Deviation Record
Deviation Owners have this many business days to initiate a deviation from the observed date.
What is 2 business days?
What are the two action types for a CAPA record?
What are Corrective Action and Preventive action record type?
This is the purpose of a Quality Incident (QI) record
What is to assess the event and determine if this needs to be elevated to a deviation ?
Its purpose is to assess of an unexpected sample test results or a sample test result that does not meet acceptance criteria to determine required actions.
What is the purpose of a TRA?
These are types of TRA type of records
What is TRA Analytical, Physical , Incoming and Method Trending
These are the classifications for causal factors.
What is confirmed, not confirmed, and probable?
What is the name of the Object in the CAPA record where I can see a link to my Deviation record?
What is the "Related Deviation object?
(PICTURE 2B)
PMA stands for
a) Preventive Maintenance Action
b) Process Monitoring Assessment
c) Process Maintenance Assessment
d) Process Monitoring Activity
What is b? Process Monitoring Assessment
A repeat testing can be repeated as long as this condition was met
What is if the original result is invalid?
This is the number of days allotted to initiate a TRA record after the event was observed
What is 2 days?
The Deviation record will move to this state once a 'Team' is defined by the owner.
What is ‘In Assessment’ state?
What are 3 meeting types that could be documented on the CAPA record?
What is CAPA Discussion, DAI, Investigation Advisory Board, Management Review, Other?
(PICTURE 3B)
Lifecycle states applicable to a PMA record in DQMS:
a) New, Assigned, Assessment, In-progress, In Approval, Closed, In Amendment
b) In initiated/Define team, In Assessment, In Approval, Closed, In Amendment/Re-open
c) In initiated, In Assessment, In Progress, In Approval, Closed, In Amendment/Re-open
What is b? In initiated/Define team, In Assessment, In Approval, Closed, In Amendment/Re-open
This is another way to call a test result outside of the established action limits or is not consistent with historical profiles.
What is an Unexpected Result (UR)?
Name of the field in a TRA record where the justification for the lots tied, not tied and considered is captured (PICTURE 3E)
A: Awareness Observed date
B: Criteria Reference Document
C: Initial OOS/ UR Result
D: Scoping Strategy
What is the "Scoping strategy" field?
This role will be removed/ retire from the Major deviation process in Veeva?
What is the Functional Area Owner?
This is what is recommended information to be documented on the “Description” field of the CAPA EV record
What is the
a) The evaluation criteria for how the effectiveness will be measured,
b) A specific, qualitative, and objective acceptance criteria, and
c) Duration of monitoring, including periodic evaluation of data, and the data analysis timeframe.
Lifecycle states applicable in DQMS for a QI record
a) Define Team, Opened, In Triage, Classify Deviation, Complete.
b) Define Team, New, Assigned, In Triage, Classify Deviation, Complete.
c) Define Team, In Triage, Classify Deviation, Complete.
What is c? Define Team, In Triage, Classify Deviation, Complete.
Number of days are allowed for completion of a TRA from the observe date of the Unexpected Event
What is 10 calendar days?
This is the name of the object in a TRA record where it is documented the triage activity associated with the UE. (PICTURE 4E)
A) Batches
B) Meeting Details
C) Review of Equipment
D) Investigation Summary
What is the Meeting Details Object?
Name 3 instances/conditions where a meeting record is necessary for a Deviation record
-Record was not initiated within 2 business days.
-To document rationale and decision for target date in excess of standard date
-Updating initial product impact
-Changing designation of a record
-Root cause analysis meetings.
-DAI
-Deviation Reportability Assessment.
-Investigation Advisory Board
-Management Review.
-Triage
When generating the 5-whys, there are several RC categories and codes available in the Root Cause Coding Map (formerly GDE-406427).
What happened to that GDE?
What is it was replaced (obsoleted) by a new Work Instruction WI-402116?
This takes place automatically in DQMS when the QI Approver selects as Verdict for the QI triage "Requires Deviation".
(PICTURE 5C)
What is DQMS initiate a deviation record and link it to the QI record?
The following options meet the intended scope of a Continuous Improvement record :
1) Select Management Review Improvements
2) Risk Assessment Activities
3) Quality Plans / Actions
4) Select Annual Product Review actions
What is : all of the above? 1,2,3 and 4
These two type of TRA record have the same workflow steps in DQMS
A) TRA Analytical
B) TRA Physical
C) TRA TRA TRA
D) TRA Incoming
What is B and D?