Example Ltd.

Quality System

Guideline
How to establish a

Quality System(QS)
for

FTO/TRTOs and FSTD-Operators

According to:
• JAR-FCL 1 (Amendment 7 / 1.12.2006)
• JAR-FCL 2 (Amendment 6 / 1.2.2007)
• JAR-FSTD A (NPA 11) / 6.4.2007
• JAR-FSTD H (NPA 12) / 6.4.2007

Feedback to author: m.friedli@procede.ch

Note:
This guideline "How to establish a Quality System" is not binding!
The intention is to provide ideas and possible solutions to build up a Quality System. There are
different possibilities to establish an effective and compliant System. Every company has to find
out its own way!
This document serves primarily as guidance material ("fil rouge") to establish a Quality System.

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 further explanation.

In addition to this guideline, FOCA provides separate and specific checklist "Self-Assessment for
Q-Systems acc. to JAR-FCL 1 / 2 incl. JAR-FSTD A / H"
which reflect the minimum requirements.
This checklist defines WHAT has to be part of a JAR-compliant Quality-System. The intention is by
means ot the use of this list of minimum requirements to catalyse the certification for both: the
FTO / TRTO and the Authority.

Introduction / Note – 17.05.2008 Page 1 of 27

 Example Ltd. Quality System

Legal background
Relevant legal Requirements:

Part M
EASA
A.025

H.025
FSTD

FSTD
1.055

2.055

1.035

3.035
JAR-

JAR-

JAR-

JAR-

JAR-
OPS

OPS
JAR
FCL

FCL

712
Operation X X
FTO X X X
Airplane

TRTO X X X
FSTD-Operation X
Operation X X
FTO Heli X X X
TRTO Heli X X X
Heli

FSTD-Operation Heli

Conclusion:
It is strongly recommended to establish an integrated Q-System covering all activities of the or-
ganisation in a separate Quality System Manual. This approach enhances the flexibility for the or-
ganisation, avoids redundancies and contradictions, facilitates the document control and increases
the acceptance on the level of employees.
This Quality System would consist of all general quality system relevant activities according all
relevant legal requirements. Specific aspects such as policies, processes, procedures and respon-
sibilities 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 such as CAME, MOE, FTO-Manual. In such
cases it is of up most importance that this is referenced in the main Quality System.
In the respective document such as CAME, MOE, FTO-Manual reference shall be made to the
main Quality System.
Where the approved continuing airworthiness management organisation is approved in accor-
dance with another Part, the Quality System may be combined with that required by the other Part,
e.g. Part 145 (see EASA Part-M 712 (d)).
In case of commercial air transport the Quality System according to EASA Part-M 712 (e) shall be
an integrated part of the operator's Quality System.

Legal Background – 17.05.2008 Page 2 of 27

 Example Ltd. Quality System

Quality System

(QS)

Issue 1
Revision 5 / 17.05.2008

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 3 of 27

 Example Ltd. Quality System

Content
1. System of Amendment...........................................................................................................5
1.1. Record of Revision........................................................................................................................ 5
1.2. Record of Temporary Revision ..................................................................................................... 5
1.3. List of Effective Pages................................................................................................................... 5
2. Quality Policy ..........................................................................................................................6
2.1. Quality Policy ................................................................................................................................ 6
2.2. Relevant external Standards......................................................................................................... 6
2.3. Internal Documents (internal Standards & Procedures) ............................................................... 6
2.4. Policy Deployment ........................................................................................................................ 6
3. Concept of Quality System ....................................................................................................7
3.1. Purpose of the Quality System ..................................................................................................... 7
3.2. Overview over the EXAMPLE Ltd.Quality System........................................................................ 7
3.3. Core Elements of the Quality System ........................................................................................... 8
4. Organisation, Responsibilities & Duties ..............................................................................9
5. Inspections............................................................................................................................10
5.1. Inspection Procedure .................................................................................................................. 10
5.2. Qualification of internal Inspectors.............................................................................................. 10
5.3. List of internal Inspectors ............................................................................................................ 11
5.4. Inspection Scopes....................................................................................................................... 11
6. Quality Audits .......................................................................................................................12
6.1. Audit Procedure .......................................................................................................................... 12
6.2. Qualification of Auditors .............................................................................................................. 13
6.3. List of internal Auditors................................................................................................................ 13
6.4. Audit Scopes ............................................................................................................................... 13
6.5. Classification of Audit Findings ................................................................................................... 13
7. QTG Running, QTG Checking and Fly-out Procedures ....................................................14
7.1. Procedure.................................................................................................................................... 14
7.2. Qualification of Checkers ............................................................................................................ 14
7.3. List of FSTD Checkers ................................................................................................................ 15
8. Feedback & Reporting..........................................................................................................15
8.1. General........................................................................................................................................ 15
8.2. Kind of Reports ........................................................................................................................... 15
8.3. Feedback about Ground Instruction............................................................................................ 16
8.4. Feedback about Flight Instruction............................................................................................... 16
8.5. FSTD Defect Reporting System.................................................................................................. 16
9. Subcontractor / Supplier Management...............................................................................17
9.1. Evaluation of Subcontractors / Suppliers .................................................................................... 17
9.2. Supervision of Subcontractors / Suppliers .................................................................................. 18
10. Management Evaluation.......................................................................................................19
10.1. Purpose of Management Evaluation........................................................................................... 19
10.2. Process of Management Evaluation ........................................................................................... 19
10.3. Data to be evaluated ................................................................................................................... 20
11. Quality System Training and Promotion ............................................................................21
11.1. Initial Training.............................................................................................................................. 21
11.2. Recurrent Training ...................................................................................................................... 22
11.3. Q-System Training Records........................................................................................................ 22
12. Document Control ................................................................................................................23
12.1. Control of Specifications / prescriptive Documents .................................................................... 23
12.2. Control of Quality System related Records................................................................................. 25
12.3. EDP: Back-up Concept ............................................................................................................... 25
13. Definitions, Abbreviations (Terminology) ..........................................................................26
13.1. Definitions.................................................................................................................................... 26
13.2. Abbreviations .............................................................................................................................. 27

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 4 of 27

 Example Ltd. Quality System

1. System of Amendment
Note:
If this Quality System is part of OM A, chapter 3, then the amendment process is defined in OM A,
chapter 0.
If the Quality System is kept as a separate Manual, the process for revision of the Quality System
should be defined in chapter 12.1.2 "Revision Procedure of the Quality Manual” and the following
tables have to be established:

1.1. Record of Revision

Issue Number Revision Number Effective Date Entered by Date
1 … 17.05.2008

1.2. Record of Temporary Revision

Issue Revision Effective Entered Date Validity / Removed Date
Number Number Date by Cancellation by

1.3. List of Effective Pages

Page Issue Revision Effective Page Issue Revi- Effective
Number Number Number Date Number Number sion Date
Number
1 1 5 17.05.2008
2 1 5 17.05.2008
3 1 5 17.05.2008
4 1 5 17.05.2008
5 1 5 17.05.2008
6 1 5 17.05.2008
7 1 5 17.05.2008
8 1 5 17.05.2008
9 1 5 17.05.2008
… … … …

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 5 of 27

 Example Ltd. Quality System

2. Quality Policy
Æ see IEM No. 1 to JAR-FCL .055 (2) and ACJ No.1 to JAR-FSTD .025 (2.2)

2.1. Quality Policy

Æ Describe the quality policy. This policy must also express the commitment to the standards
listed in 2.2 and 2.3.

2.2. Relevant external Standards

• JAR-FCL 1 / 2
• JAR-FSTD A / H
• EASA Regulation No 2042/2003 Part-M
• Swiss Air Law
• FOCA Circular Advisories
•
• …

2.3. Internal Documents (internal Standards & Procedures)

The implementation of the following standards is monitored by means of the Quality System:
• Operations Manual Parts A, B, C and D
• Training Manual
• FSTD Working procedures
• Quality Manual
• …

2.4. Policy Deployment

Æ Define how the 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 defini-
tion and communication of annual goals are part of it.
Æ To be effective, corporate goals should always be followed by an action plan (who, what, until
when?).
Æ 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
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. ….

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 6 of 27

 Example Ltd. Quality System

3. Concept of Quality System

3.1. Purpose of the Quality System

Æ See IEM No. 1 to JAR-FCL .055 (3)(6) and ACJ No.1 to JAR-FSTD .025 (2.3)(3.2)

The Quality System of EXAMPLE Ltd.

• monitors the compliance, implementation, effectiveness and efficiency of company specific
policies, standards and procedures for training, FSTD-Operations and the continuing air-
worthiness management of the aircrafts (as listed in chapter 2.2 and 2.3)
• ensures a systematic recording and analysis of non-compliances and occurrences
• ensures a systematic implementation and monitoring of corrective actions
• ensures an evaluation of the overall effectiveness of the organisation in achieving stated
objectives

3.2. Overview over the EXAMPLE Ltd. Quality System

Q-Manager

Quality Management mo
Policy Evaluation nit
ori
ng

Objectives,
Goals, Analysis
Data
Resources Evaluation
Corrective,
Recording &
preventive
Reporting
actions

Legal
Legal Fulfilment
Fulfilment
Training,
Training,Operation,
Operation,Maintenance of
Require-
Require- Maintenance
(as specified in OM, TM, CAME and
oflegal
legalre-
re-
ments
ments
(as specified in OM, TM, CAME and
FSTD quirements
quirements
FSTDworking
workingprocedures)
procedures)

Incidents, accidents, non-conformities,

non-compliances, irregularities

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 7 of 27

 Example Ltd. Quality System

3.3. Core Elements of the Quality System

Element of QS Responsible Explanation Reference
Policy AM • Commitment quality QM chapt. x
Strategy AM • rework of strategy during October QM chapt. x
Resources based on management evaluation
Annual Goals • definition of yearly budget and goals
Training HT • defining of internal standards OM A to D
CFI • ensuring conformity with internal Training Man-
CGI standards and requirements by ual
CSFI means of controlling and supervi- CAME
Maintenance CSTI sion (inspections!) of the daily activi- QM chapt 5
FSTD-Operation CAM ties
FSTD Focal Point
• analysis of feedback & reports QM chapt. 8
• supervision of relevant subcontrac- QM chapt. 9
tors
• initiation and monitoring of imple-
mented actions
Feedback & Re- All Employees • identifies and reports divergences, QM chapt. 8
porting nonconformities and chances
Audits QM • independent auditors monitor the QM chapt. 6
Auditors adherence to standards and re-
quirements by means of audits
Inspections HT • ensuring conformity with internal QM chapt. 5
CFI standards and requirements by
CGI means of controlling and supervi-
CSFI sion (inspections!) of the daily activi-
CSTI ties
CAM
FSTD Focal Point
QM
Data evaluation AM • collation and evaluation of data in QM chapt. 10
HT the specific field of activity to iden-
CFI tify trends and systematic gaps.
CGI • conclusions resulting form the data
CSFI evaluation
CSTI
CAM
FSTD Focal Point
QM
Controlling / AM • evaluation of overall effectiveness of QM chapt. 10
Management (in collaboration organisation and achievement of
Evaluation with HT, CFI, goals based on data evaluation
CGI, CSFI,
CSTI, CAM,
FSTD Focal Point
and QM)

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 8 of 27

 Example Ltd. Quality System

4. Organisation, Responsibilities & Duties

Æ see IEM No. 1 to JAR-FCL .055 (2)(4)(6.6)(12) and ACJ No.1 to JAR-FSTD .025 (2.1), (2.2.2),
(2.4)
Æ To avoid redundancies and contradictions, this chapter should refer to the relevant chapter in
the Operations Manual. In this case the definition in the Quality System could be as follows:

The company's organisational structure (organisation chart) and the Quality System related roles,
duties, responsibilities, accountabilities and authorities of managing staff such as:
• Accountable Manager (AM)
• Head of Training (HT)
• Chief Ground Instructor (CGI)
• Chief Flight Instructor (CFI)
• Chief Synthetic Flight Instructor (CSFI)
• Chief Synthetic Training Instructor (CSTI)
• Continuing Airworthiness Manager (CAM)
• Quality Manager (QM)
• FSTD Focal Point
• internal Auditors (Æ may also be defined in the audit process)
• internal Inspectors (Æ may also be defined in the inspection process)
are specified in the Operations Manual Part A, chapter 1.XX.

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 Quality System related responsibilities and competences should to be as-
signed:

Accountable Manager:
• He has the corporate authority for ensuring that all operations and maintenance activities
can be financed and carried out to the standard required by the Authority, and any addi-
tional requirements defined by the operator.
• He establishes a formal written Quality Policy Statement.
• He has the overall responsibility for the organisations Quality System including the fre-
quency, 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.

HT, CGI, CFI, CSFI, CSTI, CAM, FSTD Focal Point:

• They supervise their respective field of activities and conduct and document inspections.
• They implement corrective actions.
• They conduct periodically a data evaluation as an input to the management evaluation.

Quality Manager:
• He has direct access to the Accountable Manager.
• He has access to all parts of the operator’s and, as necessary, any sub-contractor’s organi-
sation.
• He verifies by independent quality assurance activities in the fields of training, maintenance
and FSTD operations that the standards required by the Authority, and any additional re-
quirements defined by the organisation, are adequate and being carried out under the su-

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 9 of 27

 Example Ltd. Quality System

pervision of the relevant responsible managers. For this purpose he plans and ensures the
implementation of the quality assurance activities.
• He monitors the implementation and completion of corrective action.
• He provides management with an independent assessment of corrective action, implemen-
tation and completion.
• He evaluates the effectiveness of corrective action through the follow-up process.
• He conducts periodically a data evaluation as an input to the management evaluation.

5. Quality Inspections
Æ See IEM No. 1 to JAR-FCL .055 (10) and ACJ No.1 to JAR-FSTD .025 (4.2)

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.

5.1. Inspection Procedure

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

Step Remarks Tool Responsibility

Planning & Prepara- • ad hoc planning …
tion • study relevant procedures
• consider feedback & reporting
system
Execution • …. …
Reporting • performed inspections are re- List of inspections
corded on list of inspections to performed
ensure coverage of all scopes
Initiation of meas- • in case of need initiate preven- List of pending items …
ures tive and/or corrective action
• who, what, due date?
Monitoring • verify implementation of meas- …
ures

5.2. Qualification of internal Inspectors

Æ Define the minimum requirements of qualification for internal inspectors.
Æ 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:
• familiar with the type of training conducted
• having knowledge of FSTD requirements and operation
• having knowledge of maintenance of aircrafts

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 10 of 27

 Example Ltd. Quality System

5.3. List of internal Inspectors

• The Accountable Manager, the Head of Training, the FSTD Focal Point, ………………. and
the Quality Manager perform inspections in their field of activity to monitor the compliance
with and appropriateness of internal standards.

5.4. Inspection Scopes

Æ Relevant FCL scopes are defined in IEM No.1 to JAR-FCL X.055 (10)
Æ Relevant FSTD scopes are defined in ACJ No.1 to JAR-FSTD .025 (4.2)
Æ If relevant the following matrix should be supplemented by scopes required by EASA Part M
712

Scope FCL FSTD topics Frequency Responsibility

(at least)
Actual flight train- X • … •… •…
ing • … •…
• … •…
Actual ground X • … •… •…
training • … •…
• … •…
Training Stan- X • … •… •…
dards • … •…
• … •…
Maintenance of X • … •… • CAM
Aircraft • … •…
• … •…
Technical Stan- X • … •… • CAM
dards Aircraft • … •…
• … •…
Maintenance of X • • • FSTD Focal
FSTD Point
Technical Stan- X • • • FSTD Focal
dards FSTD Point
Actual FSTD X • … • … • FSTD Focal
Operation • … • … Point
• … • …
Flight Simulator X • … • … • FSTD Focal
Safety Features • … • … Point
• … • …
… • … • … •…

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 11 of 27

 Example Ltd. Quality System

6. Quality Audits
Æ See IEM No. 1 to JAR-FCL .055 (11) to (15) and ACJ No.1 to JAR-FSTD .025 (4.5) to (4.7)
6.1. Audit Procedure
Æ Specify the company specific process
Æ Remark: It is strongly recommended that the audit plan is not a part of the Q-System, but is pub-
lished as a separate document that can be up-dated easily without submission to the Authority.

Step Remarks Tool Responsibility

Planning • establish audit plan in December Audit plan Quality Manager
• consider former List of auditors
- 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 inde-
pendence & qualification
Preparation • study relevant procedures OM, TM Auditor
• consider feedback & reporting sys- CAME, Q-Manual
tem, former audit reports, former List of pending items
actions Audit checklist
Execution • by means of different techniques: Audit checklist …
- interviews
- witnessing of activities
- examination of records
- review of documents
Reporting • storage… Tool "audit report" …
Initiation of • in case of need initiate preventive List of pending items …
measures and/or corrective action
• who, what, due date?
• classify finding see definition in 6.5
classification of find-
ings
Monitoring of • verify implementation of measure …
implementation
Monitoring of • …
effectiveness
... •

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 12 of 27

 Example Ltd. Quality System

6.2. Qualification of Auditors

Æ Define the minimum requirements of qualification for Auditors.
Æ Note that contracted auditors fall under the same category, i.e. the same qualification require-
ments and shall also be put on the List of internal Auditors.

The internal auditors of EXAMPLE Ltd. fulfil at least the following qualification criteria:
• attended a specific auditors course (note: course can be provided internal or external)
• familiar with the type of training conducted
• having knowledge of FSTD requirements and operation
• having knowledge of maintenance of aircrafts

6.3. List of internal Auditors

• The auditors (including their scopes of activity) are listed by name on the audit plan.

6.4. Audit Scopes

Æ Relevant scopes are defined in IEM No.1 to JAR-FCL X.055 (14).
Æ Relevant FSTD scopes are defined in ACJ No.1 to JAR-FSTD .025 (4.6)

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

Findings resulting from audits have to be classified as follows
• Level 1: Safety is affected* Æ no further operation / activity until closure of finding
• Level 2: Safety might be affected* Æ to be closed within due date (max. 2 months)
• Level 3: Safety not affected but of importance for company Æ to be closed within due date
agreed

*according EASA Part M (M. A. 716):

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 13 of 27

 Example Ltd. Quality System

7. QTG Running, QTG Checking and Fly-out Procedures

7.1. Procedure
Æ Specify the company specific process
Æ Remark: the internal qualification plan FSTD must not be part of the Q-System.
It is preferably maintained as a separate document.
Step Remarks Tool Responsibility
Planning of QTG • establish FSTD qualification plan internal qualification FSTD Focal
Runs, Checks after each FOCA qualification plan FSTD Point
and Fly-outs • consider former List of auditors
- qualification plan
- changes in the configuration
- changes in regulatory requiremts.
- changes in the activities
- trends
• follow-up audits when necessary
• QTG running and fly-outs to be
scheduled for each FSTD at least
every 3 months ("quarterly tests")
• assign responsible checker(s)
Preparation • study relevant procedures Master QTG Checker
• consider logbook-, maintenance- QTG running proce-
and HIL-entries, feedback & report- dures
ing system, former reports, former List of pending items
actions
Execution • establish binder with quarterly re- QTG running proce- …
run protocols, maintenance reports dures
and internal qualification plan Master QTG
FSTD (hard copies required by Fly-out procedures
FOCA)
Reporting • storage… Tool "FSTD report" …
• up-date audit plan FSTD audit plan
Initiation of • in case of need initiate preventive List of pending items …
measures and/or corrective action
• who, what, due date?
Monitoring of • verify implementation of measure …
implementation
Monitoring of • …
effectiveness

7.2. Qualification of Checkers

Æ Define the minimum requirements of qualification for checkers (i. e. Evaluation Pilots).

The checkers of EXAMPLE Ltd. fulfil at least the following qualification criteria:
• having knowledge of FSTD requirements and operation
• being familiar with the company specific audit and QTG procedures
• qualified in crew training procedures and type rated on the aircraft being simulated

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 14 of 27

 Example Ltd. Quality System

7.3. List of FSTD Checkers

• The FSTD checkers are listed by name and qualification on the specific FSTD internal
qualification plan.

8. Feedback & Reporting

Æ See IEM No. 1 to JAR-FCL .055 (7) and ACJ No.1 to JAR-FSTD .025 (3.2.2)
Æ Specify the company specific processes to gather and treat employees' feedback. The proce-
dures listed in 6.1 reflect how such processes could be documented.

8.1. General
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.
Æ If in doubt Æ report it!

8.2. Kind of Reports

8.2.1. Occurrence Reports

Step Remarks Tool Responsibility
Establish report • describe the situation •… …
• use the designated forms
• assign report to the responsible
manager within 24 h
Sort and assign • give feedback to the issuer • List of pending …
report • assign responsible manager to items
realise action
• open item on “list of pending
items”
Analyse situation • ensure reporting to FOCA within • List of pending …
Initiate measure xxx hours items
• initiate preventive or corrective
action (who, what, due date)
Monitor realisa- • • …
tion of measure
Close measure • close measure on “list of pending • List of pending …
items” items
Monitor effec- • during spot checks / inspections • …
tiveness of or audits
measure • is the improvement sustainable?
• did we get the attained success?
Æ specify the procedures for all the company specific kind of feedback and reporting in the subse-
quent chapters

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 15 of 27

 Example Ltd. Quality System

8.3. Feedback about Ground Instruction

Step Remarks Tool Responsibility
Gather feedback • • Feedback "Theory" Ground instr.

Consolidate data • • …

Analyse situation • • Head of Train-

Initiate measure ing
Monitor realisa- • • …
tion of measure
Close measure • • List of pending …
items
Monitor effec- • • …
tiveness of
measure

8.4. Feedback about Flight Instruction

Step Remarks Tool Responsibility
Gather feedback • • Feedback "…." Flight instr.

Consolidate data • • …

Analyse situation • • Head of Train-

Initiate measure ing
Monitor realisa- • • …
tion of measure
Close measure • • List of pending …
items
Monitor effec- • • …
tiveness of
measure

8.5. FSTD Defect Reporting System

Step Remarks Tool Responsibility
Establish report • describe the situation •… …
• use the designated form
• assign report to the responsible
manager
• within 24 h
Sort and assign • • …
report
Analyse situation • • List of pending …
Initiate measure items
… • • …
… • • …

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 16 of 27

 Example Ltd. Quality System

9. Subcontractor / Supplier Management

Æ See IEM No. 1 to JAR-FCL .055 (20) and ACJ No.1 to JAR-FSTD .025 (5)

9.1. Evaluation of Subcontractors / Suppliers

Æ The evaluation before ordering is not a requirement but strongly recommended.
Æ Written agreements should be established according to IEM No. 1 to JAR-FCL .055 (20 and
ACJ No.1 to JAR-FSTD .025 (5.1.2)
Æ New providers can lead to new risks. That’s why an initial risk assessment should be conducted

The most important prerequisite for a subcontractor / supplier evaluation is a clear definition of the
(safety and quality) relevant requirements. Therefore written agreements that include the quality
and safety requirements to be delivered have to be established.

Step Remarks Tool Responsibility

Definition of re- • 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 •
•

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 17 of 27

 Example Ltd. Quality System

9.2. Supervision of Subcontractors / Suppliers

Æ The monitoring concept of Subcontractors should be based on the risk assessment of the pro-
viders.
Æ 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 relevant activities of EXAMPLE Ltd. providers are monitored by the following means. These
are the general monitoring activities.

Service / Kind of supervision Frequency Responsibility

Product
Training • ensuring the validity of necessary ap- … Head of Train-
proval of organisation, instructor and ing
FSTD (JAR-FCL … and JAR-FSTD …)
• trainee's feedback report Each training Participants
• treatment of feedback according to chap-
ter 8 Feedback & Reporting
• Inspection of training provided … CGI, CFI,
CSFI, CSTI
Maintenance of • Monitoring concept according to CAME … CAM
Aircraft • visual check of the aircraft and check of before each Pilot
Tech Log flight
•…
Dry lease of • Check qualification of FSTD Before use
FSTD • Daily check after dry
lease
Maintenance of • ensuring the validity of necessary ap- … FSTD Focal
FSTD proval …) Point
• verification of service report of provider FSTD Focal
Point
• check of function as release to service FSTD Focal
Point
FSTD Manual • check compatibility / consistency with FSTD Focal
preparation manufacturer data and JAR-FSTD Point
FSTD Navigation • check up-date Within 3 FSTD Focal
Data months Point
FSTD Spare • Provision and validity of certificate of each delivery FSTD Focal
Parts spare part during the arrival of part Point
• Check of function of spare part after in- each installa- FSTD Focal
stallation / fitting tion Point
… •
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.

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 18 of 27

 Example Ltd. Quality System

10. Management Evaluation

Æ IEM No. 1 to JAR-FCL .055 (18) and ACJ No.1 to JAR-FSTD .025 (4.9) list some minimum re-
quirements for the indicators, which have to be evaluated.
Æ It is the Accountable Manager's responsibility to define the frequency and the criteria (see JAR-
FCL .055 (18) and ACJ No.1 to JAR-FSTD .025 (4.9)). We strongly recommend fixing criteria /
indicators that cover all important key performance indicators, which allow an overall evaluation
of the success of the company.
Æ A modern company derives the key performance indicators from the strategic goals (Balanced
Scorecard Approach!).
Æ Evaluations of a Management System according to ISO 9001:2000 have to consider Key Indica-
tors of the value adding processes.
Æ 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)

10.1. Purpose of Management Evaluation

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 Quality System
• 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.

10.2. Process of Management Evaluation

Step Remarks Tool Responsibility
Perform data • every 6 month Data to be evaluated Responsible
evaluation • periodical collation and evalua- see chapter 10.3 managers ac-
tion of received reports and other cording to 10.3
data
• identification of trends systematic
deviations & cluster
• suggestion of additional meas-
ures
•…
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 nec-
essary resources
• initiate measures
•…
Monitor imple- • verify completion and success of List of pending items Accountable

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 19 of 27

 Example Ltd. Quality System

mentation of initiated measures Manager

measures •…
… •

10.3. Data to be evaluated

Æ Specify the sources of information to be evaluated by the respective responsible manager

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 6
• overall effectiveness of the organisation (sum-
mary)
•…
Quality Manager • status of the implementation and effectiveness 6
of corrective and preventive actions
• audit results
• inspection results
•…
Head of Training • results from checks and examinations 6
• customer satisfaction
Chief Ground Instruc- • trainees' feedback 6
tor • inspection reports
•…
Chief Flight Instructor • trainees' feedback 6
• inspection reports
•…
Chief Synthetic Flight • trainees' feedback 6
Instructor • inspection reports
•…
Chief Synthetic Train- • trainees' feedback 6
ing Instructor • inspection reports
•…
CAM • tech. log 6
• work reports
• effectiveness of maintenance programme
•…
FSTD Focal Point • tech. log 6
• work reports (3 for QTG runs &
• effectiveness of maintenance programme Fly-outs)
• QTG Run and Fly-out reports
… •…

Æ the frequency of 12 months may not be exceeded!

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 20 of 27
 Example Ltd. Quality System

11. Quality System Training and Promotion

Æ See IEM No. 1 to JAR-FCL .055 (21)(22) and ACJ No.1 to JAR-FSTD .025 (6)
Æ All employees have to be trained appropriately and tailored to their function on the Quality Sys-
tem.
Æ Specify the company specific topics to be trained to the employees.
Æ Make sure that training records are established and stored

The goal of the Quality System training is to sensitise the employees on all levels towards accident
prevention, flight safety and quality.
The Quality Manager establishes the necessary training tools and records.

11.1. Initial Training

Every new employee will – with respect on his function – be introduced in the company’s Quality
System by the Quality Manager.

11.1.1. Introduction to the Quality System:

CGI, CFI, CSFI, CSTI

Function
Ground Instructor

FSTD Focal Point

Quality Manager
Flight Instructor

Topics

Employees
Inspector
Auditor
ACM

HT

Quality Policy X X X X X X X X
Concept of Quality System X X X X X X X X
Organisation, Responsibilities X X X X X X X X
Inspections X X X X X X X
Audits
FSTD QTG-Runs, Fly-outs
Feedback & Reporting System
Subcontractor Management
Quality System Training
Management Evaluation
Document Control
Terminology, Abbreviations & Definitions

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 21 of 27

 Example Ltd. Quality System

11.1.2. Specific Training:

FSTD Focal Point

Quality-Manager
Safety-Manager
Function

Employee
Inspector
PH, CAM
Topics

Auditor
FSO
AM
JAR-FCL course
JAR-FSTD course X
EASA Part M
Specific Quality Manager Course X
Specific Auditor’s Training X X
…
…

11.2. Recurrent Training

Recurrent Training is based on safety and quality relevant conclusions / experiences / changes
resulting of evaluating of data gathered by the implemented Q-Assurance procedures.

Source Responsibility for Training

Quality System Documentation Changes Quality Manager
Feedback & Reports Relevant Manager
Audits Quality Manager
Management Evaluation Accountable Manager
Quality goals / Company goals Accountable Manager
Flight Safety relevant Conclusions (Flight Safety Letter)
…
…

The responsible person decides about the form of training (e.g. hand out, class room training, e-
mail)

11.3. Q-System Training Records

The manager responsible for training establishes records about class room training. The responsi-
bility for the storage of Quality System related training records is defined in 12.2.

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 22 of 27

 Example Ltd. Quality System

12. Document Control

Æ See IEM No. 1 to JAR-FCL .055 (8.2)(19) and ACJ No.1 to JAR-FSTD .025 (3.3.1 h)
Æ The procedures of how to control / manage internal and external documents that can undergo
changes usually are defined in OM A.

12.1. Control of Specifications / prescriptive Documents

Æ Avoid redundancies / contradictions to the OM A, chapter 0 and chapter 2

For all the internal Standards and Procedures (see chapter 2.3) we ensure, that the valid versions
are available in the right time at the right place. The amendment of the OM, TM and the CAME is
specified in the introduction part of the respective manual.

12.1.1. Control of External Documents

Document Responsible1 for Doc. Traceability of amendment
JAR-FSTD …
JAR-FCL …
EASA Part-M CAM
Airworthiness Directives Airplane CAM
Service Bulletins Airplane CAM
Airworthiness Directives FSTD FSTD Focal Point
Service Bulletins FSTD FSTD Focal Point
Contracts (supplier / sub-contractors)
FOCA Circular Advisories
…

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.

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 23 of 27

 Example Ltd. Quality System

12.1.2. Revision procedure of the Quality System Manual

Æ Necessary only if the Quality System is documented in a separate manual.

Step Remarks Tool Responsibility

Initiate change • identify need for change within employee
Quality System Manual
• submit request in written form
to quality manager
Verify need for •… Q-Manager
change
Revise Quality •…
Manual
Crosscheck and • compatibility with standards
release • harmonisation with other
documents
• viability
• appropriateness
• ensure traceability of changes List of revisions
List of effective pages
Initiate document • submit revised pages PRA
evaluation by FOCA •
Distribute document • finalise revision Distribution list
• distribute new version
• ensure withdrawal if neces-
sary
• instruct employees
… •
Up-date document / • Supplement list of revisions List of revisions document user
manual • Destroy obsolete documents
… •…

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 24 of 27

 Example Ltd. Quality System

12.2. Control of Quality System related Records

Æ Avoid redundancies / contradictions to the OM A, chapter 2
Æ Establish list of Quality System related records only

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 5 years
managers Manager
Management Accountable 5 years
evaluation report Manager
Individual feedback 5 years
reports
Audit reports Q-Manager 5 years
List of inspections 5 years
performed
Employees introduc- …
tion programme
Attendance records …
of Quality System
training
List of pending …
items
QTG-Run reports FSTD Focal Point 5 years
Fly-out reports FSTD Focal Point 5 years
…

12.3. EDP: Back-up Concept

Æ 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

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 25 of 27

 Example Ltd. Quality System

13. Definitions, Abbreviations (Terminology)

Æ Establish list of company specific definitions and abbreviations
Æ Avoid redundancy / contradiction with OM A, chapter 0
Æ The subsequent list consist of official definitions related to Quality Management

13.1. Definitions
Æ The subsequent list consist of official definitions related to Quality Management

Term Definition Reference

Audit An audit is a systematic and independent comparison of the IEM No.1 to
way in which an operation is being conducted against the way JAR-FCL .055
in which the published operational procedures say it should be (11)
conducted.
Inspection The primary purpose of a quality inspection is to observe a IEM No.1 to
particular event/action/document etc., in order to verify JAR-FCL .055
whether established operational procedures and requirements (10)
are followed during the accomplishment of that event and
whether the required standard is achieved.
Quality Coordinated activities to direct and control an organisation with ISO 9000:2000
Management regard to quality
NOTE 1: Direction and control with regard to quality generally includes establishment of the
quality policy and quality objectives, quality planning, quality control, quality assurance and
quality improvement
Quality Policy Overall intentions and direction of an organisation related to ISO 9000:2000
quality as formally expressed top management
NOTE 1: Generally the quality policy is consistent with the overall policy of the organisation
and provides a framework for the setting of quality objectives
Quality Something sought, or aimed for, related to quality ISO 9000:2000
Objectives NOTE 1: Quality objectives are generally based on the organisations quality policy
NOTE 2: Quality objectives are generally specified for relevant functions and levels in the
organisation
….
…

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 26 of 27

 Example Ltd. Quality System

13.2. Abbreviations
Abbreviation Definition Reference
AM Accountable Manager IEM No. 1 to JAR–
A person acceptable to the Authority who has authority for FCL .055 (1)
ensuring that all training activities can be financed and ACJ No.1 to JAR-
carried out to the standards required by the Authority, and FSTD .025
additional requirements defined by the FTO/TRTO or
FSTD Operator
HT Head of Training Appendix 1a to
CGI Chief Ground Instructor JAR–FCL .055
CFI Chief Flying Instructor (11)
CSFI Chief Synthetic Flight Instructor JAR-FCL 1.405
JAR-FCL 2.300
CSTI Chief Synthetic Training Instructor JAR-FCL 1.419
JAR-FCL 2.300
CAM Continuing Airworthiness Manager EASA Part-M
M. A. 706
CAME Continuing Airworthiness Management Exposition EASA Part-M
M. A. 704
CAMO Continuing Airworthiness Management Organisation EASA Part M
QM Quality Manager IEM No. 1 to JAR–
The manager, acceptable to the Authority, responsible for FCL .055 (1)
the management of the Quality System, monitoring func- ACJ No.1 to JAR-
tion and requesting corrective actions. FSTD .025
QTG Qualification Test Guide JAR-FSTD .005
(m)
MOE Maintenance Organisation Exposition EASA Part 145
…

Quality System Issue 1 / Revision 5 – 17.05.2008 Page 27 of 27