This section captures essential audit metadata and facility identification to ensure traceability and accountability throughout the evaluation process.
Audit Reference Number
Manufacturing Plant Name
Plant Location (City, Region)
Audit Conduct Date
Lead Auditor Name
Audit Team Members
Plant Manager/Contact Person
Contact Email
Contact Phone
Is this a follow-up audit from a previous evaluation?
Assess the robustness of the Quality Management System, including certifications, documentation control, and continuous improvement mechanisms that ensure product consistency and customer satisfaction.
Is the facility certified to ISO 9001 or equivalent quality management standard?
How would you rate the overall effectiveness of the QMS implementation?
Fully Effective
Mostly Effective
Partially Effective
Ineffective
Not Implemented
Are quality manuals and procedures readily accessible to relevant personnel?
Is there a formal process for controlling document versions and changes?
Is there a documented process for handling non-conforming products?
Select all quality records that are maintained and regularly reviewed
Is there a formal continuous improvement program (e.g., Kaizen, Six Sigma)?
Rate the organization's commitment to quality culture
Very Weak
Weak
Neutral
Strong
Very Strong
Evaluate production capabilities, equipment maintenance, capacity utilization, and operational efficiency metrics that directly impact delivery performance and cost-effectiveness.
Number of production lines/work cells
Total workforce directly involved in production
Primary production shift pattern
Average capacity utilization rate (%)
Is there a preventive maintenance schedule for critical equipment?
Are production plans and schedules documented and communicated daily?
Is there real-time production monitoring or OEE (Overall Equipment Effectiveness) tracking?
Rate the condition and reliability of the following equipment categories
Poor | Fair | Good | Excellent | State-of-the-Art | |
|---|---|---|---|---|---|
Primary production machinery | |||||
Tooling and fixtures | |||||
Measurement and test equipment | |||||
Material handling equipment | |||||
IT infrastructure |
Are there identified bottlenecks limiting production output?
Assess supply chain resilience, supplier qualification processes, inventory management strategies, and logistics capabilities that ensure material availability and cost optimization.
Total number of active suppliers
Is there an approved supplier list (ASL) with formal qualification criteria?
Are suppliers regularly evaluated and re-evaluated based on performance?
Select all performance metrics used for supplier evaluation
Is there a multi-sourcing strategy for critical materials/components?
Are there formal agreements (contracts) with key suppliers outlining quality requirements?
What inventory management approach is primarily used?
Just-In-Time (JIT)
Safety Stock/Reorder Point
Materials Requirements Planning (MRP)
Hybrid approach
No formal system
Is there visibility into supplier inventory and production status (e.g., through portals or EDI)?
Are inbound logistics and material receipt processes documented and controlled?
Rate the overall resilience of the supply chain to disruptions
Very Vulnerable
Vulnerable
Moderate
Resilient
Highly Resilient
Evaluate the effectiveness of health and safety protocols, environmental management practices, and emergency preparedness to protect personnel, community, and the environment.
Is there a formal Health and Safety management system (e.g., ISO 45001)?
Are risk assessments conducted for all operations and equipment?
Is there a formal incident reporting and investigation procedure?
Is there an Environmental Management System (e.g., ISO 14001) in place?
Are employees provided with appropriate Personal Protective Equipment (PPE)?
Are regular safety training and drills conducted (e.g., fire, chemical spill, first aid)?
Are emergency response plans documented and communicated?
Is there a process for managing hazardous materials and waste?
Rate the implementation effectiveness of HSE practices in these areas
Workplace hazard identification | |
Employee safety training | |
Accident investigation | |
Emergency preparedness | |
Environmental compliance | |
Worker participation in HSE |
Assess adherence to ethical business practices, labor standards, and human rights principles throughout operations and the supply chain.
Is there a documented Code of Conduct or Business Ethics policy?
Are working hours and overtime managed in compliance with international labor standards?
Is there a policy prohibiting child labor and forced labor?
Is there a formal process for employees to report grievances or ethical concerns confidentially?
Are wages and benefits in compliance with local requirements and industry standards?
Is there an anti-corruption and anti-bribery policy?
Are suppliers required to adhere to the same ethical and labor standards?
Select all applicable labor rights that are respected and monitored
Rate the overall maturity of the organization's ethical compliance program
Non-Existent
Developing
Defined
Managed
Optimized
Evaluate the organization's ability to identify, assess, and mitigate operational, financial, and strategic risks, including preparedness for business disruptions and cyber threats.
Is there a formal enterprise risk management (ERM) framework in place?
Is there a documented Business Continuity Plan (BCP) or Disaster Recovery Plan?
Are critical business processes identified and prioritized in the BCP?
Is there a cybersecurity policy and information security management system?
Are critical data and systems backed up regularly?
Is there insurance coverage for key operational risks?
Are risk assessments performed for new products, processes, or suppliers?
Rate the maturity of risk management practices in these areas
Risk identification process | |
Risk assessment methodology | |
Risk mitigation strategies | |
Crisis communication plan | |
Testing and exercising of BCP | |
Continuous improvement of risk framework |
Evaluate the use of Key Performance Indicators (KPIs), data-driven decision making, and continuous improvement culture to drive operational excellence and strategic objectives.
Are Key Performance Indicators (KPIs) defined, tracked, and reviewed regularly?
Are KPI targets established and aligned with strategic objectives?
Is performance data visualized on dashboards or scorecards for management review?
Is there a formal process for root cause analysis for significant failures or deviations?
Are improvement projects managed formally with timelines and resources?
Is there a system for capturing and implementing employee suggestions for improvement?
Are benchmarking studies conducted against industry best practices?
Rate the overall maturity of the performance management system (1 = Ad-hoc, 5 = Optimized)
Assess the completeness, accuracy, and accessibility of documentation systems that ensure product traceability, regulatory compliance, and knowledge retention.
Is there a master list or register of all controlled documents?
Is there full traceability from raw material receipt to finished product shipment?
Are production records (batch records, device history records) completed in real-time?
Is there a defined record retention policy specifying duration and storage conditions?
Are electronic records used, and are they secure from unauthorized access or alteration?
Is there a process for document change control including review and approval?
Are obsolete documents promptly removed from points of use to prevent unintended use?
Is there a system for managing customer-specific requirements and specifications?
Document Control Effectiveness Assessment
Document Type | Controlled? | Regularly Reviewed? | Review Frequency | Accessibility Rating (1-5) | |
|---|---|---|---|---|---|
Document audit observations, non-conformances, and agree on corrective actions with clear responsibilities and timelines to drive systematic improvement.
Total number of non-conformances identified during this audit
Number of critical non-conformances requiring immediate action
Were there any observations that could escalate to non-conformance if not addressed?
Corrective Action Plan Summary
Finding ID | Description | Severity | Responsible Person | Target Closure Date | Verification Method | |
|---|---|---|---|---|---|---|
Has the plant management reviewed and agreed to the corrective action plan?
Overall audit summary and key strengths identified
Recommendations for systemic improvements beyond individual non-conformances
Recommended date for follow-up audit
Lead Auditor Signature
Plant Management Representative Signature