Perform Supplier Quality Audit using eAuditor
Supplier Quality Audit is a systematic evaluation of a supplier’s processes, products, and quality management systems to ensure they meet the buyer’s specified standards and regulatory requirements. This audit helps verify that the supplier consistently delivers goods or services that meet contractual expectations, industry norms, and safety or compliance obligations.
Performing a Supplier Quality Audit using eAuditor ensures a thorough and standardized evaluation of a supplier’s quality systems, processes, and compliance with specific industry and regulatory standards. This systematic approach helps organizations identify potential risks, improve supplier relationships, and ensure that suppliers consistently deliver quality products or services.
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Audit Preparation and Scope Definition
Before starting the audit, you need to establish clear objectives and define the scope of the audit.
- Define Audit Objectives:
Understand the purpose of the audit, such as assessing the quality management system, verifying product quality, or ensuring compliance with specific regulations like ISO 9001 or customer-specific requirements. - Select Relevant Criteria:
Choose criteria based on the supplier’s products or services. For example, if the supplier provides medical products, the criteria should include compliance with FDA or ISO 13485. - Prepare the Checklist:
Customize or create a Supplier Quality Audit checklist within eAuditor, covering areas like QMS, production processes, product quality, non-conformance management, and compliance.
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Supplier Information Gathering
Start by collecting all relevant information about the supplier to establish context for the audit.
- Supplier Details:
Record the supplier’s name, location, contact details, and a brief description of the products or services they provide. - Certification Verification:
Check if the supplier holds certifications like ISO 9001, GMP, HACCP, or any industry-specific certifications. You can upload copies of these certificates directly into eAuditor for easy reference. - Compliance Documentation:
Ensure the supplier has all necessary regulatory and safety documentation in place for their operations. This includes evidence of compliance with local, regional, and international standards.
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Quality Management System (QMS) Review
Evaluate the supplier’s quality management processes to ensure they are compliant with industry standards and capable of consistently delivering quality products.
- Document Control:
Verify that the supplier has a structured document control system to manage procedures, work instructions, and records. Review and update documents regularly. - Internal Audits:
Check the frequency and scope of the supplier’s internal audits. Ensure they are conducted regularly and that corrective actions from previous audits have been implemented. - Corrective and Preventive Actions (CAPA):
Review how the supplier handles CAPA. Verify that there’s a system for identifying non-conformances, analyzing root causes, and implementing corrective actions. - Employee Training:
Assess whether the supplier has a robust training program that ensures their workforce is knowledgeable about quality processes and compliance.
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Incoming Materials and Supplier Controls
A key area of the audit is ensuring that the supplier has appropriate controls in place to manage the materials they receive and process.
- Material Inspection and Testing:
Evaluate how incoming materials are inspected for quality and compliance. Ensure there’s a clear process for verifying the quality of raw materials or components before they enter production. - Supplier Approval Process:
Review how the supplier qualifies their own suppliers. Ensure that only approved suppliers are used and that the supplier maintains records of these approvals. - Material Traceability:
Verify that the supplier has a traceability system for raw materials, which is critical for quality control, especially for industries like pharmaceuticals or food production.
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Production and Process Controls
Next, evaluate the supplier’s production processes to ensure that they consistently produce products that meet quality standards.
- Production Process Evaluation:
Observe the manufacturing process to ensure that operations follow established procedures and best practices. Check for process standardization, control measures, and effective workflows. - Equipment Calibration:
Verify that all critical equipment used in production is properly calibrated and maintained. This helps prevent deviations that could affect product quality. - In-Process Inspections:
Review how the supplier conducts in-process inspections during production. Ensure that quality checks are done at appropriate stages to catch issues early.
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Final Product Quality and Conformance
Once the production process is complete, it’s important to evaluate the final product’s quality and ensure it meets agreed-upon specifications.
- Final Product Inspection:
Check the records of final inspections to ensure the supplier is inspecting finished goods thoroughly. This should include visual checks, functional testing, or any other relevant assessments. - Conformance to Specifications:
Verify that the final products meet the specified criteria, including dimensional accuracy, performance, and durability (if applicable). - Defect and Non-Conformance Reporting:
Review how the supplier handles defective products or non-conformances. Ensure they have a structured process for identifying, documenting, and correcting defects.
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Non-Conformance and Corrective Action Management
Assess how the supplier handles non-conformance and corrective actions. A robust system is essential for continuous improvement.
- Non-Conformance Reporting:
Evaluate the supplier’s system for reporting non-conformances. Ensure that they are documented with clear details about the issue and the impact on production. - Root Cause Analysis:
Verify that the supplier conducts root cause analysis to understand the underlying issues causing non-conformances. This helps in preventing recurrence. - Corrective Action Implementation:
Ensure that corrective actions are implemented in a timely manner and that the effectiveness of these actions is verified.
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Logistics, Packaging, and Shipping
The audit should also include an evaluation of how the supplier handles logistics and packaging to ensure safe and accurate product delivery.
- Packaging and Labeling:
Verify that products are correctly packaged and labeled according to specifications. Check that the packaging protects products from damage during transport. - Logistics and Shipping:
Evaluate the logistics process to ensure products are shipped in compliance with customer requirements. This includes checking delivery schedules, storage conditions, and transport practices.
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Workforce Competency and Training
A well-trained workforce is essential for maintaining product quality and compliance.
- Training Programs:
Evaluate the supplier’s employee training records. Ensure that employees are trained on quality standards, safety practices, and product specifications. - Competency Checks:
Verify that employees in critical roles have the necessary skills and knowledge to perform their tasks effectively.
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Health and Safety Compliance
Ensure the supplier’s operations are safe and comply with relevant health and safety regulations.
- Workplace Safety:
Evaluate the safety practices on-site, including PPE usage, safe work environments, and employee health initiatives. - Environmental and Regulatory Compliance:
Check the supplier’s compliance with environmental regulations, such as waste management, emissions control, and other relevant laws.
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Corrective Actions and Follow-up
After the audit, any identified non-conformances or issues should be addressed with corrective actions.
- Create Corrective Actions:
Document all non-conformances and assign corrective actions directly in eAuditor. Assign responsibilities and set deadlines for resolution. - Track Progress:
Monitor the progress of corrective actions using eAuditor’s dashboard to ensure that issues are addressed in a timely manner.
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Audit Report Generation and Sharing
Once the audit is complete, generate a comprehensive report to summarize the findings.
- Generate Audit Report:
Use eAuditor’s automated report generation feature to create a detailed report that includes audit findings, ratings, photos, and corrective actions. - Share the Report:
Share the report with relevant internal stakeholders and the supplier. Ensure the report is reviewed and signed off by both the auditor and the supplier representative.
Summary
Performing a Supplier Quality Audit using eAuditor ensures a comprehensive evaluation of supplier processes, product quality, and regulatory compliance. This process identifies potential risks, encourages continuous improvement, and strengthens relationships with suppliers. eAuditor streamlines the entire audit process, from preparation to report generation, providing a structured approach to manage supplier quality effectively.