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Right First Time Six Sigma Project “ Improve batch record system for Packaging ”

I-nexus ID: 3,031. Right First Time Six Sigma Project “ Improve batch record system for Packaging ”. Start Date: 01 Feb 2008 Black Belt: Marina Suryanto Sponsor: Sis Mardini (QO Manager) Process Owner: Raharsih Basrodin (Production) Team Members : Production: Lily, Yaseph, Lely

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Right First Time Six Sigma Project “ Improve batch record system for Packaging ”

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  1. I-nexus ID: 3,031 Right First Time Six Sigma Project“Improve batch record system for Packaging” Start Date: 01 Feb 2008 Black Belt: Marina Suryanto Sponsor: Sis Mardini (QO Manager) Process Owner: Raharsih Basrodin (Production) Team Members: Production: Lily, Yaseph, Lely QA: S. Wigati, Yodi, Melissa

  2. Define Measure Analyze Improve Control Problem Statement The lead time to manufacture to release is too long. Business Case • Expected business results: • Reliable supply of product • Improve quality of records • Reduce time and efforts needed to complete batch documentation

  3. Define Measure Analyze Improve Control Scope • The lead time to manufacture comprises of 2 parts i.e: • Raw material receipt to bulk film coated tablet and final blend release (Project INX 7724 by JTM) • Primary packaging to product disposition • Product : Ponstan 500 mg Film Coated Tablet (FCT) • and Terramycin (TM) Oph. Oint. • START : Ponstan  Blistering • TM  Filling ointment • STOP : Product disposition by QA • Exclude : Batch with deviation and validation

  4. Define Measure Analyze Improve Control Project Goal I Data collected from lot released in Jul 2007 to Jan 2008. II Data collected from lot released in Feb 2007 to Feb 2008 * Maximum exclude validation batch and deviation

  5. Define Measure Analyze Improve Control Process MapPackaging Flow of Ponstan 500 mg FCT (As Is)

  6. Define Measure Analyze Improve Control Process MapBatch Record Process of Ponstan 500 mg FCT (As Is) Review Batch record = Manufacturing + Packaging batch record

  7. Define Measure Analyze Improve Control Process MapPackaging Flow of TM Oph. Oint. (As Is)

  8. Define Measure Analyze Improve Control Process MapBatch Record Process of TM Oph. Oint. (As Is) Review Batch record = Manufacturing + Packaging batch record

  9. DATA PLOT PONSTAN 500 MG FCT Define Measure Analyze Improve Control Total Manufacturing LT = Production LT + Packaging to disposition LT Total manufacturing lead time ranges from 59 to 99 days with median of 77 days. Production process LT ranges from 17 to 37 days with median of 25 days. Packaging to disposition LT ranges from 38 to 77 days with average of 52 days which contributes 68% to the total LT. 8

  10. Define Measure Analyze Improve Control DATA PLOT PONSTAN 500 MG FCT LT (Pack – Disposition) = Packaging LT + Final review LT Total lead time ranges from 38 to 77 days with average of 53 days. Packaging process LT ranges from 1 to 12 days with median of 2 days. Final review LT ranges from 35 to 75 days with average of 50 days which contributes 94% to the total LT.

  11. Define Measure Analyze Improve Control DATA PLOT PONSTAN 500 MG FCT 79% of the total review LT is contributed by the production review time. Production review LT ranges from 26 – 58 days with average of 39 days. QA review LT ranges from 1 – 28 days with average of 10 days.

  12. DATA PLOT TM Oph. Oint. Define Measure Analyze Improve Control Total Manufacturing LT = Production LT + Packaging to disposition LT Total manufacturing lead time ranges from 2 to 7 days with average of 30 days. Production process LT ranges from 14 to 45 days with median of 3 days. Packaging to disposition LT ranges from 17 to 48 days with average of 27 days which contributes 90% to the total LT. 11

  13. Define Measure Analyze Improve Control DATA PLOT TM Oph. Oint. LT (Pack – Disposition) = Packaging LT + Final review LT Total LT ranges from 14 to 45 days with average of 26 days. Packaging LT ranges from 6 to 21 days with median of 10 days. Final review lead time ranges from 5 to 30 days with average of 16 days which contributes 62% to the total LT.

  14. Define Measure Analyze Improve Control DATA PLOT TM Oph. Oint. Production review time ranges from 1 – 18 days with average of 8 days. QA review lead time ranges from 1 – 25 days with average of 8 days.

  15. Define Measure Analyze Improve Control CAPABILITY ANALYSIS 100% of the batches cannot meet the lead time of max 20 days. Data is approx. normal

  16. CAPABILITY ANALYSIS Define Measure Analyze Improve Control 58% of the batches cannot meet the lead time of max 25 days. Data is approx. normal 15

  17. Define Measure Analyze Improve Control Value Stream Map Analysis (Ponstan 500 mg FCT) Total Packaging Lead Time ranges from 24 – 29 days. Total processing time (P/T) ranges from 3 – 3.5 days (23 – 26 hours) Total delay time ranges from 21 – 26 days. Delay time was 89% of total LT Processing time in batch record review ranges from 6 – 8 hours per batch with delay time 19 - 24 days. Delay time in review process needs to be minimized. Note: Data taken from measurement of 3 batches

  18. Define Measure Analyze Improve Control Value Stream Map Analysis (TM Oph Oint) Total Packaging Lead Time ranges from 22 - 33 days. Total processing time (P/T) ranges from 15 – 18 days (113 – 134 hours ) Total delay time ranges from 6 - 15 days (45 – 113 hours). Delay time was 37% of total LT. Processing time in batch record review ranges from 7 – 10 hours per batch with delay time 2 – 10 working days. Delay time in review process needs to be minimized. Note: Data taken from measurement of 3 batches

  19. Structure and content of batch record is not user friendly/ complicated 2. Effort and time needed for correcting documentation errors Flow of batch record review process is not efficient. Review level that is labor intensive involving several personnel. The overall documents of the batch record from manufacturing to packaging is reviewed at the end of the process. 4. Standard lead time for batch record review and product release is not clearly defined. Delay time during final review is high. Batch record is accumulated waiting for review and sent to QA including waiting time for approved QAP for TM Oph. Oint. Define Measure Analyze Improve Control BrainstormingWhy batch record review lead time is too long?

  20. Define Measure Analyze Improve Control Batch record is accumulated waiting for review and sent to QA Numbers of Batch Record sent to QA per month was variable ranges from 1 – 23 batch records per receiving day with median of 5/ day.

  21. Waiting time for QAP Availability Define Measure Analyze Improve Control QAP LT = Batch record receive date – QAP receive date The QA review lead time, which ranges from 1 – 25 days, includes the waiting lead time for QAP from lab. QAP LT ranges from -19 to 11 days. Minus value means that the QAP has been received prior to the batch records sent to QA. 20

  22. Define Measure Analyze Improve Control Improvement Matrix

  23. Define Measure Analyze Improve Control Improvement Matrix

  24. Improvement Matrix Define Measure Analyze Improve Control 23

  25. Proposal for New Process FlowOff-Line Printing Define Measure Analyze Improve Control 24

  26. Define Measure Analyze Improve Control Proposal for New Process FlowFolding Leaflet

  27. Define Measure Analyze Improve Control Proposal for New Process FlowFilling & Packaging of TM Oph Oint 3.5 g Korea

  28. Define Measure Analyze Improve Control Proposal for New Process FlowTM Oph Oint 3.5 g Batch Record Review Process

  29. Define Measure Analyze Improve Control Proposal for New Process FlowBlistering & Packaging of Ponstan 500 mg FCT

  30. Define Measure Analyze Improve Control Proposal for New Process FlowPonstan 500 mg FCT Batch Record Review Process

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