We're working on some new informational material for the private sector, and we're starting with compliance because every organization is beholden to regulation. Many aspects of compliance can be satisfied through proper records management, SOP practices, and auditing using Laserfiche. For this post, we will examine CAPAS.
A Corrective and Preventive Action System (CAPAS) is a roadmap of processes regulators expect manufacturers to follow to identify and solve compliance problems. Hence, they're a critical point of focus during regulating agency inspections and quality system audits. Indeed, more than just a mandated requirement, CAPAS is how manufacturers can improve their quality system to mitigate risks and avoid quality-related issues in the future.
A practical and compliant CAPA system requires a searchable and robust set of data to detect problems, find and implement solutions, and document findings and subsequent changes to SOPs.Since government investigators, auditors, and executive management all rely on CAPA documentation for reviewing compliance issues, here are essential steps to ensuring your CAPA system is both compliant and effective.
Document your CAPA process and procedures- While obvious, research has demonstrated that failing to document CAPA processes and procedures is a common compliance issue cited by regulatory agencies. For example, inadequate CAPA procedures are device manufacturers' most common inspection failures. Firms of different sizes often fail for various reasons. Small firms often lack knowledge of regulatory requirements or their products' regulatory status. Larger organizations' failures often arise from contract manufacturers or acquisitions into the holistic quality system. Many organizations use Laserfiche to manage quality processes using Workflow. Automation is critical to managing processes the same way, every time. Workflow also enhances collaboration when devising SOPs. The audit trail can be used to benchmark procedural compliance. Also, when regulators are onsite, Laserfiche search and retrieval easily provides them all the documentation they need.
Analyze quality data and identify quality issues- Currently, organizations are mandated to analyze certain types of quality data: process data, concessions, complaints, work operations, quality records, audit reports, returned products, and service records. When organizations choose what quality data to review, it is critical to review internal and external data sources. Experts raise complaints as deserving particular attention as they are a red light indication of product problems. Again, a complaint review workflow process can quickly be built with Laserfiche. Perhaps also using Laserfiche Forms as the intake mechanism. During an investigation, CAPA logs are reviewed to determine the compliance of the quality system. As such, recording all changes to methods and procedures is critical. Versioning of SOPs can be handled elegantly in Laserfiche while tracked using Audit Trail.
I hope you are finding this QA content helpful. Florida Marine Transporters found Laserfiche worked well for their CAPAS and audits. Here's an interview with their software analyst. Stay tuned for Part 2!