Process Failure Mode And Effects Analysis

PFMEA

4th Edition issued in June, 2008

Mohamed Toubar
SQE- Electrical&HVAC / GM Egypt

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Introductions

• Name
• Job title
• Experience with PFMEA
• Expectation from today’s Training.

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Agenda

• Summary and definition.

• Process Flow diagram assessment.
• Links between flow diagram / PFMEA / Control Plan.
• FMEA creation and audit.
• Risk Reduction.
• Workshop: Process Flow diagram & PFMEA Plant.
• Wrap – up.

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FMEA – What does this
Acronym mean?
F Failure
M Mode and
E Effects
A Analysis

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 Design Vs. Process FMEA

Design FMEA
• Main focus is on design of the product and specifications which enable
the product to meet the intended use.

Process FMEA
• Main focus is on the manufacturing process which will allow the
product to be made repeatedly to the print design specifications.
• Utilizes process knowledge and historical process data to identify and
help eliminate potential process failure modes.

The thought pattern for development is identical.

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 What is the FMEA purpose?

Identify potential failure modes and its causes in

order to APPLY..
PREVENTIVE ACTIONS avoiding the non
conformace of products

Preventive Tooling

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 When should we generate a FMEA?

There are three basic cases which FMEA’s are generated depending on the
scope and focus:
1st Case: New designs and new technology, or new process.
The FMEA target: the design, technology, or complete processes.
2nd Case: Design modifications, or process modifications.

The FMEA scope should be the design changing, or process changing with
focus on possible interactions due to modifications and field occurrences, as
well as past lessons learned.

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 When should we generate a FMEA?

3rd Case: The use of a design or a process which already exists in a new
environment, new location, or new application.

The FMEA scope is the impact in this new environment, or how the new
location could interfere in the design, or even in an existing process.

The FMEA is a dynamic document and it should always reflect the most
updated level, as well as the most recent relevant actions, including those
occurred after the start of regular production.

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 Lessons Learned
• 25% of our Spills were driven by change
-Process
-Product
-New Model Year Launches
-Tool Moves

• Most Spills could have been avoided if

defined processes had been followed
 Exercise

In your teams come up with a situation and example of the following terms, to
explain them to some one who has never herd of PFMEA

Failure Mode >> The reason something did not work as required

Effect >> What you would notice or experience because of the failure

Cause >> What made the failure occur

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 Flow of Cause and Affect

CAUSE Le
ad
s To

Du
eT
o
FAILURE
MODE Re
s ult
s In

EFFECT

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 

Process FMEA – Purposes



• Identify and evaluate the process functions and requirements.

• Identify and evaluate potential product and process-related failure modes, and
the effects of the potential failures on the process and customers.

• Identify the potential manufacturing or assembly process causes.

• Identify process variables on which to focus process controls for occurrence

reduction or increased detection of the failure conditions.

• Enabling the establishment of a priority system for preventive/corrective

action and controls.
• Documentation of company Know how

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 Process FMEA - Development
• It should be initiated before or at the feasibility stage, and immediately after the product
design.

• It should be initiated before tooling for production.

• It should take into account all manufacturing operations from individual components to
assemblies.

• It should include all processes within the plant that can impact the manufacturing and
assembly operations, such as shipping, receiving, transporting of material, storage,
conveyors or labeling.

• The PFMEA starts with a list from which it is expected from the process, the process
target.

• It should be initiated by the manufacturing flow, and it should identify the product
and/or process characteristics related to each operation.

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 When to do a FMEA?
CONCEPT PRODUCT QUALITY PLANNING TIMING CHART
INITIATION PROGRAM
/ APPROVAL
APPROVA PROTOTYPE PILOT LAUNCH
L
PLANNING
PLANNING
DFMEA
PRODUCT DESIGN AND DEV.
PFMEA
PROCESS DESIGN AND DEVELOPMENT

PRODUCT & PROCESS VALIDATION

PRODUCTION

FEEDBACK ASSESSMENT AND CORRECTIVE ACTION

Planning
INPUTS Product Design &
| Dev. INPUTS
Planning | Process Design &
OUTPUTS Dev. INPUTS Product & Process
Product Design & | Validation INPUTS
Dev. OUTPUTS Production
Process Design & | INPUTS
Dev. OUTPUTS Product & Process |
Validation OUTPUTS Production
OUTPUTS

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 Process FMEA - Development
FLOW DIAGRAM

STORE
MOVE
OPER

INSP.
STEP
#

3
PFMEAs
4

6 POTENTIAL
FAILUREMODEA NDEFFECTSANALYSIS
FMEANumber 1

(PROCESSFMEA) Page of

Item 2 ProcessResponsibility 3 PreparedBy 4

Model Year(s)/Vehicle(s) 5 KeyDate 6 FMEADate(Orig.) 7

CoreTeam 8

7 ProcessFunction Potential Failure

SC
Potential Effect(s) E L PotentialCause(s)/
O
C
D R.
E P. Recom mended Responsibility
ActionResults 22
Actions S OD R.
Requirements M ode of Failure VA Mechanism(s) of C Current ProcessControl T N. Action(s) &Target Taken E COP.
9 10 11 12 S Failure U 16 E 18 19 CompletionDate 21 V CT N.
S 14 R C 20
13 15
17

• “PICTURE” OF PROCESS JOB

• SHOWS FLOW OF PROCESS
• FOUNDATION FOR PFMEA,
CONTROL PLANS, TOOL CONTROL
LAYOUTS, WORK STATION PLAN
LAYOUTS, ET.
• LISTS EACH OPERATION
• CURRENT CONTROLS
• ENHANCED CONTROLS FROM RECOMMENDED
ACTIONS INST JOB
PER OPERATION: RUC
• KPCs, KCCs TION
S
• INSPECTION FREQUENCY
• GAGE & CHECKING DEVICES
• REACTION PLANS FOR NON-
CONFORMING PRODUCT
PER OPERATION:
• INSPECTION FREQUENCY
• GAGE & CHECKING DEVICES
• REACTION PLANS OF NON-
CONFORMING PRODUCT

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PROCESS FLOW DIAGRAM
in PFMEA
IMPORTANCE OF FLOW DIAGRAMS

• Usually the First “Picture” of a Process

• Provides a logical pictorial which represents the Flow of the
Process
• Used as the Foundation for PFMEAs, Control Plans, Tooling
Layouts, Work Station Layouts, Etc…
• All Operations should be shown, including Inspection,
Gauging Operations and Rework and Scrap Areas.
• The flow diagram will indicate where in the process potential
failures may occur.
• The diagram should also identify all process streams.
• A process flow diagram describes the flow of the product through the process – from
incoming to outgoing. This should include each step in a manufacturing or assembly
process as well as their related outputs (product characteristics, requirements,
deliverables, etc.) and inputs (process characteristics, sources of variation, etc.).

• The initial flow diagram is generally considered a high level process map. It needs more
detailed analysis to identify the potential failure modes.

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Example of a
Manufacturing Process
Flow Diagram

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 Flow Diagram Quick Checklist
Recommended Base Requirements of a Process Flow Diagram
• Manufacturing Process Title
• Numbering/Lettering Scheme
• Include ALL Operations
– Shipping, receiving, transportation, storage
– Gagging & KPC related operations
– Rework areas
– Scrap areas
– Labeling
• Key for Symbols; consistent use
Other sources of information useful as inputs for the team
that is developing the PFMEA:

• The DFMEA (If Available) / Drawings and design records.

• Bill of process.
• Any existing Standardized Work Documents (SOS, JES, process sheets, checklists from
similar processes)
• Error proofing master list.
• Internal and external (customer) nonconformances (i.e., known failure modes based on
historical data).
• Quality and Reliability History.
• Lessons that have been learned from previous product and process design implementation.

• Any information available that establishes best practices including items such as guidelines
and standards or standard part identification.

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Other sources of information useful as inputs for the team
that is developing the PFMEA:

• Quality performance information available from similar, previous product and process
designs, which may include:
- Process yield.
- First time capability.
- Parts per Million (PPM).
- Process capability indices (Cpk and Ppk).
- Warranty metrics.

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 The Process FMEA Cross Functional
Team
 At the beginning of the Process FMEA development the responsible
engineer shall involve directly and actively all representatives related to the
manufacturing process.

 These areas should include the following representatives: design, assembly,

manufacturing, materials, quality, technical assistance, maintenance (when
applicable), tooling (when applicable), gages (when applicable), laboratory
(when applicable), and suppliers, as well as the next operation responsible
representative.

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 What is the definition of each field in the PFMEA?

FMEA Number
Fill in the FMEA number which may be used for traceability.

Item
Fill in the name and component, subsystem, or system number under
analysis. (ex. Front door LH)

Process Responsible
Fill in the Original Equipment Manufacturer (OEM) name, department,
and group. If the supplier is known include its name.

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 What is the definition of each field in the PFMEA?

Prepared by
Fill in the name, telephone, and the responsible FMEA’s engineer
enterprise.
Model Year (s) Program(s)
It specifies the model year(s) / intended program(s) that will be applied, or
be affected by the process being analyzed (if known).
Key Date
Enter the initial PFMEA due date, which should not exceed the scheduled
start of production date. In case of a supply organization, this date should
not exceed the customer required Production Part Approval Process
(PPAP) submission date.

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 What is the definition of each field in the PFMEA?

FMEA Date
The date in which the initial FMEA was compiled and its last revision
date.
Core Team
List the names, departments, and responsible people which have the
authority for the identification, and / or realization of the tasks.

Note: It’s recommended the description of each team member name,

department, telephone number, address, etc. to be included in the
distribution list.

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 What is the definition of each field in the PFMEA?

Process Step / Process Function: it is the summarized process description, or operation

under analysis.
Ex: OP 10 / Welding of the hoop and the disc.
Notes:

1- It is recommended to record the number which corresponds to the process / operation,

for each step under analysis.

2- It is recommended to indicate concisely the process / operation purpose under analysis,

including additional information about the design system, subsystem, or component when
applicable.

3- Where the process has several operations (ex.: assemble) with different failure modes, it is
recommended to list each operation in separate.

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 Detailing the Process Function
( Verb – Noun )
Process Step Process Function ( s )
( List the Process Step to be studied ) ( Verb – Noun )
- Employee Picks Up Cover Pick-up Cover

- Employee Engages Edge of Cover to Final DVD Engage Cover

Assembly

- Employee Finishes Placing the Cover on the DVD Place Cover

- Employee Picks up Two Screws Pick-up Screw

- Employee Picks up Screw Gun Pick-up Gun

- Employee Fastens Cover to the Final DVD Torque Screw

Assembly with the Screws
What is the definition of each field in the PFMEA?

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 What is the definition of each field in the PFMEA?

Requirements: are the inputs to the process specified to meet design intent
and other customer requirements.
• If there are multiple requirements with respect to a given function, each
should be aligned on the form with the respective associated failure modes
in order to facilitate the analysis.
Potential Failure Mode: the manner in which the process could potentially
fail to meet the process requirements (including the design intent).
Ex.: Weld porosity.

• List the potential failure mode(s) for the particular operation in terms of the
process requirement(s) (e.g., as documented in the process flow diagram.)

Assume that the failure could occur but may not necessarily occur.

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 What is the definition of each field in the PFMEA?

• Potential failure modes should be described in technical terms, not as a symptom noticeable by
the customer.

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 What is the definition of each field in the PFMEA?

• If the requirements have been well defined, then the potential failure mode is
readily identifiable by determining the condition when a specific requirement is not
met.

• Each requirement may have multiple failure modes, so a large number of failure
modes identified for a single requirement usually indicates that the requirement is
not well defined.

• Other examples of Potential Failure Modes: dirty; broken; mislabeling; lack of

component; lack of adjustment; rusted; leakage; etc.

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 What is the definition of each field in the PFMEA?

Potential Effect of Failure: Potential effects of failure are defined as the effects
of the failure mode as perceived by the customer(s).

• The customer(s) in this context is not the final user only, could be the next
operation, subsequent operations or locations, the dealer, and/or the vehicle
owner.

• The product effects in the PFMEA should be consistent with those in the
corresponding DFMEA.

• For the End User, the effects should be stated in terms of product or system
performance. If the customer is the next operation or subsequent operation(s) /
location(s), the effects should be stated in terms of process / operation
performance.

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 What is the definition of each field in the PFMEA?
• In order to determine the Potential Effect(s), the following questions should be
asked:

1- Does the Potential Failure Mode physically prevent downstream processing

or cause potential damage to equipment or operators?
Examples: unable to assemble at specific operation; unable to attach at customer
facility; unable to connect at customer facility; causes excessive tool wear at
determined operation.

2- What is the potential impact on the end user?

• Independent on any controls planned or implemented including error or mistake-
proofing, consider what the End User would notice or experience. Examples: noise;
high effort; unpleasant odor; intermittent operation; water leak; rough idle; unable
to adjust; difficult to control; poor appearance.

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 What is the definition of each field in the PFMEA?

3. What would happen if an effect was detected prior to reaching the End
User?

• The potential effect at the current or receiving locations also needs to be

considered. Examples: line shutdown; stop shipment; 100 % of product
scrapped; decreased line speed; added manpower to maintain required line
rate.

• If more than one potential effect is identified when considering questions 2

and 3, all may be listed, but for purposes of the analysis, only consider the
worst case when documenting the resulting Severity ranking.

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 What is the definition of each field in the PFMEA?

Severity:
• Severity is the value associated with the most serious effect for a given
failure mode.

• Severity is a relative ranking within the scope of the individual FMEA.

• The team should agree on evaluation criteria and a ranking system and
apply them consistently, even if modified for individual process
analysis. As a common language, it is strongly recommended to use the
severity ranking as specified on AIAG FMEA manual.

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Classification:
• This column may be used to highlight high priority failure modes or causes
that may require additional engineering assessment.

• This column may also be used to classify any special product or process
characteristics (e.g., critical, key, major, significant) for components,
subsystems, or systems that may require additional process controls.

• Customer specific requirements may identify special product or process

characteristic symbols and their usage.

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Potential Cause(s) of Failure(s) Mode:

• Potential cause of failure is defined as an indication of how the failure could

occur, and is described in terms of something that can be corrected or can be
controlled.

• Potential cause of failure may be an indication of a design or process

weakness, the consequence of which is the failure mode.

• There may be one or more causes that can result in the failure mode being
analyzed.

• The cause should be detailed as concisely and completely as possible.

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Occurrence:

• Occurrence is the likelihood that a specific cause of failure will occur.

• Estimate the likelihood of occurrence of a potential cause of failure on a 1 to

10 scale.

• The “Incident per items/vehicles” is used to indicate the number of failures

that are anticipated during the process execution.

• Occurrence should be estimated using a 1 to 10 scale based upon FMEA

AIAG manual table as a guideline.
• If no history available for a failure mode, then occurrence is automatically 10.

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Current Process Control:

• Current Process Controls are descriptions of the controls that can either
prevent to the extent possible, the cause of failure from occurring or detect
the failure mode or cause of failure should it occur.

• There are two types of Process Controls to consider:

- Prevention: Eliminate (prevent) the cause of the failure or the failure

mode from occurring, or reduce its rate of occurrence.
Ex.: Preventive Poka Yoke; Statistical Process Control (SPC)

- Detection: Identify (detect) the cause of failure or the failure mode,

leading to the development of associated corrective action(s) or counter-
measures.
Ex.: Detective Poka Yoke; Process Control Plan

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Detection:
• Detection is the rank associated with the best detection control listed in the
Detection Controls column (Lowest ranking).

• Detection is a relative ranking within the scope of the individual FMEA.

• In order to achieve a lower ranking, generally the planned detection control

has to be improved.
• Detection should be estimated using AIAG FMEA table as a guideline.

• To improve Detection Ranking, generally, the process control management

should be changed.

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 Risk Priority Number (RPN):

RPN = Severity (S) x Occurrence (O) x Detection (D)

• Within the scope of the individual FMEA, this value can range between 1 and
1000.

• The use of an RPN threshold is NOT a recommended practice for determining

the need for actions, so it also will depends on Severity ranking.

• Applying thresholds assumes that RPNs are a measure of relative risk (which
they often are not) and that continuous improvement is not required (which it
is).

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• For example, if the customer applied an arbitrary threshold of 100 to the
following, the supplier would be required to take action on the characteristic B
with the RPN of 112.

• In this example, the RPN is higher for characteristic B than characteristic A.

However, the priority should be to work on A with the higher severity of 9,
although its RPN is 90 which is lower and below the threshold.
• There is no specific RPN value that requries mandatory action. i.e; PFMEA is a
live document..

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 Recommended Action(s):

• In general, prevention actions (i.e., reducing the occurrence) are preferable to

detection actions. An example of this is the use of process design error proofing
rather than random quality checks or associated inspection.

• The intent of any recommended action is to reduce rankings in the following

order: severity, occurrence, and detection.

To Reduce Severity (S) Ranking: Only a design or process revision can bring
about a reduction in the severity ranking.

To Reduce Occurrence (O) Ranking: To reduce occurrence, process and

design revisions may be required.

To Reduce Detection (D) Ranking: The preferred method is the use of

error/mistake proofing.
Increasing the frequency of inspection is usually not an effective action and
should only be used as a temporary measure to collect additional information on
the process.

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• As a common practice when the severity index is 9, or 10, a special attention must be
done to assure the risks accosted by actions, current design controls, or corrective
actions are independent on the RPN.

• In overall terms when an identified potential failure effect could be dangerous to the
assemble/manufacturing people, preventive/corrective actions should be adopted as
recommended actions to avoid the failure mode.

• For process actions, the evaluation may include but is not limited to a review of:
* Modified process flow diagram, floor plan, work instructions or preventive
maintenance plan.
* Review of equipment, fixtures or machinery specifications.
* New or modified sensing / detection device.

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Responsibility and Target Completion Date:
• Enter the name of the individual and organization responsible for completing each
recommended action including the target completion date.

• The process-responsible engineer/team leader is responsible for ensuring that all

actions recommended have been implemented or adequately addressed.

Action Results:
• This section identifies the results of any completed actions and their effect on S, O, D
rankings and RPN.

Actions Taken and Completion Date:

• After the action has been implemented, enter a brief description of the action taken
and the effective completion date.

The New RPN Calculation:

• After the preventive/corrective action has been completed, determine and record the
resulting severity, occurrence, and detection rankings. Calculate and record the
resulting action (risk) priority indicator.

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Refresh!
Maintaining PFMEAs:
• The PFMEA is a living document and should be reviewed whenever there is
a product or process design change and updated, as required. .

• Another element of on-going maintenance of PFMEAs should include a

periodic review.

• Additionally, in cases where either field issues or production issues, such as

disruptions, have occurred, the rankings should be revised accordingly.

Linkages:
• In the development of a PFMEA it is important to utilize the information and
knowledge gained in the creation of the DFMEA.

• One such connection is between the characteristics identified during the

DFMEA and PFMEA analysis.

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• Another connection is the relationship between potential design cause of failure
(DFMEA) and potential process failure mode (PFMEA).
Example: the design of a feature such as a hole can cause a particular failure
mode. The corresponding failure mode is the inability of the process to
manufacture the same feature as designed.

• While developing the PFMEA, it is the team’s responsibility to ensure that all
process related potential failure modes which lead to product related effects are
consistent between the DFMEA and the PFMEA.

• In addition to the list of Recommended Actions and their subsequent follow-up

as a result of the PFMEA activity, a Control Plan should be developed.

• When the team develops the Control Plan, they need to assure that the PFMEA
current controls are consistent with the control methods specified in the Control
Plan.

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How to audit a PFMEA
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Process FMEA check list
Customer or Internal Part No Revision Level

Yes No N/A Comment / Action Required Person Due

Question
Responsible Date
Was the Process FMEA prepared by a
1 cross functional team? Has the team
taken into account all customer specific
requirements, including FMEA
methodologies as shown in the current
edition of FMEA?

2 Have all operations including

subcontracted or outsourced processes
and services been considered?
Have all operations affecting customer
3 requirements including fit, function,
durability, governmental regulations
and safety been identified and listed
sequentially?
Were similar part / process FMEA’s
4 considered?
Have historical campaign and warranty
5 data been reviewed and used in the
analysis?
Have you applied the appropriate
6 controls to address all of the identified
failure modes?
Were severity, detection and
7 occurrence revised when corrective
action was completed?

Revision Date:
Prepared By:
Process FMEA check list
Customer or Internal Part No Revision Level

Yes No N/A Comment / Action Required Person Due

Question
Responsible Date
Do the effects consider the customer in
8 terms of the subsequent operation,
assembly and product?
Were customer plant problems used as
9 an aid in developing PFMEA?
Have causes been described in terms of
10 something that can be corrected and
controlled?
Have provisions been made to control
the cause of the failure mode prior to
11 subsequent or the next operation?

Revision Date:

Prepared By:
QSB (Quality System Basics) Audit

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 Mistakes Often Seen..
• Confusion between cause & effect
• Confusion between severity, detection & occurrence.
• Too few causes identified
• Actions not relevant or not validated
• Detection assessed too low for a visual inspection
• FMEA done only by the Quality manager the
night before a customer visit, an audit, initial
sample presentation…

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 DO AS YOU SAY
SAY AS YOU DO
YES, THIS MEANS EVERYTHING YOU DO

THE FMEA PROCESS CAN NOT HELP IMPROVE

ISSUES (CANNOT BE A PROACTIVE TOOL),
IF ALL THE FAILURE MODES ARE NOT RECORDED
IN THE DOCUMENTATION
WORKSHOP!
 Workshop Exercise – Process Flow Diagram

On the supplied process flow diagram

•Review your groups operations ( on the shop floor )
- Does it match the production process?
- Are there steps missing?
- Is there detail missing?

Make a list of the issues and differences.

 Workshop Exercise – Design Input / Requirement

• Review the supplied Drawings/Specs, get a understanding

of the requirements for the selected part.

• Make a list of all possible:

 Requirements
 Failure Modes
 Effects
 Causes
 Workshop Exercise – PFMEA
• Review the Suppliers PFMEA for ONE of your operations.
(how this operation, may affect any of the Customer Requirements?)

1. Are operations listed according to the Process flow diagram and to the physical
process on the line?
2. Are requirements specified according to the design?
3. Are all of your suggested failure modes listed ?
4. Are all of your suggested Causes listed ?
5. Are all the required process controls (prevention and detection ) identified

• Now review all the failure modes in your teams other operations on the supplied PFMEA
– Are there any further FM’s you can see if so add to list?

Any changes to process controls must be read across the

PFMEA Control Plan and Work instructions!!
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Overview
Q&A
Thank You for your time! 
Mohamed Toubar
+2 0111 001 47 47
mohamed.toubar@gm.com