Anything worth doing is worth doing well, as the saying goes. Your quality system is likely based on well-documented standard operating procedures (SOPs) to ensure product and service quality, and, therefore, the overall success of your company. Hopefully, these SOPs are efficiently communicated to employees and other stakeholders. SOP management is often tied to ongoing
quality assurance and other compliance requirements. You need to create, update, and disseminate mission-critical processes across your organization. In summary, quality systems are all about documenting processes and ensuring compliance with them.
Manufacturing employees, in particular, know the importance of SOPs. Flaws in your processes mean flaws in your product. Flaws in your product mean unsatisfied customers at best and endangered customers at worst. SOP management is a daily challenge: confirming that existing processes are compliant with regulations is difficult enough—what about proving that policies have been followed and managing policy or procedure changes?
Things Will Go Wrong
Deviations from SOPs are inevitable. The results can range from undetectable to catastrophic. When any significant deviation appears, an investigation must follow. If a fabrication machine on the factory floor starts producing substandard products, for instance, an investigation may uncover a calibration problem. The calibration instructions and sign-off processes may now need to be changed.
After an investigation uncovers the cause of a deviation, a relative corrective and preventative action (CAPA) must be taken, defined, documented, and communicated by the quality management team. The team must track the CAPA to verify that the affected employees have read, understood, and put into practice the new SOPs associated with the CAPA.
As you can see, successful SOP management includes both content and process management. SOPs must be read, understood, and followed by the appropriate people.
How Can an ECM Help?
Enterprise content management (ECM) systems offer robust access control management and version control features in order to streamline and protect the creation, modification, and management of manufacturing SOP documentation. Modern ECM systems add even more value beyond storing documents.
- Change Management
An EMC system allows you to specify a controlled change process for SOPs. If the process has significantly changed, the ECM system automatically sends required training tasks to affected employees. Your workers can easily see the changes, highlighted compared to the previous document version. - Training Management
With an ECM system, you can administer training on new procedures based on employees’ roles in the organization by using task assignments and workflows. After completing their tasks, employees sign off on their learning requirements with electronic signatures, providing you with verification of completed tasks. Role-based assignments ensure that new employees are automatically assigned relevant training requirements. - Collecting Evidence
Proving that your manufacturing company is following your SOPs can be a difficult task. EMC systems make this easier, recording the completion of recurring tasks. These records serve as evidence during audits. For example, if an SOP requires a certain machine to be at a specific setting, you can assign certain employees to check the setting daily. Your employees can then verify that they have completed this task by electronic signature. - Streamlining Processes
ECM systems can replace your paper and Excel-based spreadsheets and checklists with electronic forms that can be electronically signed. This functionality applies to all approval processes. Instead of chasing down people in the office or on the manufacturing floor for signatures, your employees can use mobile apps and digital signatures to greatly improve their workflows and streamline task management processes.
SOP management often places a heavy burden on quality teams. Advanced ECM solutions can lift this burden and help teams operate more efficiently and productively. By aligning your ECM with your SOP management, you can achieve improved auditing, transparency, security, archiving, collaboration, and process management within your organization.
M-Files for Manufacturing
As you can see, an intelligent information management system can help your manufacturing company follow its SOPs smoothly and efficiently. M-Files provides a next-generation intelligent information management platform that improves business performance by helping people find and use information more effectively. Unlike traditional ECM systems or content services platforms, M-Files unifies systems, data and content across the organization without disturbing existing systems and processes or requiring data migration. To learn more about M-Files, visit lamininsolutions.com or call 1-904-810-3299.
