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Standard operating procedure
Title: Review and revision of effective standard operating procedures
Status: PUBLIC Document no.: SOP/EMA/0013 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:
SOP/EMA/0013 (08-JUL-10) Date: 10-Jul-13 Date: 10-Jul-13 TrackWise record no.: 3882
1.
Purpose
To describe the procedure for reviewing and revising or withdrawing standard operating procedures.
2.
Scope
This SOP applies to all lead authors involved in SOP/WIN drafting and to all Heads of Sector and Section Heads.
3.
Responsibilities
Each Head of Unit, Head of Sector and Section Head under the responsibility of the Executive Director must ensure that this procedure is adhered to within their own unit, sector or section. 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 step 9 to adapt the instruction to the use of a MS Word SOP template instead of a template provided by TrackWise.
Revision of step 12 to adapt the instruction with the use of MS Visio instead of MS Power Point to revise flowcharts.
5.
Documents needed for this SOP
SOP template in MS Word (provided solely by the IQMCo).
Flow chart template in MS Visio (provided solely by the IQMCo).
SOP_WIN transmission slip (provided solely by the IQMCo).
6.
Related documents
SOP/EMA/0001: Preparation and approval of new standard operating procedures
SOP/EMA/0037: Publication of, and training on standard operating procedures and work instructions
WIN/EMA/0036: Creating flow charts for standard operating procedures and work instructions
WIN/EMA/0053: Use of TrackWise software for SOP/WIN recording and tracking
7.
Definitions
DREAM: Document records electronic archive management system
EMA bodies: Management Board, scientific committees, working parties, scientific advisory groups, etc. of the European Medicines Agency
HoS/SH: Head of Sector/Section Head IQMCo: Unit IQM co-ordinator or delegate ManualCo: IQM manual co-ordinator or delegate
SOP: Standard operating procedure - Detailed, written instructions to achieve uniformity of the performance of a specific procedure; the instructions usually cover more than one task or area within the Agency, Unit or Sector
SOP Review: To critically examine a SOP in due time before its review date to determine whether the written procedure and related forms/templates accurately describe and reflect the procedure followed in practice or not
SOP Revision: To modify a SOP and/or related forms/templates to accurately describe the procedure followed in practice as a result of a review or a change to the procedure at any time before the review date
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
8.
Process map(s)/ flow chart(s)
6. Update SOP status Create TrackWise record (WIN/EMA/
0053) Send e-mail to lead
author
11. Finalise SOP 4. Approve review of
SOP Reconfirm/appoint lead
author, review team & approver Define consultation status and publication
status
5. Inform IQMCo
7. Review SOP and related forms/templates
9. Inform IQMCo START
12. Revise flow chart (WIN/EMA/0036) 1. Is SOP due for review or requires
revision?
13. Revise SOP and forms/templates 14. Inform IQMCo 8. Is SOP obsolete? 10. Is revision required? For revision No To 26. 2. Prepare list of Unit
SOPs Forward to HoS/SH/
interested persons
3. Review list in Unit/ Sectors/Sections For review Yes To 23. To 15. Yes No
15. Check SOP format Update SOP status
Update TrackWise record (WIN/EMEA/
0053)
17. Refer SOP to EMA bodies
18. Publish on IQM web page on intranet Inform intranet news
editors
19. Announce on intranet news page 20. Evaluate and implement comments Check and finalise flow chart, SOP and related
forms/templates Inform IQMCo 16. Is consultation
with EMA bodies required?
Yes
21. Carry out QC check
22. Implement corrections, if required
23. Update SOP status Print hard copy Update TrackWise record (WIN/EMA/ 0053) Generate transmission slip Categorise in activity area/type 24. Sign SOP (lead author)
25. Read and sign SOP (approver) 26. Go to SOP/EMA/ 0037 No From 9. From 11. From 14.
9.
Procedure
Step Action Responsibility
1 For effective SOPs due for review, go to Step 2.
If an effective SOP needs to be reviewed well before its review date due to a change in the procedure, go to Step 4.
IQMCo HoS/SH/Lead author 2 On a regular basis as determined by each Unit, generate a list of SOPs
falling under the responsibility of the respective Unit that are due for review within the next 3 months or that have expired and are pending review.
Forward list to HoS, SH and other concerned persons in the respective Unit.
IQMCo
3 Review the list in the respective Unit/Sectors/Sections and prioritise review of SOPs.
HoS/SH
4 Approve review of SOP.
Re-confirm or assign lead author of SOP.
Appoint/re-appoint review team having a good knowledge of the procedure. If cross-Section/Sector/Unit representation is necessary, consult with other SH/HoS to appoint team members.
Re-assign consultation status, publication status and approver (refer to SOP/EMA/0001).
HoS/SH
5 Inform IQMCo by e-mail of SOP to be reviewed, consultation status, publication status, and lead author, review team and approver names.
Lead author
6 Update status of SOP (refer to WIN/EMA/0035). Check in to DREAM.
Create new record in TrackWise (refer to WIN/EMA/0053).
When completed, send e-mail to lead author with the link to the SOP-specific folder in DREAM.
IQMCo
7 Review the SOP and related forms/templates, if applicable, to evaluate the need for a revision or otherwise.
Lead author
8 If the procedure described in the SOP is obsolete, go to step 9. If the procedure described in the SOP is still valid, go to step 10.
Lead author
9 Inform IQMCo that the SOP is obsolete and should be withdrawn. Go to step 26.
Lead author
10 If the procedure has not changed in any way and the SOP does not require revision, go to step 11.
If the SOP needs to be revised, go to step 12.
Step Action Responsibility
11 Update the section ‘Changes since last revision’ by replacing existing text with “SOP reviewed and reissued without any changes”.
Inform IQMCo that SOP can be re-issued without changes. Go to step 23.
Lead author
12 Revise, if appropriate, the flow chart in MS Visio provided by the IQMCo (refer to WIN/EMA/0036).
Save all versions of the document in the SOP-specific folder provided.
Lead author
13 Revise the SOP using the MS Word document provided by the IQMCo. Update the section ‘Changes since last revision’ by briefly listing the changes that have been made and are included in the revised version of the SOP. Changes from previous versions recorded under the heading should be replaced by the most recent changes. If extensive changes are made, type “Extensive revision to rewrite SOP”.
Use the same approach described in SOP/EMA/0001 to describe the procedure steps. Verify if any related documents or forms, templates, etc need to be revised concurrently.
Ensure that all functions identified as responsible for specific actions described in the SOP have been consulted and engaged in the review of the SOP.
Paste the updated flow chart as a picture (enhanced metafile) in the SOP (refer to WIN/EMA/0036).
Save all versions of the revised SOP in the SOP-specific folder provided.
In case of difficulty with any part of this step, seek assistance of the IQMCo.
Lead author
14 When revision is complete, inform the IQMCo. If other EMA bodies need to be consulted, discuss the length of consultation with the IQMCo.
Note:
For a revised SOP, the length of consultation is 2 weeks;
When other EMA bodies need to be consulted the length of
consultation may be longer than the standard 2 weeks.
Lead author
15 Check that SOP has been completed according to the instructions in the template and complete checklist in TrackWise (refer to
WIN/EMA/0053).
Update status of SOP to CONSULTATION (CONFIDENTIAL) in template and check in to DREAM.
Update the TrackWise record (refer to WIN/EMA/0053) with the
Step Action Responsibility
consultation details.
Note: TrackWise sends automated notifications to lead author and ManualCo.
16 If the SOP requires consultation with EMA bodies, go to step 17. If the SOP does not require consultation with EMA bodies, go to step 18.
IQMCo
17 Refer SOP and forms/templates, if applicable, to secretariats of EMA bodies to initiate consultation.
Lead author
18 Publish the SOP on the intranet IQM web page.
Inform the News Editors to advertise the SOP consultation on the intranet news page and provide the deadline for consultation.
ManualCo
19 Announce SOP consultation on the intranet news page. Intranet news editors 20 On receipt of comments from staff and, where applicable, from EMA
bodies, acknowledge receipt by e-mail.
Evaluate comments and implement appropriate suggested improvements in the SOP.
Check and finalise flow chart, SOP and forms/templates, if applicable. Inform IQMCo when ready.
Note: TrackWise sends automated notifications to lead author and IQMCo at the end of the consultation and when there are delays in finalising a SOP after consultation.
Lead author
21 Carry out quality check (use checklist in WIN/EMA/0053) and request lead author to make corrections, if required.
IQMCo
22 Make necessary corrections to SOP and forms/templates, if required. Lead author 23 Update status of SOP to agreed publication status as informed in step
4.
Print hard copy. Check in to DREAM.
Open the SOP record in TrackWise, document quality check and update required fields (refer to WIN/EMA/0053).
Prepare the SOP_WIN transmission slip.
(Re-)Categorise the SOP in the relevant activity area and type for web publication, and document in the transmission slip.
Forward SOP and transmission slip to lead Author.
IQMCo
Step Action Responsibility
Forward to approver.
25 Read SOP and sign SOP and transmission slip. Forward to IQMCo.
Approver
26 Refer to SOP/EMA/0037. IQMCo
10.
Records
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
