Awareness Training

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IATF 16949 Key facts
• Published in Oct 2016
• Replaces ISO/TS 16949 :2009
• Existing ISO/TS certificates not valid after 14th Sept 2018
• After 1st Oct 2017 no audit shall be conducted as per ISO/TS 16949
• Upgrade possible during regular surveillance audit or recertification
audit
• Transition strategy is published on IATF website

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IATF 16949-Key Changes
• Understanding organization & its context
• Understanding needs & expectations of Interested parties
• Risk & opportunity Management
• Process for managing product safety related products & manufacturing
processes
• No more MR & CR
• Onus on Leadership & process owners
• Corporate responsibility
• Periodic testing of contingency plans
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 IATF 16949-Key Changes
• No documented procedures/ documents & records
• Documented information
• Elaborate planning to achieve Quality Objectives
• Capacity planning as part of feasibility review
• Knowledge management
• Internal & 2nd party auditor qualification- Bar raised
• Maintenance & improvements of Internal auditors
• Not just supplier but external providers

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 IATF 16949-Key Changes
• Elaborate process for selection of external providers
• Supplier development not just ISO 9001 certificate
• Second party audits
• WIs to be in language understood by user
• WI to include rules for safety
• Verification after shutdown
• Periodic overhaul of equipment
• Property of external providers
• Temporary change of process controls
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 IATF 16949-Key Changes
• Customer Authorization for disposition of NC products
• Scrap-rendered unusable prior to disposal
• Management review-Additional Inputs
• Management review at least annually
• Record retention time-specified
• Warranty Management system

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4. Context of the Organization
4.1 Understanding Organization & Its Context
Determine Relevant Internal & External issues
Relevance to Purpose & Direction
Affecting Intended Results
Monitor & Review Information about Internal & External
Issues

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4. Context of the Organization
4.2 Understanding Needs & Expectations of Interested
Parties
Determine Interested Parties
Determine Requirements of these Interested parties
Monitor & Review

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 4. Context of the Organization
4.3 Determining Scope of QMS
Consider-
Internal & External Issues
Requirements of Interested Parties
Products & Services

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4. Context of the Organization
4.3.1 Determining scope of Quality Management System-
Supplemental
 Supporting functions-on-site or remote shall be included
 Only permitted exclusion- product design and development
requirements within ISO 9001, section 8.3.
 Permitted exclusion do not include manufacturing process design

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4. Context of the Organization
4.3.2 Customer Specific Requirements

 CSRs shall be evaluated and included in scope of QMS.

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4. Context of the Organization
4.4 Quality management System and It’s Process
4.4.1
Determine Inputs Required
Outputs expected
Sequence & Interactions
Determine & Apply Criteria & Methods
Determine Resources needed & ensure availability
Assign Authority & Responsibilities
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4. Context of the Organization
4.4 Quality management System and It’s Process
4.4.1
Address Risks & Opportunities
Evaluate processes & Implement changes to ensure
Intended results
Improve the Processes & QMS

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4. Context of the Organization
4.4.1.1 Conformance of products and Processes
Ensure conformance of all products and processes including
service parts and those that are out sourced
 Conformance to customer, statutory and regulatory
requirements.

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4. Context of the Organization
4.4.1.2 Product Safety
 Documented processes for the management of product-safety related products
and manufacturing processes.
Including and where applicable;
 Identification by the organization of statutory and regulatory product-safety
requirements;
 Customer notification of requirements
 Special approval for DFMEA;
 Identification of product safety-related characteristics; Identification and controls
of safety-related characteristics of product and at the point of manufacture;
 Special approval of control plans and PFMEAs;
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4. Context of the Organization
4.4.1.2 Product Safety
Reaction plans;
 Defined responsibilities, definition of escalation process and flow of information,
including top management, and customer notification;
 Training identified by the organization or customer for personnel involved in product-
safety related products and associated manufacturing processes;
 Changes of products or process shall be approved prior to implementation, including
evaluation of potential effects on product safety from process and product changes;
 Transfer of requirements with regard to product safety throughout the supply chain,
including customer-designated sources;
 Product traceability by manufactured lot(at minimum) throughout the supply chain;
 Lessons learned for new product introduction.
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4. Context of the Organization
4.4.2
Maintain documented information to support the operation
of its processes;
Retain documented information to have confidence that the
processes are being carried out as planned.

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5. Leadership
5.1 Leadership & Commitment
Demonstrate Leadership & Commitment with Respect to QMS
by-
Taking accountability of QMS
Ensuring Quality Policy & Objectives are established
Ensuring Integration of QMS in Organization's Business
processes
Promoting Use of Process approach & Risk Based thinking
Ensuring Resources are available
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5. Leadership
5.1 Leadership & Commitment
Demonstrate Leadership & Commitment with Respect to QMS
by-
Communicating Importance of Effective Quality
Management & Conforming to QMS requirements
Ensuring QMS achieves Intended results
Engaging , Directing, Supporting Persons to contribute to
effectiveness of QMS
Promoting Improvement
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 5. Leadership

5.1 Leadership & Commitment

Demonstrate Leadership & Commitment with Respect to QMS
by-
Supporting other relevant Management Roles to
Demonstrate Leadership

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5. Leadership
5.1.1 General
5.1.1.1 Corporate responsibility
The organization shall define and implement corporate
responsibility policies including at a minimum ;
 Anti-bribery policy
 Employee code of conduct and
 Ethics escalation policy(whistle-blowing policy)

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5. Leadership
5.1.1.2 Process effectiveness and Efficiency
Top management shall review the product realization
processes and support processes to evaluate and improve
their effectiveness and efficiency.
Result used as input to management review.

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5. Leadership
5.1.1.3 Process Owners
Identify process owners
Understanding about owner role

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5. Leadership
5.1.2 Customer Focus
Demonstrate commitment & Focus by Ensuring-
Customer & Legal Requirements are determined
,understood & consistently met
Risks & Opportunities are determined & addressed
Focus on enhancing customer Satisfaction is maintained

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5. Leadership
5.2 Policy
5.2.1 Establishing Quality Policy
Appropriate to Purpose & Context
Supports strategic direction
Provides framework for establishing Quality Objectives
Includes commitment to satisfy applicable requirements
Include commitment to continual Improvement of QMS

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5. Leadership
5.2.2 Communicating Quality Policy
Shall be Available & Maintained as Documented information
Be Communicated , Understood & Applied
Available to relevant Interested Parties as applicable

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5. Leadership
5.3 Organizational Roles & Responsibilities
Assigned , Communicated & Understood for-
Ensuring QMS confirms to this standard
Ensuring Processes are delivering Intended output
Reporting Performance of QMS & Opportunity for
improvement
Ensuring Promotion of customer focus
Ensuring Integrity of QMS is maintained when changes to
QMS are planned & Implemented
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5. Leadership
5.3.1 Organizational roles, responsibilities and authorities-
Supplemental
Assign personnel with the responsibility and authority to satisfy customer.
Responsibility and authority 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 designs and development,
capacity analysis,
 logistics information,
customer scorecards, and
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 5. Leadership
5.3.2Resposibility and Authority for product requirements and
corrective actions
Top management shall ensure that:
a)Personnel responsible for conformity to product requirements have
the authority to stop shipment and stop production to correct quality
problems
b)Responsible personnel should know customer specification to avoid
shipment of NC product
c)Responsible personnel should be staffed in all shifts to avoid NC
product shipment
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6. Planning
6.1 Actions to Address Risks & Opportunities
6.1.1
Consider issues & Requirements & determine Risks &
Opportunities that need to be addressed to-
 Give assurance that QMS can achieve Intended results
 Enhance Desirable effects
 Prevent or reduce Undesirable effects
 Achieve Improvement

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6. Planning
6.1 Actions to Address Risks & Opportunities
6.1.2
Actions to address Risks & Opportunities
 How to integrate & Implement Actions in QMS processes
 Evaluate effectiveness of actions
 Actions to be proportionate to Potential Impact on
conformity of products & services

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6. Planning
6.1.2.1 Risk Analysis
Risk analysis Include at a minimum lessons learned from
product recalls,
product audits,
field returns and repairs,
complaints,
scrap and rework
 Retain documented information as evidence of the result of risk
analysis

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 6. Planning
6.1.2.2 Preventive Action
Determine and implement action(s) to eliminate the causes of
potential nonconformities
Preventive actions shall be appropriate to the severity of the potential
issues.
 Establish a process to lessen the impact of negative effects of risk
including the following:
 Determining potential non conformities and their causes;
 Evaluating the need for action to prevent occurrence of
nonconformities;
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6. Planning
6.1.2.2 Preventive Action
Determining and implementing action needed;
Documented information of action taken;
Reviewing the effectiveness of the preventive actions taken;
Utilizing lessons learned to prevent reoccurrence in similar
processes

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 6. Planning
6.1.2.3 Contingency Plans
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
 include, a notification process to the customer and other
interested parties as a supplement to a contingency plan
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6. Planning
6.1.2.3 Contingency Plans
Periodically testing of contingency plans
 Conduct annual review of contingency plan by MDT
including top management, and update as required;
 Maintain records
 The contingency plans shall include provisions to validate
that the manufactured product continues to meet customer
specifications after the re-start of production also.

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 6. Planning
6.2 Quality Objectives and Planning
6.2.1 Quality Objectives
Consistent with Quality Policy
 Measurable
 Take into account applicable Requirements
Relevant to conformity of Products & Services to enhance customer
Satisfaction
Monitored
Communicated
Updated as appropriate
Maintain documented information
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6. Planning
6.2.2 Planning to Achieve Quality Objectives
What will be done
 What resources will be required
 Who will be responsible;
 When it will be completed;
 How the results will be evaluated.

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6. Planning
6.2.2.1 Quality objectives and planning to achieve
them-Supplemental
 Ensure that quality objectives to meet customers
requirements are defined, established, and maintained for
relevant functions, processes, and levels throughout the
organization.
Annual review results used as input for annual quality
objectives and targets.

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6. Planning
6.3 Planning of Changes to QMS
Implement the Changes in Planned manner considering ;
 The purpose of the changes and their potential
consequences;
 The integrity of the QMS
 The availability of resources;
 The allocation or reallocation of responsibilities and
authorities.

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7. Support
7.1 Resources
7.1.1 General
 Determine and provide the resources for maintaining and
improving the QMS considering;
 The capabilities of, and constraints on, existing internal
resources
 What needs to be obtained from external providers.

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7. Support
7.1.2 People
 Determine & Provide persons necessary for effective
Implementation of its QMS & for Operation & Control of its
processes

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7. Support
7.1.3 Infrastructure
Determine, Provide , Maintain Infrastructure- necessary for
operation of Its processes & to achieve conformity of
products & services

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7. Support
7.1.3.1 Plant, facility and Equipment Planning
 Use MDT approach including risk identification and risk
mitigation methods for developing and improving plant,
facility, and equipments plans.
In designing plant layouts
Optimize material flow, material handling, and value added
use of floor space including control of nonconforming
product, and
Facilitate synchronous material flow, as applicable.
Methods shall be developed and implemented to evaluate
manufacturing feasibility for new product or new operations.
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7. Support
7.1.3.1 Plant, facility and Equipment Planning
Manufacturing feasibility assessment shall include capacity
planning for new as well as proposed changes to the existing
operations.
Maintain process effectiveness, including periodic re-evaluation
relative to risk, to incorporate any changes made `during process
approval, control plan maintenance and verification of job set-ups
Assessment of manufacturing feasibility and evaluation of
capacity planning shall be inputs to management reviews
These requirements should include lean mfg principles & on-site
supplier activities
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7. Support
7.1.4 Environment for the operation of process
 Determine, Provide & Maintain Environment necessary for
operation of its processes & to achieve conformity to
products & services
 Human & Physical Factors

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7. Support
7.1.4.1 Environment for operation of processes-
supplemental
 Maintain it's premises in a state of order, cleanliness, and
repair that is consistent with the product and manufacturing
process needs.

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7. Support
7.1.5 Monitoring & Measuring Resources
7.1.5.1 General
Determine and provide the resources ;
 For obtaining valid and reliable results in monitoring and measuring
processes.
 which are suitable for the purpose.
 which are maintained for their continued fitness for their purpose.
 Maintain documented information as evidence.

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7. Support
7.1.5.1.1 Measurement systems analysis
 Statistical studies shall be conducted to analyse the variation present
in the results of each type of the 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.
 Records of customer acceptance of alternative methods shall be
retained along with the results from alternative measurement
systems analysis.

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 7. Support
 7.1.5.2 Measurement Traceability
When measurement traceability is a requirement or considered
essential by organization, measuring equipment shall be-
 Calibrated or verified or both
 Traceable to national or International standard
 Identified
 Safe guarded
 Determine validity of previous measuring results & take appropriate
actions
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7. Support
 7.1.5.2.1 calibration/verification records
 Documented process for managing calibration/verification records of all IMTE
needed to provide evidence of conformity to internal requirements, legislative
and regulatory requirements, and customer-defined requirements shall be
retained.
 Calibration/verification and records shall include the following details:
 revision following engineering changes that impact measurement systems;
 any out-of-specification readings as received for calibration/verification;
an assessment of the risk of the intended use of the product caused by the out-
of-specification condition;
 when a piece of inspection measurement and test equipment is found to be
out of calibration or defective during its planned verification or calibration or
during its use, documented information on the validity of previous
measurement
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7. Support
7.1.5.2.1 calibration/verification records
Notifications to the customer if suspect product or material has been
shipped;
Statements of conformity to specification after
calibration/verification;
 Verification that the software version used for product and process
control is as specified;
records of the calibration and maintenance activities for all gauging
production-related software verification used for product and process
control
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 7. Support
7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal Laboratory
Scope that includes capability to perform the required inspection, test or
calibration services. And included in the QMS documentation.
Minimum requirements
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(such as ASTM,EN, etc.) or self defined standard.
customer requirements, if any;
review of the related records.
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7. Support
7.1.5.3.2 External Laboratory
 External laboratory facilities used for inspection, test, or
calibration services by the organization shall have a defined
laboratory scope that includes the capability to perform the
required inspection, test or calibration, and either:
 The laboratory shall be accredited to ISO/ICE 17025 or
national equivalent and includes the relevant inspection, test
or calibration service in the scope of accreditation
(certificate); the certificate of calibration or test report shall
include the mark of a national accreditation body; or
 There shall be evidence that the external laboratory is
acceptable to the customer.
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7. Support
7.1.5.3.2 External Laboratory
Calibration services may be performed by the equipment
manufacture when a qualified laboratory is not available for
a given piece of equipment. In such cases, the organization
shall ensure that the requirements listed in section 7.1.5.3.1
have been met.
 Use of calibration services, other than by qualified(or
customer accepted) laboratories, may be subject to
government regulatory confirmation, if required.

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7. Support
7.1.6 Organizational Knowledge
Determine Knowledge necessary for operation of processes
& to achieve conformity to products & services
Knowledge maintained & made available to the extent
necessary
Determine how to acquire or access necessary additional
knowledge for changing Needs & Trends

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7. Support
7.2 Competence
Determine Necessary competence of persons doing work
under it’s control that affects performance & effectiveness of
QMS
Education , Training , Experience
Take actions
Evaluate effectiveness
Retain appropriate documented information as evidence of
competence
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7. Support
7.2.1 Competence- supplemental
 Establish and maintain a documented process(es) for identifying
training needs and achieving competence of all personnel performing
activities affecting conformity to product and process requirements.
Personnel performing assigned tasks shall be qualified, as required,
with particular attention to the satisfaction of customer requirements.

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7. Support
7.2.2 Competence- on the job training
Provide on-the-job training for personnel in any new or modified
responsibilities affecting the conformity to quality requirements,
internal requirements, regulatory or legislative requirements this
shall include contract or agency personnel.
The level of detail required for on-the-job training shall be
commensurate with the level of education the personnel possess
and the complexity of the task(s) they are required to perform for
their daily work.
 Persons whose work can affect quality shall be informed about the
consequences on nonconformity to customer requirements.

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7. Support
7.2.3 Internal Auditor Competency
Documented process to verify that internal auditors are competent, taking into
account any customer-specific requirements. Maintain list of IA
 QMS auditors, manufacturing process auditors, and product auditors shall all be
able to demonstrate the following minimum competencies:
 understanding of the automotive process approach for auditing, including risk-
based thinking;
 understanding of applicable customer-specific requirements;
understanding of applicable ISO 9001 and IATF 16949 requirements related to the
scope of the audit;
understanding of applicable core tool requirements related to the scope of the
audit
understanding how to plan, conduct, report and close out audit findings
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7. Support
7.2.3 Internal Auditor Competency
Knowledge about process and product
Documented information to demonstrate competency
 Maintenance of and improvement in internal auditor
competence shall be demonstrated through;
executing a minimum number of audits per year, as defined
by organization;
maintaining knowledge of relevant requirements based on
internal changes and external changes.

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7. Support
7.2.4 Second-party auditor competency
Second-party auditors shall meet customer specific requirements for auditor
qualification and demonstrate the minimum following core competencies,
including understanding of :
the automotive process approach to auditing, including risk based thinking;
applicable customer and organization specific requirements;
applicable ISO 9001 and IATF 16949 requirements related to the scope of
the audit;
applicable manufacturing process to be audited, including PFMEA and
control plan;
applicable core tool requirements related to the scope of the audit;
how to plan, conduct, prepare audit reports, and close out audit findings.
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7. Support
7.3 Awareness
Persons are aware of-
 Quality Policy
Relevant Quality Objectives
Their contribution to effectiveness of QMS including benefits
of improved performance
Implications of not conforming with QMS requirements

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7. Support
7.3.1 Awareness- supplemental
Maintain documented information that demonstrates 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
requirements and the risks involved for the customer with no
non-conforming product.

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7. Support
7.3.2 Employee motivation and empowerment
 Maintain a documented process to motivate employees to
achieve quality objectives, to make Continual improvements,
and to create an environment that promotes innovation.
Include the promotion of quality and technological
awareness

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7. Support
7.4 Communication
Determine Internal & External communication including-
 on what it will communicate;
 when to communicate;
 with whom to communicate;
 how to communicate;
 who communicates.

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 7. Support
7.5 Documented Information
7.5.1.1 Quality Management system documentation
QMS must be documented
Format and structure depend upon organization and retain document list
The quality manual shall include, at minimum, the following:
 The scope of QMS, including details of and justification for any
exclusions;
Documented processes established for the QMS, or reference to them;
Processes and their sequence and interaction(input & output), including
type and extent of control of any outsourced processes;
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7.5.2 Creating & Updating Documented Information
While creating or updating ensure appropriate-
Identification & description
 Format & Media
 Review & Approval for suitability & adequacy

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7. Support
7.5.3 Control of documented information
7.5.3.1
 It is available and suitable for use, where and when it is
needed;
 It is adequately protected (e.g. from loss of confidentiality,
improper use, or loss of integrity).

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7.5.3.2
For control of document following activities should be done:
Distribution, access, retrieval and use;
Storage and preservation, including preservation of
legibility;
Control of changes (e.g. version control);
Retention and disposition.

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7. Support

7.5.3.2.1 Record Retention

 Define, document, and implement a record retention policy. The
control of records shall satisfy statutory, regulatory, organizational
and customer requirements.
 Production part approvals, tooling records ( including
maintenance and ownership), product and process design records,
purchase orders ( if applicable), or contracts 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 regulatory agency
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7.5.3.2.2 Engineering specifications
 Documented process describing the review, distribution and
implementation of all customer engineering standards/specifications
and related revisions based on customer schedules, as required.
 When an engineering standards/specification change result in product
design change, refer to the requirements in ISO 9001, section 8.3.6.
When an engineering standards/specification change result in product
realization process change, refer to the requirements in section 8.5.6.1.
The organization shall 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 standards/specification changes.
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8.1 Operation Planning & Control
Plan, Implement & Control Processes by:
determining the requirements for the products and services;
establishing criteria for:
The processes;
The acceptance of products and services;
Determining resources needed
Implement controls
Determine, maintain & retained documented information
 Control Planned changes & review consequences of unintended changes, taking
actions to mitigate adverse effects
Ensure outsourced processes are controlled
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8.1.1 Operational planning and control -supplemental
When planning for product realization, the following topics shall be
included:
 customer product requirements and
technical specifications;
 logistics requirements;
 manufacturing feasibility;
project planning;
 acceptance criteria.
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8.1.2 Confidentiality
Ensure the Confidentiality of customer- contracted products and
projects under development, including related product information.

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8.2 Requirements for products and services
8.2.1 Customer Communication
Customer Communication shall Include-
 providing information relating to products and services;
 handling enquiries, contracts or orders, including changes;
 obtaining customer feedback relating to products and
services, including customer complaints;
 handling or controlling customer property;
 establishing specific requirements for contingency actions,
when relevant.
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8.2.1.1 Customer Communication –supplemental
All types of communication in customer agreed language
Communicate necessary information, including data in a
customer- specified computer language and format( e.g.
computer-aided design data, electronic data interchange).

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8.2.2 Determining the requirements for products and
services
 The requirements for the products and services are defined,
including:
 any applicable statutory and regulatory requirements;
 those considered necessary by the organization;
Meet the claims for the products and services it offers.

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8.2.2.1 Determining the requirements for product and
service -supplemental
Include recycling, environmental impact and characteristics
identified as a result of organization's knowledge of the
product and manufacturing processes.
It include but not limited to the following:
All applicable government, safety and environmental
regulations related to acquisition ,
storage, recycling, elimination or disposal of material.

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8.2.3 Review of the requirements for products and services
8.2.3.1
Ensure Ability to meet the Requirements
Review before committing to Supply
Review to Include-
Stated Customer Requirements
Implied Customer Requirements
Requirements specified by the organization
Statutory & Regulatory requirements related to product & services
Contract or order requirements differing from previously expressed

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8.2.3.1
Resolve contract or order requirements differing from
previously expressed
Verbal orders to be confirmed before acceptance
Retain documented information of review

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8.2.3.1.1 Review of the requirements for products and
Services- supplemental
Retained documented evidence of a customer
authorised waiver

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8.2.3.1.2 Customer- designated special characteristics
Conform to customer requirements for designation,
approval documentation, and control of special
characteristics.

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8.2.3.1.3 Organization manufacturing feasibility
Multidisciplinary approach to determine if it's feasible that the
manufacturing processes are capable of consistently producing
product that meets all of the engineering and capacity requirements
specified by customer.
Conduct this feasibility analysis for any new manufacturing or
product technology and for any change manufacturing process or
product design.
Validate through production runs, benchmarking studies, or other
appropriate methods, their ability to make product to specifications at
required rate.

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8.2.3.2
Retain documented information, as applicable:
On the results of the review;
On any new requirements for the products and services

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8.2.4 Changes to requirements for products and services
Relevant documented information is amended
Relevant persons are made aware of the changed
requirements, when the requirements for products and
services are changed

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8.3 Design & Development of Products & services
8.3.1 General
Establish, Implement & Maintain Design & Development
process

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8.3.1.1 Design and development of products and services-
supplemental
Product and manufacturing process design and development
Focus on error prevention rather than detection.
Document the design and development process.

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8.3.2 Design & Development Planning
The nature, duration and complexity of the design and development
activities;
The required process stages, including applicable design and development
reviews;
The required design and development verification and validation activities;
The responsibilities and authorities involved in the design and development
process;
The internal and external resource needs for the design and development of
products and services;
The need to control interfaces between persons involved in the design and
development process;
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8.3.2 Design & Development Planning
 the need for involvement of customers and users in the design
and development process;
 the requirements for subsequent provision of products and
services;
 the level of control expected for the design and development
process by customers and other
relevant interested parties;
 the documented information needed to demonstrate that
design and development requirements have been met
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8.3.2.1 Design and development planning-
supplemental
Ensure that design and development planning includes
All affected stakeholders within the organization,
It's supply chain.
Examples of areas for using such a multidisciplinary approach include but are
not limited to the following:
Project management;
Product and manufacturing processes design activities ,
Development and review of product design risk analysis, including actions to
reduce potential risks;
Development and review of manufacturing process risk analysis
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8.3.2.2 Product design skill
Ensure that personnel with product design,Responsibility
are competent to achieve design requirements, Applicable
product design tools and techniques,
Applicable tools and techniques shall be identified by
organization.

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8.3.2.3 Development of products with embedded
software
A process for quality assurance for their products
Products with internally developed embedded software.
Utilized to assess the organization's software development
process. Using prioritization based on risk
Potential impact to the customer
 Software development within the scope of their internal
audit program.
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8.3.3 Design and development inputs
Functional and performance requirements;
Information derived from previous similar design and development activities;
Statutory and regulatory requirements;
Standards or codes of practice that the organization has committed to
implement;
Potential consequences of failure due to the nature of the products and
services.
Inputs shall be adequate for design and development purposes, complete
and unambiguous.
Conflicting design and development inputs shall be resolved.
Retain documented information on design and development inputs.
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8.3.3.1 Product design input
Document and review product design input requirements as a result of contract
review.
Product specifications includes but not limited to special characteristics,
Boundary and interface requirements,
Identification, traceability, and packing,
Consideration of design alternative;
Assessment of risks with the input requirements
Targets for conformity to product requirements including preservation, reliability,
durability etc.
Applicable statutory and regulatory requirements of the customer
Embedded software requirements.
A process to deploy information gained from previous design projects
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8.3.3.2 Manufacturing process design input
Document and review manufacturing process design input requirements…
Product design output data including special characteristics;
Targets for productivity, process capability, timing and cost;
Manufacturing technology alternatives;
Customer requirements, if any;
Experience from previous developments;
New materials;
Product handling and ergonomic requirements:
Design for manufacturing and design for assembly.
Use of error-proofing methods to a degree appropriate to the magnitude of
problem and commensurate the risk encountered.
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8.3.3.3 Special characteristics
A multidisciplinary approach to establish, document and implement it's process
to identify special characteristics,
Documentation of special characteristics in drawings (as required), risk analysis
(such as FMEA), control plan and standard WI
Development of control and monitoring strategies for special characteristics of
product and production processes;
Customer-specified approvals, when required;
Compliance with customer-specified definition and symbols or the organization's
equivalent symbols or notations, as defined in symbol conversion table.

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8.3.4 Design & Development Controls
Apply controls to the design and development process to ensure that:
The results to be achieved are defined;
Reviews are conducted to evaluate the ability of the results of design
and development to meet requirements;
Verification activities are conducted to ensure that the design and
development outputs meet the input requirements;
Validation activities are conducted to ensure that the resulting
products and services meet the requirements for the specified
application or intended use;
Any necessary actions are taken on problems determined during the
reviews, or verification and validation activities;
Documented
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8.3.4.1 Monitoring
Measurements at specific stages during the design and development
of products.
Processes shall be defined, analysed, and reported with summary
results as an input to management review.
When required by the customer, Measurement of the product and
process development activity shall be reported to the customer at
stages specified, or agreed to, by the customer.

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8.3.4.2 Design and development validation
Design and development validation shall be performed in
accordance with customer requirements,
Including any applicable industry and governmental agency-
issued regulatory standards.
The timing of design and development validation-alignment
with customer-specified timing, as applicable.
Where contractually agreed with the customer.

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8.3.4.3 Prototype programme
When required by the customer-prototype programme and
control plan.
 whenever possible, the same suppliers, tooling, and
manufacturing processes as will be used in production.
All performance-testing activities shall be monitored for timely
completion and conformity to requirements.
When services are outsourced- It include the type and extent of
control in the scope of it's QMS to ensure that outsourced
services conform to requirements.
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8.3.4.4 Product approval process
Establish, implement and maintain a product and
manufacturing approvals process confirming to requirements
defined by the customer(s).
Externally provided products and services per ISO 9001,
prior to submission to their part approval to the customer.
Documented product approval prior to shipment, if required
by the customer. Records of such approvals shall be retained.

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8.3.5 Design & Development Outputs
Ensure that D & D outputs-
Meet input requirements
Adequate for subsequent processes for product & service provision
Include Monitoring & Measuring requirements & acceptance
criteria
Specify characteristics essential for Intended purpose & their safe &
proper provision
Documented information must
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8.3.5.1 Design and development outputs- supplemental
The product design verified and validated against product design input
requirements.
Design risk analysis (FMEA);
Reliability study results;
Product special characteristics;
Results of product design error-proofing, such as DFSS, DFMA and FTA;
Product definition including 3D models, technical data packages,
product manufacturing information and geometric dimensioning &
tolerance (GD&T);
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8.3.5.1 Design and development outputs- supplemental
The product design verified and validated against product
design input requirements.
2D drawings, product manufacturing information and GD&T;
Product design review results;
Service diagnostic guidelines and repair and serviceability
instructions;
Service part requirements;
Packing and labelling requirements for shipping.
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8.3.5.2 Manufacturing process design output
Manufacturing process FMEA;
Maintenance plans and instructions;
Control plan;
Standard work and work instructions;
Process approval acceptance criteria;
Data for quality, reliability, maintainability and measurability;
Results of error-proofing identification and verification,
Methods of rapid detection, feedback and correction of
product/manufacturing process nonconformities
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8.3.5.2 Manufacturing process design output
Document manufacturing process design output in a manner that enables
verification against manufacturing process design inputs.
Verify the outputs against manufacturing process design inputs
requirements.
Specifications and drawings;
Special characteristics for product and manufacturing process;
Identification of process input variables that impact characteristics;
Tooling and equipment for production and control, including capability
studies of equipment and process(es);
Manufacturing process flow charts/layout, including linkage of product,
process and tooling;
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8.3.6 Design and development changes
Identify, review , Control Changes to the extent necessary to
ensure that there no adverse Impact
Retain Documented information on Design & Development
changes & results of reviews , authorization of changes &
actions taken to prevent adverse Impact

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8.3.6.1 Design and development changes-supplemental
Evaluate all design changes after initial product approval,
These changes shall be validated against customer and
approved Internally, prior to production implementation.
If required by the customer, obtain documented approval, or
a documented waiver, from the customer prior to production
implementation.
Products with embedded software, the organization shall
document the revision level of software and hardware as part
of the change record.
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8.4 Control on Outsourcing
Determine Controls
Determine & Apply Criteria for Evaluation , Selection,
Monitoring, re-evaluation
Documented information of these activities & actions
arising from same

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8.4.1.1 General-Supplemental
All product and services that affect 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.

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8.4.1.2 Supplier selection process
Documented supplier selection process.
An assessment of the selected supplier's risk to product
conformity and uninterrupted supply to organization's
product to their customer;
Relevant quality and delivery performance;
An evaluation of supplier's QMS
Multidisciplinary decision making
A software development capabilities, if applicable.
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8.4.1.2 Supplier selection process
Other supplier selection criteria
Volume of automotive business (absolute and asa percentage of
total business);
Financial stability;
Purchased product, material or services complexity;
Required technology (product or process);
Adequacy of available resources (e.g. people, infrastructure);
Design and development capabilities (including project
management);
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8.4.1.2 Supplier selection process
Other supplier selection criteria
Manufacturing capability;
Change management process;
Business continuity planning (e.g. Contingency planning);
Logistics process;
Customer service.

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8.4.1.3 Customer-directed sources (also known as
"Directed-buy")
When specified by the customer, purchase products,
materials, or services from customer-directed sources.
All requirements (except the requirements in IATF 16949,
are applicable to the organization's control of customer-
directed sources defined by the contract between the
organization and customer.

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8.4.2 Type & Extent of Control
Define controls to be applied to provider
Define controls to be applied to output
Consider Potential Impact & effectiveness of controls
applied by provider
Determine verification or other activities

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8.4.2.1 Type and extent of control-supplemental
Documented process to identify the outsourced processes and
to select the types and extent of controls
To verify the conformity of externally provided products,
processes and services to internal (organizational) and external
customer requirements.
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 risk.

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8.4.2.2. Statutory and regulatory requirements
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 customer-identified country of
destination, if provided
If the customer defines special controls for certain products with
statutory and regulatory requirements,
Implemented and maintained as defined, including at suppliers.

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8.4.2.3 Supplier quality management system development
Supplier of automotive product and services, to develop, implement and
improve a QMS certified to ISO 9001, unless otherwise authorised by the
customer
Compliance to ISO 9001, through second- party audits;
Certification to ISO 9001, through third- party audits;
 Certification to ISO 9001 with compliance to other customer-defined QMS
requirements
Certification to ISO 9001 with compliance to IATF 16949 through second-party
audits;
 Certification to 16949 through third-party audits( valid third-party certification
of the supplier to IATF 16949 by an IATF- recognized certification body).

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8.4.2.3.1 Automotive product- related software or
automotive products with embedded software
Suppliers of automotive product-related software, or automotive
products with embedded software,
To implement and maintenance a process for software quality
assurance for their products.
A software development assessment methodology utilized to assess
supplier's software development process.
Using prioritization based on risk and potential impact to customer,
Supplier to retain documented information of a software
development capability self-assessment.
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8.4.2.4 Supplier monitoring
Documented process and criteria to evaluate supplier's performance in
order to ensure the conformity of externally provided products, processes
and services and external customer requirements.
At a minimum, following supplier performance indicator:
Delivered product conformity to requirements;
Customer disruption at the receiving plant,
Delivery schedule performance;
Number of occurrences of premium freight.
If provided by customer,
 Special status customer notifications related to quality non delivery issue;
Dealer returns, warranty, field action and recalls.
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8.4.2.4.1 Second- party audit
Second party audit process in their supplier management approach. Second-
party audit maybe used for the following:
Supplier risk assessment;
Supplier monitoring;
Supplier QMS development;
Product audits;
Process audits.
Based on risk analysis, including product safety/regulatory requirements,
performance of the supplier, the organization shall retain records of second party
audit reports.
If the scope of second party audit is to assess the supplier's QMS, then the
approach shall be consistent with the automotive process approach.
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8.4.2.5 Supplier development
Priority, type, extent and timing of required supplier
development action for it's active suppliers.
Determination inputs shall include but not limited to the
following:
Performance issues identified through supplier monitoring;
Second party audit findings;
Third party quality management system certification status;
Risk analysis.
Actions necessary to resolve open (unsatisfactory) performance
issues and peruse opportunities for continual improvement.
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8.4.3 Information to external Providers
Ensure adequacy prior to communication
Requirement for –
product, Process , Service
 approval
Competency, Qualification
Interactions
Controls & Monitoring
Verification , Validation at Provider’s premises
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8.4.3.1 Information for external providers-
supplemental
Pass down all applicable statutory and regulatory
requirements
Special product and process characteristics to their suppliers
Requires the suppliers to cascade all applicable
requirements down the supply chain to the point of
manufacture.

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8.5 Production and service provision
8.5.1 Control of production and service provision
Controlled conditions include-
Availability of Documented Information that defines
Characteristics , Results to be achieved
Availability & use of suitable monitoring & Measuring Resources
Implementation of monitoring & Measuring
Use if Suitable Infrastructure & Environment
Appointment of competent personnel including required
qualification
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8.5.1 Control of production and service provision
Controlled conditions include-
Validation & Periodic Revalidation where output can not be
verified
Implementation of actions to prevent Human error
Implementation of release , Delivery & Post delivery
activities

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8.5.1.1 Control plan
Develop Control plans at the system, subsystem, component, and/or
material level for the relevant manufacturing site and all product
supplied.
Family control plans are acceptable for bulk material and similar
parts using a common manufacturing process.
Control plan for pre-launch and production that shows linkage and
incorporates information from the design risk analysis (if provided by
customer), process flow diagram, and manufacturing process risk
analysis outputs(such as FMEA).
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8.5.1.1 Control plan
Provide measurement and conformity data collected, during execution of
either the pre-launch or production control plans.
Control used for manufacturing process control, including verification of job
set-ups;
First-off/last-off part validation, as applicable;
Methods for monitoring of control exercised over special
characteristics(See Annex A)defined by both the customer and organization;
The customer-required information, if any;
Specified reaction plan when nonconforming product is detected, the
process becomes statistically unstable or not statistically capable.
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8.5.1.1 Control plan
Review control plans, and update as requires:
Determines it has shipped nonconforming product to the customer;
When any change occurs affecting product, manufacturing process,
measurement, logistics, supply sources, production volume
changes, or risk analysis(FMEA);
After a customer complaint and implementation of the associated
corrective action, when applicable;
At a set frequency based on risk analysis.
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8.5.1.2 Standardized work- operator instructions and visual
standard
Insured that standardized work documents are:
Communicated to and understood by employees who are
responsible for performing the work;
Legible;
Presented in the launguage(s) understood by personnel
responsible to follow them;
Accessible for use at the designated work area(s).
The standardized work documents include rules for operator
safety.
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8.5.1.3 Verification of job set-ups
Verify job set-ups when performed,;
Maintain documented information for set-up personnel;
Use statistical methods of verification, where applicable;
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 the first-off-parts in subsequent runs;
Retain records of process and product approval following set-up and
first-off/last-off part validations.
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8. Operation
8.5.1.4 Verification after shutdown
Define and implement the necessary actions to ensure
product compliance with requirements after a planned or
unplanned shutdown period.

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8. Operation
8.5.1.5 Total productive maintenance
 Develop, implement, and maintain a documented total productive
maintenance system.
At a minimum, the system shall include the following:
Identification of process equipment necessary to produce conforming product
at the required volume;
Availability of replacement parts for the equipment defied in item a);
Provision of resource for machine, equipment, and facility maintenance;
Packaging and preservation of equipment, tooling and gauging;
Applicable customer-specific requirements;
Documented maintenance objectives
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8. Operation
8.5.1.5 Total productive maintenance
Develop, implement, and maintain a documented total productive
maintenance system.
At a minimum, the system shall include the following:
Regular review of maintenance plan and objectives and a documented
action plan to address corrective actions where objectives are not
achieved;
Use of preventive maintenance methods;
Use of predictive maintenance method, as applicable;
Periodic overhaul.
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8. Operation
8.5.1.6 management of production tooling and
manufacturing, test, inspection tooling and equipment
Customer-owned tools, manufacturing equipments, and
test/inspection equipment are permanently marked in
visible location so that the ownership and application of
each item can be determined.
Implement a system to monitor these activities if any work
is outsourced.

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8. Operation

8.5.1.6 management of production tooling and
manufacturing, test, inspection tooling and equipment

Provide resources for tool and gauge design, fabrication, and verification activities for
production and service materials and for bulk materials, as applicable.

Establish and implement a system for production tooling management, whether owned
by the organization or the customer, including;

Maintenance and repair facilities and personnel;

Storage and recovery;

set-up;

tool-change programs for perishable tools;

Tool design modification documentation, including engineering change level of the
product;

Tool modification and revision to documentation;

Tool identification, such as serial or asset number, the status, such as production, repair
or disposal; ownership; and location.
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8. Operation
8.5.1.7 Production Scheduling
In order to meet customer orders/demands such as Just-in-
Time(JIT)
supported by information system
order driven.
include relevant planning information during production
scheduling,

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8. Operation
8.5.2 Identification and traceability
Identify Output when necessary to ensure conformity
Identify status of output
Unique Identification when traceability is a requirement-
Documented information

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8. Operation
8.5.2.1 Identification and traceability-supplemental
 Support identification of clear start and stop points for
product received by the customer or in the field that may
contain quality and/or safety related non conformities.
Conduct an analysis of internal, customer, and regulatory
traceability requirements
 Develop and document traceability plans

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 8. Operation

8.5.2.1 Identification and traceability-supplemental
Based on the levels of risk or failure severity. This plan shall define the appropriate
traceability systems, processes and methods by product, process and
manufacturing location that

Enable the organization to identify nonconforming and/or suspect product;
Enable the organization to segregate nonconforming and/or suspect product;

Ensure the ability to meet the customer and/or regulatory response time
requirements;

Ensure documented information is retained in the format(electronic, hardcopy,
archive) that enables the organization to meet response time requirements;

Ensure serialized identification of individual products, if specified by the customer
or regulatory standards;

Ensure the identification and traceability requirements are extended to externally
provided products
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8. Operation
8.5.3 Customer & External Provider Property
Exercise care
Identify , Verify, Protect & safeguard
When Lost/Damaged/Found Unsuitable-Report & Maintain
Documented information

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8. Operation
8.5.4 Preservation
Preserve outputs during Production & service provision

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8. Operation
8.5.4.1 Preservation-supplemental
identification, handing, contamination control, packaging, storage, transmission or
transportation and protection.
Apply to materials and components from external and/or internal providers from receipt
through processing, including shipment and until delivery to/acceptance by the customer.
Assess at appropriate planned intervals the condition of product in stock, the place/type
of storage container, and the storage environment.
Use an inventory management system to optimize inventory turns over time and ensure
stock rotation, such as “first-in-first-out”(FIFO).
Ensure that obsolete product is controlled in a manner similar to that of nonconforming
product.
Comply with preservations, packaging, shipping and labeling requirements as provided by
their customers.

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8. Operation
8.5.5.1 Feedback of Information from service
Process for communication to internal functions

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8. Operation
8.5.5.2 Service agreement with customer
 When there is service agreement with the customer
Verify that the relevant service centres comply with
applicable requirements;
Verify the effectiveness of any special purpose tools or
measurement equipment;
Ensure that all service personnel are trained in applicable
requirements.
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8. Operation
8.5.6 Control of changes
Review & Control changes to Production & service provision
Documented information –Results of review, Person
authorizing change, Actions arising from review

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8. Operation
8.5.6.1 Control of changes-supplemental
 Documented process to control and react to changes
Effects of changes assets
Define verification and validation activities, validate changes before implementation
Document the evidence of related risk analysis
Retain records of verification and validation
Should require production trial run for verification
When required by customer
Notify Customer
Obtained documented approval prior to implementation
Complete addition, verification and identification

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8. Operation
8.5.6.1.1 Temporary change of process controls
Identify, document and maintain list of primary process control
and approved alternate methods
Document the process that manages the use of alternate
methods
Process includes risk analysis, Severity and internal approvals
Customer approval before shipping if required
Maintain and periodic review of list of approved process controls
Standard work instruction for each alternate process control
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8. Operation
8.5.6.1.1 Temporary change of process controls
Review operation of alternate process control on daily basis
Goal is to return to standard process
Eg- Daily focused audits, Daily leadership meetings
Restart verification documented
Implement traceability

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8. Operation
8.6 Release of Products & services
Implement Planned arrangements
No Release to customer unless planned arrangements are
complete
Unless approved by Relevant authority-As applicable by
customer
Documented information-Conformity & Person authorizing
release
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8. Operation
8.6.1 Release of products and services-Supplemental
Planned arrangements met
Documented as specified in control plan
Initial release encompass product and service approval
Product and service approval accomplished after changes
following initial release

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8. Operation
8.6.2 Layout inspection and functional testing
For each product.
As specified in control plans
 Results available for customer review

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8. Operation
8.6.3 Appearance items
Appropriate resources, including lightening, for evaluation;
Masters for color, grain, gloss, metallic brilliance, texture,
distinctness of image(DOI), and haptic technology, as
appropriate;
Maintenance an control of appearance masters and evaluation
equipments;
Verification that personnel making appearance evaluations are
competent and qualified to do so.
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8. Operation
8.6.4 Verification and acceptance of conformity of externally
provided products and services
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
organization
Receiving inspection and/or testing, such as sampling based on
performance;
Second-party or third-party assessment or audits of supplier sites when
coupled with records of acceptable delivered product conformance to
requirements;
Part evaluation by the designated laboratory;
 Another method agreed with customer.
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8. Operation
8.6.5 Statutory and regulatory conformity
Process, product and services shall confirm to statutory and
regulatory and other requirements
Prior to release into production flow
Evidence required
Consider country of manufacture and countries of
destination

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8. Operation
8.6.6 Acceptance criteria
Shall be defined by organization
Where required, approved by customer
For attribute data sampling, acceptance level is zero defect

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8. Operation
8.7.1
Ensure that outputs that do not conform to their requirements are identified and
controlled to prevent their unintended use or delivery.
Appropriate action based on the nature of the nonconformity and its effect on the
conformity of products and services. This shall also apply to nonconforming products
and services detected after delivery of products, during or after the provision of
services.
Deal with nonconforming outputs in one or more of the following ways:
Correction;
Segregation, containment, return or suspension of provision of products and services;
Informing the customer;
Obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when nonconforming outputs are
corrected
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8. Operation
8.7.1.1 Customer authorisation for concession
Obtain customer concession/deviation for NC product or
manufacturing process
Customer authorization prior to further processing for “use as
is” and rework disposition
Sub component reuse shall be clearly communicated to
customer
Maintain record of expiry date or quantity
Ensure compliance with original and super seeding
specifications and requirement after expiry
Identification on each shipping container
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8. Operation
8.7.1.2 Control of nonconforming product- Customer-
specified process
Comply with applicable customer-specified controls

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8. Operation
8.7.1.3 Control of suspect product
Classified and controlled as NC product
Appropriate manufacturing personnel trained for
containment

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8. Operation
8.7.1.4 Control of reworked product
Risk analysis in rework process prior to rework
If required by customer-Approval from customer before
commencing
Documented process for rework confirmation
Instruction for disassembly or rework including re-inspection,
traceability requirement
Retain documented information including quantity, disposition,
disposition date, traceability
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8. Operation
8.7.1.5 Control of repaired product
 Risk analysis in repair process prior to repair
Approval from customer before commencing
Documented process for repair confirmation
Instruction for disassembly or repair including re-inspection,
traceability requirement
Documented customer authorization for repair
Retain documented information including quantity, disposition,
disposition date, traceability
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8. Operation
8.7.1.6 Customer notification
Notify the customer if NC product shipped
Followed with detailed documentation of event

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8. Operation
8. 7. 1. 7 Nonconforming product disposition
• The organization shall have a documented process for disposition of
nonconforming product not subject to rework or repair. For product
not meeting requirements, the organization shall verify that the
product to be scrapped is rendered unusable prior to disposal.
• The organization shall not divert nonconforming product to service or
other use without prior customer approval.

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8. Operation
8.7.2
Retain documented information that:
Describes the nonconformity;
Describes the actions taken;
Describes any concessions obtained;
Identifies the authority deciding the action in respect of the
nonconformity

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9 Performance Evaluation
9.1.1 General
What needs to be monitored
Method for monitoring , measurement , analysis &
evaluation
When to Perform
When to Analyze & Evaluate
Documented information as evidence of results

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 9 Performance Evaluation
9.1.1.1 Monitoring and measurement of manufacturing
processes
Process studies on all new manufacturing processes, verify process capability and to provide
additional input for process control, including those for special characteristics
 Maintain manufacturing process capability or performance results as specified by the
customer’s part approval process requirements.
Verify that the process flow diagram, PFMEA, and control plan are implemented, including
adherence to the following:
Measurement techniques;
Sampling plans;
Acceptance criteria;
Records of actual measurement values and/or test results for variable data;
Reaction plans
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9 Performance Evaluation
9.1.1.1 Monitoring and measurement of manufacturing
processes
Significant process events shall be recorded and retained as
documented information
The organization shall initiate a reaction plan
 Reaction plans shall include containment of product and
100% inspection, as appropriate.
A corrective action plan shall be developed and
implemented and reviewed with the approved by customer,
when required.
Maintain records of effective dates of process changes.
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9 Performance Evaluation
9.1.1.2 Identification of statistical tools
Determine the appropriate use of statistical tools.
Verify that appropriate statistical tools are included as part
of advanced product quality planning and included in design
risk analysis the process risk analysis, and the control plan.

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9 Performance Evaluation
9.1.1.3 Application of statistical concepts
 Understanding and use of statistical concepts
Statistical concepts-
variation
control (stability)
 process capability
consequences of over-adjustment

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9 Performance Evaluation
9.1.2 Customer Satisfaction
Monitor Customer’s perception
Determine method for obtaining , monitoring & reviewing

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9 Performance Evaluation
9.1.2.1 Customer satisfaction-supplemental
Monitoring Customer satisfaction
Performance indicators should include but not limited to the following:
Delivered part quality performance;
Customer disruption;
Field returns, recalls and warranty(where applicable);
Delivery schedule performance(including incidents of premium fright);
Customer notifications related to quality or delivery issues, including special
status.
Monitor performance of manufacturing processes
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9 Performance Evaluation
9.1.3 Analysis & Evaluation
Analyze & Evaluate appropriate Data & Information
Conformity to Product & services
Degree of customer Satisfaction
Performance & Effectiveness of QMS
If Planning has been Implemented effectively
Effectiveness of actions to address Risks & Opportunities
Performance of external providers
Need for improvement of QMS
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9 Performance Evaluation
9.1.3.1 Prioritization
 Trend in quality and operational performance shall be
compared with progress towards objectives and lead to
action to support prioritization of actions for improving
customer satisfaction.

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9 Performance Evaluation
9.2.1 Internal Audit
Planned Interval
Provide information on conformance to QMS & Standard, Effectively
Implemented & Maintained
Plan , Establish, Maintain audit programs
Frequency, Method, Responsibility, Planning, Reporting
Importance of process
Changes
Results of previous audit
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9 Performance Evaluation
9.2.2 Internal audit
Criteria & Scope
Objectivity & Impartiality
Results reported to relevant management
Take correction & Corrective action without undue delay
Documented information-Evidence of Implementation of
audit program & audit results

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9 Performance Evaluation
9.2.2.1 Internal Audit programme
Documented internal audit process.
Covers the entire QMS including
QMS audits
manufacturing process audits
product audits.
Prioritize based upon
risk
internal and external performance trends
 criticality of processes.
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9 Performance Evaluation
9.2.2.2 Quality Management system audit
3 year interval
Sample Customer specific QMS requirements for effective
implementation

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9 Performance Evaluation
9.2.2.3 Manufacturing Process audit
3 year interval
Organization defined approach
Customer specific required approach
As per shift-all shifts individually/separately
Audit of the effective implementation of the process risk
analysis control plan and associated documents.

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9 Performance Evaluation
9.2.2.4 Product Audit
 Organization defined approach for product
Customer specific required approach towards product

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9 Performance Evaluation
9.3.1 Management Review
Planned Intervals
Ensure continuing-
 suitability
Adequacy,
Effectiveness,
alignment with strategic direction

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9 Performance Evaluation
9.3.1.1 Management Review-Supplemental
To be conducted minimum annually
Frequency defined as per risk and compliance with customer
requirements

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9 Performance Evaluation
9.3.2 Management Review Inputs
Status of actions form previous Management Reviews
Changes in External & Internal Issues relevant to QMS
Customer Satisfaction & feedback from relevant Interested
parties
Extent to which Quality Objectives have been met
Process performance
Conformity to Product & Services
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9 Performance Evaluation
9.3.2 Management Review Inputs
Non Conformities & Corrective Actions
Monitoring & Measurement Results
Audit Results
Performance of External providers
Adequacy of resources
Effectiveness of actions taken to address Risks & Opportunities
Opportunities of Improvement

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9 Performance Evaluation
9.3.2.1 Management Review inputs-supplemental
Input to management review shall include:
Cost of poor quality
Measures of process effectiveness;
Measures of process efficiency;
Product conformance;
Assessments of manufacturing feasibility made for changes
to existing operations and for new facilities or new product;

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9 Performance Evaluation
9.3.2.1 Management Review inputs-supplemental
Input to management review shall include:
Customer satisfaction;
Review of performance against maintenance objectives;
Warranty performance(where applicable);
Review of customer scorecards(where applicable);
Identification of potential field failures ;
Actual field failures and their impact on safety or
environment.
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9 Performance Evaluation
9.3.3 Management Review Outputs
Decisions & Actions related to-
Opportunity of Improvement
Any need of changes to QMS
Resource needs
 Documented information as evidence of Management
review

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9 Performance Evaluation
9.3.3.1 Management Review outputs-supplemental
Document and implement an action plan when customer
performance targets are not met.

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10 Improvements
• 10.1 General
Determine & Select Opportunity for Improvement &
Implement necessary actions
Improving Products & Services to meet requirements &
address future needs
Correcting, Preventing or reducing Undesirable effects
Improving Performance & Effectiveness of QMS

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10 Improvements
10.2 Nonconformity and corrective action
10.2.1
When a nonconformity occurs:
React to the nonconformity
Take action to control and correct it;
Deal with the consequences;
Evaluate the need for action to eliminate the cause(s) of the
nonconformity, in order that it does not occur elsewhere, by:
Reviewing and analyzing the nonconformity;
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10 Improvements
10.2.1
Determining the causes of the nonconformity;
Determining if similar nonconformities exist, or could
potentially occur;
Implement any action needed;
Review the effectiveness of any corrective action taken;
Update risks and opportunities determined during planning,
Make changes to the quality management system, if
necessary.
Corrective actions shall be appropriate to the effects of the
NCs encountered
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10.2.2
Retain documented information as evidence of:
The nature of the nonconformities and any subsequent
actions taken;
The results of any corrective action

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 10 Improvements
10.2.3 Problem solving
Documented process includes:
Defined approach for various types and scales of problems;
Containment, interim actions and related activities
Root cause analysis, methodology used, analysis and results;
Implementations of systematic corrective actions
Verification of the effectiveness of corrective actions;
Reviewing and updating the documented information
Customer specific prescribed processes, tools or systems for
problem solving, used only if approved by the customer.
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10 Improvements
10.2.4 Error-proofing
Document error-proofing methodologies.
Inclusion of details of error-proofing method in the control
plan.
Inclusion of the test results of error-proofing device in the
process .
Maintain Records.
Challenge parts-identification, controlled, verification and
calibration
Error-proofing device failure reaction plan.
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10 Improvements
10.2.5 Warranty management system
warranty management process
method for warranty part analysis-including NTF(no trouble
found).
On CSR, implementation of required warranty management
process.

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10 Improvements
10.2.6 Customer complaints and field failure test analysis
Analysis of customer complaints and field failure
Where requested by the customer, this shall include analysis
of the interaction of embedded software of the organization’s
product within the system of the final customer’s product.
Communicating the results of testing/analysis to the
customer and also within the organization.

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10 Improvements
10.3 Continual Improvement
Suitability , Adequacy , Effectiveness of QMS
Consider Results of Analysis & Evaluation, Output from
Management Review

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10 Improvements
10.3.1 Continual improvement-Supplemental
Documented process for Continual improvement, It should
include:
a)Identification of methodology used, objectives,
measurement, effectiveness and documents informato0n;
b)Action plan with emphasis on the reduction of process
variation and waste
c)Risk analysis(such as FMEA)
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