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:B1FQAMembers: (R-L)Nilang Mehta, Ajay Puranik, Prabhakar M D, Uma K S.

A

P

D

C

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 350

1

2

3

4

5N

o O

f Day

s 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

1 2 3 4 5 6 7 8 90

1

2

3

4

5

6

7

8

9

8

3

1

3

5

4

3

4

1

Approval Time ( Days)

No

Of

Bat

ches

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 1 day 2 day 3 day 4 day

02468

101214161820 19

7

3

6

Approval Time in Days

No

Of B

atch

es

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

1 4 7 10 13 16 19 22 25 28 31 340

1

2

3

4

5

No

Of D

ays

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

Dec/99

Oct/02

Aug/05

Jun/08

Apr/11

Feb/1

4

Dec/16

Oct/19

Aug/22

Jun/25

Apr/28

Feb/3

1

Dec/33

Oct/36

Aug/39

Jun/42

Apr/45

Feb/4

8

Dec/50

Oct/53

Aug/56

Jun/59

Apr/62

Feb/6

5

Dec/67

Oct/70

Aug/73

Jun/76

Apr/79

Feb/8

2

Dec/84

Oct/87

Aug/90

Jun/93

Apr/96

Feb/9

9

Dec/01

Oct/04

Aug/07

Jun/10

Apr/13

0

1

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5

Batc

hes w

ith in

targ

et

Contact Information:

Kaizen Institute India Pvt Ltd.Ahmedabad – PuneEmail: india@kaizen.comTel: +91-79-2640 7756 / +91-9225527911Website: in.kaizen.com