Welcome To Kaizen Institute

1. Background & Targets

A
C

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 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

BMR receipt after sterility release date

Delay in BMR receipt and BPR Review

No Of Days

No Priority intimation received

1
0
1

11 13 15 17 19 21 23 25 27 29 31 33 35

2. Data Collection & Analysis

9
8

Concerns /
Problems
needing
attention :

No Of Batches

7
6
5
5

4
3

3
2
1

1
1
0

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

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

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
Mr.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

Okt.13

Nov.13

Oct-13

Dez.13

Nov-13

Jn.14

Dec-13

Feb.14

Jan-14

Mr.14

Feb-14

Apr.14

Mar-14

Apr-14