Understanding IQ, OQ, and PQ: A Guide to Validation

🚨 The Real Responsibility of CAPA – Beyond Just Closing NCs In most organizations, CAPA (Corrective and Preventive Action) is seen as just another quality department task. The reality? 👉 CAPA is not the responsibility of only the Quality team. ❌ Filling a CAPA form ❌ Attaching some evidence ❌ Closing the NC for the auditor This is what usually happens. But if CAPA is handled this way, organizations miss the real benefits. ✅ CAPA is a cross-functional responsibility – it requires MDT (Multi-Disciplinary Team) involvement. ✅ CAPA is a process improvement tool, not just a compliance requirement. ✅ CAPA helps us find the root cause, implement systemic actions, and prevent recurrence – saving time, cost, and reputation. If CAPA is owned only by Quality, it becomes a “paper exercise.” If CAPA is owned by the entire organization, it becomes a powerful driver of continuous improvement. 👉 Next time you handle a CAPA, ask yourself – Am I just closing a Non conformance, or am I actually improving the system?

CAPA Echo Chamber 2.0 — Corrective Action for the Corrective Action of the Corrective Action You can hear it from across the quality floor — that haunting echo: “We’re opening a CAPA… to address why our CAPAs are late.” And somewhere, a CAPA coordinator sighs into their spreadsheet. We’ve all seen it. A complaint triggers a deviation. The deviation becomes a CAPA. The CAPA spawns a sub-CAPA to investigate the CAPA backlog. Meanwhile, someone creates a PowerPoint titled “CAPA System Improvement Initiative.” It has twelve bullet points and no root cause. The truth? Most CAPAs aren’t about process improvement — they’re about escaping audit findings. They live in isolation, chasing symptoms in circular fashion. A maze of TrackWise fields, attachments, and “effectiveness checks” that check nothing. Lean Documents & Lean Configuration break this recursive loop by treating CAPAs as nodes in the system, not paperwork islands: • Root cause traces to the real configuration element — design, supplier, process, or risk. • Each action has lineage and consequence. • Effectiveness is measurable, not declared. • And the “closed” date doesn’t mean forgotten — it means integrated. CAPA isn’t a process. It’s a mirror. And sometimes, the reflection shows that the system itself needs corrective action. #LeanDocuments #LeanConfiguration #LDLC #CAPA #ContinuousImprovement #RootCauseAnalysis #QualityManagement #RegulatoryCompliance #OperationalExcellence #SystemsThinking #ThroughputOverCost

The Copy-Paste Trap: Why ‘More Traceability’ Sometimes Means Less Control In many quality systems, traceability is built by duplicating the same requirement or risk note into multiple places: • Into the protocol header. • Into the work instruction step. • Into the training module. • Into the batch record template. On paper, it looks like “more traceability.” In reality, each copy is now a forked truth—a parallel line of evidence that can drift out of sync the next time something changes upstream. A hypothetical scenario: An engineer updates a risk control limit in the design spec. But one test protocol still has the old number. The training slide deck is never updated. A year later, an audit flags an inconsistency—yet all the downstream documents had been “approved” at the time. This isn’t a failure of the people—it’s a failure of structure. The more we copy, the more entropy we create. Lean Documents & Lean Configuration fix this by: • Storing the limit in a single authoritative node. • Letting all downstream artifacts reference that node’s field rather than embedding the value. • Making the audit trail show where-used relationships instead of redundant text blocks. • Reducing review fatigue by ensuring approvers only sign for the parameter once. True traceability means a single chain of evidence, not a scrapbook of copies. LDLC’s biggest win here is often invisible: less paperwork drift, fewer hidden discrepancies, and stronger audit readiness. #LeanDocuments #LeanConfiguration #LDLC #Traceability #SingleSourceOfTruth #ChangeControl #AuditReady #RiskManagement #ProcessIntegrity #OperationalExcellence #ContinuousImprovement #QualityByDesign #RegulatoryCompliance #SystemsThinking #ThroughputOverCost

Corrective Action (CA): Fixes the current problem (root cause elimination). Preventive Action (PA): Ensures the potential problem doesn’t occur in the future. Steps in CAPA process: 1. Identify the problem – incident, audit finding, deviation. 2. Root cause analysis – why it happened. 3. Corrective action – resolve the issue immediately. 4. Preventive action – long-term measures to avoid recurrence. 5. Implementation & verification – track and ensure effectiveness. 6. Closure & documentation – formally close the CAPA.

We run a 3-minute test before any root cause analysis. It predicts whether the investigation will succeed or fail. The Test: Three Questions Question 1: "State the problem as an observable deviation, not a behavioral description" Pass: "Calibration verification step absent in 8 of 12 production records" Fail: "Operators aren't completing calibration verification" Question 2: "What corrective actions from previous similar events are currently in place?" If previous solutions were training, communication, or procedures - red flag. Pass: "No similar pattern" or "Previous systemic controls functioning" Fail: "We retrained 6 months ago" Question 3: "What barrier or control should have prevented this deviation or detected it immediately?" Pass: "Process control should have flagged missing verification" Fail: "Operators should remember to complete verification" Real Example: Initial: "Night shift operators aren't following inspection protocol" After Q1: "Inspection Step 4 completion: 65% night shift vs 98% day shift" After Q2: "Previous action: Protocol training 6 months ago" - Red flag After Q3: "What should prevent incomplete inspections from advancing?" Investigation Changed: From: Why don't operators follow protocol? To: Why does our system allow incomplete inspections to advance? Root Cause: Production and quality systems operated independently. Supervisors could override without documentation. Night shift faced higher time pressure. Solution: Integrated systems, override authorization requirements, scheduling revision Result: 99.2% completion across all shifts The Pattern: Pass all three: 87% permanent resolution Fail two or more: 71% recurrence within 12 months Try This Before Your Next RCA: 1. State as observable deviation, not behavior 2. Identify previous similar corrective actions 3. Define what barrier should have prevented this Can't answer clearly? Reframe before investigating. 5 minutes reframing prevents weeks investigating the wrong problem. Most failed RCAs fail in problem definition, not analysis execution. --- 💬 Which question is hardest for your organization? #RootCauseAnalysis #QualityManagement #ProblemSolving #ContinuousImprovement #SystemsThinking

The Change Control Hydra — When One Form Becomes Many It starts innocently enough. A simple change request — “Update drawing to correct a tolerance.” But as soon as you submit it, the beast awakens. Quality opens a second form: Impact Assessment. Regulatory opens another: Change Justification. Validation spawns an OQ Addendum. Supplier Quality demands a Notification Form. Before long, you’re managing a hydra of PDFs, each one referencing the others — and none actually implementing the change. Every meeting sounds the same: “Did we close the Change Control?” “No, we’re waiting for sign-off on the dependent form.” “Which one?” “…All of them.” The irony? Change Control was meant to enable agility. Instead, it institutionalized hesitation. Lean Documents & Lean Configuration cut through the chaos: • One structured node captures the full configuration change. • All impacted elements update automatically — design, risk, validation, supplier. • Reviews happen by data lineage, not email chains. • Approval closes the loop in hours, not weeks. When your QMS behaves like a network, not a hydra, every change strengthens the system instead of multiplying the paperwork. Because real control isn’t in more forms — it’s in fewer illusions. #LeanDocuments #LeanConfiguration #LDLC #ChangeControl #DesignControls #ConfigurationManagement #ContinuousImprovement #OperationalExcellence #QualitySystems #ThroughputOverCost #SystemsThinking

✓A Deviation is any unplanned or unintentional event that departs from approved procedures, specifications, or standards. ✓A Change Control is a planned, documented process used to propose, review, and approve changes before they are implemented to ensure controlled modification of systems or processes. 1️⃣ Identify the issue Something went wrong Deviation 2️⃣ Find root cause & CAPA Temporary fix + prevention plan Deviation Investigation 3️⃣ Implement permanent fix Controlled process/system/document change Change Control 💡 In short > Every Deviation doesn’t always require a Change Control, but many Change Controls are raised because of a Deviation.

Calibration Certificates: More Than Stamps It’s not enough to just file calibration certificates in a binder or digital folder. To make them a compliance weapon, ask the following questions: 🔎 Is every measurement traceable to national standards? 🔎 Are “out of tolerance” results evaluated – or ignored? 🔎 Is your calibration schedule risk-based, not just time-based? When you can answer these questions confidently, your calibration records turn from paperwork into proof. Hint: traceability is more than only having the serial number of the reference device, it includes the calibration environment, the measurement uncertainty and some more details. Quick tip: Review one calibration file today as if you were the auditor. Would you be confident to pass your own audit? If you found this helpful, feel free to Repost 🔁, follow me Beat Keller for more insights, and click the 🔔 to stay updated.

Ever wondered whether SOPs are helping your lab—or quietly slowing it down? Khalid Mohiuddin, MSc, dives into how ISO/IEC 17025 labs can balance strict SOP compliance with real-expert flexibility, using a dual-level control model. QC labs get consistency & traceability, while expert analysts can still tweak, troubleshoot, and optimize in real time. Want to see how your lab could do both without compromising quality or creativity? Click to explore the framework: http://bit.ly/3KafNMD

In Quality System have a three points are mostly Repeated (Review, Witness, Hold,Pro-active and INCR, NCR, LBE, T.Q ):💛🤔 Review (R): It's consisting of only documentation relevant only Witness (W): It's depending on the activities but not mandatory site witness or surveillance Hold (H): When activities are performed at site then make sure availability Pro-Active or CPR: It is a notification pattern piror to any activity standard voliation that called to Pro-Active Internal Non-Conformities Report (INCR) : Any activity which completed with standard violation then send notification documentation that called INCR Non-Conformities Report (NCR) : This raised from the client any major violation, Let suppose in case you already raised the INCR and this copy submit to client his acknowledgement as per Scheduled Q protocol he can't raised the NCR Log Book Entry (LBE): This is a log which consisting of all details which of (WIR, Pro-active, INCR) which all entries shared with client from his acknowledgement NCR Root Cause Investigation: Corrective actions to prevent recurrence of nonconformities maximum Seven (7) day of the issue date's Technical Query (T. Q) : Basically it is a supportive documents which behalf of you can closed the NCR. Basically it contents of different patterns to explaination root cause and standards deviation