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AS9100 Design and Development Audit Checklist

A comprehensive checklist for auditing aerospace design and development processes against AS9100 requirements, focusing on product innovation, safety, and reliability in the aviation industry.

AS9100 Design and Development Audit Checklist

by: audit-now
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About This Checklist

The AS9100 Design and Development Audit Checklist is an indispensable tool for aviation and aerospace organizations to evaluate their product design and development processes. This comprehensive checklist ensures compliance with the AS9100 standard's requirements for design and development, helping organizations maintain high standards of innovation, safety, and reliability in aerospace engineering. By systematically addressing key aspects of the design process, from initial planning to final validation, this checklist enables auditors to identify potential risks, enhance product performance, and optimize the overall development lifecycle in the aerospace industry.

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Industry

Aerospace and Defense

Standard

AS9100 - Aerospace Quality Management

Workspaces

Aerospace Offices

Occupations

Aerospace Design Engineer
Project Manager
Quality Assurance Engineer
Systems Engineer
Configuration Management Specialist
1
Is there a documented traceability process for design outputs to design inputs?

Please select the compliance status.

To ensure that all design outputs can be traced back to their respective inputs for validation.
2
Has the design validation been completed as per the plan?

Indicate if design validation has been completed.

To confirm that design validation activities have been performed to verify design outputs.
3
What is the risk assessment score for the design process?

Please provide the risk assessment score (1-5).

To evaluate the level of risk associated with the design process.
Min: 1
Target: 3
Max: 5
4
Please provide details of any engineering changes made during the design process.

Provide a detailed description of engineering changes.

To ensure proper documentation and traceability of any changes made to the design.
5
Is the configuration management process being followed?

Select the current status of the configuration management process.

To verify adherence to configuration management practices.
6
Has a formal design review been conducted for the project?

Select the status of the design review.

To ensure that all design reviews are completed and documented as part of the approval process.
7
How many design changes were made during the review process?

Enter the number of design changes.

To track the frequency of design changes and their impact on the project.
Min: 0
Target: 0
Max: 100
8
Has the design been officially approved by all stakeholders?

Indicate if the design has been approved.

To confirm that the design has received appropriate approvals necessary for project continuation.
9
What comments or feedback were provided during the design review?

Provide any comments or feedback from the design review.

To document feedback from the review for future reference and improvement.
10
Was a risk assessment conducted during the design review?

Select the risk assessment status.

To ensure that potential risks have been identified and addressed.
11
Does the design comply with all specified requirements?

Select the compliance status of the design specifications.

To verify that the design meets all the requirements set forth in the specifications.
12
When was the last quality audit conducted on the design?

Enter the date of the last quality audit.

To track the frequency of quality audits and ensure regular assessments are performed.
13
What is the defect rate observed in the design outputs?

Provide the defect rate as a percentage (0-100).

To measure the quality of the design outputs and identify areas for improvement.
Min: 0
Target: 0
Max: 100
14
Have all corrective actions been implemented for identified defects?

Indicate if corrective actions have been implemented.

To ensure that all identified issues have been addressed appropriately.
15
What is the plan for improving design quality based on audit findings?

Provide details of the quality improvement plan.

To document strategies for improving design quality and addressing audit findings.
16
What is the average cycle time for completing design projects?

Enter the average design cycle time in days.

To assess the efficiency of the design process and identify opportunities for improvement.
Min: 1
Target: 30
Max: 365
17
How would you rate the level of stakeholder engagement during the design process?

Select the level of stakeholder engagement.

To evaluate the effectiveness of communication and collaboration with stakeholders.
18
Are the appropriate design tools being utilized effectively?

Indicate if the appropriate design tools are being used.

To ensure that the necessary tools are being used to enhance design efficiency.
19
What bottlenecks have been identified in the design process?

Describe any identified bottlenecks in detail.

To document any challenges that may be hindering the efficiency of the design process.
20
Was an impact assessment conducted for design changes?

Select the status of the impact assessment for design changes.

To verify that design changes are analyzed for their impact on the overall project.
21
Are all innovation initiatives documented and tracked?

Select the status of documentation for innovation initiatives.

To ensure that all innovative efforts are captured for evaluation and improvement.
22
Is there a process in place for collecting feedback on design innovations?

Indicate if a feedback collection process is in place.

To confirm that feedback from users and stakeholders is actively sought to improve designs.
23
How many innovation workshops have been held in the past year?

Enter the number of innovation workshops held.

To assess the commitment to fostering innovation through collaborative efforts.
Min: 0
Target: 5
Max: 100
24
What notable innovations have been implemented in the design process?

Provide details of notable innovations implemented.

To document successful innovations that could serve as best practices for future projects.
25
Have metrics for evaluating innovation effectiveness been established?

Select the status of innovation metrics evaluation.

To ensure that there are quantitative measures in place to assess the impact of innovations.

FAQs

The checklist includes specific items to verify the implementation of risk assessment and mitigation strategies throughout the design and development process, as required by AS9100.

The checklist covers design planning, inputs, controls, outputs, changes, and validation stages as outlined in the AS9100 standard for design and development processes.

Participants should include design engineers, project managers, quality assurance personnel, and cross-functional team members involved in the product development process.

Audits should be conducted at key milestones throughout the development process, with a comprehensive audit performed at least annually or at the completion of major projects.

Documentation reviewed includes design plans, requirements specifications, risk assessments, design review records, verification and validation reports, and change management documentation.

Benefits of AS9100 Design and Development Audit Checklist

Ensures compliance with AS9100 design and development requirements

Improves product safety and reliability through systematic design reviews

Enhances traceability and documentation in the development process

Facilitates risk management and mitigation in aerospace design

Promotes continuous improvement in engineering practices