General Information

Name of the organization

Date of the audit

Audit team members

Contact information for key personnel

Management Systems

Quality Management System

Is there a documented quality management system in place?

Are quality objectives defined and communicated?

Is there a process for monitoring and measuring the effectiveness of the quality management system?

Environmental Management System

Is there an environmental management system implemented?

Are environmental objectives defined and monitored?

Are legal and regulatory requirements being met?

Health and Safety Management System

Is there a health and safety management system in place?

Are there documented procedures for hazard identification, risk assessment, and control?

Are employees trained on health and safety procedures?

Design and Development Process

Design Planning

Is there a documented design and development plan?

Are design inputs clearly defined and documented?

Is there a process for design review and verification?

Design Outputs

Are design outputs clearly documented?

Is there a process for design validation?

Are design changes controlled and documented?

Manufacturing and Production

Production Planning

Is there a documented production plan?

Are production processes clearly defined and documented?

Are resources allocated appropriately?

Product Verification and Validation

Is there a process for product verification and validation?

Are inspections and tests conducted as per the defined procedures?

Are non-conformities identified and addressed?

Product Release

Is there a formal process for product release?

Are products properly labeled and identified?

Is there a traceability system in place?

Supplier and Subcontractor Management

Supplier Selection and Evaluation

Is there a process for selecting and evaluating suppliers?

Are supplier performance records maintained?

Are suppliers audited periodically?

Supplier Communication and Control

Is there a mechanism for communicating requirements to suppliers?

Are suppliers provided with necessary information for product realization?

Are non-conforming products from suppliers properly handled?

Documentation and Recordkeeping

Document Control

Is there a document control procedure in place?

Are documents properly controlled, including revisions and approvals?

Are obsolete documents removed from use?

Recordkeeping

Are records maintained as required by regulations and standards?

Are records properly identified, indexed, and stored?

Are records retained for the specified duration?

Corrective and Preventive Actions

Corrective Actions

Is there a process for identifying and addressing non-conformities?

Are root causes determined and appropriate corrective actions taken?

Are corrective actions verified for effectiveness?

Preventive Actions

Is there a proactive approach to identifying potential issues?

Are preventive actions implemented to avoid recurrence?

Are preventive actions monitored and reviewed?

Management Review

Management Review Meeting

Is there a scheduled management review meeting?

Are key performance indicators discussed and reviewed?

Are actions identified and assigned for improvement?

Continuous Improvement

Continuous Improvement Process

Is there a system for collecting and analyzing data for improvement?

Are improvement opportunities identified and prioritized?

Are improvement projects implemented and tracked?

Audit Conclusion

Summary of Findings

Provide a summary of significant findings and observations.

Identify any non-conformities or areas of concern.

Recommendations

Provide recommendations for improvement based on the audit findings.

Prioritize recommendations based on severity and impact.

Audit Sign-off

Obtain signatures from the audit team and key personnel acknowledging the completion of the audit.

Note: This checklist serves as a general guide and may need to be tailored to specific engineering organizations based on their unique requirements and industry standards.