QMSCAPA 2.26.7

Recording Non-Conformance Linked to Quality Objectives and Other KPIs

QMSCAPA software can be used for recording non-conformances. It includes a module specifically for logging non-conformances, allowing you to track and address quality issues within your organization.

Alert Incident Message

Non-Conformance Form

In AS9100D and ISO 9001:2015, the process approach plays a crucial role.

Let’s break it down:

  1. Internal Processes:
    • These are the activities within an organization that contribute to achieving its objectives.
    • They involve a set of interrelated or interacting activities that use inputs (which can be tangible or intangible) to deliver an intended result.
    • Examples include production, quality control, and management processes.
    • The process approach emphasizes integration and systematic management of these internal processes.
  2. External Processes:
    • These are processes that interact with the organization from outside.
    • They may include suppliers, partners, or other external stakeholders.
    • ISO 9001:2015 also considers external issues that affect the organization (e.g., market trends, legal requirements).
    • Addressing external processes ensures the organization’s QMS is adaptable and responsive to the external business environment.

Remember, the process approach involves risk-based thinking and follows the PDCA cycle (Plan-Do-Check-Act) for continual improvement.

The QMSCAPA software module for Nonconformance and Corrective Action provides direct links to the following Quality Management Systems methods and processes:

  • Customer feedback, including complaints.
  • Corrective Actions, including “root cause analysis” with a “5 Why” and “Fault Tree” tools.
  • Quality Objectives and Key Performance Indicators
    • On-time delivery
    • Product Acceptance
    • Supplier Performance
    • Sales Order and Contract Reviews
    • Supplier Performance

Quality Measurement Tools in QMSCAPA

These tools include direct links to the AIM Nonconformance Log.

  1. Key Performance Indicators (KPI) for monitoring in-process inspections and final inspections.
  2. Manufacturing and/or production Quality Metrics.
  3. On-time delivery monitoring.
  4. Purchasing (Supplier performance) Quality Metrics.
  5. Sales Quotes, Orders and Contract Review processes.