Ways to improve documentation control:
1. Have the QA and other departments working together/open communication- if the QA and R&D work together to ensure that all proper documents are being completed correctly then this will prevent delay in product development or shipping to the customer. The R&D should also work with the regulatory department to make sure that the product they are working on abides by all company and FDA policies. If all departments work on a transparency and have open communication things would run much more smoothly.
2. Accurate documentation- Before any documentation is submitted from any department to the QA department it should be proofread to make sure that all areas of the document are accurate and complete. Having a proofreader go over all QA documentation can help ensure that there is less delay or error on the part the departments side.
3. Company expands- As a company grows, more regulations are needed, thus more the quality department needs more personnel in order to help process through all the paperwork and insure the projects are completed properly and without delay
4. Hiring people strictly for documentation – Most scientists and engineers don’t want to be bother doing all the endless paper required to get a product approved, but if the company hired interns or people whose main purpose is to complete documentation it can relieve stress on the scientists and engineers and the paperwork can be done quicker because that persons job is solely paperwork and they have nothing else to manage.
5. Train new/old employees on company documentation standards- all employees should be trained on documentation standards and should be fully aware and go through a new training process if documentation changes. This will help everyone be on the same page and more awhile if something is wrong in the documentation that may cause delay.

My current role dealing with engineering change controls involved document control and properly maintaining records of changes in manufacturing of medical device and pharmaceutical products. This information is used for regulatory filings, quality control, health authority filings, and audits. The best way to ensure that the information is properly recorded and maintained is to have an efficient system in place with an established directive for different scenarios, that outlines how to record the changes. Currently our workflow utilizes Trackwise which is a electronic system that is used for initiating, monitoring, and maintaining both change controls and investigations that are launched into products. We are in the process of creating a new workflow with another system, in which we are working on tackling the problems that cause delays and errors in documentation.

Documentation control can be catalyzed with the proper use of online systems. Online folders allow you to organize by section almost indefinitely and access it from any computer in the office. If that is combined with fillable pdf's of standard documents (like shipment documents) all the worker would have to do is go to the folder labeled "shipments" for example and fill out the pdf. The worker just has to save it and then be on their merry way. This will decrease the frequency of errors as well. The main barrier to effective technological usage is education/training. Many employees simply do not know of the techniques available with current technology/do not want to convert from an existing, less effective, system. In the long run, a company will benefit more if they hire someone to teach employees more effective technologies. Employees in no way, shape, or form should be done learning new techniques.

In response to the original post:
Document controls can seem stringent at times, however if they seem so, it is for good reason. At times, because of the controls, it can sometimes cause delays where there are different hoops that need to be jumped through in order to go from document to product in hand. However, having those hoops prevents some big mistakes from happening that would have happened had there not been document controls. In one instance at the company that I work at, there wasn't enough document control of a certain form that contained production/sterilization values for a product, which resulted in the plant manufacturing the plant to use an old form that did not have the up to date values. This caused a Non-Conformance, making us have several lots of product that were sitting on the manufacturing floor useless because they were not sterilized according to the proper standards outlined in the up to date form, all because of one out of date form. I agree that document controls can cause delays and headaches in normal operations, but I think that they are neccessary in order to prevent disasters such as the one I mentioned above.

Document Control is central for certification that has ISO Standards, Regulations and Rules. As this topic is on document control I would like to say the document control problems : 1)Out of control versioning 2) Unmanaged SOP changes 3)unwieldy reports 4) outdated emergency procedures 5) audit problems and 6) productivity drain.

Documentation control works as setting the foundation for an effective good quality system allowing organization to centralize the documents. So now talking about the ways to improve document control are : 1) Firstly develop a document control strategy. Mapping out all the documents and records that would be generated throughout the process of product. 2) Stop using paper. Electronics document system has more advantages than paper based. It is quick, increases document conformity, free employees to use their mind, increases security. 3) Follow the document management procedure. Make sure there is an actual objective evidence to prove that it happened.

Many small companies tend to do all their documentation on paper which means having years and years of information in notebooks and binders which can be difficult to find if this information was necessary. Many big companies also document on paper but also use electronic programs and time stamps to save paper and becomes easier to find this information in a database. This way you’re saving more time when looking for a specific document. This would also mean it’s easier to see if anything was missed. When people are documenting during their research, they should make sure all their information is accurate and is done in a timely manner. Also many documents such as methods and SOPs can be changed, and when this is done electronically, it’s easier to access for anyone in the company. If everything was done on paper, many of these documents would take a longer time to be approved by different people and given to people to use at a later date then when doing it electronically. This would also solve the communication system between departments.

To improve upon document control, you have to evaluate what you are currently doing. Is the reason because you are using paper files? You can switch to an electronic database using fancy software which also has the capability to print out the file when needed. Is the reason the workload? You would have to expand your quality department to compensate for the workload presented. Maybe you have a less than ideal process. You would have to re-evaluate what you are currently doing and find ways to improve your process.

The right document control system will help you to improve efficiency across your entire operations otherwise inefficiencies can cause unnecessary and potentially costly delays, and possibly lead to compliance issues. There should be a defined document hierarchy clearly describing the function and information of each controlled document .The professional technical writers can improve the quality of documents it can be done by establishing standardized training to technical writers. If a document is not easy to access precisely when it is needed, it is useless. Making documents easily accessible throughout the document lifecycle is another important document control tenet. A document's current revision status must always be identified with electronic systems, the most current document version is provided automatically , with paper-based systemshuman error can often lead to mistakes in tracking and identifying the most current revision number. Companies should routinely review their documents for continued validity and determine whether the information contained in the document is still accurate and relevant. Depending upon the findings, the document will either be re-approved as is, updated as necessary, or retired.

Document control is an important method that refines the document management system. Document control reduces documentation error and ensures that the data is searchable, information is secured and documents are consistent. Depending on the company and the industry, live documents and historical records have been evolved from manual and paper based processes to automated, software and information system based processes. Now, quality management system reply’s on technology for document control, communication of information, knowledge sharing and evidence of conformity.

The biggest problems that I see with document control come when there is a strange circumstance that happens. Funny enough, strange circumstances happen pretty often, but when they do, document control has no procedures to follow. This leads to inconsistencies between doc control personnel where each individual's opinion matters. The point of doc control is to maintain all documentation to fit under a standard. It is up to doc control to remain consistent throughout all situations and since engineers are sloppy sometimes with documentation, there needs to be a set of procedures to govern how doc control handles those circumstances. Without those set guidelines, doc control is just adding to the mess of documentation.

As a part of the Quality Unit, Document control main procedure depends on ensuring medical devices or product safety and quality. This includes ensuring the production processes security and determining restrictions needed to: accept, inspect, update, distinguish differences, know update status and provide access to the most recent document resources. The document control system must define the mission, purpose, and duties needed to achieve these parameters. It is known to strict in most cases, in particular in the medical devices industry due to FDA regulations and ISO quality standards, which would eventually delay the lunch of the product. (Ref. iso-9001-checklist website)
In order to improve document control, one can think about is to automate the control process as much as possible and make the document management process more efficient, easy to be accessed, and cost-effective. This can be done using a Document Control Software (ex. MasterControl, M-Files, eFileCabinet, DocStar ECM, etc.) which could replace the human signature by electronic ones (saving time), manage different documents simultaneously (fewer workers/more outcome), automate document review and approval processes, send auto email notifications for process updates, and integrated analytics and reports of the process. (Ref. Mastercontrol website)

ProductionMachining website defined several tips that will help in making the document managing easier and faster: 1. Organize by Department, 2. Define Responsibilities & Authorities (R&A) for Personnel, 3. Simplify Work Instructions, 4. Improve Control. (Ref. productionmachining website)

I think the best way to ensure Document Control requirements are fulfilled is to train the engineers to those high standards as soon as they start working. I know when i first started working I had to thoroughly read a Standard Operating Procedure which stringently detailed every sort of Documentation Practice from the way you write your dates to crossing words out correctly. There are specific rules to be followed and the more specific that Good Documentation Procedure is, the less room for error. After I was trained on that document, I knew what was expected of me in terms of formatting and my technical writing. I also know that sometimes Document Control seemingly makes up rules which have not been properly adopted in the Quality System and will reject certain documents for it. This is the frustrating part, when the department enacts rules without telling anyone or updating the appropriate procedure so everyone can re-train and understand the new rules. This is the correct way for the Document Control department to operate and not make enemies of the other departments.

I definitely agree with your response alexandrabuga. From a global standpoint, both 21 CFR 820 and ISO 13485 are guidelines for medical device companies to use for not only documenting, but ensuring procedures for controlling quality are in place and the medical device or in-vitro diagnostic (IVD) are complaint with regulations. With the use of electronic repositories for the Design History Files (DHF), it has become a lot more intuitive and easier to manage documenting design controls. I work for a medical device company, and our DHF repository is a customize system to ensure users are trained, have the appropriate permissions, versioning of documents is controlled, requires selection of the DHF and non-DHF as well as the category of the design control (planning, input, output, review, transfer), and manages the approval process for reviews and signatures on documentation during each phase of the product development. It is a continuously validated system, in which is approved and reviewed by quality either when necessary or bi-annually.

There are new EU regulations that are anticipated to go into effect for medical device regulations (MDR) by 2020 and IVD regulations (IVDR) by 2022. These regulations are to improve the quality, safety, and reliability of medical products. For more information, please use the link below.

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations

A Way to improve documents control is the qaulity that engineers do their jobs. Most scientists and engineers don’t want to be bother doing all the endless paper required to get a product approved. In addition to that, document control can be improved by making sure that each department is cooperative with each other. Document control system should help to improve efficiency across the entire operations because inefficiencies can cause unnecessary and costly delays. So, to improve Document Control and to create a more cohesive work environment, there should be a procedure to follow. Moreover, electronic programs and time stamps save paper and become easier to find this information in a database. This way you’re saving more time when looking for a specific document. With electronic programs it would be easier to notice if anything was missed. So, electronic programs is definitely a way to improve a documents control as well

In my role at J&J I have worked heavily with many different types of documents. The easiest way to improve document control is to make sure that everyone understands what the documents are and why they are important. When I first started at my position I was eager to learn a lot about the function of the company, so I spent a lot of time talking to people in all of our departments and was able to understand the documents that I would be working on and why they were important. But the people I work with often include unnecessary information or do not include the right information because the do not understand what the end goal of the document is. So in order to improve document control understanding of the documents must be increased.

How to go about this is a different problem. No one wants to go through more training and those who check the documentation often do not want to take the time to teach people or make documents explaining what the different documents are for. So it may fall on the heads of an intern or co-op to create a master document that explains the function of all the other documents and why they are needed.

How would you increase document understanding?