Document Control
Document Control systems deficiencies were a contributing factor to the 2010 Deepwater Horizon disaster, exacerbating human errors and systemic failures all of which led to a catastrophic oil spill with grave human, environmental, and financial costs.
While the Deepwater Horizon case is an extreme example, everyday shortcomings in document control can also lead to project delays, legal issues, rework and regulatory compliance issues. A robust document control system can mitigate risks across a spectrum of severities and probabilities, safeguarding both projects and businesses.
This blog provides a guided tour through the intricate landscape of Document Control. From understanding its core necessity in modern organizations to exploring when and how to apply it effectively, we delve into the key ingredients that shape a robust Document Control system. The challenges that arise from weak systems are illuminated and insights into the benefits of employing advanced Document Control software with specialized features are provided. Whether you're tasked with maintaining document consistency, ensuring regulatory compliance, or facilitating quick and accurate retrieval of information, this blog lays down the core standards, procedures, and best practices to elevate your Document Control strategy.
What is Document Control?
Document control encompasses the systematic management of documents throughout their lifecycle, focusing on:
Search – Quick and precise document retrieval.
Version Control – Ensuring that the most current and accurate version of a document is always available.
Access Control – Regulating who can access, edit, and distribute documents, maintaining security and confidentiality.
Organization – Structuring and storing.
Monitoring – Author, edit, review and release cycle progress monitoring.
Managing Change – Document change request, approval and implementation management.
Traceability – Providing a comprehensive record of document versions and revisions, including edit, review and approval cycles (the backbone of regulatory compliance)
Risk Mitigation – Minimizing the risk of using outdated or incorrect documents
Why is Document Control Required?
Effective document control is vital across various industries, including aerospace, defense, construction, and medical devices. The reasons for implementing such systems may vary by sector, but they commonly include:
Safety Assurance – Consistent adherence to document control protocols minimizes the risk of accidents, as seen in catastrophes like Deepwater Horizon.
Risk Mitigation – Keeping accurate records reduces the chance of rework, litigation and more.
Regulatory Compliance – Adherence to government and industry standards helps avoid expensive fines and penalties.
Efficiency Improvement – Quick access to essential documents speeds up project timelines and minimizes downtime.
Knowledge Sharing – Centralizing documents fosters teamwork and reduces the dependency on individual memory for vital information.
Consistency – Standardized templates maintain uniformity across various projects.
Version Control – Managing document versions eliminates confusion, ensuring that teams use only the latest, approved files.
Data Security – Protecting sensitive data from unauthorized access is essential for safeguarding proprietary information.
Disaster Recovery – An effective system is crucial for disaster planning, preserving critical documents against unexpected events.
When is it Time for Document Control?
While the absence or presence of document control systems comes with costs, companies typically invest in them when the financial and operational benefits outweigh the expenses of going without one.
Here are some common trigger points that may be the catalyst for formalizing and implementing a document control system:
Regulatory Changes – A new customer who demands an ISO accreditation, or a change or tightening of existing regulatory requirements, may spur a company to implement a formal document control system.
Project Complexity – As projects grow in scope and complexity, the need for a standardized way of managing documents becomes essential to keep everyone on the same page.
Data Security Concerns – With increasing risks of cyber-attacks and data breaches, a formal document control system can provide enhanced security measures to protect sensitive information.
Scale of Operations – As a company expands, perhaps across multiple locations or even countries, a formalized system becomes necessary for maintaining document consistency and uniformity.
Quality Assurance – To achieve quality certifications driven by standards like ISO 9001, AS9100 or 21 CFR Part 820, companies will need to demonstrate robust document control procedures as a part of their quality management system.
Litigation Risks – Companies in litigious sectors may implement a document control system to better track document revisions, approvals, and distributions, thereby reducing litigation risks associated with sub-par document control.
Increasing Collaboration – With more teams, departments, or external partners involved in a project, a formal system is needed to ensure that everyone has access to the correct, up-to-date information.
Streamlining Operations – An increase in operational delays due to inefficient document control is often a catalyst for adopting a more formal document control system.
Cost Savings – After experiencing losses due to poor document control—like lost work, project delays, or compliance fines—companies may find that a formal system is more cost-effective in the long run.
Technological Advancements – The availability of advanced, affordable and user-friendly document control software can make the transition more feasible and beneficial for companies, incentivizing the switch.
Regardless of the specific motivations, companies will implement a formal document control system when the time is right to tackle associated business challenges. Whether large or small, the key components for a successful document control system include a team of skilled and knowledgeable individuals, well-established procedures, and supportive technology.
A Weak Document Control System Creates Challenges
If your company lacks a robust document control system, you may be grappling with a range of challenges as shown below. Addressing these challenges is crucial for improving project outcomes, ensuring compliance, and enhancing overall operational efficiency.
Document Version Uncertainty – Difficulty in identifying the most recent and approved versions of documents, leading to errors and inconsistencies.
Regulatory Compliance Challenges – Struggling to meet industry regulations due to scattered documentation, thereby risking fines or legal repercussions.
Difficult Audits – Difficulty in preparing for audits because of missing or incomplete records, leading to stressful and time-consuming audit processes.
Geographical Disconnect – Lack of coordination between multiple locations, making it hard to manage and share documents effectively.
Slow Information Retrieval – Wasting time locating essential documents, which slows down decision-making and project timelines.
Inconsistent Knowledge Sharing – Important information is often stored in individual inboxes or local drives (or worst of all in people’s heads), creating bottlenecks in knowledge transfer.
Manual Workflow Processes – Time consuming manual tasks for document reviews, approvals, and notifications, leading to delays and increased chance of human error.
Insecure Data – Sensitive documents are not adequately protected, risking unauthorized access and intellectual property theft.
Lack of Business Continuity – Absence of a disaster recovery plan for essential documents, leaving the business vulnerable in case of system failures or other emergencies.
Storage Redundancy – Multiple copies of the same documents exist, leading to storage inefficiencies and version confusion.
Inadequate Record Retention – No clear process for how long documents should be kept or when they should be purged, leading to potential compliance issues.
Mismanaged Contracts – Difficulty in tracking the status of contracts, leading to missed deadlines and unmet obligations.
Inefficient Lifecycle Management– Difficulty in monitoring the progress of documents during the author/review/approve/release stages of the document lifecycle, leading to delays and inefficiencies.
Problematic Transmittals and Submittals – Difficulty assembling transmittals and processing submittals, which affects project timelines.
Uncontrolled Document Distribution – No centralized control over who receives what documents, creating security risks and inconsistencies.
Document Control System Ingredient #1: People
A strong document control system depends on a range of skilled professionals within a business. These roles can be categorized into two main groups: those who hold key responsibilities for overseeing the system and those who provide specialized support. Understanding these distinctions can help clarify who takes the lead in document control and who offers valuable support.
Key Roles/Functions:
Executive Sponsors – Senior management who provide the organizational approval, budget, and strategic direction for the document control system. A strong, supportive Executive Sponsor is the key to a high performance document control system (the opposite is also true).
Project Managers – Lead projects and are responsible for ensuring that document control is an integral part of project management.
Document Controllers – The linchpin of the document control process, managing every stage of a document's lifecycle.
IT Managers – Often handle the technical back-end of the document control system, ensuring it's secure, accessible, and running smoothly.
Supporting Roles/Functions:
Legal Advisors/Compliance Officers – Provide legal oversight, ensuring documents meet regulatory and industry standards but may not be involved in daily operations.
Records Managers – Specialize in the archiving and retrieval aspects of documents but generally do not oversee the entire document lifecycle.
Business Analysts – Offer insights into how to optimize the document control system for business needs but are not involved in day-to-day management.
Change Control Board – May review and approve changes to critical documents but are not usually involved in the routine control process.
Project Controllers – Use the system for financial and operational oversight in projects, and might have some say in its setup, but generally do not manage the system.
Quality Assurance/Quality Control Managers – Directly responsible for ensuring that documents meet compliance and quality standards.
Auditors/Internal Auditors – Evaluate the effectiveness and compliance of the document control system but are not involved in its regular management.
Document Control System Ingredient #2: Process
Document control standards and procedures are crucial for maintaining the integrity, accessibility, and traceability of an organization's documents. These standards outline the rules and processes that govern how documents are created, reviewed, released, and managed. By adhering to these guidelines, an organization ensures that its documentation remains consistent, compliant, and easily retrievable. Adhering to these core document control standards and procedures not only streamlines operational processes but also fosters a culture of accountability and excellence within the organization.
Below are the some standards and procedures to consider:
Document Format, Content and Structure Standard – Defines the layout, content, and structure of documents to maintain consistency across all organizational files. This standard ensures that documents follow a uniform template and contain the necessary elements for effective communication and compliance.
Document Numbering Standard – Establishes a systematic method for numbering documents to facilitate easy retrieval and traceability. This standard ensures that each document family can be uniquely identified, avoiding confusion and aiding in search operations.
Document Review, Redline and Markup Process – Sets the procedure for reviewing documents, including how to mark changes and comments. This process encourages multiple layers of review, ensuring that errors are caught and the document is of high quality before its release.
Document Release/Issuance Procedure – Outlines the steps for officially releasing or issuing a document within and outside the organization. This procedure ensures that only authorized personnel can release documents and that these are distributed to the correct recipients.
Document Distribution Procedure – Describes the methods for distributing documents to relevant parties and locations where printed and controlled documents are maintained. This procedure ensures that documents reach their intended recipients in a timely and secure manner.
Document Change Procedure – Specifies the workflow for making changes to an existing document, including who can initiate changes and how these are tracked. This procedure maintains the document’s integrity and ensures that changes are properly recorded.
Document Version and Revision Management Procedure – Governs how different versions and revisions of a document are managed and stored. This ensures that team members are always working on the most up-to-date version of a document, reducing errors and redundancies.
Document Archival Procedure – Describes how to archive old or obsolete documents while ensuring they remain retrievable for future reference or compliance checks. This procedure ensures that historical data is not lost and that the active document database remains clutter-free.
Document Transmittal Management Procedure – Sets the guidelines for transmitting documents to external parties. This ensures that documents are sent and received with a clear audit trail.
Document Submittal Management Procedure – Outlines how documents submitted to the organization, are to be received, logged, and reviewed. This procedure ensures that all incoming documents are handled in a consistent manner, meeting compliance and organizational standards.
Document Control System Ingredient #3: Technology
Effective document control relies on a range of technologies to streamline processes, improve accessibility, and enhance security. These technologies not only save time but also contribute to better project management and compliance.
Here are some key technologies that enable efficient and effective document control:
Document Control Software – Provides a centralized repository for storing, managing, and tracking documents throughout the document lifecycle. It offers features that address all document control and management challenges.
Cloud Storage – Cloud-based solutions offer remote access to documents, making it easier for geographically dispersed teams to collaborate in real-time.
Digital Signatures – Digital signatures authenticate the identity of the author and provide an additional layer of security, ensuring that the document has not been tampered with during and after the approval process.
Dashboards and Reporting Tools – These provide real-time insights into document statuses, approval workflows, and other key performance indicators, aiding in better decision-making and project management.
Mobile Access – Allows for on-the-go access to documents from mobile devices, ensuring that team members can review, edit, or approve documents from anywhere.
Document Control Software: Benefits
In today's fast-paced business environment, effective document control is more crucial than ever for ensuring seamless operations and maintaining a competitive edge. Document Control Software serves as a cornerstone for this, offering a wide array of benefits that extend from internal efficiencies to external client relations.
Below, are 11 key advantages that organizations can realize by implementing a robust Document Control Software solution. These benefits collectively contribute to enhanced operational effectiveness, better decision-making, and ultimately, a more satisfied client base.
Streamlined Workflows – Automated routing and approval processes reduce manual hand-offs, expediting the entire document lifecycle and minimizing room for errors.
Improved Efficiency – Centralized storage and advanced search features enable quick and easy retrieval of documents, cutting down on time spent searching for information.
Enhanced Collaboration – Real-time editing and commenting functionalities foster team collaboration, enabling faster decision-making and project execution.
Increased Security – Robust permission settings and encryption options protect sensitive information, ensuring that only authorized personnel can access or alter documents.
Version Control – Keeps track of changes made to documents over time, providing a history of revisions and ensuring that team members are always working on the latest version.
Regulatory Compliance – Features such as audit trails, digital signatures, and immutable records support compliance with various industry regulations and standards.
Reduced Costs – By automating many manual document control tasks, businesses can significantly cut down on operational costs related to printing, storage, and manpower.
Scalability – Being software-based, it is much easier to scale the document control solution as the organization grows, without a proportionate increase in costs or complexity.
Real-time Monitoring and Analytics – Integrated dashboards offer real-time insights into document statuses and workflow efficiencies, allowing for timely interventions and continuous improvement.
Business Continuity – Centralized, cloud-based storage ensures that critical documents are safely stored and easily accessible, even in the case of local hardware failures or other disruptions.
Client Satisfaction – The efficiency gains from Document Control Software can lead to quicker project completions and cost savings, enhancing client satisfaction and retention.
Document Control Software: Deployment Options
When evaluating Document Control Software, one of the key decisions you'll face is whether to opt for a cloud-based solution, an on-premise system, or a hybrid model. Each approach comes with its unique sets of features, benefits, and challenges, and understanding these nuances can greatly influence your decision-making process.
Cloud-based Document Control Software – Cloud-based solution providers host their document control software on their remote servers accessible via the internet. This provides the immediate benefit of accessibility; team members can access files and collaborate in real-time from any location with internet access. From a technical standpoint, cloud-based systems are generally quicker to deploy, require no in-house IT expertise, and offer seamless scalability as your needs grow. Software updates occur often and are usually automatic, ensuring you always have access to the latest features and security patches. However, these solutions might present some data sovereignty concerns depending on corporate policies and where the servers are located.
On-premise Document Control Software – On the flip side, on-premise solutions require you to host the software on your own server infrastructure. This offers the advantage of complete control over your environment. Technically, you're looking at a more complex setup process, with potentially large upfront capital expenditures for hardware and licenses. Plus, the onus is also on your internal IT team for maintenance, software updates, and addressing any system issues that arise. There's less flexibility for remote access unless you set up a Virtual Private Network (VPN), which adds another layer of complexity.
Hybrid Document Control Software – The hybrid model blends the best of both worlds. Files and data are stored in an environment controlled by the customer, while the application and business layer are hosted in an environment controlled by the software vendor. This offers a balance between control and accessibility, allowing companies to comply with data sovereignty requirements while still benefiting from the speed and flexibility of cloud-based systems.
The choice between cloud-based, on-premise, and hybrid solutions often depends on your organization's specific needs, technical capabilities, and compliance requirements. While cloud-based solutions may appeal to progressive, agile businesses, on-premise solutions often suit more conservative organizations. Hybrid models offer a middle ground for those seeking both control and flexibility. All three options have their pros and cons, and the right choice should align with your operational priorities, budget considerations, and long-term business strategy.
Document Control Software: Foundational Features
The foundational features of Document Control Software—search, access control, version control, revision control and workflow management—are vital for modern business operations. They create a robust system that makes document interactions secure, organized, and efficient, laying the groundwork for additional specialized features tailored to various industries.
Search Functionality – At the core of Document Control Software is effective search functionality. With vast amounts of documents, the ability to find files swiftly is essential. Advanced search features use metadata, content, and filters to narrow down results, enhancing productivity and saving time.
Access Control – Security is a foundational aspect of document control. Access control enables permissions to be set for individual files or folders. It's your digital gatekeeper, ensuring that only authorized personnel can access sensitive data, thus maintaining compliance and data integrity.
Version Control – Version Control is relevant during the draft or development stages of a document. It meticulously tracks every modification made, capturing a snapshot of the document each time changes are saved. This way, team members can access previous versions, compare differences, and even revert to an older version if needed. This iterative process supports collaboration and editing, ensuring that all changes are accounted for.
Revision Control – Once a document is finalized and approved it will be released. Once the revised draft is updated (using version control) it will be approved and released with a next in sequence revision identifier (example: Rev A, Rev B, etc.) for easy traceability. Superseded copies of older revisions are maintained for compliance and audit purposes.
Workflow Management – Workflow management automates document routing and offers real-time tracking during the review, approval, and release stages. This provides insight into bottlenecks and deadlines, enhancing control and efficiency.
Document Control Software: Specialized Features
Specialized features, ranging from advanced viewing and file structuring capabilities to robust integration options and mobile accessibility, provide added layers of efficiency, control, and versatility to Document Control Software. They turn a basic storage and retrieval system into a dynamic platform that can adapt to the specialized needs of various projects and industries.
Viewer Capability – Allows users to view, review, and markup various file types (be it PDFs, CAD drawings, or media files) without the need to download and open in other software applications. This feature eliminates the need to purchase, install and maintain applications and streamlines the view/review process.
File Organization and Structure – Files are structured primarily to enhance organization and accessibility within a system. Most document control software solutions achieve this through limited folder-based file organization approaches. More advanced systems utilize PLM like functionality to both manually and automatically create optimal file structure with metadata such as a project number, file category (i.e. report, drawing, spec, etc) and more.
Progress Monitoring and Reporting – A comprehensive reporting tool not only displays the status of individual documents but also provides an overview of project health. These insights help in making data-driven decisions and provide an opportunity to proactively address issues before they become problematic. The result is improved project predictability and control.
Software Integration – Document Control Software rarely operates in a vacuum. The ability to integrate with other software products like CRM systems, project management tools, or financial software brings an additional layer of functionality. This feature enhances the software’s utility and makes it a more versatile tool in an interconnected digital ecosystem.
Collaboration Features – Advanced collaboration features such as discussion boards and automated notifications facilitate seamless teamwork. They make it easier to coordinate complex projects involving multiple stakeholders, ensuring that everyone is on the same page. This enhances overall productivity and reduces the likelihood of costly errors or misunderstandings.
Mobility – The rise of remote work makes mobility features more crucial than ever. Document Control Software with mobile access ensures that team members can review or approve documents even when they're away from their desks. This enhances flexibility and ensures that work can continue uninterrupted, regardless of location.
