Centralize content to improve data flow, security
Document management and control are critical components of a plant’s quality operations. Good manufacturing practice, FDA regulations, ISO standards, and other regulatory and compliance mandates require that companies manage versions, control employee access, facilitate training initiatives, and implement appropriate change control procedures for operational documents.
Quality systems without integrated document control processes can put plants at a competitive disadvantage and significantly increase the risk of noncompliance with standards and regulations associated with cGMP, ISO, and the FDA, among others. Document management systems provide a framework for centrally organizing, managing, and tracking the important documents, information, and processes typical in plant operations, and support lean manufacturing practices and quality management programs that ensure efficient and ISO-compliant operations.
As plant operations expand, the demand for increased information storage capacity and process improvement will inevitably follow. Therefore, it’s important to select and implement a document control system that can seamlessly scale as business grows.
Implementing a security framework to enforce role-based policies and document access permissions establishes the specific level of access granted to each user, helping to ensure that only authorized employees can access sensitive or confidential documents. Controlling employee access and permissions is an important aspect of compliance and version control, as well as a critical element of processes associated with the approval, release, and distribution of critical information assets. Well-defined access permissions and associated policies and processes lead directly to a reduction in errors and mistakes on the plant floor due to the use of out-of-date or otherwise incorrect documentation.
It’s also important to select a document management solution that provides a straightforward means for authorized administrators (not just highly technical IT personnel) to update, refine, and add additional document and data types, as well as workflows and business processes that affect the business. Role-based policies can also be employed to monitor and control administrative tasks, and alert appropriate parties when appropriate.
Also, consider automating and enforcing specific document-related processes to comply with ISO and other industry standards and regulations, such as document review and approval processes, which will also further increase efficiency and worker productivity while fostering continuous improvement and collaboration.
Greg Milliken’s full article on ‘Taming the Documentation Beast’ is one of the topics in Plant Engineering’s Forecast issue, which will be published in mid-February. To receive the digital edition of Plant Engineering in time for the Forecast issue, which also will feature the 2011 Plant Engineering Salary Survey, subscribe here (it’s free!).