AMC1 21.A.239(c)(3) and (4) Design management system

SAFETY MANAGEMENT KEY PROCESSES

(a) Hazard identification processes

(1) Hazard identification should be based on a combination of reactive and proactive methods.

(2) The organisation should focus in particular on hazards that may result from non‑compliance or errors in the design of a product, part, or appliance.

(b) Safety risk management processes

(1) The organisation should develop and maintain a safety risk management process that ensures a reactive, proactive, and predictive approach composed of the following elements:

(i) analysis (e.g. in terms of the probability or likelihood as well as severity of the consequences of hazards and occurrences)

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

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

(2) The organisation should specify, within the risk management process, who has the authority to make decisions, considering point (b)(1) of this AMC.

(c) Regardless of the approval status of the subcontracted organisations, the design organisation (DO) is responsible for ensuring that hazard identification and risk management activities are performed on subcontracted activities, as required by point 21.A.239(d)(3), as well as for the monitoring of their compliance and adequacy, as required by point 21.A.239(e).

(d) Internal investigation

(1) In line with ‘just culture’ as part of the safety policy, the organisation should define how to investigate events such as errors or near misses, in order to understand not only what happened, but also how it happened, as well as to prevent or reduce the probability and/or the consequences of any future recurrence.

(2) The scope of internal investigations should extend beyond the scope of the occurrences that are required to be investigated in accordance with point 21.A.3A.

(e) Safety performance monitoring and measurement

(1) Safety performance monitoring and measurement should be the processes through which the safety performance of the organisation is verified against the safety policy and the safety objectives.

(2) This process may include, as appropriate to the size, nature, and complexity of the organisation, the following elements:

(i) safety reporting that also addresses the status of compliance with the applicable requirements;

(ii) safety reviews, including trend reviews, which should be conducted during the introduction of new technologies, the implementation of new or changed procedures, or in cases of organisational changes that may have an impact on safety;

(iii) safety audits that focus on the integrity of the organisation’s management system, and that periodically assess the status of safety risk controls;

(iv) safety surveys that examine particular elements or procedures of a specific area, such as the following:

(A) the problem areas identified;

(B) bottlenecks in the daily design management activities,

(C) the perceptions and opinions of the design management personnel; and

(D) any areas of dissent or confusion; and

(v) other indicators relevant to safety performance.

(f) Management of change

Changes to the design management system may pose new hazards or decrease the effectiveness of existing safety risk controls. The organisation should manage any safety risks that are related to change in that organisation. The management of change should be a documented process to identify external or internal change that may have an adverse effect on safety. The management of change should use of the organisation’s existing processes for hazard identification, risk assessment, and risk mitigation.

(g) Continuous improvement

The organisation should continuously seek to improve its safety performance and the effectiveness of its design management system. Continuous improvement may be achieved through review of the following elements:

(1) compliance monitoring and audits;

(2) assessments, including assessments of the effectiveness of the safety culture and of the management system, to assess in particular the effectiveness of the safety risk management processes;

(3) staff surveys, including safety culture surveys, that can provide useful feedback on how engaged the staff are in the design management system;

(4) the monitoring of events and their recurrence;

(5) the evaluation of the safety performance indicators as well as reviews of all the available safety performance information; and

(6) the identification of lessons learned.