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Corrective and Preventive Actions (CAPA) Policy

Corrective and Preventive Actions (CAPA) Policy

Purpose

To establish a structured and proactive framework for identifying, addressing, and preventing operational, safety, environmental, and compliance-related issues that deviate from standards, procedures, or regulatory requirements. The CAPA system supports continual improvement and risk mitigation throughout all business functions.

Scope

This policy applies to all Mototolo Platinum departments, employees, contractors, and suppliers involved in or affected by operational, health & safety, environmental, quality, or compliance processes.

Definitions

  • Corrective Action (CA): Action taken to eliminate the root cause of a detected non-conformance or other undesirable situation to prevent recurrence.

  • Preventive Action (PA): Action taken to eliminate the cause of a potential non-conformance or situation to prevent occurrence.

Triggers for CAPA

  • Incident or accident investigations

  • Non-conformance reports (NCRs)

  • Audit findings (internal or external)

  • Customer complaints

  • Process performance deviations

  • Environmental or legal breaches

CAPA Process Steps

1. Identification

  • Documents

  • Assign a unique CAPA number and category (e.g., HSE, Quality, Supply Chain).

2. Evaluation

  • Assess severity, frequency, and impact.

  • Determine whether immediate containment is required.

3. Root Cause Analysis (RCA)

  • Conduct RCA using tools such as:

    • 5 Whys

    • Fishbone Diagram (Ishikawa)

    • Fault Tree Analysis

4. Action Planning

  • Corrective Actions: Define steps to eliminate the current issue.

  • Preventive Actions: Define steps to address systemic weaknesses or risks.

  • Assign responsible parties, deadlines, and resource needs.

5. Implementation

  • Execute actions as outlined.

  • Document completion with evidence (e.g., updated SOPs, training records, equipment modifications).

6. Verification of Effectiveness

  • Conduct follow-up audits or monitoring to ensure the actions resolved the issue and prevent recurrence.

  • If ineffective, initiate a new CAPA or escalate.

7. Closure

  • CAPA is reviewed and signed off by the Compliance or HSE Manager.

  • Record is archived in the central CAPA register for review and reporting.

Responsibilities

  • Line Managers: Initiate and ensure completion of CAPAs within their area.

  • Quality, Safety & Compliance Teams: Facilitate analysis, track actions, and monitor system-wide trends.

  • Employees & Contractors: Cooperate during investigations and implementation.

  • Vendors/Suppliers: Respond promptly to CAPA requests and demonstrate sustainable resolutions.

CAPA Monitor

  • CAPA logs are reviewed monthly by the General Manager.

  • Trends are analyzed quarterly to identify recurring issues or risk clusters.

  • CAPA performance is reported during management reviews and compliance audits.

Failure to Comply

Non-implementation or repeated CAPA failures may result in:

  • Boys

  • Contract review or termination (suppliers)

  • Escalation to external regulatory bodies, if required

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