Addressing Internal Audit Findings

Greetings, Brave Patrons…Professor Rallis-Daw welcomes you back to the flickering candlelight of the Audit Crypt, where shadows of nonconformities still linger…

Today’s tale is one of inadvertent mishandling of internal audit findings —a grim reminder of what befalls those who ignore the warnings etched into the very bones of Clause 8.2.4 of ISO / EN ISO 13485:2016 which states that, "The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results."

And yet… in the forgotten corners of some quality management systems, findings lay inadequately addressed, which can fester in silence and rise again—stronger, darker, and far more damning.

🕯️ But beware! Not all findings require a full-blown CAPA ritual. Some merely whisper of a potential curse, a creeping nonconformity yet to bloom. Still, each audit finding should be met with resolve without undue delay, including a detailed exorcism of root causes and contributing factors, including:

• 🎃 Causes Identified (lest they return...)

• 🩸 Corrections to patch the wounds and prevent propagation of the issue forward

• 🧟‍♂️ Corrective Actions to prevent recurrence of the nonconformity

• 🕸️ Preventive Actions to ward off future horrors of potential nonconformities

• 🔍 Verification Activities (some minor nonconformities may wait for the next moon  

       cycle (next internal audit) while others demand urgent review like for major

       nonconformities)

And now, a new dread stirs from the crypt…☠️ February 2, 2026 – the day of reckoning.

For with the rise of the 21 CFR Part 820 QMSR, the FDA gains a new power—one that allows it to pry open the tomb of your internal audits, feasting its gaze upon all findings as well as supplier audit and management reviews records. No veil may hide you now.

Those who once kept their internal audit findings in a separate, secret vault must consider:Is your internal audit system ready for the light of full exposure?Or will it crumble under the weight of what lies buried?

So heed this tale, dear patrons... Act swiftly. Document thoroughly. Address audit findings without undue delay. Verify relentlessly.

For in the world of internal audits, it's not the ghost you see that undoes you—…it’s the one you thought was dead.

Until next time, Professor Rallis-Daw, Stay compliant, or be haunted by findings of audits past.