Soapbox
Automating Standard Operating Procedure Management

Quality systems at medical device and diagnostic companies are based on well documented standard operating procedures (SOPs) that are efficiently communicated to employees. Introducing SOPs and ensuring that they are followed directly contributes to product and service quality and 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 over-simplify this concept by saying that quality systems are all about documenting your current processes and making sure that the stakeholders are aware of and follow them.

Medical device and diagnostic companies, as well as military organizations, manufacturing firms, healthcare providers, 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, product quality is 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 understand the new SOPs associated with the CAPA.

Successful SOP management, therefore, links deviations and non-conformances to related processes and ensures that the SOPs have been read and understood by the appropriate people. Efficient quality systems also try to minimize deviations by encouraging proactive risk management to detect potential problem areas before accidents and deviations occur.

Device manufacturers should leverage an enterprise information management to streamline SOPs. (Figure courtesy of M-Files)

Streamlining SOP Management with EIM

Leveraging an enterprise information management (EIM) 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 EIM systems help organizations to add value far beyond storing SOP documents:

SOP management can place a significant burden on quality teams, but best-in-class EIM solutions can alleviate this burden and help teams operate more productively. By aligning EIM and SOP management, organizations can achieve improved transparency, auditing, archiving, security, collaboration and process management.

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