Filtrum Autocomp Pvt. Ltd.

SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

8.0 OPERATION

8.1 Operation Planning & Control

8.1.1 FAPL has planned & developed

processes required for product Marketing, APQP Product Customer
realization considering following AGM Dev. Procedure Realization PO,
points - Sr. Executive /PPAP file Customer
a. Quality Objectives & Development quality
& CFT
Requirements of Product – & Delivery
Established Quality Objective, rating,
Identified Product Requirements
through CSR & Drg. & prepared No
DSR, Team Feasibility. Customer
b. Processes required via flow complaints
diagram & provided resources
specific to the product – Identified
Process flow through PFD, &
Provided New equipment,
Gauging & Tooling.
c. Requirement of Product
Verification, Validation,
Monitoring, Measurement,
Inspection, Test Status activities &
acceptance criteria –
Identified in FMEA/Control Plan/
Quality plan/RM test plan/ Gauges
calibration Plan.

d. Records needed to provide

evidence that the realization
process & resulting product meets
requirements –
Identified in Inspection reports &
PPAP file.
Note: - This procedure is applicable

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 1 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

for new & changed product

developments.
Non
8.1.2 CONFIDENCIALITY ALL Disclosure
FAPL ensures the confidentiality of HOD.s Agreement
customer contacted products and s
projects under development including ( NDA )
related product information. with
various
customers.

8.2 Requirements for product &

services
8.2.1 Customer communication
& All communication with customer is
8.2.1.1 done by Marketing Dept & CEO. CEO, Procedure Delivery Customer
Marketing for rating , communic
Marketing department communicates Executive contract CQC ation via
customer information to concerned review Register , proper
person as follows. MKT/CS/01, CSR format communic
- Customer satisfaction ation
- Enquiries, contracts including Procedure of channels.
corrective &
changes All other Preventive
- Complaints Depts. action
- Delivery Information
- Handling or controlling FAPLGEN003

customer property
MR/PR/05,
- Establishing contingency plan
Contingen
Marketing department collects the
cy plan
feedback from the concerned person
& communicates back to customer.

Procedure
8.2.2 Determining requirements related of contract
to products & services: review
MKT/CS/01 100 %

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 2 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

FAPL has determined CEO, Customer customer

a) Requirements specified by Marketing P.O. requireme
customer including delivery Executive & nts
& post delivery activities by CFT identified
P.O. verification (contract through
Review) Details of DSR &
volume , Team
b) Requirements not stated by forecast feasibility
the customer (e.g. Volume;
forecast etc) but necessary for
specified or intended use DSR &
and/or planning where known Team
from customer. feasibility.

c) Captures statutory &

regulatory requirements Business
applicable to the products. Plan

d) Any additional requirements

considered additional by the
organization -from business
plan/marketing plan.

8.2.2.1 Determining the requirements for MCO for Disposal

products & services: documentation Records
The requirements related to storage, & FAPL/STR/F-
handling, recycling, elimination or Ex. Stores for 03
disposal of materials is done disposition STR/WI/02
following the procedure which covers STR/WI/06
compliance to government, safety &
environmental regulations

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 3 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

8.2.3 Review of requirements related to

the products & services:

8.2.3.1 Changes to requirements related to CEO, Procedure DSR, Team All orders
products & services: Marketing for Feasibility & reviewed
P.O.
Executive & contract Amendment for prior to
Before accepting any CFT review acceptance
contract/purchase order FAPL
ensures, MKT/CS/01
Email
a) Products requirements are Communication
defined including delivery & for
post-delivery activities. confirmation
b) Contract/order requirements of verbal
differing from those requirements
previously expressed are
resolved.
c) Requirements specified by
FAPL
d) Organizations ability to meet
the defined requirements.

Records of results of contract review

& actions arising from the review
shall be maintained.

8.2.3.1.1 All customer verbal requirements are

confirmed by the organization before
acceptance.
FAPL retains waiver from customer
if required for the products.

8.2.3.1.2 Customer designated special

characteristics:
FAPL conforms to customer
requirements for designation

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 4 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

approval documentation & control of

special characteristics ECN &
Revised
8.2.3.1.3 Organisation Manufacturing PPAP ,
Control
feasibility:
Plan/Work
Is ensured through Team feasibility Instruction
commitment as a part of APQP.
FAPL retains documented
8.2.3.2 information as applicable,
a) On the results of the review
b) On any new requirements for
products & services

Changes to requirements for

8.2.4 products & services :
FAPL ensures the amendment in
documented information confirming
the awareness of relevant persons
about changed requirements
whenever applicable.

8.3 Design & Development of products

& services :
8.3.1 As design & Development activities
are being taken care of by customer,
& FAPL follows Customer Norms.

8.3.1.1 The manufacturing process design

focuses on error prevention rather than
detection.

8.3.2 Design & Development Planning : CFT & Procedure Review

For Determining the stages and Ex. of Design & records at
controls for design and development Marketing Developme various

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 5 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

of processes, FAPL has considered: nt stages

a) The nature, duration and
complexity of the design and FAPLMKT001

development activities (DEV/PR/01)

b)The required process stages,
including applicable design and
development reviews
c) The required design and
development verification and
validation activities
d) The responsibilities and authorities
involved in the design and
development process
e) The internal and external resource
needs for the design and development
of products and 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.
8.3.2.1 Design & Development planning :
CFT approach is followed for,
a) Project management (APQP) Project As above APQP File As per
b) Development & review of Leader time line

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 6 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

manufacturing process risk

analysis (FMEA, PFD, Control
plans & standard work
instructions)

8.3.2.2 Product design skills:

The customer designs are followed
8.3.2.3 Development of products with
embedded software :
Not applicable
8.3.3 Design & Development inputs :
Applicable to Design, development
and supply for electromechanical parts
only
8.3.3.1 Product Design Input:
The customer designs are followed
for rubber & metal parts.

8.3.3.2 Manufacturing process design

input: Special
FAPL has identified, documented & CFT Characterist Actual
reviewed manufacturing process ics, records
design input requirements including PFMEA,
following, Control
a)Special characteristics of the product plans, work
b)Targets for productivity, process instructions
capability, timing & cost
c)Manufacturing technology
alternatives
d)Customer requirements, if any.
e)Experience from previous
developments
f)New materials
g)Product handling & ergonomic
requirements
h) Design for manufacturing & design

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 7 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

for assembly

This is done with the use of error

proofing methods wherever possible
considering the magnitude of
problems & commensurate with the
risk encountered

8.3.3.3 Special Characteristics : CFT CSR,

CFT identifies special characteristics Customer
determined by customer and identified P.O.,
through risk analysis by FAPL Change
a) This is covered in drawings, FMEA, Communica
control plans & work instructions by tions,
specifically marked as special FMEA,
characteristics and documented in the Control
manufacturing documents which show the Plans, Work
creation of, or the controls required, for Instructions
these special characteristics;
b) Development of control and
monitoring strategies for special
characteristics of products &
production processes are ensured
c) Customer specified approvals when
required
d) following customer symbols or
notations as per the symbols
conversion table if required

8.3.4 Design & Development Controls:

The customer designs are followed.
8.3.4.1 Monitoring: MRM &
FAPL measures effectiveness at all Project
stages & reviews summary in MRM, Management
Reports to the Customer if required. Review

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 8 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

Risks related to these measurements

also are considered
8.3.4.2 Design & Development validation:
Product design validation is done at CFT Process Process
customer end. validation validation
Process is designed and validated by checklist reports
FAPL as per past experience & setting
the parameters to achieve desired
product Quality.
8.3.4.3 Prototype program :
FAPL makes prototype program me & Ex. Project
control plan ensuring same suppliers, Marketing Management
tooling & manufacturing processes Review
that will be used in production
whenever possible.
All performance testing activities shall
be monitored for timely completion &
conformity to requirements.
8.3.4.4 Product Approval Process: CFT PPAP FAPL
FAPL has established, implemented & approval for
maintained product & manufacturing externally
approval process conforming to provided
customer requirements. products &
FAPL approves externally provided customer
products & services prior to approval if
submission of their part approval to required
the customer.
If required by the customer FAPL
obtains documented product approval
prior to shipment.

8.3.5.1 Design & Development outputs :

As per customer designs &
developments outputs
8.3.5.2 Manufacturing process design
output :

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 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

FAPL verifies the outputs against

manufacturing process design input
requirements including ,
a) Specifications & drawings
b) Special characteristics for products
& manufacturing processes.
c) Identification of process input
variables that impact characteristics
d) Tooling & equipments for
production & control including
capability studies of equipment &
processes.
e) Process flow charts
f) Capacity analysis
g) Manufacturing process FMEA
h) Maintenance plans & instructions
i) Control plan
j) Standard work & work instructions
k) process approval acceptance criteria
l) Data for Quality, reliability,
maintainability & measurability.
m) Results of error proofing
identification & verification
n) Methods of rapid detection,
feedback & correction of
product/manufacturing process
nonconformities.

8.3.6 Design & Development changes:

8.3.6.1 FAPL identifies, reviews and controls
changes made during, or subsequent
to, the design and development of
products and services, to the extent
necessary to ensure that there is no
adverse impact on conformity to

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 10 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

requirements.
FAPL retains documented information
on:
a) Design and development changes
b)The results of reviews
c) The authorization of the changes
d) The actions taken to prevent
adverse impacts.
These changes shall be validated
against customer requirements &
approved internally before starting
production.
Documented approval or waiver shall
be obtained from customer if required.

8.4 Control of Externally Provided

processes, products & services

8.4.1 General:
8.4.1.1 General ( supplemental ) Procedure
8.4.1.2
Supplier selection process for
All venders are selected on the basis purchasing
of their capability to produce product Mgr. 1) Vendor 100%
FAPLPUR001
as per specified purchase Purchase selection vendor
requirements. criteria. evaluation
PUR/PR/01.
2) Vendor or vendor
evaluation approval.
form,
3) Approved
vendor list
4) DSR &
Team
Feasibility
of product Inspection
report

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 11 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

The type & extent of control required Procedure 1) CSR with each
on each supplier is decided on the Mgr. for 2)Agreement lot
basis of “Effect of purchased product Purchase purchasing & Purchase Follow
on manufacturing process at FAPL or Order, 100%
on final product”. FAPLPUR001 3) MTC inward
4) Inward inspection
PUR/PR/01 Inspection SOP.
plan. Cross
verify
1) CSR Outside
FAPL ensures proper communication Procedure 2) Purchase Lab
to supplier for internal requirements Mgr. for Order with report
and customer expectations like Purchase purchasing all technical with
certification requirements, legal details & Supplier
compliance requirements through
FAPLPUR001 agreement spec.
Purchase Orders / Agreements and
PUR/PR/01
Annexure to P.O.
100%
1) Vendor material
Procedure selection receipt as
for criteria.
Criteria for selection, evaluation and per sepc.
purchasing 2) Vendor
re-evaluation is established. Mgr.
Purchase evaluation
FAPLPUR001
/Dy. Mgr. Form
QA 2) Supplier
PUR/PR/01 Performance
Form 100%
i.e. Vendor vendor
quality & evaluation
delivery or vendor
rating > approval.
Threshold
limit.
3) Vendor
Approval
form

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 12 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

Customer directed (Directed –buy) Necessary

8.4.1.3 sources: PO’s and
When specified by the customer FAPL reports as
purchases products, materials or applicable.
services from customer directed
sources.

Verification of Purchased Product: Dy. Mgr. Procedure Receiving All

Quality for inspection purchased
The purchased product shall be purchasing Records/ material
verified as per receiving quality Check verified
plan. FAPLPUR001 sheets prior to
use/As per
PUR/PR/01 inspection
plan.
8.4.2 Type & Extent of control :

8.4.2.1
CONTROL OVER OUTSOURCED
PROCESS:
Establish control over outsourced FAPLPUR001
process which affects QMS. Mgr. Supplier On time
PUR/PR/01
Consideration is given to in-house Purchase performance Delivery
control & control at supplier end. /Dy. Mgr. report
Outsourced activity consists of. QA
- Phosphating / Plating /
Painting/ Powder coating
Moulding
- Calibration, Testing.
Consideration for criteria’s of control

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 13 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

can be:
Authorization from designated
agencies like ISO/IATF/NABL etc.
Process/product audit at defined
frequencies at in house /Supplier end.
Performance/material testing
frequencies at in house/ Supplier end.
Recommendation of OEM etc. FAPL
ensure that the appropriate
controls are in place at the point of
manufacture.

8.4.2.2 Statutory & regulatory

requirements:
FAPL has documented their process to
ensure that purchased products,
processes & services conformed to
current applicable statutory &
regulatory requirements in the country
of receipt, the country of shipment &
customer identified country if
provided.
FAPL ensures the statutory &
regulatory requirements (including at
suppliers) are implemented in case of
certain special controls for certain
products as per customer
requirements.

8.4.2.3 Supplier Quality management

system development :
FAPL ensures adherence to
suppliers of automotive products and
services to develop, implement, and
improve a quality management system
(QMS) with the ultimate objective
of eligible organizations becoming

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 14 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

certified to this Automotive QMS

Standard.
Using a risk-based model, the
organization defined a minimum
acceptable level of QMS development
and a target QMS development level for
each supplier. Unless otherwise
authorized by the customer
[e.g., item a) below], a QMS certified to
ISO 9001 is the initial minimum
acceptable level of development. Based
on current performance and the potential
risk to the customer,
the objective is to move suppliers through
the following QMS development
progression:
b)certification to ISO 9001 through
Third party audits
c)certification to ISO 9001 with
compliance to other customer defined
QMS requirements through second
party audits
d)certification to ISO 9001 with
compliance to IATF 16949 through
second party audits
e)certification to 16949 through third
party audits
8.4.2.3.1 Automotive product related software or
automotive products with embedded
soft wares :
Not applicable to FAPL
8.4.2.4 Supplier Monitoring :
FAPL has documented process & criteria
to evaluate supplier performance.
In order to ensure conformity of
externally provided products, processes,
and services to internal and external
customer requirements.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 15 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

Following performance indicators

Monitored.
a) delivered product conformity to
requirements
b) customer disruptions at receiving
plants including yard holds and stop ships;
c) delivery schedule performance

lf provided by the customer, the

organization include the following, as
appropriate, in their
supplier performance monitoring:
e) Special status customer notifications
related to quality or delivery issues;
f) Dealer returns, warranty, field actions,
and recalls.

8.4.2.4.1 Second Party Audits:

Dy. Mgr.QA Supplier Audit Supplier
FAPL carries out second party audit QMS Report Evaluation
process by competent auditor in Process Auditors
supplier management approach for Audit Certificates
a)Supplier risk assessment
b)Supplier monitoring
c)Supplier QMS development
d)Product audits
e)Process audits

8.4.2.5 Supplier development :

Mgr. Supplier Audit
FAPL determines the priority, type, Purchase/ QMS Audit Report
extent & timing of required supplier Dy. Mgr.QA
development actions for their active
suppliers considering
a)Performance issues
b)Second party audit findings

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 16 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

c)Third party QMS certification status

d)Risk analysis

8.4.3 Information for external providers:

Mgr. Procedure P.O. / 100%
8.4.3.1
Purchase order contains all technical Purchase for Agreements. complianc
requirement related to product. purchasing e of
CSR includes all detailed information quality &
related to product. FAPLPUR001 delivery.
CSR is mutually agreed with supplier.
Vendors are given open PO and PUR/PR/01
schedules are as per re-ordering SOP.

8.5 Production & service provision

8.5.1 Control of production & service
8.5.1.1 provision :
Control plan:
FAPL has developed control plans MR / Ex. Process FAPL/QUA/F-02 Production
stage wise (Proto type, prelaunch & Production/ Control processes
Production) with linkage to process Dy. Mgr Procedure F ICS are carried
flow diagram & manufacturing risk QA at
analysis outputs (FMEA). Quality PDIR controlled
FAPL includes in control plan plans; condition.
a) Controls used for Process
manufacturing process control Work Sheet
including verification of job Instructions
set ups
b) Methods for monitoring
control over special Process
characteristics ( of customer control
FAPL) procedure
c) Customer required information

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 17 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

if any.
d) Specified reaction plan when,
NC product is detected,
process becomes unstable or
statistically incapable.
The control plans are reviewed &
updated as required if,
e) FAPL finds that NC product is
shipped to customer
f) Any change occurs affecting
product, manufacturing
process, measurement,
logistics, supply sources,
production volume changes, on
risk analysis (FMEA).
g) Customer complaint &
corrective action is
implemented, when applicable.
h) At a set frequency based on
risk analysis.
If required by customer FAPL obtains
approval from customer after review
or revision of control plan.

8.5.1.2 Standardized work- operator

instructions & visual standards:
FAPL shall ensure that standardize Work
work documents are, Work Instructions
a)Communicated to & understood by Instructions Displayed
the responsible employees. at work
b) Legible place
c) In language understood by the
responsible personnel
d) Accessible for use at the designated
work area.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 18 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

These also include rules for operator

safety.

8.5.1.3 Verification of Job setups:

FAPL shall
a) Verify job set ups when done,
such as initial run of a job, QA Setup Set up
material changeover or job Inspector/ Verification verification
change that needs new setups. Supervisor procedure sheet
b) Maintain documented
information for set up
personnel.
c) Use statistical methods of FICS
FAPL/QUA/F-02
verification where applicable.
d) Perform First off /Last off part PRD/FR/
verification as applicable. 08& Last
Retaining for comparison both off
the parts
e) Retain records of process &
product approval following set
up & First off/ Last off part
verification

8.5.1.4 Verification after shut down:

FAPL shall define & implement the QA Setup Set up
necessary actions to ensure product Inspector/ Verification verification
compliance with requirements after a Supervisor procedure sheet
planned or unplanned production shut
down period.

8.5.1.5 Total productive maintenance:

FAPL developed & maintained a Sr. Executive
FAPL/MNT/F-13
documented productive maintenance maintenance/ FAPL/MNT/F-14 MTTR /
Executive Tool
system including, Production MNT/FR/09 MTBF
maintenance
a)Identification of process equipment File
Production

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 19 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

necessary to produce conforming breakdown

product at required volume. less than
b) Availability of replacement parts 1%)
(Critical spares) for the equipment.
c) Provision of resource for machine,
equipment & facility maintenance.
d)Packaging & preservation of
equipment, tooling & gauging.
e) Applicable customer specific
requirement.
f)Documented maintenance objectives
(e.g. Machine uptime, MTBF &
MTTR).
g) Regular review of maintenance plan
& objectives along with 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

& manufacturing, test, inspection
tooling & equipment: Tool History
FAPL carry out Production Processes Sr. Executive Card Production 100%
at controlled condition by proper Production / FAPL/MNT/L-08 Tooling Availability
management of Production Tooling Executive Mgmt File. Of
as : Production PRD/FR/04 Mould Tool &
a) Maintenance & Repair preventive Fixture
facilities & personnel through maint. &
Preventive &break down Check sheet MTTR /
maintenance MTBF

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 20 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

b) Storage & recovery Production

c) Set up breakdown
d) Tool Change Programme for less than
Perishable tools 1%)
e) Tool Design Modification
Documentation, including
Engineering change level of
the product
f) Tool modification & revision
to the documentation
g) Tool identification with Sr. No.
Dept. Name, repair or disposal,
ownership & location
FAPL maintains,
1. Tool Spares Min- Max level
2. Supportive spares (Nut, Bolt,
Springs, Dowels, Bush etc.) Min-
Max level
3. Updated Tool Master List &
Critical spare list.
4. Tool Issue Register
5. Obsolete Tool List & Scrap Tool
Memo
6. Contingency Plan

8.5.1.7 Production scheduling: Trigger Process KPI

FAPL has established a documented Review
procedure for production scheduling Sr. Ex. Procedure Objective
which covers delivery performance & Production Hourly
FAPLPRD001
information during production report
scheduling. E.g. - customer orders, PRD/FR/02
supplier on time delivery performance,
capacity, lead time, inventory level,
maintenance & calibration.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 21 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

8.5.2 Identification & Traceability :

8.5.2.1 Where appropriate purchased items, in Ex. Stores / FAPL/STR/F-01 Route 100%
process items & finished items are Q.A. STR/FR/07 card, material
identified by Part no given in BOM. Inspector/ Direct identified at
The inspection Status of the parts after Supervisor printing all stages.
verification shall be disclosed via Tags. on parts,
The Traceability of all products is Identifica
maintained as required. tion tag.
FAPL conducts an analysis of internal,
customer & regulatory traceability
requirements to
a)Identify NC/ suspect product
b)Help to segregate NC/suspect
product
c)Ensure ability to meet customer
response time requirements
d)Ensure documented information is
retained in the format which helps to
meet response time requirements
e) Standardized identification is not
specified by any Customer.
f)Ensure identification & traceability
requirements for externally provided
products with safety/ regulatory
characteristics

8.5.3 Property belonging to Customer or

external providers:
a) Customer & external provider Concern List of All
property (Materials, persons Customer Customer
supplied
components, tools, Property
parts
equipments, if any will be Unique identified
identified by list. Identification on list.
no. on

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 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

b) Identification of customer & Identification customer

external provider supplied no. list. supplied
material by unique material
identification number.

c) Customer supplied material

treated same as FAPL Quality
plan/checklist Incoming 100%
purchase material & verified as verification
part regular part inspection Inspection as per
procedure i.e. as per the Report Quality
concern Quality Plans/ plan,
Checklist. 100%
compliance
d) Customer & External Provider PM. Plan PM. Check as per
FAPL/MNT/F-04 maintenance
Property is preserved same as FAPL/MNT/F-05 sheet
MNT/FR/02 plan.
FAPL own property.

e) If Customer & External PM Check

Provider Property is lost/ Sheet
Damage/unsuitable to use it
FAPL/MNT/F-06
will be communicated to FAPL/MNT/F-07 Timely
customer. Communicati Communic
FAPL shall report this to the Customer on to ation to
or External provider & Retain MNT/CS/03 Customer via customer
Documented Information on what has Email/Letter
happened.

8.5.4 Preservation :
Product at all stages are identified,
properly handled & stored, packed to Ex. Stores Procedure for Stock Material free
protect the product from being Jr. Ex. Identification Statemen from defect
unsuitable for use. All efforts are Dispatch , Handling, t, Coil
made to achieve with Inventory Storage, Issue
accuracy. Material Issue is done & Packing & Data,
ensured FIFO. Preservation FIFO
8.5.4.1 Preservation is done for & Delivery. register.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 23 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

contamination control, packaging, STR/WI/ 06

storage, transmission or
transportation & protection. FAPL/STR/WI/06
It is applicable to materials &
components from external & / or FIFO List
STR/LI/01
internal providers from receipt to
acceptance stage by customer.
Frequent checks at planned intervals
are carried out to check the condition
of products in stock, container & the
storage environment.
FIFO is followed specially for shelf
life items.
Obsolete products are treated like
Nonconforming products.

8.5.5 Post delivery activities:

FAPL meets requirement for post- Ex. Customer Field
delivery activities considering Marketing complaints & failure
a)Statutory & regulatory feedback reports
requirements
b) Potential undesired consequences
associated with products & services
c) Nature, use & intended life time of
products & services
d) Customer requirements
e) Customer feedback

8.5.5.1 Feedback of information from Records

service: after
FAPL ensures that a process for Ex. change.
information on service concern to Marketing Relevant
manufacturing, material handling, change
logistics, is established maintained documents
and implemented.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 24 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

8.5.5.2 Service agreement with customer

( NOT APPLICABLE)
Includin
8.5.6 Control of changes g
FAPL reviews and controls changes verificati
for production or service provision, to Reviewed on and
the extent necessary to ensure risk analysis. validatio
continuing conformity with n.
requirements.

8.5.6.1 FAPL retains documented

information describing the results of
the review of changes, the person(s)
authorizing the change and necessary
actions arising from the review.
FAPL defines
a) Verification and validation
activities to ensure compliance with
customer requirements,
b) Validate changes before
implementation,
c) Document the evidence of related
risk analysis,
d) Retain records of verification and
validation. Daily
FAPL Work Review
a) Notify customer of any planed Instructions
product realization changes
after the most recent product
approval,
b) Obtain documented approval
prior to implementation of the
change.
c) Complete additional
verification or identification
requirements such as product

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 25 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

trial run and new product

validation.
8.5.6.1.1 Temporary Change of process
controls:
FAPL has identified document and
maintain the list of the process
controls, including inspection
measuring test and error proofing
devices.
The list of process controls include the
primary process controls and the
approved back-up or alternate methods,
which exists. if back-up or alternate
methods exist.
Required, approval obtained from
customers for product inspected or
tested using alternate method, before
shipment.
Standard work instructions are made
available for each alternate process
control method for applicable.

8.6 Release of Product & Services:

FAPL implements planned Dy Mgr. Inspection Layout
arrangements at appropriate stages to QA & Inspection
verify that the product & service Verification
requirements have been met. as per PDIR
The release of product to customer Quality Inspection
shall not proceed until planned Plan
arrangements have been satisfactorily Lay out MTR
completed, unless otherwise Inspection
approved by relevant authority & as Plan
applicable, by customer.
The information shall be retained FAPL/QUA/F-06

which includes
QA/FR/01
a) evidence of conformity with
acceptance criteria.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 26 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

b) Traceability to the persons

authorizing the release.
FAPL ensures that planned
arrangements to verify that the
product and services are as per
control plan, Approval, and its
accomplishment. After changes
following initial release.
8.6.2 Layout inspection and functional
testing Dy. Mgr. Lay out Lay out
Layout inspection is performed for Quality Inspection Inspection
each product as specified in control Plan Reports
plans. Results are made available for FAPL/QUA/F-06

customer review if required. Layout

QA/FR/01
inspection is carried out for all parts
once in year. Functional verification
is not applicable to our parts.
8.6.3 Appearance items:
These are not applicable to FAPL.

8.6.4 Verification and acceptance of

conformity of externally provided
products and services:

FAPL ensures the quality of

externally provided process, products
and services using one or more of the
following methods.
a) Receipt and evaluation of
statistical data provided by the
supplier to the organization;
b) Receiving inspection and/or
testing , such as sampling
based on performance;
c) Assessments or audits of
supplier sites conformance to

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 27 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

requirements;
d) Part evaluation by a
designated laboratory;
e) Another method agreed with
the customer.

8.6.5 Statutory and regulatory

conformity Asst. Mgr. Statutory HR/Doc/16 Monthly
Prior to release of externally provided HR & IR Compliance Review
products in to production flow. FAPL CEO Report Meeting
confirms to be able to provide
evidence that externally provided
products & services conform to the
latest applicable statutory regulatory
& other requirements in the countries
where they are manufactured & in
customer identified countries of
destination, if provided.
8.6.6 Acceptance Criteria
It has been defined by FAPL& Dy. Mgr. QA Critical SPC Monthly
approved by customer where dimension Report
applicable Inspection
8.7 Control of Nonconforming
Outputs:
8.7.1 FAPL ensures that outputs that do not
conform to their requirements are Control of
identified and controlled to prevent Mgr. QA non Rejection Proper
their unintended use or delivery. conforming reports & disposition of
FAPL takes appropriate action based material Actions None
on the nature of the nonconformity procedure conforming
and its effect on the conformity of Material.
products and services even after FAPLGEN002

delivery of products, during or after MR/PR/06

the provision of services. FAPL deals Rework
with nonconforming outputs in one or instructions.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 28 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

more of the following ways:

a) Correction;
b) Segregation, containment, return
or suspension of provision of
products and services;
c) Informing the customer;
d) Obtaining authorization for
acceptance under concession.
Conformity to the requirements are
verified when nonconforming outputs
are corrected.

8.7.1.1 Customer authorization for

concession
a) FAPL obtains a customer concession
or deviation permit prior to further Dy.Mgr.QA Control of Rejection Proper
processing whenever the product or non reports & disposition of
manufacturing process is different from conforming Actions None
that which is currently approved. material conforming
FAPL obtain customer authorization Material
procedure
prior to further processing for “use as is”
and for repair (see 8.7.1.5) of FAPL/QUA/F-06
nonconforming product.
b) Sub components not applicable as MR/PR/06
FAPL is not doing sub assembly Repair
process. instructions.
c) Deviation records are monitored
for the parts provided under
deviation.
8.7.1.2 Control of nonconforming
products – Customer specified
process
Customer specified controls for non
conforming products not applicable at
FAPL. HR/ Training
Dy.Mgr.QA records

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 29 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

8.7.1.3 Control of suspect products. Training with check

FAPL ensures that unidentified list
products within manufacturing
process are considered as suspected
products. Manufacturing personnel
are provided training for containment
of such products.

8.7.1.4 Control of reworked product.

Any rework process on finished
product is not done for parts NA
produced at FAPL.

8.7.1.5 Control of repaired products.

Repair process is not applicable for NA
parts produced at FAPL.
Dy.Mgr.QA
8.7.1.6 Customer notification
Method of communication through Communica Mail, SMS
email, SMS, telephone followed, if tion through
any Fit, Function related parts are mail, SMS,
been dispatched to customer. telephone

8.7.1.7 Nonconforming product

disposition
NC product monitoring & disposition Dy.Mgr.QA Procedure
procedure followed as applicable for control of
8.7.2 NC Product Scrap note
FAPL has retained documented FAPLGEN002
8D report
information that:
a)Describes the nonconformity; MR/PR/06
actions taken; concessions
obtained;
b) Identifies the authority deciding
the action on nonconformity.

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 30 of 31

 Filtrum Autocomp Pvt. Ltd.
SECTION 8

ISSUED BY : MCO & APPROVED BY: CEO (When effective?) DATE : 01/02/2020

(What) Reference: IATF 16949:2016

(What?) Title of the procedure: SECTION – 8 .0 (OPERATION)

Clause What & when Who What What (How)
Number (Responsible) (Ref. (Record) Performance
Procedure) Measure

DOCUMENT NO: - QM - 8.0 REV. NO.01/01.03.2023 Page 31 of 31