Appendix 2 FIGURE 2-5. FATIGUE RISK MANAGEMENT AND SAFETY ASSURANCE
PROCESSES
SAFETY ASSURANCE
FRM PROCESSES PROCESSES
1. Identify 1. Collect and Operation(s) where Review FRMS will be Information Applied
2. Collect and Not OK 2. Evaluate Analyze Data Overall FRMS Performance Not OK 3. Identify
3. Identity Emerging Fatigue Hazards Hazards
4. Identify
4. Assess Safety Not OK Changes Affecting FRMS Risk
5.1 Select and Implement Not OK Controls and Mitigations 5. Improve Effectiveness of
5.2 Set Safety Performance FRMS OK Indicators
5.3 Flightcrew FRMS Operations Procedure Development
6. Monitor Effectiveness of Not Controls and Effective Effective mitigations Page 39
Appendix 2 SECTION 7. FRMS AUTHORIZATION PROCESS
1. HOW AN FRMS IS APPLIED. An FRMS is a data-driven system based upon scientific principles that must be evaluated and validated by the FAA for safety and effectiveness.
Typically, a certificate holder will utilize an FRMS authorization as a means to apply an AMOC to a prescriptive rule. Therefore, the certificate holder’s AMOC must be evaluated and validated for safety and effectiveness. The certificate holder must also develop flightcrew member FRMS operations procedures that are supported by the validated data and evaluated and approved by the FAA as demonstrating compliance with the FRMS authorization.
2. DEFINITION OF TERMS. The following terms are applied to FRMS and the approval process:
a. Actigraph. A wristwatch-like device containing an accelerometer to detect movement.
Activity counts are recorded every minute. The patterns of movement can be analyzed using purpose-built software to estimate when the wearer of the actigraph is asleep, and to provide some indication of how restless a sleep period is (i.e., to measure sleep quality). Actigraphs are designed to record continuously for several weeks, so they are valuable tools for monitoring sleep patterns before, during, and after a trip.
b. Biomathematical Model. A computer program (a fatigue model) designed to predict crewmember fatigue levels, based on scientific understanding of the factors contributing to fatigue. All biomathematical models have limitations that need to be understood for their appropriate use in an FRMS and the determination of predicted fatigue levels.
c. Controls. System-level defensive strategies designed to minimize fatigue risk on an ongoing basis.
d. Data. Routine or planned collection of sleep, performance, and alertness measurements.
Other sources of data include flightcrew member reports of fatigue, reports of fatigue-related events, actions taken by the certificate holder to mitigate future fatigue events, and continuous monitoring of performance indicators to determine the overall effectiveness of the FRMS.
e. Data Collection. Application of a scientific methodology during flight operations designed to acquire the information (data) necessary for comparisons between groups or conditions or across time to assess the relative levels of fatigue experienced by flightcrew members both before FRMS operations and after FRMS operations combined with mitigating strategies.
f. Data Package. A description of data collection methods, a compilation of collected data, the results of the analysis of the data with comparisons between groups or conditions or across time, and the FRMS operations procedures that are constructed to support the results of data analysis for FRMS approvals and continuous monitoring.
g. Fatigue Risk Management (FRM). The management of fatigue in a manner appropriate to the level of risk exposure and the nature of the operation in order to minimize the adverse effects of fatigue on the safety of operations.
Appendix 2
h. Fatigue Risk Management (FRM) Processes. FRM processes are one part of the day-to-day operations of the FRMS. They are designed to enable the certificate holder to achieve the safety objectives defined in its FRMS policy, and are managed by the FSAG.
i. Fatigue Safety Action Group (FSAG). A group comprised of representatives from all stakeholder groups that are responsible for coordinating all fatigue management activities in the organization.
j. Flightcrew Member FRMS Operations Procedures. Flightcrew member operations policy and procedures demonstrating compliance during operations where FRMS is applied.
k. Mitigations. System-level interventions designed to reduce a specific identified fatigue risk.
l. Reporting Intervals. Specific timeframes for when the certificate holder is required to provide reports to the FAA regarding data collection, analysis, and the demonstration of the effectiveness of their overall FRMS.
m. Safety Assurance (SA) Processes. SA processes monitor the entire FRMS to check that it is functioning as intended and meeting the safety objectives in the FRMS policy and regulatory requirements. SA processes also identify operational and organizational changes that could potentially affect the FRMS, and identify areas where the safety performance of the FRMS could be improved (continuous improvement).
n. Safety Performance. The level of safety achieved in a risk-controlled environment, measured against a safety level deemed as low as reasonably practicable.
o. Study Design. The definition of the goals or aims of the study, the description of the data collection methods, the groups or conditions that will be studied and compared, the measurements to be taken, the frequency and timing of those measurements, the crewmembers to be studied, the timeframe of the data collection, the methods of analysis, the criteria to be applied to evaluate the findings relative to the goals or aims of the study, and the proposed approach to establish that an FRMS provides an effective AMOC.
3. FRMS APPROVAL PROCESS OVERVIEW. The FRMS authorization process is a systematic and progressive approach to obtain approval of a certificate holder’s proposed FRMS.
This process provides a means for the certificate holder to demonstrate their proposed FRMS provides an AMOC for managing and mitigating fatigue along with a continuous monitoring output.
a. Meet with the FAA. Prior to development of the FRMS application package, the certificate holder should contact the Air Transportation Division (AFS-200) to schedule time to discuss their plans for operating under an FRMS. This meeting may be conducted as either an in-person meeting or a teleconference. During this meeting, the FAA will review the approval process with the certificate holder and outline all of the items required for the process.
Additionally, this meeting will serve as an opportunity for the certificate holder to ask the FAA any questions relative to any part of the approval process.
Appendix 2
b. Approval Process. The FRMS approval process consists of five phases and nine gates, all of which must be satisfactorily completed in succession. See Figure 2-6, Fatigue Risk Management System Approval Process, for a graphic representation of the FRMS approval process.
(1) The five phases of the approval process are:
Phase 1: Preapplication, Planning, and Assessment.
Phase 2: Formal Application.
Phase 3: Documentation and Data Collection Plan.
Phase 4: Demonstration and Validation.
Phase 5: Authorization, Implementation, and Monitoring.
(2) Phase 1 has four gates, Phase 2 has two gates, and Phases 3 through 5 have one gate per phase. Each gate must be satisfactorily completed in succession before the certificate holder may move to the next phase.
(3) The certificate holder is responsible for developing the requirements outlined in each gate and satisfactorily demonstrating the effectiveness of those items. The FAA is responsible for reviewing, evaluating and validating the effectiveness of each phase completed by the certificate holder.
c. Submit Application. Each part 121 certificate holder must develop their draft FRMS application package in a manner acceptable to the FAA for review. When the draft FRMS application package is ready for FAA submission, the certificate holder will electronically submit it to AFS-200 via email at 9-AWA-AVS-AFS-200-Air-Transportation-Division@faa.gov and provide its principal operations inspector (POI) with a copy. Upon receipt of the package, AFS-200 will acknowledge to the sender receipt of the package via email reply, copying the respective POI and Regional Office (RO).
d. Primary Objectives. Upon satisfactory conclusion, this process will yield four primary objectives relative to the certificate holder’s proposed FRMS, including:
Validation,
Authorization, Phased implementation, and Continuous improvement monitoring.
e. Basic Steps for the Approval of an FRMS Application Package.
(1) The certificate holder develops their plan for an AMOC to a prescriptive rule.
(2) The certificate holder presents their fatigue modeling results or another form of data acceptable to the FAA that supports their proposed AMOC.
(3) The certificate holder presents their study design to verify the AMOC.
Appendix 2
(4) The FAA reviews and validates the certificate holder’s proposed AMOC, study design, flightcrew FRMS operations procedures, and data package. If the FAA determines that the certificate holder has satisfactorily demonstrated that they can safely conduct the data collection operations outlined in the proposed application, the FAA may authorize the operation.
(5) The certificate holder conducts data collection and analysis (in real time) and submits results to the FAA.
(6) The FAA validates the certificate holder’s data collected and the associated analysis.
(7) The certificate holder submits flightcrew member FRMS operations procedures supported by the validated data that demonstrates compliance.
(8) The FAA approves the certificate holder’s FRMS operations procedures and methods for continuous performance improvement.
(9) The certificate holder inserts statements in their operations manual that each flightcrew member, scheduler, dispatcher, person holding operational control, and any person having management oversight of these areas must comply with the FAA-approved FRMS operations procedures where the FRMS is being applied to that flight operation or flight segment.
Appendix 2 FIGURE 2-6. FATIGUE RISK MANAGEMENT SYSTEM APPROVAL PROCESS
PREAPPLICATION,
PLANNING, AND
ASSESSMENT Assessment, Assessment, Gates 1-4 Planning, and Planning, and Preparation Completed Preparation
FORMAL APPLICATION Process and Process and Procedure Procedure Development Development Gates 5-6 Process and Completed Process and Procedure Procedure Development Development
DOCUMENTATION AND
DATA COLLECTION PLAN Data Collection Prep Data Collection Prep Gate 7 Completed Data Collection Data Collection
DEMONSTRATION AND
VALIDATION Data Validation Data Validation and Analysis and Analysis Gate 8 Completed Authorization Authorization
AUTHORIZATION,
IMPLEMENTATION AND
MONITORING Implementation Implementation and continuous and continuous monitoring and monitoring and improvement Gate 9 improvement Page 44
Appendix 2
4. PHASE ONE: PREAPPLICATION, PLANNING, AND ASSESSMENT. The certificate holder develops plans for a proposed AMOC to the prescriptive rule(s). The plan should be based upon fatigue modeling data or some other form of data acceptable to the FAA that supports the proposed AMOC. The certificate holder will develop appropriate FRM and SA processes to identify and document risks and to apply appropriate mitigations to reduce the likelihood and severity of those risks. The certificate holder will utilize the FRM and SA processes in the development of flightcrew member FRMS operations procedures throughout the FRMS approval process, which will be driven by data and appropriate fatigue analysis methods.
a. Certificate Holder Responsibilities. The certificate holder will develop a data package to serve as a repository for all collected and analyzed data. Additionally, the certificate holder will maintain a collection of all amendments to their draft flightcrew member FRMS operations procedures to illustrate policy and procedural changes, driven by the results of the data analysis and the FRM and SA processes.
b. Objectives. This phase is designed as the platform from which the certificate holder will present their ideas, assessment, and plans for applying for a proposed FRMS authorization.
Phase 1 also serves as the initial meeting between the certificate holder and FAA to discuss the milestones and provide their proposed FRMS planning and assessment. The FAA will review the certificate holder’s proposed FRMS plans, identify the necessary guidance resource documents, and outline the phased authorization process for their proposed FRMS. The four gates in this phase are designed to give the certificate holder the necessary tools to develop the framework for their proposed FRMS. The objective of this phase is to prepare the certificate holder for data collection and ultimately to develop their proposed FRMS. The certificate holder should expect to accomplish modifications to some of their submissions required in Gates 1-4.
(1) Gate 1. The certificate holder will:
(a) Perform a needs analysis that defines the specific operational conditions for which a proposed FRMS will be applied to justify a deviation from prescriptive rules and why such an operation must or should be conducted under alternative duty and rest conditions.
(b) Define how proposed operational procedures will require an AMOC to the prescribed flight time, duty time, and rest requirements, citing the specific regulatory section and the applicable justification.
(c) Describe how proposed operational procedures will provide sufficient fatigue mitigations to provide an AMOC to that provided by current prescriptive rules.
(d) Perform a gap analysis to:
1. Identify elements of the proposed FRMS that are already available in existing systems and process.
2. Identify existing systems and process that could be modified to meet the needs of proposed FRMS (to minimize “reinventing the wheel”).
Appendix 2
3. Identify where new systems and processes need to be developed for the proposed FRMS.
(e) Prepare an FRMS policy statement signed by the accountable executive. Expect to revise the policy statement between phases and as the proposed FRMS becomes operational. The policy statement shall:
1. Reflect the shared responsibility of management, flight and cabin crews, and other involved personnel.
2. Clearly state the safety objectives of the proposed FRMS.
3. Be signed by the accountable executive of the organization.
4. Be communicated, with visible endorsement, to all the relevant areas and levels of the organization.
5. Declare management’s commitment to effective safety reporting.
6. Declare management’s commitment to the provision of adequate resources for the proposed FRMS.
7. Declare management’s commitment to continuous improvement of the proposed FRMS.
8. Require that clear lines of accountability for management, flight and cabin crews, and all other involved personnel are identified.
9. Require periodic reviews to ensure that it remains relevant and appropriate.
(f) Develop the FRMS documentation plan. The certificate holder shall develop and keep current FRMS documentation that describes and records:
1. FRMS policy and objectives.
2. FRMS processes and procedures.
3. Accountabilities, responsibilities and authorities for these processes and procedures.
4. Mechanisms for ongoing involvement of management, flight and cabin crewmembers, and all other involved personnel.
5. FRMS training programs, training requirements and attendance records.
6. Scheduled and actual flight times, duty periods and rest periods with significant deviations and reasons for deviations noted.
Appendix 2
7. FRMS outputs including findings from collected data, recommendations, and actions taken.
NOTE: Expect to revise this document between phases and as the FRMS becomes operational.
(g) Identify and allocate financial and human resources. The FRMS accountable executive needs to have the authority and control to ensure that this happens.
(h) Establish an FSAG, or its equivalent. Define the mission of the FSAG and outline the roles and responsibilities of each member, along with company resources. The stage at which the FSAG is established will vary according to the size and complexity of the organization and the FRMS and whether there are suitably qualified people in other parts of the organization who are available to begin these activities.
(i) Develop the FRMS communication plan. The current edition of ICAO Annex 6, Part I, Appendix 8 requires the certificate holder to have an FRMS communication plan that:
1. Explains FRMS policies, procedures, and responsibilities to all stakeholders.
2. Describes communication channels used to gather and disseminate FRMS-related information.
(j) There needs to be ongoing communication to stakeholders about the activities and safety performance of the FRMS and initiatives to ensure the commitment of all stakeholders.
Communications about the activities and safety performance of the FRMS (normally from the FSAG) need to be clear, timely, and credible. The information provided also needs to be tailored to the needs and roles of different stakeholder groups, with a minimum of unnecessary or irrelevant information. The certificate holder should choose from a variety of types of communication such as electronic media (Web sites, online forums, and email), newsletters, bulletins, seminars, periodic poster campaigns in strategic locations, and the like.
(k) Communications from crewmembers are vital for fatigue hazard identification in obtaining feedback on the effectiveness of controls and mitigations and in providing information for FRMS safety performance indicators. For these communications to be open and honest, all FRMS stakeholders need to have a clear understanding of the policies governing data confidentiality and the ethical use of information provided by crewmembers. Expect to revise this document between phases and as the FRMS becomes operational.
(2) Gate 2. The certificate holder will:
(a) Develop the FRMS implementation plan. The results of the gap analysis are used as the basis for the development of the certificate holder’s FRMS implementation plan.
Essentially, this provides a roadmap describing how the development of each of the FRMS processes will proceed. Expect to revise this document between phases and as the FRMS becomes operational.
Appendix 2
(b) Develop a fatigue reporting system. A fatigue report is a method for a flightcrew member to communicate to management personnel (and the FSAG) when they encounter a nonadverse fatigue event. There should be a clear process outlining how the fatigue report will be handled to include a Root Cause Analysis (RCA) and fatigue data collection and retention. The FRMS policy must provide for protection of privacy and methods to protect the employee from adverse actions that would discourage reporting events and conditions surrounding the events. The process should outline the length of time the data will be retained and a path to mitigation or management of the fatigue occurrence. Expect to revise this document between phases and as the FRMS becomes operational.
(c) Develop a fatigue incident reporting system. A fatigue incident is defined as an adverse event, in which fatigue is suspected to have been a causal or contributing factor, that results in an accident, incident, pilot deviation or noncompliance with FRMS policies or procedures. The fatigue incident reporting system is a method by which a flightcrew member communicates an adverse fatigue event to management personnel (and the FSAG). Reports of adverse events that may be attributable wholly or in part to fatigue are similar to crew reports, and can serve as a mechanism for obtaining all relevant information regarding fatigue contributions to the incident. FRMS policy would define how an adverse event is evaluated for potential fatigue involvement, as well as define a methodology for conducting a detailed RCA.
At a minimum, the incident investigation and reporting process must obtain all the necessary information to trace the root cause of the incident, especially the potential level of fatigue and the conditions that contributed to the fatigue-related event. The fatigue reporting policy must protect the privacy of employees and minimize adverse actions that would discourage reporting events and circumstances surrounding the events. Expect to revise this document between phases and as the FRMS becomes operational.
(d) Develop a system for monitoring flight crewmember fatigue as part of an overall FRMS. The data collected provides feedback to the certificate holder regarding conditions perceived to contribute to fatigue. To maximize the utility of such reports, procedures must be developed to capture all relevant information, such as the schedule leading up to the fatigue report, the actions of the employee to obtain rest, subjective and objective evidence of fatigue, environmental conditions that may have exaggerated or contributed to fatigue, relevant health or medical conditions, specific actions related to the incident, and communications prior to and during the event. Expect to revise this document between phases and as the FRMS becomes operational.
(e) Develop a FRM process and a SA process to identify fatigue risks and apply effective safety mitigations throughout the data collection process.
(f) Develop a training plan specific to the FRMS. The list below identifies general FRMS training subjects for the training plan. In addition to the general subjects, the certificate holder’s training plan should also include specific subjects relative to their proposed FRMS. Expect to revise this document between phases and as the FRMS becomes operational.
Figure 2-7, Fatigue Risk Management System Training Outline, outlines a sample FRMS training curriculum.
Appendix 2 FIGURE 2-7. FATIGUE RISK MANAGEMENT SYSTEM TRAINING OUTLINE
1) Overview of the Fatigue Risk Management System (FRMS) concept
i. Definition ii. Purpose iii.Structural components iv.Overview of the certificate holder’s FRMS
v. Relationship between FRMS and Fatigue Risk Management Plan (FRMP) vi.AC 120-100 Basics of Aviation Fatigue vii. AC 120-103 Fatigue Risk Management Systems for Aviation Safety
2) Tools for an effective FRMS
i. Fatigue analysis methods ii. Identification and management of aviation fatigue drivers iii.Fatigue mitigation approaches iv.Positive safety culture
3) Components of an FRMS
i. Fatigue Risk Management (FRM) policy ii. Education and awareness training iii.Fatigue analysis and reporting system iv.Fatigue monitoring methods
v. Fatigue related incident reporting process vi.FRMS performance evaluation vii. Continuous improvement process
4) Roles and responsibilities
i. Certificate holder responsibilities ii. Fatigue Safety Action Group (FSAG) iii.Crewmember/employee responsibilities
iv.Federal Aviation Administration (FAA) responsibilities
5) FRMS Implementation
i. Policies and procedures ii. Organization and personnel
a) FSAG
b) Other supporting departments and personnel
c) Roles and responsibilities
iii.Tools and methods iv.Training and awareness
6) Safe scheduling policies and procedures
i. Proactive and adaptive fatigue mitigation ii. Work schedule oversight and monitoring
iii.Crew augmentation iv.Unforeseen operational circumstances
7) Records and reports
i. Schedule accuracy ii. Reports of fatigue by flightcrew members iii.Fatigue-related events iv.Records of actions of the FSAG
8) Continuous performance improvement process
i. FRMS performance evaluation ii. Work schedule modeling and fatigue risk analysis iii.Management and mitigation of fatigue risk iv.Assessment, feedback, and corrective action Page 49
Appendix 2
(3) Gate 3. The certificate holder will:
(a) Develop a data collection plan following the guidelines described in the FRM process. Expect to revise this document between phases.
1. Develop an initial data collection plan.
2. Define how the data collection plan will establish the effectiveness of the FRMS.
3. Identify the necessary resources and tools (Actigraph, Psychomotor Vigilance Testing (PVT), modeling, etc.) (FAA review).
4. Specify study design, timeline for data collection, and context of the study (FAA review).
5. FAA evaluates the data collection plan for feasibility, completeness, and credibility.
6. Adjust the plan accordingly (FAA review).
(b) Develop a data analysis plan following the guidelines described in the FRM process. Expect to revise this document between phases.
1. Describe the initial data analysis plan (FAA review).
2. Based on the proposed sleep and performance measures, define safety standards that will be used to evaluate the effectiveness of the proposed operation under alternative duty and rest conditions.
3. Describe how the data analysis plan will support the effectiveness of the FRMS based on those safety standards.
4. Describe how these data will be used to establish an AMOC.
5. Identify the necessary resources and data analysis tools (FAA review).
6. Specify study design, timeline for data analysis plan, and context of the data output.
7. Justify the proposed safety standards for establishing effectiveness of the FRMS and the validity of the data collection and analysis plan to establish that the proposed FRMS meets those standards (FAA review).
8. Adjust the plan accordingly (FAA review).
(c) Design and develop plans for proposed data collection flights in accordance with the proposed FRMS policy statement that will be used for data collection.