-
Date:
Supplier: Audit Date:
Audit Type: ISO/TS16949 Compliance OSRAM SQE:
Audit
Overvall
0.00
Quality Control
0.00
Manufacturing
0.00
Commodity
SpecificSection
Score
Points for
Green
Quality
Management
Systems
0.00
Product
Planning
Date:
Supplier
Management
0.00 0.00 NA
Certification / Audit No.
Systems acceptable,
but requires action plan
(Intermediate Risk)Systems meet or
exceed requirements.
(Minimum Risk)
Remarks:
Systems unable to meet
requirements (High Risk)
Supplier Audit Summary Sheet
0
By Whom: Result / Remark:
60,
< 80
80
< 60
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OSRAM SYLVANIA Supplier Audit
Audit Date:
Maximum Points Available: Maximum Points Available: Maximum
Points Available:
1.0 0.00 8.0 0.00 13.0 0.00
2.0 0.00 12.0 0.00 14.0 0.00
3.0 0.00 0.00 15.0 0.00
4.0 0.00 0.00 17.0 0.00
0.00 18.0 0.00
0.00 0.00
Maximum Points Available: 0.00
9.0 0.00
10.0 0.00
Maximum Points Available: 11.0 0.00 Maximum Points
Available:
5.0 0.00 16.0 0.00 0.1 0.00
6.0 0.00 19.0 0.00 0.2 0.00
7.0 0.00 0.00 0.3 0.00
0.00 0.00 0.4 0.00
0.00 0.00
NA
Section Score:
Non-Conforming Product
Quality Control
Control of Monitoring Devices195.00
Total Points:
Design and Development
Total Points: Advanced Quality Planning
60,
< 80
Section Score:
Plastics
Resource Management
Total Points:
Process Improvement
Die Cast
Inventory and Storage
Stamping
Statistical Process Control
PRODUCT PLANNING
Section Score:
Section Score:
Manufacturing Monitoring
Product Realization
Section Score:
QUALITY CONTROL
SUPPLIER MANAGEMENT
Quality Management System
Management Responsibility
MANAGEMENT
Section Score:
200.00
Total Points:
Incoming Inspection, Layout
Document Management
Identification and Traceability
Production Control
320.00
80
75.00
Supply Chain Management
Systems acceptable, but
require action plan
0.00
MANUFACTURING
Total Score:
Springs
COMMODITY SPECIFIC
365.00
Preventive Maintenance
Systems unable to meet
TRW requirements
Systems meet or exceed
requirements.
Total Points:
Supplier Facility Audit
Supplier Name:< 60
0
Revision AAudit Checklist; Score-Summary
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OSRAM SYLVANIA Supplier Audit
NOTE: Auditor must fill in, for each section, the "Number of
Questions" used during the audit.
MANAGEMENT (25%)
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15 .16
.17 .18
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 18 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12
0 0 0 0 0 0 0 0 0 0 0 0 12 0.00 0.00
.01 .02 .03 .04
0 0 0 0 4 0.00 0.00
.01 .02 .03 .04 .05 .06
0 0 0 0 0 0 6 0.00 0.00
PRODUCTION PLANNING (15%)
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14
0 0 0 0 0 0 0 0 0 0 0 0 0 0 12 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15 .16
.17 .18
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 11 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15 .16
.17
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 16 0.00 0.00
SUPPLIER MANAGEMENT (15%)
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13
0 0 0 0 0 0 0 0 0 0 0 0 0 10 0.00 0.00
QUALITY CONTROL (15%)
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15
.16
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 12 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14
0 0 0 0 0 0 0 0 0 0 0 0 0 0 9 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08
0 0 0 0 0 0 0 0 6 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15
.16
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 16 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15 .16
.17 .18 .19 .20 .21 .22 .23 .24 .25 .26
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 21 0.00
0.00
MANUFACTURING (25%)
.01 .02 .03 .04 .05 .06 .07
0 0 0 0 0 0 0 7 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15 .16
.17 .18 .19
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 15 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15 .16
.17 .18 .19 .20 .21 .22 .23 .24 .25 .26 .27 .28
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 26 0.00
0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14
0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 0.00 0.00
.01 .02 .03 .04 .05 .06 .07 .08 .09 .10 .11 .12 .13 .14 .15 .16
.17 .18 .19 .20 .21 .22 .23 .24 .25 .26
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 17 0.00
0.00
COMMODITY SPECIFIC (5%)
.11 .12 .13 .14 .15 .16
0 0 0 0 0 0 0 0.00 #DIV/0!
.21 .22 .23 .24 .25 .26 .27 .28
0 0 0 0 0 0 0 0 0 0.00 #DIV/0!
.31 .32 .33 .34 .35
0 0 0 0 0 0 0.00 #DIV/0!
.41 .42 .43 .44 .45 .46
0 0 0 0 0 0 0 0.00 #DIV/0!
Supplier Facility Audit
0 Systems unable to meet TRW
requirements (High Risk)< 60
60,
< 80
Supplier Name: Audit Date: 0-Jan-1900
Systems acceptable, but require
action plan (Intermediate Risk)
3.0 Document ManagementNumber of
Questions
80Systems meet or exceed
requirements. (Minimum Risk)
Total
Points
Total
Points
18.0 Preventive Maintenance Number of
Questions
Total
Points
4.0 Resource Management Number of
Questions
Total
Points
6.0 Design and Development Planning, Verification and Validation
Number of
Questions
Total
Points
19.0 Improvement Processes Number of
Questions
Number of
Questions
16.0 Control of Non-conforming Product Number of
Questions
8.0 Supply Chain Management Number of
Questions
Total
Points
9.0 Quality Control Number of
Questions
Awarded
Points
12.0 Incoming Inspection, Layout and Functional Testing
11.0 Control of Monitoring and Measuring Devices Number of
Questions
Total
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
2.0 Management Responsibility Number of
Questions
Total
Points
5.0 Product Realization Number of
Questions
1.0 Quality Management System Number of
Questions
7.0 Advanced Quality Planning Number of
Questions
Total
Points
10.0 Statistical Process Control
Total
Points
Total
Points
Awarded
Points
Awarded
Points
Awarded
Points
13.0 Idenfication and Traceability Number of
Questions
Total
Points
Total
Points
Awarded
Points
Awarded
Points
Awarded
Points
Number of
Questions
Total
Points
Total
Points
Total
Points
17.0 Inventory and Storage Number of
Questions
Total
Points
Awarded
Points
Awarded
Points
Number of
Questions
Total
Points
15.0 Manufacturing Monitoring and Measurement Number of
Questions
Total
Points
14.0 Production Control
Total
Points
20 Stampings Number of
Questions
20 Springs Number of
Questions
Total
Points
20 Plastics Number of
Questions
20 Die Cast
Total
Points
Number of
Questions
Total
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
Awarded
Points
Revision AAudit Checklist; Score-Detail
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OSRAM SYLVANIA Supplier Audit
5 Exceeds Expectation
4 Meets Expectation
3 Minor Issues
2 System, poor implementation
1 Poorly defined system
0 No System
4.1 Has the organization established and documented a
quality management system (QMS) in accordance
with ISO/TS16949? (4.1)
l Quality Manual
l Procedures
l Process Maps
l Manual to ISO/TS 16949 or
conversion matrix.
4.1 Has the organization implemented and maintained its
quality management system in accordance with
ISO/TS16949? (4.1)
l Quality Manual
l Procedures
l Process Maps
l Key personnel interviews.
l Examples of effective
implementation.
8.5.1 Is the organization continuously improving the
effectiveness of its quality management system?
l Management
reviews
l Examples of projects.
l Management review results.
4.1.a,b,
c
Does the organization's quality management system:
a) identify processes and applications?
b) determine sequences and interactions?
c) determine criteria/methods to ensure effective
operation and control?
l Quality Manual
l Procedures
l Process Maps
l Manual to ISO/TS 16949 or
conversion matrix.
4.1.d,e,f Does the organization's quality management system:
a) assure availability of resources and information?
b) manage, monitor and analyze processes the
system needs?
c) implement actions needed to achieve planned
results and continual improvement?
l Organizational
Charts
l Cost of Quality
Reports
l Management
Review Meeting
documentation
l Review of all elements of the
quality management system
to insure continuing suitability
and effectiveness.
l Review of cost of quality
indicators.
l Management review meeting
minutes, attendance and
adequate frequency.
l Action plans and follow-up.
4.1 Does the organization ensure control over outsourced
processes that affects product conformity with
requirements?
l Supplier Quality
function
l Purchase Orders
l Supplier Certification tracking.
l Supplier Performance reports.
l Purchase Orders with
requirements and
specifications.
4.2.1 Does the QMS documentation include:
a) quality policy and objectives?
b) a quality manual?
c) procedures required by ISO/TS 16949:2002?
d) documents needed for effective planning,
operation and control of its processes?
e) records required by ISO/TS 16949:2002?
l Quality Manual
l Procedures
l Process Maps
l Quality Manual according to
ISO/TS 16949:2002 or
conversion matrix.
l Adequacy of procedures to
the complexity of the
organization.
l Quality management system
procedures.
l Quality records.
4.2.2 Has the organization established and maintained a
quality manual that includes:
a) the scope of the qms, including details and
justification for exclusions?
b) the documented procedures established for the
QMS, or reference to them?
c) a description of the interaction between the
processes of the quality management system?
l Quality Manual
l Procedures
l Process Maps
l Quality Manual according to
ISO/TS 16949:2002 or
conversion matrix.
5.1
5.3
Is a quality policy established, communicated, and
understood throughout the organization?
l Quality Policy
l Quality Operating
System
l Quality policy statement with
objectives approved by CEO.
l Quality objective linked to
business plan.
l Interviews with randomly
selected people throughout
the organization.
l Periodic review of all
elements of quality
management system.
5.4.1 Does top management assure that quality objectives
are measurable and consistent with the quality
policy?
l Business Plan
l Quality Manual
l Correlation between
management reports, the
Business Plan and quality
policies.
5.4.1.1 Did top management define any quality objectives
and measurements? Are they used to deploy the
organization's quality policy?
l Business Plan
l Quality Manual
l Quality objectives
included/linked to business
plan.
l Scope of the Quality
objectives.
l Management review minutes,
attendance and frequency.
1.03
1.04
1.05
1.06
1.07
1.08
1.09
1.10
1.11
1.01
1.02
Audit Date:
1.0 Quality Management System
Look ForTS16949
SectionStatusQuestion
Supplier Name:
OSRAM SYLVANIA Representatives:
Address: Supplier Representatives:
City/State/Zip:
Country
No.
Note: Enter "NA" in place of score for questions not used.
Evidence Required
Supplier Facility Audit
Concerned over logistics between Siix
and Clarion
Audit Worksheet
Observations
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1.01
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SectionStatusQuestionNo. Evidence Required Observations
5.4.2 Does top management of the organization ensure
that
a) the planning of the QMS is carried out according to
section 4.1
b) the integrity of the QMS is maintained when
changes to the QMS are planned and implemented.
l Internal Audit
Procedure
l Internal audit results.
8.2.3 Does the organization apply suitable methods for
monitoring, and where applicable, measurement of
the QMS?
l Methods of
Monitoring/
Measuring QMS
processes
l Process flows with
measureables defined.
8.2.3 Does the organization's methods for monitoring and
measuring processes show the processes ability to
achieve planned results?
l Methods of
Monitoring/
Measuring QMS
processes
l Monitoring and measurement
results.
8.2.3 When planned results are not achieved by the
organization's processes, does corrective action take
place to assure conformity of the product?
l Corrective Actions l Verification and closure of
corrective actions.
8.4 Does the organization determine, collect and analyze
appropriate data to demonstrate the suitability and
effectiveness of the quality management system and
to evaluate where continual improvement of the
effectiveness of the quality system can be made?
l Internal
Performance data
l Poor quality cost indicators,
l Effectiveness and efficiency
of production processes,
l Test results,
l Process capability data,
l Quality audits,
l Results of production
inspections,
l Internal and external quality
data,
l Subcontractors rating,
l Customer reports,
l Employee information.
8.4 Does the organization's analysis of data provide
information relating to:
a) customer satisfaction?
b) conformance to product requirements?
c) characteristics and trends of processes and
products including opportunities for preventive
action?
d) Suppliers?
l Data Analysis
report
l Customer satisfaction
information.
l Product quality reports.
l Statistical charts.
l Supplier performance
indicators.
8.4.1 Does the organization compare trends in quality and
operation performance compared with progress
toward objectives and lead to action to support the
following:
a) development of priorities for prompt solutions to
customer-related problems?
b) determination of key customer related trends and
correlation to support status review, decision making
and longer term planning?
c) an information system for the timely reporting of
product information arising from usage?
l Data Analysis
report
l Customer problem resolution.
l Comparison of trends to
objectives (goals).
l Specific actions to trend
analysis.
l Prioritization of action.
5.1 Does the organization's top management have
evidence of providing commitment to continually
improving its quality management system
effectiveness by
a) communicating the importance of meeting
customer, statutory and regulatory requirements?
b) establishing the quality policy?
c) ensuring that quality objectives are established?
d) conducting management reviews?
e) ensuring availability of resources?
l Customer
specifications
l Quality Manual
l Business Plan
l Quality Metrics
l Customer defined objectives
and company goals stated in
the Business plan and their
alignment with the quality
policy statement.
l Quality Manual according to
ISO/TS 16949:2002.
l Management review meeting
minutes, attendance and
adequate frequency.
l Action plans and follow-up.
5.1.1 Does the organization's top management monitor the
product realization process and the support processes
to assure their effectiveness and efficiency?
l New Product
Launch Process
l APQP Meetings
l Review of product realization
and support processes.
l Indicators and records.
l Reporting process.
5.2 Does top management ensure that customer
requirements are determined and fulfilled with the
aim of enhancing customer satisfaction?
l Customer
specifications
l Customer
Performance
Reports
l Customer Awards
l Customer Surveys
l Description of an objective
process.
l Methodology used for
surveys.
l Original Customer data and
scope such as customer
satisfaction feedback (surveys,
scorecards, awards, etc.).
5.5.1 Does the organization's top management ensure that
the responsibilities and authorities are defined and
communicated within the organization?
l Job descriptions
l Responsibilities
matrices
l Procedures
l Responsibilities and authority
as defined in accountabilities
documents.
No.
2.03
1.12
2.04
Question Evidence Required
2.0 Management Responsibility
Look For
Audit Worksheet
Observations
1.17
1.18
2.01
2.02
Status
1.13
1.14
1.15
1.16
TS16949
Section
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OSRAM SYLVANIA Supplier Audit
1.01
Look ForTS16949
SectionStatusQuestionNo. Evidence Required Observations
5.5.2 Is there a member of management who is responsible
a) for establishing, implementing and maintaining
quality systems and processes?
b) reporting on the QMS performance?
c) reporting any need(s) for improvement?
d) promotion of awareness of customer requirements
throughout the organization?
l Organizational
Chart
l Who is the person
responsible?
l Evidence of activities
performed including
empowerment for all
applicable elements.
l Management review minutes.
5.5.2.1 Did the organization's top management designate
individual(s) to represent the needs of the customer to
address quality requirements, e.g., special
characteristics, quality objectives and related training,
corrective and preventive actions, product design
and development?
l Organizational
Chart
l Job Responsibility
l Quality function
representative in project
teams.
l Quality function participation
in milestones, decision points
(Product release, Engineering
release, )
l Responsibilities and job
description of the customer
representative.
5.6.1 Does top management of the organization review its
QMS
a) at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness?
b) for improvement opportunities and the need for
changes?
Are the records from the management review
maintained?
l Management
reviews
l Review includes all elements
of the Quality System.
l Review of quality cost
indicators.
l Evidence of continuous
improvement projects initiated
from management reviews.
l Management review minutes,
attendance and frequency.
l Action plans and follow-up.
5.6.1.1 Do management reviews include:
a) all elements of the QMS?
b) performance trends?
c) monitoring of quality objectives?
d) evaluation of cost of poor quality?
l Policy
l Business plan
l Customer
Performance
requirements
l Review includes all elements
of the Quality System.
l Trends in metrics (business
and customer satisfaction).
l Basis for continuous
improvement projects.
l Product results (quality, cost,
time) against quality policy
goals and customer specified
targets.
5.6.1.1 Are the results recorded to provide evidence of the
achievement of:
a) objectives specified in the quality policy?
b) objectives specified in the business plan?
c) customer satisfaction with supplied product?
d) supplier performance?
l Management
Reviews
l Quality Policy
l Customer
Performance
Requirements
l Supplier
Performance
Requirements
l Trends in metrics (business
and customer satisfaction).
l Basis for continuous
improvement projects.
l Management review meeting
minutes.
l Action plans and follow-up.
5.6.2
5.6.2.1
7.3.4.1
Does management review input include:
a) results of audits?
b) customer feedback?
c) process performance and product conformity?
d) status of preventive and corrective action?
e) follow-up from previous management reviews?
f) planned changes affecting the QMS?
g) recommendations for improvement?
h) analysis of actual and potential field failures and
their affect on quality, safety, or the environment?
i) definition and analysis of design/development
measurements at various stages, reported with
summary results?
l Management
Reviews
l Reports prepared for
management reviews.
l Content of management
review meeting agenda.
l Management review meeting
minutes.
l Action plans and follow-up.
5.6.3 Does output from management reviews include
decisions and actions related to:
a) improvement of the QMS and its processes?
b) improvement of product related to customer
requirements?
c) resource needs?
l Management
Reviews
l Examples of continuous
improvement projects initiated
from management reviews.
l Examples of product
improvements initiated from
management reviews.
5.5.3 Does top management ensure that appropriate
communication processes are established? Do
communications include the effectiveness of the
QMS?
l Customer
satisfaction
communiques.
l Quality operating
system charts.
l General postings.
l Bulletin boards
l Interoffice memos
l Newsletter
l Paretos, Histograms, 5 Phase,
Operation Scrap Rates,
Customer Quality and Delivery
Performance.
l All hands, Business update
meetings
2.10
2.11
Look For
2.12
No.TS16949
SectionQuestion Observations
3.0 Document Management
2.05
2.06
2.09
2.07
2.08
StatusEvidence Required
Audit Worksheet
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SectionStatusQuestionNo. Evidence Required Observations
4.2.3 Has the organization established a document control
procedure, for documents required by the QMS, to
define controls needed:
a) to approve documents before release?
b) to review and update, and re-approve
documents?
c) to ensure changes and current document revision
are clearly identified?
d) to assure relevant documents are available at
point of use?
e) to assure documents remain legible and
identifiable?
f) to ensure documents of external origin are identified
and their distribution controlled?
g) to prevent unintended use of obsolete documents,
assuring proper identification if retained?
l Document Control
Procedure
l Manual to ISO/TS 16949 or
conversion matrix.
l Document control master list
or equivalent.
l Document approval
authority.
l Document approval records.
l Availability of documents in
various locations.
l Document accessibility.
l Storage and disposal of
obsolete documents.
l Process for
notification/distribution of
documents from internal and
external origins.
l Review and approval of
revised documents.
4.2.3.1 Does the organization have a process to assure
timely
review, distribution and implementation of all
customer engineering standards/specifications and
changes? Does this take place in a timely manner?
l Customer and
Regional
Standards/Specific
ations
l Customer change
notifications
l Process for
notification/distribution of
customer engineering
standards/specifications.
l Process for implementation of
customer initiated change.
l Document changes triggered
by engineering changes.
l Records of engineering
changes implemented.
4.2.4 Has the organization established and maintained
recorded to provide evidence of conformity to the
requirements and of the effective operation of the
QMS?
l Quality
Management
System
l Record
maintenance
system
l Manual to ISO/TS 16949:2002.
l Records of document
maintenance, including
disposal.
4.2.4 Has the organization established a document
procedure to define the controls needed for the
identification, storage, protection, retrieval, retention
time and disposition of records?
l Quality
Management
System
l Record
maintenance
system
l Quality Manual according to
ISO/TS 16949:2002.
l Defined record retention time
compared to
customer/regulatory
requirements.
l Record disposal after
retention period expires.
l Identification of obsolete
records.
6.1 Does the organization determine and provide the
resources needed
a) to implement and maintain the QMS and
continually improve its effectiveness?
b) to enhance customer satisfaction by meeting
customer requirements?
l Formal
Documentation
l Job descriptions.
l Training records.
l Quality plans.
l Shift staffing/supervision.
l Personnel workload.
6.2.1 Are the personnel performing work affecting product
quality competent on the basis of appropriate
education, training, skills and experience?
l Training records
l Personnel records
l Training records
complementing the type of
work that the personnel
perform on the product.
l Personnel records.
l Interviews with personnel in
different areas.
6.2.2
6.2.2.2
Does the organization
a) determine the necessary competence for
personnel performing work affecting product quality?
b) provide training or other actions to satisfy the
needs?
c) evaluate the effectiveness of the actions taken?
d) ensure personnel are aware of the importance of
their activities and the contribution made to quality
objectives?
e) maintain appropriate records of education,
training, skills and experience?
l Job Description
l Training records
l Personnel records
l Training Plan
l Training records
complementing the type of
work that the personnel
perform on the product.
l Personnel records.
l Interviews with personnel.
6.2.2.1 Does the organization ensure that personnel with
product design responsibility are qualified to achieve
design requirements and are skilled in the applicable
tools? Are the applicable tools and techniques
identified?
l Job Description
l Training records
l Personnel records
l Product Design
Tools
l Purchase Orders
l Training records
complementing the type of
work that the personnel
perform on the product.
l Personnel records.
l Interviews with personnel.
l List of tools needed for
product design.
l Purchase Orders for tools.
l Personnel training on tools.
4.01
4.02
4.0 Resource Management
Look For
Status
4.03
Look For
No.
3.01
3.02
TS16949
SectionQuestion
3.04
No.
4.04
Observations
Observations
3.03
TS16949
SectionQuestion Evidence Required
Audit Worksheet
StatusEvidence Required
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1.01
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SectionStatusQuestionNo. Evidence Required Observations
6.2.2.3 Does the organization provide on the job training
for
new or modified jobs affecting product quality? Does
this training include contract or agency personnel?
Does it include the consequences to the customer of
nonconformity to quality requirements?
l Training records l Training records for personnel
in new assignments.
l Training records for contract
personnel.
l Training contents.
6.2.2.4 Does the organization have a process to
a) motivate employees to achieve quality objectives?
b) motivate employees to make continual
improvements?
c) create an innovational environment?
d) promote technological awareness?
e) to measure the effectiveness of the program?
l Incentive system
l Employee reviews
l Incentive, bonus, profit
sharing.
l Interviews with employees
regarding scope of
motivation.
l Employment satisfaction - are
turnover rates equal or above
geographical rate.
l Banners, posters, suggestion
7.1 Does the organization have a plan for introduction of
new product?
l Procedure l Quality planning process.
l Project planning process.
l Quality plans for new
product.
7.1 In planning product realization, does the organization
determine the following, as appropriate:
a) quality objectives and requirements for the
product?
b) the need to establish processes, documents, and
provide resources specific to the product?
c) required verification, validation, monitoring ,
inspection and test activities specific to the product
and the criteria for product acceptance?
d) records needed to provide evidence that the
realization processes and resulting product meet
requirements?
l Timelines
l Customer
standards/specifica
tions
l Customer change
notifications
l Floor plan
l Planning
documents
l Quality plan and Design
Record, Control Plan,
Operator Instructions, Product
Approval records,
resources/facilities and any
plans to enhance them.
l Design validation at various
stages of design.
l Link between process
changes and updates in the
quality plan(s).
l Gantt charts, Action plans,
Meeting minutes.
7.1 Is there a technical liaison engineer dedicated to
launch support?
l Reports
l Organization
Charts
l Engineer associated with
specific launch project teams
7.1.1 Are the customer requirements and references to its
technical specifications included in the planning of
product realization as a quality plan?
l Quality plans
l Customer
requirements
l Technical
requirements
l Control Plan.
l Customer specifications.
l Technical specifications.
7.1.2 Did the organization define acceptance criteria for
the product being developed and where required,
approved by the customer? Is the acceptance
criteria zero defects?
l Specifications
l Planning
documents
l Quality documents
l Test specification.
l Product validation test plan
with defined acceptance
criteria.
l Acceptance criteria in test
plan and test specification.
7.13 Does the organization ensure the confidentiality of
customer contracted products and projects under
development, and related product information?
l Information access
security.
l Security for
product
development.
l Controlled access to design
areas.
l Customer requirements
documentation secured.
7.14 Is there a process that assures design changes are
properly incorporated into the either the launch plan
or during the remainder of the products life (serial
production and service), including those initiated by
the organization? Activities should include:
a) assessment of effect of changes?
b) verification and validation activities, ensuring
compliance with customer requirements?
c) validation before incorporation of change?
d) impact of change on fit, form, or function?
l Change
management
process
l Impact studies
l Engineering change request.
l Change in FMEAs.
l Change records.
l Test specification.
l Evidence of design and
production validation tests
conducted for product
changes.
l Design and production test
report.
7.2.1 Does the organization determine:
a) requirements specified by customer, including the
requirements for delivery and post-delivery activities?
b) requirements not stated by the customer, but are
necessary for specified or intended use?
c) statutory or regulatory requirements related to the
product?
d) any additional requirements determined by the
organization?
l Quality Plan
l Capacity Planning
l Laws, Regulations
l Material handling
procedures
l Development requirements,
future volume forecast.
l Organizations internal
product specification.
l Process for governmental,
safety and environmental
regulations compliance.
7.2.1 Is there a process to identify and/or comply with End
of Vehicle Life (ELV) requirements?
l Policy Statement l Material data sheets
l Banned substances list
7.2.1.1 Are customer requirements for designation,
documentation and control of special characteristics
reflected throughout the organization?
l Special
Characteristics
documentation
l Interview the operators
l FMEAs
l Control Plans
5.03
5.09
5.10
5.0 Product Realization
4.06
No. Question
4.05
5.01
ObservationsEvidence Required Look For Status
5.02
5.06
5.05
5.08
TS16949
Section
5.04
5.07
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7.2.2
7.2.2.1
Does the organization ensure that
a) product requirements and risks are defined?
b) contract or order requirements differing from those
previously expressed are resolved?
c) the organizations ability to meet the defined
requirements?
l Contract review l Product Specification review.
l Resolution of differences
(memos, action plans).
l Feasibility analysis.
l Risk analysis.
l Customer terms and
conditions.
l Quote conditions.
l Records of contract review.
7.2.3 Has the organization determined and implemented
effective arrangements for communicating with
customers in relation to:
a) product information?
b) enquiries, contracts or order handling, including
amendments?
c) customer feedback, including customer
complaints?
l Customer base l Common language at the
interface level.
l Electronic data transfer
protocol.
l Electronic communications
(email, fax, etc.).
7.2.3.1 Can the organization communicate (language and
electronically) in its customer's directed
formats/languages?
l Customer base l Language of documents
submitted.
l CAD format.
l Electronic data transfer
protocol.
7.2.3.1 Does the organization have internal CAD capability? l
Design
Department
l Computer Stations.
l Plotter.
l Tape Drives.
7.3.1 During the design and development planning, does
the organization determine:
a) the design and development stages?
b) the review, verification and validation that is
appropriate to each stage?
c) the responsibilities and authorities for design and
development?
l Procedure
l Organization
Charts
l Design and Development
template.
l Product Design Review;
verification and validation
process.
l Job description for product
design and development.
7.3.1 Is a process development plan available and are the
targets maintained?
Timeline, AQP
Tracking
Gantt charts, APQP reports,
meeting minutes
7.3.2 Does the organization determine, review for
adequacy and maintain records for inputs to product
realization for:
a) functional and performance requirements?
b) applicable statutory and regulatory requirements?
c) where applicable, information derived from
previous similar designs?
d) other requirements essential for design and
development?
Are these inputs complete, unambiguous and not in
conflict with each other?
l Customer
specifications.
l Statutory and
regulatory
requirements.
l Previous/existing
products.
l Drawings.
l Customer standards.
l Specification books.
l Previous/existing product
design information.
l Feasibility contract review.
7.3.2.1 Does the organization identify, document and review
the product design inputs requirements including:
a) customer requirements (contract review)?
b) use of information?
c) targets for product quality, life, reliability,
durability,
maintainability, timing, and cost?
l Customer
specifications.
l Drawings.
l Customer standards.
l Specification books.
l Feasibility contract review.
7.3.2.2 Does the organization identify, document and review
the manufacturing process design input requirements,
including:
a) product design output?
b) targets for productivity, process capability, and
cost?
c) customers requirements, if any?
d) experience from previous developments?
l Design APQP.
l Request for Quote.
l Customer
requirements.
l Previous/existing
products.
l Design FMEA.
l Drawings.
l Customer standards.
l Specification books.
l Previous/existing product
design information.
l Feasibility contract review.
7.3.3
7.3.3.1
Do the organization's design and development
outputs
a) meet the design and development requirements?
b) provide appropriate information for purchasing,
production and service provision?
c) contain or reference product acceptance criteria?
d) specify characteristics that are essential for safe
and proper use?
e) compare favorably against product input
requirements?
f) include reliability results, product error proofing, and
product definition?
l Design testing
l Drawings
l APQP documents
l Mistake Proofing
l DV test reports.
l Engineering drawings.
l Design FMEA
6.04
5.11
6.01
6.06
6.02
6.03
6.0. Design and Development Planning, Verification and
Validation
Status
5.12
5.13
5.14
Audit Worksheet
Observations
6.05
No. Look ForQuestion Evidence RequiredTS16949
Section
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7.3.3.2 Does the organization's manufacturing process design
output include:
a) specifications and drawings?
b) manufacturing process flow chart/layout?
c) process FMEA?
d) control plan?
e) work instructions?
f) process approval acceptance criteria?
data for quality, reliability, maintainability and
measurability?
g) results of mistake proofing activities, as
appropriate?
h) methods of rapid detection and feedback of
product/manufacturing process non-conformities?
l Drawings
l APQP documents
l Mistake Proofing
l Process monitors
l PV test reports.
l Engineering drawings.
l Process FMEA
l Control Plan
l Operator Instructions
l Mistake Proofing
l Process monitors on
production equipment
l Non-conformity detection
methods
7.3.4 Does the organization perform system reviews of
design and development:
a) at suitable stages?
b) evaluating the ability of the results to meet the
requirements?
c) identifying problems and proposing solutions?
d) recording the review results and any necessary
actions maintained by the organization?
l Design Reviews
l Production Design
Status Reviews
l Design review planning and
records.
l Cross functional participation
in design reviews.
l Production
design/development status
reviews.
l Link of corrective actions to
status/design reviews.
7.3.5 Does the organization perform, maintain records of
the results and actions of design and development
verification in accordance with planned
arrangements to ensure outputs have satisfied the
input requirements?
l Design Verification
Reports
l Design verification done
according to plan.
l Comparison between outputs
and design requirements.
l Corrective actions based on
results.
7.3.6
7.3.6.1
Does the organization perform design and
development validation to ensure that the resulting
product is capable of meeting the defined
requirements? Is this completed before delivery or
implementation of the product?
l Process Validation
Test Report
l Corrective Actions
l Design validation against user
requirements/needs.
l Comparison between
customer and internal
development plans.
l Documented failure.
l Completion of PV testing
before start of production.
7.3.6.2 Does the organization have a prototype process that
includes:
a) a prototype program and control plan?
b) use of the same suppliers, tooling and
manufacturing process that will be used in
production?
c) monitoring all performance testing activities for
timely completion and conformance to
requirements?
d) maintenance of responsibility for subcontracted
services, including technical leadership?
l Prototype
Procedure or
Process
l Prototype facilities.
l Prototype records.
l Prototype control plan.
l Prototype tooling.
l Prototype test records.
l Subcontractor management.
7.3.6.3 Does the organization have detailed capacity
planning documents?
l Standard
production hour
scheduling
l Documentation
7.3.6.3 What standard hours are used for full demand
requirements?
l Procedure l Scheduling document.
l Output/Unit of Time.
7.3.6.3 Is first time quality used to determine capacity? l Shop
floor plans vs.
Actual
l Documentation
7.3.6.3 Are elements of TAKT used to establish and improve
capacity?
l Formulas
l Pace Studies
l Run at Rate
l Projections
l Documentation
7.3.6.3 At each manual operation, are the elements of work
identified with cycle times?
l Process Flow l Operations have elements
with order and time.
7.3.6.3 Does the organization have plans established to
address sudden increases in volume or to replace
rejected material?
l Procedure or
Policy
l Comparison of customer
planning vs. releases to
shipped material.
7.3.7 Does the organization's control of design and
development changes include:
a) maintenance of records relevant to those
changes?
b) review, verification and validation of changes, as
appropriate, and approved before implementation?
c) evaluation of the changes effect on constituent
parts and already delivered product?
d) maintenance of records for review of changes and
any necessary actions?
l Change
Management
Process
l Change records.
l Impact studies.
Look For
6.15
6.18
6.12
6.10
6.11
6.13
6.14
ObservationsNo. Evidence Required Status
Audit Worksheet
6.08
6.09
6.16
6.17
TS16949
SectionQuestion
6.07
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7.3.1.1 Does the organization use a multidisciplinary
approach to prepare for product realization,
including:
a) development/finalization and monitoring of special
characteristics?
b) development and review of FMEAs including
actions to reduce potential risks?
c) development and review of Control Plans?
l Product
Development
Teams
l APQP
Development
Teams
l Functions represented in
product development teams.
l Personnel involved in
definition of special
characteristics, FMEA, and
Control Plan.
7.3.2.3 Does the organization identify special
characteristics
and:
a) include all on the Control Plan?
b) comply with customer specifications and symbols?
c) identify process control documents including
drawings, FMEAs, control plans and operator
instructions with the customer's special characteristic
symbol or an equivalent symbol/notation?
l Process to identify
special
characteristics.
l Design records.
l Drawing review.
l APQP documents.
l Procedure of process map for
drawing review.
l Review of customer
requirements for special
characteristics, definitions and
symbol identification.
l Process FMEA.
l Control Plan.
l Product drawings.
l Operator instructions.
7.3.2.2 Does the Process Flow Diagram show the start of the
process at the receiving dock and the stop point the
shipping dock?
l Documentation vs.
Floor
l Receiving Dock
l Shipping Dock
7.3.2.2 Is the Process FMEA
a) created and are improvement measures
established?
b) updated when amendments are made during
launch and the established measures implemented?
c) cover items of past concerns?
d) developed to include all the steps in the Process
Flow Diagram?
e) used to drive the Continuous Improvement
Process?
l PFMEA l Improvements based on high
RPN numbers.
l New items or changes in RPN
numbers.
l Correlation between Process
Flow Diagram and Process
FMEA.
l Update due to customer
complaint.
7.3.2.2 When the same concern affects several similar parts
or processes, are all the Process FMEA's updated?
l PFMEA change
history
l Similar parts or processes.
l Updated FMEA from a similar
part/process.
7.3.2.2 Do Critical and Significant Characteristics relate
to
high severity rankings or high RPN's?
l Mistake proofing in
place
l Correlation between Process
Control Plan and Process
FMEA
7.3.2.2 Does the organization set goals to achieve
recommended actions for RPNs>100? Does the
organization have a RPN threshold?
l PFMEA l Improvements based on high
RPN numbers.
l New items or changes in RPN
numbers.
l Correlation between Process
FMEA and Control Plan.
7.5.1.1 Does the organization
a) develop a process Control Plans at the system,
subsystem, component and/or material level, for
supplied products including those for bulk materials
produced by the organization and all purchased
products and materials?
b) Was the PFMEA used to prepare it?
c) review and update control plans when any
changes occur affecting product, manufacturing
process, measurement, logistics, supply sources, or
FMEA?
l Procedure
l Control Plan
l Control plans for different
levels.
l Correlation between process
numbers on both documents;
controls identified on PFMEA
are on Control Plan.
l Matching between
product/process changes,
instability/non-capability
process results, and control
plans updating.
7.5.1.1 Does the Control Plan address incoming
material/components through processing/assembly,
rework, and packaging/shipping?
l Control Plan l Process Flow Diagram and
Control Plan have the same
process steps.
8.2.3.1 Does the organization ensure that the control plan
and process flow diagram are implemented,
including adherence to the specified:
a) measurement techniques?
b) sampling plans?
c) acceptance criteria?
d) reaction plans when acceptance criteria is not
met?
l Process Flow
Diagram
l Control Plan
l Floor vs. documents.
7.5.1.1 Are all special product/process characteristics
included in the Control Plan?
l Print Special
Characteristics
l PFMEA
l Control Plan
l Special characteristics on
drawing are also on FMEA and
Control Plan
7.5.1.1 Is the data for Control Plan items being properly
recorded?
l Control Charts
l Checksheets
l Production Control
Boards, etc.
l Completed documents as
required in the Control Plan
7.5.1.1 Is the Process Control Plan being followed? l Floor vs.
Plan l Control Plan requirements in
operator instructions, Gage
Control, Maintenance, etc.
7.5.1.1 Have provisions been made to identify and inspect
reworked products before being used?
l Documentation vs.
Floor
l Inspected Rework
7.06
7.07
7.08
7.09
7.11
7.03
7.04
7.12
7.13
7.05
7.10
7.01
7.02
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7.5.1.1 Are Mistake Proofing devices well defined for
purpose
and intent? Are Mistake Proofing devices checked
initially and regularly per an established procedure?
l Control Plan
l Devices
l Good/Bad Masters
l PFMEA
l Customer complaints.
l Lessons learned.
l Operator Instructions.
l Preventive maintenance.
l Set-up Instructions.
l Documentation of test or
calibration.
7.5.1.1 Does machine logic prevent non-conforming parts
from reaching further operations?
Visual test system
(Go/No Go)
Failed parts, 1st time quality
7.5.1.1 Does the process alert the operator if standardized
work is not followed? If not, what doesn't the process
alert you to?
PFMEA & Testing;
Operator
Instructions; Lessons
learned
Operator Instructions
7.4.1 Does the organization
a) ensure that purchased product conforms to
specified purchase products?
b) control suppliers and their product to the extent of
its effect on subsequent product realization or the
final product?
c) select suppliers based on the ability?
d) established criteria for selection evaluation, and re-
evaluation of its suppliers?
e) maintain records of the evaluations and any
actions arising from such?
l Documented
Procedure
l Incoming Inspection.
l Source Inspection.
l Process audit at supplier site.
l Control methods
l Selection system.
l Performance rating system.
l 2nd Party Audit results.
l Approved supplier records.
7.4.1 Does the organization
a) effectively manage critical sub-tier processes and
suppliers?
b) have resources assigned to Tiered activity?
c) have knowledgeable resources available to
manage issues with the critical subtier suppliers, e.g.,
heat treat, plating, etc.?
l Organization chart
l Approved supplier
list
l Supplier Quality
activity
l Supplier Performance reports.
l Part and Process Audits.
l System audits.
l Fully staffed
l Expert resources (Metallurgist,
Manufacturing Engineer, etc.)
7.4.1 Is there a process in place to notify customers of
changes in their supplier base?
l Documented
Procedure
l Examples
8.5.3 Are target agreements for continual improvement of
products and processes made and implemented with
the supplier base?
l Quality Contract
l Continuous
Improvement Plan
l Completed action items
l Update PFMEA
7.4.1.1
7.4.6
Do the suppliers demonstrate compliance with
environmental and regulatory requirements?
l Documented
Requirements
l PO Terms and
Conditions
l Requirement for suppliers to
meet all governmental
requirements and regulations.
7.4.7 Does the supplier require their supplier base to meet
the compliance requirements in ISO/TS 16949?
l Policy Statement l Copies of supplier
certifications
l Waiver letters from customers
l 2nd Party audits with Auditor
Training Certificate
7.4.8 Is there a documented supplier development process
with the goal of supplier compliance to ISO/TS
16949:2002?
l Documented
Procedure
l Supplier Rankings
l Supplier Development
Process
l Evidence of subcontractor
development
7.4.9 Does the supplier used recommended customer
sources for critical sub-tier processes when that
information is available?
l Customer list of
approved suppliers
l Sourced suppliers vs.
customer approval list
7.4.10 Does the supplier manage customer directed source,
including tool/gage suppliers, in the same manner
they do their own?
l Approved Supplier
List
l Procedure
l Scope of supplier
management process.
l Scope of Incoming Inspection
includes customer directed
sources.
7.4.2 Does the organization's purchasing information
describe the product to be purchased, including
where appropriate:
a) requirements for approval of product, procedures,
processes and equipment?
b) requirements for qualification of personnel?
c) quality management system requirements?
d) assurance of the adequacy of specified
purchased requirements before their communication
to the supplier?
l Purchase Order
l Terms and
Conditions
l Customer contract
review
l Quality requirements and
goals.
l Quality standards
requirements, i.e., ISO/TS
16949:2002, ISO9001:2000.
l Contract review extends to
suppliers.
7.3.6.3 Do all purchased parts/production materials have a
completed PPAP?
l Part Validation
Package
l Sub-components, materials
used in product shipped
7.3.6.3 Do the PPAPs contain all of the required elements
per
customer direction?
l Part Validation
Package
l Customer PPAP requirements
vs. PPAP package
8.06
8.07
8.08
8.09
7.17
No.
8.01
8.02
8.0 Supply Chain Management
StatusTS16949
SectionQuestion Evidence Required Look For
8.04
8.05
7.15
7.16
8.03
8.11
8.12
Observations
8.10
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7.3.6.3 Are these PPAPs up to date? l Part Validation
Package
l Material and test
certifications less than 1 year
old.
l Warrant Letters.
l Dimensional layouts.
7.4.3.2 Does the organization monitor supplier performance
using:
a) delivered part quality performance?
b) Customer disruptions including field returns?
c) Delivery schedule performance (including
incidents of premium freight)?
l Subcontractor
Performance
Records
l Subcontractor
Corrective Actions
l Charts for PPM, Delivery, etc..
l Supplier scorecards.
l Corrective actions.
7.4.3.2 Does the organization promote supplier monitoring of
their manufacturing processes' performance?
l Supplier
management
documents
l Evidence of continuous
improvement initiated by
supplier based on their own
monitoring of performance.
7.3.6.3 Does the organization conform to a product and
process approval procedure recognized by the
customer?
l Documented
Procedure
l Customer
Requirements
l Compliance with customer
requirements (AIAG PPAP or
VDA, in Europe).
7.5.2 For its production and service provision, does the
organization validate, and demonstrate compliance,
where the resulting output cannot be verified by
subsequent monitoring or measurement?
l Process Controls l Process validation/capability
reports.
l Process parameter monitoring
and control evidence.
7.5.2 Has the organization established arrangements for all
it process for production and service provision
including, as applicable:
a) defined criteria for review and approval of the
processes?
b) approval of equipment and qualification of
personnel?
c) use of specific methods and procedures?
d) requirements for records?
e) revalidation?
l Requirement
specification
l Qualification
records
l Requirements for operations,
equipment and personnel.
l Related records of
qualification.
l Frequency and conditions of
revalidation.
7.6.3.1 Does the organization's internal laboratory facility
have a defined scope that includes capability to
perform the required inspection, test, or calibration
services?
l Laboratory Scope l Types of laboratories used by
organization.
l Scope for each laboratory.
7.6.3.1 Is the organization's lab scope included in the
quality
management system and comply with the following
technical requirements:
a) adequacy of laboratory procedures?
b) qualifications of the laboratory personnel
conducting tests?
c) test of the commodity?
d) performing these tests correctly, traceable to the
relevant process standard?
e) review of the related quality records?
l Quality Manual l Compliance to ISO/TS
16949:2002 requirements.
7.6.3.2 Do the external/ commercial/ independent
laboratory facilities used for inspection, test or
calibration services by the organization have a
defined laboratory scope that includes capability to
perform the required inspection, test, or calibration,
and:
a) be accredited to ISO/IEC 17025 or national
equivalent?
b) have evidence that the external laboratory is
acceptable to customer?
l Commercial
Laboratory
Accreditation
records
l Customer
communication
l Certification with future
expiration date.
l Scope of approved tests from
accreditation body compared
to tests performed for
organization.
l Document from customer
acknowledging use of
laboratory or laboratories.
8.1 Has the organization planned and implemented the
monitoring, measurement, analysis and improvement
processes needed
a) to demonstrate conformity of the product?
b) to ensure conformity of the quality management
system?
c) to continually improve the effectiveness of the
quality management system?
l Internal audits
l Product
conformance
l Quality management system
audits with properly trained
internal auditors.
l Set-up, in-process and final
inspections.
l Statistical Process Control.
l Mistake Proofing.
8.2.1 Does the organization monitor information relating to
customer perception as to whether the organization
has met customer requirements as one of the
performance of the quality management system?
l Customer
Performance
Reports
l Review of information relating
to customer satisfaction
routinely/set interval.
l Customer satisfaction
performance indicators.
8.2.1.1 Are the organization's performance indicators for
customer satisfaction based on objective data and
include, but not be limited to:
a) delivered part quality performance?
b) customer disruptions including field returns?
c) delivery schedule performance (including
premium freight)?
d) customer notifications related to quality or delivery
issues?
l Customer
Performance
Reports
l PPM
l Delivery
l Number of Concerns
l Customer Disruptions
l Premium Freight
9.06
9.07
9.0 Quality Control
TS16949
Section
9.09
Question Evidence Required Look For
9.08
StatusNo.
9.01
8.13
8.14
8.15
9.02
9.03
9.04
9.05
Audit Worksheet
Observations
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SectionStatusQuestionNo. Evidence Required Observations
8.2.1.1 Does the organization monitor manufacturing
processes performance to demonstrate compliance
with customer requirements for product quality and
efficiency of the process?
l Customer
Requirements
l Measurement of
manufacturing processes
against compliance to
customer requirements.
5.5.1.1 Are the organizations production operations staffed
with personnel that ensure product quality across all
shifts?
l Organization Chart
l Employee records
l Quality Assurance responsible
personnel in all shifts.
8.2.2
8.2.2.1
Does the organization conduct internal audits at
planned intervals to determine whether the quality
management system:
a) conforms to product planning arrangements, to
the requirements of the quality management system
and ISO/TS 16949:2002?
b) is effectively implemented and maintained?
l Internal Audit
process
l Audit schedule.
l Interviews with different area
managers.
l Records of performed audits.
8.2.2 Has the organization:
a) planned an audit program that takes into
consideration the status and importance of processes
being audited?
b) defined the criteria, scope, frequency and
methods of the audit?
c) ensured objectivity and impartiality of the audit
process?
d) defined the responsibilities and requirements for
planning and conducting audits?
e) defined the responsibilities and requirements for
reporting results and maintaining records?
f) established that the manager of the audited area is
responsible to ensure that actions are taken without
undue delay to eliminate detected non-conformities?
g) ensure that internal follow-up activities include
verification of action taken?
l Internal Audit
process
l Appropriate prioritization.
l Audit schedule.
l Organization charts.
l Auditors only conduct audits
in areas that are independent
of their job functions.
l Department/individual
responsible for internal audit
activities also reports audit
results to upper management.
l Closure time for audit findings.
l Records of verification.
8.2.2.3 Does the organization audit:
a) each manufacturing process to determine its
effectiveness?
b) products at appropriate stages to verify
conformance at defined frequency?
l Internal Audit
process
l Part/Process audits.
l Line walks.
l Audit plan, process flow chart
and schedule.
l Product audit procedures
and reports.
8.2.2.4 Does the organization's internal audits:
a) cover all quality management system related
processes, activities, shifts, and scheduled according
to an annual plan?
b) increase in frequency when internal/external non-
conformances or customer complaints occur?
l Internal Audit
process
l Audit Plan.
l Audit schedule.
l Appropriate prioritization.
8.2.2.5 Are the organization's internal auditors quality to
audit
the requirements of ISO/TS 16949:2002?
l Training
Certificates
l Successful completion of an
ISO/TS 16949 Internal Audit
class taken through IOAS
approved trainer.
l Successful completion of a 1-
day ISO/TS 16949 Customer
Requirements Internal Auditor
training.
8.1.1 Does the organization determine the appropriate
statistical tools for each process during advanced
quality planning and include them in the control
plan?
l Procedure
l Control Plan
l Review of control plan.
l Review of quality plan.
l Plant floor.
8.1.2 Do personnel posses adequate statistical ability to
understand and adhere to the requirements of the
control plan?
l Employee
Development
l Training records.
l Employee interviews.
8.1.2 Are short-term capability studies conducted on new
or changed processes and equipment prior to
submitting a PPAP?
l Procedure l Capability studies for parts
recently validated and new
production equipment.
8.1.2
8.2.3.1
Does the supplier calculate long term capability? l Procedure l
Capability studies for parts in
production.
8.1.2 Are written corrective action plans established for
processes or equipment with a capability of less than
1.33?
l Statistical Charts
l Statistical Reports
l Action plan for parts and/or
equipment.
8.1.2 Is statistical data summarized and reported on a
regular basis? Is there evidence of management
response to these reports?
l Management
Report
l Periodic generation and
distribution.
l Action plans, directives or
documented activity in
response to reports.
8.1.2 What is the tightest tolerance that for which you must
produce product? Do you show process capability of
1.33 or greater for this tolerance?
l Customer
specification
l Long term capability study for
tightest toleranced
characteristic.
8.1.2 Does the supplier have a statistically based
Continuous Improvement Process (CIP), e.g., Six
Sigma?
l Documentation
l Organization
Charts
l Blackbelts.
l CIP reports.
l Posted charts/graphs.
8.2.3.1 Does the organization note significant process
events
on the control charts?
l Control Charts l Floor review.
Evidence Required Look For Status
10.05
10.06
TS16949
SectionQuestion
10.07
9.10
9.11
9.12
10.04
No.
10.0 Statistical Process Control
10.09
9.14
9.15
9.16
10.01
10.02
10.03
10.08
Observations
Audit Worksheet
9.13
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SectionStatusQuestionNo. Evidence Required Observations
8.2.3.1 Does the organization:
a) initiate appropriate the appropriate reaction plan
from the control plan for either unstable or non-
capable characteristics?
l Control Plans
l Control Charts
l Records of reactions taken.
8.2.3.1 Does the organization's reaction plans for unstable
or
non-capable characteristics include containment
and 100% inspection as appropriate?
l Control Plans
l Reaction Plans
l Contents of reaction plan for
unstable and noncapable
processes.
l Records.
8.2.3.1 Does the organization establish a corrective action
following the initiation of reaction plans, indicating
specific timing and assigned responsibilities?
l Corrective Action
Reports
l Corrective actions for initiated
reactions.
8.2.3.1 Are the organization's corrective action plans
reviewed with and approved by the customer when
so required?
l Corrective Action
approval process
l Corrective action reports.
8.2.3.1 Does the organization maintain records of the
effective dates of process changes?
l Process change
management
process
l Records of process change
dates.
7.6 Is there a procedure established to control, calibrate
and maintain inspection, measuring, and test
equipment (including test software) that is used to
demonstrate the conformance of product to
specified requirements?
l Procedure l Gage/Test Equipment Control
System
7.6 Are all inspection and test equipment affecting
product quality:
a) identified enabling calibration status to be
determined?
b) calibrated at prescribed intervals, or prior to use,
against measurement standards traceable to
international or national measurement standards?
c) adjusted or readjusted as necessary?
d) safeguarded from adjustments that would
invalidate the measurement result?
e) protected from damage and deterioration during
handling, maintenance, and storage?
l Procedures
l Documentation
l Calibration
Instructions for each
type of equipment
l Test equipment inventory.
l Certifications for calibration
masters and their traceability
to international national
recognized standard.
l Calibration results records.
l Method of control of
calibration settings.
l Calibration status
identification.
l Type, Identifier, Location,
Calibration frequency,
method, Gage R&R status,
Acceptance criteria, results,
actions
7.6 Does the organization:
a) assess and record the validity of the previous
measuring results when the equipment is not found to
conform to the requirements?
b) take appropriate action on equipment found not
conforming and any affected products?
l Procedure l Records of re-inspected
product.
l Actions taken on non-
conforming equipment and
parts affected by it.
7.6 Are Good/Bad masters used on key equipment to
ensure calibration is maintained?
l Test masters on
equipment
l Instructions
l Test Log
l Good/Bad masters
l Appropriate verification
period
7.6 Does the organization confirm the software's ability for
equipment to monitor and measure the intended
application?
l Procedure
l Documentation
l Test software.
l Comparative references
verification.
7.6.1 Are Gage R & R studies complete and current? l
Documentation
l PPAP
l Gage R&R less than one year
old
l Meets PPAP requirements
7.6.1 Does the organization:
a) conduct measurement system analysis for systems
referenced on the control plan?
b) use measurement system analytical methods and
acceptance criteria that conform to customer
requirements?
l Procedure
l Documentation
l Measurement system analysis
results.
l Check methods against
customer requirements.
l Customer approval records
for other analytical methods
used.
7.6.2 Do the records of calibration activity, for all gages,
measuring and test equipment, including employee-
and customer-owned gauges, include:
a) identification including the standard against which
it is being measured?
b) revisions following engineering changes?
c) any out-of-specification readings as received for
calibration/verification?
d) an assessment of the impact of the out-of-
specification condition?
e) statements of conformance after
calibration/verification?
f) notification to the customer if suspect product or
material has been shipped?
l Procedure
l Documentation
l Measurement equipment
records.
l Original specification of
measurement equipment.
11.05
11.06
11.07
11.08
No.
12.0 Incoming Inspection, Layout and Functional Testing
TS16949
SectionQuestion StatusEvidence Required
11.03
11.04
10.10
10.11
10.12
10.13
10.14
No.
Look For
11.01
11.0 Control of Monitoring and Measuring Devices
TS16949
Section
11.02
ObservationsQuestion Evidence Required Look For Status
Audit Worksheet
Observations
Audit Worksheet
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SectionStatusQuestionNo. Evidence Required Observations
7.4.3 Does the organization establish and implement the
inspection or other activities necessary for ensuring
that purchased product meets specified purchased
requirements?
l Procedure l Incoming inspection plans.
7.4.3 Where the organization or its customer intends to
perform verification at the supplier's premises, does
the organization state the intended verification
arrangements and method of product release in the
purchasing information?
l Purchase Order
l Terms and
Conditions
l Suppliers and subcontractors.
l Purchase order details and
contract.
7.4.3.1 Doest the organization have a process to ensure the
quality of purchased product utilizing one of the
following:
a) receipt of, and evaluation of, statistical data?
b) receiving inspection and /or testing such as
sampling based on performance?
c) second or third party assessments or audits of
suppliers sites, when coupled with records of
acceptable quality performance?
d) part evaluation by a designated laboratory?
e) another method agreed with the customer?
l Procedure l Incoming inspection.
l Source inspection.
l 2nd or 3rd part audits of
supplier sites.
l Independent evaluation of
acceptability of product by a
designated 3rd party.
7.4.3 Are Incoming parts/materials properly logged and
identified?
l Received material
log
l Raw materials
l Components for assembly
7.4.3 Are detailed Incoming Inspection procedures
available and used by employees?
l Work Instructions
l Inspection
Instructions
l Incoming requirements by
part number; material type
7.4.3 Is SPC data received from suppliers when required? l
Inspection
Instructions
l File
l SPC Charts
7.4.3 Is there a system that monitors incoming supplier
performance for quality, delivery, and premium
freight?
l QOS Reporting l Metrics for supplier
performance
l Charts
l Letters to suppliers
7.5.5.1 Are there measures in place to avoid material
contamination, handling damage and degradation
during storage?
l Storage procedure l Raw materials and
components storage
l Containers
7.5.5.1 Are all goods, from receipt of incoming materials
through shipment stored, and identified, for efficient
use and retrieval?
l Receiving
Inspection Process
Controls
l FIFO system
7.5.5.1 Where applicable, are all materials with a shelf
life
properly identified and still useable?
l Process Controls l Expired Material on shelves
7.5.1.6 Are the stock levels of parts and materials matched
to production needs?
l Material usage vs.
Shipments
l Expedited shipments
l Downtime
l Overtime
8.2.4.1 Does the organization perform a layout inspection
and a function verification to the applicable
customer engineering material and performance
standards for all products at a sufficient frequency as
specified in the control plan?
l Control Plan l Layout inspection reports.
8.2.4.1 Does the organization have layout inspection and
functional testing results available for customer
review?
l Inspection records
l Test records
l Acceptance criteria.
l Inspector performing test.
l Test results and status.
l Test date.
7.5.3 Does the organization identify the product by a
suitable means throughout product realization?
l Lot Traceability
System
l Check for positive recall.
l Suitable product identification
throughout the facility.
7.5.3 Does the traceability plan include lot control,
date/shift codes?
l Procedure l Documentation vs. Floor
7.5.3 Does the traceability originate with raw material and
purchased components, i.e., nuts, screws, etc.?
l Procedure l Documentation vs. Floor
7.5.3 Does the lot control reflect the last value added
process?
l Procedure
l Process Flow
Diagram
Lot control should reflect
batch breakdown at value
added processes
7.5.3 Are the quantities/production lot sizes matched to the
requirements and are they purposely forwarded to
the next work station?
l Procedure l Documentation vs. Floor
7.5.3 Is material identification, traceability and test
status
maintained and recorded at all production stages?
l Procedure l Documentation vs. Floor
7.5.3 Are customer requirements part of the identification
procedure?
l Procedure l Documentation
12.13
No.
No.
14.0 Production Control
Evidence RequiredTS16949
SectionQuestion
12.01
12.02
12.03
12.04
12.05
12.12
13.0 Identification and Traceability
TS16949
SectionStatusLook For
13.06
12.06
12.07
12.08
12.09
12.10
12.11
13.01
13.02
13.03
13.04
13.07
Look For Status
Question Evidence Required
Observations
Audit Worksheet
Audit Worksheet
13.05
Observations
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SectionStatusQuestionNo. Evidence Required Observations
7.5.1 Does the organization plan and carry out production
and service provision under the following controlled
conditions, as applicable:
a) the availability of information that describes the
characteristics of the product?
b) the availability of work instructions, as necessary?
c) the use of suitable equipment?
d) the availability and use of monitoring and
measuring devices?
e) implementation of monitoring and measurement?
f) the implementation of release, delivery and post-
delivery activities?
l Procedures
l Drawings /
Specifications
l Work Instructions
l Tour of plant and facilities.
l Master part or correct level
assembly drawings.
l Work Instructions at work
locations.
7.5.1.2 Do instructions for running the process exist
(operator
instructions) for all employees having responsibilities
for the operation of processes?
l Visual l Availability of work instructions
at the workstation.
7.5.1.2 Do instructions
a) have the correct content?
b) list the bill of materials, production tools, and safety
equipment needed at each operation?
c) address stop/start or line down procedures?
d) identify the critical and significant characteristics at
the stations that product them?
e) take into account the literacy and language of all
operators?
f) identify who is authorized to do what?
l Complete
Standardized Work
l Visual
l Control Plan
l Speak to Operator
l Identification
l Operator vs. Instructions.
l Documentation.
l Floor data.
l Can operators read and
understand instructions.
7.5.1.2 Are the instructions
a) short, simple, and easily understood?
b) posted appropriately for automated stations?
l Visual l Can you follow them?
l Documentation.
7.5.1.2 Does the PFMEA include failure modes for defects
that may occur as a result of a line down or cold start
situation?
l PFMEA l Operator knowledge of the
procedure
7.5.1.2 Are visual aids and/or boundary samples required? If
so, are they available to the operator?
l Visual l Documentation
7.5.1.2 Do instructions for set-up/changeover exist, and are
they readily available?
l Procedure
l Visual
l Documentation and visual
controls
7.5.1.3 Is an approval for production start issued and are
adjustment details, as well as, deviations recorded?
l Record of Set-up l 1st piece
7.5.1.3 Does the organization use statistical methods of
verification of job set-ups where applicable?
l Procedure l Set-up records.
7.5.1.3 Is proper disposal of set-up parts defined? l Visual l
Documentation.
7.5.1.3 Do set-up instructions ensure component parts are
being properly assembled?
l Set-up parts
l Visual Controls
l Tags.
l Samples.
l Visual controls, etc.
7.5.1.6 Is the operator working ahead? l Inventory areas vs.
operation areas
l Operations and rework areas.
7.5.1.6 Is Work in Progress minimized? l Material in staging
areas
l Balance of material flowing
through process.
7.5.1.6 Does the supplier have an effective material
management system?
l Documentation vs.
Floor
l Material management system
in process.
7.5.1.6 Is there discipline in place to produce only the
parts
required?
l Documentation vs.
Floor
l Operators familiarity with the
Material management system.
7.5.1.6 Does the material management system use cards
with information such as quantity and part number?
Are the cards in place from and to locations?
l Match tag vs.
material
Containers with tags.
7.5.1.6 Does the quantity produced match with the quantity
drawn?
l Documentation vs.
Floor
l Lot size.
7.5.1.7 If service is provided, has the organization
established
and maintained a process to communicate
information from service concerns to manufacturing,
engineering and design activities?
l Service Reports l Meeting reports, follow-up
and corrective
actions/responsibility/dates.
l Product service data.
7.5.1.8 Where there is a servicing agreement with the
customer, does the organization verify the
effectiveness of:
a) any organization service centers?
b) special purpose tools or measurement equipment?
c) training of servicing personnel?
l Service
Organization /
Process
l Planning of periodical audits.
l Reports and follow up.
14.18
14.19
No.
15.0 Manufacturing Monitoring & Measurement
TS16949
SectionQuestion Evidenc
