QSA

Req No. No. Question Result Improvment plan Target Responsible

Management Responsibility Element 4.1
I 4.1.1 1 Is the quality policy communicated, understood and
maintained throughout the organization?
I 4.1.2 2 Are there clearly defined and documented
responsibilities and authorities for all personnel affecting
quality?
I 4.1.2 3 Is authority delegated to personnel to:

- Prevent nonconformity reoccurrence?

- Identify & record quality problems?

- Initiate & verify corrective action?

- Control further processing?

I 4.1.2 4 Is a multi-disciplinary approach used in the design
process with direct input in decision making?
I 4.1.3 5
Is there a periodic top management review of quality
system effectiveness supported by appropriate records?
I 4.1.2.2 6 Are qualified technical personnel available for design,
process, product and service support?
I 4.1.2.3 7 Is there a clearly identified management representative
with authority and responsibility to ensure QS-9000
compliance?
I.4.1.4 8 Is there a documented business plan(s) that considers
the QS-9000 requirements including, as applicable:

- competitive product analysis,

- benchmarking,

- R & D plans

- Internal quality and operational performance measures

I 4.1.5 9 Is company level data focusing on competitors and/or
appropriate benchmarks used for improving quality,
productivity, and operation efficiency?
I 4.1.6 10 Is there a documented and objective process to measure
customer ?
E.G.: a plan with short and long term actions addressing
customer dissatisfaction factors?
I 4.2.3 11 Are cross-functional teams used for the quality planning
process?

Pagina 1
 QSA
Req No. No. Question Result Improvment plan Target Responsible
Quality System Element 4.2
I 4.2.1 1 Is there a quality manual meeting QS-9000
requirements for documentation of a comprehensive
quality system, including the following elements?
(I.4.2.1)

- Management Responsibility

- Quality Policy

- Organization

- Quality Planning

- Cross Functional Teams

- Feasibility Reviews

- Control Plans

- Process FMEAs

- Contract Review (including specifications)

- Design Control (as applicable)

- Design Review

- Design Verification

- Design Validation

- Design Changes (all suppliers)

- 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 Set-ups

- Process Changes

- Planned Preventive Maintenance

Pagina 2
 - Inspection and Testing

- Appearance Item Inspection (if applicable)

- Lab Accreditation

- Inspection, Measuring & Test Equipment

- Measurement System Analysis

- Inspection and Test Status

- Control of Nonconforming Product

- Control of Reworked Product

- Engineering Approved Product Authorization

- Corrective and Preventive Actions

- Handling, Storage, Packaging & Delivery

- Control of Quality Records

- Internal Quality Audits

- Training

- Servicing

- Statistical Techniques

- Production Part Approval

- Continuous Improvement

- Manufacturing Capabilities

- Customer Specific Requirements (if applicable)

Adequacy of quality manual?

I 4.2.3 2 Is the quality planning process consistent with the
elements of the quality system that addresses:

- Product Program plan preparation?

- Identification and acquisition of the appropriate
resources?

- Conducting design and process compatibility studies?

- Updating and maintenance of all quality control and
inspection methodology?
- Identification of suitable verification at appropriate
stages?

- Preparation of control plans and FMEAs?

- Review of standards and specifications?

Pagina 3
I 4.2.3 3 Are feasibility reviews conducted to confirm the
compatibility of design with the manufacturing process,
including capacity planning and utilization?

Pagina 4
I 4.2.3 4 Are engineering requirements met at the required
statistical process capability ?
I 4.2.3 5 Are control plans developed to the subsystem
component and/or material level?
I 4.2.3 6 Do control plans include all special characteristics,
related process, and parameters?

Are they identified as such?

I 4.2.3 7 Are control plans revised when appropriate for product
and process changes or when processes are found to
be unstable or non-capable?
I 4.2.3 8 Do control plans cover three phases: prototype, pre-
launch, and production unless exempted by the
customer?
I 4.2.3 9 Do process (and design) FMEAs consider all special
characteristics?
I 4.2.2 10 Are there adequate supporting procedures for each
element of the quality manual?
I 4.2.3.a 11 Have special characteristics been identified and
included in the Control Plan(s)?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Contract Review Element 4.3
I 4.3.2 1 Are the contract review activities adequately
documented and maintained to ensure that order
requirements are understood and are within the
supplier's capability prior to order acceptance?
I 4.3.2 2
Is there evidence of deployment of QS-9000 and
customer contract requirements into the quality system?
I 4.3.3 3 Are there provisions to document and deploy contract
changes throughout the organization?
I 4.3.3 4 Are records of contract reviews maintained?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Design Control Element 4.4
I 4.4.2 1 Have design plans for each project been established
and responsibility assigned?
I 4.4.2 2 Are responsible personnel experienced in the “Required
Skill” or appropriate equivalents?
I 4.4.4 3 Are the applicable statutory and regulatory requirements
identified?
I 4.4.4 4 Are 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?
I 4.4.6 5 Have formal documented design reviews been
conducted per the design plan?
I 4.4.5 6 Has the design output been documented and expressed
as requirements that can be verified?

Pagina 5
I 4.4.5 7 Does the design output?

- Meet the design input requirements?

- Contain or reference acceptance criteria?

- Include a review of design output documents before
release?
8 Was the design output a result of a process that
included:
I 4.4.2 - Use of the “Design Techniques” or alternatives ?

- GDT

- Analysis of cost/performance/risk trade-offs?

- Feedback from testing, production and the field?

- Analysis of design failure mode and effects (DFMEA)?

I 4.4.7 9 Is performance testing (life, durability, reliability) tracked
for timely completion and conformance?
I 4.4.7 10 Does the supplier have a comprehensive prototype
program (unless waived by the customer or made
unnecessary by the generic nature of the product
supplied)?
I 4.4.8 11 Has the design validation (characterization and
qualification testing) been performed at the specified
frequencies, results recorded, and failures addressed?
I 4.4.9 12 Are design changes documented and approved by
authorized personnel before implementation?
I 4.4.9 13 Has written customer approval or waiver been obtained
prior to a design change being implemented into
production?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Document and Data Control Element 4.5

I 4.5.2 1 Are new and revised documents reviewed and approved

by authorized personnel prior to issue?
I 4.5.2 2 Is there a master list (or equivalent) identifying document
revision status?
I 4.5.2 3
Is there timely review, distribution and implementation of
customer engineering standards/specs. and changes?
I 4.5.1 4 Are all referenced documents available on-site?
I 4.5.1 5
Are the special characteristic symbols or notations
shown on process control plans and similar documents?
I 4.5 6 Where documents or data is retained on software, are
appropriate controls maintained for changes?
QSA
Req No. No. Question Result Improvment plan Target Responsible

Pagina 6
 Purchasing Element 4.6
I 4.6.1 1 Are subcontractors evaluated and selected based on
their ability to meet quality system and quality assurance
requirements?
I 4.6.2.b 2 Does the supplier have a procedure to define the
appropriate level of control over subcontractors?
I 4.6.2.c 3 Are quality records of subcontractors kept up to date and
used to evaluate performance?
I 4.6.2 4 Is subcontractor development being conducted using the
QS-9000 (Sections I & II) as the fundamental quality
system requirement?
I 4.6.3 5 Do the purchasing documents contain data that clearly
describe the product or service being ordered?
I 4.6.4.2 6
Where applicable, is there provision for the customer (or
representative) to verify subcontractor quality onsite?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Control of Customer Supplied Product Element 4.7

I 4.7 1 Is material examined upon receipt to check quantity,

identity and transit damage?
I 4.7 2 Is material periodically inspected to detect signs of
deterioration proper conditions & storage time
limitations?
I 4.7 3 For any such product that is lost, damaged or otherwise
unsuitable for use, are records maintained and reports
provided to the customer?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Product Identification and Tracking Element 4.8

I 4.8 1 Is product identified, where appropriate, at all production

stages?
I 4.8 2 Is traceability maintained and recorded, when so
required by the customer?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Process Control Element 4.9
I 4.9 1
Have documented job instructions been developed that:
I 4.9.1 - Are accessible at the work station?
- Communicate requirements to all employees involved
in this process?
- Provide for verification of job set-ups and tool change
intervals?

- Specify monitoring of special characteristics?

- List requirements for inspection, testing, gaging and
recording results?

Pagina 7
 - Provide SAMPLE size and frequency?

- Establish approval and rejection criteria?

- List required tools and gages (with mastering at the
required frequency)?
- Document the identification and handling of non-
conforming material?

- Specify appropriate notifications and corrective actions

(including plans for unstable/non-capable processes)?
- Specify application of statistical methods required by
control plans?
- Identify relevant engineering and manufacturing
standards and the latest engineering change affecting
the instruction?

- Appropriate approvals and date?

- Operation name and number?

- Keyed to process control plan?

- Part name and number?

- Revision date for instructions?

- Visual controls?
I 4.9.c 2 Do employees perform operations/inspections according
to documented instructions?
3 Are process control requirements being met?
I 4.9.2 - Have the customer's preliminary process capability
been met ?
I 4.9.3 - Have the customer's ongoing process capability
requirements been met?
I 4.9.3 - Are special causes of variations investigated and
appropriate actions taken? (I.4.9.3)
I 4.9.3 - Are control charts annotated with significant process
events?
I 4.9.3 - Are control charts maintained and reviewed with
highest priority given to special characteristics?
I 4.9.g 4 Is there an effective planned preventive maintenance
system which includes:
- A maintenance schedule established with specific
responsibilities assigned?
- Maintenance evaluated for process capability
improvement?
- Evaluation for reduction of machine/process
downtime?
- Maintenance conducted at the prescribed frequencies
for all equipment?
- Availability of replacement parts for key manufacturing
equipment?

Pagina 8
 - Predictive maintenance methods?
I 4.9.b 5 Does the supplier have a process to identify all
applicable government, safety and environmental
regulations, including those concerning handling,
recycling, eliminating, or disposing of hazardous
materials?
I 4.9.b 6 Does the supplier have appropriate governmental
certificates indicating compliance to identified applicable
regulations?
I 4.9.b 7 Is the work environment clean, and well-organized?
I 4.9.7 8
If the supplier produces designated “appearance items”;

- Is there appropriate lighting for evaluation areas?

- Are all appropriate masters available?

- Are the masters and evaluation equipment adequately
maintained?
- Is there verification that personnel making appearance
evaluation are qualified to do so?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Inspection and Testing Element 4.10
I 4.10.2 1 Incoming Parts and Materials and Purchased Services
I 4.10.2.1 - Is purchased material controlled and verified, per the
selected system prior to release to production?
I 4.10.2.3 - Is positive identification provided for material used in
production but not verified?
I 4.10.2.1 - Where specified as the control method, do suppliers
submit (statistical) data as required?
2 In-process Inspection and Testing

Does the supplier:

I 4.10.3.a - Inspect and test product as required by the
documented procedures?
I 4.10.3.b - Hold product until the required inspections and tests
have been completed?
I 4.10.3.c - Utilize defect prevention methods, such as statistical
process control, error proofing, visual controls, rather
than defect detection?
I 4.10.4 3 At final inspection and testing, does the supplier:
- Conduct final inspection and testing in accordance with
documented procedures?
- Assure that no product is shipped until all activities
specified in the documented procedures have been
satisfactorily completed?
I 4.10.1 & II 1 4 Does the supplier use accredited laboratory facilities
when required by the customer?

Pagina 9
I 4.10.4 5 Layout inspection (reliability) and Functional Testing

- Is layout inspection conducted per the Control Plan?

- Is functional testing conducted per Control Plan ?

I 4.10.5 6 Does the supplier maintain adequate records of all
inspections and tests?

Pagina 10
 QSA
Req No. No. Question Result Improvment plan Target Responsible
Inspection, Measuring and Test Equipment Element
4.11
I 4.11. 1
Has inspection, measuring and test equipment (including
software when appropriate) been provided that is
capable of the required accuracy and precision?
I 4.11.2.a 2 Is the required accuracy/ precision (precision/tolerance)
determined?
I 4.11.4 3 Is measurement system analysis conducted (Gage R &
R) for all gages, measuring, and test equipment noted
on the control plan?
I 4.11.4 4 Are the appropriate criteria (per the Measurement
Systems Analysis Manual) used for acceptance of
measuring equipment?
I 4.11.2 5 Where test software, hardware, or comparative
references are used, is capability and stability verified
prior to use (linearity and accuracy as appropriate)?
I 4.11.2.d & I 6 Is each item of inspection, measurement, and test
4.11.3 equipment identified with a unique designation (including
employee-owned equipment)?
I 4.11.2.b 7 Is each piece of equipment calibrated at prescribed
intervals in the correct environment (including employee-
owned equipment)?
I 4.11.2.e 8 Are gage condition and actual readings recorded prior to
recalibration?
I 4.11.2.f 9 Are appropriate actions, including customer notification,
taken on product and process when inspection,
measurement, or test equipment is found to be out of
calibration?
I 4.11.2.h 10 Are inspection, measurement and test equipment
properly handled, preserved, and stored to maintain
calibration and fitness for use?
I 4.11.2.i 11 Are inspection, measurement and test facilities
(including software when applicable) safeguarded to
ensure that calibration is not disturbed?
I 4.11.3 12 Do records exist for recalibration of part-specific gages,
etc., following engineering changes?
QSA
Req No. No. Question
Inspection and Test Status Element 4.12
I 4.12.1 1 Is the identification and/or test status suitably identified
throughout the production process?
2 If required by the customer, are additional verification
requirements met for launching of new products?
QSA
Req No. No. Question
Control of Nonconforming Product Element 4.13

Pagina 11
I 4.13.1 1 Is there identification, documentation, segregation
(where possible) to a designated area, and disposition of
nonconforming and suspect product?
I 4.13.2 2
Are there clear definitions for responsibilities for review
and disposition of nonconforming and suspect product?
I 4.13.2 3 Are the nonconforming and suspect products reviewed
according to the defined procedures?
I 4.13 4 Are nonconforming and suspect parts:
I 4.13.2 - reviewed to the specified requirements
- accepted with customer-approved concessions
(EAPAs)

- reworked to approved repair standards

- regraded for alternative applications

- rejected or scrapped?
I 4.13.2 5 Are there provisions in the process that only material
that has passed the inspections and/or tests can be
provided to the customer?
I 4.13.3 6 Are the nonconformances recorded to permit defect
analysis?
I 4.13.2 7 Are reworked products reinspected and/or tested
according to the Control Plan?
I 4.13.3 8 Are the repair/rework instructions accessible and utilized
by the appropriate personnel?
I 4.13.3 9 Where applicable, are approvals obtained for products
supplied for service applications that may have visible
rework?
I 4.13.4 10 Does the supplier ensure that customer authorization is
received prior to shipping nonconforming material?
I 4.13.4 11 Does the supplier maintain records of the expiration
dates for EAPAs and quantities authorized?
QSA
Req No. No. Question
Corrective and Preventative Action Element 4.14

I 4.14.2.c 1 Are appropriate corrective actions developed to

eliminate the causes of nonconformances?
I 4.14.1 2 Does the supplier use a disciplined problem solving
method?
I 4.14.2.a 3 Are the customer complaints and reports of non-
conformances handled effectively?
I 4.14.2.b 4 Are the causes of nonconformances investigated and
the results documented?
I 4.14.2.d 5 Is the effectiveness of corrective action verified?
I 4.14.2 6 Are the returned parts from customer's locations
analyzed and are corrective actions initiated as
appropriate?

Pagina 12
I 4.14.3.a 7 Are nonconformance reports, e.g. product quality,
deviation, audit result, quality records, etc., used to
develop preventive actions?
I 4.14.3.d 8 Are the relevant information on actions taken including
changes to procedure submitted for management
review?
I 4.14.2.S 9 Is the supplier able to provide adequate failure analysis
capability?
QSA
Req No. No. Question
Handling, Storage, Packaging and Delivery Element
4.15
I 4.15.2 1 Do the supplier's material handling methods prevent
product damage and deterioration?
I 4.15.3 2 Are storage areas appropriate for preventing damage or
deterioration of the product?
I 4.15.3 3 When required by the nature of the product, is the
condition of product in stock checked at intervals to
detect deterioration?
I 4.15.4 4 Does the supplier control the packing, packaging, and
marking processes to the extent necessary to ensure
product conformance to specifications?
I 4.15.4 5
Are applicable customer packaging standards available?
I 4.15.4 6 Are applicable customer packaging standards complied
with?
I 4.15.5 7 Are methods appropriate for the product used for
preservation and segregation?
I 4.15.6 8 When contractually required, does the supplier arrange
for the protection of product quality during delivery to the
destination?
I 4.15.6 9 If the supplier's delivery performance is not 100% to
schedule, are there appropriate analyses and corrective
actions?
I 4.15.3 10 Is there an inventory management system to optimize
inventory turns and stock rotation?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Control of Quality Records Element 4.16
I 4.16 1 Are there records that show effective operation of the
quality system, including pertinent subcontractor quality
records?
I 4.16 2 Are all quality records legible and readily retrievable?
I 4.16 3 Are these records (hardcopy or electronic) stored in a
suitable environment to prevent deterioration, damage or
loss?
I 4.16 4 Are quality records retained per established procedures
and for the specified periods?

Typical records include:

Pagina 13
 - Production Part Approval Records

- Control charts

- Internal quality audits

- FMEAs
I 4.16 5 Are these records available to the customer for
evaluation upon request?
I 4.16 6 Has the supplier fulfilled responsibilities for retention
control and timely disposal of records?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Internal Quality Audits Element 4.17
I 4.17 1 Does the supplier carry out internal quality system audits
as planned?
I 4.17 2 Are personnel conducting the audit independent of the
function being audited?
I 4.17 3 Are the audits scheduled on the basis of the status and
importance of the activity?
I 4.17 4 Are the audit results documented and brought to the
attention of the responsible personnel?
I 4.17 5 Are corrective actions timely, recorded and evaluated for
effectiveness?
I 4.17 6 Does the audit include work environment and general
housekeeping?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Training Element 4.18
I 4.18 1 Have the training needs for all personnel performing
activities affecting quality been met?
I 4.18 2 Do qualifications for jobs affecting quality include
identification of appropriate education, training needs
and experience?
I 4.18 3 Are records of training maintained?
I 4.18 4 Is training effectiveness periodically evaluated?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Servicing Element 4.19
1 Is there documented verification that servicing meets the
specified requirements?
2 Have reporting and verification systems been
established to communicate data from servicing
functions to supplier manufacturing, engineering and
design activities?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Statistical Techniques Element 4.20

Pagina 14
 I 4.20.1 1 Has the supplier identified the need for statistical
techniques for establishing, controlling and verifying the
capability of process parameters and product
characteristics?
I 4.20.2 2 Are there procedures established and maintained to
implement and control the application of statistical
techniques?
I 4.20.2 3 Is advanced quality planning used to determine the
appropriate statistical techniques?
I 4.20.2 4 Are the concepts of variation, control (stability),
capability, and over-control (over adjustment)
understood throughout the organization?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Production Part Approval Process Element II 1

1 Does the supplier have complete supporting data for all

production part approval submissions?
I 4.9.6 & II 1 2 Do the supporting data show conformance to all
customer requirements, including change notification?
3 Are the supporting data organized and filed together for
each part?
I 4.6.1 4 Where the customer has an approved subcontractor list,
does the supplier purchase the relevant materials from
sources listed?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Continuous Improvement Element II 2
1 Is there evidence that continuous quality and productivity
improvement efforts are a key element of the supplier's
business?
2 Have specific improvement projects been identified?
3 Are there appropriate measurables for improvement
projects?
4 Is there evidence of improvement in these measurables
over the relevant time periods (from six months to five
years, as appropriate)?
QSA
Req No. No. Question Result Improvment plan Target Responsible
Manufacturing Capabilities Element II 3
1 Are cross-functional teams used for facilities, equipment,
and process planning in conjunction with the advanced
quality planning process?
2 Does the plant layout minimize material travel and
handling, facilitate synchronous material flow, and
maximize value added use of floor space?
3 Are mistake proofing techniques utilized where
appropriate?
4 Are resources available for tool and gage design?

Pagina 15
5 Are resources available for tool and gage fabrication?
6 Are resources available for tool and gage complete
dimensional inspection?
7 Are resources available for tool, and gage maintenance
and repair?

Pagina 16