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IATF 16949:2016

conducted for

Conducted on
24/07/2019 9:25 PM

Prepared by
Subhash Rastogi

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4 Context of the Organisation - Score (0/34) 0%

Question Response Details

4.1 Understanding the Organisation and


its Context
NOTE 1 Understanding the external context can be facilitated by considering issues arising
from legal, technological, competitive, market, cultural, social, and economic environments,
whether international, national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to
values, culture knowledge and performance of the organization.

The organization shall determine external and internal issues that are relevant to its purpose
and its strategic direction and that affect its ability to achieve the intended result(s) of its quality
management system.

Has Best Bars determined external


and internal issues relevant to its
purpose and strategic direction?

Do these Issues affect the ability to


achieve the intended result of the
QMS?

4.2 Understanding the needs and


expectations of interested parties
Has Best Bars conducted a study to determine the impact or potential impact on the
organization’s ability to consistently provide products and services that meet customer and
applicable statutory and regulatory requirements, the organization shall determine:
a)The interested parties that are relevant to the quality management system;
b)The requirements of these interested parties that are relevant to the quality management
system.

Has Best Bars determined what


requirements those parties have that
are relevant to the QMS?

Has Best Bars determined the impact


or potential impact?

The organization shall monitor and review the information about these interested parties and
their relevant requirements.

Does Best Bars monitor and review


the information about interested
parties and their relevant
requirements?

4.3 Determining the scope of the quality


management system
The organization shall determine the boundaries and applicability of the quality management
system to establish its scope.

IATF 16949:2016 -1-


Question Response Details

Has Best Bars set the boundaries and


applicability of the QMS been used to
establish the scope of the
organization?

4.3.1 (TS) Determining the scope of the


QMS - Supplementary
Supporting functions, whether of site or remote (Such as design centers, corporate
headquarters and distributions centers) shall be included in the scope of the QMS.
The only permitted exclusion permitted for the Automotive QMS standard relates to the
production design and development requirements within ISO 9001:2015, Section 8.3. The
exclusion shall be justified and maintain as documented information (See ISO 9001, Section
7.5_)
Permitted exclusions do not include manufacturing process design.

4.3.2 (TS) Customer Specific


Requirements
Customer specific requirements shall be evaluated and included in the scope of the
Organisations QMS

Is the customers specific requirements


included in the scope of Best Bars
QMS?

4.4 Quality management system and its


processes

4.4.1
The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance
with the requirements of this International Standard.

Has Best Bars established a QM


System that meets these above
requirements?

The organization shall determine the processes needed for the quality management system
and their application throughout the organization and shall determine:
a) the inputs required and the outputs expected from these processes;
b) the sequence and interaction of these processes;
c) the criteria, methods, including measurements and related performance indicators needed
to ensure the effective operation, and control of these processes;
d) the resources needed and ensure their availability;
e) the assignment of the responsibilities and authorities for these processes;
f) the risks and opportunities in accordance with the requirements of 6.1, and plan and
implement the appropriate actions to address them;
g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if
needed, the changes to processes to ensure that they achieve intended results;
h) opportunities for improvement of the processes and the quality management system.

Has Best Bars determined the


processes for the QMS?

Does Best Bars determine sequence


and interaction of the processes?

IATF 16949:2016 -2-


Question Response Details

Does Best Bars determine the inputs


and outputs for those processes?

Does Best Bars determine the criteria,


methods, measurement and related
performance indicators needed to
operate and control those processes?

Does Best Bars determine what


resources are needed and how are
these made available?

Does Best Bars assign responsibilities


and authorities for those processes?

Does Best Bars determine risks and


opportunities considered and plans
are made to implement actions to
address them?

Does Best Bars measure and evaluate


processes and, if needed, make
changes to achieve intended results?

The organization shall maintain documented information to the extent necessary to support the
operation of processes and retain documented information to the extent necessary to have
confidence that the processes are being carried out as planned.

Does Best Bars maintain documented


information to support the operation of
processes?

Is Best Bars confidence that the


processes are being carried out as
planned determined?

4.4.1.1 (TS) Conformance of products


and processes
The organisation shall ensure conformance of all products and processes, including service
parts and those that are outsourced, to all applicable customers, statutory requirements (See
Sections 8.4.2.2)

Does Best Bars conduct a risk


assessment in terms of all the
Statutory and regulatory
requirements?

4.4.1.2 (TS) Product Safety


The organisation shall have documented processes for the Management of Product Safety
related products and manufacturing processes which shall include but not limited to the
following, where applicable:

Does Best Bars identify the


organisational statutory and regulatory
product safety requirements?

IATF 16949:2016 -3-


Question Response Details

Does Best Bars notify the customer of


requirements?

Special approvals by design FMEA?

Reaction plans? (See Section 9.1.1.1)

Identification of product safety related


characteristics?

Identification and controls of safety


related characteristics of product and
at the point of manufacturing?

Special approval of control plans and


process FMEA's?

Define responsibilities, definition of


escalation processes and flow of
information, including top management
and customer notification?

Training identified by Best Bars or


customer for personnel involved in
product safety related products and
associated manufacturing processes?

Changes of product or processes shall


be approved prior to implementation,
including evaluation of potential effects
on product safety from process and
product changes (See ISO 9001
Section 8.3.6)

Transfer of requirements with regards


to product safety throughout the supply
chain, including customer designated
sources (See section 8.4.3.1)

Product trace-ability by manufactured


lot (At a minimum) throughout the
supply chain (See section 8.5.2.1

Lessons learned for new product


introduction

4.4.2
To the extent necessary, the Best Bars shall:

Does Best Bars maintain documented


information to support the operation of
its processes?

Does Best Bars retain documented


information to have confidence that the
processes are being carried out as
planned?

IATF 16949:2016 -4-


5 Leadership - Score (0/34) 0%

Question Response Details

5.1 Leadership and commitment Score (0/16) 0%

5.1.1 Leadership and commitment for the


quality management system
Top management shall demonstrate leadership and commitment with respect to the quality
management system by:
a) taking accountability of the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality
management system and are compatible with the strategic direction and the context of the
organization;
c) ensuring that the quality policy is communicated, understood and applied within the
organization;
d) ensuring the integration of the quality management system requirements into the
organization’s business processes;
e) promoting awareness of the process approach;
f) ensuring that the resources needed for the quality management system are available;
g) communicating the importance of effective quality management and of conforming to the
quality management system requirements;
h) ensuring that the quality management system achieves its intended results;
i) engaging, directing and supporting persons to contribute to the effectiveness of the quality
management system;
j) promoting continual improvement;
k) supporting other relevant management roles to demonstrate their leadership as it applies to
their areas of responsibility.

NOTE Reference to “business” in this International Standard can be interpreted broadly to


mean those activities that are core to the purposes of the organization’s existence; whether the
organization is public, private, for profit or not for profit.

Does Best Bars top management


demonstrates leadership and
commitment w.r.t. the QMS by taking
accountability of the effectiveness of
the QMS.

Does Best Bars make use of the


quality policy and objectives
established for the QMS and are they
compatible with the strategic direction
and the organizational context?

Does Best Bars communicate the


quality policy within the organization?

Are Best Bars requirements of the


QMS integrated into the business
processes?

Does Best Bars communicate the


importance of effective quality
management?

Does Best Bars ensure that the QMS


achieves its intended results?

IATF 16949:2016 -5-


Question Response Details

Does Best Bars engage, direct and


support people to contribute to the
effectiveness of the QMS?

Does Best Bars promote continual


improvement?

Does Best Bars support other relevant


management roles to demonstrate
leadership in their areas of
responsibility?

5.1.1.1 (TS) Corporate responsibility


Does Best Bars define and implement
corporate responsibility policies,
including at a minimum abd anti-
bribery policy, an employee code of
conduct, and an ethics escalation
policy (Whistle blowing policy)

5.1.1.2 (TS) Process effectiveness and


efficiency
Does Best Bars Top Management
review product realisation processes
and support processes to evaluate and
improve their effectiveness and
efficiency?
The results of the process review
activities shall be included as a input
into the Management Review (See
Section 9.3.2.1)

5.1.1.3 (TS) Process owners


Does Best Bars top management
identify process owners who are
responsible for managing the
organisations processes and related
outputs? The process owners shall
understand their roles and competent
to perform those roles (See ISO 9001,
Section 9.3.2.1)

5.1.2 Customer focus


Top management shall demonstrate leadership and commitment with respect to customer
focus by ensuring that:
a) customer requirements and applicable statutory and regulatory requirements are
determined and met;
b) the risks and opportunities that can affect conformity of products and services and the ability
to enhance customer satisfaction are determined and addressed;
c) the focus on consistently providing products and services that meet customer and applicable
statutory and regulatory requirements is maintained;
d) the focus on enhancing customer satisfaction is maintained.

IATF 16949:2016 -6-


Question Response Details

Does Best Bars top management


demonstrates leadership and
commitment w.r.t. customer focus
ensuring requirements and applicable
statutory and regulatory requirements
are determined and met.

Does Best Bars determine the risks


and opportunities that can affect
conformity of products and services?

Does Best Bars consistently provide


products and services that meet
customer and applicable statutory and
regulatory requirements?

Does Best Bars provide customer


satisfaction?

5.2 Quality policy Score (0/8) 0%

5.2.1
Top management shall establish, review and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization;
b) provides a framework for setting and reviewing quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.

Does Best Bars top management


establish, review and maintain a
quality policy?

Does Best Bars determine the Quality


Policy to be appropriate to the purpose
and context of the organization?

Does it provide a framework for setting


and reviewing quality objectives?

Does it contain a commitment to


satisfy applicable requirements?

Does it include a commitment to


continual improvement of the QMS?

5.2.2
The quality policy shall:
a) be available as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.

Is the quality policy available as


documented information?

IATF 16949:2016 -7-


Question Response Details

Is it communicated?

Is the Policy available to relevant


interested parties?

5.3 Organisational roles, responsibility Score (0/6) 0%


and authorities
Top management shall ensure that the responsibilities and authorities for relevant roles are
assigned, communicated and understood within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this
International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system, on opportunities for
improvement and on the need for change or innovation, and especially for reporting to top
management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to
the quality management system are planned and implemented.

Does top management ensure that


responsibilities and authorities for
relevant roles are assigned,
communicated and understood within
the organization?

Does top management assign the


responsibility and authority for
ensuring that the QMS conforms to the
International standard?

Does top management assign the


responsibility and authority for
ensuring processes are delivering their
intended outputs?

Is the performance of the QMS,


opportunities for improvement and the
need for change or innovation reported
to top management?

Does top management promote


customer focus within the
organization?

Is the integrity of the QMS maintained


when changes to the QMS are
planned and implemented?

5.3.1 (TS) Organisational roles, Score (0/1) 0%


responsibilities and authorities

IATF 16949:2016 -8-


Question Response Details

Does Best Bars top Management


assign personnel with the
responsibility and authority to ensure
that customer requirements are met?
These assignments shall be
documented. This includes but is not
limited to the selection of special
characteristics, setting quality
objectives and related training,
corrective and preventive actions,
product design and development,
capacity analysis, logistics information,
customer scorecards and customer
portals.

5.3.2 (TS) Responsibility and authority for


product requirements and corrective Score (0/3) 0%
actions
Does Best Bars top Management
ensure:
Personnel responsible for conformity
to product requirements have the
authority to stop shipment and stop
production to correct quality problems?

Does Best Bars production operations


across all shifts are staffed with
personnel in charge of, or delegated
responsibility for, ensuring conformity
to product requirements?

Does Best Bars personnel with


authority and responsibility for
corrective actions are promptly
informed of products or processes that
do not conform to requirements to
ensure that nonconforming products is
not shipped to the customers and that
all potential nonconforming product is
identified and contained?

IATF 16949:2016 -9-


6 Planning for the Quality Management System - Score (0/41) 0%

Question Response Details

6.1 Actions to address risks and Score (0/19) 0%


opportunities

6.1.1
When planning for the quality management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and
opportunities that
need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) prevent, or reduce, undesired effects;
c) Achieve continual improvement.

Are the internal and external issues


and interested parties considered
when planning for the QMS?

Are risks and opportunities determined


and addressed so that the QMS can
achieve its intended results?

Are risks and opportunities determined


and addressed so that the QMS can
prevent or reduce undesired effects?

Are risks and opportunities determined


and addressed so that the QMS can
achieve continual improvement?

6.1.2
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order
to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences,
sharing the risk, or retaining risk by informed decision.

The organization shall ensure that personnel with product design responsibility are competent
to achieve design requirements and are skilled in applicable tools and techniques.
Applicable tools and techniques shall be identified by the organization.

Are actions planned to address risks


and opportunities?

Are actions integrated and


implemented into the QMS processes?

Does Best Bars evaluate the


effectiveness of the actions?

Actions taken to address risks and opportunities shall be proportionate to the potential impact
on the conformity of products and services.

IATF 16949:2016 - 10 -
Question Response Details

Does Best Bars take actions to


address risks and opportunities
determined as being appropriate to the
potential impact on the conformity of
products and services?

Product design skills Score (0/3) 0%

The organization shall ensure that personnel with product design responsibility are competent
to achieve design requirements and are skilled in applicable tools and techniques.
Applicable tools and techniques shall be identified by the organization.

Does Best Bars determine that


personnel with product design
responsibility are competent to achieve
design requirements?

Does Best Bars determine skills


required in applicable tools and
techniques?

Does Best Bars identify applicable


tools and techniques?

NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order
to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences,
sharing the risk, or retaining risk by informed decision.

6.1.2.1 (TS) Risk Analysis


Does Best Bars at a minimum include
in its risk analysis lessons learned
from product recalls, product audits,
field returns and repairs, complaints
and scrap and rework?

6.1.2.2 (TS) Preventive action


Does Best Bars determine and
implement actions to eliminate the
causes of potential non conformity in
order to prevent their occurrences?
Preventive actions shall be appropriate
to the severity of the potential issues?

Does Best Bars establish a process to


lessen the impact of negative effects of
risk which includes the following:
Determining potential non-conformity
and their causes?

Evaluating the need for action to


prevent occurrences of non-
conformity?

Determining and implementing actions


needed?

IATF 16949:2016 - 11 -
Question Response Details

Documented information of action


taken?

Reviewing the effectiveness of the


preventive action taken?

Utilising lessons learned to prevent re-


occurrences in similar processes (See
ISO 9001. Section 7.1.6)

6.1.2.3 (TS) Contingency Plans


Does Best Bars

Identify and evaluate internal and


external risks to all manufacturing
processes and infrastructure
equipment essential to maintain
production output and to ensure that
customer requirements are met?

Define contingency plans according to


risk and impact to the customer?

Prepare contingency plans for


continuity of supply in the event of any
of the following key equipment failures
(Also see section 8.5.6.1.1),
interruption from externally provided
products, processes and services,
recurring natural disasters, fire, utility
interruptions, labor shortages and
infrastructure disruptions?

Include, as a supplement to the


contingency plans, a notification
process to the customer and other
interested parties for the extent and
duration of any situation impacting
customers operations?

Periodically test the contingency plans,


a notification process to the customer
and other interested parties for the
extent and duration of any situation
impacting customers operations?

Conduct contingency plan reviews (At


a minimum Annually) using
multidisciplinary team including top
Management, and update as required?

Document the contingency plans and


retain documented information
describing and revision, including the
person who authorised the change?

IATF 16949:2016 - 12 -
Question Response Details

The contingency plan shall include provisions to validate that the manufactured product
continues to meet customer specifications after the restart of production following and
emergency in which production was stopped and if the regular shutdown processes were not
followed?

6.2 Quality objectives and planning to Score (0/9) 0%


achieve them

6.2.1
The organization shall establish quality objectives at relevant functions, levels and processes.
The quality objectives shall:
a) be consistent with the quality policy,
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and the enhancement of customer
satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall retain documented information on the quality objectives.

Does Best Bars have quality objectives


and are these at all relevant functions,
levels and processes?

Are they consistent with the quality


policy?

Do they consider applicable


requirements?

Are they relevant to the conformity of


products and services and do they
enhance customer satisfaction?

Are they monitored? How? How often?

Are they communicated?

Are they updated?

Are there documented information on


the quality objectives?

6.2.2
When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated

IATF 16949:2016 - 13 -
Question Response Details

Does Best Bars determine what will be


done, with what resources, when
completed and how will results be
evaluated for quality objectives?

6.2.2.1 (TS) Quality Objectives and


planning to achieve them
Does Best Bars top Management
ensure that quality objectives to meet
customer requirements are defined,
established and maintained for
relevant functions, processes and
levels throughout the organisation?
The results of the organisations review
regarding interested parties and their
relevant requirements shall be
considered when Best Bars
establishes its annual (At a minimum)
quality objectives and related
performance targets (Internal and
External)

6.3 Planning of changes Score (0/5) 0%

Where the organization determines the need for change to the quality management system
(see 4.4) the change shall be carried out in a planned and systematic manner.
The organization shall consider:
a) the purpose of the change and any of its potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.

Are changes to the QMS planned


systematically?

Can Best Bars demonstrate the


purpose and potential consequences
of changes?

Can Best Bars demonstrate the


integrity of the QMS?

Can Best Bars demonstrate how


resources are made available?

Can Best Bars demonstrate how


responsibility and authority is allocated
or reallocated?

IATF 16949:2016 - 14 -
7 Support - Score (0/101) 0%

Question Response Details

7.1 Resources Score (0/46) 0%

7.1.1 General
The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.

Can Best Bars demonstrate how


resources are determined for the
establishment, implementation,
maintenance and continual
improvement of the QMS?

Can Best Bars demonstrate how the


capabilities and constraints on internal
resources are considered?

Can Best Bars demonstrate how


needs from external providers are
considered.

7.1.2 People
To ensure that the organization can consistently meet customer and applicable statutory and
regulatory requirements, the organization shall provide the persons necessary for the effective
operation of the quality management system, including the processes needed.

Does Best Bars provide persons


necessary to consistently meet
customer, applicable statutory and
regulatory requirements for the QMS
including the necessary processes?

7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure for the operation of
its processes to achieve conformity of products and services

Does Best Bars determine, provide


and maintain the infrastructure for the
operation of processes to achieve
products and service conformity?

7.1.3.1 (TS) Plant, facility and equipment


planning

IATF 16949:2016 - 15 -
Question Response Details

Does Best Bars use a multidisciplinary


approach including a risk identification
and risk mitigation methods when
developing and improving plant, facility
and equipment plans

In designing plant layouts, Does Best


Bars optimise material flow, material
handling, and value added use of floor
space including control of
nonconforming products?

Does Best Bars facilitate synchronous


material flow, as applicable?

Does Best Bars develop and


implement methods to evaluate
manufacturing feasibility for new
product or new operations?
Manufacturing feasibility assessments
shall include capacity planning. These
methods shall also be applicable for
evaluating proposed changes to
existing operations.

Does Best Bars maintain process


effectiveness, including periodic re-
evaluation relative to risk, to
incorporate any changes made during
process approval, control plan
maintenance (See section 8.5.1.1) and
verification of job set-ups (see section
8.5.1.3)

Note 1: These requirements should include the application of lean manufacturing principles.

Note 2: These requirements should apply to on-site supplier activities, as applicable.

Health and Safety


Where third party certification to ISO 45001 (or equivalent) is recognised, it may be used to
demonstrate the organisations conformity to the personnel safety aspects of this requirement.

7.1.4 Environment for the operation of


processes
The organization shall determine, provide and maintain the environment necessary for the
operation of its processes and to achieve conformity of products and services.

Does Best Bars determine, provide


and maintain the environment for the
operation of processes to achieve
products and service conformity?

NOTE Environment for the operation of processes can include physical, social, psychological,
environmental and other factors (such as temperature, humidity, ergonomics and cleanliness).

7.1.4.1 (TS) Environment for the


operation of processes

IATF 16949:2016 - 16 -
Question Response Details

Does Best Bars maintain its premises


is a state of order, cleanliness and
repair that is consistent with the
product and manufacturing process
needs?

7.1.5 Monitoring and measuring


resources
Where monitoring or measuring is used for evidence of conformity of products and services to
specified requirements the organization shall determine the resources needed to ensure valid
and reliable monitoring and measuring results.

Are the resources determined for


ensuring valid and reliable monitoring
and measuring results, where used?

The organization shall ensure that the resources provided:


a) are suitable for the specific type of monitoring and measurement activities being
undertaken;
b) are maintained to ensure their continued fitness for their purpose.

Does Best Bars ensure that resources


provided are suitable for the specific
monitoring and measurement activities
and are maintained to ensure
continued fitness for purpose?

The organization shall retain appropriate documented information as evidence of fitness for
purpose of monitoring and measurement resources.

Does Best Bars have documented


information which is evidence of
fitness for purpose of monitoring and
measurement resources.

Where measurement traceability is: a statutory or regulatory requirement; a customer or


relevant interested party expectation; or considered by the organization to be an essential part
of providing confidence in the validity of measurement results; measuring instruments shall be:
-verified or calibrated at specified intervals or prior to use against measurement standards
traceable to international or national measurement standards. Where no such standards exist,
the basis used for calibration or verification shall be retained as documented information;
-identified in order to determine their calibration status;
-safeguarded from adjustments, damage or deterioration that would invalidate the calibration
status and subsequent measurement results.

Does Best Bars Verify or calibrate at


specified intervals against national or
international measurement standards;

If there are no standards does Best


Bars document information which is
used as the basis used for calibration
or verification

IATF 16949:2016 - 17 -
Question Response Details

Are Best Bars measurement


instruments identified to determine
their calibration status.

Are safeguarded from adjustments

Are they safeguarded from damage


and deterioration

7.1.5.1.1 (TS) Measurement System


Analysis
Does Best Bars conduct statistical
studies to analyse the variation
present in the results of each type of
inspection, measurement and test
equipment system identified in the
control plan? The analytical methods
and acceptance criteria used shall
conform to those in reference manuals
on measurement system analysis.
Other analytical methods and
acceptance criteria may be used if
approved by the customer.

Note: Prioritisation of MSA studies should focus on critical or special product or process
characteristics.

7.1.5.2.1 (TS) Calibration/Verification


records
Does Best Bars have a documented
process for managing
calibration/verification records?
Records for the calibration/verification
activity for all gauges and measuring
and test equipment (including
employee owned equipment relevant
for measuring, customer owned
equipment, or on-site supplier owned
equipment) needed to provide
evidence of conformity to internal
requirements, legislative and
regulatory requirements and customer
defined requirements shall be retained.

Does Best Bars ensure that calibration


/verification activities and records shall
include the following details:
Revisions following engineering
changes that impact measuring
systems?

Any out of specification readings


received for calibration/verification?

An assessment of the risk of the


intended use of the product caused by
the out of spec condition?

IATF 16949:2016 - 18 -
Question Response Details

When a piece of inspection


measurement and test equipment is
found to be out of calibration or
defective during planned verification or
calibration or during use, documented
information on the validity of previous
measurement results obtained with
this piece of inspection measurement
and test equipment shall be retained,
including associated standards last
calibration date and the next due date
on the calibration report.

Notification to the customer if suspect


product or material is shipped

Statements of conformity to
specification after
calibration/verification

Verification that software version used


for product and process control is
specified

Records of the calibration and


maintenance activities for all gauging

Production related software verification


used for product and process control

7.1.5.3 (TS) Laboratory Requirements

7.1.5.3.1 (TS) Internal Laboratory


Does Best Bars internal laboratory
facility have a defined scope that
includes its capacity to perform the
required inspection, test or calibrated
service?

The laboratory shall specify and


implement as a minimum,
requirements for:
Adequacy of the laboratory technical
procedures

Competency of the laboratory


personnel

Testing of the product

Capability to perform these services


correctly, traceable to the relevant
process standard (ASTM etc.)

Customer requirements, if any

Review of the related records

IATF 16949:2016 - 19 -
Question Response Details

Note: Third party accreditation to ISO 17025 may be used to demonstrate the organisations in-
house laboratory conformity to this requirement.

7.1.5.3.2 (TS) External Laboratory


Does Best Bars define the scope used
for inspections, test and calibration
services used for external laboratory
facilities that includes the capacity to
perform the required inspection, test,
calibration?

Does Best Bars ensure that the


laboratory is ISO 17025 accredited or
national equivalent and includes the
relevant inspections, tests and
calibration services in the scope of the
accreditation Certificate?

Does Best Bars ensure that the


external laboratory is accredited by the
customer?

Note, Such evidence may be demonstrated by customer assessment, for example, or by the
customer approved third party assessment that the laboratory meets the intent of ISO 17025 or
national equivalent. The second party assessment may be performed by the organisation
assessing the laboratory using a customer approved method of assessment.

Use of calibration services, other than qualified (Or customer accepted) laboratories may be
subject to government regulatory confirmation, if required.

7.1.6 Organizational knowledge


The organization shall determine the knowledge necessary for the operation of its processes
and to achieve conformity of products and services.

Does Best Bars determine necessary


knowledge for the operation of
processes?

Does Best Bars determine necessary


knowledge to achieve conformity of
products and services?

This knowledge shall be maintained, and made available to the extent necessary.

Does Best Bars maintain this


knowledge and how do you make it
available to the extent necessary?

When addressing changing needs and trends, the organization shall consider its current
knowledge and determine how to acquire or access the necessary additional knowledge

How does Best Bars consider current


knowledge

How does Best Bars acquire additional


knowledge when addressing changing
needs and trends?

IATF 16949:2016 - 20 -
Question Response Details

NOTE 1 Organizational knowledge can include information such as intellectual property and
lessons learned.
NOTE 2 To obtain the knowledge required, the organization can consider:
a) internal sources (e.g. learning from failures and successful projects, capturing
undocumented knowledge and experience of topical experts within the organization);
b) external sources (e.g. standards, academia, conferences, gathering knowledge with
customers or
providers).

7.2 Competence
The organization shall:
a) determine the necessary competence of person(s) doing work under its control that affects
its quality performance;
b) ensure that these persons are competent on the basis of appropriate education, training, or
experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate the
effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence

Does Best Bars determine the


necessary competence of people
doing work under your control that
affects quality performance;

Does Best Bars determine


competence on the basis of
appropriate education, training or
experience?

Does Best Bars take actions to acquire


necessary competence where
applicable and how do you evaluate
the effectiveness of those actions?

Does Best Bars have documented


information where appropriate of
competence

NOTE Applicable actions can include, for example, the provision of training to, the mentoring
of, or the re-assignment of currently employed persons; or the hiring or contracting of
competent persons.

7.2.1 (TS) Competence


Does Best Bars establish and maintain
a documented process for identifying
training need including awareness
(See section 7.3.1) and achieve
competence of all personnel
performing activities affecting
conformity to product and process
requirements? Personnel performing
specific assigned tasks shall be
qualified, as required, with particular
attention to the satisfaction of
customer requirements.

IATF 16949:2016 - 21 -
Question Response Details

7.2.2 (TS) Competence - On the jib


training
Does Best Bars provide on the job
training (Which shall include customer
requirements training) for personnel
new or modified responsibilities
affecting conformity to quality
requirements, internal requirements,
regulatory or legislative requirements
which include contract or agency
personnel?

Does Best Bars administer the level of


detail required for on-the-job training
with the level of education the
personnel posses and the complexity
of the tasks they are required to
perform for their daily work? Persons
who can effect quality shall be
informed about the consequences of
non-conformity to customer
requirements.

7.2.3 (TS) Internal auditor competency


Does Best Bars have a documented
process to verify that the internal
auditors are competent, taking into
account any customer specific
requirements? For additional guidance
on auditor competencies, refer to ISO
19011.

Does Best Bars maintain a list of


qualified internal auditor?

Does Best Bars QMS auditors,


manufacturing process auditors and
product auditors able to demonstrate
the following minimum competencies:
Understanding of the automotive
process approach for auditing,
including risk thinking?

Understanding of applicable customer


specific requirement?

Understanding of the ISO 9001 and


IATF 16949 requirements related to
the scope of the auditing?

Understanding applicable core tools


requirements related to the scope of
the audit?

Understanding how to plan, conduct,


report and close out audit findings?

IATF 16949:2016 - 22 -
Question Response Details

Does Best Bars auditors demonstrate


manufacturing process technical
understanding of the relevant
manufacturing process to be audited,
including process risk analysis
(PFMEA) and control plan.

Does Best Bars product auditors


demonstrate competence in the
understanding of product requirements
and use the relevant measuring and
test equipment to verify product
conformity?

Does Best Bars provide training to


achieve competency, documented
information shall be retained to
demonstrate the trainers competency
with the above requirements?

Does Best Bars auditors execute a


minimum number of audits per year as
defined by the organisation?

Does Best Bars maintain knowledge of


relevant requirements based on
internal changes (e.g Process
technology, product technology) and
external changes (E.g ISO 9001, IATF
16949, Core tools and customer
specific requirements)?

7.2.4 (TS) Second Part auditor


competency
Does Best Bars demonstrate the
competencies of the auditors
undertaking second party audits?

Second part auditors shall meet


customer specific requirements for
auditing qualification and demonstrate
at a minimum the following core
competencies, including understanding
of the following:
The automotive process approach to
auditing, including risk base thinking?

Understanding of applicable customer


specific requirement?

Understanding of the ISO 9001 and


IATF 16949 requirements related to
the scope of the auditing?

Understanding applicable core tools


requirements related to the scope of
the audit?

IATF 16949:2016 - 23 -
Question Response Details

Understanding how to plan, conduct,


report and close out audit findings?

7.3 Awareness
Persons doing work under the organization’s control shall be aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality management system, including the
benefits of improved quality performance;
d) the implications of not conforming with the quality management system requirements.

Does Best Bars make their workers


aware of their quality policy?

Does Best Bars make their employees


aware of their relevant quality
objectives?

Does Best Bars make their employees


aware of their contribution to the
effectiveness of the QMS?

Does Best Bars make their employees


aware of the benefits of improved
performance?

Does Best Bars make their employees


aware of the implications of not
conforming with the QMS
requirements?

7.3.1 (TS) Awareness


Does Best Bars maintain documented
information that demonstrate that all
employees are aware of their impact
on product quality and the importance
of their activities in achieving,
maintaining and improving quality,
including customer specific
requirements and the risks involved for
the customer with non-conforming
product?

7.3.2 (TS) Employee motivated and


empowerment
Does Best Bars maintain a
documented process to motivate
employees to achieving quality
objectives, to make continual
improvements and to create an
environment that promotes innovation?
The process shall include the
promotion of quality and technology
awareness throughout the entire
organisation

IATF 16949:2016 - 24 -
Question Response Details

7.4 Communication
The organization shall determine the internal and external communications relevant to the
quality management system including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate.

Does Best Bars show you how to


determine internal and external
communications relevant to the QMS?

Does Best Bars show you how to


determine What?

Does Best Bars show you how to


determine When?

Does Best Bars show you how to


determine With Whom?

Does Best Bars show you how to


determine How?

7.5 Documented information Score (0/18) 0%

7.5.1 General
The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the
effectiveness of the quality management system.

What documented information does


Best Bars have as required by this
standard?

What documented information does


Best Bars have as being necessary for
the effectiveness of your QMS?

NOTE The extent of documented information for a quality management system can differ from
one
organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.

7.5.1 (TS) Quality Management System


Documentation
Is Best Bars QMS documented and
includes a quality manual which can
be a series of documents (Electronic
or hard copy)?

IATF 16949:2016 - 25 -
Question Response Details

Does the quality manual include, at a


minimum, the scope of the quality
management system, including details
of and justification for any exclusions?

Does the quality manual include, at a


minimum, documented processes
established for the QMS or reference
them?

Does the quality manual include, at a


minimum, the organisations processes
and their sequence and interactions
(inputs and outputs) including type and
extent of control of any outsourced
processes?

Does the quality manual include, at a


minimum, a document (i.e Matrix)
indicating where within the
organisations QMS their customer
specific requirements are addressed?

Note: A matrix of how the requirements of this QMS standard are addressed by the
organisations processes may be used to assist the linkages of the organisations processes
and this automotive QMS.

7.5.2 Creating and updating


When creating and updating documented information the organization shall ensure
appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.

Does Best Bars have documented


information that contains:
Identification;
Description;
and in what media format?

Does Best Bars have documented


information that can be reviewed and
approved for suitability and adequacy.

7.5.3 Control of documented information Score (0/9) 0%

7.5.3.1
Documented information required by
the quality management system and
by this International Standard shall be
controlled to ensure:
a) it is available and suitable for use,
where and when it is needed;
b) it is adequately protected (e.g. from
loss of confidentiality, improper use, or
loss of integrity).

IATF 16949:2016 - 26 -
Question Response Details

Does Best Bars show how to control


documented information.

Does Best Bars show how to make it


available and suitable for use.

How does Best Bars protect their


documented information?

7.5.3.2

Documented information of external origin determined by the organization to be necessary for


the planning and operation of the quality management system shall be identified as
appropriate, and controlled.

How does Best Bars identify as


appropriate and control documented
information of external origin which
has been determined as necessary for
the QMS

NOTE Access can imply a decision regarding the permission to view the documented
information only, or the permission and authority to view and change the documented
information.

7.5.3.2.1 (TS) Record Retention


Does Best Bars define, document and
implement a record retention policy?
The control of records shall satisfy
statutory, regulatory, organisational
and customer requirements.

Does the record retention policy


include production part approvals,
tooling records (Including maintenance
and ownership), product and process
design records, purchase ordeers (if
applicable), or controls and
amendments shall be retained for the
length of time that the product is active
for production and service
requirements, plus one calendar year,
unless otherwise specified by the
customer or regulatory agency?

Note: Production Part Approval documented information may include approved product,
applicable test equipment records or approved test data.

7.5.3.2.2 (TS) Engineering Specifications


Does Best Bars have a documented
process describing the review,
distribution and implementation of all
customer engineering
standards/specifications and related
revisions based upon customer
schedules as required?

IATF 16949:2016 - 27 -
Question Response Details

When an engineering standard/specification change results in a product design change, refer


to the requirements in ISO 9001, section 8.3.6. When and engineering standard/specification
change results in a product realisation process change, refer to the requirements in Section
8.5.6.1.

Does Best Bars retain a record of the


date on which each change is
implemented in production?
Implementation shall include updated
documents.

Review should be completed within 10 working days of receipt of notification of engineering


standards/specifications changes.

Note: A change in these standards/specifications may require and update record of customer
product part approval when these specifications are referenced on the design record or if they
effect documents of the PPAP, such as controls, risk analysis (Such as FMEAs) etc.

IATF 16949:2016 - 28 -
8 Operation - Score (0/256) 0%

Question Response Details

8.1 Operational planning and control


The organization shall plan, implement and control the processes, as outlined in 4.4, needed to
meet requirements for the provision of products and services and to implement the actions
determined in 6.1, by:
a) determining requirements for the product and services;
b) establishing criteria for the processes and for the acceptance of products and services;
c) determining the resources needed to achieve conformity to product and service
requirements;
d) implementing control of the processes in accordance with the criteria;
e) retaining documented information to the extent necessary to have confidence that the
processes have been carried out as planned and to demonstrate conformity of products and
services to requirements.

Are there processes at Best Bars


needed to meet requirements for
provision of products and services
planned, implemented and controlled?

Does Best Bars have requirements for


products and services determined?

At Best Bars is there a criteria for


processes and acceptance for
products and services determined?

Does Best Bars have a way of


determining resources

At Best Bars is process control


implemented?

At Best Bars can you show the


documented information that shows
confidence in that the processes have
been carried out as planned and can
demonstrate conformity of products
and services.

The output of this planning shall be suitable for the organization's operations.

At Best Bars have you determined that


the output from the planning process is
suitable for your operations?

The organization shall control planned changes and review the consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary.

Does Best Bars have a way to control


planned changes?

IATF 16949:2016 - 29 -
Question Response Details

Does Best Bars review the


consequences of unintended
changes?

Does Best Bars have an action that is


taken to mitigate any adverse effects?

The organization shall ensure that outsourced processes are controlled in accordance with 8.4.

At Best Bars can you show how you


control outsourced processes?

8.1.1 (TS) Operational Planning and


Control
When planning product realisation, is
the topic included, with regards to,
customer product requirements and
technical specifications?

When planning product realisation, is


the topic included, with regards to,
logistics requirements?

When planning product realisation, is


the topic included, with regards to,
manufacturing feasibility?

When planning product realisation, is


the topic included, with regards to,
project planning (Refer to ISO 9001,
section 8.3.2)?

When planning product realisation, is


the topic included, with regards to,
acceptance criteria?

The resources identified is ISO 9001, section 8.1 C refer to the required verification, validation,
monitoring, measurement, inspection and test activities specific to the product and the criteria
for product acceptance.

8.1.2 (TS) Confidentiality


Does Best Bars ensure confidentiality
of customer contracted products anbd
projects under development, including
related product information?

8.2 Determination of requirements for Score (0/21) 0%


products and services

8.2.1 Customer communication

IATF 16949:2016 - 30 -
Question Response Details

The organization shall establish the processes for communicating with customers in relation to:
a) information relating to products and services;
b) enquiries, contracts or order handling, including changes;
c) obtaining customer views and perceptions, including customer complaints;
d) the handling or treatment of customer property, if applicable;
e) specific requirements for contingency actions, when relevant.

Does Best Bars have


processes for communicating with
customers?

Does Best Bars communicate


information relating to:
Products;
Services;
Enquiries;
Contracts;
Order handling;
Customer views, perceptions and
complaints;
Handling or treatment of customer
property;

Does Best Bars have specific


requirements for contingency actions?

8.2.1.1 (TS) Customer communication


Does Best Bars ensure that the written
and verbal communication shall be in
the language agreed by the customer?
The organisation shall have the ability
to communicate necessary
information, including data in a
customer specified computer language
and format (e.g. Computer aided
design data, electronic data
interchange)

8.2.2 Determination of requirements


related to products and services
The organization shall establish, implement and maintain a process to determine the
requirements for the products and services to be offered to potential customers.

Does Best Bars have a process to


determine the requirements for
products and services to be offered to
potential customers?

Does Best Bars establish, implement


and maintain this process?

IATF 16949:2016 - 31 -
Question Response Details

The organization shall ensure that:


a) product and service requirements (including those considered necessary by the
organization), and applicable statutory and regulatory requirements, are defined;
b) it has the ability to meet the defined requirements and substantiate the claims for the
products and services it offers.

Does Best Bars show how to define


product and service requirements
including statutory and regulatory
requirements?

8.2.2.1 (TS) Determining the requirements


for product and services
Does Best Bars include recycling,
environmental impact, and
characteristics identified as a result of
the organisations knowledge of the
product and manufacturing processes?

Does Best Bars compliance to ISO


9001, section 8.2.2 item A 1 include
applicable government, safety and
environmental regulations related to
acquisition, storage, handling,
recycling, elimination, or disposal or
material?

8.2.3.1.1 (TS) Review of the requirements


for products and services
Does Best Bars retain documented
evidence of a customer authorised
waiver for the requirements stated in
ISO 9001 section 8.2.3.1 for a formal
review?

8.2.3.1.2 (TS) Customer designated


special characteristics
Does Best Bars conform to customer
requirements for designation, approval
documentation and control of special
characteristics?

8.2.3.1.3 (TS) Organisational


Manufacturing feasibility
Does Best Bars utilise a
multidisciplinary approach to conduct
an analysis if it is feasible that the
organisation's manufacturing
processes are capable of consistently
producing product that meets all of the
engineering and capacity requirements
specified by the customer?

IATF 16949:2016 - 32 -
Question Response Details

Does Best Bars conduct this feasibility


analysis for all manufacturing or
product technology new to the
organisation and for any changed
manufacturing process or product
design?

Does Best Bars validate through


production runs, bench-marking
studies or other appropriate methods
their ability to make product to
specifications at the required rate?

8.2.3 Review of requirements related to


products and services
The organization shall review, as applicable:
a) requirements specified by the customer, including the requirements for delivery and post-
delivery activities;
b) requirements not stated by the customer, but necessary for the customers' specified or
intended use, when known;
c) additional statutory and regulatory requirements applicable to the products and services;
d) contract or order requirements differing from those previously expressed.

Does Best Bars have in place a review


of Customer requirements for delivery
and post-delivery?
Requirements necessary for
customers’ specified or intended use,
where known;
Additional statutory and regulatory
requirements applicable to products
and services;
Any other contract or order
requirements.

NOTE Requirements can also include those arising from relevant interested parties.

This review shall be conducted prior to the organization’s commitment to supply products and
services to the customer and shall ensure contract or order requirements differing from those
previously defined are resolved.

Does Best Bars show that the review


is conducted prior to their commitment
to supply products and services to
their customers.

Does Best Bars show how they


resolve contract or order requirements
which differ from those previously
defined?

Where the customer does not provide a documented statement of their requirements, the
customer requirements shall be confirmed by the organization before acceptance.

IATF 16949:2016 - 33 -
Question Response Details

Does Best Bars confirm customer


requirements where the customer
does not provide a documented
statement?

Documented information describing the results of the review, including any new or changed
requirements for the products and services, shall be retained.

Can Best Bars show where they retain


documented information which
describes results of the review
including any new or changed
requirements.

Where requirements for products and services are changed, the organization shall ensure that
relevant documented information is amended and that relevant personnel are made aware of
the changed requirements.

Does Best Bars show the documented


information containing changes to
products and services

Does Best Bars ensure that relevant


personnel are made aware of those
changes?

8.3 Design and development of products Score (0/76) 0%


and services

8.3.1 General
Where the detailed requirements of the organization’s products and services are not already
established or not defined by the customer or by other interested parties, such that they are
adequate for subsequent production or service provision, the organization shall establish,
implement and maintain a design and development process.

Does Best Bars establish, implement


and maintain a design and
development process (where detailed
requirements of their products and
services are not already established or
defined by the customer or other
parties).

NOTE 1 The organization can also apply the requirements given in 8.5 to the development of
processes for production and services provision.
NOTE 2 For services, design and development planning can address the whole service
delivery process. The organization can therefore choose to consider the requirements of
clauses 8.3 and 8.5 together.

8.3.1.1 (TS) Design development of


products and services

IATF 16949:2016 - 34 -
Question Response Details

The requirements of ISO 9001, section


8.3.1 shall apply to product and
manufacturing process design and
development and shall focus on error
proofing prevention rather than
detection. Does Best bars conduct
error proofing studies?

Does Best Bars document the design


and development process?

8.3.2 Design and development planning


In determining the stages and controls for design and development, the organization shall
consider:
a) the nature, duration and complexity of the design and development activities;
b) requirements that specify particular process stages, including applicable design and
development reviews;
c) the required design and development verification and validation;
d) the responsibilities and authorities involved in the design and development process;
e) the need to control interfaces between individuals and parties involved in the design and
development process;
f) the need for involvement of customer and user groups in the design and development
process;
g) the necessary documented information to confirm that design and development
requirements have been met.

Does Best Bars determine the stages


and control for design and
development and show how they
consider:
The nature, duration and complexity of
the activities;
Requirements that specify particular
process stages including applicable
reviews;
Required verification and validation;
Responsibilities and authorities;
How interfaces are controlled between
individuals and parties;
The need for involvement of customer
and user groups.

Does Best Bars show documented


information that confirms design and
development requirements have been
met.

8.3.2.1 (TS) Design and development


planning
Does Best Bars ensure that the design
and development planning includes all
effected stakeholders within the
organisation and, as appropriate, its
supply chain?

IATF 16949:2016 - 35 -
Question Response Details

Examples of areas for using such a multidisciplinary approach include but are not limited to the
following:
Project management (APQP of VDA-RGA)
Product and manufacturing process design activities (DFM and DFA), such consideration of
the use of alternative designs and manufacturing processes
Development and review of product design risk analysis (FMEAs) including actions to reduce
potential risks
Development and review of manufacturing process risk analysis (E.g, FMEAs, Process flows,
control plans and standardised work instructions)

8.3.2.2 (TS) Product design skills


Does Best Bars ensure that personnel
with product design responsibility are
competent to achieve design
requirements and are skilled in
applicable product design tools and
techniques? Applicable design
techniques and tools shall be identified
by the organisation

Note: An example of product design skills is the application of digitised mathematically based
data.

8.3.2.3 (TS) Development of products


with embedded software
Does Best Bars ensure the use of a
process for quality assurance for their
products with internally developed
embedded software?

Does Best Bars conduct a software


development assessment
methodology use to assess the
organisations software development
process?

Does Best Bars include software


development within the scope of their
internal audit program (See section
9.2.2.1)

8.3.3 Design and development inputs


The organization shall determine:
a) requirements essential for the specific type of products and services being designed and
developed, including, as applicable, functional and performance requirements;
b) applicable statutory and regulatory requirements;
c) standards or codes of practice that the organization has committed to implement;
d) internal and external resource needs for the design and development of products and
services;
e) the potential consequences of failure due to the nature of the products and services;
f) the level of control expected of the design and development process by customers and other
relevant interested parties.

IATF 16949:2016 - 36 -
Question Response Details

Does Best Bars show how they


determine:
Requirements essential for the type of
products and services being designed
and developed, including as
applicable:
Functional & performance
requirements;
Statutory and regulatory requirements;
Standards or codes of practice where
there is a commitment to implement;
Internal and external resources
needed for the design and
development of products and services;
Potential consequences of failure;
Level of control expected of the design
and development process by
customers and other relevant parties.

Inputs shall be adequate for design and development purposes, complete, and unambiguous.
Conflicts among inputs shall be resolved.

Does Best Bars determine that inputs


are adequate, complete and
unambiguous for design and
development?

Does Best Bars resolve conflicts


among inputs?

8.3.3.1 (TS) Product design inputs


Does Best Bars identify, document and
review product design input
requirements as a result of contract
reviews?

Product design input requirements include, but not limited to the following:
Product specifications including but not limited to special characteristics (See Section 8.3.3.3)
Boundary and interface requirements
Identification, trace-ability and packaging
Consideration of design alternatives
Assessment of risks with the input requirements and the organisations ability to
mitigate/manage the risks, including a feasibility analysis
Targets for conformity to product requirements including preservation, reliability, durability,
serviceability, health and safety, environmental, development timing and cost
Applicable statutory and regulatory requirements of the customer identified country of
destination, if approved
Embedded software requirements

Best Bars shall have a process to deploy information gained from previous design projects,
competitive product analysis (Bench-marking), supplier feedback, internal input, field data and
othe relevant sources for current and future projects of a similar nature.

Note: One approach for considering design alternatives is the use of trade-off curves

8.3.3.2 (TS) Manufacturing process


design input

IATF 16949:2016 - 37 -
Question Response Details

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to product design
output data including special
characteristics?

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to targets for
productivity, process capability, timing
and cost?

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to manufacturing
technology alternatives

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to customer
requirements, if any?

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to experience from
previous developments ?

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to raw materials?

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to product handling
and ergonomic requirements?

Does Best Bars identify, document and


review manufacturing process design
inputs with regards to design for
manufacturing and design assembly?

Does the manufacturing process


design include the use of error
proofing methods to a degree
appropriate to the magnitude of the
problem and commensurate with the
risks encountered?

8.3.3.3 (TS) Special Characteristics


Does Best Bars make use of a
multidisciplinary approach to establish
and implement its processes to identify
special characteristics, including those
determined by the customers and the
risk analysis performed by the
organisation?

IATF 16949:2016 - 38 -
Question Response Details

Does the risk analysis include a


documentation of all special
characteristics in the drawing (as
required), risk analysis (Such as a
FMEA), control plans, and
standardised work/operator
instructions, special characteristics are
identified with special markings and
are cascaded through each of these
documents?

Does the risk analysis include a


development of control and monitoring
strategies for special characteristics of
products and product processes?

Does the risk analysis include


customer specified approval, when
required?

Does the risk analysis include


compliance with customer specified
definitions and symbols or the
organisations equivalent symbols or
notations, as defined in a symbol
table? The symbol conversion table
shall be submitted to the customer, if
required.

8.3.4 Design and development controls


The controls applied to the design and development process shall ensure that:
a) the results to be achieved by the design and development activities are clearly defined;
b) design and development reviews are conducted as planned;
c) verification is conducted to ensure that the design and development outputs have met the
design and development input requirements;
d) validation is conducted to ensure that the resulting products and services are capable of
meeting the requirements for the specified application or intended use (when known).

Does Best Bars have controls that are


applied to the design and development
process to ensure:
Results achieved by design and
development activities are clearly
defined?

Does Best Bars have Design and


development reviews that are
conducted as planned?

Does Best Bars outputs meet the input


requirements by verification/validation
is conducted to ensure that the
resulting products and services are
capable of meeting the requirements
for the specified application or
intended use (when known)?

8.3.4.1 (TS) Monitoring

IATF 16949:2016 - 39 -
Question Response Details

Does Best Bars make use of


measurements at specified stages
during the design and development of
products and processes that are
defined, analysed and reported with
summary results as an input to
Management review (See section
9.3.2.1)?

When required by the customer, measurements of the product and process development
activity shall be reported to the customer at stages specified by the customer.

Note: When appropriate, these measurements may include quality risks, costs, lead times,
critical paths and other measurements.

8.3.4.2 (TS) Design and development


validation
Does Best Bars ensure design and
development validation is performed
according to customer requirements,
including any applicable industry and
governmental agency issued
regulatory standards?

Does Best Bars ensure timing of the


design and development validation
shall be planned in alignment with
customer specified timing, as
applicable?

Does Best Bars, where contractually


agreed with the customer, include
evaluation of the interaction of the
organisations product, including
embedded software, within the system
of the final customers product?

8.3.4.3 (TS) Prototype Program


Does Best Bars, when required by the
customer, have a prototype program
and control plan?

Does Best Bars make use of all the


same suppliers, tooling and
manufacturing processes as will be
used in product when developing the
prototype?

Does Best Bars monitor all


performance testing activities for timely
completion and conformity to
requirements?

IATF 16949:2016 - 40 -
Question Response Details

Does Best Bars ensure when services


are outsourced, the organisation
includes the type and extent of control
in the scope of its QMS to ensure that
outsourced services conform to
requirements (See ISO 9001 section
8.4)?

8.3.4.4 (TS) Product approval process


Does Best Bars establish, implement
and maintain product and
manufacturing approval process
conforming to requirements as defined
by the customer?

Does Best Bars approve externally


provided product approval prior to
shipment, if required by the customer?
Records of their part approval shall be
retained.

Note: Product approval should be subsequent to the validation of the manufacturing process.

8.3.5 Design and development outputs


The organization shall ensure that design and development outputs:
a) meet the input requirements for design and development;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, and acceptance criteria, as
applicable;
d) ensure products to be produced, or services to be provided, are fit for intended purpose and
their safe and proper use.

Does Best Bars ensure that design


and development outputs:
Meet the input requirements for design
and development?

Does Best Bars ensure they are


adequate for the subsequent
processes for the provision of products
and services?

Does Best Bars include or reference


monitoring and measuring
requirements, and acceptance criteria,
as applicable?

Does Best Bars ensure products to be


produced, or services to be provided,
are fit for intended purpose and their
safe and proper use?

The organization shall retain the documented information resulting from the design and
development process.

8.3.5.1 (TS) Design and development


outputs

IATF 16949:2016 - 41 -
Question Response Details

Does Best Bars ensure that the


product design output shall be
expressed in terms that can be verified
and validated against product design
input requirements?

Does Best Bars product design output


include design risk analysis (FMEA)?

Does Best Bars product design output


include reliability study results?

Does Best Bars product design output


include product special
characteristics?

Does Best Bars product design output


include results of product design error
proofing, such as DFSS, DFMA and
FTA?

Does Best Bars product design output


include product definition including 3D
models, technical data packages,
product manufacturing information,
and geometric dimension and
tolerance (GD&T)?

Does Best Bars product design output


include product design review results

Does Best Bars product design output


include service diagnostics guidelines
and repair and serviceability
instructions?

Does Best Bars product design output


include service parts requirements?

Does Best Bars product design output


include packaging and rebelling
requirements for shipping?

Note: Interim design outputs should include any engineering problems being resolved through
a trade-off process.

8.3.5.2 (TS) Manufacturing process


design output
Does Best Bars document the
manufacturing process design output
in a manner that enables verification
against the manufacturing process
design outputs?

Does Best Bars verify the outputs


against manufacturing process design
input requirements?

IATF 16949:2016 - 42 -
Question Response Details

Does Best Bars manufacturing design


output include specifications and
drawing?

Does Best Bars manufacturing design


output include special characteristics
for product and manufacturing
process?

Does Best Bars manufacturing design


output include identification of process
input variables that impact
characteristics?

Does Best Bars manufacturing design


output include tooling and equipment
for production and control, including
capability studies of equipment and
processes?

Does Best Bars manufacturing design


output include manufacturing process
flow charts/layout, including linkage of
product, process and tooling?

Does Best Bars manufacturing design


output include capacity analysis?

Does Best Bars manufacturing design


output include manufacturing process
FMEA?

Does Best Bars manufacturing design


output include maintenance plans and
instructions?

Does Best Bars manufacturing design


output include control plan?

Does Best Bars manufacturing design


output include standardised work and
work instructions?

Does Best Bars manufacturing design


output include process approval
acceptance criteria?

Does Best Bars manufacturing design


output include data for quality,
reliability, maintainability and measure-
ability?

Does Best Bars manufacturing design


output include results of error proofing
identification and verification, as
appropriate?

IATF 16949:2016 - 43 -
Question Response Details

Does Best Bars manufacturing design


output include methods of rapid
detection, feedback and corrections of
product.manufacturing process non-
conformity?

8.3.6 Design and development changes


The organization shall review, control and identify changes made to design inputs and design
outputs during the design and development of products and services or subsequently, to the
extent that there is no adverse impact on conformity to requirements.

Does Best Bars review, control and


identify changes made to the design
inputs and outputs during design and
development of products and services
ensuring no impact on conformity to
requirements?

Documented information on design and development changes shall be retained.

Does Best Bars show the documented


information for design and
development changes.

8.3.6.1 (TS) Design and development


changes
Does Best Bars evaluate all design
changes after initial product approval,
including those proposed by the
organisation or its suppliers for the
potetial impact on fit, form, function,
performance and/or durability?
These changes shall be validated
against customer requirements and
approved internally from the customer
prior to production implementation.

If required by the customer, does Best


Bars, obtain documented approval, or
a documented waiver from the
customer prior to production
implementation?

For products with embedded software,


does Best Bars document the revision
level of the software and hardware as
part of the change record?

8.4 Control of externally provided Score (0/41) 0%


products and services

8.4.1 General
The organization shall ensure that externally provided processes, products, and services
conform to specified requirements.

IATF 16949:2016 - 44 -
Question Response Details

Does Best Bars ensure externally


provided processes, products and
services conform to specified
requirements?

The organization shall apply the specified requirements for the control of externally provided
products and services when:
a) products and services are provided by external providers for incorporation into the
organization’s own products and services;
b) products and services are provided directly to the customer(s) by external providers on
behalf of the organization;
c) a process or part of a process is provided by an external provider as a result of a decision
by the organization to outsource a process or function.

Does Best Bars show how they apply


specified requirements for the control
of externally provided products and
services when:
Products and services are provided by
external providers for incorporation
into your own products and services;
You provide products and services
directly to customers by external
providers on your behalf;
A process or part-process is provided
by an external provider as a result of a
decision to outsource a process or
function.

The organization shall establish and apply criteria for the evaluation, selection, monitoring of
performance and re-evaluation of external providers based on their ability to provide processes
or products and services in accordance with specified requirements.

Does Best Bars show how to establish


and apply criteria for evaluation,
selection, monitoring of performance
and re-evaluation of external
providers.

Does Best Bars assess their ability to


provide processes or products and
services in accordance with specified
requirements?

The organization shall retain appropriate documented information of the results of the
evaluations, monitoring of the performance and re-evaluations of the external providers.

Does Best Bars have documented


information with the results of
evaluations, monitoring of performance
and re-evaluations of external
providers?

8.4.1.1 (TS) General

IATF 16949:2016 - 45 -
Question Response Details

Does Best Bars include all products


and services that effect customer
requirements such as sub-assembly,
sequencing, sorting, rework and
calibration services in the scope of
their definition of externally provided
products, processes and services?

8.4.1.2 (TS) Supplier selection process


Does Best Bars have a documented
supplier selection process?

Does the supplier selection process


include an assessment of the selected
suppliers risk to product conformity
and uninterrupted supply of the
organisations product to their
customers?

Does the supplier selection process


include relevant quality and delivery
performance?

Does the supplier selection process


include an evaluation of the suppliers
QMS?

Does the supplier selection process


include multidisciplinary decision
making?

Does the supplier selection process


include an assessment of software
development capabilities?

Other suppliers selection criteria that should be considered includes the following:
Financial stability
Purchased product, material or service complexity
Required technology (product and process)
Adequacy of available resource. people, infrastructure)
Design and development capabilities
Change management process
Business continuity planning
Logistic process
customer service

8.4.1.3 Customer direct sources (Direct


buy)
When specified by the customer, does
Best bars purchase products,
materials or services from customer
directed sources?

All requirements of section 8.4 (except for the requirements in IATF 16949 Section 8.4.1.2) are
applicable to the organisations control of customer directed sources unless specific
agreements are otherwise defined by the contract between the organisation and the customer.

IATF 16949:2016 - 46 -
Question Response Details

8.4.2 Type and extent of control of


external provision
In determining the type and extent of controls to be applied to the external provision of
processes, products and services, the organization shall take into consideration:
a) the potential impact of the externally provided processes, products and services on the
organization’s ability to consistently meet customer and applicable statutory and regulatory
requirements;
b) the perceived effectiveness of the controls applied by the external provider.

Does Best Bars determine the controls


applied to the external provision of
processes, products and services and
take into consideration the following:
a) The potential impact of the
externally provided processes,
products and services on the ability to
consistently meet customer and
applicable statutory and regulatory
requirements?

Does Best Bars determine the controls


applied to the external provision of
processes, products and services and
take into consideration the following:

The organization shall establish and implement verification or other activities necessary to
ensure the externally provided processes, products and services do not adversely affect the
organization's ability to consistently deliver conforming products and services to its customers.

Can Best Bars show what verification


or other activities they have to ensure
externally provided processes,
products and services do not
adversely affect your ability to
consistently deliver conforming
products and services to your
customers?

Processes or functions of the organization which have been outsourced to an external provider
remain within the scope of the organization’s quality management system; accordingly, the
organization shall consider a) and b) above and define both the controls it intends to apply to
the external provider and those it intends to apply to the resulting process output.

When Best Bars processes or


functions have been outsourced to
external providers, how do Best Bars
consider a) and b) in 8.4.1 and how
does Best Bars define the controls
intended to be applied to the external
provider and to the resulting process
output?

8.4.2.1 (TS) Type and extent of control

IATF 16949:2016 - 47 -
Question Response Details

Does Best Bars have a documented


process to identify outsourced
processes and to select the types and
extent of controls used to verify
conformity of externally provided
products, processes and the service to
internal and external customer
requirements?

Does the process include the criteria


and actions to escalate or reduce the
types and extent of controls and
development activities based on
supplier performance and assessment
of product material or service risks?

8.4.2.2 Statutory and regulatory


requirements
Does Best Bars have a documented
process to ensure that purchased
products, processes and services
conform to the current applicable
statutory and regulatory requirements
in the country of receipt, the country of
shipment and the customer identified
country of destination, if provided?

If the customer defines special controls


for certain products with statutory and
regulatory requirements, does the Best
Bars ensure they are implemented and
maintained as defined, including at
suppliers?

8.4.2.3 Supplier QMS development


Does Best Bars require their suppliers
of automotive products and services to
develop, implement and improve a
QMS certified to ISO 9001, unless
otherwise authorised by the customer,
with a ultimate objective of becoming
certified to the IATF 16949:2016 QMS
standard.

Unless otherwise specified by the customer, the following sequence should be applied to
achieve this requirement:
Compliance to ISO 9001 through second party audits
Certification to ISO 9001 through third party audits, unless otherwise specified by the
customers, suppliers to Best Bars shall demonstrate conformity to ISO 9001 by maintaining q
third party certification issued a certification body bearing the accreditation mark of a
recognised IAF MLA member and where the accreditation body main scope include
management system certification to ISO 17021
Certification to ISO 9001 with compliance to other customer defined QMS requirements
Certification to IATF 16949 by an IATF recognised certification body

8.4.2.3.1 Automotive product related


software or automotive products with
embedded software

IATF 16949:2016 - 48 -
Question Response Details

Does Best Bars require their suppliers


of automated product related software
or automotive products with embedded
software, to implement and maintain a
process for software quality assurance
for their products?

Does Best Bars ensure that a software


development assessment
methodology shall be utilised to
assess the suppliers software
development process? Using a
prioritisation based risk and potential
impact to the customer, Best Bars
shall require the supplier to retain
documented information of a software
development capability self-
assessment.

8.4.2.4 (TS) Supplier Monitoring


Does Best Bars have a documented
process and criteria to evaluate
supplier performance in order to
ensure conformity to externally
provided products, processes and
services to internal and external
requirements?

Does Best Bars monitor supplier


performance indicators in terms of
delivered product conformity to
requirements?

Does Best Bars monitor supplier


performance indicators in terms of
customer disruptions at the receiving
plant, including yard holds and stop
ships?

Does Best Bars monitor supplier


performance indicators in terms of
delivery schedule performance?

Does Best Bars monitor supplier


performance indicators in terms of
number of premium freight?

Does Best Bars monitor supplier


performance indicators in terms of
special status customer notifications
related to quality or delivery issues?

Does Best Bars monitor supplier


performance indicators in terms of
dealer returns, warranty, field actions
and recalls?

8.4.2.4.1 (TS) Second Party Audits

IATF 16949:2016 - 49 -
Question Response Details

Does Best Bars include a second party


audit process in their supplier
management process?

Second party audits may be used for the following:


Supplier risk assessment
Supplier monitoring
Supplier QMS development
Product audits
Process audits

Based on a risk assessment analysis,


including product safety/regulatory
requirements, performance of the
supplier and QMS certification level, at
a minimum, does Best Bars document
the criteria for determining the need,
type, frequency and scope of second
party audits?

Does Best Bars retain records of the


second party audit reports?

Note: Guidance may be found in the IATF Auditor Guide and ISO 19011

8.4.2.5 (TS) Supplier Development


The organisation shall determine the priority, type, extent and timing of required supplier
development actions for its active suppliers.

Do the determination inputs include


performance issues identification
through supplier monitoring?

Do the determination inputs include


second party audit findings?

Do the determination inputs include


third party QMS certification status?

Do the determination inputs include


risk analysis?

8.4.3 Information for external providers


The organization shall communicate to external providers applicable requirements for the
following:
a) the products and services to be provided or the processes to be performed on behalf of the
organization;
b) approval or release of products and services, methods, processes or equipment;
c) competence of personnel, including necessary qualification;
d) their interactions with the organization's quality management system;
e) the control and monitoring of the external provider’s performance to be applied by the
organization;
f) verification activities that the organization, or its customer, intends to perform at the external
provider’s premises.

IATF 16949:2016 - 50 -
Question Response Details

Does Best Bars show how they


communicate to external providers,
applicable requirements for:
Products and services to be provided
or the processes to be performed on
behalf of the organization;
Approval or release of products and
services, methods, processes or
equipment;
Competence of personnel, including
necessary qualification;
Their interactions with the
organization's quality management
system;
The control and monitoring of the
external provider’s performance to be
applied by the
organization;
Verification activities that the
organization, or its customer, intends
to perform at the external provider’s
premises.

The organization shall ensure the adequacy of specified requirements prior to their
communication to the external provider.

Before Best Bars communicates with


external providers, do they ensure the
adequacy of specified requirements?

8.4.3.1 Information for external providers


Does Best Bars pass down all
applicable statutory and regulatory
requirements and special product and
process characteristics to their
suppliers and require the suppliers to
cascade all applicable requirements
down the supply chain to the point of
manufacturing?

8.5 Production and service provision Score (0/67) 0%

8.5.1 Control of production and service


provision
The organization shall implement controlled conditions for production and service provision,
including delivery and post-delivery activities.

IATF 16949:2016 - 51 -
Question Response Details

Controlled conditions shall include, as applicable:


a) the availability of documented information that defines the characteristics of the products
and services;
b) the availability of documented information that defines the activities to be performed and the
results to be achieved;
c) monitoring and measurement activities at appropriate stages to verify that criteria for control
of processes and process outputs, and acceptance criteria for products and services, have
been met.
d) the use, and control of suitable infrastructure and process environment;
e) the availability and use of suitable monitoring and measuring resources;
f) the competence and, where applicable, required qualification of persons;
g) the validation, and periodic revalidation, of the ability to achieve planned results of any
process for production and service provision where the resulting output cannot be verified by
subsequent monitoring or measurement;
h) the implementation of products and services release, delivery and post-delivery activities.

Can Best Bars show me controlled


conditions for:
a) the availability of documented
information defining the characteristics
of the products and services;
b) the availability of documented
information defining the activities to be
performed and the results to be
achieved;
c) monitoring and measurement
activities at appropriate stages to verify
that criteria for control of processes
and process outputs, and acceptance
criteria for products and services, have
been met.
d) the use, and control of suitable
infrastructure and process
environment;
e) the availability and use of suitable
monitoring and measuring resources;
f) the competence and, where
applicable, required qualification of
persons;
g) the validation, and periodic
revalidation, of the ability to achieve
planned results of any process for
production and service provision
where the resulting output cannot be
verified by subsequent monitoring or
measurement;
h) the implementation of products and
services release, delivery and post-
delivery activities.

8.5.1.1 (TS) Control Plan


Does Best Bars develop control plans
at the system, subsystem, component,
and/or material level for the relevant
manufacturing site and all product
supplied, including those processes
producing bulk materials as well as
parts?
"Family" control plans are acceptable
for bulk material and similar parts
using a common manufacturing
process.

IATF 16949:2016 - 52 -
Question Response Details

Does Best Bars have a control plan for


pre-launch and production that shows
linkage and incorporates information
from design risk analysis, process flow
diagram and manufacturing process
risk analysis outputs (Such as FMEAs)

Does Best Bars, if required by the


customer, provide measurement and
conformity data collected during
execution of either the pre-launch or
production control plans?

Does the control plans include controls


used for the manufacturing process
control, including verification of job set
ups?

Does the control plans include first


off/last off part validation, as
applicable?

Does the control plans include


methods for monitoring or control
exercised over special characteristics
defined in both the customer and the
organisation?

Does the control plans include the


customer required information?

Does the control plans include


specified reaction plan, when non-
conforming product is detected, the
process becomes statistically unstable
or not statistically capable?

Does Best Bars review the Control


plans for determining it has shipped
non conforming product to the
customer?

Does Best Bars review the Control


plans for when change occurs
affecting product, manufacturing
process, measurement, logistics,
supply sources, production volume
changes or risk analysis (FMEA)?

Does Best Bars review the Control


plans after a customer complaint and
implementation of the associated
corrective actions, when applicable?

Does Best Bars review the Control


plans at a set frequency based on a
risk analysis?

8.5.1.2 (TS) Standardised work - Operator


instructions and visual standards

IATF 16949:2016 - 53 -
Question Response Details

Does Best Bars ensure that


standardised work documents are
communicated to and understood by
the employees who are responsible for
performing the work?

Does Best Bars ensure that


standardised work documents are
legible?

Does Best Bars ensure that


standardised work documents are
presented in the language understood
by the personnel responsible to follow
them?

Does Best Bars ensure that


standardised work documents are
accessible for use at the designated
work area?

The standardised work documents shall also include rules for operator safety

8.5.1.3 (TS) Verification of job set ups


Does Best Bars verify job set-ups
when performed, such as initial run of
a job, material changeover, or job
change that requires a new sett-up?

Does Best Bars maintain documented


information for set-up personnel?

Does Best Bars use statistical


methods of verification, where
applicable?

Does Best Bars perform first off/last off


part validation, as applicable, where
appropriate, first off parts should be
retained for comparison with the last
off parts, where appropriate, last off
parts should be retained for
comparison with first off parts in
subsequent runs?

Does Best Bars retain records of


process and product approval
following set-up and first off/last off
part validation?

8.5.1.4 (TS) Verification after shut down


Does Best Bars define and implement
the necessary actions to ensure
product compliance with requirements
after planned or unplanned production
shutdown period?

8.5.1.5 Total productive maintenance


IATF 16949:2016 - 54 -
Question Response Details

Has Best Bars developed,


implemented and maintained a
document a total productive
maintenance system?

At a minimum, does the system


include identification of process
equipment necessary to produce
conforming product at the required
volume?

At a minimum, does the system


include availability of replacement
parts for the equipment and facility
maintenance?

At a minimum, does the system


include provision of resources for
machine, equipment and facility
maintenance?

At a minimum, does the system


include packaging and preservation of
equipment, tooling and gauging?

At a minimum, does the system


include applicable customer specific
requirements?

At a minimum, does the system


include documented maintenance
objectives?

At a minimum, does the system


include regular review of maintenance
plan and objectives and a documented
action plan to address corrective
actions where objectives are not
achieved?

At a minimum, does the system


include the use of preventive
maintenance methods?

At a minimum, does the system


include a predictive maintenance
methods, as applicable?

At a minimum, does the system


include periodic overhauling?

8.5.1.6 Management of production tooling


and manufacturing, test, inspection
tooling and equipment
Does Best Bars provide resources for
tool and gauge design, fabrication, and
verification activities for production and
service materials and for bulk
materials, as applicable?

IATF 16949:2016 - 55 -
Question Response Details

Has Best Bars established and


implemented a system for production
tooling management whether owned
by the organisation or the customer?
Including:
Maintenance and repair facilities and
personnel
Storage and recovery
set-up
Tool change programs for perishable
tools
Tool design modifications
documentation
Tool modification and revision to
documentation
Tool identification, such as serial or
asset number etc

The organisation shall verify that customer owned tools, manufacturing equipment and
test/inspection equipment are permanently marked in a visible location so that the ownership
and application of each item can be determined

8.5.1.7 (TS) Production Scheduling


Does Best Bars ensure that production
is scheduled in order to meet customer
order/demands such as Just In Time
and is supported by an information
system that permits access to
production information at key stages of
the process and is order driven?

Does Best Bars include relevant


planning information during production
scheduling e.g customer orders,
capacity etc?

8.5.2 Identification and trace-ability

Where necessary to ensure conformity of products and services, the organization shall use
suitable means to identify process outputs.

Does Best Bars show ways they use to


identify process outputs to ensure
conformity of products and services?

Does Best Bars have a way of


identifying the status of process
outputs?

Where traceability is a requirement, the organization shall control the unique identification of
the process outputs, and retain any documented information necessary to maintain traceability.

Does Best Bars have a way to control


the unique identification of process
outputs, where applicable?

IATF 16949:2016 - 56 -
Question Response Details

Can Best Bars show the type of


documented information that it retains?

NOTE Process outputs are the results of any activities which are ready for delivery to the
organization’s customer or to an internal customer (e.g. receiver of the inputs to the next
process); they can include products, services, intermediate parts, components, etc.

8.5.2.1 Identification and Traceability


The purpose of traceability is to support identification of clear start and stop points for product
received by the customers or in the field that may contain quality and/or safety related non-
conformities.

Has Best Bars implemented


identification and traceability
processes?

Has Best Bars conducted and analysis


of internal, customer, and regulatory
traceability requirements for all
automotive products, including
developing and documenting
traceability plans, based on the levels
of risk or failure severity for
employees, customers and
consumers?

8.5.3 Property belonging to customers or


external providers
The organization shall exercise care with property belonging to the customer or external
providers while it is under the organization's control or being used by the organization. The
organization shall identify, verify, protect and safeguard the customer’s or external provider’s
property provided for use or incorporation into the products and services.

Does Best Bars provide care for


customer or external provider’s
property while under their control?

Does Best Bars identify, verify, protect


and safeguard that property which is
provided for use or incorporation into
their products or services?

When property of the customer or external provider is incorrectly used, lost, damaged or
otherwise found to be unsuitable for use, the organization shall report this to the customer or
external provider.

Does Best Bars have means they use


to report to the customer or external
provider if their property is incorrectly
used, lost, damaged or found to be
unsuitable for use?

8.5.4 Preservation

IATF 16949:2016 - 57 -
Question Response Details

The organization shall ensure preservation of process outputs during production and service
provision, to the extent necessary to maintain conformity to requirements.

Does Best Bars ensure preservation of


process outputs during production and
service provision to maintain
conformity to product requirements?

NOTE Preservation can include identification, handling, packaging, storage, transmission or


transportation, and protection.

8.5.4.1 (TS) Preservation


Does Best Bars ensure preservation
that includes handling, identification
contamination control, packaging,
storage, transmission or transportation
and protection?

8.5.5 Post-delivery activities


As applicable, the organization shall meet requirements for post-delivery activities associated
with the products and services.

Does Best Bars meet the requirements


for post-delivery activities associated
with products and services?

In determining the extent of post-delivery activities that are required, the organization shall
consider:
a) the risks associated with the products and services;
b) the nature, use and intended lifetime of the products and services;
c) customer feedback;
d) statutory and regulatory requirements.

Can Best Bars determine:


Risk;
Nature, use and intended lifetime;
Customer feedback;
Statutory and Regulatory
requirements, when determining the
extent of post-delivery activities
required with products and services?

NOTE Post-delivery activities can include actions under warranty provisions, contractual
obligations such as maintenance services, and supplementary services such as recycling or
final disposal.

8.5.5.1 (TS) Feedback of information from


service
Does Best Bars ensure that there is a
process for communication of
information on service concerns to
manufacturing, material handling,
logistics, engineering and design
activities is established, implemented
and maintained?

IATF 16949:2016 - 58 -
Question Response Details

8.5.5.2 (TS) Service agreements with


customers
When there is a service agreement with the customer, Best Bars shall:

Verify that the relevant service centers


comply with applicable requirements?

Verify the effectiveness of any special


purpose tools or measuring
equipment?

Ensure that all service personnel are


trained in applicable requirements?

8.5.6 Control of changes


The organization shall review and control unplanned changes essential for production or
service provision to the extent necessary to ensure continuing conformity with specified
requirements.

Does Best Bars review and control


unplanned changes to ensure
continuing conformity with specified
requirements?

The organization shall retain documented information describing the results of the review of
changes, the personnel authorizing the change, and any necessary actions.

Does Best Bars have documented


information that can be shown which
describes the results of reviews of
changes, the personnel authorizing
change and any necessary actions?

8.5.6.1 (TS) Control of changes


Does Best Bars have a documented
process to control and react to
changes that impact product
realisation?
The effects of any change, including
those changes caused by the
organisation, by the customer or any
supplier shall be addressed.

Does Best Bars define verification and


validation activities to ensure
compliance with customer
requirements?

Does Best Bars validate changes


before implementation?

Does Best Bars document the


evidence of related risk analysis?

IATF 16949:2016 - 59 -
Question Response Details

Does Best Bars retain records of


verification and validation?

Changes, including those made at suppliers, should require a production trail run for
verification of changes to validate the impact of any changes on the manufacturing process.

When required by the customer, does


Best Bars notify the customer of any
planned product realisation changes
after the most recent product
approval?

When required by the customer, does


Best Bars obtain documented approval
prior to implementation of the
changes?

When required by the customer, does


Best Bars complete additional
verification or identification
requirements, such as production trail
run and new product validation?

8.5.6.1.1 (TS) Temporary change of


process controls
Has Best Bars identified, documented
and maintained a list of the process
controls, including inspection,
measuring, test and error proofing
devices, that includes the primary
process control and the approved
back-up or alternative methods?

Has Best Bars a document for the


process that mages the use of
alternative control methods?

8.6 Release of products and services


The organization shall implement the planned arrangements at appropriate stages to verify
that product and service requirements have been met. Evidence of conformity with the
acceptance criteria shall be retained.

Can Best Bars show how planned


arrangements have been implemented
at appropriate stages to verify product
and service requirements have been
met.

Can Best Bars show what evidence


they retain?

The release of products and services to the customer shall not proceed until the planned
arrangements for verification of conformity have been satisfactorily completed, unless
otherwise approved by a relevant authority and, as applicable, by the customer. Documented
information shall provide traceability to the person(s) authorizing release of products and
services for delivery to the customer.

IATF 16949:2016 - 60 -
Question Response Details

Can Best Bars show how the release


of products and services is held until
planned arrangements for verification
of conformity have been satisfactorily
completed, unless approved by a
relevant authority, or the customer if
applicable.

Does Best Bars have documented


information which shows traceability to
the person authorizing release of
products and services?

8.6.1 (TS) Release of products and


services
Does Best Bars ensure that the
planned arrangements to verify that
the product and services requirements
have been met encompass the control
plan and are documented as specified
in the control plan?

Does Best Bars ensure that the


planned arrangements for initial
release of products and services
encompass product or service
approval?

Does Best Bars ensure that product or


service approval is accomplished after
changes following initial release,
according to ISO 9001, section 8.5.6.

8.6.2 (TS) Layout inspection and


functional testing
A layout inspection and a functional verification to applicable customer engineering material
and performance standards shall be performed for each product as specified in the control
plans.

Are the results available for customer


review?

8.6.3 (TS) Appearance Items


Does Best Bars manufacture parts
designated by the customers as
"appearance Items" and if so, then this
section will apply? Refer to the IATF
16949:2016 standard.

8.6.4 (TS) Verification and acceptance of


conformity of externally provided
products and services.

IATF 16949:2016 - 61 -
Question Response Details

Does Best Bars have a process to


ensure the quality of externally
provided processes, products and
services utilizing one or more of the
following methods?:
Receipt and evaluation of statistical
data provided by the supplier to the
organisation
Receiving inspection and/or testing,
such as sampling based on
performance
Second party or third party
assessments or audits of suppliers
sites when coupled with records or
acceptable delivered product
conformance to requirements
Part evaluation by a designated
laboratory
Another method agreed by the
customer

8.6.5 (TS) Acceptance criteria


Does Best Bars have a acceptance
criteria that is defined by the
organisation and, where appropriate or
required, approved by the customer?
For attribute data sampling, the
acceptance shall be zero defects (See
section 9.1.1.1)

8.7 Control of non-conforming process


outputs, products and services
The organization shall ensure process outputs, products and services that do not conform to
requirements are identified and controlled to prevent their unintended use or delivery.

Does Best Bars identify and control


process outputs, products and
services that do not conform to
requirements and prevent their
unintended use or delivery?

The organization shall take appropriate corrective action based on the nature of the
nonconformity and its impact on the conformity of products and services. This applies also to
nonconforming products and services detected after delivery of the products or during the
provision of the service.

Does Best Bars have appropriate


corrective actions that are taken based
on the nature of the nonconformity and
its impact on the conformity of
products and services?

Does Best Bars have away of applying


this to nonconformity detected after
delivery?

IATF 16949:2016 - 62 -
Question Response Details

As applicable, the organization shall deal with nonconforming process outputs, products and
services in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for:
- use “as-is’;
- release, continuation or re-provision of the products and services;
- acceptance under concession.

Does Best Bars have a way to deal


with nonconforming process outputs,
products and services in terms of:
Correction;
Segregation, containment, return or
suspension of provision of products
and services?
Informing the customer?
Obtaining authorization for use as-is?
Release, continuation or re-provision
of the products and service?
Acceptance under concession?

Where nonconforming process outputs, products and services are corrected, conformity to the
requirements shall be verified.

Does Best Bars have a way of


verifying conformance where process
outputs, products and services are
corrected following nonconformance?

The organization shall retain documented information of actions taken on nonconforming


process outputs, products and services, including on any concessions obtained and on the
person or authority that made the decision regarding dealing with the nonconformity.

Does Best Bars have documented


information they keep following actions
taken to address nonconformities,
including any concessions obtained
and on the person or authority that
made the decision regarding dealing
with the nonconformance.

8.7.1.1 (TS) Customer authorisation for


concession
Does Best Bars obtain a customer
concession or deviation permit prior to
further processing whenever the
product or manufacturing process is
different from that which is currently
approved?

Does Best Bars obtain customer


authorisation prior to further
processing for "use as is" and rework
dispositions of non-conforming
product?

IATF 16949:2016 - 63 -
Question Response Details

Does Best Bars maintain a record of


the expiration date authorised under
concession?

8.7.1.2 (TS) Control of non-conforming


product - Customer specified process
Does Best Bars comply with applicable
customer-specified controls of
nonconforming products?

8.7.1.3 (TS) Control of suspect product


Does Best Bars ensure that all
appropriate manufacturing personnel
receive training for containment of
suspect and non-conforming product?

Does Best Bars ensure that product


with unidentified or suspect status is
classified and controlled as non
conforming product?

8.7.1.4 (TS) Control of rework product


Does Best Bars utilise risk analysis
(Such as FMEA) methodology to
asses risks in the rework process prior
to decision to rework the product? If
required, Best Bars shall obtain
approval from the customer prior to
commencing rework of the product.

Does Best Bars have a documented


process for rework confirmation in
accordance with the control plan or
other relevant documented information
to verify compliance to original
specifications?

Are the instructions for disassembly or


rework, including re-inspection and
traceability requirements accessible to
and utilised by the appropriate
personnel?

8.7.1.5 (TS) Control of repaired product


Does Best Bars utilise risk analysis
*Such as FMEA) methodology to
assess risks in the repairs process
prior to a decision to repair the
product? The organisation shall obtain
approval from the customer before
commencing repair of the product.

IATF 16949:2016 - 64 -
Question Response Details

Does Best Bars have a documented


process for repair confirmation in
accordance with the control plan or
other relevant documented
information?

Does Best Bars have a instructions for


disassemble or repair, including re-
inspection and traceability
requirements that is accessible to and
utilised by the appropriate personnel?

Does Best Bars obtain documented


customer authorisation for concession
for the product to be repaired?

Does Best Bars obtain documented


information on the disposition of
repaired product including quantity,
disposition, disposition date and
applicable traceability information?

8.7.1.6 (TS) Customer notification


Does Best Bars immediately notify the
customer in the event that
nonconforming product has been
shipped?
Initial communication shall be followed
with detailed documentation of the
event

8.7.1.7 (TS) Non-conforming product


disposition
Does Best Bars have a documented
process for disposition of non
conforming product not subject to
rework or repair?

Does Best Bars verify that product not


meeting requirements that a
verification process is in place to be
scrapped if rendered unusable prior to
disposal?

The organisation shall not divert nonconforming product to service or other use without prior
customer approval.

IATF 16949:2016 - 65 -
9 Performance Evaluation - Score (0/93) 0%

Question Response Details

9.1 Monitoring, measurement, analysis Score (0/34) 0%


and evaluation

9.1.1 General
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure
valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated.

Does Best Bars show how to


determine what needs
to be monitored and measured?

Does Best Bars show how they


determine methods for monitoring,
measurement, analysis and evaluation
to ensure valid results?

Does Best Bars show how they


determine when to perform monitoring
and measuring?

Does Best Bars show how they


determine when results shall be
analysed and evaluated?

The organization shall ensure that monitoring and measurement activities are implemented in
accordance with the determined requirements and shall retain appropriate documented
information as
evidence of the results.

Has Best Bars got documented


information that can be shown that
monitoring and measurement activities
have been implemented in accordance
with determined requirements?

The organization shall evaluate the quality performance and the effectiveness of the quality
management system.

Does Best Bars show how they


evaluate the quality performance and
the effectiveness of the QMS.

9.1.1.1 (TS) Monitoring and measurement


of manufacturing process

IATF 16949:2016 - 66 -
Question Response Details

Does Best Bars perform process


studies on all new manufacturing
processes to verify process capability
and to provide additional input for
process control, including those for
special characteristics?

Note: For some manufacturing processes, it may not be possible to demonstrate product
compliance through process capability. For those processes, alternative methods such as
batch conformance to specification may be used.

Does Best Bars maintain


manufacturing capability or
performance results as specified by
the customer?

Does Best Bars verify that the process


flow diagram, PFMEA and control plan
are implemented, including adherence
to the following:
1) Measurement techniques
2) Sample plans
3) Acceptance criteria
4) Records of actual measurement
values and/or test results for variable
data
5) Reaction plans and escalation
process when acceptance criteria are
not met?

Does Best Bars document significant


process events, such as tool change
or machine repair?
This shall be recorded and retained as
documented information

Does Best Bars initiate a reaction plan


indicated on the control plan and
evaluated impact on compliance to
specifications for characteristics that
are either not statistically capable or
are unstable?
These reaction plans shall include
containment of product and 100%
inspection, as appropriate.

Is Best Bars corrective action plan


developed and implemented by the
organisation indicating specific actions,
timing plan, and assigned
responsibility to ensure that the
process becomes stable and
statistically capable?

Does Best Bars review corrective


action plans with and approved by the
customer, when required?

Does Best Bars maintain records of


effective dates of process changes?

IATF 16949:2016 - 67 -
Question Response Details

9.1.1.2 (TS) Identification of statistical


tools
Does Best Bars determine the
appropriate use of statistical tools?

Does Best Bars verify that appropriate


statistical tools are included as part of
the advanced product quality planning
(or equivalent) process and include in
the design risk analysis (Such as
DFMEA) (Where applicable), the
process risk analysis (Such as
PFMEA), and control plan?

9.1.1.3 (TS) Application of statistical


concepts
Are Best Bars statistical statistical
concepts, such as variation, control
(Stability), process capability, and the
consequences of over-adjustment,
understood and used by employees
involved in the collection, analysis and
management of statistical data?

9.1.2 Customer satisfaction


The organization shall monitor customer perceptions of the degree to which requirements have
been met.

The organization shall monitor customer perceptions of the degree to which requirements have
been met.

Does Best Bars show how they


monitor customer perception of the
degree to which requirements have
been met?

Does Best Bars show how they obtain


information relating to customer views
and opinions of their products and
services?

The methods for obtaining and using this information shall be determined.

Does Best Bars show what methods


for obtaining and using this information
they have?

NOTE Information related to customer views can include customer satisfaction or opinion
surveys, customer data on delivered products or services quality, market-share analysis,
compliments, warranty claims and dealer reports.

9.1.2.1 (TS) Customer satisfaction

IATF 16949:2016 - 68 -
Question Response Details

Does Best Bars monitor customer


satisfaction through continual
evaluation of internal and external
performance indicators to ensure
compliance to the product and process
specifications and other customer
requirements?

Are performance indicators based on


objective evidence and include, but not
limited to the following:
1) Delivered part quality performance
2) Customer disruptions
3) Field returns, and warranty
4) Delivery schedule performance
(Including incidents or premium freight)
5) Customer notifications related to
quality or delivery issues, including
special status?

Does Best Bars monitor the


performance of manufacturing
processes to demonstrate compliance
with customer requirements for
product quality and process efficiency?

Does Best Bars monitoring include the


review of customer performance data
including on-line customer portals and
customer scorecards, where provided?

9.1.3 Analysis and evaluation


The organization shall analyse and evaluate appropriate data and information arising from
monitoring, measurement and other sources.

Does Best Bars show how they


analyse and evaluate data and
information arising from monitoring,
measurement and other sources.

The output of analysis and evaluation shall be used to:


a) demonstrate conformity of products and services to requirements;
b) assess and enhance customer satisfaction;
c) ensure conformity and effectiveness of the quality management system;
d) demonstrate that planning has been successfully implemented;
e) assess the performance of processes;
f) assess the performance of external provider(s);
g) determine the need or opportunities for improvements within the quality management
system.

Can Best Bars show how the output of


analysis and evaluation is used to:
Demonstrate conformity of products
and services to requirements?

IATF 16949:2016 - 69 -
Question Response Details

Can Best Bars show how the output of


analysis and evaluation is used to:
Demonstrate conformity of products
and services to requirements?

Assess and enhance customer


satisfaction?

Can Best Bars show how the output of


analysis and evaluation is used to:
Ensure conformity and effectiveness of
the QMS?

Can Best Bars show how the output of


analysis and evaluation is used to:
Demonstrate that planning has been
successfully implemented?

Can Best Bars show how the output of


analysis and evaluation is used to:
Assess process performance?

Can Best Bars show how the output of


analysis and evaluation is used to:
Assess performance of external
providers?

Can Best Bars show how the output of


analysis and evaluation is used to:
Determine the need or opportunities
for improvements within the QMS?

The results of analysis and evaluation shall also be used to provide inputs to management
review.

Does Best bars show where the


results of analysis and evaluation are
used to provide inputs to management
review.

9.1.3.1 (TS) Prioritisation


Does Best Bars compare operational
trends in quality and operational
performance with progress towards
objectives and lead to action support
prioritisation of actions for improving
customer satisfaction?

9.2 Internal audit Score (0/20) 0%

9.2.1

IATF 16949:2016 - 70 -
Question Response Details

The organization shall conduct internal audits at planned intervals to provide information on
whether the quality management system;
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.

Does Best Bars have internal audits


being conducted at planned intervals?

Does Best Bars have a way they


determine whether the QMS conforms
to the requirements of ISO 9001 and to
the other requirements established by
Organization? (Review records to
demonstrate conformance)

Does Best Bars have a way they


determine whether the QMS is
effectively implemented and
maintained? (Review records)

9.2.2
The organization shall:
a) plan, establish, implement and maintain an audit programme(s) including the frequency,
methods, responsibilities, planning requirements and reporting, which shall take into
consideration the quality objectives, the importance of the processes concerned, customer
feedback, changes
impacting on the organization, and the results of previous audits;
b) define the audit criteria and scope for each audit;
c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit
process;
d) ensure that the results of the audits are reported to relevant management;
e) take necessary correction and corrective actions without undue delay;
f) retain documented information as evidence of the implementation of the audit programme
and the audit results.

Can Best Bars show audit


programme(s) that takes into
consideration the quality objectives,
importance of the processes, customer
feedback, changes impacting the
organization and the results of
previous audits?

Does Best Bars show where are the


audit criteria and scope for each audit?

Can Best Bars demonstrate that


selection of auditors and the conduct
of audits are objective and impartial
and that auditors don’t audit their own
work?

Can Best Bars sow how the audit


results are reported to relevant
management?

IATF 16949:2016 - 71 -
Question Response Details

Can Best Bars demonstrate that


necessary correction and corrective
actions are taken without undue
delay?

Can Best Bars show the documented


information of the audit programme
and the audit results?

NOTE See ISO 19011 for guidance.

9.2.2.1 (TS) Internal audit program


Does Best Bars have a documented
internal audit process?

Does the internal audit process include


the development and implementation
of an internal audit program that
covers the entire quality management
system including quality management
system audits, manufacturing process
audits, and product audits?

Does Best Bars prioritise the program


based on risk, internal and external
performance trends and criticality of
the processes?

Where the organisation is responsible for software development, the organisation shall include
software development capability assessments in their internal audit program.

Does Best bars review the audit


frequency and, where appropriate,
adjust based on occurrence or process
changes, internal and external non
conformities, and/or customer
complaints?

Does Best Bars review the


effectiveness of the audit program as
part of the management review?

9.2.2.2 (TS) QMS Audit


Does Best Bars audit all QMS
processes over each three year
period, according to a annual plan?

Does Best Bars, according to an


annual program, using the process
approach to verify compliance with the
IATF 16949 QMS standard, sample
customer specific QMS requirements
for effective implementation?

9.2.2.3 (TS) Manufacturing process audit

IATF 16949:2016 - 72 -
Question Response Details

Does Best Bars audit all manufacturing


processes over a three year calendar
period to determine the effectiveness
and efficiency using customer specific
approaches for process audit?
Where not defined by the customer,
the organisation shall determine the
approach to be used.

Within each individual audit plan, does


Best Bars audit each manufacturing
process, on all shifts where it occurs,
including the appropriate sampling of
the shift handover?

Does Best Bars ensure that the


manufacturing process audits the
effective implementation of the
process risk analysis (Such as
PFMEA), control plan and associated
documentation?

9.2.2.4 (TS) Product audit


Does Best Bars audit products using
customer specific required approaches
at appropriate stages of production
and delivery to verify conformity to
specified requirements?
Where not defined by the customer,
the organisation shall define the
approach to be used.

9.3 Management Review Score (0/39) 0%

9.3.1
Top management shall review the organization's quality management system, at planned
intervals, to ensure its continuing suitability, adequacy, and effectiveness.

Does Best Bars show the frequency


that top management reviews the
organization's QMS?

Does Best Bars show how the QMS is


deemed suitable, adequate and
effective?

The management review shall be


planned and carried out taking into
consideration the status of actions
from previous management reviews?

The management review shall be


planned and carried out taking into
consideration changes in external and
internal issues that are relevant to the
quality management system including
its strategic direction?

IATF 16949:2016 - 73 -
Question Response Details

The management review shall be


planned and carried out taking into
consideration information on the
quality performance, including trends
and indicators for:
1) nonconformities and corrective
actions;
2) monitoring and measurement
results;
3) audit results;
4) customer satisfaction;
5) issues concerning external
providers and other relevant interested
parties;
6) adequacy of resources required for
maintaining an effective quality
management system;
7) process performance and
conformity of products and services?

The management review shall be


planned and carried out taking into
consideration the effectiveness of
actions taken to address risks and
opportunities (see clause 6.1)?

The management review shall be


planned and carried out taking into
consideration new potential
opportunities for continual
improvement?

Does Best Bars show what kinds of


information are reviewed in
management reviews?

Do the Management reviews include


actions status of previous reviews?

Do the Management reviews include


changes to internal/external issues
relevant to the QMS?

Do the Management reviews include


issues that affect strategy?

Do the Management reviews include


KPIs for non-conformities and
corrective actions?

Do the Management reviews include


monitor and measurement of results?

Do the Management reviews include


audit results?

Do the Management reviews include


customer satisfaction?

Do the Management reviews include


issues concerning external providers?

IATF 16949:2016 - 74 -
Question Response Details

Do the Management reviews include


issues concerning other relevant
parties?

Do the Management reviews include


adequacy of resources and
effectiveness of QMS?

Do the Management reviews include


process performance?

Do the Management reviews include


actions taken to address risks and
opportunities and their effectiveness?

Do the Management reviews include


conformity of products and services?

Do the Management reviews include


opportunities for continual
improvement?

9.3.2 Management review inputs


The management review frequency shall be increased based on risk to compliance with
customer requirements resulting from internal or external changes impacting the QMS and
performance related issues

The outputs of the management review shall include decisions and actions related to:
a) continual improvement opportunities;
b) any need for changes to the quality management system, including resource needs.

Does Best Bars show that their


management reviews include
decisions and actions relating to:
Continual improvement opportunities;
The need for changes to the QMS
including resource needs.

The organization shall retain documented information as evidence of the results of


management reviews.

Can Best Bars show what documented


information they have as evidence of
management reviews?

9.3.2.1 (TS) Management review inputs


Does the inputs to management
review include cost of poor quality
(Cost of internal and external non
conformance)?

Does the inputs to management


review include measures of process
effectiveness?

IATF 16949:2016 - 75 -
Question Response Details

Does the inputs to management


review include measures of process
efficiency?

Does the inputs to management


review include product conformance?

Does the inputs to management


review include assessments of
manufacturing feasibility made of
changes to existing operations and for
new facilities or new product (See
Section 7.1.3.1)?

Does the inputs to management


review include customer satisfaction
(See ISO 9001, Section 9.1.2)?

Does the inputs to management


review include review of performance
against maintenance objectives?

Does the inputs to management


review include warranty performance
(Where applicable)?

Does the inputs to management


review include review of customer
scorecards (Where applicable)?

Does the inputs to management


review include identification of
potential field failures identified
through risk analysis (Such as FMEA)?

Does the inputs to management


review include actual field failures and
their impact on safety or the
environment?

9.3.3 Management review outputs


Does Best Bars Management review
outputs include decisions and actions
related to opportunities for
improvement?

Does Best Bars Management review


outputs include decisions and actions
related to any need for changes to the
QMS?

Does Best Bars Management review


outputs include decisions and actions
related to resources needed?

9.3.3.1 (TS) Management review -


Supplement

IATF 16949:2016 - 76 -
Question Response Details

Does Best Bars conduct a


Management Review at least
annually?

IATF 16949:2016 - 77 -
10 Improvement - Score (0/26) 0%

Question Response Details

10 Improvement Score (0/26) 0%

10.1 General
The organization shall determine and select opportunities for improvement and implement
necessary actions to meet customer requirements and enhance customer satisfaction.

Does Best Bars show how they


determine and select opportunities for
improvement?

Can Best Bars show what necessary


actions they have implemented so
that they have met customer
requirements and enhanced customer
satisfaction?

This shall include, as appropriate:


a) improving processes to prevent nonconformities;
b) improving products and services to meet known and predicted requirements;
c) improving quality management system results.

Can Best Bars show how they have:


Improved processes to prevent
nonconformities;
Improved products and services to
meet known and predicted
requirements;
Improved QMS results.

NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g.
continual improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by
re-organization (e.g. transformation).

10.2 Nonconformity and corrective action Score (0/16) 0%

10.2.1
When a nonconformity occurs, including those arising from complaints, the organization shall:
a) react to the nonconformity, and as applicable:
1) take action to control and correct it;
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it
does not recur or occur elsewhere, by:
1) reviewing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) make changes to the quality management system, if necessary.

IATF 16949:2016 - 78 -
Question Response Details

When nonconformities occur can Best


Bars show how;
they react;
Take action to control and correct it;
Deal with the consequences;
Evaluate the need for action to
eliminate the cause so that it does not
recur or occur elsewhere by:
Reviewing the nonconformity;
Determining the cause of the
nonconformity;
Determining if similar nonconformities
exist or could potentially occur;
Actions needed are implemented;
Review the effectiveness of corrective
actions taken, if any;
Make necessary changes to the QMS.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Does Best Bars show me how


correction actions were appropriate to
the effects of the nonconformities
encountered.

NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.


NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.

10.2.2
The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.

Does Best Bars have documented


information that they can show as
evidence of:
The nature of the nonconformities and
subsequent actions taken;

Does Best Bars have documented


information that they can show as
evidence of:
The results of any corrective action.

10.2.3 (TS) Problem solving


Does Best Bars have a documented
process for problem solving that
includes a defined approach for
various types and scales of problems
(e.g new product development, current
manufacturing issues, field failures,
audit findings)?

Does Best Bars have a documented


process for problem solving that
includes containment, interim actions,
and related activities necessary for
control of nonconforming outputs (See
ISO 9001, Section 8.7)

IATF 16949:2016 - 79 -
Question Response Details

Does Best Bars have a documented


process for problem solving that
includes root cause analysis,
methodology used, analysis and
results?

Does Best Bars have a documented


process for problem solving that
includes implementation of systemic
corrective actions, including
correspondence of the impact on
similar processes and products?

Does Best Bars have a documented


process for problem solving that
includes verification of the
effectiveness of implemented
corrective actions?

Does Best Bars have a documented


process for problem solving that
includes reviewing and, where
necessary, updating the appropriate
documented information (E.g FMEA,
Control plan)?

Where the organisation has specified prescribed processes, tools, or systems for problem
solving, the organisation shall use those processes, tools, or systems unless otherwise
approved by the customer.

10.2.4 (TS) Error Proofing


Does Best Bars have a documented
process to determine the use of
appropriate error-proofing
methodologies?
Details of the method used shall be
documented in the process risk
analysis (Such as a PFMEA) and test
frequencies shall be documented in
the control plan.

Does Best Bars include the testing of


error proofing devices for failure or
simulated failure?

Does Best Bars maintain records?

"Challenged" parts, when used, shall be identified, controlled, verified, and calibrated were
feasible.

Do error proofing device failures shall


have a action plan.

10.2.5 (TS) Warranty management


systems

IATF 16949:2016 - 80 -
Question Response Details

Does Best Bars perform an analysis


on customer complaints and field
failures, including any return parts, and
shall initiate problem solving and
corrective action to prevent re-
occurrence?

When requested by the customer, this shall include analysis of the interaction of embedded
software of the organisations product within the system of the final customers product.

Does Best Bars communicate the


results of testing/analysis to the
customer and also within the
organisation.

10.3 Continual improvement


The organization shall continually improve the suitability, adequacy, and effectiveness of the
quality management system.

Can Best Bars demonstrate that they


continually improve the suitability,
adequacy and effectiveness of the
QMS.

The organization shall consider the outputs of analysis and evaluation, and the outputs from
management review, to confirm if there are areas of underperformance or opportunities that
shall be addressed as part of continual improvement.

Does Best Bars demonstrate that the


outputs of analysis and evaluation and
the outputs from management review
are considered to confirm if there are
areas of underperformance or
opportunities that shall be addressed
as part of continual improvement.

Where applicable, the organization shall select and utilise applicable tools and methodologies
for investigation of the causes of underperformance and for supporting continual improvement.

Can Best Bars show what applicable


tools and methodologies for
investigation of the causes of
underperformance and to support
continual improvement are selected?

10.3.1 (TS) Continual Improvement -


Supplemental
Does Best Bars have a documented
process for continual improvement?

Does the process include identification


of the methodology used, objectives,
measurement, effectiveness and
documented information?

IATF 16949:2016 - 81 -
Question Response Details

Does the process include a


manufacturing process improvement
action plan with emphasis on the
reduction of process variation and
waste?

Does the process include risk analysis


(FMEA)?

Note: Continual improvement is implemented once manufacturing processes are statistically


capable and stable or when product characteristics are predictable and meet customer
requirements.

IATF 16949:2016 - 82 -

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