Guideline for the Application of the SQMS-Basic Structure

Guideline

Basic Structure for a Safety & Quality Management System (SQMS) for Operators
Based on: Requirements:  (EEC) No 3922/91 Annex III amended (EU-OPS 1)  Leaflet No 44: JAR-OPS 1 Amt 13 section 2  JAR-OPS 3.035  EC Regulation No 2042/2003 (EASA Part M)  ICAO Convention on International Civil Aviation Annex 6 “Operation of Aircraft” Guidance Material:  ICAO SMM, Doc. 9859 (2nd Ed./2009) "Safety Management Manual"  FOCA-Guideline SMS-001 Implementation of Safety-Management-Systems (SMS) including Annexes 1 to 4

Purpose: The intention of this “Guideline” and the subsequent “Basic structure of a Safety and Quality Management System” is to provide ideas and possible solutions to build up a Safety & Quality Management System, which fulfils existing requirements regarding Quality Systems AND Safety management Systems for airplane operators and helicopter operators. The chosen approach will additionally provide a good starting position to implement future EASA requirements regarding Management Systems including Safety Management Systems.

Feedback to author is welcome: m.friedli@procede.ch

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Guideline for the Application of the SQMS-Basic Structure

How to use this document: There are different possibilities to establish an effective and compliant System. Every company has to find out its own way! The different chapters consist of fragments of processes and concepts that serve as samples. It is essential that each chapter has to be tailored to the size and complexity of the respective organisation and must therefore be reworked and completed comprehensively. The normal text format shows samples, while the Italic text format serves as reference to the (legal) requirements and as further explanation.

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Guideline for the Application of the SQMS-Basic Structure

Legal background
Quality System: Operators who want to achieve an Air Operator Certificate must comply with:  EEC 3922/91 Annex III amended, EU-OPS 1 (airplane operators only)  JAR-OPS 3 (helicopter operators only  frozen in Switzerland  direct implementation of respective EASA regulation in 2012)  EC Regulation No 2042/2003, EASA Part M (continuing airworthiness)  Swiss Air Law  Verordnung über die Betriebsregeln im gewerbsmässigen Luftverkehr (VBR I; SR 748.127.1) All those standards require from operators to establish and maintain a Quality System. The relevant requirements are stated in:  EU-OPS 1.035  JAR-OPS 3.035.  EASA Part M. A. 712 The purpose of the Q-System is to ensure safe operation and airworthy aircrafts. The requirements from OPS X.035 and Part M do not lead to different Quality Systems: The paragraphs EASA Part M. A. 712 (d) and 712 (d) clearly state:
“Where the approved continuing airworthiness management organisation is approved in accordance with another Part, the quality system may be combined with that required by the other Part, e.g. Part 145” “In case of commercial air transport the M.A. subpart G quality system shall be an integrated part of the operator's quality system.”

Operators who additionally want to achieve an approval as a FTO/TRTO (according to JAR-FCL 1 and / or 2) have to lay down a Quality System according to  Appendix 1a to JAR–FCL 1.055 / 3.055 (Paragraph 3) for FTO  Appendix 2 to JAR–FCL 1.055 / 3.055 (Paragraph 3) for TRTO Conclusion: It is strongly recommended to establish one but integrated Q-System covering all quality assurance activities of the operator in a separate Quality System Manual. This modular approach enhances the flexibility for the organisation, avoids redundancies and contradictions, facilitates the document control and increases the acceptance on the level of employees. Specific aspects such as policies, processes, procedures and responsibilities that are applicable only to specific parts of the organisation (e. g. Continuing Airworthiness Management Organisation CAMO, Maintenance Organisation, Flying Training Organisation FTO) may be documented in the respective document (e. g. CAME, MOE). In such cases it is of up most importance that this is referenced in the main Quality System. In the respective document (e. g. CAME, MOE) reference shall be made to the main Quality System.

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Safety Management System Existing Requirements:  ICAO Convention on International Civil Aviation Annex 6 “Operation of Aircraft”  Bundesgesetz über die Luftfahrt, §103a  Swiss Legislation: Art. 663b OR (risk assessment)  not specific to aviation industry Existing Guidance Material  ICAO Safety Management Manual (ICAO document 9859 / Ed. 2 – 2009)  FOCA Richtlinie SMS-001 Implementation of Safety-Management-Systems (SMS) (16.06.2008) According to ICAO Safety Management Manual (ICAO document 9859 / Ed. 2 – 2009, chapter 8.2) a Safety Management System should consist of the components listed below. Some of these elements are already part of Quality Systems or other OM Parts according to EUOPS 1 / JAR-OPS 3: Respective component of Components acc. to SMM Degree* EU-OPS 1 / JAR-OPS 3 Safety Policy and Objectives: Quality Policy & Goals  Management commitment and responsibility QS-related responsibilities and duties  Safety accountabilities    Appointment of key safety personnel Coordination of emergency response planning SMS documentation
Organisation, QS-related responsibilities and duties Emergency & Accident Management OM, CAME, QS

Safety Risk Management:  Hazard identification  Risk assessment and mitigation

Accident Prevention & Flight Safety Programme None

Safety Assurance:  Safety performance monitoring and measurement   The management of change Continuous improvement of the SMS

Inspections, Audits, Feedback, Subcontractor Monitoring, Management Evaluation, Flight Data Monitoring Document Control Management Evaluation

Safety Promotion:  Training and education  Safety communication

QS-Training Accident Prevention & Flight Safety Programme

* Approximate degree of fulfilling SMS-requirements with Q-System according OPS X.035
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Management System Existing proposals / tendency: EASA Notice of proposed Amendment (NPA) No 2008-22c “Organisation Requirements” The NPA No 2008-22c states in paragraph OR.GEN.200 “Management system”:
(a) An organisation shall establish and maintain a management system that includes: (1) a safety policy; (2) a process for identifying safety hazards and for evaluating and managing the associated risks; (3) clearly defined lines of safety accountability throughout the organisation, including a direct accountability for safety on the part of senior management; (4) personnel trained and competent to perform their tasks; (5) a process for reporting and analysing hazards, incidents and accidents and for taking corrective actions to prevent their recurrence; (6) an organisation manual containing all management system processes, including a process for making personnel aware of their responsibilities and an amendment procedure;. (7) a function to monitor compliance of the management system with the relevant requirements and adequacy of the procedures. Compliance monitoring shall include a feedback system of findings to the accountable manager to ensure corrective action as necessary; and (8) any additional requirements that are prescribed in this Part. (b) The management system shall correspond to the size, nature and complexity of the activities, and the hazards and associated risks inherent in these activities.

Final Conclusion: Combination of Quality System, Safety Management System and Management System The following three facts implicate the integrated approach to establish and maintain a combined Safety & Quality Management System.  Today – without considering SMS-requirements - operators deal with different requirements. It is easier to comply with them if one single Q-System is in place to monitor the performance of own standards the compliance with those requirements.  The fact that today’s requirements to a Q-System completely are part of the requirements to an SMS leads to the approach to further develop the existing Q-System with the new SMS-requirements (Remember: The purpose of the Q-System is to ensure safe operation and airworthy aircrafts!)  EASA strives to isolate organisational topics including risk-management, safety assurance into a Management System. As a consequence, the term Quality System will probably disappear, because the new approach will lead to a Management System containing a Safety Management Manual containing Safety Performance Monitoring (the former Quality Assurance Programme).  With the establishment of a SQMS a first step in this direction can be made preventing the operators from huge modifications to implement future EASA requirements This conclusion is confirmed by the statement in NPA 2008-22a - Authority and Organisation Requirements - Explanatory Note & Appendices:
“The Agency would like to emphasise that the quality system concept, as known under the JAA system and in existing EASA Parts, is integrated as a compliance monitoring system becoming an element of the management system of an organisation. The management of this compliance monitoring system, including its programme, is part of the responsibilities of the safety manager.”
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02.2010 Issue 2 / Revision 0 / 24.02. Friedli Page 6 of 53 .M.2010 .Safety & Quality Management System Safety & Quality Management System (SQMS) Issue 2 / Revision 0 / 24.

. 36 Safety Investigations ....................................................................................................34 9.................................................................................... Flight Data Monitoring............................................................................... System of Amendment......................... 23 Importance of Feedback & Reporting .........32 7................... 5............................................2..................... 27 Qualification of internal Inspectors... 4.......... 5........................................................................... 9........................... 6. Friedli ........................................ ERP Concept ..................................................... 5..2......................... 30 Qualification of Auditors ........................5................................ 31 List of internal Auditors.......................................... 9 Safety and Quality Policy ......... Organisation and Documentation ...2...........4............. Safety Studies ..... 6......... 16 Distinction between Quality Management and Safety Management Systems ........................................ 9............................................................2......................4................... 22 Classification of Risks ............................................................................... 25 Inspection Procedure ......... Reviews....................................................................................................... 20 Levels of Risk Management...................................................................................M.....................................................................................3...................................2010 ............................ 7.................. 3..................................................... 28 List of internal Inspectors ..............................................................................................................................39 10..................................... 9 Record of Temporary Revision .....................................................1.............1......41 Page 7 of 53 Issue 2 / Revision 0 / 24..10 1.9 0....................................... 21 Hazard Identification and Risk Assessment Process ..........2.................................................................................... 9............................ Feedback & Reporting............................ Record of Revision................................................................................................................................................................. 2........................................................3.................................... 10 Safety & Quality Management Organisation & Accountabilities ...........................................02..... 1............................................... 8.................29 6....................................... Emergency Response Planning ...........................................3....................1..... 7................ 6.......................... 1............................................................1. 2........................................................ 3...................1.. Risk Management ...................34 Safety Studies.................................................. 2............................................................ 2..... 32 Supervision of Subcontractors / Suppliers ............................................... 3................................ Surveys and Investigations ....................................... 31 Audit Scopes ........ 15 SQMS-Documentation ................... 18 Relation between Safety Management System and Q-Systems in Aviation ... 11..............................................1.......... 31 Evaluation of Subcontractors / Suppliers .................. 19 Paradigm Change .....................1........................................................................ Audits..2...................................3.............................. 9................ Introduction to Safety & Risk Management ........... 0.... 24 Kind of Reports ........................................................................................5..................2.. 34 Safety Reviews ................................3...................................3............... Subcontractor / Supplier Management.................................. 39 Management Evaluation.........................4................................................................................................................................4................... Safety/Quality Policy..................................... 4......................... 18 Relation between Risk-Management and Assurance Activities.................... 28 Audit Procedure ............................. 5...... 31 Classification of Audit Findings ..... 19 Mitigation / Reduction of Risks.........................................................................Safety & Quality Management System Content 0.................................... 35 Safety Survey................ 6...............................3....................... 28 Inspection Scopes............................................................................................................................21 3.. 11 Purpose of the Safety & Quality Management System...4.. 0.............................................. 9 List of Effective Pages....1...................................... 1..........................................27 5.............................................1...................................................................................................................................2... Inspections....................1..... 32 1......................................... 2................................................. 37 10.........................................................................................................................................24 4.................. 6............................18 2........................2..........

...... Control of Safety & Quality Management System related Records .... Data to be evaluated .................................................................................................... Document Control ................ EDP: Back-up Concept ...............................51 14... Definitions........................................................... 44 12..........................3.2010 ............................1.3..................................... Abbreviations (Terminology) .......... Ongoing Sensitisation........................................ Q-System Training Records................................... Process of Management Evaluation .......................................................................................................................................................48 13......2.............................. 49 13................1........................ 42 11......................2.........................M..............1.................................. Training and Communication..............................................44 12............................................................................................ 42 11..........3.....................2....................................................................Safety & Quality Management System 11................................................... 53 Issue 2 / Revision 0 / 24. Control of Specifications / prescriptive Documents ....................................................................................................... 51 14.... Safety & Quality Promotion...... 48 13.................. Purpose of Management Evaluation..............1....... 50 14..... Friedli Page 8 of 53 .................... 47 12........................................... Initial Training ......... 43 12............. Abbreviations ......... Training & Education ............. 47 13........2.............................................02........ Definitions..................

2010 24.2010 24.06.2010 24.02. Record of Temporary Revision Issue Number Revision Effective Number Date Entered by Date Validity / Cancellation Removed by Date 0.1.02.2010 24.02.2010 24.02.02. The revision process is defined in 13. Record of Revision Issue Number 1 1 2 Revision Number 1 2 0 Effective Date 01.02.Safety & Quality Management System 0.02.2010 … Page Number Issue Number Revision Number Effective Date Issue 2 / Revision 0 / 24.1.1 "Revision Procedure of the Safety & Quality Manual. System of Amendment Note: If the SQMS-Manual is kept as a separate Manual (as recommended).2010 24. chapter 3.06.3." 0.2010 .2010 24.2010 24.1 "Revision Procedure of the Safety & Quality Manual.2.2009 24." Where as the amendment process is defined in OM A.1.02. chapter 0. the process for revision of the SQMS-Manual should be defined in chapter 13.M.2009 22.02. if this document is part of OM A.2010 Entered by Date 0. List of Effective Pages Page Number 1 2 3 4 5 6 7 8 9 … Issue Revision Number Number 2 2 2 2 2 2 2 2 2 … 0 0 0 0 0 0 0 0 0 … Effective Date 24.02.02. Friedli Page 9 of 53 .

observe all applicable legal requirements and international standards and best effective practices .035 (2. technical. Safety/Quality Policy.pdf  Reason's Decision Tree for Determining the Culpability of Unsafe Acts (Origin: Shell "Hearts & Minds") http://www. Friedli Page 10 of 53 .pdf Actions to take:  Describe the safety and quality policy.enforce safety as one primary responsibility of all managers .org/gain/just_culture. Doc. but in which they are also clear about where the line must be drawn between acceptable and unacceptable behavior Informed Culture Learning Culture Those who manage an operate the system have An organisation must possess the willingness current knowledge about the human.ensure that the policy is understood.org/gain/just_culture.02.achieve the highest safety standards .1 Relevant external Standards and 1.4 SQMS-Documentation. chapter 8. implemented and maintained at all levels.  The policy should ensure the following five aspects of a positive culture: Just Culture An atmosphere of trust in which people are encouraged (even rewarded) for providing essential safety-related information.4 Management Commitment and Responsibility  FOCA-Guideline SMS-001 Implementation of Safety-Management-Systems (SMS) including Annexes 3  Hudson's Refined Just Culture Model (Origin: Shell "Hearts & Minds") http://www.2010 . and the competence to draw the right conclusions organisational and environmental factors that From its safety information system and the determine the safety of the system as a Aspects of a will to implement major reforms whole positive Culture Reporting Culture An organisational climate in which people are prepared to report their errors and near-misses Flexible Culture A culture in which an organisation is able to reconfigure themselves in the face of high tempo operations or certain kinds of danger – often shifting from the conventional hierarchical mode to a flatter mode based on: Reason (1997): The components of safety culture Issue 2 / Revision 0 / 24. Organisation and Documentation 1.flightsafety.flightsafety.Safety & Quality Management System 1. But a Safety Management System will not provide any benefit if no positive Safety Culture is established.  A safety policy must include a commitment to .2) Guidance Material:  ICAO SMM.1. This policy must also express the commitment to the standards listed in 1.  Establishing a Safety Policy is quite an easy task compared to the establishment of a safety culture throughout the whole company.provide appropriate human and financial resources .1./2009).M. 9859 (2nd Ed. Safety and Quality Policy Requirements:  AMC OPS X.

where the definition and communication of annual goals are part of it.2.4)  EU-OPS 1. (2)  Appendix 1 to EU-OPS 1./2009).2.1.5) Issue 2 / Revision 0 / 24. In December. this chapter should refer to the relevant chapter in the Operations Manual.2010 .127. what. 9859 (2nd Ed.1. ….1.1)  FOCA Circular Advisories  … The provisions of ICAO Safety Management Manual (Document 9859) are considered.6 Appointment of Key Safety Personnel  To avoid redundancies and contradictions. Friedli Page 11 of 53 . Doc.035 (2.5 Safety Accountabilities & 8.Safety & Quality Management System 1. complies with the following legal requirements  EEC No 3922/91 Annex III amended (EU-OPS 1) / JAR-OPS 3  Leaflet No 44: JAR-OPS 1 Amt 13 section 2  JAR-FCL 1 / JAR-FCL 2  EC Regulation No 2042/2003 (EASA Part M)  Swiss Air Law  Verordnung über die Betriebsregeln im gewerbsmässigen Luftverkehr (VBR I.M.1.  It is recommended to synchronise the goal setting with the management evaluation (see chapter 10).  To be effective.4.02.005 (b) 1 Guidance Material:  ICAO SMM. until when?).2. the Accountable Manager fixes annual company goals and the budget based on the safety & quality policy and the yearly adjusted strategy. Relevant external Standards Example Ltd. …. Safety and Quality Objectives (Policy Deployment)  Define how the safety and quality policy is deployed within the company.  Small and very small organisations ( see AMC OPS X. 2. corporate goals should always be followed by an action plan (who. The company goals are the basis for the agreement of individual goals during the yearly employee's talk in January.2.2)): The post of the Accountable Manager and the Quality Manager may be combined  (see AMC OPS X. SR 748. chapter 8. Any kind of company specific standard of safety performance must respect the safety and quality policy statement… 1. Safety & Quality Management Organisation & Accountabilities Requirements:  AMC-OPS X.035 (2. Preferably this process should be combined with the business planning and steering process of the organisation.175 (1). 1.035 (7. 2.  The corporate commitment to safety from the highest organisational level is essential including the non punitive policy for disciplinary matters.

duties. the post of Quality Manager may be held by a nominated postholder if external auditors are used.M. At least the following QS and SMS related responsibilities and competences should also to be assigned in OM A.005 (b)1) 1.  He promotes corporate culture for safety and quality. accountabilities and authorities of managing staff such as  Accountable Manager (AM)  Nominated Postholder Flight Operations (PFO)  Nominated Postholder Ground Operations (PGO)  Nominated Postholder Crew Training (PCT)  Continuing Airworthiness Manager (CAM) are specified in the Operations Manual Part A. This applies also where the accountable manager is holding one or several of the nominated posts.XX.5 and 8. maintenance and performance of the AOC holders Safety and Quality System including the frequency. chapter 1.2010 .02. chapter 1. responsibilities. Friedli Page 12 of 53 . Organisation The company's organisational structure and the safety & quality system related roles.6) Accountable Manager:  He has full control of the financial resources required for the operations authorized to be conducted under the operations certificate  He has full control of the human resources required for the operations authorized to be conducted under the operations certificate  He has final authority over operations authorized to be conducted under the operations certificate  He has direct responsibility for the conduct of the organization’s affairs.Safety & Quality Management System  In the case of a very small operator. ( see Appendix 1 to EU-OPS 1. Issue 2 / Revision 0 / 24. to the Accountable Manger and the nominated Postholders (see AMCOPS X.  He has the ultimate responsibility and accountability for the implementation.  He has the ultimate responsibility to provide the necessary resources for the implementation of corrective actions. The respective definitions for  Safety Manager  Quality Manager  Flight Safety Manager see hereafter.035 and ICAO SMM chapters 8. format and structure of the internal management evaluation activities. It is strongly recommended to include the delegation of duties & responsibilities in case of absence and/or the designation of deputies.1. Note that the names of functions may vary if not specified by legislation.2.  He establishes and signs a formal written Safety & Quality Policy Statement.

including its programme. is integrated as a compliance monitoring system becoming an element of the management system of an organisation. According to EU-OPS 1 / JAR-OPS 3 the Q-Manager maintains a Quality Assurance Programme to ensure safe operation and airworthy aircrafts.2.2.  He establishes. Friedli Page 13 of 53 . by conducting and documenting monitoring activities such as inspections analysis of records. administration and maintenance of the effective SQMS:  He has direct access to the Accountable Manager and relevant managing staff. etc.Authority and Organisation Requirements .Safety & Quality Management System Nominated Postholders.M.  They ensure that documentation is processed.02.  They have the authority to resolve issues and take and implement action implement corrective and preventive actions within their department. implements. g. stored and filed according to the quality system requirements  They conduct periodically a data evaluation as an input to the management evaluation. In other words he is the Safety Assurance Manager! As a conclusion it would be possible to combine the functions of Safety Manager and Quality Manager. as known under the JAA system and in existing EASA Parts.2. maintains and further develops the SQMS on behalf of the Accountable Manager  He facilitates hazard identification and safety risk analysis and management  He monitors the implementation and effectiveness of corrective and preventive actions  He provides periodic data evaluation reports on the organisations safety and safety performance as an input to the management evaluation. if the function holder has specific know-how on both Safety & Risk Management and Quality Management. The next paragraphs distinguish the responsibilities of the Safety Manager and the Quality Manager.” A special emphasis has to be set on harmonising the responsibilities stated in 1.2 Safety Manager and 1.2. The management of this compliance monitoring system. The Safety Manager is the responsible and focal point for the development. But in the other parts of this document the functions are combined and the term Safety & Quality Manager is used.3 Quality Manager if the functions are assigned to two different persons.  They promote corporate culture for safety and quality. Safety Manager: Note: it is a matter of fact that the two sources of requirements (EU-OPS 1 / JAR-OPS 3 and ICAO SMM) are not (yet) harmonised. This statement is proposed by NPA 2008-22a .  He maintains records and safety documentation  He plans and organises staff safety training  He advices senior managers on safety matters and assists line managers  He oversees hazard identification systems  He is authorized to conduct safety audits of any aspect of the operation. 1.2010 .Explanatory Note & Appendices: “The Agency would like to emphasise that the quality system concept.  He is involved in occurrence / accident investigations  He monitors compliance Issue 2 / Revision 0 / 24. It is the operator’s decision to assign these functions to one or two persons. Continuing Airworthiness Manager:  They ensure safety performance monitoring in their field of activity e. is part of the responsibilities of the safety manager.

. are adequate and being carried out under the supervision of the relevant Nominated Postholder. Friedli Page 14 of 53 . maintenance.  He promotes corporate culture for safety and quality.Safety & Quality Management System    He monitors safety concerns in the aviation industry and their perceived impact in the organization’s operations aimed at service delivery He coordinates and communicates (on behalf of the Accountable Executive) on safety issues within the organization.4.02. and any additional requirements defined by the operator. any sub-contractor’s organisation. maintains and further develops the Quality Assurance Programme  He has access to all parts of the operator’s and. Issue 2 / Revision 0 / 24.2010 .3.M. crew training and ground operations. The safety review board should monitor:  safety performance against the safety policy and objectives.2. 1. and  the effectiveness of the safety supervision of contracted operations.035 and must be harmonised with the responsibilities of the Safety Manager)  He has direct access to the Accountable Manager.  He monitors the implementation and effectiveness of preventive and corrective action through the follow-up process.  He verifies by monitoring activity in the fields of flight operations. implements. It ensures that appropriate resources are allocated to achieve the established safety performance and gives strategic direction to the safety action group. For this purpose he plans and ensures the implementation of the quality assurance activities.  He conducts periodically a data evaluation as an input to the management evaluation.2. external agencies. contractors and stakeholders as appropriate He promotes corporate culture for safety and quality. 1. as well as with the National Authority. Safety Review Board  ICAO SMM chapter 8.  He establishes.6. that the standards required by the Authority. as necessary.6 Note: In small organisations the responsibilities of the Safety Review Board may be assigned to the management meeting (e. g.  He provides management with an independent assessment of corrective action. Quality Manager: (Note: subsequent list of responsibilities bases on AMC-OPS X. postholder meeting) The Safety review board is a high level committee that considers strategic safety functions.  the effectiveness of the SMS implementation plan. It is chaired by the accountable manager and be composed of the nominated Postholders and the Safety & Quality Manager. implementation and completion.

6.5. Flight Safety Officer FSO  He is responsible fort he implementation and maintenance of the accident prevention and flight safety program as defined in OM A chapter XX  He implements corrective actions. supervisors and staff from operational areas.6. The members are:  Safety & Quality Manager (Chairman)  ….M. mitigation and maintenance of risks to or below acceptable levels  monitors the compliance.  He conducts periodically a data evaluation as an input to the management evaluation. Friedli Page 15 of 53 .  He promotes corporate culture for safety and quality.2010 . proactive and predictive analysis of hazards and assessment of their risks  ensures eradication.035 (2.4 SQMS-Documentation  ensures systematic implementation and monitoring of corrective actions  ensures an evaluation of the overall effectiveness of the organisation to achieve stated objectives to ensure continuous improvement Issue 2 / Revision 0 / 24. relevant functions to be listed The safety action group must:  oversee operational safety  resolve identified risks  assess the impact on safety of operational changes  implement corrective action plans and  ensure that corrective action is achieved within agreed timescales. It comprises of managers. Purpose of the Safety & Quality Management System  AMC OPS X. standards and procedures for flight and ground operations. postholder meeting) The safety action group reports to and take strategic direction from the safety review board. 1.Safety & Quality Management System 1.3) The Safety & Quality Management System of EXAMPLE Ltd:  ensures a high awareness of the employees with regard to safety  ensures pro-active gathering of safety relevant data  ensures a systematic recording and analysis of any kind of feedback incl. g.2. training and the continuing airworthiness management of the aircrafts (as listed in chapter 1.2. 1.3.1. effectiveness and efficiency of company specific and safety related policies. The safety action group must review the effectiveness of previous safety recommendations and safety promotion.1 Relevant external Standards and 1.02. occurrences and latent conditions  ensures reactive.8 Note: In small organisations the responsibilities of the Safety Review Board may be assigned to the management meeting (e. Safety Action Group  ICAO SMM chapter 8. implementation.

proactively and reactively manage the risks and to ensure the compliance with and the appropriateness of the company specific manuals.Safety & Quality Management System 1.4. B. preventive actions Recording occurences & hazards Data Evaluation & RiskAssessment Legal Legal RequireRequirements ments Operation / /Maintenance Operation Maintenance Incidents. set up the manuals listed below. accidents. non-compliances.02. Overview over the EXAMPLE Ltd. 1 Issue 2 / Revision 0 / 24.' Safety & Quality Management System S&Q-Manager Safety & Quality Policy Objectives. irregularities & potential hazards Fulfilment Fulfilment of legal reof legal requirements quirements Core Elements: Element of SQMS Policy Strategy Resources Annual Goals Responsible AM AM Explanation    commitment to safety and quality rework of strategy based on management evaluation and company environment definition of annual goals including measurable safety indicators Reference SQMS ch. 1 & OM A ch.2010 .4. 1. non-conformities.  Operations Manual A. SQMS-Documentation Example Ltd. Safety Indicators.M.1. Friedli Page 16 of 53 . Resources Management Evaluation mo nit or i ng /o ve rs igh t Analysing occurences & hazards Corrective. The application and implementation of those documents contribute to ensure safe operation and airworthy aircrafts. C and D  Continuing Airworthiness Management Exposition CAME  Cabin Safety Procedure Manual  Emergency & Accident Handling Manual  … The SQMS itself enables the company to predictively. 3 SQMS ch.

7 SQMS ch.  authorization by key personnel for actions contained in the plan.make safety recommendations .determine root causes.  coordination of efforts to cope with the emergency.  assignment of emergency responsibilities. 7. 3 SQMS ch. 6. 11 Ensuring that there is  orderly and efficient transition from normal to emergency operations.02. collation and evaluation of data in the specific field of activity to identify trends and systematic gaps. 5. Surveys and Investigations All Employees   Appointed Teams / Managing staff Audits S&QM Auditors Postholders FSO S&QM AM Postholders FSO S&QM Managing staff   Inspections Data evaluation       Risk management Controlling / Management Evaluation Emergency and Response Plan Accountable Manager (in collaboration with PH.Safety & Quality Management System Element of SQMS Operations Responsible PH Flt Ops PH CT PH Gnd Ops CAM FSO Explanation   defining of internal safety standards Reference OM A to D CAME & … SQMS ch. 5     Feedback & Reporting Safety Studies. risk mitigation and communication evaluation of overall effectiveness of organisation and achievement of goals / safety indicators based on data evaluation SQMS ch. Friedli Page 17 of 53 .2010 . etc to . 4 SQMS ch. SQMS ch. 4. nonconformities and (potential) hazards incl. Reviews. CAM.thereby prevent accidents independent auditors monitor the adherence to standards and requirements by means of audits line superiors or supervisors monitor the adherence to internal standards and requirements during daily business by means of inspections. OM A ch. 8 SQMS ch. 8 SQMS ch. 9 SQMS ch.identify hazards . Risk-Assessment analysis of situations. 10 Issue 2 / Revision 0 / 24.implement mitigation actions and . 4. and  safe continuation of operations or return to normal operations as soon as possible. 5 SQMS ch. 6 SQMS ch. conditions.  delegation of emergency authority. S&QManager and FSO) Accountable Manager ensuring conformity with internal standards and requirements by means of controlling and supervision (inspections!) of the daily activities analysis of feedback & reports Flight data monitoring supervision of relevant subcontractors initiation and monitoring of implemented actions identification and reporting of divergences. assessment of risks based on likelihood and severity.M. . 11 SQMS ch. drawing conclusions resulting form the data evaluation identification of hazards.

or EASArequirements provides important elements of a Safety Management System such as auditing.035 must be considered as part of an effective Safety Management System.035 are covered.2. surveys.035 training & promotion.200 Management System Therefore Q-System according to EU-OPS 1. Risk Management)  focuses on safety assurance  focuses on safety promotion System to establish policy and objectives and to achieve those objectives NOTE: A management system of an organization can include different management systems.GEN. feedback & reporting and data evaluation.02. Legal & normative Basis / Guidance Material ISO 9001 Quality Management EU-OPS 1. Friedli Page 18 of 53 . a financial management system or an environmental management system. As we talk about a Safety Management System automatically all the Safety Assurance activities as defined in Q-Systems in Aviation are included.035 JAR-OPS 3.M. explicit and comprehensive process for managing safety risk in order to achieve acceptable or tolerable safety Ensuring safe production and service delivery by corporate approach in which the risk of harm to persons. For practical reasons it is recommended to talk about a Safety and Quality Management System to emphasise that all requirements coming from ICAO SMM and OPS x.1. Introduction to Safety & Risk Management 2.2010 . Distinction between Quality Management and Safety Management Systems It is of vital importance to realise the difference between the following management systems: System Quality Management System (Quality System)  general term! Quality System for Operators  Aviation! Safety Management System  general term! Purpose Ensuring the fulfilment of customer requirements and product / service related legal requirements  focus is product/service quality Ensuring safe operations and airworthy aircrafts  focuses on safety  mainly focuses on safety assurance activities A systematic.035 / JAR-OPS 3. to ICAO Safety Management Manual Q-System acc. such as a quality management system. investigations.  focuses on safety achievement (incl. Safety Management System acc.035 EASA Part M A.712 ISO 31000 RiskManagement In Aviation: ICAO Safety Management Manual Management System  general term! In Aviation: NPA 2008-22c Organisation Requirements: OR. etc must be developed. environment and damage is limited to an acceptable level. Issue 2 / Revision 0 / 24. a safety management system. But many other important elements such as risk-management. to OPS x. Relation between Safety Management System and Q-Systems in Aviation The following picture reflects that the classical Quality System according to JAR. 2.Safety & Quality Management System 2.

Friedli. Friedli Page 19 of 53 . Safety Risk Management Describe System Potential New Hazard Ineffective Control Safety Assurance Preventive / Corrective Action non-conformance Identify Hazards conformance Analyse Safety Risks Analysis of Data Assess Safety Risks Continuous Monitoring Feedback & Reporting Auditing Investigations Information Acquisition acceptable unacceptable Operation / Maintenance Control Safety Risk (Mitigation) based on: FAA Advisory Circular 120-92 2.Safety & Quality Management System 2. PROCEDE Existing fences Further mitigation new fences Risk Issue 2 / Revision 0 / 24.M.4. Mitigation / Reduction of Risks The core question to answer is: Can we accept the residual risks? m/c syste any omp Hazard Risk limit e of th monitoring Verification of effectiveness Risk accept (ALARP*) monitoring reduce *ALARP = as low as reasonably practicable By M.02. Relation between Risk-Management and Assurance Activities Risk-Management and Safety Assurance activities are both very important elements of a Safety Management System.2010 .3.

Pro-active Safety Management  Based on mandatory and voluntary reporting systems.035 / JAR-OPS 3. Analysis of occurrence reports 2. 2.Safety & Quality Management System 2.3. Friedli Page 20 of 53 .2010 . Paradigm Change  Today’s quality systems according to EU-OPS 1.5. Reactive Safety Management  Based on Investigation of accidents and serious incidents  Based upon the notion of waiting until something breaks  Important is that also triggering causes and contributory factors to risks are identified  Analysis of “what happened and why?”  e. Those systems must be further developed to be more proactive and even predictive.5.M. A Safety Management System will develop according different maturity levels from  reactive Safety Management over  pro-active Safety Management to  predictive Safety Management and  finally generative Safety Management 2. safety audits.5.02. Predictive Safety Management  Aggressively seeking information from variety of sources which may be indicative of emerging safety risks  Based upon the notion that we have to look for trouble and not to wait for it. inspections and surveys  Based upon the notion that failures can be minimised by identifying safety risk within a system before it fails and that necessary actions can be taken to reduce such risks  Analysis of “what happens and why?”  Risk-Analysis of already implemented procedures before incidents occur. g.1.2.  Analysis of “what could happen and why?”  Risk-Analysis of new procedure before implementation Issue 2 / Revision 0 / 24.035 consist of proactive and reactive quality assurance activities.5.

Doc. Levels of Risk Management In EXAMPLE Ltd. analysis and elimination (and/or mitigation to an acceptable or tolerable level) of hazards. Risk-based decisions during daily business.1. 9859 (2nd Ed. Doc.M. … Awareness of employees to identify hazards and to act according the risk. The Internal Control System acc. chapter 3 “Introduction to Safety Management”  ICAO SMM. Prioritisation of reports for further investigation and follow up.Safety & Quality Management System 3. 9859 (2nd Ed./2009).balance sheet total > 10 Mio. we conduct risk management on the following levels to identify hazards and initiate respective mitigation actions: Level Strategic / corporate level Projects & Change Management Purpose Company wide identification of hazards and assessment of risks. Process Company risk assessment Project risk assessment Supplier risk assessment Document control Feedback & Reporting … Daily operation Feedback & Reporting … Monitoring of safety relevant services / products * Note: With this approach we also comply with the Swiss Legislation. 9859 (2nd Ed. 663b OR.organisations fulfilling at least two of the three criteria: . Risk Management Guidance Material:  ICAO SMM. as well as the subsequent risks.quoted on the stock exchange . Friedli Page 21 of 53 .* Identification of hazards and assessment of risk in case of  Implementation of new or modification of processes / procedures  contracting new providers  implementation of new or modification of tools  implementation of new or modification of aircrafts etc./2009)./2009). Doc.2010 .more than 50 employees. 728b OR and to disclose the results of risk assessments carried out in compliance with amended Art. which compels companies to introduce an Internal Control System for financial reporting pursuant to Art. chapter 4 “Hazards”  ICAO SMM./2009). 3. CHF Issue 2 / Revision 0 / 24. to Swiss OR is relevant to companies fulfilling the following criteria: . . 9859 (2nd Ed. Doc. that threaten the viability of an organisation.turnover > 20 Mio. Incoming feedback undergoes a risk-assessment.02. 728a OR and Art. chapter 6 “ICAO Safety Management SARPs”  The subsequent samples should be further developed based on the information given in the ICAO document Risk management is the identification. CHF . chapter 5 “Safety Risks”  ICAO SMM.

4..M. Safety Performance Indicator)   Monitor realisation AND effectiveness.2  acc. to chapter 9. based on measurement criteria  Initiate further mitigation activities if necessary ensure permanent record of:  final results of the safety assessment.Safety & Quality Management System The subsequent process is applied on all these levels: 3.  the arguments and evidence demonstrating that the risks have been eliminated.g.4.02.1  acc.2.3. to chapter 3.4  acc. initiate investigation  Use classification of severity  Use classification of probability  Use risk classification scheme  is risk unacceptable / tolerable / acceptable?  define action and action plan  Re-evaluate risk: is risk "as low as reasonably practicable (ALARP) "?  is risk tolerable?  if no: abandon project  assign responsible person and fix due date(s)  define measurement criteria for effectiveness (evtl. Hazard Identification and Risk Assessment Process Step Describe system to be evaluated Identify hazards Remarks  purpose of the system  system's boundaries and the external interfaces  the environment in which the system will operate possible sources might be:  equipment (hard. or have been adequately controlled and reduced to a tolerable level Tool  …  SHEL-Model  Concept according to James Reason (acc.3) Assess severity / consequences Assess probability Evaluate risk Decide upon acceptance Define mitigation activities Implement mitigation activities Monitor implementation Finalise documentation   Tool….  … Issue 2 / Revision 0 / 24. to chapter 3.3. Friedli Page 22 of 53 .2010 .3  …  Bow-Tie-Model (see chapter 9.2)  acc. to chapter 3.and software)  operating environment (e. airspace and air route design)  human operators  human/machine interface  operational procedures  maintenance procedures and  external services  evtl. physical conditions. to chapter 9.3.

9859 (2nd Ed.Safety & Quality Management System 3. chapter 5.5 3.2010 . Classification of Risks Risk Severity Catastrophic A Hazardous B unacceptable unacceptable tolerable tolerable acceptable Major C unacceptable tolerable tolerable tolerable acceptable Minor D tolerable tolerable tolerable acceptable acceptable Negligible E tolerable tolerable acceptable acceptable acceptable Risk Probability of Occurrence Frequent 5 unacceptable unacceptable unacceptable tolerable acceptable Occasional 4 Remote 3 Improbable 2 Extremely Improbable 1 according to ICAO SMM./2009)./2009). Doc.3. chapter 5. Doc.3. 9859 (2nd Ed./2009). chapter 5.3.M. Classification of Severity Class People A B C D E Catastrophic Hazardous Major Minor Negligible  Multiple deaths  Serious injury  …  …  … Interpretation / Impact on … Assets  Equipment destroyed  Major equipment damage  …  …  … Environment  …  …  …  …  … Note: interpretation aids may be found in ICAO SMM. Friedli Page 23 of 53 . Doc.2.3.6 Issue 2 / Revision 0 / 24.02. 9859 (2nd Ed.3. Classification of Risks The risk is the factor resulting from severity and likelihood: Risk = severity x likelihood 3.1. Classification of Probability Class Qualitatively 5 4 3 2 1 Frequent Occasional Remote Improbable Extremely Improbable  …  …  …  …  Should never occur in whole fleet life Interpretation Quantitatively  1 to 10-3 per flight hour  …  …  …  <10-9 per flight hour Note: interpretation aids may be found in ICAO SMM.5 3.

1000 1000 . mitigated or eliminated to finally increase our level of safety. 4.  Make reference to Operations Manual Part A chapter 11.  other aviation personnel could learn from the report. Hazards and incidents shall be reported if it is believed that:  something can be done to improve safety.100 Accidents Serious Incidents Incidents Latent conditions 100 . Feedback & Reporting Requirements:  AMC OPS X. threats and latent conditions even if they didn't lead to an incident or accident: 1-5 30 .037 (a)(2) and IEM OPS 1. failures. "Effective Safety Reporting" and 9. or  the system and its inherent defences did not work as expected.2)  ACJ OPS 1.02. Friedli Page 24 of 53 . The procedures listed below reflect how such processes could be documented. 9859 (2nd Ed.5 “Hazard Reporting” Actions to take:  Specify the company specific processes to gather and treat employees' feedback.1.M. deviations./2009).8.   If in doubt  report it! Issue 2 / Revision 0 / 24.2. Handling of accidents and occurrences.2010 .Safety & Quality Management System 4.037  Directive 2003/42/EC on Occurrence Reporting in Civil Aviation Guidance Material:  ICAO SMM. Importance of Feedback & Reporting Today we are used to share the lessons learned from incidents and accidents. Doc. chapter 2.6.4000 Any hazard that has the potential to cause damage or injury or that threatens the viability of our organisation has to be reported to get analysed. But there is also a high potential to learn out of errors.035 (3.

M. initiate investigation initiate preventive or corrective action (who.4.3) FSO Analyse situation Initiate actions       Safety Report Monitoring  Model acc.4) … Monitor realisation of action Close action Monitor effectiveness of action   close measure on “Safety Report Monitoring”  during spot checks / inspections or audits and / or measurement criteria (SPI)  Is the improvement sustainable?  Did we get the attained success?  Safety Report Monitoring  Safety Report Monitoring  Safety Report Monitoring … … … 4. to James Reason (see chapter 9.2. Kind of Reports 4.2010 .2. due date)  define measurement criteria (evtl.Safety & Quality Management System 4. Flight Crew Reports FCR Step Establish report Sort and assign report Analyse situation Initiate action Remarks  …  …  analyse root cause(s) and human factor(s)  initiate preventive or corrective action (who. Air Safety Reports Step Establish report Remarks        describe the situation use the designated forms describe (potential) hazard give feedback to the issuer assess the risk assign responsible manager to realise action within 24 h open item on “Safety Report Monitoring Tool” ensure reporting to FOCA within xxx hours analyse root cause(s) and human factor(s) Evtl.2. Friedli Page 25 of 53 . due date) define measurement criteria (evtl.2)  Investigations (see chapter 9. what.4.1. to James Reason (see chapter 9. SPI) to evaluate effectiveness Tool  … Responsibility Pilot Sort and assign report  Safety Report Monitoring  Risk-Management (chapter 3.02.2)  Safety Report Monitoring  … Responsibility Pilot … … Monitor realisation of action Close action … … Issue 2 / Revision 0 / 24. what. SPI) to evaluate effectiveness  …  … Tool  FCR-Form  Safety Report Monitoring  Safety Report Monitoring  Model acc.2.

2.4)  …  …  … … Monitor realisation of action Close action Monitor effectiveness of action … … … 4.2.4.3. XY… Report Step Establish report Sort and assign report … Remarks  …  …  … Tool  …  …  … Responsibility … … … Issue 2 / Revision 0 / 24.2010 . SPI) to evaluate effectiveness  …  …  … Tool  CCR-Form  Safety Report Monitoring Responsibility Pilot FSO Analyse situation Initiate action  Safety Report Monitoring  Model acc. what. to James Reason (see chapter 9. to chapter 3 Risk-Management)  neutralise report  assign responsible manager to realise action  open item on “Safety Report Monitoring Tool”  analyse root cause(s) and human factor(s)  initiate preventive or corrective action (who. Friedli Page 26 of 53 .M.4. initiate investigation  define measurement criteria (evtl.02.Safety & Quality Management System Step Monitor effectiveness of action Remarks  during spot checks / inspections or audits and / or measurement criteria (SPI)  Is the improvement sustainable?  Did we get the attained success? Tool  … Responsibility … 4. due date)  evtl. Confidential Crew Reports CCR Step Establish report Sort and assign report Remarks  …  give feedback to the issuer  assess the risk (acc.2)  Investigations (see chapter 9.

Doc.035 (4. Friedli Page 27 of 53 .2. As a minimum./2009). This as part of their managing function and responsibility. internal inspectors have to observe particular events / actions / documents in order to verify whether established operational procedures and requirements are followed and the required standards are achieved. 4. Inspections Requirements:  AMC OPS X. Note: inspections are just one way to monitor the effectiveness and implementation of procedures. By respecting the inspection procedure. due date)  define measurement criteria (evtl.02. 5. to get the confidence that the implemented processes including controls are effective and performing. Or in other words. 9859 (2nd Ed. If deficiencies have been identified:  Assess the risk  analyse root cause(s) and human factor(s)  initiate preventive or corrective action (who.5 Safety Assurance and chapter 9.1.6 Safety Performance Monitoring and Measurement Actions to take:  Define a concept reflecting the monitoring activities of line superiors including the respective frequencies and kind of recording. what. chapter 9. SPI) to evaluate effectiveness initiate preventive and/or corrective action  verify implementation and effectiveness of action  performed inspections are recorded on list of inspections to ensure coverage of all scopes Tool … Responsibility … Execution Initiation of action … Risk-Management (chapter 3.M.Safety & Quality Management System 5.3) List of pending items … … Monitoring Reporting … List of inspections performed … … Issue 2 / Revision 0 / 24. the inspection results as well as corrective actions resulting from inspections have to be documented Step Planning & Preparation Remarks  ad hoc planning  study relevant procedures  consider feedback & reporting system  …. Inspection Procedure  Specify the company specific process to conduct inspections.8) Guidance Material:  ICAO SMM.2010 .

Qualification of internal Inspectors  Define the minimum requirements of qualification for internal inspectors. i. if it is established based on the results of the management evaluation (risk oriented approach) Area Flight Ops topics  Operational Flight Plan  Mass & Balance  Duty time  LPC / OPC / Line Check Frequency (at least) Tools / Kind of record Responsib.  Note that contracted inspectors fall under the same category. the nominated Postholders. ………………. Inspection Scopes  Typical examples of scopes are defined in AMC OPS X. List of internal Inspectors  It is recommended to refer to the respective functions according to the organisational chart or to refer to a separate list. 5.02.2.4.2010 .2. fulfil at least the following qualification criteria:  operational and maintenance know-ledge  …  … 5. Friedli Page 28 of 53 . and the Safety. to OM ….035 (4.       … … … … … …       Checklist xy … … … … … Ground Ops Crew Training       Documents on aircraft Flight Support Services Load Control … Training Standards Training Records … … … … … … … …  Validity of ratings & licences  …  Weekly  …  None (IT-Tool)  … Issue 2 / Revision 0 / 24.& Quality Manager perform or delegate inspections in their field of activity to monitor the compliance with and appropriateness of internal standards.Safety & Quality Management System 5.3.M. … … …  Each document  Visa on document  …  …  list of inspections  monthly performed   Acc.)  The Accountable Manager. The inspectors of EXAMPLE Ltd.2)  Safety critical activities (according their priority set in the risk assessment) should be inspected / monitored therefore the subsequent list should be supplemented / specified according the risk assessment  Specify inspection scopes and define minimum frequency using the matrix below or refer to this list of inspections scopes. (Changes of inspectors would lead to an amendment of the S&Q-Manual if the list would be part of it.e. the same qualification requirements and shall also be put on the List of internal Inspectors.

6 Safety Performance Monitoring and Measurement Note: According to ICAO SMM.035.8) Guidance Material:  ICAO SMM. Friedli Page 29 of 53 . compliance with approved procedures and instructions. Doc. 9859 (2nd Ed. Even if the focus is set on compliance a qualified auditor never will limit his activities on this issue. procedures required to ensure safe operational practices and airworthy aeroplanes. they continue to perform and are effective in maintaining continuing operational safety Safety audits should go beyond just checking compliance with regulatory requirements and conformance with the organisation's standards. While internal audits are often thought of as a test or “grading” of an organization’s activities. they are an essential tool for safety assurance. activities and resources of line units. Issue 2 / Revision 0 / 24. chapter 9. 6. the intention of Quality Audits is to monitor the compliance with. According to AMC OPS X.Safety & Quality Management System Area Continuing Airworthiness Management topics  Maintenance Interface  Technical Standards  Hard-/Software up-date of Electronic Flight Bag System  …  Frequency (at least)  …  …  … Tools / Kind of record  …  …  … Responsib. 9859. and the adequacy of.02. once safety risk controls have been implemented. His responsibility is to identify any kind of potential for improvement.  are used to ensure that the structure of the SMS is sound in terms of staffing. Audits  focus on the integrity of the organization’s SMS and periodically assess the status of safety risk controls. The auditor should assess whether the procedures in use are appropriate and whether there are any work practices that could have unforeseen safety consequences. levels of competency and training to operate equipment and facilities and maintain required levels of performance./2009). to help managers in charge of activities supporting the delivery of services to control that. … … …  …   …  … … ….5 Safety Assurance and chapter 9.2010 . Doc.035 (4. etc. Audits Requirements:  AMC OPS X.M.3 to 4.  are not intended to be in-depth audits of the technical processes but rather they are intended to provide assurance of the safety management functions.

changes in the organisation .. Therefore there is no need to make any difference between these two kinds of audits. 6. Step Planning Remarks  establish audit plan in December  consider former . former audit reports. SPI) to evaluate effectiveness  verify implementation of measure  …  … OM CAME S&Q-Manual List of pending items Audit checklist Audit checklist Auditor … Tool "audit report" List of pending items classification of findings see 6. .changes in regulatory requiremts.5 … … … … … … … Issue 2 / Revision 0 / 24.M.trends  follow-up audits when necessary  all aspects/scopes at least 1x within 12 months  assign auditor(s): consider independence & qualification  study relevant procedures  consider feedback & reporting system. Friedli Page 30 of 53 .& Quality Manager SQM Preparation Execution Reporting Initiation of action Monitoring of implementation Monitoring of effectiveness .changes in the activities . Audit Procedure  Specify the company specific process  Remark: It is strongly recommended that the audit plan is not a part of the Q-System.examination of records .review of documents  Establish audit report  Store report at … If deficiencies have been identified:  Assess the risks and classify finding  analyse root cause(s) and human factor(s)  initiate preventive or corrective action (who.witnessing of activities .1.interviews .. former actions Tool Audit plan List of auditors Responsibility Safety.audit plan .Safety & Quality Management System Conclusion: Safety Audits and Quality Audits (as required by AMC-OPS X.02. but is published as a separate document that can be up-dated easily without submission to the Authority. what.2010 . due date)  define measurement criteria (evtl.  by means of different techniques: . Essential is that competent auditors are in charge.035) almost have the same purpose and monitor the same activities.

But in future it would make sense to use the same philosophy and approach to classify findings as defined in 3. Classification of Audit Findings Note: Today operators have to comply with EASA Part M 716.873 (d):  consider Electronic Flight Bag: TGL 36 The audit scopes are defined in the audit plan. Friedli Page 31 of 53 .4.M.02.3 Classification of Risks Findings resulting from audits have to be classified according EASA Part M (M.3 Risk-Management) Level 2: Safety might be affected  to be closed within due date (max. safety might be affected…).3 Risk-Management)  Issue 2 / Revision 0 / 24. which is maintained as a separate document to ensure the flexibility for recording audits performed and for scheduling additional audits.6).  consider Navigation Data: TGL 10 (10. 2 months)  corresponds level “tolerable” (see chapter 3.035 (4. Audit Scopes  Minimum scopes to be monitored are given in AMC OPS X. 716):  Level 1: Safety is affected  no further operation / activity until closure of finding  corresponds level “unacceptable” (see chapter 3. 6.3.2. List of internal Auditors Refer to separate list of auditors to ensure flexibility and to avoid amendment of the Quality System in case of changes in the auditors' team.  The auditors (including their scopes of activity) are listed by name on the audit plan. Qualification of Auditors  Define the minimum requirements of qualification for Auditors.5. A.6) and OPS 1. fulfil at least the following qualification criteria:  operational and maintenance know-ledge  attended an specific auditors course  …  … 6.2010 . which requests a kind of risk-assessment (safety affected. The internal auditors of EXAMPLE Ltd. 6.Safety & Quality Management System 6.

…) . Where corrective and/or preventive actions become necessary they shall be processed as defined for audits. Friedli Page 32 of 53 .if not in budget: .035 (5)  OPS 1. That’s why an initial risk assessment should be conducted The most important prerequisite for a subcontractor / supplier evaluation is a clear definition of the (safety and quality) relevant requirements.  Written agreements should be established according to AMC OPS X.873 (a) and 1.submit Accountable Manager  criteria (safety. Step Definition of requirements Remarks  define standards of performance  above CHF 1’000.6) regarding Navigation Data Base  Airplane Operators: See FOCA Flight Ops Directive OD O-004 SFI “Ground Inspections” (16.2. inspections or feedback & reporting. Supervision of Subcontractors / Suppliers  The monitoring concept of Subcontractors should consider risk assessment of providers.04. What is defined in such a table should be reflected in the audit / inspection plan where applicable. Subcontractor / Supplier Management Requirements:  AMC OPS X. showing service/product.Safety & Quality Management System 7.  the subsequent matrix reflects POSSIBLE approaches to supervise subcontractors.2)  New providers can lead to new risks. Evaluation of Subcontractors / Suppliers  The evaluation before ordering is not a requirement but strongly recommended.873 (d) as well as TGL 10 (10.02.1.written form . frequency of supervision (initial and repetitive) and responsibility. Therefore written agreements that include the quality and safety requirements to be delivered have to be established. kind of supervision. Issue 2 / Revision 0 / 24.035 (5.2010 .  Guidance Material for supplier risk assessment can be requested from FOCA SBAU  All subcontracted services should be deployed in a table. quality.2008) 7.…. Each operator must tailor this concept to his complexity and risk of operation.1. Companies providing scheduled flights must consider FOCA Flight Ops Directive OD O-004 SFI “Ground Inspections”.  …  …  …  …  … Tool … Responsibility … Assess the risks Call for bids Contract review Sign contract … Supplier risk analysis … … … … … … … … … 7.M..

to risk assessment … … … … … … … Pilot PH Gnd Ops … Pilot Dispatch / Pilot PH Gnd Ops … … … Pilot PH Gnd Ops … … CAM Pilot PH Gnd Ops Pilot PH Flt Ops Pilot … Ground Handling  supervision of ground handling activities  sample checks (inspections) by crew based on checklist provided by dispatch  risk assessment  audit*      … … Monitoring by crew according OM A part 8. to risk assessment … … Supplier Risk Assessement Acc. providers are monitored by the following means.Safety & Quality Management System The safety related activities of EXAMPLE Ltd.2  Occurrence report in case of occurrences  risk assessment  audit* of fuel providers - CAM Supplier Risk Assessment Acc. to risk assessment Each flight … Supplier Risk Assessement Acc. These are the general monitoring activities. The monitoring concept is specifically tailored for subcontractors based on a risk assessment ( risk assessment tool for subcontractors).2010 . Friedli Page 33 of 53 .02.2 Occurrence report in case of occurrences risk assessment De-/Anti-Icing  audit* of de-/anti-icing providers Flight Support Navigation Data Providers Flight Performance Data Provider Providers of data for take-off performance calculation Flight Operations / Wet lease        … Availability of Letter of Acceptance Occurrence report in case of occurrences Comparison of delivered product with order Occurrence report in case of occurrences Comparison of delivered product with order Occurrence report in case of occurrences  … Issue 2 / Revision 0 / 24.M. to risk assessment Each training Responsibility PH CT PH CT Participants Maintenance Fuelling  supervision of maintenance according continuing airworthiness management exposition came  fuel check according OM A part 8. Service / Product Training Kind of supervision  ensuring the validity of necessary approval (JAR-FCL 1/2 and JAR-FSTD …)  inspection of training provided  trainee's feedback report  treatment of feedback according feedback & reporting Frequency … Acc.

Flight Data Monitoring  Flight Data Monitoring is requested by EU-OPS 1. To monitor the implementation the corrective measure is tracked on the list of pending items.1. Friedli Page 34 of 53 . Safety arguments based on isolated occurrences and anecdotal information may not be enough. Because of their nature. Safety Study Procedure Step Identify the need for Safety Study Plan Safety Study Remarks  Conclude order to Safety Action Group  define & assign activities  define need for the assistance of specialists  …  Identify safety deficiencies If deficiencies have been identified:  Assess the risks  analyse root cause(s) and human factor(s)  initiate preventive or corrective action (who. safety studies are more appropriate to address system safety deficiencies rather than identify specific. and which may have been addressed on an industry.10 “Safety Studies" Safety studies are a source of information on generic safety concerns and/or systemic safety deficiencies. Reviews. An organization might experience a safety concern which is of a global nature.1. Doc. individual hazards. due date)  define measurement criteria (evtl. 9./2009).2010 . what. 8. 9. to chapter 3. Some pervasive safety issues can best be understood through an examination in the broadest possible context. Surveys and Investigations 9.it also may be integrated in the Quality System. 9859 (2nd Ed. the preventive or corrective measure is submitted to the supplier in written form. *The relevant Postholder in collaboration with the Safety & Quality-Manager decides about the necessity for the conduction of a supplier audit in case of negative trends. Safety Studies Guidance Material:  ICAO SMM.  Flight Data Monitoring is an important information acquisition to identify (potential) hazards.037 (a) . Tool … … Responsibility Safety Review Board Safety Action Group SAG SAG SAG … Conduct Study Evaluate and conclude results Initiation of actions … … Acc. Safety Studies.or State-wide scale.1.02.6.2 Tool… Issue 2 / Revision 0 / 24. chapter 9.037a (4) for airplanes in excess of 27'000kg maximum take-off weight.  It usually is laid down in OM A chapter 2 but – according to EU-OPS 1. Safety studies are rather large analyses encompassing broad safety concerns.M.Safety & Quality Management System If there is a need for action.

2010 .2. Doc. Friedli Page 35 of 53 . SPI) to evaluate effectiveness  … Tool … … … … Responsibility … … … … 9. 9859 (2nd Ed. or in situations of a structural change in operations.6.Safety & Quality Management System Step Implement actions Monitoring of implementation Monitoring of effectiveness … Remarks SPI) to evaluate effectiveness   verify implementation of measure  based on measurement criteria (evtl. by providing a roadmap to safe and effective change. by allocating importance and urgency to each hazard. The mitigation will be appropriate if it actually addresses the hazard.M. Safety reviews ensure safety performance during periods of change.02. change or implementation of procedures. Issue 2 / Revision 0 / 24. The mitigation will be effective if it consistently manages the safety risks under normal operating conditions in order to reduce the safety risks to ALARP./2009). Safety reviews are conducted during introduction and deployment of new technologies. Safety Reviews Guidance Material:  ICAO SMM. The SAG also proposes a prioritization of the responses/mitigations.11 “Safety Reviews" Safety reviews are linked to the management of change and ensure safety performance under changing operational conditions. chapter 9.

2010 .abnormal operations  conduct risk-assessment  analyse root causes and human factors  initiate preventive or corrective action (who.2 … Safety Action Group … Implement action Monitor implementation and effectiveness … … … … Line manager Safety Action Group Safety Action Group 9.management accountabilities .3. Since surveys are subjective.1. 9859 (2nd Ed.M.safety measurement . questionnaires and informal confidential interviews. Safety Review Procedure Step Remarks Define Objective  define objective that is linked to the change under consideration ( e.6. such as problem areas or bottlenecks in daily operations.14 “Safety Surveys" Safety surveys examine particular elements or procedures of a specific operation.2./2009).02. g. what.operational personnel skills .hazard identification and safety risk assessment/mitigation . due date)  define measurement criteria (evtl. verification may be needed before corrective action can be taken.technical systems . SPI) to evaluate effectiveness  …  assess the appropriateness and effectiveness of the mitigations  … Tool … Responsibility Safety Action Group Review performance of activity … Safety Action Group produce a list of hazard concerns initiate mitigation activities According to chapter 3.Safety & Quality Management System 9. Friedli Page 36 of 53 . Issue 2 / Revision 0 / 24. chapter 9. Safety Survey Guidance Material:  ICAO SMM. evaluating the appropriateness and effectiveness of the safety management activities related to a project)  look for effective performance of the safety management activities under the proposed changes such as: . Safety surveys may involve the use of checklists. Surveys may provide an inexpensive source of significant safety information. assess the safety risks associated with the change. perceptions and opinions of operational personnel and areas of dissent or confusion. Doc.

15 Safety Investigations" Investigations include the gathering and analysis of information.2 Investigation concept acc.Safety & Quality Management System 9.4. Doc.1./2009). Friedli Page 37 of 53 .physical examination . to J.02. Investigation Procedure Step Decide to investigate or not Plan activities Remarks  Initiate Investigation Team  define & assign activities  define need for the assistance of specialists  identify events and underlying factors  identify and validate perceived safety hazards  relevant sources might be: . They must be conducted in case of:  accidents and serious incidents  risk-assessed occurrences classified as "unacceptable" or "review"  recurring safety issues  need arising from Flight Data Monitoring 9.6.interviews Tool … … Responsibility Safety. SPI) to evaluate effectiveness  …  assess the appropriateness and effectiveness of the mitigations  … Tool … Responsibility Safety Action Group … … Safety Action Group … Conduct survey Evaluate results produce a list of hazard concerns initiate mitigation activities … … According to chapter 3.documentation & records . chapter 9. Safety Survey Procedure Step Remarks Plan survey  Define topics and tools to conduct survey  …  …  …  conduct risk-assessment  analyse root causes and human factors  initiate preventive or corrective action (who. what.& Quality Manager Investigation Team Investigation Team Data collection See 9. the publication of safety recommendations.2010 .4. Reason Issue 2 / Revision 0 / 24.2 … Implement action Monitor implementation and effectiveness … … … … Line manager Safety Action Group Safety Action Group 9. when appropriate.3. due date)  define measurement criteria (evtl.4. 9859 (2nd Ed.M.1. the drawing of conclusions. including the determination of causes and. Safety Investigations  ICAO SMM.

4.Safety & Quality Management System Step Remarks .2 See 9.4.safety databases  reconstruct logical progression  analyse facts and determine findings regarding underlying factors and hazards  estimate risk and determine acceptability for each hazard  identify defences that are missing or inadequate  identify and evaluate risk control options  communicate safety message to stakeholders  store records … Tool Responsibility Sequence of events Integrated investigation Risk assessment Defence analysis Risk control analysis Safety communication Close investigation … … Investigation Team Investigation Team Investigation Team Investigation Team Investigation Team Investigation Team Investigation Team According to chapter 3. Conditions present in the system before the accident made evident by triggering factors. Investigation Concept according to James Reason Activities over which an organisation has a reasonable degree of direct control.2.3 Bow-TieModel … … The investigation concept and the Bow-Tie-Model may increase the effectiveness of investigation activities: 9.direct observation of actions .02.4. Page 38 of 53 Issue 2 / Revision 0 / 24. Factors that directly influence the efficiency of people in aviation workplaces.2010 .simulations .M. Friedli .specialist advice .3 Bow-TieModel See 9. Organisational Processes Workplace Conditions Latent Conditions Active Faillures Defences Actions or inactions by people that have an immediate adverse effect Resources to protect against the risks that organisations involved in production activities must confront.

agreements with local authorities.2. Emergency Response Planning Guidance Material:  ICAO SMM. 10. Organisation The ERP should outline management's intentions with respect to the responding organisations 10. Bow-Tie-Model Preventive Controls Recovery Controls Hazard Consequence Reduction of Probability  reduce occurrence  “keep the tiger in the cage” Reduction of Severity  reduce damage  “shoot him… “ 10. and who will make external notifications and by what means. 9859 (2nd Ed. Issue 2 / Revision 0 / 24./2009).1. 9859 (2nd Ed.02.Safety & Quality Management System 9.3.M. chapter 11 " Handling of Accidents. Friedli Page 39 of 53 . Notifications The ERP should specify who in the organisation should be notified of an emergency.2010 . governing laws and regulations for investigations.3./2009). chapter 11): 10. and company policies and priorities.1.4. Doc. for example. Governing Policies The ERP should provide direction for responding to emergencies. Incidents and Occurrences" must be considered  The Emergency Response Planning usually is documented in a separate ERP Manual 10. Attachment B “Emergency Response Planning” Note:  The interface to OM A. Doc.1. ERP Concept The ERP concept should at least consist of (ICAO SMM.1.1.

technical records.11. Initial Response Depending on the circumstances.1. a command post (CP) may be established at or near the accident site. Records In addition to the organisation's need to maintain logs of events and activities.training and checking results.flight recorders and respective flight recorder records (cockpit and flight data). Additional Assistance Employees with appropriate training and experience can provide useful support during the preparation. airport authorities.flight planning relevant records. News media How the company responds to the media may affect how well the company recovers from the event. . 10. Although coordination of the activities of these stakeholders is the responsibility of the State's police and/or investigating authority.6. Family Assistance The ERP should also include guidance on the organisation's approach to assisting the families of accident victims (crew and passengers Post-critical incident stress counselling). an initial response team may be dispatched to the accident site to augment local resources and oversee the organisation's interests 10.1. . the organisation will be required to provide information to a State investigation team.7. 10. Special emphasis should be given on procedures for the retention of relevant data in safe custody pending their disposition as determined in accordance with Annex 13.g.5. Formal Investigations Guidance for company personnel dealing with State accident investigators and police should be provided in the ERP.8.1. Considered as relevant data are: . the aircraft operator should clarify the following aspects of activity at the accident site. exercising and updating of an organisation's ERP.M.2010 .1.Safety & Quality Management System 10. State accident investigators. In addition. 10. 10.10. 10. police. Issue 2 / Revision 0 / 24.02. Friedli Page 40 of 53 .4. Accident Site After a major accident.9. 10.1.1.1. fire-fighters. . coroners. relief agencies (e. representatives from many jurisdictions have legitimate reasons for accessing the site. the Red Cross) and the media. The ERP should provide guidance for personnel working in stressful situations. Crisis Management Centre (CMC) A CMC should be established at the organisation's headquarters once the activation criteria have been met.1. This may include specifying duty limits and providing for post-critical incident stress counselling. for example. medics.

This may result in amendments being made to the ERP and associated checklists. Some safety performance indicators are shown as examples. Act.  A modern company derives the key performance indicators from the strategic goals (Balanced Scorecard Approach!). which allow an overall evaluation of the success of the company.  Evaluations of a Management System according to ISO 9001:2008 have to consider Key Indicators of the value adding processes.9) lists some minimum requirements for the indicators.  The following scheme might be helpful to understand the difference between the treatment of individual problems during daily business (reporting system) and the periodical evaluation of the different sources (management evaluation) Achievement AM of annual goals Issue 2 / Revision 0 / 24. 11. We strongly recommend fixing criteria / indicators that cover all important key performance indicators.1.12.9.M.035 (4.Safety & Quality Management System 10.02.2. Log WorkReports Inspection Reports … Anonymus Report Inspection Reports FDM … Page 41 of 53 Closed loops in individual cases .2010 . Post-occurrence Review Direction should be provided to ensure that following the emergency key personnel carry out a full debriefing and record all significant lessons learned.9.3)). chapter 6. Guidance Material:  ICAO document 9859. … FCR ATIR Duty Time Infraction Inspection Reports … FCR Inspection Reports Audit Reports … Trainingforms Check Results Training Feedback Inspection Reports … Tech. indicates that safety performance indicators and safety targets should be defined to evaluate the success of the safety management system. Management Evaluation Requirements:  AMC OPS X.3 and 4. Friedli Management Evaluation Reporting System Periodical evaluation of procedures & data SQM PH Flt Ops PH Gnd Ops PH CT CAM FSO Audit reports Inspection Reports Status of Corr.035 (2.6 and 6.  It is the Accountable Manager's responsibility to define the frequency and the criteria (see AMC OPS X. which have to be evaluated.

11.Safety & Quality Management System 11.main focus for inspections and audits (input to planning) .  Results of the management evaluation should be . systematic review by the management to evaluate  the overall effectiveness of the organisation  the achievement of stated objectives  the effectiveness of the Safety & Quality Management System  the evaluation of the safety health  the operational policies and procedures.1.main focus for training The management evaluation is a comprehensive.3 Responsibility Responsible managers according to 11. responsibilities and due dates) .02. Friedli Page 42 of 53 .actions (incl.3 Establish management review report List of pending items Accountable Manager Monitor implementation of measures … List of pending items Accountable Manager … … Issue 2 / Revision 0 / 24. Process of Management Evaluation Step Perform data evaluation Remarks  periodical collation and evaluation of received reports and other data  identification of trends systematic deviations & cluster  suggestion of additional measures  …  consolidate the results of data evaluation  evaluate fulfilment of annual goals  evaluate the overall effectiveness of the organisation  decide upon measures and necessary resources  initiate measures  …  verify completion and success of initiated measures  …  … Tool Data to be evaluated and frequency see chapter 11.new company objectives and targets on Safety Performance Indicators .2. Purpose of Management Evaluation  It is important that the management evaluation really contributes to steer the company.M.2010 . By means of this data evaluation negative trends and major weaknesses are identified and corrected by eliminating their root causes.

3.& QualityManager 4 PH Flt Ops 4 PH Gnd Ops 4 PH CT 4 CAM 4 FSO 4 1 4 Issue 2 / Revision 0 / 24.Safety & Quality Management System 11. log work reports effectiveness of maintenance programme safety performance indicator YY … anonymous reports flight data monitoring results safety performance indicator XX … Frequency (months) 4 Safety. 9859 (2nd Ed. The following sources of information are analysed and criteria are evaluated according to the respective frequency. to chapter 3 evaluation of safety health (team approach / based on indicators according to ICAO SMM. Friedli Page 43 of 53 . Data to be evaluated  Specify the sources of information to be evaluated by the respective responsible manager  The evaluation can be done as a single management review or as a set of different evaluation activities with different frequencies. The reports of the individual responsible managers will be collated into the Management Review Report and discussed during the Management Review Meeting. In any case the respective records including corrective actions must be established to provide objective evidence.2010 .02. Corrective and or preventive actions are initiated and tracked on the list of pending items: Responsible Manager Accountable Manager Criteria / Source of data                                    achievement of annual goals overall effectiveness of the organisation (summary) company risk assessment acc. Doc.M. stations./2009) (Appendix 1 to chapter 10) … status of the implementation and effectiveness of corrective and preventive actions audit results inspection results safety performance indicator XZ … flight crew reports duty time infraction reports inspection reports safety performance indicator XY … flight crew reports inspection reports quality level of ground handling agents. etc Risk Assessments of stations safety performance indicator YZ … training and checking results trainees feedback quality level of training providers safety performance indicator ZZ … tech.

Doc. Safety/Quality Policy. Subcontractor / Supplier Management 8. SQMS Initial Training a) Basic Training: Content of SQMS-Manual Safety Review Board Function PH. Training and Education 13. Abbreviations Issue 2 / Revision 0 / 24. Friedli X X … X X … X X … FSO Topics according to SQMS-Chapters AM … … Page 44 of 53 Safety Action Group Employee Inspector Auditor . Risk Management 4.Management Evaluation 12. 12.1. Studies.11 Safety Promotion – Training and Education and chapter 9. Flight Data Monitoring 9.035 (6) "Quality System Training" Guidance Material:  ICAO SMM.1.Safety & Quality Management System 12. flight safety and quality. Audits 7. Initial Training Every new employee will – with respect on his function – be introduced in the company’s Safety & Quality Management System 12. chapter 9.  Make sure that training records are established and stored The goal of the Safety & Quality Management System training is to sensitise the employees on all levels towards accident prevention.  Specify the company specific topics to be trained to the employees.02.Emergency Response Planning 11.2010 . Training & Education Requirements:  AMC OPS X.Definitions. Organisation & Documentation 2. Inspections 6./2009).12 Safety Promotion – Communication  All employees have to be trained appropriately and tailored to their function on the Safety & Quality Management System.Document Control 14. 9859 (2nd Ed. CAM S. Feedback & Reporting 5. Safety & Quality Promotion. Reviews.1.& Q-Manager 0.Safety & Quality Promotion.M. Surveys and Investigations 10. Introduction to Safety & Risk-Mgmt 3. System of Amendment 1.

 know the Safety & Quality Policy  know the general content of SQMSManual  are aware of importance of hazard reporting and risk-analysis  are enabled to apply knowledge gained in practise SQM The lesson plan is controlled and maintained as a separate document to ensure necessary flexibility for improvements / amendments by the Safety & Quality Manager. chapter 9. b) Advanced Training: Guidance Material:  Specific topics can be found in ICAO SMM.11 Safety Promotion – Training and Education and chapter 9.02. Doc. Safety Review Board Safety Action Group S.12 Safety Promotion – Communication Prerequisite for advanced training: the Module 1 “Basic Training” must have been attended. Friedli Page 45 of 53 . consequences and risks  Safety Risk Management Process including roles and responsibilities  Safety Reporting and Safety Reporting System Standards of Performance The trainees Instruct. 9859 (2nd Ed. CAM Auditor FSO Issue 2 / Revision 0 / 24.M./2009).2010 .& Q-Manager Function Module Topic AM 2 3 4 5 6 7 8 9 10 11 12 Advanced SQMS-Training Risk-Management-Training Emergency Response Training (Management) Emergency Response Training (Operations) Training in legal standards Safety Assurance / QS in Aviation Specific Safety Management Training FSO-Training Auditor’s Training Inspector’s Training … X X X X … X X X X … X X X X … … … … … Employee Inspector PH.Safety & Quality Management System The module 1 “basic training” consists of: Content Fundamentals and overview based on the content of SQMS-Manual:  Safety & Quality Policy  Safety & Quality related procedures and responsibilities  Functioning and interrelation of SMS and Quality Assurance (classical Q-System)  Recognising and reporting of hazards  Definition of hazards.

consistently assess risks and initiate mitigation measures  Is enabled to act in case of emergencies according to the company specific procedures … Module 4: Emergency Response Planning  company specific procedures for ERP including at least: . Friedli Page 46 of 53 .contingency management . Risk-Management.planning . Safety Assurance (Q-System).2010 . implement and maintain the company’s safety management system including the safety assurance activities  Is able to establish.Safety & Quality Management System Content Module 2: Advanced SQMS-Training  Relation between Safety Management. safety risk assessment and mitigation  Is enabled to identify hazards. 9859: Safety Management Manual) external Module 8: FSO-Training  Processing of feedback reports and  Procedures for evaluation of safety relevant (if applicable: FDM) evaluation data and initiation of measures (proposals for measures) … Module 9: Auditor’s-Training  Conduction and reporting of inspections and audits  Process for implementation and monitoring of actions  Is able to conduct.02. implement and maintain the company’s quality assurance programme  Is able to establish.post-occurrence review … Module 5: Training in legal standards       National and international standards National Air Law EEC 3922/91 Annexe III (EU-OPS 1) ICAO SMM (Doc 9859) JAR-FCL 1 EC 2042/2003 (EASA Part M)  Knows the content and relevance of legal requirements and is able to fulfil these requirements  Is able to act in case of changes in legislation and to adapt the companies own standards external Module 6: Safety Assurance (Specific Training on Quality Systems in Aviation)  Basic Training on Quality Management  Specific training in Quality Assurance  Is able to establish. Accident Prevention and Flight Safety Programme  SQMS Communication & Promotion  Creation of a positive safety culture  Involvement of operational staff  Process of initiation and monitoring of actions  Change Management  Safety data analysis  Management Evaluation Standards of Performance  Is enabled to actively promote Safety & Quality within the organisation  Is enabled to evaluate data to identify trends and systematic weaknesses within the organisation Instruct.initial response . evaluate and document audits and to initiate measures according to the company procedures  Is able to conduct. SQM Module 3: Risk-Management-Training  safety process. implement and maintain the accident prevention and flight safety programme external Module 7: Specific Safety Management Training  Basic Training on Safety Management  ICAO-Requirements to SMS (ICAO Doc. hazard identification.M. evaluate and document inspections and to initiate measures according to the company procedures SQM Module 10: Inspector’s Training  Conduction and reporting of inspections  Process for implementation and monitoring of actions SQM Issue 2 / Revision 0 / 24.crisis management .

e-mail) 12. FDM.2.M.Safety & Quality Management System 12.2.& Quality-Manager … The responsible person decides about the kind of communication or even specific training (e.3.& Quality-Manager Respective Postholder / FSO Safety.2010 . hand out.02. Issue 2 / Revision 0 / 24. Friedli Page 47 of 53 . Ongoing Sensitisation. etc Conclusions from Audits Conclusions from Management Evaluation Safety and Quality goals Flight Safety relevant Conclusions Urgent Safety Information … Tool Safety Bulletin Safety Bulletin … … … Company Safety News Letter (monthly) e-mail … Responsibility Safety. Training and Communication Ongoing sensitisation is based on safety and quality relevant conclusions / experiences / changes resulting of evaluating of data gathered by the implemented Q-Assurance and risk assessment procedures. Q-System Training Records The responsibility for the storage of Safety & Quality Management System related training records is defined in 13.g.& Quality-Manager Accountable Manager Accountable Manager Flight Safety Officer Relevant Postholder. class room training. FSO Safety. Source Safety & Quality Management System Documentation Changes Urgent Communication of conclusions from Feedback & Reports.

2 j. The amendment of all of the company specific Manuals (e. Document Control Requirements:  AMC OPS X. 4. chapter 0 and chapter 2 For all the internal Standards and Procedures (see chapter 1.1.2 Risk-Assessment Process to ensure the management of change.M. g.8 “The management of change”  The procedures of how to control / manage internal and external documents that can undergo changes usually are defined in OM A.1. Step Initiate change Remarks  identify need for change within SQMSManual  submit request in written form to S&Q Manager  …              … compatibility with standards harmonisation with other documents viability & appropriateness assessment of risks ensure traceability of changes submit revised pages Tool Responsibility employee Verify need for change Revise SQMS-Manual Crosscheck and release Safety.4 SQMS-Documentation) we ensure. 13. Friedli . OM.Safety & Quality Management System 13. Doc.2010 . 13. that the valid versions are available in the right time at the right place.2 RiskAssessment FOCA Form “PRA” OM Revision compliance list Distribution list … Initiate document evaluation by FOCA Distribute document Up-date document / manual … Add effective date distribute new version (also to FOCA) ensure withdrawal if necessary instruct employees … … document user  … Page 48 of 53 Issue 2 / Revision 0 / 24.10) Guidance Material:  ICAO SMM. Revision procedure of the Safety & Quality Manual  Necessary.02./2009).035 (3. Control of Specifications / prescriptive Documents  Avoid redundancies / contradictions to the OM A. Each revision of a safety relevant procedure leads to a risk-assessment according to chapter 3.3. 9859 (2nd Ed. CAME) is specified in the introduction part of the respective manual. chapter 9.1.& QualityManager … … Chapter 3. only if the Safety & Quality Management System is documented in a separate manual.

PH Flt Ops Traceability of amendment EU-OPS 1 / JAR-OPS 3 JAR-FSTD … JAR-FCL … EASA Part-M Swiss Air Law FOCA Circular Advisories Airworthiness Directives AFM MMEL Service Bulletins Contracts (supplier / sub-contractors) … 1 CAM Each responsible person ensures that  changes of the documents are communicated to all people concerned  necessary changes of internal documents are made based on amendments of external documents  invalid / overridden versions are clearly identified as such  overridden documents are stored to ensure the necessary traceability – if necessary. date of issue. author)  systematically stored for the period required  destroyed after storage period in a controlled manner Issue 2 / Revision 0 / 24. Control of Safety & Quality Management System related Records  Avoid redundancies / contradictions to the OM A. 13.Safety & Quality Management System 13. chapter 2  Establish list of Safety & Quality Management System related records only  Check all the chapters of the Safety & Quality Management System with regard to resulting records Records are documents or data stating results achieved or providing evidence of activities performed.M. Document Control of External Documents Responsible1 for Doc.2010 . To ensure an authorised and quick access to records.1. Friedli Page 49 of 53 .2. they have to be  identified properly (at least: title.02.2.

frequency of back-up .storage-place of data storage medium .responsibility for back-up .Safety & Quality Management System Document Data evaluation of managers Management evaluation report Individual feedback reports Audit reports List of inspections performed Employees introduction programme Attendance records of Safety & Quality Management System training List of pending items Report monitoring tool Company Risk Assessment Project Risk Assessment Investigation results Flight Data Monitoring analysis reports … Responsibility Accountable Manager Accountable Manager Place of Storage Period of storage 5 years 5 years 5 years S&Q-Manager 5 years 5 years Accountable Manager Project Manager 13.data retrieval / recovery Issue 2 / Revision 0 / 24. Friedli Page 50 of 53 .3.2010 .02.M. EDP: Back-up Concept  Specify concept for periodical back-up of electronic data consisting of: .

in order to verify whether established operational procedures and requirements are followed during the accomplishment of that event and whether the required standard is achieved. or .7.2.1 b)  Establish list of company specific definitions and abbreviations  Avoid redundancy / contradiction with OM A.Safety & Quality Management System 14.1 ICAO SMS Course Quality Assurance Probability Quality Improvement Quality Management ISO 9000 ICAO Doc 9859 ch.. in a non-structured way Designated measures to address the hazard and bring under organizational control the safety risk probability and severity of the consequences of the hazard. The measures taken to eradicate a hazard or to reduce the severity or likelihood of a risk (avoidance. 9859 (1st Ed. quality assurance and quality improvement Reference AMC OPS X. . Definitions  The subsequent list consist of official definitions related to Quality and Safety & Risk Management Term Audit Definition An audit is a systematic and independent comparison of the way in which an operation is being conducted against the way in which the published operational procedures say it should be conducted.3./2006) (10.2 ISO 9000 ISO 9000 Issue 2 / Revision 0 / 24. quality planning. reduction. chapter 0 14. witnessing actual work practices.2010 .1) Mitigation ICAO SMM. Definitions.3. A condition or an object with the potential to cause . Part of quality management focused on increasing the ability to fulfil quality requirements Coordinated activities to direct and control an organisation with regard to quality NOTE 1: Direction and control with regard to quality generally includes establishment of the quality policy and quality objectives. Abbreviations (Terminology) Requirements:  AMC-OPS 1.M. quality control.reduction of ability to perform a prescribed function. . Carrying out informal "walk-arounds" of all operational areas of the organisation. The primary purpose of a quality inspection is to observe a particular event/action/document etc. 5.3 Inspection AMC OPS X.035 (4. etc.035 (3.1) Hazard ICAO Doc 9859 ch.1. Doc.2. Friedli Page 51 of 53 .035 (4. Talking to workers and supervisors.loss of material. segregation of exposure).4. 4.6) ICAO Doc 9859 ch.damage to equipment or structures.injuries to personnel.3. 5.02. Part of Q-Management focused on providing confidence that quality requirements will be fulfilled The likelihood that an unsafe event or condition might occur.

5 Safety performance targets ICAO Doc 9859 ch. Friedli Page 52 of 53 . 5. measurable objectives reflecting the safety performance of an SMS.8 Safety requirements Safety Risk Management ICAO SMS Course Based on ICAO Doc 9859 ch.4 Safety Safety performance indicators Safety is the state in which the possibility of harm to persons or of property damage is reduced to. and/or mitigation of the safety risks of the consequences of hazards that threaten the capabilities of an organization.6. taking as reference the worst foreseeable situation ICAO Doc 9859 ch. Safety performance target values are expressed in numerical terms. technology and systems.1 ICAO SMS Course ICAO Doc 9859 ch. analysis and elimination. Short-term. 2.3.2 System Safety Deficiency Severity Issue 2 / Revision 0 / 24. 6. The possible consequences of an unsafe event or condition. an acceptable level through a continuing process of hazard identification and safety risk management. they should be obvious.Safety & Quality Management System Term Quality Objectives Definition Something sought. and maintained at or below.2. 5. Part of Q-Management focused on fulfilling quality requirements Overall intentions and direction of an organisation related to quality as formally expressed top management NOTE 1: Generally the quality policy is consistent with the overall policy of the organisation and provides a framework for the setting of quality objectives The consequence of hazard. measurable.6. or aimed for. taking as reference the worst foreseeable situation. acceptable to stakeholders and linked to the safety performance indicator The safety requirements should be satisfied in terms of operational procedures. programmes.02.2.8 ICAO Doc 9859 ch.2010 . and contingency arrangements (=measures) The identification.5. 5. measurable and linked to the safety concerns of an SMS Safety performance target values are long-term. to a level as low as reasonably practicable (ALARP) The circumstance that permit hazards of a like nature to exist. measured in terms of predicted probability and severity. related to quality NOTE 1: Quality objectives are generally based on the organisations quality policy NOTE 2: Quality objectives are generally specified for relevant functions and levels in the organisation Part of Q-Management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives.M. 6. Reference ISO 9000 Quality Planning Quality Control Quality Policy ISO 9000 ISO 9000 ISO 9000 Risk ICAO Doc 9859 ch. They should be obvious. measurable objectives reflecting the safety performance of an SMS expressed in numerical terms.

2010 .035 or JAR-OPS 3. 704 ICAO Doc 9859 Attachment B ICAO Doc 9859 Attachment B EU-OPS 1. 1 to ch. monitoring function and requesting corrective actions.035).037 (a)(4) Appendix 1 to EUOPS 1. Safety Manager Note: NPA 2008-22a . Abbreviations Abbreviation Definition ALARP As low as reasonably practicable AM Accountable Manager A person acceptable to the Authority who has authority for ensuring that all training activities can be financed and carried out to the standards required by the Authority. NIL Issue 2 / Revision 0 / 24.1 iii) SM ICAO Doc 9859 (App.Safety & Quality Management System 14. A. Friedli Page 53 of 53 . A.Explanatory Note & Appendices .5) AMC OPS X.1 i) CAM CAME CMC ERP FSO PH CT PH Flt Ops PH Gnd Ops QM EASA Part-M M.035 (2.2) Appendix 1 to EUOPS 1.states: The management of this compliance monitoring system (meant is the Q-System according to EU-OPS 1.2) Appendix 1 to EUOPS 1. including its programme.Authority and Organisation Requirements . 5.1045 (1. and additional requirements defined by the operator Continuing Airworthiness Manager Continuing Airworthiness Management Exposition Crisis Management Center Emergency Response Planning Flight Safety Officer Nominated Postholder Crew Training Nominated Postholder Flight Operations Nominated Postholder Ground Operations Quality Manager The manager.035 (2. 706 EASA Part-M M.3.1045 (1. acceptable to the Authority.M.” SQM S&Q-Manager W Reference ICAO Doc 9859 (ch.02.2. responsible for the management of the Quality System. is part of the responsibilities of the safety manager. 5) Safety & Quality Manager This term is used in this document to make clear that both functions may be combined and assigned to the same person.2) AMC OPS X.1045 (1.

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