Summary of "La norme EN 9100 2016 Gauthier AGULLO"

Summary of Business-Specific Content from the Video on EN 9100:2016 by Gauthier Agullo

Overview of EN 9100 Standard

EN 9100 is a quality management standard specifically designed for organizations supplying the aerospace and defense industries. It is particularly critical for SMEs and small businesses aiming to work with major aerospace clients.

Key points include:

Certification Importance: Certification is mandatory to be listed in the OASIS database, which aerospace and defense companies use to select qualified suppliers.
Foundation: Built upon ISO 9001, incorporating its requirements plus additional aerospace-specific criteria.
Alignment with ISO 9001:2016: Follows the High-Level Structure (HLS) common to ISO management system standards, ensuring consistent framework elements (clauses 4 to 10).

Key Additional Requirements and Frameworks Introduced by EN 9100

Project Management

Requires end-to-end control of projects from launch to closure.
Emphasizes feedback loops and comprehensive control of all company activities within projects.

Risk and Opportunity Management

Extends traditional risk analysis to include opportunity identification.
Risk/opportunity assessments must cover all operational controls and processes within the management system.

Configuration Management

Focus on managing product configurations and their components (subsets/indices).
Requires ensuring product compliance before release and maintaining conformity throughout the product lifecycle.

Product Lifecycle Management

Attention to product safety and compliance from design through recycling.
Ensures products do not pose safety risks during use or at end-of-life.

Counterfeit Parts Prevention

Mandates internal awareness programs and preventive actions to avoid the use of counterfeit components.
Requires strict entry controls and risk mitigation strategies.

Special Requirements and Key Characteristics

Identification and management of customer-specific “special” requirements.
Selection of key product characteristics and critical elements to meet these requirements.

Special Processes Control

Applies to processes where product verification destroys the product (e.g., testing a match by burning it).
Uses a 5-step qualification method focusing on:
- Methods used
- Workforce skills and control
- Environment control
- Materials and equipment validation

First Article Review

Mandatory review for all new or modified products (new articles or new indices).
Ensures the entire system supporting the new article is validated before production.

Audit and Continuous Improvement Framework

Worst Grid (Worse Grid)

An audit tool used by external auditors to evaluate processes during certification audits.
Focuses on validating process activities, improvement actions, and performance indicators.
Provides a general framework to assess process effectiveness and continual improvement.

Actionable Recommendations

SMEs aiming to enter aerospace supply chains must prioritize EN 9100 certification.
Implement robust project management and risk/opportunity frameworks aligned with EN 9100.
Establish configuration management practices to track product versions and subsets.
Develop internal training and controls to prevent counterfeit parts infiltration.
Define and monitor key characteristics and special processes with strict controls.
Conduct thorough first article reviews to ensure product and process readiness.
Prepare for audits using tools like the worst grid to continuously improve processes and performance metrics.

Presenters / Source

Gauthier Agullo

This summary captures the business execution insights related to quality management, risk control, project and product lifecycle management, and audit readiness as outlined in the EN 9100:2016 aerospace standard.