1. ExTAG Training Workshop Calgary 2012 QAR related Issues
Ron Sinclair MBE Chair - ExTAG

2. QAR related Issues Issuing and Registering aspects Auditing aspects
Status between visit and completion
Change of QAR issuing ExCB
QAR issue number on certificates
Auditing aspects
Subcontractors
Stockist/Assemblers
Ex Mark aspects

3. QAR Results ?
20%?
Certification to be issued/maintained
75%?
Certification to be issued maintained subject to written clearance of NCRs
5%?
Certification to be issued/maintained subject to satisfactory follow-up visit
<1%
Certification to be refused/suspended

4. Visit through to Completion
QAR status between completing the audit visit and signing off NCR actions ?
QAR is signed by auditor on completion of audit but before NCR actions are completed ?
Is the QAR signed off by ExCB before or after NCR actions are completed ?
What (in general) is an acceptable time to complete actions ? (OD009 suggests it is the Certificate issuing ExCB that determines this, not the QAR issuing ExCB – How ?)

5. Visit through to Completion
Re-assessment
New QAR summary created when QAR issued
Validity date 36 months after visit or 36 months after previous validity date ?
What about the interim period ?
New QAR not issued, but old QAR out of validity
Retain original record but move date ?
Add comment in comment field ?

6. Visit through to Completion
Interim Surveillance
Add information to existing QAR record
New audit date recorded as Interim Surveillance
Validity date unchanged, even if NCRs remain outstanding

7. QAR “out of date” lists ExCB QAR list – very useful ?
QARs out of date but only referencing cancelled certificates still appear
Can ask secretariat to manually remove such QARs from lists

8. QAR “out of date” lists ExCB Certificate list – Very long list –
Useful , but too much data ?
All issues of certificates – Why ?
Cancelled certificates ?
Very long list –
ExCBs QARs already identified easily from the ExCB QAR list
Desirable to find certificates where QAR is issued by another ExCB

9. QAR “out of date” lists Problems revealed –
Manufacturer does not tell ExCB when changing QAR issuing ExCB, forgetting to request a certificate re-issue
QAR ExCB adds such a certificate as a “Manual Insertion” certificate number
Manual insertion seems to be at the bottom of over half the difficulties, as they are not automatically on the certificate

10. QAR issue number
Customer or inspection body refusing to believe that reference on a certificate to a previous (non-current) edition of the QAR is acceptable
When new issue of certificate, should the QAR issue number be updated ?
Do we need to list the QAR issue number on the certificate ?

11. Auditing Aspects
Auditing (and issuing of QAR) or not for sites that do not hold a certificate
Prohibited for ATEX following discussions in ExNB ?
OK for IECEx as more than one manufacturing location can be listed
Defining extent of manufacture versus assembly of a kit of parts

12. Stockist / Assembler
ATEX Guidelines recognise a particular role for an organisation that completes final assembly of a kit of parts directly under the control of the kit manufacturer
Typical example – final fit out of terminals in an Ex e junction box based on drawings and instructions supplied by the manufacturer
Guidelines effectively require manufacturer to take responsibility for work of Stockist/Assembler which can be verified at audit of manufacturer

13. From ATEX Guidelines 3.7.5.2 “Assemblies with various configurations”
“Although in this case the parts are not necessarily put together by the manufacturer of the assembly, and placed on the market as a single functional unit, the manufacturer is responsible for the compliance of the assembly as long as the parts are chosen from the defined range and selected and combined according to his instructions.”

14. Stockist / Assembler
IECEx does not currently have a formal recognition of the role of the stockist/assembler, but there are two possible situations
Stockist/Assembler takes final responsibility
Manufacturer takes final responsibility
How do we differentiate ?

15. Stockist / Assembler
If the Stockist/Assembler is to take final responsibility:
Could have own Certificate
Must have own QAR, to be listed either on own certificate or on manufacturer’s certificate as an alternative manufacturing address

16. Stockist / Assembler If Manufacturer is to take final responsibility
Stockist/Assembler is not listed as a manufacturing site
Treated as a subcontracted activity
Manufacturer has to demonstrate full control of the process
Normally this would involve receiving full records of everything assembled

17. Stockist / Assembler Records are key to making this work
For manufacturer to retain responsibility
Receive “as built” records for every item
Retain records as required by
For traceability and recall purposes
Audit the Stockist/Assembler at an appropriate frequency
To confirm work carried out correctly
To confirm records are correct

18. Stockist / Assembler
Role of ExCB when Manufacturer accepts responsibility for the actions of the Stockist/Assembler
Ensure that documents recorded in the certificate/ExTR give sufficient information for any assembly to comply without possibility of error
When performing the QAR assessments to confirm that all necessary record trails are in place and procedures being followed
To confirm the manufacturer is auditing the activities of the Stockist/Assembler

19. IECEx Mark Audit Issues
As conceived, the Mark Licence structure seemed to assume that the Mark Licencing ExCB, the Certificate issuing ExCB and the QAR issuing ExCB were the same organisation
In practice, if the certificate and QAR ExCBs are different, the certificate ExCB has to take full responsibility for the Mark Licence activity (Decision handed down from IEC)

20. IECEx Mark Audit Issues
How to handle if Mark Licencing ExCB does not issue QAR ?
Perform separate audit on manufacturer related only to Mark issues ?
Expensive
Contract QAR ExCB to perform Mark audit ?
Requires cooperation and communication

21. IECEx Mark Audit Issues
Cost
Zero from IECEx
Audit time ?
Half day ?
Full day ?
WG5 and ExMarkCo looking at addendum to QAR to record Mark surveillance
Also looking at how to do Mark surveillance when related to Unit Verification

22. Other issues
Any related issues to be raised from the floor