Factory Production Control EN version A-EN12966 -FPC-Enquiry version
CEN 2002 All rights of exploitation in any form and by any means reserved world wide for EN national members Ref. No. prEN 12966-3
EUROPEAN STANDARD CEN TC 226 WG3 NxxxE NORME EUROPEENNE prEN 12966-3 EUROPISCHE NORM 8 February 2002
UDC Descriptors :
English version
Variable message signs Factory Production Control
Signalisation routire verticale Panneaux messages variables - Partie 3 : contrle de production en usine Ortsfeste, vertikale Verkehrszeichen Wechselverkehrszeichen - Teil 3: Fertigungskontrolle
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 226.
If this draft becomes a European Standard, CEN members are bound to comply with the requirements of the CEN Internal Regulations, which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French and German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to CEN Central Secretariat has the same status as the official version.
CEN
European Committee for Standardisation Comit Europen de Normalisation Europisches Komitee fr Normung
Central Secretariat : rue de Stassart, 36 B-1050 Brussels
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Contents
Foreword..................................................................................................... 3 1 SCOPE.................................................................................................. 3 2 NORMATIVE REFERENCES.............................................................. 4 3 DEFINITIONS, SYMBOLS AND ABBREVIATIONS.......................... 4 3.1 Factory Production Control (FPC):........................................................................4 3.2 Attestation of Conformity (AC) System 1: ............................................................5 3.3 Batch: .........................................................................................................................5 3.4 Individual (and non-series): ....................................................................................5 4 FACTORY PRODUCTION CONTROL REQUIREMENTS................ 6 4.1 General Comments .................................................................................................6 4.2 Factory Production Control System......................................................................7 4.3 Quality records .........................................................................................................8 4.4 Control of non-conforming products .....................................................................8 4.5 Traceability................................................................................................................8 5 COMMON REQUIREMENTS............................................................... 9 5.1 Raw materials and constituents.............................................................................9 5.2 Controls and tests during manufacture ................................................................9 5.3 Final testing...............................................................................................................9 5.4 Handling and Storage .............................................................................................9 6 SPECIFIC REQUIREMENTS............................................................. 10 Annex A (informative)............................................................................. 11 Bibliography ........................................................................................................................11 Annex B (informative)............................................................................. 12 Examples of test forms to register the results of a conformity review.......................12
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FOREWORD This European Standard has been prepared by the Technical Committee CEN/TC 226 "Road Equipment", of which the secretariat is held by AFNOR.
This document is currently submitted to TC 226/WG 3 for approval to prEN enquiry.
This European Standard, EN 12966, comprises the following parts:
Part 1: Variable message signs Part 2: Initial type testing Part 3: (this part) Factory production control
In accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
No existing European Standard is superseded. 1 SCOPE This part of this European standard describes the requirements on Factory Production Control (FPC) system 1, as required by the Directive 89/106/EEC in support of its legal requirements, with which the manufacturers of variable message signs shall comply, when their products have to bear the European Commission conformity marking: CE marking. It is based upon the requirements of the Construction Products Directive (CPD: Annex A, ref. 1) and on the guidance given by the European Commission (EC) for the Factory Production Control (FPC) of construction products (Annex A, ref. 2). It is to be considered as a guide to the manufacturer and the certification bodies involved in the FPC of variable message signs as it is specifying which sorts of parameters and tests have to be taken into consideration within the FPC, but leaving the precise test methods to be applied to be chosen depending on the characteristics of the manufacturers facilities and production methods as usual in third party assessment and surveillance of Quality Systems. The precise parameters and methods will be found in the manufacturers written procedures and agreed upon by manufacturer and the third party responsible for the initial assessment of the FPC. prEN 12966-2 Page 4 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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Manufacturers having an FPC system which complies with EN ISO 9000 series, and which addresses the requirements of the appropriate harmonised standard are recognised as satisfying the FPC requirements of the Directive and therefore this European Standard. In the case of individual (and non-series) production, a declaration of conformity, as far as the Factory Production Control is concerned, in accordance to CPD/Annex III (2)(ii) third possibility shall suffice. NOTE: The requirements described in this part of this European standard are applicable to the products under the scope of the European Standard Variable Massage Signs. Fixed, Vertical Road Traffic Signs are not covered by this European standard. 2 NORMATIVE REFERENCES This part of the European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this part only when incorporated in it by amended revision. For undated references the latest edition of the publication referred to applies. EN ISO 8402Quality management and quality assurance Vocabulary EN ISO 9000Quality Systems. Model for quality assurance in design/development, production, Installation and servicing EN 12966 Variable Message Signs 3 DEFINITIONS, SYMBOLS AND ABBREVIATIONS For the purposes of this part of this European standard the following definitions apply together with the definitions in EN 8402 and in EN 12966 Part 1Variable Message Signs 3.1 Factory Production Control (FPC): The permanent internal control of production exercised by the manufacturer, as it is specified in the Annex III of the Construction Products Directive (CPD). All the elements, requirements and provisions required by the manufacturer shall be documented in a systematic manner in the form of written policies and procedures. This production control system documentation shall ensure a common understanding of quality assurance and enable the achievement of the required product prEN 12966-2 Page 5 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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characteristics and the effective operation of the production control system to be checked. 3.2 Attestation of Conformity (AC) System 1: The attestation of conformity system shall be system 1 as described in the Annex III of the Construction Products Directive (CPD). Certification of the conformity of the product by an approved certification body, on the basis of: (a) tasks for the manufacturer 1. factory production control; 2. Testing of samples taken at the factory in accordance with a prescribed test plan; (b) tasks for the approved body 1. initial type-testing of the product; 2. initial inspection of the factory and of the factory production control; 3. continuous surveillance, assessment and approval of the factory production control
NOTE: The specification of the system should be such that it can be implemented even where performance does not need to be determined for a certain characteristic, because at least one Member State has no legal requirement at all for such characteristic [ see Article 2.1. of the CPD and, where applicable, clause 1.2.3. of the Interpretati ve Documents]. In those cases, the verification of such a characteristic must not be imposed on the manufacturer if he does not wish to declare the performance of the product in that respect. 3.3 Batch: The amount of product manufactured as one complete operation. 3.4 Individual (and non-series): Manufacturing process where successive items are not identical prEN 12966-2 Page 6 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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4 FACTORY PRODUCTION CONTROL REQUIREMENTS 4.1 General Comments The manufacturer shall exercise a permanent FPC. The manufacturer is responsible for organising the effective implementation of the FPC system. Tasks and responsibilities in the production control organisation shall be documented and this documentation shall be kept up-to-date. In each factory, the manufacturer may delegate, among other things, the action to a person having the necessary authority to: a) identify procedures to demonstrate conformity of the product at the appropriate stages; b) identify and record any instance of non-conformity; c) identify procedures to correct instances of non-conformity. The manufacturer shall draw up and keep up-to-date documents defining the FPC which he applies. The manufacturers documentation and procedures shall be appropriate to the product and the manufacturing process. All FPC systems shall achieve an appropriate level of confidence in the conformity of the product. The elements mentioned and the requirements set out must be adaptable: a) to the particular features of the manufacturing processes. In particular, production control must be able to be adapted depending on the degree of automation of the manufacturing chain, adjustment devices, self adjustments, which manufacture may comprise; b) to the performance level the product is intended to have where the technical specification of the product provides for a range of performance levels and where the risk resulting from not achieving the intended performance varies with the level. These procedures must be chosen in the interests of ensuring that the level of confidence obtained by the production control is effectively the same for all conceivable situations of manufacture. The manufacturer shall implement these procedures and instructions, record these operations and their results and use these results to correct any deviations, repair the effects of such deviations, treat any resulting instances of non-conformity, solve the problems of non-conformity of products and, if necessary, revise the FPC to rectify the cause of non-conformity. prEN 12966-2 Page 7 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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There shall be an approved body to undertake the following tasks: 1. Initial type testing of products 2. Initial inspection of the factory and the factory production control 3. Regular surveillance, assessment and approval of the factory production control Factory Production Control therefore brings together operational techniques and all measures allowing maintenance and control of the conformity of the product with technical specifications. Its implementation may be achieved by controls and tests on measuring equipment, raw materials and constituents, processes, machines and manufacturing equipment and finished products, including material properties in products, and by making use of the results thus obtained. Attestation of conformity cannot be achieved in the absence of such a control. 4.2 Factory Production Control System The System (production control operation) shall at least include the necessary procedures for: 1. the specification and verification of raw materials and relevant constituents; 2. the controls and tests to be carried out during manufacture 3. the verifications and tests carried out on finished products according to the test regime specified in clause 6 of this standard; 4. the control of the necessary installations, equipment and trained personal to execute the tests on the raw materials, the tests during production and the final quality control tests as it is specified in clause 6 of this standard. The controls and tests during manufacture and their frequency shall be chosen based upon the product type and composition, the manufacturing process and its complexity, the sensitivity of the product features to variations in manufacturing parameters, etc. The test methods to be applied and the tolerances for the results of all tests used, are to be laid down in the Quality System of the manufacturer. The appropriate calibrations shall be carried out on defined measuring and test instruments. Frequency of testing shall be in accordance with the test plan of the manufacturer, unless otherwise specified in this standard, and shall be carried out according to the test methods indicated in this standard. These methods shall be direct methods. In the case of certain characteristics, indirect test methods can be used if a definite correlation or relationship can be established between the specific characteristic (the one to be verified) and another characteristic which is easier or safer to measure. prEN 12966-2 Page 8 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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4.3 Quality records The quality records shall include everything that is necessary to the control of raw materials and constituents, to control the production process and the final product. The description of the products, date of manufacture, test method adopted, test result and acceptance criteria shall be entered in the register under the signature of the person responsible for control who carried out the verification. In case of non-conformity: the corrective actions, taken to rectify the situation, shall be indicated in the register. 4.4 Control of non-conforming products If control or test results show that the product does not meet the requirements, the necessary corrective action shall be immediately taken. Products (or batches) not conforming shall be isolated and properly identified. Once the fault if possible has been corrected, the test or verification in question shall be repeated. Non-conforming products shall be reviewed in accordance with documented procedures. In certain cases, non-conforming products may be accepted with or without repair by concession. With regard to any control result not meeting the requirements of the technical specification, the corrective measures taken to rectify the situation (e.g. a further test carried out or modification of manufacturing, process, throwing away) must be recorded. In case of any product delivered before the tests results are available, a procedure and record shall be maintained for notifying customers. If the results show a non- conformity, and the product shall not be accepted without repair (by concession), a recall procedure shall be provided in that case. 4.5 Traceability The manufacturer or his agent shall keep full records of individual products (or batches), including their related manufacturing details and characteristics, and keep records of to whom these products were first sold. prEN 12966-2 Page 9 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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5 COMMON REQUIREMENTS The manufacturer shall have available the installations, equipment and personal which enable him to carry out the necessary verifications and tests. The manufacturer shall calibrate or verify and maintain the control, measuring or test equipment in good operating condition, whether or not it belongs to him. The equipment shall be used in conformity with the specification or the test reference system to which the specification refers. NOTE: The manufacturer, or his agent, may meet these requirements by concluding subcontracting agreement with one or more organisations or persons having the necessary skills and equipment. 5.1 Raw materials and constituents The manufacturer shall draw up and keep up-to-date documented procedures and instruction for the quality control and testing all materials and constituents, in particular those characteristics which have a direct influence on the properties of the final product. 5.2 Controls and tests during manufacture The manufacturer shall draw up and keep up-to-date documented procedures and instructions for carrying out the appropriate control during the manufacture. 5.3 Final testing The minimum frequency of final testing shall be as designated in clause 6. If a manufacturer operates a certified Quality System (according to EN ISO 9000 series of standards), an alternative frequency based upon statistical observations may be agreed with the Notified Body. 5.4 Handling and Storage Whilst the product is under the control of the manufacturer, they shall ensure that packaging, handling and storage, do not damage the product and that it remains compliant with the applicable technical specification. prEN 12966-2 Page 10 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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6 SPECIFIC REQUIREMENTS The test methods for the characteristics included in this clause are those specified in chapter 9 of part 1 of this specification. On basis of each batch, unless otherwise stated in the manufacturers Quality System (according to EN ISO 9001) approved by one of the notified bodies in the framework of the CPD, the final control testing shall include at least: a) colour chromaticity coordinates according to the appropriate class (C1 or C2) b) luminance limits according to the appropriate class (L1,L2 or L3) c) luminance ratio according to the appropriate class (R1 or R2) d) beam width according to the appropriate class (B1,B2,B3,B4,B5,B6 or B7) uniformity of light emitting elements Variable message signs making use of retro-reflective and non retro-reflective materials shall meet the specific relevant requirements as stated in EN 12899. Fixed vertical road signs Evaluation of conformity Part 4: Requirements for factory production control clause 6. prEN 12966-2 Page 11 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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ANNEX A (INFORMATIVE) Bibliography
List of references used in the text and of useful test methods.
Construction Products Directive of 22 December 1988 (89/106/EEC), published in the O.J. of the E.C. No. L40 of 11 February 1989, modified by the Directive of 22 July (93/68/EEC) published in the O.J. of the E.C. No. L220 of 30 August 1993.
Guide for the definition of Factory Production Control in technical specifications relating to Construction Products 95/135 Rev. 1, European Commission DG-III, Brussels, 6.7.1995 prEN 12966-2 Page 12 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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ANNEX B (INFORMATIVE) Examples of test forms to register the results of a conformity review Conformity Review Variable Message Sign (Name of test subject)
CE-Ident-No applicable standard prEN 12966 Class applicable QS-documents Product-name Product-ident-No Supplier LOT-N0 Suppliers document-No 1
Date of supply 1
Summary sheet Variance comparison Specification requirements Actual values Test No a B c .. a b c .. Result Signature 01 02 03 .. n Sample reference
Table 1 Form for test results: actual values and requested values NOTE: Use a new record sheet for each test-sample. testing equipment testing procedure document
pass fail sample reference stock-identification-code corrective and preventive action necessary
2nd test necessary reason of defect
1 If raw material is tested prEN 12966-2 Page 13 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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needed action responsible deadline of action Auditor: Signature: Date of audit:
Conformity Review Variable Message Sign (Name of test subject)
Manufacturer applicable standard prEN 12966 CE-Ident-No applicable QS-documents Class Product-name Product-ident-No
Chromaticity Co-ordinates Colour x y Pass Fail Signature
Note: Use for each test sample a new sheet of record. Put the x, y values in system of coordinates in the table. The result meets the requirements if the values are inside the indicated boxes as mentioned in table 2 for class C1 and table 3 for class C2 in clause 7.3.2 of this standard.
testing equipment testing procedure document
pass fail corrective and preventive action necessary
2nd test necessary reason of defect needed action responsible deadline of action
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Auditor: Signature: Date of audit:
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Conformity Review Variable Message Sign (Name of test subject)
Manufacturer applicable standard prEN 12966 CE-Ident-No applicable QS-documents Class Product-name Product-ident-No
Colour: WHITE Luminace (cd/m) Class: L3 L2 L1 Sign illuminance (lx) Minimum Recorded value Minimum recorded value Minimum Recorded value Maximum 40.000 12.400 6.200* 3.100* 62.000 4.000 2.200 1.100 550 11.000 400 600 300 150 3.000 40 250 200 100 1.250 < 4 75 60 30 375 Signature Passed Y/N Passed Y/N Passed Y/N NOTE: Use for each test sample a new sheet of record. This table only is meant as an example for white light; for the colours white/yellow, yellow, green, red or blue see respectively table 4b, 4c, 4d, 4 e or 4f of clause 7.3.3. of this standard
testing equipment testing procedure document
pass fail corrective and preventive action necessary
2nd test necessary reason of defect needed action responsible deadline of action
Auditor: Signature: Date of audit:
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Conformity Review Variable Message Sign (Name of test subject)
Manufacturer applicable standard prEN 12966 CE-Ident-No applicable QS-documents Class Product-name Product-ident-No
Minumum luminance ratio Class R2 R1 ON AXIS OFF AXIS ONAXIS OFF AXIS Colour min value min value min value min value white 10 5 5 3 white/yellow 8,5 4,25 4,25 2,55 yellow 6 3 3 1,8 green 3 1,5 1,5 0,9 red 2,5 1,25 1,25 0,75 blue 1 0,5 0,5 0,3 Signature Passed Y/N Passed Y/N Passed Y/N Passed Y/N Note: Use for each test-sample a new sheet of record. Test procedures and definitions ON AXIS and OFF AXIS according prEN 12966, 9.3.2.3.
testing equipment testing procedure document
pass fail corrective and preventive action necessary
2nd test necessary reason of defect needed action responsible deadline of action
Auditor: Signature: Date of audit:
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Conformity Review Variable Message Sign (Name of test subject)
Manufacturer applicable standard prEN 12966 CE-Ident-No applicable QS-documents Class Product-name Product-ident-No
Viewing angle (degrees) Beam width class Minimum horizontal and vertical angles Recorded angles with 50% of ON AXIS B1
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NOTE: Use for each test-sample a new sheet of record. Test procedures according prEN12966clause 9.3.3, Beam Width. None of the recorded values < 50% ON AXIS value may be present in the shaded area. prEN 12966-2 Page 19 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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testing equipment testing procedure document
pass fail corrective and preventive action necessary
2nd test necessary reason of defect needed action responsible deadline of action
Auditor: Signature: Date of audit:
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Conformity Review Variable Message Sign (Name of test subject)
Manufacturer applicable standard prEN 12966 CE-Ident-No applicable QS-documents Class Product-name Product-ident-No
Uniformity Recorded value Calculated Ratio Maximum Ratio H L H:L H:L Recorded average value of the 12% highest light emitting elements
Recorded average value of the 12% lowest light emitting elements
3:1 Recorded average value of the 4% highest light emitting elements H Recorded average value of the 4%lowest light emitting elements
5:1 Signature Passed Y/N Passed Y/N NOTE: Use for each test-sample a new sheet of record. Test procedures according prEN 12966 clause 9.3.4. Test must be executed for each seperate colour.
testing equipment testing procedure document
pass fail corrective and preventive action necessary
2nd test necessary reason of defect needed action responsible deadline of action Auditor: Signature: Date of audit: prEN 12966-2 Page 21 Factory Production Control EN version A-EN12966 -FPC-Enquiry version
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