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Conditions for approval required by: Philippe Canteau
Certification of Aerospace Products to international quality Standards
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Conditions to MCR qualification (ACP-008) of EN2865-060 nuts under ISO5858 technical specification:
• The qualification by analogy has been used too much broadly without enough justification to prove the conformity of the manufactured parts against their technical definition in the EN2865 standard and ISO 5858 technical specification.
• The QTP states that many tests of technical specification ISO 5858 are non applicable (N/A) without any justification what so ever, leaving ASD-CERT to approve without justifications. Are those justifications for non-realized tests inside another qualification? It is not even indicated in report 1034.
• This MCR qualification has to be a standalone report giving a complete qualification, for each test of ISO 5858. If a “N/A” is indicated, where the justification could be easily found for conformity avoiding a hassle to find it ? Is it inside another qualification? This has to be indicated in the QTP, in the QTS and in the QTR.
• For example, there is no dimensional report. It is rather stated that this is a partial qualification due to the change of passivation and MOS2 lubrication sources, where those results for measured values can be found to make it complete and standalone?
• For example marking is indicated as “N/A”. Where conformity to marking could be found with this partial qualification? This report 1034 should be complete and standalone indicating all the necessary information to make sure about the conformity of the parts to their standards.
Conditions to MCR qualification (ACP-008) of EN2865-060 nuts under ISO5858 technical specification:
• The qualification by analogy has been used too much broadly without enough justification to prove the conformity of the manufactured parts against their technical definition in the EN2865 standard and ISO 5858 technical specification.
Sorry, I don’t agree with your view at this point.
ASD-Cert Quality Manual, Revision issued 19/12/2017, p23/62. As published on the ASD website
QUALIFICATION BY ANALOGY
Qualification by analogy can be used to reduce the amount of required testing.
Qualification by analogy to already qualified products is permissible if materials, designs and manufacturing processes and locations are identical. When materials, designs or manufacturing processes or location or technical requirements differ, additional tests to prove the conformity to the technical specifications shall be conducted.
The line Substantiation by analogy in the qualification report #1034 states:
The Nut is a qualified product, materials, designs and manufacturing processes and locations are still identical and is still in production. Partial qualification had be performed because the passivation and the MOS2 lubrication of the Nut has been subcontracted due to the fire in the surface treatment department in 2019.
If we look what is stated in the ASD-Cert Quality Manual and in the qualification report #1034, only the surface treatment is different and it must therefore be demonstrated that it still complies with the EN2865 Standard and the ISO5858 Technical specification. These test to be performed are clearly stated in the relevant QTR and the QTS & QTP in which the results in the QTR are stated, shows that everything still meets the requirements.
In my opinion, the requirements set in the ASD Quality Manual have been fully followed in this qualification and a justification has indeed been given in the qualification report #1034 line: ‘Substantiation by analogy.
• The QTP states that many tests of technical specification ISO 5858 are non applicable (N/A) without any justification what so ever, leaving ASD-CERT to approve without justifications. Are those justifications for non-realized tests inside another qualification? It is not even indicated in report 1034.
The statement in the QTP that some tests are not applicable (N/A) is entirely correct, because these tests do not differ from the already approved product. See qualification by analogy for justification for not performing these tests.
• This MCR qualification has to be a standalone report giving a complete qualification, for each test of ISO 5858. If a “N/A” is indicated, where the justification could be easily found for conformity avoiding a hassle to find it ? Is it inside another qualification? This has to be indicated in the QTP, in the QTS and in the QTR.
The ACP008 qualification report #1034 published on the ASD-Cert website is a complete standalone report with all the how’s and why’s listed.
If we look at the ACP008 report in the aforementioned Quality Manual, p53/62 this is also still followed. Only item 18 should have been checked with “Yes”. The requirements in “Explain” line are also met here.
To establish the requested relationship, the QTR line in the report could refer to the fact that this MCR qualification is related to the approved ACP003 qualification #797 with QP566
• For example, there is no dimensional report. It is rather stated that this is a partial qualification due to the change of passivation and MOS2 lubrication sources, where those results for measured values can be found to make it complete and standalone?
See again the statement regarding qualification by analogy. In itself nothing has been changed to the product, only an outsourcing has taken place which has no direct influence on the dimensions given on the drawing.
• For example marking is indicated as “N/A”. Where conformity to marking could be found with this partial qualification? This report 1034 should be complete and standalone indicating all the necessary information to make sure about the conformity of the parts to their standards.
Again, see the points mentioned earlier in which it is clear that this is a qualification at analogy and not all the test has to be performed.
The statement:
This ACP008 qualification is related to the approved ACP003 qualification #797 with QP566
This statement has been added to the QTP part in the report