pr - safety programming and monitoring procedure · web viewreference documents a) contextual...

European Aviation Safety Agency Procedure

Safety programming and monitoring Doc #Approval Date

PR.SFPRG.00001-00118/11/2016

Safety programming and monitoring

PR.SFPRG.00001-001

Name Validation Date

Prepared by: Antonio Gonzalez Gomez Validated 15/11/2016

Verified by: Kai Bauer Validated 15/11/2016

Reviewed by: Valérie Landry-Sivel Validated 15/11/2016

Approved by: Jean-Marc Cluzeau Validated 15/11/2016

Authorised by: Luc TYTGAT Validated 18/11/2016

© European Aviation Safety Agency. All rights reserved. ISO9001 CertifiedProprietary document. Copies are not controlled. Confirm revision status through the EASA-Internet/Intranet.

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An agency of the European Union



PR.SFPRG.00001-00118/11/2016

DOCUMENT CONTROL SHEET

Reference documents

a) Contextual documents

COM (2015) - 599 Final - The European Aviation Safety Programme Document - 2nd edition of 7 December 2015, chapter 2 European Safety Risk ManagementCOM(2011) - 670 Final - Communication from the Commission to the Council and the European Parliament -Setting up an Aviation Safety Management System for EuropeCommission regulation template - Template of Commission Regulation. Annex of EASA opinionFAA-EASA Rulemaking cooperation guidelinesMB Decision 01-2004 - Decision of the Management Board of 3rd of February 2004 concerning the arrangements to be applied by the Agency for public access to documentsMB Decision 18-2015 - Decision of the Management Board concerning the procedure to be applied by the Agency for the issuing of opinions, certification specifications and guidance material ("Rulemaking procedure")PO.SFPRG.00002 - Code of Conduct for external experts supporting EASARegulation (EC) 1049/2001 - Regulation (EC) of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documentsRegulation (EC) 216/2008 - Regulation of European Parliament and of Council of 20 Feb. 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency and repealing Council Directive 91/670/EEC, Regulation (EC)1592/2002 and Directive 2004/36/ERegulation (EC) 45/2001 - Regulation of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such datab) Internal documents

FO.REVOP.00106ED DecisionFO.SFPRG.00003Annual safety reviewFO.SFPRG.00004CRDFO.SFPRG.00005 - Multi-annual programmeFO.SFPRG.00006RMP status reportFO.SFPRG.00007Activity sheetsFO.SFPRG.00008EPAS status reportTE.SFPRG.00009 - First draft EPAS/RMP

Abbreviations/Definitions

CAG: Collaboration and Analysis Group MAB: Member State Advisory BodySAB: Stakeholder Advisory BodySRP: Safety Risk PanelESC: EASA Safety CommitteePIA: Preliminary Impact Assessment


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RMP: Rulemaking ProgrammeEPAS: European Plan for Aviation Safety

Log of issues

Issue Issue date Change description

001 18/11/2016 First issue prepared by Rodrigo Priego.


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INTRODUCTION

Purpose and scopeThis procedure defines how the Safety Programmes, including the Rulemaking Programme (RMP) and the European Plan for Aviation Safety (EPAS), are developed and monitored. The responsibility for overseeing and coordinating the programming process lies with SM.2.1. SM.2.1. issues a planning cycle document at the beginning of the year with the main milestones of the planning cycle taking into account the Management Board and Advisory Bodies’ meeting dates. The responsibility of the technical content of the Safety Programmes lies with the respective operational department HoD. In case of horizontal actions, the responsibility is with the project manager nominated to manage the action and the HoD to which the project manager is reporting to.

Legal frameworkManagement Board Decision 18/2015 of 18 December 2015 amending and replacing MB Decision 01-2012 of 13/03/2012.COM(2011) 670 final – Communication from the Commission to the Council and the European Parliament -Setting up an Aviation Safety Management System for EuropeCOM(2015) 599 final – ANNEX 1 to the Report to the European Pariliament and the Council - The European Aviation Safety Programme Document 2nd edition

Basic PrinciplesThe Programmes have a five year horizon in line with the Multi-Annual Work Programme (MAP) of the Agency. The first year is a commitment with reference to those actions allocated to the Agency. For the years 2 to 5 the information given is indicative. For the actions assigned to the Member States, the Agency has no responsibility for their implementation but monitors them.


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Structure of process chartsSafety programming and monitoring

Safety programmingand monitoring

PR.SFPRG.00001-001

Develop prioritisedproposals

Develop strategic priorities

Monitor existing actionsand resources

Drafting and consultationon EPAS/RMP


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Develop strategic priorities

EASA strategicobjectives

defined

Safety riskportofolio defined

AND

Draft paper onstrategic

priorities for theprogrammes

Annual safetyreview

Multi-annualprogramme

Safety ProgrammesSection Manager

Safety ManagementTeam Leader

approve thepaper internally

ESC

Safety Risk Panel

Send paper forconsultation


MAB/SABis addressed to

Review thecomments

received


CRD

Update thestrategicpriorities

according tocomments

Strategicpriorities defined

Drafting andconsultation on

EPAS/RMP

Programme Integrationofficer

contributes to

Safety ProgrammesSection ManagerTE - First draft

EPAS/RMP


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Activity Description to the process activity

Draft paper on strategic priorities for the programmes

In order to prepare the initial paper on strategic priorities SM2.1 takes into account: - The annual safety review (domain specific safety risk portfolios) - EASA’s strategic plan (published in the Multiannual Work Programme)

approve the paper internally The initial draft is shared with planning focal points, responsible section managers in CT, FS and SM1

Send paper for consultation The draft strategic priorities paper is submitted to MAB and SAB for 1 month consultation. The draft is also submitted for information to FAA and TCCA.Comments are collected in a draft CRD by SM2.1.

Review the comments received The CRD is provided to the operational departments for drafting answers. New actions received during the consultation are recorded in the candidate issue register.

Update the strategic priorities according to comments

The comments that are accepted are directly incorporated in the chapter on strategic priorities which forms part of the next edition of the RMP/EPAS

Internal Process Interfaces

Drafting and consultation on EPAS/RMP


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is addressed to

Develop firstdraft

EPAS/RMP

Perform externalconsultation on

first draftEPAS/RMP

Perform internalconsultation on

first draftEPAS/RMP

Develop ToR

Head of technicaldepartment

RulemakingProgramme

completed

Final list ofcandidate

actions issuedStrategic

priorities definedExisting actions

and resourcesdefined

Developprioritisedproposals

Developstrategicpriorities

Monitor existingactions and

resources

PROMA

Executive Director

Certification Director

Flight Standards Director

Strategy and SafetyManagement Director

MAB/SAB

Rulemaking ProcessAssistant

CRD









Management Board


resources


resources

contributes to

contributes to

contributes to


AND

Candidate issueregister

Safety ProgrammeSection

Technical SectionManager

contributes to

Review thecomments

received on firstdraft EPAS/RMP

contributes to

Develop finalEPAS Develop final

RMP

AND

Submit theEPAS to MB for

endorsement

is addressed to

EPAScompleted

EPAS (MBMoM)

TeBs/STeBs SectorialCommittees


contributes to


AND

TE - First draftEPAS/RMP

TE - First draftEPAS/RMP

Rulemakingprogramme (ED

Decision)

ED Decision


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Develop first draft EPAS/RMP The responsibility for overseeing and coordinating the RMP/EPAS development process lies with SM.2. The responsibility of the technical content lies with the Technical Department HoD. In case of horizontal actions, the responsibility is with the project manager nominated to manage the action and the HoD to which the project manager is reporting to.The Technical Departments develop the first draft of the Safety Programmes, taking into account the following criteria:- Resources (including other Departments and Directorates) in function of ongoing tasks as well as current and future expertise and staff levels as indicated in the Agency’s staffing plan;- Strategic priorities and PIA scores: If a task is part of the strategic priorities or has a high PIA score, the task should be implemented with priority. - Comments received from MAB/SAB on the PIAs and their priority;- Any agreement taken with FAA as part of the rulemaking cooperation framework.

Perform internal consultation on first draft EPAS/RMP

After validation by the Head of technical department a dedicated coordination meeting with Directors is organised.

Perform external consultation on first draft EPAS/RMP

Once the draft RMP/EPAS has been validated by the Directors it is submitted to MAB,SAB, TeB, STeB and Sectorial Committees for 1 month operational consultation.The draft RMP/EPAS is also submitted for information to FAA and TCCA.

Review the comments received on first draft EPAS/RMP

Comments from MAB/SAB and EC are collected in a draft CRD. The CRD is provided to the technical departments for drafting answers and reviewing (when applicable) the draft RMP/EPAS. The document is now split into two separate documents: EPAS (safety actions only) and RMP.

Develop final EPAS The safety part of the integrated programme is now extracted and formatted for final endorsement.

Submit the EPAS to MB for endorsement

The final version of the EPAS is presented to the MB for endorsement and then published on the Agency’s website.

Develop final RMP The RMTs are extracted from the integrated programme and formatted for final approval. The RMP contains also other (non-rulemaking) actions for information purposes. The RMP is then submitted as an annex to the Agency’s single programming document (SPD) for written consultation with the Management Board. Following the Management Board an ED Decision formally adopting the Rulemaking Programme is issued and the RMP is published on the Agency’s website.


Develop prioritised proposalsDevelop strategic prioritiesMonitor existing actions and resourcesDevelop ToR


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Monitor existing actions and resources

EASA businessplanning

completedMS EPAS

reports available

PROMA

Activity sheets

MS EPASreports

Update status ofactions in

internaldatabase


AND

Collection ofinformation from

MS started

consolidate listof actions from

MS

Issue regularstatus report Programme Integration

officer

EPAS statusreport

RMP statusreport

Organiseprogrammingcoordination

meetings



Head of Strategy &Programmes Department

contributes to

contributes to

perform finalupdate of existing

actionsprogrammed

versus resources

Existing actionsand resources

defined



contributes to

contributes to

PROMA


EPAS/RMP

RulemakingProgramme

completed


EPAS/RMP

EPAScompleted


EPAS/RMPSafety Management

Team Leader


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Update status of actions in internal database

The actions that are published on EPAS and RMP are recorded in an internal data base (excel) named PROMA. The database contains all information related to each individual action as well as any related changes.

consolidate list of actions from MS

During the first quarter of the year the list of actions owned by Member States is extracted from the EPAS in a separate excel file. The excel file is completed with additional guidance for States to report on the status of the actions under their leadership and submitted to them for completion. The list of EPAS focal points is used for the distribution.

Issue regular status report On a regular basis PROMA is queried to obtain the latest status of the actions. Depending on the status of actions and intended actions different reports are prepared: - On a monthly basis a rulemaking dashboard with rulemaking deliverables is presented to ESC - For the remaining tasks (RES, SPT and FOT) the status is updated twice a year - For the tasks owned by States (MST), the status is updated once a year. The status of MST actions is summarized on a yearly basis, published as an Annex to the EPAS and discussed with States at the SM TeB.

Organise programming coordination meetings

As part of the preparation of every new edition of the EPAS/RMP several coordination meetings are organised with planning focal points in CT, FS and SM1. During these meetings the latest status of existing actions, resources as well as candidate issues is discussed.

perform final update of existing actions programmed versus resources

PROMA is updated in order to capture the outcome of the discussions with operational departments regarding their available resources for the following planning cycle.




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is addressed to

Develop prioritised proposals

Initial list ofactions validated

Calculate a costeffectiveness

ratio of thesafety action

Make firstrecommendation

for prioritisedaction

LaunchPreliminary

ImpactAssessment

PreliminaryImpact

AssessmentReport

Safety Risk Panel

Validateinternally the listof actions based

on PIAs

Safety Risk Panel

ESC

SafetyPerformance

AND Effectiveness ofaction to be

evaluated

is addressed to

Lead Expert

Safety Analysis Officer

Technical Expert

Safety Promotion Team

is addressed to

Lead Expert

Proposal for newissue identified

Reviewcandidate issue

XORCandidate safetyissue identified

Candidate non-safety issue

identifiedIdentification of

Safety Issues

Consult PIAswith

stakeholders

Validate thePIAs for

programming

Collaborative AnalysisGroups

MAB/SAB


ESC

Impact AssessmentNetwork

contributes to


EPAS/RMP

Impact AssessmentOfficer

contributes to

contributes to

contributes to


XOR

PreliminaryImpact

AssessmentReport

PreliminaryImpact

AssessmentReport

Assessment ofSafety Issues

Final list ofcandidate

actions issued


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Review candidate issue The Agency receives proposals for rulemaking tasks/activities as well as candidate issues on a continuous basis from a wide range of sources: European Commission’s requests, , ICAO programme, FAA look A-head programme, the Standardisation Annual Report, Network of Analysts (NoA), Safety Risk Management Process (SRM), internal and external stakeholders.An initial review of the received candidate issues is carried out in order to identify if it is a safety or no-safety one. While safety related proposals are dealt with through the SRM process, non-safety related proposals are subject to an initial review carried out by the planning focal points in FS and CT. SM2 is the owner of the central data base for candidate issues and ensures consistency.The possible outcomes of the initial review of proposals are:· Not accepted (not in EASA remit; already addressed in current actions) · For safety issues Safety Risk Assessment needed (input to the SRM process)· For non-safety issues Further assessment needed (further discussion with CT, FS is required)· Accepted, action already in RMP/EPAS – Add to exiting action area: Review existing Safety Analysis/PIA; Add to existing rulemaking/SP project, · Accepted, action already in progress, but not in EPAS/RMP – This includes routine updates of rules or other actions that are not captured in the RMP/EPAS due to their low significance· Accepted – candidate action for RMP/EPASThe core data on the candidate issue and the outcome of the proposal is recorded in the candidate issue register.

Launch Preliminary Impact Assessment

The objective of programming is to ensure that the European resources are used most effectively to mitigate safety risks. To achieve this, the potential safety actions (coming from SRM) as well as non-safety actions need to be assessed in terms of required resources and time for their effective implementation, as well as other impacts..In order to assess the potential actions in terms of their safety benefit, implementation costs and other impacts, a Preliminary Impact Assessment (PIA) is launched. The PIA is managed by a lead expert from a technical domain The lead expert will decide on a team of expert where SM2 co-ordinates the PIA development and provides economic input as well as safety promotion inputs and SM1 provides inputs for the safety assessment.When the proposals are accepted, but relate to an existing action area or on-going action, the subject preliminary impact assessment is reviewed with a view to see if it needs to be further updated.

Calculate a cost effectiveness ratio of the safety action

The types of action under consideration may include rulemaking, safety promotion (such as developing leaflets, videos, research projects, training, or international cooperation campaigns), focused oversight, member state action, research.For each action the safety benefits and cost implementation are translated into scales to ensure their comparability.


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The potential safety benefits and their related implementation costs are then computed in a cost-effectiveness ratio in order to support the prioritisation of the actions.

Make first recommendation for prioritised action

The PIA contains the first recommendation on the actions that need to be taken to mitigate a certain risk based on the initial list of potential actions coordinated through the Collaborative Groups and based on input from all feedback loops. The recommendation seeks to identify options that bring the highest safety benefit with the lowest possible cost within the shorter possible implementation time. The outcome is summarised in a PIA report

Validate internally the list of actions based on PIAs

The PIA report is consulted with the IA network and addressed to the Safety Risk Panel for validation. PIA reports related to both safety and non-safety actions are submitted to the SRP. After being validated by the SRP, the PIA is then submitted to ESC and cleared for external consultation.

Consult PIAs with stakeholders After having obtained the clearance from the ESC, the draft PIA is then consulted externally with CAGs and advisory bodies (MAB and SAB). The safety programmes section manager launches the external consultation.

Validate the PIAs for programming

Once the PIAs have been consulted externally and all comments are taken into consideration, the ESC performs the final validation of the PIA. The candidate actions proposed in the PIA and validated by the ESC are then taken into consideration for the next programming cycle.Short term actions such us workshops or SIBs that need to be executed before the next programming cycle are monitored via the Safety Promotion process.The actions that are not taken forward for programming are recorded in the PIA report.


Identification of Safety IssuesAssessment of Safety IssuesDrafting and consultation on EPAS/RMPSafety Performance


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RECORDS

Appendix A : Operational Documents


Record Activity

EPAS (MB MoM) - Submit the EPAS to MB for endorsement

Rulemaking programme (ED Decision) - Develop final RMP

CRD [FO.SFPRG.00004-000] - Review the comments received on first draft EPAS/RMP

Develop prioritised proposals

Record Activity

Preliminary Impact Assessment Report - Make first recommendation for prioritised action

Preliminary Impact Assessment Report - Validate internally the list of actions based on PIAs

Preliminary Impact Assessment Report - Validate the PIAs for programming

Appendix B : External Documents


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