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Deviation Assignment

The document appears to be a form for reporting product or policy deviations that includes sections for details of the deviation, proposed resolutions, reviews, and corrective actions. It will require information on deviation type, details, proposed solutions, review, and steps to address the issue and prevent reoccurrence. An effective deviation policy needs sections for summarizing the event, analyzing root causes and impacts, and outlining corrective and preventative actions with assessments of their effectiveness.

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Doshi Priyal
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
120 views

Deviation Assignment

The document appears to be a form for reporting product or policy deviations that includes sections for details of the deviation, proposed resolutions, reviews, and corrective actions. It will require information on deviation type, details, proposed solutions, review, and steps to address the issue and prevent reoccurrence. An effective deviation policy needs sections for summarizing the event, analyzing root causes and impacts, and outlining corrective and preventative actions with assessments of their effectiveness.

Uploaded by

Doshi Priyal
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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PRODUCT DEVIATION FORM|DÉVIATION DU PRODUCT FORME

POLICY DEVIATION FORM| DÉVIATION DE LA POLITIQUE FORME

DATE|DATE: CONTROL#|CONTRÔLE#: FORM#|FORME#

LOCATION|EMPLACEMENT: ODER #|ODER#:


MACHINE|MACHINE: PROCESS|PROCESSUS:
v
EQUIPMENT|ÉQUIPEMENT: SUPERVISOR|SUPERVISEUR/USE :

PRODUCT DETAILS|DÉTAILS DU PRODUIT:

TYPE OF DEVIATION|TYPE DE DÉVIATION:


DEVIATION DETAILS|DÉTAILS DE DÉVIATION:

PROPOSED SETTLEMENT|RÈGLEMENT PROPOSÉ: RECOMENTATION TYPE|TYPE DE RECOMENTATION:

 REPAIR|RÉPARATION
 REWORK|RÉUTILISER
 REPLACE|REMPLACER
 RETURN|REVENIR

DEVIATION REVIEWED REPORT|RAPPORT RÉVISÉ PAR DÉVIATION:


REVENIR

CORRECTIVE ACTIONS & SETTLEMENTS|ACTIONS CORRECTIVES ET RÈGLEMENTS:

QA INITIAL REVIEWER|
EXAMINATEUR INITIAL QA SIGNATURE|SIGNATURE DATE|DATE
PART 1
There are two main categories of deviation

 Planned Deviation:
Planned Deviation is any deviation from documented procedure opted deliberately for
temporary period to avoid unavoidable situation without affecting the quality and safety of
product/procedure.

 Unplanned Deviation:
An unplanned deviation indicates a state of noncompliance from the designed systems or
procedures at any stage of manufacturing, packaging, testing, holding, or storage of drug
product.

PART 2

According to me four critical sections for creating a robust deviation policy is as below

 EVENT SUMMERY
1. Who, what, when, where details should be mentioned.
2. only facts, data or observations prior to, during and/or after the event must be
cited, no assumptions.
3. Must be in mentioned in chronological order as much as possible
4. How that event was dealt at the time of incident must be written.
 Materials/machine/personnel affected with their
root cause analysis
1. What type of machine or material are damaged or could have damaged must me
mentioned while drafting? Same thing for personnel who is directly or indirectly
related with process is either injured or not that risk must be addressed
2. Risks must be categorized as Incident, minor, major or critical with details about
it.
3. Root cause must be done by various methods like Isikawa method, fish bone
analysis, 5 Ys etc.

 Impact assessment.
1. A clear description of the effect of the deviation event on product quality,
including all lots affected or potentially affected.
2. The assessment and resulting conclusions must be objective and scientific based.

 Corrective Actions preventative Actions (CAPA)


1. Credentials of suitable corrective and preventative actions should be
accomplished based on the root cause investigation segment and should address
all root causes identified.
2. A strategy for assessing the efficiency of actions taken should be developed and
executed.

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