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, Planning, and Gates 1-4 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. F RM S outputs including findings from collected data, recommendations, and actions taken.
NOTE: E xp ect 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 7 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 (websites, 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
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.
Appendix 2
1. The data collection plan information shall outline the following operational parameters and indicate to what extent they will exceed prescriptive flight time and duty limitations:
• Pre- and post-rest duty requirements,
• Start time (acclimated) of the FDP,
• Start time (unacclimated) of the FDP,
• Flightcrew complement (number of pilots) and unbiased method to select voluntary study participants,
• Predominant direction of flight (north, south, east, or west),
• Duration of the proposed FDP,
• Length of total flight time,
• Maximum proposed flight deck duty period for each flightcrew member during that FDP,
• Number of planned theater crossings,
• The number of flight segments and the timing of the takeoffs and landings for acclimated and unacclimated flightcrew members,
• Provisions for layover rest, and
• Number and class of installed onboard rest facilities.
2. Consider and compensate for the length of typical delays.
3. If required, propose a petition for exemption for the data collection operation based upon the data collection plan. If an exemption is required, the FAA will impose applicable safety limitations and conditions associated with the proposed exemption.
4. If required, the certificate holder will file a petition for exemption. If granted, the exemption will be limited in duration to collect the data.
(4) Gate 4. The certificate holder will:
(a) Define the scope of the data collection requirement utilizing the guidelines described in Section 4. In addition, the certificate holder shall satisfactorily demonstrate that all data collection flights can be safely conducted utilizing the processes outlined in the FRM and the FRMS SA sections of this appendix The plan shall, as a minimum, accomplish the following:
1. Develop flightcrew member operational procedures based upon FRM processes and SA processes for operations where FRMS will be applied.
2. Develop an in-flight rest scheme for flightcrew members operations on the data collection flights. Define target sleep patterns for in-flight rest.
3. Develop pre- and post-FDP rest schemes for the data collection flights. Define target sleep patterns for pre- and post-duty rest periods.
4. Develop any special procedures specifically applicable to the planned data collection flights.
Appendix 2
5. Provide a list of aircraft that will be authorized for data collection by make, model, and series (M/M/S), to include a description (class) of the installed onboard rest facility.
6. Develop procedures for situations when an operating flightcrew member becomes fatigued in-flight and mitigations to reduce the flightcrew member’s level of fatigue.
(b) Develop FRMS processes based on reactive hazard identification, including risk assessment and the development, implementation, and monitoring of appropriate controls and mitigations based upon the planned data collection flights.
1. Identify hazards, risk assessment, risk mitigation, SA process, and promotion process based upon the planned data collection flights.
2. Verify that FRMS documentation processes are established to support the current version of the FRMS.
3. Verify FRMS training program activities are established to support the current version of the FRMS. (Stakeholders need training to ensure that they are competent to undertake their responsibilities in the FRMS as the implementation plan rolls out.)
4. Develop a method for exclusively retaining all FRMS training records and implement that process.
5. Verify FRMS communication processes are established to support the current version of the proposed FRMS.
5. PHASE TWO: FORMAL APPLICATION. Upon satisfactory completion of Gates 1–4, the certificate holder may proceed to Phase Two. This phase involves the certificate holder submitting all their formal documentation (as required in Gates 1–4) to the FAA as outlined in Gates 5 and 6. The FAA will evaluate and validate the certificate holder’s documentation. Upon satisfactory completion of Gates 5 and 6, the certificate holder may proceed to Phase Three.
Based upon the certificate holder’s proposed AMOC, the certificate holder will develop and submit a proposed data collection plan and a data analysis plan for review, evaluation, and validation. The data collection plan will outline the resources and methods for collecting all measurements. The data analysis plan will describe the method(s) for analyzing the data and how the results will be applied to evaluate the effectiveness of the FRMS. At this stage, the primary focus for the FAA will be to determine that the data collection operation can be safely conducted. Secondly, the FAA will evaluate the effectiveness of the data collection plan and the data analysis plan. The certificate holder will revise, as necessary, their operational procedures for data collection, which will be reviewed and evaluated by the FAA prior to authorizing the certificate holder to collect data. The certificate holder will also revise the operating manual to direct flightcrew members, schedulers, dispatchers, personnel holding operational control and persons having direct management oversight of these areas to comply with the FRMS operation procedures whenever the FRMS is applied to a flight or series of flights.
a. Gate 5. The certificate holder will provide documented evidence of the following items, which will be reviewed, evaluated and validated by the FAA:
Appendix 2
• Formal FRMS policy statement.
• Formal documentation plan.
• Formal communications plan.
• Formal training plan.
• Formal implementation plan.
• Formal description of flightcrew member fatigue monitoring process.
• Formal reporting process to include fatigue reporting and fatigue incident reporting, which will include RCA.
• A performance evaluation process to support continuous improvement of the FRMS.
• Formal documentation of the data collection and analysis plan to support the policy statement.
• That roles and responsibilities for ensuring the safety performance of the FRMS are developed, to include the roles and responsibilities of the FSAG.
• That the necessary communication channels are active.
• That FRMS processes based on reactive, proactive, and predictive hazard identification are operational, including risk assessment and the development, implementation, and monitoring of appropriate controls and mitigations.
• That FRMS documentation processes have been established to support the current version of the proposed FRMS.
• That FRMS training activities have been established to support the current version of the proposed FRMS.
• That FRMS communication processes have been established to support the current version of the proposed FRMS.
b. Gate 6. The FAA will review, evaluate, and validate the following:
• FRMS safety performance indicators have been developed and agreed on.
• Formal statement of how the FRMS will demonstrate an effective AMOC.
• The procedures and processes for periodic evaluation of the safety performance indicators have been established.
• Appropriate feedback has been established between the FRMS processes and the FRMS SA processes.
• FRMS documentation processes are fully implemented.
• FRMS training processes are fully implemented.
• FRMS communication processes are fully implemented.
• Processes for monitoring the effectiveness of controls and mitigations are fully implemented.
6. PHASE THREE: DOCUMENTATION AND DATA COLLECTION PLAN. Upon satisfactory completion of Gates 5–6, the certificate holder may proceed to Phase Three. The certificate holder will provide the FAA with their planned data collection flight information.
a. Overview. During this phase, the FAA will evaluate the certificate holder’s data collection plan and all their documentation outlining their policies and procedures to support all flight operations during data collection. Upon satisfactory completion of Gate 7, if required, the certificate holder will be authorized by exemption to collect data for their proposed FRMS.
Appendix 2
b. Gate 7. The FAA will:
(1) Assess and model the proposed data collection flight plan information to determine the anticipated levels of fatigue.
(2) Evaluate the certificate holder’s documentation outlining their policies and procedures to support all flight operations during data collection.
(3) Determine whether the certificate holder’s proposed FRMS can demonstrate an effective AMOC.
(4) Assess any fatigue modeling analysis of the proposed AMOC if any part of the justification is based on modeling. The FAA will review justification of the modeling choice and all modeling assumptions, parameters, and initial conditions, including the modeling safety standard that serves as the baseline for evaluation of fatigue or performance estimates under the FRMS operation.
(5) Validate and authorize data collection and that the data collection and analysis method will be sufficient to demonstrate an effective AMOC. The FAA will evaluate the data collection and analysis plan based on the guidelines described in the FRM process. Collect and analyze data.
(6) Evaluate policy, documentation, procedures, and processes.
(7) Evaluate safety performance indicators and provide input.
(8) Evaluate proposed FRMS policy and documentation, along with processes and procedures.
(9) Evaluate the FRM process and SA, based on the guidelines provided in the SA process.
(10) Upon satisfactory evaluation and validation, approve the proposed data collection flight operation information.
(11) Issue applicable exemption with specific limitations and conditions for the data collection flight operation.
(12) With the certificate holder, establish, agree upon, and document reporting intervals.
(13) The certificate holder is then ready for data collection.
(14) If required, the FAA authorizes the certificate holder through an exemption to collect data for a specific duration.
7. PHASE FOUR: DEMONSTRATION AND VALIDATION. The certificate holder will collect and analyze the data. The data collected and analyzed will be compiled into a data package. Throughout this process, the certificate holder will also collect and analyze other data,