https://eauditor.app/2024/04/29/manufacturing-process-audit-checklist/ Manufacturing process audit checklist that can be customized based on the specific processes, industry standards, and regulatory requirements applicable to your organization: Manufacturing process audit checklist Process Documentation and Control: Are process flowcharts, SOPs, work instructions, and other relevant documentation available and up-to-date? Is there a documented change control process for updating procedures? Are employees trained on the latest procedures? Equipment and Facilities: Are equipment and machinery properly maintained and calibrated? Is there a preventive maintenance schedule in place? Are safety features installed and operational? Is the production area clean and organized? Raw Material Handling and Storage: Are raw materials stored in appropriate conditions to prevent contamination or degradation? Is there a first-in-first-out (FIFO) system in place to manage inventory? Are materials properly labeled and identified? Production Process: Is the production process consistent with approved procedures? Are there adequate controls to ensure product quality and consistency? Are critical process parameters monitored and documented? Is there a system for tracking production batches or lots? Quality Control and Assurance: Are quality control checks performed at key stages of the production process? Are inspection records maintained? Is there a process for handling non-conforming products? Are quality metrics monitored and analyzed for trends? Employee Training and Competence: Are employees trained on relevant procedures, safety protocols, and quality standards? Have competency assessments conducted periodically? Are training records maintained? Health and Safety: Are safety protocols followed by employees? Have personal protective equipment (PPE) been provided and used where required? Are emergency procedures clearly communicated and practiced? Environmental Compliance: Are environmental regulations complied with, such as waste disposal and emissions control? Are there measures in place to minimize environmental impact? Supplier Management: Are suppliers evaluated and monitored for quality and reliability? Is there a process for handling supplier non-conformities? Continuous Improvement: Are there mechanisms in place for identifying and implementing process improvements? Are feedback mechanisms available for employees to suggest improvements? Is lesson learned from previous audits or incidents incorporated into the improvement process? Manufacturing process audit checklist Remember, this manufacturing process audit checklist is not exhaustive and should be tailored to suit the specific processes, industry requirements, and organizational priorities.

1. Manufacturing Process
Audit Checklist with
eAuditor
Manufacturing process audits are essential for ensuring quality,
compliance, and continuous improvement in production
environments. A comprehensive audit checklist helps organizations
systematically evaluate their processes against industry standards and
regulatory requirements.
eAuditor Audits & Inspections offers a streamlined approach to
conducting these critical assessments, enabling real-time data
collection, analysis, and reporting. This presentation explores key
components of an effective manufacturing audit checklist and how
eAuditor can enhance your audit processes.
by eAuditor Audits & Inspections
https://eAuditor.app

2. Process Documentation and Control
Updated Documentation
Ensure process flowcharts,
SOPs, work instructions, and
other relevant documentation
are available and up-to-date
Change Control
Verify documented change
control process exists for
updating procedures
Employee Training
Confirm employees are trained
on the latest procedures and
documentation

3. Equipment, Facilities, and Materials
Equipment Management
• Proper maintenance and
calibration of machinery
• Preventive maintenance
schedule implementation
• Operational safety features
Facility Conditions
• Clean and organized production
areas
• Appropriate environmental
controls
• Workspace efficiency and safety
Material Handling
• Proper storage conditions to
prevent contamination
• FIFO inventory management
system
• Clear labeling and identification
of materials

4. Production Process and Quality Control
Process Consistency
Verify production processes align with approved procedures and
include adequate controls for product quality and consistency
Parameter Monitoring
Ensure critical process parameters are monitored and properly
documented with systems for tracking production batches or lots
Quality Checks
Confirm quality control checks are performed at key production
stages with maintained inspection records
Non-Conformance Handling
Evaluate processes for handling non-conforming products and
analyze quality metrics for trends

5. Employee Training and Safety
Safety Culture
Organizational commitment to safety excellence
Safety Protocols
Established procedures and PPE requirements
Competency Training
Comprehensive training on procedures and standards
Documentation
Maintained training records and assessments
Employee training and safety form the foundation of manufacturing excellence. Proper training ensures workers understand
procedures, quality standards, and safety protocols. Regular competency assessments verify knowledge retention, while
comprehensive documentation provides evidence of compliance and identifies training needs.

6. Environmental Compliance and Supplier Management
Environmental Regulations
Verify compliance with waste disposal and emissions control
regulations. Assess measures implemented to minimize
environmental impact throughout manufacturing processes.
Sustainability Initiatives
Evaluate programs for resource conservation, energy efficiency,
and sustainable practices that reduce the environmental footprint
of manufacturing operations.
Supplier Evaluation
Review processes for evaluating and monitoring suppliers for
quality and reliability. Check documentation of supplier
qualifications and performance metrics.
Non-Conformity Management
Assess procedures for handling supplier non-conformities,
including corrective action requests, follow-up verification, and
continuous improvement initiatives.

7. Continuous Improvement
Identify Opportunities
Mechanisms for identifying process
improvements
Employee Feedback
Systems for collecting improvement
suggestions
Lessons Learned
Incorporation of insights from previous
audits
Measure Results
Tracking improvements and validating
effectiveness
Continuous improvement is vital for manufacturing excellence. By establishing robust mechanisms for identifying opportunities,
organizations can systematically enhance their processes. Employee feedback provides valuable frontline insights, while lessons
learned from previous audits prevent recurring issues. Measuring results validates improvement efforts and drives ongoing
optimization.

8. eAuditor: Streamlining
Manufacturing Audits
Define Requirements
Identify specific objectives and checklist items needed for your manufacturing
process audit. Customize based on your organization's unique processes and
compliance needs.
Utilize Key Features
Leverage eAuditor's dynamic checklists, data entry fields, photo capture
capabilities, automatic timestamping, and comprehensive reporting
functionality to conduct thorough audits.
Analyze and Act
Use collected audit data to analyze trends, identify improvement areas, and
track corrective actions. Implement continuous improvement initiatives
based on findings.
eAuditor Audits & Inspections transforms the manufacturing audit process with secure
data storage, integrity measures, and user-friendly interfaces. Available on both Apple
and Android platforms, it provides an efficient tool for quality assurance and compliance
management in your organization.