Speaking from my experience at my internship, document control works well when all documentation is organized and tracked consistently over the course of the project. It is quite easy for documentation to get mixed up or lost in one's files especially if a project spans a few years and has been passed around to different engineers. Document control could improve and operate smoothly if there was a set organizational method from the beginning of the project and remains consistent over its course. It saves plenty of time especially when final reports and documents need to completed and signed. 

One of the biggest issue that I have noticed is that there are always gap in the way documents are completed. In the sense that, the completion of form is dependent on the approver not the procedure. Establishing document practices will provide proper guidelines for other to follow, however in most cases they always things that full under "well that is supposed to be understand" or "we have always done it this way". These two things leave a lot of room for gaps to occur between two team members. 

People who are well-trained in composing these meticulous documents would speed up the process with minor issues. Documentation is what defines the product, providing a detailed explanation of how the product works as well as ensuring that it meets quality standards. People who work in QA, manufacturing, and the R&D department could benefit from workshops dealing with documentation and control so that efficiency can be sought after so that the launching of the product can be done at the time that it was projected.

Document control has to be strict for every company. For example, the document might be a new instruction, restriction, or format published by the government department. Missing any one of them might be a significant false for product marketing. But these documents usually change depending on what kind of device is developed. Moreover, it might be changed because the government updates the law. So making people know what this document does and how to do it is necessary. Creating a platform containing all document updates and all past paper documents might be helpful. People can find new formats and past examples at the same time. However, small or new companies can't do this because they don't have enough data and funds. And category and making indexes are also tricky for various devices.

Document control is paramount in any project, traceability is one of the core principles of quality. As documentation is so prevalent and deeply ingrained in everything we do during a project, streamlining and ergonomics are required. A document can be robust but unreadable. Oftentimes during a project we are sidelined by overlong documentation processes, or multiple duplication of the same information. The solution to this issue is more often than not centralization. As mentioned in the lecture this week, most countries are moving to adopt ISO standards in order to decrease confusion and bureaucracy. Centralization only goes so far however; good documentation relies on careful thought being put into the actual implementation of strategies. Documentation should occur where it is necessary and beneficial to do so, not at every possible moment. Streamlined documentation processes with easy to understand procedures curated by thoughtful management will increase productivity and reduce time wasted.

I think documentation processes may be improved by those responsible ensuring that documents are completed in their entirety. Delays caused by documentation may be due to inconsistencies and the documentation of inaccurate information. As a professional in clinical laboratory sciences and technology, document control is of great importance and systems may be implemented to keep better track of consumables, reagents, and instruments used during processes. The systems used are centralized across all departments and allow digital tracking of pertinent information to be submitted to the quality department. I think that by implementing a digital system/software that is used friendly for those responsible for submitting documentation, there will be improvements in document control

Document control should definitely be considered one of the foundational elements of the company’s quality management system. So, there should be great time and effort put into ensuring it is one of the most compliant and efficient systems in the QMS. One way to ensure the system’s efficiency is to transition from a paper-based document control system to an electronic QMS that manages all documents as well as the associated revisions and approvals when changes are needed. Smaller companies may be able to have a paper-based QMS that does not require a great deal of time when document routing is required but once a company reaches a certain size, an e-QMS is necessary. Also, because the document control system houses the procedures that governs the company’s quality activity, it is critical that documents properly capture the activity that compliant and is actually executed. There should not be multiple documents with repetitive information nor should there be multiple documents governing the same process. This will also help to eliminate audit findings and manufacturing errors.

In order to shorten the turn around of document control (documents reviewed by quality department) having to submit document electronically. Or even having an online portal where employees can review documents in one place. This will not only keep the documents in order, but employees can be notified when documents have been approved or corrections need to be made. 

Controlling document modifications and revisions entails keeping track of important versions of a company's policies and procedures. When handled properly, this process requires a large amount of time. Since this can be done from anywhere, using a document management system would assist shorten the time it takes to evaluate and approve documents. Overall, creating a central storage site for documents, create different levels of control for the various types of documents and make sure there is something in place to track documents down in the storage.

Document control is a crucial component of an efficient internal control system, which is necessary for compliance with regulations like ISO 9001, ISO 13485, IATF 16949, etc. When done manually, document control includes maintaining relevant (i.e., current) versions of policies and procedures at the point of use.
Additionally, managing and controlling the distribution of documents with external origins can be a nightmare. Additionally, it's challenging to keep printed materials current in the field, and the problem only gets worse as more locations and users are added. There must be a better approach. Employees, vendors, and even your auditor should have easy access to your approved documents online with the restricted permissions you specify. Create a user account, grant readers access, and inform them of their new account. Users within an organization will then have access to approved documents, and you won't need to worry about whether they have the most recent version. Online, company documents are readily available to employees. Use pre-defined categories to categorize your documents or create your own categories based on your needs. 

Document control has improved as technology has improved. Lab batch records or protocol have been written in simple word documents in the past and now they are generated in software that is layered with a SCADA program. SCADA is Supervisory Control and Data Acquisition and it is used in labs for example as a means of collecting data during a process. Similar software requires GMP / GLP approval to be used in a manufacturing facility as these products are registered with the FDA or EPA to be marketed into the public. The data control software feature requires many signatures and follows rules and regulations very very closely. This allows for every process to be uniform and to be replicated in any other manufacturing facility. All of this is for the benefit of the public and maintaining transparency.

Document control is an important aspect of quality management in both R&D and manufacturing processes. Here are some ways in which document control can be improved in R&D and manufacturing:

1. Standardization of document formats and naming conventions: Having standardized document formats and naming conventions can help ensure that documents are easily identifiable, searchable, and accessible. This can help prevent document duplication and errors, as well as save time and resources.

2. Electronic document management systems (EDMS): Implementing an EDMS can streamline document control processes by allowing for the efficient creation, review, approval, and distribution of documents. An EDMS can also provide version control, audit trails, and access control, which can improve compliance and accountability.

3. Revision and change control procedures: Having clear and effective revision and change control procedures can ensure that documents are up-to-date and accurate. This includes procedures for document review, approval, and release, as well as procedures for managing document changes and revisions.

4. Training and communication: Providing training and communication on document control procedures can help ensure that employees understand the importance of document control and are knowledgeable about the procedures they need to follow. This can help improve compliance and reduce errors and non-conformities.

5. Continuous improvement: Document control processes should be regularly reviewed and evaluated to identify areas for improvement. This includes monitoring document control metrics, such as document approval times, revision cycles, and error rates, and taking action to address any issues or inefficiencies that are identified.

The biggest issue I've seen that people dislike when working in a manufacturing company is change. No one likes change or having to do things differently than what was deemed 'acceptable' in the past. This applies across any department in any job or situation. Although this disdain will be present, there are different ways where the change and improvements can be handled to relay information more effectively. With Document Control for example, if there are changes made to documents that are more stringent, communicating these in a large team meeting setting can be much more effective then just having people 'sign off' that they've been trained after reading the updated procedure. 

I've seen this approach taken recently at my company. The Quality director herself lead several meetings over the course of a few days to introduce the other engineers to a new change that was done to a previous validation document format. She carefully explained all the changes and used helpful and easy metaphors as examples for how to approach different situations outlined in the validation doc. If this were to be done for large scale changes, I see changes made from Document Control or Quality being much more effective in their delivery. 

While document control will be more manageable for the QA and R&D departments if documents are completed without errors, missing information, or false data. Balancing research and documentation simultaneously is one of the most challenging aspects of the job, since scientists must efficiently ensure accuracy in both areas. While mistakes are inevitable, they can be minimized with careful attention and precision. Whether using an electronic notebook or handwritten records, documentation will always present some challenges. However, accuracy, precision, and attentiveness can significantly enhance document control.

This was a very interesting point that I had never had to deal with prior to reading this discussion. If the complaint is that there is too much precision required than there are a few solutions. Firstly, it is important that employees handling documentation have the correct training and knowledge required for certain approvals. Not only that, but they must ensure that this training is accurately depicted to others who will be on the team. Also, there must be someone willing to be extra meticulous in observing the documents to ensure that there is no issues when trying to gain approval on certain documentation