SQMS Basic Structure for Operators Iss2 Rev 0 20100224

Guideline for the Application of the SQMS-Basic Structure

Introduction / Note - 24.02.2010 - M. Friedli Page 1 of 53

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 Man-agement System” is to provide ideas and possible solutions to build up a Safety & Quality Man-agement System, which fulfils existing requirements regarding Quality Systems AND Safety man-agement Systems for airplane operators and helicopter operators. The chosen approach will addi-tionally provide a good starting position to implement future EASA requirements regarding Man-agement Systems including Safety Management Systems. Feedback to author is welcome: [email protected]

mailto:[email protected]



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 organi-sation 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.



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 rele-vant 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 para-graphs 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 assur-ance activities of the operator in a separate Quality System Manual. This modular approach en-hances 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 ref-erenced in the main Quality System.

In the respective document (e. g. CAME, MOE) reference shall be made to the main Quality Sys-tem.



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 EU-OPS 1 / JAR-OPS 3: Components acc. to SMM Respective component of

EU-OPS 1 / JAR-OPS 3 Degree*

Safety Policy and Objectives:

Management commitment and re-sponsibility

Quality Policy & Goals

Safety accountabilities

QS-related responsibilities and duties

Appointment of key safety personnel Organisation, QS-related responsibilities and duties

Coordination of emergency response planning

Emergency & Accident Management

SMS documentation

OM, CAME, QS

Safety Risk Management:

Hazard identification Accident Prevention & Flight Safety Pro-gramme

Risk assessment and mitigation None

Safety Assurance:

Safety performance monitoring and measurement

Inspections, Audits, Feedback, Subcon-tractor Monitoring, Management Evalua-tion, Flight Data Monitoring

The management of change

Document Control

Continuous improvement of the SMS Management Evaluation

Safety Promotion:

Training and education

QS-Training

Safety communication Accident Prevention & Flight Safety Pro-gramme

* Approximate degree of fulfilling SMS-requirements with Q-System according OPS X.035



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 account-ability 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 ac-tions 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 ade-quacy 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 require-ments. It is easier to comply with them if one single Q-System is in place to monitor the per-formance 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 dis-appear, because the new approach will lead to a Management System containing a Safety Management Manual containing Safety Performance Monitoring (the former Quality Assur-ance 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 Re-quirements - Explanatory Note & Appendices: “The Agency would like to emphasise that the quality system concept, as known under the JAA sys-tem and in existing EASA Parts, is integrated as a compliance monitoring system becoming an ele-ment of the management system of an organisation. The management of this compliance monitoring system, including its programme, is part of the re-sponsibilities of the safety manager.”

Safety & Quality Management System

Issue 2 / Revision 0 / 24.02.2010 - M. Friedli Page 6 of 53


(SQMS)

Issue 2 / Revision 0 / 24.02.2010



Content 0. System of Amendment...........................................................................................................9

0.1. Record of Revision........................................................................................................................ 9 0.2. Record of Temporary Revision ..................................................................................................... 9 0.3. List of Effective Pages................................................................................................................... 9

1. Safety/Quality Policy, Organisation and Documentation .................................................10 1.1. Safety and Quality Policy ............................................................................................................ 10 1.2. Safety & Quality Management Organisation & Accountabilities ................................................. 11 1.3. Purpose of the Safety & Quality Management System............................................................... 15 1.4. SQMS-Documentation ................................................................................................................ 16

2. Introduction to Safety & Risk Management .......................................................................18 2.1. Distinction between Quality Management and Safety Management Systems ........................... 18 2.2. Relation between Safety Management System and Q-Systems in Aviation .............................. 18 2.3. Relation between Risk-Management and Assurance Activities.................................................. 19 2.4. Mitigation / Reduction of Risks.................................................................................................... 19 2.5. Paradigm Change ....................................................................................................................... 20

3. Risk Management .................................................................................................................21 3.1. Levels of Risk Management........................................................................................................ 21 3.2. Hazard Identification and Risk Assessment Process ................................................................. 22 3.3. Classification of Risks ................................................................................................................. 23

4. Feedback & Reporting..........................................................................................................24 4.1. Importance of Feedback & Reporting ......................................................................................... 24 4.2. Kind of Reports ........................................................................................................................... 25

5. Inspections............................................................................................................................27 5.1. Inspection Procedure .................................................................................................................. 27 5.2. Qualification of internal Inspectors.............................................................................................. 28 5.3. List of internal Inspectors ............................................................................................................ 28 5.4. Inspection Scopes....................................................................................................................... 28

6. Audits.....................................................................................................................................29 6.1. Audit Procedure .......................................................................................................................... 30 6.2. Qualification of Auditors .............................................................................................................. 31 6.3. List of internal Auditors................................................................................................................ 31 6.4. Audit Scopes ............................................................................................................................... 31 6.5. Classification of Audit Findings ................................................................................................... 31

7. Subcontractor / Supplier Management...............................................................................32 7.1. Evaluation of Subcontractors / Suppliers .................................................................................... 32 7.2. Supervision of Subcontractors / Suppliers .................................................................................. 32

8. Flight Data Monitoring..........................................................................................................34

9. Safety Studies, Reviews, Surveys and Investigations ......................................................34 9.1. Safety Studies ............................................................................................................................. 34 9.2. Safety Reviews ........................................................................................................................... 35 9.3. Safety Survey.............................................................................................................................. 36 9.4. Safety Investigations ................................................................................................................... 37

10. Emergency Response Planning ..........................................................................................39 10.1. ERP Concept .............................................................................................................................. 39

11. Management Evaluation.......................................................................................................41



11.1. Purpose of Management Evaluation........................................................................................... 42 11.2. Process of Management Evaluation ........................................................................................... 42 11.3. Data to be evaluated ................................................................................................................... 43

12. Safety & Quality Promotion, Training & Education ...........................................................44 12.1. Initial Training.............................................................................................................................. 44 12.2. Ongoing Sensitisation, Training and Communication................................................................. 47 12.3. Q-System Training Records........................................................................................................ 47

13. Document Control ................................................................................................................48 13.1. Control of Specifications / prescriptive Documents .................................................................... 48 13.2. Control of Safety & Quality Management System related Records............................................ 49 13.3. EDP: Back-up Concept ............................................................................................................... 50

14. Definitions, Abbreviations (Terminology) ..........................................................................51 14.1. Definitions.................................................................................................................................... 51 14.2. Abbreviations .............................................................................................................................. 53



0. System of Amendment Note: If the SQMS-Manual is kept as a separate Manual (as recommended), the process for revision of the SQMS-Manual should be defined in chapter 13.1.1 "Revision Procedure of the Safety & Quality Manual." Where as the amendment process is defined in OM A, chapter 0, if this document is part of OM A, chapter 3. The revision process is defined in 13.1.1 "Revision Procedure of the Safety & Quality Manual."

0.1. Record of Revision

Issue Number Revision Number Effective Date Entered by Date 1 1 01.06.2009

1 2 22.06.2009

2 0 24.02.2010

0.2. Record of Temporary Revision

Issue Number

Revision Number

Effective Date

Entered

by

Date Validity / Cancellation

Removed by

Date

0.3. List of Effective Pages

Page Number

Issue Number

Revision Number

Effective Date

Page Number

Issue Number

Revi-sion Number

Effective Date

1 2 0 24.02.2010

2 2 0 24.02.2010

3 2 0 24.02.2010

4 2 0 24.02.2010

5 2 0 24.02.2010

6 2 0 24.02.2010

7 2 0 24.02.2010

8 2 0 24.02.2010

9 2 0 24.02.2010

… … … …



1. Safety/Quality Policy, Organisation and Documentation

1.1. Safety and Quality Policy

Requirements: AMC OPS X.035 (2.2) Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 8.4 Management Commitment and Responsibil-

ity 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.flightsafety.org/gain/just_culture.pdf Reason's Decision Tree for Determining the Culpability of Unsafe Acts (Origin: Shell "Hearts &

Minds") http://www.flightsafety.org/gain/just_culture.pdf Actions to take: Describe the safety and quality policy. This policy must also express the commitment to the

standards listed in 1.1.1 Relevant external Standards and 1.4 SQMS-Documentation. A safety policy must include a commitment to

- achieve the highest safety standards - observe all applicable legal requirements and international standards and best effective practices - provide appropriate human and financial resources - enforce safety as one primary responsibility of all managers - ensure that the policy is understood, implemented and maintained at all levels.

Establishing a Safety Policy is quite an easy task compared to the establishment of a safety culture throughout the whole company. But a Safety Management System will not provide any benefit if no positive Safety Culture is established.

The policy should ensure the following five aspects of a positive culture:

Aspects of a positive Culture

Reporting CultureAn organisational climate in which people

are prepared to report their errors and near-misses

Informed CultureThose who manage an operate the system havecurrent knowledge about the human, technical, organisational and environmental factors that

determine the safety of the system as a whole

Learning CultureAn organisation must possess the willingness

and the competence to draw the right conclusionsFrom its safety information system and the

will to implement major reforms

Flexible CultureA 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

Just CultureAn atmosphere of trust in which people are

encouraged (even rewarded) for providing essentialsafety-related information, but in which they are also

clear about where the line must be drawnbetween acceptable and unacceptable

behavior

based on: Reason (1997): The components of safety culture

http://www.flightsafety.org/gain/just_culture.pdf






1.1.1. Relevant external Standards

Example Ltd. 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; SR 748.127.1)

FOCA Circular Advisories

… The provisions of ICAO Safety Management Manual (Document 9859) are considered.

1.1.2. Safety and Quality Objectives (Policy Deployment)

Define how the safety and quality policy is deployed within the company. Preferably this process should be combined with the business planning and steering process of the organisation, where the definition and communication of annual goals are part of it.

The corporate commitment to safety from the highest organisational level is essential including the non punitive policy for disciplinary matters.

To be effective, corporate goals should always be followed by an action plan (who, what, until when?).

It is recommended to synchronise the goal setting with the management evaluation (see chapter 10).

In December, the Accountable Manager fixes annual company goals and the budget based on the safety & quality policy and the yearly adjusted strategy. …. The company goals are the basis for the agreement of individual goals during the yearly em-ployee's talk in January. …. Any kind of company specific standard of safety performance must respect the safety and quality policy statement…

1.2. Safety & Quality Management Organisation & Accountabilities

Requirements: AMC-OPS X.035 (2.1, 2.2.2, 2.4) EU-OPS 1.175 (1), (2) Appendix 1 to EU-OPS 1.005 (b) 1 Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 8.5 Safety Accountabilities & 8.6 Appointment

of Key Safety Personnel To avoid redundancies and contradictions, this chapter should refer to the relevant chapter in

the Operations Manual. Small and very small organisations ( see AMC OPS X.035 (7.2)):

The post of the Accountable Manager and the Quality Manager may be combined (see AMC OPS X.035 (2.4.5)



In the case of a very small operator, the post of Quality Manager may be held by a nominated postholder if external auditors are used. This applies also where the accountable manager is holding one or several of the nominated posts. ( see Appendix 1 to EU-OPS 1.005 (b)1)

1.2.1. Organisation

The company's organisational structure and the safety & quality system related roles, duties, re-sponsibilities, 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, chapter 1.XX.

The respective definitions for

Safety Manager

Quality Manager

Flight Safety Manager

see hereafter. Note that the names of functions may vary if not specified by legislation. It is strongly recommended to include the delegation of duties & responsibilities in case of absence and/or the designation of deputies. At least the following QS and SMS related responsibilities and competences should also to be as-signed in OM A, chapter 1, to the Accountable Manger and the nominated Postholders (see AMC-OPS X.035 and ICAO SMM chapters 8.5 and 8.6) 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 con-ducted under the operations certificate

He has final authority over operations authorized to be conducted under the operations cer-tificate

He has direct responsibility for the conduct of the organization’s affairs.

He establishes and signs a formal written Safety & Quality Policy Statement.

He has the ultimate responsibility and accountability for the implementation, maintenance and performance of the AOC holders Safety and Quality System including the frequency, format and structure of the internal management evaluation activities.

He has the ultimate responsibility to provide the necessary resources for the implementa-tion of corrective actions.

He promotes corporate culture for safety and quality.



Nominated Postholders, Continuing Airworthiness Manager:

They ensure safety performance monitoring in their field of activity e. g. by conducting and documenting monitoring activities such as inspections analysis of records, etc.

They have the authority to resolve issues and take and implement action implement correc-tive and preventive actions within their department.

They ensure that documentation is processed, stored and filed according to the quality sys-tem requirements

They conduct periodically a data evaluation as an input to the management evaluation.

They promote corporate culture for safety and quality.

1.2.2. 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. According to EU-OPS 1 / JAR-OPS 3 the Q-Manager maintains a Quality Assurance Programme to ensure safe operation and airworthy aircrafts. 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, if the function holder has specific know-how on both Safety & Risk Management and Quality Management. This statement is proposed by NPA 2008-22a - Authority and Organisation Requirements - Ex-planatory 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 man-agement system of an organisation. The management of this compliance monitoring system, including its programme, is part of the responsibili-ties of the safety manager.” A special emphasis has to be set on harmonising the responsibilities stated in 1.2.2 Safety Man-ager and 1.2.3 Quality Manager if the functions are assigned to two different persons. The next paragraphs distinguish the responsibilities of the Safety Manager and the Quality Man-ager. But in the other parts of this document the functions are combined and the term Safety & Quality Manager is used. It is the operator’s decision to assign these functions to one or two per-sons. The Safety Manager is the responsible and focal point for the development, administration and maintenance of the effective SQMS:

He has direct access to the Accountable Manager and relevant managing staff.

He establishes, implements, 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 per-formance as an input to the management evaluation.

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.

He is involved in occurrence / accident investigations

He monitors compliance



He monitors safety concerns in the aviation industry and their perceived impact in the or-ganization’s operations aimed at service delivery

He coordinates and communicates (on behalf of the Accountable Executive) on safety is-sues within the organization, as well as with the National Authority, external agencies, con-tractors and stakeholders as appropriate

He promotes corporate culture for safety and quality. 1.2.3. Quality Manager:

(Note: subsequent list of responsibilities bases on AMC-OPS X.035 and must be harmonised with the responsibilities of the Safety Manager)

He has direct access to the Accountable Manager.

He establishes, implements, maintains and further develops the Quality Assurance Pro-gramme

He has access to all parts of the operator’s and, as necessary, any sub-contractor’s organi-sation.

He verifies by monitoring activity in the fields of flight operations, maintenance, crew train-ing and ground operations, that the standards required by the Authority, and any additional requirements defined by the operator, are adequate and being carried out under the super-vision of the relevant Nominated Postholder. For this purpose he plans and ensures the im-plementation of the quality assurance activities.

He monitors the implementation and effectiveness of preventive and corrective action through the follow-up process..

He provides management with an independent assessment of corrective action, implemen-tation and completion.

He conducts periodically a data evaluation as an input to the management evaluation.


1.2.4. Safety Review Board

ICAO SMM chapter 8.6.6 Note: In small organisations the responsibilities of the Safety Review Board may be assigned to the management meeting (e. g. postholder meeting) The Safety review board is a high level committee that considers strategic safety functions. It is chaired by the accountable manager and be composed of the nominated Postholders and the Safety & Quality Manager. The safety review board should monitor:

safety performance against the safety policy and objectives;

the effectiveness of the SMS implementation plan; and

the effectiveness of the safety supervision of contracted operations. It ensures that appropriate resources are allocated to achieve the established safety performance and gives strategic direction to the safety action group.



1.2.5. Safety Action Group

ICAO SMM chapter 8.6.8 Note: In small organisations the responsibilities of the Safety Review Board may be assigned to the management meeting (e. g. postholder meeting) The safety action group reports to and take strategic direction from the safety review board. It comprises of managers, supervisors and staff from operational areas. The members are:

Safety & Quality Manager (Chairman)

…. 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. The safety action group must review the effectiveness of previous safety recommendations and safety promotion.

1.2.6. 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.

He conducts periodically a data evaluation as an input to the management evaluation.


1.3. Purpose of the Safety & Quality Management System AMC OPS X.035 (2.3)

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. occurrences and latent conditions

ensures reactive, proactive and predictive analysis of hazards and assessment of their risks

ensures eradication, mitigation and maintenance of risks to or below acceptable levels

monitors the compliance, implementation, effectiveness and efficiency of company specific and safety related policies, standards and procedures for flight and ground operations, training and the continuing airworthiness management of the aircrafts (as listed in chapter 1.1.1 Relevant external Standards and 1.4 SQMS-Documentation

ensures systematic implementation and monitoring of corrective actions

ensures an evaluation of the overall effectiveness of the organisation to achieve stated ob-jectives to ensure continuous improvement



1.4. SQMS-Documentation

Example Ltd. set up the manuals listed below. The application and implementation of those docu-ments contribute to ensure safe operation and airworthy aircrafts.

Operations Manual A, B, C and D

Continuing Airworthiness Management Exposition CAME

Cabin Safety Procedure Manual

Emergency & Accident Handling Manual

… The SQMS itself enables the company to predictively, proactively and reactively manage the risks and to ensure the compliance with and the appropriateness of the company specific manuals.

1.4.1. Overview over the EXAMPLE Ltd.' Safety & Quality Management System

LegalRequire-ments

LegalRequire-ments

Fulfilment of legal re-quirements

Fulfilment of legal re-quirementsOperation / MaintenanceOperation / Maintenance

Management Evaluation

Safety & Quality Policy

Objectives, Safety

Indicators,Resources

Analysing occurences &

hazards

Corrective, preventive

actions

Recording occurences &

hazards

Incidents, accidents, non-conformities, non-compliances, irregularities & potential hazards

Data Evaluation &

Risk-Assessment

S&Q-Managermonitoring / oversight

Core Elements:

Element of SQMS

Responsible Explanation Reference

Policy AM commitment to safety and quality SQMS ch. 1 & OM A ch. 3

Strategy Resources Annual Goals

AM rework of strategy based on management evaluation and company environment

definition of annual goals including meas-urable safety indicators

SQMS ch. 1



Element of SQMS

Responsible Explanation Reference

Operations PH Flt Ops PH CT PH Gnd Ops CAM FSO

defining of internal safety standards

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

OM A to D CAME & … SQMS ch. 5 SQMS ch. 4, SQMS ch. 8 SQMS ch. 7 SQMS ch. 4, 5, 6, 7, 8

Feedback & Reporting

All Employees identification and reporting of diver-gences, nonconformities and (potential) hazards incl. Risk-Assessment

SQMS ch. 4

Safety Studies, Reviews, Sur-veys and In-vestigations

Appointed Teams / Managing staff

analysis of situations, conditions, etc to - identify hazards - determine root causes, - make safety recommendations - implement mitigation actions and - thereby prevent accidents

SQMS ch. 9

Audits S&QM Auditors

independent auditors monitor the adher-ence to standards and requirements by means of audits

SQMS ch. 6

Inspections Postholders FSO S&QM

line superiors or supervisors monitor the adherence to internal standards and re-quirements during daily business by means of inspections.

SQMS ch. 5

Data evaluation AM Postholders FSO S&QM

collation and evaluation of data in the spe-cific field of activity to identify trends and systematic gaps.

drawing conclusions resulting form the data evaluation

SQMS ch. 11

Risk manage-ment

Managing staff identification of hazards, assessment of risks based on likelihood

and severity, risk mitigation and communication

SQMS ch. 3

Controlling / Management Evaluation

Accountable Man-ager (in collaboration with PH, CAM, S&Q-Manager and FSO)

evaluation of overall effectiveness of or-ganisation and achievement of goals / safety indicators based on data evaluation

SQMS ch. 11

Emergency and Response Plan

Accountable Man-ager

Ensuring that there is orderly and efficient transition from normal

to emergency operations; delegation of emergency authority; assignment of emergency responsibilities; authorization by key personnel for actions

contained in the plan; coordination of efforts to cope with the

emergency; and safe continuation of operations or return to

normal operations as soon as possible.

OM A ch. 10



2. Introduction to Safety & Risk Management

2.1. Distinction between Quality Management and Safety Management Systems

It is of vital importance to realise the difference between the following management systems:

System Purpose Legal & normative Ba-sis / Guidance Material

Quality Manage-ment System (Quality System) general term!

Ensuring the fulfilment of customer requirements and product / service related legal requirements focus is product/service quality

ISO 9001 Quality Management

Quality System for Operators Aviation!

Ensuring safe operations and airworthy aircrafts focuses on safety mainly focuses on safety assurance activities

EU-OPS 1.035 JAR-OPS 3.035 EASA Part M A.712

Safety Manage-ment System general term!

A systematic, explicit and comprehensive process for managing safety risk in order to achieve acceptable or tolerable safety Ensuring safe production and service delivery by corpo-rate approach in which the risk of harm to persons, envi-ronment and damage is limited to an acceptable level. focuses on safety achievement (incl. Risk Manage-

ment) focuses on safety assurance focuses on safety promotion

ISO 31000 Risk-Management In Aviation: ICAO Safety Management Manual

Management Sys-tem general term!

System to establish policy and objectives and to achieve those objectives NOTE: A management system of an organization can include different management systems, such as a quality management system, a safety management system, a financial management system or an environmental man-agement system.

In Aviation: NPA 2008-22c Organisa-tion Requirements: OR.GEN.200 Management System

Therefore Q-System according to EU-OPS 1.035 / JAR-OPS 3.035 must be considered as part of an effective Safety Management System.

2.2. Relation between Safety Management System and Q-Systems in Aviation

The following picture reflects that the classical Quality System according to JAR- or EASA-requirements provides important elements of a Safety Management System such as auditing, feedback & reporting and data evaluation. As we talk about a Safety Management System automatically all the Safety Assurance activities as defined in Q-Systems in Aviation are in-cluded. But many other important elements suchas risk-management, investigations, surveys,

training & promotion, etc must be de

veloped.

Safety Management Systemacc. to ICAO Safety Management Manual

Q-Systemacc. to OPS x.035

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.035 are covered.



2.3. Relation between Risk-Management and Assurance Activities

Risk-Management and Safety Assurance activities are both very important elements of a Safety Management System.

Safety Risk Management Safety Assurance

Information Acquisition

Preventive / Corrective Action

Continuous Monitoring

AuditingInvesti-gations

non-conformance

Potential New HazardIneffective Control

Control Safety Risk (Mitigation)

unaccep-table

Describe System

Identify Hazards

Analyse Safety Risks

Assess Safety Risks

Operation / Maintenanceacceptable

Analysis of Data

conformance


based on: FAA Advisory Circular 120-92

2.4. Mitigation / Reduction of Risks

The core question to answer is: Can we accept the residual risks?

Hazard

Risk

Risk

Risk

Verificationof effectiveness

accept (ALARP*)

reduce

Existing fences

Further mitigationnew fences

monitoring

monitoring

*ALARP = as low as reasonably practicable

limit of the system / company

By M. Friedli, PROCEDE



2.5. Paradigm Change

Today’s quality systems according to EU-OPS 1.035 / JAR-OPS 3.035 consist of proactive and reactive quality assurance activities. Those systems must be further developed to be more pro-active and even predictive.

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

2.5.1. 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. g. Analysis of occurrence reports

2.5.2. Pro-active Safety Management

Based on mandatory and voluntary reporting systems, safety audits, inspections and sur-veys

Based upon the notion that failures can be minimised by identifying safety risk within a sys-tem 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.

2.5.3. Predictive Safety Management

Aggressively seeking information from variety of sources which may be indicative of emerg-ing safety risks

Based upon the notion that we have to look for trouble and not to wait for it. Analysis of “what could happen and why?” Risk-Analysis of new procedure before implementation



3. Risk Management Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 3 “Introduction to Safety Management” ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 4 “Hazards” ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 5 “Safety Risks” ICAO SMM, Doc. 9859 (2nd Ed./2009), 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, analysis and elimination (and/or mitigation to an acceptable or tolerable level) of hazards, as well as the subsequent risks, that threaten the viability of an or-ganisation.

3.1. Levels of Risk Management

In EXAMPLE Ltd. we conduct risk management on the following levels to identify hazards and initi-ate respective mitigation actions:

Level Purpose Process Strategic / corporate level

Company wide identification of hazards and as-sessment of risks.*

Company risk assessment

Projects & Change Management

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.

Project risk assessment Supplier risk assessment Document control

Feedback & Re-porting

Incoming feedback undergoes a risk-assessment. Prioritisation of reports for further investigation and follow up.


… … …

Daily operation Awareness of employees to identify hazards and to act according the risk. Risk-based decisions during daily business.

Monitoring of safety relevant services / products

* Note: With this approach we also comply with the Swiss Legislation, which compels companies to introduce an Internal Control System for financial reporting pursuant to Art. 728a OR and Art. 728b OR and to disclose the results of risk assessments carried out in compliance with amended Art. 663b OR. The Internal Control System acc. to Swiss OR is relevant to companies fulfilling the following criteria: - quoted on the stock exchange - organisations fulfilling at least two of the three criteria: - more than 50 employees, - balance sheet total > 10 Mio. CHF - turnover > 20 Mio. CHF



The subsequent process is applied on all these levels:

3.2. Hazard Identification and Risk Assessment Process Step Remarks Tool Describe system to be evaluated

purpose of the system system's boundaries and the external interfaces the environment in which the system will operate

…

Identify hazards possible sources might be: equipment (hard- and software) operating environment (e.g. physical conditions,

airspace and air route design) human operators human/machine interface operational procedures maintenance procedures and external services evtl. initiate investigation

SHEL-Model

Concept according to James Reason (acc. to chapter 9.4.2)

acc. to chapter 9.4

Assess severity / consequences

Use classification of severity acc. to chapter 3.3.1

Assess probability Use classification of probability acc. to chapter 3.3.2

Evaluate risk Use risk classification scheme acc. to chapter 3.3.3

Decide upon ac-ceptance

is risk unacceptable / tolerable / acceptable? …

Define mitigation activities

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. Safety Performance Indicator)

Bow-Tie-Model (see chapter 9.4.3)

Implement miti-gation activities

Monitor imple-mentation

Monitor realisation AND effectiveness. based on measurement criteria

Initiate further mitigation activities if necessary

Tool…..

Finalise documen-tation

ensure permanent record of:

final results of the safety assessment,

the arguments and evidence demonstrating that the risks have been eliminated, or have been adequately controlled and reduced to a tolerable level

…



3.3. Classification of Risks

The risk is the factor resulting from severity and likelihood:

Risk = severity x likelihood

3.3.1. Classification of Severity

Interpretation / Impact on … Class People Assets Environment

A Catastrophic Multiple deaths Equipment destroyed …

B Hazardous Serious injury Major equipment damage

…

C Major … … …

D Minor … … …

E Negligible … … …

Note: interpretation aids may be found in ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 5.5

3.3.2. Classification of Probability

Interpretation Class Qualitatively Quantitatively

5 Frequent … 1 to 10-3 per flight hour

4 Occasional … …

3 Remote … …

2 Improbable … …

1 Extremely Improbable Should never occur in whole fleet life

<10-9 per flight hour

Note: interpretation aids may be found in ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 5.5

3.3.3. Classification of Risks

Risk Severity

Catastrophic

A Hazardous

B Major

C Minor

D Negligible

E

Frequent 5 unacceptable unacceptable unacceptable tolerable tolerable

Occasional 4 unacceptable unacceptable tolerable tolerable tolerable

Remote 3 unacceptable tolerable tolerable tolerable acceptable

Improbable 2 tolerable tolerable tolerable acceptable acceptable

Ris

k P

rob

ab

ility

of

Oc-

curr

ence

Extremely Improbable 1

acceptable acceptable acceptable acceptable acceptable

according to ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 5.6



4. Feedback & Reporting Requirements: AMC OPS X.035 (3.2.2) ACJ OPS 1.037 (a)(2) and IEM OPS 1.037 Directive 2003/42/EC on Occurrence Reporting in Civil Aviation Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 2.8. "Effective Safety Reporting" and 9.6.5

“Hazard Reporting” Actions to take: Specify the company specific processes to gather and treat employees' feedback. The proce-

dures listed below reflect how such processes could be documented. Make reference to Operations Manual Part A chapter 11, Handling of accidents and occur-

rences.

4.1. Importance of Feedback & Reporting

Today we are used to share the lessons learned from incidents and accidents. But there is also a high potential to learn out of errors, failures, deviations, threats and latent conditions even if they didn't lead to an incident or accident:

1-5 Accidents

30 - 100 Serious Incidents

100 - 1000 Incidents

1000 - 4000 Latent conditions

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, mitigated or eliminated to finally increase our level of safety. Hazards and incidents shall be reported if it is believed that:

something can be done to improve safety;

other aviation personnel could learn from the report; or

the system and its inherent defences did not work as expected.

If in doubt report it!



4.2. Kind of Reports

4.2.1. Air Safety Reports

Step Remarks Tool Responsibility Establish report describe the situation

use the designated forms

describe (potential) hazard

… Pilot

Sort and assign report

give feedback to the issuer

assess the risk

assign responsible manager to real-ise action within 24 h

open item on “Safety Report Moni-toring Tool”

Safety Report Moni-toring

Risk-Management (chapter 3.3)

FSO

Analyse situation Initiate actions

ensure reporting to FOCA within xxx hours

analyse root cause(s) and human factor(s)

Evtl. initiate investigation

initiate preventive or corrective ac-tion (who, what, due date)

define measurement criteria (evtl. SPI) to evaluate effectiveness


Model acc. to James Reason (see chapter 9.4.2)

Investigations (see chapter 9.4)

…

Monitor realisation of action


…

Close action close measure on “Safety Report Monitoring”


…

Monitor effective-ness of action

during spot checks / inspections or audits and / or measurement criteria (SPI)

Is the improvement sustainable?

Did we get the attained success?


…

4.2.2. Flight Crew Reports FCR

Step Remarks Tool Responsibility Establish report … FCR-Form Pilot


… Safety Report Moni-toring

…

Analyse situation Initiate action






…


… Safety Report Moni-toring

…

Close action … … …



Step Remarks Tool Responsibility Monitor effective-ness of action

during spot checks / inspections or audits and / or measurement criteria (SPI)

Is the improvement sustainable?

Did we get the attained success?

… …

4.2.3. Confidential Crew Reports CCR

Step Remarks Tool Responsibility Establish report … CCR-Form Pilot


give feedback to the issuer

assess the risk (acc. to chapter 3 Risk-Management)

neutralise report

assign responsible manager to real-ise action

open item on “Safety Report Moni-toring Tool”


FSO

Analyse situation Initiate action



evtl. initiate investigation




Investigations (see chapter 9.4)

…


… … …

Close action … … …

Monitor effective-ness of action

… … …

4.2.4. XY… Report

Step Remarks Tool Responsibility Establish report … … …


… … …

… … … …



5. Inspections Requirements: AMC OPS X.035 (4.2, 4.8) Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.5 Safety Assurance and chapter 9.6 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. Note: inspections are just one way to monitor the effective-ness and implementation of procedures.

By respecting the inspection procedure, internal inspectors have to observe particular events / ac-tions / documents in order to verify whether established operational procedures and requirements are followed and the required standards are achieved. Or in other words, to get the confidence that the implemented processes including controls are effective and performing. This as part of their managing function and responsibility.

5.1. Inspection Procedure

Specify the company specific process to conduct inspections. As a minimum, the inspection results as well as corrective actions resulting from inspections have to be documented

Step Remarks Tool Responsibility Planning & Prepara-tion

ad hoc planning

study relevant procedures

consider feedback & reporting sys-tem

… …

Execution …. … …

Initiation of action If deficiencies have been identified:

Assess the risk


initiate preventive or corrective action (who, what, due date)

define measurement criteria (evtl. SPI) to evaluate effectiveness initi-ate preventive and/or corrective ac-tion

Risk-Management (chapter 3.3) List of pending items

…

Monitoring verify implementation and effec-tiveness of action

… …

Reporting performed inspections are recorded on list of inspections to ensure coverage of all scopes

List of inspections performed

…



5.2. Qualification of internal Inspectors

Define the minimum requirements of qualification for internal inspectors. Note that contracted inspectors fall under the same category, i.e. the same qualification re-

quirements and shall also be put on the List of internal Inspectors. The inspectors of EXAMPLE Ltd. fulfil at least the following qualification criteria:

operational and maintenance know-ledge

…

…

5.3. 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. (Changes of inspectors would lead to an amendment of the S&Q-Manual if the list would be part of it.)

The Accountable Manager, the nominated Postholders, ………………. and the Safety- & Quality Manager perform or delegate inspections in their field of activity to monitor the com-pliance with and appropriateness of internal standards.

5.4. Inspection Scopes

Typical examples of scopes are defined in AMC OPS X.035 (4.2.2) 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, if it is established based on the results of the management evaluation (risk oriented approach)

Area topics Frequency (at least)

Tools / Kind of record

Responsib.

Operational Flight Plan Each document Visa on document …

Mass & Balance … … …

Duty time monthly list of inspections performed

…

LPC / OPC / Line Check Acc. to OM ….

Flight Ops

Documents on aircraft … Checklist xy …

Flight Support Services … … …

Load Control … … … Ground Ops

… … … …

Training Standards … … …

Training Records … … …

Validity of ratings & li-cences

Weekly None (IT-Tool) …

Crew Training

… … … …



Area topics Frequency (at least)

Tools / Kind of record

Responsib.

Maintenance Interface … … …

Technical Standards … … …

Hard-/Software up-date of Electronic Flight Bag Sys-tem

… … …

Continuing Airworthiness Management

… … … …

…. …

6. Audits Requirements: AMC OPS X.035 (4.3 to 4.8) Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.5 Safety Assurance and chapter 9.6 Safety

Performance Monitoring and Measurement Note: According to ICAO SMM, Doc. 9859, Audits

focus on the integrity of the organization’s SMS and periodically assess the status of safety risk controls.

are not intended to be in-depth audits of the technical processes but rather they are in-tended to provide assurance of the safety management functions, activities and resources of line units.

are used to ensure that the structure of the SMS is sound in terms of staffing, compliance with approved procedures and instructions, levels of competency and training to operate equipment and facilities and maintain required levels of performance, etc.

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, to help managers in charge of activities sup-porting the delivery of services to control that, once safety risk controls have been imple-mented, they continue to perform and are effective in maintaining continuing operational safety Safety audits should go beyond just checking compliance with regulatory requirements and con-formance with the organisation's standards. The auditor should assess whether the procedures in use are appropriate and whether there are any work practices that could have unforeseen safety consequences. According to AMC OPS X.035, the intention of Quality Audits is to monitor the compliance with, and the adequacy of, procedures required to ensure safe operational practices and airworthy aero-planes. Even if the focus is set on compliance a qualified auditor never will limit his activities on this issue. His responsibility is to identify any kind of potential for improvement.



Conclusion: Safety Audits and Quality Audits (as required by AMC-OPS X.035) almost have the same purpose and monitor the same activities. Therefore there is no need to make any difference between these two kinds of audits. Essential is that competent auditors are in charge.

6.1. Audit Procedure

Specify the company specific process Remark: It is strongly recommended that the audit plan is not a part of the Q-System, but is pub-

lished as a separate document that can be up-dated easily without submission to the Authority.

Step Remarks Tool Responsibility Planning establish audit plan in December

consider former - audit plan - changes in the organisation - changes in regulatory requiremts. - changes in the activities - trends

follow-up audits when necessary

all aspects/scopes at least 1x within 12 months

assign auditor(s): consider independ-ence & qualification

Audit plan List of auditors

Safety- & Quality Manager SQM

Preparation study relevant procedures

consider feedback & reporting system, former audit reports, former actions

OM CAME S&Q-Manual List of pending items Audit checklist

Auditor

Execution by means of different techniques: - interviews - witnessing of activities - examination of records - review of documents

Audit checklist

…

Reporting Establish audit report

Store report at …

Tool "audit report" …

Initiation of action If deficiencies have been identified:

Assess the risks and classify finding




List of pending items classification of find-ings see 6.5

…

Monitoring of im-plementation

verify implementation of measure … …

Monitoring of effec-tiveness

… … …

... … …



6.2. Qualification of Auditors

Define the minimum requirements of qualification for Auditors. The internal auditors of EXAMPLE Ltd. fulfil at least the following qualification criteria:

operational and maintenance know-ledge

attended an specific auditors course

… …

6.3. 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.

6.4. Audit Scopes

Minimum scopes to be monitored are given in AMC OPS X.035 (4.6). consider Navigation Data: TGL 10 (10.6) and OPS 1.873 (d): consider Electronic Flight Bag: TGL 36 The audit scopes are defined in the audit plan, which is maintained as a separate document to ensure the flexibility for recording audits performed and for scheduling additional audits.

6.5. Classification of Audit Findings

Note: Today operators have to comply with EASA Part M 716, which requests a kind of risk-assessment (safety affected, safety might be affected…). But in future it would make sense to use the same philosophy and approach to classify findings as defined in 3.3 Classification of Risks Findings resulting from audits have to be classified according EASA Part M (M. A. 716):

Level 1: Safety is affected no further operation / activity until closure of finding corresponds level “unacceptable” (see chapter 3.3 Risk-Management)

Level 2: Safety might be affected to be closed within due date (max. 2 months) corresponds level “tolerable” (see chapter 3.3 Risk-Management)



7. Subcontractor / Supplier Management Requirements: AMC OPS X.035 (5) OPS 1.873 (a) and 1.873 (d) as well as TGL 10 (10.6) regarding Navigation Data Base Airplane Operators: See FOCA Flight Ops Directive OD O-004 SFI “Ground Inspections”

(16.04.2008)

7.1. Evaluation of Subcontractors / Suppliers

The evaluation before ordering is not a requirement but strongly recommended. Written agreements should be established according to AMC OPS X.035 (5.1.2) New providers can lead to new risks. 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. Therefore written agreements that include the quality and safety requirements to be delivered have to be established.

Step Remarks Tool Responsibility Definition of re-quirements

define standards of performance

above CHF 1’000.- if not in budget: - written form - submit Accountable Manager

criteria (safety, quality, …) - ….

… …

Assess the risks … Supplier risk analysis … Call for bids … … … Contract review … … … Sign contract … … … … … … …

7.2. Supervision of Subcontractors / Suppliers

The monitoring concept of Subcontractors should consider risk assessment of providers. Guidance Material for supplier risk assessment can be requested from FOCA SBAU All subcontracted services should be deployed in a table, showing service/product, kind of su-

pervision, frequency of supervision (initial and repetitive) and responsibility. What is defined in such a table should be reflected in the audit / inspection plan where applicable. Where correc-tive and/or preventive actions become necessary they shall be processed as defined for audits, inspections or feedback & reporting.

the subsequent matrix reflects POSSIBLE approaches to supervise subcontractors. Each op-erator must tailor this concept to his complexity and risk of operation. Companies providing scheduled flights must consider FOCA Flight Ops Directive OD O-004 SFI “Ground Inspec-tions”.

http://www.bazl.admin.ch/fachleute/flugbetrieb/00326/01220/index.html?lang=de

http://www.bazl.admin.ch/fachleute/flugbetrieb/00326/01220/index.html?lang=de



The safety related activities of EXAMPLE Ltd. providers are monitored by the following means. These are the general monitoring activities. The monitoring concept is specifically tailored for sub-contractors based on a risk assessment ( risk assessment tool for subcontractors).

Service / Product

Kind of supervision Frequency Responsibility

ensuring the validity of necessary approval (JAR-FCL 1/2 and JAR-FSTD …)

… PH CT

inspection of training provided Acc. to risk assessment

PH CT

Training

trainee's feedback report

treatment of feedback according feedback & reporting

Each training Participants

Maintenance supervision of maintenance according con-tinuing airworthiness management exposition came

- CAM

fuel check according OM A part 8.2

Occurrence report in case of occurrences

- Pilot

risk assessment Supplier Risk Assessment

PH Gnd Ops

Fuelling

audit* of fuel providers Acc. to risk assessment

…

supervision of ground handling activities Each flight Pilot

sample checks (inspections) by crew based on checklist provided by dispatch

… Dispatch / Pilot

risk assessment Supplier Risk Assessement

PH Gnd Ops

audit* Acc. to risk assessment

…

… … …

Ground Handling

… … …

Monitoring by crew according OM A part 8.2

Occurrence report in case of occurrences

- Pilot

risk assessment Supplier Risk Assessement

PH Gnd Ops

De-/Anti-Icing

audit* of de-/anti-icing providers Acc. to risk assessment

…

Flight Support … … …

Availability of Letter of Acceptance … CAM Navigation Data Providers Occurrence report in case of occurrences … Pilot

Comparison of delivered product with order … PH Gnd Ops Flight Performance Data Provider Occurrence report in case of occurrences … Pilot

Comparison of delivered product with order PH Flt Ops Providers of data for take-off per-formance calcula-tion

Occurrence report in case of occurrences … Pilot

Flight Operations / Wet lease

… … …



If there is a need for action, the preventive or corrective measure is submitted to the supplier in written form. To monitor the implementation the corrective measure is tracked on the list of pending items. *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.

8. Flight Data Monitoring Flight Data Monitoring is requested by EU-OPS 1.037a (4) for airplanes in excess of 27'000kg

maximum take-off weight. Flight Data Monitoring is an important information acquisition to identify (potential) hazards. It usually is laid down in OM A chapter 2 but – according to EU-OPS 1.037 (a) - it also may be

integrated in the Quality System.

9. Safety Studies, Reviews, Surveys and Investigations

9.1. Safety Studies

Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.6.10 “Safety Studies" Safety studies are a source of information on generic safety concerns and/or systemic safety defi-ciencies. Safety studies are rather large analyses encompassing broad safety concerns. Some pervasive safety issues can best be understood through an examination in the broadest possible context. An organization might experience a safety concern which is of a global nature, and which may have been addressed on an industry- or State-wide scale. Safety arguments based on isolated occurrences and anecdotal information may not be enough. Because of their nature, safety studies are more appropriate to address system safety deficiencies rather than identify specific, individual hazards.

9.1.1. Safety Study Procedure

Step Remarks Tool Responsibility Identify the need for Safety Study

Conclude order to Safety Action Group

… Safety Review Board

Plan Safety Study define & assign activities

define need for the assistance of specialists

… Safety Action Group SAG

Conduct Study … … SAG

Evaluate and con-clude results

Identify safety deficiencies … SAG

Initiation of actions If deficiencies have been identified:

Assess the risks



define measurement criteria (evtl.

Acc. to chapter 3.2 Tool…

…



Step Remarks Tool Responsibility SPI) to evaluate effectiveness

Implement actions … …

Monitoring of imple-mentation

verify implementation of measure … …

Monitoring of effec-tiveness

based on measurement criteria (evtl. SPI) to evaluate effectiveness

… …

… … … …

9.2. Safety Reviews

Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.6.11 “Safety Reviews" Safety reviews are linked to the management of change and ensure safety performance under changing operational conditions; Safety reviews ensure safety performance during periods of change, by providing a roadmap to safe and effective change. Safety reviews are conducted during introduction and deployment of new technologies, change or implementation of procedures, or in situations of a structural change in operations. The mitigation will be appropriate if it actually addresses the hazard. 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. The SAG also proposes a prioritization of the responses/mitigations, by allocating importance and urgency to each hazard.



9.2.1. Safety Review Procedure

Step Remarks Tool Responsibility Define Objective define objective that is linked to the

change under consideration ( e. g. assess the safety risks associated with the change, evaluating the ap-propriateness and effectiveness of the safety management activities related to a project)

… Safety Action Group

Review performance of activity

look for effective performance of the safety management activities under the proposed changes such as: - hazard identification and safety risk assessment/mitigation - safety measurement - management accountabilities - operational personnel skills - technical systems - abnormal operations


produce a list of haz-ard concerns

conduct risk-assessment According to chapter 3.2

Safety Action Group

initiate mitigation ac-tivities

analyse root causes and human factors



… …

Implement action … … Line manager

Monitor implementa-tion and effectiveness

assess the appropriateness and effectiveness of the mitigations


… … … Safety Action Group

9.3. Safety Survey

Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.6.14 “Safety Surveys" Safety surveys examine particular elements or procedures of a specific operation, such as problem areas or bottlenecks in daily operations, perceptions and opinions of operational personnel and areas of dissent or confusion. Safety surveys may involve the use of checklists, questionnaires and informal confidential inter-views. Since surveys are subjective, verification may be needed before corrective action can be taken. Surveys may provide an inexpensive source of significant safety information.



9.3.1. Safety Survey Procedure

Step Remarks Tool Responsibility Plan survey Define topics and tools to conduct

survey

…


Conduct survey … … … Evaluate results … … … produce a list of haz-ard concerns

conduct risk-assessment According to chapter 3.2

Safety Action Group

initiate mitigation ac-tivities

analyse root causes and human factors



… …

Implement action … … Line manager

Monitor implementa-tion and effectiveness

assess the appropriateness and effectiveness of the mitigations


… … … Safety Action Group

9.4. Safety Investigations

ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.6.15 Safety Investigations" Investigations include the gathering and analysis of information, the drawing of conclusions, includ-ing the determination of causes and, when appropriate, the publication of safety recommendations. 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

9.4.1. Investigation Procedure

Step Remarks Tool Responsibility Decide to investigate or not

Initiate Investigation Team … Safety- & Quality Manager

Plan activities define & assign activities

define need for the assistance of specialists

… Investigation Team

Data collection identify events and underlying fac-tors

identify and validate perceived safety hazards

relevant sources might be: - physical examination - documentation & records - interviews

See 9.4.2 Investiga-tion concept acc. to J. Reason

Investigation Team



Step Remarks Tool Responsibility - direct observation of actions - simulations - specialist advice - safety databases

Sequence of events reconstruct logical progression … Investigation Team

Integrated investiga-tion

analyse facts and determine find-ings regarding underlying factors and hazards


Risk assessment estimate risk and determine ac-ceptability for each hazard

According to chapter 3.2

Investigation Team

Defence analysis identify defences that are missing or inadequate

See 9.4.3 Bow-Tie-Model

Investigation Team

Risk control analysis identify and evaluate risk control options

See 9.4.3 Bow-Tie-Model

Investigation Team

Safety communication communicate safety message to stakeholders


Close investigation store records … … Investigation Team

The investigation concept and the Bow-Tie-Model may increase the effectiveness of investigation activities:

9.4.2. Investigation Concept according to James Reason

Organisational Processes

Latent ConditionsWorkplace Conditions

DefencesActive Faillures

Resources to protect against the risks that

organisations involved in production activities must

confront.

Conditions present in the system before the accident made evident by triggering

factors.

Actions or inactions by people that have an

immediate adverse effect

Factors that directly influence the efficiency of

people in aviation workplaces.

Activities over which an organisation has a

reasonable degree of direct control.



9.4.3. Bow-Tie-Model

Reduction of Probability

Conse-quence

Preventive Controls Recovery Controls

Hazard

Reduction of Severity reduce occurrence “keep the tiger in the cage”

reduce damage “shoot him… “

10. Emergency Response Planning Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), Attachment B “Emergency Response Planning” Note: The interface to OM A, chapter 11 " Handling of Accidents, Incidents and Occurrences" must be

considered The Emergency Response Planning usually is documented in a separate ERP Manual

10.1. ERP Concept

The ERP concept should at least consist of (ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 11):

10.1.1. Governing Policies

The ERP should provide direction for responding to emergencies, for example, governing laws and regulations for investigations, agreements with local authorities, and company policies and priori-ties.

10.1.2. Organisation

The ERP should outline management's intentions with respect to the responding organisations

10.1.3. Notifications

The ERP should specify who in the organisation should be notified of an emergency, and who will make external notifications and by what means.



10.1.4. Initial Response

Depending on the circumstances, an initial response team may be dispatched to the accident site to augment local resources and oversee the organisation's interests

10.1.5. Additional Assistance

Employees with appropriate training and experience can provide useful support during the prepara-tion, exercising and updating of an organisation's ERP.

10.1.6. Crisis Management Centre (CMC)

A CMC should be established at the organisation's headquarters once the activation criteria have been met. In addition, a command post (CP) may be established at or near the accident site.

10.1.7. Records

In addition to the organisation's need to maintain logs of events and activities, the organisation will be required to provide information to a State investigation team. Special emphasis should be given on procedures for the retention of relevant data in safe custody pending their disposition as deter-mined in accordance with Annex 13. Considered as relevant data are: - flight recorders and respective flight recorder records (cockpit and flight data), - training and checking results, - technical records, - flight planning relevant records.

10.1.8. Accident Site

After a major accident, representatives from many jurisdictions have legitimate reasons for access-ing the site, for example, police, fire-fighters, medics, airport authorities, coroners, State accident investigators, relief agencies (e.g. the Red Cross) and the media. Although coordination of the ac-tivities of these stakeholders is the responsibility of the State's police and/or investigating authority, the aircraft operator should clarify the following aspects of activity at the accident site.

10.1.9. News media

How the company responds to the media may affect how well the company recovers from the event.

10.1.10. Formal Investigations

Guidance for company personnel dealing with State accident investigators and police should be provided in the ERP.

10.1.11. 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). The ERP should provide guidance for personnel working in stressful situations. This may include specifying duty limits and providing for post-critical incident stress counselling.



10.1.12. 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. This may result in amendments being made to the ERP and associated checklists.

11. Management Evaluation Requirements: AMC OPS X.035 (4.9) lists some minimum requirements for the indicators, which have to be

evaluated. It is the Accountable Manager's responsibility to define the frequency and the criteria (see AMC

OPS X.035 (2.2.3 and 4.9.3)). We strongly recommend fixing criteria / indicators that cover all important key performance indicators, which allow an overall evaluation of the success of the company.

Guidance Material: ICAO document 9859, chapter 6.6 and 6.9, indicates that safety performance indicators and

safety targets should be defined to evaluate the success of the safety management system. Some safety performance indicators are shown as examples.

A modern company derives the key performance indicators from the strategic goals (Balanced Scorecard Approach!).

Evaluations of a Management System according to ISO 9001:2008 have to consider Key Indica-tors of the value adding processes.

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)

PH Flt Ops CAM FSO

SQM

FCRAudit

reportsTraining-

forms

ATIR

Duty TimeInfraction

Check Results

Training Feedback

Tech. Log

Work-Reports

AnonymusReport

InspectionReports

FCR

InspectionReports

InspectionReports

InspectionReports

InspectionReports

InspectionReports

Reporting S

ystemAM

Mana

gement E

valuation

Closed loops in

individual cases

Periodical evaluation

of procedu

res & data

PH Gnd Ops PH CT

FDMStatus of Corr. Act.

Achievementof annual goals

Audit Reports

… …

… …… …



11.1. Purpose of Management Evaluation

It is important that the management evaluation really contributes to steer the company. Results of the management evaluation should be - new company objectives and targets on Safety Performance Indicators - actions (incl. responsibilities and due dates) - main focus for inspections and audits (input to planning) - main focus for training The management evaluation is a comprehensive, systematic review by the management to evalu-ate

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. By means of this data evaluation negative trends and major weaknesses are identified and cor-rected by eliminating their root causes.

11.2. Process of Management Evaluation

Step Remarks Tool Responsibility Perform data evaluation

periodical collation and evaluation of received reports and other data

identification of trends systematic deviations & cluster

suggestion of additional measures

…

Data to be evaluated and frequency see chapter 11.3

Responsible managers accord-ing to 11.3

Establish man-agement review report

consolidate the results of data evaluation

evaluate fulfilment of annual goals

evaluate the overall effectiveness of the organisation

decide upon measures and neces-sary resources

initiate measures

…

List of pending items Accountable Manager

Monitor implemen-tation of measures

verify completion and success of initiated measures

…

List of pending items Accountable Manager

… … … …



11.3. 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. In any case the respective records including corrective ac-tions must be established to provide objective evidence.

The following sources of information are analysed and criteria are evaluated according to the re-spective frequency. The reports of the individual responsible managers will be collated into the Management Review Report and discussed during the Management Review Meeting. Corrective and or preventive actions are initiated and tracked on the list of pending items:

Responsible Manager

Criteria / Source of data Frequency (months)

Accountable Manager achievement of annual goals overall effectiveness of the organisation (summary) company risk assessment acc. to chapter 3 evaluation of safety health (team approach / based

on indicators according to ICAO SMM, Doc. 9859 (2nd Ed./2009) (Appendix 1 to chapter 10)

…

4

Safety- & Quality-Manager

status of the implementation and effectiveness of corrective and preventive actions

audit results inspection results safety performance indicator XZ …

4

PH Flt Ops flight crew reports duty time infraction reports inspection reports safety performance indicator XY …

4

PH Gnd Ops flight crew reports inspection reports quality level of ground handling agents, stations, etc Risk Assessments of stations safety performance indicator YZ …

4

PH CT training and checking results trainees feedback quality level of training providers safety performance indicator ZZ …

4

CAM tech. log work reports effectiveness of maintenance programme safety performance indicator YY …

4

FSO anonymous reports flight data monitoring results safety performance indicator XX …

4 1 4



12. Safety & Quality Promotion, Training & Education Requirements: AMC OPS X.035 (6) "Quality System Training"

Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.11 Safety Promotion – Training and Education

and chapter 9.12 Safety Promotion – Communication All employees have to be trained appropriately and tailored to their function on the Safety &

Quality Management System. Specify the company specific topics to be trained to the employees. 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, flight safety and quality.

12.1. Initial Training

Every new employee will – with respect on his function – be introduced in the company’s Safety & Quality Management System

12.1.1. SQMS Initial Training

a) Basic Training: Content of SQMS-Manual

Function

Topics according to SQMS-Chapters

AM

PH

, CA

M

FS

O

S-

& Q

-Man

ager

Au

dit

or

Insp

ecto

r

Em

plo

yee

Saf

ety

Rev

iew

B

oar

d

Saf

ety

Act

ion

G

rou

p

0. System of Amendment X X X …

1. Safety/Quality Policy, Organisation & Documenta-tion

X X X …

2. Introduction to Safety & Risk-Mgmt … … …

3. Risk Management

4. Feedback & Reporting

5. Inspections

6. Audits

7. Subcontractor / Supplier Management

8. Flight Data Monitoring

9. Studies, Reviews, Surveys and Investigations

10. Emergency Response Planning

11. Management Evaluation

12. Safety & Quality Promotion, Training and Educa-tion

13. Document Control

14. Definitions, Abbreviations



The module 1 “basic training” consists of:

Content Standards of Performance Instruct. Fundamentals and overview based on the content of SQMS-Manual:

Safety & Quality Policy Safety & Quality related procedures and re-

sponsibilities Functioning and interrelation of SMS and Qual-

ity Assurance (classical Q-System) Recognising and reporting of hazards Definition of hazards, consequences and risks Safety Risk Management Process including

roles and responsibilities Safety Reporting and Safety Reporting System

The trainees

know the Safety & Quality Policy know the general content of SQMS-

Manual are aware of importance of hazard re-

porting 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 flexibil-ity for improvements / amendments by the Safety & Quality Manager. b) Advanced Training: Guidance Material: Specific topics can be found in ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.11 Safety

Promotion – Training and Education and chapter 9.12 Safety Promotion – Communication Prerequisite for advanced training: the Module 1 “Basic Training” must have been attended.

Mod

ule

Function

Topic

AM

PH, C

AM

FSO

S- &

Q-M

anag

er

Aud

itor

Insp

ecto

r

Empl

oyee

Safe

ty R

evie

w B

oard

Safe

ty A

ctio

n G

roup

2 Advanced SQMS-Training X X X …

3 Risk-Management-Training X X X …

4 Emergency Response Training (Management)

X X X …

5 Emergency Response Training (Operations)

X X X …

6 Training in legal standards … … …

7 Safety Assurance / QS in Aviation

8 Specific Safety Management Training

9 FSO-Training

10 Auditor’s Training

11 Inspector’s Training

12 …



Content Standards of Performance Instruct.

Module 2: Advanced SQMS-Training

Relation between Safety Management, Safety As-surance (Q-System), Risk-Management, 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

Is enabled to actively promote Safety & Quality within the organisation

Is enabled to evaluate data to identify trends and systematic weaknesses within the organi-sation

SQM

Module 3: Risk-Management-Training

safety process, hazard identification, safety risk assessment and mitigation

Is enabled to identify hazards, consistently assess risks and initiate mitigation measures

…

Module 4: Emergency Response Planning

company specific procedures for ERP including at least: - planning - initial response - crisis management - contingency management - post-occurrence review

Is enabled to act in case of emergencies ac-cording to the company specific procedures

…

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 re-quirements and is able to fulfil these require-ments

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, implement and maintain the company’s quality assurance programme

external

Module 7: Specific Safety Management Training

Basic Training on Safety Management

ICAO-Requirements to SMS (ICAO Doc. 9859: Safety Management Manual)

Is able to establish, implement and maintain the company’s safety management system includ-ing the safety assurance activities

external

Module 8: FSO-Training

Processing of feedback reports and

Procedures for evaluation of safety relevant (if appli-cable: FDM) evaluation data and initiation of meas-ures (proposals for measures)

Is able to establish, implement and maintain the accident prevention and flight safety pro-gramme

…

Module 9: Auditor’s-Training

Conduction and reporting of inspections and audits

Process for implementation and monitoring of ac-tions

Is able to conduct, evaluate and document audits 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 ac-tions

Is able to conduct, evaluate and document inspections and to initiate measures according to the company procedures

SQM



12.2. Ongoing Sensitisation, 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.

Source Tool Responsibility

Safety & Quality Management System Docu-mentation Changes

Safety Bulletin Safety- & Quality-Manager

Urgent Communication of conclusions from Feedback & Reports, FDM, etc

Safety Bulletin Respective Postholder / FSO

Conclusions from Audits … Safety- & Quality-Manager

Conclusions from Management Evaluation … Accountable Manager

Safety and Quality goals … Accountable Manager

Flight Safety relevant Conclusions Company Safety News Letter (monthly)

Flight Safety Officer

Urgent Safety Information e-mail Relevant Postholder, FSO Safety- & Quality-Manager

… … …

The responsible person decides about the kind of communication or even specific training (e.g. hand out, class room training, e-mail)

12.3. Q-System Training Records

The responsibility for the storage of Safety & Quality Management System related training records is defined in 13.2.



13. Document Control Requirements: AMC OPS X.035 (3.3.2 j, 4.10) Guidance Material: ICAO SMM, Doc. 9859 (2nd Ed./2009), chapter 9.8 “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.

13.1. Control of Specifications / prescriptive Documents

Avoid redundancies / contradictions to the OM A, chapter 0 and chapter 2 For all the internal Standards and Procedures (see chapter 1.4 SQMS-Documentation) we ensure, that the valid versions are available in the right time at the right place. The amendment of all of the company specific Manuals (e. g. OM, CAME) is specified in the introduction part of the respective manual. Each revision of a safety relevant procedure leads to a risk-assessment according to chapter 3.2 Risk-Assessment Process to ensure the management of change.

13.1.1. Revision procedure of the Safety & Quality Manual

Necessary, only if the Safety & Quality Management System is documented in a separate man-ual.

Step Remarks Tool Responsibility Initiate change identify need for change within SQMS-

Manual

submit request in written form to S&Q Manager

employee

Verify need for change

… Safety- & Quality-Manager

Revise SQMS-Manual … …

Crosscheck and re-lease

compatibility with standards

harmonisation with other documents

viability & appropriateness

assessment of risks

ensure traceability of changes

Chapter 3.2 Risk-Assessment

…

Initiate document evaluation by FOCA

submit revised pages

FOCA Form “PRA” OM Revision com-pliance list

…

Distribute document Add effective date

distribute new version (also to FOCA)

ensure withdrawal if necessary

instruct employees

Distribution list …

Up-date document / manual

… document user

… …



13.1.2. Control of External Documents

Document Responsible1 for Doc. Traceability of amendment EU-OPS 1 / JAR-OPS 3 PH Flt Ops

JAR-FSTD …

JAR-FCL …

EASA Part-M CAM

Swiss Air Law

FOCA Circular Advisories

Airworthiness Directives

AFM

MMEL

Service Bulletins

Contracts (supplier / sub-contractors)

…

1Each 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.

13.2. Control of Safety & Quality Management System related Records

Avoid redundancies / contradictions to the OM A, 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 re-

cords Records are documents or data stating results achieved or providing evidence of activities per-formed. To ensure an authorised and quick access to records, they have to be

identified properly (at least: title, date of issue, author)

systematically stored for the period required

destroyed after storage period in a controlled manner



Document Responsibility Place of Storage Period of storage Data evaluation of managers


5 years

Management evalua-tion report


5 years

Individual feedback reports

5 years

Audit reports S&Q-Manager 5 years

List of inspections performed

5 years

Employees introduc-tion programme

Attendance records of Safety & Quality Man-agement System train-ing

List of pending items

Report monitoring tool

Company Risk As-sessment


Project Risk Assess-ment

Project Manager

Investigation results

Flight Data Monitoring analysis reports

…

13.3. EDP: Back-up Concept

Specify concept for periodical back-up of electronic data consisting of: - responsibility for back-up - frequency of back-up - storage-place of data storage medium - data retrieval / recovery



14. Definitions, Abbreviations (Terminology) Requirements: AMC-OPS 1.035 (3.3.1 b) Establish list of company specific definitions and abbreviations Avoid redundancy / contradiction with OM A, chapter 0

14.1. Definitions

The subsequent list consist of official definitions related to Quality and Safety & Risk Manage-ment

Term Definition Reference Audit

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.

AMC OPS X.035 (4.3.1)

Hazard A condition or an object with the potential to cause - injuries to personnel, - damage to equipment or structures, - loss of material, or - reduction of ability to perform a prescribed function.

ICAO Doc 9859 ch. 4.2.3

Inspection

The primary purpose of a quality inspection is to observe a par-ticular event/action/document etc., in order to verify whether established operational procedures and requirements are fol-lowed during the accomplishment of that event and whether the required standard is achieved. Carrying out informal "walk-arounds" of all operational areas of the organisation. Talking to workers and supervisors, witnessing actual work practices, etc. in a non-structured way

AMC OPS X.035 (4.2.1) ICAO SMM, Doc. 9859 (1st Ed./2006) (10.3.6)

Mitigation 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 se-verity or likelihood of a risk (avoidance, reduction, segregation of exposure).

ICAO Doc 9859 ch. 5.7.1 ICAO SMS Course

Quality Assurance

Part of Q-Management focused on providing confidence that quality requirements will be fulfilled

ISO 9000

Probability The likelihood that an unsafe event or condition might occur. ICAO Doc 9859 ch. 5.4.2

Quality Improvement

Part of quality management focused on increasing the ability to fulfil quality requirements

ISO 9000

Quality Management

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 objec-tives, quality planning, quality control, quality assurance and quality improvement

ISO 9000



Term Definition Reference Quality Objectives

Something sought, or aimed for, related to quality NOTE 1: Quality objectives are generally based on the organisa-tions quality policy NOTE 2: Quality objectives are generally specified for relevant functions and levels in the organisation

ISO 9000

Quality Planning

Part of Q-Management focused on setting quality objectives and specifying necessary operational processes and related re-sources to fulfil the quality objectives.

ISO 9000

Quality Control Part of Q-Management focused on fulfilling quality requirements ISO 9000

Quality Policy 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 over-all policy of the organisation and provides a framework for the setting of quality objectives

ISO 9000

Risk The consequence of hazard, measured in terms of predicted probability and severity, taking as reference the worst foreseeable situation.

ICAO Doc 9859 ch. 5.2.8

Safety Safety is the state in which the possibility of harm to persons or of property damage is reduced to, and maintained at or below, an acceptable level through a continuing process of hazard iden-tification and safety risk management.

ICAO Doc 9859 ch. 2.2.4

Safety perform-ance indicators

Short-term, measurable objectives reflecting the safety perform-ance of an SMS expressed in numerical terms. They should be obvious, measurable and linked to the safety concerns of an SMS

ICAO Doc 9859 ch. 6.6.5

Safety perform-ance targets

Safety performance target values are long-term, measurable objectives reflecting the safety performance of an SMS. Safety performance target values are expressed in numerical terms; they should be obvious, measurable, acceptable to stakeholders and linked to the safety performance indicator

ICAO Doc 9859 ch. 6.6.8

Safety require-ments

The safety requirements should be satisfied in terms of opera-tional procedures, technology and systems, programmes, and contingency arrangements (=measures)

ICAO SMS Course

Safety Risk Man-agement

The identification, analysis and elimination, and/or mitigation of the safety risks of the consequences of hazards that threaten the capabilities of an organization, to a level as low as reasonably practicable (ALARP)

Based on ICAO Doc 9859 ch. 5.3.1

System Safety Deficiency

The circumstance that permit hazards of a like nature to exist. ICAO SMS Course

Severity The possible consequences of an unsafe event or condition, taking as reference the worst foreseeable situation

ICAO Doc 9859 ch. 5.5.2



14.2. Abbreviations

Abbreviation Definition Reference

ALARP As low as reasonably practicable ICAO Doc 9859 (ch. 5.3.5)

AM Accountable Manager A person acceptable to the Authority who has authority for en-suring that all training activities can be financed and carried out to the standards required by the Authority, and additional re-quirements defined by the operator

AMC OPS X.035 (2.1 i)

CAM Continuing Airworthiness Manager EASA Part-M M. A. 706

CAME Continuing Airworthiness Management Exposition EASA Part-M M. A. 704

CMC Crisis Management Center ICAO Doc 9859 Attachment B

ERP Emergency Response Planning ICAO Doc 9859 Attachment B

FSO Flight Safety Officer EU-OPS 1.037 (a)(4)

PH CT Nominated Postholder Crew Training Appendix 1 to EU-OPS 1.1045 (1.2)

PH Flt Ops Nominated Postholder Flight Operations Appendix 1 to EU-OPS 1.1045 (1.2)

PH Gnd Ops Nominated Postholder Ground Operations Appendix 1 to EU-OPS 1.1045 (1.2)

QM Quality Manager The manager, acceptable to the Authority, responsible for the management of the Quality System, monitoring function and requesting corrective actions.

AMC OPS X.035 (2,1 iii)

SM Safety Manager Note: NPA 2008-22a - Authority and Organisation Require-ments - Explanatory Note & Appendices - states: The management of this compliance monitoring system (meant is the Q-System according to EU-OPS 1.035 or JAR-OPS 3.035), including its programme, is part of the responsibilities of the safety manager.”

ICAO Doc 9859 (App. 1 to ch. 5)

SQM S&Q-Manager

Safety & Quality Manager This term is used in this document to make clear that both func-tions may be combined and assigned to the same person.

NIL

W