AMC-ELA No 1 to 21.A.165(e);(f) Obligations of the holder –Reporting to the design holder    

CAA ORS9 Decision No. 1

The production organisation should record and evaluate any occurrences that may affect the safety of the product. Occurrence reports are collected and assessed in order to identify adverse trends, or to address deficiencies, and to extract reportable occurrences.

The production organisation should share all of its information that is related to potential product deficiencies, observed in the field or during or after production and delivery, with the design approval holder. The production and the design organisations should jointly determine any product design and / or corrective actions that may be required in the field.

The production organisation should have procedures in their quality system to determine whether a production-related deficiency results in an ‘unsafe condition’ in accordance with point 21.A.3B. This may be done by applying the method described in ASTM F2295, as follows:

1. any occurrence that is categorised as an ‘urgent safety of flight situation’ in ASTM F2295 is considered to be an ‘unsafe situation’; and

2. any occurrence that falls into the category of a ‘potential safety of flight bulletin’ in ASTM F2295 is considered to have the potential to be an ‘unsafe situation’. Further analysis is required, and possibly in coordination with the CAA or with CAA.

Production deficiencies, in which the assessment leads to a potential ‘unsafe situation’, should be reported to the CAA, within the terms and in the manner determined by the CAA.

If the design and production entities both work within one consolidated team, then it is sufficient for either the design or the production entity to establish and maintain an internal occurrence reporting system that is accessible to both entities.