What elements should be defined in the documentation of the safety risk management process required by point 21L.B.16?

The documentation should define: (1) the means used for hazard identification and related data sources, including data from other competent authorities in the State or other Member States; (2) risk management steps including analysis (probability and severity), assessment (tolerability), and control (mitigation) of risks; (3) responsibility for hazard identification and risk management; (4) responsibility for follow-up of risk-mitigation actions; (5) levels of management with authority to decide on risk tolerability; (6) means to assess effectiveness of risk-mitigation actions; and (7) the link with the compliance-monitoring function.

What evidence should a competent authority provide to demonstrate that its safety risk management process is operational?

Competent authorities should be able to provide evidence that: (1) persons involved in internal safety risk management activities are properly trained; (2) hazards impacting the authority's capabilities have been identified and risk assessments documented; (3) regular meetings at appropriate management levels discuss risks and decide on tolerability and mitigation; (4) the risk management process is triggered on changes affecting capability to perform Part 21 Light tasks; (5) a record of mitigation actions is maintained with status and owner; (6) there is follow-up on implementation of all mitigation actions; (7) mitigation actions are assessed for effectiveness; and (8) risk assessment results are periodically reviewed for relevance.

Who should have the authority to make decisions regarding the tolerability of risks under the safety risk management process?

The levels of management that have the authority to make decisions regarding the tolerability of risks should be defined in the documentation of the safety risk management process.

What should be included in the record of actions taken to mitigate risks?

The record should show the status of each action and the owner of the action.

How should the effectiveness of risk-mitigation actions be assessed?

The means to assess the effectiveness of risk-mitigation actions should be defined in the safety risk management process documentation, and risk-mitigation actions should be assessed for their effectiveness as part of demonstrating the process is operational.

What is the link between the safety risk management process and the compliance-monitoring function?

The link with the compliance-monitoring function should be defined in the documentation of the safety risk management process.

What should be done with the results of risk assessments periodically?

The results of risk assessments should be periodically reviewed to check whether they remain relevant.

AMC1 21L.B.16(a)(5) Management system

Q: How should the risk management steps be broken down according to AMC1 21L.B.16(a)(5)?

The risk management steps should include: (i) analysis in terms of the probability and severity of the consequences of hazards and occurrences; (ii) assessment in terms of the tolerability; and (iii) control in terms of the mitigation of risks to an acceptable level.

Q: When should the safety risk management process be triggered in addition to the initial hazard identification exercise?

The risk management process should be triggered as a minimum whenever changes occur that may affect the competent authority's capability to perform any of the tasks required by Part 21 Light.

Q: What data sources should be considered for hazard identification according to AMC1 21L.B.16(a)(5)?

The means used for hazard identification should take into account data that comes from other competent authorities with which the competent authority interfaces in the State or from the competent authorities of other Member States.

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AMC1 21L.B.16(a)(5) Management system

ED Decision 2023/013/R

SAFETY RISK MANAGEMENT PROCESS

(a) The safety risk management process required by point 21L.B.16 should be documented. The following should be defined in the related documentation:

(1) the means used for hazard identification and the related data sources, taking into account data that comes from other competent authorities with which the competent authority interfaces in the State or from the competent authorities of other Member States;

(2) risk management steps including:

(i) analysis (in terms of the probability and severity of the consequences of hazards and occurrences);

(ii) assessment (in terms of the tolerability); and

(iii) control (in terms of the mitigation) of risks to an acceptable level;

(3) who has the responsibility for hazard identification and risk management;

(4) who has the responsibility for the follow-up of risk-mitigation actions;

(5) the levels of management that have the authority to make decisions regarding the tolerability of risks;

(6) the means to assess the effectiveness of risk-mitigation actions; and

(7) the link with the compliance-monitoring function.

(b) To demonstrate that the safety risk management process is operational, competent authorities should be able to provide evidence that:

(1) the persons involved in internal safety risk management activities are properly trained;

(2) hazards that could impact on the authority’s capabilities to perform its tasks and discharge its responsibilities have been identified, and the related risk assessment is documented;

(3) regular meetings take place at appropriate levels of management of the competent authority to discuss the risks identified and to decide on the risk tolerability and possible risk-mitigation actions;

(4) in addition to the initial hazard identification exercise, the risk management process is triggered as a minimum whenever changes occur that may affect the competent authority’s capability to perform any of the tasks required by Part 21 Light;

(5) a record of the actions taken to mitigate risks is maintained, showing the status of each action and the owner of the action;

(6) there is follow-up on the implementation of all risk-mitigation actions;

(7) risk-mitigation actions are assessed for their effectiveness;

(8) the results of risk assessments are periodically reviewed to check whether they remain relevant.

Details

Source-Title: AMC1 21L.B.16(a)(5) Management system View latest amendments

Erulesid: ERULES-1963177438-22216 Compare versions

Domain: Initial airworthiness

Amendedby: Issue 1

Applicabilitydate: 21 October, 2023

Entryintoforcedate: 21 October, 2023

Regulatorysource: ED Decision 2023/013/R Navigate

Regulatorysubject: Part 21 Light

Typeofcontent: AMC to IR (Acceptable means of compliance to implementing rule)

Parentir: 21L.B.16 Management system

Origin: EASA

Category: EAR