Standard operating procedure Title: Steps involved in outsourcing of services Status: PUBLIC Document no.: SOP/EMA/0083 Lead author Approver Effective date: 18-12-2014 Name: Caroline Maignen Name: Stefano Marino Review date: 18-12-2017 Signature: On file Signature: On file Supersedes: SOP/EMA/0083 (19-05-2011) Date: 26-11-2014 Date: 18-12-2014 TrackWise record no.: 4287 1. Purpose The purpose of this SOP is to set out the steps involved in outsourcing of services to ensure a consistent and documented approach to outsourcing across the Agency. 2. Scope 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 to execute the project under his/her responsibility. The may also be the same person as the Authorising Officer. 4. Changes since last revision This 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 of implementation. There are no changes to the procedure itself. 5. Documents needed for this SOP The following forms for this SOP are required and can be found in the location identified: 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5505 Send a question via our website www.ema.europa.eu/contact An 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 in Word, File, New, Contracts tab. Recommended templates for invitations to tender, tender documents, mandatory filing plan and appointment of committees can be found on the Procurement webpage. ACPC report templates are available in Word, File, New, Contracts tab and on the Procurement webpage. 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 1 January 2014 in particular Title V Procurement thereof (financial microsite) Rules for the implementation of certain provisions of the Agency s Financial Regulation applicable as 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 of personal data by the European Union institutions and bodies (data protection microsite) 7. Definitions In this SOP, the following definitions apply: Authorising Officer (): The Authorising Officer of the Agency is the Executive Director but powers may be delegated by the Executive Director to an Authorising Officer by delegation. The Authorising Officer implements the Agency s budget in accordance with the financial rules of the Agency, on his/her own responsibility and within the limits of the appropriations authorised. The Authorising Officer is responsible for implementing revenue and expenditure in accordance with the principles of sound financial management and for ensuring that the requirements of legality and regularity are complied with. The Authorising Officer acts in accordance with the Charter of tasks and 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 also ensures that where the services or any part of them are being migrated to an exit transferee such migration takes place in a project managed, professional and orderly manner with minimal business disruption. An exit plan is prepared at the outset of the contract and is an integral contractual annex. Ex post evaluation: This refers to activities conducted to evaluate the human and financial resources allocated and the results obtained to verify their consistency with the initial objectives. SOP/EMA/0083, Page 2/6
Outsourcing: a long-term, results orientated relationship with an external service provider, which is organisationally and economically independent, for activities traditionally performed within an organisation and which constitutes a complete business process to be undertaken with a degree of management control and risk. Outsourcing is usually undertaken to save money, improve quality and/or free resources for other core activities. Procurement decision: This is a document signed by the Authorising Officer of his/her decision to start a procurement procedure. It will refer to the strategic and/or legal context of the procurement (e.g. Work Programme, ESB or EEB decision etc). It will indicate the expected deliverables of the contract and objectives to be achieved, any particular risks or milestones. In case of re-tendering it shall indicate whether or not an ex post evaluation of the performance of the contract to date has been carried out. : the person who is responsible for the planning and execution of the project, ensuring its success by minimising risks. In some cases the may be the same person as the Authorising Officer. Service Level Agreement (SLA): a contractual document which defines the standard, quality and/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. SOP/EMA/0083, Page 3/6
8. Process map(s)/ flow chart(s) Start 9. Start planning the transition to outsourcing company. 1. Identify services to be outsourced and discuss with Hdiv/Ddep. Analyse benefits and disadvantages of outsourcing and budget/ cost benefit. Discuss if any staff affected and alternative employment. 2. Identify sponsor and project manager, project team, other resources required, stakeholders. Hold discussions with stakeholders. 10. Finalise contract and Annexes for signature. Ensure financial commitment is in place. 11. Make arrangements for incoming contractor: training etc, exchange of knowledge from outgoing contractor, if applicable. 12. Within 6 months of contract signature or earlier, finalise SLA and Exit Plan. 3. Prepare project initiation document setting out business case and financial impact analysis, objectives, scope, acceptance criteria, assumptions, constraints, risks, controls, timescale. Agree budget line and confirm budget is available. 13. Contract management: performance review. Keep records of meetings. Monitor services. Keep Contract annexes up to date. 14. Audit of contract and/or benchmarking. 4. Submit to Hdiv for approval and document decision. ED makes final decision. Agree to proceed? No 15. Update contract: price reviews, reviews of SLA, changes to services. Yes 5. Decide on procurement procedure and timetable. Prepare procurement decision and ex post evaluation (if applicable). 16. Before end of contract: evaluate whether to continue with outsourcing. Prepare ex post evaluation. Document lessons learned. Proceed? Yes 17. Go out to tender again. No 6. Conduct procurement procedure in accordance with SOPs. 18. Implement exit arrangements: Ensure transfer of knowledge to new incoming contractor, if applicable. 7. Submit to ACPC for opinion 8. Make award decision on outcome of tender. Proceed? Yes End SOP/EMA/0083, Page 4/6
9. Procedure Step Action Responsibility 1. Identify services to be outsourced and discuss with Head of Department, if applicable, and Head of Division. Analyse benefits and disadvantages of outsourcing and budget/cost benefit. Discuss if any staff affected and alternative employment. 2. Identify sponsor, project manager and project team, other resources required, stakeholders. Hold discussions with stakeholders. 3. Prepare project initiation document setting out business case and financial impact analysis, objectives, scope, acceptance criteria, assumptions, constraints, risks, controls, timescale, service levels required. Agree budget line and confirm budget is available. 4. Submit project initiation document to Heads of Division for approval and document the decision. Based on approval of the Heads of Division, the Executive Director makes the final decision whether or not to proceed with the outsourcing. Such decision is documented. If the project is approved, continue with step 5. If the project is not approved, the procedure ends here. 5. Decide procurement procedure to be followed and establish timetable. Provide advance information of planned procurement to the Contracts and Procurement team in Legal Department. Drafting and signature of procurement decision. In case of re-tender, provision of ex post evaluation report, taking into account any lessons learned. 6. Conduct procurement procedure in accordance with relevant SOPs (see 5. Documents needed for this SOP). Head of Department Head of Division / / Heads of Division Executive Director 7. Submit to ACPC for opinion. 8. Make award decision on outcome of the tender, based on ACPC s opinion. 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. Keep relevant staff members informed. 10. Following relevant SOPs, finalise contract and annexes for signature. Ensure financial commitment is in place. 11. Make arrangements for incoming contractor: e.g. training, exchange of knowledge from outgoing contractor, if applicable. Keep relevant staff members informed. SOP/EMA/0083, Page 5/6
12. Within 6 months of contract signature or earlier, finalise SLA and Exit Plan and other annexes. 13. Conduct contract management and carry out performance review. Keep records of meetings. Monitor services. Ensure contract annexes are kept up-to-date. 14. Audit of contract and/or benchmarking. Appointed auditor or benchmarker 15. Update contract: price reviews, review of SLA, exit plan, review if changes to services are required. 16. Before end of contract, evaluate whether to continue with outsourcing. Prepare ex post evaluation and document any lessons learned. If it is decided to continue with outsourcing, continue with step 17. If it is decided to no longer outsource the service, continue with step 18. 17. Launch a new tender and return to step 6. 18. Implement exit arrangements, ensure transfer of knowledge to new incoming contractor, as applicable. 10. Records All tender documentation and other records relating to procurement procedures will be collected and maintained by the electronically in Document Records Electronic Archive Management, ensuring appropriate levels of security in the folders of the relevant Division/Department, and in hard copy in the Division of the Authorising Officer or in the Agency s official off-site storage facility. The shall conserve the supporting documentation for the relevant period as stated in the Agency s Business Classification Scheme. The shall also retain in the same way and for the same duration all project initiation documents in relation to the outsourcing. SOP/EMA/0083, Page 6/6