ISO 9001:2015 Supplier Audit Checklist - Manufacturing

Auditors can use the ISO 9001:2015 Supplier Audit Form to inspect and evaluate the quality of a current or prospective supplier/vendor's processes. The audit checklist covers various topics, including audit scoring criteria, process activity map - equipment & facilities, personnel, control processes, and more.

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ISO 9001:2015 Supplier Audit Checklist - Manufacturing

Training & Awareness

Design & Development Support

Quality Planning

Audit Details

Customer Documentation

Audit Scoring Criteria

5. MINOR N/C: Definition/Impact: A medium risk, minor non-conformance resulting in deviation from process practice not likely to result in the failure of the management system or process that will not result in the delivery of non-conforming products nor reduce the effectiveness of the QMS.

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Procurement

Equipment & Facilities

Incoming Material

Personnel

Manufacturing Quality

Control Processes

Non-Conforming Outputs

Process Inputs

Monitoring & Measurement

Pocess Name/Description

Maintenance

Process Outputs

Process Control

Instructions & Procedures

Storage & Packing

Support Processes

Findings Summary

Key Performance Indicators

Quality Management

Continuous Improvement

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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ISO 9001:2015 Supplier Audit Checklist - Manufacturing

1. Audit Question: Is the skill and education level required for each job documented and appropriate training provided?

2. Audit Evidence: Look for use of training aids and work instructions at work stations

3. Audit Question: Is employee qualification/certification maintained where the quality outcome of the process cannot be verified and is strongly dependent upon operator skill?

4. Audit Evidence: Qualification records, certification history

5. Audit Question: Are suitable methods used to verify training effectiveness?

6. Audit Evidence: Records of testing, production quality records, audit records, interview workers to validate training records

7. Audit Question: Are suitable records of maintained?

8. Audit Evidence: Job descriptions, job skills assessment, training records, training manuals

1. Audit Question: Are customer needs and requirements incorporated into product designs and/or manufacturing processes?

2. Audit Evidence: Market studies, customer/end-user surveys, technical design reviews

3. Audit Question: Are Critical-to-Quality (CTQ) characteristics are identified, understood and records retained?

4. Audit Evidence: Process capability studies, process plan, manufacturing verification tests

5. Audit Question: Are product specifications and drawings generated, controlled and maintained for new or changed product designs?

6. Audit Evidence: Product characteristics, application requirements and other information for safe and proper use and disposal

7. Audit Question: Is design validation is an integral part of the design process and occurs prior to production release?

8. Audit Evidence: Design results, manufacturability, productivity and cost studies, confirmation that product fulfils its specified requirements or intended use or applications

9. Audit Question: Are human and technical resources are adequate to meet the requirements for design collaboration, tooling design and electronic drawing and data exchange?

10. Audit Evidence: Qualification of technical staff. Equipment/software capabilities, CAD

1. Audit Question: Are production samples inspected and provided to customers upon request?

2. Audit Evidence: Completed PPAP or similar forms, inspection reports, availability of qualified resources

3. Audit Question: Are customer production requirements and quality specifications are reviewed to ensure they can be met on a consistent basis?

4. Audit Evidence: Procedures, design/process review, capacity plans, resource plans, product test, storage, packaging and shipment requirements

5. Audit Question: Are reliability test plans developed and routinely followed?

6. Audit Evidence: Reliability test plans, test reports

7. Audit Question: Is testing is used to verify the design specifications, drive design improvements and provide an on-going check of materials and workmanship?

8. Audit Evidence: Improvement/corrective actions taken, design changes implemented

9. Audit Question: Is product reliability test data is available upon request and historical test performance data shows a highly stable process and product design?

10. Audit Evidence: Reliability test summary reports/charts

1. Ensures the audit is conducted systematically;

2. Promotes audit planning;

3. Ensures a consistent audit approach;

4. Actively supports your organization’s audit process (ISO 9001:2015, Clause 9.2.1);

5. Provides a repository for notes collected during the audit;

6. Ensures uniformity in the performance of different auditors;

7. Provides reference to objective evidence.

1. Audit Question: Are new and revised customer specifications reviewed and implemented in a timely manner?

2. Audit Evidence: Technical review of methods to be used, capability studies on similar parts, documented review procedure

3. Audit Question: Are current process control documents in place and used for production start-up and continuing production?

4. Audit Evidence: Specifications, engineering drawings, change notices, work instructions and specifications as applicable

5. Audit Question: Does customer notification/approval occur for changes to control plans, manufacturing site, product transfers, raw material or product obsolescence?

6. Audit Evidence: Customer notification procedure on major changes

7. Audit Question: Is there a record control system is in place for the identification, storage, protection?

8. Audit Evidence: Document control procedure

9. Audit Question: Are quality records maintained?

10. Audit Evidence: List of records to be kept with retention periods specified

1. COMPLIANT: Definition/Impact: Compliant means adherence with the requirements of the standard and the QMS. The process is implemented and documented and records exist to verify this.

2. COMPLIANT: Action/Mitigation: Continue to monitor trends/indicators.

3. OFI: Definition/Impact: A low risk issue that offers an opportunity to improve current practice. Processes may cumbersome or overly complex but meet their targets and objectives. Unresolved OFIs may degrade over time to become non-compliant.

4. OFI: Action/Mitigation: Review and implement actions to improve the process(s). Monitor trends/indicators to determine if improvement was achieved.

5. MINOR N/C: Definition/Impact: A medium risk, minor non-conformance resulting in deviation from process practice not likely to result in the failure of the management system or process that will not result in the delivery of non-conforming products nor reduce the effectiveness of the QMS.

6. MINOR N/C: Action/Mitigation: Investigate root cause(s) and implement corrective action by next reporting period or next scheduled audit.

7. COMPLIANT: Definition/Impact: A high risk, major non-conformance which directly impacts upon customer requirements, likely to result in the customer receiving non-conforming products or services, or which may reduce the effectiveness of the QMS.

8. COMPLIANT: Action/Mitigation: Implement immediate containment action, investigate root cause(s) and apply corrective action. Re-audit in 4 weeks to verify correction.

1. Audit Question: Is there a formal process used for the selection, qualification and re-qualification of suppliers?

2. Audit Evidence: Supplier quality audits and corrective actions, engineering testing, approval records, production trials

3. Audit Question: Are purchases from unapproved suppliers prevented by a properly controlled and available approved supplier list?

4. Audit Evidence: Approved supplier list, procedures, production material receipt records

5. Audit Question: Are preventive actions taken to continuously improve performance of the supplier base?

6. Audit Evidence: Supplier quality performance analysis, performance trends, supplier audit reports

7. Audit Question: Does the supplier assurance system ensure that all purchased product or material conforms to defined specifications and applicable regulatory or customer requirements?

8. Audit Evidence: Receiving inspection, supplier audits, source inspection, qualification testing, Certificate of Compliance, component marking, labelling, etc.

9. Audit Question: Does a system exist for the identification, verification and protection of customer supplied product that includes notifying the customer if product is damaged or lost?

10. Audit Evidence: Procedures, segregation during storage, limited and controlled access to stored inventories

1. What equipment and resources are required?

2. Is equipment suitable and properly maintained?

3. Is the work environment maintained?

4. Is there evidence of appropriate maintenance of all equipment used by this process?

1. Audit Question: Is receiving inspection performed per documented procedures and detailed work instructions?

2. Audit Evidence: Procedures, inspection instructions resources (manpower and equipment) allocated for incoming inspection

3. Audit Question: Is inspected material adequately identified as to acceptance or rejection and traceable to receiving inspection report?

4. Audit Evidence: Quality control label, marking or use of designated hold area as indicated in the procedure

5. Audit Question: Do supplier corrective action requests requiring root cause investigation show responses are analyzed?

6. Audit Evidence: Availability of written procedure, standardized corrective action form, analysis of corrective action cycle time and closure measurements

1. Review employee skill lists for the process.

2. Are there lists of skills for each position?

3. Do they show enough detail?

4. This is often a finding, where lists are generic with inadequate detail.

5. Training is a key process of any system.

6. Are there particular skills you want to evaluate?