Assessment
Tooling & Equipment
(QSA-TE)
- Incorporates questions covering all “shalls” and “shoulds” from the QS-9000 Third
Edition and the TE Supplement. Certain questions address multiple TE Supplement
requirements as indicated within the ( ) following the question.
- The “variables score” method is now based on a 0 to 10 point score for each element.
Acknowledgments for this effort are due to the AIAG Sub-Tier Quality Assessment Workgroup,
Tooling & Equipment Supplement Workgroup, and the Chrysler, Ford, GM Supplier Quality
Requirements Task Force, as well as the Task Force Steering Committee for their guidance and
support.
June 1998
i
ii
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
Table of Contents
Foreword ........................................................................................................................................................ i
Purpose ......................................................................................................................................................... 1
Application ................................................................................................................................................... 1
Assessment Process ...................................................................................................................................... 1
Assessment Method ...................................................................................................................................... 1
Audit Summary Alternatives ........................................................................................................................ 2
Definitions .................................................................................................................................................... 2
Evaluation Process for Using Recommended/Not Recommended Method ................................................. 3
Evaluation Process for Using a Variables Score Method .............................................................................. 4
Reporting of Audit Findings ......................................................................................................................... 5
Use of Scores in Sourcing Decisions ............................................................................................................ 5
Process for Second Party Assessment .......................................................................................................... 6
Quality System Assessment Tooling & Equipment Cover Sheet ................................................................. 9
Quality System Assessment Tooling & Equipment Record of Findings .................................................... 10
Quality System Assessment Tooling & Equipment General Comments .................................................... 11
Document Review ...................................................................................................................................... 13
Element 4.1 - Management Responsibility ................................................................................................ 15
4.1.1 Quality Policy .............................................................................................................................. 15
4.1.2 Organization ................................................................................................................................ 15
4.1.3 Management Review ................................................................................................................... 16
4.1.4 Business Plan .............................................................................................................................. 16
4.1.5 Analysis and Use of Company Level Data .................................................................................. 16
4.1.6 Customer Satisfaction ................................................................................................................. 17
Element 4.2 - Quality System ..................................................................................................................... 18
4.2.2 Quality System Procedures ......................................................................................................... 18
4.2.3 Quality Planning ......................................................................................................................... 18
4.2.4 Machinery Qualification Runoff ................................................................................................. 19
4.2.5 Continuous Improvement ............................................................................................................ 20
4.2.6 Facilities and Tooling Management ............................................................................................ 20
Element 4.3 - Contract Review ................................................................................................................... 22
4.3.2 Review ......................................................................................................................................... 22
4.3.3 Amendment to Contract .............................................................................................................. 22
4.3.4 Records ....................................................................................................................................... 22
iii
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
Table of Contents (Continued)
Element 4.4 - Design Control ..................................................................................................................... 23
4.4.1 General ........................................................................................................................................ 23
4.4.2 Design and Development Planning ............................................................................................. 23
4.4.3 Organizational and Technical Interfaces ..................................................................................... 23
4.4.4 Design Input ................................................................................................................................ 23
4.4.5 Design Output ............................................................................................................................. 24
4.4.6 Design Review ............................................................................................................................ 24
4.4.7 Design Verification ..................................................................................................................... 24
4.4.8 Design Validation ........................................................................................................................ 24
4.4.9 Design Changes .......................................................................................................................... 25
4.4.10 Customer Prototype Support ..................................................................................................... 25
4.4.11 Confidentiality .......................................................................................................................... 25
Element 4.5 - Document and Data Control ................................................................................................ 26
4.5.1 General ........................................................................................................................................ 26
4.5.2 Document and Data Approval and Issue ..................................................................................... 26
4.5.3 Document and Data Changes ...................................................................................................... 26
Element 4.6 - Purchasing ............................................................................................................................ 28
4.6.1 General ........................................................................................................................................ 28
4.6.2 Evaluation of Subcontractors ...................................................................................................... 28
4.6.3 Purchasing Data .......................................................................................................................... 28
4.6.4 Verification of Purchased Product .............................................................................................. 29
Element 4.7 - Control of Customer Supplied Product ................................................................................ 30
4.7.1 Customer Owned Tooling ........................................................................................................... 30
Element 4.8 - Product Identification and Traceability................................................................................ 31
Element 4.9 - Process Control .................................................................................................................... 32
4.9.1 Process Monitoring and Operator Instructions ........................................................................... 33
4.9.3 Modified Process Control Requirements .................................................................................... 34
4.9.4 Verification of Job Setups ........................................................................................................... 34
4.9.5 Process Changes .......................................................................................................................... 34
Element 4.10 - Inspection and Testing ........................................................................................................ 35
4.10.1 General ...................................................................................................................................... 35
4.10.2 Receiving Inspection and Testing .............................................................................................. 35
4.10.3 In-Process Inspection and Testing ............................................................................................. 35
4.10.4 Final Inspection and Testing ...................................................................................................... 36
4.10.5 Inspection and Test Records ...................................................................................................... 36
4.10.6 Supplier Laboratory Requirements ........................................................................................... 36
4.10.7 Accredited Laboratories ............................................................................................................ 37
iv
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
Table of Contents (Continued)
Element 4.11 - Inspection, Measuring and Test Equipment ....................................................................... 38
4.11.1 General ...................................................................................................................................... 38
4.11.2 Control Procedure ..................................................................................................................... 38
4.11.3 Inspection, Measuring and Test Equipment Records ................................................................ 40
4.11.4 Measuring System Analysis ...................................................................................................... 40
Element 4.12 - Inspection and Test Status .................................................................................................. 41
4.12.1 Supplemental Verification ......................................................................................................... 41
Element 4.13 - Control of Nonconforming Product ................................................................................... 42
4.13.1 General ...................................................................................................................................... 42
4.13.2 Review and Disposition of Nonconforming Product ................................................................ 42
Element 4.14 - Corrective and Preventive Action ...................................................................................... 44
4.14.1 General ...................................................................................................................................... 44
4.14.2 Corrective Action ...................................................................................................................... 44
4.14.3 Preventive Action ...................................................................................................................... 45
Element 4.15 - Handling, Storage, Packaging, Preservation and Delivery ................................................ 46
4.15.2 Handling .................................................................................................................................... 46
4.15.3 Storage ...................................................................................................................................... 46
4.15.4 Packaging .................................................................................................................................. 46
4.15.5 Preservation ............................................................................................................................... 46
4.15.6 Delivery ..................................................................................................................................... 46
Element 4.16 - Control of Quality Records ................................................................................................ 48
4.16.1 Record Retention ...................................................................................................................... 48
Element 4.17 - Internal Quality Audits ....................................................................................................... 49
4.17.1 Internal Audit Schedules ........................................................................................................... 49
Element 4.18 - Training .............................................................................................................................. 50
4.18.1 Training Effectiveness ............................................................................................................... 50
Element 4.19 - Servicing ............................................................................................................................ 51
4.19.1 Feedback of Information from Service ..................................................................................... 51
Element 4.20 - Statistical Techniques ......................................................................................................... 52
4.20.1 Identification of Need ............................................................................................................... 52
4.20.2 Procedures ................................................................................................................................. 52
4.20.3 Selection of Statistical Tools ..................................................................................................... 52
4.20.4 Knowledge of Basic Statistical Concepts ................................................................................. 52
Chrysler-Specific ........................................................................................................................................ 53
Ford-Specific .............................................................................................................................................. 54
General Motors-Specific ............................................................................................................................ 55
v
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
GENERAL ASSESSMENT INSTRUCTIONS
AND GUIDELINES
Purpose This Quality System Assessment Tooling &
Equipment (QSA-TE) is used to determine
conformance to the Quality System Requirements
QS-9000 and the Tooling & Equipment
Supplement (TE Supplement). Proper use of the
QSA-TE will ensure that all requirements are
addressed and promote consistency between activities
and personnel determining QS-9000 TE Supplement
conformance.
A MINOR NONCONFORMITY is a TE
Supplement noncompliance that judgment and
experience indicate is not likely to :
2
It may be either:
3
Evaluation Process for Using
a Variables Score Method:
Description Score
Supplier is not familiar with the requirements of the element and has no
relevant source documentation (flow charts, forecasts, plans, procedures, 0
strategies, etc.) in this area.
Within each element the result (0 to 10) is marked in the appropriate row on the Record
of Findings page. Final score is obtained by adding the point score column and dividing
by the number of scored elements. TO BE RECOMMENDED A MINIMUM SCORE
OF SEVEN IS REQUIRED ON EVERY APPLICABLE ELEMENT.
4
Evaluation Process... ELEMENTS NOT APPLICABLE TO A
PARTICULAR SUPPLIER
Variables Score Method
(Continued) Certain elements such as 4.7 (Control of Customer
Supplied Product) and 4.19 (Servicing) will not apply
to every supplier. In such cases, “N/A” is entered in
place of the score.
5
Process for Second Party Assessment
1. Supplier provides requested To promote optimum use of resources, the manual
and other requested materials should be provided to
materials [e.g. quality manual, the customer at least two weeks prior to the on-site
procedures (level two audit. Also, the supplier will typically be asked to
provide:
documentation)] to customer. - a self-assessment as requested by the customer
- plans, if any, for third party quality systems
registration
- audits, if any, by other customers using the
QSA-TE.
5. Customer prepares Audit The checklist for the on-site audit is the QSA-TE
plus any additional questions identif ied in the
Checklist. documentation review. Additional space is provided
in the QSA-TE for such questions.
6
Process for Second Party Assessment
1
Supplier provides
requested
materials
2
DOCUMENT
REVIEW
4
3
Documentation
Supplier makes
OK? necessary
revisions
5
Customer
prepares
audit
checklist
6
Customer
conducts on-site
audit
8
7 Supplier
Customer
corrects
identifies
nonconformities
nonconformities;
forwards
documentation
10 9
Satisfactory Documentation
completion of YES satisfactory? NO
audit
7
Process for Second Party Assessment
6. Customer conducts on-site audit. The customer uses the checklist to evaluate the
supplier’s operations. This audit shall be conducted at
supplier sites and remote locations as applicable (e.g.,
Engineering, Purchasing).
10.Customer advises supplier of Customer provides final audit result to supplier (e.g.,
recommended/not recommended).
audit result.
8
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
COVER SHEET
Supplier:
Facility Address:
Scope of Audit:
Products/Lines Audited:
Score, If Applicable
Comments:
9
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
RECORD OF FINDINGS
Documentation Review
4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document and Data Control
4.6 Purchasing
4.7 Control of Customer Supplied Product
4.8 Product Identification and Traceability
4.9 Process Control
4.10 Inspection and Testing
4.11 Inspection, Measuring, & Test Equipment
4.12 Inspection and Test Status
4.13 Control of Nonconforming Product
4.14 Corrective and Preventive Action
4.15 Handling, Storage, Packaging, Preservation, & Delivery
4.16 Control of Quality Records
4.17 Internal Quality Audits
4.18 Training
4.19 Servicing
4.20 Statistical Techniques
Customer-specific (if applicable)
TOTALS:
10
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
GENERAL COMMENTS
Element No. Comments
11
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
GENERAL COMMENTS
Element No. Comments
12
DOCUMENT REVIEW
(Note: This is the basic documentation review for the audit.)
Question Assessor Notes - Implementation evidence
0.1 ** Has a quality manual covering the
requirements of TE Supplement been
prepared? Does the quality manual
include or make reference to quality
system procedures and outline the
structure of the documentation used in
the quality system? (4.2.1)
- Management Responsibility
- Quality policy
- Organization
- Management Representative
- Management Review
- Business Plan
- Customer Satisfaction
- Quality Planning
- Cross Functional Teams
- Feasibility Reviews
- Control Plans
- Process FMEAs
- Contract Review
- Design Control (as applicable)
- Design Review
- Design Verification
- Design Validation
- Design Changes
- Machinery Qualifications Runoff
- Continuous Improvement
- Facilities and Tooling Management
- Document and Data Control
- Document Changes
- Purchasing
- Subcontractor evaluation
- Control of Customer Supplied
Product
- Product Identification and Traceability
- Process Control
- Process Monitoring
- Process Capability/Performance
- Verification of Setups
- Process Changes
- Planned Preventive Maintenance
- Predictive Maintenance
- Inspection and Testing
- Appearance Item Inspection
(if applicable)
- Lab Accreditation (if required)
- Inspection, Measuring & Test
Equipment
- Measuring System Analysis
- Inspection and Test Status
- Control of Nonconforming Product
13
DOCUMENT REVIEW
(Note: This is the basic documentation review for the audit.)
Question Assessor Notes - Implementation evidence
- Corrective and Preventive Actions
- Handling, Storage Packaging,
Preservation & Delivery
- Control of Quality records
- Internal Quality Audits
- Training
- Servicing
- Statistical Techniques
- Applicable Customer Specific
Requirements
14
ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY
ELEMENT ASSESSOR NOTES RESULTS
4.1 - Management
Responsibility
15
ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)
Question Assessor Notes - Implementation evidence
1.9 Does the supplier use a multi-
disciplinary approach for decision
making? (4.1.2.4)
1.10 Does the supplier have the ability to
communicate necessary information
and data in the customer prescribed
format? (4.1.2.4)
1.11 Is management with responsibility and
authority for corrective action promptly
informed of products or processes that
become non-compliant with specified
requirements? (4.1.2.5)
4.1.3 Management Review
1.12 ** Does the supplier’s management with
executive responsibility review all quality
system elements at defined intervals to
insure its continuing suitability and
effectiveness? (4.1.3;4.1.3.1; 4.16)
4.1.4 Business Plan
1.13 ** Does the supplier utilize a formal,
documented, comprehensive business
plan that includes short-term and longer-
term goals and plan(s)? (4.1.4)
1.14 Does the business plan address customer
requirements for quality, reliability,
maintainability and durability? (4.1.4)
1.15 Is the business plan under document
control? (4.1.4)
1.16 Are goals and plans based on analysis of
competitive products and benchmarking
inside and outside the automotive
industry? (4.1.4)
1.17* Are there methods in place to determine
cur rent and future customer
expectations? (4.1.4)
1.18 Does the supplier have an objective
process that def ines the scope and
collection of information (customer
expectations and customer satisfaction),
frequency and methods of collection?
(4.1.4; 4.1.6)
1.19* Are there documented methods to track,
update, revise and review the business
plan to ensure it is communicated and
followed throughout the organization, as
appropriate? (4.1.4)
4.1.5 Analysis and Use of Company Level Data
1.20 Does the supplier document trends in the
quality, operational performance, and
current quality levels for key product and
service features? (4.1.5)
16
ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)
Question Assessor Notes - Implementation evidence
1.21 ** Are trends in data and information
compared with:
- competitors
- appropriate benchmarks
- progress toward business objectives,
to lead to appropriate action to
support:
• developing priorities for resolving
customer problems
• determination of key customer-
related trends? (4.1.5)
4.1.6 Customer Satisfaction
1.22 * Is there a documented process to
measure customer satisfaction that
includes frequency of determination, and
how objectivity and validity are assured?
(4.1.6)
1.23 Are trends in customer satisfaction and
key indicators of customer dissatisfaction
documented, supported by objective
information, and reviewed by senior
management? (4.1.6)
1.24 * Is there evidence the supplier notifies
within 5 working days, the certification
body/registrar when a customer places
the site in any status listed in QS-9000?
(4.1.6.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
17
ELEMENT 4.2 - QUALITY SYSTEM
ELEMENT ASSESSOR NOTES RESULTS
18
ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)
Question Assessor Notes - Implementation evidence
2.7 Does quality planning address the
implementation of reliability and
maintainability throughout the life cycle
process? (4.2.3.1)
2.8 Do the supplier’s design control and
process control policies and practices
consider as appropriate due care and
product safety? (4.2.3.4)
2.9 * Does the supplier promote internal
awareness of safety considerations?
(4.2.3.4)
2.10 Is a process FMEA available for each
piece of machinery?
2.11* Do process FMEAs consider all Special
Characteristics? (4.2.3.5)
2.12 Is there evidence of efforts to achieve
defect prevention versus detection, using
PFMEA information? (4.2.3.5)
2.13 ** Are mistake proofing techniques utilized
where appropriate, which include but is
not limited to planning of process,
facilities, equipment and tooling, and in
problem resolution?
(4.2.3.6; 4.10.3; 4.14.1.2)
2.14 * Are control plans developed by multi-
disciplinary approach to the system,
subsystem, component, and/or material
level, and list all controls used for
process control? (4.2.3.7)
2.15 * Is a control plan available for each piece
of machinery? (4.2.3.7)
2.16 ** Are control plans reviewed and updated
as appropriate when any of the following
occurs:
- product or process changes
- processes are found to be unstable or
non-capable
- inspection method, frequency, etc. is
revised? (4.2.3.7)
4.2.4 Machinery Qualification Runoff
2.17 ** Has the supplier fulf illed the
requirements for the Machinery
Qualification Runoff portion of the TE
Supplement through the documentation
of:
- 50/20-hour dry run
- Preliminary evaluation
- Process Potential (Pp)
- Potential Process Capability (Ppk)
- Reliability verification
- Customer plan 20-hour dry run
- Short-term process performance
(Stability)
- Long-term process performance
(Capability)? (4.2.4)
19
ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)
Question Assessor Notes - Implementation evidence
4.2.5 Continuous Improvement
2.18 ** Is there evidence of continuous
improvement in quality (extending to
product characteristics), service (timing
and delivery) and price, that benefit all
customers? (4.2.5.1; 4.1.6)
2.19 Does continuous improvement extend
to product characteristics with the
highest priority on special
characteristics? (4.2.5.1)
2.20 Does the supplier have a prioritized
action plan for continuous improvement
in processes that have demonstrated
stability, acceptable capability and
performance? (4.2.5.1)
2.21 * Has the supplier identified opportunities
and implemented appropriate projects for
quality and productivity improvement?
(4.2.5.2)
2.22 Has the supplier demonstrated
knowledge and used appropriate
continuous improvement measures and
methodologies? (4.2.5.3)
4.2.6 Facilities and Tooling Management
2.23 Is a multi-disciplinary approach used
for developing facilities, equipment,
and process planning in conjunction
with the advanced quality planning
process? (4.2.6.1; 4.2.3.7)
2.24 ** Does the plant layout minimize material
travel and handling, facilitate
synchronous material flow, and
maximize value-added use of floor
space? (4.2.6.1)
2.25 Are methods developed for evaluating
the effectiveness of existing operations
and processes which consider the overall
work plan, appropriate automation,
ergonomics and human factors, operator
and line balance, storage and buffer
inventory levels, and value added labor
content? (4.2.6.1)
2.26* Has the supplier established and
implemented a system for tool
management that includes maintenance
and repair facilities and personnel,
storage and recovery, set-up, and tool
change programs for perishable tools,
tool modification including tool design
modification? (4.2.6.2)
20
ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)
Question Assessor Notes - Implementation evidence
2.27 Are appropriate technical resources
available for tool and gage design,
fabrication and full dimensional
inspection? (4.2.6.2)
2.28 * If tooling activities are subcontracted,
is there a system to track and
follow-up these activities? (4.2.6.2)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
21
ELEMENT 4.3 - CONTRACT REVIEW
ELEMENT ASSESSOR NOTES RESULTS
22
ELEMENT 4.4 - DESIGN CONTROL
ELEMENT ASSESSOR NOTES RESULTS
23
ELEMENT 4.4 - DESIGN CONTROL (CONTINUED)
Question Assessor Notes - Implementation evidence
4.4.5 Design Output
4.9 * Has the design output been documented
and expressed in terms that can be
verified and validated against design
input requirements and:
- meet the design input requirements?
- contain or reference acceptance
criteria?
- identify Special Characteristics?
- include a review of design output
documents before release?
- adequately address maintainability
features? (4.4.5)
4.10 * Was the design output a result of a
process that included:
- efforts to simplify, optimize, innovate,
and reduce waste ?
- GDT (as applicable)?
- analysis of cost/performance/risk
tradeoffs?
- feedback from testing, production and
the field (e.g., MTBF, MTTR,
maintenance issues)?
- analysis of design failure mode and
effects (DFMEA)? (4.4.5.1)
4.4.6 Design Review
4.11 ** Are there records of formal documented
design reviews by the appropriate
functions conducted at appropriate
stages of design per the design plan?
(4.4.6; 4.16)
4.12 Is there a system in place to confirm that
tooling and equipment designs meet
performance objectives before
construction using a comprehensive
prototype program and/or predictive
reliability and maintainability techniques
(e.g., simulation or mathematical
modeling, thermal analysis, stress
analysis, fault tree analysis)?
(4.4.6; 4.16)
4.4.7 Design Verification
4.13 Are there records to demonstrate that
design verification has been performed
to ensure that design output meets design
input requirements. (4.4.7; 4.16)
4.4.8 Design Validation
4.14 Has design validation been performed to
ensure that product conforms to defined
user needs and/or requirements? (4.4.8)
4.15 * Is design validation performed in
conjunction with the customer timing
requirements? (4.4.8.1)
24
ELEMENT 4.4 - DESIGN CONTROL (CONTINUED)
Question Assessor Notes - Implementation evidence
4.16 Are there records for design validation,
and do they include design failures?
(4.4.8.1; 4.16)
4.17 * Are design failures addressed through
the designated corrective and preventive
action procedures? (4.4.8.1)
4.4.9 Design Changes
4.18 * Are design changes identified,
documented, logged, reviewed and
approved by authorized personnel before
implementation? (4.4.9)
4.19 * Has written customer approval or waiver
been obtained prior to a design change
being implemented into production?
(4.4.9.1)
4.20 For proprietary designs, does the
supplier evaluate with the customer the
impact of the design change on form, fit,
function, performance and/or durability?
(4.4.9.1)
4.21 * Does the supplier consider the impact of
design changes on the system in which
the product is used? (4.4.9.2)
4.4.10 Customer Prototype Support
4.22 ** When required by the customer, does the
supplier have a comprehensive prototype
program ? (4.4.10)
4.23 Is there evidence of performance testing
including, as appropriate, reliability,
maintainability, durability and product
life cycle? (4.4.10)
4.24 Are accelerated life cycle testing records
available on crucial components,
machinery or equipment? (4.4.10)
4.4.11 Confidentiality
4.25 Does the supplier ensure confidentiality
of customer contracted product under
development and related product
information? (4.4.11)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
25
ELEMENT 4.5 - DOCUMENT AND DATA CONTROL
ELEMENT ASSESSOR NOTES RESULTS
26
ELEMENT 4.5 - DOCUMENT AND DATA CONTROL (CONTINUED)
Question Assessor Notes - Implementation evidence
5.11 Do the designated functions or
organizations have access to pertinent
background information upon which to
base the review and approval? (4.5.3)
5.12 Are all changes in documents identified
either in the document or in
attachments? (4.5.3)
5.13 Are all referenced documents available
on-site? (4.5.3)
5.14 Where documents or data are retained
on software, are appropriate controls
maintained for changes? (4.5.3)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
27
ELEMENT 4.6 - PURCHASING
ELEMENT ASSESSOR NOTES RESULTS
4.6 - Purchasing
28
ELEMENT 4.6 - PURCHASING (CONTINUED)
Question Assessor Notes - Implementation evidence
6.11 Is there evidence of supplier review
and approval of purchasing documents
for adequacy to the specif ied
requirements prior to release? (4.6.3)
4.6.4 Verification of Purchased Product
6.12 When applicable, do purchasing
documents specify verif ication
arrangements and method of product
release for purchased product at the
subcontractor’s premises? (4.6.4.1)
6.13 Where specified in the contract (4.3), is
the customer (or their designated
representative) afforded the right to
verify product conformance to the
requirements at the supplier’s/
subcontractor’s premises? (4.6.4.2)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
29
ELEMENT 4.7 - CONTROL OF CUSTOMER SUPPLIED PRODUCT
ELEMENT ASSESSOR NOTES RESULTS
30
ELEMENT 4.8 - PRODUCT IDENTIFICATION AND TRACEABILITY
ELEMENT ASSESSOR NOTES RESULTS
31
ELEMENT 4.9 - PROCESS CONTROL
ELEMENT ASSESSOR NOTES RESULTS
32
ELEMENT 4.9 - PROCESS CONTROL (CONTINUED)
Question Assessor Notes - Implementation evidence
9.7 Do controlled conditions include
compliance with reference standards/
codes, quality plans and/or documented
procedures? (4.9.c)
9.8 * Do controlled conditions include the
monitoring and control of suitable
process parameters and product
characteristics, including designation
and documentation of Special
Characteristics? (4.9.d; 4.9.d.1)
9.9 Do controlled conditions include the
approval of processes and equipment, as
appropriate? (4.9.e)
9.10 Do controlled conditions include criteria
for workmanship stipulated in the
clearest practical manner? (4.9.f)
9.11 Do controlled conditions include suitable
maintenance of equipment to ensure
continuing process capability? (4.9.g)
9.12 ** Is there an effective planned preventive
maintenance system that identifies key
process equipment, provides appropriate
resources, and includes at a minimum:
- A procedure describing planned
maintenance activities?
- Scheduled maintenance activities?
- Predictive maintenance methods?
- A procedure for packaging and
preservation of equipment, tooling
and gaging?
- Availability of replacement parts for
key manufacturing equipment?
- Documenting, evaluating and
improving maintenance objectives?
(4.9.g.1)
9.13 * Are qualified operators and/or
continuous monitoring and process
control used where the results of the
processes cannot fully be verified by
subsequent inspection and testing? (4.9)
9.14 Are qualification requirements for
special process operations and
associated equipment and personnel
specified and are records maintained?
(4.9; 4.16; 4.18)
4.9.1 Process Monitoring and Operator Instructions
9.15 * Have documented process monitoring
and operator instructions been prepared
for all employees having responsibilities
for operation of processes, are they
understood and accessible at the
workstation? (4.9.4)
33
ELEMENT 4.9 - PROCESS CONTROL (CONTINUED)
Question Assessor Notes - Implementation evidence
4.9.3 Modified Process Control Requirements
9.16 Are control plans annotated accordingly
when the customer requires different
capability or performance? (4.9.3)
4.9.4 Verification of Job Setups
9.17 * Does the supplier verify job setups, using
statistical methods where applicable?
(4.9.4)
4.9.5 Process Changes
9.18 * Does the supplier maintain record(s) of
process change effective dates?
(4.9.5; 4.5.3)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
34
ELEMENT 4.10 - INSPECTION AND TESTING
ELEMENT ASSESSOR NOTES RESULTS
35
ELEMENT 4.10 - INSPECTION AND TESTING (CONTINUED)
Question Assessor Notes - Implementation evidence
10.8 Are process activities directed toward
defect prevention methods, such as
statistical process control, mistake
proofing, visual controls, rather than
defect detection? (4.10.3.c)
4.10.4 Final Inspection and Testing
10.9 ** Does the supplier carry out final
inspection and testing in accordance
with the quality plan (Control Plan) and/
or documented procedures? (4.10.4)
10.10 Does the quality plan (Control Plan)
mandate that all specified inspections
and tests, incoming, in process, and
final, must be performed and that they
meet specified requirements? (4.10.4)
10.11 ** Does the supplier assure that no product
is dispatched until all activities specified
in the documented procedures have been
satisfactorily completed and that the
associated data and documentation is
available and authorized? (4.10.4)
10.12 * Does the supplier conduct scheduled
audits of the packaged final product to
verify conformance to all specif ied
requirements? (4.10.4.2)
4.10.5 Inspection and Test Records
10.13 * Does the supplier maintain records
which provide evidence that the product
has been inspected and/or tested clearly
showing whether the product has passed
or failed inspection based on the defined
acceptance criteria, and identifying the
authority responsible for the product
release? (4.10.5; 4.16)
10.14 Is product that fails any inspection and/
or test addressed under control of
nonconforming product?
(4.10.5;4.13; 4.16)
4.10.6 Supplier Laboratory Requirements
10.15 * Does the laboratory have a scope and
document its policies, systems,
programs, procedures, instructions and
f indings to assure the quality of
calibration and tests performed?
(4.10.6.1; 4.10.6.3)
10.16 Do lab personnel have appropriate
background and experience? (4.10.6.2)
10.17 * Are items retained until final data is
complete to enable traceability to raw
data? (4.10.6.3)
36
ELEMENT 4.10 - INSPECTION AND TESTING (CONTINUED)
Question Assessor Notes - Implementation evidence
10.18 * Does the laboratory use test and/or
calibration methods that meet the needs
of the customer and are appropriate for
the intended use? (4.10.6.5)
10.19 Is test capability verif ied prior to
performing the testing work? (4.10.6.5)
4.10.7 Accredited Laboratories
10.20 ** When the supplier uses independent/
commercial laboratories are they
accredited? (4.10.7)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
37
ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT
ELEMENT ASSESSOR NOTES RESULTS
38
ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT (CONTINUED)
Question Assessor Notes - Implementation evidence
11.9 Is the calibration of inspection,
measuring or test equipment performed
by a qualified laboratory (see QS-9000,
4.11.2.b.1) or customer recognized
government agency? (4.11.2.b.1)
11.10 ** Does the process for calibration of
inspection, measuring and test
equipment include the following:
- Type of equipment?
- Unique identification?
- Location?
- Frequency of checks?
- Check method?
- Acceptance criteria?
- Corrective actions? (4.11.2.c)
11.11 Has the supplier identified inspection,
measuring and test equipment with a
suitable indicator or approved
identification record to show the
calibration status? (4.11.2.d)
11.12 Does the supplier maintain calibration
records for inspection, measuring and
test equipment? (4.11.2.e; 4.16)
11.13 Does the supplier assess and document
the validity of previous inspection and
test results when inspection, measuring
and test equipment is found out of
calibration? (4.11.2.f)
11.14 Has the supplier ensured that the
environmental conditions are controlled,
recorded and suitable for inspections,
measurements and tests being carried
out? (4.10.6.4; 4.11.2.g; 4.16)
11.15 ** Has the supplier ensured that the
handling, preservation and storage of
inspection, measuring and test
equipment is such that the accuracy for
fitness for use is maintained? (4.11.2.h)
11.16 * Has the supplier safeguarded the
inspection, measuring and test facilities,
including both hardware and test
software, from adjustments which would
invalidate the calibration setting?
(4.11.2.i)
39
ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT (CONTINUED)
Question Assessor Notes - Implementation evidence
4.11.3 Inspection, Measuring and Test Equipment Records
11.17 * Do records of the calibration/verification
activity for all gages, measuring, and test
equipment, including employee-owned
gages, include:
- Revisions following engineering
changes (if appropriate)?
- Any out of specification readings as
received for calibration?
- Statements of conformance to
specification after calibration?
- Notification to customer if suspect
material or product may have been
shipped?
(4.11.3)
4.11.4 Measuring System Analysis
11.18 ** For measurement systems referenced in
the Control Plan, is there evidence that
appropriate statistical studies (e.g., bias,
linearity, stability, repeatability and
reproducibility) have been conducted to
analyze the variation present in the
results of each type of measuring and test
equipment system? (4.11.4)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
40
ELEMENT 4.12 - INSPECTION AND TEST STATUS
ELEMENT ASSESSOR NOTES RESULTS
41
ELEMENT 4.13 - CONTROL OF NONCONFORMING PRODUCT
ELEMENT ASSESSOR NOTES RESULTS
4.13 - Control of
Nonconforming Product
42
ELEMENT 4.13 - CONTROL OF NONCONFORMING PRODUCT (CONTINUED)
Question Assessor Notes - Implementation evidence
13.8 * Does the supplier quantify and analyze
nonconforming product, establish a
prioritized reduction plan and track
progress? (4.13.2.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
43
ELEMENT 4.14 - CORRECTIVE AND PREVENTIVE ACTION
ELEMENT ASSESSOR NOTES RESULTS
44
ELEMENT 4.14 - CORRECTIVE AND PREVENTIVE ACTION (CONTINUED)
Question Assessor Notes - Implementation evidence
14.12 * Where applicable, does the supplier
consider the impact of corrective actions
on other products? (4.14.2.2)
4.14.3 Preventive Action
14.13 * Do procedures for preventive action
include the use of appropriate sources of
information, e.g., product quality,
deviation, audit result, quality records,
etc., to develop preventive actions?
(4.14.3.a)
14.14 Do procedures for preventive action
include the determination of steps
needed to deal with problems requiring
preventive action? (4.14.3.b)
14.15 Do procedures for preventive action
include initiation of preventive action
and application of controls to ensure that
it is effective? (4.14.3.c)
14.16 ** Do procedures for preventive action
include provisions that the relevant
information on actions taken is
submitted for management review?
(4.14.3.d; 4.1.3)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
45
ELEMENT 4.15 - HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY
ELEMENT ASSESSOR NOTES RESULTS
46
ELEMENT 4.15 - HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY (CONTINUED)
Question Assessor Notes - Implementation evidence
15.11 ** Has the supplier established a system to
support 100% on-time shipments to meet
customer requirements? (4.15.6.1)
15.12 Are management planning and control
timing plans used to adjust for changes
as required?
(4.15.6.1)
15.13 Is critical path scheduling used for
complex manufacturing systems?
(4.15.6.1)
15.14 ** Has the supplier established a scheduling
process to accurately control start and
end timing for component/assembly
manufacturing, equipment test, runoff,
installation and tryout? (4.15.6.1)
15.15 ** Does the scheduling process include
subcontractors and material procurement
timing and capacity resource planning?
(4.15.6.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
47
ELEMENT 4.16 - CONTROL OF QUALITY RECORDS
ELEMENT ASSESSOR NOTES RESULTS
48
ELEMENT 4.17 - INTERNAL QUALITY AUDITS
ELEMENT ASSESSOR NOTES RESULTS
49
ELEMENT 4.18 - TRAINING
ELEMENT ASSESSOR NOTES RESULTS
4.18 - Training
50
ELEMENT 4.19 - SERVICING
ELEMENT ASSESSOR NOTES RESULTS
4.19 - Servicing
51
ELEMENT 4.20 - STATISTICAL TECHNIQUES
ELEMENT ASSESSOR NOTES RESULTS
52
CHRYSLER SPECIFIC
ELEMENT ASSESSOR NOTES RESULTS
Chrysler Specific
53
FORD SPECIFIC
ELEMENT ASSESSOR NOTES RESULTS
Ford Specific
54
GENERAL MOTORS SPECIFIC
ELEMENT ASSESSOR NOTES RESULTS
55
Notes