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GM2 ORA.FSTD.100 General
Available versions for ERULES-1963177438-11029
ED Decision 2012/007/R
found in: Aircrew (1178/2011) Part-FCL Part-MED Part-CC Part-ARA Part-ORA Part-DTO (Aug 2023)
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GM2 ORA.FSTD.100 General ED Decision 2012/007/R COMPLIANCE MONITORING – ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs <table border="1" cellpadding="0" cellspacing="0" width="603"><tr><td colspan="4" width="603"><p>COMPLIANCE MONITORING ASSESSMENT</p><p>FOR ORGANISATIONS OPERATING FSTDs </p></td></tr><tr><td valign="top" width="263"><p>Organisation: </p></td><td colspan="3" valign="top" width="340"></td></tr><tr><td valign="top" width="263"><p>Site Assessed: </p></td><td colspan="3" valign="top" width="340"></td></tr><tr><td valign="top" width="263"><p>Date of Assessment: </p></td><td colspan="3" valign="top" width="340"></td></tr><tr><td valign="top" width="263"><p>Accountable Manager: </p></td><td colspan="3" valign="top" width="340"></td></tr><tr><td valign="top" width="263"><p>Compliance Monitoring Manager: </p></td><td colspan="3" valign="top" width="340"></td></tr><tr><td valign="top" width="263"><p>Number and Type of FSTDs: </p></td><td colspan="3" valign="top" width="340"></td></tr><tr><td valign="top" width="263"><p>CM Manual Reference: </p></td><td colspan="3" valign="top" width="340"></td></tr><tr><td valign="top" width="263"><p>Audit Area </p></td><td valign="top" width="80"><p>CM/Proc Ref </p></td><td valign="top" width="137"><p>Comments </p></td><td valign="top" width="122"><p>Satisfactory</p><p>Y/N </p></td></tr><tr><td colspan="4" valign="top" width="603"><p>1. ACCOUNTABLE MANAGER </p></td></tr><tr><td valign="top" width="263"><p>Has an accountable manager (AM) with overall responsibility for compliance monitoring (CM) been nominated? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>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? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Has a formal written compliance policy statement been established, included in the CM manual and signed by the accountable manager? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td colspan="4" valign="top" width="603"><p>2. COMPLIANCE MONITORING MANAGER </p></td></tr><tr><td valign="top" width="263"><p>Has a compliance monitoring manager (CM manager) been nominated? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are the posts of CM manager and AM combined? If so, is the independence of compliance audits assured? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM manager have overall responsibility and authority to:</p><p align="left">a) verify that standards are met; and </p><p align="left">b) ensure that the compliance monitoring programme is established, implemented and maintained? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM manager have direct access to the AM? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM manager have access to all parts of the organisation operating an FSTD and as necessary any sub-contractor’s organisation? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td colspan="4" valign="top" width="603"><p>3. COMPLIANCE MONITORING (CM)</p></td></tr><tr><td valign="top" width="263"><p>Has CM been established by the operator? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is CM properly documented? (see Section 4) </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is the CM structured according to the size and complexity of the operator? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM include the following as a minimum: </p><p align="left">a) monitoring of compliance with required technical standards; </p><p align="left">b) identification of corrective actions and person responsible for rectification; </p><p align="left">c) a feedback system to accountable manager to ensure corrective action are promptly addressed; </p><p align="left">d) reporting of significant noncompliances to the competent authority; </p><p align="left">e) a compliance monitoring programme to verify continued compliance with applicable requirements, standards and procedures.</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p align="left">a)</p><p>b)</p><p>c)</p><p align="left">d)</p><p>e)</p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is the CM structured according to the size and complexity of the operator? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are the responsibilities of the CM manager defined to include, as a minimum: </p><p align="left">a) monitoring of corrective action programme; </p><p align="left">b) ensuring that the corrective actions contain the necessary elements; </p><p align="left">c) providing management with an independent assessment of corrective action, implementation and completion; </p><p align="left">d) evaluation of the effectiveness of the corrective action programme. </p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a)</p><p>b) </p><p>c) </p><p>d) </p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are adequate financial, material and human resources in place to support CM? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are management evaluations/reviews of CM held at least quarterly? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the management evaluation ensure that the CMS is working effectively and is it comprehensive and well documented? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>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: </p><p align="left">a) schedule and perform quality inspections and audits, including unscheduled audits when required; </p><p align="left">b) identify and record any concerns or findings, and the evidence necessary to substantiate such concerns or findings; </p><p align="left">c) initiate or recommend solutions to concerns or findings through designated reporting channels; </p><p align="left">d) verify the implementation of solutions within specific timescales.</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a) </p><p>b) </p><p>c) </p><p>d)</p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is there sufficient auditor resource available and can their required level of independence be demonstrated? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Do the auditors report directly to the compliance monitoring manager?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the defined audit schedule cover the following areas, within each 12 month period? </p><p align="left">a) organisation </p><p align="left">b) plans and objectives </p><p align="left">c) maintenance procedures </p><p align="left">d) FSTD qualification level; </p><p align="left">e) supervision </p><p align="left">f) FSTD technical status </p><p align="left">g) manuals, logs and records </p><p align="left">h) defect deferral </p><p align="left">i) personnel training </p><p align="left">j) aircraft and simulator configuration management, including Airworthiness Directives</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a)</p><p>b)</p><p>c)</p><p>d) </p><p>e)</p><p>f)</p><p>g)</p><p>h)</p><p>i)</p><p>j)</p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>How are audit noncompliances recorded? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are procedures in place to ensure that corrective actions are taken in response to findings? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are records of the compliance monitoring programme: </p><p>a) accurate </p><p>b) complete and </p><p>c) readily accessible? </p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a) </p><p>b) </p><p>c) </p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is there an acceptable and effective procedure for providing a briefing on the CM to all personnel? </p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is there an acceptable and effective procedure for ensuring that all those responsible for managing the CM receive training covering: </p><p align="left">a) an introduction to the concept of the CM; </p><p align="left">b) compliance management; </p><p align="left">c) the concept of compliance assurance; </p><p align="left">d) CM manuals; </p><p align="left">e) audit techniques; </p><p align="left">f) reporting and recording; </p><p align="left">g) how the CM supports continuous improvement within the organisation.</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a) </p><p>b) </p><p>c) </p><p>d) </p><p>e) </p><p>f) </p><p>g) </p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are suitable training records maintained?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are activities within the CM sub-contracted out to external agencies?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Do written agreements exist between the organisation and the sub-contractor clearly defining the services and standard to be provided?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are the procedures in place to ensure that the necessary authorisations/ approval when required are held by a sub-contractor?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Are the procedures in place to establish that the subcontractor has the necessary technical competence?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td colspan="4" valign="top" width="603"><p>4. CM MANUAL</p></td></tr><tr><td valign="top" width="263"><p>What is the current status of the CM manual – amendment and issue date?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is there a procedure in place to control copies and the distribution of the CM manual?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is the CM manual signed by the accountable manager and the compliance monitoring manager?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM manual include, either directly or by reference to other documents, the following: </p><p align="left">a) a description of the organisation; </p><p align="left">b) reference to appropriate FSTD technical standards; </p><p align="left">c) allocation of duties and responsibilities; </p><p align="left">d) audit procedures; </p><p align="left">e) reporting procedures; </p><p align="left">f) follow-up and corrective action procedures; </p><p align="left">g) document retention policy; </p><p align="left">h) training records</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a)</p><p>b)</p><p>c)</p><p>d) </p><p>e)</p><p>f) </p><p>g)</p><p>h)</p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Is there a document retention policy covering: </p><p align="left">a) audit schedules; </p><p align="left">b) inspection and audit reports; </p><p align="left">c) responses to findings; </p><p align="left">d) corrective action reports; </p><p align="left">e) follow-up and closure reports; </p><p align="left">f) management evaluation reports. </p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a) </p><p>b) </p><p>c) </p><p>d) </p><p>e) </p><p>f) </p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM manual </p><p>include, either directly or by reference to other documents, the following procedures for day to day operation of the FSTD: </p><p align="left">a) defect reporting systems; </p><p align="left">b) defect rectification processes; </p><p align="left">c) tracking mechanisms; </p><p align="left">d) preventative maintenance programmes; </p><p align="left">e) spares handling; </p><p align="left">f) equipment calibration; </p><p align="left">g) configuration management of the device including visual, IOS and navigation databases; </p><p align="left">h) configuration control system to ensure the continued integrity of the hardware and software qualified; </p><p align="left">i) QTG running and function and subjective tests.</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a)</p><p>b)</p><p>c)</p><p>d)</p><p>e)</p><p>f)</p><p>g)</p><p>h)</p><p>i)</p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM manual </p><p>include, either directly or by reference to other documents, procedures for notification of the competent authorities of the following: </p><p align="left">a) any change in the organisation including company name, location, management; </p><p align="left">b) major changes to a qualified device; </p><p align="left">c) deactivation or relocation of a qualified device; </p><p align="left">d) major failures of a qualified device; </p><p align="left">e) major safety issue associated with the installation.</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a) </p><p>b)</p><p>c)</p><p>d)</p><p>e)</p></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CM manual define acceptable and effective procedures to ensure compliance with applicable health and safety regulations, including:</p><p align="left">a) safety briefings; </p><p align="left">b) fire/smoke detection and suppression; </p><p align="left">c) protection against electrical, mechanical, hydraulic and pneumatic hazards; </p><p align="left">d) other items as defined in <a href="#_DxCrossRefBm1199964193">AMC1 ORA.FSTD.115</a></p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a)</p><p>b)</p><p>c)</p><p>d) </p></td><td valign="top" width="122"><p></p></td></tr><tr><td valign="top" width="263"><p>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?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td colspan="4" valign="top" width="603"><p>5. COMPLIANCE MEASURES</p></td></tr><tr><td valign="top" width="263"><p>Have compliance monitoring objectives been developed from the policy statement, and included either directly or by reference in the CMS manual?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Does the CMS include processes to produce and review appropriate metrics data?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"></td></tr><tr><td valign="top" width="263"><p>Do these compliance measures track the following: </p><p align="left">a) FSTD availability; </p><p align="left">b) numbers of defects; </p><p align="left">c) open defects; </p><p align="left">d) defect closure rates; </p><p align="left">e) training session interrupt rates; </p><p align="left">f) training session compliance rating.</p></td><td valign="top" width="80"></td><td valign="top" width="137"><p>a) </p><p>b) </p><p>c) </p><p>d) </p><p>e) </p><p>f) </p></td><td valign="top" width="122"><p></p></td></tr><tr><td valign="top" width="263"><p>Do the compliance measures support the compliance objectives?</p></td><td valign="top" width="80"></td><td valign="top" width="137"></td><td valign="top" width="122"><p></p></td></tr><tr><td colspan="4" valign="top" width="603"><p>Required actions/Comments</p><p>Signature:……………………………………………………….</p><p>Date:………………………………….</p></td></tr></table>
GM2 ORA.FSTD.100 General ED Decision 2012/007/R COMPLIANCE MONITORING – ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs <table border="1" cellpadding="0" cellspacing="0" width="603"> <tr> <td colspan="4" width="603"> <p>COMPLIANCE MONITORING ASSESSMENT</p> <p>FOR ORGANISATIONS OPERATING FSTDs </p> </td> </tr> <tr> <td valign="top" width="263"> <p>Organisation: </p> </td> <td colspan="3" valign="top" width="340"> </td> </tr> <tr> <td valign="top" width="263"> <p>Site Assessed: </p> </td> <td colspan="3" valign="top" width="340"> </td> </tr> <tr> <td valign="top" width="263"> <p>Date of Assessment: </p> </td> <td colspan="3" valign="top" width="340"> </td> </tr> <tr> <td valign="top" width="263"> <p>Accountable Manager: </p> </td> <td colspan="3" valign="top" width="340"> </td> </tr> <tr> <td valign="top" width="263"> <p>Compliance Monitoring Manager: </p> </td> <td colspan="3" valign="top" width="340"> </td> </tr> <tr> <td valign="top" width="263"> <p>Number and Type of FSTDs: </p> </td> <td colspan="3" valign="top" width="340"> </td> </tr> <tr> <td valign="top" width="263"> <p>CM Manual Reference: </p> </td> <td colspan="3" valign="top" width="340"> </td> </tr> <tr> <td valign="top" width="263"> <p>Audit Area </p> </td> <td valign="top" width="80"> <p>CM/Proc Ref </p> </td> <td valign="top" width="137"> <p>Comments </p> </td> <td valign="top" width="122"> <p>Satisfactory</p> <p>Y/N </p> </td> </tr> <tr> <td colspan="4" valign="top" width="603"> <p>1. ACCOUNTABLE MANAGER </p> </td> </tr> <tr> <td valign="top" width="263"> <p>Has an accountable manager (AM) with overall responsibility for compliance monitoring (CM) been nominated? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>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? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Has a formal written compliance policy statement been established, included in the CM manual and signed by the accountable manager? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td colspan="4" valign="top" width="603"> <p>2. COMPLIANCE MONITORING MANAGER </p> </td> </tr> <tr> <td valign="top" width="263"> <p>Has a compliance monitoring manager (CM manager) been nominated? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are the posts of CM manager and AM combined? If so, is the independence of compliance audits assured? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM manager have overall responsibility and authority to:</p> <p align="left">a) verify that standards are met; and </p> <p align="left">b) ensure that the compliance monitoring programme is established, implemented and maintained? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM manager have direct access to the AM? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM manager have access to all parts of the organisation operating an FSTD and as necessary any sub-contractor’s organisation? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td colspan="4" valign="top" width="603"> <p>3. COMPLIANCE MONITORING (CM)</p> </td> </tr> <tr> <td valign="top" width="263"> <p>Has CM been established by the operator? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is CM properly documented? (see Section 4) </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is the CM structured according to the size and complexity of the operator? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM include the following as a minimum: </p> <p align="left">a) monitoring of compliance with required technical standards; </p> <p align="left">b) identification of corrective actions and person responsible for rectification; </p> <p align="left">c) a feedback system to accountable manager to ensure corrective action are promptly addressed; </p> <p align="left">d) reporting of significant noncompliances to the competent authority; </p> <p align="left">e) a compliance monitoring programme to verify continued compliance with applicable requirements, standards and procedures.</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p align="left">a)</p> <p>b)</p> <p>c)</p> <p align="left">d)</p> <p>e)</p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is the CM structured according to the size and complexity of the operator? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are the responsibilities of the CM manager defined to include, as a minimum: </p> <p align="left">a) monitoring of corrective action programme; </p> <p align="left">b) ensuring that the corrective actions contain the necessary elements; </p> <p align="left">c) providing management with an independent assessment of corrective action, implementation and completion; </p> <p align="left">d) evaluation of the effectiveness of the corrective action programme. </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a)</p> <p>b) </p> <p>c) </p> <p>d) </p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are adequate financial, material and human resources in place to support CM? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are management evaluations/reviews of CM held at least quarterly? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the management evaluation ensure that the CMS is working effectively and is it comprehensive and well documented? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>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: </p> <p align="left">a) schedule and perform quality inspections and audits, including unscheduled audits when required; </p> <p align="left">b) identify and record any concerns or findings, and the evidence necessary to substantiate such concerns or findings; </p> <p align="left">c) initiate or recommend solutions to concerns or findings through designated reporting channels; </p> <p align="left">d) verify the implementation of solutions within specific timescales.</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a) </p> <p>b) </p> <p>c) </p> <p>d)</p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is there sufficient auditor resource available and can their required level of independence be demonstrated? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Do the auditors report directly to the compliance monitoring manager?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the defined audit schedule cover the following areas, within each 12 month period? </p> <p align="left">a) organisation </p> <p align="left">b) plans and objectives </p> <p align="left">c) maintenance procedures </p> <p align="left">d) FSTD qualification level; </p> <p align="left">e) supervision </p> <p align="left">f) FSTD technical status </p> <p align="left">g) manuals, logs and records </p> <p align="left">h) defect deferral </p> <p align="left">i) personnel training </p> <p align="left">j) aircraft and simulator configuration management, including Airworthiness Directives</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a)</p> <p>b)</p> <p>c)</p> <p>d) </p> <p>e)</p> <p>f)</p> <p>g)</p> <p>h)</p> <p>i)</p> <p>j)</p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>How are audit noncompliances recorded? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are procedures in place to ensure that corrective actions are taken in response to findings? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are records of the compliance monitoring programme: </p> <p>a) accurate </p> <p>b) complete and </p> <p>c) readily accessible? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a) </p> <p>b) </p> <p>c) </p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is there an acceptable and effective procedure for providing a briefing on the CM to all personnel? </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is there an acceptable and effective procedure for ensuring that all those responsible for managing the CM receive training covering: </p> <p align="left">a) an introduction to the concept of the CM; </p> <p align="left">b) compliance management; </p> <p align="left">c) the concept of compliance assurance; </p> <p align="left">d) CM manuals; </p> <p align="left">e) audit techniques; </p> <p align="left">f) reporting and recording; </p> <p align="left">g) how the CM supports continuous improvement within the organisation.</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a) </p> <p>b) </p> <p>c) </p> <p>d) </p> <p>e) </p> <p>f) </p> <p>g) </p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are suitable training records maintained?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are activities within the CM sub-contracted out to external agencies?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Do written agreements exist between the organisation and the sub-contractor clearly defining the services and standard to be provided?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are the procedures in place to ensure that the necessary authorisations/ approval when required are held by a sub-contractor?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Are the procedures in place to establish that the subcontractor has the necessary technical competence?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td colspan="4" valign="top" width="603"> <p>4. CM MANUAL</p> </td> </tr> <tr> <td valign="top" width="263"> <p>What is the current status of the CM manual – amendment and issue date?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is there a procedure in place to control copies and the distribution of the CM manual?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is the CM manual signed by the accountable manager and the compliance monitoring manager?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM manual include, either directly or by reference to other documents, the following: </p> <p align="left">a) a description of the organisation; </p> <p align="left">b) reference to appropriate FSTD technical standards; </p> <p align="left">c) allocation of duties and responsibilities; </p> <p align="left">d) audit procedures; </p> <p align="left">e) reporting procedures; </p> <p align="left">f) follow-up and corrective action procedures; </p> <p align="left">g) document retention policy; </p> <p align="left">h) training records</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a)</p> <p>b)</p> <p>c)</p> <p>d) </p> <p>e)</p> <p>f) </p> <p>g)</p> <p>h)</p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Is there a document retention policy covering: </p> <p align="left">a) audit schedules; </p> <p align="left">b) inspection and audit reports; </p> <p align="left">c) responses to findings; </p> <p align="left">d) corrective action reports; </p> <p align="left">e) follow-up and closure reports; </p> <p align="left">f) management evaluation reports. </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a) </p> <p>b) </p> <p>c) </p> <p>d) </p> <p>e) </p> <p>f) </p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM manual </p> <p>include, either directly or by reference to other documents, the following procedures for day to day operation of the FSTD: </p> <p align="left">a) defect reporting systems; </p> <p align="left">b) defect rectification processes; </p> <p align="left">c) tracking mechanisms; </p> <p align="left">d) preventative maintenance programmes; </p> <p align="left">e) spares handling; </p> <p align="left">f) equipment calibration; </p> <p align="left">g) configuration management of the device including visual, IOS and navigation databases; </p> <p align="left">h) configuration control system to ensure the continued integrity of the hardware and software qualified; </p> <p align="left">i) QTG running and function and subjective tests.</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a)</p> <p>b)</p> <p>c)</p> <p>d)</p> <p>e)</p> <p>f)</p> <p>g)</p> <p>h)</p> <p>i)</p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM manual </p> <p>include, either directly or by reference to other documents, procedures for notification of the competent authorities of the following: </p> <p align="left">a) any change in the organisation including company name, location, management; </p> <p align="left">b) major changes to a qualified device; </p> <p align="left">c) deactivation or relocation of a qualified device; </p> <p align="left">d) major failures of a qualified device; </p> <p align="left">e) major safety issue associated with the installation.</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a) </p> <p>b)</p> <p>c)</p> <p>d)</p> <p>e)</p> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CM manual define acceptable and effective procedures to ensure compliance with applicable health and safety regulations, including:</p> <p align="left">a) safety briefings; </p> <p align="left">b) fire/smoke detection and suppression; </p> <p align="left">c) protection against electrical, mechanical, hydraulic and pneumatic hazards; </p> <p align="left">d) other items as defined in <a href="#_DxCrossRefBm894736341">AMC1 ORA.FSTD.115</a> </p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a)</p> <p>b)</p> <p>c)</p> <p>d) </p> </td> <td valign="top" width="122"> <p></p> </td> </tr> <tr> <td valign="top" width="263"> <p>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?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td colspan="4" valign="top" width="603"> <p>5. COMPLIANCE MEASURES</p> </td> </tr> <tr> <td valign="top" width="263"> <p>Have compliance monitoring objectives been developed from the policy statement, and included either directly or by reference in the CMS manual?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Does the CMS include processes to produce and review appropriate metrics data?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> </td> </tr> <tr> <td valign="top" width="263"> <p>Do these compliance measures track the following: </p> <p align="left">a) FSTD availability; </p> <p align="left">b) numbers of defects; </p> <p align="left">c) open defects; </p> <p align="left">d) defect closure rates; </p> <p align="left">e) training session interrupt rates; </p> <p align="left">f) training session compliance rating.</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> <p>a) </p> <p>b) </p> <p>c) </p> <p>d) </p> <p>e) </p> <p>f) </p> </td> <td valign="top" width="122"> <p></p> </td> </tr> <tr> <td valign="top" width="263"> <p>Do the compliance measures support the compliance objectives?</p> </td> <td valign="top" width="80"> </td> <td valign="top" width="137"> </td> <td valign="top" width="122"> <p></p> </td> </tr> <tr> <td colspan="4" valign="top" width="603"> <p>Required actions/Comments</p> <p>Signature:……………………………………………………….</p> <p>Date:………………………………….</p> </td> </tr> </table>
##### GM2 ORA.FSTD.100 General *ED Decision 2012/007/R* **COMPLIANCE MONITORING – ASSESSMENT FOR ORGANISATIONS OPERATING FSTDs** <table cellpadding="7" cellspacing="0"> <col/> <col/> <col/> <col/> <tr> <td colspan="4"><p align="center"> <b>COMPLIANCE MONITORING ASSESSMENT</b></p> <p align="center"><b>FOR ORGANISATIONS OPERATING FSTDs </b> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Organisation: </p> </td> <td colspan="3"><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Site Assessed: </p> </td> <td colspan="3"><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Date of Assessment: </p> </td> <td colspan="3"><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Accountable Manager: </p> </td> <td colspan="3"><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Compliance Monitoring Manager: </p> </td> <td colspan="3"><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Number and Type of FSTDs: </p> </td> <td colspan="3"><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> CM Manual Reference: </p> </td> <td colspan="3"><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Audit Area </p> </td> <td><p align="left"> CM/Proc Ref </p> </td> <td><p align="left"> Comments </p> </td> <td><p align="left"> Satisfactory</p> <p align="left">Y/N </p> </td> </tr> <tr> <td colspan="4" valign="top"><p align="left"> <b>1. ACCOUNTABLE MANAGER </b> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Has an accountable manager (AM) with overall responsibility for compliance monitoring (CM) been nominated? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> 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? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Has a formal written compliance policy statement been established, included in the CM manual and signed by the accountable manager? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr> <td colspan="4" valign="top"><p align="left"> <b>2. COMPLIANCE MONITORING MANAGER </b> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Has a compliance monitoring manager (CM manager) been nominated? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are the posts of CM manager and AM combined? If so, is the independence of compliance audits assured? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM manager have overall responsibility and authority to:</p> <p align="left"> a) verify that standards are met; and </p> <p align="left"> b) ensure that the compliance monitoring programme is established, implemented and maintained? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM manager have direct access to the AM? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM manager have access to all parts of the organisation operating an FSTD and as necessary any sub-contractor’s organisation? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr> <td colspan="4" valign="top"><p align="left"> <b>3. COMPLIANCE MONITORING (CM)</b></p> </td> </tr> <tr valign="top"> <td><p align="left"> Has CM been established by the operator? </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is CM properly documented? (see Section 4) </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is the CM structured according to the size and complexity of the operator? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM include the following as a minimum: </p> <p align="left"> a) monitoring of compliance with required technical standards; </p> <p align="left"> b) identification of corrective actions and person responsible for rectification; </p> <p align="left"> c) a feedback system to accountable manager to ensure corrective action are promptly addressed; </p> <p align="left"> d) reporting of significant noncompliances to the competent authority; </p> <p align="left"> e) a compliance monitoring programme to verify continued compliance with applicable requirements, standards and procedures.</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> a)</p> <p align="left"> <br/> </p> <p align="left"> b)</p> <p align="left"> <br/> </p> <p align="left"> c)</p> <p align="left"> <br/> </p> <p align="left"> d)</p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left">e)</p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is the CM structured according to the size and complexity of the operator? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are the responsibilities of the CM manager defined to include, as a minimum: </p> <p align="left"> a) monitoring of corrective action programme; </p> <p align="left"> b) ensuring that the corrective actions contain the necessary elements; </p> <p align="left"> c) providing management with an independent assessment of corrective action, implementation and completion; </p> <p align="left"> d) evaluation of the effectiveness of the corrective action programme. </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> <br/> </p> <p align="left"> a)</p> <p align="left"> <br/> </p> <p align="left"> b) </p> <p align="left"> <br/> </p> <p align="left"> c) </p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left">d) </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are adequate financial, material and human resources in place to support CM? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are management evaluations/reviews of CM held at least quarterly? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the management evaluation ensure that the CMS is working effectively and is it comprehensive and well documented? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> 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: </p> <p align="left"> a) schedule and perform quality inspections and audits, including unscheduled audits when required; </p> <p align="left"> b) identify and record any concerns or findings, and the evidence necessary to substantiate such concerns or findings; </p> <p align="left"> c) initiate or recommend solutions to concerns or findings through designated reporting channels; </p> <p align="left"> d) verify the implementation of solutions within specific timescales.</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> a) </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> b) </p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> c) </p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left">d)</p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is there sufficient auditor resource available and can their required level of independence be demonstrated? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Do the auditors report directly to the compliance monitoring manager?</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the defined audit schedule cover the following areas, within each 12 month period? </p> <p align="left"> a) organisation </p> <p align="left"> b) plans and objectives </p> <p align="left"> c) maintenance procedures </p> <p align="left"> d) FSTD qualification level; </p> <p align="left"> e) supervision </p> <p align="left"> f) FSTD technical status </p> <p align="left"> g) manuals, logs and records </p> <p align="left"> h) defect deferral </p> <p align="left"> i) personnel training </p> <p align="left"> j) aircraft and simulator configuration management, including Airworthiness Directives</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> a)</p> <p align="left"> b)</p> <p align="left"> c)</p> <p align="left"> d) </p> <p align="left"> e)</p> <p align="left"> f)</p> <p align="left"> g)</p> <p align="left"> h)</p> <p align="left"> i)</p> <p align="left">j)</p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> How are audit noncompliances recorded? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are procedures in place to ensure that corrective actions are taken in response to findings? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are records of the compliance monitoring programme: </p> <p align="left"> a) accurate </p> <p align="left"> b) complete and </p> <p align="left">c) readily accessible? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> <br/> </p> <p align="left"> a) </p> <p align="left"> b) </p> <p align="left">c) </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is there an acceptable and effective procedure for providing a briefing on the CM to all personnel? </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is there an acceptable and effective procedure for ensuring that all those responsible for managing the CM receive training covering: </p> <p align="left"> a) an introduction to the concept of the CM; </p> <p align="left"> b) compliance management; </p> <p align="left"> c) the concept of compliance assurance; </p> <p align="left"> d) CM manuals; </p> <p align="left"> e) audit techniques; </p> <p align="left"> f) reporting and recording; </p> <p align="left"> g) how the CM supports continuous improvement within the organisation.</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> a) </p> <p align="left"> <br/> </p> <p align="left"> b) </p> <p align="left"> c) </p> <p align="left"> d) </p> <p align="left"> e) </p> <p align="left"> f) </p> <p align="left">g) </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are suitable training records maintained?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are activities within the CM sub-contracted out to external agencies?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Do written agreements exist between the organisation and the sub-contractor clearly defining the services and standard to be provided?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are the procedures in place to ensure that the necessary authorisations/ approval when required are held by a sub-contractor?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Are the procedures in place to establish that the subcontractor has the necessary technical competence?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr> <td colspan="4" valign="top"><p align="left"> <b>4. CM MANUAL</b></p> </td> </tr> <tr valign="top"> <td><p align="left"> What is the current status of the CM manual – amendment and issue date?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is there a procedure in place to control copies and the distribution of the CM manual?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is the CM manual signed by the accountable manager and the compliance monitoring manager?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM manual include, either directly or by reference to other documents, the following: </p> <p align="left"> a) a description of the organisation; </p> <p align="left"> b) reference to appropriate FSTD technical standards; </p> <p align="left"> c) allocation of duties and responsibilities; </p> <p align="left"> d) audit procedures; </p> <p align="left"> e) reporting procedures; </p> <p align="left"> f) follow-up and corrective action procedures; </p> <p align="left"> g) document retention policy; </p> <p align="left"> h) training records</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> a)</p> <p align="left"> b)</p> <p align="left"> <br/> </p> <p align="left"> c)</p> <p align="left"> <br/> </p> <p align="left"> d) </p> <p align="left"> e)</p> <p align="left"> f) </p> <p align="left"> <br/> </p> <p align="left"> g)</p> <p align="left">h)</p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Is there a document retention policy covering: </p> <p align="left"> a) audit schedules; </p> <p align="left"> b) inspection and audit reports; </p> <p align="left"> c) responses to findings; </p> <p align="left"> d) corrective action reports; </p> <p align="left"> e) follow-up and closure reports; </p> <p align="left"> f) management evaluation reports. </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> a) </p> <p align="left"> b) </p> <p align="left"> c) </p> <p align="left"> d) </p> <p align="left"> e) </p> <p align="left">f) </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM manual </p> <p align="left"> include, either directly or by reference to other documents, the following procedures for day to day operation of the FSTD: </p> <p align="left"> a) defect reporting systems; </p> <p align="left"> b) defect rectification processes; </p> <p align="left"> c) tracking mechanisms; </p> <p align="left"> d) preventative maintenance programmes; </p> <p align="left"> e) spares handling; </p> <p align="left"> f) equipment calibration; </p> <p align="left"> g) configuration management of the device including visual, IOS and navigation databases; </p> <p align="left"> h) configuration control system to ensure the continued integrity of the hardware and software qualified; </p> <p align="left"> i) QTG running and function and subjective tests.</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> a)</p> <p align="left"> b)</p> <p align="left"> c)</p> <p align="left"> d)</p> <p align="left"> <br/> </p> <p align="left"> e)</p> <p align="left"> f)</p> <p align="left"> g)</p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> h)</p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left">i)</p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM manual </p> <p align="left"> include, either directly or by reference to other documents, procedures for notification of the competent authorities of the following: </p> <p align="left"> a) any change in the organisation including company name, location, management; </p> <p align="left"> b) major changes to a qualified device; </p> <p align="left"> c) deactivation or relocation of a qualified device; </p> <p align="left"> d) major failures of a qualified device; </p> <p align="left"> e) major safety issue associated with the installation.</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> a) </p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> b)</p> <p align="left"> c)</p> <p align="left"> <br/> </p> <p align="left"> d)</p> <p align="left">e)</p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CM manual define acceptable and effective procedures to ensure compliance with applicable health and safety regulations, including:</p> <p align="left"> a) safety briefings; </p> <p align="left"> b) fire/smoke detection and suppression; </p> <p align="left"> c) protection against electrical, mechanical, hydraulic and pneumatic hazards; </p> <p align="left"> d) other items as defined in <a href="#_DxCrossRefBm1743304017">AMC1 ORA.FSTD.115</a> </p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> </p> <p align="left"> <br/> </p> <p align="left"> a)</p> <p align="left"> b)</p> <p align="left"> c)</p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left">d) </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> 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?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr> <td colspan="4" valign="top"><p align="left"> <b>5. COMPLIANCE MEASURES</b></p> </td> </tr> <tr valign="top"> <td><p align="left"> Have compliance monitoring objectives been developed from the policy statement, and included either directly or by reference in the CMS manual?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Does the CMS include processes to produce and review appropriate metrics data?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Do these compliance measures track the following: </p> <p align="left"> a) FSTD availability; </p> <p align="left"> b) numbers of defects; </p> <p align="left"> c) open defects; </p> <p align="left"> d) defect closure rates; </p> <p align="left"> e) training session interrupt rates; </p> <p align="left"> f) training session compliance rating.</p> </td> <td><p align="left"> </p> </td> <td><p align="left"> </p> <p align="left"> </p> <p align="left"> a) </p> <p align="left"> b) </p> <p align="left"> c) </p> <p align="left"> d) </p> <p align="left"> e) </p> <p align="left">f) </p> </td> <td><p align="left"> </p> </td> </tr> <tr valign="top"> <td><p align="left"> Do the compliance measures support the compliance objectives?</p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> <td><p align="left"> <br/> </p> </td> </tr> <tr> <td colspan="4" valign="top"><p align="left"> <b>Required actions/Comments</b></p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> <br/> </p> <p align="left"> Signature:……………………………………………………….</p> <p align="left"> <br/> </p> <p align="left">Date:………………………………….</p> </td> </tr> </table>