1.

EXECUTIVE SUMMARY AND THEOROTICAL

BACKGROUND

IATF 16949:2016 is the International Standard for Automotive Quality Management

Systems. IATF 16949 was jointly developed by The International Automotive Task Force
(IATF) members and submitted to the International Organization for Standardization
(ISO) for approval and publication.

The document is a common automotive quality system requirement based on ISO 9001,
and customer specific requirements from the automotive sector.

IATF 16949 emphasizes the development of a process oriented quality management

system that provides for continual improvement, defect prevention and reduction of
variation and waste in the supply chain. The goal is to meet customer requirements
efficiently and effectively.

IATF 16949:2016 (replaces ISO/TS 16949:2009) is a standard that establishes the

requirements for a Quality Management System (QMS), specifically for the automotive
sector. The ISO/TS 16949 was originally created in 1999 to harmonize different
assessment and certification schemes worldwide in the supply chain for the automotive
sector.

The primary focus of the project is the development of a Quality Management System
that provides for continual improvement, emphasizing defect prevention and the
reduction of variation and waste in the supply chain. The standard, combined with
applicable Customer-Specific Requirements (CSR’s), define the QMS requirements for
automotive production, service and/or accessory parts.

Our project is an independent QMS standard that is fully aligned with the structure and
requirements of ISO 9001:2015. Therefore, QMS cannot be implemented alone as a
stand-alone document, but must be implemented as a supplement and in conjunction
with ISO 9001:2015.

After October 01, 2017, audits cannot be conducted to ISO/TS 16949 and organizations
done their transition to the new IATF 16949 in line with their current audit cycle,
 according to the allowable timing requirements. Failure to conduct the audit within the
allowable timing requirements requires the organization to start over with an initial
certification audit. The transition audit shall be the duration of a recertification audit plus
additional time for a documentation review. All supporting functions on site or at a
remote location shall be included in the transition process

The project provides guidance and tools for companies and organizations who want to ensure
that their products consistently meet customer requirements and that quality and customer
satisfaction are consistently improved. Requirements for certification of project to IATF
16949 are defined in the 2016 Revision 5 of the rules for achieving and maintaining IATF
recognition.
The project consists of IATF 16949 standards is a supplemental standard and is used in
conjunction with the ISO standards:
 IATF 16949 – establishes the Automotive supplemental requirements of a quality
management system
 ISO 9001 – defines the base requirements of a quality management system
 ISO 9000 – covers the basic concepts and language
 ISO 9004 – focuses on how to make a quality management system more efficient and
effective
 ISO 19011 – provides guidance on internal (1st party) and external (2nd party) audits
of quality management systems
 ISO 31000 – outlines risk management principles and guidelines
Our project defines the criteria for an automotive-based QMS with the goal to become 3rd
party registered. It can be used by any supplier, large or small, and should be applied
throughout the automotive supply chain. In fact, there over 65,000 suppliers worldwide
which are currently certified to ISO/TS 16949. All requirements of IATF 16949 are
applicable unless suppliers do not provide product design related functions. Requirements are
generic and are intended to be applicable to any supplier providing design and development,
production and, when relevant, assembly, installation and services of automotive related
products, including products with embedded software. The IATF 16949 standard is
applicable to sites of the organization where manufacturing of customer-specified production
parts, service parts, and/or accessory parts occur.
The standard is based on seven Quality Management Principles, including a strong customer
focus, the motivation and implication of top management, the process approach and continual
improvement.
These Quality Management Principles are defined as follows:
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence-based decision making
7. Relationship management

Why Implement IATF 16949

Implementing IATF 16949 ensures that customers receive consistent, good quality products
and services, which in turn may bring many business benefits. IATF 16949 specifies
requirements for a Quality Management System when an organization wants to:
 Demonstrate its ability to consistently provide products that meet customer and
applicable statutory, regulatory and product safety requirements
 Enhance customer satisfaction through the effective application of the system
 Implement processes for improvement of the system
 Define overall context, who is affected and what they expect
 Clearly state objectives and identify new business opportunities
 Put customers first, making sure their needs are consistently met and enhance their
satisfaction
 Have repeat customers, increase customer loyalty, add new clients and increase
business
 Expand into new markets, as some sectors and clients require IATF 16949 before
doing business
 Identify and address the risks associated with your organization
 Work in a more efficient way to increase productivity and efficiency, bringing internal
costs down
 Become more socially responsible through the documentation and implementation of
corporate responsibility polices

When to Implement IATF 16949

Compliance to the IATF 16949 standard can be done at any time but is typically used when:
 Customers specify this requirement as part of the contract
 Organizations want to improve their products and customer satisfaction
3.0 RESEARCH METHODOLOGY :
3.1 INTRODUCTION

IATF 16949 emphasizes the development of a process oriented quality management system that
provides for continual improvement, defect prevention and reduction of variation and waste in the
supply chain. The goal is to meet customer requirements efficiently and effectively.

IATF 16949:2016 (replaces ISO/TS 16949:2009) is a standard that establishes the requirements
for a Quality Management System (QMS), specifically for the automotive sector. The ISO/TS
16949 was originally created in 1999 to harmonize different assessment and certification
schemes worldwide in the supply chain for the automotive sector.

3.2 OBJECTIVE OF PROJECT

IATF 16949 emphasizes the development of a process oriented quality management

system that provides for continual improvement, defect prevention and reduction of
variation and waste in the supply chain. The goal is to meet customer requirements
efficiently and effectively

3.3 RESEARCH DESIGN AND METHODOLOGY:

IATF 16949

One of the automotive industry’s most widely used international standards for quality
management, ISO/TS 16949, has evolved with the publication of a new global industry
standard called as Automotive Quality Management System Standard – IATF 16949. On
October 3rd, 2016 IATF 16949:2016 was published by the IATF and supersedes and
replaces the current ISO/TS 16949

Home Management Systems IATF 16949

This Automotive QMS along with applicable automotive customer – specific

requirements, ISO

9001: 2015 requirements, and ISO 9000:2015 defines the fundamental quality
management system Requirements for automotive production and relevant service parts
organizations.

The Goal of this Automotive QMS Standard is the development of a quality management
system that provides for continual improvement, emphasizing defect prevention and the
reduction of variation and waste in the supply chainThe potential benefits for an
organization implementing this Automotive QMS are consistently meeting product,
services, customer requirements & meeting applicable statutory and regulatory
requirements.

Improved operational processes and greater efficiency

enhancing opportunities for customer satisfaction

Mitigate risk and improve opportunity management with a greater application of risk-
based thinking

Increase involvement of your leadership team

enriching quality and continual improvement to the heart of the organization.

This Automotive QMS employs the process approach, which incorporates the Plan-Do-
Check-Act

(PDCA) cycle and risk-based thinking. The PDCA cycle enables an organization to
ensure that its processes are adequately resourced and managed, and that opportunities
for improvement are determined and acted on.

Why IATF is required?

Obtaining the IATF 16949 certification demonstrates that the organisation has met the
Automotive QMS requirements to create a process of continual improvements with an
emphasis on defect prevention and reduction of variation and waste in the supply chain.

Who can Implement IATF?

This Automotive QMS is applicable to all sites of an Organisation where customer-

specified production parts, service parts, or accessory parts are manufactured throughout
the automotive supply chain.

IATF 16949:2016 Automotive Quality Management System

IATF 16949:2016 is the global technical specification and quality management standard
for the automotive industry. Based on ISO 9001:2015, it was published in October 2016
and replaces ISO/TS 16949. It is designed to be used in conjunction with ISO 9001:2015
and contains supplemental requirements specific to the automotive industry rather than
being a standalone QMS. It specifies the requirements for establishing, implementing,
maintaining and continually improving a QMS for any organization, in the automotive
industry regardless of size. It brings together standards from across Europe and the US.
IATF 16949:2016 outlines everything you need to know about achieving best practice
when designing, developing, manufacturing, installing or servicing automotive products.
ISO/TS 16949 from 2009, a technical specification for automotive sector quality
management systems, has become one of the most widely used international standards in
the automotive industry, harmonizing the different assessment and certification systems
in the global automotive supply chain. On October 3, 2016, IATF 16949:2016 was
published by the IATF and therefore supersedes and replaces the current ISO/TS
16949:2009, defining the requirements of a Quality Management System for
organizations in the automotive industry. This means that organizations in the
automotive industry seeking IATF 16969 certification must also comply with ISO
9001:2015. QMS, is a collection of policies, processes, documented procedures, and
records. This collection of documentation defines the set of internal rules that will govern
how your company creates and delivers your product or service to your customers. The
QMS must be tailored to the needs of your company and the product or service you
provide, but the IATF 16949 standard provides a set of guidelines to help make sure that
you do not miss any crucial elements that a QMS needs to be successful. It is intended to
be used by organizations of any size or industry, and can be used by any company. As an
international standard, it is recognized as the basis for any company to create a system to
ensure customer satisfaction and improvement, and as such, many companies demand
this as the minimum requirement for an organization to be a supplier. The goal of the
standard is the development of a QMS that:

Provides for continual improvement

Emphasizes defect prevention

Includes specific requirements and tools from the automotive industry

Promotes the reduction of variation and waste in the supply chain

Changes from ISO/TS 16949:2009 to IATF 16949:2016

The new standard is based on Annex SL – the new high level structure. This is a common
framework for all ISO management systems. This helps to keep consistency, align
different management system standards, offer matching sub-clauses against the top level
structure and apply common language across all standards. It will be easier for
organizations to incorporate their QMS into core business processes and get more
involvement from senior management. IATF 16949 requires complete conformance to all
ISO 9001:2015 requirements and identifies the supplemental automotive management
system requirements (which are extensive). The majority of these supplemental
requirements are carry-over from ISO/TS 16949:2009
Highlights of the changes include the following:

High level structure: The new standard is based on Annex SL – the new high level
structure. This is a common framework for all ISO management systems. This helps to
keep consistency, align different management system standards, offer matching sub-
clauses against the top level structure and apply common language across all standards. It
will be easier for organizations to incorporate their QMS into core business processes and
get more involvement from senior management. The Plan-Do-Check-Act (PDCA) cycle
can be applied to all processes and to the quality management system as a whole. ISO
9001 embraces a new structure by switching from eight clauses to ten clauses in the 2015
revision. This change allows the standard to better align with business strategic direction,
become more compatible with other management system standards, and incorporate the
Plan-Do-Check-Act approach, as shown below. Unlike ISO/TS 16949 and some other
industry-specific standards, IATF 16949 does not contain the ISO 9001:2015 text. The
document contains only the automotive-specific additional requirements; however, the
organization is still required to comply with ISO 9001:2015. IATF 16949 clarifies that it
is a supplement to be used in conjunction with ISO 9001:2015. IATF 16949 shares the
same general section headings and clause structure as ISO 9001:2015, without reciting
the text. This ensures all IATF 16949 requirements are fully aligned with the ISO
9001:2015 high level structure. An organization is not required to reflect the new ten-
clause structure and terminology in the documentation of their organization’s quality
management system. The purpose of the new structure is to provide a clear presentation
of the requirements; it is not to intended to be a model for documenting an organization’s
policies, objectives and processes.

New Terms

RISK-BASED THINKING

Risk mitigation takes center stage in IATF 16949, as it does in ISO 9001:2015. IATF
16949 adds a number of specific risk-related requirements to minimize the likelihood of
failure during new program development and to maximize the potential realization of
planned activities. These additions are the result of industry best practices intended to
make businesses safer and more stable by identifying and mitigating risk. To ensure risk-
based thinking is pervasive throughout the organization, top management needs to be
actively engaged. Responsibilities include:

Conducting contingency planning reviews

Identifying and supporting of process owners

Participating in the escalation process related to product safety

Ensuring achievement of customer performance targets and quality objectives

Implementing corporate responsibility initiatives including an anti-bribery policy, an

employee code of conduct, and an ethics escalation policy (“whistle-blowing policy”)

IATF 16949 requires that “organizations shall ensure conformance of all products and
processes, including service parts and those that are outsourced.” This use of the word
“ensure” implies that the organization needs to establish and maintain a system that
mitigates the risk of nonconformance throughout the supply chain. The organization is
ultimately responsible for all conformity and must cascade all applicable requirements
down the supply chain to the point of manufacture. The standard reinforces the concept
of a “multidisciplinary approach” throughout the product lifecycle, and particularly
during design and development planning activities. IATF 16949 adds additional controls
for the management of development projects throughout the cycle, which eventually
concludes with a product approval process. As well, the automotive standard adds a large
number of requirements to specifically address the development of manufacturing
processes. Manufacturing processes may have the same output requirements as those
specified for the product; however, customers often require the use of specific
Automotive Core Tools, such as capturing and analyzing risk via a PFMEA. These sorts
of considerations are included in IATF 16949 in an attempt to mitigate risk even before
manufacturing the product or installing machinery. Survival in the automotive industry
requires continuous change to address internal and external issues. Organizations need to
adopt a process to assess the risk of changes and take appropriate action. IATF 16949
requirements to manage changes include:

Assessing manufacturing feasibility for changes to existing operations.

Evaluating design changes after initial product approval.

Reviewing control plans for changes affecting product, manufacturing process,

measurement, logistics, supply sources, production volume changes, or risk analysis.

Controlling and reacting to changes that impact product realization, including changes
caused by the organization, the customer, or any supplier. This includes both permanent
and temporary changes.

Adjusting the frequency of internal audits based on occurrence of process changes.

Other sources of risk, such as how to deal with nonconforming outputs, are covered in
more detail to ensure suppliers are aligned with their customers.
INTEGRATION OF CUSTOMER-SPECIFIC REQUIREMENTS

IATF 16949 integrates many common industry practices previously found in customer-
specific requirements. Integrating these common practices as requirements encourages
commonality throughout the industry and aims to reduce the need for extensive customer-
specific requirements in these areas. Also important is the clear distinction between
customer requirements and customer-specific requirements (CSRs). In IATF 16949, these
two terms are defined as follows:

Customer Requirements: All requirements specified by the customer (e.g., technical,

commercial, product and manufacturing process-related requirements, general terms and
conditions, customer-specific requirements, etc.)

Customer-Specific Requirements: Interpretations of or supplemental requirements linked

to a specific clause(s) of this Automotive QMS Standard.

The new standard more clearly defines these two terms to reduce misunderstandings, and
to facilitate the sampling of customer-specific quality management system requirements
for effective implementation. For example, the organization needs to review and agree
with customer requirements such as packaging manuals and manufacturing process
guidelines. However, for customer-specific requirements, organizations need to review
and agree after considering the impact on their entire QMS. Here are some examples of
areas that were previously customer-specific requirements that are now included in more
detail in IATF 16949:

Manufacturing feasibility

Warranty management

Temporary change of process controls

Supplier quality management system development

Second-party audits

Control plan

Problem-solving methodologies

Control of changes

Total productive maintenance

Standardized work

FIRST AND SECOND PARTY AUDITOR COMPETENCY

IATF 16949 adds additional requirements for both first and second-party auditors, which
include:

Organizations shall have a documented process to verify internal auditor competency.

When training internal auditors, documented information shall be retained to demonstrate

trainer’s competency with the additional requirements.

Organizations shall demonstrate the competency of second-party auditors, and second-

party auditors shall meet customer-specific requirements for auditor qualification.

This standard also outlines the minimum competencies for auditors, which include:

Automotive process approach for auditing, including risk-based thinking

Applicable core tools requirements

Applicable customer-specific requirements

Software development assessment methodologies, if applicable

These changes may require a competence gap analysis followed by additional auditor
training and development activities.

PRODUCT SAFETY

Product safety is an entirely new section in the IATF standard, and a transitioning
organization must have documented processes for the management of product-safety
related products and manufacturing processes. New requirements related to product
safety include, where applicable:

Special approval of control plans and FMEAs

Training identified by the organization or customer for personnel involved in product-

safety related products and associated manufacturing processes

Transfer of requirements with regard to product safety throughout the supply chain,
including customer-designated sources
This clause highlights the fact that a product should perform to its designed or intended
purpose without causing unacceptable harm or damage. Organizations must have
processes in place to ensure product safety throughout the entire product lifecycle.

MANUFACTURING FEASIBILITY

In the new standard, an organization is required to assess if they are capable of achieving
the performance and timing targets specified by the customer, otherwise known as
manufacturing feasibility. While ISO/TS 16949 did require this kind of manufacturing
feasibility analysis, it did not impose specific requirements. The new standard’s specific
requirements include:

Using a multidisciplinary approach

Performing the analysis for any new manufacturing or product technology and for any
changed manufacturing process or product design

Validating their ability to make product specifications at the required rate through
production runs, benchmarking studies or other appropriate methods

1.0 Purpose

1.1 To establish and maintain a uniform method of controlling the

production process.

2.0 Scope

2.1 This Quality system procedure applies to manufacturing activities for

all the items manufacturing at MFL Kuruli

3.0 References.
3.1 IATF 16949 :2016

1. Process Flow Chart

2. Control Plan
3. Die Setting Work Instruction
4. Operation Work Instructions
5. Hot Inspection Plan

4.0 Definitions / Abbreviations.

4.1 See Quality System Manual

5.0 Responsibilities.

5.1 Production In-Charge

5.1.1 To prepare, review, update and monitor this process.

5.2 Top Management

5.2.1 To approve and distribute this process.

6.0 Procedure

6.1 Product Realization Planning

6.1.1 Production In-Charge ensures the availability of all quality documents

6.1.2 All quality documents shall identify and easily accessible for the shift
people

6.1.2 Production In-Charge identifies the resources required to execute the

job including material, machines, tools, processes and skill of
manpower.

6.1.3 QC In-Charge ensures availability of Control Plan / work instructions

to identify the process details and parameters to be checked during
the process and any measuring and monitoring devices to be used.

6.1.4 Material Quality In-Charge identifies the special processes, prepare,

review and approve the special process details, qualifies the same
and trains the operators.

6.2 Production Planning / Scheduling

6.2.1 Marketing In-charge prepares the dispatch schedule based on

customer’s requirement.

6.2.2 Production In-Charge prepares the Monthly Production Plan based

on customer monthly dispatch schedule, Work In-Process.
6.2.3 Production In-charge works out the Raw material requirement and
issues to purchase.

6.2.4 Production issues the Work Order to cutting section based on

Monthly Production Plan.

6.2.5 Cutting section refers the Work Order to Laboratory, Which identifies
the correct material, tests, issues the heat code records the details in
Material release note and informs cutting section.

6.2.6 Cutting section cuts the material, identifies by heat code and issues
to production along with Cut Blank Issue note.

6.2.7 Operation planning / Machine loading and actual production is

recorded on daily basis in Daily Production Log Book.
6.2.8 Production In-Charge prepares the production schedule break-up
date-wise and the actual production quantities are recorded.

6.2.9 Tool room issues the die after die inspection for use as per
production requirements on Die Release Note.

6.2.10 Press Shop ensures that dies are set as per work instruction & set up
verification is carried out by Quality Control Department through 1st
piece inspection report

6.2.11 Press Shop ensures that production is carried out as per details given
in the work instruction for production for that particular component

6.2.12 Hot Inspection Supervisors inspects the job as per frequency &
methods detailed in Hot Inspection Plan & reports are generated.
6.2.13 Press Shop ensures that timely corrective action is initiated on non-
conformities reported during production & Quality Control
Supervisors verifies the result

6.2.14 Production In-Charge monitors the production Status at every

manufacturing stage including rejections if any at end of the day
through Daily Inspection Shift Report and QC In-Charge records the
Non-Conformance, it’s reasons and rectification actions in the same.

6.2.15 In case if any deviation during production stage it has to be

approved by Plant Head

6.2.16 After production, production department ensures proper storage of

forging in bin with proper identification tag.

6.3 Quality Planning

6.3.1 Production In-Charge / MDT decide the manufacturing sequence of

the job and prepare the process flow chart.

6.3.2 QA In-Charge / MDT prepares the following quality documents

 Raw Material (Technical Data Sheet) Acceptance Standard.

 Process Flow Chart & Process Failure Mode and Effect analysis.
 Control Plan.
 Work Instructions.
 These quality documents details the process and product parameters
to be checked during the process and any measuring and monitoring
devices to be used.

6.3.3 Control Plan shall include

 Details of manufacturing process control.

 Methods for monitoring controls exercised over special
characteristics.
 Customer specific requirements if any.
 Reaction plans in case results are not consistently satisfactory.

6.4 Resource Identification

6.4.1 Production In-Charge identifies the resources required to execute the

job including material, machines, tools, processes and skill of
manpower.

6.4.2 Production In-Charge in consultation with Plant Head

Organizes the additional resources required like Material, Machines,
Manpower or Subcontractors.

6.4.3 QA In-Charge shall identify the monitoring and measuring devices

and ensures its availability.

6.4.4 QA In-Charge shall train the operator or inspection operators to use

monitoring and measuring devices.

6.5 Work / Process Instructions

6.5.1 The Control Plans and necessary Work Instruction like job setting,
safety, Process Related etc. are made available near to the machines
which is accessible to the Operator and Production Supervisors

6.5.2 Production In-Charge shall ensure that activities for Manufacturing

are carried out as specified in relevant Process flow chart, Control
Plan and applicable documented procedure.

6.6 Process Control for Special Characteristics

6.6.1 The Special Characteristics are suitably identified in the Control Plan
and the Operators and Production Supervisors are trained in the
importance of these characteristics, so as to monitor these
Characteristics during production.

6.6.2 Control Plan identifies SPC techniques to be used. Production In-

Charge ensures that Corrective Action and necessary Disposition
Actions are taken as per Reaction Plan referred in Control Plan.

6.6.3 The requirement specified in relevant customer’s specifications,

standards shall be complied, unless otherwise accepted under
concession.

6.7 Verification of Job Set-up

6.7.1 Production In-Charge / QA In-Charge shall carry out the Production

Start-up.

6.7.2 Production In-Charge shall carry out the Die Set-up as per the Work
Instruction for Die setting. After the successful completion of the Die
Setting, QC inspector carry out first piece approval as per the Control
Plan. After 1st piece approval, then only regular production starts.
6.7.2 Production In-Charge / Production Supervisor shall inspect the Last
Part and compare with 1st Part to evaluate the die condition.

6.7.3 Tool Room In-Charge prepares the die pull-out report in consultation
with Production and QA.

7.0 Records.

1. Cutting Inspection Report :

F/CUTT/01-02
2. Ready stock of cut blank : F/CUTT/03
3. Process Set Up Report :F/PROD/07
4. Daily Production Report :F/PRPD /06
5. Cut Blank Issue Slip :F/CUTT/07
6. Hardness log book :
R/MQC/01-02
7. Continuous Hardening/ Normalizing F/C Log Book :
R/MQC/02-02A
8. Continuous Tempering F/C Log Book :
R/MQC/02-02B
9. Microstructure Log Book :
R/MQC/11-01
10. Calibration Record : F/QC/16
11. Heat Treatment Process Qualification : F/MQC/09
14. H.T. Material Release Note : F/MQC/11
15. Daily H.T. Production Report : F/MQC/02
8.0 Work Instructions

List is maintained by respective Departments

PROCESS VALIDATION
UNIT: - 1000 TP - 2 KAF NO. :- 5166
IBH: - 310 KW PART NAME :- CON ROD
STOCK SIZE :- 45 dia CUSTOMEER :- V.S.T PRECISION
COIL SIZE :- 45 DIA MATERIAL SPECIFICATION :- EN9

THICKNESS
TRIAL SR. VISUAL
TEMP.
NO. NO. DEFECT
Reqd Actual

1 10800C 30.80+0.5/-0.0 31.6 U/F

1 2 10800C 30.80+0.5/-0.0 31.6 U/F

3 10800C 30.80+0.5/-0.0 31.6 U/F

1 11000C 30.80+0.5/-0.0 31.2 Max

2 2 11000C 30.80+0.5/-0.0 31.2 Max

3 11000C 30.80+0.5/-0.0 31.2 Max

1 11200C 30.80+0.5/-0.0 31.1 OK

2 11200C 30.80+0.5/-0.0 31.0 OK

3 OK

3 11200C 30.80+0.5/-0.0 30.9

 1 11800C 30.80+0.5/-0.0 31.2 OK

4 2 11800C 30.80+0.5/-0.0 30.9 OK

3 11800C 30.80+0.5/-0.0 30.9 OK

1 12000C 30.80+0.5/-0.0 30.9 OK

5 2 12000C 30.80+0.5/-0.0 30.9 OK

3 12000C 30.80+0.5/-0.0 30.9 OK

1 12200C 30.80+0.5/-0.0 30.2 THK U/S

6 2 12200C 30.80+0.5/-0.0 30.3 THK U/S

3 12200C 30.80+0.5/-0.0 30.3 THK U/S

Conclusion: - During trial thickness & u/f observe ok for temp 11000C to
12000C hence range 11000C to 12000 is accepted.
 CONTEXT OF Doc, No Annexure
ORGANIZATION- -I
INTERESTED PARTIES FOR
Rev. Date 01/05/201
METALYST FORGINGS 9
LIMITED
Rev No. 00
4.Analysis of Data
This includes analysis requirements for performance & effectiveness of the QMS, as well
as the effectiveness of actions taken to address risks and opportunities.

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the quality management system;

d) if planning has been implemented effectively;

e) the effectiveness of actions taken to address risks and opportunities;

f) the performance of external providers;

g) the need for improvements to the quality management system.

The emphasis of the requirement changed from the ISO/TS 16949 standard’s “Analysis
of data” to the prioritization of actions based on performance and risk management.
Actions to improve customer satisfaction need to take precedence as the organization
considers trends and drives towards improvement.

Internal Audit Program

It strengthened the need to drive a risk-based approach to the development and

deployment of an organization-wide internal audit program. Internal audit activities are
considered a process, which requires a clear definition of expected inputs, planned
activities, intended outputs, and monitored performance. The process needs to identify
and evaluate the level of risk related to each QMS process, internal and external
performance trends, and process criticality. Then, the process would need to continuously
monitor this information to trigger special internal audits and/or to plan periodic internal
audits.

Quality management system audit

Strengthen the quality management system audit and the use of the process approach,
which further drives process improvements organization-wide. There is a 3-year window
to audit all of the QMS processes, but the schedule should be based on risk. The audit
program is continuously monitoring information that could trigger the need for an
unplanned internal audit. The use of the automotive process approach, including risk-
based thinking, needs to be applied during the audit. The internal audit must also sample
customer-specific QMS requirements for effective implementation.

Manufacturing process audit

Strengthens the formal approaches to ensure organizations achieve the benefits of

effective manufacturing process audits. Shift handover should be considered a significant
process event; internal auditors should look for objective evidence of an effective process
to communicate and address relevant information. The audit must also evaluate the
effective implementation of the process risk analysis (PFMEA), control plan, and
associated documents.

Product audit

The strengthened product audit requirements now require the use of customer-specified
approaches, when applicable. If not applicable, the organization shall define their
process. There are customers who specify the use of VDA 6.3 for Manufacturing audits.
If not specified by a customer, an internal process must be defined. This could be the
currently defined process based on the IATF2016 Requirements.

1.0 Purpose

1.1 To define and document a procedure for Product safety characteristics.

This procedure also helps in defining the product safety characteristics and it’s
implication on
product performance.

2.0 Scope

2.1 This procedure applies to products manufactured and shipped from METALYST to
its customer. The procedure is used to define the product safety characteristics.

3.0 Inputs / References

3.1 IATF 16949:2016

 4.0 Authorities & Responsibilities

4.1 MDT, HOD Engineering

4.1.1 To prepare, update and adhere this process.

4.2 HOD (QA)
4.2.1 To approve and distribute the Process
5.0 Process
6.0 Records : Nil
Sr.
Activity Flow Output
No. Key Input

1 Statutory & Regulatory Identification by METALYST of statutory Documentation of statutory

Requirements and regulatory product-safety and regulatory product
requirements including customer safety requirements
notification

Identification and controls of safety-

Documentation of special
Customer designated related characteristics of product at the
2 characteristics with special
special characteristics point of manufacture.
symbols/

special approval of control plans and

Documented approval from
process PFMEA
PFMEA & Control Plan customer for PFMEA &
3 Control Plan

Preparation of reaction plan Detailed reaction plan,

Escalation matrix along with
Historical data of field defined responsibilities &
4 failures, accidents , authorities
warranty etc
Sr.
Key Input Activity Flow Output
No.
5 Responsibilities &
Authorities with respect to
release of product/ control
over non-confirming
product
Competency Needs
6 Identification of training needs for
Engineering change
requests
7 & documentation
Externally provided
products & services
8 safety
Lessons learned
9
Prepare escalation matrix Escalation matrix along
with defined
responsibilities &
authorities
Training need identification
& provision of training.
personnel involved in product-safety
related products and associated
manufacturing processes
Approval of changes,
Approval of changes of product or
validation of these changes
process prior to implementation,
including evaluation of potential effects
on product safety from process and
product changes
Communication, Transfer of
Communication to
requirements with regard to product
suppliers on requirements
safety throughout the supply chain
with regard to product
along with traceability requirements
Complies lessons learned for new
Documentation of lessons
product introduction
learned
Benefits of IATF 16949

The benefits of IATF 16949 cannot be overstated; companies large and small have used
this standard to great effect, discovering and securing tremendous cost and efficiency
savings. The new standard will help you to introduce an integrated approach with other
management system standards. It will bring quality and continual improvement into the
heart of the organization. It will increase the involvement of the leadership team. It will
help to mitigate risk and improve opportunity management with a greater application of
risk-based thinking. One of the major changes in IATF 16949:2016 is that it brings
quality management and continual improvement into the heart of an organization. This
means that the new standard is an opportunity for organizations to align their strategic
direction with their quality management system. The starting point of the new version of
the standard is to identify internal and external parties and issues which affect the QMS.
This means that it can be used to help enhance and monitor the performance of an
organization, based on a higher level strategic view. Here are just a few of these benefits:
Improve your image and credibility – When customers see that you are certified by a
recognized certification body, they will understand that you have implemented a system
that is focused on meeting customer requirements and improvement. This improves their
trust that you will deliver what you have promised.

Qualify to supply the automotive industry – This is one of the main drives for
companies to get certified against IATF 16949. In order to get big customers from the
automotive industry, you have to demonstrate that you are able to provide high-quality
products with no defects, and an IATF 16949 certificate will prove it.

Improve customer satisfaction – One of the key principles of the IATF 16949 QMS is
the focus on improving customer satisfaction by identifying and meeting customer
requirements and needs. By improving satisfaction, you improve repeat customer
business.

Fully integrated processes – By using the process approach of IATF 16949, you not
only look at the individual processes in your organization but also at the interactions of
those processes. By doing this, you can more easily find areas for improvement and
resource savings within your organization.

Use evidence-based decision making – Ensuring that you are making decisions based on
good evidence is a key to the success of an IATF 16949 QMS. By ensuring that your
decisions are based on good evidence, you can better target resources to the best effect to
correct problems and improve your organizational efficiency and effectiveness.

Create a culture of continual improvement – With continual improvement as the main

output of the QMS, you can attain ever-increasing gains in savings of time, money, and
other resources. By making this the culture of your company, you can focus your
workforce on improving the processes they are directly responsible for.

Engage your people – Who better than the people working within a process to help find
the best solutions for improving that process? By focusing your workforce on not only
managing but also improving the processes, they will be more engaged in the outcome of
the organization.

Facilitate continual improvement: Regular assessment will ensure you continually use,
monitor and improve your processes

Increase market opportunities so you can demonstrate to customers excellent levels of

safety, reliability and traceability throughout the supply chain. Increase efficiency that
will save you time, money and resources. Ensure compliance with a system supported by
regulatory authorities that helps to mitigate your risks