Standard operating procedure

Title: Hand over file

Status: PUBLIC Document no.: SOP/EMA/0127

Lead author Approver Effective date: 01-APR-2013
Name: Frances Nuttall Name: Andreas Pott Review date: 01-APR-2016
Signature: Signature: Supersedes: [TW 3729]
“On file” “On file” SOP/EMA/0127 (01-DEC-2012)
Date: 20-MAR-2013 Date: 24-MAR-2013 TrackWise record no.: 3815

1. Purpose
The SOP is in compliance with the internal control standards (EMA/MB/555181/2010) and in particular
ICS 3: staff allocation and mobility and ICS 10: business continuity.

The purpose of a handover is to ensure continuity of operations when the staff member, usually
responsible, is not available due to temporary or permanent absence. A handover can be supported by
a discussion to explain the status of the tasks, a summary of the work status in an e-
mail/memorandum or, a more detailed file.

For consistency and the efficient running of the Agency’s work it is important that, in the event of
planned absence of staff, the business is allowed to continue smoothly. Good information and
comprehensive communication is the key factor for a valuable hand over to the named “back up” or
successor taking over the duties.

When a staff member leaves the Agency for a long scheduled absence or indefinitely the person taking
over the duties needs to have a clear picture of the objectives and role and responsibilities of the job in
question. It is important that they have an understanding of the role they are taking on and how it
relates to the mission of the Agency. Therefore they need to receive the relevant information which
will enable them to continue to carry on the duties in the most efficient way.

In preparing a hand over not only the nature and context of the job must be considered (based on the
job description) but it also needs to take into account the knowledge of the back-up/successor.

Preparation for a handover (file/or discussion) means that relevant information needs to be maintained
(paper and /or electronic), on a continuing basis. The SOP also addresses general issues that need to
be considered in every handover.

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2. Scope
This SOP applies to all members of staff of the European Medicines Agency.

3. Responsibilities
It is the responsibility of Head of Unit, Head of Sector and Section Head to ensure that this procedure
is adhered to within their own unit, sector or section.

It is the responsibility of each individual who are about to go on short / long term absences or leave
their current position / the Agency to prepare a hand over file.

The responsibility for the execution of a particular part of this procedure is identified in the right-hand
column of section 9.

4. Changes since last revision

New SOP which was previously a work instruction.

5. Documents needed for this SOP

There is no specific template available for handovers because they will be different according to the
length of absence and depending of the section/sector/unit as work can hugely vary throughout the
Agency.

6. Related documents
Internal Control Standards (EMA/MB/555181/2010)

Individual Job Description

Work Plan

7. Definitions
The term ’file’ as used in this SOP refers to the relevant set of documents or the discussion to enable a
handover.

Back up: EMA colleague(s) named in the job description in the section - “In case of absence duties
assumed by:”

In order to ensure that back up colleague(s) named in the job description is able to easily take over
the duties, particularly in the case of unplanned absence, it is essential that regular contacts within the
team (e.g. sector meetings/bilateral) should take place. There should be on-going communication
between the parties to ensure a good overall understanding of the tasks carried out. Filing should be
up to date and regularly done (e.g. documents, files should be properly documented with notes to file
so that follow up can be easily ascertained) or, the location of any outstanding filing should be agreed
between parties.

Short term absence: A short-term absence arises in the case of planned or unplanned leave (e.g.
annual leave, special leave, short term sick leave or one month of parental/family leave/unpaid leave).

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The back-up person will take over the duties to the extent necessary for the short absence. It is
important that there is regular communication with the back-up person, so that this person is aware of
how the work and documents are organised as well as the status of tasks/actions.

Long term planned absence: Examples of long-term planned absences are maternity leave, more than
one month family/parental/unpaid leave, transfer to another unit/sector/section or, departure from the
agency where staff will be replaced on the full time basis.

The absence may be covered with a replacement person brought in to take over the duties of the post
or there may be some re-assignment of the duties within the team together with a replacement
person. In these cases there should be an overlap period so that the person(s) taking over the duties
is/are properly trained / briefed by the outgoing colleague.

Long term unplanned absence: It can arise due to long term sick leave.

It is not always possible to prepare a detailed handover in case of unplanned absences.

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8. Process map(s)/ flow chart(s)

START

1.
Assess type of hand
over needed

oral

Written

2. Prepare hand over

3. Train back up 3. Train back up

4. File hand over

5. Original Person returns Yes

No 6. Briefing by back up

END

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9. Procedure
Step Action Responsibility

1 Assess type of hand over according to the length of absence Individual staff
Staff away on short term leave can prepare an oral hand over (outgoing person)

Staff going on long term planned absences or staff moving to a

different section/sector/unit or leaving the Agency have to prepare
a written hand over

2. Prepare hand over Individual staff

(outgoing person)
The hand over needs to take into account the knowledge of the
back-up or replacing person. HoU/HoS/SH/Group
leaders
The hand over should contain information such as:

 Description of the duties and how they fit within the

Agency/Unit/Sector/Section

 Training on protocol and procedures e.g. SOPs/WINs and

explanation of relevant documents

 Advising status of on-going tasks

 Explanation on the objectives, priorities

However, regarding the length of absence and the knowledge of

the back-up, a written hand over may not always be required.

For written hand over: the format can be either a WIN, a briefing
note, a check list, or a schedule prepared to give all information in
order to ensure the continuity of work.

The annex to this SOP presents a suggestion of useful

documents/information that could be included in a hand over file.

The outgoing person has to make sure that the documentation

concerned for the tasks is up to date and easily available, and if
needed, revise it when preparing the hand over.

3. Train back up Individual staff

concerned
The departing person has to arrange the back-up briefing before
(outgoing person and
their departure.
back up)
For planned long term or permanent absence there should be,
where possible, an overlap of the duties, ideally the person taking
over should arrive prior to the departure of the agent in order to
work shadow the staff leaving or, if such an overlap is not possible,
an existing staff member could serve as a bridge.

For a staff member going on short term absence the back-up

person should be briefed in time before the person goes on leave
to allow for any follow up questions.

4. File (electronic / paper) hand over Individual staff

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 Step Action Responsibility

5. Notification of return of staff member

6. Feed back from hand over Back up / successor
When the staff member returns from absence a hand over should
be prepared to give updates on the status of the tasks.
(Go to step 2 for guidance)

10. Records
Hand over files are stored under:

Cabinet 14. Business Areas Operations/ 14.Unit name / x-Unit Administration / Staff Matters / Back-
ups and Hand overs

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Annex SOP/EMA/0127
Suggested list of documents / information to be included in a hand over file

For New staff:

 The Agency's mission statement

 Regulations relating to the business of the Agency as relevant to the position in question

 Annual Report (including summary)

 EMA Financial Regulations

 EMA Financial Implementing rules

 Internal Website addresses

 Institutions Website addresses

For New staff and back-ups:

 Road Map
Look at the Road Map as needed for the purpose of the job

 Work Programme
Look at the Agency work programme as needed for relevant things linked to the job

 In the case of senior management, a report describing the achievements against annual objectives
i.e. the most recent mid-year report, a description of measures for proper handover of
documentation on operational and organisation issues, an indication of problems, existing or
potential, that could be subject to a reservation in the next annual activity report and measures
taken or proposed to solve them.

 Job description

 Agency / Unit / Sector / Section organisational charts

 Unit / sector / section / individual Work plan

Look at the section / sector work plan, as applicable and identify any items or priorities for the role

 Position objectives and performance indicators

 Prepare, update a to-do list and advise on the status of each task and objective.
What is needed is a summary of the current state of the work of the agent leaving their post,
current and upcoming priorities, clear details of deadlines and subsequent tasks to be done and
documentation concerned or where to find it, on-going for information, waiting for actions and by
whom, urgent things to be chased up, particular deliverables which are expected.

 Description of each task with a workflow of the next steps for each activity. If these do not exist to
prepare a coherent/informative summary to explain the steps to follow.

 Listing of relevant SOPs/WINs

Annex SOP/EMA/0127 - PUBLIC

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