REDUCTION OF APPROVAL TIME

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Welcome To Kaizen Institute
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1. Background Targets
Project Title Reduction of Approval time
Company Name BIOCON LTD
Gemba QUALITY ASSURANCE
GKW Dates 1st August TO 31st August
Preliminary Objectives
To Reduce the Approval time for Vials ( IP stage) to 3 days from sterility release date

Team NameB1FQA Members (R-L)Nilang Mehta, Ajay Puranik, Prabhakar M D, Uma K S.
Current Situation Target
Concerns / Issues Needing Attention
IP Stage Approval time in days
There is a variation in Approval time for an average of 6 to 10 Days
BMR receipt after sterility release date
Delay in BMR receipt and BPR Review
No Priority intimation received
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2. Data Collection Analysis

• Concerns / Problems needing attention
• Large variations in Batch Approval days.
• Average 4.6 Days
• Range 8 Days

Only 37 with in 3 days
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3. Before After Process Mapping
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4. Actions during GKW

1. BMR Submission before Sterility release date.
2. Weekly updates from QA to stake holders of all
   concerned departments
3. Time taken for approval tracked internally by QA
   using a tracker.
4. Priority changes received from SCM
5. Average after actions 1.9 days

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4. Results non monetary benefits
Control Point Before Kaizen Target After Kaizen Improved One time Financial Benefit Annual Benefit (Money Value)
of Batches with in target 36 100 83 40

Av. Batch Approval days 4.6 Days 3 Days 1.9 Days 59




Target vs Result Trend Graph Control Point
Non Monetary Benefits
Improved team work







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5. Monitoring through Gemba Graphs
Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Source of Data Source of Data Source of Data      
Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba Biocon- Gemba frequency of updation frequency of updation frequency of updation 5th of every month 5th of every month 5th of every month
KAIZEN PROGRESS REVIEW KAIZEN PROGRESS REVIEW KAIZEN PROGRESS REVIEW KAIZEN PROGRESS REVIEW KAIZEN PROGRESS REVIEW KAIZEN PROGRESS REVIEW KAIZEN PROGRESS REVIEW Year 2013 2013 Location Location Biocon Park Biocon Park
Objective Batch released in target date Batch released in target date Batch released in target date Batch released in target date Batch released in target date Target 3 days 3 days 3 days Good Good  
Gebma QA QA Owner Uma Uma Target 3 days 3 days 3 days Good Good    
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
Mar-13 Apr-13 May-13 Jun-13 Jul-13 Aug-13 Sep-13 Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14
5 5 3 3 2 2                
3 3 3 3 3 3 3 3 3 3 3 3 3 3
   
   
                           
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Contact Information Kaizen Institute India Pvt
Ltd. Ahmedabad Pune Email india_at_kaizen.com Tel
91-79-2640 7756 / 91-9225527911 Website
in.kaizen.com