Manufacturing Plant & Supply Chain Audit Evaluation Form

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?

Previous Audit Reference Number

Is the facility certified to ISO 9001 or equivalent quality management standard?

Certification Body and Certificate Number

Describe the alternative quality management framework in place

How would you rate the overall effectiveness of the QMS implementation?

Are quality manuals and procedures readily accessible to relevant personnel?

Describe accessibility issues and impact on operations

Is there a formal process for controlling document versions and changes?

How frequently are documents reviewed and updated? (in months)

Is there a documented process for handling non-conforming products?

Briefly describe the disposition process (rework, scrap, concession)

Select all quality records that are maintained and regularly reviewed

Is there a formal continuous improvement program (e.g., Kaizen, Six Sigma)?

Describe recent improvements and their measurable impact

Rate the organization's commitment to quality culture

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?

Describe the maintenance tracking system and average equipment uptime (%)

Are production plans and schedules documented and communicated daily?

Explain how production priorities are managed without formal scheduling

Is there real-time production monitoring or OEE (Overall Equipment Effectiveness) tracking?

Average OEE percentage (if tracked)

Rate the condition and reliability of the following equipment categories

Are there identified bottlenecks limiting production output?

Describe the bottleneck and any mitigation plans

Total number of active suppliers

Is there an approved supplier list (ASL) with formal qualification criteria?

List the top 3 qualification criteria (e.g., quality certification, financial stability, capacity)

Are suppliers regularly evaluated and re-evaluated based on performance?

Evaluation frequency (in months)

Select all performance metrics used for supplier evaluation

Is there a multi-sourcing strategy for critical materials/components?

Explain the risk mitigation approach for single-source dependencies

Are there formal agreements (contracts) with key suppliers outlining quality requirements?

Describe how quality expectations are communicated without formal contracts

What inventory management approach is primarily used?

Is there visibility into supplier inventory and production status (e.g., through portals or EDI)?

Percentage of spend covered by such visibility (%)

Are inbound logistics and material receipt processes documented and controlled?

Select verification steps performed upon receipt

Rate the overall resilience of the supply chain to disruptions

Is there a formal Health and Safety management system (e.g., ISO 45001)?

Year of initial certification

Describe the alternative safety management approach

Are risk assessments conducted for all operations and equipment?

Frequency of risk assessment review (in months)

Is there a formal incident reporting and investigation procedure?

Number of recordable incidents in the last 12 months

Is there an Environmental Management System (e.g., ISO 14001) in place?

Select monitored environmental aspects

Are employees provided with appropriate Personal Protective Equipment (PPE)?

Select provided PPE categories

Are regular safety training and drills conducted (e.g., fire, chemical spill, first aid)?

Average training hours per employee per year

Are emergency response plans documented and communicated?

Select available emergency response elements

Is there a process for managing hazardous materials and waste?

Describe storage, handling, and disposal procedures

Rate the implementation effectiveness of HSE practices in these areas

Is there a documented Code of Conduct or Business Ethics policy?

Is the Code of Conduct communicated to all employees and suppliers?

Explain the communication gap and planned improvements

Are working hours and overtime managed in compliance with international labor standards?

Maximum weekly working hours allowed (including overtime)

Describe the deviations and justification

Is there a policy prohibiting child labor and forced labor?

Are there verification mechanisms in place (e.g., age verification, voluntary work confirmation)?

Is there a formal process for employees to report grievances or ethical concerns confidentially?

Is there protection against retaliation for whistleblowers?

Are wages and benefits in compliance with local requirements and industry standards?

Describe the areas of non-compliance and corrective action plan

Is there an anti-corruption and anti-bribery policy?

Are employees and suppliers trained on anti-corruption practices?

Are suppliers required to adhere to the same ethical and labor standards?

Are suppliers audited for compliance with these standards?

Select all applicable labor rights that are respected and monitored

Rate the overall maturity of the organization's ethical compliance program

Is there a formal enterprise risk management (ERM) framework in place?

Describe the key risk categories identified (e.g., operational, financial, reputational)

Is there a documented Business Continuity Plan (BCP) or Disaster Recovery Plan?

Select covered disruption scenarios

Are critical business processes identified and prioritized in the BCP?

Recovery Time Objective (RTO) for critical operations (in hours)

Is there a cybersecurity policy and information security management system?

Select implemented cybersecurity measures

Are critical data and systems backed up regularly?

Backup frequency and storage location (e.g., daily, offsite cloud)

Is there insurance coverage for key operational risks?

Select types of insurance coverage

Are risk assessments performed for new products, processes, or suppliers?

Explain how risks are managed when introducing new elements

Rate the maturity of risk management practices in these areas

Are Key Performance Indicators (KPIs) defined, tracked, and reviewed regularly?

Select tracked operational KPIs

Are KPI targets established and aligned with strategic objectives?

Provide examples of recent performance against key targets

Is performance data visualized on dashboards or scorecards for management review?

Frequency of management review meetings (e.g., weekly, monthly)

Is there a formal process for root cause analysis for significant failures or deviations?

Select used root cause analysis methodologies

Are improvement projects managed formally with timelines and resources?

Describe a recent successful improvement initiative and its results

Is there a system for capturing and implementing employee suggestions for improvement?

Approximate number of employee suggestions implemented in the last year

Are benchmarking studies conducted against industry best practices?

Describe the benchmarking scope and key findings

Rate the overall maturity of the performance management system (1 = Ad-hoc, 5 = Optimized)

Is there a master list or register of all controlled documents?

Is there full traceability from raw material receipt to finished product shipment?

Describe the traceability system (e.g., lot numbers, serial numbers, barcode/RFID)

Are production records (batch records, device history records) completed in real-time?

Explain the record completion process and potential risks of retrospective documentation

Is there a defined record retention policy specifying duration and storage conditions?

Typical retention period for production records (in years)

Are electronic records used, and are they secure from unauthorized access or alteration?

Select electronic record security measures

Is there a process for document change control including review and approval?

Are changes communicated to all affected parties before implementation?

Are obsolete documents promptly removed from points of use to prevent unintended use?

Is there a system for managing customer-specific requirements and specifications?

Describe how customer requirements are flowed down to production and quality control

Document Control Effectiveness Assessment

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?

Describe these observations and recommended preventive actions

Corrective Action Plan Summary

Has the plant management reviewed and agreed to the corrective action plan?

Management representative name and title

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