1. Purpose
To establish a systematic process for isolating, logging, and analyzing unusual or exceptional Quality Control (QC) failures
2. Definition: QC Exception
A QC Exception
3. Procedure: Maintaining the QC Exception Log
Step 1: Identification & Isolation
When an inspector encounters a failure that qualifies as an exception, they must immediately:
- Tag and quarantine the affected units.
- Notify the QC Supervisor and Production Line Lead.
- Clearly note the failure as "EXCEPTION" on the initial inspection report.
Step 2: Log Entry Creation
The QC Supervisor is responsible for creating a new entry in the QC Exception Digital Log
Field
Description
Exception ID
Unique reference number (e.g., EXC-2023-087).
Date & Time
When the exception was discovered.
Product/PO Number
Affected product and purchase order.
Detailed Description
Clear description of the failure, including photos/videos.
Initial Containment Action
Immediate steps taken (quarantine, sorting, line stoppage).
Assigned Investigator
Person responsible for root cause analysis (RCA).
Status
Open / Under Investigation / Resolved / Closed.
Step 3: Root Cause Analysis (RCA) & Action
The assigned investigator (e.g., Quality Engineer) must:
- Perform a thorough root cause analysis using tools like 5 WhysFishbone Diagram.
- Update the log with the confirmed root cause.
- Define and record corrective and preventive actions (CAPA).
- Set a target date for implementation and verification.
Step 4: Verification & Closure
Once CAPA is implemented, the QC Supervisor must verify its effectiveness over a defined period (e.g., one production run). After successful verification:
- Update the log Status
- Add a brief summary of the verification results.
- If relevant, update standard work instructions or checklists to include this new failure mode.
4. Responsibilities
- QC Inspectors:
- QC Supervisors:
- Quality Engineers:
- Production & Purchasing:
- Quality Manager:
- QC Supervisors:
5. Key Benefits
Prevent Recurrence
Systematic RCA addresses the source, not just the symptom.
Knowledge Preservation
The log becomes a valuable database for troubleshooting and training.
Process Improvement
Highlights systemic weaknesses in the supply chain or production process.
Enhanced Communication
Provides a clear record for communication with suppliers and clients regarding major issues.