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GM2 ORA.FSTD.100 General

ED Decision 2012/007/R

COMPLIANCE MONITORING – ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs

COMPLIANCE MONITORING ASSESSMENT

FOR ORGANISATIONS OPERATING FSTDs

Organisation:

Site Assessed:

Date of Assessment:

Accountable Manager:

Compliance Monitoring Manager:

Number and Type of FSTDs:

CM Manual Reference:

Audit Area

CM/Proc Ref

Comments

Satisfactory

Y/N

1. ACCOUNTABLE MANAGER

Has an accountable manager (AM) with overall responsibility for compliance monitoring (CM) been nominated?

Does the accountable manager have corporate authority to ensure all necessary activities can be financed and carried out to the standard required by the competent authority?

Has a formal written compliance policy statement been established, included in the CM manual and signed by the accountable manager?

2. COMPLIANCE MONITORING MANAGER

Has a compliance monitoring manager (CM manager) been nominated?

Are the posts of CM manager and AM combined? If so, is the independence of compliance audits assured?

Does the CM manager have overall responsibility and authority to:

a) verify that standards are met; and

b) ensure that the compliance monitoring programme is established, implemented and maintained?

Does the CM manager have direct access to the AM?

Does the CM manager have access to all parts of the organisation operating an FSTD and as necessary any sub-contractor’s organisation?

3. COMPLIANCE MONITORING (CM)

Has CM been established by the operator?


Is CM properly documented? (see Section 4)




Is the CM structured according to the size and complexity of the operator?

Does the CM include the following as a minimum:

a) monitoring of compliance with required technical standards;

b) identification of corrective actions and person responsible for rectification;

c) a feedback system to accountable manager to ensure corrective action are promptly addressed;

d) reporting of significant noncompliances to the competent authority;

e) a compliance monitoring programme to verify continued compliance with applicable requirements, standards and procedures.

a)


b)


c)


d)



e)

Is the CM structured according to the size and complexity of the operator?

Are the responsibilities of the CM manager defined to include, as a minimum:

a) monitoring of corrective action programme;

b) ensuring that the corrective actions contain the necessary elements;

c) providing management with an independent assessment of corrective action, implementation and completion;

d) evaluation of the effectiveness of the corrective action programme.


a)


b)


c)




d)

Are adequate financial, material and human resources in place to support CM?

Are management evaluations/reviews of CM held at least quarterly?

Does the management evaluation ensure that the CMS is working effectively and is it comprehensive and well documented?

Does the compliance monitoring programme identify the processes necessary and the persons within the organisation who have the training, experience, responsibility and authority to carry out the following:

a) schedule and perform quality inspections and audits, including unscheduled audits when required;

b) identify and record any concerns or findings, and the evidence necessary to substantiate such concerns or findings;

c) initiate or recommend solutions to concerns or findings through designated reporting channels;

d) verify the implementation of solutions within specific timescales.

a)

b)




c)



d)

Is there sufficient auditor resource available and can their required level of independence be demonstrated?

Do the auditors report directly to the compliance monitoring manager?

Does the defined audit schedule cover the following areas, within each 12 month period?

a) organisation

b) plans and objectives

c) maintenance procedures

d) FSTD qualification level;

e) supervision

f) FSTD technical status

g) manuals, logs and records

h) defect deferral

i) personnel training

j) aircraft and simulator configuration management, including Airworthiness Directives

a)

b)

c)

d)

e)

f)

g)

h)

i)

j)

How are audit noncompliances recorded?

Are procedures in place to ensure that corrective actions are taken in response to findings?

Are records of the compliance monitoring programme:

a) accurate

b) complete and

c) readily accessible?


a)

b)

c)

Is there an acceptable and effective procedure for providing a briefing on the CM to all personnel?

Is there an acceptable and effective procedure for ensuring that all those responsible for managing the CM receive training covering:

a) an introduction to the concept of the CM;

b) compliance management;

c) the concept of compliance assurance;

d) CM manuals;

e) audit techniques;

f) reporting and recording;

g) how the CM supports continuous improvement within the organisation.

a)


b)

c)

d)

e)

f)

g)

Are suitable training records maintained?




Are activities within the CM sub-contracted out to external agencies?




Do written agreements exist between the organisation and the sub-contractor clearly defining the services and standard to be provided?




Are the procedures in place to ensure that the necessary authorisations/ approval when required are held by a sub-contractor?




Are the procedures in place to establish that the subcontractor has the necessary technical competence?




4. CM MANUAL

What is the current status of the CM manual – amendment and issue date?




Is there a procedure in place to control copies and the distribution of the CM manual?




Is the CM manual signed by the accountable manager and the compliance monitoring manager?




Does the CM manual include, either directly or by reference to other documents, the following:

a) a description of the organisation;

b) reference to appropriate FSTD technical standards;

c) allocation of duties and responsibilities;

d) audit procedures;

e) reporting procedures;

f) follow-up and corrective action procedures;

g) document retention policy;

h) training records

a)

b)


c)


d)

e)

f)


g)

h)

Is there a document retention policy covering:

a) audit schedules;

b) inspection and audit reports;

c) responses to findings;

d) corrective action reports;

e) follow-up and closure reports;

f) management evaluation reports.



a)

b)

c)

d)

e)

f)

Does the CM manual

include, either directly or by reference to other documents, the following procedures for day to day operation of the FSTD:

a) defect reporting systems;

b) defect rectification processes;

c) tracking mechanisms;

d) preventative maintenance programmes;

e) spares handling;

f) equipment calibration;

g) configuration management of the device including visual, IOS and navigation databases;

h) configuration control system to ensure the continued integrity of the hardware and software qualified;

i) QTG running and function and subjective tests.

a)

b)

c)

d)


e)

f)

g)



h)



i)

Does the CM manual

include, either directly or by reference to other documents, procedures for notification of the competent authorities of the following:

a) any change in the organisation including company name, location, management;

b) major changes to a qualified device;

c) deactivation or relocation of a qualified device;

d) major failures of a qualified device;

e) major safety issue associated with the installation.



a)



b)

c)


d)

e)


Does the CM manual define acceptable and effective procedures to ensure compliance with applicable health and safety regulations, including:

a) safety briefings;

b) fire/smoke detection and suppression;

c) protection against electrical, mechanical, hydraulic and pneumatic hazards;

d) other items as defined in AMC1 ORA.FSTD.115


a)

b)

c)



d)

Does the CM manual include acceptable and effective procedures for regularly checking FSTD safety features such as emergency stops and emergency lighting, and are such tests recorded?




5. COMPLIANCE MEASURES

Have compliance monitoring objectives been developed from the policy statement, and included either directly or by reference in the CMS manual?




Does the CMS include processes to produce and review appropriate metrics data?




Do these compliance measures track the following:

a) FSTD availability;

b) numbers of defects;

c) open defects;

d) defect closure rates;

e) training session interrupt rates;

f) training session compliance rating.

a)

b)

c)

d)

e)

f)

Do the compliance measures support the compliance objectives?




Required actions/Comments




Signature:……………………………………………………….


Date:………………………………….