CAPA Q
CAPA
Study online at https://quizlet.com/_j1x6lc
1. purpose of a CAPA system - 3 robust tool used to keep problems from happening or repeat-
ing:
- collect and analyze quality information
-identify and investigate product and quality problems
-take appropriate and effective corrective and preventative ac-
tions to prevent their occurrence or recurrence
2. Nonconformity nonfulfillment of a specified requirement such as an out-of-spec
result, product complaint, process deviation or other discrepan-
cy
3. failure investigation assessment of how the failure occurred
what timeline should be doc- -exact product, component, process or test invovled
umented? -where the failure occurred
-who experienced and who reported the failure
-how it occurred in terms of details that could have contributed
to the failure
timeline from failure report to investigation conclusion should
be documented
4. problem statment includes both an object and effect. the clearly stated, compre-
hensive problem statement is the foundation of the root cause
investigation
5. root cause investigation process that determines the cause(s) of the observed failure or
deviation, and which is sufficiently rigorous to detect all potential
causes, not just the most obvious
also requires investigation of those recommended solutions to
assure they would be effective to prevent occurrence or re-
currence, and that they will not have an adverse effect on the
product
1 of 19
, CAPA Q
CAPA
Study online at https://quizlet.com/_j1x6lc
6. correction action to eliminate a detected nonconformity
7. corrective action action taken to remove the cause of a nonconformity
8. preventative action action taken to eliminate the cause of a potential nonconformity
or another undesirable potential situation
9. effectiveness checks used to demonstrate that the desired result has been achieved
with documented criteria to determine the desired effectiveness
10. concession allowed action bounded by the time or condition (eg. 'use as is'
product disposition where the concession is approved prior to
use of a nonconforming component
11. deviation allowed action
-approved in advance that is bound by time or condition.
ex. deviation might be approved where there will be a known
departure from approved process specifications for a specific
time but with no adverse impact on product
OR
-approved after a nonconformance has been observed in order
to approve acceptance of the nonconforming component, prod-
uct or process under defined conditions and with evidence that
there is no adverse impact on product
12. Time frames for closing CA- RISK
PAs - FDA is supportive
of systems that are based
on__________
13. have to find way to prioritize CAPAs
2 of 19
, CAPA Q
CAPA
Study online at https://quizlet.com/_j1x6lc
how to ensure you are oper-
ating in a state of control for
CAPAs =?
14. CAPA risk level: high risk level
occurring so frequently that
almost all lots could be im-
pacted or all processes or all
records
15. CAPA risk level: high risk level
event that could lead to
death, serious injury or ill-
ness
16. CAPA risk level high risk level
-event that could result in a
warning letterer other criti-
cal finding
17. CAPA risk level medium risk level
occurring frequently and im-
pacts more than one lot or
process or several records
18. CAPA risk level: medium risk level
event that could result in mi-
nor injuries or illnesses
19. CAPA risk level medium risk level
event that could result in ma-
jor FDA 483 observations or
findings
3 of 19
CAPA
Study online at https://quizlet.com/_j1x6lc
1. purpose of a CAPA system - 3 robust tool used to keep problems from happening or repeat-
ing:
- collect and analyze quality information
-identify and investigate product and quality problems
-take appropriate and effective corrective and preventative ac-
tions to prevent their occurrence or recurrence
2. Nonconformity nonfulfillment of a specified requirement such as an out-of-spec
result, product complaint, process deviation or other discrepan-
cy
3. failure investigation assessment of how the failure occurred
what timeline should be doc- -exact product, component, process or test invovled
umented? -where the failure occurred
-who experienced and who reported the failure
-how it occurred in terms of details that could have contributed
to the failure
timeline from failure report to investigation conclusion should
be documented
4. problem statment includes both an object and effect. the clearly stated, compre-
hensive problem statement is the foundation of the root cause
investigation
5. root cause investigation process that determines the cause(s) of the observed failure or
deviation, and which is sufficiently rigorous to detect all potential
causes, not just the most obvious
also requires investigation of those recommended solutions to
assure they would be effective to prevent occurrence or re-
currence, and that they will not have an adverse effect on the
product
1 of 19
, CAPA Q
CAPA
Study online at https://quizlet.com/_j1x6lc
6. correction action to eliminate a detected nonconformity
7. corrective action action taken to remove the cause of a nonconformity
8. preventative action action taken to eliminate the cause of a potential nonconformity
or another undesirable potential situation
9. effectiveness checks used to demonstrate that the desired result has been achieved
with documented criteria to determine the desired effectiveness
10. concession allowed action bounded by the time or condition (eg. 'use as is'
product disposition where the concession is approved prior to
use of a nonconforming component
11. deviation allowed action
-approved in advance that is bound by time or condition.
ex. deviation might be approved where there will be a known
departure from approved process specifications for a specific
time but with no adverse impact on product
OR
-approved after a nonconformance has been observed in order
to approve acceptance of the nonconforming component, prod-
uct or process under defined conditions and with evidence that
there is no adverse impact on product
12. Time frames for closing CA- RISK
PAs - FDA is supportive
of systems that are based
on__________
13. have to find way to prioritize CAPAs
2 of 19
, CAPA Q
CAPA
Study online at https://quizlet.com/_j1x6lc
how to ensure you are oper-
ating in a state of control for
CAPAs =?
14. CAPA risk level: high risk level
occurring so frequently that
almost all lots could be im-
pacted or all processes or all
records
15. CAPA risk level: high risk level
event that could lead to
death, serious injury or ill-
ness
16. CAPA risk level high risk level
-event that could result in a
warning letterer other criti-
cal finding
17. CAPA risk level medium risk level
occurring frequently and im-
pacts more than one lot or
process or several records
18. CAPA risk level: medium risk level
event that could result in mi-
nor injuries or illnesses
19. CAPA risk level medium risk level
event that could result in ma-
jor FDA 483 observations or
findings
3 of 19
