Advisory Circular. Fatigue Risk Management System Implementation Procedures. Issuing Office: Civil Aviation, Standards Document No.

Transcription

1 Advisory Circular Subject: Fatigue Risk Management System Implementation Procedures Issuing Office: Civil Aviation, Standards Document No.: AC File Classification No.: Z Issue No.: 01 RDIMS No.: V6 Effective Date: YYYY-MM-DD TABLE OF CONTENTS 1.0 INTRODUCTION Purpose Applicability Description of Changes REFERENCES AND REQUIREMENTS Reference Documents Cancelled Documents Definitions and Abbreviations BACKGROUND COMING INTO FORCE WHAT IS A FATIGUE RISK MANAGEMENT SYSTEM? FRMS REGULATORY REQUIREMENTS WHAT IS A VARIANCE TO THE CARS? THE INITIAL AND CONTINUING EXEMPTION PROCESS FRMS DEVELOPMENT AND IMPLEMENTATION PROCESS Phase 1 - PREPARATION Phase 2 Initial Exemption and Notice of Intent Phase 3 SAFETY CASE DEVELOPMENT AND VALIDATION PHASE 4 LETTER OF CONFIRMATION CONTINUING EXEMPTION Phase 5 Continuous Improvement and Monitoring INFORMATION MANAGEMENT DOCUMENT HISTORY CONTACT OFFICE APPENDIX A - DATA COLLECTION AND ANALYSIS USING FATIGUE MODELING APPENDIX B - SAFETY CASE DEVELOPMENT APPENDIX C NOTICE OF INTENT TEMPLATE APPENDIX D - BIBLIOGRAPHY... 39

2 Figure 1 FRMS Development and Implementation Process... 8 Figure 2 Safety Case Development Figure 3 Validation examples Figure 4 - Biomathematical Modelling Output Figure 5 Scoring Matrix Based on Work Rest Rules Figure 6 - Flight Crew Schedule: Day Before, Day of, & Day After Flight YYYY-MM-DD 2 of 40 AC 700-XXX Issue 01

3 1.0 INTRODUCTION (1) This Advisory Circular (AC) is provided for information and guidance purposes. It describes an example of an acceptable means, but not the only means, of demonstrating compliance with regulations. This AC on its own does not change, create, amend or permit deviations from regulatory requirements, nor does it establish minimum standards. 1.1 Purpose (1) The purpose of this document is to describe the procedures an air operator must follow to qualify for a variance to the prescriptive flight, duty and rest requirements as per CAR Applicability (1) This document applies to the holders of Air Operator Certificates in CAR 705, 704, 703 and Description of Changes (1) Not applicable. 2.0 REFERENCES AND REQUIREMENTS 2.1 Reference Documents (1) It is intended that the following reference materials be used in conjunction with this document: (a) Part VII, Subpart 700 and Part 702 of the Canadian Aviation Regulations (CARs) Commercial Air Services; (b) (c) 2.2 Cancelled Documents (1) Not applicable. Advisory Circular (AC) 700-XXX, Issue 01, 2017-MM-DD Flight Crew Member Fatigue Management Prescriptive Requirements; Advisory Circular (AC) 700-XXX, Issue 01, 2017-MM-DD Fatigue Risk Management System Requirements. (2) By default, it is understood that the publication of a new issue of a document automatically renders any earlier issues of the same document null and void. 2.3 Definitions and Abbreviations (1) The following definitions are used in this document: Actigraph: A wristwatch-like device containing an accelerometer to detect movement. Activity counts are recorded per unit time, for example every minute. The patterns of movement can be analyzed using purpose-built software to estimate when the wearer of the actiwatch was asleep, and to provide some indication of how restless a sleep period was (i.e. sleep quality). Actigraphs are designed to record continuously for several weeks so they are valuable tools for monitoring sleep patterns, for example before, during, and after a trip or work pattern. Adverse Effect: As a result of a variance to the CARs fatigue is not increased and alertness is not decreased in comparison to when the flight is operated in accordance with the prescriptive regulatory requirements. Alertness: The extent to which a person is fully awake and aware and mentally responsive and perceptive. Continuing Exemption - A second exemption that allows an air operator to continue to deviate from CAR to provided certain conditions are met. YYYY-MM-DD 3 of 40 AC 700-XXX Issue 01

4 Document: Certificates, manuals, work instructions, uncompleted checklists and any other papers or equivalent electronic publications that detail the organization s policies, processes and procedures, training curricula, etc. that are required to hold a Canadian Aviation Document (CAD). Documents exclude records. Initial Exemption: A first or initial exemption that allows an air operator to deviate from CAR to provided certain conditions are met. Fatigue: A physiological state of reduced mental or physical performance capability resulting from sleep loss, extended wakefulness, physical activity, or a combination thereof, that can impair a flight crew member s alertness and ability to safely operate an aircraft or perform safety-related duties. Fatigue data: Fatigue-related facts, observations, measurements, or statistics collected for analysis to gain knowledge and make decisions. Sources of fatigue data include but are not limited to: Flight crew sleep, performance, and alertness measurements, fatigue hazard and event reports and investigation results, safety performance indicator measurements, audit and review findings. Fatigue hazard: A work-related source of potential fatigue that could cause a fatiguerelated error and contribute to an aircraft incident or accident. Fatigue Information: Fatigue data processed, organized or analyzed so as to make it useful for fatigue risk management purposes. Fatigue Modeling: A method to predict an average level of flight crew member fatigue for a work schedule, based on scientific understanding of factors contributing to fatigue. Fatigue risk: The assessed likelihood and severity of the consequence(s) that could result from a fatigue-related error caused by a fatigue hazard. Fatigue Risk Management System: A scientifically-based, data-driven set of integrated management practices, beliefs and procedures for identifying and managing fatigue and safety risks. An FRMS allows a systematic and structured approach to implementing processes to prevent and manage fatigue, and to audit the control processes for effectiveness and compliance. Outputs: Products, services, information, and/or materials provided to stakeholders (internal/external) from a process. Policy: The set of guiding principles, formulated and enforced by the governing body of an organization, to direct its actions in pursuit of objectives. Prescriptive requirements: The set of flight and duty time limitations (including flight time, flight duty period, duty period limitations, and rest period requirements) contained in Division III of Part VI of the Canadian Aviation Regulations. Procedure: A fixed, step-by-step sequence of activities or course of action that must be followed in the same order to correctly perform a task. Process: A group of interrelated or interacting activities (with definite start and end points) that convert inputs into outputs. Record: The specific details of events that have occurred during the performance of activities authorized by a CAD. Records include (but are not limited to) hazard registers, risks assessments, completed checklists, audit findings, training records, and submissions made under internal fatigue reporting systems. Regulatory requirements: The Canadian Aviation Regulations and standards as well as any documentation. YYYY-MM-DD 4 of 40 AC 700-XXX Issue 01

5 Safety case: A structured argument, supported by evidence, intended to justify that a variance to the regulations is acceptably safe for a specific application in a specific operating environment. Safety Management System: A documented system for managing risks that integrates operations and technical processes with the management of financial and human resources to ensure aviation safety or the safety of the public. Safety performance indicator: A data-based parameter used for monitoring and assessing safety performance. System: A group of inter-dependent processes and people working together to achieve a defined result. A system comprises policies, processes and procedures. Variance: A permitted derogation by means of an exemption from the Canadian Aviation Regulations as prescribed in CAR to (2) The following abbreviations are used in this document: AC: Advisory Circular CAR: Canadian Aviation Regulations FDP: Flight duty period FRMS: Fatigue Risk Management System PVT: Psychomotor Vigilance Testing SMS: Safety Management System SPI: Safety Performance Indicator TCCA: Transport Canada Civil Aviation WOCL: Window of Circadian Low 3.0 BACKGROUND (1) In 2018, TCCA published revised regulatory requirements respecting flight crew fatigue management. The proposal contained two options for managing flight crew fatigue: prescriptive flight, duty and rest period requirements and an FRMS scheme. (2) The FRMS option provides a more flexible, operationally-based alternative for managing flight crew fatigue based on scientific data, fatigue modelling and real time fatigue and alertness assessments. 4.0 COMING INTO FORCE (1) The FRMS requirements in CAR are available to all air operators regulated under Part VII of the CARs. Depending on the type of operation, the applicability date, that is the date in which FRMS comes into force, varies. (2) Upon publication in Canada Gazette Part II, FRMS will be available for use in: (a) (b) (c) CAR 705 AOC holders after 12 months; CAR 704 and 703 AOC holders after 48 months; and CAR 702 AOC holders immediately. YYYY-MM-DD 5 of 40 AC 700-XXX Issue 01

6 5.0 WHAT IS A FATIGUE RISK MANAGEMENT SYSTEM? (1) An FRMS is a management system that allows an air operator to adapt their policies, procedures and practices to the specific conditions and unique demands of their operating environment. (2) With an FRMS, operators are still required to respect prescriptive requirements, however, under an FRMS they may be exempted from these requirements based on a variance supported by a safety case. The operator must demonstrate to TCCA that they have appropriate processes and risk controls in place to ensure the variance does not increase pilot fatigue or decrease pilot alertness. (3) If an organization is able to operate safely and satisfactorily within the prescriptive limitations, there is no requirement to have an FRMS. The cost and complexity of implementing an FRMS may not be necessary when operations stay within the prescribed requirements and fatiguerelated risk is low. Note: Detailed information about the components of FRMS can be found in AC XXX: Fatigue Risk Management System Requirements (Insert hyperlink). 6.0 FRMS REGULATORY REQUIREMENTS (1) The use of an FRMS to manage flight crew fatigue is voluntary. FRMS implementation is mandatory only when an air operator wishes to use a variance to the CARs to operate a flight. (2) In order to benefit from a variance to the CARs, air operators must demonstrate that they meet the conditions and requirements established in CAR to These include the required components of an FRMS, as well as the specific conditions an air operator must meet when using an FRMS to support a variance. (3) The four components of an FRMS are: (a) Fatigue management plan (CAR ); (b) Fatigue risk management process (CAR ); (c) Fatigue risk management promotion (CAR ); and (d) Fatigue risk management system quality assurance (CAR ). (4) The FRMS regulatory requirements for the use of a variance from the prescriptive requirements are described in detail in this document and include the following key provisions: (a) (b) (c) (d) (e) (f) (g) CAR (1) and (2) Initial exemption; CAR Notice of Intent; CAR FRMS - Establishment; CAR Safety Case; CAR FRMS - Initial Audit; CAR Continuing Exemption; and CAR Variance - Monitoring of Effects. (5) CAR (4) also includes a list of regulations that may not be exempted under the FRMS. The following prescriptive requirements may not be exempted: (a) (b) (c) CAR (1)(c) maximum annual flight time; CAR (1)(a) maximum annual duty time; CAR designation of home base; YYYY-MM-DD 6 of 40 AC 700-XXX Issue 01

7 (d) (e) CAR nutrition break; and CAR (1)(a) - maximum annual flight time. (6) Air operators that fail to meet the conditions and requirements of Division IV of Part VII of the CARs, will be required to demonstrate immediate compliance with the prescriptive requirements from which they have been exempted. Note: There will be cases where a variance to the CARs is not appropriate due to the adverse impact on flight crew fatigue and alertness the variance poses. Where the predictive analysis shows an elevated risk and there is no risk control available to reduce that risk to an acceptable level, the air operator may not proceed to use a variance to the CARs. Note: FRMS is intended as a way to better manage flight crew fatigue and alertness. In some case it may not be possible to validate the safety case with respect to the variance being sought. 7.0 WHAT IS A VARIANCE TO THE CARS? (1) A variance is a permitted derogation, by means of an exemption, from CAR to and CAR to (2) The regulatory scheme for FRMS provides an air operator with the ability to use a variance to the CARs, through an exemption scheme contained within the regulation itself. Air operators do not need to apply for an exemption, however, they must meet all of the requirements of CAR to in order to operate a flight using a variance. (3) Air operators considering the development and implementation of an FRMS to support a variance to the CARs, must notify TCCA by way of a Notice of Intent described in CAR The Notice of Intent must be received at least 1 year in advance of the intended permanent use of the continuing exemption to the CARs. (4) At any time during the process TCCA: (a) (b) (c) Reserves the right to review the FRMS, the supporting safety case and all related data, documentation and outputs generated by the FRMS; May request changes to the safety case including but not limited to the development of additional data, analysis and risk controls; and Reserves the right to review that these actions have taken place. (5) Where a safety case is deemed unacceptable, TCCA will advise the air operator by letter that they may not use the variance and must immediately comply with the prescriptive limits. 8.0 THE INITIAL AND CONTINUING EXEMPTION PROCESS (1) The regulatory scheme for FRMS is based on an initial and a continuing exemption: The initial exemption in CAR provides the air operator with the ability to operate a flight using a variance to the CARs. The continuing exemption in CAR provides the authority to continue operating the flight, in accordance with the variance, provided all conditions continue to be met. (2) CAR (1) and (2) describe the conditions that must be met to qualify for an initial exemption to the CARs. The air operator must: (a) (b) Send a Notice of Intent to the Minister that complies with CAR ; and Have established and implemented the following components of the FRMS: YYYY-MM-DD 7 of 40 AC 700-XXX Issue 01

8 (i) (ii) A fatigue risk management plan, and A fatigue risk management process. (3) To qualify for a continuing exemption (CAR ) the air operator must: (a) (b) (c) (d) Establish and implement the following components of an FRMS: (i) (ii) A fatigue risk management promotion program; and A fatigue risk management quality assurance program; Complete an audit of the FRMS; Validate the safety case as per CAR (4); and Submit a letter of confirmation stating: (i) (ii) (iii) (iv) The date on which the air operator will start using the variance and for which flights; A statement that the FRMS meets the requirements of the Division; A confirmation that the FRMS has been audited; and A confirmation that the safety case for each variance has been completed and that the variances have no adverse effect on fatigue and alertness. (4) The letter of confirmation must be received by TCCA 30 calendar days before the planned use of the ongoing variance. This will serve as notification to TCCA that the air operator has met the conditions of the continuing exemption and will provide sufficient time for TCCA to review the submission if necessary. 9.0 FRMS DEVELOPMENT AND IMPLEMENTATION PROCESS Figure 1 FRMS Development and Implementation Process 1. Preparation 2. Initial Exemption and Notice of Intent 3. Safety case development and Validation 4. Letter of Confirmation - Continuing Exemption 5. Continuous improvement and monitoring 9.1 Phase 1 - PREPARATION (1) Figure 1 shows the 5 phases an air operator must complete in order to meet the requirements of Division IV. Each phase, from the initial FRMS decision-making to the on-going monitoring after the CARs exemption becomes continuing, is described below. (2) Before starting the development and implementation of an FRMS, operators are encouraged to contact TCCA to discuss what is involved in using FRMS processes to manage a variance. This YYYY-MM-DD 8 of 40 AC 700-XXX Issue 01

9 action is important because it establishes a contact point for FRMS and will provide the necessary information on how to use the FRMS to support a variance from the CARs. Note: Please contact the Chief, Technical Program Evaluation and Coordination for general information relating to FRMS implementation and usage. (3) Air operators should review their current flight schedules and determine the extent to which they can operate within the prescriptive requirements. Where a problem or problems are identified, the air operator should determine whether they can modify their flight schedules to work within these limits. This will help identify the percentage of flights within their roster that will require a variance to continue operating. (4) While implementing an FRMS is good fatigue management practice and FRMS is recommended for all air operators, this basic analysis will provide a better idea of the extent to which an FRMS is voluntary or a necessity for continued operations. (5) CAR to 120, Division IV contains the regulatory requirements for FRMS. Air operators will need to review this Subpart of the CARs to gain an understanding of FRMS requirements, as well as AC 700-XXX for an interpretation of the intent of each provision and the methods by which the FRMS can be implemented. (6) While reviewing these documents, operators should consider their FRMS needs in relation to the size and complexity of their organization. As with all system requirements, the scope of the system will vary based on the organization and should always be tailored to meet their individual needs. (7) Air operators who have already implemented a safety management system (SMS) may use the relevant components and elements to satisfy the FRMS requirements. However, air operators must be able to demonstrate how they meet the CARs FRMS requirements through a table of concordance. (8) Additionally, air operators must meet all of the regulatory requirements for FRMS and be able to show that they have tailored their existing SMS components to address fatigue specifically and in a manner that is effective. An example of this would be the adaptation of the SMS risk assessment terminology to specifically reflect fatigue risks. Note: A good example of how to tailor risk criteria is provided in AC 700-XXX, p.20-21, and sections Assess Fatigue Risks. Insert hyperlink 9.2 Phase 2 Initial Exemption and Notice of Intent (1) In order to use the regulatory exemption, air operators must provide written advice to TCCA by way of a Notice of Intent. The notice indicates to TCCA that the air operator is, on an interim basis, using a variance to the CARs to collect evidence to support and validate their safety case. (2) Before sending the Notice of Intent, the air operator must have established and implemented: (a) (b) A fatigue risk management plan; and A fatigue risk management process. (3) The FRMS does not have to be fully implemented before the initial notification to TCCA is made, however, the fatigue risk management process including data collection, hazard identification, risk management and the fatigue risk management policy framework will need to be in place to develop the safety case. Without these basic components in place, it will be impossible to meet the safety case requirements contained in CAR (4) Additionally, as the air operator progresses with the development, implementation and validation of a safety case, to effectively collect the data required to do this, they will need to implement fatigue training, fatigue awareness and promotion. YYYY-MM-DD 9 of 40 AC 700-XXX Issue 01

10 (5) The Notice of Intent must contain the following: (a) (b) (c) (d) (e) A declaration of the air operator s intent to establish (document), implement and maintain (upkeep) all components of an FRMS as described in CAR to CAR ; Details of the flight that will be operated using the variance and the CAR being exempted; A description of the manner in which the flight will vary from the regulation being exempted; A detailed description of the safety case that will be developed to support the variance; and The name of the person responsible for implementing the FRMS. Note: For the purposes of this document and the CARs requirements, a flight may include more than one flight segment operated by a flight crew member and more than one flight duty period assigned to that flight crew member. Note: For additional information regarding the development of the Notice of Intent please see Appendix C. (6) The Notice of Intent must be sent and received by TCCA at least 1 year in advance of the intended use of the continuing exemption. The air operator should send the Notice of Intent to their TCCA principal operations inspector (POI). (7) As the development and implementation of the FRMS is a collaborative effort that will require cooperation and participation of flight crew members, CAR requires the air operator to involve flight crew bargaining agents, or where there is no bargaining agent, its employees or a representative selected by its employees, in the development of the fatigue reporting policy and procedures. Note: AC 700-XXX describes in detail the FRMS and provides examples of the components and elements of the FRMS for small and large operators. Insert hyper link Note: Additional information on FRMS can be found on the TCCA website at Fatigue Risk Management System for Canadian Aviation - FRMS Toolbox - TCCA. (8) In accordance with CAR all FRMS policies, procedures and processes must be fully documented. As such, it is a good idea to review the published TCCA guidance and determine the most appropriate FRMS for the size and complexity of your organization. (9) The FRMS documentation and all related records and outputs of the FRMS must be made available to TCCA upon request and will usually be reviewed during TCCA s regularly scheduled surveillance of the air operator. Note: For additional information on policies, procedures and processes refer to AC 700-XXX or TP Fatigue Risk Management System for the Canadian Aviation Industry - Policies and Procedures Development Guidelines. AC 700-XXX also contains a bibliography of FRMS resources for review. 9.3 Phase 3 SAFETY CASE DEVELOPMENT AND VALIDATION (1) Air operators seeking a variance from the prescriptive requirements must develop a safety case to support each variance request. This will take time and will require the development and implementation of a defined set of FRMS processes to support and validate the safety case. (2) Air operators will have 24 months from the date identified in their Notice of Intent to validate their safety case. If the safety case is not validated before the end of this time period, the air operator must immediately comply with the prescriptive requirements from which they are being exempted. YYYY-MM-DD 10 of 40 AC 700-XXX Issue 01

11 (3) A validated safety case demonstrates to TCCA that neither flight crew alertness nor fatigue are adversely affected by the proposed variance. As such, it is important that the air operator fully understands the requirements of the safety case and has a solid foundation for the FRMS. (4) A safety case is essentially a fatigue risk assessment that identifies the fatigue hazards and risks associated with a variance to the prescriptive requirements for a specific flight. The safety case describes controls that will be put in place to mitigate the risk and to measure, on an ongoing basis, that neither flight crew fatigue nor alertness are adversely impacted as a result of the variance. (5) The safety case must be methodical in that it is process driven, repeatable and transparent and able to explain and validate the air operator s assumptions. In other words, the safety case demonstrates that the assumptions with respect to the hazards, risks and controls are not just a hunch. They are evidence based and provable through data collection. (6) Fatigue assessment procedures will be required to monitor the safety case and implement effective corrective and preventative measures to combat any adverse changes in pilot fatigue and alertness. (7) As per CAR (2) the safety case must contain the following information: (a) (b) (c) (d) (e) (f) (g) A description of the flight being operated and a reference to the regulation being exempted; The data collection methodology and data that will be used to establish the baseline levels of fatigue and alertness; The data collection methods used to evaluate the safety case on an ongoing basis; An analysis of the impact of the variance on flight crew member s levels of fatigue and alertness and the findings of the risk assessment; Procedures to measure the impact of the variance on levels of fatigue and alertness; The preventative and corrective measures applied to counteract any adverse impact on fatigue and alertness levels; and The means that will be used to monitor the effectiveness of the FRMS in managing the safety case. (8) Figure 2 shows the development and implementation stages required to build a robust safety case. The following directions will explain each step in this process. Figure 2 Safety Case Development Description of Variance Data Collection and anlaysis Risk Control Develop & Implement Performance indicator Development Continuous Monitoring Safety Case Validation STEP 1 Description of variance (i) The air operator must describe which CAR they are seeking a variance from and what they specifically want to do in respect to the variance. As the use of a variance is not limited to flight duty period (FDP) extensions and can be applied to most other flight duty and rest requirements in the CARs, the complexity of the variance being sought will determine the complexity of the safety case being developed. YYYY-MM-DD 11 of 40 AC 700-XXX Issue 01

12 For example: ABC airlines is seeking a variance from the maximum flight duty period limits as per CAR (4). ABC airlines is seeking a variance that will allow a hour FDP from Toronto to Puerto Vallarta Puerto Vallarta to Toronto. CAR (4) restricts the FDP to 12 hours. ABC Airlines is seeking a variance to allow for a 1.25 hour extension to a FDP of 13 hours and 15 minutes. Check in YYZ 6:45 Departure YYZ 08:00 Arrival PVR 13:00 Departure PVR 15:00 Arrival YYZ 20:00 Total Flight Duty Period = 13:15 (b) STEP 2 Data Collection and Data Analysis (i) (ii) (iii) In order to assess the impact the variance will have on flight crew fatigue and alertness, the air operator must evaluate a similar flight operated using the prescriptive requirements as a comparative analysis to establish the baseline level of fatigue and alertness. In the example shown in Step 1, if the flight was operated using the prescriptive requirements, the extension of 1.25 hours would require an augmented flight crew or a change in the time of check in and flight departure. As this is a comparative analysis, the initial stage of data collection will rely largely on predictive data. Some form of fatigue modeling, either an automated biomathematical or manual tool using work/rest limits, is useful for determining the equivalence of a schedule operated with a variance compared to a flight operated with an augmented flight crew. Note: The exception to this scenario is where an air operator is currently not subject to the revised prescriptive requirements, and is currently operating the flight it will eventually need a variance to operate. In this case the air operator must assess the hazards and risks and develop corrective measures in relation to the existing flight schedule. (iv) (v) The biomathematical modelling software may have an internal scale for scoring fatigue levels or may convert the scale into comparative sleepiness scale as a determinant of what is an acceptable level of fatigue and alertness. Two commonly used models are the Samn-Perelli and the Karolinska sleepiness scales. In the Karolinska scale an acceptable score is usually defined as between 5-6 on the scale. Using the Samn-Perelli an acceptable score is between However, depending on the schedule and where and when fatigue is shown to be present, a higher score may be acceptable provided mitigations are in place. Larger more complex organizations will benefit from the use of a biomathematical model, however, it isn t always necessary and small companies will not need to make this investment. A simple pencil and paper model based on work/rest rules can be used to determine whether fatigue or alertness are impacted by the YYYY-MM-DD 12 of 40 AC 700-XXX Issue 01

13 variance. In order to use this manual fatigue model, however, air operators will have to know some of the basic fatigue principles defined in the sleep science. Note: A detailed description of the use of fatigue modelling, sleepiness scales and basic fatigue rules can be found in Appendix A of this AC. The example in Step 1 is used in Appendix A to demonstrate use of manual fatigue modelling. (vi) The fatigue modelling will predict where fatigue may be present and alertness is diminished, and should consider factors relating to flight crew members such as: (A) (B) (C) (D) The time of day of work and breaks; The duration of work and breaks; Work history in the preceding days; and The biological limits on recovery sleep. Note: Examples of fatigue modeling using work/rest rules can be found in TP Fatigue Risk Management for the Canadian Aviation Industry: Introduction to Fatigue Audit Tools. Guidance on proactive, predictive and reactive methods of data collection and analysis can be found in AC 700-XXX (insert hyper link). (vii) (viii) When the initial data to support the safety case has been collected, the air operator is required to analyze the data and determine the hazards and fatigue risks in relation to the baseline level of fatigue and alertness. The air operator will need to describe in the safety case how they have collected and analyzed the data and detail their preliminary assumptions based on this initial analysis. The FRMS risk assessment process can be used to determine the level of risk associated with the variance and to determine the appropriate risk control to reduce or eliminate any fatigue risks. STEP 3 Risk Control Development and Implementation (i) (ii) Risk controls must be developed and implemented to reduce to an acceptable level any increase in fatigue or decrease in alertness caused by the variance. An acceptable level is defined as the level of fatigue or alertness equivalent to within 5% of the fatigue risk apparent using a similar flight operated in accordance with the prescriptive requirements. A scale such as the Samn-Perelli scale of the Karolinska scale as shown in Appendix A can be useful in establishing the baseline level. Note: Where the analysis shows that the baseline schedule may result in high levels of fatigue and a degradation in alertness, the air operator must implement risk controls to reduce the adverse effects of the schedule. Where the risk controls are ineffective, the air operator should consider whether the flight is safe to operate within the prescriptive limits. (iii) (iv) Based on the modelling of the example detailed in Step 1 and in Appendix A, risk controls would be required to operate the flight in a safe manner. Risk controls could include making sure the flight crew member was not scheduled the day before the variance flight or was given a short FDP - thereby providing adequate opportunity for a nap and maximum rest. Additionally, given that the flight crew member had to wake up during their Window of Circadian Low (WOCL), additional rest should be given the next day. Risk controls can be complex or as simple as increased education to flight crew about the fatigue risk specific to a particular flight. The extent of the risk control will depend on the outcome of the initial data collection and analysis phase. YYYY-MM-DD 13 of 40 AC 700-XXX Issue 01

14 (d) (e) Ongoing monitoring through data collection and analysis will confirm if the initial assumptions and risk controls where correct. Note: There will be scenarios where the risk controls applied to reduce the adverse effects of the variance on flight crew fatigue and alertness are ineffective. Even after a re-analysis and application of new risk controls. Where this situation occurs, the air operator may not continue to use either the initial or continuing exemption. Note: Please see Appendix C of AC 700-XXX FRMS Requirements for examples of risk controls. STEP 4 SPI Development (i) (ii) In order to measure whether the risk controls are working appropriately, safety performance indicators will need to be developed, implemented and measured. Safety performance indicators (SPI) are used to monitor whether the risk controls are managing the identified hazards and risks. SPIs can take the form of operational objectives such as setting targets that cannot be exceeded or rules that cannot be broken, e.g. no duty to end in the WOCL; however, in the context of the safety case, because it is specific to the variance, the SPIs will need to be focused on proactive monitoring of crew member fatigue. Note: Please see Appendix B of AC 700-XXX FRMS Requirements for examples of SPIs. STEP 5 Continuous Monitoring (i) (ii) (iii) (iv) (v) To assess whether the risk controls are working, air operators must continuously monitor the impact of the variance on flight crew fatigue and alertness. This is accomplished through the ongoing measurement of flight crew fatigue and alertness levels using data collection methods. Fatigue modelling is a good tool to employ for the initial analysis, however, for the ongoing monitoring of the variance, real time data collection will be required comprising reactive, proactive and predictive data. The ongoing collection of data should include a combination of: (A) (B) (C) Reactive data (self-reporting of fatigue, fatigue hazards, and fatiguerelated events) to confirm the risk controls; Proactive data collection in the form of sleep quality and rest measurements, flight crew surveys and/or psychomotor vigilance testing; and Predictive data from analysis of flight crew schedules using previous experience, evidence-based scheduling practices; and some form of fatigue modeling. Depending on the complexity of the variance being sought a combination of data, collected from more than source, must be used. The data must include the flight crew operating the flight subject to the variance. Where it appears that the risk controls are performing to the acceptable level (equivalent to within 5% of the baseline level of fatigue and alertness) they become part of normal operations and are monitored using FRMS quality assurance processes. If the risk controls do not result in the acceptable level of fatigue and alertness, the air operator must re-enter the FRM process at the appropriate step. This will YYYY-MM-DD 14 of 40 AC 700-XXX Issue 01

15 (f) (vi) usually require returning to the hazard identification stage and reassessing the initial assumptions made to determine if all fatigue hazards and risks have been identified. The air operator must continue to analyze the flight being operated under the variance by continuing to collect data in relation to the flight. Should new hazards and risks be identified, adjustments will need to be made to the fatigue risk controls and the SPIs, to measure the effectiveness of the revised intervention. In all cases, where the ongoing validation identifies that the controls are not working, the safety case must be reviewed and adjusted. Note: Depending on the complexity of the variance, the amount and type of data required to be collected may vary. For example, when using a variance to shorten a rest period, data collection measures such as actigraphy, sleep diaries and pilot surveys may be useful. However, when collecting data to support a FDP extension, the use of pilot surveys (top of descent) or brief psychomotor vigilance testing (PVT) and behavioral monitoring may be more appropriate methods. The type of monitoring will also vary based on the size and complexity of the company and the size of the flight crew population being monitored. Note: The IATA Common Protocol for Minimum Data Collection Variable s in Aviation Operations describes 5 levels of data collection and provides examples of data collection methods and templates. Note: Examples of acceptable monitoring are actigraphs, pilot surveys, sleep diaries, work rest rules modeling, top of descent surveys, behavioral monitoring, and psychomotor vigilance testing. Additional examples can be found in AC 700-XXX.Insert Link STEP 6 Safety Case Validation (i) (ii) (iii) The safety case must be validated through the ongoing assessment and use of the FRMS until the air operator is satisfied there is sufficient data to confirm completion of the safety case and to support a continuing exemption from the regulations. In order to do this, the air operator must collect at least 1 years worth of data to support the safety case. Where the flight variance is operated throughout the year, the data collection should reflect this. In order to proceed with a letter of confirmation advising TCCA that the safety case is valid, the air operator must provide 20 examples with not more than a 5% failure rate (1 out of 20) showing no more than a 5% deviation in flight crew fatigue and alertness levels for each sample. Where the air operator has more than one failure in the sample, the accumulation of the 20 samples must begin again. Figure 3 shows three scenarios. The data must be collected within 24 months of sending the Notice of Intent. Note: All data relating to the safety case and the FRMS should be readily available, upon request, to TCCA. Note: The development and validation of a safety case using operational data provides evidence to TCCA that the variance does not adversely impact flight crew alertness or fatigue YYYY-MM-DD 15 of 40 AC 700-XXX Issue 01

16 Figure 3 Validation examples 5% deviation from baseline Scenario 1: Data collected over a period of 12 months with only one deviation from the baseline of 5%. 12 MONTHS OF DATA Letter of Confirmation (LOC) Scenario 2: Data collected over a period of 24 months with more than one deviation from the baseline of 5%, but 19 samples under the 5% deviation 24 MONTHS OF DATA COLLECTION 5% deviation from baseline LOC Scenario 3: Data collected over a period of 24 months with more than one deviation from the baseline of 5% and a failure to collect 19/20 effective samples. 24 MONTHS OF DATA COLLECTION 5% deviation from baseline Not eligible for the continuing exemption (g) As each safety case will contain a different set of assumptions regarding hazards and risks and will be based on different parameters for the flight, an individual safety case will usually be required for each requested variance unless the following criteria apply to the variance: (i) (ii) (iii) (iv) The difference in the duration of the flights does not exceed 30 minutes; The flights are operated in the same time zone or across the same number of time zones in the same direction; The flights are operated with aircraft of the same type and configuration; The flights are operated with the same number of flight crew; YYYY-MM-DD 16 of 40 AC 700-XXX Issue 01

17 (v) (vi) (vii) The operating environments of the flights are similar; The flights are operated at the same time of day or within 30 minutes of the start time; and Other hazards or risks associated with the flights are similar. 9.4 PHASE 4 LETTER OF CONFIRMATION CONTINUING EXEMPTION (1) In accordance with CAR (4) a safety case is considered complete when the following conditions have been met: The air operator is able to provide data, collected over a period of not less than one year, of at least 20 consecutive examples of data collection and test results show that the variance (as stated in the Notice of Intent) did not have an adverse impact on the flight crew s levels of fatigue or alertness. The 20 examples must contain no more than 1 example of a deviation greater than 5% from the baseline. Note: Where an air operator has more than one result in a sample of 20 showing a variation of more than 5% from the acceptable level of fatigue and alertness, the air operator will review the safety case and begin the sampling process again until a successful sample is achieved. In cases where 19 out of 20 acceptable samples are not achieved within the 24 month time frame, the air operator will revert back to the prescriptive requirements. A fatigue risk assessment of the proposed variance has been conducted and the findings of the assessment have been analyzed; and Measures to mitigate any hazards and risks related to the variance have been developed and the measures have been monitored to assess whether they have effectively corrected any increases in levels of flight crew fatigue and decreases in pilot alertness. Corrective measures have been put in place to address any additional findings obtained under paragraph (c) if the mitigation measures did not achieve the desired effect on flight crew fatigue and alertness; and The air operator can demonstrate that the mitigations and corrective measures are effective in maintaining the acceptable level of flight crew fatigue and alertness. (2) An air operator may use data derived from another operator for 25% of the data required to complete the sample of 20 provided the data meets the parameters established in section 9.7(g) of this AC as per CAR (3). (3) When the air operator is satisfied that the safety case has been validated and the data sampling provides evidence of this, an initial audit of the FRMS must take place. The audit confirms that the FRMS is functioning the way it is intended and will provide an assessment of the effectiveness of the FRMS. The air operator must meet the requirements of CAR in order to complete the audit. Note: Additional information on FRMS Quality Assurance can be found in AC 700-XXX. Insert hyperlink (4) All four components of an FRMS must be established, implemented and maintained before the letter of confirmation can be sent. This includes the: FRM plan, FRM process, FRM promotion program and FRM quality assurance program. (5) When all the requirements have been met to validate the safety case, the air operator must send a letter of confirmation to their TCCA principal operations inspector. The letter advises TCCA that all of the conditions for the initial exemption have been met and serves notice that the air operator will be using a continuing exemption to support the continued use of the variance. The letter of confirmation must contain: YYYY-MM-DD 17 of 40 AC 700-XXX Issue 01

18 The date upon which the air operator will begin using the continuing exemption; A declaration that the FRMS meets the requirements of CAR , Division IV; A confirmation that the FRMS has been audited; and A confirmation that the safety case for each variance has been completed and the variances have no adverse effect on fatigue or alertness. (6) An air operator who fails to validate their safety case within 24 months of sending the original Notice of Intent, may not be exempted from the same provision for a period of five years after the expiration of that time period. 9.5 Phase 5 Continuous Improvement and Monitoring (1) In order to maintain and continuously improve the FRMS and to continue monitoring the safety case, air operators must on an ongoing basis audit and review the FRMS. Additionally the air operator must continue to monitor the effectiveness of the safety case to ensure that fatigue and alertness levels are not adversely impacted. (2) CAR requires an annual audit of the FRMS to ensure that the FRMS continues to be maintained and where findings of non-compliance with the FRMS processes and procedures are found, corrective and preventative measures are implemented, as necessary, and monitored for effectiveness. (3) Air operators must also, on an annual basis, review the effectiveness of the FRMS in achieving its safety objectives. Where the safety objectives are not being met, the air operator will review FRMS processes and SPI accuracy to determine the root cause and contributing factors. As necessary, corrective measures must be applied and monitored. (4) In order to monitor the effects of the variance on flight crew fatigue and alertness levels, the air operator must continue to monitor the safety case at a minimum of every six months. This involves collecting a representative sample of data, using the data collection method established in the safety case, for each 6-month period over which the flight is operated. The following chart provides an example of a sampling based on lot size. i Lot Size Sample Size All (5) Where the audit, review or safety case monitoring reveal any findings, the air operator must implement corrective and preventative measures and monitor the measures for effectiveness. (6) The functions of the FRMS quality assurance program should normally be carried out by persons not involved in the duties being audited or reviewed. However, in the case of smaller operators the independence of these functions may not be feasible. In these cases, the air operator shall complete a risk analysis that addresses any increased risk to aviation safety or compromise to the audit, of assigning the function to a person involved with the task being audited. Note: Refer to AC 700-XXX FRMS Requirements for information on independence of audits and reviews. Insert hyperlink 10.0 INFORMATION MANAGEMENT (1) Not applicable. YYYY-MM-DD 18 of 40 AC 700-XXX Issue 01

19 11.0 DOCUMENT HISTORY (1) Not applicable CONTACT OFFICE For more information, please contact: Chief, Technical Program Evaluation and Coordination (AARTT) Phone: Fax: If you have suggestions for amending this document, please submit them to the address above. Robert Sincennes Director, Standards Civil Aviation TCCA YYYY-MM-DD 19 of 40 AC 700-XXX Issue 01

20 APPENDIX A - DATA COLLECTION AND ANALYSIS USING FATIGUE MODELING 1.0 Biomathematical Fatigue Modelling (1) The initial comparative analysis of the flight schedule will require the use of predictive fatigue modelling usually accomplished through biomathematical or manual fatigue modelling techniques. Note: The exception to this scenario is where an air operator is currently not subject to the revised prescriptive requirements and is currently operating the flight it will eventually need a variance to operate. The air operator will be able to use real time data collected in advance of the new regulations coming into effect. (2) Biomathematical or manual fatigue models using work/rest limits are useful tools for determining the equivalence of a schedule operated with a variance, compared to a flight operated with an augmented flight crew. The fatigue modelling will highlight where fatigue may be present and alertness is diminished, and should take into consideration the following factors relating to flight crew members such as: (i) (ii) (iii) (iv) The time of day of work and breaks; The duration of work and breaks; Work history in the preceding days; and The biological limits on recovery sleep. (3) Many biomathematical models are capable of assessing other influences on fatigue and alertness such as: Time zone changes; Homeostatic sleep drive (chemical driven internal impulse to sleep or be awake); Chronic sleep restriction; Sleep inertia; Circadian phase input; Sleep quality; Work type; and Time on task. Note: For additional information on biomathematical models, see the CASA comparative analysis at (4) Using the example of the planned variance by ABC Airline to operate YYZ-PVR-YYZ below, a biomathematical analysis would compare the flight crew members potential fatigue level compared to a flight operated using the prescriptive limits Figure 4 shows a diagrammatic output of a biomathematical model highlighting where fatigue may be present. Biomathematical models allow the air operator to establish a comparative YYYY-MM-DD 20 of 40 AC 700-XXX Issue 01

21 baseline using the prescriptive requirements as the measure of effectiveness and the variance as the comparative. Where the model highlights a difference in fatigue and alertness, interventions or risk controls are required. Figure 4 ii - Biomathematical Modelling Output (5) While biomathematical models are a useful predictive tool for understanding where fatigue may be present, there are limits to their usefulness. Biomathematical models provide a tool that incorporates aspects of the fatigue science into scheduling through predictions of fatigue risk levels, performance levels and sleep times or opportunities. The draw backs are that the data is a composite of the population as a whole and doesn t reflect the individual specifically. That s why other data collection methods are required to validate the individual s fatigue levels based on the initial assumptions derived from the predictive data. (6) Table 1 shows fatigue levels and their corresponding Fatigue Avoidance Scheduling Tool (FAST) Effectiveness Scores. Based on the score, interventions may or not be required. Often times, the fatigue score varies throughout the flights; as such risk controls will need to be developed that address these variations. Table 1 iii - Fatigue levels and their corresponding FAST Effectiveness Scores Severely Fatigued Extremely Fatigued Very Fatigued Moderately Fatigued Fatigued Not Fatigued Cumulative >90 Interval >90 (7) Using the Sleep, Activity, Fatigue and Task Effectiveness - Fatigue Avoidance Scheduling Tool (SAFTE-FAST) effectiveness score it is possible to predict the likelihood of a lapse or an error based on inputs relating to time awake, sleep history and a comparative of the relative impairment based on blood alcohol concentration. YYYY-MM-DD 21 of 40 AC 700-XXX Issue 01

22 Effectiveness Score Table 2 iv Relationship between Effectiveness Scores and BAC Lapse Likelihood Hours Awake (Hr:Min) : : : :00 BAC Equivalent : : : : : :00 (8) Biomathematical models often use sleepiness scales such as the Karolinska or Samn-Perelli models. Most biomathematical models provide a fatigue or alertness prediction value over a given work period. These values are generally expressed on a subjective scale. Other models, such as Fatigue Audit InterDyne (FAID), have an internal score aligned with the hours of work per week. For example, a score of 40 on FAID is considered not fatiguing whereas anything over 60 requires attention. (9) The most commonly used scales in the aviation context are the Karolinska Sleepiness Scale (Åkerstedt & Gillberg, 1990) and the Samn-Perelli fatigue scale (Samn & Perelli, 1982). (10) The Karolinska Sleepiness Scale (KSS) shown in Table 3 is a one-dimensional scale ranging from 1 (very alert) to 9 (very sleepy, great effort to keep awake). It has been validated against objective measurement of sleepiness such as electroencephalographic (EEG) and electrooculographic (EOG) activity (Åkerstedt & Gillberg, 1990) and performance evaluation (Kaida et al, 2006). The KSS is the metric used by the sleep/wake predictor (SWP) model. The Fatigue Risk Index (FRI) model estimates the probability (multiplied by 100) that fatigue will reach a value of 7 or higher on the KSS (Folkard et al, 2007). v Karolinska Sleepiness Scale Table 3 - Karolinska Sleepiness Scale Rating 1 Very alert 2 3 Alert normal level Neither alert nor sleepy Sleepy, but no effort to keep awake 8 9 Very sleepy, great effort to keep awake YYYY-MM-DD 22 of 40 AC 700-XXX Issue 01

23 Note: It is generally accepted that a value of 5-6 on the Karolinska scale is acceptable. A value of 7 or higher on the KSS is associated with intrusions of sleep and an increased risk of impaired performance. (11) The Samn-Perelli (SP) shown in Table 4 is a 7-point scale with possible scores ranging from 1 (fully alert, wide awake) to 7 (completely exhausted, unable to function effectively). This scale has been validated and is widely used in aviation (Samn & Perelli, 1982; Samel et al, 1997) and is one of the metrics provided as an output of the System for Aircrew Fatigue Evaluation (SAFE) and Sleep, Activity, Fatigue and Task Effectiveness - Fatigue Avoidance Scheduling Tool (SAFTE-FAST) models. Note: It is generally accepted that a value of on the Samn-Perelli sleepiness scale is acceptable. Values of 5 and 6 on this scale are considered as Fatigue Class II where flying duty is permissible but not recommended. A value of 7 is considered as Fatigue Class I, i.e., Severe fatigue. Performance definitively impaired. Flying duty not recommended. Safety of flight in jeopardy. Samn-Perelli Sleepiness Scale Risk Level Table 4 Samn-Perelli Ratings vi Controls 1-3 Low No specific controls necessary. Except in the presence of higher level indicators of fatigue (i.e. symptoms, errors or incidents) 4-5 Moderate Initiate moderate fatigue risk mitigation actions 6 High Initiate high fatigue risk mitigation actions 7 Very High Intolerable risk. No individual roistered beyond this threshold. (12) It should be noted that all of these scores require the establishment of a threshold to determine what is fatiguing. In the context of FRMS in aviation, the baseline is the prescriptive requirements. However, given that regulations are a one size fits all solution, depending on the application of the regulation to any given schedule, fatigue and alertness may still be sub-optimal. As such, the threshold for predictively assessing a schedule using a prescriptive requirement as a baseline must always identify and control any unacceptable risk with respect to the baseline measure. (13) Another option for establishing the baseline level of fatigue and alertness is to use the fatigue science shown in Table 5 as a guide for what is acceptable and what isn t. In the context of aviation it is not always possible use the fatigue science as a baseline and flexibility is required because of the 24/7 nature of operations. However, using the science as a litmus test, in relation to a proposed variance, is a good idea and gives you another indicator of fatigue risk in relation to the proposed variance and the established fatigue science. Note: Sleepiness scales such as Karolinska, Samn-Perelli, Visual Analogue Scale (VAS), Epworth or Pittsburg Sleepiness Scales provide a framework for the assessment of fatigue and alertness. These scales will often be used to determine levels of fatigue through self assessment, PVT testing, flight crew fatigue surveys and top of descent testing. Depending on the data you are hoping to collect, one scale may be preferable to another. YYYY-MM-DD 23 of 40 AC 700-XXX Issue 01

24 2.0 Fatigue Modelling Using Manual Techniques (1) Manual fatigue modelling can be simple to use and a robust alternative to a biomathematical model. Table 5 highlights some basic requirements and limits derived from the sleep science that are useful to know before using a manual fatigue model. Note: Manual fatigue modeling is generally used in smaller organizations with less complex and varied flight schedules. (2) As with biomathematical modelling, manual modelling requires the establishment of a threshold to determine what is fatiguing. The baseline for FRMS in the CARs is the prescriptive requirements. When using manual modelling it is helpful to have a basic knowledge of what the science says with respect to length of duty day and rest, to better understand fatigue likelihood scores and the thresholds that are used to determine where interventions are required. Table 5 gives a basic overview of the fatigue science. Table 5 Principles of Fatigue Science Requirement Rest period (Sleep opportunity) Time on task (Length of FDP) Wakefulness (Time awake) Consecutive night duties Long rest period (Day off) Science On average, humans need 8 hours sleep per 24 hour period, to sustain performance vii Research show individuals need 9 hours in bed to obtain 8 hours sleep Limit of 12 hour duty period per 24 hour period as performance declines incrementally after 12 hours. viii The number of errors committed doubles after 10 hours on task compared to 8 with a threefold increase at 16 hours. ix 17 hours of wakefulness equates to an equivalent blood alcohol level of 0.05% x 24 hours of wakefulness equates to an equivalent blood alcohol level of 0.10% The risk of making an error increases exponentially based on each consecutive night of duty worked (6%, 17%, and 36%) xi 2 days off in 7 are required to counteract cumulative fatigue xii (3) Table 6 shows a set of basic work/rules that respect the science. If an air operator applies these principles to their schedules, fatigue should not be a problem. Table 6 Prescriptive Rule Set Based on Fatigue Science Fatigue is unlikely to be a problem in a workplace if the schedule is consistent with the following rules No more than 48h worked [4X12] per week No shift more than 12h No break less than 12h No more than 12h night work per week [ ] At least 1 X 36h break per 7 day period YYYY-MM-DD 24 of 40 AC 700-XXX Issue 01

25 (4) Fatigue Likelihood Model - Manual fatigue models are based on rules that apply to sleep, work, night work and consecutive days worked. In the model shown in Table 7, a fatigue likelihood score is calculated using specific parameters. Each parameter is assessed, given a score and added up to provide a numeric sum of between 0 and 40 that indicates the degree of sleep opportunity provided by the schedule. When a basic work rest rule is exceeded, the score increases depending on the extent to which the rule is violated. Schedules with a lower score offer a greater sleep opportunity. (5) A flight crew member s schedule can be plotted and assessed using a color scale: green to red. Based on the simple rule of an 8 hour work day being acceptable and 14+ hours being unacceptable, a work schedule can be analyzed to determine where fatigue might be increased and alertness decreased. When the plot doesn t show the color green, risk controls may be required. (6) Table 7 shows work and rest parameters related to fatigue and a simple scoring matrix. The score for each of the variables is added up and plotted in Figure 5. In order to use this model, you will need to input all of the information relating to the flight crew member s schedule for 7 days prior to the variance being operated. Table 7- Fatigue Likelihood Scoring Matrix for Work Schedules Score a) Total hours per 7 days b) Maximum shift duration c) Minimum short break duration d) Maximum night work per 7 days e) Long break frequency 36 hours hours hours hours in 7 days 1 in 7 days 1 in 14 days 1 in 21 days 1 in 28 days Figure 5 Scoring Matrix Based on Work Rest Rules xiii Score (7) Work/Rest Rules Model - Another method to manually review and assess a schedule for fatigue is the prior sleep/wake rules model. Using the fatigue science shown in Table 5 as a guide, a simple calculation can give you an indication of the likelihood of fatigue being present. You can do a relatively simple calculation to determine whether you ve an individual has had enough sleep. For example: (a) X = sleep in the past 24 hours (b) Y = sleep in the past 48 hours [how many hours of sleep you ve had over the past two days] (c) Z = time since your last sleep [how many hours since you woke up] (8) In general, you are likely to be experiencing some form of fatigue-related impairment if: YYYY-MM-DD 25 of 40 AC 700-XXX Issue 01

26 (a) (b) (c) X is less than 8 hours Y is less than 15 hours Z is greater than Y (9) In a typical FRMS, these scores may be used to determine whether risk controls are required to reduce the increased risk posed by the use of the variance. Table 8 shows the scoring mechanism for using prior sleep wake rules as a manual fatigue modeling technique. Note: The threshold is determined by the air operator, however, it should respect the regulatory framework and/or the fatigue science. Prior sleep factor Table 8 Prior Sleep Wake Rules Threshold value Score X (sleep in prior 24 hours) 8 hours Add 4 points for each hour below threshold Y (sleep in prior 48 hours) 16 hours Add 2 points for each hour below threshold Z (time awake since last sleep) Y Add 1 point for each hour of wakefulness greater than Y (10) Using the example shown in Appendix A, section 1.(4) of the variance YYZ-PVR-YYZ and, assuming that risk controls where applied to the flight crew member s schedule the day before and the day after the flight variance, Figure 6 shows where the maximum shift duration and rest rules have been violated and highlights why risk controls are required. (11) An analysis of the flight crew member s work rest history over the preceding days provides the ability to score the schedule. The following points have been considered in this scenario: (a) (b) (c) Assuming that the flight crew member did not fly or had a short FDP the day before, it would be possible to nap during the afternoon and go to bed at 22:00 hours. The early start required for a 6:30 check in would mean that the maximum amount of sleep obtained, considering time required to wake up, personnel hygiene, food and travel to work, would be 6.5 hours. The sleep would be truncated and the flight crew member would wake up in the WOCL. Assuming the pilot had a full night s sleep the night before the early start. (d) By the time the flight concluded in YYZ the pilot would have been awake for over 17 hours and on task for 13.5 hours. (12) Figure 6 graphically depicts the flight crew member s schedule with respect to rest and time awake over the past 48 hours. Table 9 provides a sleep wake score for the flight crew based on the prior sleep/wake rules shown in Table 8. YYYY-MM-DD 26 of 40 AC 700-XXX Issue 01

27 Figure 6 - Flight Crew Schedule: Day Before, Day of, & Day After Flight Operated with a Variance Table 9 Sleep Wake Hours Flight Crew YYZ-PVR-YYZ Prior sleep factor Threshold value 1 Score (X) hours 6 (Y) hours 3 (Z) 17.5 Z - Y 4 Score 13 Score (13) A score of 10 or more is considered serious and risk controls should be put in place to manage the elevated risk. The air operator s fatigue risk management process should define what 1 Threshold numbers should be set by the operator. They should adhere to the fatigue science and basic rules of rest and wakefulness. YYYY-MM-DD 27 of 40 AC 700-XXX Issue 01

28 mitigations will need to be put in place. The mitigations will need to be measured to ensure there is no adverse effect on fatigue and alertness of the flight crew. (14) A decision tree or decision making matrix can be a useful tool in determining what actions to take where fatigue is identified as a hazard. Using the score card, standard actions can be developed in response to the score. This will ensure standardisation and a consistent response based on the score or fatigue level identified. YYYY-MM-DD 28 of 40 AC 700-XXX Issue 01

29 APPENDIX B - SAFETY CASE DEVELOPMENT 1. PURPOSE (1) This appendix provides additional information in relation to the development of safety cases to support regulatory variances. (2) CAR (2) contains specific requirements for building a safety case to support a variance to the CARs prescriptive requirements. A safety case is essentially a fatigue risk assessment that identifies the hazards and risks involved with a variance from prescriptive requirements for a specific pairing, route or schedule. (3) The safety case describes the variance to the regulations and the fatigue risk management system processes in place to ensure risk controls are effectively and consistently applied and measured for effectiveness. (4) The development of a safety case demonstrates to TCCA that your organization has the capability to develop and implement an FRMS and fully understand the risks associated with the variance you are requesting. The key steps in developing a safety case are shown in Figure 7. Figure 7 Safety Case Development Description of Variance Data Collection and anlaysis Risk Control Develop & Implement Performance indicator Development Continuous Monitoring Safety Case Validation 2.0 DESCRIPTION OF VARIANCE STEP 1 (1) Describe the variance being sought, for example: Air operator: ABC Airlines Flight description: Yellowknife Calgary Halifax St Johns Crew Check in Location Departure Arrival Flight time* FDP Running Total 22:30 CYZF 23:30 02: hours 3.5 CYYC 03:00 08: hours 9.8 CYHZ 09:20 11: hours 12.5 TOTAL FDP ON ARRIVAL AT CYYT 12.5 hours Note: A 1 hour turnaround time is assumed before the next flight sector. Air operators should have data relating to taxi times and should calculate difference in times due to seasonal variables such as snow delays and de-icing. (2) Current regulations allow a maximum flight duty period of 11 hours for a FDP with 1-4 sectors of greater than 50 minutes duration. The FDP will commence at 22:30 hours and terminate at 11:00 (Yellowknife time). This flight will operate four times a week Monday through Thursday. (3) Information should be provided relating to: (a) The flight crew or crews that will operate the flight: YYYY-MM-DD 29 of 40 AC 700-XXX Issue 01