Professional Documents
Culture Documents
conducted for
Conducted on
24/07/2019 9:25 PM
Prepared by
Subhash Rastogi
Score
Score 0/0 - 0%
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.
The organization shall monitor and review the information about these interested parties and
their relevant requirements.
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.
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.
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.
4.4.2
To the extent necessary, the Best Bars shall:
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.
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 it communicated?
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.
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.
Actions taken to address risks and opportunities shall be proportionate to the potential impact
on the conformity of products and services.
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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.
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.
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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?
6.2.1
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.
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
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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.
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7 Support - Score (0/101) 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.
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.
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
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Note 1: These requirements should include the application of lean manufacturing principles.
NOTE Environment for the operation of processes can include physical, social, psychological,
environmental and other factors (such as temperature, humidity, ergonomics and cleanliness).
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The organization shall retain appropriate documented information as evidence of fitness for
purpose of monitoring and measurement resources.
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Note: Prioritisation of MSA studies should focus on critical or special product or process
characteristics.
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Statements of conformity to
specification after
calibration/verification
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Note: Third party accreditation to ISO 17025 may be used to demonstrate the organisations in-
house laboratory conformity to this requirement.
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.
This knowledge shall be maintained, and made 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
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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
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.
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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.
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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.
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.
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.
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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.
7.5.3.1
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).
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7.5.3.2
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.
Note: Production Part Approval documented information may include approved product,
applicable test equipment records or approved test data.
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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.
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8 Operation - Score (0/256) 0%
The output of this planning shall be suitable for the organization's operations.
The organization shall control planned changes and review the consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary.
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The organization shall ensure that outsourced processes are controlled in accordance with 8.4.
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.
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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.
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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.
Where the customer does not provide a documented statement of their requirements, the
customer requirements shall be confirmed by the organization before acceptance.
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Documented information describing the results of the review, including any new or changed
requirements for the products and services, shall be retained.
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.
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.
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.
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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)
Note: An example of product design skills is the application of digitised mathematically based
data.
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Inputs shall be adequate for design and development purposes, complete, and unambiguous.
Conflicts among inputs shall be resolved.
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
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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.
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Note: Product approval should be subsequent to the validation of the manufacturing process.
The organization shall retain the documented information resulting from the design and
development process.
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Note: Interim design outputs should include any engineering problems being resolved through
a trade-off process.
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8.4.1 General
The organization shall ensure that externally provided processes, products, and services
conform to specified requirements.
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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.
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.
The organization shall retain appropriate documented information of the results of the
evaluations, monitoring of the performance and re-evaluations of the external providers.
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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
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.
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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.
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.
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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
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Note: Guidance may be found in the IATF Auditor Guide and ISO 19011
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The organization shall ensure the adequacy of specified requirements prior to their
communication to the external provider.
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The standardised work documents shall also include rules for operator safety
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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
Where necessary to ensure conformity of products and services, the organization shall use
suitable means to identify 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.
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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.
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.
8.5.4 Preservation
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The organization shall ensure preservation of process outputs during production and service
provision, to the extent necessary to maintain conformity to requirements.
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.
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.
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The organization shall retain documented information describing the results of the review of
changes, the personnel authorizing the change, and any necessary actions.
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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.
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.
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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.
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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.
Where nonconforming process outputs, products and services are corrected, conformity to the
requirements shall be verified.
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The organisation shall not divert nonconforming product to service or other use without prior
customer approval.
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9 Performance Evaluation - Score (0/93) 0%
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.
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.
The organization shall evaluate the quality performance and the effectiveness of the quality
management system.
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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.
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The organization shall monitor customer perceptions of the degree to which requirements have
been met.
The methods for obtaining and using this information shall be determined.
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.
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The results of analysis and evaluation shall also be used to provide inputs to management
review.
9.2.1
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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.
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.
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Where the organisation is responsible for software development, the organisation shall include
software development capability assessments in their internal audit program.
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9.3.1
Top management shall review the organization's quality management system, at planned
intervals, to ensure its continuing suitability, adequacy, and effectiveness.
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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.
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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.
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).
10.2.1
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.
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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.
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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.
"Challenged" parts, when used, shall be identified, controlled, verified, and calibrated were
feasible.
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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.
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.
Where applicable, the organization shall select and utilise applicable tools and methodologies
for investigation of the causes of underperformance and for supporting continual improvement.
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