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!
Document control will be easier for QA and R&D department if documents that need to be filled out, are entered without any error or miss information or mainly without any false information. Working on research and documenting at the same time, is the hardest part of the job since scientist have to be accurate about both. Therefore, mistakes are inevitable but at the same time if taken care and precision, this can be avoided or can be reduced to minimal. Whether it is electric notebook or hand written, documentation along with research will always have some or other issues. Accuracy, precision and attentiveness can improve document control.
Hi Hruship101,
Read the below information:
How You Determine Whether a Document Requires Quality Document Control Measures
Companies should not view quality document control mandates, such as ISO 9001, as a curse. In truth, they can be blessings in disguise. Organizations that effectively control and manage their documented information enjoy a distinct competitive advantage, not to mention a more efficient quality team, enhanced product quality, improved brand equity, and, ultimately, a reduced cost of compliance. This begs the question: given all of the advantages of effective document management, why do so many regulated companies continue to struggle with or postpone the implementation of effective quality document control procedures? For many, it's a simple as knowing which documents need to be controlled and which do not. While this seems quite basic, it makes sense when one considers the vast amount of documentation that might require control within an organization. Although FDA regulations and international standards require regulated companies to establish compliant documentation processes, few, if any, concrete guidelines are given. Conversely, the ISO 9001 standard provides direct guidance on this matter.
Section 4.2.3 of the standard states: "All documents required by the quality management system shall be controlled." In other words, if the document in question relates to any of the requirements discussed in ISO 9001, quality document control measures are required. For example, if the information contained in the document guides the production of the goods or services provided by the company, it must be controlled. If personnel make production decisions based on the information contained in the document, it must be controlled. If the information contained in the document is critical to product safety, the document must be controlled. Finally, if the verification, inspection, or testing of the company's products, i.e., goods or services, are guided by the information contained in the document, quality document control procedures are necessary.
The Basic Tenets of Effective Quality Document Control
While not exhaustive, the aforementioned examples illustrate some of the considerations an organization should examine when determining whether a document should be controlled. Once this fundamental determination is made, the quality team can move on to the actual process of controlling the document by employing several quality document control procedures. These procedures include:
Document Approval - Before a document is utilized, it must be approved for accuracy and/or adequacy. In paper-based document management systems, this is usually achieved by requiring authorized persons to sign or initial the document. This can be a complex and time consuming process, particularly if the document requires the approval of several employees from different departments. When these departments are spread out geographically, the complexity increases.
Periodic Document Review, Revision, and Reapproval - ISO 9001introduced the quality document control procedure of requiring companies to routinely review their documents for continued validity. It's important to note, however, that this requirement goes beyond routine document revision. Rather, it refers to the process of periodically recalling documents to determine whether the information contained in the document is still accurate and relevant. Depending upon the findings, the document will either be reapproved as is, updated as necessary, or retired. These types of quality document control reviews can either be triggered on a strictly periodic basis, e.g., annually, or because of business events (e.g., product changes), technological breakthroughs and the like. One disadvantage of the periodic approach is, unless an automated document management system is in place, its success depends heavily upon the employee in charge, and whether he or she is disciplined enough to conduct the reviews within the specified time frame in addition to performing all of his or her other daily tasks.
Revision Status Control - A document's current revision status must always be identified. This important quality document control procedure prohibits the use of obsolete or unapproved documents, which can compromise compliance. With electronic systems, the most current document version is provided automatically. However, with paper-based systems, human error can often lead to mistakes in tracking and identifying the most current revision number.
Document Accessibility - If a document is not easy to access precisely when it is needed, it's virtually useless. It also contradicts the ISO 9001 requirement that "relevant versions of applicable documents are available at points of use." Making documents easily accessible throughout the document lifecycle is another important quality document control tenet.
As you can see, the basic tenets of document control are relatively simple, and simplicity is key. Just as some companies make of the mistake of not having enough document controls in place, others make the equally critical mistake of implementing too much complexity into their document procedures, which can lead to ambiguity, and an excessive supply of unnecessary information. Good documentation practices can dramatically improve an organization's efficiency and effectiveness. Implementing the basic tenets of quality document control will unburden your quality management system of superfluous documentation.
Find the Right Balance Between Quality Document Control and Simplicity with MasterControl
MasterControl Inc. is the foremost global provider of enterprise quality document control management software specifically designed to ensure conformance with regulatory requirements such as ISO 9001:2000. Web-based and configurable, the MasterControl document control management solution, MasterControl Documents, enables highly regulated companies to streamline their document control processes, and to provide its users with the relevant documentation they need quickly and easily. Furthermore, MasterControl makes is possible to connect document management with other quality process, such as CAPA and change control, ensuring that compliance and overall quality improvements are continually promoted across the enterprise. Here are just some of the ways in which MasterControl Documents simplifies the quality document control procedures outlined above.
Automates document routing, escalation, and approval - Typically, product documentation has a complex lifecycle that is further complicated with workflows and routing. MasterControl reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks. Automating these processes helps sustain compliance - and eliminates the human error than can occur with the periodic approach to document review.
Eliminates out-of-sync metadata - Any change made to document metadata, which includes document attributes like title, author, etc., must be tracked, and a reason for the change must be provided. This is simply a fact of good quality document control. When revising a Microsoft Word® document, updated metadata information can be automatically transferred to the document header from the InfoCard, which is the MasterControl tool used to provide basic document information.
Improves change control - With MasterControl, users are able to seamlessly track the changes between the revisions of an item in the MasterControl system and make them available for review.
Simplifies revision number control - Being able to control the revision number of a document is one of the most challenging aspects of quality document control, particularly in paper-based systems where human error is inevitable. MasterControl's automatic revision control feature ensures that only the most recent version of a document is made available, which helps users avoid the mistake of obtaining information from obsolete or unapproved documents.
Promotes fast, easy document accessibility - Because MasterControl allows you to capture and store all of your important documentation in one secure, centralized location, employees across departments, as well as across the world, can easily search for an access the information they need. Furthermore, automating your paper processes with MasterControl enables you to implement consistent, efficient quality document control workflow processes that minimize the time it takes to locate, revise, and approve documents, which can help you avoid being unable to locate an important document during a critical audit or inspection.
https://www.mastercontrol.com/document-control-software/control/quality.html
Document control of a QA department is meant to assure that all documentation for a project is in order so when the FDA or some other organization comes for an audit, for example, the company team is prepared to show they are abiding by their standards. With that being said, perhaps one thing that can be improved in order to make documentation less "strict" is for organizations to come together and compile one big standard record that international companies and smaller ones will have to abide by. This seems extremely unlikely since multiple organizations will have to combine, so a more viable solution will be one that takes place within the company it self. Perhaps expanding a QA/QS department will lighten the load on the department on whole; so, for a bit more investment dollars the company can have a faster process. Another possible solution would be for other departments to comply with the quality department so there is no conflict when information or protocols go between said departments.
Making sure that both the R&D and quality engineers do their jobs would make it extremely easy improve a document. Besides that, the improvements comes with time. As Dr. Simon mentioned in the presentation, as the company grows in the size more rules needs to followed and thus more quality engineers are needed.
This is a little out of my scope of my job, but I was just at conference and the large device companies use different systems. For example Cognition has a platform called Cockpit, which a risk management and design control platform for medical device, and pharma development teams.
21 CFR 820.40 instructs companies to establish and maintain procedures to control all documents required by Part 820 of the Quality System Regulation established by FDA. For Document Approval and Distribution, you designate one or more people to review documents for adequacy and approve prior to issuance.Document approval includes date and signature of approving person(s). Document Changes-have changes to documents reviewed and approved by same person(s) designated in part Communicate changes to the appropriate personnel in a timely manner. The Cockpit Platform provides a single, backed-up repository for creating Design and Development Plans along with Risk Management Plans. The platform also auto-populates a Design History File (DHF) that can be used as supporting evidence for the Design Controls process as defined by 21 CFR 820.30. I think using electronic systems like this one are great so you can see who is working on the documents so if something changes you can see exactly who made a change and go to them to discuss.
The largest issue that I have seen in Document control is that there is an inconsistency in how documents are suppose to be completed. The established documentation practices document will give a great deal of guidelines for the other departments to follow, but they usually fail to completely encompass everything that needs to be done. This leaves room for opinions. I think one of the best ways to ruin the quality is when people's opinion begin to become facts. The difference needs to be clearer to the Manufacturing and R&D department so documents can be done correctly and efficiently.
Document control is also essential to prevent information loss. It’s not unheard of for a particularly knowledgeable employee’s loss (due to any reason, from resignation to death) to cripple an R&D/manufacturing project, a QA program, or a related process. Document control ensures that a company can keep important information in place in case of disaster.
This is just one of the many benefits of document control, of course. As others have mentioned it leads to enhanced transparency, better assessment ability, and improved accountability. In general, document control benefits a business more than it may benefit individual employees. As such, it may be worth incentivizing superior document control by employees in some ways. And as others have mentioned, a well-developed protocol that instructs employees on good documentation practice will save them a lot of time and frustration.
There are issues with the quality department being strict in following regulations and rules, which many times cause delays in the release of products. However, document control is necessary in all companies and needed to ensure the success of products. Document control can be improved by making sure that each department is cooperative with each other. The documents to be completed are always changing with the new regulations being made on a daily basis. All departments should be notified immediately when there has been a change, so they do not create a product that will go to quality department which well end up being rejected or delayed. There needs to be a better communication system between the departments. Document control is key in creating effective products.
Document control in QA department can be made easier by:
Having a Self-hosted DMS which is a good option for small to midsize departments. It helps to reduce administration time, increase productivity and save money and also gives you complete control over critical corporate data.
Also, having a Cloud-Hosted DMS will enable easy access to the system files from anywhere that has an online access, and provides easy backup since the data is automatically saved in the cloud.
I agree with williamzembricki in stating that the largest issue with Document Control is the inconsistency. While Document Control exists to protect the entire company, there are some changes in the policy that come without warning or even without explanation. This makes it very difficult for engineers or anyone else in the company to comply to the proper documentation practices. To improve Document Control and to create a more cohesive work environment, there should exist a document or a procedure to follow. Additionally, within the software that houses the documentation, there should be an automatic update of revisions, such as in the cross referenced documents.
I can understand why documentation can be an annoyance as well unnecessary to a certain extent. However, it is an integral step in preventing certain mishaps and keeping everything in accord. The main reason companies document things is to make sure they have everything noted in case the company is ever sued it has something to fall back on. One way to improve documentation is preventing repetition. One of the issues with so much documentation is that there is a lot of repetitive documentation. The forms can be streamlined and made easier to fill out.
I currently work in manufacturing and everything we do is review by Quality. Our department has a good relationship with QA who reviews our batch records. This may just be so due to the fact that manufacturing doesn’t really get to have much say in the process. Our process is defined by process development, we simply manufacture the produce and adhere to the standards that QA has for carrying out the process. However, when worked in Validation and was working on validating equipment for the GxP labs. That’s when I encountered a variety of problem with Quality in submitting the document that were needed to carry out the process. In my experience process development and research would defiantly have ore problems with Quality.
I will talk one way I think can improve document control.
That is promoting training and documentation.
Every employee charged with handling some form of document should be trained in content management and proper handling policies as determined by credit union policy. Processes may differ slightly from the lending and member service areas, which tend to generate the greatest amounts of paper, to the teller stations, human resources department and less document-intensive environments. But the end process, whether full or only partially automated, should apply to all paper-handling staffers at all levels.
Documentation control involves tracking document changes, revisions, and maintain of relevant versions company’s policies and procedures. This process takes significant amount of time when manaully done. The use of documentation management system would help reduce the lagging time for review and approval of document as this can done from anywhere. Activity log for every document are kept automatically, simplify audits and ensuring compliance.
