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Supplier Quality Management System

Audit Checklist
(ISO 9000:2000, TS 16949:2002)

Supplier: _________________________________________________________________________________________________________________

Plant/Location: ________________________________________________ Date: _____________________________________

Audit Team: ___________________________________________


____________________________________________

____________________________________________
____________________________________________
Scope of Audit: ___________________________________________________________________________________________

Number of C.A.R. s: __________________________________________ Corrective Action Due: ___________________________________________

Potential suppliers may be requested to conduct a self-assessment of their quality system to determine eligibility. The Nova Sourcing Team shall
determine eligibility after analysis of the self-assessment. Results of the Checklist shall be documented and communicated to the supplier by the Nova
Sourcing Team.

NOTE: Sections in red are questions relevant to TS 16949


APPENDIX A

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ISO 9001:2000 and/or
Q# Audit Question Evidence
ISO/TS 16949 Clause Text
4 Quality management system
4.1 General requirements
4.1q1 The organization shall establish, document, Has Supplier established, documented,
implement and maintain a quality implemented and maintained a QMS
management system and continually and continually improved its
improve its effectiveness in accordance effectiveness in accordance with ISO
with the requirements of this International 9001:2000? (Questions in section 4.1
Standard. are verified throughout the audit)
4.1q2a The organization shall a) identify the Where has Supplier identified the
processes needed for the quality processes needed for the QMS and their
management system and their application application throughout Supplier? (See
throughout the organization (see 1.2), 4.2.2)
4.1q2b The organization shall b) determine the Where has Supplier determined the
sequence and interaction of these sequence and interaction of QMS
processes, processes? (See 4.2.2)
4.1q2c The organization shall c) determine criteria What are the criteria and methods
and methods needed to ensure that both Supplier uses to ensure that the
the operation and control of these operation and control of QMS processes
processes are effective, are effective?
4.1q2d The organization shall d) ensure the Has Supplier provided resources and
availability of resources and information information needed to support the
necessary to support the operation and operation and monitoring of QMS
monitoring of these processes, processes? (See section 6)
4.1q2e The organization shall e) monitor, measure How does Supplier monitor, measure
and analyze these processes, and and analyze QMS processes? (See
section 8)

4.1q2f The organization shall f) implement actions How has Supplier implemented actions
necessary to achieve planned results and necessary to achieve planned results
continual improvement of these processes. and continual improvement of processes
needed for the QMS?
4.1q3 These processes shall be managed by the Are processes needed for the QMS
organization in accordance with the managed by Supplier in accordance with
requirements of this International Standard. the requirements of ISO 9001:2000?
4.1q4 Where an organization chooses to When Supplier out sources any process
outsource any process that affects product that affects product conformity with
conformity with requirements, the requirements, how is control ensured
organization shall ensure control over such over such processes? (See 7.4)
processes.
4.1q5 Control of such outsourced processes shall Where is the control of outsourced
be identified within the quality management processes that affect product conformity
system. with requirements identified within the
QMS? (See 7.4)

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ISO 9001:2000 and/or
Q# Audit Question Evidence
ISO/TS 16949 Clause Text
NOTE Processes needed for the quality management system referred to above should
include processes for management activities, provision of resources, product realization
and measurement.
4.1.1 General requirements Supplemental
T4.1.1q1 Ensuring control over outsourced Does Supplier have adequate control
processes shall not absolve the over outsourced processes to ensure
organization of the responsibility of conformity to all customer requirements?
conformity to all customer requirements. (See 7.4)

NOTE See also 7.4.1 and 7.4.1.3.


4.2 Documentation requirements
4.2.1 General
4.2.1q1a The quality management system Does Supplier have documented
documentation shall include statements of a quality policy and quality
a) documented statements of a quality objectives? (See 5.3, 5.4.1)
policy and quality objectives,
Does Supplier have a quality manual?
b) a quality manual,
(See 4.2.2)
c) documented procedures required by
this International Standard, Does Supplier have the documented
d) documents needed by the organization procedures required by ISO 9001:2000?
to ensure the effective planning, (See 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, 8.5.3)
operation and control of its processes, Are adequate documents in place to
and ensure the effective planning, operation
e) records required by this International and control of Suppliers processes?
Standard (see 4.2.4).
Does documentation include the records
required by ISO 9001:2000?
NOTE 1 Where the term documented procedure appears within this International
Standard, this means that the procedure is established, documented, implemented and
maintained.
NOTE 2 The extent of the quality management system documentation can differ from one
organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual
4.2.2q1a The organization shall establish and Where in the quality manual is the scope
maintain a quality manual that includes of the QMS identified, including details
a) the scope of the quality management of and justification for exclusions?
system, including details of and
justification for any exclusions (see 1.2), Where does the quality manual contain
b) the documented procedures or reference the documented
established for the quality management procedures established for the QMS?
system, or reference to them, and
c) a description of the interaction between Where does the quality manual include a
the processes of the quality description of the interaction between
management system. the processes of the QMS?

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ISO 9001:2000 and/or
Q# Audit Question Evidence
ISO/TS 16949 Clause Text
4.2.3 Control of documents
4.2.3q1 Documents required by the quality How are the documents required by the
management system shall be controlled. QMS controlled?
Records are a special type of document and
shall be controlled according to the (Documents should be reviewed throughout
requirements given in 4.2.4. the audit)
4.2.3q2 A documented procedure shall be Can you show a documented procedure
established to define the controls needed that defines the controls needed for each of
a) to approve documents for adequacy the following?
prior to issue, a) approve documents for adequacy prior
b) to review and update as necessary and to issue?
re-approve documents? b) review and update as necessary and
c) to ensure that changes and the current re-approve documents?
revision status of documents are c) ensure that changes and the current
identified? revision status of documents are
d) to ensure that relevant versions of identified?
applicable documents are available at d) ensure that relevant versions of
points of use? applicable documents are available at
e) to ensure that documents remain points of use?
legible and readily identifiable? e) ensure that documents remain legible
f) to ensure that documents of external and readily identifiable?
origin are identified and their f) ensure that documents of external
distribution controlled? origin are identified and their
g) to prevent the unintended use of distribution controlled?
obsolete documents, and to apply g) prevent the unintended use of obsolete
suitable identification to them if they are documents, and to apply suitable
retained for any purpose. identification to them if they are
retained for any purpose.
4.2.3.1 Engineering specifications
T4.2.3.1q1 The organization shall have a process to What process do you have to assure the
assure the timely review, distribution and timely review, distribution and
implementation of all customer engineering implementation of customer
standards/ specifications and changes specifications and changes?
based on customer-required schedule.
Does it meet customer-required
schedule(s)?
T4.2.3.1q2 Timely review should be as soon as Does the review occur in two weeks or
possible, and shall not exceed two working less?
weeks.
T4.2.3.1q3 The organization shall maintain a record of What records do you have showing
the date on which each change is implementation dates of changes?
implemented in production. Implementation
shall include updated documents. Is there evidence showing that
documents are updated?
NOTE A change in these standards/ specifications requires an updated record of
customer production part approval when these specifications are referenced on the
design record or if they affect documents of production part approval process, such as
control plan, FMEAs, etc.

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ISO 9001:2000 and/or
Q# Audit Question Evidence
ISO/TS 16949 Clause Text
4.2.4 Control of records
4.2.4q1 Records shall be established and What records exist that provide evidence
maintained to provide evidence of of conformity to requirements and of the
conformity to requirements and of effective operation of the QMS? (Should
the effective operation of the quality be reviewed throughout the audit)
management system.
4.2.4q2 Records shall remain legible, readily Are records legible, readily identifiable
identifiable and retrievable. and retrievable? (Should be reviewed
throughout the audit)
4.2.4q3 A documented procedure shall be Does Supplier have a documented
established to define the controls needed procedure defining the controls needed
for the identification, storage, protection, for the identification, storage, protection,
retrieval, retention time and disposition of retrieval, retention time and disposition
records. of records?

NOTE 1 Disposition above includes disposal.


NOTE 2 Records also include customer-specified records.
4.2.4.1 Records retention
T4.2.4.1q1 The control of records shall satisfy Have the record requirements been
regulatory and customer requirements. reviewed to ensure conformance with
regulatory and customer requirements?

5 Management responsibility
5.1 Management commitment
5.1q1a Top management shall provide evidence of How does top management
its commitment to the development and communicate the importance of meeting
implementation of the quality management customer and legal requirements
system and continually improving its throughout its organization?
effectiveness by
a) communicating to the organization the Has a company quality policy been
importance of meeting customer as well established? (See 5.3)
as statutory and regulatory
requirements, What are the quality objectives
b) establishing the quality policy, established by top management? (See
c) ensuring that quality objectives are 5.4.1)
established,
d) conducting management reviews, and Does top management conduct
e) ensuring the availability of resources. management reviews? (See 5.6)

How does top management ensure the


availability of resources to support and
continually improve the QMS?
5.1.1 Process efficiency
T5.1.1q1 Top management shall review the product How does top management review
realization processes and the support product realization and support
processes to assure their effectiveness and processes to ensure effectiveness and
efficiency. efficiency? (5.6?)

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5.2 Customer focus
5.2q1 Top management shall ensure that customer How does top management ensure that
requirements are determined and are met customer requirements are determined
with the aim of enhancing customer and met?
satisfaction (see 7.2.1 & 8.2.1)
5.3 Quality policy
5.3q1a Top management shall ensure that the How does top management ensure that
quality policy the quality policy is appropriate to the
a) is appropriate to the purpose of the purpose of Supplier?
organization,
Does the quality policy include a
b) includes a commitment to comply with
commitment to comply with
requirements and continually improve
requirements and continually improve
the effectiveness of the quality
QMS effectiveness?
management system,
c) provides a framework for establishing Are the contents of the quality policy
and reviewing quality objectives, relevant to Supplier, and measurable?
d) is communicated and understood Is the quality policy communicated and
within the organization, and understood within Supplier?
e) is reviewed for continuing suitability.
Is there an established process to
review the quality policy for continuing
suitability?
5.4 Planning
5.4.1 Quality objectives
5.4.1q1 Top management shall ensure that quality Has top management established quality
objectives, including those needed to meet objectives (including those needed to
requirements for product [see 7.1 a)], are meet requirements for product) at
established at relevant functions and levels relevant functions and levels within
within the organization. Supplier?

5.4.1q2 The quality objectives shall be measurable Are the quality objectives consistent with
and consistent with the quality policy. the quality policy? What are the
measurements?

5.4.1.1 Quality objectives Supplemental


T5.4.1.1q1 Top management shall define quality Are quality objectives and metrics
objectives and measurements that shall be included in the business plan?
included in the business plan and used to
deploy the quality policy.

NOTE Quality objectives should address customer expectations and be


achievable within a defined time period.
5.4.2 Quality management system planning
5.4.2q1a Top management shall ensure that a) How do you ensure that the planning of
the planning of the quality management the QMS is carried out in order to
system is carried out in order to meet meet the requirements given in ISO
the requirements given in 4.1, as well as 9001:2000 section 4.1, as well as the
the quality objectives, and quality objectives?

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5.4.2q1b Top management shall ensure that b) How do you ensure that the integrity of
the integrity of the quality management the QMS is maintained when changes to
system is maintained when changes to the QMS are planned and implemented?
the quality management system are
planned and implemented.

5.5 Responsibility, authority and communication


5.5.1 Responsibility and authority
5.5.1q1 Top management shall ensure that How are responsibilities and authorities
responsibilities and authorities are defined defined and communicated within
and communicated within the organization. Supplier? (Verify throughout audit)

5.5.1.1 Responsibility for quality


T5.5.1.1q1 Managers with responsibility and authority How are managers responsible for
for corrective action shall be promptly corrective action informed of
informed of products or processes which do nonconforming products or processes?
not conform to requirements.
Are they informed in a timely manner?
T5.5.1.1q2 Personnel responsible for product quality Do personnel responsible for product
shall have the authority to stop production quality have the authority to stop
to correct quality problems. production to correct quality problems?

T5.5.1.1q3 Production operations across all shifts shall What personnel on each shift have
be staffed with personnel in charge of, or responsibility for ensuring product
delegated responsibility for, ensuring quality?
product quality.
5.5.2 Management representative
5.5.2q1a Top management shall appoint a member Who is your ISO 9001:2000
of management who, irrespective of other management representative?
responsibilities, shall have responsibility
and authority that includes Does the management representative
a) ensuring that processes needed for the have responsibility and authority to:
quality management system are a) ensure that processes needed for the
established, implemented and QMS are established, implemented and
maintained, maintained?
b) reporting to top management on the b) report to top management on the
performance of the quality performance of the QMS and any need
management system and any need for for improvement?
improvement, and c) ensure the promotion of awareness of
b) c) ensuring the promotion of customer requirements throughout
awareness of customer requirements Supplier?
throughout the organization.
NOTE The responsibility of a management representative can include liaison with external
parties on matters relating to the quality management system.

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5.5.2.1 Customer representative
T5.5.2.1q1 Top management shall designate Who has top management designated to
personnel with responsibility and ensure that customer requirements are
authority to ensure that customer addressed?
requirements are addressed.
Does their responsibility and authority
This includes selection of special include selection of special
characteristics, setting quality objectives characteristics, setting quality objectives
and related training, corrective and and related training, corrective and
preventive actions, product design and preventive actions, product design and
development. development?

5.5.3 Internal communication


5.5.3q1 Top management shall ensure that How is information regarding
appropriate communication processes the effectiveness of the QMS
are established within the organization communicated within Supplier?
and that communication takes place
regarding the effectiveness of the quality
management system.

5.6 Management review


5.6.1 General
5.6.1q1 Top management shall review the What is the frequency that top
organization's quality management system, management reviews Supplier's QMS?
at planned intervals, to ensure its
continuing suitability, adequacy and
effectiveness.

5.6.1q2 This review shall include assessing What kinds of information are reviewed
opportunities for improvement and the need in management reviews? (must include
for changes to the quality management suitability, adequacy and effectiveness
system, including the quality policy and of QMS; improvement; & changes to the
quality objectives. QMS, quality policy and objectives)

5.6.1q3 Records from management reviews shall Can you show me records from recent
be maintained (see 4.2.4). management reviews?

5.6.1.1 Quality management system performance


T5.6.1.1q1 These reviews shall include all Do management reviews include all
requirements of the quality management requirements of the quality management
system and its performance trends as an system and performance trends? (Verify
essential part of the continual improvement records)
process.
T5.6.1.1q2 Part of the management review shall be the Can you show management review
monitoring of quality objectives, and the records including monitoring of quality
regular reporting and evaluation of the cost objectives, and cost of poor quality
of poor quality (see 8.4.1 and 8.5.1). metrics? (Verify records)

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T5.6.1.1q3 These results shall be recorded to provide, Can you show records providing
as a minimum, evidence of the achievement evidence of achievement of the quality
of objectives specified in the business plan,
and customer satisfaction with product
- the quality objectives specified in the supplied?
business plan, and
customer satisfaction with product
supplied.
5.6.2 Review input
5.6.2q1 The input to management review shall Can you show that each of the following
include information on was included in review(s)?
a) results of audits, a) results of audits,
b) customer feedback, b) customer feedback,
c) process performance and product c) process performance and product
conformity, conformity,
d) status of preventive and corrective d) status of preventive and corrective
actions, actions,
e) follow-up actions from previous e) follow-up actions from previous
management reviews, management reviews,
f) changes that could affect the quality f) changes that could affect the quality
management system, and management system, and
g) g) recommendations for improvement. g) recommendations for improvement

5.6.2.1 Review input Supplemental


T5.6.2.1q1 Input to management review shall include Do records show input to management
an analysis of actual and potential field- review includes analysis of actual
failures and their impact on quality, safety and potential field-failures and their
or the environment. impact?
(See also 7.3.4.1)
5.6.3 Review output
5.6.3q1 The output from the management review What decisions or actions have resulted
shall include any decisions and actions from management reviews for each of
related to the following?
a) improvement of the effectiveness of the
a) improvement of the effectiveness of the quality management system and its
quality management system and its processes,
processes, b) improvement of product related to
b) improvement of product related to customer requirements, and
customer requirements, and c) resource needs.
c) resource needs.
6 Resource management
6.1 Provision of resources
6.1q1 The organization shall determine and What resources has Supplier provided to
provide the resources needed implement and maintain the QMS and
a) to implement and maintain the quality continually improve its effectiveness?
management system and continually
improve its effectiveness, and What resources has Supplier provided
b) to enhance customer satisfaction by to ensure that customer requirements
meeting customer requirements. are met? (See 6.2, 6.3, 6.4)

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6.2 Human resources
6.2.1 General
6.2.1q1 Personnel performing work affecting (While auditing, select some personnel
product quality shall be competent on performing work affecting product quality)
the basis of appropriate education, What are the education, training, skills
training, skills and experience. and experience required by this
job/task?
How does this person meet those
qualifications?
6.2.2 Competence, awareness and training
6.2.2q1 The organization shall How do you determine the necessary
a) determine the necessary competence education, training, skills and experience
for personnel performing work affecting for people performing work affecting
product quality, product quality?
b) provide training or take other actions to
What training or other actions do you
satisfy these needs,
provide to satisfy the needs of
c) evaluate the effectiveness of the
actions taken, personnel? (records)
d) ensure that its personnel are aware of When you provide training or other
the relevance and importance of their actions to satisfy competence needs,
activities and how they contribute to the how do you evaluate the effectiveness
achievement of the quality objectives, of those actions? (records)
and
(Sample throughout Supplier)
e) maintain appropriate records of
education, training, skills and How do your activities contribute to the
experience (see 4.2.4). achievement of quality objectives?
Where do you maintain records of
education, training, skills and
experience?
6.2.2.1 Product design skills
T6.2.2.1q1 The organization shall ensure that What tools and techniques has the
personnel with product design responsibility Supplier identified as necessary for
are competent to achieve design product design personnel?
requirements and are skilled in applicable
What records do you have showing that
tools and techniques.
product design personnel are competent
Applicable tools and techniques shall be
to design and are skilled in the identified
identified by the organization.
tools and techniques?
6.2.2.2 Training
T6.2.2.2q1 The organization shall establish and Can you show documented
maintain documented procedures for procedures for identifying training
identifying training needs and achieving needs and achieving competence of all
competence of all personnel performing personnel performing activities affecting
activities affecting product quality. product quality?

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T6.2.2.2q2 Personnel performing specific assigned What records do you have that
tasks shall be qualified, as required, with personnel performing specific
particular attention to the satisfaction of assigned tasks are qualified -
customer requirements. especially to meet customer
requirements. (See 6.2.2e)

NOTE 1 This applies to all employees having an effect on quality at all levels of the
organization.

NOTE 2 An example of the customer specific requirements is the application of digitized


mathematically based data.

6.2.2.3 Training on the job


T6.2.2.3q1 The organization shall provide on-the-job What kinds of on-the-job training
training for personnel in any new or do you provide for people in new
modified job affecting product quality, or changed jobs?
including contract or agency personnel.
Does this include contract and
agency personnel?

T6.2.2.3q2 Personnel whose work can affect quality How do you inform personnel about the
shall be informed about the consequences consequences to the customer of
to the customer of nonconformity to quality nonconformity to quality requirements?
requirements. (Sample throughout Supplier)

6.2.2.4 Employee motivation and empowerment


T6.2.2.4q1 The organization shall have a process to What process has been established to
motivate employees to achieve quality motivate employees to
objectives, to make continual
improvements, and to create an - achieve quality objectives,
environment to promote innovation. - to make continual improvements, and
- to create an environment to promote
innovation?

T6.2.2.4q2 The process shall include the promotion of Does the process include the promotion
quality and technological awareness of quality and technological awareness
throughout the whole organization. throughout the entire Supplier?

T6.2.2.4q3 The organization shall have a process to What process has been established
measure the extent to which its personnel to measure the extent to which
are aware of the relevance and importance personnel are aware of the relevance
of their activities and how they contribute to and importance of their activities
the achievement of the quality objectives and how they contribute to the
[see 6.2.2 d)]. achievement of the quality
objectives?
(See 6.2.2d)

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6.3 Infrastructure
6.3q1 The organization shall determine, provide Are the buildings, workspace, and
and maintain the infrastructure needed to utilities provided appropriate to achieve
achieve conformity to product requirements. conformity to product requirements?
Infrastructure includes, as applicable How are they maintained?
a) buildings, workspace and associated
utilities, What kind of process equipment (both
b) process equipment (both hardware and hardware and software) is necessary to
software), and conform to product requirements? How
c) supporting services (such as transport is the equipment maintained?
or communication).
What supporting services (such as
transport or communication) are needed
to ensure that product meets
requirements? How are they
maintained?

6.3.1 Plant, facility and equipment planning


T6.3.1q1 The organization shall use a multidisciplinary What groups are involved in developing
approach (see 7.3.1.1) for developing plant, plant, facility and equipment plans?
facility and equipment plans. (Must be multidisciplinary)

T6.3.1q2 Plant layouts shall optimize material travel, Can you show that plant layouts
handling and value-added use of floor optimize material travel, handling and
space, and shall facilitate synchronous floor space use, and facilitate
material flow. synchronous material flow?

T6.3.1q3 Methods shall be developed and What methods are used to evaluate and
implemented to evaluate and monitor the monitor the effectiveness of existing
effectiveness of existing operations. operations?

NOTE These requirements should focus on lean manufacturing principles and the link to the
effectiveness of the quality management system.

6.3.2 Contingency plans


T6.3.2q1 The organization shall prepare contingency Can you show me contingency plans for
plans to satisfy customer requirements in each of the following?
the event of an emergency such as utility - Utility interruptions
interruptions, labour shortages, key - Labor shortages
equipment failure and field returns. - Key equipment failure(s)
- Field returns
6.4 Work environment
6.4q1 The organization shall determine and What kind of work environment is
manage the work environment needed to required to achieve conformity to
achieve conformity to product requirements. product requirements? How is this
environment managed and maintained?

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6.4.1 Personnel safety to achieve product quality
T6.4.1q1 Product safety and means to minimize How are product safety and potential
potential risks to employees shall be risks to employees addressed by
addressed by the organization, especially in Supplier?
the design and development process and in
manufacturing process activities.
6.4.2 Cleanliness of premises
T6.4.2q1 The organization shall maintain its premises Does Supplier maintain the state of
in a state of order, cleanliness and repair order, cleanliness and repair needed for
consistent with the product and products and manufacturing processes?
manufacturing process needs. (Verify throughout audit)

7 Product realization
7.1 Planning of product realization
7.1q1 The organization shall plan and develop Where are the processes needed for
the processes needed for product product realization identified?
realization.

7.1q2 Planning of product realization shall be Is the planning of product realization


consistent with the requirements of the consistent with the requirements of the
other processes of the quality management other processes of the QMS? (Verify
system (see 4.1). there are no inconsistencies or conflicts
between quality system procedures)

7.1q3 In planning product realization, the Where in the product realization process
organization shall determine the following, do you determine the quality objectives
as appropriate: and requirements for products?
a) quality objectives and requirements for
the product; When planning for product realization,
b) the need to establish processes, how do you establish processes,
documents, and provide resources documents, and provide resources
specific to the product; specific to the product
c) required verification, validation,
monitoring, inspection and test activities How do you determine verification,
specific to the product and the criteria for validation, monitoring, inspection and
product acceptance; test activities specific to the product, and
d) records needed to provide evidence that the criteria for product acceptance?
the realization processes and resulting
product meet requirements (see 4.2.4). What records exist showing that both
the realization processes and the
product meet requirements?

7.1q4 The output of this planning shall be in a What are the outputs of product
form suitable for the organization's method realization planning? Are they in a form
of operations. suitable for Supplier?

NOTE 1 A document specifying the processes of the quality management system


(including the product realization processes) and the resources to be applied to a specific
product, project or contract, can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the
development of product realization processes.

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NOTE Some customers refer to project management or advanced product quality
planning as a means to achieve product realization. Advanced product quality planning
embodies the concepts of error prevention and continual improvement as contrasted with
error detection, and is based on a multidisciplinary approach.
7.1.1 Planning of product realization Supplemental
T7.1.1q1 Customer requirements and references to Does the quality plan include customer
its technical specifications shall be included requirements and reference to technical
in the planning of product realization as a specifications?
component of the quality plan.
7.1.2 Acceptance Criteria
T7.1.2q1 Acceptance criteria shall be defined by the Where are acceptance criteria defined?
organization and, where required, approved When required, does the customer
by the customer. approve them?

T7.1.2q2 For attribute data sampling, the acceptance When attribute data sampling, is the
level shall be zero defects (see 8.2.3.1). acceptance level zero defects?

7.1.3 Confidentiality
T7.1.3q1 The organization shall ensure the How does Supplier ensure the
confidentiality of customer-contracted confidentiality of customer-contracted
products and projects under development, products, projects under development,
and related product information. and related product information?

7.1.4 Change control


T7.1.4q1 The organization shall have a process to What process is there to control and
control and react to changes that impact react to changes that impact product
product realization. realization?

T7.1.4q2 The effects of any change, including those How are the effects of changes
changes caused by any supplier, shall be assessed, including changes caused
assessed, and verification and validation by suppliers? , and verification and
activities shall be defined, to ensure validation activities shall be defined,
compliance with customer requirements. to ensure compliance with customer
requirements.

T7.1.4q3 Changes shall be validated before Are changes validated before


implementation. implementation?

T7.1.4q4 For proprietary designs, impact on form, fit Is impact on form, fit and function
and function (including performance and/or (including performance and/or
durability) shall be reviewed with the durability) reviewed with the
customer so that all effects can be properly customer for proprietary designs
evaluated. so that all effects can be properly
evaluated?

T7.1.4q5 When required by the customer, additional Do you have evidence that any
verification/identification requirements, such additional verification/identification
as those required for new product requirements required by the
introduction, shall be met. customer are met?

10/15/08 Rev. 1 Page 14 of 45 John Farmer, Ph.D.


NOTE 1 Any product realization change affecting customer requirements requires
notification to, and agreement from, the customer.

NOTE 2 The above requirement applies to product and manufacturing process


changes.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.1q1a The organization shall determine How does Supplier determine each of
the following requirements?
a) requirements specified by the
customer, including the requirements a)requirements specified by the customer,
for delivery and post-delivery activities, including the requirements for delivery
b) requirements not stated by the and post-delivery activities,
customer but necessary for specified or b) requirements not stated by the customer
intended use, where known, but necessary for specified or intended
c) statutory and regulatory requirements use, where known,
related to the product, and c) statutory and regulatory requirements
d) any additional requirements related to the product, and
determined by the organization. d) any additional requirements determined
by Supplier.
NOTE 1 Post-delivery activities include any after-sales product service provided as part of
the customer contract or purchase order.
NOTE 2 This requirement includes recycling, environmental impact and characteristics
identified as a result of the organizations knowledge of the product and manufacturing
processes (see 7.3.2.3).
NOTE 3 Compliance to item c) includes all applicable government, safety and
environmental regulations, applied to acquisition, storage, handling, recycling, elimination
or disposal of materials.

7.2.1.1 Customer-designated special characteristics


T7.2.1.1q1 The organization shall demonstrate How do you meet customer
conformity to customer requirements for requirements for designation,
designation, documentation and control of documentation and control of
special characteristics. special characteristics?

7.2.2 Review of requirements related to the product


7.2.2q1 The organization shall review the What kind of review is done to ensure
requirements related to the product. This that Supplier has the ability to meet
review shall be conducted prior to the requirements before committing to
organization's commitment to supply a supply product?
product to the customer (e.g. submission of
tenders, acceptance of contracts or orders, How do you ensure that product
acceptance of changes to contracts or requirements are defined and reviewed
orders) and shall ensure that before committing to supply product?
a) product requirements are defined, How do you ensure that contract or
b) contract or order requirements order requirements differing from those
c) the organization has the ability to meet previously expressed are resolved
the defined requirements. before committing to supply product?

10/15/08 Rev. 1 Page 15 of 45 John Farmer, Ph.D.


7.2.2q2 Records of the results of the review and Can you show me records of the product
actions arising from the review shall be requirement review results and actions
maintained (see 4.2.4). resulting from them?
7.2.2q3 Where the customer provides no When customers dont have
documented statement of requirement, the documented requirements, how do you
customer requirements shall be confirmed confirm their requirements before
by the organization before acceptance. accepting orders?
7.2.2q4 Where product requirements are changed, When product requirements are
the organization shall ensure that relevant changed, how do you ensure that
documents are amended and that relevant relevant documents are changed and
personnel are made aware of the changed that relevant personnel are made aware
requirements. of the changes?
NOTE In some situations, such as internet sales, a formal review is impractical for each order.
Instead the review can cover relevant product information such as catalogues or advertising material.
7.2.2.1 Review of requirements related to the product Supplemental
T7.2.2.1q1 Waiving the requirement stated in 7.2.2 for If you have waived the requirement for
a formal review (see note) shall require a formal review above, have you
customer authorization. obtained customer authorization?
7.2.2.2 Organization manufacturing feasibility
T7.2.2.2q1 The organization shall investigate, confirm What documents do you have that show
and document the manufacturing feasibility investigation and confirmation of
of the proposed products in the contract manufacturing feasibility in the contract
review process, including risk analysis. review process for proposed products,
including risk analysis?

7.2.3 Customer communication


7.2.3q1 The organization shall determine and What method(s) are used to
implement effective arrangements for communicate with customers regarding
communicating with customers in relation to - product information?
a) product information, - enquiries, contracts, or order handling,
b) enquiries, contracts or order including amendments?
c) customer feedback, including customer - feedback, including customer
complaints. complaints?

X 7.2.3.1 Customer communication Supplemental


X The organization shall have the ability to Do your customers require information
communicate necessary information, to be communicated in specific
including data, in a customer-specified languages and/or formats?
language and format (e.g. computer-aided
design data, electronic data exchange). If so, how do you meet those
requirements?

7.3 Design and development


NOTE The requirements of 7.3 include product and manufacturing process design and
development, and focus on error prevention rather than detection.
7.3.1 Design and development planning
7.3.1q1 The organization shall plan and control the Can you explain to me the process used
design and development of product. by Supplier to plan and control the
design and development of product?

10/15/08 Rev. 1 Page 16 of 45 John Farmer, Ph.D.


7.3.1q2 During the design and development What are the stages in the design and
planning, the organization shall determine development process?
How do you determine the review,
a) the design and development stages, verification and validation activities
b) the review, verification and validation appropriate to each design and
that are appropriate to each design and development stage?
development stage, and How /where are design and
c) the responsibilities and authorities for development responsibilities and
design and development. authorities defined?

7.3.1q3 The organization shall manage the How does Supplier ensure effective
interfaces between different groups communication and clear assignment of
involved in design and development to responsibility between different groups
ensure effective communication and clear involved in design and development?
assignment of responsibility.
7.3.1q4 Planning output shall be updated, as As product design and development
appropriate, as the design and progresses, how are the planning
development progresses. outputs updated?

7.3.1.1 Multidisciplinary approach


T7.3.1.1q1 The organization shall use a Do you use a multidisciplinary approach
multidisciplinary approach to prepare for to prepare for product realization? Does
product realization, including it include:
- development/finalization and monitoring - development/finalization and
of special characteristics monitoring of special characteristics
- development and review of FMEAs, - development and review of FMEAs,
including actions to reduce potential including actions to reduce potential
risks, and
risks,
- development and review of control plans.
- development and review of control
plans.

NOTE A multidisciplinary approach typically includes the organization's design,


manufacturing, engineering, quality, production and other appropriate personnel.
7.3.2 Design and development inputs
7.3.2q1a Inputs relating to product requirements shall What are the design inputs relating to
be determined and records maintained (see each of the following product
4.2.4). These inputs shall include requirements?

a) functional and performance a) functional and performance


requirements, requirements,
b) applicable statutory and regulatory b) applicable statutory and regulatory
requirements, requirements,
c) where applicable, information derived c) where applicable, information derived
from previous similar designs, and from previous similar designs, and
d) other requirements essential for design d) other requirements essential for design
and development. and development.
Where are they recorded?

7.3.2q2 These inputs shall be reviewed for How & when are the design and
adequacy. development inputs reviewed for
adequacy?

10/15/08 Rev. 1 Page 17 of 45 John Farmer, Ph.D.


7.3.2q3 Requirements shall be complete, How does Supplier ensure that
unambiguous and not in conflict with each requirements are complete,
other. unambiguous and dont conflict with
each other?
NOTE Special characteristics (see 7.2.1.1) are included in this requirement.
7.3.2.1 Product design input
T7.3.2.1q1 The organization shall identify, document Where is product design input
and review the product design inputs requirements documented?
requirements, including the following: (including the following:
- customer requirements (contract review) - contract reviews of requirements such
such as special characteristics (see as special characteristics,
7.3.2.3), identification, traceability and identification, traceability and
packaging; packaging;
- use of information: the organization shall - a process to deploy information
have a process to deploy information gained from previous design projects,
gained from previous design projects, competitor analysis, supplier
competitor analysis, supplier feedback, feedback, internal input, field data,
internal input, field data, and other and other relevant sources, for current
relevant sources, for current and future and future projects of a similar nature;
projects of a similar nature; - targets for product quality, life,
- targets for product quality, life, reliability, reliability, durability, maintainability,
durability, maintainability, timing and timing and cost.)
cost. Can you show me they are reviewed?
7.3.2.2 Manufacturing process design input
T7.3.2.2q1 The organization shall identify, document Where are manufacturing process
and review the manufacturing process design input requirements documented?
design input requirements, including (including the following:
- product design output data - product design output data
- targets for productivity, process capability - targets for productivity, process
and cost, capability and cost,
- customers requirements, if any, and - customers requirements, if any, and
- experience from previous developments. - experience from previous
developments.)
Can you show me they are reviewed?
NOTE The manufacturing process design includes the use of error-proofing methods to a degree
appropriate to the magnitude of the problems and commensurate with the risks encountered.
7.3.2.3 Special characteristics
T7.3.2.3q1 The organization shall identify special Can you show me that all special
characteristics [see 7.3.3 d)] and characteristics are identified and
- include all special characteristics in the included in drawings, FMEAs, control
control plan, plans, and operator instructions?
- comply with customer-specified
Are the customer-specified (or
definitions and symbols, and
equivalent) symbols used?
- identify process control documents in-
cluding drawings, FMEAs, control plans, Do they meet customer-specified
and operator instructions with the definitions?
customers SC symbol or equivalent Do they include process steps that affect
symbol to include those process steps special characteristics?
that affect special characteristics.
NOTE Special characteristics can include product characteristics and process parameters.

10/15/08 Rev. 1 Page 18 of 45 John Farmer, Ph.D.


7.3.3 Design and development outputs
7.3.3q1 The outputs of design and development How can design and development
shall be provided in a form that enables outputs be verified against the inputs?
verification against the design and (see 7.3.5q1) Are these outputs
development input and shall be approved approved prior to release?
prior to release.
7.3.3q2 Design and development outputs shall Can you show me examples of design
a) meet the input requirements for design and development outputs and how they
and development, meet the input requirements?
b) provide appropriate information for
What outputs include information for
purchasing, production and for service
purchasing, production and service?
provision,
c) contain or reference product acceptance Where are product acceptance criteria
criteria, and specified?
d) specify the characteristics of the product Where are product characteristics
that are essential for its safe and proper needed for safe and proper use
use. specified?
7.3.3.1 Product design outputs Supplemental
T7.3.3.1q1 The product design output shall be Can you show that the product design
expressed in terms that can be verified and outputs include
validated against product design input - design FMEA, reliability results
requirements. - product special characteristics,
The product design output shall include specifications,
- design FMEA, reliability results - product error-proofing, as appropriate,
- product special characteristics, - product definition including drawings or
specifications, mathematically based data,
- product error-proofing, as appropriate, - product design reviews results, and
- product definition including drawings or - diagnostic guidelines where applicable
mathematically based data, Are the outputs expressed in terms that
- product design reviews results, and can be verified and validated against
- diagnostic guidelines where applicable product design input requirements?
7.3.3.2 Manufacturing process design output
T7.3.3.1q1 The manufacturing process design output Can you show that the manufacturing
shall be expressed in terms that can be process design outputs include
verified against manufacturing process - specifications and drawings,
design input requirements and validated. - manufacturing process flow chart/
The manufacturing process design output layout,
shall include - manufacturing process FMEAs,
- specifications and drawings. - control plans,
- manufacturing process flow chart/ layout, - work instructions,
- manufacturing process FMEAs, - process approval acceptance criteria,
- control plan (see 7.5.1.1), - data for quality, reliability,
- work instructions, maintainability and measurability
- process approval acceptance criteria, - results of error-proofing activities, as
- data for quality, reliability, maintainability appropriate, and
and measurability - methods of rapid detection and
- results of error-proofing activities, as feedback of product/manufacturing
appropriate, and process nonconformities.
- methods of rapid detection and feedback The manufacturing process design output
of product/manufacturing process shall be expressed in terms that can be
nonconformities. verified against manufacturing process
design input requirements and validated.

10/15/08 Rev. 1 Page 19 of 45 John Farmer, Ph.D.


7.3.4 Design and development review
7.3.4q1a At suitable stages, systematic reviews of At what stages of design and
design and development shall be performed development do you perform reviews
in accordance with planned arrangements to evaluate if the results meet
(see 7.3.1) requirements? (See 7.3.1q2b)
a) to evaluate the ability of the results of
design and development to meet Can you show me some problems that
requirements, and
have been identified and actions
b) to identify any problems and propose
necessary actions. proposed at these reviews?
7.3.4q2 Participants in such reviews shall include What functions are represented at these
representatives of functions concerned with reviews?
the design and development stage(s) being
reviewed At each stage, are all functions
concerned with that stage represented?
7.3.4q3 Records of the results of the reviews and Can you show me records of the results
any necessary actions shall be maintained of the reviews and any necessary
(see 4.2.4). actions taken?
NOTE These reviews are normally coordinated with the design phases and include manufacturing
process design and development.
7.3.4.1 Monitoring
T7.3.4.1q1 Measurements at specified stages of Can you show me reports of analysis of
design and development shall be defined, measurements at specified design and
analyzed and reported with summary development stages?
results as an input to management review.
Are summary results included in
management reviews? (See 5.6.2)
NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as
appropriate.
7.3.5 Design and development verification
7.3.5q1 Verification shall be performed in What verification activities are performed
accordance with planned arrangements to ensure that the design and
(see 7.3.1) to ensure that the design and development outputs have met the input
development outputs have met the design requirements? (See 7.3.3q1)
and development input requirements.
7.3.5q2 Records of the results of the verification Can you show me records of the results
and any necessary actions shall be of the verification activities and resulting
maintained (see 4.2.4). actions?
7.3.6 Design and development validation
7.3.6q1 Design and development validation shall be What design and development validation
performed in accordance with planned activities are performed to ensure that
arrangements (see 7.3.1) to ensure that the the product is capable of meeting the
resulting product is capable of meeting the requirements for the intended use?
requirements for the specified application or
intended use, where known.
7.3.6q2 Wherever practicable, validation shall be Do records show that validation is done
completed prior to the delivery or before product shipment?
implementation of the product. If not, is the justification recorded?
7.3.6q3 Records of the results of validation and any Can you show me records of the
necessary actions shall be maintained (see validation activity results and any follow-
4.2.4). up actions?
NOTE 1 The validation process normally includes an analysis of field reports for similar products.

10/15/08 Rev. 1 Page 20 of 45 John Farmer, Ph.D.


NOTE 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing
processes.
7.3.6.1 Design and development validation Supplemental
T7.3.6.1q1 Design and development validation shall be Is design and development validation
performed in accordance with customer performed in accordance with customer
requirements including programme timing. requirements, including program timing?

7.3.6.2 Prototype program


T7.3.6.2q1 When required by the customer, the Do your customer(s) require a prototype
organization shall have a prototype program and control plan?
program and control plan.
If so, can you describe the program?

Can you show me the control plan(s)?


T7.3.6.2q2 The organization shall use, whenever Does Suppliers prototype program use
possible, the same suppliers, tooling and the same suppliers, tooling and
manufacturing processes as will be used in manufacturing processes as will be used
production. in production? If not, what is the
justification?
T7.3.6.2q3 All performance testing activities shall be What records show that performance-
monitored for timely completion and testing activities are monitored for timely
conformance to requirements. completion and conformance to
requirements?
T7.3.6.2q4 While services may be outsourced, the Are any prototyping services
organization shall be responsible for the outsourced?
outsourced services, including technical
leadership. If so, who is responsible for the
outsourced services, including technical
leadership?

7.3.6.3 Product approval process


T7.3.6.3q1 The organization shall conform to a product What product and/or process approval
and process approval procedure procedure(s) do your customer(s)
recognized by the customer. require?

Can you show me records of both


process and product approvals?

NOTE Product approval should be subsequent to the verification of the manufacturing


process.
T7.3.6.3q2 This product and manufacturing process Do you have evidence that the product
approval procedure shall also be applied to and manufacturing process approval
suppliers. procedures are applied to suppliers?
(See 7.4.2)

7.3.7 Control of design and development changes


7.3.7q1 Design and development changes shall be How are design and development
identified and records maintained. changes identified? Where are the
records kept?

10/15/08 Rev. 1 Page 21 of 45 John Farmer, Ph.D.


7.3.7q2 The changes shall be reviewed, verified Are changes reviewed, verified,
and validated, as appropriate, and validated, and approved before
approved before implementation. implementation?
7.3.7q3 The review of design and development Can you show me evidence that the
changes shall include evaluation of the review of design and development
effect of the changes on constituent parts changes includes evaluation of the
and product already delivered. effect on component parts and products
in the field?
7.3.7q4 Records of the results of the review of Can you show me records of the results
changes and any necessary actions shall of change reviews and any necessary
be maintained (see 4.2.4). actions?
NOTE 1 Design and development changes include all changes during the product program life (see
7.1.4).
7.4 Purchasing
7.4.1 Purchasing process
7.4.1q1 The organization shall ensure that How do you ensure that purchased
purchased product conforms to specified product conforms to specified purchase
purchase requirements. requirements?

7.4.1q2 The type and extent of control applied to How do you determine the type and
the supplier and the purchased product extent of control applied to the supplier
shall be dependent upon the effect of the and the purchased product?
purchased product on subsequent product
realization or the final product.

7.4.1q3 The organization shall evaluate and select How do you evaluate and select
suppliers based on their ability to supply suppliers? (based on their ability to
product in accordance with the supply product in accordance with
organization's requirements. Suppliers requirements)

7.4.1q4 Criteria for selection, evaluation and re- Can you show me the criteria for
evaluation shall be established. selection, evaluation and re-evaluation
of suppliers?

7.4.1q5 Records of the results of evaluations and Can you show me records of the results
any necessary actions arising from the of supplier evaluations and any
evaluation shall be maintained (see 4.2.4). necessary actions? (verify that criteria
have been met)

NOTE 1 Purchased products above includes all products and services that affect customer
requirements such as sub-assembly, sequencing, sorting, rework and calibration services.
NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the
organization should verify the continuity of the suppliers quality system and its effectiveness.
7.4.1.1 Regulatory conformity
T7.4.1.1q1 All purchased products or materials used in What evidence is there that all
product shall conform to applicable purchased products or materials
regulatory requirements. used in product conform to regulatory
requirements?

10/15/08 Rev. 1 Page 22 of 45 John Farmer, Ph.D.


7.4.1.2 Supplier quality management system development
T7.4.1.2q1 The organization shall perform supplier What supplier development actions are
quality management system development being taken toward the goal of supplier
with the goal of supplier conformity with this conformity with TS 16949?
Technical Specification. Conformity with
ISO 9001:2000 is the first step in achieving Do your suppliers quality management
this goal. systems conform with ISO 9001:2000?
(see below)
NOTE The prioritization of suppliers for development depends upon, for example, the suppliers
quality performance and the importance of the product supplied.
T7.4.1.2q2 Unless otherwise specified by the Are all of your suppliers registered to
customer, suppliers to the organization ISO 9001:2000?
shall be third party registered to ISO
9001:2000 by an accredited third-party If not, do you have written waivers from
certification body. applicable customer(s)?

7.4.1.3 Customer-approved sources


T7.4.1.3q1 Where specified by the contract (e.g. Do your customer(s) specify supplier(s)
customer engineering drawing, in contracts/ purchase orders?
specification), the organization shall
purchase products, materials or services (This includes products, materials,
from approved sources. The use of services, tooling, & gages, )
customer-designated sources, including
tool/gauge suppliers, does not relieve the
If so, can you show that the customer-
organization of the responsibility for
designated sources are being used as
ensuring the quality of purchased products.
required?

7.4.2 Purchasing information


7.4.2q1 Purchasing information shall describe the Do orders/contracts include
product to be purchased, including where requirements for approval of product,
appropriate procedures, processes and equipment?
a) requirements for approval of product,
procedures, processes and equipment, Do require any qualification of supplier
b) requirements for qualification of personnel?
personnel, and
c) quality management system If so, can you show where the
requirements. requirement is documented?

Do you have any QMS requirements of


your suppliers?

If so, can you show me where they are


required?

7.4.2q2 The organization shall ensure the adequacy How does Supplier ensure the
of specified purchase requirements prior to adequacy of purchasing requirements
their communication to the supplier. before communicating them to the
supplier?

10/15/08 Rev. 1 Page 23 of 45 John Farmer, Ph.D.


7.4.3 Verification of purchased product
7.4.3q1 The organization shall establish and What inspection or other activities are
implement the inspection or other activities used to ensure that purchased product
necessary for ensuring that purchased meets your purchasing requirements?
product meets specified purchase
requirements.

7.4.3q2 Where the organization or its customer Do you ever perform product verification
intends to perform verification at the at the supplier's site?
supplier's premises, the organization shall
state the intended verification arrangements If so, where are the verification
and method of product release in the arrangements and method of product
purchasing information. release identified?

7.4.3.1 Incoming product quality


T7.4.3.1q1 The organization shall have a process to What processes are in place to assure
assure the quality of purchased product (see the quality of purchased product?
7.4.3) utilizing one or more of the following
methods: (Must include one or more of following:
- receipt of, and evaluation of, statistical - evaluation of supplier statistical data
data by the organization; - receiving inspection and/or testing
- receiving inspection and/or testing such as - second- or third-party audits of
sampling based on performance;
suppliers, along with records of
- second- or third-party assessments or
acceptable quality
audits of supplier sites, when coupled with
records of acceptable delivered product - laboratory part evaluation
quality; - another method agreed with the
- part evaluation by a designated laboratory; customer)
- another method agreed with the customer.

7.4.3.2 Supplier monitoring


T7.4.3.2q1 Supplier performance shall be monitored How do you monitor supplier
through the following indicators: performance?
- delivered product quality; (Must include the following indicators:)
- customer disruptions including field returns;
- delivery schedule performance (including - delivered product quality
incidents of premium freight); - customer disruptions including field
- special status customer notifications related returns
to quality or delivery issues. - delivery schedule performance
(including incidents of premium freight)
- special status customer notifications
related to quality or delivery issues

T7.4.3.2q2 The organization shall promote supplier How do you promote supplier
monitoring of the performance of their monitoring of the performance
manufacturing processes. of their manufacturing
processes?

10/15/08 Rev. 1 Page 24 of 45 John Farmer, Ph.D.


7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1q1a The organization shall plan and carry out When carrying out production (or
production and service provision under service) are all of the following
controlled conditions. Controlled conditions controlled conditions in place?
shall include, as applicable
a) the availability of information that a) Is information that describes the
describes the characteristics of the characteristics of the product
product, available?
b) the availability of work instructions, as b) Are appropriate work instructions
necessary, available (if needed)?
c) the use of suitable equipment, (See 7.5.1.2)
d) the availability and use of monitoring c) Is suitable equipment used for
and measuring devices, carrying out production (or service)?
e) the implementation of monitoring and d) Are appropriate gages, etc. used in
measurement, and production (or service)? (See 7.6)
f) the implementation of release, delivery e) Are appropriate kinds of monitoring
and post-delivery activities. and measurement done? (See 8.2.4)
f) Are proper release, delivery and post-
delivery activities in place?
7.5.1.1 Control plan
T7.5.1.1q1 The organization shall Can you show me control plans
- develop control plans (see annex A) at for system, subsystem, and
the system, subsystem, component component/ material levels for
and/or material level for the product product supplied?
supplied, including those for processes
Can you show me control plans
producing bulk materials as well as parts,
for both pre-launch and
and
production?
- have a control plan for pre-launch and
production that takes into account the Can you show how the control
design FMEA and manufacturing process plans take into consideration
FMEA outputs. design FMEA and process FMEA
information?
(See annex A)
T7.5.1.1q2 The control plan shall (Review control plans to ensure they:
- list the controls used for the - list controls used for manufacturing
manufacturing process control, process control
- include methods for monitoring of control - include methods for monitoring of control
exercised over special characteristics of special characteristics
(see 7.3.2.3) defined both by the - include customer-required information, if
customer and the organization, any)
- include the customer-required Can you show that specified reaction
information, if any, and plans have been carried out when a
- initiate the specified reaction plan (see process becomes unstable or not
8.2.3.1) when the process becomes statistically capable?
unstable or not statistically capable.
T7.5.1.1q3 Control plans shall be reviewed and What conditions initiate the review and
updated when any change occurs affecting update of control plans?
product, manufacturing process,
measurement, logistics, supply sources or
FMEA (see 7.1.4).

10/15/08 Rev. 1 Page 25 of 45 John Farmer, Ph.D.


NOTE Customer approval may be required after review or update of the control plan.
7.5.1.2 Work instructions
T7.5.1.2q1 The organization shall prepare documented Do all employees responsible for
work instructions for all employees having processes that impact product quality
responsibilities for the operation of have documented work instructions?
processes that impact product quality. (Verify throughout audit)
These instructions shall be accessible for
use at the work station. Are they accessible for use at the
workstation?
T7.5.1.2q2 These instructions shall be derived from How are the work instructions
sources such as the quality plan, the control developed?
plan and the product realization process.

7.5.1.3 Verification of job set-ups


T7.5.1.3q1 Job set-ups shall be verified whenever Can you show me records of job setups
performed, such as an initial run of a job, that are being performed?
material changeover or job change.
Do they occur at the initial run of a job,
material changeover, or job change?

T7.5.1.3q2 Work instructions shall be available for set- What work instructions do you have for
up personnel. job setup personnel?

T7.5.1.3q3 The organization shall use statistical What statistical methods are used to
methods of verification where applicable. verify job setups?

NOTE Last-off-part comparisons are recommended.


7.5.1.4 Preventive and predictive maintenance
T7.5.1.4q1 The organization shall identify key process How do you identify key process
equipment and provide resources for equipment?
machine/equipment maintenance and
develop an effective planned total Can you walk me through your total
preventive maintenance system. preventive maintenance system?

T7.5.1.4q2 As a minimum, this system shall include the (Verify that the PM system includes the
following: following:
- planned maintenance activities; - planned maintenance activities
- packaging and preservation of - packaging and preservation of
equipment, tooling and gauging; equipment, tooling and gauging
- availability of replacement parts for key - availability of replacement parts for key
manufacturing equipment; manufacturing equipment
- documenting, evaluating and improving - documenting, evaluating and improving
maintenance objectives. maintenance objectives)

10/15/08 Rev. 1 Page 26 of 45 John Farmer, Ph.D.


T7.5.1.4q3 The organization shall utilize predictive What predictive maintenance methods
maintenance methods to continually do you use?
improve the effectiveness and the efficiency
of production equipment. Can you demonstrate that predictive
maintenance has resulted in continual
improvement of the effectiveness and
efficiency of production equipment?

7.5.1.5 Management of production tooling


T7.5.1.5q1 The organization shall provide resources for What resources have Supplier provided
tool and gauge design, fabrication and for tool and gage design, fabrication and
verification activities. verification activities?

T7.5.1.5q2 The organization shall establish and Does the production tooling
implement a system for production tooling management system include:
management including: - maintenance and repair facilities and
- maintenance and repair facilities and personnel
personnel; - storage and recovery
- storage and recovery, - set-up
- set-up; - perishable tool change programs
- tool-change program for perishable tools; - tool design modification
- tool design modification documentation, documentation, including engineering
including engineering change level; change level
- tool modification and revision to - tool modification and revision to
documentation; documentation
- tool identification, defining the status, - tool identification, defining the status,
such as production, repair or disposal. such as production, repair or disposal.

T7.5.1.5q3 The organization shall implement a system Are any tooling management activities
to monitor these activities if any work is outsourced?
outsourced.
If so, how are these activities
monitored?

NOTE This requirement also applies to the availability of tools for vehicle service parts.
7.5.1.6 Production scheduling
T7.5.1.6q1 Production shall be scheduled in order to Can you demonstrate that customer
meet customer requirements, such as just- scheduling requirements (such as just-
in-time supported by an information system in-time) are being met?
that permits access to production
information at key stages of the process
and is order driven.

7.5.1.7 Feedback of information from service


T7.5.1.7q1 A process for communication of information What is your process to communicate
on service concerns to manufacturing, information on service concerns to
engineering and design activities shall be manufacturing, engineering, and
established and maintained. design?
NOTE The intent of the addition of service concerns to this sub-clause is to ensure that the
organization is aware of nonconformities that occur external to its organization.

10/15/08 Rev. 1 Page 27 of 45 John Farmer, Ph.D.


7.5.1.8 Service agreement with customer
T7.5.1.8q1 When there is a service agreement with the Do you have any service agreement(s)
customer, the organization shall verify the with customers? If so, how do you verify
effectiveness of the effectiveness of
- any organization service centers, - any Supplier service centers,
- any special-purpose tools or - any special-purpose tools or
measurement equipment, and measurement equipment, and
- the training of service personnel. - the training of service personnel?

7.5.2 Validation of processes for production and service provision


7.5.2q1 The organization shall validate any Do you have any production or service
processes for production and service processes where the resulting output
provision where the resulting output cannot cannot be verified later? (This applies to
be verified by subsequent monitoring or all processes in TS 16949)
measurement. This includes any processes
where deficiencies become apparent only If so, how to you validate them?
after the product is in use or the service
has been delivered.

7.5.2q2 Validation shall demonstrate the ability of Can you show me records that
these processes to achieve planned results. demonstrate that the validation done has
met the requirements?
7.5.2q3a The organization shall establish How are these special processes
arrangements for these processes reviewed and approved?
including, as applicable
a) defined criteria for review and approval Can you show me records of personnel
of the processes, and equipment qualification?
b) approval of equipment and qualification
of personnel, Where are specific methods and
c) use of specific methods and procedures procedures defined?
d) requirements for records (see 4.2.4),
and Can you show me records for these
e) revalidation. processes?

When changes are made to processes,


how do you revalidate them?

7.5.2.1 Validation of processes for production and service provision


Supplemental
T7.5.2.1q1 The requirements of 7.5.2 shall apply to all Are all production processes validated
processes for production and service per 7.5.2 above?
provision.

7.5.3 Identification and traceability 7.5.3 Identification and traceability


7.5.3q1 Where appropriate, the organization shall How do you identify product throughout
identify the product by suitable means your processes? (Verify in production,
throughout product realization. storage, segregation areas, etc.)

10/15/08 Rev. 1 Page 28 of 45 John Farmer, Ph.D.


7.5.3q2 The organization shall identify the product How is product inspection status
status with respect to monitoring and identified? (Verify in production,
measurement requirements. storage, segregation areas, etc.)

7.5.3q3 Where traceability is a requirement, the Can you show me unique identification
organization shall control and record the records for products requiring
unique identification of the product (see traceability?
4.2.4).
NOTE In some industry sectors, configuration management is a means by which identification and
traceability are maintained.
X NOTE Inspection and test status is not indicated by the location of product in the production flow
unless inherently obvious such as material in an automated production transfer process. Alternatives
are permitted, if the status is clearly identified, documented, and achieves the designated purpose.
X 7.5.3.1 Identification and traceability Supplemental
X The words Where appropriate in 7.5.3 Is all product suitably identified?
above, shall not apply.

7.5.4 Customer property


7.5.4q1 The organization shall exercise care with Do you use any customer-owned
customer property while it is under the property? (Product, packaging,
organizations control or being used by the drawings, tooling, gages)
organization. (If so, ask questions below)
7.5.4q2 The organization shall identify, verify, How do you ensure that customer-
protect and safeguard customer property owned property is identified, verified,
provided for use or incorporation into the protected, and safeguarded?
product.
7.5.4q3 If any customer property is lost, damaged If any customer property is lost,
or otherwise found to be unsuitable for use, damaged etc., how is it reported to the
this shall be reported to the customer and customer? Can you show me records
records maintained (see 4.2.4). regarding this?

NOTE Customer property can include intellectual property.


NOTE Customer-owned returnable packaging is included in this clause.
7.5.4.1 Customer-owned production tooling
T7.5.4.1q1 Customer-owned tools, manufacturing, test, How are customer-owned tools and
inspection tooling and equipment shall be equipment identified?
permanently marked so that the ownership
of each item is visible, and can be
determined.

7.5.5 Preservation of product


7.5.5q1 The organization shall preserve the How do you preserve the conformity of
conformity of product during internal product during internal processing and
processing and delivery to the intended delivery?
destination. (Verify product throughout audit)

7.5.5q2 This preservation shall include How do identification, handling,


identification, handling, packaging, storage packaging, storage and protection
and protection. address the preservation of product?

10/15/08 Rev. 1 Page 29 of 45 John Farmer, Ph.D.


7.5.5q3 Preservation shall also apply to the Does this also apply to component
constituent parts of a product. parts?

7.5.5.1 Storage and inventory


T7.5.5.1q1 In order to detect deterioration, the How do you assess the condition of
condition of product in stock shall be product in stock to detect deterioration?
assessed at appropriate planned intervals.
T7.5.5.1q2 The organization shall use an inventory Can you walk me through your inventory
management system to optimize inventory management system?
turns over time and assure stock rotation,
How does the system optimize inventory
such as "first-in-first-out" (FIFO).
turns over time and assure stock
rotation?
T7.5.5.1q3 Obsolete product shall be controlled in a How is obsolete product controlled to
similar manner to nonconforming product. prevent its unintended use or delivery?
(See 8.3)
7.6 Control of monitoring and measuring devices
7.6q1 The organization shall determine the How do you determine the
monitoring and measurement to be measurements to be taken and the
undertaken and the monitoring and measuring equipment needed to
measuring devices needed to provide demonstrate conformity with
evidence of conformity of product to requirements?
determined requirements (see 7.2.1).
7.6q2 The organization shall establish processes What process is in place to ensure
to ensure that monitoring and measurement that measurements are taken per
can be carried out and are carried out in a the requirements?
manner that is consistent with the
monitoring and measurement requirements.

7.6q3a Where necessary ensure valid results, a) How do you ensure that measuring and
measuring equipment shall test equipment is calibrated or verified
a) be calibrated or verified at specified proper frequencies with NIST traceable
intervals, or prior to use, against standards? If no such standards exist,
measurement standards traceable to where do you record the basis used for
international or national measurement calibration or verification?
standards; where no such standards b) What process is used to adjust or re-
exist, the basis used for calibration or adjust measuring and test equipment
verification shall be recorded; when needed?
b) be adjusted or re-adjusted as necessary; c) How are measuring tools identified to
c) be identified to enable the calibration enable the calibration status to be
status to be determined; determined?
d) be safeguarded from adjustments that d) How do you safeguard measuring
would invalidate the measurement equipment from adjustments that
result; would invalidate the measurement
e) be protected from damage and results?
deterioration during handling, e) How do you ensure that measuring
maintenance and storage. its test equipment is protected from
damage and deterioration during
handling, maintenance and storage?

10/15/08 Rev. 1 Page 30 of 45 John Farmer, Ph.D.


7.6q4 In addition, the organization shall assess When equipment is found to be out of
and record the validity of the previous calibration, how do you assess and
measuring results when the equipment is record the validity of the previous
found not to conform to requirements. measuring results?
7.6q5 The organization shall take appropriate What actions do you take on the
action on the equipment and any product equipment and any product affected?
affected.
7.6q6 Records of the results of calibration and Can I see your records of the results of
verification shall be maintained (see 4.2.4). calibration and verification?
7.6q7 When used in the monitoring and Do you use computer software for
measurement of specified requirements, monitoring and measurement?
the ability of computer software to satisfy If so, is its ability to perform
the intended application shall be confirmed. that function confirmed prior to
This shall be undertaken prior to initial use initial use and reconfirmed as
and reconfirmed as necessary. necessary?
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
NOTE A number or other identifier traceable to the device calibration record meets the intent of
requirement c) above.
7.6.1 Measurement system analysis
T7.6.1q1 Statistical studies shall be conducted Can you show me R&R studies for
to analyse the variation present in the each type of measuring and test
results of each type of measuring equipment system referenced in the
and test equipment system. control plan?
This requirement shall apply to (Or other statistical studies analyzing
measurement systems referenced the variation in measurement & test
in control plan. The analytical results)
methods and acceptance criteria
used shall conform to those in Do the methods and acceptance
customer reference manuals on criteria conform to those in
measurement systems analysis. customer reference manuals on
Other analytical methods and MSA or does the customer approve
acceptance criteria may be used if them?
approved by the customer.
7.6.2 Calibration/verification records
T7.6.2q1 Records of the calibration/verification Can you show that calibration records
activity for all gauges, measuring and test include:
equipment, needed to provide evidence of - equipment identification, including the
conformity of product to determined measurement standard against which
requirements, including employee- and the equipment is calibrated,
customer-owned equipment, shall include - revisions following engineering
- equipment identification, including the changes,
measurement standard against which the
- any out-of-specification readings as
equipment is calibrated,
received for calibration/verification,
- revisions following engineering changes,
- any out-of-specification readings as - an assessment of the impact of out-of-
received for calibration/verification, specification condition,
- an assessment of the impact of out-of- - statements of conformity to
specification condition, specification after calibration/
- statements of conformity to specification verification, and
after calibration/verification, and - notification to the customer if suspect
- notification to the customer if suspect product or material has been shipped?
product or material has been shipped.

10/15/08 Rev. 1 Page 31 of 45 John Farmer, Ph.D.


7.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
T7.6.3.1q1 An organizations internal laboratory facility Does Supplier have an internal
shall have a defined scope that includes its laboratory?
capability to perform the required
inspection, test or calibration services. This If so, can you show me a documented
laboratory scope shall be included in the laboratory scope including its capability
quality management system to perform inspection, test, or calibration
documentation. services?

T7.6.3.1q2 The laboratory shall specify and implement, Where are laboratory technical
as a minimum, technical requirements for requirements specified for
- adequacy of laboratory procedures, - adequacy of laboratory procedures,
- competency of the laboratory personnel, - competency of the laboratory
- testing of the product, personnel,
- capability to perform these services - testing of the product,
correctly, traceable to the relevant - capability to perform these services
process standard (such as ASTM, EN, correctly, traceable to the relevant
etc.), and process standard, and
- review of the related records?
- review of the related records.
Have these requirements been
implemented?

NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house


laboratory conformity to this requirement but is not mandatory.
7.6.3.2 External laboratory
T7.6.3.2q1 External/commercial/independent Can you show me laboratory scope(s)
laboratory facilities used for inspection, test for external/commercial/independent
or calibration services by the organization laboratory facilities that include the
shall have a defined laboratory scope that capability to perform the required
includes the capability to perform the inspection, test or calibration?
required inspection, test or calibration, and
either Can I see evidence that each laboratory
- there shall be evidence that the external is either accredited, or is acceptable to
laboratory is acceptable to the customer, the customer(s)?
or
- the laboratory shall be accredited to
ISO/IEC 17025 or national equivalent.

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or


by customer-approved second-party assessment that the laboratory meets the intent of
ISO/IEC 17025 or national equivalent.
NOTE 2 When a qualified laboratory is not available for a given piece of equipment,
calibration services may be performed by the equipment manufacturer. In such cases, the
organization should ensure that the requirements listed in 7.6.3.1 have been met.

10/15/08 Rev. 1 Page 32 of 45 John Farmer, Ph.D.


8 Measurement, analysis and improvement
8.1 General
8.1q1a The organization shall plan and implement How do you plan and implement
the monitoring, measurement, analysis and measurement, analysis and
improvement processes needed improvement processes needed to
a) to demonstrate conformity of the product, demonstrate products conform to
requirements?

8.1q1b The organization shall plan and implement How do you plan and implement
the monitoring, measurement, analysis and measurement, analysis and
improvement processes needed improvement processes needed to
b) to ensure conformity of the quality ensure conformity of the QMS?
management system, and

8.1q1c The organization shall plan and implement How do you plan and implement
the monitoring, measurement, analysis and measurement, analysis and
improvement processes needed improvement processes needed to
c) to continually improve the effectiveness continually improve the effectiveness of
of the quality management system. the QMS?

8.1q2 This shall include determination of How do you determine what methods to
applicable methods, including statistical use, including statistical techniques?
techniques, and the extent of their use. How do you determine the extent of their
use?

8.1.1 Identification of statistical tools


T8.1.1q1 Appropriate statistical tools for each Have appropriate statistical tools for
process shall be determined during each process been determined and
advance quality planning and included in included in the control plan? (see
the control plan. 7.5.1.1)

8.1.2 Knowledge of basic statistical concepts


T8.1.2q1 Basic statistical concepts, such as variation, How does Supplier ensure that basic
control (stability), process capability and statistical concepts are understood and
over-adjustment shall be understood and utilized throughout Supplier? (verify
utilized throughout the organization. throughout audit)
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.1q1 As one of the measurements of the How do you obtain information about
performance of the quality management customer perception as to whether
system, the organization shall monitor Supplier has met customer
information relating to customer perception requirements?
as to whether the organization has met
customer requirements. The methods for How is this information used?
obtaining and using this information shall be
determined.

10/15/08 Rev. 1 Page 33 of 45 John Farmer, Ph.D.


NOTE Consideration should be given to both internal and external customers.

8.2.1.1 Customer satisfaction Supplemental


T8.2.1.1q1 Customer satisfaction with the organization What realization process performance
shall be monitored through continual indicators are used to monitor customer
evaluation of performance of the realization satisfaction?
processes. Performance indicators shall be
Do they include at least:
based on objective data and include, but not
- delivered part quality performance,
be limited to:
- customer disruptions including field
- delivered part quality performance,
- customer disruptions including field returns, returns,
- delivery schedule performance
- delivery schedule performance (including
(including incidents of premium
incidents of premium freight), and
freight), and
- customer notifications related to quality or
delivery issues. - customer notifications related to
quality or delivery issues?

T8.2.1.1q2 The organization shall monitor the How do you monitor manufacturing
performance of manufacturing processes processes to demonstrate compliance
to demonstrate compliance with customer with customer requirements for product
requirements for product quality and quality and process efficiency?
efficiency of the process.
8.2.2 Internal audit
8.2.2q1 The organization shall conduct internal Are internal audits being conducted at
audits at planned intervals to determine planned intervals?
whether the quality management system
a) conforms to the planned arrangements Do they determine whether the QMS
(see 7.1), to the requirements of this conforms to the requirements of ISO
International Standard and to the quality 9001 and to the other requirements
management system requirements established by Supplier? (Review
established by the organization, and records to demonstrate conformance)
b) is effectively implemented and
maintained. Do they determine whether the QMS is
effectively implemented and
maintained? (Review records)
8.2.2q2 An audit programme shall be planned, Can you show me an audit plan that
taking into consideration the status and takes into consideration the importance
importance of the processes and areas to of the processes and areas to be
be audited, as well as the results of audited, and the results of previous
previous audits. audits?

8.2.2q3 The audit criteria, scope, frequency and Where are the audit criteria, scope,
methods shall be defined. frequency and methods defined?

8.2.2q4 Selection of auditors and conduct of audits Can you demonstrate that selection of
shall ensure objectivity and impartiality of auditors and the conduct of audits are
the audit process. Auditors shall not audit objective and impartial, and that auditors
their own work. dont audit their own work?

10/15/08 Rev. 1 Page 34 of 45 John Farmer, Ph.D.


8.2.2q5 The responsibilities and requirements for Can you show me your internal audit
planning and conducting audits, and for procedure?
reporting results and maintaining records
(see 4.2.4) shall be defined in a Can you show me the records of
documented procedure. internal QMS audits?

8.2.2q6 The management responsible for the area Who ensures that actions are taken to
being audited shall ensure that actions are eliminate detected nonconformities and
taken without undue delay to eliminate their causes?
detected nonconformities and their causes.
Are they being taken care of in a timely
manner? (verify with records)

8.2.2q7 Follow-up activities shall include the What activities are done to verify the
verification of the actions taken and the actions taken, and how are the
reporting of verification results (see 8.5.2). verification results reported?

NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.

8.2.2.1 Quality management system audit


T8.2.2.1q1 The organization shall audit its quality Do you have audit records showing that
management system to verify compliance the entire QMS is being audited?
with this Technical Specification and any
additional quality management system
requirements.
8.2.2.2 Manufacturing process audit
T8.2.2.2q1 The organization shall audit each Do you have records showing that each
manufacturing process to determine its manufacturing process is being audited
effectiveness. to determine its effectiveness?

8.2.2.3 Product audit


T8.2.2.3q1 The organization shall audit products at Are there records showing that products
appropriate stages of production and are being audited at appropriate stages
delivery to verify conformity to all specified of production and delivery?
requirements, such as product dimensions,
functionality, packaging and labelling, at a Do the audits verify conformity to all
defined frequency. specified requirements?

8.2.2.4 Internal audit plans


T8.2.2.4q1 Internal audits shall cover all quality Can you show me an annual audit plan?
management related processes, activities
and shifts, and shall be scheduled Does it show that audits cover all QMS
according to an annual plan. processes, activities and shifts?

10/15/08 Rev. 1 Page 35 of 45 John Farmer, Ph.D.


T8.2.2.4q2 When internal/external nonconformities or Is there evidence that audit frequency is
customer complaints occur, the audit increased due to nonconformances or
frequency shall be appropriately increased. customer complaints?
NOTE Specific checklists should be used Are specific checklists used for each audit?
for each audit.
8.2.2.5 Internal auditor qualification
T8.2.2.5q1 The organization shall have internal How do you determine competence of
auditors who are qualified to audit the internal auditors to audit the
requirements of this Technical Specification requirements of TS 16949? (See 6.2.2.2
(see 6.2.2.2). also customer specific requirements).
8.2.3 Monitoring and measurement of processes
8.2.3q1 The organization shall apply suitable What methods are used to monitor and
methods for monitoring and, where measure the QMS processes?
applicable, measurement of the quality
management system processes.
8.2.3q2 These methods shall demonstrate the Can you show that they have achieved
ability of the processes to achieve planned the desired results?
results.
8.2.3q3 When planned results are not achieved, When the desired results are not
correction and corrective action shall be achieved, what actions are taken to
taken, as appropriate, to ensure conformity ensure that the product meets
of the product.
requirements?
8.2.3.1 Monitoring and measurement of manufacturing processes
T8.2.3.1q1 The organization shall perform process Can you show me process studies that
studies on all new manufacturing (including have been performed on new
assembly or sequencing) processes to manufacturing processes?
verify process capability and to provide
additional input for process control.
T8.2.3.1q2 The results of process studies shall be Can you show examples of results of
documented with specifications, where process studies being documented with
applicable, for means of production, specifications? Are they used for
measurement and test, and maintenance instructions?
instructions.
T8.2.3.1q3 These documents shall include objectives Do the documents include objectives for
for manufacturing process capability, manufacturing process capability,
reliability, maintainability and availability, as reliability, maintainability, availability,
well as acceptance criteria. and acceptance criteria?
T8.2.3.1q4 The organization shall maintain Do records show that manufacturing
manufacturing process capability or process capability or original customer-
performance as specified by the customer approved performance is being
part approval process requirements.
maintained?
T8.2.3.1q5 The organization shall ensure that the control May I have a copy of the process flow
plan and process flow diagram are implemented, diagram and control plan for (mfg.
including adherence to the specified process) to review the production line
- measurement techniques,
with?
- sampling plans,
- acceptance criteria, and (Review for adherence to specified
- reaction plans when acceptance criteria requirements)
are not met.

10/15/08 Rev. 1 Page 36 of 45 John Farmer, Ph.D.


T8.2.3.1q6 Significant process events, such as tool Can you show that process events like
change or machine repair, shall be tool changes or machine repairs are
recorded. being recorded (on control charts)?
T8.2.3.1q7 The organization shall initiate a reaction Can you show me that reaction plans
plan from the control plan for characteristics have been followed for characteristics
that are either not statistically capable or that are not statistically capable or are
are unstable. These reaction plans shall unstable?
include containment of product and 100 %
inspection as appropriate. Do the reaction plans include

containment of product and 100 %
inspection as appropriate?
T8.2.3.1q8 A corrective action plan shall then be Have corrective action plan(s) been
completed by the organization, indicating completed by the Supplier, with timing
specific timing and assigned responsibilities and responsibilities to assure that
to assure that the process becomes stable
processes become stable and capable?
and capable.
T8.2.3.1q9 The plans shall be reviewed with and When required, have CA plans been
approved by the customer when so required. reviewed and approved by the
customer?
T8.2.3.1q10 The organization shall maintain records of Can you show me records of effective
effective dates of process changes. dates of process changes?

8.2.4 Monitoring and measurement of product


8.2.4q1 The organization shall monitor and What characteristics are checked to
measure the characteristics of the product verify that product requirements have
to verify that product requirements have been met?
been met.
8.2.4q2 This shall be carried out at appropriate At what stages of the product realization
stages of the product realization process in process do monitoring and measuring
accordance with the planned arrangements activities take place?
(see 7.1).
8.2.4q3 Evidence of conformity with the acceptance How is evidence of conformity with
criteria shall be maintained. acceptance criteria maintained?

8.2.4q4 Records shall indicate the person(s) Can you show me records that indicate
authorizing release of product (see 4.2.4). who has authorized release of product
to the next stage of the process?
8.2.4q5 Product release and service delivery shall How do you ensure that product is not
not proceed until the planned arrangements released until the all requirements have
(see 7.1) have been satisfactorily been met? If product must be released
completed, unless otherwise approved by a prior to this, how is it approved?
relevant authority and, where applicable, by
the customer.
NOTE When selecting product parameters to monitor compliance to specified internal and external
requirements, the organization determines the types of product characteristics, leading to
- the types of measurement,
- suitable measurement means, and
- the capability and skills required.

10/15/08 Rev. 1 Page 37 of 45 John Farmer, Ph.D.


8.2.4.1 Layout inspection and functional testing
T8.2.4.1q1 A layout inspection and a functional Can you show me layout inspection and
verification to applicable customer functional verification results?
engineering material and performance
Do they address applicable customer
standards shall be performed for each
specifications and correlate with the
product as specified in the control plans.
control plan requirements?
Results shall be available for customer
review. Are results available for customer
review?
NOTE Layout inspection is the complete measurement of all product dimensions shown on the
design records.
8.2.4.2 Appearance items
T8.2.4.2q1 For organizations manufacturing parts Do you provide parts designated by
designated by the customer as customer(s) as appearance items?
appearance items, the organization shall
If so can you show that you have:
provide
- appropriate resources including
- appropriate resources including lighting
for evaluation, lighting for evaluation,
- masters for color, grain, gloss, metallic
- masters for colour, grain, gloss, metallic
brilliance, texture, distinctness of
brilliance, texture, distinctness of image
image (DOI), as appropriate,
(DOI), as appropriate,
- maintenance and control of
- maintenance and control of appearance
appearance masters and evaluation
masters and evaluation equipment, and
equipment, and
- verification that personnel making
- verification that personnel making
appearance evaluations are competent
appearance evaluations are
and qualified to do so.
competent and qualified to do so
8.3 Control of nonconforming product
8.3q1 The organization shall ensure that product How do you ensure that nonconforming
which does not conform to product products are identified and controlled to
requirements is identified and controlled to prevent unintended use or delivery?
prevent its unintended use or delivery. (Verify product throughout audit)
8.3q2 The controls and related responsibilities Can you show me your documented
and authorities for dealing with procedure defining the controls for
nonconforming product shall be defined in a dealing with nonconforming product?
documented procedure.
Does it include related responsibilities
and authorities?

8.3q3 The organization shall deal with When you have nonconforming
nonconforming product by one or more of product, what methods do you
the following ways: use to deal with it?
a) by taking action to eliminate the
detected nonconformity;
c) by authorizing its use, release or
acceptance under concession by a
relevant authority and, where
applicable, by the customer;
d) by taking action to preclude its original
intended use or application.

10/15/08 Rev. 1 Page 38 of 45 John Farmer, Ph.D.


8.3q4 Records of the nature of nonconformities Can you show me records of
and any subsequent actions taken, nonconforming product and any actions
including concessions obtained, shall be taken?
maintained (see 4.2.4).
Are there any records of concessions
obtained?

8.3q5 When nonconforming product is corrected it When nonconforming product is


shall be subject to re-verification to corrected, can you demonstrate that it is
demonstrate conformity to the re-verified to ensure it conforms to
requirements. requirements?

8.3q6 When nonconforming product is detected When nonconforming product is


after delivery or use has started, the detected after shipment, what actions
organization shall take action appropriate to are taken, such as containment?
the effects, or potential effects, of the (Verify corrective action records)
nonconformity.
8.3.1 Control of nonconforming product Supplemental
T8.3.1q1 Product with unidentified or suspect status How are unidentified or suspect
shall be classified as nonconforming products treated?
product (see 7.5.3).
8.3.2 Control of reworked product
T8.3.2q1 Instructions for rework, including re- Can you show me instructions for
inspection requirements, shall be rework?
accessible to and utilized by the appropriate
Do they include re-inspection
personnel.
requirements?

Are they accessible and utilized?

8.3.3 Customer information


T8.3.3q1 Customers shall be informed promptly in Do you have evidence that customers
the event that nonconforming product has are promptly notified if nonconforming
been shipped. product is shipped?

8.3.4 Customer waiver


T8.3.4q1 The organization shall obtain a customer Can you show me records of customer
concession or deviation permit prior to approvals prior to processing, whenever
further processing whenever the product or deviations from approved product or
manufacturing process is different from that manufacturing processes occur?
which is currently approved.
T8.3.4q2 The organization shall maintain a record of Do the records indicate expiration date
the expiration date or quantity authorized. and/or quantity authorized?

T8.3.4q3 The organization shall also ensure How do you ensure that original
compliance with the original or superseding requirements are met when the
specifications and requirements when the authorization expires?
authorization expires.
T8.3.4q4 Material shipped on an authorization shall How do you identify material shipped on
be properly identified on each shipping an authorization?
container.

10/15/08 Rev. 1 Page 39 of 45 John Farmer, Ph.D.


T8.3.4q5 This applies equally to purchased product. Do you have records that this process is
The organization shall agree with any applied to purchased products also?
requests from suppliers before submission
to the customer. Do you review and agree with supplier
deviation requests before submitting
them to the customer for approval?

8.4 Analysis of data


8.4q1 The organization shall determine, collect What data is collected and analyzed to
and analyse appropriate data to demonstrate the suitability and
demonstrate the suitability and effectiveness of the QMS and to
effectiveness of the quality management evaluate where continual improvement
system and to evaluate where of its effectiveness can be made?
continual improvement of the
effectiveness of the quality management
system can be made. This shall
include data generated as a result of
monitoring and measurement and
from other relevant sources.

8.4q2a The analysis of data shall provide information What information does this analysis
relating to provide relating to:
a) customer satisfaction (see 8.2.1), - customer satisfaction? (See 5.6)
b) conformity to product requirements (see - conformity to product requirements?
7.2.1), (See 5.6)
c) characteristics and trends of - characteristics and trends of
processes and products including processes and products? (See 5.6)
opportunities for preventive action, - suppliers? (See 7.4.1)
and
d) suppliers.

8.4.1 Analysis and use of data


T8.4.1q1 Trends in quality and operational How do you compare trends in quality
performance shall be compared with and operational performance with
progress toward objectives and lead to progress toward objectives?
action to support the following:
- development of priorities for prompt Does the comparison lead to action to
solutions to customer-related problems; supporting the following?
- determination of key customer-related - development of priorities for prompt
trends and correlation for status review, solutions to customer-related
decision-making and longer term problems;
planning; - determination of key customer-
- an information system for the timely related trends and correlation
reporting of product information arising for status review, decision-
from usage. making and longer term
planning;
- an information system for the
timely reporting of product
information arising from
usage.

NOTE Data should be compared with those of competitors and/or appropriate


benchmarks.

10/15/08 Rev. 1 Page 40 of 45 John Farmer, Ph.D.


8.5 Improvement
8.5.1 Continual improvement
8.5.1q1 The organization shall continually improve Can you demonstrate that Suppliers
the effectiveness of the quality QMS effectiveness continually
management system through the use of the improves?
quality policy, quality objectives, audit
results, analysis of data, corrective and What tools do you use?
preventive actions and management (See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3)
review.
8.5.1.1 Continual improvement of the Supplier
T8.5.1.1q1 The organization shall define a process for Where has Supplier defined a process
continual improvement (see examples in for continual improvement?
annex B of ISO 9004:2000).

8.5.1.2 Manufacturing process improvement


T8.5.1.2q1 Manufacturing process improvement shall Can you show that CI efforts focus on
continually focus upon control and control and reduction of variation in
reduction of variation in product product and process characteristics
characteristics and manufacturing process (after capability, stability, and
parameters. conformity)?

NOTE 1 Controlled characteristics are documented in the control plan.


NOTE 2 Continual improvement is implemented once manufacturing processes are
capable and stable, or product characteristics are predictable and meet customer
requirements.

8.5.2 Corrective action 8.5.2 Corrective action


8.5.2q1 The organization shall take action to Do corrective actions records identify
eliminate the cause of nonconformities in and address root cause(s)?
order to prevent recurrence. (Do root causes match actions?)

8.5.2q2 Corrective actions shall be appropriate to Are actions taken appropriate to the
the effects of the nonconformities severity of the problem?
encountered.
8.5.2q3 A documented procedure shall be Can you show me a documented
established to define requirements for procedure defining requirements for
a) reviewing nonconformities (including each of the following?
customer complaints), a) reviewing nonconformities (including
b) determining the causes of customer complaints)
nonconformities, b) determining the causes of
c) evaluating the need for action to ensure nonconformities
that nonconformities do not recur, c) evaluating the need for action to ensure
d) determining and implementing action that nonconformities do not recur
needed, d) determining and implementing action
e) records of the results of action taken needed
(see 4.2.4), and e) records of the results of action taken
f) reviewing corrective action taken. f) reviewing corrective action taken

10/15/08 Rev. 1 Page 41 of 45 John Farmer, Ph.D.


8.5.2q4 e) records of the results of action taken Can you show me records of corrective
(see 4.2.4) actions taken?

8.5.2.1 Problem solving


T8.5.2.1q1 The organization shall have a defined Where is the process for problem
process for problem solving leading to root solving defined?
cause identification and elimination. Does it lead to root cause identification
and elimination? (Review records)

T8.5.2.1q2 If a customer-prescribed problem-solving If one or more customer requires a


format exists, the organization shall use the specific problem-solving format can you
prescribed format. show me records documented as
required?

8.5.2.2 Error-proofing
T8.5.2.2q1 The organization shall use error-proofing Can you show that error-proofing
methods in their corrective action process. methods are used in the corrective
action process?

8.5.2.3 Corrective action impact


T8.5.2.3q1 The organization shall apply to other similar Can you show that corrective actions are
processes and products the corrective applied to other similar processes and
action, and controls implemented, to products?
eliminate the cause of a nonconformity.
8.5.2.4 Rejected product test/analysis
T8.5.2.4q1 The organization shall analyse parts Can you show me records of analysis of
rejected by the customer's manufacturing parts rejected by customer
plants, engineering facilities and manufacturing plants, engineering
dealerships. The organization shall facilities and dealerships?
minimize the cycle time of this process.
Records of these analyses shall be kept How long does the analysis take?
and made available upon request. The
organization shall perform analysis and Are records made available (to
initiate corrective action to prevent customers) upon request?
recurrence.
Is the time consistent with the
determination of root cause, corrective
action and monitoring the effectiveness
of implementation?

NOTE Cycle time related to rejected product analysis should be consistent with the
determination of root cause, corrective action and monitoring the effectiveness of
implementation.

10/15/08 Rev. 1 Page 42 of 45 John Farmer, Ph.D.


8.5.3 Preventive action 8.5.3 Preventive action
8.5.3q1 The organization shall determine action to How do you determine potential
eliminate the causes of potential nonconformities to take action on?
nonconformities in order to prevent their
occurrence. Do preventive action records identify
and address root cause(s)?

8.5.3q2 Preventive actions shall be appropriate to Are actions taken appropriate to the
the effects of the potential problems. severity of the problem?

8.5.3q3 A documented procedure shall be Can you show me a documented


established to define requirements for procedure defining requirements for
a) determining potential nonconformities each of the following?
and their causes, a) determining potential nonconformities
b) evaluating the need for action to prevent and their causes,
occurrence of nonconformities, b) evaluating the need for action to prevent
c) determining and implementing action occurrence of nonconformities,
needed, c) determining and implementing action
d) records of results of action taken (see needed,
4.2.4), and d) records of results of action taken (see
e) reviewing preventive action taken. 4.2.4), and
e) reviewing preventive action taken.

8.5.3q4 d) records of results of action taken (see Can you show me records of preventive
4.2.4) actions taken?

Annex A Control plan


A.1 Phases of the control plan
TAXA.1q1 The control plan shall cover three distinct Can you show me control plans that
phases as appropriate. cover prototype, pre-launch, and
a) Prototype: a description of the dimensional
measurements, material and performance production?
tests that will occur during building of the
prototype. The organization shall have a If all three types are not used, does
prototype control plan if required by the Suppliers scope of certification justify
customer.
b) Pre-launch: a description of the dimensional their absence?
measurements, material and performance
tests that occur after prototype and before full
production. Pre-launch is defined as a
production phase in the process of product
realization which may be required after
prototype build.
c) Production: documentation of product/process
characteristics, process controls, tests and
measurement systems that occur during mass
production.
TAXA.1q2 Each part shall have a control plan but, in Can you show me the control plan for (part
many cases, family control plans may cover x)?
a number of similar parts produced using a Do you have family control plans?
common process.
(If so, are the only differences in the parts
dimensional not form, application or function?)

10/15/08 Rev. 1 Page 43 of 45 John Farmer, Ph.D.


TAXA.1q3 Control plans are an output of the quality plan. Are control plans outputs of the quality plan?

A.2 Elements of the control plan


TAXA.1q1 The organization shall develop a control Do the control plans include the
plan that includes, as a minimum, the following minimum contents:
following contents. a) General data
a) General data - control plan number,
- control plan number, - issue date, and revision date, if any,
- issue date, and revision date, if any, - customer information (see customer
- customer information (see customer requirements),
requirements), - Supplier's name/site designation,
- organization's name/site designation, - part number(s),
- part number(s), - part name/description,
- part name/description, - engineering change level,
- engineering change level, - phase covered (prototype, pre-launch,
- phase covered (prototype, pre-launch,
production), production),
- key contact, - key contact,
- part/process step number, - part/process step number,
- process name/operation description. - process name/operation description.
b) Product control b) Product control
- product-related special characteristics, - product-related special characteristics,
- other characteristics for control - other characteristics for control
(number, product or process), (number, product or process),
- specification/tolerance. - specification/tolerance.
c) Process control c) Process control
- process parameters, - process parameters,
- process-related special - process-related special characteristics,
characteristics, - machines, jigs, fixtures, tools for
- machines, jigs, fixtures, tools for manufacturing.
manufacturing. d) Methods
d) Methods - evaluation measurement technique,
- evaluation measurement technique, - error-proofing,
- error-proofing, - sample size and frequency,
- sample size and frequency, - control method.
- control method. e) Reaction plan and corrective actions
e) Reaction plan and corrective actions - reaction plan (include or reference),
- reaction plan (include or reference), - corrective action.
- corrective action.

10/15/08 Rev. 1 Page 44 of 45 John Farmer, Ph.D.


Additional audit checklist questions
Q# Requirement Text Audit Question Objective Evidence

10/15/08 Rev. 1 Page 45 of 45 John Farmer, Ph.D.

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