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European Medicines Agency

Standard Operating Procedure

Title: Preparation and approval of new Work Instructions

PUBLIC Document no.: SOP/EMEA/0033

Lead Author Approver Effective Date: 22-MAY-07

Name: John S. Forte Name: Thomas Lönngren Review Date: 21-MAY-10

Signature: on file Signature: on file Supersedes:


SOP/EMEA/0033 (16-JAN-06)
Date: 08-MAY-07 Date: 11-MAY-10

1. Purpose
To enable the development and presentation of Work Instructions (WIN) at the EMEA in a consistent
way by the use of the EMEA WIN template. An existing WIN should be revised according to the SOP
on Review and Revision of Effective Work Instructions (SOP/EMEA/0034).

2. Scope
This SOP applies to all members of staff in EMEA Directorate, Units and Sectors.

3. Responsibilities
Each Unit and Sector Head under the responsibility of the Executive Director must ensure that this
procedure is adhered to within their own unit or sector. The responsibility for the execution of each
step of this procedure is identified under 9. Procedure.

4. Changes since last revision


Revision of SOP to reflect changes following introduction of TrackWise software for recording and
tracking of SOPs and WIN.

5. Documents needed for this SOP


WIN Template in MS Word (in TrackWise; provided solely by the IQMCo).
Process Map Template in MS PowerPoint (provided by the IQMCo, if required).
Transmission Slip – SOPs/WIN (in TrackWise; provided solely by the IQMCo).

6. Related documents
SOP/EMEA/0001: Preparation and approval of new Standard Operating Procedures
SOP/EMEA/0037: Publication or withdrawal of SOPs/WIN
WIN/EMEA/0035: Creating and maintaining SOP/WIN folders in EDMS
WIN/EMEA/0036: Creating flow charts
WIN/EMEA/0053: Use of TrackWise software for SOP/WIN recording and tracking

7. Definitions
EMEA Bodies: Management Board, Scientific Committees, Working Parties, Scientific Advisory
Groups, etc.
HoU/HoS: Head of Unit/Head of Sector

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IQMCo: IQM Co-ordinator or delegate
SOP: Standard Operating Procedure - Detailed, written instructions to achieve uniformity of the
performance of a specific process; the instructions usually cover more than one task or area within the
Agency, Unit or Sector.
TrackWise: Software for the tracking of processes and the creation and archiving of related records
and associated documents. The SOP/WIN Management module is intended for the recording and
tracking of SOPs and WIN.
WIN: Work Instructions - Detailed descriptions of how to perform and record tasks; they may be, for
example, detailed written descriptions, flow charts, checklists, pictures, or combinations thereof
(definition adapted from ISO/TR 10013:2001 – Guidelines for quality management system
documentation)

8. Process Map(s)/ Flow Chart(s)

START

1. Determine need for new WIN


Assign lead author
Define scope, title, publication status and
need for consultation
Appoint drafting team
Determine Approver

2. Inform Unit IQM Co by e-mail

3. Assign WIN Doc. No.


Create e-folder structure
(WIN/EMEA/0035)
Create TrackWise record & WIN template
(WIN/EMEA/0053)
Forward automated e-mail to Lead author

4. Draft WIN and consult as required

5. Check and finalise WIN and related


forms/templates
Inform IQMCo

6. Carry out QC check

7. Implement corrections, if required

8. Update WIN status


Print hard copy
Update TrackWise record and
generate transmission slip
(WIN/EMEA/0053)

9. Sign WIN (Lead author)

10. Read and sign WIN (Approver)

11. Go to SOP/EMEA/0037

END

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SOP/EMEA/0033, 22-MAY-07
9. Procedure
Step Action Responsibility
1 Determine need for new WIN. HoU/HoS
Assign Lead author of WIN.
Define scope and purpose of WIN with Lead author.
Appoint drafting team having a good knowledge of the tasks involved. If
cross-Sector/Unit representation is necessary, consult with other HoS to
appoint team members.
Determine who will be the approver of the WIN.
Determine the consultation status, i.e. whether the WIN will be developed
solely within the Unit/Sector or will be subject to wider consultation.
WIN that are very specific to tasks undertaken by a restricted group of
persons or within a Sector/Unit are unlikely to require cross-Agency
consultation.
Determine publication status of final WIN, i.e. PUBLIC (for publication
on intranet and external web site) or CONFIDENTIAL (for publication on
intranet and title only on external web site).
2 Inform Unit IQMCo by e-mail of WIN title, publication status, need for Lead author
consultation or otherwise, and Lead author, drafting team and approver
names.
3 Verify if any other SOP or WIN for similar processes at the EMEA exists IQMCo
or is under development to avoid duplication or divergence. If not assign
WIN document number and create WIN-specific folder in EDMS (refer to
WIN/EMEA/0035). Create new record and WIN template in TrackWise,
and forward automated email to Lead author (refer to WIN/EMEA/0053).
4 Complete WIN template provided by the IQMCo. Lead
WIN can be adapted to suit the purpose of the document. They may author/drafting
consist of, for example, a process map, description of steps in a procedure, team
a check list, pictorial images/screen shots or a combination of two or more
of these.
If a process map is required, prepare it in PowerPoint (refer to
WIN/EMEA/0036). Save all versions of the document in the WIN-
specific folder provided. Insert a black and white copy of the updated
process map in the WIN (refer to WIN/EMEA/0036).
If the steps in a procedure are to be documented, describe them as clear
and concise steps, based on the process map (if applicable). If referring to
other documents, use the document title/number without version number.
Save all versions of the WIN in the WIN-specific folder provided.
If the procedure described in the WIN requires the use of templates/forms,
develop them in parallel to the WIN, NOT as appendices to the WIN.
Refer to them in the WIN, and save the template/form in the WIN-specific
folder.
If other Sectors/Units need to be consulted on the content of the WIN,
request comments within a prescribed period not exceeding 4 weeks. If
other EMEA bodies need to be consulted the length of consultation may
be longer than 4 weeks. The consultation procedure described in
SOP/EMEA/0001 may be followed.
In case of difficulty with any part of this Step, seek assistance of the Unit
IQMCo.
5 If consultation has been requested, evaluate comments and implement Lead
author/drafting

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SOP/EMEA/0033, 22-MAY-07
Step Action Responsibility
appropriate suggested improvements in the WIN. team
Check and finalise WIN and Process Map or forms/templates, if
applicable.
Inform IQMCo when ready.
6 Carry out quality check (use checklist in WIN/EMEA/0053) and request IQMCo
Lead author to make corrections, if required.
7 Make necessary corrections to WIN and forms/templates, if required. Lead author
8 Update status of WIN as informed in Step 2, print hard copy and check in
to EDMS.
Open the SOP record in TrackWise, document quality check and update
required fields. Generate transmission slip. (Refer to WIN/EMEA/0053.)
Forward WIN and transmission slip to Lead Author.
9 Sign WIN and transmission slip. Lead author
Forward to Approver.
10 Read WIN. Approver
Sign WIN and transmission slip.
Forward to IQMCo.
11 Refer to SOP/EMEA/0037. IQMCo

10. Records
Electronic records of WIN are generated and saved in TrackWise. Electronic documents are saved in
EDMS.

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SOP/EMEA/0033, 22-MAY-07