Quality systems at many companies and organizations are based on well documented standard operating procedures (SOPs) that are efficiently communicated and trained to employees and other stakeholders. Introducing SOPs, and ensuring that they are followed, directly contributes to product and service quality and therefore the overall success of an organization. SOP management includes creating, updating and disseminating information about mission-critical processes, and is often tied to compliance requirements and ongoing quality assurance activities. One could simplify all this by saying that quality systems are all about documenting your current processes and making sure that the stakeholders are aware of them and that they follow these processes.
Military organizations, manufacturing companies, healthcare providers, pharmaceutical firms and enterprises in many other industries face the day-to-day challenges of SOP management. Confirming that existing processes are compliant with regulations and proving that policies have been followed is challenging enough, but what about managing this process when things change?
Deviations and CAPAs
Deviations inevitably occur, and the results can range from undetectable to catastrophic. For example, a fabrication machine on the factory floor may have been calibrated incorrectly. As a result, the product quality standards are compromised. An investigation uncovers the calibration problem, and ultimately highlights the need for a change to the calibration instructions and the calibration sign-off process.
When any significant deviation is discovered, a related corrective and preventative action (CAPA) must be defined, documented and communicated by the quality management team. The CAPA must then be tracked to verify that the impacted individuals have read and understood the new SOPs associated with the CAPA.
Successful SOP management, therefore, encompasses both content and process management to ensure SOPs have been read and understood by the appropriate people.
Streamlining SOP Management with ECM
Leveraging an enterprise content management (ECM) system for managing the creation, modification and management of SOP documentation makes sense as these systems typically offer robust access control management and version control features. However, modern ECM systems help organizations to add value far beyond just storing the SOP documents with features such as:
- Training management – Training on new procedures can be administered via an ECM solution based on employees’ roles in the organization by using workflows and task assignments. Employees “sign off” on their learning requirements with electronic signatures, which provide evidence and verification of completed tasks. Role-based assignments also ensure that new employees are assigned relevant learning requirements automatically.
- Change management – An ECM system can help you to specify a controlled change process for SOPs. Tasks for learning requirements are automatically re-sent to employees if the process has significantly changed, and employees can easily see the highlighted changes compared to the previous version.
- Collecting evidence – Proving to auditors that the organization is following the processes outlined in SOPs can be tricky. ECM systems record the completion of recurring tasks, which serves as evidence during the audit process. If an SOP says that the refrigerator temperature must be checked every day, you can assign this task to appropriate employees who can then verify completion of this task with an electronic signature.
- Streamlining processes – ECM systems help replace paper and Excel-based checklists with electronic forms that leverage electronic and/or digital signatures. The same applies to all approval processes — instead of chasing down people in the office for ink signatures, mobile apps and digital signatures can be used to dramatically streamline approval and task management processes.
SOP management can place a significant burden on quality teams, but best-in-class ECM solutions can alleviate this burden and help teams operate more productively. By aligning ECM and SOP management, organizations are achieving improved transparency, auditing, archiving, security, collaboration and process management.