SOP for Failure Investigation and CAPA

(Formerly known as Ess Dee Aluminium Ltd.)

Management System

PURPOSE

• 1.1 To establish a structured procedure for investigating quality failures, identifying root causes, and assigning CAPAs in aluminium foil manufacturing.

SCOPE

• 2.1 Applicable to all foil production lines, including incoming raw materials (aluminium ingots, coils), rolling, annealing, slitting, and final packaging.

REFERENCE(S) & ATTACHMENTS

• 3.1 References
  • 3.1.1 ISO 15378:2017
• 3.2 Attachments: Nil

RESPONSIBILITY

• 4.1 Production Head
  • 4.1.1 To ensure the training of the SOP to all concerned department personnel involved in implementation of the SOP.
  • 4.1.2 To ensure the implementation of the SOP after training.
• 4.2 Quality Assurance Person
  • 4.2.1 To check the SOP.
  • 4.2.2 To maintain the original copy of the SOP.
  • 4.2.3 To issue controlled copy of the SOP.
  • 4.2.4 To maintain issuance record of SOP.
  • 4.2.5 To retrieve the controlled copy of the SOP when it is superseded / obsolete & maintain its record.
• 4.3 QA Head
  • 4.3.1 To approve new or revised SOP.
  • 4.3.2 To ensure the implementation of the defined system.
• 4.4 Plant Head
  • 4.4.1 To approve new or revised SOP.
  • 4.4.2 To ensure the implementation of the defined system.

DISTRIBUTION

• 5.1 Quality Control
• 5.2 Production
• 5.3 Quality Assurance

DEFINITION(S) & ABBREVIATION(S)

• 6.1 Definitions
  • 6.1.1 Nil
• 6.2 Abbreviations
  • 6.2.1 CAPA: Corrective Action and Preventive Action

(Formerly known as Ess Dee Aluminium Ltd.)

Management System

PROCEDURE

• 7.1 Failure Identification & Quarantine
  • 7.1.1 Detection: Operators, QA inspectors, or customer complaints trigger the failure report. Common foil defects include pinholes, gauge variations, surface scratches, oil stains, or poor winding tension.
  • 7.1.2 Immediate Action: The production supervisor must immediately stop the affected process, segregate the defective material, and apply a “HOLD” / Quarantine tag.
  • 7.1.3 Initiation: The QA team issues a numbered Failure Investigation Report

(Fir).

• 7.2 Root Cause Analysis (RCA)
  • 7.2.1 A cross-functional team (Production, QA, Engineering) shall be formed to investigate the problem. The investigation must review:
  • 7.2.1.1 Machine / Equipment: Condition of mill rolls, tension controls, and annealing furnace settings.
  • 7.2.1.2 Material: Supplier coil specs, thickness compliance, and surface treatment.
  • 7.2.1.3 Method / Process: Rolling speed, coolant / lubricant flow, and gauge control.
  • 7.2.1.4 Investigation Tools: Utilize RCA tools such as the Fishbone Diagram (Ishikawa) or 5-Whys Analysis to find the fundamental cause.
• 7.3 CAPA Action Plan
  • 7.3.1 Once the root cause is established, the team must determine a CAPA plan:
  • 7.3.1.1 Correction: Immediate rework, scrap disposal, or downgrading of the affected foil batch.
  • 7.3.1.2 Corrective Action: Measures taken to ensure the specific failure does not recur (e.g. replacing worn-out mill rolls, recalibrating thickness gauges).
  • 7.3.1.3 Preventive Action: Proactive measures to eliminate the causes of potential failures across all lines (e.g. updating equipment maintenance schedules, introducing new operator training protocols).
• 7.4 Implementation & Documentation of Quality Assurance.
  • 7.4.2 Execution: Responsible department heads implement the required actions within the agreed target deadlines.
• 7.5 Effectiveness Check

(Formerly known as Ess Dee Aluminium Ltd.)

Management System

• 7.5.1 Verification: Quality Assurance conducts an effectiveness check [30 to 90 days] after implementation to ensure the defect has not reappeared.
• 7.5.2 Closure: If verification is successful, QA formally closes the CAPA record. If it fails, the CAPA must be reopened and re-investigated.

REVISION HISTORY

Effective Revision No. 00 CC No. Date

Details of revision: New SOP