Standard operating procedures (SOPs) serve as blueprints for consistent and reliable operations, providing the precise steps to be followed when performing specific business-critical tasks. In the manufacturing environment, everything from equipment operation and product assembly to maintenance procedures and quality assurance processes are controlled under the guidance of SOPs.
Whether an organization is operating in accordance with the Current Good Manufacturing Practices (cGMP), ISO 9001 or an industry-imposed regulation, its quality-related processes and best practices are explicitly dictated by its SOPs. However, quality management systems should not only focus on documenting the procedures but also ensuring that existing processes and procedures are completed in a repeatable and audit-proof manner. It also enables employees and other stakeholders to track incidents, identify new risks and modify SOPs accordingly — a collaboration that ultimately results in better manufacturing outcomes.
The SOP Evolution
Most managers and employees understand what SOPs are. But all too often once documented, these standards are printed out, filed away and forgotten until needed. While this paper-based paradigm is shifting, this paper-based process is often replicated in a network file folder environment where multiple electronic versions of SOPs reside in different folders and business systems.
In order to effectively guide what a company is doing and promote proven best practices, SOPs must be treated as living documents with the power to continually improve upon past business results. Even in the most rigid environments where virtually everything is controlled, evolving SOPs can represent opportunities to further cut costs, increase productivity and optimize quality assurance.
The Power of Automation
While quality and compliance rely heavily on the creation, sharing and maintenance of SOPs, it is through automation that optimal SOP management is achieved. This entails the deployment of an automation-enabling solution upon which all employees — from quality managers to front-line employees — are trained. Ongoing access to the solution is also essential to ensure that SOPs are uniformly managed, modified and updated as needed, while also providing the ability for managers to track and verify which employees have received and read all relevant SOPs. This key component of automated SOP management may be the most critical and valuable to your organization.
To date, manufacturers have taken two approaches to automation enablement. The first is procuring a purpose-built system that covers the unique requirements for quality management, such as managing records and tracking deviations. The shortcoming with this approach is that quality management systems are often isolated repositories, which are frequently not integrated with other business systems. As a result, manufacturers make a significant investment in a solution that can only be used for one purpose.
The other approach is the utilization of electronic information management (EIM) systems, which are capable of integrating with existing enterprise and legacy systems, and can also support applications designed specifically for quality management purposes. To administrate SOP management across the full spectrum of a quality manager’s requirements, an EIM solution must extend beyond mere document control. They need to also offer support for class-based permissions and access controls that are based on an information asset and its content, as opposed to where it is stored. This is not only critical for highly regulated industries where sensitive data and processes are managed, but it also facilitates automation across a wide range of quality workflows, such as change control, CAPAs (corrective and preventative actions) and training management.
Streamlining SOP Management with EIM
When manufacturing involves products or processes with rigorous compliance requirements, SOP management tasks can be particularly challenging. An EIM solution can alleviate many of these challenges, helping organizations automate the creation, modification and management of SOP documentation while also streamlining other processes that are critical to quality systems, including:
- Deviations and CAPAs: When a deviation is occurs, related corrective and preventative actions (CAPAs) must be defined, documented and communicated by the quality management team. Linking these actions to the change requests of the associated SOPs improves the processes, reduces risks, and ensures that employees can be trained to work according to the updated processes.
- Automate Manual Processes and Workflows: EIM systems can eliminate paper- and Excel-based processes with electronic forms that leverage digital signatures. As a result, SOP-related workflows such as change orders and purchase order approvals can be fully automated with verification that every step in a business process is followed.
- Certifications and Audits: In a manufacturing environment, any new version of an SOP must be authorized with a supervisor’s signature. Similarly, when new employees access and read training manuals, their manager must be able to prove that they have done so. Collecting evidence that specific processes have been followed is often one of the most challenging aspects of a manufacturer’s quality system. An EIM solution can be configured to automatically organize and manage all quality-related documents and associated processes with complete version history, security, workflow and publishing.
- Change Controls: Controlling access of SOPs and associated workflow is made simple in an EIM system, particularly with metadata-driven systems that enable access permissions for entire classes of SOP documents to be set automatically and dynamically. Consequentially, SOPs can be approved only by the process owners and all changes are audit trailed.
With technology advancements and globalization, the supply chains and day-to-day operations of today’s manufacturers have become increasingly complex, and the processes around assuring quality and compliance are now anything but static. Further, in a global economy where competition is fierce, consumer confidence is fickle and regulatory oversight is stringent, manufacturers simply cannot risk a breach in quality or compliance. That’s why the days of manual and inefficient SOP management are fast becoming a thing of the past — replaced by new automated, metadata-driven EIM approaches that empower organizations to eliminate errors, increase productivity and improve manufacturing outcomes.
Mika Javanainen is Senior Director of Product Management at M-Files Corporation.