1.

Creating a New Deviation

1. Person who observed the deviation will enter the following into the module

 Deviation ID (Automatically entered by the system)

 Equipment Involved (Not required)
 Short Description (Required Input)
 Deviation observer (Automatically the Logged-In person) Commented [TMAP1]: Not always. There can be times
 Date or Time Occurred that an operator observed it but the one who prepares the
 Date or Time Recognized deviation report is the engineer or someone higher than
 Date or Time Reported operator. Maybe we can have a PIC/author for the deviation
 List detailed description which contains initial reaction to deviation, possible causes, and details but the observer can be different?
of the standard or procedure that deviated.
Commented [TMAP2]: Isn’t there too many times to log
 List Departments affected, products/batches affected, procedures affected
here?
 Tag Quality Assurance Personnel
They are all useful but aren’t they too many?

2. QA will acknowledge the new record (This will be included in the tasks of the QA person) Commented [TMAP3]: Separate all there.
1. Immediate Corrective Action
3. Status of Deviation Record will be OPEN. 2. Possible Cause
3. Details of the standard or procedure that deviated
2. QA Approval to execute CAPA
Commented [TMAP4]: They probably have to have it
1. Tag Deviation Category (Incident, Minor, Major, Critical) approved with a department manager or equivalent first
2. Review Departments Affected, Products/Batches Affected, Procedures Affected before sending the request to QA
3. Review and approve detailed description.
4. Determine if CAPA is needed or not. w Commented [TMAP5]: QA will set the time to close the
5. Initiate or connect an existing CAPA plan if needed (The details of the CAPA plan will be recorded in a separate page but deviation. There should be a deadline.
will be accessible from the deviation record)
(NOTE: 1 CAPA Plan can address multiple deviations, also Multiple CAPA plans will be able to address the deviation).
Commented [TMAP6]: There should be a notification to
all tagged person every time someone approves it, and who
3. Performing CAPA (Applicable when CAPA needs to be executed)
is the current person that needs to approve it and the
deadline for him to approve or reject it…
1. The following items must be input in the CAPA page (Each CAPA Plan must have its own unique number) Commented [TMAP7]: Tell Mike who has to do this.

 Item Number (Automatically generated (1, 2, ...)

 CAPA Activity
 Target Completion Date (Person Responsible for Activity will be notified in the dashboard when
this approaches)
 Person Responsible for Activity
 Approver - will verify that the activity was performed according to applicable standards.
 Actual Completion Date - after Approver marks activity completed. This will be automatically
filled.
 Comments

4. Closing the Deviation Commented [TMAP8]: Also, what will happen if the
approver rejects the submitted. Where will it go back? Will
there be option to add comments on why it was rejected?
1. A Deviation Report (contains detailed CAPA results, etc) must be authored, reviewed, and approved in the EDMS. The Will the deadline be pushed or not?
document number of the deviation record will be referenced in the Deviation Record.
2. After the Deviation Report is uploaded, the QA person (from Step 2) will be notified so the Deviation can be closed.
3. A final review of the current contents of the deviation record, the QA person will be redirected to a final confirmation
page.
4. On the final confirmation page, the following conformation statements will be checked. Form of questioning is Yes/ No/
N/A. For No and N/A answers, there must be an input box for justification (This serves as formal closure of the deviation).

 All corrective and preventive actions are applied according to quality assurance department
instructions.
 The action produced the desired effect on the quality management system
 The actions prevent and decrease the risk of the deviation to be repeated in the future.
 The actions did not have an adverse effect on the quality managment system which were not foreseen
when they were first agreed upon.