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1.5 Templates Pack: NCR, CAPA, Audit, Calibration, Incoming Report

A template is not a form; it is a data collection instrument. If you allow free-text chaos in your records, you cannot calculate a Pareto chart, you cannot trend supplier performance, and you cannot predict failures.

This section defines the Minimum Viable Fields required for a robust Quality Management System. Whether you use Excel, Jira, or a dedicated QMS software, these data points are non-negotiable. They act as the "primary keys" that link your quality data to your engineering reality.

Non-Conformance Report (NCR)

The NCR is the atomic unit of failure data. It must capture the "What" and the "How Many" with absolute precision to support the MRB process (refer to Chapter 9.1).

Critical Data Architecture:

  • Defect Code (Standardized): Do not allow "Bad solder." Use IPC-610-Soldering-Bridge. If you use free text -> Then you cannot automate analysis.
  • Traceability ID: Date Code, Lot Number, or Serial Number. Without this, you cannot bound the risk, forcing you to recall everything.
  • Quantities: You must distinguish between Qty Received, Qty Inspected, Qty Suspect, and Qty Rejected.
    • Pro-Tip: "Yield" is calculated based on Qty Inspected, not Qty Received.

Corrective and Preventive Action (CAPA)

The CAPA template is a logic flow, not a questionnaire. It forces the user to move from Symptom to System (refer to Chapter 9.2).

Mandatory Logic Fields:

  • Problem Statement (5W1H): Who, What, Where, When, Why, How.
    • Bad: "Unit failed."
    • Good: "Unit SN123 failed output voltage test at 45°C during burn-in."
  • Root Cause Category: Design, Process, Component, or Software.
  • Action Type:
    • Correction: Immediate containment (e.g., "Screen stock").
    • Corrective Action: Root cause elimination (e.g., "Change mold tool").
    • Validation Method: How will you prove the fix works? (e.g., "Test 30 units from next run").

Audit Checklist

An audit without evidence is just an opinion. The template must force the auditor to record facts, not feelings (refer to Chapter 8).

Structure:

  • Reference Standard: (e.g., ISO 9001:2015, Clause 8.5.1).
  • Objective Evidence: The auditor must record the specific document number, serial number, or record ID viewed.
    • Entry: "Checked training record for Operator A. Smith. Found Record #TR-2024-05."
  • Finding Grade:
    • Major: System breakdown or direct risk to product.
    • Minor: Single lapse in compliance.
    • Observation: Opportunity for improvement (OFI).

Calibration Record

The Traceability Chain:

  • Asset ID: Unique identifier of the tool.
  • Master Standard Used: The Asset ID of the "Gold Standard" used to calibrate the tool.
  • As-Found / As-Left Data:
    • As-Found: The reading before adjustment. (Crucial! If this is out of tolerance -> Then you must review all products measured since the last calibration).
    • As-Left: The reading after adjustment.

Incoming Quality (IQC) Report

This is the firewall log. It justifies why you pay—or don't pay—a supplier (refer to Chapter 4.3).

Inspection Logic:

  • AQL Level: (e.g., Level II, 0.65).
  • Sample Size: Calculated strictly from the AQL table.
  • Defect Breakdown:
    • Critical: Safety issue (Automatic Reject).
    • Major: Functional failure.
    • Minor: Cosmetic imperfection.
  • Decision: PASS, REJECT, or UAI (Use As Is - requires Deviation #).

Final Checklist: Data Integrity

Record Type

The "Kill" Field (Missing = Invalid Record)

Engineering Reason

NCR

Traceability ID

Without this, you cannot isolate the "Blast Radius" of the defect.

CAPA

Validation Evidence

A CAPA is not closed until the fix is proven effective.

Audit

Objective Evidence

"Process looks good" is not audit data. Specific file names/IDs are required.

Calibration

"As-Found" Data

Required to determine if previous production is suspect.

IQC Report

Sample Size

Must match the Lot Size via AQL. Inspecting 10 random units is statistical garbage.


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