Supplier Audit

Checklist
Supplier Audit Checklist
System & Process Compliance Auditing

Guidance
About this Checklist
The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure that audits address the
necessary requirements. It stands as a reference point before, during and after the audit process and used correctly will provide the following
benefits:
 Ensures the audit is conducted systematically;
 Promotes audit planning;
 Ensures a consistent audit approach;
 Provides a repository for notes collected during the audit;
 Ensures uniformity in the performance of different auditors;
 Provides reference to objective evidence.
This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2015, each required
is phrased as a question. This audit checklist may be used for element compliance audits and for process audits.

Document Ref: Page 1 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Audit Scoring Criteria

A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to your organization. The audit’s role is to provide
assurance that key risks to your organization’s objectives are being well controlled.

The audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of any system or processes being audited. The rating
system is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method for scoring each audit finding. At the end of the
audit, you can transfer the findings into an Excel spreadsheet to create charts, summary tables and trend data to paste into your audit report or management
review documentation.

This methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and process audits) that your organization will likely
undertake.

Finding Definition/Impact Action/Mitigation

COMPLIAN Compliant means adherence with the requirements of the standard and the QMS. The
Continue to monitor trends/indicators.
T process is implemented and documented and records exist to verify this.

A low risk issue that offers an opportunity to improve current practice. Processes may Review and implement actions to improve the process(s).
OFI cumbersome or overly complex but meet their targets and objectives. Unresolved OFIs Monitor trends/indicators to determine if improvement was
may degrade over time to become non-compliant. achieved.

A medium risk, minor non-conformance resulting in deviation from process practice not
Investigate root cause(s) and implement corrective action by
MINOR N/C likely to result in the failure of the management system or process that will not result in
next reporting period or next scheduled audit.
the delivery of non-conforming products nor reduce the effectiveness of the QMS.

A high risk, major non-conformance which directly impacts upon customer requirements, Implement immediate containment action, investigate root
MAJOR N/C likely to result in the customer receiving non-conforming products or services, or which cause(s) and apply corrective action. Re-audit in 4 weeks to
may reduce the effectiveness of the QMS. verify correction.

Document Ref: Page 2 of 20

Supplier Audit Checklist
System & Process Compliance Auditing
Process Activity Map
EQUIPMENT & FACILITIES:
What equipment and resources are required?
Is equipment suitable and properly
maintained? Is the work environment
maintained?
Is there evidence of appropriate maintenance
of all equipment used by this process?
PROCESS INPUTS:
What triggers the process?
What inputs are required?
Where do the inputs come from?
Are they received in a timely manner?
Are they fit for purpose?
INSTRUCTIONS & PROCEDURES:
Review the documents that describe and
control the process. Review all the important
steps and activities of the process being
audited. This info must be documented within
the QMS. Evaluate how effectively the process
flows through the steps. Do you see roadblocks
or issues?
Document Ref:
PERSONNEL:
Review employee skill lists for the process. Are
there lists of skills for each position? Do they
show enough detail? This is often a finding,
where lists are generic with inadequate detail.
Training is a key process of any system. Are
there particular skills you want to evaluate?
PROCESS NAME/DESCRIPTION:
What steps are involved in the process?
What happens at each step in the process?
What documents and records are generated?
Is the process implemented in accordance with
procedures, instructions or plans?
Are controls applied as described?
SUPPORT PROCESSES:
As you audit, you will see how it connects and
interacts with other processes. Interactions
with other processes are always important. As
you audit the, you will see how it connects and
interacts with other processes. Audit the
relevant links to related processes and support
processes.
CONTROL PROCESSES:
How is the process defined and who is
responsible? How are customer requirements
defined? What specifications apply defined?
What objectives and targets apply process?
What controls/check points are there? What
acceptance criteria exist?
PROCESS OUPUTS:
What is the product produced by this process?
Are product measures in place to ensure that
product meets requirements?
How are processes measured?
Are product and process measures achieved?
What feedback is received from customers?
KEY PERFORMANCE
INDICATORS:
Review metrics and performance with
Managers, Supervisors and operators. They
should know how things are running,
objectives, customer issues, problem areas. If
they do not, the requirements were not met. Is
there evidence that quality objectives and
targets affected by this process are being
achieved?
Page 3 of 20
Supplier Audit Checklist
System & Process Compliance Auditing

Supplier Audit Questions

Quality Management
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Quality manual and all procedures

Is the quality system documented, controlled and maintained
1 show revision control (sign-offs &
to clearly describe current practice?
dates), history of changes

Product quality yield data, problems

Do quality reports, trend charts and data analysis identify
and corresponding improvement
2 areas of opportunity and are used by management on a
actions, status of preventive/
routine basis?
corrective/audit results

Are quality-performance targets clearly defined, included in Strategic and tactical objectives,
3
the business plan and monitored for improvements? goals, action plans, etc.

Does executive management participate in periodic quality Analysis of field failures, inspection
4 system reviews that address quality related feedback from yields, resource needs, internal audit
customers and internal quality metrics? results, corrective action status, etc.

Document Ref: Page 4 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Continuous Improvement
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Management review meetings, goal

Are preventive actions taken based on the analysis of
setting, performance measurement,
5 significant business trends, design reviews, customer
internal audits, action plans, customer
satisfaction surveys or other meaningful inputs?
surveys

Is there a formal approach used to actively pursue cost Employee involvement/recognition

6 containment and other continual improvement activities program, Lean, Six Sigma, kaizen, SPC,
throughout the organization? 5-S, cost reduction programme

Is a corrective action system in place that provides root cause Corrective actions, trend charts,
7 analysis and takes timely and effective action to prevent meeting minutes, non-conformance
recurrence? frequency & cost analysis

Does the corrective action system cover customer, internal Management review meetings and
8
and supplier issues? corrective actions

Document Ref: Page 5 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Training & Awareness

Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Is the skill and education level required for each job Look for use of training aids and work
9
documented and appropriate training provided? instructions at work stations

Is employee qualification/certification maintained where the

Qualification records, certification
10 quality outcome of the process cannot be verified and is
history
strongly dependent upon operator skill?

Records of testing, production quality

11 Are suitable methods used to verify training effectiveness? records, audit records, interview
workers to validate training records

Job descriptions, job skills assessment,

12 Are suitable records of maintained?
training records, training manuals

Document Ref: Page 6 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Design & Development Support

Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Are customer needs and requirements incorporated into Market studies, customer/end-user
13
product designs and/or manufacturing processes? surveys, technical design reviews

Are Critical-to-Quality (CTQ) characteristics are identified, Process capability studies, process
14
understood and records retained? plan, manufacturing verification tests

Are product specifications and drawings generated, Product characteristics, application

15 controlled and maintained for new or changed product requirements and other information
designs? for safe and proper use and disposal
Design results, manufacturability,
productivity and cost studies,
Is design validation is an integral part of the design process
16 confirmation that product fulfils its
and occurs prior to production release?
specified requirements or intended
use or applications
Are human and technical resources are adequate to meet the
Qualification of technical staff.
17 requirements for design collaboration, tooling design and
Equipment/software capabilities, CAD
electronic drawing and data exchange?

Document Ref: Page 7 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Quality Planning
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Completed PPAP or similar forms,

Are production samples inspected and provided to
18 inspection reports, availability of
customers upon request?
qualified resources

Procedures, design/process review,

Are customer production requirements and quality
capacity plans, resource plans,
19 specifications are reviewed to ensure they can be met on a
product test, storage, packaging and
consistent basis?
shipment requirements

20 Are reliability test plans developed and routinely followed? Reliability test plans, test reports

Is testing is used to verify the design specifications, drive

Improvement/corrective actions
21 design improvements and provide an on-going check of
taken, design changes implemented
materials and workmanship?

Is product reliability test data is available upon request and

Reliability test summary
22 historical test performance data shows a highly stable
reports/charts
process and product design?

Document Ref: Page 8 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Customer Documentation
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Technical review of methods to be

Are new and revised customer specifications reviewed and
23 used, capability studies on similar
implemented in a timely manner?
parts, documented review procedure

Specifications, engineering drawings,

Are current process control documents in place and used for
24 change notices, work instructions and
production start-up and continuing production?
specifications as applicable

Does customer notification/approval occur for changes to

Customer notification procedure on
25 control plans, manufacturing site, product transfers, raw
major changes
material or product obsolescence?

Is there a record control system is in place for the

26 identification, storage, protection, retrieval, retention time, Document control procedure
and disposition of quality records?

List of records to be kept with

27 Are quality records maintained?
retention periods specified

Document Ref: Page 9 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Procurement
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Supplier quality audits and corrective

Is there a formal process used for the selection, qualification
28 actions, engineering testing, approval
and re-qualification of suppliers?
records, production trials

Are purchases from unapproved suppliers prevented by a Approved supplier list, procedures,
29
properly controlled and available approved supplier list? production material receipt records

Supplier quality performance analysis,

Are preventive actions taken to continuously improve
30 performance trends, supplier audit
performance of the supplier base?
reports

Receiving inspection, supplier audits,

Does the supplier assurance system ensure that all purchased
source inspection, qualification
31 product or material conforms to defined specifications and
testing, Certificate of Compliance,
applicable regulatory or customer requirements?
component marking, labelling, etc.

Does a system exist for the identification, verification and Procedures, segregation during
32 protection of customer supplied product that includes storage, limited and controlled access
notifying the customer if product is damaged or lost? to stored inventories

Document Ref: Page 10 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Incoming Material
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Procedures, inspection instructions

Is receiving inspection performed per documented
33 resources (manpower and equipment)
procedures and detailed work instructions?
allocated for incoming inspection

Quality control label, marking or use

Is inspected material adequately identified as to acceptance
34 of designated hold area as indicated
or rejection and traceable to receiving inspection report?
in the procedure

Availability of written procedure,

Do supplier corrective action requests requiring root cause standardized corrective action form,
35
investigation show responses are analyzed? analysis of corrective action cycle time
and closure measurements

Document Ref: Page 11 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Manufacturing Quality
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Qualification plan that includes

Is there is a formal method used to qualify new or rebuilt established goals for process yields.
36
production equipment prior to production use? Records of process capability, review
and approval
Process flow chart, statistical tools,
Are control plans used to plan and deploy inspection and key inspection points, inspection
37
test functions throughout the production process? frequency, inspection/test method,
gaging used, acceptable yield rates

Are appropriate work instructions are available where needed

Sample size, frequency, method,
38 that accurately describe all work methods including
document control dates/revision level
inspections and tests to be done during production?

Are appropriate inspections, tests and process adjustments Records of inspections performed at
39 made per applicable work instructions to verify conformance incoming, first piece, in-process
at key points throughout the process and prior to shipment? and/or final inspection or test

Batch records, travellers, tags, labels,

Is the inspection and process status of the product identified
40 product markings or use of
and maintained throughout the production process?
designated and identified areas

Corrective actions, records of

Are customers notified of low yield production lots or issues
41 customer notifications, reliability test
that affect product reliability?
data

Document Ref: Page 12 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Non-conforming Outputs
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Are nonconforming materials, parts and assemblies are

Tags, marking, controlled staging
42 segregated (where practical) and identified to prevent
areas
unapproved use?

Is reworked material, parts and assemblies are re-inspected

43 Inspection record, tag and stamp
or re-tested to confirm compliance to requirements?

Is the use of nonconforming material is documented under a Written procedure, waiver or

44
formal waiver or concession system? concession records

Serial number records, lot number,

Is product traceability maintained to facilitate problem
45 date of manufacture, labelling and
evaluation and corrective action?
marking of containers or product

Is there a positive recall system to notify customers of Documented procedure and review of
46
nonconforming product that has already been shipped? system

Document Ref: Page 13 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Monitoring & Measurement

Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Are gauge repeatability and reproducibility studies

47 conducted to verify suitability of measuring devices for their GR&R studies, reports
use in checking product quality or control of processes?

Calibration stickers and records,

Are measuring devices and gauges and test equipment are
positive identification or segregation
48 routinely calibrated and controlled per documented
of out-of-calibration devices, and
procedures?
inventory, location & status records.

Are gauges and test equipment calibrated against standards Calibration procedures, and
49
traceable to a recognized regulatory body or agency? calibration stickers and other records

Are assessments made to check the validity of previous

Assessment records and corrective
50 measurements done on products where out-of-calibration
actions
measuring devices were used?

Are appropriate controls are in place to verify the suitability Verification methods and records,
51 and accuracy of computer software prior to initial use in revision levels, distribution/use
checking product quality or control of processes? control

Document Ref: Page 14 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Maintenance
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Are tools stored in an appropriate, clearly defined area, with

Review of storage area, labelling,
52 systematic tracking that provides traceability, particularly of
tooling records
customer-owned tools and equipment?

Does a formal preventive maintenance system (PM) exist for Review of system, PM plans, PM
53
production equipment, tools and fixtures? schedule and compliance results

Is the preventive maintenance schedule is followed since No equipment, tools, or fixtures are in
54 product cannot be made with tools that are outside of use that are outside TPM schedule, or
maintenance period? have unclear status

Document Ref: Page 15 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Process Control
Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Histograms, run charts, SPC charts,

Are key part characteristics and process parameters are
pareto analysis, cause and effect
55 reviewed and statistically based controls and/or problem
diagrams, mistake proofing, reaction
solving tools are used to control variation?
plan & process corrections.

Documented reaction plan and

Are written improvement plans are implemented to reduce process corrections. SPC trend charts
56
sources of variation? showing current status vs. goals,
improvement plans

Documented process capability

Is process capability is measured and actions are taken to
57 studies and results (actual vs target
maintain established minimum Cpk/Ppk targets?
Cpk/Ppk)

Are out of control conditions are noted on charts and

58 documented corrective action is taken to bring the process Control charts
back into control?

Document Ref: Page 16 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Storage & Packing

Audit Findings
(Score ‘1’ per box) Opportunities for
Audit Evidence
Improvement (OFI)

COMPLIANT

MAJOR N/C
MINOR N/C
Ref Audit Question

OFI
Provide reference to documented Provide suggestions for process
information to justify the finding improvement

Are areas around the facility clean and orderly and are tools Observe production, office & product
59 and equipment properly stored and readily available for use storage areas. (Sort, Set-in-order,
and is lighting and air quality are adequate? Shine, Standardize, Sustain + Safety)

Is proper equipment and methods used to prevent product Observe handling and transit of raw
60 damage or loss in all phases of the material handling material, work-in-process, and
process? finished goods.

Are documented procedures followed to ensure proper FIFO practices are defined, packaging
61 control and preservation of handling, storage (FIFO), specifications, test results, handling
packaging, and delivery of product? and storage procedures.

Is the suitability of product packaging reviewed and concerns Technical review, packaging/shipping
62 communicated to the customer prior to initial production tests, packaging work instructions,
shipment? carton strength tests

Is stored product/material periodically inspected, and where Lists of shelf-life sensitive materials.
63 applicable, actions are taken to prevent deterioration per Look for poor storage conditions and
documented procedures? damage. Handling procedures

Have contingency plans been developed that describe Process covering utility interruptions,
64 actions to be taken in the event of a major interruption of the labour shortages, key equipment
manufacturing process? failures, major production issues

Document Ref: Page 17 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Findings Summary
Non-conformance
No. ISO/Specification Ref. Summary Root Cause NCR No. Rectification Date

Corrective Action
No. ISO/Specification Ref. Summary Root Cause CAR No. Rectification Date

Opportunities for Improvement

No. ISO/Specification Ref. Summary Root Cause PAR No. Implementation Date

Document Ref: Page 18 of 20

Supplier Audit Checklist
System & Process Compliance Auditing

Observations, Comments & Notes

Document Ref: Page 19 of 20