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  • Project leader (Black Belt) : Paramjeet Singh(Plant In-Charge CV-4)

    Project Sponsor : Jayesh Patel(Manager Operational Excellence- Black Belt)

    Program Champion : K C Sharma(VP and Site head)

    Disha Program Leader : Pankaj Agarwal(VP OpEx)

    Capacity Improvementof

    Bulk drug product

    1

    Lupin Limited: Entry for QCI

  • Project Leader: Paramjeet Singh Lupin Limited, 198-202, New Industrial Area no 2, Mandideep 462046, District: Raisen, Madhya Pradesh Phone: +91 7480 410396, Mobile :8818908285 Mail: paramjeetsingh@lupin.com

    Project Sponcer: Jayesh Patel Lupin Limited, 198-202, New Industrial Area no 2, Mandideep 462046, District: Raisen, Madhya Pradesh Phone: +91 7480 410400, Mobile :9617777485 Mail: jayeshbpatel@lupin.com

    Site Head: K.C.Sharma Lupin Limited, 198-202, New Industrial Area no 2, Mandideep 462046, District: Raisen, Madhya Pradesh Phone: +91 7480 410422, Mobile :9617770422 Mail: Krishancsharma@lupin.com

    Program Leader: Pankaj Agarwal Lupin Ltd, 159 CST Road, Kalina, Santacruz (E) Mumbai 400 098. India, Phone: +91 22 6640 2701 Fax: +91 22 6640 2051 Mail: pankajagarwal1@lupin.com

    2

    Contact information

  • Build a sustainable operating model for improving and sustaining profitability by developing continuousimprovement capabilities within Lupin

    Kicked off in 2012 at two pilot sites, has covered all sites of Lupin in India Top driven Steering committee chaired by MD Uses Lean Six Sigma approach for continuous process improvement A pool of trained .. Black Belts and 72 Green Belts have been created Saved over INR 70 Cr since inception of the program

    3

    DISHA Operational Excellence Program at -MDP

  • Project Title: Capacity Improvement of a bulk drug product Duration: Oct-14 to March-15 Project Leader: Paramjeet Singh This is a large plant with 12 stages spread over 3 blocks, 40 reactors, 7 centrifuge, 5 WFE, 4 IEC, 6 dryers ,1 RO

    unit & Hydrogenation plant Plant is operated by 97 Permanent and 92 contract workers- 3 shifts 7 days a week This project followed LEAN approach , wherever required DMAIC tools were also used Detailed VSM ( Value Stream Map) was made with cycle time at each step Based on the cycle time at each step and TAKT time required bottleneck operations were identified Bottlenecks were identified through a three level drilldown

    Step wise capacity Equipment wise Process wise

    Each bottleneck was discussed in detail with Process Development and Production to identify VA/NVA. Pilot was done with identified themes Shortlisted ideas were implemented and sustained over three months from Mar to May. Financial validation of the project

    * The name of the product is NOTdisclosed due to confidentiality

    4

    Executive Summary of the Project

  • Business Case Scope Increasing the plant throughput from 10.0 to 11.0 TPM will

    help in meeting the customer demand as well as deliver usa net profit of 2.69 Cr/Annum.

    All in-house manufacturing steps are in scope of theproject

    Goal Statement Increase the takt rate of bulk drug plant from 10 TPM to 11TPM@ 26 days

    Project Team Project Plan Mr. Bhupendra Singh Mr. Priyesh chokade Mr. Ranjit sitole & Vasu babu Mr. Shahanawaz & Suyeb Mr. Vishal Pandey Mr. Radheshyam Gothwad Mr. Naresh Lodha

    Mr. Dr. Venu Mr. Alkesh patel Mr. Sunil Mishra Mr. Mohit Gupta Mr. Ruby Sharma Mr. Amit Saxena Mr. Sameer D.

    Tollgate ScheduledDefine: 25/10/14Measure: 25/11/14Analyze: 22/12/14Improve: 25/01/15Control: 20/02/15

    API Throughput Improvement

  • Project Approach

    Step wise capacity

    Equipmentwise

    capacityOperationwise study

    Steps having capacity is >= 11 MT are removed from scope Reduced 3 steps from scope

    Equipment capacity is >= 11 MT are removed from scope Reduced 12 equipment's from scope

    Detailed VSM exercise was done to identify the losses

    Idea generation to reducethe time cycle

    Pilot with identifiedsolution theme

    Full scaleimplementation

    Control andsustenance plan

  • Process flow diagram & Step wise evaluation

    Step- 1 Outsourced

    Step- 2

    Step- 3 Outsourced

    Step-5

    Step- 6

    Step- 7

    Step- 8

    Step- 9

    Step- 10 Step- 11 Step- 12

    LIS-2, LIS-5 & LIS-6 steps is already having 11.0 MT capacity hencenot need to work further.

    LIS-7 to LIS-12 steps needs to increase the capacity form 10 to 11MT/month

    LIS-1 & LIS-3 both are out of scope as outsourced

    10.1

    10.3 10

    10.3

    10.1

    10.3

    11.4

    14.5 11

    Step-12 Step-11 Step-10 Step-9 Step-8 Step-7 Step-6 Step-5 Step-2

    Step wise capacity MT/Month Currrent takt rate MT/Month Target takt rate MT/Month

  • Step details are further drilldown to equipmentdetails (1/2)

    10.8

    10.3 10.3

    R-19-1006 R-19-705 R-19-1007

    10.3 10.1 12.217.2

    10.2

    R-19-806 R-19-807 R-19-704 R-19-701 R-19-809

    10.3

    27.5

    14.9

    R-20-1003 R-19-1004 PF-20-1001

    14.3 10.7 10.7 10.3 10.0 11.3

    R-20-1005 /1006 ANFD-06-001 WFE19-1002 R -19-1008 R -19-1009 R-19-1010

    LIS-10

    LIS-7 LIS-8 LIS-9

    Equipment wise evaluation provided the Key equipment list where time cycle needs to be reduced 11 Equipment's capacity needs to be improved at LIS-7 to LIS-10 stage

  • Step details are further drilldown to equipmentdetails (2/2)

    10.7 11.4 11.213.7

    10.4 10.3 11.5 10.6

    17.4

    IEC-03/04/05 V-19-1139 R.O-19-1101 R-19-1101 WFE-19-1101 R-19-1105 R-19-1103/4 CF-1102/602 RVD-19-1103

    10.8 10.2 10.1 10.2

    27.6

    10.7

    R-19-1102 WFE-19-1201 R-19-1205/6/7 CF-19-1202/1101 M-19-1201 VTD-19-1202/1204

    LIS-11

    LIS-12

    Equipment wise evaluation provided the Key equipment list where time cycle needs to be reduced 9 Equipment's capacity needs to be improved at LIS-11 & LIS-12 stage

  • Summary for scope drilldown

    Sr.No Step

    1 LIS-2

    2 LIS-5

    3 LIS-6

    4 LIS-7

    5 LIS-8

    6 LIS-9

    7 LIS-10

    8 LIS-11

    9 LIS-12

    Sr.No Step

    1 LIS-7

    2 LIS-8

    3 LIS-9

    4 LIS-10

    5 LIS-11

    6 LIS-12

    LIS-7 LIS-8R-19-1006 R-19-806 R-19-701R-19-705 R-19-807 R-19-809R-19-1007 R-19-704LIS-9 LIS-10R-20-1003 R-20-1005/6 WFE-19-1002R-20-1004 R-19-1008 R-19-1009PF-20-1001 ANFD-06-001 R-19-1010

    LIS-11IEC-03/04/05 WFE-19-1101 CF-19-1102/602V-19-1139 R-19-1105 RVD-19-1103RO-19-1101 R-19-1103/04 R-19-1101

    LIS-12R-19-1102 WFE-19-1202 R-19-1205/6/7CF-19-1201 CF-19-1102 M-19-1201VTD-19-1202 VTD-19-1204

    LIS-7 LIS-8R-19-1006 R-19-806R-19-705 R-19-807R-19-1007 R-19-809

    LIS-9 LIS-10R-20-1003 ANFD-06-001

    WFE-19-1002R-19-1008/09

    LIS-11IEC-03/04/05 WFE-19-1101CF-1102/602 R-19-1105

    LIS-12R-19-1102 WFE-19-1201CF-19-1201 CF-19-1102VTD-19-1202 VTD-19-1204R-19-1205/6/73 steps reduced from scope

    12 equipment's are reduced from scope

  • Complete-VSMFocused VSM exercise carried out for LIS-7 to LIS-12 steps. To understand the process Identify Value added and Non-Value added activities Generate relevant ideas for cycle time reduction

    R M

    Order Planning ToPlant executive

    Order Planning ToLot Incharge

    Order Planning ToShift Incharge

    ProductionPlanning & Control

    Ware house

    I

    FIFO

    RawMaterial

    Order RequirementTo Production

    ManagerProduction

    Planning & Control

    Forecast Monthly

    I

    Lotshifting

    Lot Area

    2 officer2 Operator6 Casuals

    10

    Sylilation & Condensation

    7 Operator7 Casuals

    14

    Centrifuge

    7/2 Officer14/2 Casuals 10

    Milling

    7/2 Officer7/2 Casuals 7

    Drying

    4/2 Officer14/2 Casuals 9

    Hydrolysis

    7/2 Officer7/2 Casuals 7

    Precipitation

    7/2 Officer7/2 Casuals 7

    Sifting

    4/2 Officer7/2 Casuals

    5

    FPP5 Operator6 Officer27 Casuals

    38

    I

    ApprovedSolvent

    ApprovedSolvent

    ApprovedSolvent

    I

    Order Planning ToSolvent Rec Incharge

    Lot 6Batches

    SOP

    VM

    SRP Area

    5 officer10 Operator7 Casuals

    22Truck

    SOP

    VM

    SOP

    VM

    SOP

    VM

    SOP

    VM

    SOP

    VM

    In Process QalityCheck IPQC

    VM VM VM

    SOP SOPSOP

    Process Cycle Time(min)Value Added Time (minTAKT Rate (min)

    7.23.16.5

    P C TV A T

    7.21.86.5TAKT Rate

    P C TV A T

    71.76.5TAKT Rate

    P C TV A T

    6.93

    6.5TAKT Rate

    P C TV A T

    3.53

    6.5TAKT Rate

    P C TV A T

    8.26

    6.5TAKT Rate

    P C TV A T

    3.83

    6.5TAKT time

    11

    Value stream mapping activity Efforts Took over 7-Days to complete ( 25 Hrs)

    18 Meter chart paper used

    27 members including PD lab, Process Engg. &

    production.

    Identified all hidden factors & key parameters impacting

    the process

    Value stream mapping activity Efforts Took over 7-Days to complete ( 25 Hrs)

    18 Meter chart paper used

    27 members including PD lab, Process Engg. &

    production.

    Identified all hidden factors & key parameters impacting

    the process

    Value Stream Map

  • Step-7 Separate utility line provision

    15

    20

    30

    15

    30

    120

    25

    20

    90

    25

    40

    15

    70

    10

    Reactor cleaning

    Layer seperation

    Settaling

    Agitate & Cool

    Toluene charging

    Agitate & HPLC

    K2CO3 add.

    Charge TFAL & BCF

    Agitate & Cooling

    Charge sodiumcarbonate

    Charge potablewater

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