FULL DAY PRODUCTION RUN REPORT

GENERAL INFORMATION:

Part Number: Part description: Drawing No / Issue:

Supplier: Process: Project No:
FDPR Audit No: Issuer: Issue Date:
Initial Process audit: Date: Result:
Follow up Process audit: Date: Result:

TitanX annual forecasted volume

PRODUCTION RESULT:

Process Yes / No ð YES

Operator training Product Yes / No ð YES
Safety Yes / No ð YES

Process capacity FDPR Target FDPR Results Status Comments

Number of hours FDPR OK
Parts produced OK
Number of shifts OK
Cycle Time / part (sec) OK
Number of operators OK
Daily capacity (Takt Time) OK
Set-up time (minutes) OK
Other…. OK

Process capability FDPR Target FDPR Results Status Comments

Line Reject N/A
Line Reject (PPM) #DIV/0! OK
Line Scrap N/A
Line Scrap (PPM) #DIV/0! OK
Reliability of equipment OK
Number and types of reworks OK
Other… OK

PROCESS AUDIT (during FDPR) Results : ð OK

PROCESS AUDIT (during FDPR) OR LATEST APPROVED PROCESS AUDIT:
Progress
Date for Audit Number of CRI = 0 Number of 0< CRI < 50 Number of 0 CRI = >50 Total Number of Applicable CRI
Indicator

Comments:
FDPR approved X
FDPR FINAL RESULT: FDPR approved under conditions
FDPR not approved

Next Full Day Production Run Date:

Supplier auditee Position Date and Signature

TitanX Auditor Position Date and Signature

INITIAL SAMPLES

Parts taken by auditor or kept by the supplier ( 1 parts will be kept by supplier):
Initial Samples traceability. Specific label with identification:
Other Comments:

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885362146.xlsx
 Audit Qualification YES/ NO

ents:

885362146.xlsx
885362146.xlsx
Supplier: Site : Performed by:

Technological family: Product: Date:

CRITERIA YES NO COMMENTS

No Chapeter 1: OAP.pp completed 0 0

1.1 RF and Quality Assurance File completed

1 Is the complete "File of Mandatory Requirements" (RF) avaliable?

©: The "File of Mandatory Requirements" shall be avaliable, up to date and approved.

In case of modification or carry over, check if QAF has been updated

2 Is complete Quality Assurance File (QAF) avaliable?

©: The QAF shall conform to the requirements specified @ stage 2 (RF)

and to what was accepted @ stage 3 by both parties.

1.2 Revisions and Changes

3 Analysis of any revisions, conserns expressed or changes made since stage 3?

©: The documentation may have changed (e.g. with respect to plans,

product and process FMEA, material specifications, survelliance plan,

or any other specific document). Examine any

concerns expressed during the acceptance @ stage 3. Check the updates.

Check that the FMEA rating is complete.

1.3 Validation Reports

4 Are reports avaliable for inhouse testing, inspection, validation of products,

and validation of production processes before manufacturing and submission of Iss (stage 5)?

©: e.g. check that equipment and tooling have been qulified

5 Characteristics in compliance to plans and specifications?

©: For periodic audits (existing process), check the full Initial Samples documentation

6 Cmk ≥2,0 and Cpk ≥1,67 for processes with critical R, or S characteristics?

©: If SPC is applicable, ensure that studies to check normal distrubution have been performed.
©: In the case of an existing product / process, Cpk shall be used (e.g. periodic or selective audits)

©: If SPC is not applicable or capability requirement not met, implement

Poka - Yoke or 100 % inspection

885362146.xlsx
 CRITERIA YES NO COMMENTS

Chapeter 2: Purchasing - Incoming product Storage 0 0

2.1 Purchasing and Incomming Product inspection

7 Are production supplies dependent on acceptance of IS?

©: Check each component / raw material of the reference being audited. Example of

lock-out mechanism: "Closed" order for IS. "Open/Blanket" order only after Iss have been accepted.

Identification and Traceability

8 Identification and traceability of material batches (lots) and components

with controlled, critical R or S characteristics?

9 Quality Status: AWAITING DECISION, ACCEPTED, REJECTED, ACCEPTED UNDER WAIVER,

REWORK, etc.?

©: Formats used linked to procedures

©: Origin of traceability, list of followed-up components defined?

2.2 Inspection Equipment

10 Suitable inspection equipment avaliable and calibrated?

©: In relation to the products, tolerances (Gage R&R, etc.) range etc.

2.3 Storage, Handling and Scheduling

11 Management of security (safety) stock of components and materials?

©: Existence, rotation, storage conditions, etc.

12 Rotation of stock (FIFO), expiry dates respected?

©: Perishable items.

2.6 External Operations (Subcontractors and Suppliers)

Product

13 Tracebility of R/S and critical characteristics?

Process

14 Initial samples accepted?

885362146.xlsx
 CRITERIA YES NO COMMENTS

Chapeter 3: Manufacturing Workstations 0 0

3.1 Work instructions

15 At each workstation and consistent with the surveillance (control) plan? Up to date and Applied?

©: Procedures and work instructions listed in plan

3.2 Internal Product Flow

16 Identifcation and traceability of work in progress during production (R=10 if R/S characteristic)

©: Identification: Partnumber, revision number, marking, visability, legibility, etc…

Traceability: Existence of a link between the source and destination of the product.

17 No risk of damage at the workstations and during transfers?

©: Packaging, handling equipment, intermediate storage areas, etc…

Transfer between lines are clearly defined and respected

3.3 Start of Propduction and Machine / Line Start-Up

18 Is there a procedure for authorizing the start of production?

©: Procedure applied at start-up, elimination

of parts used to set-up and tune equipment. Presence and conformance of production

start-up parts. Start of production: Long shut-downs, team

changeover, material lot changeover, reference changeover, etc…

19 Parameters affecting the process (external or internal)?

©: Identified, specified, under control, recorded, etc. Controlled

acess to machine settings (e.g. Temperature, air pressure, voltage, cleanliness, etc.).

20 Traceability through product markings?

©: Inspection stamp, date of manufacture, mold number, etc.

3.4 Production Equipment
21 Measurement and Inspection equipment?
©: Inspection equipment, calibration and master parts: recorded, operational
maintained, calibrated, R/R test, etc.
22 Control of incidents occuring during production?
©: E.g of production incidents: energy supply failures (electricity, water, air pressure…),
shortages of parts, materials or consumbles, tool equipment failures…
©: Modes of detection, reaction in case of failure, traceability, analysis, elimination
of non-conforming products and decision marking on WIP are described and respected.

23 Anti-error (Poka-Yoke) systems?

©: Planned, completed, operational. During the audit, check that

they are in place and effective.

885362146.xlsx
24 Special processes?

©: Continues monitoring of the process parameters, recording, guarantee that the operation has

been completed. Verification of special processes can only be verified by destructive testing.

3.5 Product Conformance

25 Identification of quality status: AWAITING DECISION,

ACCEPTED, REJECTED, ACCEPTED UNDER WAIVER, REWORKED, etc.?

26 Correct application of inspections based on (SPC) and management of

deviations with corrective actions? SPC rules applied correctly?

©: Management of process variability and process capabilities.

27 Final validation of the product before transfer to another location, sub-contrcting, or

release for external operations?

3.6 Equipment Maintenance

28 Second level maintenance (performed by Maintenance Department)?

©: Instructions, check lists, scheduling, recording, equipment life-cycle sheets,

existence and management of spare parts, measuremnt equipment etc.

3.8 Nonconformity Management

29 Is there a procedure for managing non-conformances?

©: Identification, isolation at the workstation, recording waivers,

rejections, quarantine, returns, etc.

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 CRITERIA YES NO COMMENTS

Chapeter 4: PACKAGING - STORAGE OF FINISHED PRODUCT - SHIPPING 0 0

4.1 Packaging

30 Use of instruction sheets for packaging?

©: In accordance with customer requirements (Packing Diagram), risk analysis.

CRITERIA YES NO

Chapeter 6: PERSONNEL - ENVIROMENT - SAFETY 0 0

6.1 Personnel

31 Personnel trained and authorised to perform the tasks required. Work instructions

and procedures understood and respected?

©: e.g. Authorised fork-lift driver, quality control, special resources.

Each operator (all in teams) is trained to: safety on workstations, all standard operating

modes of workstations (start up, quality, 1st level maintenance, supply,

first defect stop guidelines, R/S - critcal & subjective characteristics).

There is a regular requalification of operators for subjective caracteristics.

32 Flexibility and multi-competence skills measured and monitoried?

©: e.g Cross-training matrix

6.2 Enviroment and Safety

33 General Enviroment: Order, cleanliness, lightning, atmosphere, noise?

©: Floor marking, measured criteria from cleanliness, results displayed.

If noise level not conform to national regulation or Sanhua rule, actions to recover

must be implemented and followed up.

34 Safety rules displayed at the workstations and adhered to?

Final Result: Þ Missing Data

If you completed the document and the TOTAL Q 34 Total number of questions
final message is "Missing Data" or "Too
NB YES 0 Total number of YES answered
many answers", please check here that
(NB NA) + (NB YES) + (NB NO) = TOTAL NB NO 0 Total number of NO answered
Q

885362146.xlsx
 SUMMARY Audit No:
PROCESS AUDIT Date:

Choice
- INTERNAL AUDIT
- EXTERNAL AUDIT

INTERNAL AUDIT EXTERNAL AUDIT X

Vehicule : Supplier :
Part : Site :
Subject : Part number/Product family :
Site : Process:
Requested/Dpt.: Requested/Dpt.: SQA&D

Scope of process Audit :

AUDITORS AUDITEE
Dpt : Dpt :

Lead Auditor : Department :

Task Preparation started Audit Report Follow-up 1 Follow-up 2

SCHEDULE Planned
Completed 12/30/1899

INITIAL AUDIT FOLLOW-UP AUDIT

Date: N° 1: N° 2: #REF!
Number of CRI=0 104 #REF!
Number of 0 < CRI < 50 0 #REF!
RESULT Number of CRI > 50 0 #REF!
Total number of Applicable CRI #REF!
Progresse Indicator #REF!
Process Qualification YES NO YES NO YES NO

Positiv points:

NOTES :

Points to be improved:

SIGNATURE OF THE AUDITOR: SIGNATURE OF THE AUDITEE:

DISTRIBUTION : Purchasing Director, Group SQAD Director, Lead Category Buyer, Supplier.
Page 1/2
 Audit No : Follow-up : --
Supplier : 0
Process : 0
Part number/
Product family : 0
Date: 12/30/1899

AUDIT RESULT

SATISFACTORY ACCEPTABLE INSUFFICIENT Number

Number of Number of Number of of Risk indices
CRI = 0 CRI < 50 CRI > 50 evaluated
Chapter 1:

QAP.pp 9 0 0 9

Chapter 2:

Purchasing - Incoming goods - Storage 33 0 0 33

Chapter 3:

Manufacturing Workstations 31 0 0 31

Chapter 4:
Packaging - Storage of Finished
Products - Shipping 15 0 0 15

Chapter 5:
Inspection - Testing - Laboratory -
Metrology 8 0 0 8

Chapter 6:

Personnel - Environment - safety 7 0 0 7

Chapter 7:

Measurement of performances 1 0 0 1

TOTAL 104 0 0 104

LEVEL INDICATOR (LI) 0

PROGRESS INDICATOR (PI) 100%

(PI = NUMBER OF CRI=0 / TOTAL NUMBER OF CRI x 100)

Page 2/2
 PROCESS AUDIT QUESTIONNAIRE

Internal audit : Reference: Supplier : Prepared by :

External audit : X Reference: 0 Site : Date :

Rating of conformance C :
0 = Conformity to requirement (*).
4 = The requirement is taken into account but implementation is not systematic or not effective. Risk of failure not completely eliminated; preventive action
needed.
7 = The requirement is taken into account but solution is not implemented or without real application. Important risk of failure (product or process).
Corrective action needed.
10 = The requirement is not taken into account or, non conformity with a direct effect on the product; immediate countermeasure and corrective action are
mandatory.
(*) : Conformity to requirement of Quality Assurance File (solution planned in the QAF is implemented, is sufficient, is applied without deviation and is
followed up.

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

CHAPTER 1: Q.A.P.pp completed

1.1 RF and Quality Assurance File completed

1 1 Is the complete "File of Mandatory Requirements" (RF) available? ✘0 5 0 0 1

©: The "File of Mandatory Requirements" shall be available, up to date, and approved.

In case of modification or carry over, check if RF has been updated
1 2 Is complete Quality Assurance File (QAF) available? ### 10 0 0 2
©: The QAF shall conform to the requirements specified @ stage 2 (RF)
and to what was accepted @ stage 3 by both parties.
In case of modification or carry over, check if QAF has been updated
1 3 1.2 Revisions and Changes ### 5 0 0 3
Analysis of any revisions, concerns expressed or changes made since stage 3?
©: The documentation may have changed (e.g. with respect to plans,
product and process FMEA, material specifications, surveillance plan,
or any other specific document). Examine any
concerns expressed during the acceptance @ stage 3. Check the updates.
Check that the FMEA rating is complete.
1 4 Analysis of any critical points (if necessary) ? ### 5 0 0 4
©: For example, check that critical RPNs have been identified. The criticality
of each RPN is up to the judgment of the auditor. Verification of
corrective action implementation is dealt with in Question 53.

R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 1/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 1: Q.A.P.pp completed

1.3 Validation Reports

1 5 Are reports available for inhouse testing, inspection, validation of products, ### 10 0 0 5
and validation of production processes before manufacture and submission of ISs (stage 5) ?
©: e.g. check that equipment and tooling have been qualified.
(
1 6 Characteristics in compliance to plans and specifications? ### 10 0 0 6
©: For periodic audits (existing process), check the full
Initial Samples documentation.
7 Cmk ≥ 2.0 and Cpk ≥1.67 for processes with ### 10 0 0 7
critical, R, or S characteristics?
©: If SPC is applicable, ensure that studies to check normal distribution have been performed.
©: In the case of an existing product / process, Cpk shall be used (e.g. periodic or selective audits).

©: If SPC is not applicable or capability requirement not met, implement

Poka - Yoke or 100 % inspection.

Questions 8 and 9 apply only for audits of processes already in serial production
©: e.g. before transfer, during periodic audit.

1.4 Initial Samples File

1 8 All documents of Initial Samples Files as defined in the QAPpp check list are ### 10 0 0 8
available and approved ?
©: e.g. FPDR report, process audit report, Initial Samples test and inspection reports
Initial Samples approval record, packaging validation including back up packaging,
TitanX line testing records, full traceability of records vs Initial Samples, …
In case of modification or carry over, check if new I.S. have been presented and approved.

1.5 Quality Monitoring File

9 Quality monitoring file is available, complete and upadted ? ### 10 0 0 9
©: All records of continuous conformance testing as defined in the Surveillance Plan
are available (e.g. results of products audits, of functional testing)
©: Results of products audits and continuous conformance tests must be compared
with the ones of Initial Samples

TOTAL CHAPTER 1: Number CRI =0 : 9 Number 0<CRI<50: 0 Number CRI>/=50: 0 Total number CRI : 9
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 2/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

CHAPTER 2: PURCHASING - INCOMING PRODUCT - STORAGE

2.1 Purchasing and Incoming Product Inspection

2 10 Purchase orders with specific requirements? ### 5 0 0 10
©: Revision level included.

2 11 Are production supplies dependent on acceptance of ISs? ### 5 0 0 11

©: Check each component / raw material of the reference being audited. Example of 1
lock-out mechanism: "Closed" order for IS, "Open/ Blanket" order only after
ISs have been accepted.

2.1.1 Incoming Product Administration

2 12 Is there a procedure for administrative reception of products ? ### 5 0 0 12
©: This is a check that the delivery conforms to the purchase
order: Identification, revision, packaging, presence
of certificate of analysis, check on delivery note, inspection
stamp, shelf life, etc.

2 13 Is there a procedure for checking incoming deliveries ### 5 0 0 13

of special batches?
©: Prototypes, test batches, initial samples, pre-production
parts, etc. Check on waivers, modifications, etc.

2 14 Are incoming products kept in separate and formal areas? ### 5 0 0 14

©: E.g. Products to be inspected, products awaiting decisions, etc.
Areas formally identified / boundaries respected.

R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 3/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 2: PURCHASING - INCOMING PRODUCT - STORAGE

2.1.2 Products Subject To Incoming Inspection

2 15 Is there a procedure for incoming goods inspection? ### 10 0 0 15
©: The product ordered and the product delivered have the same
index of definition (revision level), inspection and test plans, sampling and acceptance
rules, analysis results, disposition of nonconforming product, archiving of records, ...

2.1.3 Products Subject To PQA Delivery

2 16 List of PQA'able and PQA'd products ? ### 5 0 0 16
©: Example: Computerized management of PQA, and the status of each reference.

2 17 Physical identification of PQA status? ### 5 0 0 17

2 18 Is there an audit procedure for incoming references? ### 5 0 0 18

©: Periodic audit of references subject to PQA. Does an audit schedule exist?

2 19 PQA documentation with revision numbers for each product family ### 5 0 0 19
(IS, preproduction, etc …) ?

2.1.4 Identification And Traceability

2 20 Identification and traceability of material batches (lots) and components ### 10 0 0 20
with controlled, critical, R or S characteristics?

2 21 Quality Status: AWAITING DECISION, ACCEPTED, ### 10 0 0 21

REJECTED, ACCEPTED UNDER WAIVER, REWORK, etc.?
©: Formats used linked to procedures.
©: Origin of traceability, list of followed-up components defined?

R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 4/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 2: PURCHASING - INCOMING PRODUCT - STORAGE

2.2 Inspection Equipment

2 22 Suitable inspection equipment available and calibrated? ### 10 0 0 22
©: In relation to the products, tolerances (Gage R&R , etc.), range, etc.

2 23 Special laboratory and measurement inspection performed? ### 5 0 0 23

©: If applicable. Example: Periodic verification that raw materials conform
to the certificates supplied.

2.3 Storage - Warehouses - Logistics

2.3.1 Storage, Handling, and Scheduling:

2 24 Is there a procedure for handling and storage ? ### 5 0 0 24

2 25 Appropriate storage conditions, functional layout, and locations identified? ### 5 0 0 25

©: Risk of damage
2 26 Management of security (safety) stock of components and materials? ### 5 0 0 26
©: Existence, rotation, storage conditions, etc.

2 27 Rotation of stock (FIFO), expiry dates respected? ### 10 0 0 27

©: Perishable items.

2 28 Maintenance of storage and handling equipment? ### 5 0 0 28

2 29 Handling equipment and methods suitable for the product and the safety of personnel? ### 5 0 0 29
©: Including back-up equipment.
2 30 Off-site storage or back-up storage? ### 5 0 0 30
©: Functional responsibility, storage conditions and quality, evaluation
of any additional risk.
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 5/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 2: PURCHASING - INCOMING PRODUCT - STORAGE

2.3.2 Packaging and Identification:

2 31 Packaging suitable for the product and in conformance with specifications? ### 5 0 0 31
©: Dimensions, quantities, no risk of deterioration, etc.

2 32 Rules for identification of complete and partial (removal and return to warehouse) ### 5 0 0 32
batches (lots) adhered to : FIFO, lot control, expiration dates, ...?

2.3.3 Change / Revision Management:

2 33 Procedures for controlling the movements of modified or revised products… ### 10 0 0 33
versions, identification, management of unusable products, end of production, build-out ?

2.4 Nonconformity Management - Supplier

2 34 Is there a procedure for non-conformity management? ### 10 0 0 34
©: Logistical and / or technical non-conformances. Formal area for
non-conforming product with controlled access, identification,
isolation, waivers, rejection, quarantine, returns, etc.

2 35 Is there a procedure for managing corrective actions? ### 10 0 0 35

©: Recording and analysis of defects, action plans.

2.5 Regulatory and Safety Characteristics

2 36 Do all documents and packages carry the necessary Safety and Regulatory symbols? ### 5 0 0 36
Is the positioning of the symbols suitable?

R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 6/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 2: PURCHASING - INCOMING PRODUCT - STORAGE

2.6 External Operations (Subcontractors and Suppliers)

©: This applies to operations sub-contracted by the supplier; and to components
purchased by the supplier.
In this case, all or part of this questionnaire may be applied .

For chapter 2.6 : for all R/S characteristics, verifications must be done at tier two supplier by tier one
supplier with TitanX.
The following questions (37 - 41) must be asked as an absolute minimum:
2.6.1. Product:
2 37 Specifications clearly defined in the purchase order? ### 5 0 0 37
©: Revision level

2 38 Traceability of R/S and critical characteristics? ### 10 0 0 38

2 39 Inspection report on delivery? ### 5 0 0 39

2.6.2. PROCESS
40 Surveillance (Control) plan validated? ### 5 0 0 40
©: Surveillance plan covers process from receiving & incoming inspection through
manufacturing and until shipping. It must also describe continuous conformance tests
(product audits) with description and frequency of tests and measurements
to be performed.

2 41 Process audited and qualified? ### 5 0 0 41

2 42 Initial samples accepted? ### 10 0 0 42

TOTAL CHAPTER 2: Number CRI =0 : 33 Number 0<CRI<50: 0 Number CRI>/=50: 0 Total number CRI : 33
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 7/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

CHAPTER 3: MANUFACTURING WORKSTATIONS

Process: Workstation:
3.1 Surveillance (Control Plan) Verification
Work Instructions:
3 43 At each workstation and consistent with the surveillance (control) plan ? ### 5 0 0 43
©: Procedures and work instructions listed in plan.

3 44 Up to date? ### 5 0 0 44

3 45 Applied? ### 10 0 0 45
©: Traceability documentation (through each stage of the process), work
instructions and procedures: manufacturing processes, inspections, first
and second level maintenance, safety, adjustment, reference changeovers,
record (manufacture and inspection), identification of Regulatory and
Safety characteristics, etc...

3.2 Internal Product Flow

3 46 Loading and unloading at workstations? ### 5 0 0 46
©: Appropriate handling, FIFO at the workstation and intermediate storage.

3 47 Identification and traceability of work in progress during production (R=10 if R/S characteristic) ### 5 0 0 47
©: Identification: Part number, revision number, marking, visibility, legibility, etc...
Traceability: Existence of a link between the source and destination of the product.

3 48 No risk of damage at the workstations and during transfers? ### 5 0 0 48

©: Packaging, handling equipment, intermediate storage areas, etc...
Transfer between lines are clearly defined and respected.
3 49 Production planning in conformance with Sanhua requirements in ### 5 0 0 49
terms of delivery (Kanban, DDR, etc.) ? Identification of urgent batches?

R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 8/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 3: MANUFACTURING WORKSTATIONS

3.3 Start of Production and Machine / Line Start-up

3 50 Is there a procedure for authorizing the start of production? ### 10 0 0 50
©: Procedure applied at start-up, elimination
of parts used to set-up and tune equipment. Presence and conformance of production
start-up parts. Start of production: Long shut-downs, team
changeover, material lot changeover, reference changeover, etc…

3 51 Parameters affecting the process (external or internal)? ### 10 0 0 51

©: Identified, specified, under control, recorded, etc. Controlled
access to machine settings (e.g. Temperature, air pressure, voltage cleanliness, etc.).

3 52 Traceability through product markings? ### 5 0 0 52

©: Inspection stamp, date of manufacture, mold number, etc.

3.4 Production Equipment

3 53 Verification of process FMEA? ### 10 0 0 53
©: Corrective actions implemented for critical RPN, list of
product / process parameters checked at the workstation, updated
(modifications, incidents, revisions, etc.)

3 54 Verification of process parameters? ### 5 0 0 54

©: Critical process parameters must be clearly identified with tolerances. Each parameter
modification is registered with complete traceability: date, value and reason for change.
3 55 Measurement and Inspection equipment? ### 10 0 0 55
©: Inspection equipment, calibration and master parts : recorded, operational,
maintained, calibrated, R/R test, etc.

3 56 Control of incidents occuring during production? ### 5 0 0 56

©: E.g. of production incidents: energy supply failures (electricity, water, air pressure…),
shortages of parts, materials or consumbles, tool equipment failures…
©: Modes of detection, reaction in case of failure, traceablity, analysis, elimination
of non-conforming products and decision making on WIP are described and respected.

R: Risque N/A : not applicable No.: Question number ©: Notes and comments Page 9/15
Notes:
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 3: MANUFACTURING WORKSTATIONS

3 57 Management of downgraded processes? ### 5 0 0 57
©: Capacities, capabilities, balanced cycles, productivity, etc.

3 58 Anti-error ( Poka-Yoke) systems? ### 10 0 0 58

©: Planned, completed, operational. During the audit, check that
they are in place and effective.

3 59 Process audits? ### 5 0 0 59

©: Question applicable to process audit(s) on the supplier's process performed by the supplier.

3 60 Special processes? ### 10 0 0 60

©: Continuous monitoring of the process parameters, recording,
guarantee that the operation has been completed. Verification of special processes can only be
verified by destructive testing.

3.5 Product Conformance

3 61 Identification of quality status: AWAITING DECISION, ### 10 0 0 61
ACCEPTED, REJECTED, ACCEPTED UNDER WAIVER, REWORKED, etc.?

3 62 Correct application of inspections based on (SPC) and management of ### 10 0 0 62

deviations with corrective actions? SPC rules applied correctly?
©: Management of process variability and process capabilities.

3 63 Recording of inspections, other than SPC, in accordance with instructions? ### 5 0 0 63

3 64 Final validation of the product before transfer to another location, sub-contracting, or ### 10 0 0 64
release for external operations?

3 65 Product audits? ### 5 0 0 65

©: Planned, completed, results systematically in use.
Actual production compared to I.SS results to be performed on regular basis (min. once / year)

3.6 Equipment Maintenance

3 66 First level maintenance (performed by operators)? ### 5 0 0 66
©: Instructions, check lists, records of completion, verification of
proper operation of the anti-error systems, measurement equipment, etc.

R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 10/15
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PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 3: MANUFACTURING WORKSTATIONS

3 67 Second level maintenance (performed by Maintenance Department)? ### 10 0 0 67

©: Instructions, check lists, scheduling, recording, equipment life-cycle sheets,
existence and management of spare parts, measurement equipment, etc.

3.7 Tooling Maintenance and Management

3 68 Identification and validation? ### 5 0 0 68
©: Tooling conformance report, spare parts list, tooling service sheet,
modifications, Sanhua or customer ownership plate, etc.

3 69 Maintenance of tooling sufficient to guarantee product quality? ### 10 0 0 69

©: Preparation, verification, repair, recording….

3.8 Nonconformity Management

3 70 Is there a procedure for managing non-conformances? ### 10 0 0 70
©: Identification, isolation at the workstation, recording, waivers,
rejections, quarantine, returns, etc.

3 71 Is there a procedure for managing corrective and ### 10 0 0 71

preventive actions and using the results?
©: Effectiveness of corrective and preventive actions (non recurrence).

3.9 Product / Process Modifications

3 72 Is there a procedure for managing modifications and changes? ### 5 0 0 72

3 73 Internal and external validation by I.S. ? ### 10 0 0 73

©: I.S. approved before modifications and changes are applied,
information to customers, documentation updated (revision numbers) etc.

TOTAL CHAPTER 3: Number CRI =0 : 31 Number 0<CRI<50: 0 Number CRI>/=50: 0 Total Number CRI : 31
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 11/15
Notes:
 0
PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

CHAPTER 4: PACKAGING - STORAGE OF FINISHED PRODUCT - SHIPPING

4.1 Packaging
4 74 Use of instruction sheets for packaging? ### 5 0 0 74
©: In accordance with customer requirements (Packaging Diagram), risk analysis.

4.2 Identification
4 75 In accordance with customer requirements? ### 5 0 0 75
©: Galia / Odette / AIAG labels, Safety and Regulatory symbols, "fragile" marking.

4 76 Anti-error systems to prevent product mixing and incorrect identification? ### 5 0 0 76

4 77 Identification of approved deviations and modifications? ### 5 0 0 77

4.3 Stockage
4 78 Suitable and formally identified storage areas? ### 10 0 0 78
©: Conditions and quality of storage, adequate space, identification,
revision numbers, FIFO, expiry dates, audits, etc.

4 79 Maintenance of storage, handling, weighing, counting, and packaging equipment? ### 5 0 0 79

4 80 Management of off-site or back-up storage areas? ### 10 0 0 80

©: Defined responsibilities, conditions and quality of storage, FIFO,
audits, etc.

4 81 Handling equipment and methods suitable for the product and the safety of personnel? ### 5 0 0 81
©: Including back-up equipment.

R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 12/15
Notes:
 0
PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

... CHAPTER 4: PACKAGING - STORAGE OF FINISHED PRODUCT - SHIPPING

4.4 Shipping
4 82 Is there a shipping procedure? ### 10 0 0 82
©: Shipping instruction sheets, release of lots with
inspection check-list, conformance of documents, anti-error systems.

4 83 Clear responsibilities - personnel? ### 5 0 0 83

©: Customer/ supplier, emergency contacts

4 84 Defined shipping (preparation) area? ### 5 0 0 84

©: If shipping area is close to goods inwards, analyze the risks of mixing products.

4 85 Transport audit? ### 5 0 0 85

©: Consolidation area for each carrier, platform, instruction and check sheets, etc.

4 86 Management of security (safety) stock? ### 5 0 0 86

©: Risk analysis, safety stock plan, customer approval, revision numbers controlled?

4 87 Conditions of use at the customer understood and taken into account? ### 5 0 0 87

4.5 Nonconformity Management

4 88 Is there a procedure for managing non-conformances? ### 5 0 0 88
©: Includes management of logistics complaints.

TOTAL CHAPTER 4: Number CRI =0 : 15 Number 0<CRI<50: 0 Number CRI>/=50: 0 Total Number CRI : 15
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 13/15
Notes:
 0
PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

CHAPTER 5: INSPECTION - TESTING - METROLOGY - LABORATORY

5.1 Laboratory / Measurement Inspection and Testing
5 89 Appropriate organisation and resources? ### 10 0 0 89
©: External assistance if necessary, approved / accredited source etc.

5 90 Is there a test; and calibration procedure? ### 5 0 0 90

©: Existence, suitability, and application

5 91 Schedules? ### 5 0 0 91
©: Existence, respected, and updated

5 92 Results? ### 10 0 0 92
©: Recording, approval, distribution, archiving, conformance to specifications,
implementation of corrective actions if non-conformance detected.

5.2 Reliability Testing

5 93 Appropriate organisation and resources? ### 10 0 0 93
©: External asistance if necessary, etc.

5 94 Is there a test; and calibration procedure? ### 5 0 0 94

©: Existence, suitability, and application

5 95 Schedules? ### 5 0 0 95
©: Existence, application, and updating

5 96 Results ? ### 10 0 0 96
©: Recording, approval, distribution, archiving, conformance to specifications,
implementation of corrective actions if non-conformance is detected.

TOTAL CHAPTER 5: Number CRI =0 : 8 Number 0<CRI<50: 0 Number CRI>/=50: 0 Total Number CRI : 8
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 14/15
Notes:
 0
PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

CHAPTER 6: PERSONNEL - ENVIRONMENT - SAFETY

6.1 Personnel
6 97 Personnel trained and authorised to perform the tasks required. Work instructions ### 0 0 0 97
and procedures understood and respected?
©: e.g. Authorised fork-lift driver, quality control, special resources.
Each operator (in all teams) is trained to : safety on workstations, all standard operating
modes of workstations (start up, production, quality, 1st level maintenance, supply,
first defect stop guidelines, R/S - critical & subjective characteristics).
There is a regular requalification of operators for subjective caracteristics.

6 98 Flexibility and multi-competence skills measured and monitored? ### 0 0 0 98

©: e.g. Cross-training matrix

6.2 Environment and Safety

6 99 Organised workflow? ### 0 0 0 99
©: Ergonomic workstations, logical flow of work between workstations.

100 General Environment : Order, cleanliness, lighting, atmosphere, noise? ### 0 0 0 100
©: Floor marking, measured criteria fro cleanliness, results dipslayed.
If noise is level is not conform to national regulation or TitanX rule, actions to recover
must be implemented and followed up.

101 Waste management is under control and conform to ISO 14001? ### 0 0 0 101
©: Rules for management and storage of dangerous products defined and respected
Selective sorting of waste, appropriate management of special waste,
Periodical analysis of industrial rejects (smoke, water)

6 102 Safety rules displayed at the workstations and adhered to? ### 0 0 0 102

6 103 Adequate and clear displays? ### 0 0 0 103

©: Daily and monthly data, up to date, and understood by personnel.

TOTAL CHAPTER 6: Number CRI =0 : 7 Number 0<CRI<50: 0 Number CRI>/=50: 0 Total number CRI : 7
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 15/15
Notes:
 0
PROCESS AUDIT QUESTIONNAIRE

No CRITERIA N/A R C CRI COMMENTS (mandatory in case of non conformity) CAR

CHAPTER 7: MEASUREMENT OF PERFORMANCES

7.1 Verification of performances and monitoring of continuous improvement
6 104 In incoming, warehouses and on the production lines concerned by this process audit, ### 5 0 0 104
are indicators available to verify that objectives are met and to monitor improvement ?

©: e.g. Quality, Cost, Delivery indicators

TOTAL CHAPTER 7 : Number CRI =0 : 1 Number 0<CRI<50: 0 Number CRI>/=50: 0 Total number CRI : 1
R: Risk N/A : not applicable No.: Question number ©: Notes and comments Page 15/15
Notes:
 Audit No : Follow-up : 1º
Supplier :
Process
Part :
number/
Product family :
Date:

AUDIT RESULT

SATISFACTORY ACCEPTABLE INSUFFICIENT Number

Number of Number of Number of of Risk indices
CRI = 0 CRI < 50 CRI > 50 evaluated
Chapter 1:

QAP.pp 9 0 0 9

Chapter 2:

Purchasing - Incoming goods - Storage 33 0 0 33

Chapter 3:

Manufacturing Workstations 31 0 0 31

Chapter 4:
Packaging - Storage of Finished
Products - Shipping 15 0 0 15

Chapter 5:
Inspection - Testing - Laboratory -
Metrology 0 0 0 0

Chapter 6:

Personnel - Environment - safety 0 0 0 0

Chapter 7:

Measurement of performances 0 0 0 0

TOTAL 88 0 0 88

LEVEL INDICATOR (LI) 0

PROGRESS INDICATOR (PI) 100%

(PI = NUMBER OF CRI=0 / TOTAL NUMBER OF CRI x 100)

Page 2/2
 CORRECTIVE ACTION REQUEST CAR
Process Audit N° 1

Company / Branch / Division: Critical CAR: Audit Nº:

0 NO
Process : Auditor: Auditee:

Date:
Non-conformance: CRI / IRC= 0 SIGNATURES:

0 AUDITEE:

AUDITOR:

RESPONSE BY: CHAPTER & CRITERION:

CHAPTER: 1 / CRITERION: 1
Root Cause:
Conduct a Root Cause Analysis to determine correct Root Cause of the problem.
(Possible tool/method to use is 5 Whys and to reproduce the defect to confirm the correct Root Cause).

PILOT:

Corrective Action/ Solution:

Develop Permanent Solution(s) that address each Root Cause.

Prevent Recurrence:
Prevent recurrance of the problem, at the problem site and across the organization.
Generalization/ Standardization:
Questions to ask DATE OF IMPLEMENTATION:
-> Can this problem occur on a similar product?
-> Can this problem occur on a similar line?
-> Can this problem occur on a similar process?

CAR Closing Date:

Signature of Auditor:
 Process Audit- Action Plan

PROCESS AUDIT - ACTION PLAN

Internal audit : Reference: Lea

External audit : X Reference: 0 Supplier : 0 D

CAR Question Initial Date of Follow

Non conformity Root Cause: Pilote Corrective Action/ Solution Prevent recurrence
N° N° R C CRI Implementation R
0

1 1 5 0 0 5

2 2 10 0 0 10

3 3 5 0 0 5

4 4 5 0 0 5

5 5 10 0 0 10

6 6 10 0 0 10

7 7 10 0 0 10

8 8 10 0 0 10

9 9 10 0 0 10

10 10 5 0 0 5

11 11 5 0 0 5

12 12 5 0 0 5

13 13 5 0 0 5

14 14 5 0 0 5

15 15 10 0 0 10

16 16 5 0 0 5

17 17 5 0 0 5

18 18 5 0 0 5

19 19 5 0 0 5

20 20 10 0 0 10

21 21 10 0 0 10

22 22 0 10 0 0 10

23 23 0 5 0 0 5

24 24 0 5 0 0 5

25 25 0 5 0 0 5

885362146.xlsx
DIT - ACTION PLAN
Lead auditor: 0

Date:

Follow up 1 Follow up 2
Closing date
C CRI R C CRI

10

10

10

10

10

10

10

10

10

10

885362146.xlsx
DATE Revision# Responsible Revision Description
Approved By