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AS9100 Design and Development Process Audit Checklist

A detailed checklist for auditing and improving product design and development processes in aerospace and defense organizations, ensuring compliance with AS9100 standards

AS9100 Design and Development Process Audit Checklist

by: audit-now
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About This Checklist

The AS9100 Design and Development Process Audit Checklist is an essential tool for aerospace and defense organizations to evaluate and enhance their product design and development practices. This comprehensive checklist addresses key aspects of the design process, from initial concept to final validation, ensuring alignment with AS9100 standards. By implementing this checklist, companies can streamline their design processes, improve product performance, reduce development risks, and ensure regulatory compliance. Effective design and development practices are crucial for innovation, competitiveness, and meeting the stringent safety and performance requirements of the aerospace and defense sector.

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Industry

Aerospace and Defense

Standard

AS9100 - Aerospace Quality Management

Workspaces

Design laboratories
Prototype testing facilities
Engineering Offices

Occupations

Design Engineer
Systems Engineer
Project Manager
Quality Assurance Engineer
Product Development Manager
1
Have all design requirements been reviewed and approved?
2
What is the percentage of design verification completed?
Min: 0
Target: 100
Max: 100
3
Please provide notes on any design changes made during the process.
4
How often are design review meetings held?
5
What is the outcome of the design validation tests?
6
Describe the design validation process utilized.
7
How many validation tests were conducted?
Min: 0
Target: 10
Max: 100
8
Is the design compliant with validation criteria?
9
Summarize the feedback received from the most recent design review.
10
List any action items identified during the design review.
11
What is the defect rate observed during design verification?
Min: 0
Target: 5
Max: 100
12
How well does the design process adhere to AS9100 standards?
13
What are the primary risks associated with the design?
14
How many risk mitigation actions have been implemented?
Min: 0
Target: 3
Max: 50
15
Provide additional notes regarding the risk assessment process.
16
How often are design risks reviewed?
17
Is the design documentation properly controlled and updated?
18
How many revisions have been made to the design documents?
Min: 0
Target: 5
Max: 100
19
Provide comments on the current documentation practices.
20
How often is the design documentation reviewed for accuracy?

FAQs

The checklist covers design planning, requirements management, design inputs and outputs, design reviews, verification and validation processes, and design change management in line with AS9100 standards.

It provides a structured approach to identify and mitigate risks throughout the design process, including technical, schedule, and resource-related risks, ensuring a more robust final product.

The audit team should include design engineers, systems engineers, quality assurance specialists, project managers, and representatives from manufacturing and customer support to ensure comprehensive coverage.

These audits should be conducted at key milestones throughout the product development lifecycle, as well as annually for ongoing projects or when significant design changes are proposed.

The checklist ensures that safety and reliability considerations are integrated throughout the design process, from initial requirements definition to final design validation, reducing the risk of in-service failures.

Benefits of AS9100 Design and Development Process Audit Checklist

Ensures compliance with AS9100 design and development requirements

Improves consistency and quality in the product design process

Enhances traceability of design decisions and changes

Facilitates better integration of safety and reliability considerations

Supports efficient design verification and validation processes