Audit Questionnaire

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									This form is a template for entities or individuals to use if they are being audited. It
allows for optimal user customization by including standard clauses as well as giving the
user the opportunity to add any additional clauses as they see fit. This form should be
used by entities or individuals that are being audited to organize and expedite the
process.
               North America
                                                        Audit Question List
                                                              ISO 16949:1999
Requirements                                      What to Look For                              Objective evidence

ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY
  1.1 Has the supplier's management with          Documented policy statement with clearly
  executive responsibility defined and            defined measurable quality objectives
  documented its quality policy objectives for    approved by CEO
  quality, and its commitment to quality?
  (4.1.1.1)
  1.2 Is the quality policy relevant to           Defined objectives organizational    goals
  expectations and needs of the customer?         company goals stated in the business plan
  (4.1.1.1)                                       and their alignment with the quality policy
                                                  statement
 1.3 Is the quality policy implemented,           Direct interviews with randomly selected
 understood and maintained throughout the         people of the organization and top
 organization?           (4.1.1.1)                management
 1.4 Are the goals, objectives and
 measurements to deploy the quality policy
 defined?      (4.1.1.1)
 1.5 Are the objectives for achieving quality     Quality objectives linked to the business
 objectives included in the business plan?        plan.
 (4.1.1.2)                                        Scope of the quality objectives
 1.6 Does the supplier have an objective          Description of an objective process
 process for determining customer                 Methodology used for surveys
 satisfaction, including frequency of             Original customer data and scope such as
 determination and how objectivity and validity   customer satisfaction feedback (surveys,
 are assured?       (4.1.1.2)                     scorecards, awards etc.)
 1.7 Are trends in customer satisfaction and
 dissatisfaction documented and supported by
 objective information? (4.1.1.2)
 1.8 Does the quality policy intent include       Quality policy document
 continuous improvement in quality, service,      Records of improvement
 cost and technology? (4.1.1.3)
 1.9 Has the supplier identified opportunities    Examples and status of quality and
 and implemented appropriate projects for         productivity improvements projects.
 quality and productivity improvement?            Management review results
 (4.1.1.3)




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                                                             Audit Question List
                                                                    ISO 16949:1999
Requirements                                           What to Look For                                   Objective evidence

1.10 Has the supplier used appropriate                      Training records for continuous
continuous improvement measures and                         improvement methodologies
methodologies?        (4.1.1.3)                            Examples of use of DOE, SPC, value
                                                            analysis, benchmarking, etc.
                                                          FMEA RPN reduction
                                                            Quality Indices, e.g. Cpk showing
                                                            improvement over 1.33 overtime
1.11 Has the responsibility, authority,                Responsibilities and authority as defined in
interrelationship of personnel who manage,             job descriptions, responsibilities matrices,
perform, and verify work affecting quality been        procedures, accountabilities documents
defined and documented?               (4.1.2.1)


1.12 Is authority delegated to personnel who             Responsibilities and authority as defined
have the organizational freedom to:                       in job descriptions, responsibilities
    a) Initiate action to prevent nonconformity           matrices, procedures, accountabilities
        occurrence?                                       documents
    b) Identify and record quality problems?            Quality records
    c) Initiate, implement and verify corrective
        action?
    d) Control further processing? (4.1.2.1)

1.13 Has the supplier assigned the responsibility to        Quality function representative in project
represent the needs of the customer in                      teams
internal functions? (4.1.2.1.1)                            Quality function participation in
                                                            milestones decision points (Production
                                                            release, Engineering release,...)
                                                           Responsibilities and job description of
                                                            the customer representative (ex. Quality
                                                            function)
1.14 Is management with responsibility and                 Select examples of non-compliance from
authority for corrective action promptly informed          suitable sources such as internal or
of products/processes that become non-                     external concerns/complaints, etc.
compliant?      (4.1.2.1.2)                               Communication channels and timeliness




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                North America
                                                             Audit Question List
                                                                   ISO 16949:1999
Requirements                                           What to Look For                                Objective evidence

1.15 Do the personnel responsible for quality             Who is responsible for quality in the
have the authority to stop production in order to          production process
correct quality problems?     (4.1.2.1.2)                How the authority is defined 
                                                        Recent examples
1.16 Has the supplier identified the resource Job       Training records
descriptions     requirements,      and    provided     Quality Plans 
adequate resources including the assignment of         Shift staffing
trained personnel for management,                       Personnel workload
performance of work and verification activities,
including internal audits? (4.1.2.2.1)
1.17 Are all shifts staffed with personnel with        Quality Assurance responsible
quality assurance responsibility?       (4.1.2.2.2)    personnel in all shifts

1.18 Is there a clearly identified management          Who is the person in charge of this
representative with authority and responsibility       responsibilities
to ensure TS compliance,        and to report on the   Evidence of activities performing including
performance of the performed including                 empowerment for all applicable system
quality system?         (4.7.2.3)                      elements including design, sales,
                                                       manufacturing, delivery, etc.
                                                       Management review minutes
1.19 Does the supplier have a system in place to       Product planning process conforming to
ensure management of appropriate activities            customer specific requirements
during concept development, prototype and              Specific project management requirements
production, according to customer requirements         (Contract Review)
(see Bibliography)?          (4.1.2.4)
1.20 Does the supplier use a multi-disciplinary        Project records such as milestones decision
approach for decision making?         (4.1.2.4)        points during product and process realization
                                                       Contract Review
1.21 Does the supplier have the ability to              Common language at the interface level 
communicate necessary information and data in          Common language for technical
the customer prescribed language? (4.1.2.4)                specifications and important document 
                                                       Customer/supplier EDI system
                                                           requirements and supplier capabilities




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                North America
                                                           Audit Question List
                                                                   ISO 16949:1999
Requirements                                         What to Look For                                  Objective evidence

1 22 Does the management review include all          Review of all the elements of the quality
the elements of the quality system and its           system to ensure its continuing suitability and
performance, as well as the monitoring of            effectiveness
strategic quality objectives and regular             Review of quality cost indicators
evaluation and reporting of the cost of poor         Management review meeting minutes,
                                                     attendance and adequate frequency Action
quality? (4.1.3.1; 4.1.3.2; 4.1 4.3.d) (4.1.4)       plans and follow-up
1 23 Does the supplier utilize a controlled and      Business plan
comprehensive business plan that includes            Evidence of top executive approval.
short-term and longer-term goals and plan(s)?        Document Control procedure
                                                     Master List - reference to Business Plan
                                                     Comprehensive, e.g. all business aspects,
                                                     not just quality
                                                     Goals and Objective
1.24 Are goals and plans based on analysis of        Benchmarking reports and analysis of data
competitive products and benchmarking inside         Marketing and competitor analysis data
and outside the automotive industry? (4.1.4)


1.25 Are there methods in place to determine         Methodology employed, such as, surveys,
current and future customer expectations?            meetings, etc.
(4.1.4)                                              Evidence that this is an ongoing activity
1.26 Does the Supplier use an objective process to   Data collection and analysis system
define the scope, collection and analysis of         availability
information, including the frequency and method of   Planning
collection? (4.1.4)
1.27 Are there documented methods to track,          Evidence of verification that it is followed
update, revise and review the business plan to       (e.g. records of periodical management
ensure it is communicated and followed               meetings)
throughout the organization, as appropriate?
(4.1.4)
1 28 Does the supplier document trends in the        Internal performance data such as:
quality, operational performance, and current           Poor quality cost indicators
quality levels for key product and service              Effectiveness and efficiency of
features?           (4.1.5)                                production processes
                                                        Test results
                                                        Process capability data
                                                        Quality audits


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                North America
                                                        Audit Question List
                                                               ISO 16949:1999
Requirements                                       What to Look For                        Objective evidence

                                                     Results of product inspections
                                                     Internal and external quality data
                                                       Subcontractors rating
                                                     Customer reports
                                                     Employees information -


1.29 Are trends in data and information            Customer problem resolution
compared with progress toward business             Comparison of trends to
objectives, to lead to appropriate action to       objectives (goals)
support:                                           Specific actions to trend
  developing priorities for resolving            analysis
 customer problems                                 Prioritization of action
  determination of key customer-related
    trends
  an information system for timely
  reporting of product information? (4.1.5)
1 30 Does the supplier have a process for            Incentive systems used
motivating the employees to achieve quality
objectives and continuous improvement? (4.1.6)
1.31 Does the supplier have a process for          Personnel interview
promoting quality awareness at all levels of the   Activities such as
company?           (4.1.6)                           Formalized programs which are
                                                       approved by Top    Management
                                                     Structured training
                                                     Quality circles
                                                     Use of visual aids
1.32 Does the supplier have a process for          Measurement of employee satisfaction
measurement of employee satisfaction and
employee understanding of appropriate quality
objectives? (4.1.6)




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                North America
                                                         Audit Question List
                                                                ISO 16949:1999
Requirements                                       What to Look For                                 Objective evidence

1 33 Does the supplier's quality policy and        Preventive activities in design and process
practices address due care regarding product       control
safety and means to minimize potential risks to    Knowledge and application of legislation
employees, customers, users and the                Risk analysis such as FMEA
environment? (4.1.7.1)                             Results of internal/external audits including:
                                                   - System certifications
                                                   - Corrective actions
                                                   Records of accidents Safety-related
                                                   customer complaints
1.34 Does the supplier promote internal            Personnel training Warning related to the
awareness of safety considerations relative to     potential consequences of product defects
its own product?   (4.1.7.1)                       (e.g. Movies, pictures, posters, samples)




1.35 Does the supplier have a process to           Process for government, safety and
ensure compliance with all applicable              environmental regulations compliance
government, safety and environmental               Internal audit results Design/Process Quality
regulations, including those concerning storage,   Records Product descriptions (e.g. manuals)
handling, recycling, eliminating or disposing of   Appropriate product identification
materials?     (4.1.7.2)




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                North America
                                                             Audit Question List
                                                                   ISO 16949:1999
Requirements                                           What to Look For                                 Objective evidence

4.2     - Quality System
2.0 Has the supplier implemented a quality             Quality manual according to ISO/TS 16949 or
system described in a Quality Manual that              one with a conversion matrix.
covers the requirements of ISO/TS 16949 with
related procedures? (4.2.1 ;4.2.2.2)


2 1 Are there adequate supporting                      Adequacy of the procedures to the
.procedures (Level 2) for each element of the          complexity of the organization
quality manual, and are they effectively               Procedure Manual and master document list
implemented? (4.2.2; 4.4.1; 4.9.la; 4.10.1.1,.         Key personnel interview
                                                       Examples of effective implementation
411.1.1; 4.12; 4.12.1.1; 4.14.1.1; 4.13.1.1,
4.15.1;4. 16. 1;4. 17. 1;4.20.2)
2.2 Is the quality planning process consistent with    Development of Quality plan(s)
all other requirements of the quality system,          Link between quality plan and Design
documented in a suitable format, and does it           Record, Control Plan, Operator Instructions,
consider as appropriate, the elements of the quality   Product Approval records, resources facilities
system that address:                                   and any plans to enhance them
o Preparation of quality plans?                        Design validation at the various stages of the
o Identification and acquisition of all                design
     inspection & production/service resources?        Link between process changes and updates in
o Conducting design and process feasibility            the quality plan(s)
     studies?
o Updating and maintenance of all quality
     control and inspection methodology?
o Identification of suitable verification at
     appropriate stages?
o      Production, installation and servicing
     processes which directly affect quality
(4.2.3.1)


2.3 Does the quality plan include the customer         Quality plans
requirements and references to appropriate             Customer specifications
technical specifications? (4.2.3.2)                    Technical specifications




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                North America
                                                            Audit Question List
                                                                   ISO 16949:1999
Requirements                                          What to Look For                              Objective evidence

2.4 Does the supplier have a process for              Quality Planning process
developing product and/or service that meets          Project Planning process
the customer requirements for timing, quality,        Quality Plans for new products
cost, and delivery, product design for design
responsible suppliers?         (4.2.4)
2.5 For project management is there evidence of       Job descriptions
dedicated project manager and project team with       Team composition has to be cross-functional
appropriate resources and defined                     Organization charts
special responsibilities and organizational           Documentation for project management
interfaces?                                           process.
(4.2.4; 4.1.2.1; 4.1.2.2; 4.1.2.4)

2.6 Does the supplier ensure confidentiality of       Information access security
customer contracted product under                     Security for product development.
development, and related product information?
(4.2.4)
2.7 Is there a process to define, analyze and         Indicators and records
report to management measurements of the              Reporting process
product realization? Does it include at a
minimum quality risks, costs, lead-times, and
critical paths?    (4.2.4.1)
2.8 Is there evidence of status review and            Product design and development status
appropriate corrective action at the appropriate      reviews
stages in the product realization?        (4.2.4.2)   Link of corrective action to status reviews

2.9 Does the supplier convene multi-disciplinary      . Functions represented in product
teams for planning the production of new or           development teams
changed products including special                    Personnel involved in definition of special
characteristics, FMEA, and Control Plan?              characteristics, FMEA, and Control Plan
(4.2.4.3; 4.2.4.4)
2.10 Does the supplier use in the product             Knowledge of customer advanced product
development process appropriate tools and             quality plan and control plan manuals, or
techniques as referenced in customer manuals          similar Implementation of the appropriate
or similar?     (4.2.4.5)                             techniques in the different product
                                                      development steps
2.11 Does the supplier perform potential              Use of risk analysis
nonconformity analysis and implement                  Product and process FMEA's

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                  North America
                                                               Audit Question List
                                                                       ISO 16949:1999
Requirements                                             What to Look For                              Objective evidence

appropriate corrective action, including all             Special characteristics list
special characteristics in process, FMEA's and
conforming to customers requirements, if any,
regarding review and approval of FMEA and
Control Plans?               (4.2.4.5)




2.12 Are mistake proofing techniques utilized,           Examples of mistake proofing
where appropriate, which includes but is not
limited to planning of process, facilities,
equipment and tooling, and in problem
resolution?       (4.2.4.4; 4.10.3; 4.14.1.2,4.2.4.5)

2.13 Does the supplier perform process studies           Process capability measurements results as
and verity process capability for all new                appropriate for all new processes
processes?        (4.2.4.5)                              Related actions based on the results

2.14 Do these studies result in documented               Basis for production, measurement and test,
specifications for means of production,                  and maintenance specifications
measurement and test, and maintenance
instructions?                                            Defined acceptance criteria based on
Do they include the objectives for process               objectives
capability, reliability, maintainability, availability
and the acceptance criteria?             (4.2.4.5)

2.15 When specified in the contract, does the            Job description
supplier have.                                           Specific training records
- Appropriate resources and facilities to use            Services sub-contractor management system
computer-aided design, engineering and                   (choice, evaluation and control) if
analysis compatible with the customer                    subcontracted.
systems?                                                 Evidence of compatibility with customer
- Computer-aided methods to use numerical                systems.
design and drawing data for production tooling
and prototypes?
- If any of these functions is/are sub-contracted,
has the supplier provided technical leadership?
(4.2.4.6)

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               North America
                                                           Audit Question List
                                                                   ISO 16949:1999
Requirements                                         What to Look For                                  Objective evidence

2.16 Are all special characteristics appropriately   Process to establish special Characteristics
identified, complying with specific customer         Design Record
definition and included in the control plan?         Review customer requirements for special
(4.2.4.7)                                            characteristics, definitions and symbol
                                                     identification.
                                                     Control plans
2.17 Are process control documents marked            Use of symbol to identity special
with the appropriate special characteristic          characteristics in the process control
symbol to indicate the steps that affect the         documents for each process step
special characteristics? (4.2.4.7)
2.18 Is manufacturing feasibility investigated,      Feasibility studies
confirmed, and documented, prior to contracting
proposed products? (4.2.4.8; 4.3)
2 19 Are process design input requirements           Design FMEA
identified, documented and reviewed?                 Productivity, process capability, costs targets
(4.2.4.9.2)                                          Customer requirements, if any
                                                     Experience from previous development
2.20 Are the process design output data              Process specifications and drawings
expressed in terms that can be verified and          Process FMEA's
validated against the design input, and are          Job instructions
records maintained to evidence the verification?     Process approval acceptance criteria
(4.2.4.9.3; 4.2.4.9.4)                               Quality, reliability, maintainability data
                                                     Mistake-proofing activities results
                                                     Nonconformity detection methods
                                                     Product/Process verification plans
2 21 Are control plans developed by multi-           Control plan team composition
disciplinary approach to the system, subsystem,      Control plans for different product levels
component, and/or material level, and list all
controls used for process control and
verifications? (4.2.4.10;4.l0.4.l)

2.22 Do control plans include the customer           Control Plans for applicable Stages
     required information, reaction plan, and        Control Plan framework with data
     does it cover prototype (if applicable), pre-
     launch and production phases?
Annex B      (4.2.4.10)
2.23 Are control plans reviewed and updated          Matching between product/process changes,


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                North America
                                                         Audit Question List
                                                                ISO 16949:1999
Requirements                                       What to Look For                                  Objective evidence

as appropriate when any of the following occurs:   instability/non capability process results, and
  Product or process changes                      control plans updating
  Processes are found to be unstable or non-
     capable
  Inspection method, frequency, etc. is
     revised?      (4.2.4.10)
2 24 Does the supplier fully comply with all       Compliance with requirements regarding
requirements set forth in the customer product     customer product approval process
approval process?     (4.2.4.11)

2.25 Does the supplier utilize a product           Product approval process documentation
approval process for subcontractors? (4.2.4.11)    and records for subcontractors

2.26 Is there evidence that product changes        Product change validation records
are properly validated?  (4.2.4.11)                Subcontractor product change validation
                                                   records
2.27 Is the customer notified of all changes,      Customer change notification
and is there approval for the change as            process/records
applicable?            (4.2.4.10)                  Customer approval, as applicable
2 28 Does the supplier use a multidisciplinary     Team composition has to be cross-functional
approach to developing plant, facility and
equipment plans? (4.2.5)
2.29 Does the plant layout minimize material       Process flow analysis Plant layout (current
travel and handling, facilitate synchronous        and planned)
material flow, and maximize value-added use of
floor space9                 (4.2.5)

2.30 Are methods developed for evaluating the      Metrics for ergonomics, automation, line
effectiveness of existing operations and           balance, inventory levels
processes?              (4.2.5)
2.31Are appropriate technical resources            Tool/gage design staffing and qualification
available for tool and gage design, fabrication
and full dimensional inspection?         (4.2.6)




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                North America
                                                           Audit Question List
                                                                  ISO 16949:1999
Requirements                                         What to Look For                                Objective evidence

2.32 Has the supplier established and                Tool management process
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)
2.33 If tooling management is sub-contracted, is     Sub-contractor management system (choice,
there a system to track and follow-up these          evaluation and control)
activities?         (4.2.6)

2 34 Does continuous improvement extend to           Records showing improvement in special
product characteristics and process parameters       characteristics
with the highest priority on special                 Reduction in process parameter variation
characteristics?        (4.2.7)

2.35 Does the supplier have a prioritized action     Continuous improvement plans, initiatives
plan for continuous improvement? (4.2.7)

2.36 Do records evidence the measurement of          Policy, business plan and customer
the quality system effectiveness in meeting the      satisfaction metrics Reports
objectives of the quality policy, business plan      Product results (quality, cost, time) against
and the customer satisfaction with the product?      quality policy goals and customer specified
(4.2.8)                                              targets

2 37 Is there evidence that quality system           Trends in metrics (business and customer
performance results are used for continuous          satisfaction)
improvement or corrective action?          (4.2.8)   Basis for continuous improvement projects




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                                                           Audit Question List
                                                                  ISO 16949:1999
Requirements                                         What to Look For                        Objective evidence

4.3     - Contract Review
3.1 Does the supplier review a tender, contract or   Resolutions of differences
order, to ensure that the requirements are           Feasibility  assessments
understood and can be met, and if any                Customer contracts
misunderstanding arises that the differences are
resolved prior to contract or order acceptance?
(4.3.2.])


3.2 Does the supplier have a process to identify     Process for determining cost elements
the appropriate cost elements when developing
quotations? (4.3.2.2)



3.3 Does the customer ensure that all customer       Process used to ensure that customer
specific requirements are met?        (4.3.2.2;      specific requirements are met
4.2.4.6; 4.2.4.7)




3 4 Are there provisions that document and           Change control process Contract
deploy contract amendments to the functions          amendments
concerned? (4.3.3)




3.5 Are records of contract reviews maintained       Records of contract review
(4.3.4; 4.16)




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                                                         Audit Question List
                                                                ISO 16949:1999
Requirements                                        What to Look For                               Objective evidence

4.4 - Design Control
4.1 Have design plans for each project been         Examples of design plans and responsibility
established, updated and responsibilities           assignment
assigned?
4.2 Are responsible personnel qualified in the      Training records complementing the type of
“required Skills” and equipped with adequate        design activity
resources as appropriate?                           Personnel records
                                                    Interviews with design personnel

4.3 Does the supplier have access to research       Appropriate facilities and equipment
and development facilities?                         (internal or external)


4.4 Are the organizational interfaces between       Defined organizational interfaces with roles
groups defined and is there evidence of the         and communication processes
necessary information being documented,
transmitted and regularly reviewed?
(4.4.3)


4 5 Are design input requirements including the     Design input Records & Documents
applicable statutory and regulatory requirements,   Records of supplier review
product life, reliability, durability and
maintainability objectives identified documented
and reviewed? (4.4.4.1; 4.4.4.2)

4.6 Are incomplete, ambiguous or conflicting        Customer specification analysis
requirements resolved? (4.4.4.1)                    Feasibility contract review minutes.

4 8 Has the design output been documented and       Design output records
expressed in terms that can be verified and         matching criteria established
validated against design input requirements.'      in design input requirements
Meet the design input requirements?
 Contain or reference acceptance criteria? 
Identify' Special Characteristics?
 Include a review of design output documents
     before release? (4.4.5.1)


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                                                            Audit Question List
                                                                   ISO 16949:1999
Requirements                                           What to Look For                              Objective evidence

4.9 Was the design output a result of a process that   Techniques / tools used in the design
included:                                              process
 Efforts to simplify, optimize, innovate, and
     reduce waste such as QFD, DFM, DFA, VE,
     DOE or appropriate alternatives? 
GDT (as applicable)?
 Analysis of cost/performance/risk trade- offs? 
Feedback from testing, production and the
     field?
      Analysis of design failure mode and effects
     (DFMEA)?        (4.4.5.2)
4 10 Are there records of formal documented            Design review planning and records
design reviews by the appropriate functions            Design review extended to all functions
conducted at appropriate stages of design per the      affected by it
design plan? (4.4.6)
4 11 Are there records to demonstrate that             Design verification done in accordance to
design verification has been performed at              plan
appropriate stages to ensure that design output          Comparison between outputs and
meets design input requirements?             (4.4.7)        design requirements
                                                         Corrective actions based on results-
4 12 Has design validation been performed to           Design validation against user requirements
ensure that product conforms to defined user           / needs
needs and/or requirements including customer             Comparison between customer plan
timing requirements (4.4.8.1;4.4.8.2)                       and internal development plans
                                                         Design validation records
                                                         Documented failure
4,13 Are design failures addressed through the         Corrective action process for the design
designated corrective and preventive action            activity
procedures?         (4.4.8.2)                          Corrective Action Records

4.14 When required by the customer, does the           Prototype facilities
supplier have a comprehensive prototype                Prototype records
program? (4.4.8.3)




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                                                        Audit Question List
                                                               ISO 16949:1999
Requirements                                      What to Look For                            Objective evidence

4.15 Wherever possible, are the subcontractor's Design/prototype /production
tooling and process for prototype the same as the Tooling Prototype realization and test
ones that will be used in production?   (4.4.8.3) conditions must be known and controlled .



4.16 Is the performance testing tracked for timely Test records
completion and conformance? (4.4.8.3)

4.17 If prototype activities have been sub-        Sub-contractor management as appropriate
contracted has the supplier provided technical
leadership?        (4.4.8.3)

418 Are design changes identified, documented,       Design change approval
reviewed and approved by authorized personnel        Process Change records
before implementation?    (4.4.9.1)

4.19 Does the supplier consider the impact of        Impact study including proprietary
design changes on the system in which the              design
product is used, the customer process and other      Change management process
related products and systems, including
proprietary design? (4.4.9.2;4.2.4. I)




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                                                          Audit Question List
                                                                  ISO 16949:1999
Requirements                                        What to Look For                                 Objective evidence

4.5- DOCUMENT AND DATA CONTROL
5 1 Are all documents and data under document       Master List
control including appropriate external
Documents? (4.5.1)
5 2 Are all documents and data reviewed and         Document approval authority
approved by authorized personnel prior to use?      Document approval records
(4.5.2.1)
5 3 Is there a master list (or equivalent)          Master list or equivalent
identifying document revision status readily
available?       (4.5.2.1)
5.4 Has the supplier established a process to       Availability of documents in various locations
ensure that pertinent issues of appropriate         Knowledge of documents location
documents are available at all locations where      Document accessibility
operations essential to the effective functioning
of the quality system are performed? (4.5.2.1.a)
5.5 Has the supplier established a process to       Storage and disposal of obsolete documents
ensure that invalid and/or obsolete documents
are promptly removed from all points of use, or
otherwise assured against unintended use?
(4.5.2.1.b)
5.6 Is there timely review, distribution and        Process for notification distribution of
implementation of customer engineering              customer engineering standards changes
standards/specifications and changes? (4.5.2.2)
5.7 Does the supplier maintain a record of the      Records of engineering changes
date on which engineering changes are               implemented
implemented in production? (4.5.2.2; 4.16)
5 8 Does implementation of changes include          Document changes triggered by engineering
updates to all appropriate documents? (4.5.2.2)     changes
5 9 Are changes in documents and data               Review and approval of revised documents
reviewed and approved by the same functions/
organizations that originally performed the
review and approval, (unless specifically
designated otherwise)? (4.5.3)




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Requirements                                    What to Look For                              Objective evidence

5.10 Do the designated functions or             Interview key personnel
organizations have access to pertinent
background information upon which to base the
review and approval? (4.5.3)
5.11 Are all changes in documents identified    Method to identify changes to either in the
(4.5.3)                                         document or in documents attachments?




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Requirements                                          What to Look For                              Objective evidence

4.6- PURCHASING,
6 1 Where specified by the contract does the          Approved suppliers list if applicable
supplier use materials and services from the          How are these lists used
approved subcontractor list? (4.6.1.1; 4.3)
6.2 Do all materials used in part manufacture           Audit results from government and
conform to all applicable governmental, safety            environment organizations
and environmental regulations as they apply to          Supplier Internal Audits
the country of manufacture and sale? (4.6.1.2)          Warrants or certificates of compliance 
                                                       Audits of subcontractors
6 3 Are sub-contractors evaluated and selected        Selection system
based on their ability to meet quality system and     Performance rating system
quality assurance requirements?         (4.6.2. Ia)
6.4 Does the supplier define the appropriate          Subcontractor records
type and extent of control over subcontractors?
                                                      Subcontractor monitoring system
(4.6.1b)
6.5 Are quality records of acceptable                 Approved subcontractor records
subcontractors established and maintained?
(4.6.2.lc; 4.16)
6.6 Is subcontractor quality system development       Supplier development process Evidence of
being conducted with the goal of subcontractor        subcontract or development
compliance to TS 16949 or existing customer
quality system requirements?         (4.6.2.2)
6.7 Is 100% on time delivery a requirement of         Purchase Order/Contract or Amendment
the subcontractors and does the supplier              Purchasing planning communication with
convey all the necessary information to achieve       sub-contractors
that? (4.6.2.3)
6.8 Is there evidence of a system to monitor the      Subcontractor performance Records
delivery performance of subcontractors,               Subcontractor corrective action
including all premium freight, and evidence of
appropriate corrective action?        (4.6.2.3)
6 9 Do the purchasing documents contain -             Purchase order / release data clearly
service being ordered? (4.6.3)                        describing the product or
6.10 Is there evidence of supplier review and         Purchase order/release review
approval of purchasing documents for adequacy         process
to the specified requirements prior to release?

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(4.6.3)
6.11 When applicable, do purchasing                   Supplier and subcontractor purchase orders
documents specify verification arrangements           and contracts
and method of product release for purchased
product at the subcontractors premises?
(4.6.41)
 6.12 Where specified in the contract (4.3), is the   Contract review for customer right to verify
customer (or their designated representative),
afforded the right to verify product conformance to
the requirements at the supplier’s
subcontractors premises?         (4.6.4.2)




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Requirements                                        What to Look For                                Objective evidence

4.7- CONTROL OF CUSTOMER-SUPPLIED PRODUCT
7 1 Is there evidence that product that is lost, Damage to customer supplied product
damaged or otherwise unsuitable for use is       reports
recorded and reported to the customer?           What happened to customer owned
(4.7.1, 4.16)                                    returnable packaging?
                                                 How was it accounted for?


7.2 Are customer-owned tools and equipment          Permanent identification of tooling and
permanently marked so that ownership of each        equipment ownership
item is visually apparent? (4.7.2)




4.8 - PRODUCT IDENTIFICATION AND TRACEABILITY
8.1 Is product identification maintained through all Check for positive recall Suitable product
stages of production, delivery and                   identification throughout the facility
installation? (4.8; 4.10.2.3, 4.10.3b)               Traceability from raw materials to delivered
                                                     product.




8.2 How is traceability maintained and recorded     Integration of customer traceability
when required by the customer? (4.8; 4.16)          requirements




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Requirements                                           What to Look For                             Objective evidence

4.9 PROCESS CONTROL
9.1 Does the supplier identify and plan the            Quality plan
production; installation and servicing processes       Control plan
which directly affect quality ensure that these
processes are carried out under controlled
conditions? (4.9.1.1)
9.2 Do controlled conditions include use of            Tour of plant and facilities
suitable production, installation and servicing
equipment, and suitable working environment?
(4.9.1.b)
9.3 Do controlled conditions include compliance        Adherence to referenced standards, quality
with reference standards/ codes, quality plans         plans and/or documented procedures
and/or documented procedures?          (4.9.1.1.c)     Tour of plant and facilities

9.4 Do controlled conditions include the moni-         Control Charts and SPC Tools
toring and control of suitable process para-           Evidence of effective control
meters and product characteristics?       4.9.1.1.d)
9.5 Do controlled conditions include the               Process approval records
approval of processes and equipment, as
appropriate?           (4.9.1. i.e.)
9.6 Do controlled conditions include criteria for      Acceptance Criteria
workmanship stipulated in the clearest practical       Visual aids
manner? (4.9.1.14)                                     Work instructions
9.7 Are qualified operators and/or continuous          Operator qualification Training Records
monitoring and process control used where the          Process parameters monitoring and control
results of the processes cannot fully be verified      evidence
by subsequent inspection and testing? (4.9.1.1)
9.8 Are qualification requirements for special         Requirement specification for operations,
process operations and associated equipment            equipment and personnel Related records of
and personnel spec fled and are records                qualification
maintained? (4.9.1.1)
9.9 Are the premises maintained in a state of          Tour of plant
order, cleanliness and repair appropriate to the
product manufactured? (4.9.1.2)




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9.10 Does the supplier have contingency plans     Contingency plans Identification of Key
to reasonably protect the customer's supply of    Equipment
product in the event of emergency? (4.9.1.3)
9.11 Are customer requirements for designation,   Designation and control of special
documentation and control of Special              characteristics Quality documents: control
Characteristics in compliance? Is documentation   plan, specifications, drawings, etc. shall
available? (4.9.1.4)                              report the special characteristics designation
9.12 Is there an effective planned preventive     System effectiveness demonstrated by
maintenance system that identifies key process    specifics measurement indicator
equipment, provides appropriate resources, and    Key equipment list
includes at a minimum:                            Maintenance records
o Planned maintenance activities?                 Predictive maintenance examples
o Predictive maintenance methods?                 Plant tour
o Packaging and preservation of equipment,
  tooling, and gages?
o Availability of replacement parts for key
  manufacturing equipment?
o Documenting, evaluating and improving
  maintenance objectives?
(4.9.1.5; 4.9.l.l.g)
9 13 Have documented job instructions             Availability of job instructions at the
prepared and derived from appropriate sources     workstation
been prepared for all employees having            Link between job instructions and source
responsibilities for operation of processes and   documents, e.g. Control Plan, Design
are they accessible at the workstation? (4.9.2)   Record, FMEA




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9.14 Do process monitoring and job instructions       Job instructions contents
include or reference, as appropriate:                 Predetermined reaction plan
  Operation name and number keyed to
      process flow diagram?
  Part name and part number?
  Current engineering level/date?
  Required tools, gages and other
      equipment?
      Material identification and disposition
      instructions?
  Customer and supplier designated Special
      Characteristics?
  SPC requirements?
      Relevant engineering and manufacturing
      standards?
  Inspections and test instructions? 
 Reaction plan?
  Revision date and approvals? 
 Visual aids?
  Tool change intervals and set-up
      instructions?                  (4.9.2)
9.15 Does the supplier maintain or exceed the         Current Cpk/Ppk versus customer approved
process capability or performance as approved         Cpk/Ppk
via customer part approval process through the        Existing reaction plan
implementation and adherence to the Control           Verifying the accuracy of Cpk/ Ppk
Plan, Process Flow Diagram, measurement               calculations
technique, sampling plans, and reaction plans
when acceptance criteria are not met? (4.9.3)

9.16 Are significant process events recorded on       Process events recorded
the control charts?      (4.9.3)

9.17 Does the supplier initiate the appropriate
reaction plan from the control plan for unstable or
non-capable characteristics? (4.9.3)

9.18 Does the reaction plan include as                Contents of reaction plan
appropriate: Containment and 100% inspection?
Processes Specific corrective action timing?


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9.19 Does the supplier maintain record(s) of .   Records
Process change records process change            - Responsibility assignment?
effective dates? (4.9.3)                         - Customer approval?

9 20 Does the supplier verify job set-ups, and   Job set-up records and Approval
use statistical methods where applicable?
(4.9.4)

9.21 Are job instructions available for set-up   Set-up instructions
personnel?              (4.9.4)
9.22 For customer designated appearance          Maintenance/Control and storage conditions of
items:                                           masters
 Is there appropriate lighting for the          Visual aids
    evaluation area(s)?                          Personnel quantification / training records
 Are all appropriate masters available?         Tour of facility
 Are the masters and evaluation equipment
    adequately maintained and controlled?
 Is there verification that personnel making
    appearance evaluation are qualified?
    (4.9.5)




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4.10- INSPECTION AND TESTING
10.1 Are the required inspection and testing,       Control Plans
and the records established, and detailed .in the   Inspection Instructions
quality plan or documented procedures?
(4.10.1.1)
10.2 Is appropriate acceptance criteria for all     Inspection instruction/records
situations documented and zero defects for          Acceptance Criteria
attribute data?       (4.10.1.2)                    Control Plans

10.3 Does the supplier ensure that incoming          Material certifications
product is not used or processed (except for         Subcontractor Data
urgent production purposes), until it has been       Inspection records
inspected or otherwise verified as conforming to     Receipt and evaluation of statistical data by
specified requirements? (4.10.21, 4.10.2.4;           supplier
4.10.2.2)                                            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


10.4 Does the Supplier inspect and test product     In-process inspection instructions
as required by the quality plan (Control Plan)      Control Plans
and/or the documented procedures? (4.10.3.a)        Records

10.5 Does the supplier carry out final inspection   Control Plans
and testing in accordance with the quality plan     Final inspection records
(Control Plan) and/or documented procedures?
(4.10.4.1)


10.6 Does the supplier assure that no product is    Inspection records and Approvals Label/tag of
dispatched until all activities specified in the    identification of inspection and test status in
documented procedures have been                     various area of the operation.
satisfactorily completed and that the associated
data and documentation is available and
authorized? (4.10.4.1)



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10.7 Are layout inspection and functional          Layout inspection reports
verification performed for all products at         Control plan
frequencies established by control plan?
(4.10.4.2)
10.8 Does the supplier maintain records which      Inspection records that include acceptance
provide evidence that the product has been         criteria
inspected and/or tested clearly showing whether    Inspector performing the test, test status and,
the product has passed or failed inspection        testing date
based on the defined acceptance criteria and
identifying the authority responsible for the
product release?             (4.10.5)
10.9 Is product that fails any inspection and/or   Identification tag
test addressed under control of non- conforming    Area non conforming material
product?       (4.10.5)
10.10 Do inspection records identify the           Release of product by authorized personnel
inspection authority responsible for the release
of product?       (4.10.5)-
10.11 Does the laboratory have a scope and         Laboratory Scope
does it comply with ISO/IEC Guide 17025?           (See TS Glossary)
(4.10.6)




10.12 When the supplier uses independent/          Commercial Laboratory
commercial laboratories are they accredited to     Accreditation records
ISO/IEC Guide 17025 or a national equivalent?
(4.10.6)




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4.11- CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT
11.1 Inspection, measuring, and test equipment Management system analysis studies
used in a manner which ensures that the            including Gage Repeatability &
measurement uncertainty is known and is            Reproducibility
consistent with the required measurement
capability?            (4.11.1)
11.2 Where test software or comparative            Test software/comparative references
references such as test hardware are used as       verification
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?
(4.11.1.1)
11.3 Does the supplier establish the extent and     Verification schedule and records
frequency of such checks and maintain records as
evidence of control? (4.11.1.1)
11.4 For measurement systems referenced in          Study results
the Control Plan is there evidence that
appropriate statistical studies have been
conducted to analyze the variation present in the
results of each type of measuring and test
equipment system? (4.11.1.2)
11.5 Do analytical methods and acceptance           Check methods against customer
criteria used conform to those in the customer      measurement system analysis requirements.
reference manuals on measurement system
analysis (see bibliography) as appropriate,         Customer approval records, for other
including bias, linearity, stability and            analytical methods used
measurement repeatability and reproducibility
studies?
When other methods are used are they
approved by the customer? (4.11.1.2)
11.6 Has the supplier determined the                Test equipment accuracy and precision
measurements to be made and the accuracy            capability related to the required
required and selected the appropriate               measurement
inspection, measuring and test equipment that is
capable of the required accuracy and precision?
(4.11.2.a)


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11.7 Has the supplier identified, and maintained      Test equipment inventory
calibration records for all inspection, measuring     Certifications for calibration masters and their
and test equipment that can affect product            traceability to international national
quality and calibrated and adjusted them at           recognized standard
prescribed intervals, against certified equipment
having a known valid relationship to                  Calibration results records
internationally or nationally recognized
standards.
Where no such standard exists is the basis for
calibration documented?         (4.11.2.b; 4.ll.2e)
11.8 Does the process for calibration of              Calibration instructions that Include method,
inspection, measuring and test equipment              frequency, acceptance criteria and corrective
include the following.'                               action,
- Type of equipment?
- Unique identification?
- Location?
- Frequency of checks?
- Check method?
- Acceptance criteria?
- Corrective actions?     (4.11.2.c)
11.9 Has the supplier identified inspection,          Calibration status identification
measuring and test equipment with a suitable
indicator or approved identification record to
show the calibration status?         (4.11.2.d)
11.10 Does the supplier assess and document           Records of re-inspected product
the validity of previous inspection and test
results when inspection, measuring and test
equipment is found out of calibration? (4.11j)

11.11 Has the supplier ensured that the               Facility tour
environmental conditions are suitable for
inspections, measurements and tests being
carried out?_(4.ll.2.g; 4.16)




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11.12 Has the supplier ensured that the             Handling and storage of equipment at work
handling, preservation and storage of inspection    station and warehouse
measuring and test equipment is such that the       Facility tour
accuracy for fitness for use is maintained?
(4.11.2.h)
11.13 Has the supplier safeguarded the              Test premises access and Security Method of
inspection, measuring and test facilities,          control of calibration settings
including both hardware and test software, from
adjustments which would invalidate the
calibration setting? (4. 11. 2.i)
11.14 Do records of the calibration/ Measuring.     Measurement equipment verification activity for
and test equipment measurement equipment            all gages, records
include:                                            Original specification of (including employee
Revisions following engineering changes (if         owned gages)
appropriate)?
Any out of specification readings as received for
calibration/verification? Statements of
conformance to specification after calibration
Verification
Notification to customer if suspect material or
product has been shipped? (4.ll.3)




4.12 - INSPECTION AND TEST STATUS
12.1 Are the inspection and test status of          Inspection records
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)




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4.13 CONTROL OF NONCONFORMING PRODUCT
13.1 Does the control of nonconforming product Follow one or more or product
and suspect material provide for identification, nonconforming case and verify the flow
documentation, evaluation, segregation (when (identification, segregation, etc.)
practical, disposition, and for obsolete products
notification of all appropriate functions?
(4.13.1.14.15.3.2)
13 2 Does the supplier provide for visual                 Follow one or more non-conforming case
identification of nonconforming or suspect                and verify segregation area.
product, and for quarantine the visual
identification and areas? (4.13.1.2)
13.3 Does the supplier quantify and analyze               prioritized reduction plan and track of
nonconforming product, establish a product                nonconforming material
reduction monitoring system progress?
(4.13.1.3)
13.4 Is the customer promptly informed when               Method to communicate with the customer,
nonconforming material has been shipped?                  for non-conforming products.
(4.13.1.3)                                                Records
13.5 Is the responsibility for review and authority for   Procedures
the disposition of non-conforming product                 Work instructions
defined? (4.13.2)

13.6 Are nonconforming and suspect products               Follow one or more non-conforming case and
reviewed in accordance with documented                    verify in the plant, the flow (identification,
procedures, and, reworked to meet the specified           segregation, etc.)
requirements
- Accepted with or without repair by concession
- Regarded for alternative applications, or -
rejected or scrapped?       (4.13.2)
13.7 When required, is the proposed use or                Records of concessions
repair of product, which does not conform to
specified requirements, reported for concession to
the customer? (4.13.2)




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13.8 Is the description of nonconformity that has     Records of customer acceptance of non
been accepted, and of repairs, recorded to            conforming material
denote the actual condition? (4.13.2)
13.9 Are repaired and/or reworked/products re-        Reworked product flow must guarantee the
inspected and/or tested according to the quality      re-inspection in accordance to control plan.
plan (Control plan) and/or documented                 Inspection/testing records for
procedures?      (4.13.2)                             reworked/repaired product


13.10 Are the rework instructions accessible and      Plant Tour
utilized by the appropriate personnel in their work
areas? (4.13.3)
13.11 Does the suppler obtain customer                Records of subcontractor authorization
authorization prior to shipment whenever
product or process is different from the one
currently approved?             (4.13.4)

13.12 Does the supplier concur with any               Records
requests from a subcontractor before
submission to the customer? (4.13.4)

13.13 Does the supplier maintain records of the       Records
expiration dates and quantities authorized?
(4.13.4)

13.14 Is compliance with the original or              Shipping container labeling specific and clear
superseding specification and requirements            identification
ensured when authorization expires?      (4.13.4)


13 15 Is material shipped on an authorization         Shipping container labeling specific and clear
properly identified on each shipping container?       identification
(4.13.4)




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4.14 -Corrective and Preventive Action
14.1 Are appropriate corrective or preventive      Coherence between action and document
actions developed to eliminate the causes of       change
actual or potential non-conformances?(4.14.1.1)    Records of changes


14.2 Are changes to the documented                 Coherence between action and document
procedures resulting from corrective or            change
preventive action implemented and recorded?        Records of changes
(4.14.1.1)

14.3    Does the supplier use a disciplined        Responses to customer complaints
problem solving method to address internal or
external non-conformances used? (4.14.1.2)
14.4 Does the supplier respond to external non-    Responses to customer complaints
conformances in the customer prescribed            Customer formats
manner?      (4.14.1.2)
14.5 Does the supplier use mistake-proofing        Examples
methodology, as appropriate, in their corrective
and preventive action process? (4.14.1.3)
14.6 Do procedures for corrective action           List of customer complaints
include:
 Effective handling of customer complaints        Root Cause Analysis and records
     and reports of non-conformances;
 investigation of the causes of non-              Determination of corrective action needed
     conformances relating to product,
 process and quality system and recording of      Corrective action taken
     the results;
 determination of corrective action               Corrective action effectiveness
 needed to eliminate the cause of non-
     conformance;
     application of controls to ensure that
     corrective action is taken and that it is
     effective? (4.14.2.a-b-c-d)




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14.7 apply the corrective actions and controls       Where applicable, does the supplier Review of
implemented to similar products and processes?       documents related to similar products and
(4.14.2.2)                                           processes
14.8 Are returned parts from Customer                List of returned parts
manufacturing plants, engineering facilities, and    Records of analysis
dealerships analyzed in minimum time, and are        Minimalization of cycle time Examples
records of this analysis kept and made available
upon request? (4.14.2.3)

14.9 Where appropriate, does the supplier initiate
corrective action and process changes to prevent
recurrence? (4.14.2.3)
14.10 Do procedures for preventive action            Sources of information used for preventive
include: the use of appropriate sources of           action
information, e.g., product quality, deviation,       Root cause determination (FMEA, FTA, etc.)
audit result, quality records, etc., to develop      Records and result analysis
preventive actions; determination of steps
needed to deal with problems requiring
preventive action; initiation of preventive action
and application of controls to ensure that it is
effective (4.14.3.a-b-c)




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4.15-Handling, Storage, Packaging, Preservation and Delivery
15 1 Does the supplier have documented and          Procedure development and documentation
established procedures for handling, storage,
packaging, preservation and deliveries of
product? (4.15.1)
15.2 Have methods for the handling of product to Facilities appropriate
prevent damage or product deterioration been
provided? (4.15.2)
15.3 Are designated storage areas or stock of all     Plant    Tour
storage and rooms used to prevent damage or           stock rooms
deterioration of the product pending use or
delivery? (4.15.3.1)

15.4 Have appropriate methods for authorized          Process and facilities to authorizing receipt to
movement of product from one area to another          and dispatch from designated storage areas or
areas been stipulated? (4.15.3.1)                     stock rooms
15.5 Is the condition of product in stock/storage     Inspection records
assessed at appropriate intervals to
specifications detects deterioration? (4.15.3.1)
15.6 Does the supplier use an inventory               Inventory management system
management system to optimize inventory               Evidence of FIFO
turns, assure stock rotation and minimize             Control of obsolete product
inventory levels?   (4.15.3.2)
15.7 Does the supplier control the packaging          Internal process
and marking processes so as to ensure product         Packaging audit
conformance to specifications?         (4.15.4.1)
15.8 Does the supplier comply with all customer       Customer requirements
packaging requirements, including those for           Packaging sample audit
service parts? (4.15.4.2)
15.9 Does the supplier have a system to ensure        Product labeling system
that all materials shipped are labeled according to   Customer requirements
customer requirements? (4.15.4.3)                     Labeling audit
15.10 Have appropriate methods for                    Procedure
preservation and segregation of product been          Plant tour
applied when the product is under the suppliers'
control?     (4.15.5)

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15.11 Does the supplier arrange for the                Procedures Plant tour
protection of the quality of the product after final   Returned material records
inspection and test and does it extend to include      Customer complaints
delivery to destination when specified?
(4.15.6.1)
15.12 Has the supplier established a system to         Customer production and service
support 100% on-time shipments to meet                 requirements vs. delivery history
customer production and service requirements?
(4.15.6.2)
15.13 If the supplier's delivery performance is        Delivery problem records
not 100% to schedule, is there evidence of             Corrective actions plan and realization
implemented corrective actions, and of
communication regarding delivery problem
information to the customer? (4.15.6.2)
15.14 Does the supplier have a systematic              Delivery monitoring system with closed loops
approach to develop, evaluate and monitor
adherence to established lead-time
requirements?       (4.15.6.2)
15.15 Has the supplier implemented a system to         Delivery performance monitoring
track performance to customer delivery
requirements and premium freight? (4.15.6.2)
15.16 Does the supplier maintain records of            Premium freight records
supplier responsible premium freight? (4.15.6.2)
15.17 Are materials shipped in conformance             Customer Requirements Specifications
with the customer requirements, adhering to up-        Delivery records
to-date customer specified transportation mode,
routings and containers?         (4.15.6.2)

15.18 Is supplier's production scheduling activity     Process for production scheduling The
order driven and based on a system to meet the         scheduling system should be based on a
customer requirements for delivery? (4.15.6.3)         "pull" and not on a "push" system.
15.19 Does the supplier have a computerized            System for receiving customer planning
System to receive computerized customer                information
information and ship schedules, unless other
method is agreed with the customer? (4.15.6.4)


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                                                                   ISO 16949:1999
Requirements                                        What to Look For                               Objective evidence

15 20 Does the supplier have a computerized         Advance Shipment Notice (ASN) system
system for transmitting advanced ship notices to
the customer, unless other method is agreed
with the customer? (4.15.6.5)
15.21 Does the supplier have a back-up method       Alternate method of a ASNs failure
in the event the on-line system fails? (4.15.6.5)
15.22 Has the supplier verified that all ASNs       Verification
match shipping documents and labels?
(4.15.6.5)



4.16-Control of Quality Records
16.1 Are records maintained to demonstrate          Records maintenance system, including
conformance to specified requirements and the       disposal of records
effective operation of the quality system?
(4.16.1)
16.2 Does the control of quality records include    Subcontractor quality performance records
pertinent subcontractor quality records? (4.16.1)
16.3 Where agreed contractually are quality         Defined record retention time compared to
records available to the customer for evaluation    customer regulatory requirements
for an agreed period?                  (4.16.1)
16.4 Are all quality records legible readily        Environment and storage conditions must be
retrievable and stored in a suitable environment    compatible with the file storage medium (ex:
to prevent deterioration, damage, and loss?         hard copy, floppy disk, etc.)
(4.16.1)
16.5 Has the supplier defined the quality system    Defined record retention time compared to
related document and record retention periods to    customer/ regulatory requirements
satisfy as a minimum regulatory and                 Record disposal after retention period
customer requirements? (4. 16.2; 4.16.1 ;4.5.2.     expires
Ic)                                                 Including identification of obsolescence
                                                    documents
                                                    Identification of invalid obsolete documents




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                                                                  ISO 16949:1999
Requirements                                        What to Look For                             Objective evidence

4.17- INTERNAL QUALITY AUDITS
17.1 Are the audits scheduled and carried out       Audit schedule
on the basis of the status and importance of the    Records of performed audits
activity? (4.171)                                   Appropriate prioritization
17.2 Are personnel conducting the audit             Organization chart
independent of the function being audited?
(4.17.1)
17.3 Are the audit results recorded and brought     Auditreport
to the attention of the responsible personnel?
(4.17.1)
17,4 Are corrective actions carried out on a        Closure time for audit findings
timely based (4.17.1)
17.5 Are there follow-up audit activities           Records for recording
verifying the effectiveness of the corrective
actions taken? (4.17.1)

17.6 Does the audit frequency increase based on     Audit frequency
internal/  external    nonconformities   and/or
customer r complaints? (4 17 2 1)
17.7 Does internal auditing cover all shifts?       Interview with the different area managers
(4.17.2.2)                                          Audit reports
                                                    Audit plan activities and
17.8 Is there an annual plan for scheduled
Auditplans and schedule system audits?
(4.17.2.2)
17.9 Are product realization and production         Audit    plans
processes audited to determine the                  Audit reports
effectiveness of process performance?
(4.17.2.3)
17.10 Does the supplier perform product audits at   Auditplan, process flow chart and schedule
various stages of production and delivery, at an    Product-audit procedure and reports
appropriate frequency? (4.17.2.4)
17.11 Does the supplier comply with the             Compliance to customer requirements
customer requirements for internal auditor
qualification?   (4.17.3)



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                                                              Audit Question List
                                                                     ISO 16949:1999
Requirements                                            What to Look For                                Objective evidence

4.18- Training
18.1 Are personnel qualified based upon                 Training plan
appropriate education, training requirements,           Employees previous experience
and/or experience as required and have the              Training requirements
training needs for all personnel performing             Training records
activities affecting quality been met? (4.1.1;          Job descriptions
4.16.2)
18.2 Is training periodically evaluated for             Audit/appraisal of training performance
effectiveness? (4.18.2)                                 Surveys / questionnaires
                                                        Performance reviews
                                                        Pre and post testing
18.3 Are customer specific requirements given           Comparison between content customer             (
special attention in the training program?              needs and training programs
(4.18.2)
18.4 When appropriate, does the supplier                Training records for personnel in new
provide on the job training for personnel in any        assignments
new or modified job affecting quality, and does it      Training records for contract personnel
include contract or agency personnel.        (4.18.3)

18.5 Is the personnel affecting quality, informed       Training contents
about the consequences for the customer of
nonconformities with quality standards? (4.18.3)
4.19- SERVICING
19.1 Is there documented evidence that a                Service reports
servicing meets the specified requirements?
(4.19.1)
19.2 Is there a procedure to communicate                Meeting reports, follow up and corrective
information on service concerns to supplier             actions/ responsibility/dates Product service
manufacturing, engineering and design                   data
activities? (4.19.2)
19.3 If applicable, does the supplier verify the        Planning of periodical audits
effectiveness of:                                       Reports and follow up
   any supplier service centers,
   special purpose tools,
   training of servicing personnel(4.19.3)




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                                                             Audit Question List
                                                                    ISO 16949:1999
Requirements                                           What to Look For                                  Objective evidence

ELEMENT 4.20- Statistical TECHNIQUES
20.1 Has the supplier identified the need for          Review of control plan
statistical techniques for establishing; Review of     Plant tour of process parameters and product
quality plan controlling and verifying the             characteristics?
capability (4.20.2)
20 2 Are the statistical tools for each process        Advanced product quality planning records
determined during advance quality planning and         Control Plan Quality plan
are they included in the control plan?      (4.20.3)

20.3 Are basic statistical concepts understood         Interview with personnel including
                                                       management demonstrating the knowledge of
at all levels of the organization, as appropriate?     major statistical concepts like variation and
(4.20.4)                                               distribution, process control, cause and effect
                                                       relationship, common and special causes.
                                                       Statistical techniques training records(




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