IECEx QUALITY ASSESSMENT REPORT - · PDF fileEN ISO/IEC 80079-34:2011 incl. A.2 and A.5. Next Quality Audit due: ... IECEx QUALITY ASSESSMENT REPORT CONFIDENTIAL IECEx QAR

IECExQUALITY ASSESSMENT REPORT

CONFIDENTIAL IECEx QAR Reference No.:Audit Report No.:

NO/PRE/QAR15.0001PRE-QAR-271864

IECEx F-001 V1 Issued 2015-02-09 Page 1 of 6

ManufacturerInclude Address with post code

: Highlight Secure asKrokvikN-6143, FiskåNORWAY

Site(s) auditedInclude Address with post code

: Highlight Secure asKrokvikN-6143, FiskåNORWAY

VP metall ASRaufoss Industripark, bygn. 53N-2830, RaufossNORWAY

Product Description : Safety plug, Ex e

Number of Employees : Totally 1 employee in Highlight Secure.Totally 20 employees in VP metall.

Scope of Audit : Initial assessment

List all applicable IECEx Certificates : (To be issued)

Electrical equipment with type(s) ofprotection of : Ex e

Audit Team Leader : Asgeir Holt

Audit Date : 2014-10-16 (Highlight Secure) and 2014-12-03 (VP metall)

Contents:1 Summary Report2. Audit information3. Documentation Review and Assessment of Implementation4. Observations

Nemko GroupNemko AS, Gaustadalléen 30, P.O. Box 73 Blindern, 0314 Oslo, NorwayTEL +47 22 96 03 30 FAX +47 22 96 05 50 EMAIL [email protected] NUMBER NO974404532nemko.com/no





1. Summary Report

Assessment Summary and Conclusions:

The audit was conducted according to the agreed audit programme. The audit team was met witha positive and professional atmosphere. In general, the QA system seems to be well implementedand is functioning satisfactorily, but some improvements should be possible.Totally 12 nonconformities found during the audit. See NCR reports listed below. Correctiveactions received and approved prior to issuing this QAR.As a result of the audit some observations / suggestions for improvement were found - seeAppendix 1, page 6 of this report. Observations found will be checked out during next surveillanceaudit.

All phases of the production assembly processes are carried out by the external factory VP Metall,Raufoss.VP metall (Varmpresse metal) is purchasing the raw material to be used for the machining of theplugs. Initially, the plugs are hot forged (in high temperature) into the right raw shape, using aspecialized tool. Following that, the raw plugs are sent to the neighbour company Raufoss Water &Gas (RWG) for machining, (statistical) product control (and marking). Finally, the plugs are sentback to VP Metall for final control and shipment to Highlight Secure. VP metall will also ship directlyto certain high volume customers (i.e. Glamox).

Ex production normally by customer order – some production for stock for small volume customers.

The audit was carried out as a combined initial audit for IECEx QAR and ATEX QAN. Ref. ATEXNotification to be issued by DNV Nemko Presafe AS, acc. toEN ISO/IEC 80079-34:2011 incl. A.2 and A.5.

Next Quality Audit due: 2015-10 (Highlight Secure) and 2016-06 (VP metall)(Both: surveillance)

Non-Conformities 12

NCR No.(s): PRE-QAR-271864/1; PRE-QAR-271864/2; PRE-QAR-271864/3; PRE-QAR-271864/4; PRE-QAR-271864/5; PRE-QAR-271864/6; PRE-QAR-271864/7; PRE-QAR-271864/8; PRE-QAR-271864/9; PRE-QAR-271864/10; PRE-QAR-271864/11; PRE-QAR-271864/12

Audit Team Leader Recommendations:

• Certification to be issued. Corrective action to be verified at next surveillance visit.

Audit Team Leader Signature2015-02-09

IECEx CB2015-02-09





2. Audit Information

2.1 Scope of Audit:

Type B initial assessment of manufacturer without a certified QMS

2.2 Audit Criteria : OD 025 Ed. 3.0; (Checklist acc. to) EN ISO/IEC80079-34:2011; ISO/IEC 17050-1/-2; ISO9001:2008

2.3 Date(s) and Duration of Audit : 2014-10-16 (Highlight Secure - HS) and 2014-12-03 (VP metall - VPM)Totally 2 auditor day on site

2.4 Composition of Audit Team:

Name Position Role in AuditAsgeir Holt ATEX & IECEx Lead Auditor ATEX & IECEx Lead Auditor

2.5 Interviewed Representatives of Manufacturer (Auditee):

Name PositionAmrvin Nerland (HS) Managing Director / QA Manager / Ex responsible

personKari-Anne Haug (VPM) Quality & HSE ManagerJohnny Tollefsbøl (VPM) Managing Director / Ex coordinator

2.6 Critical Suppliers:

Name of Supplier Critical item or service providedRaufoss Water & Gas (RWG) Machining, marking and verification processes

Note: The supplier of the machined plugs is considered safety critical (including their supplier ofraw material), in addition to supplier(s) of o-rings and nuts that can be supplied with the products(or can be presupposed supplied separately by high volume customers (i.e. Glamox)).





3. Documentation Review and Assessment of Implementation(For surveillance audits, major document changes only may be reviewed)

IECEx OD005 clausesAssessed(Y, N orN/A)

Manufacturer’s Doc. Ref.

CommentsNCRRef.

4. Quality Management System Highligh Secure QAM4.1 General requirements Y QAM, S1 NCR 14.2 Documentation requirements Y QAM, S64.2.3 Control of documents Y QAM, S6/S3.3.4/S5.2/S7 / Doc.

matrixNCR 2,NCR12

4.2.4 Control of records Y QAM, S.6.3 / Records NCR 3

5. Management Responsibility5.1 Management commitment N -5.2 Customer focus N -5.3 Quality Policy Y QAM, S25.4 Planning Y QAM, S2 NCR 45.5 Responsibility, authority and

communicationY QAM, S3 / Job instructions NCR 5

5.6 Management review Y QAM, S7.2 / MoM NCR 6

6. Resource Management6.2 Human Resources Y QAM, S4 / Competence matrix6.3 Infrastructure N -6.4 Work environment N -

7. Product Realization7.1 Planning of product realization N -7.2 Customer related processes Y QAM, S4 / Sales process7.3 Design and development N -7.4 Purchasing Y QAM, S5 / Materials receipt control NCR 7,

NCR 87.5 Production and service provision Y QAM, S5 / Instruction manuals and

Tour – visual7.6 Control of monitoring & measuring

devicesY QAM, S4 / Records & Certificates

8. Measurement, Analysis & Improvement8.2 Monitoring & measurement Y QAM, S7 NCR 98.2.2 Internal Audit Y QAM, S7 / Audit plan and reports NCR

108.2.4 Monitoring & measurement of product Y QAM, S78.3 Control of non-conforming product Y QAM, S7 / records NCR

118.4 Analysis of data N -8.5 Improvement N -





Annex A: Information relevant to particular types of protection

A.2 General - Material composition of (partsof) enclosures

Y (CoC / Mat.cert)(Sub-supplier activity)

A.3 Ex d - flameproof enclosuresA.3.1 Verification N/AA.3.2 Castings N/AA.3.3 Machining N/AA.3.4 Cemented joints and potted assemblies N/AA.3.5 Routine pressure testing N/AA.3.6 Flanged joints N/AA.3.7 Sintered components N/A

A.4 Ex i - intrinsic safetyA.4.1 Components for intrinsically safe

productsN/A

A.4.2 Printed circuit boards (PCB) N/AA.4.2.1 Non-populated PCB's N/AA.4.2.2 Populated PCB's N/AA.4.3 Sub-assemblies and assemblies N/AA.4.4 Tests N/AA.4.5 Intrinsically safe circuits and assemblies

housed in Ex d, Ex p or Ex q enclosuresN/A

A.5 Ex e – increased safety (Sub-supplier activity)A.5.1 Ingress protection Y (Production process / visual verification)A.5.2 Internal wiring and contact integrity N/AA.5.3 Rotating machines N/AA.5.4 Windings N/AA.5.5 Terminal boxes N/AA.5.6 Cable glands, terminals and other

accessoriesY (Production process / visual verification)

A.5.7 Routine verifications and tests Y (Production process / visual verification)

A.6 Ex p – pressured apparatusA.6.1 Ingress protection N/AA.6.2 Tests N/A

A.7 Ex m – encapsulationA.7.1 Production documentation N/AA.7.2 Tests N/A

A.8 Ex o – oil immersion- Tests N/A

N/AA.9 Ex q – powder fillingA.9.1 Material control N/AA.9.2 Filling N/AA.9.3 Ingress protection N/AA.9.4 Tests N/A





4. Observations

Appendix 1 – Summary of observations.

OBSERVATIONS:No Clause Summary of observations

1 5.5.1 a)(Ref. 6.2.2)(VPM)

It is the responsible manufacturer’s responsibility to make sure that the local Ex coordinator hasa satisfactorily level of Ex competence, related to the appropriate type of protection and thespecific production process.

2 5.6.1 c) /5.6.2(VPM)

It should be specified that Ex shall be a topic on the annual management review – meaning thata status review is to be presented by the Ex coordinator.

3 7.4.1 e)(Ref. A.5.6)(VPM)

The ongoing ability of all Ex related suppliers to provide product, process or service shall bereviewed at periods not exceeding one year.The review shall be based on on-site audits for products, processes or services furtherdescribed in Annex A of ISO/IEC 80079-34.(i.e RWG – machining and verification.)

4 8.2.2(VPM)

It should be specified that the Ex production line for Highlight Secure shall be a part of theinternal audit program. The intervals should not exceed 14 months.

Other recommendations:- (Ref. Cl. 7.2.2 - HS) It is recommended to include the type of Ex protection as well as the ambient

temperature of the equipment in the warranty statement.

Documents

IECEx QUALITY ASSESSMENT REPORT - · PDF fileEN ISO/IEC 80079-34:2011 incl. A.2 and A.5. Next Quality Audit due: ... IECEx QUALITY ASSESSMENT REPORT CONFIDENTIAL IECEx QAR