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Ref. No.

: PI-QM-08
QUALITY MANUAL Rev. No.: 01
Rev. Date: 20.03.2019
OPERATION Page 1 of 22

8.0 OPERATION
8.1 Operational Planning and Control.
Development I/C & Proprietor are responsible for Product development activity as per procedure for
engineering. APQP reflects the structured approach followed for new product development. The
evidence & planning of each activity can be seen through timing plan itself
Product realization activities will be planned for new product or change in existing process. Each activity
defined in APQP timing plan will have activity description, Responsibility and target date defined.
During preparation of new product development Product realization time plan for new parts (APQP
timing Plan),
Development I/C has ensure that determination of as appropriate,
 The process planning and activities are carries as per the APQP Planning Chart and Process chart for
Engineering Activity.
 Quality objectives and requirements for the product and service.
 Need to establish processes, documents and provide product and service specific resources.
 Required verification, validation, monitoring, inspection and test activities specific to product and
service are determined in quality plan and acceptance criteria are also defined and documented.
 Quality Plan, production planning & order review documents provides the evidence of product &
service realisation processes and resulting product and service are met with the requirements.
 as an evidence that new product meets all customer requirements

8.1.1 Operational planning and control - supplemental


Development I/C will ensure that, During development stage, customer requirements & references to its
technical specifications (such as Materials Specifications, Mechanical & Physical Properties specification
sheet, National & International Standards, Pictorials, Microstructure requirements, Dimensions etc.) are
included in the APQP & in the documented system like PFC, PFMEA, Quality plan, stage control plan,
stage control plan work instructions, list etc.
APQP includes
a) Logistics requirements.
b) Customer Review/Feasibility is one of the stages of APQP to capture overall customer requirements.
c) NPD planning
d) Acceptance criteria for the product in the form of control plan /stage wise control plan and wherever
required is approved by the customer.
Development I/C identified the resources for required verification, validation, monitoring,
measurement, inspection and test activities specific to the Products and the criteria for products
acceptance
Control Plan is also one of the stages of APQP, and it addresses customer technical specifications .

8.1.2 Confidentially
Development I/C will ensure that Confidentiality of customer’s drawing, technical specification, product
design & product at the time of new product development, as well during continual production is
maintained. Development I/C will maintain confidentiality by making it as a policy not to hand over the
complete above mentioned design data/ information to one particular supplier & also no technical
information will be provided to any of our customer’s competitor.
The outsourced suppliers are not given any customer drawings or specifications.

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Documented information Reference:


Procedure for APQP
Advance Product Quality Planning timing chart
Process Chart for Engineering

8.2 Requirements for Products and Services


8.2.1 Customer Communication:
In PI, effective arrangements for communication with customers are established in relation to;
a) Production Information – Is provided to customers through website, e-mail facility for interaction,
participation in exhibitions, arranging seminars, to provide information etc.
b) Enquiries, contracts or order handling including changes (Amendments) is done by use of facilities –
like phone, what’s app, e-mail, dealer network etc.
c) Customer feedback, including customer complaints & customer expectation, specific requirements –
are determined through meetings, e-mails, customer satisfaction surveys, Customer audit etc.
d) If any customer property is lost, damaged or otherwise found to be unsuitable for use, the same will
be reported to customer

8.2.1.1 Customer Communication - supplemental


In PI, communication is done in customer specified language & format (computer aided design data,
electronic data exchange) the same is determined during the contract review stage by Development I/C,
i.e., determination of customer specific system requirements.

8.2.2 Determination the requirements for Products and services


Proprietor ensures that all the customer specific Quality Management System requirements are
determined. Procedure for New enquiry handling explain the of new enquiry handling and explains how
product and service requirements are understood and executed.
a) Requirements specified by the customer are collected which also includes requirement for delivery
& post delivery activities.
b) Requirement not stated by the customer, but necessary for specified or intended use, is identified &
has become part of process.
c) Statutory & regulatory requirements related to product and service.
d) Based on the requirement of the products and service, additional requirement of the products and
service will be determined & taken care.

REPEAT ORDER/ EXISTING PRODUCT AND SERVICE REQUIREMENT:


Proprietor receives the customer schedules for repeat order/ existing requirements, the customer
requirement may be verbally communicated or in form of schedule or Purchase Order; will be reviewed.

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8.2.2.1 Determination the requirements for Products and services - supplemental


Proprietor will ensure that customer’s authorization is taken for waiving any of the requirements stated
by the customer. Customer requirements will include recycling, environmental impact, and
characteristics identified as a result of the organization's knowledge of the product and manufacturing
processes.
Customer requirements will include but not be limited to the following:
All applicable government, safety, and environmental regulations related to acquisition, storage,
handling, recycling, elimination, or disposal of material.

8.2.3 Review the requirements for Products and services


8.2.3.1 While review of customer requirements through feasibility study, Proprietor & Development I/C
ensure that
a) Review of requirement for new products and service
b) Review of requirement for repeat/ regular product and service
c) Product and service Requirements are defined.
d) Applicable statutory and regulatory requirements to the Products and services and listed.
c) Contract or order requirement differing from those previously expressed are resolved & the
organization has the ability to meet the defined requirements.
d) Documented Information of the result of the review will maintain as procedure for handling of new
enquiry & regular requirements
Proprietor will ensure that customer’s authorization is taken for waiving any of the requirements stated
by the customer.

8.2.3.1.1 Review of requirements related to the product - Supplemental:


Proprietor will ensure that customer’s authorization is taken for waiving any of the requirements stated
by the customer.

8.2.3.1.2 Customer-Designated Special Characteristics:


Customer representative through CFT approach will document & establish control on customer
designated special characteristics in list of customer specific requirements. If it is not specified by the
customer, Development I/C will designate the product characteristics or process parameter which
affects a product's/ process safety or compliance with regulatory requirements and fit & function. The
same will be reflected in applicable documents list of customer specific requirements, Stage control plan
and will be controlled.

8.2.3.1.3 Organization manufacturing feasibility:


PI will utilize a multidisciplinary approach / cross function team (CFT) to conduct an analysis to
determine if it is feasible that the PI's manufacturing processes are capable of consistently producing
product that meets all of the engineering and capacity requirements specified by the customer.
The PI will conduct this feasibility analysis for any manufacturing or product technology new to the PI
through Team feasibility study and for any changed manufacturing process or product design through
ECN

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

8.2.3.2
Proprietor will maintained the documented information for the Result of the Review of requirement for
repeat/ regular product and service will be done and details are documented in the PO / order
acceptance.
Review of requirement for new product and service will be and details are documented in the Team
feasibility study for new product and Service

8.2.4 Changes to requirements for Products and services


Amendment to a Contract:
a) Proprietor will receive all the amendments to a contract and he will communicate this information
through production planning.
b) Development I/C/ Proprietor will receive all the technical changes & will be taken as per procedure
for change management
c) In case if any of the customers stated requirements are required to be taken waiver, prior customer's
authorization will be taken from concerned customer's function
d) Development I/C / Proprietor will control & react to changes that impact product and services. The
effects of any change, including those changes caused by any supplier, is assessed, verified &
validated to ensure compliance with customer requirements. Changes are validated before
implementation. All process changed will be controlled through “Engineering change Note” [ECN]

8.3 Design & Development of Products and services.


8.3.1 General
The requirements of 8.3 are applicable in terms of manufacturing process design.
In PI, system is established, implemented & maintained to control the design & development of
Products & Services and documented in APQP timing chart for new product and service

8.3.2 Design & Development Planning:


The APQP timing chart will be carried out by Development I/C to determine;
a) The nature, duration and complexity of the design and development activities
b) The design & Development stages
c) The Review, verification, and validation that are appropriate to each stage
d) The responsibilities and authorities for design & development
e) The internal and external resource needs for the design and development of Products & Services
f) The need to control interfaces between persons involved in the design and development process
g) The need for involvement of customers and users in the design and development process;
h) The requirements for subsequent provision of Products and services
i) The level of control expected for the design and development process by customers and other
Relevant interested parties
j) The documented information needed to demonstrate that design and development requirements
have been met.
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PI will manage the interfaces between different groups involved in design & development to ensure
effective communication and clear assignment of responsibility
Planning documented Information will be updated, as the design & development progresses.
8.3.2.1 Design and development planning - supplemental
Development I/C will ensure that design and development planning includes all affected process owner
Within the PI and, as appropriate, its supply chain. Development I/C using CFT approach for following
stages:
a) Project management through APQP timing chart
b) Product and manufacturing process design activities through PFMEA, such as consideration of the
use of alternative designs and manufacturing processes;
c) Development and review of manufacturing process risk analysis through PFMEA, PFC, control Plan &
SOP/WI.
Top Management will ensure that CFT includes the organization's design, manufacturing, engineering,
quality, production, purchasing, supplier, maintenance, and other appropriate functions'

8.3.2.2 Product design skills


Top management is ensuring that personal with process design responsibilities are competent to
achieve process requirements and are skilled in applicable tools and technique. Required Process design
skills are defined in competency requirements.

8.3.2,3 Development of products with embedded software


Presently not using the any design related software in PI

8.3.3 Design & Development Inputs:


This clause is taken under exclusion.
PI is carrying out Manufacture and supply of Machined metal components and fabricated assembly for
automotive industries as per Customer drawings & specifications only therefore identifying product
requirements is not included in the scope

8.3.3.1 Product design input


This clause is taken under exclusion.
PI is carrying out Manufacture and supply of Machined metal components and fabricated assembly for
automotive industries as per Customer drawings & specifications only therefore identifying product
requirements is not included in the scope.

8.3.3.2 Manufacturing process design input


Any new product development will be carried out with CFT. CFT approach as per the Procedure for
APQP. The development activities will start from the first phase of the procedure, the details of plan;
review & documented information reference are mentioned in the APQP. APQP procedure ensures that:
a) product design output data including special characteristics;
b) targets for productivity, process capability, timing, and cost;
c) manufacturing technology alternatives;
d) customer requirements, if any;
e) experience from previous developments;
f) new materials;

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g) product handling and ergonomic requirements; and


h) Design for manufacturing and design for assembly.
The manufacturing process design will include the use of error-proofing methods to a degree
Appropriate to the magnitude of the problem(s) and commensurate with the risks encountered

8.3.3.3 Special characteristics


Development I/C & Quality I/C identifies special characteristics and include all special characteristics at
the time of new product development and documented in stage control plan Complies with customer-
specified definitions and symbols if any Identifies Work Instructions, stage drawing, Process Flow
Diagrams, FMEAs & Control plan and operator instructions with the customer’s special characteristics
symbol or PI equivalent symbol (<SC>) or notation to include those process steps that affect special
characteristics. Special characteristics details will communicate to customer if required

8.3.4 Design and development controls


Development I/C Monitors the design and development timing plan (APQP timing chart) for each
activity in accordance to the planned arrangement at various phases/ stages to ensure that;
a) Activities are carried out to meet the customer requirements.
b) To identify any problems & propose necessary actions, at the end of each phase/ stage reporting is
done to the Management, & if necessary action plan is derived.
Participants in such reviews include production operator,
Development I/C Verifies outputs in accordance with the planned arrangements to ensure the Design &
development outputs meet the Design & development inputs. Development I/C approve the drawings,
and other design documents. Documented information of the results of reviews, verifies and any
necessary actions will be maintained. As per Control Plan, validation of product is carried out like
Inspection & Testing. Documented information of validation and necessary actions will be maintained.

8.3.4.1 Monitoring.
Regular Reviews & Measurements will be done to ensure that the product meets the customer
requirements & the activities are carried out as defined.
Development I/C Verifies outputs in accordance with the planned arrangements to ensure the Design &
development outputs meet the Design & development inputs. Development I/C approve the drawings,
and other design documents. Documented information of the results of reviews, verifies and any
necessary actions will be maintained. As per Control Plan, validation of product is carried out like
Inspection & Testing, Process Audit. Product audit Documented information of validation and necessary
actions will be maintained.

8.3.4.2 Design and development validation.


The customer requirements specified on the drawing, technical specification sheet etc. are inspected/
validated; the documented information of the same is maintained in Initial Sample Submission report/
dimensional report/ PDI report/ Layout inspection report with PPAP documents.

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In PI the Design & Development Validation will be performed in accordance with customer requirements
such as drawing, technical specification sheet, delivery schedule requirements which are reflected in the
APQP timing Chart.

8.3.4.3 Prototype program:


When required by the customer, Development I/C will prepare a Prototype program & control plan. In
such cases will use, wherever possible, the same suppliers, tooling’s & manufacturing processes as will
be used in production.
All the performance testing such as special process validation, etc., will be monitored for timely
completion & conformity to requirements.
Whenever chooses to outsource any of the process, necessary controls & the whole responsibility will
be taken by Development I/C including technical leadership.

8.3.4.5 Product approval process:


Development I/C & Quality I/C will confirm with the customer's engineering function, its Manufacturing
Process Approval Procedure at the time of contract review itself. The Production Part Approval Process
will be carried out with reference to the contract review check sheet, as per the procedure for PPAP. This
product and manufacturing process approval procedure shall also be applicable to suppliers and supplier
PPAP will be maintained by development dept.

8.3.5 Design & Development Outputs:


Development I/C formulates the design outputs in form of product drawing /part drawing, process flow
chart, work order, job card and control plan. Development I/C ensures that these outputs meets the
design & development input and will be approved prior to release.
Design & development outputs will be;
a) Provide information for purchasing (job card, bill of materials), production (process drawings,
instructions) and service provision (user manual).
b) Test plans, quality Plans, Control plans, SOP/WI
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance
criteria
d) specify the characteristics of the products and services that are essential for their intended purpose
and their safe and proper provision.

8.3.5.1 Design and development outputs - supplemental


Product design provided by customer in the form of drawings & technical specifications. PI is carrying
out manufacturing of Manufacture and supply of Machined metal components and fabricated
assembly for automotive industries as per Customer specifications only.

8.3.5.2 Manufacturing process design output


In PI Manufacturing Process Design output is in a form that can be verified against manufacturing
process design input requirements and are validated the manufacturing Process design outputs are;
a) specifications and drawings;

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b) special characteristics for product and manufacturing process;


c) identification of process input variables that impact characteristics;
d) tooling and equipment for production and control, including capability studies of equipment and
process(es);
e) manufacturing process flow charts/layout, including linkage of product, process, and tooling;
capacity analysis
f) manufacturing process FMEA
g) maintenance plans and instructions
h) control plan
i) standard work and work instructions
j) process approval acceptance criteria
k) data for quality, reliability, maintainability, and measurability;
l) results of error-proofing identification and verification, as appropriate;
m) Methods of rapid detection, feedback, and correction of product manufacturing process Non-
conformities.

8.3.6 Control of Design & Development changes.


Development I/C & Quality I/C will ensure that changes are identified & documented information
maintained as per procedure for change management. The changes will be reviewed, verified, &
validated as appropriate & approved before implementation. The review of Design & Development
changes will include evaluation of the effect of the changes on constituent frames & frames already
delivered.
Documented information’s of the results of review of the changes & any necessary actions will be
maintained in the ECN & management review report.
Any changes in Products & Services requirements Risk analysis will be reviewed for mitigations
plan/action plan.

8.3.6.1 Design and Development Changes - Supplemental


The PI will evaluate all design changes after initial product approval, including those proposed
by the organization or its suppliers, for potential impact on iit, form, function, performance, and/or
durability. These changes will validated against customer requirements and approved internally,
prior to production implementation through ECN.
lf required by the customer, the organization shall obtain ECN/documented approval, or a documented
waiver, from the customer prior to production implementation.

Documented Information Reference:


APQP Procedure
PPAP Procedure
Procedure for control of Change Management

8.4 Control of Externally provided processes, Products and services.


8.4.1 General

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Purchase manager has ensuring that purchased products conform to the specified purchase
requirements and purchasing activity is carried out as per procedure flow chart for purchasing process
Procedure for supplier selection, evaluation & re-evaluation is explains the detailed criteria for selection,
evaluating & re-evaluation of supplier. Refer Procedure for supplier selection, evaluation & re-
evaluation.
Suppliers are categorized A, B, C, D such as A-Critical, B-Major, C-Consumable, D-Accessories supplier
(Maintain more than 3 supplier for each material in each category).
List of approved suppliers explains the control exercised on each supplier, basis for type & extent of
control, needs & expectations are, the nature of manufacturing carried out by supplier & the further
operation that could be carried out in PI. Based on the performance of the supplier over a period of
time, flexibility will be given in control. Maintain the documented information for Black listed/D-Listed
supplier in NC register.

8.4.1.1 General - supplemental


The PI will include all products and services that affect customer requirements such as subassembly,
sequencing, sorting, rework, and calibration services in the scope of their definition of externally
provided products, processes, and services.

8.4. 1.2 Supplier Selection process


The PI will have a documented Procedure for supplier selection, evaluation & re-evaluation. The
Procedure for supplier selection, evaluation & re-evaluation selection process will include:
a) an assessment of the selected supplier's risk to product conformity and uninterrupted supply of
b) the PI's product to their customers;
c) relevant quality and delivery performance:
d) an evaluation of the supplier's quality management system;
e) multidisciplinary decision making; and
f) An assessment of software development capabilities, if applicable.

Other supplier selection criteria that should be considered include the following:
 volume of automotive business (absolute and as a percentage of total business);
 financial stability;
 purchased product, material, or service complexity;
 required technology (product or process);
 adequacy of available resources
 design and development capabilities (including project management);
 manufacturing capability;
 change management process;
 business continuity planning (disaster preparedness, contingency planning);
 logistics process;
 Customer service.
8.4.1.3 Customer-directed sources
When specified by the customer, the PI will purchase products, materials, or services from
Customer-directed sources. All customer approved supplier evaluated as per process chart for supplier
evaluation & re-evaluation

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8.4.2 Type and Extent of control.


List of approved suppliers explains the control exercised on each supplier, basis for type & extent of
control are, the nature of manufacturing carried out by supplier & the further operation that could be
carried out in PI. Based on the performance of the supplier over a period of time, Based on the flexibility
will be given in control.
Incoming raw material inspection will be done as per incoming quality for raw materials & outsourced
process & Documented Information are maintained.
Whenever PI or its customer intends to perform verification at the supplier’s premises, Quality I/C will
state the intended verification arrangements & method of product release in the Purchase
Communication.
Supplier Monitoring: Supplier effectiveness performance will be monitored by Purchase I/C, through
following indicators;
 Delivered Product quality.
 Delivery schedule performance
Documented information maintained in Purchase Register and Supplier Performance Rating

8.4.2.1 Type and extent of control - supplemental


The Purchase I/C will have a documented process to identify outsourced processes and to select the
Types and extent of controls used to verify conformity of externally provided products, processes, and
services to internal (organizational) and external customer requirements & Documented in list of
approved supplier
The Procedure for supplier selection, evaluation & re-evaluation selection process will include the
criteria and actions to escalate or reduce the types and extent of controls and development activities
based on supplier performance and assessment of product, material, or service risks.

8.4.2.2 Statutory and regulatory requirements


The Purchase I/C ensure that purchased products, processes, and services conform to the current
applicable statutory and regulatory requirements in the country of receipt, the country of shipment, and
the customer-identified country of destination, if provided. lf the customer defines special controls for
certain products with statutory and regulatory requirements, the Purchase I/C will ensure they are
implemented and maintained as defined, including at suppliers.
8.4.2.3 Supplier quality management system development
The Purchase I/C ensure the suppliers of automotive products and services to develop, implement, and
improve a quality management system certified to ISO 9001, unless otherwise authorized by the
customer, with the ultimate objective of becoming certified to this Automotive QMS Standard. Unless
otherwise specified by the customer, the following sequence should be applied to achieve this
requirement:
a) compliance to ISO 9001 through second-party audits;
b) certification to ISO 9001 through third-party audits; unless otherwise specified by the customer,
suppliers to the organization shall demonstrate conformity to ISO 900'1 by maintaining a third
party certification issued by a certification body, certification to ISO 9001 with compliance to other
customer-defined QMS requirements through supplier process audits by qualified auditor;
Purchase I/C ensure that ISO 9001:2015 or IATF 16949:2016 certificate validity by collection of
certification

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8.4.2.3.1 Automotive product-related software or automotive products with embedded


software
Not applicable due no software used for outsource.

8.4-2.4 Supplier monitoring


Supplier performance will be monitored by Purchase I/C, through following indicators;
a) Delivered product conformity to requirements.
b) Customer disruptions at the receiving plant, including yard holds and stop ships
c) Delivery schedule performance;
d) Number of occurrences of premium freight.
e) Special status customer notifications related to quality or delivery issues
f) Dealer returns, warranty, field actions, and recalls.
Purchase I/C will carry out Supplier’s monitoring of their manufacturing processes; status will be
documented in supplier end performance report and reviewed in MRM.

8.4.2.4, 1 Second- party audits


The PI will conduct the supplier QMS / Process audit frequently as per plan and Audit check include
following:
a) Supplier risk assessment;
b) Supplier monitoring;
c) Supplier QMS development:
d) product audits:
e) Process audits.
Based on a risk analysis, including product safety/regulatory requirements, performance of the supplier,
and QMS certification level, at a minimum, the organization shall document the criteria for determining
the need, type, frequency, and scope of second-party audits.
The Quality I/C retain the documented information of the second-party audit reports.
lf the scope of the second-party audit is to assess the supplier's quality management system, then the
approach shall be consistent with the automotive process approach.

8.4.2.5 Supplier development


The Purchase I/C will determine the priority, type, extent, and timing actions for of required supplier
development its active suppliers. Determination inputs will include but are not limited to the following:
a) performance issues identified through supplier monitoring
b) second-party audit findings
c) third-party quality management system certification status;
d) Risk analysis.
The Purchase I/C will implement actions necessary to resolve open (unsatisfactory) performance issues
and pursue opportunities for continual improvement.

8.4.3 Information for external providers


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Planning of Purchasing is done based on the customer requirements and schedule by Purchase I/C, if
required. Outsourcing planning is done based on the customer requirements and schedules, if required.
PO / Verbal is the mode of communicating Purchasing information; however product details, type
of process & schedule is communicated through PO or verbal/email/ written schedule.
Purchasing information includes as appropriate
a) Requirements for approval of product and service, procedures, processes and equipment,
b) Requirements for competence , qualification of personnel, and
c) Quality management system requirements.
d) Applicable statutory and regulatory requirements.
e) Inspection / Verification method of PI or customer requirements.
Purchase I/C ensures the adequacy of specified purchase requirements prior to their communication to
the supplier.
8.4.3.1 Information for external providers - supplemental
The Purchase I/C will pass down all applicable statutory and regulatory requirements and special
product and process characteristics to their suppliers and require the suppliers cascade all applicable
requirements down the supply chain to the point of manufacture'
Documented information Reference:
 Procedure for Supplier evaluation & re-evaluation
 Incoming Quality Plan
 Supplier QMS Audit Plan
 Supplier QMS Audit Report.
 Supplier end performance report

8.5 Production and service provision


8.5.1 Control of production and service provision
Production I/C have established system to plan and carry out a production and service provision under
controlled conditions. Based on the customer schedules the manufacturing activities are planned.
All the production and service provision activities are carried out as per the respective Process Flow
chart for STEEL SHEETS Components
a) Part/ Process parameter chart, Work Instructions, SOP, Control plan, Drawings are made available at
the point of use that describes the characteristics of the product and service.
b) Work Instruction is displayed wherever required.
c) Suitable equipment is in use.
d) Suitable working environment & Infrastructure like Machinery, Equipments, Measuring and
monitoring devices are made available.
e) ensure that actions are implemented to prevent the human error.
f) the appointment of competent persons, including any required qualification;
g) Implementation of measurement and monitoring.
h) And implementation of release, delivery and post delivery activities.

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i) Validation and periodic re-validation of Curing (heating) processes & painting process for production
and service provision. Validation will be done to demonstrate the ability of these processes to
achieve planned results.

8.5.1.1 Control plan


Control Plan is prepared for Pre launch and Production stage by Development I/C & Quality I/C. Control
Plan is prepared as per guidelines given in annexure A of IATF16949: 2016. The PI will have a control
plan. for prelaunch and production that shows linkage and incorporates information from the design risk
analysis if provided by the customer, process flow diagram, and manufacturing process risk analysis
outputs such as FMEA.

Control Plans include;


a) List the controls used for manufacturing process control
b) controls used for the manufacturing process control, including verification of job set-ups
c) first off/last-off part validation, as applicable;
d) Include methods for monitoring of control exercised over special characteristics defined by both PI
and the customer
e) Include customer-required information, if any
f) Initiate the specified reaction plan when the process becomes unstable or not statistically capable
g) methods for monitoring of control exercised over special characteristics (see Annex A) defined by
both the customer an PI
h) the customer-required information, if any
i) Specified reaction plan, when nonconforming product is detected, the process becomes statistically
unstable or not statistically capable.
Development I/C & Quality I/C will review the control plans, and update as required, for any of the
following:
a) nonconforming product shipped to the customer
b) when any change occurs affecting product, manufacturing process, measurement, logistics,
supply sources, production volume changes, or risk analysis
c) after a customer complaint and implementation of the associated corrective action, when
applicable
d) at a set frequency based on a risk analysis.
Development I/C will obtain customer approval after review or revision of the control plan, if required
by the customer.

8.5.1 .2 Standardized work - operator instructions and visual standards


The Production I/C will ensure that SOP documents are:
a) communicated to and understood by the employees who are responsible for performing the work
b) legible
c) presented in the language(s) understood by the personnel responsible to follow them;
d) Accessible for use at the designated work area(s).
The SOP documents will also include rules for operator safety

8.5.1.3 Verification of job set-ups


Production I/C & Quality I/C will
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a) Carry out job set up when the new product developed /Initial run of a job , Job changed/new set up
made, materials changed and first samples are taken, it is treated as the set up.
b) During set-up approval process and product characteristics will be checked and documented
information maintained in set up approval report
c) use statistical methods of verification, where applicable
d) perform first off/last off part validation, as applicable; where appropriate, first-off parts should be
retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for
comparison with first off parts in subsequent runs;

Quality I/C will verify the samples from the same. If any discrepancy, the appropriate action will be
taken. Job set up instructions are made available in SOP. Production I/C Job set-ups are carried out as
per work instructions established in SOP.

8.5.1.4 Verification after shutdown


The Production I/C define and implement the necessary actions to ensure product compliance with
requirements after a planned or unplanned production shutdown period

8.5.1.5 Total productive maintenance


The Production I/C develop, implement, and maintain a documented total productive maintenance
system.
At a minimum, the system will include the following:
a) Identification of process equipment necessary to produce conforming product at the required
volume.
b) availability of replacement parts for the equipment identified
c) provision of resource for machine, equipment, and facility maintenance
d) packaging and preservation of equipment, tooling, and gauging
e) applicable customer-specific requirements
f) Preventive Maintenance compliance metrics. Performance to the maintenance objectives will form
an input into management review, documented maintenance objectives, for example: OEE (Overall
Equipment Effectiveness)' MTBF (Mean Time Between Failure), and MTTR (Mean Time To Repair)
g) Regular review maintenance plan and objectives and a documented action plan to address
corrective actions where objectives are not achieved
h) use of preventive maintenance methods
i) use of predictive maintenance methods, as applicable
j) Periodic overhaul.

8.5.1.6 Management of production tooling and manufacturing, test, inspection


Tooling and equipment
Toolings are managed by production dept as per “Tool room process chart. The procedure explains the
system:-
a) For Tools/Die maintenance of Repair facility and personnel
b) For storage and recovery set up
c) For Tools/Die change programmers for perishable tools
d) For Tools/Die design modification documentation, including engineering change level
e) For Tools/Die modification and revision of documentation
f) For Tools/Die identification, defining the status, such as production, repair or disposal
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g) The Development will implement a system to monitor these activities if any work is outsourced.

Customer-owned Mould, manufacturing, test, inspection tooling and equipment will be permanently
marked so that the ownership of each item is visible, and can be determined. All the customer owned
tooling has been permanently marked with ownership mark such as number plate/part no. Verified,
protected & safeguarded. If any customer property is lost, damaged or otherwise found to be unsuitable
for use, the same will be reported to customer & documented information maintained.
The Development I/C implement a system to monitor these activities if any work is outsourced.

8.5.1.7 Production scheduling


Production Planning is made by Production I/C on receipt of Customer Schedule in order to meet
customer requirements, so as to make timely deliveries as per customer demands such as Just-ln-Time
(JlT). & system is developed to give production information at key stages such as raw material stock,
Semi-finished stock, stock at final inspection & ready for dispatch stock.
The Production I/C include relevant planning information during production scheduling, e.g., customer
orders, supplier on time delivery performance, capacity, shared loading (multi-part station), lead time,
inventory level, preventive maintenance, and calibration.

8.5.2 Identification and traceability


Products status is identified as per the following;
Identify the Component by using Red Color Marker - if rejection,
Mention details on Component by using Blue color / black marker - if rework,
OK mark by using job card display on the job - After Inspection
The Raw Materials, Consumables, Packing Materials and Finished Goods are identified by various
methods such as by Visual Recognition, by Identify the Racks in which the material is stored and Marking
Areas as applicable.
For Traceability product is maintained as per customer requirements, wherever required and also Job
card and component code no are maintained for the production batch.

8.5.2.1 Identification and traceability - supplemental


Production I/C maintain the Job card for traceability and Job card displayed on the part in the
production process stages. Production I/C take component code approval on each Molding of raw
materials and create the job card and component code no addressed on the raw materials bar and job
card.
The Job card defines the appropriate traceability systems, processes, and methods by product, process,
and manufacturing location that:
a) enable the organization to identify nonconforming and/or suspect product;
b) enable the organization to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time requirements;
d) ensure documented information is retained in the Job card that enables the organization to meet
the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer or regulatory
standards
f) ensure the identification and traceability requirements are extended to externally provided
products with safety/regulatory characteristics.

8.5.3 Property belonging to Customers of external providers


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Customer supplied intellectual property such as product specification, Product sample, drawing or
relevant technical literatures or personal data are also treated as customer’s property. In case wherein
customer has provided any property the same will be identified, verified, protected & safeguarded. If
any customer property is lost, damaged or otherwise found to be unsuitable for use, the same will be
reported to customer & documented information of correspondence will be maintained.
Any material received from customer is inspected & verified against the delivery Challan. Customer
property is identified by customer’s name with a tag. The customer property is stored in racks, so as to
avoid damage or deterioration & is maintained so as to ensure availability as & when required for use. In
case of any damage, loss, or unsuitable to use the same will be communicated to the customer &
documented information of the same will be maintained.

8.5.4 Preservation
Conformity of the product is preserved during Internal Processing and Delivery to the intended
destination. Preservation includes identification, handling, storage and protection.
Packaging of the products is done as specified by the customer or as defined by PI, so as to ensure safe
delivery to intended destination.
Storage and Protection of the Product is done by using adequate storage facilities such as, Demarked
Areas. Materials such as, Stainless steel, paints, thinner, sealant, hardware accessories used in the
organization are stored so as to ensure safety from in fire hazards.
Inventory:
The inventory management PI will maintain Minimum Stock level for raw materials and other materials
for production so as to ensure proper inventory turnover time and monthly inventory turnover ratio will
reviewed.

8.5.4.1 Preservation – supplemental


Preservation will include identification, handling, contamination control, storage, Transmission or
transportation, and protection.
Steel sheet component and other products conformity is preserved during internal processing & delivery
in following way;
a) Raw materials on receipt are unloaded in designated areas. During internal processing, Steel sheet
component at each stage is piled/ placed in order. Handling of Steel sheets components and other
products are manual or bins at all stages.
b) Secured storage space, racks will be provided for all items in stores, to prevent damage or
deterioration of product
c) In-charge Stores has periodically checked all the items in store to ensure that they are used, while
they are fit for use. Any disposition action taken by Stores I/C for such material has been
documented.
d) Necessary preservation measures have also is ensured for the materials. Stores I/C have maintained
a list of `Shelf-Life' items and have ensured that the materials are not used beyond the Shelf-Life
period. Stores In-charge shall adopt `First-in-First-out' method for issuing those items

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e) If any Specific requirement of customer for packaging, it will be taken care at the time of dispatch/
storage by dispatch supervisor.
f) Stores In-charge performs the conditional stock verification activity at planned intervals to verify
the condition of the material in stock. First in- First out (FIFO) system is utilized to ensure that stock
rotation takes place. Any obsolete or non-conforming material/ product will be controlled as per
the procedure for Control of NC product.
g) The inventory management PI will maintain Minimum Stock level for raw materials and other
materials for production so as to ensure proper inventory turnover time and monthly inventory
turnover ratio will reviewed in objectives. Store I/C maintain the raw material and child part stock
register & Bin cards to know the stock level at any interval.

8.5.5 Post – delivery activities


PI meets the requirements of post delivery activities associated with Steel sheet component and
services.
PI will considered while defining of the post delivery activities are
a) Statutory and regulatory requirements.
b) the potential undesired consequences associated with its Steel sheet component and services
c) the nature, use and intended lifetime of its STEEL SHEETS component and services
d) customer requirements
e) Customer feedback

8.5.5.1 Feedback of information from service


The PI will ensure that a process for communication of information on service concerns to
manufacturing, material handling, logistics, engineering, and design activities is established,
Implemented, and maintained.
Proprietor ensures that the organization is aware of nonconforming product(s) and material(s) that may
be identified at the customer location or in the field.
Field complaints received by customers are reviewed and then corrective action is taken and
communicates back to Customer as per quality system procedure for corrective action.

8.5.5.2 Service agreement with customer


When there is a service agreement with the customer, the PI will:
a) verify / that the relevant service centers comply with applicable requirements
b) verify the effectiveness of any special purpose tools or measurement equipment
c) Ensure that all service personnel are trained in applicable requirements.

8.5.6 Control Changes


Development I/C will control & react to changes that impact product and services. The effects of any
change, including those changes caused by any supplier, is assessed, verified & validated to ensure
compliance with customer requirements. Changes are validated before implementation. All process
changed will be controlled through “Engineering change Note” [ECN].

8.5.6.1 Control of changes - supplemental


Development I/C & Quality I/C will ensure that changes are identified & documented information
maintained as per procedure for change management. The changes will be reviewed, verified, risk

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analysis & validated as appropriate & approved before implementation. The review of Design &
Development changes will include evaluation of the effect of the changes on constituent products &
products already delivered.
Documented information of the results of validation & review of the changes & any necessary actions
will be maintained in the ECN & management review report.
ECN will maintained for the changes to part design, manufacturing location, or manufacturing process

8.5.6.1.1 Temporary change of process controls


The PI will identify, document, and maintain a list of the process controls, including inspection,
measuring, test, and error-proofing devices, that includes the primary process control and the approved
back-up or alternate methods.
The PI will document the process that manages the use of alternate control methods. The PI will include
in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained
prior to production implementation of the alternate control method.
Before shipping product that was inspected or tested using the alternate method, if required, the
organization shall obtain approval from the customer(s). The PI will maintain and periodically
review a list of approved alternate process control methods that are referenced in the control plan.
Standard work instructions will be available for each alternate process control method. The PI will
review the operation of alternate process controls on a daily basis, at a minimum, to verify
implementation of standard work with the goal to return to the standard process as defined by the
control plan as soon as possible. Example methods include but are not limited to the following:
a) Daily quality focused audits –Process audit
b) Daily leadership meetings.
Restart verification is documented for a defined period based on severity and confirmation that all
features of the error-proofing device or process are effectively reinstated.
The PI will implement traceability of all product produced while any alternate process control
devices or processes are being used (verification and retention of first piece and last piece from
every shift).

8.6 Release of Products and Services.


Product Measurement is carried at different stages as follows;
a) All incoming material/raw materials will be inspected as per incoming quality /control plan/work
instruction by Quality I/C & Store I/C and documented information will be maintained.
b) In process inspection is carried out as per stage control plans/Work instruction and documented
production report, in-process inspection report by production supervisor/Quality Inspector.
c) Final inspection STEEL SHEETS components will be carried as per Stage control plan/quality plan and
documented information will be maintained in PDI report by Quality I/C.
d) Quality I/C ensure that, no STEEL SHEETS components and other products will be delivered, unless it
has undergone all inspection stages as define.
Documented information are maintained at all stages as a evidence of meeting specification. Respective
documented information are approved by personnel, as defined in Work Instruction for responsibility &
authority. No Products & Services will be delivered, unless it has undergone all inspection stages as
defined.

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8.6.l Release of products and services - supplemental


The Quality I/C ensure that the planned arrangements to verify that the product and service
requirements as specified in the Control plan. The Quality I.c will ensure that the planned
arrangements for initial release of products and services encompass product or service approval.
The Quality I/C will ensure that product or service approval is accomplished after changes

8.6.2 Layout inspection and functional testing


Layout Inspection will be carried out for the final product Layout & functional inspection activity will be
carried out as per the Layout inspection plan or as per customer requirements. Quality I/C have planned
the layout inspection activities. Results of the layout inspection will be made available for customer
review as when required. Initial layout inspection report is made for all new development and is a part
of PPAP file Layout inspection is the complete measurement of all product dimensions shown on the
design/ drawings

8.6.3 Appearance items


PI, presently, does not have any item for which it has to meet criteria of appearance.

8.6.4 Verification and acceptance of conformity of externally provided products and Services
Quality I/C inspect the incoming raw materials as per Incoming Inspection control Plan and maintain the
inward inspection report and raw materials or customer approval will take before processing and
maintain the production card throughout the manufacturing process.

8.6.5 Statutory and regulatory conformity


Prior to release of externally provided products into its production flow Purchase I/C will ensure /
confirm and provide the evidence that externally provided processes, products, and services conform to
the latest applicable statutory, regulatory, and other requirements like free from any hazardous effects
to human and environment

8.6.6 Acceptance criteria


Acceptance criteria will be defined by the Development I/C in control plan and, where appropriate or
required, approved by the customer. For attribute data sampling, the acceptance level will be zero
defects

8.7 Control of nonconforming outputs.


8.7.1
Products & Services, which does not conform to requirement are identified & kept in designated areas &
controlled to prevent unintended use or delivery.
Procedure for Control of Non-conforming outputs defines responsibility & Authority for dealing with
non-conforming Components..
Non-conformance at various stages is documented & actions taken, including concessions obtained by
relevant authority.
Re-inspection details will be documented after carrying out rework. When Non-conformance
Components are detected after delivery, or use has started, then quality I/C will take action appropriate
to the effects, or potential effect of the Non-conformance.
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On detection of any Non-conformance, Quality Inspector takes;


a) Any unidentified or suspect status product and service is also treated as NC output.
b) Suitable correction & Documented Information the statuses in Non-conformance register.
c) Decision by authorized person, as defined in “Procedure for control Of N.C. Products & Services
Action to preclude and service its original intended use or application.
d) If non-conformity of a product and service is ascertained only after its delivery or start of use, a
company takes measures corresponding to consequences of the non-conformity or potential
consequences of the non-conformity.
e) Reworked Products & Services are subjected to re-inspection and Documented Information will
maintain.
Non-conformance register at various stages is used to document information all action taken, including
concessions obtained by relevant authority.
At any given time, if the Products & Services are found to be nonconforming or suspect, Quality I/C
treats it initially as Nonconforming output. After investigating the status the product and service is
assigned its actual status.

8.7.1.1 Customer authorization for concession


The Quality I/C will obtain a customer concession or deviation permit prior to further processing
whenever the product or manufacturing process is different from that which is currently approved.
The Quality I/C will obtain customer authorization prior to further processing for "use as is" and rework
dispositions of nonconforming product. lf sub-components are reused in the manufacturing process,
that sub-component reuse shall be clearly communicated to the customer in the concession or deviation
permit through ECN.
The Quality I/C will maintain a ECN of the expiration date or quantity authorized under concession.
The Quality I/C will also ensure compliance with the original or superseding specifications and
requirements when the authorization expires. Material shipped under concession will be properly
identified on each shipping container (this applies equally to purchase product). The Quality I/C will
approve any requests from suppliers before submission to the customer.

8.7.1.2 Control of nonconforming product - customer-specified process


The Quality I/C will comply with applicable customer-specified controls for nonconforming product(s).

8.7.1.3 Control of suspect product


The Quality I/C ensure that product with unidentified or suspect status is classified and controlled as
nonconforming product. And ensure that all appropriate manufacturing personnel receive training for
containment of suspect and nonconforming product.

8.7.1.4 Control of reworked product


The Production I/C & Quality I/C will utilize risk analysis (such as FMEA) methodology to assess risks in
the rework process prior to a decision to rework the product. lf required by the customer, the Quality I/C
obtain approval from the customer prior to commencing rework of the product.

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Reworking will be done as per the instructions provided in the respective stage control plan by skilled /
appropriate personnel to meet the specified requirements. Reworked items will be taken up for re-
inspection. Documented information of reworking carried & re-inspection status will be maintained in
the respective N.C. register.
The Production I/C retain documented information on the disposition of reworked product including
quantity, disposition, disposition date, and applicable traceability information .

8.7.1.5 Control of repaired product


The Production I/C & Quality I/C utilize risk analysis (such as FMEA) methodology to assess risks in the
repair process prior to a decision to repair the product. The Quality I/C obtain approval from the
customer before commencing repair of the product.
Repair work will be done as per the instructions provided in the respective stage control plan by skilled /
appropriate personnel to meet the specified requirements. Repaired items will be taken up for re-
inspection. Documented information of reworking carried & re-inspection status will be maintained in
the respective N.C. register
The Quality I/C obtain a documented customer authorization for concession for the product to be
repaired
The Quality I/C retain documented information on the disposition of reworked product including
quantity, disposition, disposition date, and applicable traceability information .

8.7.1.6 Customer notification


The Quality I/C/ Customer representative will immediately notify the customer(s) in the event that
nonconforming product has been shipped. Initial communication will be followed with detailed
documentation of the event.

8.7.1.7 Nonconforming product disposition


The Quality I/C will 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 Quality I/C/ Development I/C not divert nonconforming product to service or other use without
prior customer approval.

8.7.2 The Quality I/C will retain documented information that


N C Register calls for

a) describes the nonconformity;


b) describes the actions taken;
c) describes any concessions obtained;
d) Identifies the authority deciding the action in respect of the nonconformity.

Documented information Reference:

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 Procedure for Control of Documented Information


 Procedure for control of Nonconforming outputs
 Procedure for change management
 ECN
 N C Register
 Incoming raw materials inspection control plan

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