In this Presentation we are showing how to Reduce the Approval Time for Vials (IP Stage) to 3 days from sterility release date. To find out more kindly check out: http://in.kaizen.com/

1. Welcome To Kaizen Institute

2. Concerns / Issues Needing Attention
Preliminary Objectives
Current Situation & Target
To Reduce the Approval time for Vials ( IP
stage) to 3 days from sterility release date
Company
Name:
BIOCON LTD
Gemba: QUALITY ASSURANCE
GKW Dates: 1st August TO 31st August
Project Title: Reduction of Approval time
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
Team Name:B1FQA
Members: (R-L)Nilang Mehta, Ajay Puranik, Prabhakar M D,
Uma K S.
A
P
D
C
0
1
2
3
4
5
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35
NoOfDays
IP Stage Approval time in days
1. Background & Targets

3. 2. Data Collection & Analysis
Concerns /
Problems
needing
attention :
1.Large
variations in
Batch
Approval days.
2.Average = 4.6
Days
3.Range 8 Days
8
3
1
3
5
4
3
4
1
0
1
2
3
4
5
6
7
8
9
1 2 3 4 5 6 7 8 9
NoOfBatches
Approval Time ( Days)
Only 37 % with in 3 days

4. 3. Before After Process Mapping

5. 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 0
2
4
6
8
10
12
14
16
18
20
1 day 2 day 3 day 4 day
19
7
3
6
NoOfBatches
Approval Time in Days

6. 4. Results & non monetary benefits
6
Control Point Before Kaizen Target After
Kaizen
%
Improve
d
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
Improved team work
Non Monetary Benefits
0
1
2
3
4
5
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35
NoOfDays

7. 5. Monitoring through Gemba Graphs
7
Biocon- Gemba
Source of Data
frequency of updation 5th of every month
KAIZEN PROGRESS REVIEW Year 2013 Location Biocon Park
Objective Batch released in target date
Target 3 days Good
Gebma QA Owner Uma
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
0
1
1
2
2
3
3
4
4
5
5
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
Batcheswithintarget