What are nonconformance codes used for? - ANSWER To identify specific
failure modes
Noncomformace 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 product types or may be specific to a product
type or functional area. True or False? - ANSWER True.
Each Material Exception generated at Recieving Inspection 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 does the severity of the noncomformance depend on? - ANSWER It
depends upon where, within the manufacturing environment, the material is
being used and what the severity level is for 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 assembled to evaluate
and define the scope of official 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 will you do as an Abbott employee with access to the CAPA platform? -
ANSWER Execute activities related to the documentation of exception reports
To what is the CAPA Process Rubric utilized? - ANSWER It is utilized as a
standard from which you can create and document excellent exception reports
(ER)
It is also used for other people to assess whether your report is of good standard
or not.
What does the rubric contain? - ANSWER Job Aid for Identification,
Evaluation, Investigation, and Resolution Plans
What does the rubric not contain? - ANSWER Does not address the
Implementation, Confirmation, or Verification elements of the CAPA process
failure modes
Noncomformace 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 product types or may be specific to a product
type or functional area. True or False? - ANSWER True.
Each Material Exception generated at Recieving Inspection 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 does the severity of the noncomformance depend on? - ANSWER It
depends upon where, within the manufacturing environment, the material is
being used and what the severity level is for 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 assembled to evaluate
and define the scope of official 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 will you do as an Abbott employee with access to the CAPA platform? -
ANSWER Execute activities related to the documentation of exception reports
To what is the CAPA Process Rubric utilized? - ANSWER It is utilized as a
standard from which you can create and document excellent exception reports
(ER)
It is also used for other people to assess whether your report is of good standard
or not.
What does the rubric contain? - ANSWER Job Aid for Identification,
Evaluation, Investigation, and Resolution Plans
What does the rubric not contain? - ANSWER Does not address the
Implementation, Confirmation, or Verification elements of the CAPA process
