How to Establish Quality Sys QMS FTO-TRTO

Example Ltd. Quality System

Introduction / Note – 17.05.2008 of 27

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: [email protected] 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.


Legal Background – 17.05.2008 of 27

Legal background Relevant legal Requirements:

JAR

-FC

L 1.

055

JAR

-FC

L 2.

055

JAR

-FS

TD

A.0

25

JAR

FS

TD

H.0

25

JAR

-O

PS

1.03

5

JAR

-O

PS

3.03

5

EASA

Pa

rt M

71

2

Operation X X

FTO X X X

TRTO X X X

Airp

lane

FSTD-Operation X

Operation X X

FTO Heli X X X

TRTO Heli X X X

Hel

i

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.


Quality System Issue 1 / Revision 5 – 17.05.2008 of 27

Quality System

(QS)

Issue 1 Revision 5 / 17.05.2008



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



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 Number

Revision Number

Effective Date

Entered by

Date Validity / Cancellation

Removed by

Date

1.3. List of Effective Pages

Page Number

Issue Number

Revision Number

Effective Date

Page Number

Issue Number

Revi-sion Number

Effective Date

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 … … … …



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

2.1. Quality Policy 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 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.

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 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. ….



3. Concept of Quality System

3.1. Purpose of the Quality System 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

LegalRequire-ments

LegalRequire-ments

Fulfilment of legal re-quirements

Fulfilment of legal re-quirements

Training, Operation, Maintenance(as specified in OM, TM, CAME and

FSTD working procedures)

Training, Operation, Maintenance(as specified in OM, TM, CAME and

FSTD working procedures)

Management Evaluation

Quality Policy

Objectives, Goals,

Resources

Analysis

Corrective, preventive

actionsRecording &

Reporting

Incidents, accidents, non-conformities, non-compliances, irregularities

Data Evaluation

Q-Manager

monitoring



3.3. Core Elements of the Quality System

Element of QS Responsible Explanation Reference Policy AM • Commitment quality QM chapt. x Strategy Resources Annual Goals

AM • rework of strategy during October based on management evaluation

• definition of yearly budget and goals

QM chapt. x

Training Maintenance FSTD-Operation

HT CFI CGI CSFI CSTI CAM FSTD Focal Point

• defining of internal standards • ensuring conformity with internal

standards and requirements by means of controlling and supervi-sion (inspections!) of the daily activi-ties

• analysis of feedback & reports • supervision of relevant subcontrac-

tors • initiation and monitoring of imple-

mented actions

OM A to D Training Man-ual CAME QM chapt 5 QM chapt. 8 QM chapt. 9

Feedback & Re-porting

All Employees • identifies and reports divergences, nonconformities and chances

QM chapt. 8

Audits QM Auditors

• independent auditors monitor the adherence to standards and re-quirements by means of audits

QM chapt. 6

Inspections HT CFI CGI CSFI CSTI CAM FSTD Focal Point QM

• ensuring conformity with internal standards and requirements by means of controlling and supervi-sion (inspections!) of the daily activi-ties

QM chapt. 5

Data evaluation AM HT CFI CGI CSFI CSTI CAM FSTD Focal Point QM

• collation and evaluation of data in the specific field of activity to iden-tify trends and systematic gaps.

• conclusions resulting form the data evaluation

QM chapt. 10

Controlling / Management Evaluation

AM (in collaboration with HT, CFI, CGI, CSFI, CSTI, CAM, FSTD Focal Point and QM)

• evaluation of overall effectiveness of organisation and achievement of goals based on data evaluation

QM chapt. 10



4. Organisation, Responsibilities & Duties 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)

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 ( may also be defined in the audit process) • internal Inspectors ( 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-



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

Step Remarks Tool Responsibility Planning & Prepara-tion

• ad hoc planning • study relevant procedures • consider feedback & reporting

system

…

Execution • …. … Reporting • performed inspections are re-

corded on list of inspections to ensure coverage of all scopes

List of inspections performed

Initiation of meas-ures

• in case of need initiate preven-tive and/or corrective action

• who, what, due date?

List of pending items …

Monitoring • verify implementation of meas-ures

…

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: • familiar with the type of training conducted • having knowledge of FSTD requirements and operation • having knowledge of maintenance of aircrafts



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

712 Scope FCL FSTD topics Frequency

(at least) Responsibility

Actual flight train-ing

X • … • … • …

• … • … • …

• …

Actual ground training

X • … • … • …

• … • … • …

• …

Training Stan-dards

X • … • … • …

• … • … • …

• …

Maintenance of Aircraft

X • … • … • …

• … • … • …

• CAM

Technical Stan-dards Aircraft

X • … • … • …

• … • … • …

• CAM

Maintenance of FSTD

X • • • FSTD Focal Point

Technical Stan-dards FSTD

X • • • FSTD Focal Point

Actual FSTD Operation

X • … • … • …

• … • … • …

• FSTD Focal Point

Flight Simulator Safety Features

X • … • … • …

• … • … • …

• FSTD Focal Point

… • … • … • …



6. Quality Audits 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 Specify the company specific process Remark: It is strongly recommended that the audit plan is not a part of the Q-System, but is pub-lished as a separate document that can be up-dated easily without submission to the Authority.

Step Remarks Tool Responsibility Planning • establish audit plan in December

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

• follow-up audits when necessary • all aspects/scopes at least 1x

within 12 months • assign auditor(s): consider inde-

pendence & qualification

Audit plan List of auditors

Quality Manager

Preparation • study relevant procedures • consider feedback & reporting sys-

tem, former audit reports, former actions

OM, TM CAME, Q-Manual List of pending items Audit checklist

Auditor

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

Audit checklist

…

Reporting • storage… Tool "audit report" … Initiation of measures

• in case of need initiate preventive and/or corrective action

• who, what, due date? • classify finding

List of pending items see definition in 6.5 classification of find-ings

…

Monitoring of implementation

• verify implementation of measure …

Monitoring of effectiveness

• …

... •



6.2. Qualification of Auditors Define the minimum requirements of qualification for Auditors. 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 Relevant scopes are defined in IEM No.1 to JAR-FCL X.055 (14). 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* no further operation / activity until closure of finding • Level 2: Safety might be affected* to be closed within due date (max. 2 months) • Level 3: Safety not affected but of importance for company to be closed within due date

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



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

7.1. Procedure Specify the company specific process 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 Runs, Checks and Fly-outs

• establish FSTD qualification plan after each FOCA qualification

• consider former - 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)

internal qualification plan FSTD List of auditors

FSTD Focal Point

Preparation • study relevant procedures • consider logbook-, maintenance-

and HIL-entries, feedback & report-ing system, former reports, former actions

Master QTG QTG running proce-dures List of pending items

Checker

Execution • establish binder with quarterly re-run protocols, maintenance reports and internal qualification plan FSTD (hard copies required by FOCA)

QTG running proce-dures Master QTG Fly-out procedures

…

Reporting • storage… • up-date audit plan

Tool "FSTD report" FSTD audit plan

…

Initiation of measures

• in case of need initiate preventive and/or corrective action

• who, what, due date?

List of pending items …

Monitoring of implementation

• verify implementation of measure …

Monitoring of effectiveness

• …

7.2. Qualification of Checkers 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



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 See IEM No. 1 to JAR-FCL .055 (7) and ACJ No.1 to JAR-FSTD .025 (3.2.2) 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.

If in doubt 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 report

• give feedback to the issuer • assign responsible manager to

realise action • open item on “list of pending

items”

• List of pending items

…

Analyse situation Initiate measure

• ensure reporting to FOCA within xxx hours

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


…

Monitor realisa-tion of measure

• • …

Close measure • close measure on “list of pending items”


…

Monitor effec-tiveness of measure

• during spot checks / inspections or audits

• is the improvement sustainable? • did we get the attained success?

• …

specify the procedures for all the company specific kind of feedback and reporting in the subse-quent chapters



8.3. Feedback about Ground Instruction

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

Consolidate data • • …


• • Head of Train-ing


• • …

Close measure • • List of pending items

…


• • …

8.4. Feedback about Flight Instruction

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

Consolidate data • • …


• • Head of Train-ing


• • …

Close measure • • List of pending items

…


• • …

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

• • …


• • List of pending items

…

… • • … … • • …



9. Subcontractor / Supplier Management See IEM No. 1 to JAR-FCL .055 (20) and ACJ No.1 to JAR-FSTD .025 (5)

9.1. Evaluation of Subcontractors / Suppliers The evaluation before ordering is not a requirement but strongly recommended. 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)

New providers can lead to new risks. That’s why an initial risk assessment should be conducted

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

• define standards of performance • above CHF 1’000.- if not in

budget: - written form - submit Accountable Manager

• criteria (safety, quality, …) - …. - …. - …

•

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



9.2. Supervision of Subcontractors / Suppliers The monitoring concept of Subcontractors should be based on the risk assessment of the pro-viders.

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 / Product

Kind of supervision Frequency Responsibility

• ensuring the validity of necessary ap-proval of organisation, instructor and FSTD (JAR-FCL … and JAR-FSTD …)

… Head of Train-ing

• trainee's feedback report • treatment of feedback according to chap-

ter 8 Feedback & Reporting

Each training Participants

Training

• Inspection of training provided … CGI, CFI, CSFI, CSTI

• Monitoring concept according to CAME … CAM • visual check of the aircraft and check of

Tech Log before each flight

Pilot Maintenance of Aircraft

• … Dry lease of FSTD

• Check qualification of FSTD • Daily check

Before use after dry lease

• ensuring the validity of necessary ap-proval …)

… FSTD Focal Point

• verification of service report of provider FSTD Focal Point

Maintenance of FSTD

• check of function as release to service FSTD Focal Point

FSTD Manual preparation

• check compatibility / consistency with manufacturer data and JAR-FSTD

FSTD Focal Point

FSTD Navigation Data

• check up-date Within 3 months

FSTD Focal Point

• Provision and validity of certificate of spare part during the arrival of part

each delivery FSTD Focal Point

FSTD Spare Parts

• Check of function of spare part after in-stallation / fitting

each installa-tion

FSTD Focal 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.



10. Management Evaluation 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.

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.

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

Evaluations of a Management System according to ISO 9001:2000 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)

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 evaluation

• every 6 month • periodical collation and evalua-

tion of received reports and other data

• identification of trends systematic deviations & cluster

• suggestion of additional meas-ures

• …

Data to be evaluated see chapter 10.3

Responsible managers ac-cording to 10.3

Establish man-agement review report

• consolidate the results of data evaluation

• evaluate fulfilment of annual goals

• evaluate the overall effectiveness of the organisation

• decide upon measures and nec-essary resources

• initiate measures • …

List of pending items Accountable Manager

Monitor imple- • verify completion and success of List of pending items Accountable



mentation of measures

initiated measures • …

Manager

… •

10.3. Data to be evaluated 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 Manager

Criteria / Source of data Frequency (months)

Accountable Manager • achievement of annual goals • overall effectiveness of the organisation (sum-

mary) • …

6

Quality Manager • status of the implementation and effectiveness of corrective and preventive actions

• audit results • inspection results • …

6

Head of Training • results from checks and examinations • customer satisfaction

6

Chief Ground Instruc-tor

• trainees' feedback • inspection reports • …

6

Chief Flight Instructor • trainees' feedback • inspection reports • …

6

Chief Synthetic Flight Instructor


6

Chief Synthetic Train-ing Instructor


6

CAM • tech. log • work reports • effectiveness of maintenance programme • …

6

FSTD Focal Point • tech. log • work reports • effectiveness of maintenance programme • QTG Run and Fly-out reports

6 (3 for QTG runs &

Fly-outs)

… • …

the frequency of 12 months may not be exceeded!



11. Quality System Training and Promotion See IEM No. 1 to JAR-FCL .055 (21)(22) and ACJ No.1 to JAR-FSTD .025 (6) All employees have to be trained appropriately and tailored to their function on the Quality Sys-tem.

Specify the company specific topics to be trained to the employees. 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:

Function

Topics

AC

M

HT

CG

I, C

FI, C

SFI,

CST

I

Gro

und

Inst

ruct

or

Flig

ht In

stru

ctor

FSTD

Foc

al P

oint

Qua

lity

Man

ager

Aud

itor

Insp

ecto

r

Empl

oyee

s

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



11.1.2. Specific Training:

Function

Topics

AM

PH, C

AM

FSO

Safe

ty-M

anag

er

Qua

lity-

Man

ager

FSTD

Foc

al P

oint

Aud

itor

Insp

ecto

r

Empl

oyee

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.



12. Document Control See IEM No. 1 to JAR-FCL .055 (8.2)(19) and ACJ No.1 to JAR-FSTD .025 (3.3.1 h) 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 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 …

1Each responsible person ensures that • changes of the documents are communicated to all people concerned • necessary changes of internal documents are made based on amendments of external

documents • invalid / overridden versions are clearly identified as such • overridden documents are stored to ensure the necessary traceability – if necessary.



12.1.2. Revision procedure of the Quality System Manual Necessary only if the Quality System is documented in a separate manual.

Step Remarks Tool Responsibility Initiate change • identify need for change within

Quality System Manual • submit request in written form

to quality manager

employee

Verify need for change

• … Q-Manager

Revise Quality Manual

• …

Crosscheck and release

• compatibility with standards • harmonisation with other

documents • viability • appropriateness • ensure traceability of changes

List of revisions List of effective pages

Initiate document evaluation by FOCA

• submit revised pages •

PRA

Distribute document • finalise revision • distribute new version • ensure withdrawal if neces-

sary • instruct employees

Distribution list

… • Up-date document / manual

• Supplement list of revisions • Destroy obsolete documents

List of revisions

document user

… • …



12.2. Control of Quality System related Records Avoid redundancies / contradictions to the OM A, chapter 2 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 managers

Accountable Manager

5 years

Management evaluation report

Accountable Manager

5 years

Individual feedback reports

5 years

Audit reports Q-Manager 5 years List of inspections performed

5 years

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 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



13. Definitions, Abbreviations (Terminology) Establish list of company specific definitions and abbreviations Avoid redundancy / contradiction with OM A, chapter 0 The subsequent list consist of official definitions related to Quality Management

13.1. Definitions 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 way in which an operation is being conducted against the way in which the published operational procedures say it should be conducted.

IEM No.1 to JAR-FCL .055 (11)

Inspection

The primary purpose of a quality inspection is to observe a particular event/action/document etc., in order to verify whether established operational procedures and requirements are followed during the accomplishment of that event and whether the required standard is achieved.

IEM No.1 to JAR-FCL .055 (10)

Quality Management

Coordinated activities to direct and control an organisation with regard to quality NOTE 1: Direction and control with regard to quality generally includes establishment of the quality policy and quality objectives, quality planning, quality control, quality assurance and quality improvement

ISO 9000:2000

Quality Policy Overall intentions and direction of an organisation related to quality as formally expressed top management NOTE 1: Generally the quality policy is consistent with the overall policy of the organisation and provides a framework for the setting of quality objectives

ISO 9000:2000

Quality Objectives

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

ISO 9000:2000

….

…



13.2. Abbreviations

Abbreviation Definition Reference AM Accountable Manager

A person acceptable to the Authority who has authority for ensuring that all training activities can be financed and carried out to the standards required by the Authority, and additional requirements defined by the FTO/TRTO or FSTD Operator

IEM No. 1 to JAR–FCL .055 (1) ACJ No.1 to JAR-FSTD .025

HT Head of Training CGI Chief Ground Instructor CFI Chief Flying Instructor

Appendix 1a to JAR–FCL .055 (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

The manager, acceptable to the Authority, responsible for the management of the Quality System, monitoring func-tion and requesting corrective actions.

IEM No. 1 to JAR–FCL .055 (1) ACJ No.1 to JAR-FSTD .025

QTG Qualification Test Guide JAR-FSTD .005 (m)

MOE Maintenance Organisation Exposition EASA Part 145 …

How to Establish Quality Sys QMS FTO-TRTO

Documents

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