I do agree with you and I have seen that in my company as well. I feel the quality department is more strict when it comes to documentation which can delay a project. However, Personally, I think it is part of risk management to make sure everything is good in term of quality before you deliver the final product to the customer. And, I believe that's what differentiates one company from another is the quality of the product. most of the company can build a product by quality in term of reliability and support is very important especially in the industrial market. The legacy product creates the name awareness and good reputation. In my opinion, the quality department has a big impact on these facts. Also, it is very important as we learned how to document everything to cover yourself from any legal problems.
If the concern is about delay of product launch due to strict documentation and doc. control, I think that other departments need to understand and fully familiarize with 'Good Document Practices'(GDP). The quality department is very very picky about how and when things are documented and personally, I don't think that should change. Quality is the minimum a medical device company can offer along with the device's function and effectiveness. Therefore, I don't think quality or quality control should be compromised. Although it may seem tedious and silly to document devices and processes in the exact format the Quality expects it, it assures a standard format, it shows that the company is in a state of control, and it shows liability to what is being delivered.
So my answer to your concern about passing launch dates due to quality control is that other departments must take quality seriously and document files as per protocols to avoid delays.
Document control can be improved by ensuring each department in the company is cooperative with other department and co-worker. The documents are to be completed and updated with the new regulations on daily basis. When there are changes to be made, all departments should be notified so they do not continue making a product that will eventually go through the quality department which may be rejected or delayed as we discussed on other forum on the quality topic. Therefore, I think the most important point that needs to be improved when it comes to documenting control is to have a better communication system among the departments. Since document control is the main focal point in creating effective products. The point of document control is to maintain all documentation and updated under a quality standard. This includes setting certain guideline where each department can follow without making an error.
Document management is also necessary to avoid data loss. An R&D/manufacturing project, a QA program, or a related process might be crippled by the loss of a very experienced person (for whatever cause, from resignation to death). Document management guarantees that critical information is preserved in the event of a disaster. Of all, this is only one of the numerous advantages of document control. It leads to more openness, greater evaluation capability, and higher accountability, as others have stated. In general, document control is more beneficial to a company than it is to individual employees. As a result, superior document control by workers may be worth rewarding in some ways.
Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the lot to be shipped to the customer on time. What are some of the ways document control can improve? Please share your thoughts/opinions.
Thanks!
Being more organized goes a long way. If you know where everything is it can decrease room for error. It shows you are prepared and focused. Also, thoroughly checking dates and times to make sure no errors occur. Small steps can save time in the end. Time will be saved and you can be more productive because you don't have to continuously stop to correct something. Your representatives, providers, and surprisingly your inspector can undoubtedly log in to rapidly get to your supported archives online with restricted consents that you characterize. Set up a client account, give access advantages, and advise your perusers of their new record. Presently the entirety of your clients will approach supported archives, and you will not need to contemplate whether they have the most recent rendition. Representatives can undoubtedly find organization records on the web. Put together your reports utilizing preset classes, or classify as indicated by your requirements.
With a good document control system in place, you can manage access to sensitive documents and restrict them to only the right people at a time. This comes in more so in highly regulated industries where leakages or unintended data exposure could easily lead to non-compliance, destruction of brand reputation, and a loss of competitive advantage. DCS works to protect sensitive documents from unauthorized parties, and it should also allow for easy access to those who actually are authorized. This means they can search for, find, and retrieve both active and archived documents.
Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the lot to be shipped to the customer on time. What are some of the ways document control can improve? Please share your thoughts/opinions.
Thanks!
Not that I believe document control should improve. In most cases it may slow done production because you have the same individual doing all the work. If the company would hire someone whose job was specially to do the documentation then the production side would have to suffer from delay. However, if the company is okay with the delays then the employees should be okay with it too.
Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the lot to be shipped to the customer on time. What are some of the ways document control can improve? Please share your thoughts/opinions.
Thanks!
Some of the ways document control can improve is to make sure that there is a system that is in place to control how documents are taken care of so that nothing is missed. That there is a efficiency to the the process such as having data integrity, that all documentation is legible and accurate. That all the documents are keep up and that they are in real time so that nothing is falling behind. That the documents are true and nothing is fabricated, that someone is in place to go over the documents and ensuring that all of this is in place so that things move smoothly.
A document control system ensures a document control system is by introducing automation to the process thereby reducing human error. Automation provides for a large quantity of data to be managed effectively with very little error and at a faster speed. Another way to improve document control is to ensure that everyone knows what role they play and what they are responsible for during the document's life cycle.
Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the lot to be shipped to the customer on time. What are some of the ways document control can improve? Please share your thoughts/opinions.
Thanks!
Some ways document control could be improved is by insuring that all documents produced by each department is put into an electronic system. For instance, if you need to improve documentation that is handled by laboratory personnel, there needs to electronic systems like LIMS or Labware put in place. This way when results from test are generated, they can immediately be put into these systems where they can always be found. Also, everything that comes into the lab, no matter how small or insignificant it may seem, should be logged into this electronic system. In the case of physical paperwork that contains raw data, one person should have the responsibility of filing this paperwork so it should always be found when needed. Lastly, document everything done in the lab and make sure everything has a place.
@cjm64 I agree with everything you have said, I think understanding the documents and their purpose/end goal is critical for the documentation to be completed correctly. Having been in a similar situation, I think one solution to help improve people's understandings of important documents is for their to be mandatory classes/trainings held by the quality department/Head of interns and coops that can help describe the process and specify why the documents are important and how they should be filled out. I also agree that a master document should be created, but I find that whenever a document is assigned as apart of a training curriculum, most coops/interns/employees might click through or brush over the document instead of truly understanding it, which leads to the vicious cycle of the documents not being completed correctly.
Personally, I think taking a class or listening to someone explain the purpose of a document is incredibly beneficial. I was able to understand certain documents by asking to meet with quality engineers and have them explained to me directly, why they are important, and how to complete them.
Does anyone have any other ideas of how document understanding can be improved?
Thanks,
Matt
I think one way Document Control can improve is by switching to purely electronic documents. This kind of electronic system can make it easier to track and organize documents. In R&D and manufacturing, it would be helpful if each scientist or engineer has an iPad that they can use to follow SOPs and fill out batch records. Additionally, an electronic database would make it easier to locate old records. For example, in preparation for audits sometimes a company may need to locate batch records from multiple years ago. For a large company with thousands of different documents it would be easier to locate this kind of document electronically. Also storing large amounts of paper records can take up a lot of space. If another company is storying your records and documents it can be extremely costly depending on how many documents they are storing and for how long. While there are a lot of positive reasons for switching to a purely electronic document control system, what are some drawbacks? In your experience, does your company have an electronic or paper document control system? Is a hybrid of both used?
I would believe the first step is to have a centralized system for all control documents. As a company grows, some divisions update their internal procedures more frequently and with different objectives than others. Over the course of just a few years, the entire company can be using different databases tied to various input catalogs that all output different information. While much of the information may be overlap across systems, no one would necessarily know considering you are usually only involved in your own systems. This creates confusion when searching for specific information that may not be usually accessible to your team. A centralized system would allow all the information flowing into a company to be sorted by the same system, allowing the output and stored data to be easily accessible to everyone.
A QA department's document control is intended to ensure that all project paperwork is in order, so that when the FDA or another entity arrives for an audit, for example, the firm team is ready to demonstrate that they are adhering to their standards. With that in mind, one way that may be improved to make documentation less "tight" is for enterprises to band together and develop a single large standard record that both worldwide and smaller businesses must follow. Because numerous groups will have to merge, this appears implausible, thus a more viable solution will be one that takes place within the corporation itself.Apparently increasing a QA/QS department will ease the pressure on the department as a whole, allowing the corporation to have a faster process for a little more money. Another option is for other departments to follow the quality department's guidelines so that there are no conflicts when information or protocols are shared between them.
