PHASE- I(PLAN) :
PHASE- I(PLAN) 1. SOP DRAFT DOCUMENT
2. REVIEW ON DRAFT DOCUMENT
3. AWARENESS TRAINING
4. ASSIGNING RESPONSIBILITIES
5.CARRYING OUT MOCK AUDIT
6. FIND OUT THE GAPS
7. AREAS NEED ATTENTION
PHASE II(DO) :
PHASE II(DO) 1.IMPLEMENT THE AUDIT FINDINGS
2.CHECK FOR SUITABILITY
3.FACILITATE THE TRANSITION
4.VENDOR EDUCATION & TRAINING
5.LET THE SYSTEM RUN
PHASE-III(CHECK) :
PHASE-III(CHECK) AUDIT THE SYSTEM
FIND OUT THE GREY AREAS
FIND OUT THE GAPS
IDENTIFY THE CRITICAL PROCESS
IDENTIFY POSSIBLE CONTAMINATION
SOURCE (MIX UP POINTS)
DO THE ROOT CAUSE ANALYSIS
PHASE-III(ACT) :
PHASE-III(ACT) FIX THE ROOT CAUSE
SET UP CAPA FOR SAME
IMPLEMENT IT
CHECK FOR ITS EFFECTIVENESS
CONTINUALLY IMPROVE THE SYSTEM.