Transcription
Standard operating procedureTitle: Steps involved in outsourcing of servicesStatus: PUBLICDocument no.: SOP/EMA/0083Lead authorApproverEffective date: 18-12-2014Name: Caroline MaignenName: Stefano MarinoReview date: 18-12-2017Signature: On fileSignature: On fileSupersedes:Date: 26-11-2014Date: 18-12-2014SOP/EMA/0083 (19-05-2011)TrackWise record no.: 42871. PurposeThe purpose of this SOP is to set out the steps involved in outsourcing of services to ensure aconsistent and documented approach to outsourcing across the Agency.2. ScopeThis SOP shall guide all Divisions and Departments at the Agency.3. ResponsibilitiesIt is the responsibility of the Authorising Officer concerned to ensure that steps are followed anddocumented.The Authorising Officer may appoint a Project Manager to execute the project under his/herresponsibility. The Project Manager may also be the same person as the Authorising Officer.4. Changes since last revisionThis SOP replaces SOP/ADM/0083 of 27 April 2011. The changes are minor and relate to terminology(Division, Department) and updated references to the Agency’s Financial Regulation and its rules ofimplementation. There are no changes to the procedure itself.5. Documents needed for this SOPThe following forms for this SOP are required and can be found in the location identified:30 Churchill Place Canary Wharf London E14 5EU United KingdomTelephone 44 (0)20 3660 6000 Facsimile 44 (0)20 3660 5505Send a question via our website www.ema.europa.eu/contactAn agency of the European Union European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.
Standard procurement contract templates for outsourcing including Exit Plan are available inWord, File, New, Contracts tab. Recommended templates for invitations to tender, tender documents, mandatory filing planand appointment of committees can be found on the Procurement webpage. ACPC report templates are available in Word, File, New, Contracts tab and on the Procurementwebpage.6. Related documents Public Procurement Directive DIR/2004/18/EC (procurement microsite) Financial Regulation applicable to the budget of the European Medicines Agency applicable as of 1January 2014 in particular Title V Procurement thereof (financial microsite) Rules for the implementation of certain provisions of the Agency’s Financial Regulation applicableas of 1 January 2014 (financial microsite) SOP/EMA/0121: How to Conduct a Procurement Procedure (IQM microsite) Rules of Procedure of the Advisory Committee on Procurement and Contracts (financial microsite),as may be updated from time to time. Vade Mecum on Public Procurement Procedures in the Commission (procurement microsite) Guidelines for Staff and Managers on Outsourcing, 21 October 2005 (procurement microsite) Information Note on Service Level Agreements (SLAs), 3 March 2010 (procurement microsite) Regulation (EC) No 45/2001 on the protection of individuals with regard to the processing ofpersonal data by the European Union institutions and bodies (data protection microsite)7. DefinitionsIn this SOP, the following definitions apply: Authorising Officer (AO): The Authorising Officer of the Agency is the Executive Director butpowers may be delegated by the Executive Director to an Authorising Officer by delegation. TheAuthorising Officer implements the Agency’s budget in accordance with the financial rules of theAgency, on his/her own responsibility and within the limits of the appropriations authorised. TheAuthorising Officer is responsible for implementing revenue and expenditure in accordance with theprinciples of sound financial management and for ensuring that the requirements of legality andregularity are complied with. The Authorising Officer acts in accordance with the Charter of tasksand responsibilities of authorising officers by delegation. Exit Plan: a contractual document which ensures that, on expiry or termination of the contract,the services shall continue without interruption and/or degradation of the deliverables. It alsoensures that where the services or any part of them are being migrated to an exit transferee suchmigration takes place in a project managed, professional and orderly manner with minimalbusiness disruption. An exit plan is prepared at the outset of the contract and is an integralcontractual annex. Ex post evaluation: This refers to activities conducted to evaluate the human and financialresources allocated and the results obtained to verify their consistency with the initial objectives.Standard operating procedure – PUBLICSOP/EMA/0083,Page 2/6
Outsourcing: a long-term, results orientated relationship with an external service provider, whichis organisationally and economically independent, for activities traditionally performed within anorganisation and which constitutes a complete business process to be undertaken with a degree ofmanagement control and risk. Outsourcing is usually undertaken to save money, improve qualityand/or free resources for other core activities. Procurement decision: This is a document signed by the Authorising Officer of his/her decision tostart a procurement procedure. It will refer to the strategic and/or legal context of theprocurement (e.g. Work Programme, ESB or EEB decision etc). It will indicate the expecteddeliverables of the contract and objectives to be achieved, any particular risks or milestones. Incase of re-tendering it shall indicate whether or not an ex post evaluation of the performance ofthe contract to date has been carried out. Project Manager: the person who is responsible for the planning and execution of the project,ensuring its success by minimising risks. In some cases the Project Manager may be the sameperson as the Authorising Officer. Service Level Agreement (SLA): a contractual document which defines the standard, qualityand/or the way that services are to be provided. An SLA can/may be an integral contractual annex. Sponsor: the person who is ultimately responsible for the project. Stakeholder: a party who might be affected by the outsourcing.Standard operating procedure – PUBLICSOP/EMA/0083,Page 3/6
8. Process map(s)/ flow chart(s)Start9. Start planning the transitionto outsourcing company.10. Finalise contract andAnnexes for signature. Ensurefinancial commitment is inplace.1. Identify services to be outsourcedand discuss with Hdiv/Ddep. Analysebenefits and disadvantages ofoutsourcing and budget/ cost benefit.Discuss if any staff affected andalternative employment.11. Make arrangements forincoming contractor: trainingetc, exchange of knowledgefrom outgoing contractor, ifapplicable.2. Identify sponsor andproject manager, project team,other resources required,stakeholders.Hold discussions with stakeholders.12. Within 6 months ofcontract signature or earlier,finalise SLA and Exit Plan.13. Contract management:performance review. Keeprecords of meetings.Monitor services. KeepContract annexes up to date.3. Prepare project initiation documentsetting out business case and financialimpact analysis, objectives, scope,acceptance criteria, assumptions,constraints, risks, controls, timescale.Agree budget line and confirm budget isavailable.4. Submit to Hdiv forapproval and document decision.ED makes final decision.Agree to proceed?14. Audit ofcontract and/orbenchmarking.No15. Update contract: pricereviews, reviews of SLA,changes to services.16. Before end ofcontract: evaluate whetherto continue with outsourcing.Prepare ex post evaluation.Document lessons learned.Proceed?Yes5. Decide on procurementprocedure and timetable. Prepareprocurement decision andex post evaluation(if applicable).NoYes17. Go out to tender again.6. Conduct procurement procedurein accordance with SOPs.18. Implement exitarrangements: Ensuretransfer of knowledge tonew incoming contractor,if applicable.7. Submit to ACPC for opinion8. Make awarddecision on outcome oftender. Proceed?YesStandard operating procedure – PUBLICSOP/EMA/0083,EndPage 4/6
9. ProcedureStepActionResponsibility1.Identify services to be outsourced and discuss with Head ofAODepartment, if applicable, and Head of Division. Analyse benefitsand disadvantages of outsourcing and budget/cost benefit. Discussif any staff affected and alternative employment.Head ofDepartmentHead of Division2.Identify sponsor, project manager and project team, otherAOresources required, stakeholders. Hold discussions withstakeholders.3.Prepare project initiation document setting out business case andfinancial impact analysis, objectives, scope, acceptance criteria,assumptions, constraints, risks, controls, timescale, service levelsAO/Project Managerrequired. Agree budget line and confirm budget is available.4.Submit project initiation document to Heads of Division for approvaland document the decision. Based on approval of the Heads ofDivision, the Executive Director makes the final decision whether orAO/Project Managernot to proceed with the outsourcing. Such decision is documented.Heads of DivisionIf the project is approved, continue with step 5.Executive DirectorIf the project is not approved, the procedure ends here.5.Decide procurement procedure to be followed and establishAOtimetable. Provide advance information of planned procurement tothe Contracts and Procurement team in Legal Department. Draftingand signature of procurement decision. In case of re-tender,provision of ex post evaluation report, taking into account anylessons learned.6.Conduct procurement procedure in accordance with relevant SOPsAO(see 5. Documents needed for this SOP).7.Submit to ACPC for opinion.AO8.Make award decision on outcome of the tender, based on ACPC’sAOopinion. Keep relevant staff members informed.If decision is to proceed, continue with step 9.If the decision is not to proceed, the procedure ends here.9.Start planning the transition to the outsourcing company. KeepProject Managerrelevant staff members informed.10.Following relevant SOPs, finalise contract and annexes for signature.AOEnsure financial commitment is in place.11.Make arrangements for incoming contractor: e.g. training, exchangeProject Managerof knowledge from outgoing contractor, if applicable. Keep relevantstaff members informed.Standard operating procedure – PUBLICSOP/EMA/0083,Page 5/6
12.Within 6 months of contract signature or earlier, finalise SLA andAOExit Plan and other annexes.13.Conduct contract management and carry out performance review.AOKeep records of meetings. Monitor services. Ensure contractannexes are kept up-to-date.14.Audit of contract and/or benchmarking.Appointed auditoror benchmarker15.Update contract: price reviews, review of SLA, exit plan, review ifAOchanges to services are required.16.Before end of contract, evaluate whether to continue withAOoutsourcing. Prepare ex post evaluation and document any lessonslearned.If it is decided to continue with outsourcing, continue with step 17.If it is decided to no longer outsource the service, continue with step18.17.Launch a new tender and return to step 6.AO18.Implement exit arrangements, ensure transfer of knowledge to newAOincoming contractor, as applicable.Project Manager10. RecordsAll tender documentation and other records relating to procurement procedures will be collected andmaintained by the AO electronically in Document Records Electronic Archive Management, ensuringappropriate levels of security in the folders of the relevant Division/Department, and in hard copy inthe Division of the Authorising Officer or in the Agency’s official off-site storage facility. The AO shallconserve the supporting documentation for the relevant period as stated in the Agency’s BusinessClassification Scheme. The AO shall also retain in the same way and for the same duration all projectinitiation documents in relation to the outsourcing.Standard operating procedure – PUBLICSOP/EMA/0083,Page 6/6
This SOP shall guide all Divisions and Departments at the Agency. 3. Responsibilities It is the responsibility of the Authorising Officer concerned to ensure that steps are followed and documented. The Authorising Officer may appoint a Project Manager to execute the project under his/her responsibility. The Project Manager may also be the same person as the Authorising Officer. 4. Changes .
