Empowering Your CAPA Process: Inside ION's Non-Conformance Tracking Solution

Out with the old, in with the new. We’re making quality management sexy again (and easier too).

Quality lies at the heart of every successful manufacturing organization. When customers receive a quality product, they can sense and trust that it will fulfill its intended purpose. This establishment of trust enables customers to seamlessly integrate the product into daily life and advocate for it to others. This feedback loop constitutes a win-win scenario for both the customer and the manufacturer. For the manufacturer, corrective actions and preventive actions, CAPA, are a must have to achieve this level of success.

There are numerous systems that support the industry-standard quality in manufacturing organizations. Whenever a product or process deviates from its intended state, an issue is recorded. This initiates a comprehensive process to determine why the issue occurred, what corrective actions should be taken, and how to prevent its recurrence (CAPA). Common industry terms used for documenting these issues include non-conformance tracking, further actions, root cause analysis (RCA), corrective action reports (CAR), and preventative action plans. Forums such as material review boards (MRB) and process failure modes and effects analysis (PFMEA) meetings bring together engineers, suppliers, designers, and quality experts to generate this documentation.

Navigating certifications and requirements such as AS9100 can often feel like trudging through a slow, cumbersome, and inflexible process. While the industry's insistence on structured quality checkpoints is undoubtedly warranted, the unintended consequence for manufacturers operating in highly complex ecosystems like aerospace and energy, is the emergence of labyrinthine file-hoarding procedures and rigidity that stifle innovation. In many cases, the crux of the issue lies in the lack of digital integration and the fragmentation of internal systems.

Enter ION Factory OS – your ultimate CAPA-solving partner. Whenever a technician or team member encounters an issue demanding resolution and flags it in the system, ION automatically captures all pertinent details: from associated parts to processes and even supplier-related documentation. This comprehensive contextual data is swiftly relayed to the engineering team tasked with resolving the issue. With crucial information at their fingertips, engineers can quickly determine the best course of action, pinpointing the root cause of any non-conformance. With a few clicks, they can then integrate those corrective actions into other processes with minimal (if any) disruption to production. 

Because ION was built with collaboration and real-time feedback loops at the forefront, all the related data – the redlining process along with the corrective actions needed to fix the occurrence – are automatically communicated to design and procurement teams so they can rapidly escalate concerns with suppliers when necessary. 

Taking it a step further, ION’s intelligent workflows and rules logic control any further work being done with that particular component based on the results from the CAPA study.  For instance, if the study reveals that all upstream products should be held before undergoing the same process that led to the issue, a change in hold state can automatically prevent further assembly. This is especially helpful when a batch of supplier parts is defective and the supplier needs to replace the material before proceeding. 

The flexibility of ION and its programmability makes it so complex rules can be established as a result of an issue, corrective action, or preventative action findings. If you want to require specific sign-offs and qualification logic that prevents certain steps within work instructions from moving forward or a different course of action, ION can accommodate it.

Made possible through an integration with JIRA, ION passes bi-directional information on disposition, ticket status, and hold status to keep the manufacturing floor and continuous improvement project teams aligned at the project level. This allows teams to use systems they are already using while tapping into the data that only ION Factory OS can provide.

To further leverage that data, First Resonance is currently testing a Further Actions (CAPA) solution that can handle any type of escalating action. Whether the identified issue needs to be escalated to a supplier corrective action, internal preventative action, or continuous improvement project, all of these “further actions” will be captured in ION. The Further Actions feature is specifically designed to connect your quality team with your production team so everyone is speaking the same language, in the same software. Reach out to First Resonance to be an early adopter of ION Further Actions today and close the time gaps that archaic MES systems have perpetuated for decades.