Standard operating procedure

Title: Publication of, and training on standard operating procedures and work instructions
Status: PUBLIC

Document no.: SOP/EMA/0037

Lead author

Approver

Effective date: 10-Jul-13

Name: Mario Benetti

Name: Guido Rasi

Review date: 10-Jul-16

Signature: On file

Signature: On file

Supersedes:

Date: 10-Jul-13

Date: 10-Jul-13

SOP/EMA/0037 (31-AUG-11)
TrackWise record no.: 3949

1. Purpose
To describe the procedure for publishing new and reviewed standard operating procedures and work
instructions, withdrawing obsolete SOPs and WIN, and maintaining courses in SAP HR IMS.

2. Scope
This SOP applies to:

IQM co-ordinators and their delegates in all Units;

Web publishers and Intranet News Editors;

IQM Manual co-ordinator.

3. Responsibilities
Each Head of Unit under the responsibility of the Executive Director must ensure that this procedure is
adhered to within their own unit. 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

Revision of SOP title to cover training aspects.

Revision of step 4 to adapt instructions on adding title to file summary in MS Word 2010.

Revision of steps 6 and 21 to describe creation of PDF versions in MS Word 2010.

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom

Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416
E-mail info@ema.europa.eu Website www.ema.europa.eu

An agency of the European Union

European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

Addition of new steps 16 to 19, 28, and 32 to 39 to describe how to maintain courses in SAP HR
IMS and update Units SOP/WIN training matrices.

Revision of Annex 1 to adapt instructions to use of MS Office 2010.

5. Documents needed for this SOP

Annual submission schedule (located on the intranet at

http://emeaplus/EMEAPlus_WebsiteNew/IQM/html/IQMCo.htm)

Units SOP/WIN training matrices (located in DREAM at Cabinets/06. Corporate governance/06.2

Integrated Management System/2. IMS Manual/5. SOPs and WINs/SAP unit matrices)

6. Related documents

WIN/EMA/0053: Use of TrackWise software for SOP/WIN recording and tracking

SAP-HR-II IMS - User Manual for the back-end (located on the intranet at
http://emeaplus/EMEAPlus_WebsiteNew/IQM/html/Manuals.htm)

7. Definitions
A-HR-PER: Personnel Section
DREAM: Document records electronic archive management system
IQMCo: Unit IQM co-ordinator or delegate
ManualCo: IQM manual co-ordinator or delegate
SAP HR IMS: IMS learning solution module in the Human Resources component of SAP system
SOP: Standard operating procedure
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

Standard operating procedure PUBLIC

SOP/EMA/0037, 10-Jul-13

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

Start

Obsolete

1. Is
SOP/WIN
for publication or
obsolete?
For publication
2. Record quality check

19. Update WORD

document

3. Update hard copy

4. Update Word document

20. Update PowerPoint/
Visio document
5. Update Visio document
21. Create PDF version of
Word document

6. Create PDF version of

Word document

22. Update folder name

23. Update TrackWise

record (WIN/EMA/0053)

7. Status of
SOP/WIN?

Confidential SOP/WIN

For external publication

No

24. Is
SOP/WIN published on
external
web site?
Yes
25. Remove SOP/WIN from
external web site
26. Remove SOP/WIN from
IMS manual
27. Delimit the training
course in SAP
28. File hard copy as
obsolete

10. Send PDF to external

website drive
11. Update TrackWise
record (WIN/EMA/0053).
Send hard copy to Web
Publishers

8. Update TrackWise record

(WIN/EMA/0053)
9. Send hard copy to
ManualCo

12. Publish SOP/WIN on

external web site
13. Send hard copy to
ManualCo
14. Open TrackWise record
(WIN/EMA/0053). Publish
SOP/WIN in IMS manual

15. Update TrackWise

record (WIN/EMA/0053).
File hard copy in Master file

16. Is SOP/WIN
new or revised?

Revised
17. Delimit training course
for superseded version in
SAP

New

18. Create new training

course in SAP
29. Inform intranet news
editors
To step
30.

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From
step
29.
30. Announce on intranet
news page

31. Request report of staff

updates

32. Are there

any changes in the
matrices?
Yes
33. Update each Unit
matrices
34. Send updated matrices
to IQMCos

35. Confirm changes

No

36. Assign courses

37. Send updated matrix to

ManualCo
38. Upload new data in SAP
HR IMS

End

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9. Procedure
Step

Action

Responsibility

If the SOP/WIN is due for publication, go to step 2.

IQMCo

If the SOP/WIN is obsolete, go to step 19.

Publication of SOP/WIN
2

Open the SOP/WIN record in TrackWise (refer to WIN/EMA/0053)

IQMCo

and carry out and record the quality check (Check of Signed-off
SOP/WIN (before publication)) while performing steps 3 and 4
below.
3

Update header of original, signed hard copy in ink with Effective

IQMCo

Date and Review Date using the format DD-MMM-YY, e.g. 08-JUN07.
The Effective Date should not be earlier than the date of signature
by the approver.
The Review Date should be the Effective Date plus the validity
period prescribed by the EMA, e.g. 3 years from the Effective Date.
Update footer of signed hard copy in ink with the same Effective
Date using the format DD-MMM-YY on each page (except the first)
next to the document number.
4

Update in typing the header of the MS Word document with On

IQMCo

file in the signature cells and with the original dates of signature
by the lead author and approver and the Effective Date and Review
Date using the format DD-MMM-YY.
Update in typing the footer with the final status and with the
Effective Date using the format DD-MMM-YY. The final footer
should have these details:
Standard operating procedure - <STATUS>
<SOP/a/bbbb>, <DD-MMM-YY>

Page x/y

Go to File>Properties>Advanced properties. In the Summary tab,

enter in the Title field the title of the SOP/WIN including the
document number and type in the same format used for the MS
Word file name, e.g. 0037 SOP - Publication of, and training on
SOPs and WINs.
Check in the MS Word document in DREAM.

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Step

Action

Responsibility

If a related flow chart is available in the SOP/WIN folder in DREAM

IQMCo

as a MS Visio document, highlight the document name in DREAM,

right-click on the mouse and select Check Out.
Highlight again the name of the MS Visio document in DREAM,
right-click on the mouse and select Check In. Type Ver DD-MMMYY (the date refers to the effective date of the corresponding
SOP/WIN as determined in step 3) in the Label field and Check in
as Same version.
6

Create a PDF version of the MS Word document using PDF rendition

IQMCo

in DREAM or File>Save as>Save as type>PDF in MS Word.

Open PDF version in Adobe Acrobat. Go to File>Properties. In the
Description tab, check that the Title field contains the title of the
SOP/WIN including the document number in the same format used
for the MS Word file name, e.g. 0037 SOP - Publication of, and
training on SOPs and WINs, inherited from the MS Word document.
If not, correct the title.
Check in the PDF file using the Check in from file function as the
next minor version of the MS Word document inserting Ver DDMMM-YY in the Label field (the date refers to the SOP/WIN
effective date).
7

If the SOP/WIN is confidential, go to step 8.

IQMCo

If the SOP/WIN is for external publication, go to step 10.

Confidential SOP/WIN
8

Update required fields in the SOP/WIN record in TrackWise.

IQMCo

Remember to close off the record for the superseded version (refer
to WIN/EMA/0053).
9

Forward hard copy of confidential SOP/WIN and transmission slip to

IQMCo

Manual Co.
Go to step 14.
Public SOP/WIN for external publication
10

Highlight the name of the PDF version of the SOP/WIN in DREAM,

IQMCo

right-click on the mouse and select Export. In the Select Folder

pop-up window select the IQM folder at G:\External Information
Draft\SIGN OFF\IQM (for publication on the external website), and
click OK. Do not modify the file name.
11

Update required fields in the SOP/WIN record in TrackWise.

IQMCo

Remember to close off the record for the superseded version (refer
to WIN/EMA/0053).
Forward hard copy of SOP/WIN and transmission slip to Web
Publishers.

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Step

Action

Responsibility

12

Publish details and PDF of public SOP/WIN (saved in G:\External

Web Publishers

Information Draft\SIGN OFF\IQM) on the external web page

corresponding to the activity area and type indicated on the
transmission slip.
IMS Manual and Master File
13

Send hard copy of SOP/WIN and transmission slip to ManualCo.

Web Publishers

14

Open SOP/WIN record in TrackWise (refer to WIN/EMA/0053).

ManualCo

Publish title and PDF of SOP/WIN (saved in TrackWise) in intranetbased IMS Manual.
15

Update required fields in TrackWise (refer to WIN/EMA/0053).

ManualCo

File hard copy of SOP/WIN and transmission slip in controlled

documents master file.
Updating SAP HR IMS database
16

If published SOP/WIN is a reviewed version, go to step 17.

Manual Co

If published SOP/WIN is a new document, go to step 18.

17

In SAP HR IMS module, delimit the training course for the

ManualCo

superseded version of the published SOP/WIN (refer to SAP-HR-II

IMS - User Manual for the back-end).
Note: All records of relationships to staff will be delimited and will
be visible on reports.
18

Create a new training course for the published reviewed version of

ManualCo

the SOP/WIN (refer to SAP-HR-II IMS - User Manual for the backend).
Obsolete SOP/WIN
19

Open the Word document in DREAM in edit view. Insert text

IQMCo

watermark stating Obsolete (DD-MMM-YY), where DD-MMM-YY is

the current date (refer to Annex 1 for detailed instructions).
When checking in the document in DREAM, select Properties and in
the EMA tab insert OBSOLETE in the name field between the
SOP/WIN number and the title, e.g. 0037 SOP - OBSOLETE Publication of, and training on SOPs and WINs. Finally check in as
Same version.
20

If a related flow chart is available in the SOP/WIN folder in DREAM

IQMCo

as a MS PowerPoint or MS Visio document, open the document in

edit view. Insert text stating Obsolete (DD-MMM-YY), where DDMMM-YY is the current date (refer to Annex 1 for detailed
instructions).
Repeat the procedure described in step 19 to insert OBSOLETE in
the file name, e.g. Process Map 0037 SOP - OBSOLETE Standard operating procedure PUBLIC
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Step

Action

Responsibility

Publication of, and training on SOPs and WINs. Type Obsolete in

the Label field and Check in as Same version.
21

Create a PDF version of the MS Word document using PDF rendition

IQMCo

in DREAM or File>Save as>Save as type>PDF in MS Word.

Check in the PDF file using the Check in from file function as the
next minor version of the MS Word document inserting Obsolete
in the Label field.
22

Modify the name of the DREAM folder containing the documents

IQMCo

from steps 19 to 21 by selecting Properties and in the EMA tab add

OBSOLETE in the Name field, e.g. 0037 SOP - OBSOLETE Publication of, and training on SOPs and WINs".
23

Open and update the SOP/WIN record in TrackWise (refer to

IQMCo

WIN/EMA/0053).
24

If obsolete version of SOP/WIN is published on the external web

IQMCo

site, go to step 25.

If not published on external web site, go to step 26.
25

Remove title and PDF document from external web site.

Web publishers

26

Remove title and PDF document from intranet-based IMS Manual.

ManualCo

Note: TrackWise sends an automated notification to the ManualCo.

27

In SAP HR IMS module, delimit the training course for the obsolete

ManualCo

SOP/WIN (refer to SAP-HR-II IMS - User Manual for the back-end).

Note: All records of relationships to staff will be delimited and will
be visible on reports.
28

File signed hard copy of SOP/WIN retained in controlled documents

ManualCo

master file as obsolete.

Announcement on intranet
29

Inform

by

e-mail

Intranet

News

Editors

to

advertise

ManualCo

new/reviewed/obsolete SOP/WIN on the intranet news page.

30

Announce new/reviewed/obsolete SOP/WIN on the intranet news

Intranet

page.

News Editors

Updating Units SOP/WIN training matrices

Note: The annual submission schedule sets out the deadlines for
the key steps described in steps 31 to 38. Deadlines are calculated
as working days (excluding weekends and Agency holidays) from
day X (the working day preceding the 1st or 16th day of every
month).
Day X-8: Checking of staff updates

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Step

Action

Responsibility

31

Request report of staff updates since previous scheduled report

ManualCo

from A-HR-PER.
Note: Updates include new staff, staff that left the Agency and
internal staff movements.
32

If there are changes to SOP/WIN list and/or staff list, go to step

ManualCo

34.
If there are no changes, procedure ends.
Day X-7: Updating and transmission of matrices
33

Update each Unit matrix to reflect the following changes since the

ManualCo

previous update.

New SOP/WIN: insert new column in matrix using pink for the
background.

New Staff: insert new row in matrix using pink for the
background.

Reviewed SOP/WIN: change background colour in SOP/WIN

column to yellow.

Obsolete SOP/WIN: change background colour in SOP/WIN

column to red.

Staff that left the Agency: change background colour in

SOP/WIN column to red.

Staff movement within the Agency: highlight the row using

green colour.

34

Send updated matrices to the respective Unit IQMCos.

ManualCo

Day X-6 to X-3: SOPs/WIN assignment to staff

35

Confirm that the staff changes and movements in the respective

IQMCo

unit matrix are correct.

If necessary, liaise with ManualCo to update Units matrices.
Liaise with Heads of Sector/Section Heads to confirm staff training
profiles.

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Step

Action

Responsibility

36

In the unit matrix, where applicable, assigns courses to staff by

IQMCo

inserting the character 1 in the matrix:

For new or reviewed SOP/WIN: assign SOP/WIN to staff

members that need to be trained based on the responsible
positions identified in the SOP/WIN.

For new staff: assign applicable SOPs/WIN to staff member

based on position and responsibilities (can be copied from
training profile of another staff member in same position and
with same responsibilities).

For staff that left the Agency: no action required.

For internal staff movement:

In previous staff members unit, confirm staff movement;

In staff members new unit, assign applicable SOPs/WIN to

staff member based on new position and responsibilities
(can be copied from training profile of another staff
member in same position and with same responsibilities);

For

staff

movement

within

same

unit,

if

position/responsibilities have changed, assign applicable

SOPs/WIN to staff member or, if position/responsibilities
have not changed and current training profile still applies,
no changes are required.
Day X-2: Transmission of matrices
37

Send completed matrix to ManualCo.

IQMCo

Day X: Uploading new matrices in SAP HR IMS

38

Refer to SAP-HR-II IMS - User Manual for the back-end.

ManualCo

10. Records
When completed and approved the original, signed hard copy of a SOP or WIN is retained by the IQM
Manual Co-ordinator in the controlled documents master file.
Electronic records of SOPs are generated and saved in TrackWise.
Electronic documents are filed, in DREAM under: Cabinets/06. Corporate governance/06.2 Integrated
Management System/2. IMS Manual/5. SOPs and WINs.
Electronic IQM training courses are created in SAP HR IMS.

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Annex 1 Instructions on inserting watermarks in obsolete

SOPs/WIN
For MS Word documents:
1.1

With MS Word document in edit view, select Page layout>Watermark>Custom watermark.

1.2

In the Printed Watermark window, select Text watermark and type Obsolete (DD-MMM-YY) in

the Text field, select Verdana font and black as the colour and untick Semitransparent. Click on OK for
watermark to be inserted in each page of the document.

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For MS PowerPoint documents:

1.3

With MS PowerPoint document in edit view, select Inser>WordArt and select style as indicated

below.

1.4

In the text box, type Obsolete (DD-MMM-YY). If the document consists of more than one

page, copy the WordArt text and paste it on each page.

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For MS Visio documents:

1.5

With MS Visio document in edit view, select Insert > Text Box > Horizontal.

1.6

Drag icon over page and draw text box. Type Obsolete (DD-MMM-YY) and change font to

Verdana size 36pt. Repeat on each page of the document.

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