Deviation management or Deviation handling
consider following step :
1.
Event Detection
2.
Decision Making Process / Deviation Categorization
3.
Deviation Treatment
4.
Root cause investigation
5. CAPA
Event Detection:
When
any activity or operation performed without following the established and
detected by the any person it should be identified and documented. personnel
shall aware of possible undesirable events and clearly know what to do in terms
of documenting and communicating them.
Decision Making Process / Deviation
Categorization:
After Identifying the undesirable event
person shall know that what activity shall be performed The way personnel react and make decisions
can be systemized and improved by the use of a decision tree to initially
screen events based on their risk and impact on the product in order to
categorize, record, and investigate them as needed.
Deviation
Treatment
A
pre-existent QRM will contribute to determine the categorization of the
deviation. If QRM has not been performed, it may be carried out at this time as
part of the impact assessment in order to determine the criticality of the
process parameters involved, and the risk to the patient.
On
the bases of criticality deviations can be categorized as
Minor
Deviation
Major
Deviation
Critical
Deviation
Root cause analysis:
Root
cause analysis shall be performed to find out the why this undesirable event
occur by using different tools. Most probably route cause analysis key step in
handling major and critical deviations as it will provide objective evidence to
implement CAPA.
CAPA:
Corrective
Actions are taken to eliminate the root causes of deviations, and should be
based on good quality investigations. Corrective actions should be QA approved
before implemented and their efficacy verified in a documented manner, activity
that could require a significant period of time. Corrective actions could be
transferred to an independent CAPA system to avoid unnecessary delay for
deviation closure.
Closure OF Deviation:
After completion of
all action deviation shall be closed with proper action taken and training if
training required.
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