21.A.125B Findings and observations

ROOT CAUSE ANALYSIS

(a)It is important that the analysis does not primarily focus on establishing who or what caused the non-compliance, but on why it was caused. Establishing the root cause(s) of non-compliance often requires an overarching view of the events and circumstances that led to it, to identify all the possible systemic and contributing factors (human factors (HF), regulatory, organisational, technical factors, etc.) in addition to the direct factors.

(b)A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree, to identify the chain of events that led to the non-compliance, may not properly reflect the complexity of the issue, and therefore, there is a risk that important factors that must be considered to prevent reoccurrence will be ignored. Such an inappropriate or partial root cause analysis often leads to applying ‘quick fixes’ that only address the symptoms of the non-compliance. A peer review of the results of the root cause analysis may increase its reliability and objectivity.

FINDING-RELATED CORRECTIVE-ACTION PLAN AND IMPLEMENTATION After receipt of notification of findings, the organisation should identify and define the action for all findings, to address the effects of the non-compliance, as well as its root cause(s) and contributing factor(s). Depending on the issues identified, the organisation may need to take immediate corrective action. The corrective action plan should: include the correction of the issue, corrective and preventive action, as well as the planning to implement them; and be timely submitted to the competent authority for acceptance before it is effectively implemented. After receiving the competent authority’s acceptance of the corrective action plan, the organisation should implement the associated action. Within the agreed period, the organisation should inform the competent authority that the corrective action plan has been implemented and should send the associated pieces of evidence, on request from the competent authority.

DUE CONSIDERATION TO OBSERVATIONS For each observation that is notified by the competent authority, the organisation should analyse the related issues and determine when action is needed. The handling of the observations may follow a process similar to the handling of the findings by the organisation. The organisation should record the analysis and the related outputs, such as action taken, or the reasons why no action was taken.

ROOT CAUSE ANALYSIS

(a)It is important that the analysis does not primarily focus on establishing who or what caused the non-compliance, but on why it was caused. Establishing the root cause(s) of non-compliance often requires an overarching view of the events and circumstances that led to it, to identify all the possible systemic and contributing factors (human factors (HF), regulatory, organisational, technical factors, etc.) in addition to the direct factors.

(b)A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree, to identify the chain of events that led to the non-compliance, may not properly reflect the complexity of the issue, and therefore, there is a risk that important factors that must be considered to prevent reoccurrence will be ignored. Such an inappropriate or partial root cause analysis often leads to applying ‘quick fixes’ that only address the symptoms of the non-compliance. A peer review of the results of the root cause analysis may increase its reliability and objectivity.

FINDING-RELATED CORRECTIVE-ACTION PLAN AND IMPLEMENTATION After receipt of notification of findings, the organisation should identify and define the action for all findings, to address the effects of the non-compliance, as well as its root cause(s) and contributing factor(s). Depending on the issues identified, the organisation may need to take immediate corrective action. The corrective action plan should: include the correction of the issue, corrective and preventive action, as well as the planning to implement them; and be timely submitted to the competent authority for acceptance before it is effectively implemented. After receiving the competent authority’s acceptance of the corrective action plan, the organisation should implement the associated action. Within the agreed period, the organisation should inform the competent authority that the corrective action plan has been implemented and should send the associated pieces of evidence, on request from the competent authority.

DUE CONSIDERATION TO OBSERVATIONS For each observation that is notified by the competent authority, the organisation should analyse the related issues and determine when action is needed. The handling of the observations may follow a process similar to the handling of the findings by the organisation. The organisation should record the analysis and the related outputs, such as action taken, or the reasons why no action was taken.

ROOT CAUSE ANALYSIS

(a)It is important that the analysis does not primarily focus on establishing who or what caused the non-compliance, but on why it was caused. Establishing the root cause(s) of non-compliance often requires an overarching view of the events and circumstances that led to it, to identify all the possible systemic and contributing factors (human factors (HF), regulatory, organisational, technical factors, etc.) in addition to the direct factors.

(b)A narrow focus on single events or failures, or the use of a simple, linear model, such as a fault tree, to identify the chain of events that led to the non-compliance, may not properly reflect the complexity of the issue, and therefore, there is a risk that important factors that must be considered to prevent reoccurrence will be ignored. Such an inappropriate or partial root cause analysis often leads to applying ‘quick fixes’ that only address the symptoms of the non-compliance. A peer review of the results of the root cause analysis may increase its reliability and objectivity.

FINDING-RELATED CORRECTIVE-ACTION PLAN AND IMPLEMENTATION After receipt of notification of findings, the organisation should identify and define the action for all findings, to address the effects of the non-compliance, as well as its root cause(s) and contributing factor(s). Depending on the issues identified, the organisation may need to take immediate corrective action. The corrective action plan should: include the correction of the issue, corrective and preventive action, as well as the planning to implement them; and be timely submitted to the competent authority for acceptance before it is effectively implemented. After receiving the competent authority’s acceptance of the corrective action plan, the organisation should implement the associated action. Within the agreed period, the organisation should inform the competent authority that the corrective action plan has been implemented and should send the associated pieces of evidence, on request from the competent authority.

DUE CONSIDERATION TO OBSERVATIONS For each observation that is notified by the competent authority, the organisation should analyse the related issues and determine when action is needed. The handling of the observations may follow a process similar to the handling of the findings by the organisation. The organisation should record the analysis and the related outputs, such as action taken, or the reasons why no action was taken.