Streamline Testing and Release for MMF

Page 1

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1. Background & Targets

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P

Project Title: Streamline testing and release for MMF Company Name:

BIOCON LTD

Gemba:

QUALITY CONTROL-BIOCON CAMPUS

D

GKW Dates: 5th Nov TO 6th September

•Preliminary Objectives To reduce FP testing time in MMF from current avg of 6.89 days to 5 days

Team Name:Immuno Members: (L-R) Applachari,Praveen,Sunil,Vijay and Babu

Current Situation & Target

•Concerns / Issues Needing Attention

Source of Data Frequency of updation Location June-August2013

Biocon- Gemba Month

KAIZEN PROGRESS REVIEW Objective Test completion days Gebma

There is variation in FP test times from 3 days to 9 days

Owner

QC - IS Lab

Vijay

Target

Each batch Campus Good

5 days

8

7

6

Consumption of chemical

5

3

2

1

1B 2B B 3B 4B 5B 6B 7B 8B 9 10B B 1B 12B 13B 14B 1B 2B 3B 4B 5B 6B 7B 8B 9 10B B 1B 12B 13B 14B 15B 16B 17B 1B 2B 3B 4B 5B 6B 7B 8B 9 10B B 1B 12B 13B 14

Man power under training

rg in esw atch B

4

0

B1 B2

4 5

7 5

B3

3 5

B4

4 5

B5

4 5

B6

4 5

B7

3 5

B8

B9

4 5

B10 B11 B12 B13 B14 B 1

4 5

2 5

3 5

2 5

2 5

1 5

2 5

B2

4 5

B3

3 5

B4

3 5

B5

4 5

B6

4 5

B7

2 5

B8

B9

5 5

B10 B11 B12 B13

3 5

4 5

4 5

4 5

4 5

B14

B15 B16

4 5

4 5

3 5

B1 7

2 5

B1

5 5

B2

B3

5 5

B4

4 5

5 5

B5

4 5

B6

B7

4 5

3 5

B8

B9

5 5

B10

5 5

B11

4 5

B12

3 5

4 5

B13

B14

2 5

5

5

5

5

5

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5

5

5

5


2. Data Collection & Analysis Concerns / Problems needing attention : 1.Large variations in test completion days. 2.Average = 6.9 Days 3.High consumption of chemicals

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3. Before After Process Mapping Handlers Prodn QA QC-Micro

Process mapping - Before Day-1 Day-2 PRF Generation

Day-3

Day-4

Day-5

Day-6

Day-7

Prior intimation to QC & QA

Inspection

Planning, Prioritization

Sampling

Ana l ysis planing

Tes ts-3,4,5

Tes ts-6,7,8

Tes ts9,10,11

Tes ts12,13

Revi ew

Tes ts-1,2

QC-Analytical Process mapping - After Handlers Day-1 Day-2 Prodn QA QC-Micro

Day-3

Day-4

Day-5

Day-6

Day-7

PRF Generation,Intimation Inspection Sampling Ana l ysis planing

QC-Analytical

Tes ts-1,2,3

Tes ts-4,5,6

Tes ts-7,8,9

Tes ts10,11,12

Tes ts-13 Revi ew

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4. Results & non monetary benefits Control Point

Before Kaizen

Av. % Batches within 5 days

Target

37

100

Batch completion days

6.9

5

5’S’ Audit score

60&

Capacity in No of batches per month

20

After Kaizen

% Improve d

88

51

90%

90%

30

25

25

33

One time Financial Benefit

Annual Benefit (Money Value)

Check Points

Target vs Result Trend Graph – Control Point Source of Data Frequency of updation June-August2013 Location

Biocon- Gemba Month

KAIZEN PROGRESS REVIEW Objective Test completion days Gebma

Owner

QC - IS Lab

Vijay

Target

•Non Monetary Benefits Improved work place

Each batch Campus Good

5 days

Team spirit

8

7

6

5

inrg Batchesw

4

3

2

1

1BB2 B3B4 B5B6 B7B8 B10B1B9 B12B13 B14B1 B2B3 B4B5 B6B7 B8 B10B1B9 B12B13 B14B15 B16B17 B1B2 B3B4 B5B6 B7B8 B10B1B9 B12B13 B14

0

B1 B 2 B3 B4 B5 B6 B7

4 5

7 5

3 5

4 5

4 5

4 5

3 5

B8

B9 B10 B11 B12 B13 B14 B 1 B 2 B 3 B 4 B 5 B 6 B 7

4 5

4 5

2 5

3 5

2 5

2 5

1 5

2 5

4 5

3 5

3 5

4 5

4 5

2 5

B8

B9 B10 B11 B12 B13 B14 B15 B16

5 5

3 5

4 5

4 5

4 5

4 5

4 5

4 5

B1 B1 7

3 2 5 5

5 5

B2

B3

5 5

B4 B5

4 5

5 5

4 5

B6

B7

4 5

3 5

B8

B9

5 5

B10

5 5

B11

4 5

B12

3 5

4 5

B13

B14

2 5

5

5

5

5

5

5

5

5

5

4

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5. Monitoring through Gemba & Obeya graphs Source of Data Frequency of updation June-August2013 Location

Biocon- Gemba Month

KAIZEN PROGRESS REVIEW Objective Test completion days Gebma

Owner

QC - IS Lab

Vijay

Target

Each batch Campus Good

5 days

8

7

6

5

rg in w s e h tc a B

4

3

2

B 1 2 B 3 B 4 B 5 B 6 B 7 B 8 B 9 B 0 1 B 1 B 2 1 B 3 1 B 4 1 B 1 B 2 B 3 B 4 B 5 B 6 B 7 B 8 B 9 B 0 1 B 1 B 2 1 B 3 1 B 4 1 B 5 1 B 6 1 B 7 1 B 1 B 2 B 3 B 4 B 5 B 6 B 7 B 8 B 9 B 0 1 B 1 B 2 1 B 3 1 B 4 1 B

1

0

B1 B2

4 5

7 5

B3

B4

3 5

B5

4 5

B6

4 5

4 5

B7

3 5

B8

B9

4 5

B10

4 5

2 5

B11

B12

3 5

B13

2 5

B14

2 5

1 5

B1

2 5

B2

4 5

B3

B4

3 5

B5

3 5

B6

4 5

B7

4 5

B8

2 5

B9

5 5

B10

3 5

B11

4 5

B12

4 5

4 5

B13

B14

4 5

4 5

B15 B16

4 5

B1 7

3 5

B1

2 5

5 5

B2

B3

5 5

B4

4 5

Biocon- Obeya Year

KAIZEN PROGRESS REVIEW No of test with in target days

Objective Gebma

QC - IS Lab

Owner

N ov/1 2

Ja n/13

Target

Vijay

5 5

B5

4 5

B6

B7

4 5

B8

3 5

B9

5 5

B10

5 5

B11

4 5

B12

3 5

B13

4 5

B14

2 5

5

5

5

5

5

5

5

5

5

Source of Data frequency of updation 5th of every month 2013 Campus Location

80% with in 5days 100 % with in 7 days

Good

1 20%

1 00%

g r n i w s e h c t a B

80 %

60 %

40 %

20 %

0%

Nov/12

56% 80% 98% 100%

De c/12

92% 80% 99% 100%

Dec/ 12

Ja n/13

70% 80% 97% 100%

Feb/13

Fe b/13

55% 80% 100% 100%

Ma r/ 13

Ma r/13

92% 80% 100% 100%

Apr/ 13

Apr/13

100% 80% 100% 100%

Ma y/1 3

May/13

100% 80% 100% 100%

Jun/13

Jun/13

93% 80% 100% 100%

Jul/13

Aug/13

Jul/13

100% 80% 100% 100%

5 •Double click on sheet to edit

Se p/13

Aug/13

100% 80% 100% 100%

Oct /1 3

Se p/13

Nov/1 3

Oct/13

De c/ 13

Nov/13

De c/13

80%

80%

80%

80%

100%

100%

100%

100%

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