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SUPPLIER NAME ADRESS

Requirements Typical Objective Evidence


1.1.The quality system is
documented, controlled, and
maintained to clearly describe
current practice. Documented
procedures required. Records
Quality manual and all QS procedures
show revision control (sign-offs &
dates), history of changes, quality
organization's responsibilities
1.2.Quality reports, trend charts and
data analysis identify areas of
opportunity and are used by
management on a routine basis.
Records required.
Product quality yield data, top problems
and corresponding improvement
actions, status of preventive/corrective
actions taken, internal audit results
1.3.Quality performance targets are
clearly defined, included in the
business plan and monitored for
improvements.
Strategic and tactical objectives, goals,
action plans, etc.
1.4.Executive management
participates in periodic quality
system reviews that address quality
related feedback from customers
and internal quality metrics. Records
required.
Analysis of field failures, inspection
yields, resource needs, internal audit
results, corrective action status, etc.
2.1.Preventive actions are taken
based on the analysis of significant
business trends, design reviews,
customer satisfaction surveys or
other meaningful inputs.
Documented procedures required.
Records required.
Management review meetings, goal
setting, performance measurement,
internal audits, action plans, customer
surveys
2.2.A formal approach is used to
actively pursue cost containment
and other continual improvement
activities throughout the
organization. Documented
procedures required. Records
required.
Employee involvement / recognition
program, Lean, Six Sigma, kaizen,
SPC, 5-S, cost reduction program,
preventive actions
2.3.A corrective action system is in
place that provides root cause
analysis and takes timely and
effective action to prevent
recurrence. Documented
procedures required. Records
required.
Corrective action records, trend charts,
meeting minutes, nonconformance
frequency & cost analysis. Does CA
system cover customer, internal &
supplier issues?
3.1.The skill and education level
required for each job is documented
and appropriate training / re-training
is provided. Records required.
Job descriptions, job skills assessment,
training records, training manuals. Look
for use of training aids & work
instructions at work stations.
3.2.Inspected material is adequately
identified as to acceptance or
rejection and traceable to receiving
inspection report. Records required.
Qualification records, certification
history, etc.
3.3.Suitable methods are used to
verify training effectiveness.
Records required.
Records of student testing, production
quality records, audit records, interview
workers to validate training records.
Look for use of training aids & work
instructions at work stations.
4.1.Customer needs and
requirements are incorporated into
product designs and/or
manufacturing processes. Critical-to-
Quality (CTQ) characteristics are
identified and understood. Records
required.
Market studies, customer/end-user
surveys, technical design reviews, mfg
process capability studies, formal
process qualification plan,
manufacturing verification tests, pilot
runs, etc.
4.2.Product specifications and
drawings are generated, controlled
and maintained for new or changed
product designs. Records required.
Complete product characteristics,
application requirements, and other
information essential for its safe and
proper use and eventual disposal, etc.
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Responsibility Status
ROOT CAUSE
& Scope of Problem
Including Other Areas
REMEDIAL ACTION
Immediate Actions Taken to
Address Issue / Finding
Supplier
CA-PA
Req'd?
(Y / N)
CORRECTIVE ACTION
Taken to Address Root Cause
& Prevent Recurrence
PREVENTIVE ACTION
Actions Taken to Prevent
Similar Issues in Other
Areas
Completion
Date
(mm/dd/yy)
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Audit
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SUPPLIER AUDIT CHECKLIST
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SUPPLIER NAME ADRESS
Requirements Typical Objective Evidence
Responsibility Status
ROOT CAUSE
& Scope of Problem
Including Other Areas
REMEDIAL ACTION
Immediate Actions Taken to
Address Issue / Finding
Supplier
CA-PA
Req'd?
(Y / N)
CORRECTIVE ACTION
Taken to Address Root Cause
& Prevent Recurrence
PREVENTIVE ACTION
Actions Taken to Prevent
Similar Issues in Other
Areas
Completion
Date
(mm/dd/yy)
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SUPPLIER AUDIT CHECKLIST
4.3.Design validation is an integral
part of the design process and
occurs prior to production release.
Records required.
Design results, manufacturability,
productivity and cost studies,
confirmation that product fulfills its
specified requirements or intended use
or applications, design-FMEA, etc.
4.4.Human and technical resources
are adequate to meet STI SANOH
requirements for design
collaboration, tooling design and
electronic drawing and data
exchange.
Qualification of technical staff.
Equipment/software capabilities; CAD,
PRO-E, etc.
5.1.Production samples are
inspected and provided to
customers upon request. Records
required.
Completed PPAP or similar forms,
inspection reports, availability of
qualified resources
5.2.Customer production
requirements and quality
specifications are reviewed to
ensure they can be met on a
consistent basis. Records required.
Procedures, design / process review
minutes, FMEA's, mfg capacity plans,
resource plans that address all product
test, storage, packaging and shipment
requirements
6.1.New and revised customer
specifications are reviewed and
implemented in a timely manner.
Documented procedures required.
Technical review of methods to be
used, capability studies on similar
parts, documented review procedure,
ie., APQP, PPAP.
6.2.Current process control
documents are in place and used for
production start-up and continuing
production. Documented procedures
required.
Customer specifications, engineering
drawings, change notices, work
instructions and specifications as
applicable.
6.3.Customer notification / approval
occurs for changes to Control Plans,
manufacturing site, product
transfers, raw material or product
obsolescence. Records required.
Customer notification procedure on
major changes & compliance to Jedec
standards JESD 46 and JESD 48 (or
equivalent, if app.). Signed material /
process change requests. Customers
are notified of RoHS compliance status
change.
6.4.Quality records are maintained.
A record control system is in place
for the identification, storage,
protection, retrieval, retention time,
and disposition of quality records.
Procedures, list of records to be kept
with retention periods specified
7.1.A formal process is used for the
selection, qualification and re-
qualification of suppliers. Records
required.
Supplier quality system audits and
related corrective actions, engineering
testing and approval records, plant
production trials
7.2.Purchases from unapproved
suppliers are prevented by a
properly controlled and available
Approved Supplier List (ASL).
Records required.
ASL, procedures for control and use of
ASL, production material receipt
records
7.3.Preventive actions are taken to
continuously improve performance
of the supplier base. Records
required.
Supplier quality performance analysis,
performance trends, supplier audit
reports, Inflation Model, documented
goals regarding raw material cost
containment
7.4.A supplier quality assurance
system ensures that all purchased
product or material conforms to
defined specifications and
applicable regulatory or customer
requirements. Records required.
Receiving inspection, supplier audits,
source inspection, qualification testing,
Certificate of Compliance (COC),
component marking, labeling, etc.
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SUPPLIER NAME ADRESS
Requirements Typical Objective Evidence
Responsibility Status
ROOT CAUSE
& Scope of Problem
Including Other Areas
REMEDIAL ACTION
Immediate Actions Taken to
Address Issue / Finding
Supplier
CA-PA
Req'd?
(Y / N)
CORRECTIVE ACTION
Taken to Address Root Cause
& Prevent Recurrence
PREVENTIVE ACTION
Actions Taken to Prevent
Similar Issues in Other
Areas
Completion
Date
(mm/dd/yy)
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Audit
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SUPPLIER AUDIT CHECKLIST
7.5.A system exists for the
identification, verification and
protection of customer supplied
product that includes notifying the
customer if product is damaged or
lost. Records required.
Procedures, segregation during storage,
limited and controlled access to stored
inventories
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SUPPLIER NAME ADRESS
Requirements Typical Objective Evidence
Responsibility Status
ROOT CAUSE
& Scope of Problem
Including Other Areas
REMEDIAL ACTION
Immediate Actions Taken to
Address Issue / Finding
Supplier
CA-PA
Req'd?
(Y / N)
CORRECTIVE ACTION
Taken to Address Root Cause
& Prevent Recurrence
PREVENTIVE ACTION
Actions Taken to Prevent
Similar Issues in Other
Areas
Completion
Date
(mm/dd/yy)
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SUPPLIER AUDIT CHECKLIST
8.1.Receiving inspection is
performed per documented
procedures and detailed work
instructions. Records required.
Procedures, inspection instructions
resources (manpower and equipment)
allocated for incoming inspection
8.2.Inspected material is adequately
identified as to acceptance or
rejection and traceable to receiving
inspection report. Records required.
Quality Control label, marking or use of
designated hold area as indicated in the
procedure
8.3.Supplier corrective action
requests require root cause
investigation and records show
responses are analyzed.
Documented procedures required.
Records required.
Availability of written procedure,
standardized Corrective Action form,
analysis of corrective action cycle time
and closure measurements
9.1.There is a formal method used
to qualify new or rebuilt production
equipment prior to production use.
Qualification plan that includes
established goals for process yields/up-
time, etc. and record of process
capability, review and approval, etc.
9.2.Control Plans are used to plan
and deploy inspection and test
functions throughout the production
process.
Process flow diagram, statistical tools
to be used, key inspection points,
inspection frequency, records, control
responsibility, inspection/test method,
gaging used, acceptable yield rates
9.3.Appropriate work instructions
are available where needed that
accurately describe all work
methods including inspections and
tests to be done during production.
Sample size, frequency, method,
document control dates/revision level,
etc. Handling procedures for Electro-
Static Discharge (ESD), RoHS
compliant materials & other process
conditions.
9.4.Appropriate inspections, tests
and process adjustments are made
per applicable work instructions to
verify conformance at key points
throughout the process and prior to
shipment. Records required.
Records of inspections performed at
incoming, first piece, in-process and/or
final inspection or test. Capability
study, material test, RoHS and other
regulatory tests, etc.
9.5.The inspection and process
status of product is identified and
maintained throughout the
production process. Records
required.
Batch records, travelers, tags, labels,
product markings or use of designated
& identified areas.
10.1.Process capability is measured
and actions are taken to maintain
established minimum Cpk/Ppk
targets.
Documented process capability studies
and results (actual vs target Cpk/Ppk)
10.2.Out of control conditions are
noted on charts and documented
corrective action is taken to bring
the process back into control.
Documented procedures required.
Records required.
Control charts
11.1Nonconforming materials, parts
and assemblies are segregated
(where practical) and identified to
prevent unapproved use.
Documented procedures required.
Records required.
Tags, marking, controlled staging
areas, etc. Look for mixing of RoHS
compliant & non-compliant materials.
11.2.Reworked material, parts and
assemblies are re-inspected or re-
tested to confirm compliance to
requirements. Records required.
Inspection record, tag, stamp, etc.
11.3.Use of nonconforming material
is documented under a formal
waiver or concession system.
Records required.
Written procedure, waiver or
concession records 1
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SUPPLIER NAME ADRESS
Requirements Typical Objective Evidence
Responsibility Status
ROOT CAUSE
& Scope of Problem
Including Other Areas
REMEDIAL ACTION
Immediate Actions Taken to
Address Issue / Finding
Supplier
CA-PA
Req'd?
(Y / N)
CORRECTIVE ACTION
Taken to Address Root Cause
& Prevent Recurrence
PREVENTIVE ACTION
Actions Taken to Prevent
Similar Issues in Other
Areas
Completion
Date
(mm/dd/yy)
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SUPPLIER AUDIT CHECKLIST
11.4.Product traceability is
maintained (to the extent required by
STI Sanoh) to facilitate problem
evaluation and corrective action.
Documented procedures required.
Records required.
Serial number records, lot number, date
of manufacture, labeling and marking of
containers or product, etc. Look for
mixing of RoHS compliant & non-
compliant materials.
11.5.Resolving customer complaints
through systematic approach and
closure based on effectiveness
monitoring
Customer complaint register and 8D
reports
11.6.There is a positive recall
system to notify customers of
nonconforming product that has
already been shipped. Records
required.
Documented procedure and review of
system
12.1.Gage Repeatability &
Reproducibility studies are
conducted to verify suitability of
measuring devices for their use in
checking product quality or control
of processes. Records required.
GR&R studies, reports
12.2.Measuring devices, gaging and
test equipment are routinely
calibrated and controlled per
documented procedures. Records
required.
Gage calibration stickers, calibration
records, positive identification or
segregation of out-of-calibration
devices, and inventory, location &
status records, etc.
12.3.Gages and test equipment are
calibrated against standards
traceable to a recognized regulatory
body or agency. Records required.
Calibration procedures, and calibration
stickers and other records.
12.4.Assessments are made to
check the validity of previous
measurements done on products
where out-of-calibration measuring
devices were used. Records
required.
Assessment records, corrective actions,
etc.
13.1.A formal Preventive
Maintenance system exists for
production equipment, tools and
Review of system, PM plans, PM
schedule and compliance results
13.2.Preventive Maintenance
schedule is followed. Product cannot
be made with tools that are outside
of maintenance period. Performance
is audited
No equipment, tools, or fixtures are in
use that are outside TPM schedule, or
have unclear status

14.1.Areas around the facility are
clean and orderly. Tools and
equipment are properly stored and
readily available for use. Lighting
and air quality are adequate.
Observe production, office & product
storage areas for use of 5S/6S
principles (Sort, Set-in-order, Shine,
Standardize, Sustain + Safety)
14.2.Proper equipment and methods
are used to prevent product damage
or loss in all phases of the material
handling process.
Observe handling and transit of raw
material, work-in-process, and finished
goods.
14.3.Documented procedures are
followed to ensure proper control
and preservation of handling,
storage (FIFO), packaging, and
delivery of product.
FIFO practices are defined, packaging
specifications, test results, handling and
storage procedures.
14.4.Suitability of product packaging
is reviewed and any concerns are
communicated to the customer prior
to initial production shipment.
Packaging tests if required. Records
required.
Technical review, packaging/shipping
tests, packaging work instructions,
carton strength tests
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SUPPLIER NAME ADRESS
Requirements Typical Objective Evidence
Responsibility Status
ROOT CAUSE
& Scope of Problem
Including Other Areas
REMEDIAL ACTION
Immediate Actions Taken to
Address Issue / Finding
Supplier
CA-PA
Req'd?
(Y / N)
CORRECTIVE ACTION
Taken to Address Root Cause
& Prevent Recurrence
PREVENTIVE ACTION
Actions Taken to Prevent
Similar Issues in Other
Areas
Completion
Date
(mm/dd/yy)
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SUPPLIER AUDIT CHECKLIST
14.5.Contingency plans have been
developed that describe actions to
be taken in the event of a major
interruption of the manufacturing
process.
Process covering utility interruptions,
labor shortages, key equipment failures,
major production issues.
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SUPPLIER NAME ADRESS
Requirements Typical Objective Evidence
Responsibility Status
ROOT CAUSE
& Scope of Problem
Including Other Areas
REMEDIAL ACTION
Immediate Actions Taken to
Address Issue / Finding
Supplier
CA-PA
Req'd?
(Y / N)
CORRECTIVE ACTION
Taken to Address Root Cause
& Prevent Recurrence
PREVENTIVE ACTION
Actions Taken to Prevent
Similar Issues in Other
Areas
Completion
Date
(mm/dd/yy)
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Audit
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SUPPLIER AUDIT CHECKLIST
TOTAL SCORES FOR THIS CHECKLIST ONLY
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On-Site
Audit Std
Chklst
SCORE
Maximum Total Score Available: 0 208
Actual Score:
DATE OF AUDIT:
SUPPLIER NAME:
STI SANOH AUDITOR NAME: SUPPLIER AUDITEE NAME:
SIGN: SIGN:
Doc.no:FM:QA:37:00
AUDIT RESULT EVALUATION METHOD MINIMUM REQUIREMENT
SCORING GUIDELINES
D-Poor.If the audit score is <60,Reaudit required after improvement
C-Average.If the audit score is>=60,CA required
B-Good.If the audit score is>=70,CA required
A-Excellent .If the audit score is >=90, No CA required
1 = RARELY COMPLIES; Corrective actions planned or in-progress
0 = REQUIREMENT NOT ADDRESSED
((AUDIT SCORE)/208-(POINTS NA *4))*100 B
EVALUATION RATING
4= NO NON-COMPLIANCES; Exceeds Minimum Requirement / No CA required
3 = NO NON-COMPLIANCES; Meets Minimum Requirement / No CA required
2 = SOME NON-COMPLIANCES; Corrective actions planned or in-progress

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