In Part 2 of this series, we explored what a working QMS looks like in a laboratory — the kind that lives in daily work, not just on paper.

But even a well-structured, integrated, and regularly reviewed QMS can miss a critical element: risk management.
Without it, the system reacts to problems instead of preventing them.

🧠 What Risk Management Really Means in a Lab

Risk management isn’t just a clause in ISO 17025 or a slide in your training manual.
It’s the habit of thinking ahead — identifying what could go wrong, assessing the potential impact, and putting controls in place before an issue happens.

In a laboratory, risks can affect:

• Test accuracy – incorrect calibration, contaminated reagents, environmental fluctuations

• Sample integrity – mishandling, poor storage, cross-contamination

• Compliance – outdated SOPs, incomplete records, missed training

• Safety – improper waste disposal, chemical handling errors

The strength of a lab’s QMS is not just in what it documents, but in how well it anticipates and prevents failure.

🚨 The Common Gaps in Lab Risk Management

Despite being part of most QMS frameworks, risk management often fails in practice because:

1. It’s Treated as a One-Time Activity
   Many labs only perform risk assessments during initial accreditation or major changes.
   Risks evolve daily — equipment ages, staff changes, methods update.

2. It’s Too Generic
   Risk registers are often filled with vague entries like “Equipment breakdown” without specific causes, likelihood, or tailored controls.

3. It’s Reactive, Not Preventive
   Problems are addressed only after they happen, instead of proactively identifying weak points.

4. It’s Isolated from Daily Work
   The risk assessment document sits in a folder — not actively influencing how tasks are carried out.

🧪 Integrating Risk Thinking into Daily QMS

Risk management becomes powerful when it moves from document to mindset.
Here’s how to embed it:

• Micro Risk Assessments – Before starting a task, mentally (or in brief discussions) review potential issues:
  Is the equipment in the right condition? Are reagents valid? Is the environment suitable?

• Risk-Based Decision Making – Prioritize actions based on the potential impact, not just convenience or speed.

• Visual Risk Reminders – Simple signage like “Check expiry before use” or “Temperature logs updated?” can trigger preventive action.

• Link Risk to CAPA – Every non-conformity should not just be corrected but analyzed for its underlying risk and how to prevent recurrence.

📂 Example: A Small Risk with Big Impact

Scenario: A temperature-controlled incubator is due for calibration next week.
The risk? If the temperature drifts even slightly before then, results from the current batch of tests could be compromised.

Risk-based action: Instead of waiting for the scheduled calibration, the lab checks temperature stability daily until calibration is complete.
This small step prevents a potential batch failure — and the loss of credibility that would follow.

🧭 Making Risk Management a QMS Strength

• Review your risk register at least quarterly — update it with real examples from daily work.

• Involve all staff in risk identification — technicians often spot small issues before they become big ones.

• Document not just the risk, but the mitigation in action. This shows auditors that risk management is active, not theoretical.

📅 Next in the Series

In Part 4, we’ll tackle Internal Audits — the most misunderstood QMS tool, and how to make them a driver of improvement instead of a compliance formality.

📥 Free Resource: My Internal Audit Checklist for Labs isn’t just for audits — you can adapt it for risk-based micro-checks too.
👉 areebaqms

#QMS #ISO17025 #LabQuality #RiskManagement #Microbiology #ContinuousImprovement #AuditReady #CAPA #InternalAudit

In Part 1 of this series, we asked: Is your lab actually practicing QMS, or just doing paperwork?

That question revealed a common reality: Many labs have a Quality Management System (QMS) on paper, but the real test is whether it’s alive in daily work.

Now, let’s go one level deeper. What does a working QMS actually look like in practice — the kind that runs smoothly every day, not just during audit week?

🧪 The 3 Layers of a Living QMS

1️⃣ Foundation – The Standards & Structure

Every strong QMS starts with a framework — ISO 17025, ISO 9001, GMP, or industry-specific equivalents. These define:

• The requirements your lab must meet
• The language everyone uses (so “non-conformity” means the same thing to everyone)
• The documentation hierarchy — policies, SOPs, work instructions, forms

But here’s the truth: having a standard isn’t the same as living it. I’ve seen labs that proudly display ISO certificates, yet half the staff couldn’t explain the standard’s main clauses.

The foundation is important — but without the next layer, it’s just a frame with no walls.

2️⃣ Integration – Quality in the Daily Workflow

This is where many systems break. Quality isn’t something the QA officer does in the office — it should be embedded into every routine task.

In a well-integrated QMS:

• Equipment calibration isn’t a standalone task — it’s accompanied by environmental checks, operator verification, and correct record entry.
• Sample handling follows the SOP every time, even on the busiest days.
• Deviations aren’t ignored because “we’re short on time” — they’re addressed immediately to prevent recurrence.

In a weakly integrated QMS:

• Procedures are skipped if they slow down production.
• Records are filled after the fact — sometimes from memory.
• Staff assume quality is “someone else’s responsibility.”

Integration means QMS isn’t a separate activity — it’s how the work is done.

3️⃣ Feedback – Continuous Checks & Improvements

Even with structure and integration, no system is perfect. That’s why the third layer — feedback loops — is critical.

Strong feedback mechanisms include:

• Internal audits that actually look for weaknesses, not just confirm compliance.
• CAPA systems where root cause analysis is done thoroughly, not just labelled “operator error.”
• Management reviews that act on audit findings and trend data, not just file them.

Without feedback, a QMS becomes static — and a static system is one step away from becoming obsolete.

🔍 How You Know Your QMS Is Actually Working

Signs of a healthy QMS include:

• Consistency without supervision — staff follow procedures correctly without being reminded.
• Alignment between documents and reality — the SOP says what’s actually done, not what should be done in theory.
• Shared responsibility — everyone understands their role in maintaining quality.
• Proactive problem-solving — deviations lead to improvement, not just paperwork.

🚫 Red Flags That It’s Only on Paper

If you see these patterns, your QMS might look fine in audits but fail in practice:

• “Audit week” panic — cleaning, calibrations, and updates happen only before auditors arrive.
• Repeated non-conformities across multiple audits.
• Records filled to meet a deadline, not at the time of the activity.
• Staff who say, “That’s the quality team’s job.”

🧭 Moving From Paper to Practice

If you recognize gaps, here’s where to start:

1. Walk the process yourself — Choose a lab activity and observe it from start to finish. Does it match the documented SOP?
2. Involve staff in reviews — The people doing the work often know exactly where the gaps are.
3. Run micro-audits — Small, targeted checks on one area per month keep systems healthy without overwhelming the team.
4. Explain the ‘why’ in training — People follow rules better when they understand their purpose.

📅 What’s Next in the Series

In Part 3, we’ll look at one of the most underestimated strengths of a QMS — risk management — and why it should be built into every process, not treated as a side activity.

Until then, take one process in your lab this week, trace it step-by-step, and see if the way it’s done matches the way it’s documented. The results might surprise you.

📥 Free Tool: Download my Internal Audit Checklist for Labs — designed for real lab environments, so you can find gaps before the auditor does. 👉ISO-17025

In many microbiology labs, QMS is treated like a checklist.

Equipment calibrated? ✅
QC run? ✅
Documents filled? ✅

But here’s the question no one wants to ask:
Are we doing quality work — or just completing tasks that look like quality?

🎯 The Surface vs. the System

It’s easy to assume that if you're:

• Calibrating equipment

• Running control samples

• Recording results in a logbook

...then you’re fulfilling your quality obligations.

But real QMS goes deeper than that.

It’s not just about equipment performance — it’s about the entire environment that affects your data integrity.

For example:

✅ You calibrate your balance.
But ❌ how often do you check environmental conditions like air drafts or humidity?

✅ You run daily QC samples on analyzers.
But ❌ do you ensure the workspace is decontaminated, staff are trained, and SOPs are being followed — not bypassed?

✅ You document deviations.
But ❌ do you perform actual root cause analysis, or just write “operator error” and close the case?

🧪 Common Misconceptions

Here are some issues seen in real labs:

• Calibration = Control
  → Not true. Calibration checks accuracy. Quality control checks consistency under routine conditions.

• QC = Running control samples
  → Also incomplete. QC involves assessing the full process — from sample prep to environment to operator competency.

• Documentation = Compliance
  → Only if it reflects what’s truly happening. If SOPs aren’t being followed, documentation alone doesn’t protect quality.

🧠 So What Is Real QMS, Then?

True QMS means your lab environment, staff, process, and mindset are aligned.
It means quality isn’t just an audit season activity — it’s how your lab breathes every day.

That includes:

• Regular review of why procedures exist

• Involvement of staff in process improvement

• Treating sanitation and documentation with equal seriousness

• Audits that feel like feedback — not threats

🚀 The Goal of This Series

This article is part of the new QMS from Scratch series — made for lab professionals who are tired of pretending QMS is “just documents.”

We’ll talk about:

• What QMS actually looks like in daily practice

• How to fix small habits that damage big systems

• And how to grow from checklists… to culture

💡 Want a real-world starting point?
Download my free Internal Audit Checklist for Labs — a tool to help you self-assess before an auditor walks in.
👉 ISO 17025 : Internal Audit Checklist

Let’s build labs that don’t just pass audits — but deserve trust.

#QMS #ISO17025 #Microbiology #LabQuality #AuditReady #DocumentControl #CAPA #LabTraining #ScientificIntegrity