Nitto Belgium Report VDA 6.

3 Processaudit Order No:

NBE_VDA6.3_SILVALAC_15
Report Date: 092021
Audited Organisation: Silvalac
Postcode and Town: 08730 Santa Margarida i Els Monjos
Street: C/ Illes Balears 19 - 23
Senior Manager: Ignacio Canales
Plant Manager: Jose Hierro
Q-Management: Pere Bertran
Audit Date: 15.09.2021 - 16.09.2021
Audit Reason: Related to complaints, NBE will check the process and the implementation and
effectiveness of corrective actions
Audit Request (Department) : NBE (Quality Department NBE)

Audit Item
VDA 6.3 Audit:
Process elements P4 P6
P4: Implementation of the product and process development P5: Supplier management
P6: Process analysis production

Auditor/Audit Team
Name Department Certificate No Organisation
Ben Vaes Quality P-6.3-1904-C-33100 Nitto Belgium NV

Distribution
Name Department Organisation E-Mail
Jose Hierro Plant Manager Silvalac SA jah@silvalac.com
Alberto Alcacer Sales Manager Silvalac SA aaj@silvalac.com
Rafael Echegaray Production Manager Silvalac SA rechegaray@silvalac.com
Pere Bertran Quality Manager Silvalac SA pbertran@silvalac.com
Chema Casado Quality Manager Silvalac SA jmcasado@silvalac.com
Stefan Maussen Management NBE Nitto Belgium NV stefan. maussen@nitto.com
Johan Mariën Quality Department NBE Nitto Belgium NV johan.marien@nitto.com
Tom Roman Purchase Department NBE Nitto Belgium NV tom.roman@nitto.com
Vicky Lenaers Purchase Department NBE Nitto Belgium NV vicky.lenaers@nitto.com
Koen Vanharen Production Manager NBE Nitto Belgium NV koen.vanharen@nitto.com
Lorenzo Taramaschi Quality Department NBE Nitto Belgium NV lorenzo.taramaschi@nitto.com

Participants
Name Department Organisation E-Mail
Rafael Echegaray Production Manager Silvalac SA rechegaray@silvalac.com
Pere Bertran Quality Manager Silvalac SA pbertran@silvalac.com
Chema Casado Quality Manager Silvalac SA jmcasado@silvalac.com

Annex:
Report Summary Audit
Findings

Software Version: 1.8.7 1/6

Nitto Belgium Report VDA 6.3 Processaudit Order No:
NBE_VDA6.3_SILVALAC_15
Report Date: 092021
Report for quality capability
Audit Date: 15.09.2021 - 16.09.2021 Audited shift: Day
Audited Organisation: Silvalac Postcode and Town: 08730 Santa Margarida i Els Monjos
Suppl.-No: 101273 D-U-N-S No:

Audit Item
VDA 6.3 Audit:
Process elements P4 P6
P4: Implementation of the product and process development P5: Supplier management
P6: Process analysis production

Audit Result
Evaluated process element Evaluation Index EG [%] Rating
P4,P5,P6 EG (P4,P5,P6) 76 C
Classification scale: A = 90 - 100% quality capable; B>=80 - <90% conditionally quality capable; C = 0 - < 80% not quality capable.

Summary, Focus Points, further course of Action:

Thank you very much for the hospitality, open communication and positive atmosphere during the audit.
The persons I have spoke with are well aware of their tasks and responsibilities and there is a lot of awareness for the required quality for Nitto film.
Also the introduction of tools for problem solving (such as 5WHY-analysis) is very positive.

During the audit following significant findings were observed:

- No quality agreement available, not ensuring change management
- No parts are evaluated as critical parts
- No process FMEA available
- No proper validation of engineering test and process changes
- No completed control plan for extruder 37
- Work instructions not all updated in control plan
- Protocols are available, but without link to procedure number
- Much knowledge with Quality and Production Manager, responsibilities should be general implemented to increase agility of the
organisation
- Fish eye performance from production not compliant with product specification, corona treatment is not secured as air is still present

Improvement Plan
Step Activity Deadline
1 Define root cause and corrective actions in action plan 15.10.2021

Ben Vaes Manager of Audit Department: Johan Mariën Ben Vaes

(Auditor) Silvalac

Software Version: 1.8.7 2/6

Nitto Belgium Report VDA 6.3 Processaudit Order No:
NBE_VDA6.3_SILVALAC_15
Report Date: 092021
Audit Findings
Audit Date: 15.09.2021 - 16.09.2021
Audited Organisation: Silvalac Postcode and Town: 08730 Santa Margarida i Els Monjos
4.1 * Are the actions from the Product and process development plans implemented?
P4 Implementation of the Product and process development
Audit Finding(s): Reference: Process Points: 6
* No FMEA or risk analysis available
* Inspection plan (for mechanical properties / dimensions / visual aspect)
* Purchase order with link to approved spec revision is available

4.2 Are personnel resources available and are they qualified to ensure the start of the serial production?
Audit Finding(s): Reference: Process Points: 10
Training plan (Quality control) available and signed
Example Test method: ME-14: ('TREATMENT MEASURES'): updated on 20/01/2021
Training plan: initiated on 28/01/2021 - finished on 02/02/2021

4.3 Are the material resources available and suitable to ensure the start of the serial production?
Audit Finding(s): Reference: Process Points: 8
Test plan for each product is available with reference to test methods (ME-xx)
Availability of raw materials controlled by logistic department
Contract with RM-suppliers is made by Purchase manager of Group Alvarez with fixed MOQ (per month) Issues
with availability of packaging material for film material related to extr 37

4.4 * Are the required approvals and releases for the Product and process development available?
Audit Finding(s): Reference: Process Points: 8
Signed product specification is available, TDS + MSDS + GPL raw materials available
Description of product specification (YPE046TRU) is not correct
4.5 Are the manufacturing and inspection specifications derived from the Product and process development and are they implemented? Audit
Finding(s): Reference: Process Points: 6
Product test plan with defined tolerance available (according product specification)
No product audit plan is available

4.6 Is a performance test carried out under series conditions for the series release?
Audit Finding(s): Reference: Process Points: 10
Test performance is carried out with extrusion run in production, on production extruder, work instructions are available

4.7 Are the processes established for securing customer care / customer satisfaction / customer service as well as the field failure analysis?
Audit Finding(s): Reference: Process Points: 4
Contingency plan available (for Extruder 37 no back-up available) document 'Business Continuity Management System'
No concept to ensure supply of spare parts available

4.8 * Is there a controlled method for the Product handover from development to serial production?

Audit Finding(s): Reference: Process Points: 10

2 procedures available:
* MP-04 Revision de Pedidos Rev.10 (25-04-16)
* MP-57 Gestion del Cambio Rev.1 (22-11-19)

P5 Supplier Management
5.1 Are only approved and quality capable suppliers selected?
Audit Finding(s): Points: 10
Supplier certificates available
Exxon Mobil Chemical Company: ISO9001:2015 / ISO 14001 / ISO45001
Supplier selection based upon raw material certificates, values are registered in system

5.2 Are the customer's requirements taken into account in the supply chain?
Audit Finding(s): Points: 4
No quality agreement available, not ensuring change management
Raw material specifications are available, selection between suppliers is done based upon these specifications

5.3 Have target agreements for delivery performance been agreed with suppliers and implemented?
Audit Finding(s): Points: 8

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Nitto Belgium Report VDA 6.3 Processaudit Order No:
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Report Date: 092021
Supplier evaluation system on yearly basis with corrective action plan is available (= follow-up of quality performance based upon rejected raw material
out of agreed specification or due to quality issues of finished product)
Quality of raw materials is followed up by CoA with tolerances defined in the system (responsibility of warehouse)
When raw material is out of spec info is given to Quality Department who will make an official complaint with request for corrective actions No follow-up
of historical data for raw materials

5.4 * Are the necessary releases available for purchased products and services?
Audit Finding(s): Points: 10
Raw material specification available, approval is done by Quality Department, Purchase is informed and is responsible for implementation of raw material in
Approved RM List 'Lista de Proveedores Y Materias primas homologadas'

5.5* Is the agreed upon quality of the purchased products and services ensured?
Audit Finding(s): Points: 10
Test certificates available, raw material supplier complaint handling system available

5.6 Are incoming goods stored appropriately?

Audit Finding(s): Points: 8
Warehouse for box materials, dedicated silo's (locked) for bulk material
FIFO is handled by logistic manager by positioning oldest raw material in such a way that they will be taken first by operators, quarantine area available
with red label (Control Calidad / Retenido / Motivo) + goods are locked in the Agil system

5.7 Are personnel qualified for the various tasks and are responsibilities defined?
Audit Finding(s): Points: 10
HRM: follow-up of employees with available certificates/qualifications and need for training
Much knowledge with Quality and Production Manager, responsibilities should be general implemented to increase agility of the organisation

P6 Process analysis /production

6.1.1 Has the project been transferred from development to serial production and is a reliable start guaranteed?
Audit Finding(s): Reference: Points: n.a.
No process FMEA available for Extruder 37
Purchase order is used as customer release

6.1.2 Are the necessary quantities / production batch sizes of incoming materials available at the agreed upon time and at the correct storage
location / work-station?
Audit Finding(s): Reference: Points: 10
Raw materials are delivered in correct quantities and correct storage location. Inventory is controlled via AGIL

6.1.3 Are incoming materials stored appropriately and are transport facilities / packing arrangements suitable for the special characteristics of the
incoming materials?
Audit Finding(s): Reference: Points: 10
Raw materials available in boxes, bulk raw materials in dedicated silo's, with unique locks
Separate zone for blocked raw materials (red label), also blocked in the system
TDS available with information about storage conditions: Lyondell Basell

6.1.4 Are the necessary identifications / records / approvals available and allocated appropriately to the incoming materials?
Audit Finding(s): Reference: Points: 10
Warehouse Raw materials: all boxes identified
Registration of raw materials in system AGIL
Traceability of raw materials in production available: 'Consulta Trazabilidad'

6.1.5* Are changes to the Product or process made during the serial production tracked and documented?
Audit Finding(s): Reference: Points: 4
Revision of roll 18 due to surface damage registered: 14/09/2021
'Protocolo de revision de rodillos de pasa'
No proper validation of engineering test and process/parameter changes

6.2.1 Are the specifications of the control plan complete and have they been effectively implemented?
Audit Finding(s): Reference: Points: 4
Control plan for extruder 35 is implemented , but not yet available for extr 37 Work
instructions: are not all updated in control plan
Test methods not correctly linked with properties in control plan
'Ficha de proceso': registration of process parameters Protocols are
available, but without link to procedure number

6.2.2 Does a repeat release for the restart of production take place?
Audit Finding(s): Reference: Points: 10
After solving the issue, restart according to standard procedure, produced and blocked material is evaluated by Quality Control Department

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Report Date: 092021
(scrap or rewind to remove affected parts)

6.2.3 * Are special characteristics managed in the production?

Audit Finding(s): Reference: Points: 4
Deviations are not communicated to the customer, no request for approval from customer

6.2.4 * Are non-released and/or defective parts managed?

Audit Finding(s): Reference: Points: 10
Defective parts are blocked in the system and placed in restricted zone, identified with a red label.

6.2.5 Is the flow of materials and parts secured against mixing / wrong items?
Audit Finding(s): Reference: Points: 8
Materials are labelled correct.
Production recipe only indicates raw material name, no barcode to verify correct raw material is used Document
'Consulta trazabilidad' available

6.3.1* Are the employees able to fulfil their given tasks?

Audit Finding(s): Reference: Points: 10
Quality Control Department: internal training plan available
HRM: evidence of qualification (certificates)

6.3.2 Do the employees know their responsibilities and authority in the monitoring of the quality of Product and process quality?
Audit Finding(s): Reference: Points: n.a.
Not evaluated with operators

6.3.3 Are the necessary personnel resources available?

Audit Finding(s): Reference: Points: 4
Much knowledge with Quality and Production Manager, responsibilities should be general implemented to increase agility of the organisation

6.4.1 * Can the Product-specific requirements from the customer be met with the manufacturing equipment?
Audit Finding(s): Reference: Points: 4
Fish eye performance from production not compliant with product specification, corona treatment is not secured as air is still present

6.4.2 Is the maintenance of the manufacturing equipment and tools controlled?

Audit Finding(s): Reference: Points: 6
INS-MAN-004: Cleaning of active anti-static bars
INS-MAN-005: Check anti-static brush
INS-MAN-006: Hardness check of rubber rolls INS-
MAN-007: Treater checking and adjustment INS-
MAN-008: Checking idler rolls
INS-MAN-009: Repair silicon treater roll
INS-EXT-018: Pressure check
INS-PH02-34: Precleaning procedure available No
critical spare parts defined

6.4.3 * Can the quality requirements be effectively monitored with the measurement and test facilities in use?
Audit Finding(s): Reference: Points: 10
Calibration plan available ('Plan de control de calibracion' - Rev 26)
Evidence of the calibration of inspection equipment available
Micrometer(Reference 40009.10): calibration 18/12/2020
Certificate of calibration (ASSI Sistemas) available

6.4.4 Are the work and inspection stations appropriate for the needs?
Audit Finding(s): Reference: Points: 10
5S is implemented

6.4.5 Are tools, equipment and test equipment stored properly?

Audit Finding(s): Reference: Points: 10
There are defined storage locations, all equipment has a unique reference number

6.5.1 Are there targets set for the manufacturing process?

Audit Finding(s): Reference: Points: 10
Daily follow-up of production (produced/scrap quantity)

6.5.2 Is quality and process data collected in a way that allows analysis?
Audit Finding(s): Reference: Points: 6

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Nitto Belgium Report VDA 6.3 Processaudit Order No:
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Report Date: 092021
KPI available in production and quality control No
trend charts available

6.5.3 * In the case of deviations from Product and process requirements, are the causes analysed and the corrective actions checked for effectiveness?
Audit Finding(s): Reference: Points: 4
No waivers available for deviations
Implementation of 5 WHY method is ongoing

6.5.4 Are processes and products audited regularly?

Audit Finding(s): Reference: Points: 6
Yearly internal intercompany and external company audit
No product audits are performed

6.6.1 Do the quantities / production batch sizes meet the needs and are they systematically directed to the next process step?
Audit Finding(s): Reference: Points: n.a. 1
continuous process (extrusion)

6.6.2 Are products / components stored in an appropriate manner and are transport facilities / packing arrangements suitable for the special characteristics
of the products / components?
Audit Finding(s): Reference: Points: n.a.
not evaluated

6.6.3 Are the necessary records / releases retained?

Audit Finding(s): Reference: Points: 6
Batch related data not always clear (traceability): certificates (different Purchase orders for 1 production order)

6.6.4 * Are customer requirements met at the delivery of the final Product?
Audit Finding(s): Reference: Points: 4
Customer specific requirements (regarding corona treatment) are not updated in the product specification, also not mentioning outside measurement

Software Version: 1.8.7 6/6