CAPA Quiz Questions and Complete
Solutions Graded A+
What are noncomforance codes used for? - Answer: To identify specific failure modes
Noncomformance codes may be linked to severity levels. True or False? - Answer: True, they may also
be used to identify trends of related to types of noncomformances so they can be prioritized for
corrective or preventative action.
These codes may be shared across products types or may be specific to a product type or functional
area. True or False? - Answer: True.
Each Material Exception generated at Recieving Inspection (RI) is assigned a severity code of ________ -
Answer: It is assigned a code of 'Not Applicable' (N/A) cause the material has not been incorporated into
a finished good product.
What is the severity of the noncomformance dependent on? - Answer: It is dependent on where the
material is used in the manufacturing environment and the severity level associated with that process.
Affected Product - Answer: Product Susceptible to a removal or correction, this includes marketed and
distributed product, any product within direct control of Abbott
Tier I or Tier II Panel - Answer: A management team formed to review and determine the extent of
formal product action
Field Alert Report (FAR) - Answer: A report submitted to the FDA district office regarding:
(i) Information concerning any incident that causes the drug product or its labeling to be mistaken for,
or applied to, another article.
, (ii) Information concerning any bacteriological contamination, or any significant chemical, physical, or
other change or deterioration in the distributed drug product, or any failure of one or more distributed
batches of the drug product to meet the specification established for it in the application.
What is the task you do as an Abbott employee who has access to the CAPA platform? - Answer:
Perform tasks associated with documenting exception reports
What is the CAPA Process Rubric used for? - Answer: It is used as a standard from which you can create
and document excellent exception reports (ER)
It is also used for other people to evaluate whether your report is of good standard or not.
What content does the rubric contain? - Answer: Job Aid for Identification, Evaluation, Investigation, and
Resolution Plans
What content does the rubric not contain? - Answer: Does not address the Implementation,
Confirmation, or Verification elements of the CAPA process
What is a rubric and who uses it? - Answer: A rubric is a set of instructions or rules that are used to help
improve the quality of what is being evaluated
A rubric contains estabnlished guidelines that are used for comparing skill levels. These guidelines help
assess subjective content against objective criteria to determine the level of quality performed.
You are probably used to seeing rubrics used as grading tools for performances. So its used an
assessment tool, a way to make an objective assessment of the level of quality.
Why do we need a CAPA Process Rubric? - Answer: Helps Abbott in areas where audit results have
indicated we need to improve.
Provides all roles clarity around what must be included in an ER.
Makes writing and reviewing process more efficient.
What are all the roles involved in the CAPA process? - Answer: Initiator/Evaluator, Investigatior,
Resolution Planner, and Approver
Solutions Graded A+
What are noncomforance codes used for? - Answer: To identify specific failure modes
Noncomformance codes may be linked to severity levels. True or False? - Answer: True, they may also
be used to identify trends of related to types of noncomformances so they can be prioritized for
corrective or preventative action.
These codes may be shared across products types or may be specific to a product type or functional
area. True or False? - Answer: True.
Each Material Exception generated at Recieving Inspection (RI) is assigned a severity code of ________ -
Answer: It is assigned a code of 'Not Applicable' (N/A) cause the material has not been incorporated into
a finished good product.
What is the severity of the noncomformance dependent on? - Answer: It is dependent on where the
material is used in the manufacturing environment and the severity level associated with that process.
Affected Product - Answer: Product Susceptible to a removal or correction, this includes marketed and
distributed product, any product within direct control of Abbott
Tier I or Tier II Panel - Answer: A management team formed to review and determine the extent of
formal product action
Field Alert Report (FAR) - Answer: A report submitted to the FDA district office regarding:
(i) Information concerning any incident that causes the drug product or its labeling to be mistaken for,
or applied to, another article.
, (ii) Information concerning any bacteriological contamination, or any significant chemical, physical, or
other change or deterioration in the distributed drug product, or any failure of one or more distributed
batches of the drug product to meet the specification established for it in the application.
What is the task you do as an Abbott employee who has access to the CAPA platform? - Answer:
Perform tasks associated with documenting exception reports
What is the CAPA Process Rubric used for? - Answer: It is used as a standard from which you can create
and document excellent exception reports (ER)
It is also used for other people to evaluate whether your report is of good standard or not.
What content does the rubric contain? - Answer: Job Aid for Identification, Evaluation, Investigation, and
Resolution Plans
What content does the rubric not contain? - Answer: Does not address the Implementation,
Confirmation, or Verification elements of the CAPA process
What is a rubric and who uses it? - Answer: A rubric is a set of instructions or rules that are used to help
improve the quality of what is being evaluated
A rubric contains estabnlished guidelines that are used for comparing skill levels. These guidelines help
assess subjective content against objective criteria to determine the level of quality performed.
You are probably used to seeing rubrics used as grading tools for performances. So its used an
assessment tool, a way to make an objective assessment of the level of quality.
Why do we need a CAPA Process Rubric? - Answer: Helps Abbott in areas where audit results have
indicated we need to improve.
Provides all roles clarity around what must be included in an ER.
Makes writing and reviewing process more efficient.
What are all the roles involved in the CAPA process? - Answer: Initiator/Evaluator, Investigatior,
Resolution Planner, and Approver
