In Part 4, we explored internal audits — and how they should drive improvement, not just compliance. But identifying a problem is only the first step. The real value of a QMS comes from what happens after a non-conformity is found.

🧠 What “Closing the Loop” Really Means

Closing the feedback loop means ensuring that:

1. A non-conformity is identified.
2. The root cause is understood.
3. Corrective actions are taken.
4. The effectiveness of those actions is verified.
5. Lessons learned are shared so the issue doesn’t reappear.

Without all five steps, the loop stays open — and problems resurface.

🚨 The Common Pitfalls

1. Quick Fixes Without Root Cause Analysis Example: Equipment failed calibration → recalibrate and move on. But why did it fail? If the cause is ignored, the problem may repeat.
2. No Follow-Up on Corrective Actions Actions are assigned but never verified for effectiveness.
3. Blame Over Learning If the culture focuses on “who messed up” instead of “what went wrong,” people hide mistakes instead of reporting them.
4. Isolated Fixes Problems are solved locally but not shared, so other departments repeat the same mistakes.

🧪 The Role of CAPA

Corrective and Preventive Action (CAPA) is the formal QMS process to close the loop. A strong CAPA system:

• Links each non-conformity to a documented root cause
• Includes preventive measures for similar risks in other areas
• Has deadlines and assigned responsibilities
• Tracks whether the fix worked in the long term

📂 Example: A Repeat Non-Conformity

Scenario: During two consecutive audits, a lab was found to have incomplete temperature logs for sample storage.

Weak response: Remind staff to fill the logs. Strong response:

• Identify why logs are missed (e.g., lack of clear responsibility, inconvenient location of log sheets, no automated reminders).
• Implement preventive measures (e.g., assign log checks to specific shifts, move logbook closer to storage, use digital logging with alerts).
• Review logs weekly for 3 months to ensure the fix is effective.

🧭 Creating a Culture of Continuous Improvement

Closing the loop isn’t just a formality — it’s how you turn every issue into a learning opportunity. That requires:

• Transparency – encourage reporting without fear of blame
• Shared Learning – communicate fixes across the lab so others can benefit
• Management Support – leaders must treat CAPA as a priority, not just paperwork

📅 Series Wrap-Up

Over the last five parts, we’ve looked at:

1. The difference between paper QMS and real QMS
2. The 3 layers of a working QMS
3. Risk management as a daily habit
4. Internal audits that actually improve performance
5. Closing the feedback loop through effective CAPA

A QMS is never “done” — it’s a living system that grows stronger when each part supports the others.

📥 Free Tool: My Internal Audit Checklist for Labs helps you spot non-conformities early — so you can close the loop before they become major problems. 👉ISO 17025

#QMS #ISO17025 #CAPA #NonConformity #ContinuousImprovement #LabQuality #Microbiology #AuditReady

 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

1. “Audits are for finding mistakes.” In reality, they’re for finding opportunities — even when things are already working.
2. “Audits should only be done by the QA team.” Cross-functional auditing brings fresh eyes to a process and reduces blind spots.
3. “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

1. 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.
2. Go Beyond the Checklist Use the checklist as a guide, not a script. Ask “Why?” and “Show me” at every step.
3. Document and Act Findings are useless without follow-up. Assign corrective actions, set deadlines, and review completion.
4. 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