Is this a new Level of current Level of difficulty to Level of complexity to

Clause Applicable Process(es) Justification Justification

requirement? implementation implement implement
1 = Fully implemented 1 = Not difficult 1 = Not complex
Yes/No/Partially
5 = Nothing in place 5 = Very difficult 25 = Very complex
4.0 Context of the Organization

4.1. Understanding A new structure of presentation

At a general level athe is needed. To describe the
the organization and Partially Plan strategic 2 requirements are incuded into 4 internal and external issues and 8
its context the Qmanual
influencies

Regular monitoring of internal New responsibilities, new

Plan strategic 5 4 20
and external issues is missing monitoring sheet.

4.2 Understanding the

needs and Yes Plan strategic 5 New topic 3 Team work to identify all 15
expectations of expectations and needs
interested parties

4.3 Determining the No 2 The actual scope is defined but 2 The scope it shoud be linked to 4
scope of the QMS not as IATF require internal and external issues,

Support function are not

4.3.1 Determining the Partially Strategie 2 documented and not included 2 There a just 4 support functions 4
scope of the QMS into the scope (quotation is (IT, SSM, Quotation, Accounting)
external process, SSM service

4.3.2 Customer
Need to evaluate a huge amount
speecifica yes Conceptie 5 CR are not included in the QMS 5 of information from CSR's 25
requirements
4.4 QMS and its no Strategie 2 The processes are defined 2 4
processes

4.4.1 no Strategie 4 Procesele sunt stabilite 2 New topic Risk and OPP 8

Responsabilitate pentru
conformitatea proceselor externe.
4.4.1.1 yes 5 notiune noua 5 Se asigura Conformitatea tuturor 25
proceselor si produselor prin
abordare bazata pe risc

Necesara dezvoltarea unui poces

Notiune existenta, cerinta in
4.4.1.2 yes 4 standard imbunatatita 5 de control al caracteristicilor 20
speciale

All main processes are Need to review the processes and

4.4.2 yes 1 documented 4 their own KPI's 4

5.0 Leadership

Still to define new Some jobs should be set on GM

5.1 yes 2 respoonsibilities for managers 5 JD 10
according to the

Actual GM is deeply involved to

5.1.1 Partially 2 demonstrate leadership 4 Risk base thinking is a new issue 8
5.1.1.1 Corporate Partially 2 Code of coduct exists 2 to organize an ethics escalation 4
responsibility policy

5.1.1.2 Process
effectiveness and no Manufacturing 1 TRS and Scrap analysis 1 - 1
efficiency

5.1.1.3 Process There is stated on each process

no All proceses 1 description the accountability and 0
owners responsibilities for each step

5.1.2 Customer focus no Customer satisfaction 1 Existing process 1 Implemented 1

5.2 Policy no Strategie 1 1 1

5.2.1 Establishing the no Strategie 2 Missing commitment to satisfy 1 2

Q Policy applicable requirements

5.2.2 Comunication of no Strategie 1 - 1 - 1

Q Policy

5.3 Organizational
roles, responsibilities no RU 1 - 1 - 1
and authorities

5.3.1 Organizational Missing responsibility to ensure

need to document the
roles, responsibilities no RU 5 that the customer requirements 2
assignment
10
and authorities are met
5.3.2 Responsibility
and authority for no RU 1 Reaction plan with 1 No further action needed 1
product requirements responsibilities is available
and corrective actions

6.0 Planning

All QMS should be revised and for

PFMEA set only the risks of the
6.1.1 yes Conceptie 5 products 5 each processs the risk should be 25
assesed

6.1.2 yes Conceptie 5 missing plan to set th R&O. 5 To identify and asses all risks 25

To collect all information from

6.1.2.1 Risk Analysis yes Conceptie 5 missing plan to set th R&O. 3 previous complains product 15
audits, scrap rework

6.1.2.2 Preventive Process already implemented,

Partially Conceptie 1 requeste by the previous version 1 Implemented 1
actions TS

A general CP is done. Need to go

6.1.2.3 Contingency Team work to identify all risks and
deeper and analyze internal and
Partially production 4 4 countermeasurements for all 16
plan external risks to all manufacturing products
processes
6.2.1 Quality
KPI set. Missing few, specific for
objectives and plannig Partially Strategie 3 actual standard 3 Team work to identify KPI 9
to achieve them

6.2.2 Quality KPI are defined. Remain to The actual KPI documentary does
objectives and plannig Partially Strategie 2 addapt them to the actual 4 not contain the resources needed 8
to achieve them standard to achieve KPI

6.2.2.1 Quality
objectives and plannig yes Strategie 5 The KPI are not linked to the 5 To get the targets from the 25
to achieve them- customer requirements. customers
suplemental

6.3 Planning of Change management is

no production 2 documented, but not 3 To find responsible 6
changes implemented

7.0 Support

7.1.1, Resources, no Strategie 1 Budget available 1 1

General

7.1.2 People no production 1 1 not required others 1

Missing records for information

7.1.3 Infrastructure no production 2 and communication technology 1 Existing external support 2
 feasibility commitment is not To build the team and manage
7.1.3.1 Infrastructure Partially Conceptie 3 done through a multidisciplinary 3 the changes of all processes 9
approach.

7.1.4 Environment for

Planning of the Working places is To take in consideration of all
the operation of no Conceptie 1 a running process 2 factors 2
processes

7.1.4.1 Environment for

the operation of no production 1 to keep clean the WP 3 Missing 5S 3
processes

7.1.5.1 Monitoring nd
measuring resources no Control si masurare 1 Implemented and running 1 Implemented 1
general

7.1.5.1.1 MSA no Conceptie 1 MSA Implemented and running 1 Implemented 1

7.1.5.2 Measurement no Conceptie 1 EMM are under control 1 Implemented 1

traceability

7.1.5.2.1.
To review the process and
Calibration/verification Partially Control si masurare 3 EMM process is existing, 1 document it 3
records
7.1.5.3 laboratory 0
requirements

To implement requirements for

adequacy, competencies, testing
7.1.5.3.1 Internal Partially Control si masurare 2 To define the laboratory scope 2 of the product, capability to 4
laboratory (documented, need updates) perform measurments traceable
to national standards,
requirements

7.1.5.3.2 External Partially Control si masurare 1 External laboratory accredited to 1 Implemented 1

laboratory ISO 17025

7.1.6 Organizational yes RU 3 The knowledges required for 3 To define all knowledges sources, 9
knowledge bussines running are not listed internal and external

Existing process, Competence list There is a lack of training proves

7.2 Competence no production 2 need updates 3 and missing of the training plan 6

7.2.1 Competence Partially production 2 process is already documented, 2 Process need adjustments 4

7.2.2 On-the-job training no production 1 on job training is running 1 Process need adjustments 1
 There is a documented process
7.2.3 Internal auditor Partially QMS 3 for auditing, but it does not 3 Only one auditor. 9
competency contain the methods to verify the
auditors competencies

7.2.4 Second party Short auditor list not required to

No special auditor for second
yes QMS 3 1 have any second party auditor as 3
auditor competency party audit ther is just one supplier

Existing process but it does not

To define a method to aware the
define a methode to aware the
people of their contribution to
7.3 Awareness Partially production 3 personal. Something already 3
the benefits of improvement
9
started with the product performance
destination

Mising documented information To define the employees impact

7.3.1 Awareness Partially production 4 that all employees are aware of 4 on product quality, 16
their impact on product quality

7.3.2 Employee
Missing documented process to
motivation and Partially production 5
motivate employees
5 To find motivation means 25
empowerment

7.4 Communication no servicii suport 1 Implemented and running 1 Implemented 1

7.5 Documented no QMS 1 Implemented and running. Only 1 Implemented 1

information terminology changed
 Implemented and running. Only
7.5.1 General no QMS 1 terminology changed 1 Implemented 1

7.5.1.1 QMS The documentation need a ful To identify all process to be

Partially QMS 3 updating to the new IATF 3 documented. To address the CSR 9
documentation structure and requirements in QMS (

7.5.2 Creating and Partially QMS 2 Existing. Need updates 3 To review the list and all 6
updating documentation codes

7.5.3.1 Control of
To define the availability and
documented no QMS 1 Existing. Need updates 3 protection 3
information

7.5.3.2 Control of
to add documents from external
documented no QMS 2 origins to the list 3 Identifying of all external 6
information

7.5.3.2.1 Record yes QMS 3 Missing record retention policy 3 To find a way to retain a massive 9
retention based on CR and legal req qty of information

7.5.3.2.2 Engineering Missing documented process to

yes Conceptie 5 describe the review and 5 To build a new process step 25
specification implementation of CR

8.0 Operation
 The production processes are
8.1 Operational planning Partially Conceptie 3 defined and the new ones follow 1 APQP status review 3
and control the APQP req. Missing risk analize
for customer requirements

8.1.1 Operational APQP already implemented to To gather all the information from
Partially Conceptie 3 add risk analysis for customer 4 12
planning and control requirements CR.

8.1.2 Confidentiality no 1 Contractual 1 Contractual 1

8.2 Requirements for product and services 0

Info for customer already

available
8.2.1 Customer - info relating to products New process which will include
no Comercial 2 - handling contracts 3 quotation and customer 6
communication - feedback communication
-customer property
- req for contingency actions

8.2.1.1 Customer no Comercial 1 languages agreed english 1 Implemented 1

communication

8.2.2 Determining the The regulatory and statutory req

are defined through APQP they To review for each product the
requirements for no Conceptie 1 are set in PFD CP and PFMEA. 5 CSR 5
product and services

8.2.2.1 Determining the The requirement should be

requirements for yes Conceptie 2 extended to environmental 1 IMDS active 2
product and services impact, recycling (IMDS)
8.2.3.1 Review of the
requirements for no Conceptie 1 PPAP implemented 1 Implemented 1
products and services

8.2.3.1.1 Review of the Documented deviation requests

requirements for no Conceptie 1 (waiver) are available when 1 Implemented 1
products and services needed to have on entire activity,
supplemental from PPAP to serial prod

8.2.3.1.2 Customer
No changes accepted for already
designated special no Conceptie 1 approved serial process 0
characteristics

8.2.3.1.3 Organisation Missing multidisciplinary Process update with

approach of feasibility
manufacturing Partially Conceptie 3 commitment. Missing TFC 5 responsibilities and team 15
feasibility gathering . To identify all CSR
validation

8.2.3.2Review of the To find a way to review the

Missing documented review of
requirements for Partially Conceptie 2 requirements 4 implementation of the 8
products and services requirements

8.2.4 Changes to
The changes in CR is already an TFC is done for each change
requirements for no Conceptie 1 implemented process 1 request 1
products and services

8.3 Design and development of products and services 0

8.3.1 Design and

Implemetation of a standardized
development of no Conceptie 2 Existing, not documented 3 follow up sheet 6
products and services
8.3.1.1 Design and Error prevention is more focused Implemented< documented
development of no Conceptie 4 than detection. Missing 2 process 8
products and services documented Process

8.3.2 Design and no Conceptie 1 Existing, not documented 3 Team to define the entire process 3
development planning

8.3.2.1 Design and Implemented, missing To document PFMEA CP and PFD

development planning no Conceptie 1 documented instruction for PFD 3 activities 3
supplemental PFMEA CP

8.3.2.2 Product design N/A 0

skills

8.3.2.3 Development of
products with N/A 0
embedded software

8.3.3 design and no Conceptie 1 Process design implemented 1 Running 1

development imputs

8.3.3.1 N/A 0
8.3.3.2 Manufacturing Partially Conceptie 3 New requirements for inputs 3 Error proffing is a must have 9
process design input

8.3.3.3 Special All SC to be included into the

Partially Conceptie 2 PFMEA To use signs for SC and 3 To identify all SC, set lists 6
characteristics deploy them to the operators

8.3.4 Design and Partially Conceptie 2 APQP already implemented 1 PPAP process used to validate the 2
development controls design

missing from MRM measurement To find a way to analyze

8.3.4.1 Monitoring yes Strategie 5 at specified stages during process 5 measurements at each design 25
design step

8.3.4.2 Design and The validation shall take in

no Strategie 1 PPAP implemented 1 consideration the CSR, standards 1
development validation and legal issues,

8.3.4.3 Prototype no Strategie 1 Control plan for Prototype is 1 Nothing to implement 1

programme available if required

8.3.4.4 no Strategie 1 PPAP implemented 1 Nothing to implement 1

 The process design outputs are
8.3.5 no Strategie 1 available (WI, Measuring reports, 1 Nothing to implement 1
Parameter sheets)

8.3.5.1 N/A 0

Already existing
Drawing, SC for product and
8.3.5.2 Manufacturing process, Tooling, PFD, MSA,
no Strategie 2 Capacity analysis, PFMEA,
process design outputs Maintenance plan, CP, WI,
Acceptance criteria, Poka yok
evalidation.
To define methodes for rapid
detection and correction of
2 4
process NC (Might be sampling
from CP?)

8.3.6 Design and no Strategie 1 Change process already set 2 To define actions to prevent 2
development changes adverse impact

The change process shall state:

8.3.6.1 Design and
development changes
- changes to be validated before
implementation
no Strategie 3 - after initial approval any 3 To implement the change 9
changes must be validated process
- validation must be done with
the customer when affect a CSR

8.4 Control for externally provided processes, products and services 0

8.4.1 General no servicii suport 1 Implemented, 1 Nothing to implement 1

criteria for supplier evaluation are

set. To add the calibration Monitoring of the sorting
8.4.1.1 General no servicii suport 2 services into the supplier list, 2 companies 4
sorting companies
 Missing risk assesment of the
selected supplier to product
8.4.1.2 Supplier Assesing the risk
conformity and unintrerrupted
no servicii suport 3 4 Plan the evaluation os Supplier 12
selection process supply QMS
Missing evaluation of supplier
QMS

All requirements from 8.4.1.2 are

8.4.1.3 Direct buy yes servicii suport 5 not applicable to the customer 1 Nothing to implement 5
directed sources

8.4.2 Type and extent of The procedure should contain

no servicii suport 2 which control will be in place to 3 Defining of a supplier manual 6
control manage the supplier

8.4.2.1 Type and extent Incomplete information about

no servicii suport 3 controls applied and escalation 4 To define the escalation process 12
of control process

the identification of statutory and

8.4.2.2 Statutory and yes servicii suport 3 regulatory requirements need to 1 Only porcedure update 3
regulatory requirements consider the country of shipment
or delivery

8.4.2.3 Supplier quality The suppliers should be asked to To have a deep analyze of the
management system yes servicii suport 1 pass through several steps from 5 supplier 5
development 9001 to IATF certification

8.4.2.3.1 Automotive
product-related software
or automotive products N/A 0
with embedded
software
8.4.2.4 Supplier need to update the supplier To define the criteria and find a
Partially servicii suport 3 criteria based on the IATF 3 9
monitoring requirements way to monitor

8.4.2.4.1 Second-party yes servicii suport 3 No audit to supplier 4 How to include the second party 12
audits audit into the QMS

8.4.2.5 Supplier Supplier development based on

yes servicii suport 5 No supplier development 3 performance audit certification 15
development status and risk analysis

8.4.3 Information Partially servicii suport 4 No supplier manual 4 To collect all needed information 16
external providers to be passed to the suppliers

8.4.3.1 Information Partially servicii suport 4 No supplier manual 4 To collect all needed information 16
external providers to be passed to the suppliers

8.5 Production and service provision 0

8.5.1 Control of The information about the

product and the results to be
production and service no Realizare produs 1
achieved are available
1 Nothing to implement 1
provision Maintenance in place

8.5.1 Control of Suitable measuring eq is available

production and service no Control si masurare 1 The monitoring and measuring 1 nothing to implement 1
provision activities are in place
8.5.1 Partially Control si masurare 2 Action to prevent human error 1 Through PFMEA 2

Release delivery and post delivery

8.5.1 Partially Realizare produs 2 activities 2 Post delivery activities 4

8.5.1.1 Control plan no Conceptie 1 CP exist 1 Nothing to implement 1

8.5.1.2 Standardized
work - operator no Realizare produs 1 On going process 1 Nothing to implement 1
instruction and visual
standards

8.5.1.3 Verification of no Realizare produs 1 On going process 1 Nothing to implement 1

job set-ups

8.5.1.4 Verification after yes Realizare produs 4 No requirements in QMS related 5 To define all activities needed for 20
shutdown to the shotdown activities shotdown

8.5.1.5 Total productive To evaluate all maintenance

no Realizare produs 4 No documented procedure 5 activities and include them into a 20
maintenance procedure
8.5.1.6 Management of
production tooling and
manufacturing, test, Partially
inspection tooling and
equipmant
8.5.1.7 Production
scheduling
8.5.2 Identification and
traceability
8.5.2.1 Identification
and traceability
8.5.3 Property belonging
to customer ao external
providers
8.5.4 Preservation
8.5.4.1 Preservation
No documentation in place to To find the resources for
Realizare produs 4 define tool setups, tool 5 implementation 20
modification tool change program
no Realizare produs 1 Implemented 1 Nothing to implement 1
no Realizare produs 1 Implemented 1 Nothing to implement 1
no Realizare produs 1 labeling assure the back tracing. 1 Nothing to implement 1
Individual ID marked on each part
no Realizare produs 1 Implemented 1 Nothing to implement 1
no Realizare produs 1 Implemented 1 nothing to implement 1
no Realizare produs 2 Missing WI 1 Just document 2
8.5.5 Post delivery yes Realizare produs 2 Missing WI 1 to review the CSR Statutory and 2
activities regulatory req

8.5.5.1 Feed back of

Missing details about Field
information from Partially Produs neconform 2 returns into the procedure 2 Just document 4
services

8.5.5.2 Service
agreement with N/A 0
customer

8.5.6 Control of changes no Conceptie 1 Change process already set 1 Nothing to implement 1

8.5.6.1 Control of To describe how the changes are To update the procedure as IATF
Partially Conceptie 3 handled. 2 6
changes All changes followed by a trial run ask

8.5.6.1.1 Temporary
No alternate methods available To find resources for alternate
changes of process yes Conceptie 5 for already implemented CP's 5 methods 25
controls

8.6 Release of products no Control si masurare 1 Releasing is implemted process. 1 Nothing to implement 1
and services Startup process is running
8.6.1 Release of Partially Audit 3 Control Plan review/audit is not 3 Time and resources needed to 9
products and services done into a planned manner review and update all CP's

layout inspection to be set on Add a line at each CP. To ask

8.6.2 layout inspection no Control si masurare 2 each CP. To set frequency at 1 customer for frequency if not 2
Customer request available

8.6.3 Appearance items NA 0

8.6.4 Verification and

aceptance conformity of no servicii suport 1 incoming inspection is in place 1 Nothing to implement 1
externally provided
products and services

To retain records that proves the

8.6.5 Statutory and To identify the S&R from France
products are conform with
yes servicii suport 3 5 and ask for conformity proves. 15
regulatory conformity Statutory and regulatory req of HOW can we know the S&R ??
the country they are produced

Defect catalog available for each

8.6.6 Acceptance criteria no Conceptie 1 product 1 Nothing to implement 1

8.7 0

8.7.1 Control of no Produs neconform 1 Implemented process 1 Nothing to implement 1

nonconforming outputs
8.7.1.1 Customer
To identify a place where to
authorization for no Produs neconform 1 Implemented process 2 document the req 2
concession

8.7.1.2 Control of
nonconforming products no Produs neconform 1 Implemented process 1 Nothing to implement 1
- customer specified
process

8.7.1.3 Control of no Produs neconform 2 Training for continment available 1 Nothing to implement 2
suspect product but not specified into the process

8.7.1.4 Control of no Produs neconform 4 Risk analysis to perform rework 5 To identify the risks on each 20
reworked product product rework (PFMEA)

8.7.1.5 Control of N/A 0

repaired product

8.7.1.6 Customer no Produs neconform 3 The requirement is not 1 Documentation update 3

notification documented

8.7.1.7 Nonconforming Partially Produs neconform 5 Missing documented process to 5 To implement a new process 25
product disposition describe the NCP disposition
8.7.2 no Produs neconform 1 Implemented process 1 Nothing to implement 1

9.0 Performance Evaluation

9.1 .1 Monitoring,
measurement, analysis no management calitate 1 Audit process imlemented 1 Nothing to implement 1
and evaluation

9.1.1.1 Monitoring nd
measurement of The SPC is in place, the toolsa are To find the resources to analyze,
Partially Control si masurare 3 available, still not running 3 9
manufacturing process. react and implement CA
processes

9.1.1.2 Identification of no Control si masurare 1 QDAS available. SPC is included 1 Nothing to implement 1
statistical tools into CP and PFMEA

9.1.1.3 Aplication of QDAS implemented, process

no Control si masurare 1 known by the people involved in 1 Nothing to implement 1
statistical concepts capturing and analyze of the data

9.1.2 Customer no management calitate 1 Implemented process 1 Nothing to implement 1

satisfaction

9.1.2.1 Customer Focus on warranty management.

satisfaction - Partially management calitate 2 The customer satisfaction should 2 To implement the required KPI 4
Supplemental be analyzed through KPI
 KPI existing for each requirement To address the risks and manage
9.1.3 Analysis and Missing KPI related to the an AP with action taken to
no Strategie 3 effectiveness of action taken to 3 9
evaluation address the risks and eliminate the risks or reduce their
impact
opportunities

The KPI analyze should lead to an

improvement of customer
To make the prioritization of
9.1.3.1 Prioritization Partially Strategie 2 satisfaction. The actions should 2
actions
4
clasified and prioritized based on
this

9.2 Internal audit 0

9.2.1 Internal audit no Audit 1 Audit process implemented 1 Nothing to implement 1

9.2.2 Internal audit no Audit 1 Audit process implemented 1 Nothing to implement 1

9.2.2.1 Internal audit Prioritization based on risk,

no Audit 2 trends and critically of the 1 Documentation update 2
programme processes

9.2.2.2 QMS audit Partially Audit 2 QMS audit on 3 years calendar 1 Documentation update 2

The audit should take in

9.2.2.3 Manufacturing no Audit 2 consideration the implementation 2 Check list update 4
process audit of the process risk analysis. Focus
on shoft changes
9.2.2.4 Product audit no Audit 1 Implemented process 1 Nothing to implement 1

9.3 Management review 0

9.3.1 Management Partially Strategie 1 MRM in place 1 Nothing to implement 1

review

9.3.1.1 Management The frequency of MRM to be

Partially Strategie 2 increased based on risk to 1 Documentation update 2
review - supplemental compliance with customer req.

9.3.2 Management new inputs for MRM as adequacy

Partially Strategie 5 of resources, and effectiveness of 5 To define all inputs 25
review inputs action taken to address the R&O

9.3.2.1 Management
review inputs - yes Strategie 5 New imputs for MRM 5 To define all inputs 25
supplementa;

9.3.3 Management Partially Strategie 3 New definition of the outputs 3 To update the procedure as IATF 9
review outputs ask

Missing AP for that situation

To open a new AP sheet based on
9.3.3.1 Partially Strategie 3 when the customer targets are 2
customer satisfaction
6
not met

10.0 Improvement
 New topic, instead of Preventive
10.1 General Partially Produs neconform 2 actions now there is 5 To identify OPP for improvement 10
Opportunities for improvement.

The corrective actions are an

10.2.1 Nonconformity
Partially
and corrective action
It is taking in consideration entire
implemented process. Need to
Produs neconform 2 3 system not just manufacturing 6
take in consideration the risk and processes
opportunities

10.2.2 Nonconformity no Produs neconform 1 Implemented process 1 Nothing to implement 1

and corrective action

Activities exists but the process is Extension of the process over the
10.2.3 Problem solving Partially Produs neconform 4 not documented 2 entire QMS 8

Testing is done and record To identify all EP from PFMEA and

10.2.4 Error proofing Partially Conceptie 3 retained. Missing documented 3 set a reaction plan 9
process

10.2.5 Warranty N/A 0

management system

10.2.6 Customer
Analysis of complained parts is in
complaints and field no Produs neconform 1 place 3 Documentation update 3
failure test and analysis

10.3 Continual no Strategie 1 Output of MRM 1 Nothing to implement 1

improvement
 To set the start of the To set the PFMEA as a start for
10.3.1 Partially Strategie 3 improvement process from 2 C.imp. 6
PFMEA and risk matrix
 Action Required

To define the customer portofolio

Supplier network, contractual relationship, legal
requirements, Competitors. Changes in technologies

To document the organizational context

To include a review of it in the management review meeting

To define, direct customers, employees, suppliers, partners,

insurance, service providers, competitors, authorities, fire
brigades
To define all customer specific requirements
To define an internal Qmanual for supplier

To build the scope as a description of the processes,

products, external and internal issues,

To include the support function into the SCOPE.

To set exclusions is aplicable. If yes to be documented

To identify and set the CR into a matrix and add the risks for
each
The Specific CR related to the product to include in the
PFMEA
To build a process for evaluation of customer specific
requirements
To review process map and all processes. ALL processes shall
be Documented.
To set KPI for each process.
To address the risk and opportunities of all processes.
To organize the evaluation of each process (CODIR).
To set improvement criteria for each process

To implement risk base thinking on all product and processes

(PFMEA)

De documentat un proces de tinere sub control a produselor

si proceselor legate de siguranta produselor . To document a
process for control of product and processes

All processes shall be documented. All records that proves

the processes are being caried out as planned, shall be
retained.

Update the GM JD

GM have responsibility for QMS

GM assure resources
GM responsible for improvement
GM responsible for Policy and Objectives and KPI monitoring
TO implement Risk based thinking
to implement corporate responsibility policies.
Anti-bribery policy, ethics escalation policy

To review the job descriptions to align with the processes

responsibilities

Focus on Customer satisfacton

to review the policy and add the commitment

To set a documented decision for having a responsible person

to ensure that the customer requirements are met
About:
Special characteristic
Quality objectives
Training
Preventive actions
Capacity analysis
Logistic
Score cards
Portals
-

To adress the risks and opprortunities

for Internal and external issues
for each process
for each product (opp)

R&O plan to include

- actions
- effectiveness of the actions

Risk assesment based on impact over the producte, severity,

likelihood

Actions to focus on avoiding risk, eliminating the source,

changing the likelihood,
OPP means new practices, addresing new customers, new
tehnologies.

To review the PFMEA to include all specific risks from

previous defects, complaints field returns

To evaluate internal and external risks to all manufacturing

processes (by product). Contingency plan for continuity of
supply in the event of equipment failure, supply disruptions,
natural disasters, fire, labor shortage,
To review the Q Policy
To review all KPI and add new ones

To define the resources to achieve the KPI. WHAT, WHO,

WHEN, HOW, WITH WHAT.

To addapt the KPI to the customer requirements,

To promote them into the company
To review them for adequacy

Change process should be updated with the statement that

they will be carried out in a planned manner,
resources needed, responsibilities, the purpose and
consequences

To review the organigramm based on the new requirements.

To include in maintenance plan the information and

communication technology
To build a process for TFC, set responsibilities and team. To
include in PFMEA of each product the risks identified during
TFC and capacity planning

Factors to be taken in consideration when plan a WP

- social, psychological, physical

To implement 5S

MSA to be done on all measuring devices from CP, including

visual check.

To review the process of keeping under control of EMM,

based on the actual standard

A documented process is mandatory. To review the

information from the actual records and the requirements
from IATF
To implement the Laboratory Scope (already existing as a
documented infromation) Need to be up to date and trained

To retain proves for 17025 certification of the external labo

To set a list of existing and required knowledges based on

intelectual property, lesson learned from failure and succesful
projects, improvements, standards, knowledges from
customer or external providers

To get proves for training

To plan the 2017 training

To document the process for identifying of training needs

including awareness. And customer requirements

To add customer requirements in on job training

To have a Documented process to verify that the internal
auditor are competent taking in account any customer
specific requirements
To retain a list of auditors
The auditors shall have minimum competencies for process
aproach, risk base thinking, Customer req, Core tools, plan,
conduct report and close an audit
The process auditors should have technical knowledges
PFMEA CP
Product auditors should demonstrate competencies in
understanding of product requirments and measurement
methodes

To define the second party auditor list. They shall have the
same competencies like internal auditors

To include in training program information about the quality

policy, quality objectives, the implication of non conforming
with the QMS req.

Awareness on
- impact on product quality,
- importance in achieving improving quality and Customer
req
- risk to deliver nonconformities

To document the motivation and empowerment process that

include the promotion of quality and tehnological awareness
through organization
To revise the Process map
To revise all existing processes
To identify all needs to document
Quality manual is required but it can be a list of procedures
linked to the IATF requirements (matrix)
The link between procedures and IATF requirements is
mandatory
Need to show in QMS where the customer specific req are
addressed

Updating of the documentation list and the procedures, WI,

forms codes and revisions

To place the documentation on server as PDF's. To protect

the original Word file against the unauthorized changes

To be retained for entire time the product is active plus one

year
- PPAP
- tooling records
- process design
- purchase orders
- contracts
To add retention policy to the Document control process

To include the IATF requirements into the Conceptie process

- review, distribution, implementation of CR
- Changes related to product will follow 8.3.6 9001
- changes in processe will follow 8.5.6.1 IATF
- review of changes to be completed in 10 days
- changes to be reflected in all PPAP docs
To bulid the production process as it will contain
- requirements for product
- criteria for process and acceptance
- resources
- control
- retained documentation
- outsourced processes are under control

Additional to 8.1
- customer product requirements and tech spec
- logistic req
- TFC
- Project plan
- acceptance criteria

To document the Comercial process

To include the info for customer into the Comercial process

To review PFMEA and CP to add CSR

To build the process Conceptie
To define TFC steps
Validation by some methodes of TFC is mandatory
(production run) To include in Validation the CSR
To include capacity evaluation
Any change should pass through TFC

Prior PPAP a process audit in mandatory.

To analyze the posibility to implement EPC or LSR

To set a plan for design, VDA maturity level, proposed

To set comunication channels and reporting
To document the Design process. (PFD, PFMEA, CP, WI)

The project plan to include responsibilities, customer,

interfaces
Interfaces of Design planning - relationship between Quality
end Eng production and Customer

The PPFD PFMEA CP activities to be set under Conception

process and documented as WI
error proffing to be set on high risks. To include the inputs
into the Conceptie process

To make all SC lists available to operators

To organize internal meetings to follow the APQP status

during design stages.
To define the APQP team

To include into MRM report the measurement at different

design stages. APQP status might be the tool. The
measurement can include quality risks, costs, lead time, etc

To define the CSR, gather all standards and set them into the
document list
To add as an output the methodes for rapid detection of
process NC

To modify the existing procedure and add actions to prevent

the negative impact of the changes over the product

To review the entire Changes pocedure and set it accordingly

to IATF requirements

TEAM WORK to evaluate and monitor the supplier

To include the calibration and sorting companies into the

monitoring activities
To document a procedure for evaluation
To identify the risks on products and delivery
To evaluate the QMS of suppliers which have direct influence
on products
To add all IATF selection criteria into an evaluation sheet

To define which suppliers are already directed sources (CPS,

TRIGO, HOLLEN)

To implement a supplier manual where will be stated all the

requirements and control applied to the suppliers.

Documented process to identify the outsourced processes

and select the type of controls, based on risks. To include in it
the actions to escalate or reduce the type of control based on
performance and assesment of products.
The requirements for supplier to include internal and CSR

The documented procedure to include the identifing of the

statutory and regulatory req. To set and cascade the required
controls of requested by Customer

Need to identify all the suppliers and their certification status

Documented process to evaluate the supplier performance.
To align it to the IATF req
The customer evaluation which is affected by supplier
performace should be passed to the supplier

To document the type need and frequency of the supplier

auditing.
To set KPI for supplier, risk assesment. Product audit and
process audit

To include into the documented process the supplier

development

To build the suplier manual and include in it

- the product to be provided
- the approval for products
- methodes, processes
- compentence required
- subsuppliers
- controls
- validation activities

To add the statutory and regulatory requirements

Special characteristics
To cascade all these to all subsuppliers
To identify and include post delivery activities into the
production process

To include operator safety into the WI

To include in setup sheet info about the setup personal

To have a general WI for Shotdown

To include into the specific WI how should proceed

The maintenance system shall be documented.

To include:
- list of equipmants
- availability of spare parts
- resources
- packaging of machine tooling and gauging
- CSR
- KPI (OEE, MTBF)
- Review of maintenance plan and KPI to adress CA
- preventive maintenance
- periodic ovehaul
To set in place a procedure for tool control
To include :
Tool setups WI
Tool modification
Tool change program
Storage,
Recovery
Maintenance

To define an WI to include all IATF req

FIFO to apply
Obsolete product control
To define an WI based on 9001 req

To add a branch into the produs neconform procedure to

state details regarding of field failures and how to handle

Documented process to control and react to changes.

To document a process that manage the alternates methods

To maintain a list of controls that include the primary process
and alternate methids
To updare the CP procedure with the required audit/review /
updarte of CP.
To add an audit plan for CP review

To update all CP with layout inspection. Check with the

customer the frequency

To check and align the incoming inspection pocess with IATF

To retain proves thet the externally provided products are

conform to S&R req of the country they are purchased.
To identify the S&R req of suppliers and customers countries
To review and update the PN process and add the customer
concession

Controlled shipping requirements from customer should be

followed

Training required for containment to be documented into the

PN process

To document a process for rework and asses the risks into the
PFMEA
To retain records about the qty activity and traceability

To add the customer notification into the PN process

To document the NCP disposition procedure under PN

process.
To document an WI how to handle the SPC.
To set responsibilities and find resources.
If CpCpk unstable, need proves of 100% check
Keep records about tool changes, machine repair.
To set KPI Scrap%, OEE, and CpCpk for each manufacturing
process.

KPI to check and set into the List

- delivered part QTY performance
- customer disruptions
- field returns, recalls, warranty
- delivery performance
- Customer notification, special status
To be implemented KPI related to the effectiveness of action
taken to address the risks and opportunities

ImplementedKPI - Conformity of the products

- customer satisfaction
- QMS performance (KPI on each process)
- Action plan impementation effectiveness
- performance of the external providers
- need for improvements to QMS

To set the requirement into the MRM procedure

Need training on 19011 standard

Documented process. To set inputs, outputs, monitoring

criteria, planned activities

To arrange the QMS audit programme over 3 year period. To

include also the unplanned audits, when required by
negetive trends

To review and update the CL with risk analysis. To focus on

shift handover
To set into the MRM procedure the need to increase the
frequency of MRM when changes are in place that affect the
QMS

To align the MRM report template to the new IATF req

To align the MRM report template to the new IATF req

To align the MRM report template to the new IATF req

To update the file Action plan with a new sheet and add the
customer satisfaction based actions
To set based on PFMEA or risk matrix, an improvement
programm with the same frequency like MRM.

To update the process Corrective actions and align with the

new IATF requirements

To document the process problem solving . To extent on

QMS. The using of the customer tools is mandatory.
The systemic corrective actions become mandatory

Documented process. Error-proofing must be documented

into the PFMEA and test frequencies shall be documented in
the control plan.
Error proofing should be tested and records kept. Error
proofing device failure shall have a reaction plan

To update the process Reclamatii

Documented process. An improvement is considered
implemented when the process become stable and the
product characteristics are predictable.
Mandatory documents and records required by IATF 16949:2016
Scope of Quality Management System ( 4.3)
Documented process for the management of product safety related products and manufacturing processes ( 4.4.1.2)
Quality Policy ( 5.2)
Responsibilities and authorities to ensure that customer requirements are met ( 5.3.1)
Results of risk analysis ( 6.1.2.1)
Preventive action record ( 6.1.2.2)
Contingency plan ( 6.1.2.3)
Quality Objectives ( 6.2)
Records of customer acceptance of alternative measurement methods ( 7.1.5.1.1)
Documented process for managing calibration/verification records ( 7.1.5.2.1)
Maintenance and Calibration Record ( 7.1.5.2.1)
Documented process for identification of training needs including awareness and achieving awareness ( 7.2.1)
Documented process to verify competence of internal auditors ( 7.2.3)
List of qualified internal auditors ( 7.2.3)
Documented information on trainers competency ( 7.2.3)
Documented information on employees awareness ( 7.3.1)
Documented process to motivate employees ( 7.3.2)
Quality Manual ( 7.5.1.1)
Record retention policy ( 7.5.3.2.1)
Documented process for review, distribution and implementation of customer engineering standards/specifications ( 7.5.3
Registry of Customer Complaints ( 8.2)
Product requirements review records ( 8.2.3.2)
Procedure for design and development ( 8.3.1.1)
Record about design and development outputs review ( 8.3.2)
Records about manufacturing process design input requirements ( 8.3.3.2)
Document a process to identify special characteristics ( 8.3.3.3)
Records of design and development controls ( 8.3.4)
Documented product approval ( 8.3.4.4)
Records of design and development outputs ( 8.3.5)
Manufacturing process design output ( 8.3.5.2)
Design and development changes records ( 8.3.6)
Documented approval or waiver of the customer regarding the changes in design ( 8.3.6.1)
Documented supplier selection process ( 8.4.1.2)
Documented process to identify and control externally provided processes, products ( 8.4.2.1)
Documented process to ensure compliance with statutory and regulatory requirements of purchased processes, products (
Documented process and criteria for supplier evaluation ( 8.4.2.4)
Records of second-party audit reports ( 8.4.2.4.1)
Characteristics of product to be produced ( 8.5.1)
Control plan (8.5.1.1)
Total productive maintenance system ( 8.5.1.5)
Records of traceability ( 8.5.2.1)
Records about customer property ( 8.5.3)
Production change control records ( 8.5.6)
Documented process to control and react to changes in product realization ( 8.5.6.1)
Documented approval by the customer prior to implementation of the change ( 8.8.5.6.1)
Documented process for management of the use of alternate control methods ( 8.5.6.1.1)
Record of conformity of product with acceptance criteria ( 8.6)
Record of expiration date or quantity authorized under concession ( 8.7.1.1)
Documented process for rework confirmation ( 8.7.1.4)
Record on disposition of reworked product ( 8.7.1.4)
Notification to the customer about the nonconformity ( 8.7.1.6)
Documented process for disposition of nonconforming product ( 8.7.1.7)
Record of nonconforming outputs ( 8.7.2)
Monitoring and measurement results ( 9.1.1)
Internal audit program ( 9.2)
Results of internal audits ( 9.2)
Documented internal audit process ( 9.2.2.1)
Results of the management review ( 9.3)
Action plan when customer performance targets are not met ( 9.3.3.1)
Results of corrective actions ( 10.1)
Documented process for problem solving ( 10.2.3)
Documented process to determine the use of error-proofing methodologies ( 10.2.4)
Documented process for continual improvement ( 10.3.1)

NOT mandatory
Records of training, skills, experience and qualifications ( 7.2)
Procedure for determining context of the organization and interested parties ( 4.1 4.2)
Procedure for addressing risks and opportunities ( 6.1)
Procedure for competence, training and awareness (7.1.2, 7.2 and 7.3)
Procedure for equipment maintenance and measuring equipment ( 7.1.5)
Procedure for document and record control ( 7.5)
Sales procedure ( 8.2)
Procedure for production ( 8.5)
Warehousing procedure ( 8.5.4)
Procedure for management of nonconformities and corrective actions ( s 8.7 and 10.2)
Procedure for monitoring customer satisfaction ( 9.1.2)
Procedure for management review ( 9.3)
 Process to document Status
Strategie Not conform
Dezvoltare industrializare x Missing
Strategie To be reviewed
Strategie To be reviewed
Dezvoltare industrializare Missing
Not conform
incomplete
Strategie Not conform
Dezvoltare industrializare Missing
EMM x ok
EMM ok
RU x To be reviewed
RU x Missing
RU Missing
RU Missing
RU Missing
RU x Missing
QM To be reviewed
QM Missing
QM x Missing
QM ok
Dezvoltare industrializare To be reviewed
Dezvoltare industrializare x Missing
Dezvoltare industrializare Missing
Dezvoltare industrializare To be reviewed
Dezvoltare industrializare x Missing
Dezvoltare industrializare Missing
Dezvoltare industrializare To be reviewed
Dezvoltare industrializare To be reviewed
Dezvoltare industrializare To be reviewed
Dezvoltare industrializare To be reviewed
Dezvoltare industrializare To be reviewed
QM To be reviewed
Achizitii x Missing
Achizitii x Missing
Achizitii x Missing
QM ok
Dezvoltare industrializare Missing
Dezvoltare industrializare ok
Prod Missing
Prod ok
Prod ok
Dezvoltare industrializare To be reviewed
Dezvoltare industrializare x Missing
Dezvoltare industrializare TBD
Dezvoltare industrializare x Missing
Prod TBD
Prod TBD
Prod x Missing
TBD
QM ok
QM x Missing
Prod ok
Prod ok
QM ok
QM ok
QM x ok
Strategie ok
Strategie Missing
QM ok
QM x To be reviewed
Dezvoltare industrializare x Missing
Strategie x To be reviewed
The quality manual should include most of following elements:
title and table of contents
scope of the QMS
exclusions from IATF 16949
versioning information and approval
QMS description
the business process model of the organization
definition of responsibilities for all personnel
references to relevant documents and relevant appendices