ts16949 2002 Checklist

Requirements What to look for Assessor notes / Objective Evidence
4.1 - QUALITY MANAGEMENT SYSTEM

4.1.1 Has the organization established and documented a Quality Manual according to ISO/TS16949:2002 or
quality management system in accordance with the one with a conversion matrix.
requirements of ISO/TS16949:2002?
(4.1)
4.1.2 Has the organization implemented and maintained its  Key personnel interview
established quality management system in  Examples of effective implementation
accordance with the requirements of
ISO/TS16949:2002?
(4.1)
4.1.3 Is the organization continually improving the  Examples and status of quality management
effectiveness of its quality management system in system continuous improvement projects, not
accordance with the requirements of corrective actions.
ISO/TS16949:2002?  Management review results
(4.1.1.1)
4.1.4 Does the organizations quality management system:  Quality Manual according to ISO/TS16949:2002
a) identify the processes needed for the quality or one with conversion matrix.
management system and their application
throughout the organization?
b) Determine the sequence and interaction of
these processes?
c) Determine criteria and methods needed to
ensure that both the operation and control of
these processes are effective?
(4.1 a, b, c)
4.1.5 Does the organization’s quality management system:  Review of all the elements of the quality
a) ensure the availability of resources and management system to ensure its continuing
information necessary to support the suitability and effectiveness.
operation and monitoring of the processes  Review of quality cost indicators
needed for its quality management system?  Management review meeting minutes, attendance
b) Monitor, measure and analyze the processes and adequate frequency
needed for its quality management system?  Actions plans and follow up
c) Implement actions necessary to achieve
planned results and continual improvement
of the processes needed for its quality
system?
(4.1 d,e,f)
4.1.6 Does the organization manage the processes needed
for its quality management system in accordance
with the requirement of ISO/TS16949:2002?
(4.1)
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4.1.7 Does the organization ensure control over outsourced
processes that affects product conformity with
requirements?
(4.1)
4.1.8 Is the control of the organization’s outsourced  Quality Manual according to ISO/TS16949:2002
processes that affects product quality conformity or one with a conversion matrix
with requirements identified within the quality
management system?
(4.1)
4.2 - DOCUMENTATION REQUIREMENTS
4.2.1 Does the quality management system  Quality manual according to ISO/TS16949:2002 or
documentation include the following: one with a conversion matrix
a) documented statements of a quality policy  Adequacy of the procedures to the complexity of the
and quality objectives organization
b) a quality manual?  Quality Management system procedures
c) Documented procedures required by  Quality Records
ISO/TS16949:2002?
d) Documents needed by the organization to
ensure the effective planning, operation and
control of its processes?
e) Records required by ISO/TS16949:2002
(see element 4.2.4)
(4.2.1)
4.2.2 QUALITY MANUAL
4.2.2 Has the organization established and maintained a  Quality manual according to ISO/TS16949:2002
quality manual that includes: or one with a conversion matrix
a) the scope of the quality management system,
including details of and justification for
any exclusions (see section 1.2 of
ISO/TS16949:2002)?
b) The documented procedures established for
the quality management system, or
reference to them?
c) A description of the interaction between the
processes of the quality management
system?
(4.2.2)
4.2.3 CONTROL OF DOCUMENTS
4.2.3 Does the organization control the documents  Quality manual according to ISO/TS16949:2002
required by the quality management system? or one with conversion matrix
(4.2.3)  Document control master list or equivalent
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4.2.4 Has the organization established a documented  Document approval authority
procedure to define controls needed:  Document approval records
a) to approve documents for adequacy prior to  Availability of documents in various locations
issue?  Knowledge of document location
b) To review and update as necessary and re-  Document accessibility
approve documents?  Storage and disposal of obsolete documents
c) To ensure that changes and the current  Process for notification/distribution of documents
revision status of documents are identified? from internal and external origins
d) To ensure that relevant versions of
 Review and approval of revised documents
applicable documents are available at points
of use?
e) To ensure that documents remain legible
and readily identifiable?
f) To ensure that documents of external origin
are identified and their distribution
controlled?
g) To prevent the unintended use of obsolete
documents, and to apply suitable
identification to them if they are retained for
any purpose?
(4.2.3)
4.2.3.1 ENGINEERING SPECIFICATIONS
4.2.5 Does the organization have a process to assure the  Process for notification/distribution of customer
timely review, distribution and implementation of all engineering standards changes
customer engineering standards/specifications and  Process for implementation of customer initiated
changes (including the updating of appropriate changes
documents) based on customer required schedule?  Document changes triggered by engineering
(4.2.3.1) changes
4.2.6 Does the organization maintain a record of the date  Records of engineering changes implemented
on which each change is implemented in production?
(4.2.3.1)
4.2.4 CONTROL OF RECORDS
4.2.7 Has the organization established and maintained  Quality management system records
records to provide evidence of conformity to  Records of maintenance system, including
requirements and of the effective operation of the disposal of records
quality management system?
(4.2.4)
4.2.8 Are records legible, readily identifiable and  Quality management system records legibility
retrievable?  Identification of quality management system
records
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 Environment and storage conditions must be
(4.2.4) compatible with the file storage medium (ex.
Hard copy, floppy disk, etc.)
4.2.9 Has the organization established a documented  Quality manual according to
procedure to define the controls needed for the ISO/TS16949:2002
identification, storage, protection, retrieval, retention  Defined retention time compared to
time and disposition of records? customer/regulatory requirements
 Record disposal after retention period expires
 Including identification of obsolescence
(4.2.4) documents
 Identification of invalid/obsolete documents
4.2.10 Does the organization treat quality records as a  Evidence of quality records being maintained
special type of document and control them according and controlled per quality manual
to the requirements given in questions 4.2.7 and
4.2.8?
(4.2.4)
5 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
5.1.1 Does top management have evidence of providing  Documents policy statement with clearly
commitment to the development and implementation defined and measurable quality objectives
of its quality management system? approved by CEO
(5.1)
5.1.2 Does the organizations top management have  Customer defined objectives
evidence of providing commitment to continually (Customer specifications) and company goals
improving its quality management system stated in the business plan and their alignment
effectiveness by with the quality policy statement.
a) communicating to the organization the  Quality manual according to
importance of meeting customer as well as ISO/TS16949:2002
statutory and regulatory requirements?  Management reviews meeting
b) Establishing the quality policy? minutes, attendance and adequate frequency
c) Ensuring that quality objectives are  Action plans and follow-up
established?
d) Conducting management reviews?
e) Ensuring the availability of resources?
(5.1)
5.1.1 PROCESS EFFICIENCY
5.1.3 Does organization’s top management monitor the  Review of product realization and support
product realization processes and the support processes by top management
processes to assure their effectiveness and  Indicators and records
efficiency?  Reporting process
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(5.1.1)
5.2 CUSTOMER FOCUS
5.2.1 Does top management ensure that customer  Description of an objective process
requirements are determined and fulfilled with the  Methodology used for surveys
aim of enhancing customer satisfaction?  Original customer data and scope such as
customer satisfaction feedback (surveys,
(5.2) scorecards, awards, etc.)
5.3 QUALITY POLICY
5.3.1 Does top management ensure that the quality policy:  Documented policy statement with
a) is appropriate to the purpose of the clearly defined and measurable quality objectives
organization? approved by CEO
b) Includes a commitment to comply with  Records of improvement
requirements and continually improve the  Quality objectives included/linked to
effectiveness of the quality management the business plan.
system?  Scope of the quality objectives
c) Provides a framework for establishing and  Direct interviews with randomly
reviewing quality objectives? selected people of the organization
d) Is communicated and understood  Evidence of periodic review of the
throughout the organization? quality policy
e) Is reviewed for continuing suitability?  Review of all the elements of the
(5.3) quality system to insure its continuing suitability
and effectiveness
5.4 QUALITY OBJECTIVES
5.4.1 Does the organizations top management ensure that
quality objectives, including those needed to meet
requirements for product (see section 7.1 of the
ISO/TS16949:2002 technical specification) are
established at relevant functions and levels within the
organization?
(5.4.1)
5.4.2 Are the organization’s quality objectives measurable  Quality cost indicators and quality indices
and consistent with the quality policy?  Quality objectives included/linked to the business
(5.4.1) plan
5.4.3 Did top management define any quality objectives  Quality objectives included/linked to the
and measurements? business plan
(5.4.1.1)  Scope of the quality objectives
5.4.4 Are the organization’s quality objectives and  Quality objectives included/linked to the
measurements included in the business plan and used business plan
by top management to deploy the organization’s  Management review meeting minutes,
quality policy? attendance and adequate frequency
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(5.4.1.1)
5.4.2 QUALITY MANAGEMENT SYSTEM
PLANNING
5.4.5 Does top management of the organization ensure  Internal audit results
that:
a) the planning of the quality management
system is carried out in order to meet the
general quality management system
requirements stated in section 4.1 of
ISO/TS16949:2002, as well as the quality
objectives?
b) The integrity of the quality management
system is maintained when changes to the
quality management system are planned and
implemented?
(5.4.2)
5.5 RESPONSIBILITY, AUTHORITY AND
COMMUNICATION
5.5.1 RESPONSIBILITY AND AUTHORITY
5.5.1 Does the organizations top management ensure that  Responsibilities and authority as
the responsibilities and authorities are defined and defined in job descriptions, responsibilities,
communicated within the organization? matrices, procedures and accountabilities
(5.5.1) documents.
5.5.1.1 QUALITY RESPONSIBILITY
5.5.2 Is management with responsibility and authority for  Select examples of non-compliance
corrective action promptly informed of products or from suitable sources such as internal or external
processes that do not conform to requirements? concerns/complaints etc.
(5.5.1.1)  Communication channels and
timeliness
5.5.3 Does the organizations personnel responsible for  Who is responsible for quality in the
quality have the authority to stop production to production process?
correct quality problems?  How the authority is defined?
(5.5.1.1)  Recent examples
5.5.4 Are the organizations production operations staffed  Quality Assurance responsible personnel in all
with personnel that ensure product quality across all shifts
shifts?
(5.5.1.1)
5.5.2 MANAGEMENT REPRESENTATIVE
5.5.5 Did the organization’s top management appoint a  Who is the person in charge of this
member of management who, irrespective of other responsibility?
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responsibilities, shall have responsibility and  Evidence of activities performed
authority that includes: including empowerment for all applicable system
a) ensuring that processes needed for the elements including design, sales, manufacturing,
quality management system are established, delivery, etc.
implemented and maintained?  Management review minutes
b) Reporting to top management on the
performance of the quality management
system and for any need for improvement?
c) Ensuring the promotion of awareness of
customer requirements throughout the
organization?
(5.5.2)
5.5.2.1 CUSTOMER REPRESENTATIVE
5.5.6 Did the organization’s top management designate  Quality function representative in project
individual(s) to represent the needs of the customer teams
to address quality requirements, such as selection of  Quality function participation in milestones
special characteristics, setting quality objectives and decision points (Production release, Engineering
related training, corrective and preventive actions, release…)
product design and development.  Responsibilities and job description of the
(5.5.2.1) customer representative (ex Quality function)
5.5.3 INTERNAL COMMUNICATION
5.5.7 Does top management ensure that appropriate  Communication channels and timeliness
communication processes are established within the
organization?
(5.5.3)
5.5.8 Does top management ensure that communication  Communication channels and timeliness
takes place within the organization regarding the
effectiveness of the quality management system?
(5.5.3)
5.6 MANAGEMENT REVIEW
5.6.4 GENERAL
5.6.1 Does the organization’s top management review its  Review of all the elements of the quality
quality management system, at planned intervals, to management system to insure its continuing
ensure its continuing suitability, adequacy and suitability and effectiveness
effectiveness?  Review of quality cost indicators
 Management review meeting minutes,
attendance and adequate frequency
(5.6.1)  Action plans and follow up
5.6.2 Do the organization’s management reviews include  Evidence of continuous improvement projects
assessing opportunities for improvement and the initiated from management reviews
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need for changes to the quality management system,
including the quality policy and quality objectives?
(5.6.1)
5.6.3 Are the organization’s records from management  Retention of management review meeting
reviews maintained? minutes
(5.6.1)
5.6.1.1 QUALITY MANAGEMENT SYSTEM
PERFORMANCE
5.6.4 Do the management reviews include all elements of  Review of all the elements of the quality
the quality management system and its performance system to insure its continuing suitability and
trends as an essential part of the continual effectiveness.
improvement process?  Trends in metrics (business and customer
satisfaction)
(5.6.1.1)  Basis for continuous improvement projects
5.6.5 Do the management reviews include monitoring of  Policy, business plan and customer
quality objectives, and the regular reporting and satisfaction metrics report
evaluation of the cost of poor quality (see elements  Product results (quality, cost, time) against
8.4.1 and 8.5.1 of ISO/TS16949:2002(E))? quality policy goals and customer specified
(5.6.1.1) targets
5.6.6 Are the results of the management reviews recorded  Trends in metrics (business and customer
to provide, as a minimum, evidence of the satisfaction)
achievement of:  Basis for continuous improvement projects
- objectives specified in the quality policy?  Management review meeting minutes
- Objectives specified in the business plan?  Action plans and follow up
- Customer satisfaction with product supplied?
(5.6.1.1)
5.6.2 REVIEW INPUT
5.6.7 Does the organization’s input to its management  Reports prepared for management reviews
review include information on:  Management review meeting minutes
a) results of audits  Action plans and follow up
b) customer feedback  Content of management review meeting agenda
c) process performance and product
conformity
d) status of preventive and corrective action
e) follow up actions from previous
management reviews
f) planned changes that could affect the
quality management system
g) recommendations for improvement
(5.6.2)
5.6.2.1 REVIEW INPUT – SUPPLEMENTAL
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5.6.8 Do management reviews include an analysis of  Content of management review meeting minutes
actual and potential field-failures and their impact on
quality, safety or the environment?
(5.6.2.1)
5.6.3 REVIEW OUTPUT
5.6.9 Does the output from the organization’s management  Examples of continuous improvement projects
review include any decisions and actions related to: initiated from management reviews
a) improvement of the effectiveness of the  Examples of product improvements initiated
quality management system and its from management reviews
processes?
b) Improvement of product related to customer
requirements?
c) Resource needs?
(5.6.3)
6 RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURCES
6.1.1 Does the organization determine and provide the  Job descriptions
resources needed  Training records
a) to implement and maintain the quality  Quality Plans
management system and continually  Shift staffing/supervision
improve its effectiveness?  Personnel workload
b) To enhance customer satisfaction by
meeting customer requirements?
(6.1)
6.2 HUMAN RESOURCES
6.2.1 GENERAL
6.2.2 Are the personnel performing work affecting product  Training records complementing the type of
quality competent on the basis of appropriate work that the personnel perform on the product
education, training, skills and experience?  Personnel records
(6.2.1)  Interviews with design personnel
6.2.2 COMPETENCE, AWARENESS AND
TRAINING
6.2.3 Does the organization  Job description
a) determine the necessary competence for  Qualification for each position
personnel performing work affecting  Training plan
product quality?  Training records
b) Provide training or take other actions to
satisfy these needs?
c) Evaluate the effectiveness of the actions
taken?
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d) Ensure that its personnel are aware of the
relevance and importance of their activities
and how they contribute to the achievement
of the quality objectives?
e) Maintain appropriate records of education,
training, skills and experience?
(6.2.2)
6.2.2.1 PRODUCT DESIGN SKILLS
6.2.4 Does the organization ensure that personnel with  Training records complementing the type of
product design responsibility are qualified to achieve design activity
design requirements and are skilled in applicable  Personnel records
tools and techniques?  Interviews with design personnel
(6.2.2.1)
6.2.5 Has the organization identified applicable tools and  Listing of tools needed for product design
techniques needed for product design?  Personnel training on product design techniques
needed
(6.2.2.1)  PO(s) on tools needed
6.2.2.2 TRAINING
6.2.6 Has the organization established and maintained  Quality Manual according to ISO/TS16949:2002
documented procedures for identifying training
needs and achieving competence of all personnel
performing activities affecting product quality.
(6.2.2.2)
6.2.7 Are the personnel performing specific assigned tasks  Training records complementing the type of
qualified on the basis of education, training, skills tasks assigned to personnel
and/or experience, as required?  Personnel records
(6.2.2.2)  Interviews with personnel
6.2.8 Has the organization given attention to training that  Evidence of personnel training that satisfies
satisfies customer specific requirements? customer specific requirements.
(6.2.2.2)
6.2.2.3 TRAINING ON THE JOB
6.2.9 Does the organization provide on the job training for  Training records for personnel in new
personnel in any new or modified job affecting assignments
product quality including contract or agency  Training records for contract personnel
personnel?
(6.2.2.3)
6.2.10 Are the personnel affecting quality, informed about  Training contents
the consequences to the customer of nonconformity
to quality requirements?
(6.2.2.3)
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6.2.2.4 EMPLOYEE MOTIVATION AND
EMPOWERMENT
6.2.11 Does the organization have a process for motivation  Incentive systems used
of employees to achieve quality objectives, to make
continual improvements and create an environment
to promote innovation?
(6.2.2.4)
6.2.12 Does the organizations employee motivation process  Scope of employee motivation
include promotion of quality and technological
awareness through the whole organization?
(6.2.2.4)
6.2.13 Does the organization have a process for  Measurement of employee satisfaction
measurement to ensure that its personnel are aware
of the relevance and importance of their activities
and how they contribute to the achievement of the
quality objectives?
(6.2.2.4)
6.3 INFRASTRUCTURE
6.3.1 Does the organization determine, provide and  Quality manual according to ISO/TS16949:2002
maintain the infrastructure needed to achieve  Product results – internal and external product
conformity to product requirements? failure rate
(6.3)
6.3.1 PLANT, FACILITY AND EQUIPMENT
PLANNING
6.3.2 Does the organization use a multidisciplinary  Team composition has to be cross functional
approach for developing plant, facility and
equipment plans?
(6.3.1)
6.3.3 Is the organizations plant layouts optimized for  Process flow analysis
material travel, handling and value-added use of  Plant layout (current and planned)
floor space and shall facilitate synchronous material
flow?
(6.3.1)
6.3.4 Has the organization developed and implemented  Metrics for ergonomics, automation, line
methods to evaluate and monitor the effectiveness of balance, inventory levels
existing operations?
(6.3.1)
6.3.2 CONTINGENCY PLANS
6.3.5 Has the organization prepared contingency plans to  Contingency Plans
satisfy the customer requirements in the event of an  Identification of key equipment
emergency, such as utility interruptions, labor
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shortages, key equipment failure and field returns?
(6.3.2)
6.4 WORK ENVIRONMENT
6.4.1 Does the organization determine and manage the  Quality manual according to ISO/TS16949:2002
work environment needed to achieve conformity to
product requirements?
(6.4)
6.4.1 PERSONNEL SAFETY
6.4.2 Does the organization’s quality policy and practices  Preventive activities in design and process
address the product safety and means to minimize control
potential risks to employees, especially in design and  Knowledge and application of legislation
development process and in the manufacturing  Risk analysis such as FMEA
process activities?  Results of internal/external audits including:
- System certifications
- Corrective actions
 Records of accidents
 Safety related customer
(6.4.1) complaints
6.4.2 CLEANLINESS OF PREMISES
6.4.3 Does the organization maintain its premises in a state  Tour of plant
of order cleanliness and repair consistent with the
product?
(6.4.2)
7 PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
7.1.1 Has the organization planned and developed the  Quality planning process
process needed for product realization?  Project planning process
(7.1)  Quality plans for new products
7.1.2 Is the organizations planning of product realization  Development of quality plan(s)
consistent with the requirements of the other
processes of the quality management system?
(7.1)
7.1.3 In planning product realization, does the organization  Quality plan and design record, control plan,
determine the following, as appropriate: operator instructions, product approval records,
a) quality objectives and requirements for the resources/facilities and any plans to enhance them
product?  Design validation at the various stages of the
b) The need to establish processes, documents, design
and provide resources specific to the  Link between process changes and updates in the
product? quality plan(s)
c) Required verification, validation,
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monitoring, inspection and test activities
specific to the product and the criteria for
product acceptance?
d) Records needed to provide evidence that the
realization processes and resulting product
meet requirements?
(7.1)
7.1.4 Is the organization’s planning of product realization  Product realization output format and content
output in a form suitable for the organization’s
method of operations?
(7.1)
7.1.1 PLANNING OF PRODUCT REALIZATION –
SUPPLEMENTAL
7.1.5 Are the customer requirements and references to its  Quality plans
technical specifications included in the planning of  Customer specifications
product realization as a quality plan?  Technical specifications
(7.1.1)
7.1.2 ACCEPTANCE CRITERIA
7.1.6 Did the organization define acceptance criteria for  Test specification
the product being developed and where required,  Product validation test plan with defined
approved by the customer? acceptance criteria
(7.1.2)
7.1.7 Is the organizations acceptance criteria for attribute  Acceptance criteria in test plan and test
data sampling zero defects? specifications
(7.1.2)
7.1.3 CONFIDENTIALITY
7.1.8 Does the organization ensure the confidentiality of  Information access security
customer contracted products and projects under  Security for product development
development, and related product information.
(7.1.3)
7.1.4 CHANGE CONTROL
7.1.9 Does the organization have a process to control and  Engineering change request process
react to changes that impact product realization  Change records
including those initiated by the supplier?
(7.1.4)
7.1.10 Does the organization assess the effects of changes?  Impact study including proprietary design
(7.1.4)  Change management process
7.1.11 Has the organization defined the verification and  Test specification
validation activities for changes, to ensure  Product validation test plan with defined
compliance with customer requirements? acceptance criteria
(7.1.4)
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7.1.12 Does the organization validate changes before  Evidence of design and production validation
implementation? tests conducted for product changes
(7.1.4)
7.1.13 Does the organization review proprietary designs,  Impact study including proprietary design
impact on form, fit, function, (including  Change management process
performance, and/or durability) with the customer so
that all effects can be properly evaluated
(7.1.4)
7.1.14 Does the organization meet additional  Design and production validation test report
verification/identification requirements such as those
required for the new product introduction when
required by the customer?
(7.1.4)
7.2 CUSTOMER RELATED PROCESSES
7.2.1 DETERMINATION OF REQUIREMENTS
RELATED TO THE PRODUCT
7.2.1 Does the organization determine:  Process for government, safety and
a) requirements specified by the customer, environmental regulations compliance
including the requirements for delivery and  Organization’s internal product specification
post delivery activities?
b) Requirements not stated by the customer
but necessary for specified or intended use,
where known?
c) Statutory and regulatory requirements
related to the product?
d) Any additional requirements determined by
the organization?
(7.2.1)
7.2.1.1 CUSTOMER DESIGNATED SPECIAL
CHARACTERISTICS
7.2.2 Can the organization demonstrate conformity to  Designation and control of special
customer requirements for designation, characteristics
documentation and control of special characteristics?  Quality documents: control plan,
specifications, drawings, etc. shall report the
(7.2.1.1) special characteristics designation
7.2.2 REVIEW OF REQUIREMENTS RELATED TO
THE PRODUCT
7.2.3 Does the organization review the requirements  Feasibility studies
related to a product prior to the organization’s
commitment to supply to the customer?
(7.2.2)
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7.2.4 Does the organization ensure that  Customer contract review
a) product requirements are defined?  Product specification review
b) Contract or order requirements differing  Resolution of differences
from those previously expressed are  Feasibility assessments
resolved?
c) The organization has the ability to meet the
defined requirements?
(7.2.2)
7.2.5 Does the organization maintain records of the results  Records of contract review
of the review and actions arising from the review?
(7.2.2)
7.2.6 Where the Customer provides no documented  Sign off design validation and production
statement of requirement, does the organization validation test plan with acceptance criteria
confirm the customer requirements before
acceptance?
(7.2.2)
7.2.2.1 ORGANIZATION MANUFACTURING
FEASIBILITY
7.2.7 Does the organization investigate, confirm and  Feasibility studies
document the manufacturing feasibility of the  Risk analysis
proposed products in the contract review process
including risk analysis?
(7.2.2.1)
7.2.3 CUSTOMER COMMUNICATION
7.2.8 Has the organization determined and implemented  Common language at the interface level
effective arrangements for communicating with
customers in relation to:
a) product information?
b) Enquires, contracts or order handling,
including amendments?
c) Customer feedback, including Customer
complaints?
(7.2.3)
7.2.3.1 CUSTOMER COMMUNICATION –
SUPPLEMENTAL
7.2.9 Does the organization have the ability to  Common language at the interface level
communicate necessary information including data  Common language for technical specifications
in a customer specified language and format? and important documents
 Customer/Supplier EDI system requirements
(7.2.3.1) and supplier capabilities
7.3 DESIGN AND DEVELOPMENT
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7.3.1 DESIGN AND DEVELOPMENT PLANNING
7.3.1 Does the organization plan and control the design  The organization taking lead in product design
and development of product? and development activities.
 The organization managing the product design
and development processes.
 Project records such as milestones decision
points are controlled and approved by the
(7.3.1) organization
7.3.2 During the design and development planning, does  Product design and development process
the organization determine:  Product design review; verification and
a) the design and development stages? validation process
b) The review, verification and validation that  Job description for product design and
is appropriate to each design and development personnel
development stage?
c) The responsibilities and authorities for
design and development?
(7.3.1)
7.3.3 Does the organization manage the interfaces between  Internal audit results
different groups involved in design and development  Review of organizational interfaces with roles
to ensure effective communication and clear and communication processes.
assignment of responsibility?
(7.3.1)
7.3.4 Is the organization’s product design and  Evidence of product design and development
development planning output updated, as planning output updated as design and
appropriate, as the design and development development progresses
progresses?
(7.3.1)
7.3.1.1 MULTIDISCIPLANRY APPROACH
7.3.5 Does the organization use a multidisciplinary  Functions represented in product development
approach to prepare for product realization, including teams.
- development/finalization and monitoring of  Personnel involved in definition of special
special characteristics? characteristics, FMEA and Control Plan
- Development, and review of FMEAs
including actions to reduce potential risks?
- Development, and review of control plans?
(7.3.1.1
7.3.2 DESIGN AND DEVELOPMENT INPUTS
7.3.6 Does the organization determine inputs relating to  Design input records and documents
product requirements and maintain the related
records?
(7.3.2)
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7.3.7 Does the organization’s inputs relating to product  Customer specification
requirements include:  Statutory and regulatory requirements
a) functional and performance requirements?  Previous/existing product design information
b) Applicable statutory and regulatory  Product benchmarking
requirements?
c) Where applicable, information derived from
previous similar designs?
d) Other requirements essential for design and
development?
(7.3.2)
7.3.8 Does organization review its inputs relating to  Customer specification analysis
product requirements for adequacy?  Feasibility contract review
(7.3.2)
7.3.9 Are the inputs relating to product requirements  Customer specification analysis
complete, unambiguous and not in conflict with each  Feasibility contract review minutes.
other?
(7.3.2)
7.3.2.1 PRODUCT DESIGN INPUT
7.3.10 Does the organization identify, document and review  Customer specification analysis
the product design inputs requirements including:  Feasibility contract review minutes
- customer requirements (contract review)?
- Use of information (the organization shall
have a process to deploy information
gained)?
- Targets for product quality, life, reliability,
durability, maintainability, timing and cost.
(7.3.2.1)
7.3.2.2 MANUFACTURING PROCESS DESIGN
INPUT
7.3.1.1 Does the organization identify, document and review  Design FMEA
the manufacturing process design input  Productivity, process capability, costs targets
requirements, including:  Regulations
- product design output data?  Customer requirements, if any
- Targets for productivity, process capability and  Experience from previous development
cost?
- Customer’s requirements if any?
- Experience from previous developments?
(7.3.2.2)
7.3.2.3 SPECIAL CHARACTERISTICS
7.3.12 Does the organization identify special characteristics  Process to establish special characteristics.
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and:  Design Records
- include all special characteristics in the control  Review customer requirements for special
plan? characteristics, definitions and symbol
- Comply with customer specified definitions and identification
symbols?  Control plans
- Identify process control documents including  Product drawings
drawings, FMEAs, control plans, and operator  Operator instructions
instructions with the customer’s special
characteristic symbol or the organization’s
equivalent symbol or notation to include those
process steps that affect special characteristics?
(7.3.2.3)
7.3.3 DESIGN AND DEVELOPMENT OUTPUTS
7.3.13 Does the organization provide outputs of design and  Design output records matching criteria
development in a form that enables verification established in design input requirements
against the design and development input and
approved prior to release?
(7.3.3)
7.3.14 Do the organization’s design and development  DV test reports that show test results;
outputs: acceptance criteria
a) meet the input requirements for design and  Engineering drawings
development?
b) Provide appropriate information for
purchasing, production and for service
provision?
c) Contain or reference product acceptance
criteria?
d) Specify the characteristics of the product
that are essential for its safe and proper use?
(7.3.3)
7.3.3.1 PRODUCT DESIGN OUTPUTS –
SUPPLEMENTAL
7.3.15 Is the organization’s product design output expressed  Design output records matching criteria
in terms that can be verified and validated against established in design input requirements?
product design input requirements?
(7.3.3.1)
7.3.16 Does the organization’s product design output  Availability of all applicable product design
include: output documents
- design FMEA, reliability results?
- Product special characteristics, specifications?
- Product error proofing, as appropriate?
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- Product definition including drawings?
- Product design reviews results?
- Diagnostic guidelines where applicable?
(7.3.3.1)
7.3.3.2 MANUFACTURING PROCESS DESIGN
OUTPUT
7.3.17 Is the organizations manufacturing process design  Process specifications and drawings
output expressed in terms that can be verified against  Process FMEAs
manufacturing process design input requirements and  Job instructions
validated?  Process approval, acceptance criteria
 Quality, reliability, maintainability data
 Mistake proofing activities results
 Nonconformity detection methods
(7.3.3.2)
 Product / process verification plans
7.3.18 Does the organization’s manufacturing process  Availability of all applicable process design
design output include: output documents
- specifications and drawings?
- Manufacturing process flow chart / layout?
- Manufacturing process FMEAs?
- Control plan?
- Work instructions?
- Process approval acceptance criteria?
- Data for quality, reliability, maintainability and
measurability?
- Results of error-proofing activities, as
appropriate?
- Methods of rapid detection and feedback of
product/manufacturing process non-
conformities?
(7.3.3.2)
7.3.4 DESIGN AND DEVELOPMENT REVIEW
7.3.19 Does the organization perform systemic reviews of  Design review planning and records
design and development at suitable stages in  Design review extended to all functions
accordance with planned arrangements: affected by it
a) to evaluate the ability of the results of  Product design and development status
design and development to fulfill reviews
requirements?  Link of corrective action to status reviews
b) To identify any problems and propose
necessary actions?
(7.3.4)
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7.3.20 Do the participants in the systematic reviews of  Link of corrective action to status/design
design and development identify any problems and reviews
propose necessary actions?
(7.3.4)
7.3.21 Are the records of the results of the reviews and any  Design review planning and records
necessary actions maintained by the organization? maintained
(7.3.4)
7.3.4.1 MONITORING
7.3.22 Does the organization define and analyze  Project reviews at different phases of product
measurements at specified stages of design and realization process for all active projects.
development and reported with summary results as  Policy deployment summary results
an input to management review.
(7.3.4.1)
7.3.5 DESIGN AND DEVELOPMENT
VERIFICATION
7.3.23 Does the organization perform design and  Design verification done according to the
development verification in accordance with planned planning
arrangements to ensure that the design and  Comparison between outputs and design
development outputs have satisfied the design and requirements
development input requirements?  Corrective actions based on results
(7.3.5)
7.3.24 Does the organization maintain records of the results  Design verification reports
of the verification and any necessary actions?
(7.3.5)
7.3.6 DESIGN AND DEVELOPMENT VALIDATION
7.3.25 Does the organization perform design and  Design validation against user
development validation, accordance with planned requirements/needs.
arrangements (see element 7.3.1 of  Comparison between customer plan and
ISO/TS16949:2002) to ensure that the resulting internal development plans
product is capable of meeting the requirements for  Design validation records
the specified application or intended use, where  Documented failure
known?
(7.3.6)
7.3.26 Wherever practicable, does the organization  Completion of product validation testing prior
complete design and development validation prior to to start of production
the delivery or implementation of the product?
(7.3.6)
7.3.27 Does the organization maintain records of the results  Product validation test report
of validation and any necessary actions?  Corrective action process for the design
activity
(7.3.6)  Corrective action records
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7.3.6.1 DESIGN AND DEVELOPMENT VALIDATION
– SUPPLEMENTAL
7.3.28 Does the organization perform design and  Design validation against user requirements /
development validation in accordance with customer needs
requirements including program timing?  Comparison between customer plan and
internal development plan
 Design validation records
(7.3.6.1)  Documented failure
7.3.6.2 PROTOTYPE PROGRAM
7.3.29 When required by the customer, does the  Prototype facilities
organization have a prototype program and control  Prototype records
plan?  Prototype control plan
(7.3.6.2)
7.3.30 Wherever possible, does the organization use the  Design/prototype/production tooling
same suppliers, tooling and manufacturing processes  Prototype realization and test conditions must
as it will be used in production? be known and controlled
(7.3.6.2)
7.3.31 Does the organization monitor all performance  Test records
testing activities for timely completion and
conformance to requirements?
(7.3.6.2)
7.3.32 Is the organization responsible for the subcontracted  Subcontractor management as appropriate
services, including technical leadership?
(7.3.6.2)
7.3.6.3 PRODUCT APPROVAL PROCESS
7.3.33 Does the organization conform to a product and  Compliance with customer requirements
process approval procedure recognized by the regarding product approval process
customer?
(7.3.6.3)
7.3.34 Does the organization apply a product and process  Product approval process documentation and
approval procedure recognized by the customer to its records for suppliers
suppliers?
(7.3.6.3)
7.3.7 CONTROL OF DESIGN AND DEVELOPMENT
CHANGES
7.3.35 Does the organization identify design and  Change records
development changes and maintain records relevant
to those changes?
(7.3.7)
7.3.36 Does the organization review, verify and validate  Design change approval process
Page 21 Of44
design and development changes, as appropriate, and
approved before implementation?
(7.3.7)
7.3.37 Does the organization’s review of design and  Impact study including proprietary design
development changes include evaluation of the effect  Change management process
of the changes on constituent parts and already
delivered product?
(7.3.7)
7.3.38 Does the organization maintain records of the results  Change records
for the review of design and development changes
and any necessary actions?
(7.3.7)
7.4 PURCHASING
7.4.1 PURCHASING PROCESS
7.4.1 Does the organization ensure that purchased product  Organization’s incoming inspection
conforms to specified purchase requirements?  Source inspection
(7.4.1)  Process audit at supplier’s site
7.4.2 Does the organizations type and extent of control  Control methods determined by effect of the
applied to the supplier and the purchased product purchased product on subsequent product
depend upon the effect of the purchased product on realization or final product
subsequent product realization or the final product?
(7.4.1)
7.4.3 Does the organization evaluate and select suppliers  Selection system
based on their ability to supply products in  Performance rating system
accordance with the organization’s requirements?  Organization’s supplier manual
(7.4.1)
7.4.4 Has the organization established criteria for  Selection system
selection, evaluation and re-evaluation of its  Performance rating system
suppliers?
(7.4.1)
7.4.5 Does the organization maintain records of the results  Suppliers 2nd party audit results conducted by
of supplier evaluations and any necessary actions the organization
arising from the supplier evaluation?  Approved supplier records
(7.4.1)
7.4.1.1 REGULATORY COMPLIANCE
7.4.6 Do all purchase products or materials used in the  Audit results from government and
organization’s product satisfy applicable regulatory environment organizations
requirements?  Supplier internal audits
 Warrants or certificates of compliance
(7.4.1.1)  Audits of suppliers
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7.4.1.2 SUPPLIER QUALITY MANAGEMENT
SYSTEM DEVELOPMENT
7.4.7 Are the organization’s suppliers registered to  Copies of suppliers ISO9001:2000 certificates
ISO9001:2000 by a third party?
(7.4.1.2)
7.4.8 Does the organization perform quality management  Supplier development process
system development with the goal of supplier  Evidence of subcontractor development
compliance to ISO/TS16949:2002?
(7.4.1.2)
7.4.1.3 CUSTOMER APPROVED SOURCES
7.4.9 Where specified by the contract, does the  Approved suppliers list if applicable
organization purchase products, materials or services  How are these lists used?
from approved sources?
(7.4.1.3)
7.4.10 Is the organization responsible for ensuring the  Scope of organization’s incoming inspection
quality of purchased products supplied by customer- includes purchased products supplied by
designated sources, including tool/gage suppliers? customer designated sources
 Scope of organization’s supplier management
(7.4.1.3) process includes customer designated sources
7.4.2 PURCHASING INFORMATION
7.4.1.1 Does the organization’s purchasing information  Purchase order / release
describe the product to be purchased, including  Commercial contract
where appropriate:
a) requirements for approval of product,
procedures, processes and equipment?
b) Requirements for qualification of
personnel?
c) Quality management system requirements?
(7.4.2)
7.4.12 Does the organization ensure the adequacy of  Review of contract/purchase order extends to
specified purchase requirements prior to their suppliers
communication to the supplier?
(7.4.2)
7.4.3 VERIFICATION OF PURCHASED PRODUCT
7.4.13 Does the organization establish and implement the  Incoming inspection plans
inspection or other activities necessary for ensuring
that purchased product meets specified purchase
requirements?
(7.4.3)
7.4.14 Where the organization or its customer intends to  Supplier and subcontractors
perform verification at the supplier’s premises, does
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the organization state the intended verification  Purchase order and contract
arrangements and method of product release in the
purchasing information?
(7.4.3)
7.4.3.1 INCOMING PRODUCT QUALITY
7.4.15 Does the organization have a process to ensure the  Subcontractor performance records
quality of purchased product utilizing one or more of  Subcontractor corrective action
the following methods:
- receipt of and evaluation of statistical data by
the organization?
- Receiving inspection and/or testing such as
sampling based on performance?
- Second or third party assessments or audits of
supplier sites, when coupled with records of
acceptable quality performance?
- Part evaluation by a designated laboratory?
- Another method agreed with the customer?
(7.4.3.1)
7.4.3.2 SUPPLIER MONITORING
7.4.16 Does the organization monitor supplier performance  Subcontractor performance records
through the following indicators:  Subcontractor corrective action
- Delivered part quality performance?
- Customer disruptions including field returns?
- Delivery schedule performance (including
incidents of premium freight)?
(7.4.3.2)
7.4.17 Does the organization promote supplier monitoring  Evidence of continuous improvements
of their manufacturing processes’ performance? implemented by the suppliers through review
of their own monitoring of manufacturing
(7.4.3.2) processes’ performance
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 CONTROL OF PRODUCTION AND SERVICE
PROVISION
7.5.1 Does the organization plan and carry out production  Tour of plant and facilities
and service provision under the following controlled  Master part or correct level assembly
conditions, as applicable: drawings
a) the availability of information that describes  Work instructions at work stations
the characteristics of the product?
b) The availability of work instructions, as
necessary?
c) The use of suitable equipment?
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d) The availability and use of monitoring and
measuring devices?
e) The implementation of monitoring and
measurement?
f) The implementation of release, delivery and
post delivery activities?
(7.5.1)
7.5.1.1 CONTROL PLAN
7.5.2 Does the organization:  Control plans for different product levels
- develop control plans at the system subsystem,  DFMEA and PFMEA were used as inputs to
component and/or material level, for the the control plans.
product supplied, including those for bulk
materials produced by the organization and all
purchased products and materials?
- Have a control plan for pre-launch and
production that take into account the design
FMEA and manufacturing process FMEA
outputs?
(7.5.1.1)
7.5.3 Does the organization’s control plan:  Review of control plans
- list the controls used for the  Control plans for applicable stages
manufacturing process control?  Control plan framework with data
- Includes methods for monitoring
and recording results of control
exercised over special
characteristics (see 7.3.2.3 of
ISO/TS16949:2002) defined by
both the customer and the
organization?
- Include the customer required
information if any?
- Initiate the specified reaction plan
(See 8.2.3.1 of
ISO/TS16949:2002) when the
process becomes unstable or non
capable?
(7.5.1.1)
7.5.4 Does the organization review and update control  Matching between product/process changes,
plans when any change occurs affecting product, instability / non capability process results, and
manufacturing process, measurement, logistics, control plans updating
supply sources or FMEA (see 7.1.4 of
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ISO/TS16949:2002)?
(7.5.1.1)
7.5.1.2 WORK INSTRUCTIONS
7.5.5 Has the organization prepared documented work  Availability of job instructions at the
instructions for all employees having responsibilities workstation
for the operation of processes?
(7.5.1.2)
7.5.6 Are the organization’s work instructions accessible  Availability of job instructions at the
for use at the workstation? workstation
(7.5.1.2)
7.5.7 Are the organization’s work instructions derived  Link between job instructions and source
from sources such as the quality plan, the control documents, e.g. Control Plan, design record,
plan and the product realization process? FMEA
(7.5.1.2)
7.5.1.3 VERIFICATION OF JOB SET-UPS
7.5.8 Does the organization verify job set-ups whenever  Job set up records and approval
performed?
(7.5.1.3)
7.5.9 Are the organization’s work instructions available  Set up instructions
for set up personnel?
(7.5.1.3)
7.5.10 Does the organization use statistical methods of  Job set up records
verification of job set-ups where applicable?
(7.5.1.3)
7.5.1.4 PREVENTIVE AND PREDICTIVE
MAINTENANCE
7.5.11 Does the organization identify key process  Existence of preventive maintenance
equipment and provide resources for
machine/equipment maintenance and develop an
effective planned total preventive maintenance
system?
(7.5.1.4)
7.5.12 Does the organization’s preventive maintenance  System effectiveness demonstrated by
system minimally include the following: specifics measurement indicator
- planned maintenance activities?  Key equipment list
- Packaging and preservation of  Maintenance records
equipment, tooling and gauging?  Predictive maintenance examples
- Availability of replacement parts  Plant tour
for key manufacturing equipment?
- Documenting, evaluating and
improving maintenance objectives?
Page 26 Of44
(7.5.1.4)
7.5.13 Does the organization utilize predictive maintenance  Predictive maintenance examples
methods to continually improve the effectiveness of
its preventive system?
(7.5.1.4)
7.5.14 Does the organization provide resources for tool and  Tool/gage design staffing and qualification
gage design, fabrication and verification activities?
(7.5.1.5)
7.5.15 Does the organization establish and implement a  Tool management process
system for tooling management including:
- maintenance and repair facilities and
personnel?
- Storage and recovery?
- Set up?
- Tool change programs for perishable tools?
- Tool design modification documentation,
including engineering change level?
- Tool modification and revision to
documentation?
- Tooling identification defining the status?
(7.5.1.5)
7.5.16 Has the organization implemented a system to  Subcontractor management system (choice,
monitor its tooling management activities if any evaluation and control)
work is outsourced?
(7.5.1.5)
7.5.1.6 PRODUCTION SCHEDULING
7.5.17 Is the organization’s production scheduled in order to  Process for production scheduling
meet customer requirements?  The scheduling system should be based on a
(7.5.1.6) “pull” and not on a “push” system
7.5.1.7 FEEDBACK OF INFORMATION FROM
SERVICE
7.5.18 Has the organization established and maintained a  Meeting reports, follow up and corrective
process for communication of information on service actions/responsibility/dates
concerns to manufacturing, engineering and design  Product service data
activities?
(7.5.1.7)
7.5.1.8 SERVICING AGREEMENT WITH
CUSTOMER
7.5.19 When there is a servicing agreement with the  Planning of periodical audits
customer, does the organization verify the  Reports and follow up
effectiveness of:
Page 27 Of44
- any organization service centers?
- Special purpose tools or measurement
equipment?
- Training of servicing personnel?
(7.5.1.8)
7.5.2 VALIDATION OF PROCESSES FOR
PRODUCTION AND SERVICE PROVISION
7.5.20 Does the organization validate any processes for all  Process validation / capability studies results
its production and service provision where the  Process parameters monitoring and control
resulting output cannot be verified by subsequent evidence
monitoring or measurement?
(7.5.2)
7.5.21 Does the organization’s validation of processes for  Process validation/capability results
all its production and service provision demonstrate
the ability of these processes to achieve planned
results?
(7.5.2)
7.5.22 Has the organization established arrangements for all  Requirement specification for operations,
its processes for production and service provision equipment and personnel
including, as applicable:  Related records of qualification
a) defined criteria for review and approval of  Frequency and conditions of revalidation
the processes?
b) Approval of equipment and qualification of
personnel?
c) Use of specific methods and procedures?
d) Requirements for records?
e) Revalidation?
(7.5.2)
7.5.3 IDENTIFICATION AND TRACEABILITY
7.5.23 Does the organization identify the product by  Check for positive recall
suitable means throughout product realization?  Suitable product identification throughout the
facility
 Traceability from raw materials to delivered
(7.5.3) product.
7.5.24 Does the organization identify the product status  Clear identification of work in process,
with respect to monitoring and measurement finished goods and rejected goods and/or
requirements? components
(7.5.3)  Inspection records
7.5.25 Where traceability is a requirement, does the  Traceability system
organization control and record the unique
identification of the product (see 4.2.4 of
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ISO/TS16949:2002)?
7.5.3)
7.5.4 CUSTOMER PROPERTY
7.5.26 Does the organization exercise care with customer  Handling procedure of customer properly
properly while it is under the organization’s control
or being used by the organization?
(7.5.4)
7.5.27 Does the organization identify, verify, protect and  Product identification
safeguard customer property provided for use or  Storage environment
incorporation into the product?
(7.5.4)
7.5.28 Does the organization report to the customer and  Damage to customer supplied product reports
maintain records for customer property that is lost,  What happened to customer owned returnable
damaged or otherwise found to be unsuitable for packaging? How was it accounted for?
use?
(7.5.4)
7.5.4.1 CUSTOMER OWNED TOOLING
7.5.29 Are the customer owned tools, manufacturing, test,  Permanent identification of tooling and
inspection tooling and equipment permanently equipment ownership
marked so that the ownership of each item is visible,
and can be determined?
(7.5.4.1)
7.5.5 PRESERVATION OF PRODUCT
7.5.30 Does the organization preserve the conformity of  Procedure development and documentation
product during internal processing and delivery to  Plant tour
the intended destination?
(7.5.5)
7.5.31 Does the organization’s preservation of product  Product preservation procedures
include identification, handling, packaging, storage  Plant tour
and protection.
((7.5.5)
7.5.32 Does the organization’s preservation of production  Scope product preservation procedures
apply to the constituent parts of a product?  Plant tour
(7.5.5)
7.5.5.1 STORAGE AND INVENTORY
7.5.33 Does the organization assess the condition of product  Storage product specifications
in stock at appropriate planned intervals to detect  Inspection records
deterioration?  Plant tour
(7.5.5.1)
7.5.34 Does the organization use an inventory management  Inventory management system
system to optimize inventory turns over time and
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assure stock rotation?  Evidence of FIFO
(7.5.5.1)  Control of obsolete product
7.5.35 Does the organization control obsolete product in a  Obsolete products stored in quarantine area
similar manner to nonconforming product?
(7.5.5.1)
7.6 CONTROL OF MONITORING AND
MEASURING DEVICES
7.6.1 Has the organization determined the monitoring and  Test equipment accuracy and precision
measurement to be undertaken and the monitoring capability related to the required measurement
and measuring devices needed to provide evidence of
conformity of product to determined requirements?
(7.6)
7.6.2 Has the organization established processes to ensure  Monitoring and measurement trials during
that monitoring and measurement can be carried out prototype builds
and are carried out in a manner that is consistent with  Procedure address in organization’s quality
the monitoring and measurement requirements? manual in accordance to ISO/TS16949:2002
(7.6)
7.6.3 Where necessary to ensure valid results, are the  Test equipment inventory
organization’s measuring equipment:  Certifications for calibration masters and their
a) calibrated or verified at specified intervals, traceability to international and/or national
or prior to use, against measurement recognized standard
standards traceable to international or  Calibration record results
national measurement standards?  Method of control of calibration settings
b) Adjusted or re-adjusted as necessary?  Calibration status identification
c) Identified to enable the calibration status to
be determined?
d) Safeguarded from adjustments that would
invalidate the measurement result?
e) Protected from damage and deterioration
during handling, maintenance and storage?
(7.6)
7.6.4 Does the organization assess and record the validity  Records of re-inspected product
of the previous measuring results when the
equipment is found not to conform to requirements?
(7.6)
7.6.5 Does the organization take appropriate action on the  Actions taken on the equipment that are found
equipment that is found not conforming to not conforming to requirements and any
requirements and any product affected by it? product that was affected by it
(7.6)
7.6.6 Does the organization maintain records of the results  Gage study records
of calibration and verification (see 4.2.4 of
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ISO/TS16949:2002)?
(7.6)
7.6.7 When the equipment is used in the monitoring and  Product labeling system
measurement of specified requirements, has the  Customer requirements
organization confirmed the ability of computer  Labeling audit
software to satisfy the intended application?
(7.6)
7.6.8 Has the organization undertaken the confirmation of  Test software / comparative references
computer software satisfying an intended application validation
prior to initial use and reconfirmed as necessary?
(7.6)
7.6.1 MEASUREMENT SYTEM ANALYSIS
7.6.9 Does the organization conduct statistical studies to  Measurement system analysis studies
analyze the variation present in the results of each including Gage Repeatability and
type of measuring and test equipment system? Reproducability
(7.6.1)
7.6.10 Does the organization conduct measurement system  Measurement system analysis results
analysis for measurement systems referenced in the
control plan?
(7.6.1)
7.6.11 Does the organization use measurement system  Check methods against customer
analytical methods and acceptance criteria that measurement system analysis requirements
conform to those in customer reference manuals on  Customer approval records, for other
measurement systems analysis? analytical methods used
(7.6.1)
7.6.2 CALIBRATION RECORDS
7.6.12 Does the organization’s records of the calibration  Measurement equipment records
activity for all gages, measuring and test equipment,  Original specification of measurement
including employee and customer owned gages, equipment
include:
a) equipment identification including the
measurement standard against which the
equipment is calibrated?
b) Revisions following engineering changes?
c) Any out of specification readings as
received for calibration/verification?
d) An assessment of the impact of out of
specification condition?
e) Statements of conformance to specification
after calibration/verification?
f) Notification to the customer if suspect
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product or material has been shipped?
(7.6.2)
7.6.3 LABORATORY REQUIREMENTS
7.6.3.1 INTERNAL LABORATORY
7.6.13 Does the organization’s internal laboratory facility  Laboratory scope
have a defined scope that includes capability to
perform the required inspection, test or calibration
services?
(7.6.3.1)
7.6.14 Is the organization’s lab scope included in the quality  Organization’s quality manual per
management system and comply with technical ISO/TS16949:2002
requirements including:
- adequacy of the laboratory procedures
- qualifications of the laboratory personnel
conducting tests?
- Testing of the commodity?
- Performing these tests correctly, traceable to
the relevant process standard?
- Review of the related quality records?
(7.6.3.1)
7.6.3.2 EXTERNAL LABORATORY
7.6.15 Do the external / commercial / independent  Commercial Laboratory Accreditation records
laboratory facilities used for inspection, test or
calibration services by the organization have a
defined laboratory scope that includes capability to
perform the required inspection, test or calibration
and:
- be accredited to ISO/IEC 17025 or national
equivalent?
- Have evidence that the external laboratory is
acceptable to the customer?
(7.6.3.2)
8 MEASUREMENT, ANALYSIS AND
IMPROVEMENT
8.1 GENERAL
8.1.1 Has the organization planned and implemented the  Internal audit results
monitoring, measurement, analysis and improvement  Product conformance data
processes needed
a) to demonstrate conformity of the product?
b) To ensure conformity of the quality
management system?
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c) To continually improve the effectiveness of
the quality management system?
(8.1)
8.1.2 Has the organization determined the applicable  Methods used for organization’s monitoring,
methods and the extent of their use for its measurement, analysis and improvement
monitoring, measurement, analysis and improvement processes
processes?
(8.1)
8.1.1 IDENTIFICATION OF STATISTICAL TOOLS
8.1.3 Does the organization determine the appropriate  Review of control plan
statistical tools for each process during advance  Review of quality plan
quality planning and included in the control plan?  Plant tour
(8.1.1)
8.1.2 KNOWLEDGE OF BASIC STATISTICAL
CONCEPTS
8.1.4 Does the organization understand basic statistical  Interview with personnel including
concepts , such as variation, control (stability), management demonstrating the knowledge of
process capability and over-adjustment? major statistical concepts like variation and
distribution, process control, cause and effect
relationship, common and special causes
(8.1.2)  Statistical techniques training records
8.1.5 Does the organization utilize basic statistical  Basic statistical study reports
concepts throughout its establishment?
(8.1.2)
8.2 MONITORING AND MEASUREMENT
8.2.1 CUSTOMER SATISFACTION
8.2.1 Does the organization monitor information relating  Review of information relating to customer
to customer perception as to whether the satisfaction routinely/set interval
organization has met customer requirements as one  Customer satisfaction performance indicators
of the performance of the quality management
system?
(8.2.1)
8.2.2 Has the organization determined the methods for  Methods for obtaining information relating to
obtaining information relating to customer customer perception as to whether the
perception as the whether the organization has met organization has met customer requirements
customer requirements?
(8.2.1)
8.2.1.1 CUSTOMER SATISFACTION –
SUPPLEMENTAL
8.2.3 Does the organization monitor customer satisfaction  Continual evaluation of performance of
through continual evaluation of performance of the
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realization process? realization processes.
(8.2.1.1)
8.2.4 Are the organization’s performance indicators for  Review of performance indicators for
customer satisfaction based on objective data and customer satisfaction
include, but not limited to:
- delivered part quality
performance?
- Customer disruptions including
field returns?
- Delivery schedule performance
(including incidents of premium
freight)?
- Customer notifications related to
quality or delivery issues?
(8.2.1.1)
8.2.5 Does the organization monitor manufacturing  Measurement of manufacturing processes
processes performance to demonstrate compliance against compliance to customer requirements
with customer requirements for product quality and
efficiency of the process?
(8.2.1.1)
8.2.2 INTERNAL AUDIT
8.2.6 Does the organization conduct internal audits at  Audit schedule
planned intervals to determine whether the quality  Records of performed audits
management system:
a) conforms to the planned arrangements (see
7.1) to the requirements of
ISO/TS16949:2002 and to the quality
management system requirements
established by the organization?
b) Is effectively implemented and maintained?
c) (8.2.2)
8.2.7 Has the organization planned for an audit program  Appropriate prioritization
that takes into consideration the status and
importance of the processes and areas to be audited,
as well as the results of previous audits?
(8.2.2)
8.2.8 Has the organization defined the internal audit  Audit schedule
criteria, scope, frequency and methods?  Internal audit procedure stated in quality
(8.2.2) manual
8.2.9 Does the organization ensure objectivity and  Organization charts
impartiality of the audit process in the selection of  Auditors only conduct audits in areas that are
Page 34 Of44
auditors and conduct of internal audits? independent of their job functions
8.2.10 Has the organization defined the responsibilities and  Department or individual responsible for
requirements for planning and conducting audits, and internal audit activities and also the reporting
for reporting results and maintaining records in a of audit results to upper management
documented procedure?
8.2.11 Does the management responsible for the area being  Closure time for audit findings
audited ensure that actions are taken without undue
delay to eliminate detected non-conformities and
their causes?
(8.2.2)
8.2.12 Does the organization’s internal audit follow up  Records of verification
activities include the verification of the actions taken
and the reporting of verification results (see element
8.5.2 of ISO/TS16949:2002)??
(8.2.2)
8.2.2.1 QUALITY MANAGEMENT SYSTEM AUDIT
8.2.13 Does the organization audit its quality management  Audit plans and schedule
system to verify compliance with ISO/TS16949:2002  Interview with different area managers
and any additional quality management system  Audit reports
requirements?
(8.2.2.2)
8.2.2.2 MANUFACTURING PROCESS AUDIT
8.2.14 Does the organization audit each manufacturing  Audit plans
process to determine its effectiveness  Audit reports
8.2.2.3 PRODUCT AUDIT
8.2.15 Does the organization audit products at appropriate  Audit plan, process flow chart and schedule
stages of production and delivery to verify  Product audit procedure and reports
conformance to all specified requirements at a
defined frequency?
(8.2.2.3)
8.2.2.4 INTERNAL AUDIT PLANS
8.2.16 Does the organization’s internal audits cover all  Audit plan
quality management related processes, activities and  Audit schedule
shifts, and scheduled according to an annual plan?
(8.2.2.4)
8.2.17 Does the organization increase its audit frequency  Audit schedule
appropriately when internal/external non-  Appropriate prioritization
conformities or customer complaints occur?
(8.2.2.4)
8.2.2.5 INTERNAL AUDITOR QUALIFICATION
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8.2.18 Are the organization’s internal auditors qualified to  Compliance to customer requirements
audit the requirements of ISO/TS16949:2002 (see
element 6.2.2.2)?
(8.2.2.5)
8.2.3 MONITORING AND MEASUREMENT OF
PROCESSES
8.2.19 Does the organization apply suitable methods for  Methods of monitoring/measuring of quality
monitoring and, where applicable, measurement of management system processes
the quality management system processes?
(8.2.3)
8.2.20 Does the organization’s methods for monitoring and  Monitoring and measurement results
measurement of processes demonstrate the ability of
the processes to achieve planned results?
(8.2.3)
8.2.21 When planned results are not achieved by the  Planned/executed corrective actions
organization’s processes, does the organization take
correction and corrective action to ensure conformity
of the product?
(8.2.3)
8.2.3.1 MONITORING AND MEASUREMENT OF
MANUFACTURING PROCESSES
8.2.22 Does the organization perform process studies on all  Preliminary process capability results
new manufacturing processes to verify process  Production control plan
capability and to provide additional input for process
control?
(8.2.3.1)
8.2.23 Does the organization document the results of  Process study reports
process studies with specifications where applicable  Plan/executed actions from process study
for means of production, measurement and test, and results
maintenance instructions?
(8.2.3.1)
8.2.24 Does the organization’s documents for monitoring  Monitoring and measurement of
and measurement of manufacturing processes manufacturing process documents
include objectives for manufacturing process
capability, reliability, maintainability and availability
as well as acceptance criteria?
(8.2.3.1)
8.2.25 Does the organization maintain manufacturing  Current Cpk/Ppk versus customer approved
process capability or performance as specified by the Cpk/Ppk
customer part approval process requirements?  Existing reaction plan
 Verifying the accuracy of Cpk/Ppk
Page 36 Of44
(8.2.3.1) calculations
8.2.26 Does the organization ensure that the control plan  Review of production line to process flow
and process flow diagram are implemented, diagram and control plan
including adherence to the specified:
- measurement techniques?
- sampling plans?
- Acceptance criteria?
- Reactions plans when acceptance
criteria are not met?
(8.2.3.1)
8.2.27 Does the organization note significant process events  Review of control charts
on the control charts?
(8.2.3.1)
8.2.28 Does the organization initiate the appropriate  Records of reaction taken
reaction plan from the control plan for characteristics
that are either unstable or non-capable?
(8.2.3.1)
8.2.29 Does the organization’s reaction plans for  Contents of reaction plan for unstable and
characteristics that are either unstable or non-capable non-capable processes
include containment of product and 100% inspection  Records
as appropriate?
(8.2.3.1)
8.2.30 Does the organization establish a corrective action  Corrective action reports
following the initiation of reaction plans, indicating
specific timing and assigned responsibilities to
assure that the process becomes stable and capable?
(8.2.3.1)
8.2.31 Are the organization’s corrective action plans  Corrective action approval process
reviewed with and approved by the customer when  Corrective action reports
so required?
(8.2.3.1)
8.2.32 Does the organization maintain records of effective  Records of process change dates
dates of process changes?
(8.2.3.1)
8.2.4 MONITORING AND MEASUREMENT OF
PRODUCT
8.2.33 Does the organization monitor and measure the  Control plans
characteristics of the product to verify that product  Inspection Instructions
requirements have been met?  Records
(8.2.4)
8.2.34 Does the organization monitor and measure the  Control plans
Page 37 Of44
characteristics of the product at appropriate stages of  Inspection instructions
the product realization process in accordance with  Records
the planned arrangements (see element 7.1 of
ISO/TS16949:2002)?
(8.2.4)
8.2.35 Does the organization maintain evidence of product  Inspection records that include acceptance
conformity with the acceptance criteria? criteria, inspector performing the test, test
(8.2.4) status and testing date
8.2.36 Does the organization’s records on monitoring and  Inspection records that indicate the person(s)
measurement of product indicate the person(s) authorizing release of product
authorizing release of product (see element 4.2.4 of
ISO/TS16949:2002)?
(8.2.4)
8.2.37 Are the organization’s product releases and service  Release of product and service delivery after
delivery proceeding only after all the planned all planned arrangement is satisfactorily
arrangements (see element 7.1 of completed
ISO/TS16949:2002) have been satisfactorily
completed, unless otherwise approved by a relevant
authority, and where applicable by the customer?
(8.2.4)
8.2.4.1 LAYOUT INSPECTION AND FUNCTIONAL
TESTING
8.2.38 Does the organization perform a layout inspection  Layout inspection reports
and a functional verification to applicable customer  Control Plan
engineering material and performance standards for
all products at a sufficient frequency as specified in
the control plan?
(8.2.4.1)
8.2.39 Does the organization have layout inspection and  Inspection records that include acceptance
functional testing results available for customer criteria, inspector performing the test, test
review? status and testing date
(8.2.4.1)
8.2.4.2 APPEARANCE ITEMS
8.2.40 For organizations manufacturing parts designated by  Maintenance / Control and storage conditions
the customer as “appearance items” does the of masters
organization provide:  Visual aids
- appropriate resources including  Personnel qualification / training records
lighting for evaluation?  Tour of facility
- Masters for color, grain, gloss,
metallic brilliance, texture,
distinctness of image (DOI) as
Page 38 Of44
appropriate?
- Maintenance and control of
appearance masters and evaluation
equipment?
- Verification that personnel making
appearance evaluations are
qualified to do so?
(8.2.4.2)
8.3 CONTROL OF NONCONFORMING
PRODUCT
8.3.1 Does the organization ensure that product which  Follow one or more nonconforming case and
does not conform to product requirements is verify the flow (identification, segregation,
identified and controlled to prevent its unintended etc.)
use or delivery?  Obsolete products
(8.3)
8.3.2 Does the organization define the controls and related  Procedure addressed in quality manual
responsibilities and authorities for dealing with
nonconforming product in a documented procedure?
(8.3)
8.3.3 Does the organization deal with nonconforming  Follow one or more non-conforming cases and
product by one or more of the following ways: verify the visual identification and segregation
a) by taking action to eliminate the detected area
nonconformity?  Records of concession
b) By authorizing its use, release or acceptance
under concession by a relevant authority
and, where applicable, by the customer?
c) By taking action to preclude its original
intended use or application?
8.3.4 Does the organization maintain records of the nature  Records
of nonconformities and any subsequent actions
taken, including concessions obtained (see element
4.2.4 of ISO/TS16949:2002)?
(8.2.3)
8.3.5 When nonconforming product is corrected, does the  Instruction for re-qualifying corrected
organization re-verify to demonstrate conformity to nonconforming product
the requirements?
(8.2.3)
8.3.6 When nonconforming product is detected after  Follow one or more nonconforming cases and
delivery or use has started, does the organization take verify the flow (identification, segregation,
action appropriate to the effects, or potential effects etc.)
of the nonconformity?
Page 39 Of44
(8.2.3)
8.3.1 CONTROL OF NONCONFORMING
PRODUCT – SUPPLEMENTAL
8.3.7 Does the organization classify unidentified or  Follow one or more nonconforming cases and
suspect status product as nonconforming product verify the flow (identification, segregation,
(see 7.5.3 of ISO/TS16949:2002)? etc.)
(8.3.1)
8.3.2 CONTROL OF REWORKED PRODUCT
8.3.8 Are the organization’s instructions for rework,  Rework instructions
including re-inspection requirements accessible and
utilized by the appropriate personnel?
8.3.3 CUSTOMER INFORMATION
8.3.9 Does the organization inform the customers  Follow one or more nonconforming cases and
promptly in the event that nonconforming product verify the flow (identification, segregation,
has been shipped? etc.)
(8.3.3)  Procedure stated in quality manual
8.3.4 CUSTOMER WAIVER
8.3.10 Does the organization obtain customer concession or  Following one or more nonconforming cases
deviation permit prior to further processing and verify the flow (identification,
whenever the product or manufacturing process is segregation, etc. )
different from that which is currently approved?
(8.3.4)
8.3.11 Does the organization maintain a record of the  Record of concession with expiration date
expiration date or quantity authorized by customer
concession or deviation permit?
(8.3.4)
8.3.12 Does the organization ensure compliance with the  Inspection results
original or superseding specifications and
requirements when the authorization for deviation
expires?
(8.3.4)
8.3.13 Does the organization properly identify on each  Proper label/identification for material
shipping container material shipped on an shipped on authorization
authorization?
(8.3.4
8.3.14 Does the organization apply the customer waiver  Process defined in quality manual
requirements for production product to purchased
product as well?
(8.3.4)
8.3.15 Does the organization agree with any product  Process defined in quality manual
Page 40 Of44
concession requests from suppliers before
submission to the customer?
(8.3.4)
8.4 ANALYSIS OF DATA
8.4.1 Does the organization determine, collect and analyze  Internal performance data such as:
appropriate data to demonstrate the suitability and - Poor quality cost indicators
effectiveness of the quality management system and - Effectiveness and efficiency of
to evaluate where continual improvement of the production processes
effectives of the quality management system can be - Test results
made? - Process capability data
- Quality audits
- Results of product inspections
- Internal and external quality data
- Subcontractors rating
- Customer reports
(8.4) - Employee’s information
8.4.2 Does the organization’s data analysis include data  Data analysis report
generated as a result of monitoring and measurement
and from other relevant sources?
(8.4)
8.4.3 Does the organization’s analysis of data provide  Data analysis report
information relating to:
a) customer satisfaction (see element 8.2.1 of
ISO/TS16949:2002)?
b) Conformance to product requirements (see
element 7.2.1 of ISO/TS16949:2002)?
c) Characteristics and trends of processes and
products including opportunities for
preventive action?
d) Suppliers?
(8.4)
8.4.1 ANALYSIS AND USE OF DATA
8.4.4 Does the organization compare trends in quality and  Customer problem resolution
operational performance compared with progress  Comparison of trends to objectives (goals)
toward objectives and lead to action to support the  Specific actions to trend analysis
following:  Prioritization of action
- development of priorities for prompt solutions
to customer-related problems?
- Determination of key customer related trends
and correlation to support status review,
decision making and longer term planning?
Page 41 Of44
- An information system for the timely reporting
of product information arising from usage?
(8.4.1)
8.5 IMPROVEMENT
8.5.1 CONTINUAL IMPROVEMENT
8.5.1 Does the organization continually improve the  Examples of continuous projects initiated
effectiveness of the quality management system from quality policy, quality objectives, audit
through the use of the quality policy, quality results, analysis of data, corrective and
objectives, audit results, analysis of data, corrective preventive actions and management reviews
and preventive actions and management review?
(8.5.1)
8.5.1.1 ORGANIZATION CONTINUAL
IMPROVEMENT
8.5.2 Has the organization defined a process for continual  Procedure as stated in quality manual
improvement?
(8.5.1.1)
8.5.1.2 MANUFACTURING PROCESS
IMPROVEMENT
8.5.3 Does the organization’s continual improvement  Records showing improvement in special
focus upon control and reduction of variation in characteristics
products of characteristics and manufacturing  Reduction in process parameter variation
process parameters?
(8.5.1.2)
8.5.2 CORRECTIVE ACTION
8.5.4 Does the organization take action to eliminate the  Examples
cause of non-conformities in order to prevent
recurrence?
(8.5.2)
8.5.5 Are the organization’s corrective actions appropriate  Review examples
to the effects of the non-conformities encountered?
(8.5.2)
8.5.6 Has the organization established a documented  List of customer complaints
procedure to define requirements for:  Root cause analysis and records
a) reviewing non-conformities (including  Determination of corrective action needed
customer complaints)?  Corrective action taken
b) Evaluating the need for action to ensure that  Corrective action effectiveness
non-conformities do not recur?
c) Determining and implementing action
needed?
d) Records of the results of action taken (see
element 4.2 of ISO/TS16949:2002)?
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e) Reviewing corrective action taken?
(8.5.2)
8.5.2.1 PROBLEM SOLVING
8.5.7 Does the organization have a defined process for  Problem solving process used by organization
problem solving leading to root cause identification
and elimination?
(8.5.2.1)
8.5.8 If a customer-prescribed problem solving format  Responses to customer complaints
exists, does the organization use the prescribed  Customer formats
format?
(8.5.2.1)
8.5.2.2 ERROR PROOFING
8.5.9 Does the organization use error proofing methods in  Examples
their corrective action process?
(8.5.2.2)
8.5.2.3 CORRECTIVE ACTION IMPACT
8.5.10 Does the organization apply the corrective action,  Review of documents related to similar
and controls implemented to eliminate the cause of a products and processes
nonconformity to other similar processes and
products?
(8.5.2.3)
8.5.2.4 REJECTED PRODUCT TEST / ANALYSIS
8.5.11 Does the organization analyze parts rejected by the  List of returned parts
customer’s manufacturing plants, engineering  Records of analysis
facilities and dealerships?  Minimalization of cycle time
(8.5.2.4)
8.5.12 Does the organization minimize the cycle time of its  Review product/test analysis process
rejected product test/analysis process?
(8.5.2.4)
8.5.13 Does the organization keep records of its rejected  Records
product test/analysis and make available upon
request?
(8.5.2.4)
8.5.14 Does the organization perform analysis and, initiate  Examples
corrective action to prevent recurrence?
(8.5.2.4)
8.5.3 PREVENTIVE ACTION
8.5.15 Does the organization determine action to eliminate  Examples
the causes of potential nonconformities in order to
prevent their occurrence?
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(8.5.3)
8.5.16 Are the organization’s preventive actions appropriate  Examples
to the effects of potential problems?
(8.5.3)
8.5.17 Has the organization established a documented  Sources of information used for preventive
procedure to define requirements for: action
a) determining potential non-conformities and  Root cause determination (FMEA, FTA, etc.)
their causes?  Records and result analysis
b) Evaluating the need for action to prevent
occurrence of non-conformities?
c) Determining and implementing action
needed?
d) Records of results of action taken (see
element 4.2.4 of ISO/TS16949:2002)?
e) Reviewing preventive action taken?
(8.5.3)
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Requirements What to look for Assessor notes / Objective Evidence

4.1 - QUALITY MANAGEMENT SYSTEM

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