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NB-CPD/SG02/07/044r1 Page 1 of 17

GNB-CPD

SG02

Guidance from the Group of Notif ied Bodiesfor the Construction Products Directive

89/106/EEC

NB-CPD/SG02/07/044r1

Issued: 20 April 2012

APPROVED -GUIDANCE

GNB-CPD posit ion paper from SG02 - EN 13263-1:2005+A1:2009

Certification of silica fume for concrete

General scope, limi tations and aim of th is guidance for notif ied bodies

This position paper contains guidance for notified bodies (NBs) involved in the certification of silicafume for concrete according to EN 13263-1:2005+A1:2009. The purpose is to help NBs work

equivalently and come to common judgments. This guidance contains informative material (whichNBs should or may follow) and/or normative guidance (which NBs shall follow or at least workequivalently to as circumstances demand).

The primary document for NBs is the edition of the relevant harmonized standard that is currentlycited in the Official Journal of the EU to which the manufacturer works. This guidance is thoughtnecessary to provide clarity and completeness for NBs so that they can work equivalently. Itsupplements and makes practical for NBsthe harmonized standard EN 13263-1:2005+A1:2009,approved AG guidance, and Standing Committee guidance in the form of GPs, which also apply -unless otherwise explicitly stated in this guidance. This position paper should notcontradict norextend the scope of the work and role of a NB, nor impose additional burdens on the manufacturer,beyond those laid down in the CPD and EN 13263-1:2005+A1:2009.

This guidance should be considered valid until the relevant standards are amended to include theguidance (as thought fit by the CEN/TC); or until guidance from Commission, SCC or AG haschanged on relevant matters. Whereupon, the paper should be considered for withdrawal/revisionand be replaced by new guidance as necessary.

This position paper was considered approved in its original form by SG02 on 13 September 2006and by Advisory Group on 2 January 2007, and in its revised form by SG02 on 2 November 2011and by Advisory Group on 1 April 2012.

Paragraphs that have been changed from NB-CPD/SG02/07/044 are indicated as follows:

modified text or paragraph by a broken left border line;

new paragraph by a solid left border line, and;

where previous paragraphs have been removed by .

Also Annexes 1 and 3 from the previous edition have been deleted.

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Contents

1 Foreword ..................................................................................................................................................... 3

2 Scope and field of application ..................................................................................................................... 3

3 Reference list .............................................................................................................................................. 3

4

Terminology ................................................................................................................................................ 4

5 EC silica fume certification process (for a new factory) .............................................................................. 5

6 Starting / application / acceptance - 1stPhase ............................................................................................ 6

7 Initial inspection of the factory and factory production control - 2nd

Phase ................................................. 6

8 Initial Audit Sampling/Type testing and issue of EC certificate of conformity - 3rd

Phase .......................... 8

9 Initial period - 4thPhase .............................................................................................................................. 9

10 Maintaining the EC certificate of conformity ............................................................................................. 10

11 Continuous surveillance, assessment and approval of factory production control ................................... 11

12

Quality records .......................................................................................................................................... 12

13 EC certificate of conformity ....................................................................................................................... 12

14 Proficiency testing ..................................................................................................................................... 12

Annex A Example of a reference checklist .................................................................................................... 13

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1 0BForeword

Sector Group 02 of the Group of Notified Bodies for the Construction Products Directive89/106/EEC has prepared this document to assist NBs in following equivalent procedures incertifying the conformity of silica fume with Annex ZA of EN 13263-1.

The scope of this document is to supplement this standard and EN 13263-2 taking intoconsideration the necessary internal procedures of the certification bodies. All the activities of thenotified certification body, necessary to achieve the EC certificate of conformity, are reported andexplained in the sequence of the certification activity. In preparing this edition of the position paperSG02 has taken into consideration the experience of certification/inspection bodies and testinglaboratories notified in the field of silica fume of working to the documents in the reference list.

It is emphasized that only the silica fume manufacturer/authorized representative is responsible forensuring that silica fumes bearing the CE Marking have all the characteristics required by Annex ZAof EN 13263-1.

To maintain equivalent use and interpretation of this document, notified bodies are strongly invitedto raise any questions, remarks, or problems related to the use of this document with the secretariatof NB-CPD/SG02. The address of the secretariat can be found on the CIRCA websiteHhttp://www.forum.europa.eu.int/Members/irc/nbg/cpdgnb/libraryH.

2 1BScope and field of application

This document defines and describes the sequence of the main operational procedures to befollowed by a notified certification body in granting EC certificate of conformity for silica fume on thebasis of the requirements of Annex ZA of EN 13263-1. In case of undated references the latest

version (including amendments and corrigenda) cited in the Official Journal of the European Unionapplies, as per 3.2 and 3.3 of NB-CPD/AG/08/009.

EN 13263-1 covers silica fume intended for use as a type II addition for the production of concreteincluding in particular cast-in-situ or prefabricated structural concrete conforming to EN 206-1.Silica fume according to EN 13263-1 may also be used in mortars and grouts.

3 2BReference list

EN 13263-1, Silica fume for concrete Part 1: Definition, requirements and conformity criteria,including annex ZA

EN 13263-2, Silica fume for concrete Part 2: Conformity evaluation

EN ISO 9000, Quality management systems - Fundamentals and vocabulary (for definitions only)

NB-CPD/AG/03/001, Numbering of certificates of conformity

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NB-CPD/AG/03/002, Guidance to notified bodies on the attestation of conformity under theConstruction Products Directive 89/106/EEC

NB-CPD/AG/03/003, Examples of EC certificates of conformity

NB-CPD/AG/03/004, Checklists for initial inspection of factory and factory production control and

continuous surveillance of factory production control

NB-CPD/AG/07/008, Guidance to Notified Bodies in certifying own brand labelled product and thoseinvolving significant subcontract manufacturing

NB-CPD/AG/08/009, The consequences for NBs of corrigenda, amendments and revisions toharmonized European standards

4 3BTerminology

For those terms that are not included in the documents listed in clause 3 and for those that neededto be detailed, the definition is given below:

Appl icant

Manufacturer applying for the EC certificate of conformity for silica fume produced in one factory,directly or through its authorised representative.

Audi t sample

Spot sample taken under the responsibility of the notified certification body at the point(s) of releaseof silica fume from the factory and/or depot supplied with silica fume by the factory.

Authorised representat ive

Any natural or legal person, expressly designated by the manufacturer to act on his behalf. Theauthorised representative must be established inside the EEA.

Brand name

A unique proprietary name owned and used by a manufacturer for a type of silica fume.

CIRCA

The European Commission Website dedicated to the Construct Products Directive (CPD) in which iscontained all the information concerning the general co-ordination (GNB-CPD Advisory Group ) and

the specific co-ordination (sector groups) of bodies under the CPD. Relevant information may befound at any time by consulting:Hhttp://forum.europa.eu.int/Members/irc/enterprise/cpdgnb/homeH.

EC certificate of conformity

A certificate which entitles the manufacturer to affix the CE marking.

EC certified s ilica fume

Silica fume for which an EC certificate of conformity has been issued.

EC declaration of conformity

Declaration by the manufacturer or its authorised representative in conformity with Annex ZA ofEN 13263-1.

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Manufacturer

Any natural or legal person who manufactures a construction product or who has such a productdesigned or manufactured, and markets that product under his name or trademark. The

manufacturer is responsible for that product, and for the purposes of CE marking this includesensuring that it complies with the harmonised part of the standard and achieves the performance hehas declared.

Inspector

Person appointed under the responsibility of the notified certification body to perform the activities ofinspection and/or audit sampling.

Non-Conformity

For the CE certification of silica fume two types of non-conformities are possible:

a product non-conformity (PNC) in case the product does not fulfil the requirements of theproduct when the test results are evaluated as described in EN 13263-2;

a system non-conformity (SNC) in case the factory production control system does not complywith the requirements in EN 13263-2. The notified certification body may introduce differentlevels of SNC combined with actions to be taken by the manufacturer.

5 4BEC silica fume certi fication process (for a new factory)

The system to be followed by the notified certification body to grant the EC certificate (in the case ofa new factory) is divided into four main operative phases. A further phase concerns continuous

surveillance (see clause 11).

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Scheme of reference for the EC silica fume certification process

1st

- Starting/Application/Acceptance (see clause 6):

Application receipt/acceptance

Acceptance of the application

Examination of the received documents

2nd- Initial inspection of the factory and factory production contro l (see clause 7):

Assessment of the quality documentation

Initial inspection of the factory and factory production control

Initial inspection of the laboratory of the factory

Report of the results of the initial inspection

3rd

- Initial Audit sampling/Type testing and issue of EC certificate of conformity(see clause 8):

Audit SamplingTesting of the first audit sample

Evaluation of the results of the first audit sample

Issue of the EC certificate of conformity and information to the manufacturer

Additional identification of silica fume

4th

- Initial period (see clause 9):

Subsequent audit samples

Testing of the subsequent audit samples

Receiving testing results

Evaluation of the auto-control results

Evaluation of the subsequent audit samples results

Decision that the EC certificate of conformity remains valid (and information to the manufacturer)

6 5BStarting / application / acceptance - 1st

Phase

For application procedure, see NB-CPD/AG/03/002.

7 6BInitial inspection of the factory and factory production control -2

ndPhase

For initial inspection procedure, see NB-CPD/AG/03/002.

During the initial inspection of the factory, the inspector should use a checklist, in addition to all ofthe relevant document listed in clause 3, (see an example in Annex A).

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7.1 14BAssessment of the quali ty documentation

During the initial inspection the manufacturer shall make available to the inspector the latestcontrolled version of the works quality manual and of the related quality documents.

The inspector shall verify that the works quality manual and related quality documents are correctlyimplemented and applied in compliance with EN 13263-2.

7.2 15BInitial inspection of the factory and factory production control

The main actions to be taken are reported in EN 13263-2 5.5.1, 5.5.2, and 5.5.3.

The inspector, among others, shall verify that each silica fume silo bears the information concerningthe type or other indications necessary for a unique identification of the silica fume (brand name,etc.).

A unique identification of the silica fume/silos shall be available for sampling, process control andloading.

During the initial inspection, the first audit samples could be taken and the manufacturer shall statewhich cement (ref. EN 13263-1 3.30) to be used when testing activity index according toEN 13263-1 5.3.3.

The assessment of depot(s) should be included in the initial inspection.

7.3 16BInitial inspection of the laboratory of the factory

The main actions to be taken are reported in EN 13263-2 5.5.4.

In the case where some auto-control tests are performed by an external laboratory as mentioned inthe works quality manual, the notified body shall inspect this external laboratory to verify therecords, competency and confidentiality at least once per year.

Annex A.3.3 gives requirements for the equipment that shall be functioning in the laboratory forautocontrol testing.

7.4 17BReport of the initial inspection

The main actions to be taken are reported in EN 13263-2 5.5.5 and 5.2.3. General information oninitial inspection for product certification is given in NB-CPD/AG/03/002.

In the event of non-conformity of the factory production control system (SNC) or a product non-conformity (PNC), the certification body should take appropriate decisions/actions to ensure that thefactory production control is correctly applied by the manufacturer and/or corrective actions aretaken to ensure product conformity as per document NB-CPD/AG/03/002.

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8 7BInitial Audit Sampling/Type testing and issue of EC certif icate ofconformity - 3

rdPhase

8.1 18BAudi t sampl ing

The main actions to be taken are reported in EN 13263-2 5.4.1, 5.4.2, 5.4.4, and 5.6.1.

8.2 19BTesting of the first audit sample

The actions to be taken are reported in EN 13263-2 5.4.3 and 5.4.4.

8.3 20BEvaluation of the results of the first audit sample

The main actions to be taken are reported in EN 13263-2 5.6.2, 5.6.3.

The manufacturer shall inform the notified certification body of the results of the testing on auditsamples as soon as they are available.

The test results of the testing laboratory shall be sent to the manufacturer only by the notifiedcertification body, and in any case always after the receipt of the correspondent internal test results.

At the end of the tests of the first audit sample the notified certification body shall send a test reportto the manufacturer.

The test results of the testing laboratory and the manufacturer have to be equivalent (taking intoconsideration the reliability of the test method) and both must comply with the requirements ofEN 13263-1.

8.4 21BIssue of the EC certificate of conformity and information to the manufacturer

It is recommended that each EC certificate of conformity should refer only to one silica fumeproduced in a specific factory.

NOTE An advantage of issuing separate certificates for different plants and products is that it may beeasier to withdraw one certificate, if problems arise with one type of product (or the product is notproduced anymore), than to revise a complex certificate covering multiple products and sites.

The notified certification body shall issue the EC certificate of conformity after the positive results ofthe 2ndand 3rdphases and shall immediately inform the applicant.

At this time some results of the autocontrol for that silica fume will be available. They shall also becompared with the requirements of EN 13263-1 in order to make the conclusion of the notifiedcertification body as reliable as possible. In this case all available results of the autocontrol shouldcomply with the requirements of EN 13263-1.

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8.5 22BAddi tional identif icat ion of s il ica fume

A manufacturer may produce different silica fumes complying to the same standard designation.Additional identification is required to distinguish between these silica fumes, which shall be used bythe manufacturer and all documents relating to marking and shall be given in the certificate.

For this purpose, these products receive an additional identification in the form of a number or oftwo lower case letters, between parentheses. For the numbering system this number should be 1for the second certified silica fume, 2 for the next, and so on. For the lettering system the lettersshall be chosen in such a way to avoid confusion with letters used for cement and concretestandard and regulation indications across the EEA countries.

Example: The designation (1) or (st) is given to a silica fume produced in a factory that alreadyhas a certificate for a silica fume with different (additional) properties, but complying with therequirements for that product in EN 13263-1.

This indication must always accompany the CE-marking information of the silica fume to which it is

given even if other silica fumes are no longer produced. This enables backward traceability of thissilica fume and its test results. Once an indication is used for a certain silica fume it may never beused again for another silica fume produced by the same factory.

When this additional identification is given to a silica fume the following note shall be added in theCE certificate of conformity under additional identification:

The indication between parentheses is added to distinguish this silica fume from anothercertified silica fume produced by this factory. This indication must for this reason be added tothe standard designation of this silica fume.

9 8BInitial period - 4thPhase

9.1 23BSubsequent audit samples

The actions to be taken are reported in EN 13263-2 4.3.1, 5.4.1, and 5.4.2.

The notified certification body should devise an audit sample programme that takes into account allpoints of release including depots and the amount of testing should be based on the proportion ofeach product dispatched, but having regard to the overall practicality and effectiveness of theautocontrol testing specified in the product standard EN 13263-1. To enable this, the notified

certification body should request the manufacturer to inform it in advance of the proportions of eachsilica fume that it expects to sell directly from the factory, and through each individual depot.

In this case, the manufacturers auto-control sample programme could be organised in the sameway, and evidence of it could be given in the quality documents of the factory.

9.2 24BTesting of the subsequent audit samples

The actions to be taken are reported in EN 13263-2 5.4.3.

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9.3 25BReceiving testing results

The manufacturer shall inform the notified certification body of the results of the testing on auditsamples and autocontrol as soon as they are available.

The test results of the testing laboratory shall be sent to the manufacturer only by the notifiedcertification body, and not before receipt of the correspondent internal test results.

9.4 26BEvaluation of the auto-control results

The actions to be taken are reported in EN 13263-2 5.6.

9.5 27BEvaluation of the subsequent audit samples results

The actions to be taken are given in EN 13263-2 5.6.

It is within the responsibility of the notified certification body to take immediate action in the case ofdoubts concerning the test results. The manufacturer shall be informed about these actions.

9.6 28BDecision that the EC certif icate of conformi ty remains valid (and information tothe manufacturer)

When the evaluation of the first initial period of autocontrol results is confirmed, as well as theresults of the external tests and all the aspects related to factory production control, at the end of theinitial period the notified certification body should inform the manufacturer of the confirmation of

validity of the first issue of the EC certificate of conformity.

10 9BMaintaining the EC certificate of conformity

The scheme to be followed by the notified certification body to maintain the validity of the ECcertificate is shown below.

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Overview of actions in relation to EC certification of conformity continuoussurveillance, assessment and approval of factory production control (see clause 11)

Annual inspection to the factory, FPC and laboratory

Management of the non conformities/corrective actions following the annual inspection to thefactory, FPC and laboratory

Evaluation of the results of autocontrol testing of samples

Management of the non conformities/corrective actions following the evaluation of the resultsof autocontrol testing of samples

Audit sample results

Management of the non conformities/corrective actions following the evaluation of the resultsof audit testing

Decision that the EC certificate of conformity remains valid (and information to themanufacturer)

11 10BContinuous surveillance, assessment and approval of factoryproduction control

11.1 29BAnnual inspect ion to the factory, FPC and laboratory

The actions to be taken are reported in EN 13263-2 5.2.1, 5.2.2, and 5.2.3.

11.2 30BManagement of the non conformities/corrective actions following the annual

inspection to the factory, FPC and laboratory


11.3 31BEvaluation of the results of auto-control testing of samples

The actions to be taken are reported in EN 13263-2 5.3.

11.4 32BManagement of the non conformities/corrective actions following the

evaluation of the results o f auto-control testing of samples


11.5 33BAudi t sample results

The actions to be taken are reported in EN 13263-2 5.4.5, and 5.4.6.

Each sample shall be tested for all the required properties.

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11.6 34BManagement of the non conformities/corrective actions following theevaluation of the results of audit testing


11.7 35BValidity of the EC certificate of conformity

Following evaluation of the results of the autocontrol and audit samples as per table 1 ofEN 13263-2, and audit of factory production control, the certification body should consider thevalidity of the EC certificate.

During the period of validity of the certificate, the notified certification body may re-issue the ECcertificate of conformity, maintaining the same number. This re-issue shall contain also the date ofthe first issue.

12 11BQuality records

The actions to be taken are reported in EN 13263-2 4.1.4.2.

13 12BEC certificate of conformity

The format of the certificate should follow the latest examples given in NB-CPD/AG/03/003.Examples for attestation of conformity system 1+ in languages other than English may be availableon GNB-CPD CIRCA, in subfolders of AG Guidance - Horizontal Guidance & Information.

However, these might not have been translated from the current version. Certificates derived fromtranslations of earlier versions should be modified to match the latest English language version.(Hhttp://circa.europa.eu/Members/irc/nbg/cdpgnb/library?l=/pendingsreferencesinsoj/guidance_horizontal&vm=detailed&sb=TitleH).

The proposed numbering system for EC certificates is set out in NB-CPD/AG/03/001.

An EC certificate must always show the organization placing the silica fume on the market as themanufacturer. In cases where that organization has the silica fume manufactured for it by aseparate organization, the factory(ies) shown on the certificate shall be all those where the silicafume may have been made, although the factory details may be given in a coded format. Forfurther details see NB-CPD/AG/07/008.

14 13BProficiency testing

The requirements are reported in EN 13263-2 5.4.7.

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Annex A Example of a reference checklis t

There is a generic checklist given in NB-CPD/AG/03/004 for purposes of inspecting factory and

FPC, however the checklist given below is more specific to silica fume production.

The numbers of the relevant clauses of EN 13263-2 are given in brackets at the end of eachheading.

Each notified body conducting certification of silica fume should prepare its own checklist. Thefollowing checklist is an example of the issues which may be relevant.

A.1 General requirements (4.1)

A.1.1 Works quali ty manual (4.1.2)

Does the factory have a controlled copy of the works quality manual?

Is the year of the first issue of the works quality manual recorded?

Is there a distribution list of the works quality manual and related quality documents?

Is there evidence of receipt of the copies (controlled or not) of the works quality manual (and relatedquality documents) by the persons indicated in the distribution list?

A.1.2 Management system (4.1.3)

Does the works quality manual show the organisation structure?

A.1.3 Qual ity pol icy statement (4.1.3.1)

Does the works quality manual show the quality objectives of the manufacturer/factory?

Are there defined responsibilities concerning quality?

Are the resources required to reach and maintain the quality objectives available?

A.1.4 Management representative (4.1.3.2)

Is there an appointed management representative?

A.1.5 Internal audits and management review (4.1.3.3)

Is there any list of persons charged with internal audit?

Are the members of this list independent of the area to be audited?

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A.1.6 Training (4.1.3.4)

Is there evidence of the competence of the personnel involved in the quality production/controlprocess?

Is there a defined programme for the training of the personnel involved in the qualityproduction/control process?

Are there personal sheets/files for recording the experience/training of each person involved in thequality production/control process?

A.1.7 Document control (4.1.4.1)

Does a control ensure that the appropriate issue of all documents are available at essential

locations?

Does a control ensure that the changes or modifications to any document are effectivelyintroduced?

Has a master list been established to identify the current version of documents in order to preventthe use of non-applicable documents?

A.1.8 Qual ity records (4.1.4.2)

Are the Factory Production records kept for a minimum period of three years?

Are the factory production records for the products kept for a minimum period of ten years?

Is there suitable back-up of electronic records?

A.2 Internal qual ity control (4.2)

A.2.1 Process control (4.2.1 and 4.2.1.1)

Are the steps of the production process described in a flow chart?

Are targets and control limits defined for each production step?

Are corrective measures set if control limits are exceeded?

Are there procedures for controlled proportioning of the silica fumes to achieve required targetproperties?

What are the method(s) and frequencies adopted to collect process control data. Are thesemethods made available to the factory managers?

Are there procedures intended to avoid contamination:

of silica fume (through separate, adequate storing facilities)?

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during production, handling and at point of dispatching?

Are there silos for stocking products in bulk before dispatch?

A.2.2 Provisions for processing plants (4.2.1.2)

Are there procedures to ensure each consignment of incoming silica fume is documented andcontrolled as required?

Are there procedures for the controlled processing of the silica fume?

A.2.3 Control of of f-specif icat ion production (4.2.1.3)

Are there procedures for controlling the silica fume produced that does not comply with the controllimits set by the manufacturer?

Are there procedure aimed at avoiding the dispatch of silica fume that proves not to be incompliance with the specifications provided in EN 13263-1?

A.2.4 Measuring and testing (4.2.2)

Do the quality documents define the equipment required for control and test activities duringproduction?

A.2.5 Inspection, measur ing and test equipment (4.2.2.1)

Are there procedures to control and calibrate the test equipment used during production?

Are there records of the control and calibration of the test equipment used during production?

Is there an inspection/testing plan for all the steps of the production process?

A.2.6 Handling, storage, packaging and del ivery (4.2.3)

Are there procedures for assuring that the silica fume does not become contaminated whilst beingconveyed inside the works to the silo?

Are there procedures for assuring that the silica fume does not become contaminated whilst beingconveyed inside the depots from the unloading point to the silo?

Is the silica fume contained in each silo uniquely and clearly identified, in conformity with thecomplete name that will appear on the EC Certificate of conformity?

For the external depot(s) only, if applicable: Is the silica fume contained in each silo of the depotuniquely and clearly identified, in conformity with the complete name that will appear on the ECcertificate of conformity and also with the identification of the factory in which it was produced?

Is there a diagram showing handling and feeding lines to the silos, deviations, dispatching andsampling points?

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Are there procedures aimed at ensuring that the loaded silica fume complies with the customersspecifications?

Does the Works Quality Manual contain the list of the Depots of the Factory?

Have the weighing machines at the gate been approved and certified?

A.3 Autocontrol tes ting of samples (4.3)

A.3.1 Sampling and test ing (4.3.1)

Is there a procedure describing the autocontrol plan for each silica fume?

Do these controls and tests frequencies comply with the requirements of EN 13263-1?

For silica fumes sold discontinuously, are the test frequencies and sampling points specified in theworks quality manual and agreed with the notified certification body?

Is the sampling plan in proportion to the production of bulk silica fume and production from depotsaccording to the relevant sale quantities?

Is autocontrol data transmitted to the certification body in due time?

Do the test procedures comply with the test methods given in EN 13263-1?

For which tests does the silica fume factory use an external laboratory? Is this recorded in theworks quality manual?

Has the manufacturer agreed for inspections of the external laboratory by the notified certificationbody?

Are the test procedures for possible alternative test methods for determining the silica fumeproperties reported in the quality documents?

Are the registers containing the autocontrol data correctly completed, updated and made available?

Are working/technical instructions available for the repetition of test results in the event of failure?

Are there instructions for repeating tests which have failed? Are the above recorded?

What is the frequency of the statistical assessment according to the criteria provided inEN 13263-1?

Are records concerning the autocontrol data retained for at least 10 years?

A.3.2 Correct ive act ions (4.3.2)

Does the works quality manual provide corrective actions procedures to be carried out in order toeliminate the causes of non-compliance?

In case of non-compliance with the single results limit values conformity criteria, does the worksquality manual provide a procedure for a review of the factory production control?

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NB CPD/SG02/07/044r1 Page 17 of 17

In such cases, is the notified certification body informed?

In case of non-compliance of a sample taken at the delivery point:

has the manufacturer determined the quantity of non-complying materials?

has the manufacturer taken all the necessary precautions to avoid dispatch of the product?

has the manufacturer informed the customers that they could have been given non-complyingsilica fume?

Are the corrective measures taken due to a non-compliance recorded and traceable?

Is the efficacy of the corrective measures controlled and recorded?

A.3.3 Measuring and test equipment for autocontrol test ing (4.3.3)

Is there a list of the measuring equipment used for autocontrol tests?

Is there a procedure for controlling and calibrating the test equipment?

Do the control and calibration procedures include:

equipment identification?

equipment supplier and model?

location of the equipment?

control frequency?

control method?

approval criteria?

reference samples/instruments?

measures to be taken in case the results of the control/calibration are not satisfactory?

Is each item of equipment identified by a label reporting:

dates of the last and next control/calibrations?

authorised signature?

Is non-calibrated equipment identified with a label indicating that it is out of service?

A.3.4 Qual ity records (4.3.4)

Are autocontrol results recorded and traceable?

Is the documentation relevant to the control and calibration of test equipment recorded andtraceable?

Does the works quality manual show that autocontrol results and control/calibration documentationare kept for at least 10 years?

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