Compliance audits are externally and domestically driven inspections of a firm’s compliance with regulatory or legal requirements, market standards, license conditions, contractual obligations, and other formal responsibilities. Compliance audits, like financial, administrative, and certifying audits, are similar in that they usually target standards, processes, or regulatory constraints that are required for organizations. Compliance auditing, as a category, is more general than other kinds in terms of who performs these audits, the purpose, or the organizational elements or issue areas that allow for audits.
Large and small companies may improve their audit scores by properly combining document management with Quality and Compliance procedures. Many firms that previously saw document indexing & quality management as separate activities are increasingly pursuing an integrated perspective on compliance & quality, constructing a strong value infrastructure on a solid base of document management.
What Exactly Is Document Indexing?
Document indexing inside a system for document management relates to how we arrange our digital documents. Our DMS (document management system) indexes data such as a file’s name or the time and date it was produced to assist us in finding documents by entering search phrases.
A document indexing technique is most effective when everybody in our DMS arranges and labels all directories and files consistently. To achieve the greatest outcomes, educate our personnel on indexing procedures. Nobody will have trouble looking for or exchanging project files if everyone adopts the same indexing approach in the system for document management.
Requirements For an Effective Document Management Process
We believe that the document management process for improving audit results should be consistent with:
- Instant access to all plant and business documents at all levels within the enterprise based on appropriate roles and privileges. (Companies, factories, distributors, suppliers, etc.)
- Create a simple document lifecycle management framework that includes document creation, change management, administrative approval and regulatory recording, and real-time and historical reporting by document indexing services.
- Allows auditors to review product documentation processes and controls. For example, auditors can create checklists based on established procedures and documentation to quickly create an appropriate audit package.
- Ensure changes to documented SOPs (Standard Operating Procedure) and process manuals trigger appropriate organizational learning processes. Many regulations require evidence of adequate training in documented SOPs and changes to procedures.
- Reduce the complexity of document handling in offline & email contexts. Implementing offline and email document management is critical as process documentation, SOPs, and vendor agreements are managed together. In most cases, documents must be processed by a third-party vendor without access to a document management environment. All document changes and approvals must be recorded in the system in an offline environment.
Ideas For Improving the Audit Score Through Effective Documentation
Look For Systems That Can Automate the Full Document Lifecycle
A well-designed document control solution may assist us in managing the whole lifetime of a document.
- It includes the creation, change management, approval, archiving, and storage of all documents.
- Reuse existing document lifecycle models.
- Track and save data by integrating easily with our current document management architecture and document store via data entry services.
- Allow dedicated role-based groups to work together throughout the supply chain during the document lifecycle.
Find Practical and Usable Mobile Solutions for Our Entire Extended Organization
Many document management programs fail because the system is difficult for users to use when working with documents in the field. Forward-thinking organizations are pushing for offline and mobile document solutions to enable compliance and quality organizations to manage document lifecycles in the field and not have to re-enter updates when they return to the office. Reintroducing document changes is a mistake we think can be avoided. Simple questions to ask and consider:
- Can a good organization handle documents via email? Can documents be processed remotely via email and automatically synced with a centralized document management solution?
- Can a handheld device such as a PDA (Personal digital assistant) be used for document lifecycle management? Do real-time approved rules confirm document approval and review when users modify documents in the domain?
Find A Document Management Solution with Built-In Process Management Capabilities
A well-designed document management solution should seamlessly integrate with process management capabilities to help increase audit outcomes. Changes to SOP and documentation must follow process changes and vice versa.
- Can the process described in the SOP be implemented using process flows?
- Does the system provide automatic alerts when SOPs change? These changes may mean that we need to control the changes in our process.
- Can we effectively adjust standard operating procedures and controls based on audit results?
Find An Easy-To-Manage Document Management Solution
A universal document management solution works as well as a document repository. However, when building a compliance and quality records management solution, auditability and traceability are paramount. Simple questions to ask and consider:
- Is it possible to have a holistic view of all document changes for audit purposes?
- Can auditors review all aspects of document retention and lifecycle to determine process compliance?
- Can compliance and quality alerts be triggered based on rules set by internal or external auditors?
Conclusion
By carefully integrating document audits with compliance and quality processes, large and mid-sized manufacturers can significantly improve their audit results. Many organizations that previously treated document control and quality control as separate initiatives are now taking a more integrated approach to compliance and quality by building a solid quality infrastructure on top of a strong document control foundation.