Welcome To Kaizen Institute
1. Background & Targets
A C
Project Title: Reduction of Approval time Company Name:
BIOCON LTD
Gemba:
QUALITY ASSURANCE
P
D
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 Name:B1FQA 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
5
BMR receipt after sterility release date
3
Delay in BMR receipt and BPR Review
2
No Of Days
No Priority intimation received
4
1 0 1
3
5
7
9
11 13 15 17 19 21 23 25 27 29 31 33 35
2. Data Collection & Analysis
9 8
Concerns / Problems needing attention :
8
No Of Batches
7 6 5 5
4
4
4 3
3
3
3 2 1
1 1 0
1
2
3
4
5
6
7
8
9
Approval Time ( Days) Only 37 % with in 3 days
1.Large variations in Batch Approval days. 2.Average = 4.6 Days 3.Range 8 Days
3. Before After Process Mapping
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
No Of Batches
4. Actions during GKW
20 18 16 14 12 10 8 6 4 2 0
19
7
6 3
1 day
2 day 3 day Approval Time in Days
4 day
4. Results & non monetary benefits Control Point
Before Kaizen
Target
After Kaizen
% Improve d
% 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
5 4
No Of Days
3 2 1 0 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35
6
One time Financial Benefit
Annual Benefit (Money Value)
5. Monitoring through Gemba Graphs Source of Data
Biocon- Gemba
frequency of updation Year
KAIZEN PROGRESS REVIEW Objective
2013
5th of every month Biocon Park
Location
Batch released in target date Target
Gebma
QA
Owner
Good
3 days
Uma
5 5
Batches with in target
4 4 3 3 2 2 1 1 0 M채r.13
Mar-13
Apr.13
Apr-13
Mai.13
May-13
Jun.13
Jun-13
Jul.13
Jul-13
Aug.13
Aug-13
Sep.13
Sep-13
5
5
3
3
2
2
3
3
3
3
3
3
Okt.13
Nov.13
Oct-13
3
7
Dez.13
Nov-13
3
J채n.14
Dec-13
3
Feb.14
Jan-14
3
M채r.14
Feb-14
3
Apr.14
Mar-14
3
Apr-14
3
3