1.3 Incident / Near-Miss Reporting + CAPA linkage

A silent factory is a dangerous factory. In high-reliability organizations, bad news must travel fast. If an operator hides a minor shock or a small spill out of fear of punishment, the system loses the critical data signal needed to prevent a fatality.

This chapter establishes the protocol for capturing failure signals (Incidents & Near-Misses) and converting them into engineering improvements via the CAPA (Corrective and Preventive Action) system.

The Reporting Logic: Signal vs. Noise

Treat every unplanned event as a system data point. We do not report to "tattle"; we report to debug the facility.

Classification Matrix

Use strict definitions to categorize events. Do not rely on subjective feelings.

• Incident: An event resulting in actual harm (Injury, Property Damage, Environmental Release).
  • Example: Forklift impacts racking; chemical burns on arm.
• Near-Miss: An event where the barrier held, but luck played a factor. This is a "Free Lesson."
  • Example: A heavy fixture falls but lands 10cm from an operator's foot.
• Unsafe Condition: A static hazard waiting for a trigger.
  • Example: A fire extinguisher blocked by pallets.

Decision Logic for Reporting:

• If an event required First Aid or outside medical help -> Then Trigger Level 1 Investigation (24hr Root Cause Analysis).
• If an event had potential for fatality (e.g., Arc Flash near-miss) -> Then Treat as Actual Incident (Full RCA required).
• If an unsafe condition is observed -> Then Log it. If fixed immediately (e.g., moving the pallet), close the log instantly.

The CAPA Loop (Corrective & Preventive Action)

Reporting is useless without resolution. The CAPA system is the engineering feedback loop that prevents recurrence.

Do not confuse "Correction" with "Corrective Action."

Term	Definition	Engineering Example
Correction	Immediate containment. Stop the bleeding.	Action: Mop up the oil spill.
Corrective Action	Remove the direct cause.	Action: Replace the leaking gasket on the hydraulic pump.
Preventive Action	Systemic fix to eliminate the risk class.	Action: Switch to a magnetic-drive pump (seal-less) across the facility.

Investigation Protocol

The goal of an investigation is Root Cause, not Blame.

• Method: Use 5 Whys for minor incidents; use Fishbone (Ishikawa) for complex failures.
• Rule: If the root cause is "Human Error," the investigation is incomplete. You must ask why the system allowed a human to err (e.g., poor labeling, fatigue, bad ergonomics).

Pro-Tip: Never close a CAPA with "Retrain Operator." Training is the weakest administrative control. If the operator failed, the process failed. Engineer the hazard out (e.g., add a physical guard).

Final Checklist

Control Point	Requirement	Critical State
Reporting Window	Time from event to log	< 2 Hours
Near-Miss Ratio	Healthy reporting culture	> 10 Near-Misses per 1 Incident
CAPA Closure	Standard Incident	< 14 Days
High Risk CAPA	Open Item Status	Interim Controls Active
Feedback	Reporter notified of fix	Mandatory