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Quality System

Assessment
Tooling & Equipment
(QSA-TE)

Second Edition, Issued June, 1998


First Edition, Issued July, 1996
Copyright © 1998
Chrysler Corporation, Ford Motor Company, General Motors Corporation
FOREWORD TO THE SECOND EDITION
The QSA-TE Second Edition is based upon the content of the QS-9000 Third Edition and the
Tooling and Equipment Supplement (TE Supplement) Second Edition.

The QSA-TE Second Edition incorporates several key changes as follows:

- 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.

- The inclusion of company specific questions.

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

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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.

Application The QSA-TE may be used in several different ways


according to the needs of the customer and supplier:

- first party - supplier self-assessment of its


quality system, this document must be used in
its entirety.
- second party - customer assessment of
supplier quality system (includes first tier
supplier assessment of subcontractors), all
questions or a subset. Certain customers will,
as a minimum, use the questions marked with
a double asterisk (**) for this purpose.
- third party - by a quality systems certification
body/registrar as input to an audit checklist, at
a minimum the (*) and (**).

Assessment Process The QSA-TE process is defined in Appendix A of


the TE Supplement and QS-9000. The order of the
questions in the QSA-TE does not imply the audit
sequence.

Assessment Method The assessment method is composed of three major


phases:

Phase I - Quality System Documentation Review


This review determines if the quality manual (and
supporting documentation as required) meets all
requirements of the TE Supplement. Use Question
0.1, Document Review of the QSA-TE.

Phase II - On-site Audit


This phase determines the degree and effectiveness of
the implementation of the quality system at the
supplier’s site and remote locations.
1
Phase III - Analysis and Report A review of the
findings of the first two phases is used to determine
supplier conformance to the TE Supplement.

Audit Summary The auditor/customer will determine which of two


alternatives will be used to summarize audit findings:
Alternatives
- Recommended/not recommended
- Variable score

Each of the elements may be classified in one of two


ways, depending on the customer’s requirements:

- As a “conforms or minor/major non-


conformance” status for that element.
- As a 0 to 10 point rating for the element, see
Evaluation Process for Using a Variables Score
Method.

Definitions A MAJOR NONCONFORMITY is either:

- The absence or total breakdown of a system to


meet a TE Supplement requirement. A
number of minor nonconformities against one
requirement which when combined can
represent a total breakdown of the system and
thus be considered a major nonconformity.

- Any noncompliance that would result in the


probable shipment of a nonconforming
product. A condition that may result in the
failure or materially reduce the usability of the
products or services for their intended purpose

- A noncompliance that judgment and


experience indicate is likely either to result in
the failure of the quality system or to
materially reduce its ability to assure
controlled processes and products.

A MINOR NONCONFORMITY is a TE
Supplement noncompliance that judgment and
experience indicate is not likely to :

- result in the failure of the quality system, or


- reduce its ability to assure controlled
processes, or
- result in the probable shipment of
nonconforming product.

2
It may be either:

- a failure in some part of the supplier’s


documented quality system relative to TE
Supplement, or
- one or more observed lapse(s) in following a
requirement of the company’s quality system.

OPPORTUNITY FOR IMPROVEMENT - an


observed situation which is NOT a major or minor
nonconformity, but where results achieved, based
upon the auditor’s judgment and experience in that
commodity, are not optimal. These opportunities
shall be recorded in the final audit report for the
benefit of the customer.

CONFORMS - no major or minor nonconformities


were noted in the audit.

ADEQUACY - as used in this document means that


the specif ic supplier documentation meets TE
Supplement intent given the scope of the supplier’s
operations.

In support of continuous improvement, the auditor


should identify quality system strengths, weaknesses
and shall record opportunities for improvement.

An overall evaluation of “recommended” will be


Evaluation Process for given when the audit does not identify any
Using Recommended/Not nonconformities.

Recommended Method: An “open” status exists under the following


conditions:

- a major nonconformity is noted in the audit, or


- one or more minor nonconformity(ies) are
noted in the audit

This can be converted to a “recommended” within


ninety days, or otherwise agreed to time frame, with
acceptance of satisfactory evidence of conformity.
On-site verif ication is at the discretion of the
auditor(s). An overall evaluation of “not
recommended” will be given if the audit process
identifies more than one major nonconformity. Lack
of nonconformity resolution within the specified time
frame will also result in a “not recommended”
evaluation.

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.

Supplier is familiar with the requirements of the element but there is no


evidence of source documentation, planning or implementation. 1
Supplier is familiar with requirements of the element and has preliminary
source documentation with incomplete plans for implementation. 2
Source documentation is available. Implementation (with assigned
responsibilities) has just started, (0 - 30% complete). 3
Source documentation is available and implementation is in progress (30 - 60
% complete). Deficiencies have been identified but improvements are not 4
quantifiable.

Implementation has progressed (60 - 80% complete) and there is preliminary


evidence of relevant results. 5

Implementation is nearly complete (80 - 95%) and documented evidence of


implementation effectiveness exists. 6
Full implementation of source documentation for the requirement and
complete confirmed evidence of implementation effectiveness. The supplier 7
has met minimum requirements.

Analysis of results and on-going continuous improvement can be


demonstrated in key areas linked to customer satisfaction. 8
Supplier has reached world class performance and is able to show growth beyond the
TE Supplement requirements and continuous improvement in all areas. 9
Supplier is best-in-class and is able to demonstrate significant innovation in
new ways to show relevant results beyond the customer requirements. The 10
supplier sets the industry benchmark.

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.

Reporting of Audit Where conformance to the TE Supplement is


demonstrated but def inite opportunities for
Findings continuous improvement exist, these should be
identified.

For first or second party audits only, the auditor


should identify quality system strengths and
weaknesses.

Use of Scores in Sourcing Regardless of the scoring method each customer’s


purchasing activity will establish their own policy for
Decisions using assessment results in sourcing decisions..1

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.

2. Documentation Review. The customer reviews the materials provided by the


supplier for adequacy in meeting the TE Supplement
per Question 0.1 of the QSA-TE. If requirements
are identified that go beyond TE Supplement, they
should be noted for inclusion in the audit checklist.
Any inadequacies found should be clearly defined
and communicated to the supplier.

3. Documentation OK? The customer advises the supplier of any revisions


required in the quality system documentation to meet
the TE Supplement. Normally, the on-site audit will
be delayed pending satisfactory resolution of the
inadequacies.

4. Supplier makes necessary The supplier revises the quality system


documentation as necessary.
revisions.

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).

If there are multiple operations (e.g., machining,


assembly) within a plant that are essentially identical,
the customer may audit these on a sampling basis.
Significant observations should be communicated
immediately to the supplier. Some customers may
conduct an audit using the questions marked with a
double asterisk (**) as a minimum to evaluate
potential suppliers.

7. Customer identifies any All nonconformities found must be included in the


summary report. Some customers will also provide
nonconformities. the detailed checklist.

8. Supplier corrects nonconformities If the supplier can correct minor nonconformities


during the course of the audit, such corrections will
(and advises customer). be noted in the report. For other nonconformities, the
supplier will determine a date by which the corrective
action will be complete. The supplier will advise the
customer when the corrective action(s) are
completed.

9. Customer verification. Based on the nature of the nonconformities, the


customer will verify the effectiveness of the
corrective actions on-site and/or via documentation
review.

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:

Supplier Code: Audit Date:

Scope of Audit:

Products/Lines Audited:

Reason For Audit:

Audit Type: Initial Surveillance Follow-up Other

Audit Results: Recommended Open Not Recommended

Score, If Applicable

Follow-up Required: Yes No Date:

Comments:

Auditor Name Phone

9
QUALITY SYSTEM ASSESSMENT
TOOLING & EQUIPMENT
RECORD OF FINDINGS

Nonconformities Point Score


Element Conforms
Minor Major (if applicable)

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:

Target date for correction of all nonconformities: _________________________


Point Score Calculation (if applicable)
Final score is obtained by adding the point score column and dividing by the number of scored elements.

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

Question Assessor Notes - Implementation evidence


4.1.1 Quality Policy
1.1 Has the supplier’s management with
executive responsibility defined and
documented its quality policy, objectives
for quality, reliability, maintainability,
and durability and its commitment to
these objectives? (4.1.1)
1.2 Is the quality policy relevant to
organizational goals and the
expectations and needs of the customer?
(4.1.1)
1.3 * Is the quality policy implemented,
understood and maintained throughout
the organization? (4.1.1)
4.1.2 Organization
1.4 ** Has the responsibility, authority,
interrelationship of personnel who
manage, perform, and verify work
affecting quality been defined and
documented? (4.1.2.1)
1.5 Is authority delegated to personnel who
have the organizational freedom to:
- Prevent nonconformity occurrence?
- Identify & record quality problems?
- Initiate, implement & verify
corrective action?
- Control further processing?
- Represent the needs of the customer
in internal functions? (4.1.2.1)
1.6 Has the supplier identified the resource
requirements, and provided adequate
resources including the assignment of
trained personnel for management,
performance of work and verification
activities, including internal audits?
(4.1.2.2)
1.7 * Is there a clearly identified management
representative with authority and
responsibility to ensure TE Supplement
compliance, and to report on the
performance of the quality system?
(4.1.2.3)
1.8 Does the supplier have a system in place
to ensure management of appropriate
activities during concept development,
prototype, production and installation?
(4.1.2.4)

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

4.2 - Quality System

Question Assessor Notes - Implementation evidence


4.2.2 Quality System Procedures
2.1 ** Are there adequate supporting
procedures (Level 2) for each element of
the quality manual? (4.2.2)
4.2.3 Quality Planning
2.2 ** Is the quality planning process consistent
with all other requirements of the quality
system, documented in a suitable format,
and does it consider as appropriate the
elements of the quality system that
address:
- Identification and acquisition of all
inspection & production/service
resources?
- Conducting design and process
feasibility studies?
- Updating and maintenance of all
quality control and inspection
methodology?
- Identification of suitable verification
at appropriate stages?
- Production, installation and servicing
processes which directly affect quality
- Preparation of control plans and
FMEAs?
- Review of standards and
specifications? (4.2.3)
2.3 * Is there evidence of an implemented
advanced product quality planning
process? (4.2.3.1; 4.2.3.2)
2.4 Does the supplier convene multi-
disciplinary teams for the production of
new or changed products that use
appropriate techniques incorporating
reliability and maintainability into a
plan? (4.2.3.1)
2.5 When required by the customer, are the
process steps that affect Special
Characteristics in process control
guidelines and similar documents
marked with the customer’s special
characteristic symbol? (4.2.3.2)
2.6 ** Is manufacturing feasibility investigated,
conf irmed, and documented, (Team
Feasibility Commitment form) prior to
contracting proposed products? (4.2.3.3)

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

4.3 - Contract Review

Question Assessor Notes - Implementation evidence


4.3.2 Review
3.1 * Does the supplier review a tender,
contract or order to ensure that the
requirements are understood and can be
met, and if any misunderstanding arises
that the differences are resolved prior to
contract or order acceptance? (4.3.2)
3.2 * Are customer specif ic contract
requirements, including those in TE
Supplement, Section II deployed to the
functions concerned and fully met?
(4.3.2; 4.12.1)
4.3.3 Amendment to Contract
3.3 * Are there provisions to document and
deploy contract amendments to the
functions concerned? (4.3.3)
4.3.4 Records
3.4 ** Are records of contract reviews
maintained? (4.3.4; 4.16)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

22
ELEMENT 4.4 - DESIGN CONTROL
ELEMENT ASSESSOR NOTES RESULTS

4.4 - Design Control

Question Assessor Notes - Implementation evidence


4.4.1 General
4.1 Is there a process to deploy information
gained from previous design projects to
current and future ones of similar
nature? (4.4.1.1)
4.4.2 Design and Development Planning
4.2 * Have design plans for each project been
established and responsibility assigned?
(4.4.2)
4.3 Are plans updated as the design evolves?
(4.4.2)
4.4 * Are responsible personnel qualified in
the “Required Skills” and equipped with
adequate resources as appropriate?
(4.4.2.1; 4.18)
4.4.3 Organizational and Technical Interfaces
4.5 Are the organizational interfaces
between groups defined and is there
evidence of the necessary information
being documented, transmitted and
regularly reviewed? (4.4.3)
4.4.4 Design Input
4.6 * Are design input requirements including
the applicable statutory and regulatory
requirements identified, documented and
reviewed? (4.4.4;. 4.3)
4.7 Are incomplete, ambiguous or
conflicting requirements resolved?
(4.4.4; 4.3)
4.8 ** Do the following exist, if not waived by
the customer:
- Appropriate resources and facilities
available to use computer-aided
design, engineering and analysis?
- If CAD/CAE is sub-contracted, has
the supplier provided technical
leadership?
- Are CAD/CAE systems capable of
two way interface with customer
systems? (4.4.4.1)

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

4.5 - Document and Data


Control

Question Assessor Notes - Implementation evidence


4.5.1 General
5.1 Are documents of external origin under
document control? (4.5.1)
4.5.2 Document and Data Approval and Issue
5.2 ** Are documents and data reviewed and
approved by authorized personnel prior
to issue? (4.5.2)
5.3 ** Is there a master list (or equivalent)
identifying document revision status
readily available? (4.5.2)
5.4 * Has the supplier established a process to
ensure that pertinent issues of
appropriate documents are available at
all locations where operations essential
to the effective functioning of the quality
system are performed? (4.5.2.a)
5.5 Has the supplier established a process to
ensure that invalid and/or obsolete
documents are promptly removed from
all points of use, or otherwise assured
against unintended use? (4.5.2.b)
5.6 Are obsolete documents retained for
legal and/or knowledge base purposes
suitably identified? (4.5.2.c)
5.7 * Is there timely review, distribution and
implementation of customer engineering
standards/specifications and changes?
(4.5.2.1)
5.8 * Does the supplier maintain a record of
the date on which engineering changes
are implemented in production?
(4.5.2.1; 4.16)
5.9 Does implementation of changes include
updates to all appropriate documents?
(4.5.2.1)
4.5.3 Document and Data Changes
5.10 Are changes in documents and data
reviewed and approved by the same
functions/organizations that originally
performed the review and approval,
(unless specifically designated
otherwise)? (4.5.3)

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

Question Assessor Notes - Implementation evidence


4.6.1 General
6.1 Where there is a customer-approved
subcontractor list, is it used by the
supplier as required? (4.6.1.1)
6.2 Do all purchased materials used in part
manufacture conform to all applicable
governmental, safety and environmental
regulations as they apply to the country
of manufacture and sale? (4.6.1.2)
4.6.2 Evaluation of Subcontractors
6.3 ** Are subcontractors evaluated and
selected based on their ability to meet
quality system and quality assurance
requirements? (4.6.2.a)
6.4 ** Does the supplier define the appropriate
type and extent of control over
subcontractors? (4.6.2.b)
6.5 ** Are quality records (4.16) of acceptable
subcontractors established and
maintained? (4.6.2.c)
6.6 * Is subcontractor quality system
development being conducted using the
TE Supplement, Section I as the
fundamental quality system
requirement with the goal of
subcontractor compliance to TE
Supplement? (4.6.2.1)
6.7 ** Is 100% on time delivery a requirement
of the subcontractors? (4.6.2.2)
6.8 * Is there appropriate planning information
and purchasing commitments, provided
by the supplier, to enable the
subcontractors to meet the required
100% on-time delivery? (4.6.2.2)
6.9 * Is there evidence of a system to monitor
the delivery performance of
subcontractors, including all premium
freight and evidence of appropriate
corrective action? (4.6.2.2)
4.6.3 Purchasing Data
6.10 * Do the purchasing documents contain
data clearly describing the product or
service being ordered? (4.6.3)

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

4.7 - Control of Customer


Supplied Product

Question Assessor Notes - Implementation evidence


7.1 Is there evidence that product that is lost,
damaged or otherwise unsuitable for use
is recorded and reported to the
customer? (4.7; 4.16)
4.7.1 Customer Owned Tooling
7.2 * Are customer-owned tools and
equipment permanently marked so that
ownership of each item is visually
apparent? (4.7.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

30
ELEMENT 4.8 - PRODUCT IDENTIFICATION AND TRACEABILITY
ELEMENT ASSESSOR NOTES RESULTS

4.8 - Product Identification


and Traceability

Question Assessor Notes - Implementation evidence


8.1 * Is there a tracking system in place to
track:
- Components and sub-assemblies to
their next operation by job number?
- Cross-referenced to engineering
drawings?
- Bill of material or equivalent?
(4.8)
8.2 ** Are resources available for tool and gage
design, fabrication, and complete
dimensional inspection?
If any of the functions in question 8.1 are
subcontracted, the respective question
becomes: is an effective tracking and
follow-up system available for the
subcontracted function? (4.8; 4.16)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

31
ELEMENT 4.9 - PROCESS CONTROL
ELEMENT ASSESSOR NOTES RESULTS

4.9 - Process Control

Question Assessor Notes - Implementation evidence


9.1 * Have documented job instructions/
procedures been developed that:
- Are accessible at the work station?
- Communicate requirements to all
employees involved in this process?
- Specify monitoring of special
characteristics?
- List requirements for inspection,
testing, gauging and recording
results?
- Establish approval and rejection
criteria?
- List required tools and gages (with
mastering at required frequency)?
(4.9.a)
9.2 * Do employees perform operations/
inspections according to documented
instructions? (4.9.a)
9.3 * Are process control requirements being
met (where applicable):
- Have the customer’s Initial Process
Studies requirements been met?
- Have the customer’s ongoing process
performance requirements been met?
- Are special causes of variation
investigated and appropriate actions
taken?
- Are control charts annotated with
significant process events?
- Are control charts maintained and
reviewed with highest priority given
to special characteristics? (4.9.a)
9.4 * Do controlled conditions include
documented procedures defining the
manner of production, installation and
servicing, where their absence could
adversely affect quality? (4.9.a)
9.5 ** Do controlled conditions include use of
suitable production, installation and
servicing equipment, and suitable
working environment including but not
limited to maintaining premises in a
state of order, cleanliness and repair?
(4.9.b; 4.9.b.1; 4.10.6.4)
9.6 * Does the supplier have contingency
plans to reasonably protect the
customer’s supply of product in the event
of emergency? (4.9.b.2)

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

4.10 - Inspection and Testing

Question Assessor Notes - Implementation evidence


4.10.1 General
10.1 * For attribute data with acceptance
criteria other than zero defects, does the
supplier document acceptance criteria
and have customer approval? (4.10.1.1)
4.10.2 Receiving Inspection and Testing
10.2 ** Does the supplier ensure that incoming
product is not used or processed (except
for urgent production purposes), until it
has been inspected or otherwise verified
as conforming to specified requirements
in accordance with the quality plan
and/or documented procedures?
(4.10.2.1)
10.3 Is the amount and nature of receiving
inspection based on the control exercised
at the subcontractor’s premises and
records of conformance? (4.10.2.2)
10.4 ** Is positive identification provided and
recorded for material used in production
but not verified? (4.10.2.3; 4.16)
10.5 * Does the supplier incoming quality
system use one or more of the following
methods:
- Receipt and evaluation of statistical
data by supplier?
- Receiving inspection and/or testing?
- Second or third party assessments or
audits of subcontractor sites when
coupled with records of acceptable
performance?
- Evaluations by accredited
laboratories? (4.10.2.4)
4.10.3 In-process Inspection and Testing
10.6 ** Does the Supplier inspect and test
product as required by the quality plan
(Control Plan) and/or the documented
procedures? (4.10.3.a)
10.7 ** Does the supplier hold product until the
required inspections and tests have been
completed or necessary reports have
been received and verified, except for
release under positive recall (see
4.10.2.3)? (4.10.3.b)

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

4.11 - Inspection, Measuring


and Test Equipment

Question Assessor Notes - Implementation evidence


4.11.1 General
11.1 Is inspection, measuring, and test
equipment used in a manner which
insures that the measurement uncertainty
is known and is consistent with the
required measurement capability?
(4.11.1)
11.2 Where test software or comparative
references such as test hardware are
used as suitable forms of inspection, are
they checked to prove that they are
capable of verifying the acceptability of
the product prior to release for use
during production, installation, or
servicing? (4.11.1)
11.3 * Does the supplier establish the extent
and frequency of such checks, and
maintain records as evidence of control?
(4.11.1; 4.16)
11.4 Is technical data pertaining to the
inspection, measuring and test
equipment available for review by the
customer, if they so require, for
verification that the inspection,
measuring, and test equipment is
functionally adequate? (4.11.1)
4.11.2 Control Procedure
11.5 Has the supplier determined the
measurements to be made and the
accuracy required? (4.11.2.a)
11.6 * Has inspection, measuring, and test
equipment been provided that is capable
of the required accuracy and precision?
(4.11.2.a)
11.7 * Has the supplier identif ied all
inspection, measuring and test
equipment that can affect product
quality? (4.11.2.b)
11.8 ** Is each piece of equipment calibrated at
prescribed intervals, against certified
equipment having a known valid
relationship to internationally or
nationally recognized standards, and in
the correct environment?
(4.11.2.b; 4.10.6.5)

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

4.12 - Inspection and


Test Status

Question Assessor Notes - Implementation evidence


12.1 * Is the inspection and test status of
product identified by suitable means, so
that the conformance status of the
product with regard to inspection and
tests performed is recognizable and
understood? (4.12)
12.2 Is identification of inspection and test
status maintained as defined in the
quality plan (Control plan) and/or
documented procedures throughout
production, installation and servicing of
product? (4.12)
4.12.1 Supplemental Verification
12.3 When required by the customer, are
additional verif ication/identif ication
requirements met? (4.12.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

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ELEMENT 4.13 - CONTROL OF NONCONFORMING PRODUCT
ELEMENT ASSESSOR NOTES RESULTS

4.13 - Control of
Nonconforming Product

Question Assessor Notes - Implementation evidence


4.13.1 General
13.1 ** Does the control of nonconforming
product and suspect material or product
provide for identification,
documentation, evaluation, segregation
(when practical), disposition, and for
notification of all appropriate functions?
(4.13.1; 4.13.1.1)
13.2 * Does the supplier provide for visual
identif ication of nonconforming or
suspect product, and for quarantine
areas? (4.13.1.2)
4.13.2 Review and Disposition of Nonconforming Product
13.3 * Is the responsibility for review and
authority for the disposition of
nonconforming product defined? (4.13.2)
13.4 * Are nonconforming and suspect products
reviewed in accordance with documented
procedures, and:
- Reworked to meet the specified
requirements,
- Accepted with or without repair by
concession,
- Regraded for alternative
applications, or
- Rejected or scrapped? (4.13.2)
13.5 When required, is the proposed use or
repair of product which does not
conform to specified requirements
reported for concession to the customer?
(4.13.2)
13.6 Is the description of nonconformity that
has been accepted, and of repairs,
recorded to denote the actual condition?
(4.13.2; 4.16)
13.7 ** Are repaired and/or reworked products
reinspected and/or tested according to
the quality plan (Control plan) and/or
documented procedures? (4.13.2)

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

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ELEMENT 4.14 - CORRECTIVE AND PREVENTIVE ACTION
ELEMENT ASSESSOR NOTES RESULTS

4.14 - Corrective and


Preventive Action

Question Assessor Notes - Implementation evidence


4.14.1 General
14.1 ** Are the appropriate corrective or
preventive actions developed to eliminate
the causes of actual or potential
nonconformances? (4.14.1)
14.2 Are changes to the documented
procedures resulting from corrective or
preventive action implemented and
recorded? (4.14.1)
14.3 ** Does the supplier use a disciplined
problem solving method to address
internal or external nonconformances?
(4.14.1.1)
14.4 Does the supplier respond to external
nonconformances in the customer
prescribed manner? (4.14.1.1)
14.5 Does the supplier use mistake proofing
methodology, as appropriate, in their
corrective and preventive action process?
(4.14.1.2)
4.14.2 Corrective Action
14.6 ** Do procedures for corrective action
include effective handling of customer
complaints and reports of
nonconformances? (4.14.2.a)
14.7 Do procedures for corrective action
include investigation of the causes of
nonconformances relating to product,
process and quality system, and
recording of the results? (4.14.2.b; 4.16)
14.8 * Do procedures for corrective action
include determination of the corrective
action needed to eliminate the cause of
nonconformance? (4.14.2.c)
14.9 ** Do procedures for corrective action
include application of controls to ensure
that corrective action is taken and that it
is effective? (4.14.2.d)
14.10 * Are returned parts from customer
manufacturing plants analyzed, and are
records of this analysis kept and made
available upon request? (4.14.2.1)
14.11 Where appropriate, does the supplier
initiate corrective action and process
changes to prevent recurrence? (4.14.2.1)

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

4.15 - Handling, Storage,


Packaging, Preservation
and Delivery

Question Assessor Notes - Implementation evidence


4.15.2 Handling
15.1 ** Have methods for the handling of
product to prevent damage or
deterioration been provided? (4.15.2)
4.15.3 Storage
15.2 Are designated storage areas or stock
rooms used to prevent damage or
deterioration of the product pending use
or delivery? (4.15.3)
15.3 Have appropriate methods for
authorizing receipt to and dispatch from
designated storage areas or stock rooms
been stipulated? (4.15.3)
15.4 * Is the condition of product in stock
assessed at appropriate intervals to
detect deterioration? (4.15.3)
15.5 ** Does the supplier use an inventory
management system to optimize
inventory turns, assure stock rotation and
minimize inventory levels? (4.15.3.1)
4.15.4 Packaging
15.6 Does the supplier control the packing,
packaging and marking processes so as
to ensure product conformance to
specifications? (4.15.4)
15.7 ** Are applicable customer packaging
standards/guidelines (including service
part packaging standards) complied
with? (4.15.4.1)
15.8 ** Has a system been developed to ensure
that all materials shipped are labeled
according to customer requirements?
(4.15.4.2)
4.15.5 Preservation
15.9 * Have appropriate methods for
preservation and segregation of product
been applied when the product is under
the supplier’s control? (4.15.5)
4.15.6 Delivery
15.10 * Does the supplier arrange for the
protection of the quality of product after
final inspection and test, and when
contractually specified does it extend to
include delivery to destination? (4.15.6)

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

4.16 - Control of Quality


Records

Question Assessor Notes - Implementation evidence


16.1 * Are records maintained to demonstrate
conformance to specified requirements
and the effective operation of the quality
system? (4.16)
16.2 * Does the control of quality records
include pertinent subcontractor quality
records? (4.16)
16.3 * Are all quality records legible, readily
retrievable and stored in a suitable
environment to prevent deterioration,
damage, and loss? (4.16)
16.4 Are retention times for quality records
established and maintained? (4.16)
16.5 ** Where agreed contractually, are quality
records available to the customer for
evaluation for an agreed period? (4.16)
4.16.1 Record Retention
16.6 * Are the following retained at a minimum
for:
- Machinery qualif ication runoffs,
purchase orders and all amendments,
specif ication information,
qualification data and approval, for
the life cycle of the equipment?
- Quality performance records for one
calendar year after the year in which
they were created?
- Internal quality audits and
management review records for three
years? (4.16.1)
16.7 * Is there evidence of records disposal as
established in the record retention?
(4.16.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

48
ELEMENT 4.17 - INTERNAL QUALITY AUDITS
ELEMENT ASSESSOR NOTES RESULTS

4.17 - Internal Quality Audits

Question Assessor Notes - Implementation evidence


17.1 ** Does the supplier carry out internal
quality system audits as planned? (4.17)
17.2 ** Are the audits scheduled on the basis of
the status and importance of the activity?
(4.17, 4.17.1)
17.3 * Are personnel conducting the audit
independent of the function being
audited? (4.17)
17.4 ** Are the audit results recorded and
brought to the attention of the
responsible personnel? (4.17; 4.16)
17.5 ** Are corrective actions carried out on a
timely basis? (4.17)
17.6 ** Are there follow-up audit activities for
recording and verifying the effectiveness
of the corrective actions taken?
(4.17; 4.16)
4.17.1 Internal Audit Schedules
17.7 Does internal auditing cover all shifts?
(4.17.1)
17.8 Is the internal auditing audit schedule
updated annually? (4.17.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

49
ELEMENT 4.18 - TRAINING
ELEMENT ASSESSOR NOTES RESULTS

4.18 - Training

Question Assessor Notes - Implementation evidence


18.1 * Have the training needs for all personnel
performing activities affecting quality
been met? (4.18)
18.2 ** Are personnel qualified based upon
appropriate education, training
requirements, and/or experience as
required? (4.18; 4.10.6.2)
18.3 Are appropriate training records
maintained? (4.18; 4.16)
4.18.1 Training Effectiveness
18.4 Does the training program include
reliability and maintainability? (4.18)
18.5 * Is training periodically evaluated for
effectiveness? (4.18.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

50
ELEMENT 4.19 - SERVICING
ELEMENT ASSESSOR NOTES RESULTS

4.19 - Servicing

Question Assessor Notes - Implementation evidence


19.1 * Is there documented evidence that
servicing meets the specified
requirements? (4.19)
4.19.1 Feedback of Information from Service
19.2 * Have reporting and verification systems
been established to communicate
information on service concerns to
supplier manufacturing, engineering and
design activities? (4.19.1)
19.3 * Does the supplier have a service
communication feedback process to
include maintenance and reliability data
to appropriate activities? (4.19.1)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

51
ELEMENT 4.20 - STATISTICAL TECHNIQUES
ELEMENT ASSESSOR NOTES RESULTS

4.20 - Statistical Techniques

Question Assessor Notes - Implementation evidence


4.20.1 Identification of Need
20.1 * Has the supplier identified the need for
statistical techniques including process
controls, reliability and maintainability
analysis? (4.20.1; 4.10.6.6)
4.20.2 Procedures
20.2 * Are there documented procedures
established and maintained to implement
and control the application of statistical
techniques? (4.20.2)
4.20.3 Selection of Statistical Tools
20.3 * Are appropriate statistical tools for each
process determined during advanced
quality planning and included in the
control plan? (4.20.3)
4.20.4 Knowledge of Basic Statistical Concepts
20.4 * Are the concepts of variation, control
(stability), capability, and overadjustment
understood throughout the organization
as appropriate? (4.20.4)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

52
CHRYSLER SPECIFIC
ELEMENT ASSESSOR NOTES RESULTS

Chrysler Specific

Question Assessor Notes - Implementation evidence


C.1** Are special characteristics, if applicable,
identified with the symbols <S>, <E>
<N>, <T>, and <H> being controlled
with appropriate measurement systems?
C.2** Does the supplier demonstrate
knowledge of the following standards, if
required, for product manufactured (<S>
PF-Safety, <E> PF-Emissions, <N> PF-
Noise, <T> PF-Theft Prevention, <H>
PS-9336)?
C.3** Are internal quality audits performed at
least once per year?
C.4** Are Chrysler 7-Step reports completed
for all nonconformances?
C.5** Are there records of written notification
to designated customer functions prior to
implementation of proposed material,
process and/or manufacturing location
changes?
C.6** Does the supplier notify the designated
customer functions of sub-supplier issues
and/or potential supply or capacity
issues?
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

53
FORD SPECIFIC
ELEMENT ASSESSOR NOTES RESULTS

Ford Specific

Question Assessor Notes - Implementation evidence


F.1 ** Does the supplier effectively use the
Ford QOS methodology?
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

54
GENERAL MOTORS SPECIFIC
ELEMENT ASSESSOR NOTES RESULTS

General Motors Specific

Question Assessor Notes - Implementation evidence


G.1** Does the supplier have procedures and
processes in place to address the
appropriate General Procedures?
G.2 ** Do NAO suppliers verify annually that
they have the latest version of the
General Procedures and manuals?
G.3 ** Does the supplier have current customer
contact information?
G.4 ** Does the supplier have a timed action
plan to address Year 2000 (Y2K)
readiness regarding products, business
operating systems and subcontractors
which provides for individual unit and
enterprise testing?
G.5 ** Is the supplier in compliance with GM
NAO requirements for electronic
communications and ASNs, if
applicable? (4.15.6.3; 4.15.6.4)
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

55
Notes

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