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PED 2014/68/EU - Is this Traceability audit finding correct?

#1
Hi all,

Hopefully you can help with my PED 2014/68/EU query.

My company has been certified to PED Module H for many years.

During a recent audit, the auditor raised a finding, citing the Essential Safety Requirements point 3.1.5 Traceability and stated that: "The material manufacturers ISO9001 certificate are required from the mill in which the material is manufactured."

We retain our metal suppliers ISO9001 certificates as standard but they are often stockholders for the material not the mill were the material is produced. The material is identified by the supplier and we receive the material certificate. This is checked and the material is tagged and traced by us internally.

ESR 3.1.5 states: "Suitable procedures shall be established and maintained for identifying the material making up the components of the equipment which contribute to pressure resistance by suitable means from receipt, through production, up to the final test of the manufactured pressure equipment."

In your experience, is the auditors finding correct, or should I be pushing back?

Many thanks in advance

Glen
 

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Ronen E

Problem Solver
Staff member
Super Moderator
#2
Sounds to me that as long as you have full traceability of the material to the source you are fine. ISO 9001 certificates of mills seem irrelevant to that requirement.

Added in edit: The above doesn't represent a proper review of all applicable PED clauses, it is only a response to the contents of the post and the text cited in it.
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#3
In your experience, is the auditors finding correct, or should I be pushing back?
Even though I am not a subject matter expert on PED, I've had some training on the topic. The PED states:

The equipment manufacturer shall take appropriate measures to ensure that the material used conforms with the required specification. In particular, documentation prepared by the material manufacturer affirming compliance with a specification shall be obtained for all materials.

For the main pressure-bearing parts of equipment in categories II, III and IV, this shall take the form of a certificate of specific product control.

Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Union and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this point.
The interpretation that I was provided for this, in more mundane terms is that the mills producing the pressure bearing materials have to be ISO 9001 certified by a certification body that is accredited by an accreditation body in an European Union country.

So, in principle, yes, you should have a system in place to monitor that the MILLS (forget the distributors) where the material comes from has a valid quality system (ISO 9001) certified, issued by a CB with the proper European accreditation, in good standing, IF you are basically relying on the material certificates to demonstrate conformance with requirements. Many times, the material (inspection) certificate has the logo of the CB that certified the quality system of the mill, but, technically that is not sufficient.

Good luck.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Union and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this point.
Sounds to me more like an option (presumption of conformity) than a hard requirement, but I'm not a subject matter expert either.
 
#5
Hi All,

Thanks for the input and assistance.
I had a trawl through the guidance document (cannot post link to the document) and found the following information:

G-04 (page 161) mostly talks about internal marking and traceability.
G-05 (page 162) starts talking about the manufacturers appropriate quality system
G-07 (page 165) again mentions the manufacturers appropriate quality system
G-16 (page 174) finally mentions the Manufacturers must have a quality assurance system of at least ISO9001. So yes, we need to ensure the manufacturers have ISO9001 certificates.

I guess the confusion started with the auditor not citing the part of the standard that's states this correctly.

Thanks for the assistance

Glen
 
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