Work instructions

Title: Managing improvement actions in TrackWise Applies to: IQM coordinators Status: PUBLIC Lead Author Name: Monia Tuis Signature: On file Approver Name: Guido Rasi Signature: On file Document no.: WIN/EMA/0056 Effective Date: 21-FEB-12 Review Date: 21-FEB-15 Supersedes: WIN/EMEA/0056 (23-FEB-09) TW2079 Date: 14-FEB-12 Date: 14-FEB-12 TrackWise record no.: 3299

1. Changes since last revision

Re-configuration and simplification of procedure in TrackWise.

2. Records
Records generated are saved in TrackWise. Documentation pertaining to improvement action plans is saved in the relevant folder in DREAM under Cabinets\06. Corporate Governance\0.6.6 Audit\Internal audit\Annual audit programme\year. DREAM files can be attached to TrackWise records and viewed through these records.

3. Related documents
WIN/EMA/0059: managing recommendations in TrackWise

4. Definitions
Auditee management: Head of Unit(s) and/or Head of Sector(s) and/or Section Head(s) responsible for the area/process audited and/or who have been involved in the audit D-IA: DREAM: IAP: Internal Audit Sector Document Records Electronic Archive Management system written improvement action plan developed by auditee management

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, 2012. Reproduction is authorised provided the source is acknowledged.

IQMCo: TW:

IQM Coordinator(s) TrackWise

5. Flowchart

Additional Business Rules: 1. If Action Item is overdue value of field Status will be changed to overdue by the system. 2. If due date is not respected: enter new due date with justification for the extension. 3. If due date is extended, reminders will be sent out in accordance with the new deadline.

6. Instructions
Creation of detailed improvement action plan: The improvement action plan is prepared by the auditee management and entered in TW by the IQM coordinator(s) in response to the recommendation/s of the audit. It is therefore part of the

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recommendation process and the related record in TW and entered in a grid attached to this record. Refer to WIN/EMA/0059 managing recommendation/s in TW for the recommendation process. Tracking of the elaboration and implementation of the improvement action plan: This WIN details the procedure of entering data, implementing, monitoring and verifying the individual action items which together make up the implementation of the improvement action plan. It contains the basic steps of the procedure since different units/sectors may have slightly different steps in this process. Step 1. Action Log on to TW using your Windows log-on and password Screenshot: Responsibility IQMCo

2.

Find the relevant recommendation record for which an Action Item needs to be created. The Action Item must be created at the stage: Pending Improvement Action Plan (IAP). The IAP record will be a child record of the recommendation record. Hint: On the desktop screen, make sure that the scope selected includes action items as otherwise the child button will not appear. See the next screenshot:

IQMCo

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Step

Action

Responsibility

Screenshot of recommendation record with the child button:

3.

The child button will appear at the top of the screen when the process allows for the creation of an action item (IAP). See above screenshot.

IQMCo

Click the child button, TW will open a new Action Item record in a new window.

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Step

Action Screenshot:

Responsibility

In order to create the action item, a minimum of data must be entered: General information Assigned to: indicate the name of the staff member to whom the responsibility for implementing the improvement action will be assigned by the auditee management. This information can be found on the Improvement Action Plan approved by auditee management. The field is not blocked, so the name can be changed at a later stage if necessary Sector IQM co-ordinator: indicate the name of the IQM coordinator responsible for the monitoring of the implementation of this action at Sector level, if applicable Owner (Unit): select the name of the unit to which the responsibility for the implementation of the action item is assigned Sector/Section: select the name of the Sector/Section to which the responsibility for the implementation of the action item is assigned, if applicable Subject: in this field, refer to the number of the recommendation

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Step

Action and indicate which issue the Action Item addresses Improvement Action Type: select the source for the improvement action from the drop-down list Action Details Action detail description: enter details of the improvement action which is to be implemented, Action remarks: insert remarks, if any, with regard to the action, Action attached files: attach any relevant documents from DREAM (e.g. evidence/files/e-mails), Key dates Starting date: select the date when the implementation of the improvement action starts, Due Date: select the date by when the improvement action must be finalised. TW will send a reminder to assigned to 14 working days before the deadline. NB: For tracking purposes, should the field be amended, the field name will turn red. Status: TW will automatically update the record status. No need to select any information, Justification: enter details of the reason for not implementing the action within the due date. Reason/s should be provided every time the due dates are not respected (i.e. for due date 1st and 2nd extension), Justification attached files: attach e-mail/s or documents justifing extensions to the due date/s, Due Date, 1st extension: if the due date is to be extended, select the new date by when the improvement action must be finalised. This revised new date must have been agreed by auditee management. NB: For audit tracking purposes, should the field be amended, the field name will turn red. Due Date, 2nd extension: if the due date is to be extended a second time, select the new date by when the improvement action must be finalised. This revised new date must have been agreed by auditee management. N.B.: For tracking purposes, should the field be amended, the field name will turn red. If you try to save the record without entering all required data, the fields with missing and required data will be highlighted with a red arrow. The Due Date, 1st extension and Due Date , 2nd extension are to be left blank when the Action Item is first created. Save the record, the record screen closes. Its status will be Opened.

Responsibility

4.

At this stage it is possible to cancel the record, if it has been created

IQMCo

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Step

Action by mistake, or if it is not necessary for one reason or another. From the drop-down menu attached to the field Activity Type, select option Cancel, enter a justification/explanation in the field Activity Summary and Save the record. Screenshot:

Responsibility

If the action has been completed during the audit, select option Cancel, enter information about the action taken in the field Activity Summary and Save the record. This will ensure that a record is kept of the action taken and will help the planning of future audits. 5. If the record is OK, it can be promoted in order to start the actual procedure. Select activity type Submit and Save to promote the status to Work in Progress. IQMCo

At this stage, TW sends a notification to the assigned to inform them of

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Step

Action the assigned task.

Responsibility

6.

TW sends an e-mail reminder to assigned to and the IQM coordinator(s) 14 days prior to the expiry of the deadline for completion of the IAP. After completion of the improvement action, auditee management, assigned to and the IQM co-ordinator review the completed action and decide whether it has been implemented according to the IAP agreed with D-IA and that the recommendation has been properly addressed. If agreed, the IQM coordinator promotes the status of the record by selecting Verified from drop-down menu under Post Any Activity. His/her electronic signature is required to promote the record. This will promote the record to status Closed Done. NB! The electronic signature of the IQM co-ordinator implies that (s)he has obtained the agreement of the relevant manager and that documents to that effect are kept on file.

IQMCo

7.

D-IA are notified by TW when all Action Items pertaining to one recommendation are closed. Refer to WIN/EMA/0059 managing recommendations in TW.

TW

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