Standard operating procedure
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1 Standard operating procedure Title: Requesting and recording of exceptions and non-compliance events Status: Public Document no.: SOPEMA0044 Lead author Approver Effective date: Name: Mario Benetti Name: Guido Rasi Review date: Signature: Signature on file Signature: Signature on File Supersedes: SOPEMA0044 (28-JUL-2014) TW4037 Date: Date: TrackWise record no Purpose The procedure describes the approval, registration and follow up of exceptions andor non-compliance events as in accordance with the standard for internal control on recording exceptions (standard No. 8), the Agency shall [.] track and give prior approval to control overrides or deviations from policies and procedures. The aim of reporting exception andor non-compliance is to ensure that any deviation from established policies or procedures is documented, justified and approved at an appropriate level before decisionaction is taken. 2. Scope The procedure is applicable to all Agency staff through the hierarchy. This procedure is without prejudice to the one described in the charter of tasks and responsibilities of the verifying officer and verifying assistant(s). in paragraph 3 (doc. Ref n. EMA ). The present procedure does not cover irregular activities which are described in a separate procedure dealing with reporting suspected improprieties (doc. Ref n. EMEA ). 3. Responsibilities It is the responsibility of the Executive Director, Heads of Division and Department, Authorising Officers by delegationsub-delegation to ensure that staff is aware of and complies with this procedure. Specific responsibilities are outlined in section Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0)20 Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 4. Changes since last revision Title edit Rename of managerial titles following the reorganisationrestructuring Review the steps and description of the procedure Update the request for an exception form (Annex I and Annex II) Addition of point 11 on transparency 5. Documents needed for this SOP Register of exceptions (Cabinets06. Corporate governance06.2 Integrated Management System6. Internal controlsexceptions) Template for requesting an exception (Word-File-New-Templates-Agency-More-request for exception) 6. Related documents Standards for internal control (EMAMB ) 7. Definitions ED: Executive Director AO: Authorising Officer by delegation sub-delegation HDiv: Head(s) of Division HDep: Head(s) of Department A-SG: Strategic Planning & Governance Department : Quality Assurance & Risk Management A-FI-VFO: Verification Office EXB: Executive Board Exception: 1. It constitutes a deviation from established processes and procedures (action of replacing one or more steps in established processprocedures with another action or no action) or, an overriding of controls (action which goes against the results of previous controls) but does not constitute a breach of regulatory andor contractual provisions and, 2. It is not foreseen in already existing processesprocedures and, 3. It is approved by the responsible person before action is taken (ex ante) Non-compliance: 1. It constitutes a deviation from established processes and procedures or an overriding of controls or a gap in existing controls and, 2. It might entail a breach of existing regulatory andor contractual provisions, and 3. It is detected after action was taken (ex post). Standard operating procedure PUBLIC SOPEMA0044, Page 28
3 Regulatory provisions (e.g. Regulation, Directive, Financial regulation, Implementing rules, Rules of application, Staff regulations, Data protection regulation, Access to documents). Contractual provisions (e.g. contracts with entities outside of the European Medicines Agency) Procedures (e.g. internal implementing rules, manuals, guidelines, SOPs, WINs ) 8. Process map(s) flow chart(s) Start 1. Complete template and forward it to Head of Division Authorising Officer by Delegation 2. Head of Division Authorising Officer sends request to A- FI-VFO and A-SG- QRM 3. A-FI-VFO and validate or reject the request and inform staff member Rejected Validated 5. obtain decision from the Executive Director Refused 4. Originator advise on alternative course of action Granted 6. Notify Head of Division or delegated Authorising Officer to proceed in accordance with decision taken by ED 7. Register the exceptionnoncompliance together with the decisions taken and file originals End Standard operating procedure PUBLIC SOPEMA0044, Page 38
4 9. Procedure Step Action Responsibility 1. Request an exception or report a non-compliance event by completing a request form (Annex I) and forward it to Head of Division or AO by Delegation for validation. The request should: Staff member initiating the requestoriginator Indicate which regulatory andor contractual provisions; policyprocedureregulationprocess is not respected. Describe the type of transactionevent and amount concerned. Explain the exceptional circumstances that justify an exception request or that caused a non-compliance. Describe the risk (e.g. reputational, financial or legal). Indicate the actions taken to mitigate the resulting risk andor measures proposed to avoid repetition of the situation. 2 Send request to Verification Office (A-FI-VFO) and Quality Assurance & Risk Management (). Head of Division Authorising Officer by Delegation 3 A-FI-VFO and validate or reject the request. If request is rejected inform staff member of decision. If the request is rejected go to step 4. A-FI-VFO If the request is validated go to step 5. 4 Advise on alternative course of action. Originator 5 Quality Assurance & Risk Management () obtain decision from the Executive Director. If the request is granted go to step 6. If the request is refused go to step 4. 6 Notify Head of Division or delegated Authorising Officer to proceed in accordance with decision taken by ED. 7 Register the exceptionnon-compliance and decision taken and file original request. Standard operating procedure PUBLIC SOPEMA0044, Page 48
5 10. Records Electronic files: The register of exceptionsnon-compliances, including the completed forms and the supportive documentation, are kept in the appropriately labelled folder in the electronic document management system: Cabinets06. Corporate governance06.2 Integrated Management System6. Internal controlsexceptions Document security setting: For non-confidential documents the ACL EMA_default_staffonly should be used. For confidential issues an ACL with an appropriate access level should be chosen. Signed originals: Originals of signed forms are kept by the : Quality Assurance & Risk Management 11. Transparency The register of exceptions and non-compliances is submitted to the Executive Board (EXB) annually for information. Standard operating procedure PUBLIC SOPEMA0044, Page 58
6 ANNEX 1 Request for an exception reporting of non-compliance event CONFIDENTIAL (To be delivered by hand) URGENT Please call requester and inform of decision by (DDMMYYYY) (For non-urgent requests, information will be processed within 24 hours after decision) Exception Non-compliance event Division: Name: Office: Tel: Policy or procedure this request for exceptionreport of non-compliance refers to is in conflict with (enclose reference) 1 : Financial Regulations Staff RegulationImplementing RulesLegal base Contract Grant Agreement Call for tenders call for proposals Other (please specify) Type of transactionevent and amount concerned 2 Exceptional circumstances that require an exception request caused a non-compliance event Resulting risk of the exception non-compliance (consequences of the event) Measures to be taken to mitigate the resulting risks and ensure that such a situation does not reoccur: Validation Opinion of the verification office (A-FI-VFO): Opinion of the quality assurance and risk management function (): Head of Division or delegated Authorising Officer validates the application: Yes No Date:... Signature:... 1 To attach the relevant documents 2 In case the amount cannot be determined or if the impact is not financial please indicate the significance e.g. important immaterial Request for an exception reporting of non-compliance event PUBLIC SOPEMA0044, Page 68
7 Decision Opinion of the Executive Director: Granted Refused Date:... Signature:... Justification if refusing request or if granting exception to regulatory or contractual obligations: Registration - For exception and non-compliance Reference Number: Date of registration in exceptions register by Internal Control Coordinator (): Date:... Signature:... Request for an exception reporting of non-compliance event PUBLIC SOPEMA0044, Page 78
8 ANNEX 2 DELIVER BY HAND Transmission slip Request for exceptions and recording of non-compliance URGENT Please call requester and inform of decision by (DDMMYYYY) (For non-urgent requests, information will be processed within 24 hours after decision) Exception Non-compliance event Title brief description Transmission Name Signature Date Office Tel. No. Initiator Head of DivisionAO A-FI-VFO Executive Director Return to Initiator Initiator Comments: (Notify resolution to the initiator) The transmission is effective on 15-JUL Please refer to SOPEMA0044 for details of the procedure. DELIVER BY HAND PUBLIC SOPEMA0044, Page 88
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