Efectis France

Voie Romaine
F-57280 Maizières-lès-Metz INSPECTION REPORT
Tél : +33 (0)3 87 51 11 11
Fax : +33 (0)3 87 51 10 58

CONTINUOUS SURVEILLANCE INSPECTION OF FACTORY PRODUCTION CONTROL

REPORT
n° EFR-19-003040
CE MARKING FIRE DAMPERS
System of assessment and verification of constancy of performance level 1
CERTIFICATION OF PRODUCTS USED FOR THE FIRE PROTETCTION OF BUILDINGS – FOR
APPLICATION OUTSIDE EEA

Date of inspection October, 01st and 02nd, 2019

Notified body (CE Marking - EFECTIS France Identification n° : 1812

Fire Dampers) Route de l'orme des merisiers
Espace technologique - Bâtiment
Apollo
F – 91193 SAINT-AUBIN

Certification body EFECTIS France

(Certification of products used Route de l'orme des merisiers
for the fire protection of Espace technologique - Bâtiment
buildings - for application Apollo
outside EEA) F – 91193 SAINT-AUBIN

Accredited inspection body EFECTIS France

Route de l'orme des merisiers
Espace technologique - Bâtiment Apollo
F – 91193 SAINT-AUBIN

Implantation concerned by the EFECTIS France

accreditation granted and Voie Romaine
having carried out the F-57280 Maizières-lès-Metz
inspection

Holder KLIMAOPREMA
Gradna 78A
HR – 10430 SAMOBOR

Inspected Units KLIMAOPREMA KLIMAOPREMA

Gradna 78A Industrijka 19
HR - 10430 SAMOBOR HR - 35400 NOVA GRADISKA

Products ref. • Circular fire dampers ref. FDC25 and FDC40

• Rectangular fire dampers FD25 and FD40
See details in §1 of this report

Copies of this document are allowed only in full.

FOR 43 VUK M SASU au capital de 1 512 170 € - SIRET 490 550 712 00023 – RCS Evry B 490 550 712 – TVA FR 61490550712 – APE 7120 B Page 1 of 22
 EFR-19-003040 INSPECTION REPORT

SUBJECT OT THE REPORT

Inspection of production facility and its subcontractors (if relevant) of factory production control in accordance
with the harmonized technical specifications, in application of the EU Construction Products Regulation
305/2011 of March 9th, 2011 (CE Marking), and in application of the certification rules ref. DAP21
(Certification of products used for the fire protection of buildings - for application outside EEA)

Harmonized technical : NF EN 15650 :2010

specifications
Certification rules : Certification rules DAP21 ind. E : Certification of products used for the fire
protection of buildings - for application outside EEA
Rules and conditions for the affixing of CE marking réf. DAP08 ind. H
Specific documents : Guidance Document TF N 548 rév. 1
Position Paper NB-CPR/AG/03/002r3 et NB-CPR/AG/03/004
Classification reports ref. EFR-16-004034 rev. 3 and EFR-16-004034 rev. 3
justifying declared performances
Product range concerned by : • Circular fire dampers ref. FDC25 and FDC40
the inspection Certificate of constancy of performance n°: 1812-CPR-1161
Distributors: Certificates of constancy of performance n°1812-CPR-1163
(réf. CIRCE AXIO 3, FRANCE AIR) and n°1812-CPR-1323 (réf. TFEC25-
TFEC40, F.C.R Spa)
Certificate of compliance n°: EFR-1801-0075_18-0

• Rectangular fire dampers FD25 and FD40

Certificate of constancy of performance n°: 1812-CPR-1162
Distributors: Certificates of constancy of performance n°1812-CPR-1164
(réf. REF 500 4, FRANCE AIR) and n°1812-CPR-1324 (réf. TFER25-
TFEC40, F.C.R Spa)
Certificate of compliance n°: EFR-1801-0076_18-0
Inspection type : 2019 continuous surveillance
Inspection date and duration : October, 01st and 02nd, 2019

PERSONS PRESENT DURING THE INSPECTION

Mr JAKLENEC Tomislav– Head of R&D

Mr SIMIC Andrija – Production manager / FPC responsible
Mr MUHVIC Dragan – Technical Office
Mr DOROTIC Tino – Head of quality control
Mr OBRAZ Robert– Quality Manager
KLIMAOPREMA :
Mr MEHIC Jasminko – Head of back office
Mr ARSLANOVIC Nermin – Quality Control
Mr BEVANDA Toni – Purchasing Department
Mrs BOLF Natasa – Human Resources
M. GALIK Martin – Leakage test
EFECTIS France : M. Benjamin FOULON – FPC Inspector

REPORT

CHANGES IN FACILITY SINCE PREVIOUS EVALUATION

• Revision of the classification reports (see CR ref. EFR-16-004034 rev. 3 and EFR-16-004034 rev. 3)
• Mr DOLENEC and Mr VIDAK from the technical office left the company in the beginning of 2019
• Mr DOROTIC Tino (Head of quality control) arrived in 03/2019, taking the previous position of Mr
DUNAJ who left the company.

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• Mr MUHVIC Dragan take the previous position of Mr VIDAK (arrival in 03/2019)

• The assembly of the mechanisms of the products has been moved from Samobor to Nova Gradiska
(same means of assembly)
• Implementation of a new machin for the implementation of the intumescent seals on the casings

TOPICS EVALUATED DURING INSPECTION

Evaluated (E) /
Topic Comments (if any)
Non Evaluated (NE)
Organisation and management
Responsibilities et Authority E -
Direction review E -
Production
Processes and Methods: job description and
provisions (methods, equipment,
E -
environment, material, means), observation
and interview
Means : maintenance of tools and
E -
equipments
Means : validity of tools and equipments E -
Production Control
Provisions and results of components and
raw materials reception controls (including
E -
collection of material certificates, certificate
of compliance of incoming materials...)
Provisions and results of controls carried out
E -
during manufacture
Provisions and results of checks on finished
E -
products
Personnel
Skills of management E -
Skills of support personnel (metrology,
E -
maintenance, ...)
Skills of production personnel E -
Metrology
Processes and Methods: description of the
tasks and provisions regarding the
E -
management of measurement, control and
testing equipments
Validity of measurement, control and testing
E -
equipments
Conception
Provisions regarding the control of the
design means (configuration, performance E -
management, derivatives and options, ...)
Validity of design means E -

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Evaluated (E) /
Topic Comments (if any)
Non Evaluated (NE)
Records and documentation of the
quality management system
Description of rules for document
management (approval, modification, new E -
documents’ distribution, ...)
Description of rules regarding records
management (duration and location of
E -
storage, external documents’ management,
...)
Products’ preservation
Provisions regarding storage, delivery,
E -
handling, traceability
Purchasing, subcontracting
Provisions regarding purchasing /
E -
components’ subcontracting
Non-compliances and Claims
Provisions regarding non-compliances’ and
E -
claims’ management
Essential external documentation
Presence of the potential certification rules,
E -
and of the technical specifications in force
Analyze and inclusion of the developments
E -
of the relevant external documentation
Compliance of the inspected product to
E FD40 and FDC25
the type testing

Referential Certification rules réf. DAP 21

Article Section 8, §5 (fire dampers) Appendix D
Disposition
checked

Referential NF EN 15650
Article § 6.3 Appendix E
Disposition
√ √
checked

Referential General EC certification rules ref. DAP 08

Article Appendix A
Disposition
√
checked

DOCUMENTS EVALUATED DURING THE INSPECTION

The following documents were evaluated during the inspection.

Document ref. Revision Document title Requirements of the standard

and/or the certification rules
OB- 06/2018 Organigram NF EN 15650 §6.3
6.2.0.3.01 DAP 08 Annexe A
- - ISO 9001v2015 certificate (valid until
03.03.2021) by DNV-GL
- 01/18 Quality policy
- 18/10/16 Quality documentation list

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Document ref. Revision Document title Requirements of the standard

and/or the certification rules
- 02/18 Revue de direction NF EN 15650 §6.3
KO-PK J Quality manual (09/2018) DAP 08 Annexe A
OP-8.3.0.1 C Nonconformity procédure
OP-8.5.2.1 C Corrective action procedure
OP-8.5.3.1 C Preventive actions procédure
OP-4.2.3.1 D Documentation procédure
OP-4.2.4.1 1 Recording procedure
- 2018 Competencies Matrix
OB-8.3.0.01 B Non conformity formular
- 2018 General overview of non-conformity treatment
OB-7.6.0.1 C List of Measurement and control equipment
- - External report of calibration (SISTEMSKA
TECHNIKA)
- - Software INFRA (purchasing) and
SMARTPROv2 (manufacturing)
RU-8.2.4 A Cutting machine instruction
14/5
RU-8.2.4.1 A Incomings goods control
RU- A NAPER plate contrôle instruction on machine
8.2.4.14/4 ROVER24 (BIESSE)
RU-8.2.4.18 B Entry control of raw materials
RU- C Work instruction (manufacturing and
8.2.4.8/36 control) :FD25 and FD40
RU- D Work instruction (manufacturing and
8.2.4.8/32 control) :FDC25
RU- B Work instruction (manufacturing and control) :
8.2.4.8/33 FDC40
- - Cycling test bench and Leakage test bench
- - Purchasing order (NAPER)
I-4040/16-1 - Fire resistance test report (FDC40)
I-4049/16-1 - Fire resistance test report (FDC25)
- - Cycling control report
RU-8.2.4.1 B Control procedure
OP-8.2.2.1 1 Internal audit procedure
- - Internal audit schedule
- 2018 Training plan of the internal auditors
RU-7.6.0.4 A Calibration instruction of calipers
RU-7.6.0.5 A Calibration instruction of meter
OB-7.6.0.2 2018 Internal calibration report
- 2018 External calibration report
15995p0457/ 03/2018 Certificate of calibration pressiometer
0458 (BEOGRAD Laboratory)
KO-RU-008 D Managing of the equipments
KO-OB-001- - List of the equipments
RU-008
RU-8.2.4.8/ C Mechanism assembly instruction
41->43
- 01/02/17 List of people able to do the Mechanism
assembly
KO-OB- B Internal Audits planification
001/OP002
KO-OB- 09/2018 Internal audit reports
002/OP002
KO-OB-008 2018 Internal audits training program

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Document ref. Revision Document title Requirements of the standard

and/or the certification rules
NF EN 15650 §6.3
KO-OB- 2018 Internal audits training records DAP 08 Annexe A
007/OP008
OP-7.4.0.1 E Purchasing procedure
RU-7.4.0.1 2018 Supplier evaluation (COMMIT, BELIMO)
- 2018 List of evaluated supplier
KO-RU- B Supplier evaluation procedure
001/PP003
KO-OP-008 3 Training processus
644.00.00.00 2018 Final control (technical)
.104
644.00.00.00 2018 Final control (electrical)
.105
644.00.00.00 2018 Final control (cycling tests)
.106
644.00.00.00 2018 Final control (Leakage test)
.101
644.00.00.00 2018 Table of value for leakage test
.110
RU-8.2.4.17 B Leakage test
KO-OB-049 2018 Competencies Matrix
KO-RU-0001 D Controls incoming goods
KO-OB-001- - Table for the different kinds of controls
RU-001
EFR-18- 2018 Technical Inspection (modification)
002108/B

Possible comments on the evaluated documents : The allocated time didn’t permit to check the dispositions
concerning the distributors: following of FPC testing of the distributed products, checking of the sending and
treatment of FPC results, and stamping of the sending products

DEVIATIONS

See the end of Factory Production Control (FPC) Inspection form in Appendix 2 of this report.

Comment: deviation not presenting particular risk towards the FPC, but which must be taken into account
before the continuous surveillance of the FPC.

Minor deviation: deviation not presenting effective risk towards the FPC if corrective actions are engaged
into a limited period.

Major deviation: deviation presenting an immediate influence towards the functioning and effectiveness of
the FPC so that a non conformity product could be placed on the market, and/or with a requirement.

During the inspection, no deviation was found.

ANALYSIS OF MANUFACTURER’S ANSWERS TO POSSIBLE DEVIATIONS OF THE PREVIOUS INSPECTION :

Reference of the previous evaluation report: EFR-18-002523

The answers to the deviations F1(a,b), F2(a,b) and F3(a,b) are satisfactory, see closed sheets dated
October, 02nd, 2019 in Appendix 1 to this report.
The implementation of corrective actions has been verified.

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a) : deviation according to EFECTIS France CE marking – Fire Dampers requirements (NF EN

15650 and DAP08)
b) : deviation according to Certification of products used for the fire protection of buildings - for
application outside EEA” requirements (DAP21)

STRENGHTS AND SENSITIVE ISSUES OF THE INSPECTED COMPANY

Strengths:
- Manufacturing processes,
- Communication to the operators concerning the new design of the product (change of the
intumescent seals, see classification report updated)
- Quantity of cycling and sealing tests upper than required in the standard

Sensitive issues and improvement possibilities:

- Making the Nova Gradiska skill matrix available to the Human Resources Department
- Increasing the capacity of the leakage bench test
- Reflexion on the establishment of the suppliers evaluation

CONCLUSIONS

During the inspection, the following deviations were found (see details on appendix):

Deviation n°
Process of activity
MAJOR deviation MINOR deviation Comment
Organisation and management - - -
Production - - -
Production control - - -
Personnel - - -
Metrology - - -
Design - - -
Records, documentation of the quality
- - -
system
Products’ preservation - - -
Purchasing, subcontracting - - -
Claims and non-compliances - - -
Number of deviations (by type) 0 0 0
Total number of deviations 0

a) : deviation according to EFECTIS France CE marking – Fire Dampers requirements (NF EN

15650 and DAP08)
b) : deviation according to Certification of products used for the fire protection of buildings -
for application outside EEA” requirements (DAP21)

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APPRECIATION / DEVIATION(S) ANALYSIS

The factory production control system of the ranges listed in §1 of this report is conform to the requirements
of the harmonized technical specifications mentioned in chapter 1 under the EU Construction Products
Regulation No. 305/2011 (CE marking), and DAP21 certification rules (Certification of products used for the
fire protection of buildings - for application outside EEA).

Maizières-lès-Metz, October 09th, 2019

FOULON Benjamin
FPC Inspector

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APPENDIX 1
FOLLOW UP OF THE DEVIATIONS FROM THE PREVIOUS INSPECTION

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APPENDIX 2
FORM OF END OF THE INSPECTION PURPOSE OF THIS REPORT

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