and D do make sure to explain in detail and also help with suggesting solutions as well.
Quality department has to be more involved in other department in order to have better relation with them because just telling those department to fix the issue and not actually helping them fix it can effect the relation in such a way that those department will start to hate. Quality department have to guide other departments so they are in compliance with the regulations and follow the rules set by the company. Quality departments have to find a way to fix the issue that other departments are having, after they compile with the rules, so it does not effect their work flow and allow them to achive what they are trying to achive, this can help fix quality departments relation with other department.
From the lecture as we saw that major work of quality department is to oversee if all other department have abide to procedure which are set by regulatory boards in order to get certified and if a department doesn't abide to any procedure to make sure that department do abide to the procedure. This leads to having bad relation with other department. What are the ways we can think of to overcome such shortcoming and make sure procedures are also followed.
For example relation between R&D and Quality.
In my experience, typically, the quality department doesn't have much of a relationship with the other departments. The reason for that is its function is pretty straight forward. The quality department is responsible for checking whatever product they are checking and give judgment, such as pass or not pass. After that, the reports should be available for the other department's access, and everything can be learned from those documents. Other than management, human resources, etc. the only an unusual job a quality department might have is that sometimes they need to reply to the costumers and/or contact with the incoming material for a specific defect which is going on for some time.
To improve the overall Standard of the company it is very important all the departments ensure data transparency to make sure Quality department takes steps to document it and makes sure it does not happen. This can be achieved only if the departments have a nice relation with each other. Although Quality is pretty straight forward department, it is essential all departments work together to provide better results.
It has a major effect on the performance and developments initiatives for other departments, which the quality department makes sure that the works of other departments are done properly. However, since the quality department makes the examinations that assure to meet planned products, the other departments feel anxiety from quality because they check their work.
