Welcome To Kaizen Institute

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

No

Of

Da

ys

IP Stage Approval time in days

1. Background & Targets

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

No

Of B

atc

hes

Approval Time ( Days) Only 37 % with in 3 days

3. Before After Process Mapping

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

No

Of

Ba

tch

es

Approval Time in Days

4. Results & non monetary benefits

6

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 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

No

Of

Da

ys

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

Mr.13 Apr.13 Mai.13 Jun.13 Jul.13 Aug.13 Sep.13 Okt.13 Nov.13 Dez.13 Jn.14 Feb.14 Mr.14 Apr.14

Ba

tch

es

wit

h i

n t

arg

et