SQMS Basic Structure For Operators Iss2 Rev 0 20100224

Guideline for the Application of
the SQMS-Basic Structure
Guideline
Basic Structure for a

Safety & Quality Management System
(SQMS) for Operators
Based on:
Requirements:
 (EEC) No 3922/91 Annex III amended (EU-OPS 1)
 Leaflet No 44: JAR-OPS 1 Amt 13 section 2
 JAR-OPS 3.035
 EC Regulation No 2042/2003 (EASA Part M)
 ICAO Convention on International Civil Aviation Annex 6 “Operation of Aircraft”
Guidance Material:
 ICAO SMM, Doc. 9859 (2nd Ed./2009) "Safety Management Manual"
 FOCA-Guideline SMS-001 Implementation of Safety-Management-Systems (SMS)
including Annexes 1 to 4
Purpose:
The intention of this “Guideline” and the subsequent “Basic structure of a Safety and Quality 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: m.friedli@procede.ch
Introduction / Note - 24.02.2010 - M. Friedli Page 1 of 53

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 Degree*
EU-OPS 1 / JAR-OPS 3
Safety Policy and Objectives:
 Management commitment and re- Quality Policy & Goals
sponsibility
 Safety accountabilities QS-related responsibilities and duties
 Appointment of key safety personnel Organisation, QS-related responsibilities

and duties
 Coordination of emergency response Emergency & Accident Management
planning
 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 Inspections, Audits, Feedback, Subcon-
measurement 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
(SQMS)
Issue 2 / Revision 0 / 24.02.2010
Issue 2 / Revision 0 / 24.02.2010 - M. Friedli Page 6 of 53

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 Revision Effective Entered Date Validity / Removed Date
Number Number Date by Cancellation by
0.3. List of Effective Pages

Page Issue Revision Effective Page Issue Revi- Effective
Number Number Number Date Number Number sion Date
Number
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:
Just Culture
An atmosphere of trust in which people are
encouraged (even rewarded) for providing essential
safety-related information, but in which they are also
clear about where the line must be drawn
between acceptable and unacceptable
Informed Culture behavior Learning Culture
Those who manage an operate the system have An organisation must possess the willingness
current knowledge about the human, technical, and the competence to draw the right conclusions
organisational and environmental factors that From its safety information system and the
determine the safety of the system as a Aspects of a will to implement major reforms
whole positive Culture
Reporting Culture Flexible Culture

An organisational climate in which people A culture in which an organisation is able
are prepared to report their errors and near-misses to reconfigure themselves in the face of
high tempo operations or certain kinds of
danger – often shifting from the conventional
hierarchical mode to a flatter mode
based on: Reason (1997): The components of safety culture

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
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
S&Q-Manager
Safety & mo
Management nit
Quality or i
Evaluation ng
Policy /o
ve
rs igh
t
Objectives, Analysing
Safety occurences & Data
Indicators, hazards Evaluation &
Risk-
Resources Assessment
Corrective, Recording
preventive occurences &
actions hazards
Legal
Legal Fulfilment
Fulfilment
Require-
Require- of
oflegal
legalre-
re-
Operation
Operation/ /Maintenance
Maintenance
ments
ments quirements
quirements
Incidents, accidents, non-conformities,
non-compliances, irregularities
& potential hazards
Core Elements:
Element of Responsible Explanation Reference
SQMS
Policy AM  commitment to safety and quality SQMS ch. 1 &
OM A ch. 3
Strategy AM  rework of strategy based on management SQMS ch. 1
Resources evaluation and company environment
Annual Goals  definition of annual goals including meas-
urable safety indicators

Element of Responsible Explanation Reference

SQMS
Operations PH Flt Ops  defining of internal safety standards OM A to D
PH CT CAME & …
PH Gnd Ops
CAM  ensuring conformity with internal standards SQMS ch. 5
FSO and requirements by means of controlling
and supervision (inspections!) of the daily
activities
 analysis of feedback & reports SQMS ch. 4,
 Flight data monitoring SQMS ch. 8
 supervision of relevant subcontractors SQMS ch. 7
 initiation and monitoring of implemented SQMS ch. 4,
actions 5, 6, 7, 8
Feedback & All Employees  identification and reporting of diver- SQMS ch. 4
Reporting gences, nonconformities and (potential)
hazards incl. Risk-Assessment
Safety Studies, Appointed Teams /  analysis of situations, conditions, etc to SQMS ch. 9
Reviews, Sur- Managing staff - identify hazards
veys and In- - determine root causes,
vestigations - make safety recommendations
- implement mitigation actions and
- thereby prevent accidents
Audits S&QM  independent auditors monitor the adher- SQMS ch. 6
Auditors ence to standards and requirements by
means of audits
Inspections Postholders  line superiors or supervisors monitor the SQMS ch. 5
FSO adherence to internal standards and re-
S&QM quirements during daily business by
means of inspections.
Data evaluation AM  collation and evaluation of data in the spe- SQMS ch. 11
Postholders cific field of activity to identify trends and
FSO systematic gaps.
S&QM  drawing conclusions resulting form the
data evaluation
Risk manage- Managing staff  identification of hazards, SQMS ch. 3
ment  assessment of risks based on likelihood
and severity,
 risk mitigation and communication
Controlling / Accountable Man-  evaluation of overall effectiveness of or- SQMS ch. 11
Management ager ganisation and achievement of goals /
Evaluation (in collaboration with safety indicators based on data evaluation
PH, CAM, S&Q-
Manager and FSO)
Emergency and Accountable Man- Ensuring that there is OM A ch. 10
Response Plan ager  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.

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- Ensuring the fulfilment of customer requirements and ISO 9001
ment System product / service related legal requirements Quality Management
(Quality System)  focus is product/service quality
 general term!
Quality System Ensuring safe operations and airworthy aircrafts EU-OPS 1.035
for Operators  focuses on safety JAR-OPS 3.035
 Aviation!  mainly focuses on safety assurance activities EASA Part M A.712
Safety Manage- A systematic, explicit and comprehensive process for ISO 31000 Risk-
ment System managing safety risk in order to achieve acceptable or Management
 general term! tolerable safety In Aviation:
Ensuring safe production and service delivery by corpo- ICAO Safety Management
rate approach in which the risk of harm to persons, envi- Manual
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
Management Sys- System to establish policy and objectives and to achieve In Aviation:
tem those objectives NPA 2008-22c Organisa-
 general term! NOTE: A management system of an organization can tion Requirements:
include different management systems, such as a quality OR.GEN.200 Management
management system, a safety management system, a System
financial management system or an environmental man-
agement 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 Safety Management System such as auditing,
acc. to ICAO Safety Management Manual feedback & reporting and data evaluation.
As we talk about a Safety Management System
Q-System automatically all the Safety Assurance activities
acc. to OPS x.035 as defined in Q-Systems in Aviation are in-
cluded. But many other important elements such
as risk-management, investigations, surveys,
training & promotion, etc must be developed.
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

Preventive / Corrective
Describe System
Action
non-conformance
Potential New Hazard
Identify Hazards Ineffective Control conformance
Analysis of Data
Analyse Safety Risks
Continuous Feedback & Investi-

Assess Safety Risks Auditing
Monitoring Reporting gations
Information Acquisition
acceptable
unaccep- Operation / Maintenance
table
Control Safety Risk
(Mitigation)
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?
any
omp
m/c
Hazard e syste
of th
limit
Risk
monitoring
Verification of effectiveness
Risk
Existing fences
accept (ALARP*)
monitoring
reduce
*ALARP = as low as reasonably practicable Further mitigation Risk
new fences
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 / Company wide identification of hazards and as- Company risk assessment
corporate level sessment of risks.*
Projects & Change Identification of hazards and assessment of risk in Project risk assessment
Management case of Supplier risk assessment
 Implementation of new or modification of Document control
processes / procedures
 contracting new providers
 implementation of new or modification of tools
 implementation of new or modification of
aircrafts etc.
Feedback & Re- Incoming feedback undergoes a risk-assessment. Feedback & Reporting
porting Prioritisation of reports for further investigation and
follow up.
… … …
Daily operation Awareness of employees to identify hazards and to Monitoring of safety relevant
act according the risk. services / products
Risk-based decisions during daily business.
* 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  purpose of the system  …
be evaluated  system's boundaries and the external interfaces
 the environment in which the system will operate
Identify hazards possible sources might be:  SHEL-Model
 equipment (hard- and software)  Concept according to James
 operating environment (e.g. physical conditions, Reason (acc. to chapter 9.4.2)
airspace and air route design)
 human operators
 human/machine interface
 operational procedures
 maintenance procedures and
 external services
 acc. to chapter 9.4
 evtl. initiate investigation
Assess severity /  Use classification of severity  acc. to chapter 3.3.1
consequences
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-  is risk unacceptable / tolerable / acceptable?  …

ceptance
Define mitigation  define action and action plan  Bow-Tie-Model (see chapter
activities  Re-evaluate risk: is risk "as low as reasonably 9.4.3)
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)
Implement miti-  
gation activities
Monitor imple-  Monitor realisation AND effectiveness. based on  Tool…..
mentation measurement criteria
 Initiate further mitigation activities if necessary
Finalise documen- ensure permanent record of:  …
tation  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
Class Interpretation / Impact on …

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
Class Interpretation
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  <10-9 per flight hour
fleet life
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 Hazardous Major Minor Negligible
A B C D E
Frequent 5 unacceptable unacceptable unacceptable tolerable tolerable

Risk Probability of Oc-
Occasional 4 unacceptable unacceptable tolerable tolerable tolerable

currence
Remote 3 unacceptable tolerable tolerable tolerable acceptable
Improbable 2 tolerable tolerable tolerable acceptable acceptable
Extremely
acceptable acceptable acceptable acceptable acceptable
Improbable 1
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  … Pilot
 use the designated forms
 describe (potential) hazard
Sort and assign  give feedback to the issuer  Safety Report Moni- FSO
report  assess the risk toring
 assign responsible manager to real-  Risk-Management
ise action within 24 h (chapter 3.3)
 open item on “Safety Report Moni-
toring Tool”
Analyse situation  ensure reporting to FOCA within xxx  Safety Report Moni- …
Initiate actions hours toring
 analyse root cause(s) and human  Model acc. to James
factor(s) Reason (see chapter
 Evtl. initiate investigation 9.4.2)
 initiate preventive or corrective ac-  Investigations (see
tion (who, what, due date) chapter 9.4)
 define measurement criteria (evtl.
SPI) to evaluate effectiveness
Monitor realisation   Safety Report Moni- …
of action toring
Close action  close measure on “Safety Report  Safety Report Moni- …
Monitoring” toring
Monitor effective-  during spot checks / inspections or  Safety Report Moni- …
ness of action audits and / or measurement criteria toring
(SPI)
 Is the improvement sustainable?
 Did we get the attained success?
4.2.2. Flight Crew Reports FCR

Establish report  …  FCR-Form Pilot
Sort and assign  …  Safety Report Moni- …

report toring
Analyse situation  analyse root cause(s) and human  Safety Report Moni- …
Initiate action factor(s) toring
 initiate preventive or corrective ac-  Model acc. to James
tion (who, what, due date) Reason (see chapter
 define measurement criteria (evtl. 9.4.2)
Monitor realisation  …  Safety Report Moni- …
of action toring
Close action  …  … …


Monitor effective-  during spot checks / inspections or  … …
ness of action audits and / or measurement criteria
(SPI)
 Is the improvement sustainable?
 Did we get the attained success?
4.2.3. Confidential Crew Reports CCR

Establish report  …  CCR-Form Pilot
Sort and assign  give feedback to the issuer  Safety Report Moni- FSO
report  assess the risk (acc. to chapter 3 toring
Risk-Management)
 neutralise report
 assign responsible manager to real-
ise action
 open item on “Safety Report Moni-
toring Tool”
Analyse situation  analyse root cause(s) and human  Safety Report Moni- …
Initiate action factor(s) toring
 initiate preventive or corrective ac-  Model acc. to James
tion (who, what, due date) Reason (see chapter
 evtl. initiate investigation 9.4.2)
 define measurement criteria (evtl.  Investigations (see
SPI) to evaluate effectiveness chapter 9.4)
Monitor realisation  …  … …
of action
Close action  …  … …
Monitor effective-  …  … …
ness of action
4.2.4. XY… Report

Establish report  …  … …
Sort and assign  …  … …

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

Planning & Prepara-  ad hoc planning … …
tion  study relevant procedures
 consider feedback & reporting sys-
tem
Execution  …. … …
Initiation of action If deficiencies have been identified: …
 Assess the risk Risk-Management
 analyse root cause(s) and human (chapter 3.3)
factor(s)
 initiate preventive or corrective List of pending items
action (who, what, due date)
SPI) to evaluate effectiveness initi-
ate preventive and/or corrective ac-
tion
Monitoring  verify implementation and effec- … …
tiveness of action
Reporting  performed inspections are recorded List of inspections …
on list of inspections to ensure performed
coverage of all scopes

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 Tools / Responsib.

(at least) Kind of record
Flight Ops  Operational Flight Plan  Each document  Visa on document …
 Mass & Balance  …  … …
 Duty time  monthly  list of inspections …
performed
 LPC / OPC / Line Check   Acc. to OM ….
 Documents on aircraft  …  Checklist xy …
Ground Ops  Flight Support Services  …  … …
 Load Control  …  … …
 …  …  … …
Crew Training  Training Standards  …  … …
 Training Records  …  … …
 Validity of ratings & li-  Weekly  None (IT-Tool) …
cences
 …  …  … …

Area topics Frequency Tools / Responsib.

(at least) Kind of record
Continuing  Maintenance Interface  …  … …
Airworthiness  Technical Standards  …  … …
Management
 Hard-/Software up-date of  …  … …
Electronic Flight Bag Sys-
tem
 …  …  … …
….    …
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.

Planning  establish audit plan in December Audit plan Safety- & Quality
 consider former List of auditors Manager SQM
- 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
Preparation  study relevant procedures OM Auditor
 consider feedback & reporting system, CAME
former audit reports, former actions S&Q-Manual
List of pending items
Audit checklist
Execution  by means of different techniques: Audit checklist …
- interviews
- witnessing of activities
- examination of records
- review of documents
Reporting  Establish audit report Tool "audit report" …
 Store report at …
Initiation of action If deficiencies have been identified: List of pending items …
 Assess the risks and classify finding classification of find-
ings see 6.5
 analyse root cause(s) and human
factor(s)
 initiate preventive or corrective action
(who, what, due date)
 define measurement criteria (evtl. SPI)
to evaluate effectiveness
Monitoring of im-  verify implementation of measure … …
plementation
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.

Definition of re-  define standards of performance … …
quirements  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”.

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 / Kind of supervision Frequency Responsibility

Product
Training  ensuring the validity of necessary approval … PH CT
(JAR-FCL 1/2 and JAR-FSTD …)
 inspection of training provided Acc. to risk PH CT
assessment
 trainee's feedback report Each training Participants
 treatment of feedback according
feedback & reporting
Maintenance  supervision of maintenance according con- - CAM
tinuing airworthiness management exposition
came
Fuelling  fuel check according OM A part 8.2 - Pilot
 Occurrence report in case of occurrences
 risk assessment Supplier Risk PH Gnd Ops
Assessment
 audit* of fuel providers Acc. to risk …
assessment
Ground Handling  supervision of ground handling activities Each flight Pilot
 sample checks (inspections) by crew based … Dispatch / Pilot
on checklist provided by dispatch
Assessement
 audit* Acc. to risk …
assessment
 … … …
 … … …
De-/Anti-Icing  Monitoring by crew according OM A part 8.2 - Pilot
 Occurrence report in case of occurrences
Assessement
 audit* of de-/anti-icing providers Acc. to risk …
assessment
Flight Support  … … …
Navigation Data  Availability of Letter of Acceptance … CAM
Providers  Occurrence report in case of occurrences … Pilot
Flight Performance  Comparison of delivered product with order … PH Gnd Ops
Data Provider  Occurrence report in case of occurrences … Pilot
Providers of data  Comparison of delivered product with order PH Flt Ops
for take-off per-  Occurrence report in case of occurrences … Pilot
formance calcula-
tion
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

Identify the need for  Conclude order to Safety Action … Safety Review
Safety Study Group Board
Plan Safety Study  define & assign activities … Safety Action
 define need for the assistance of Group SAG
specialists
Conduct Study  … … SAG
Evaluate and con-  Identify safety deficiencies … SAG
clude results
Initiation of actions If deficiencies have been identified: …
 Assess the risks Acc. to chapter 3.2
 analyse root cause(s) and human
factor(s)
 initiate preventive or corrective Tool…


Implement actions  … …
Monitoring of imple-  verify implementation of measure … …
mentation
Monitoring of effec-  based on measurement criteria … …
tiveness (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

Define Objective  define objective that is linked to the … Safety Action
change under consideration ( e. g. Group
assess the safety risks associated
with the change, evaluating the ap-
propriateness and effectiveness of
the safety management activities
related to a project)
Review performance  look for effective performance of … Safety Action
of activity the safety management activities Group
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-  conduct risk-assessment According to chapter Safety Action
ard concerns 3.2 Group
initiate mitigation ac-  analyse root causes and human … …
tivities factors
 initiate preventive or corrective
Implement action  … … Line manager
Monitor implementa-  assess the appropriateness and … Safety Action
tion and effectiveness effectiveness of the mitigations Group
…  … … 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

Plan survey  Define topics and tools to conduct … Safety Action
survey Group
 …
Conduct survey  … … …
Evaluate results  … … …
produce a list of haz-  conduct risk-assessment According to chapter Safety Action
ard concerns 3.2 Group
initiate mitigation ac-  analyse root causes and human … …
tivities factors
 initiate preventive or corrective
Implement action  … … Line manager
Monitor implementa-  assess the appropriateness and … Safety Action
tion and effectiveness effectiveness of the mitigations Group
…  … … 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

Decide to investigate  Initiate Investigation Team … Safety- & Quality
or not Manager
Plan activities  define & assign activities … Investigation
 define need for the assistance of Team
specialists
Data collection  identify events and underlying fac- See 9.4.2 Investiga- Investigation
tors tion concept acc. to J. Team
 identify and validate perceived Reason
safety hazards
 relevant sources might be:
- physical examination
- documentation & records
- interviews

- direct observation of actions
- simulations
- specialist advice
- safety databases
Sequence of events  reconstruct logical progression … Investigation
Team
Integrated investiga-  analyse facts and determine find- … Investigation
tion ings regarding underlying factors Team
and hazards
Risk assessment  estimate risk and determine ac- According to chapter Investigation
ceptability for each hazard 3.2 Team
Defence analysis  identify defences that are missing See 9.4.3 Bow-Tie- Investigation
or inadequate Model Team
Risk control analysis  identify and evaluate risk control See 9.4.3 Bow-Tie- Investigation
options Model Team
Safety communication  communicate safety message to … Investigation
stakeholders Team
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
Activities over which an

organisation has a
reasonable degree of direct
Factors that directly control. Conditions present in the
influence the efficiency of system before the accident
people in aviation made evident by triggering
workplaces. factors.
Organisational Processes
Workplace Conditions Latent Conditions
Active Faillures Defences
Resources to protect
Actions or inactions by against the risks that
people that have an organisations involved in
immediate adverse effect production activities must
confront.

9.4.3. Bow-Tie-Model
Preventive Controls Recovery Controls
Conse-
Hazard
quence
Reduction of Probability Reduction of Severity

 reduce occurrence  reduce damage
 “keep the tiger in the cage”  “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)
Achievement
Management Evaluation
AM of annual goals
Periodical evaluation
of procedures & data
PH PH
PH CT CAM FSO
Flt Ops Gnd Ops
SQM
Audit Training- Anonymus

FCR FCR Tech. Log
reports forms Report
Reporting System
Closed loops in
individual cases
Inspection Inspection Check Work- Inspection

ATIR
Reports Reports Results Reports Reports
Status of Duty Time Audit Training Inspection
FDM
Corr. Act. Infraction Reports Feedback Reports
Inspection Inspection
… … … …
Reports 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

Perform data  periodical collation and evaluation of Data to be evaluated Responsible
evaluation received reports and other data and frequency see managers accord-
 identification of trends systematic chapter 11.3 ing to 11.3
deviations & cluster
 suggestion of additional measures
 …
Establish man-  consolidate the results of data List of pending items Accountable
agement review evaluation Manager
report  evaluate fulfilment of annual goals
 evaluate the overall effectiveness of
the organisation
 decide upon measures and neces-
sary resources
 initiate measures
 …
Monitor implemen-  verify completion and success of List of pending items Accountable
tation of measures initiated measures 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 Criteria / Source of data Frequency
Manager (months)
Accountable Manager  achievement of annual goals 4
 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)
 …
Safety- & Quality-  status of the implementation and effectiveness of 4
Manager corrective and preventive actions
 audit results
 inspection results
 safety performance indicator XZ
 …
PH Flt Ops  flight crew reports 4
 duty time infraction reports
 inspection reports
 safety performance indicator XY
 …
PH Gnd Ops  flight crew reports 4
 inspection reports
 quality level of ground handling agents, stations, etc
 Risk Assessments of stations
 safety performance indicator YZ
 …
PH CT  training and checking results 4
 trainees feedback
 quality level of training providers
 safety performance indicator ZZ
 …
CAM  tech. log 4
 work reports
 effectiveness of maintenance programme
 safety performance indicator YY
 …
FSO  anonymous reports 4
 flight data monitoring results 1
 safety performance indicator XX 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
S- & Q-Manager
Function
Safety Review
Safety Action
Employee
Inspector
PH, CAM
Auditor
Group
Topics according to SQMS-Chapters Board
FSO
AM
0. System of Amendment X X X …
1. Safety/Quality Policy, Organisation & Documenta-
X X X …
tion
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 The trainees SQM
of SQMS-Manual:  know the Safety & Quality Policy
 Safety & Quality Policy  know the general content of SQMS-
 Safety & Quality related procedures and re- Manual
sponsibilities  are aware of importance of hazard re-
 Functioning and interrelation of SMS and Qual- porting and risk-analysis
ity Assurance (classical Q-System)  are enabled to apply knowledge gained
 Recognising and reporting of hazards in practise
 Definition of hazards, consequences and risks
 Safety Risk Management Process including
roles and responsibilities
 Safety Reporting and Safety Reporting System
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.
Safety Review Board
Safety Action Group

Function
S- & Q-Manager
Module
Employee
Inspector
PH, CAM
Auditor
Topic
FSO
AM
2 Advanced SQMS-Training X X X …
3 Risk-Management-Training X X X …
4 Emergency Response Training
X X X …
(Management)
5 Emergency Response Training
X X X …
(Operations)
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-  Is enabled to actively promote Safety & Quality SQM
surance (Q-System), Risk-Management, Accident within the organisation
Prevention and Flight Safety Programme  Is enabled to evaluate data to identify trends
 SQMS Communication & Promotion and systematic weaknesses within the organi-
 Creation of a positive safety culture sation
 Involvement of operational staff
 Process of initiation and monitoring of actions
 Change Management
 Safety data analysis
 Management Evaluation
Module 3: Risk-Management-Training
 safety process, hazard identification, safety risk  Is enabled to identify hazards, consistently …
assessment and mitigation assess risks and initiate mitigation measures
Module 4: Emergency Response Planning
 company specific procedures for ERP including at  Is enabled to act in case of emergencies ac- …
least: cording to the company specific procedures
- planning
- initial response
- crisis management
- contingency management
- post-occurrence review
Module 5: Training in legal standards
 National and international standards  Knows the content and relevance of legal re- external
 National Air Law quirements and is able to fulfil these require-
ments
 EEC 3922/91 Annexe III (EU-OPS 1)
 Is able to act in case of changes in legislation
 ICAO SMM (Doc 9859)
and to adapt the companies own standards
 JAR-FCL 1
 EC 2042/2003 (EASA Part M)
Module 6: Safety Assurance (Specific Training on Quality Systems in Aviation)
 Basic Training on Quality Management  Is able to establish, implement and maintain the external
 Specific training in Quality Assurance company’s quality assurance programme
Module 7: Specific Safety Management Training
 Basic Training on Safety Management  Is able to establish, implement and maintain the external
 ICAO-Requirements to SMS company’s safety management system includ-
(ICAO Doc. 9859: Safety Management Manual) ing the safety assurance activities
Module 8: FSO-Training
 Processing of feedback reports and  Is able to establish, implement and maintain the …
 Procedures for evaluation of safety relevant (if appli- accident prevention and flight safety pro-
cable: FDM) evaluation data and initiation of meas- gramme
ures (proposals for measures)
Module 9: Auditor’s-Training
 Conduction and reporting of inspections and audits  Is able to conduct, evaluate and document SQM
 Process for implementation and monitoring of ac- audits and to initiate measures according to the
tions company procedures
Module 10: Inspector’s Training
 Conduction and reporting of inspections  Is able to conduct, evaluate and document SQM
 Process for implementation and monitoring of ac- inspections and to initiate measures according
tions to the company procedures

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- Safety Bulletin Safety- & Quality-Manager
mentation Changes
Urgent Communication of conclusions from Safety Bulletin Respective Postholder / FSO
Feedback & Reports, FDM, etc
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 Flight Safety Officer
Letter (monthly)
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.

Initiate change  identify need for change within SQMS- employee
Manual
 submit request in written form to S&Q
Manager
Verify need for  … Safety- & Quality-
change Manager
Revise SQMS-Manual  … …
Crosscheck and re-  compatibility with standards …
lease  harmonisation with other documents
 viability & appropriateness
 assessment of risks Chapter 3.2 Risk-
Assessment
 ensure traceability of changes
Initiate document  submit revised pages FOCA Form “PRA” …
evaluation by FOCA  OM Revision com-
pliance list
Distribute document  Add effective date Distribution list …
 distribute new version (also to FOCA)
 ensure withdrawal if necessary
 instruct employees
Up-date document /  … document user
manual
…  …
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)
…
1
Each responsible person ensures that
 changes of the documents are communicated to all people concerned
 necessary changes of internal documents are made based on amendments of external
documents
 invalid / overridden versions are clearly identified as such
 overridden documents are stored to ensure the necessary traceability – if necessary.
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 Accountable Man- 5 years
managers ager
Management evalua- Accountable Man- 5 years
tion report ager
Individual feedback 5 years
reports
Audit reports S&Q-Manager 5 years
List of inspections 5 years
performed
Employees introduc-
tion programme
Attendance records of
Safety & Quality Man-
agement System train-
ing
List of pending items
Report monitoring tool
Company Risk As- Accountable Man-
sessment ager
Project Risk Assess- Project Manager
ment
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 AMC OPS X.035
in which an operation is being conducted against the way in (4.3.1)
which the published operational procedures say it should be
conducted.
Hazard A condition or an object with the potential to cause ICAO Doc 9859
- injuries to personnel, ch. 4.2.3
- damage to equipment or structures,
- loss of material, or
- reduction of ability to perform a prescribed function.
Inspection The primary purpose of a quality inspection is to observe a par- AMC OPS X.035
ticular event/action/document etc., in order to verify whether (4.2.1)
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
ICAO SMM, Doc.
the organisation. Talking to workers and supervisors, witnessing
9859 (1st Ed./2006)
actual work practices, etc. in a non-structured way
(10.3.6)
Mitigation Designated measures to address the hazard and bring under ICAO Doc 9859
organizational control the safety risk probability and severity of ch. 5.7.1
the consequences of the hazard.
The measures taken to eradicate a hazard or to reduce the se- ICAO SMS Course
verity or likelihood of a risk (avoidance, reduction, segregation of
exposure).
Quality Part of Q-Management focused on providing confidence that ISO 9000
Assurance quality requirements will be fulfilled
Probability The likelihood that an unsafe event or condition might occur. ICAO Doc 9859
ch. 5.4.2
Quality Part of quality management focused on increasing the ability to ISO 9000
Improvement fulfil quality requirements
Quality Coordinated activities to direct and control an organisation with ISO 9000
Management 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

Term Definition Reference

Quality Something sought, or aimed for, related to quality ISO 9000
Objectives 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
Quality Part of Q-Management focused on setting quality objectives and ISO 9000
Planning specifying necessary operational processes and related re-
sources to fulfil the quality objectives.
Quality Control Part of Q-Management focused on fulfilling quality requirements ISO 9000
Quality Policy Overall intentions and direction of an organisation related to ISO 9000
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
Risk The consequence of hazard, measured in terms of predicted ICAO Doc 9859
probability and severity, taking as reference the worst foreseeable ch. 5.2.8
situation.
Safety Safety is the state in which the possibility of harm to persons or ICAO Doc 9859
of property damage is reduced to, and maintained at or below, ch. 2.2.4
an acceptable level through a continuing process of hazard iden-
tification and safety risk management.
Safety perform- Short-term, measurable objectives reflecting the safety perform- ICAO Doc 9859
ance indicators ance of an SMS expressed in numerical terms. ch. 6.6.5
They should be obvious, measurable and linked to the safety
concerns of an SMS
Safety perform- Safety performance target values are long-term, measurable ICAO Doc 9859
ance targets objectives reflecting the safety performance of an SMS. ch. 6.6.8
Safety performance target values are expressed in numerical
terms; they should be obvious, measurable, acceptable to
stakeholders and linked to the safety performance indicator
Safety require- The safety requirements should be satisfied in terms of opera- ICAO SMS Course
ments tional procedures, technology and systems, programmes, and
contingency arrangements (=measures)
Safety Risk Man- The identification, analysis and elimination, and/or mitigation of Based on
agement the safety risks of the consequences of hazards that threaten the ICAO Doc 9859
capabilities of an organization, to a level as low as reasonably ch. 5.3.1
practicable (ALARP)
System Safety The circumstance that permit hazards of a like nature to exist. ICAO SMS Course
Deficiency
Severity The possible consequences of an unsafe event or condition, ICAO Doc 9859
taking as reference the worst foreseeable situation 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 AMC OPS X.035
A person acceptable to the Authority who has authority for en- (2.1 i)
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
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 AMC OPS X.035
The manager, acceptable to the Authority, responsible for the (2,1 iii)
management of the Quality System, monitoring function and
requesting corrective actions.
SM Safety Manager ICAO Doc 9859
(App. 1 to ch. 5)
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.”
SQM Safety & Quality Manager NIL

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

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Guideline for the Application of

the SQMS-Basic Structure

Basic Structure for a

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

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

How to use this document:

Introduction / Note - 24.02.2010 - M. Friedli Page 2 of 53

Operators who additionally want to achieve an approval as a FTO/TRTO (according to JAR-FCL 1

Introduction / Note - 24.02.2010 - M. Friedli Page 3 of 53

Safety Management System

Existing Guidance Material

 Appointment of key safety personnel Organisation, QS-related responsibilities

Safety Risk Management:

 Continuous improvement of the SMS Management Evaluation

 Safety communication Accident Prevention & Flight Safety Pro-

Safety & Quality

Issue 2 / Revision 0 / 24.02.2010

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11.1. Purpose of Management Evaluation........................................................................................... 42

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0.1. Record of Revision

0.2. Record of Temporary Revision

0.3. List of Effective Pages

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1. Safety/Quality Policy, Organisation and Documentation

1.1. Safety and Quality Policy

Reporting Culture Flexible Culture

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

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1.1.1. Relevant external Standards

1.1.2. Safety and Quality Objectives (Policy Deployment)

1.2. Safety & Quality Management Organisation & Accountabilities

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Issue 2 / Revision 0 / 24.02.2010 - M. Friedli Page 12 of 53

Nominated Postholders, Continuing Airworthiness Manager:

1.2.2. Safety Manager:

1.2.3. Quality Manager:

1.2.4. Safety Review Board

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1.2.5. Safety Action Group

The safety action group must:

1.2.6. Flight Safety Officer FSO

1.3. Purpose of the Safety & Quality Management System

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Element of Responsible Explanation Reference

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2. Introduction to Safety & Risk Management

2.1. Distinction between Quality Management and Safety Management Systems

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

2.3. Relation between Risk-Management and Assurance Activities

Safety Risk Management Safety Assurance

Continuous Feedback & Investi-

2.4. Mitigation / Reduction of Risks

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2.5. Paradigm Change

2.5.1. Reactive Safety Management

2.5.2. Pro-active Safety Management

2.5.3. Predictive Safety Management

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3.1. Levels of Risk Management

Level Purpose Process

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