"Internal Audits: The Most Misunderstood QMS Tool"
In Part 3, we discussed risk management — and how a proactive mindset can prevent problems before they happen. Now let’s look at a tool that should help with that, but in many labs doesn’t live up to its potential: the internal audit.
🧠 What Internal Audits Are Supposed to Be
In theory, an internal audit is your lab’s own health check:
- A chance to find gaps before the external auditor does
- A structured review of whether the QMS works in practice
- An opportunity to improve efficiency and compliance
Done right, it’s like preventive medicine for your quality system.
🚨 The Reality in Many Labs
Here’s what actually happens in some places:
- Audits are done right before the external audit as “practice runs”
- Checklists are rushed through to tick boxes, not explore processes
- Findings are softened to avoid “making trouble” internally
- The same non-conformities reappear year after year
This turns a powerful improvement tool into just another compliance chore.
🧪 The 3 Myths About Internal Audits
- “Audits are for finding mistakes.” In reality, they’re for finding opportunities — even when things are already working.
- “Audits should only be done by the QA team.” Cross-functional auditing brings fresh eyes to a process and reduces blind spots.
- “If nothing is found, it means everything is fine.” No findings could mean you didn’t look deep enough.
🔍 How to Make Internal Audits Work for You
- Audit Throughout the Year Spread internal audits across the calendar. Don’t wait for “audit season.” Example: Audit equipment calibration in February, sample storage in April, documentation in June.
- Go Beyond the Checklist Use the checklist as a guide, not a script. Ask “Why?” and “Show me” at every step.
- Document and Act Findings are useless without follow-up. Assign corrective actions, set deadlines, and review completion.
- Look for Trends, Not Just Incidents A single missed record may not be a crisis — but repeated misses show a deeper issue.
📂 A Small Shift with Big Results
Scenario: Your audit finds that SOP training records for new staff are incomplete. A typical fix? Remind staff to sign forms. A better fix? Review the training process to ensure records are created during, not after, training — and assign accountability for follow-up.
This not only solves the immediate gap but prevents it from becoming a recurring finding.
🧭 The Auditor’s Mindset
A good internal auditor:
- Is curious, not confrontational
- Treats findings as opportunities, not failures
- Understands the process being audited but remains objective
- Follows up to confirm that fixes actually work
📅 Next in the Series
In Part 5, we’ll cover From Non-Conformity to Improvement — turning findings and CAPA into real progress instead of repeated paperwork.
📥 Free Tool: My Internal Audit Checklist for Labs is built to help you ask the right questions and find gaps that matter. 👉 Lab Quality
#QMS #ISO17025 #InternalAudit #LabQuality #AuditReady #ContinuousImprovement #CAPA #Microbiology
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