This is true for hazardous location equipment where mandatory regional schemes (e.g. ATEX) and national schemes (e.g. hazloc) apply. It also applies to the voluntary IECEx certification scheme. We carry out production control audits under the ATEX and Hazloc schemes.

Key points of production control

  • Control of purchasing
  • Control of documents
  • Goods inwards inspection
  • Production procedures
  • Final inspection
  • Internal audits

The three schemes (ATEX, IECEx and hazloc) use slightly different approaches to the production control audits. However the IECEx and ATEX schemes have some similarity. These three schemes are described briefly:

ATEX

Of the three, the ATEX scheme has the greatest complexity due to the five applicable production control Annexes of the ATEX directive (IV, V, VI, VII and VIII). The output from the audit is a Quality Assurance Notification (QAN).

  • Annexes IV and VII are based upon ISO9001 approval, supplemented by the additional requirements of standard EN13980. These additional requirements are applied by a Notified Body over a three year cycle (normally in two visits).
  • Annexes V and VI have more product focussed inspections applied by a Notified Body over a three year cycle (normally one visit per annum).
  • Annex VIII is internal production control based on a basic quality system but it is not subject to third party audit.

IECEx

The production control element of this scheme utilises IECEx document OD/005 (available from the IECEx website). OD/005 describes the processes and controls that need to be in place to support production of IECEx certified equipment. The requirements are based on ISO9001 approval and are virtually identical to the ATEX production control standard EN13980. The IECEx audit takes place annually. The output from the audit is a Quality Assurance Report (QAR).

Hazloc

This is a product focussed control of production for the US market. It follows similar principles to Annex VI of the ATEX directive. The audit takes place up to four times per year.

Notes on establishing effective ATEX production control

  • The production control (or factory inspection) stage ensures continued conformity.  A Notified Body must be involved in this stage for all category 1 and 2 equipment.
  • The Notified Body will issue a Quality Assurance Notification when a product complies with the requirements of one of the Annexes IV, V, VI or VII.  The production control Annexes are divided into two types, which correspond to equipment categories.  Annexes IV and V apply to category 1 or category 2 equipment. Annexes VI and VII apply to category 2 equipment.  Annex V is a rarely used procedure because it relies upon witnessed tests of every production sample by the Notified Body.
  • Where EN13980 is used, manufacturers usually need to make minor modifications to their quality system documentation in order to comply with the specific requirements of the standard.  Due to the relative infrequency of inspections when compared to the USA Hazloc System, the quality of the ISO9001 system and the associated internal audit process are particularly important.  However, the requirements of EN13980 have some equivalence to Hazloc requirements (e.g. purchasing documentation and stock control) and hence should not present significant problems to manufacturers who are familiar with the US approach.