AMC1 21.A.3A(e) Reporting system

FOLLOW-UP TO, AND CLOSURE OF, REPORTED OCCURRENCES

(a) The organisation should transmit the following information to the competent authority within 30 days from the date of notification of the occurrence to the competent authority:

(1) the latest position of the design organisation (DO) as to whether an unsafe condition is confirmed;

(2) the results of the analysis and of the first investigation — including the cause(s) of the occurrence, if known; and

(3) the measures it has taken, intends to take, or proposes to be taken, including:

(i) containment measures that have already been defined by the reporting organisation and put in place (if any) ; and

(ii) in the case of reports made by the DO, for unsafe conditions, a risk assessment supporting that the product can be operated safely (see GM 21.A.3B(d)(4)) until the corrective action is defined and implemented, or that immediate mitigation measures need to be implemented until a more refined risk assessment can be provided.

Organisations are encouraged to provide a complete analysis and follow-up as soon as available and, in principle, no later than 3 months after the occurrence notification. It is recognised that analysing an occurrence may take longer than 3 months, especially if the investigation is complex or where the services of a special investigator are required.

The requirements for follow-up are not intended to jeopardise the quality and thoroughness of an occurrence analysis. It may be detrimental to safety if the analysis is completed in a rush within the encouraged 3-month period without properly establishing the root cause(s), making a risk assessment, and determining whether remedial action is required.

The design approval holder (DAH) and the production approval holder (PAH) should cooperate, as necessary, to ensure that any corrective action can be implemented. In addition, affected organisations are expected to cooperate under their respective regulatory framework from the reporting of an occurrence until its closure, to ensure complete results.

The final (close-out) report should include:

— the final DAH position as to whether an unsafe condition exists;

— the results of the occurrence analysis and of the final investigation, including the cause(s) of the occurrence;

— any corrective and preventive action by the reporting organisation; and

— in the case of reports made by the DO, a risk assessment supporting that those corrective and preventive measures allow the product to be operated safely (see GM 21.A.3B(d)(4)).

(b) Notwithstanding point (a), when the organisation identifies that no unsafe condition exists as a result of its analysis of a voluntarily reported occurrence, it can delay further communication to the competent authority up to the issuance of the final report and report the occurrence as closed upon issue (data exchange). In such cases, no follow-up report should be submitted. The final report to EASA should include confirmation and justification that no unsafe condition exists. The organisation is requested to provide information on the cause(s) of the occurrence and on any corrective or preventive action that was taken by the organisation.

This way of reporting should not be understood as an accepted deviation from the requirements of Part 21. If at any stage during the investigation, the organisation identifies that a possible unsafe condition exists, this should be communicated to EASA via a mandatory report within 72 hours.