Standard operating procedure
Title: Review and revision of effective work instructions
Status: PUBLIC Document no.: SOP/EMA/0034 Lead author Approver Effective date: 10-Jul-13 Name: Mario Benetti Name: Guido Rasi Review date: 10-Jul16 Signature: On file Signature: On file Supersedes:
SOP/EMA/0034 (08-JUL-10) Date: 10-Jul-13 Date: 10-Jul-13 TrackWise record no.: 3883
1.
Purpose
To describe the procedure for reviewing and revising or withdrawing work instructions.
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, if required.
5.
Documents needed for this SOP
WIN template in MS Word (provided solely by the IQMCo).
Flow chart template in MS Visio (provided solely by the IQMCo, if required).
SOP_WIN transmission slip (provided solely by the IQMCo).
6.
Related documents
SOP/EMA/0013: Review and revision of effective standard operating procedures
SOP/EMA/0033: Preparation and approval of new work instructions
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 instruction 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
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 WIN Review: To critically examine a WIN in due time before its review date to determine whether the written instructions/content and related forms/templates accurately describe and reflect the tasks followed in practice or not
WIN Revision: To modify a WIN and related forms/templates to accurately describe the tasks followed in practice as a result of a review or a change in the tasks at any time before the review date
8.
Process map(s)/ flow chart(s)
11. Finalise WIN 4. Approve review of WIN
Reconfirm/appoint lead author, review team &
approver Determine need for
consultation Define publication status
5. Review WIN and related forms/templates
9. Inform IQMCo START
1. Is WIN due for review or requires
revision?
12. Revise WIN and forms/templates 8. Is WIN obsolete? 10. Is revision required? For revision Yes No To 21. 2. Prepare list of Unit
WIN. Forward to HoS/SH/
interested persons
3. Review list in Unit/ Sectors/Sections For review No Yes To 18. 7. Update WIN status.
Create TrackWise record (WIN/EMA/0053). Send e-mail to lead author
END 17. Implement corrections, if required
18. Update WIN status Print hard copy Update TrackWise record
(WIN/EMA/0053) Generate transmission slip
Categorise in activity area/type
19. Sign WIN (lead author)
20. Read and sign WIN (approver) 21. Go to SOP/EMA/0037 From 9. From 11. From 13. 14. Is consultation required?
16. Carry out QC check No
Yes 15. Go to SOP/EMA/0013
9.
Procedure
Step Action Responsibility
1 For effective WIN due for review, go to step 2.
If an effective WIN 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 WIN
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 WIN.
HoS/SH
4 Approve review of WIN.
Re-confirm or assign lead author of WIN.
Appoint/re-appoint review team having a good knowledge of the tasks involved. If cross-Section/Sector/Unit representation is necessary, consult with other SH/HoS/HoU to appoint team members.
Re-assign consultation status, publication status and approver (refer to SOP/EMA/0033).
HoS/SH
5 Inform IQMCo by e-mail of WIN to be reviewed, need for consultation or otherwise, publication status, and lead author, review team and approver names.
Lead author
6 Update status of WIN (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 WIN-specific folder in DREAM.
IQMCo
7 Review the WIN and related forms/templates, if applicable, to evaluate the need for a revision or otherwise.
Lead author
8 If the procedure described in the WIN is obsolete, go to step 9. If the procedure described in the WIN is still valid, go to step 10.
Step Action Responsibility
10 If the procedure has not changed in any way and the WIN does not require revision, go to step 11.
If the WIN needs to be revised, go to step 12.
Lead author
11 Update the section ‘Changes since last revision’ by replacing existing text with “WIN reviewed and reissued without any changes”.
Inform IQMCo that WIN can be re-issued without changes. Go to step 18.
Lead author
12 Revise the WIN 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 WIN. 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 WIN”.
Use the same approach described in SOP/EMA/0033 to update the content of the WIN. 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 WIN have been consulted and engaged in the review of the WIN.
If the WIN contains a flow chart, revise the MS Visio version available in the same WIN-specific folder. Paste the updated flow chart as a picture (enhanced metafile) in the SOP (refer to WIN/EMA/0036). Save all versions of the revised WIN in the WIN-specific folder provided.
In case of difficulty with any part of this step, seek assistance of the IQMCo.
Lead author
13 When revision is completed, inform IQMCo and discuss the required length of consultation.
Note:
For a revised WIN, the length of consultation is 2 weeks;
If other EMA bodies need to be consulted the length of
consultation may be longer than the standard 2 weeks (there is no maximum length in this case).
Lead author
14 If consultation has been requested, go to step 15.
If the WIN is very specific to tasks undertaken by a restricted group of persons no cross Agency consultation is required. Go to step 16.
Lead author
Step Action Responsibility
16 Carry out quality check (use checklist in WIN/EMA/0053) and request lead author to make corrections, if required.
IQMCo
17 Make necessary corrections to WIN and forms/templates, if required. Lead author 18 Update status of WIN to agreed publication status as informed in
step 4.
Print hard copy. Check in to DREAM.
Open the WIN record in TrackWise, document quality check and update required fields (refer to WIN/EMA/0053).
Prepare the SOP_WIN transmission slip.
(Re-)Categorise the WIN in the relevant activity area and type for web publication, and document in the transmission slip.
Forward WIN and transmission slip to lead author.
IQMCo
19 Sign WIN and transmission slip. Forward to approver.
Lead author
20 Read WIN and sign WIN and transmission slip. Forward to IQMCo.
Approver
21 Refer to SOP/EMA/0037. IQMCo
10.
Records
Electronic records of WIN 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
