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.

ISO 9001:2015 Supplier Audit Checklist - Manufacturing



Audit Details

1. Ensures the audit is conducted systematically;


Photo Comment

2. Promotes audit planning;


Photo Comment

3. Ensures a consistent audit approach;


Photo Comment

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


Photo Comment

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


Photo Comment

6. Ensures uniformity in the performance of different auditors;


Photo Comment

7. Provides reference to objective evidence.


Photo Comment
Customer Documentation

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

6. Audit Evidence: Customer notification procedure on major changes


Photo Comment

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


Photo Comment

8. Audit Evidence: Document control procedure


Photo Comment

9. Audit Question: Are quality records maintained?


Photo Comment

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


Photo Comment
Audit Scoring Criteria

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.


Photo Comment

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


Photo Comment

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.


Photo Comment

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


Photo Comment

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.


Photo Comment

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


Photo Comment

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.


Photo Comment

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


Photo Comment
Procurement

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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?


Photo Comment

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


Photo Comment

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?


Photo Comment

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


Photo Comment
Equipment & Facilities

1. What equipment and resources are required?


Photo Comment

2. Is equipment suitable and properly maintained?


Photo Comment

3. Is the work environment maintained?


Photo Comment

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


Photo Comment
Incoming Material

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment
Personnel

1. Review employee skill lists for the process.


Photo Comment

2. Are there lists of skills for each position?


Photo Comment

3. Do they show enough detail?


Photo Comment

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


Photo Comment

5. Training is a key process of any system.


Photo Comment

6. Are there particular skills you want to evaluate?


Photo Comment
Manufacturing Quality

1. Audit Question: Is there is a formal method used to qualify new or rebuilt production equipment prior to production use?


Photo Comment

2. Audit Evidence: Qualification plan that includes established goals for process yields. Records of process capability, review and approval


Photo Comment

3. Audit Question: Are control plans used to plan and deploy inspection and test functions throughout the production process?


Photo Comment

4. Audit Evidence: Process flow chart, statistical tools, key inspection points, inspection frequency, inspection/test method, gaging used, acceptable yield rates


Photo Comment

5. Audit Question: Are appropriate work instructions are available where needed that accurately describe all work methods including inspections and tests to be done during production?


Photo Comment

6. Audit Evidence: Sample size, frequency, method, document control dates/revision level


Photo Comment

7. Audit Question: Are appropriate inspections, tests and process adjustments made per applicable work instructions to verify conformance at key points throughout the process and prior to shipment?


Photo Comment

8. Audit Evidence: Records of inspections performed at incoming, first piece, in-process and/or final inspection or test


Photo Comment

9. Audit Question: Is the inspection and process status of the product identified and maintained throughout the production process?


Photo Comment

10. Audit Evidence: Batch records, travellers, tags, labels, product markings or use of designated and identified areas


Photo Comment

11. Audit Question: Are customers notified of low yield production lots or issues that affect product reliability?


Photo Comment

12. Audit Evidence: Corrective actions, records of customer notifications, reliability test data


Photo Comment
Control Processes

1. How is the process defined and who is responsible?


Photo Comment

2. How are customer requirements defined?


Photo Comment

3. What specifications apply defined?


Photo Comment

4. What objectives and targets apply process?


Photo Comment

5. What controls/check points are there?


Photo Comment

6. What acceptance criteria exist?


Photo Comment
Non-Conforming Outputs

1. Audit Question: Are nonconforming materials, parts and assemblies are segregated (where practical) and identified to prevent unapproved use?


Photo Comment

2. Audit Evidence: Tags, marking, controlled staging areas


Photo Comment

3. Audit Question: Is reworked material, parts and assemblies are re-inspected or re-tested to confirm compliance to requirements?


Photo Comment

4. Audit Evidence: Inspection record, tag and stamp


Photo Comment

5. Audit Question: Is the use of nonconforming material is documented under a formal waiver or concession system?


Photo Comment

6. Audit Evidence: Written procedure, waiver or concession records


Photo Comment

7. Audit Question: Is product traceability maintained to facilitate problem evaluation and corrective action?


Photo Comment

8. Audit Evidence: Serial number records, lot number, date of manufacture, labelling and marking of containers or product


Photo Comment

9. Audit Question: Is there a positive recall system to notify customers of nonconforming product that has already been shipped?


Photo Comment

10. Audit Evidence: Documented procedure and review of system


Photo Comment
Process Inputs

1. What triggers the process?


Photo Comment

2. What inputs are required?


Photo Comment

3. Where do the inputs come from?


Photo Comment

4. Are they received in a timely manner?


Photo Comment

5. Are they fit for purpose?


Photo Comment
Monitoring & Measurement

1. Audit Question: Are gauge repeatability and reproducibility studies conducted to verify suitability of measuring devices for their use in checking product quality or control of processes?


Photo Comment

2. Audit Evidence: GR & R studies, reports


Photo Comment

3. Audit Question: Are measuring devices and gauges and test equipment are routinely calibrated and controlled per documented procedures?


Photo Comment

4. Audit Evidence: Calibration stickers and records, positive identification or segregation of out-of-calibration devices, and inventory, location & status records


Photo Comment

5. Audit Question: Are gauges and test equipment calibrated against standards traceable to a recognized regulatory body or agency?


Photo Comment

6. Audit Evidence: Calibration procedures, and calibration stickers and other records


Photo Comment

7. Audit Question: Are assessments made to check the validity of previous measurements done on products where out-of-calibration measuring devices were used?


Photo Comment

8. Audit Evidence: Assessment records and corrective actions


Photo Comment

9. Audit Question: Are appropriate controls are in place to verify the suitability and accuracy of computer software prior to initial use in checking product quality or control of processes?


Photo Comment

10. Audit Evidence: Verification methods and records, revision levels, distribution/use control


Photo Comment
Pocess Name/Description

1. What steps are involved in the process?


Photo Comment

2. What happens at each step in the process?


Photo Comment

3. What documents and records are generated?


Photo Comment

4. Is the process implemented in accordance with procedures, instructions or plans?


Photo Comment

5. Are controls applied as described?


Photo Comment
Maintenance

1. Audit Question: Are tools stored in an appropriate, clearly defined area, with systematic tracking that provides traceability, particularly of customer-owned tools and equipment?


Photo Comment

2. Audit Evidence: GR & R studies, reportsAudit Evidence: Review of storage area, labelling, tooling records


Photo Comment

3. Audit Question: Does a formal preventive maintenance system (PM) exist for production equipment, tools and fixtures?


Photo Comment

4. Audit Evidence: Review of system, PM plans, PM schedule and compliance results


Photo Comment

5. Audit Question: Is the preventive maintenance schedule is followed since product cannot be made with tools that are outside of maintenance period?


Photo Comment

6. Audit Evidence: No equipment, tools, or fixtures are in use that are outside TPM schedule, or have unclear status


Photo Comment
Process Outputs

1. What is the product produced by this process?


Photo Comment

2. Are product measures in place to ensure that product meets requirements?


Photo Comment

3. How are processes measured?


Photo Comment

4. Are product and process measures achieved?


Photo Comment

5. What feedback is received from customers?


Photo Comment
Process Control

1. Audit Question: Are key part characteristics and process parameters are reviewed and statistically based controls and/or problem solving tools are used to control variation?


Photo Comment

2. Audit Evidence: Histograms, run charts, SPC charts, pareto analysis, cause and effect diagrams, mistake proofing, reaction plan & process corrections.


Photo Comment

3. Audit Question: Are written improvement plans are implemented to reduce sources of variation?


Photo Comment

4. Audit Evidence: Documented reaction plan and process corrections. SPC trend charts showing current status vs. goals, improvement plans


Photo Comment

5. Audit Question: Is process capability is measured and actions are taken to maintain established minimum Cpk/Ppk targets?


Photo Comment

6. Audit Evidence: Documented process capability studies and results (actual vs target Cpk/Ppk)


Photo Comment

7. Audit Question: Are out of control conditions are noted on charts and documented corrective action is taken to bring the process back into control?


Photo Comment

8. Audit Evidence: Control charts


Photo Comment
Instructions & Procedures

1. Review the documents that describe and control the process.


Photo Comment

2. Review all the important steps and activities of the process being audited.


Photo Comment

3. This info must be documented within the QMS.


Photo Comment

4. Evaluate how effectively the process flows through the steps.


Photo Comment

5. Do you see roadblocks or issues?


Photo Comment
Storage & Packing

1. Audit Question: Are areas around the facility clean and orderly and are tools and equipment properly stored and readily available for use and is lighting and air quality are adequate?


Photo Comment

2. Audit Evidence: Observe production, office & product storage areas. (Sort, Set-in-order, Shine, Standardize, Sustain + Safety)


Photo Comment

3. Audit Question: Is proper equipment and methods used to prevent product damage or loss in all phases of the material handling process?


Photo Comment

4. Audit Evidence: Observe handling and transit of raw material, work-in-process, and finished goods.


Photo Comment

5. Audit Question: Are documented procedures followed to ensure proper control and preservation of handling, storage (FIFO), packaging, and delivery of product?


Photo Comment

6. Audit Evidence: FIFO practices are defined, packaging specifications, test results, handling and storage procedures.


Photo Comment

7. Audit Question: Is the suitability of product packaging reviewed and concerns communicated to the customer prior to initial production shipment?


Photo Comment

8. Audit Evidence: Technical review, packaging/shipping tests, packaging work instructions, carton strength tests


Photo Comment

9. Audit Question: Is stored product/material periodically inspected, and where applicable, actions are taken to prevent deterioration per documented procedures?


Photo Comment

10. Audit Evidence: Lists of shelf-life sensitive materials. Look for poor storage conditions and damage. Handling procedures


Photo Comment

11. Audit Question: Have contingency plans been developed that describe actions to be taken in the event of a major interruption of the manufacturing process?


Photo Comment

12. Audit Evidence: Process covering utility interruptions, labour shortages, key equipment failures, major production issues


Photo Comment
Support Processes

1. As you audit, you will see how it connects and interacts with other processes.


Photo Comment

2. Interactions with other processes are always important.


Photo Comment

3. As you audit the, you will see how it connects and interacts with other processes.


Photo Comment

4. Audit the relevant links to related processes and support processes.


Photo Comment
Findings Summary

1. Non-conformance


Photo Comment

2. Corrective Action


Photo Comment

3. Opportunities for Improvement


Photo Comment

4. Observations, Comments & Notes


Photo Comment
Key Performance Indicators

1. Review metrics and performance with Managers, Supervisors and operators.


Photo Comment

2. They should know how things are running, objectives, customer issues, problem areas.


Photo Comment

3. If they do not, the requirements were not met.


Photo Comment

4. Is there evidence that quality objectives and targets affected by this process are being achieved?


Photo Comment
Quality Management

1. Audit Question: Is the quality system documented, controlled and maintained to clearly describe current practice?


Photo Comment

2. Audit Evidence: Quality manual and all procedures show revision control (sign-offs & dates), history of changes


Photo Comment

3. Audit Question: Do quality reports, trend charts and data analysis identify areas of opportunity and are used by management on a routine basis?


Photo Comment

4. Audit Evidence: Product quality yield data, problems and corresponding improvement actions, status of preventive/ corrective/audit results


Photo Comment

5. Audit Question: Are quality-performance targets clearly defined, included in the business plan and monitored for improvements?


Photo Comment

6. Audit Evidence: Strategic and tactical objectives, goals, action plans, etc.


Photo Comment

7. Audit Question: Does executive management participate in periodic quality system reviews that address quality related feedback from customers and internal quality metrics?


Photo Comment

8. Audit Evidence: Analysis of field failures, inspection yields, resource needs, internal audit results, corrective action status, etc.


Photo Comment
Continuous Improvement

1. Audit Question: Are preventive actions taken based on the analysis of significant business trends, design reviews, customer satisfaction surveys or other meaningful inputs?


Photo Comment

2. Audit Evidence: Management review meetings, goal setting, performance measurement, internal audits, action plans, customer surveys


Photo Comment

3. Audit Question: Is there a formal approach used to actively pursue cost containment and other continual improvement activities throughout the organization?


Photo Comment

4. Audit Evidence: Employee involvement/recognition program, Lean, Six Sigma, kaizen, SPC, 5-S, cost reduction programme


Photo Comment

5. Audit Question: Is a corrective action system in place that provides root cause analysis and takes timely and effective action to prevent recurrence?


Photo Comment

6. Audit Evidence: Corrective actions, trend charts, meeting minutes, non-conformance frequency & cost analysis


Photo Comment

7. Audit Question: Does the corrective action system cover customer, internal and supplier issues?


Photo Comment

8. Audit Evidence: Management review meetings and corrective actions


Photo Comment
Training & Awareness

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


Photo Comment

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


Photo Comment

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?


Photo Comment

4. Audit Evidence: Qualification records, certification history


Photo Comment

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


Photo Comment

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


Photo Comment

7. Audit Question: Are suitable records of maintained?


Photo Comment

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


Photo Comment
Design & Development Support

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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?


Photo Comment

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


Photo Comment
Quality Planning

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

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


Photo Comment

6. Audit Evidence: Reliability test plans, test reports


Photo Comment

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?


Photo Comment

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


Photo Comment

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?


Photo Comment

10. Audit Evidence: Reliability test summary reports/charts


Photo Comment

Is this sample what you are looking for?
Sign up to use & customise this template, or create your own custom checklist:

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.

Seeing is Believing

Get a live demo customized to your unique needs, or get started with a 14-day FREE trial.