IATF 16949-Transition Actions

IATF
16949:2016
Key Changes from ISO/TS 16949: 2009
Quality Growth Services Pvt. Ltd.

H-13, Kirti Nagar, New Delhi-110 015
Tel.: +91-11-25431737, 25918332
e-mail: qgs@qgspl.com
PresentaGon Overview
IATF 16949 history
IATF Approach
Overview of IATF 16949
Risk Based Thinking
IATF 16949- Changes to Focus & by whom

© February 18, Quality Growth Services. Unpublished proprietary work available only under license. All rights reserved. 2
Quality Growth Services 1

ISO/TS 16949
First ediGon: Second ediGon: Third ediGon: First ediGon:

ISO/TS ISO/TS ISO/TS IATF
16949-1999 16949-2002 16949-2009 16949-2016
•  Base document •  Base document •  Base document is •  Base document is
was ISO was ISO ISO 9001-2008 ISO 9001-2015
9001-1994 9001-2000
Approach of IATF 16949
Key is to engage three gears

PDCA
Process
Approach
Risk Based
Thinking

IATF 16949 REQUIREMENTS
ISO 9001:2015
IATF
16949:2016
Auto specific
Supplemental
requirements
ISO/TS 16949: 8 Clauses & ISO

9001 imbedded in the standard IATF 16949: 10 Clauses & Only
supplemenal requirements
Model of ISO 9001: 2015

QUALITY MANAGEMENT SYSTEM
Organization & Customer
Its Context Support Satisfaction
(4) (7)
Operation
(8) DO
PLAN
Performance Result of
Customer Planning Leadership Evaluation
Requirements (6) (5) the QMS
(9)
Needs and CHECK

ACT
Expectations of
relevant Products
Improvement
interested and Services
(10)
Parties
(4)

4.1, 4.2 & 6. 1
Understanding Contextual Issues, Related Interested ParGes & Risk
Assessment
§  Determine
§  Issues Affecting Organization QMS
§  Interested Parties in the Issues
§  Requirements of Interesting Parties
§  Impact on Customer, Operational Loss and Legal
compliance
§  Impact Score
§  Existing Controls & Related QMS Documents
§  Occurrence Rate of Non-compliance despite control
§  Overall Risk = Impact Score X Occurrence Rate
§  Actions Plan if Risk Score is high.
Implementation Responsibility: All Departments

6.1.2.1 : While doing Risk Analysis

Must include:
•  lessons learned from product recalls,
•  product audits,
•  field returns and repairs,
•  complaints, scrap, and rework.
Implementation Responsibility:
APQP Team Leader, Engineering, Production & QA
6.1.2.2
Take PrevenGve AcGons based on PotenGal Risks
idenGfied

Corporate Responsibility
Personnel of company should be aware about

an anA-bribery policy,
an employee code of conduct, and
an ethics escalaAon policy ("whistle-blowing policy").
Implementation Responsibility: HR & All HODs
4.4..1.2 Product Safety

•  Be conversant with the process requirements
•  Safety CharacterisGcs of the product to be include it in FMEA,
including control in the event of rework & Control Plan
•  Display these on the related machines
•  Keep records of training to related operators
•  In case, any BOP/Job Work has Safety CharacterisGcs, it should
be defined in PO/Drawing
1.  1st : APQP Team, Production, QA & Purchase
2.  2nd & 3rd Bullet: APQP Team
3.  4th Bullet: Production & QA
4.  5th Bullet: Purchase/SQA

5.2 Policy
Linkage of Quality Policy with Vision & Mission
Policy to be made available to the relevant Interested

ParAes
Implementation Responsibility : MR
5.3.1 Ensuring Customer Req. are met
Define who will interact with customers for following &

convey in the company:
•  SelecGon of special characterisGcs: APQP Team
•  Se`ng quality objecGves and related training: APQP Team/QA
•  CorrecGve and prevenGve acGons: QA
•  Product design and development: APQP Team
•  Capacity analysis: ProducGon Team/APQP Team
•  LogisGcs informaGon: APQP Team/Sales
•  Customer scorecards and customer portals: Sales/QA
5.3.2 Authority to stop producGon : QA Team

Authority to stop shipment : Head (QA)

6.1.2.3 : ConGngency Plans
Include following Risk and their Impact in ConAngency plan:
•  Infrastructure disrupAon
•  interrupAon from externally provided products,
processes, and services;
•  recurring natural disasters
•  Cyber ARack; and fire;
6.1.2.3 : Prepare plan for tesGng conGngent condiGons

•  Periodically Tested
•  Review at least annually –Involve top management
Res: Production, Maintenance, Purchase, HR/Admin & IT

CONTINGENCY PLAN
S. ConKn. Impact ExisKng Control Related Recovery Resp Outsourci Is If Yes, If No,
No. Cond. (Internal Work Time Limit ng (App. / TesKn Freq. Reasons
Performance, InstrucKon Not App.) g Reqd
Customer / / Format if
Legal Any
Compliance)
1 Non No Take power from DG 15 Electrical NA No N/A At Least
availabilit ProducGon/ set and conGnue Minutes Shig I/C once /
y of Less minimum operaGon and week of
Power ProducGon like minimum lighGng OperaGon DG
than target etc. Shig I/C. working
carried
out
2 ParGal Less Feeder redundancy is 2 Hours Electrical NA Yes Once
availabilit ProducGon available, follow Shig I/C / Year
y of than target change over and
Power procedure OperaGon
(Single Shig I/C
Feeder /
Incomer
Working)

6.2.2.1 : Quality ObjecAves
AcAon plan for objecAves to be prepared. Which

should include:
What will be done
What resources will be required
Who will be responsible
When it will be completed
How the results will be evaluated
Implementation Resp : All HODs

7.3 AWARENESS
7.4
7.2 COMPETENCE
COMMUNICATION
7.1 RESOURCES
7 7.5 DOCUMENTED
SUPPORT INFORMATION
Clause-7
SUPPORT

7.1. Resources
7.1.2 PEOPLE: Keep records of number of

personnel required and available: Resp: HR
7.1.3 INFRASTRUCTURE : Maintain details of

Infrastructure Required & available: Resp:ProducGon,
Maintenance, QA, HR/Admin
7.1.4 ENVIRONMENT: Maintain details of Environmental
CondiGons Required & Controls to maintain in
Environment matrix
Resp: HR
IDENTIFICATION AND MONITORING OF OPERATIONAL ENVIRONMENT

NAME OF DEPT.(S)
{Details related to Temperature, LighGng, Noise, Humidity and House Keeping} Keep separate details for Shop Floor and
offices, if applicable.
S. OperaGonal Desired Desired Controlling Means Resp. for Env. Cond. Related
No. Environmental CondiGon CondiGon Maint. Ok / Not Ok WI / IMP
Parameters Office Plant Area
1 IlluminaGon Minimum Minimum AutomaGc ON/OFF Elect OK

Level 500 Lux 100 Lux Timers/ Lux Meter
checking
2 Noise Level 60 dB 90 dB PPEs as defined for high Mech OK

noise area
4 Humidity Ambient Ambient Regular Monitoring Elect OK
5 Air Quality OperaGon OK
6 Work Place <25 Degree <40 Air CondiGoning /Heat OperaGon OK
Temperature Celcius Degree Shields / VenGlaGon Fans
Celcius
7 Waste Disposal Zero Waste Zero Waste Bins at designated Mech/Elect OK

at Dept Waste at areas + Regular disposal
Level Dept Level

IDENTIFICATION AND MONITORING OF INFRASTRUCTURE
{Details related to Hardware (machines /equipment/drives/motors/transformers etc.), UGliGes, Material TransportaGon

Means (Cranes etc.) , InspecGon & TesGng Aids (Measuring instruments/Gauges etc.) and Computer Hardware &
Sogware required as applicable to Processes of the department.}
In case, Present CondiGon of exisGng infrastructure quanGty available is

"Not Ok" to meet department objecGves or new to be installed, iniGate Improvement Plans (AcGon Plan) preparaGon.
S. Required Responsibility Qty. Reqd. (Including in Qty. Gap of QuanKty to Present Planned
No. Infrastructure for Maintenance OperaKonal & Stand Availabl meet OrganizaKonal CondiKon AcKon if not
By/Spare) e Targets of Qty. OK
If any (E-F) Available
Ok/Not OK
1 Tunnel Furnaces OPRN/MECH/ 2 2 0 OK

ELECT
2 TF Blower motors ELECT 12 12 0 OK
3 TF Roller drives ELECT 435 410 25 OK
4 TF thermocouple ELECT 81 81 0 OK
5 TF Actutators ELECT 202 202 0 OK
7.1.3.1 Plant Facility and Equipment Planning

•  Carry out Risk Assessment for developing &
improving plant, facility & equipments plan
•  For new product(s) or new operaAons evaluate
manufacturing feasibility.
•  Carry out capacity planning as a part of
manufacturing feasibilty and proposed changes
to exisAng operaAons.
Implementation Resp.:
1.  1st
& 2nd
Bullet : APQP Team
2.  3 Bullet: Production/PPC
rd

7.1.5.2.1 Calibra<on Record
CalibraAon / VerificaAon Records to include:
•  Check that Associated standard’s last calibraAon

date and the next due date on the calibraAon report
is provided.
•  Maintain List of soZware versions used for product
and process control equipment
Implementation Resp : QA, Engineering &

Maintenance
Socware and Control

S. No. Process / Test Socware Provided by Type of Control / Version Date
Method DescripKon TesKng No.

7.1.5.3.2 External Laboratory
Verify that relevant calibraGon
service in the scope of the
accreditaGon (cerGficate) of
laboratory
Verify that cerAficate issued for

calibraAon or test report contains
mark of related naAonal
accreditaAon body,
Implementation Resp : QA
7.1.6 OrganizaGonal Knowledge
Determine the knowledge for operaAon of its processes
Maintain the knowledge
Make knowledge available to the extent necessary
Determine how to acquire or access any necessary addiAonal

knowledge and required updates.


OperaKonal Knowledge Accessibility
FuncKon Quality Assurance
Level Reference Based Knowledge Required Accessibility LocaKon*
for operaKon of its processes
Manager QA Test Method for product tesGng Hard Copy (QA Department)
ASTM Standards Hard Copy (QA Department)
IMS Procedures Shared Drive
Core Tools books referred in IATF Hard Copies (QA Department)
Customer Specific Requirements Hard Copy (QA Department)

Equipment Manuals Hard Copy (QA Department)
Internal Training Material Sog Copy (Head QA Computer)
* Accessibility can be through WI/Processes displayed/available at wok locaGon, SAP,

Share Point, etc.
7.2.2 Competence: On the Job Training
Ensure these persons are competent on the basis of

appropriate education, training or experience
On Job Training to include customer requirements where it

affects quality requirements & legal requirements
Applicable to all personnel in New or Modified Responsibili<es

(affecAng quality, internal and regulatory requirements)
Implementation Resp :
Direct: HR & Support: Production, QA and Maintenance

COMPETENCE MATRIX FOR EMPLOYEES
Name of Department:
Date of EvaluaKon:
Knowledge Inputs Required to Afain Desired Present Status Further
Competence AcKons
Level Required
Desired Knowledge & Skill for Edu. Exp. Training Edu. Exp. Trg.
Assigned PosiKon
HOD 1. Planning & Organizing Departmental Degree 10 1. Safety Norms

(Process OperaGons Engg. / Years applicable in Mill
Owner) 2. Knowledge of XYZ Department Science OperaGons
Machines, Graduate 2 CommunicaGon
3. Knowledge of HSE related to Skills
Departmental OperaGons 3 Finance for non
4. Knowledge of Applicable IATF finance
requirements 4. IATF Awareness
5. SAP OperaGons
6. CommunicaGon Skill
7. PresentaGon Skill
COMPETENCE MATRIX FOR EMPLOYEES

Name of Department:
Date of EvaluaKon:
Knowledge Inputs Required to Afain Desired Present Status Further
Competence AcKons
Level
Required
Desired Knowledge & Skill for Edu. Exp. Training Edu. Exp. Trg.
Assigned PosiKon
SecGon 1. Planning & Organizing SecGon Degree / 7 1. Safety Norms
Head working Diploma / Years applicable in related
2. Knowledge of XYZ SecGon machines, Science machine OperaGons
3. Knowledge of HSE related to SecGon Graduate 2. IATF Awareness
machines OperaGons 3. Peer
4. Knowledge of Applicable IATF CommunicaGon
requirements 4. AIA as per ISO
5. MS Office OperaGon 14001
6. Core Quality Tools: Core Tools-APQP, 5. Core Tools-APQP,
PPAP, FMEA, SPC PPAP, FMEA, SPC
7. SAP OperaGons 6. Internal Auditor for
8. Add necessary Technical knowledge IATF
7. Internal Auditor
for ISO 14001
8. Add Necessary
Technical Training

7.2.3 & 7.2.4 Auditor competency
Maintain list of qualified auditors:
AutomoAve Process Approach
Risk-based thinking;
Customer-specific requirements;
ISO 9001 and IATF 16949
Core tool requirements
Plan, conduct, report, and close out audit findings.
Implementation Resp : MR
List of Qualified Internal Auditors

S. Name Emp Quall Wor IAT Trai Core Tools PS CSR Process Related Measurement / Approved for
No. No. k F ned P Competence Test Method
Exp. by (Define Process Knowledge
where he / she
can Audit)
APQ FMEA/ PP SP MS Inte Proc Pro Seco

P Contr AP C A rnal ess duc rd
ol Plan QM t Part
S y
1 DME 20 YES YES YES YESYESYESYES YES Engi Prod Qu Q Dim √ √ √ √

yrs neer ucGoalit MS ensi
In ing n y onal
Engg
2 DME 10 YES YES YES YESYESYESYES YES Dim Co √ √

Yrs ensi aG
in onal ng
Prod
.

7.4 CommunicaAon
Maintain a CommunicaGons Matrix relevant to the QMS
•  what it will communicate

•  when to communicate
•  with whom to communicate
•  how to communicate
•  who communicates
COMMUNICATION MATRIX
Dept. / Sec : QA As On: 1 June, 2017
S. DescripKon of Mode Resp. Freq. / To be Communicated
No. Comm. When
Plant Head Prod Head Lab Dispat QA SAP Custo Supplier
Head Prod. Sup. (QA) Chemi ch Intern mer
st al
Record
s
1 Daily Quality E-Mail QA (O) Daily ✓

✓
✓
✓ ✓ ✓

Report
2 In-Process E-Mail QA Every ✓

✓
✓
✓ ✓
✓

Sample Report Chem. Shig
3 Finished Good Hard QA Daily

✓ ✓

Test Reports Copy Chem.
Include all types of applicable CommunicaGons emerging from the FuncGon / SecGon and communicated with in
organizaGon OR to concerned External Interested Party (individual/group/organizaGon).
Mode of communicaGon can vary from Hard/Sog Copy, MeeGng(s), Display at NoGce Boards, Circulars, Verbal or through
Company BulleGns / News Levers etc.

7.5 Documented informaAon
Maintain a matrix detailing customer-specific

requirements & related QMS Processes / Work
InstrucAons / Check Sheets
Implementation Resp : APQP Team
S. Customer Name Client 1 Name Client 2 Related IATF Owner

No. Specific Processes / Clause
Requirement WI / Check No.
List
1 Delivery 1. 100% on-Gme delivery (page a) As per Extranet

Requirements 32/46) same for sub suppliers. b) Returnable packaging
2. communicate any delay or as per GPS
risk to the affected Ford
customer
2 Specific 1. InspecGon and a) Traceability record as

records to be Measurement Records-min 2 per customer manual
maintained years (refer page 19/46).
2. QMS Audit records & MRM
records - min 3 years.
3. APQP/PPAP record - Gll
product live for producGon/
service requirement+1
calendar year.
4. Training records-min 3 years
from the date of training

7.5.3.2.2 Engineering specificaAons (earlier 4.2.3.1)
Control of Engg. Specs as per related process.
Review to be done within 10 working days
8.4 CONTROL OF
EXTERNALLY PROVIDED
8.3 DESIGN AND PROCESS, PRODUCTS AND
DEVELOPMENT OF SERVICES
PRODUCTS AND SERVICES 8.5 PRODUCTION AND
SERVICE PROVISION
8.2
REQUIREMENTS 8.6 RELEASE OF
FOR PRODUCTS PRODUCTS AND
AND SERVICES SERVICES
8.1 OPERATIONAL 8.7 CONTROL OF

PLANNING AND 8 OPERATION NONCONFORMING
CONTROL OUTPUTS
Earlier the Title was Product RealizaKon & Clause No-7

8.2
REQUIREMENTS FOR
PRODUCTS AND SERVICES
8.2.1 8.2.2 8.2.3 8.2.4

CUSTOMER DETERMINING THE REVIEW OF THE CHANGES TO
COMMUNICATION REQUIREMENTS REQUIREMENTS FOR REQUIREMENTS
FOR PRODUCTS PRODUCTS AND FOR PRODUCTS
AND SERVICES SERVICES AND SERVICES
8.3.3.1 Product design input (earlier 7.3.2.1)
Boundary and interface requirements,
ConsideraAon of design alternaAves
Assessment of Risk
Consider preservaAon, health, safety and

environment
NOTE One approach for considering design alternaAves is

the use of trade-off curves.
Implementation Resp : Engg

Trade-off Curve Resolve Contradic<ons
A good soluGon resolves the

contradicGon that is the cause of the
problem.
Tradeoff Examples
•  The product gets stronger (good)

–  but the weight increases (bad).
•  The faster the automobile airbag deploys, the better it
protects the occupant (good),
–  but the more likely it is to injure or kill small people or out-of-position people
(bad)
•  Software is made easier to use (good)

–  but versatility decreases (bad).
•  The hot coffee is enjoyable to drink (good)
–  but can burn the customer (bad).
•  Training gets more thorough (good)
–  but requires more time (bad).

8.2.3.1.2 OrganizaAon manufacturing feasibility
•  As a part of APQP/Change Requirements, ensure :

–  manufacturing processes are capable of consistently producing
product that meets all of the engineering and capacity
requirements specified by the customer.
–  Conduct feasibility analysis for any manufacturing or product
technology new to the organizaAon and for any changed
manufacturing process or product design.
–  ValidaAon records of Rate of Run (ProducAon Rate to customer
desired delivery rate).
Implementation Resp : APQP Team

8.3.3.2 Manufacturing process design input

(earlier 7.3.2.2)
•  Product specificaAons including special characterisAcs;
•  targets for producAvity, process capability, Aming, and
cost;
•  manufacturing technology alternaAves;
•  customer requirements, if any;
•  experience from previous developments;
•  new materials;
•  product handling and ergonomic requirements;

APQP Team / Engineering / HR

8.3.3.3 Special CharacterisAcs (earlier 7.3.2.3)
•  Prepare Special CharacterisAcs symbol conversion

table detailing customer-specified definiAons and
symbols or the organizaAon's equivalent symbols or
notaAons
Implementation Resp : Engineering

SPECIAL CHARACTERISTICS CONVERSION TABLE
S. Company Cust Cust Cust Cust Cust Cust

Cate. Type Sev.
No. Symbol 1 2 3 4 5 6
Safety Cr

1 CriGcal ≥9
Legal Cr

Performance Maj

2 Major 5-8
FuncGon Maj

Fitment Maj


8.3.5.1 Design and development outputs —
supplemental – (Product Related)
•  Results of product design error-proofing, such as DFSS, DFMA,
and FTA;
•  Product definiAon including 3D models, technical data
Packages, product manufacturing informaAon, and geometric
dimensioning & tolerancing(GD&T);
•  2D drawings, product manufacturing informaAon, and
geometric dimensioning & tolerancing(GD&T);
•  Service part requirements;
•  Packaging and labeling requirements for shipping.
Implementation Resp : Engineering
8.3.5.2 Manufacturing process Design and development

outputs — supplemental (earlier 7.3.3.2)
•  Special characterisAcs for product and manufacturing process;

•  IdenAficaAon of process input variables that impact
characterisAcs;
•  Tooling and equipment for producAon and control, including
capability studies of equipment and process(es);
•  Linkage of product, process, and tooling;
•  Capacity Analysis;
•  Tools & Equipment Maintenance Plans and Instruc<ons;
•  Method of CorrecAon of Products (when found non-conforming in
rapid detecAon)
APQP Team / Engineering & Production

8.4.1.2 Supplier selecAon process (earlier 7.4.1)
Implement modified supplier selecAon criteria with

following addiAons: :
•  volume of automoAve business (absolute and as a percentage of
total business);
•  financial stability;
•  adequacy of available resources (e.g., people, infrastructure);
•  manufacturing capability;
•  change management process;
•  business conAnuity planning (e.g., disaster preparedness,
ConAngency planning);
•  logisAcs process;
Purchase/SQA: For Changes in supplier selection process
8.4.2.1 Control on Outsourced Processes

Typically these will be :
•  CalibraAon
•  Transport Services
•  Shipping Services
•  Job Work
Monitor their performance as defined
Implementation Resp : Purchase

8.4.2.2 Statutory and regulatory requirements (earlier
7.4.1.1 regulatory conformity)
Before placing purchase orders, ensure that

products are in compliance to countries of:
•  of receipt,
•  shipment, and
•  desAnaAon (where given customer OR product is for export)
Where defined by customer, ensure compliance to

statutory & regulatory requirements, by self and
suppliers,
Implementation Resp : Purchase
8.4.2.3 Supplier quality management system

development(earlier 7.4.1.2)
•  Ensure that suppliers are cerGfied to ISO
9001 by IAF-MLA accredited body
•  Those not cerGfied make plan for second
party audit leading to acGons eventually
MAQMSR
cerGficaGon to ISO 9001: 2015 CONTROL PLANS
•  Those CerGfied make their development PROCESS APPROACH
plan with customer-defined QMS PERFORMANCE
requirements, such as “Min. Auto QMS INTERNAL AUDITING
Req. for Sub-Tier Suppliers” (MAQMSR) or CONTROL OF NON-
equivalent through second-party audits; CONFORMING
PRODUCT
•  No acGons required for those cerGfied to PART APPROVAL
IATF 16949 MANAGEMENT
Implementation Resp : SQA RESPONSIBILITY

8.4.2.4.1 Second-party audits
Prepare Second Party audits plan and carry out. Plan

be based on:
•  Product safety / regulatory requirements,
•  Performance of the supplier, and
•  QMS cerAficaAon level,
Retain records of the second-party audit reports.
Implementation Resp : SQA

8.4.2.5 Supplier development

Prepare plan for supplier development acGons for
acGve suppliers based on:
•  Performance issues idenGfied through supplier monitoring
•  Second-party audit findings (see SecGon 8.4.2.4.1);
•  Third-party quality management system cerGficaGon status;
•  Risk analysis.
AcGons are :
•  ResoluGon of open (unsaGsfactory) performance issues and
•  pursuing opportuniGes for conGnual improvement.


8.5.1.1 Control Plan (earlier 7.5.1.1)
Review the Control Plans at set frequency –
Recommended once/Year
For transiAon audit, review them once before audit.
In case, number of control plans are large, do partly

now and make acAon plan for balance
Production, Engineering and QA
8.5.1.2 Standardised work — Operator InstrucAons and

visual standards
Ensure operator safety guidelines are

included in Work Area(s)
Work InstrucGons should be in the language

understood by the operators
Implementation Resp : Production


8.5.1.3 VerificaAon of job set-ups
first-off parts should

be retained for
last-off-parts should be
comparison with the
retained for comparison
last-off parts;
with first-off parts in
subsequent runs;
Earlier ONLY Last Off Comparison was recommended

8.5.1.4 VerificaAon aZer shutdown
Define and implement the necessary acAons to ensure

product compliance with requirements aZer a planned or
unplanned producAon shutdown period.

8.5.1.5 Total produc<ve maintenance (earlier 7.5.1.4
Preven<ve and predic<ve maintenance)
TPM System to include

• Monitor Maintenance objecAves : OEE, MTBF, MTTR
and PrevenAve Maintenance compliance metrics.
• Prepare correcAve AcAon Plans when not achieved
• Report Maintenance ObjecAves Performance in MRM
• Prepare Periodic Overhaul Plan and implementaAon.
Implementation Resp : Maintenance

8.5.1.6 Management of producAon tooling and manufacturing,

test, inspecAon tooling and equipment
Establish system for:

§  Tool design modificaGon documentaGon, including
engineering change level of the product
§  Tool IdenAficaAon by serial / asset number
•  Permanent marking on each customer-owned tools,
manufacturing equipment,& test / inspecGon
equipment to enable their ownership and applicaGon
Implementation Resp : Tool Room / QA / Production

8.5.1.7 ProducAon scheduling (earlier 7.5.1.6)
While preparing ProducAon Scheduling

pay due aRenAon to line stoppage due
to prevenAve maintenance:
Implementation Resp : PPC

8.5.2.1 IdenAficaAon and traceability – supplemental
Develop system that:
•  Enables idenAfying & segregaAng nonconforming and/or

suspect product;
•  Ensures ability to meet the customer and/or regulatory
response Ame requirements;
•  Serial no. to individual products, if specified by the
customer or regulatory standards;
•  Ensures idenAficaAon and traceability details of externally
provided products with safety/regulatory characterisAcs.
Implementation Resp.: Store / Prod. / QA /Dispatch


8.5.3 Property belonging to Customers OR external
providers
•  Added control on external providers property too in

addiAon to Customers property
•  These can be materials, components, tools and
equipment, premises, intellectual property and personal
data

Store / Production / QA / Dispatch
8.5.6.1 Control of changes – supplemental
•  In addiAon to ECN & PCN now addresses 4M Change

too.
Implementation Resp.: Production / QA

8.5.6.1 Control of changes – supplemental (earlier 7.1.4)
•  noGfy the customer of any planned product realizaGon

changes ager the most recent product approval;
•  obtain documented approval, prior to implementaGon of the
change;
•  complete addiGonal verificaGon or idenGficaGon
requirements, such as producGon trial run and new product
validaGon.
8.5.6.1.1 Temporary change of process controls

Prepare Primary Process Control and approved back-up or alternate
methods in prescribed format.
For both methods

•  Maintain a list of process controls,
•  inspecGon, measuring, test, and
•  error-proofing devices
Approved alternate process control methods be referenced in the
control plan
Ensure that for each alternate process control method, standard

work instrucGons is maintained.
APQP Team / Engineering & QA

Obtain approval of Head (ProducGon) & Head (QA) before
use of alternate method
When Alternate Process Control is in use, at least once a day

review the operaGon of alternate process controls to verify
implementaGon of standard work with the goal
On daily basis, Head ProducGon to evaluate readiness for

returning to standard process
Implementation Resp : Production & QA

Obtain customer approval before shipping

product inspected or tested using the
alternate method

Maintain restart verificaGon records for a defined period based

on severity and confirmaGon that all features of the error-
proofing device or process are effecGvely reinstated.
Implement traceability of products produced when any

alternate process control devices or processes are being used
LIST OF PRIMARY AND ALTERNATE/ TEMPORARY PROCESS CONTROLS

NAME OF DEPARTMENT:
Sr. Process LocaKon of use DescripKon Type of Alternate Control Linked Resp. for Approval
No (Stage / of Primary Control Method/device WI / to be
Machine / Controls (Prev. / Det.) Format Daily Daily taken for
OperaKon) review audit use of
of Opn. alternate
methods
/ device
1 Charging of Pressure Vessel Weight PrevenGve Manual Charging and WI/OP/ P - HOD
Base oil control Weight Checking 16 (Prod.)
Pressure through PLC Through Weight
Vessel indicator
2 Charging Of Pressure Vessel Weight DetecGve External Weighing WI/OP/ P - HOD

favy Acid to indicator of Machine 01 (Prod.)
pressure pressure
vessel vessel

8.6.5 Statutory and regulatory conformity
Prior to release of externally provided products

into its producAon flow,
•  confirm & provide evidence that externally provided

processes, products, and services conform to the
latest applicable statutory, regulatory, and other
requirements in the countries:
•  where they are manufactured &
•  customer-idenAfied desAnaAon

8.7.1.4 & 8.7.1.5Control of repair & rework

•  Include risk of rework & repair in FMEA
•  Rework controls be defined in the control plan or other relevant
documented informaAon to verify compliance to original
specificaAons.
•  Repair controls be defined in the control plan or other relevant
documented informaAon to comply with relevant specificaAon
•  Retain records of the disposiAon of reworked / repaired products
including quanAty, disposiAon, disposiAon date, and traceability
•  Obtain customer approval, if proposed to send repaired items to
customers.
Implementation Responsibility :
1 , 2 & 3 Bullets: Engineering
st nd rd
4th & 5th Bullets: QA


List of Risk Analysis for Rework / Repair
Sr. Prod. Type of Type of Risk involved Impact on ExisKng Any

No. Process rework repair on during rework / Subsequent Controls further
product repair Processes / (During acKon
Customer repair / planned to
rework) & improve
verificaKon
1 PainGng Filling Puvy 1. Under filling 1. Life of WI-XYZ
to fill pin 2. Incomplete Product
holes/ Bonding reduces
Uneven 2. Poor
Surface Appearance
2 Machini Burr 1. Burr Fully not 1. Fitment WI-XYZ
ng Removal removed during
2. Injury to person assembly
during deburring 2. Scratches
on maGng
parts
9.2 Internal
audit
9.1 Monitoring,
9.3
measurement,
Management
analysis and
review
evaluaGon
9
Performance
evaluaGon
9. PERFORMANCE EVALUATION

9.1.2.1 Customer saKsfacKon – supplemental (earlier 8.2.1)
§  Ensure that following are evaluated as a part of

customer saAsfacAon process:
§  Performance indicators to include: recalls, field failure &
rejecAon / failure at client end
§  online customer portals and customer scorecards, where
provided
9.2.2.1 Internal audit programme (earlier 8.2.2.4)
•  PrioriAzed based on risk

•  Audit frequency to be adjusted based on change in
management / occurrence of process changes


9.2.2.2 Quality management system audit
Make three-year Audit calendar
Use process approach to verify

compliance
Sample CSR controls for effecAve

implementaAon.
9.2.2.3 Manufacturing process audit (earlier 8.2.2.2)

Plan Audit of all manufacturing processes over each three-year
calendar period,
Where customer-specific required approaches defined, Use it
Audit should be planned for all shigs especially focus during

during shig change over
Audit to focus on effecGve implementaGon of the PFMEA,

control plan, WIs & check sheets

9.2.2.4 Product audit (earlier 8.2.2.3)

•  Using customer-specific required approaches else define the
approach to be used.

9.3.2 Management Review Input (earlier 5.6 review input)

Carry out Review which should include:
•  changes in external and internal issues & feedback from interested parAes
•  Performance of external providers;
•  EffecAveness and Efficiencies of product realizaGon & support processes
•  the effecAveness of acAons taken to address risks and opportuniAes
•  Review Actual ObjecAve Achieved V/S Planned
•  EffecAveness of the audit programme
•  Performance Target defined by Customer V/S Achieved
•  Review of Customer Scorecard
•  Assessments of manufacturing feasibility made for changes to exisGng
operaGons and for new faciliGes or new product
•  Warranty performance (where applicable);
•  IdenGficaGon of potenGal field failures idenGfied in FMEA
•  Actual field failures and their impact on safety or the environment.


9.3.3.1 Management Review outputs – supplemental

•  document and implement an acAon plan when customer
performance targets are not met.
10.2
Nonconformity
and correcGve
acGon
10.3
10.1
ConGnual
General
improvement
10
Improvement
10. IMPROVEMENT

Clause 10: Improvement
10.1 General (adopted from ISO 9001:2015)

•  address future needs and expectaGons;
•  correcGng, prevenGng or reducing undesired effects;
NOTE Examples of improvement can include correc<on,

correc<ve ac<on, con<nual improvement, breakthrough
change, innova<on and re-organiza<on
10.2.3 Problem solving (earlier 8.5.2.1)

§  Understand process established for problem solving & use
prescribed format. Demonstrate capability to use quality tools
like
§  Pareto Analysis
§  F/B Diagram and
§  Why-Why Analysis
§  Either make separate process OR Work InstrucAon / Guideline
supporAng CorrecAve AcAon Process

10.2.3 Problem solving (earlier 8.5.2.1)
Following Logical Problem Solving Steps have been defined:
containment, interim acAons, and related acAviAes necessary for control of

nonconforming outputs
root cause analysis, methodology used, analysis, and results;
systemic correcGve acGons, including consideraGon of the impact on similar

processes and products;
verificaGon of the effecGveness of implemented correcGve acGons;
reviewing and, where necessary, updaGng the appropriate documented

informaGon (e.g., PFMEA, control plan).
Use customer specific prescribed processes, tools, or systems

10.2.4 Error proofing (earlier 8.5.2.2)

Prepare List of Error Proofing Devices;
Ensure they are referred in PFMEA
Include these control in Control Plan & also define reacAon plan
of device these failures
Keep records of their tesAng for failure or simulated failure.
1.  Defining Error Proofing devices in FMEA/Control : APQP Team
2.  Testing of Error Proofing devices: Production/QA

LIST OF ERROR PROOFING IMPEMENTED IN ----------------------- AND THEIR EFFECTIVENESS MONITORING PLAN
Department Month;
Sr. Machine/ Pot . / Actual Error Related Prev. / TesGng/ Res. ReacGon 1 2 3
No. Equip. failure or proofing to Det. VerificaGon plan /
Descrip. situaGon / details / (Quality Freq. Alternate
charact. to be Devices /Safety) method if
controlled used mistake
through error proofing fail
proofing
1 Grease To prevent rise PLC Quality Prev. Once / Year Maint. OpGcal

Cooking & Fall in Control & Safety Temp.

Oven cooking Sensors
Temperature
beyond
tolerance limit
Master Pieces (Challenge Part) Control

Challenge Fixture ID / Control method Frequency of Resp. Date Shig
Part details Serial No. (VerificaGon / (verificaGon/
calibraGon) calibraGon)

10.2.5 Warranty management systems
•  Implement a warranty management process; (follow
customer specified approach, where specified)

•  Process to include a method for warranty part analysis,
including NTF (No Trouble Found).
Implementation Responsibility: QA
END OF SESSION

IATF 16949-Transition Actions

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IATF

Quality Growth Services Pvt. Ltd.

Overview of IATF 16949

Risk Based Thinking

IATF 16949- Changes to Focus & by whom

Quality Growth Services 1

First ediGon: Second ediGon: Third ediGon: First ediGon:

Approach of IATF 16949

Key is to engage three gears

Quality Growth Services 2

ISO/TS 16949: 8 Clauses & ISO

Model of ISO 9001: 2015

Needs and CHECK

Quality Growth Services 3

Implementation Responsibility: All Departments

6.1.2.1 : While doing Risk Analysis

Quality Growth Services 4

Personnel of company should be aware about

an employee code of conduct, and

an ethics escalaAon policy ("whistle-blowing policy").

Implementation Responsibility: HR & All HODs

4.4..1.2 Product Safety

Quality Growth Services 5

Linkage of Quality Policy with Vision & Mission

Policy to be made available to the relevant Interested

5.3.1 Ensuring Customer Req. are met

Deﬁne who will interact with customers for following &

5.3.2 Authority to stop producGon : QA Team

Quality Growth Services 6

6.1.2.3 : Prepare plan for tesGng conGngent condiGons

Res: Production, Maintenance, Purchase, HR/Admin & IT

Quality Growth Services 7

AcAon plan for objecAves to be prepared. Which

What resources will be required

Who will be responsible

When it will be completed

How the results will be evaluated

Implementation Resp : All HODs

Quality Growth Services 8

7.1.2 PEOPLE: Keep records of number of

7.1.3 INFRASTRUCTURE : Maintain details of

IDENTIFICATION AND MONITORING OF OPERATIONAL ENVIRONMENT

1 IlluminaGon Minimum Minimum AutomaGc ON/OFF Elect OK

2 Noise Level 60 dB 90 dB PPEs as deﬁned for high Mech OK

7 Waste Disposal Zero Waste Zero Waste Bins at designated Mech/Elect OK

Quality Growth Services 9

{Details related to Hardware (machines /equipment/drives/motors/transformers etc.), UGliGes, Material TransportaGon

In case, Present CondiGon of exisGng infrastructure quanGty available is

1 Tunnel Furnaces OPRN/MECH/ 2 2 0 OK

2 TF Blower motors ELECT 12 12 0 OK

3 TF Roller drives ELECT 435 410 25 OK

5 TF Actutators ELECT 202 202 0 OK

7.1.3.1 Plant Facility and Equipment Planning

Quality Growth Services 10

CalibraAon / VeriﬁcaAon Records to include:

• Check that Associated standard’s last calibraAon

Implementation Resp : QA, Engineering &

Socware and Control

Quality Growth Services 11

Verify that cerAﬁcate issued for

7.1.6 OrganizaGonal Knowledge

Determine the knowledge for operaAon of its processes

Maintain the knowledge

Make knowledge available to the extent necessary

•  Check that Associated standard’s last calibraAon

•  what it will communicate

•  The product gets stronger (good)

•  Software is made easier to use (good)

•  As a part of APQP/Change Requirements, ensure :

•  Prepare Special CharacterisAcs symbol conversion

•  Special characterisAcs for product and manufacturing process;