IECEx 02 Audits according to OD 005 Theo Pijpker Certification Manager KEMA Quality B.V.

Topics Why audits? Use of OD 005 under IECEx 02 Benefit of ISO 9001 certification Audit differences Multiple production sites Common NCs Major/minor NCs Reporting Registration of QAR on IECEx website

Why audits? IECEx 02 is an ISO 67 No. 5 product certification system, which requires: surveillance of the production process/QS surveillance by testing or inspection of samples from the factory or the open market, or both Goal: full control of production every single product must meet the Ex-specifications

Use of OD 005 OD 005 specifies the requirements for quality systems used for production sites of the manufacturer OD 005 is linked to ISO 9001:2000 note: OD 005 must be updated to match with ISO 9001:2008 once it is published Provides additional requirements related to Ex-equipment note: informative Annex A and B are considered normative by KEMA Standard IEC/ISO 80079-34 is being developed by SC31M as future successor of OD 005

Benefit of ISO 9001 certification Good basis for compliance with OD 005 Reduction of IECEx audit frequency from 12 to 18 months (provided that a good ISO 9001 audit has been conducted) Reduction of actual IECEx audit time

Audit differences - 1 Initial audit: 100% audit covering all types of protection and all product groups 100% evidence is collected to support the audit findings usually 10 to 15 non-conformities; some are major sometimes additional corrective actions audit required

Audit differences - 2 Focus of Follow-up audit: corrective actions to NCs of previous audit changes to quality management system new products new types of protection usually 0 to 5 minor non-conformities usually no additional corrective actions audit required

Audit differences - 3 Reassessment audit: 100% audit covering all types of protection and all product groups (identical to initial audit) evidence is collected as far as it is not already in possession of KEMA corrective actions to NCs of previous audit usually 0 to 5 minor non-conformities usually no additional corrective actions audit required

Audit differences? Difference between initial / follow-up and reassessment audits is merely theoretical In practice there is often no clear difference between the audits due to changes in products, types op protection, management system, etc. Only relatively small and stable companies fit more-or-less in the 3 audit type model; large companies with several production sites usually don’t fit in.

Multiple production sites Sites usually operate under the same quality system Sites differ in product(group) and types of protection Sites differ in quality level, even within the same quality system Audit planning determined case-by-case, all production sites are audited at least 1 x 3 years

Common NCs Control of documents: not up-to-date poor traceability between scheduled drawings and related drawings Evaluation of suppliers: not evaluated on a regular basis evaluated on wrong criteria Control of monitoring and measuring devices not calibrated (example: go/no go calipers) used outside calibrated range (example: dielectric strength test equipment)

Common NCs Routine tests: method and equipment used no tests conducted wrong test method (example: even faulty products pass dielectric strength test) faulty test equipment Verification of incoming products poor verification declaration of conformity missing Control of Ex m potting material

Major / minor NCs No differentiation between major / minor NCs; instead: NCs that directly affect the safety level must be solved as soon as possible, evidence of implementation must be provided to KEMA and sometimes a corrective actions audit is conducted to verify correct implementation other NCs: proposed solution must be provided to KEMA within agreed time, evidence of implementation will be verified during next audit

Reporting Drafting of detailed audit report (QAR) is found quite time-consuming in current IECEx format KEMA uses an adapted IECEx format thus reducing the time needed for reporting without loosing quality/information --> Example of KEMA format Full audit report is sent to manufacturer

Registration of QARs QARs are only registered on IECEx website when the quality system is found to meet OD 005 (no major NCs, nor many minor NCs) Before CoC is issued, the on-line QAR is checked: If type of protection or equipment group are not in the scope of the QAR, manufacturer must contact the ExCB that conducts the audits. CoC placed on hold. Copy of full audit report is not required, valid on-line QAR with correct scope is sufficient.

Thank you for your attention Theo Pijpker KEMA Quality B.V.