Right First Time Six Sigma Project

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Right First Time Six Sigma ProjectImprove batch
record system for Packaging
I-nexus ID 3,031
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
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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

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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

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Project Goal
PROJECT GOAL METRIC BASELINE CURRENT GOAL
Reduction of packaging lead time (LT) Working Days Ponstan I Average 53 TM Oph II Average 26 TBD Ponstan Max 20 days/ batch TM Oph Max 25 days/ batch
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
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Process MapPackaging Flow of Ponstan 500 mg FCT
(As Is)
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Process MapBatch Record Process of Ponstan 500
mg FCT (As Is)
Review Batch record Manufacturing Packaging
batch record
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Process MapPackaging Flow of TM Oph. Oint. (As
Is)
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Process MapBatch Record Process of TM Oph. Oint.
(As Is)
Review Batch record Manufacturing Packaging
batch record
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DATA PLOT PONSTAN 500 MG FCT
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.
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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.
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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.
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DATA PLOT TM Oph. Oint.
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.
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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.
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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.
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CAPABILITY ANALYSIS
100 of the batches cannot meet the lead time of
max 20 days. Data is approx. normal
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CAPABILITY ANALYSIS
58 of the batches cannot meet the lead time of
max 25 days. Data is approx. normal
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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
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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
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BrainstormingWhy batch record review lead
time is too long?

• 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.

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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.
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Waiting time for QAP Availability
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.
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Improvement Matrix
Potential Xs Proposed Solution Supporting Data
Structure and content of batch record is not user friendly/ complicated Excessive data entries, excessive signatures, Many separate forms are linked to the batch record for data recording. Excessive data verification during IPC between Production and QA Re-structure of batch record both contents and format. The content is also analyzed and some improvements are made to comply with PQS regulatory requirements. Some of IPC activities and data verification will be transferred from QA to Production as per risk assessment. QA Risk assessment New IPC matrix Numbers of signatures for the new format of batch packaging records are reduced by approx. 50 (Ponstan FCT 52 TM Oph 58)
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Improvement Matrix
Potential Xs Proposed Solution Supporting Data
Documentation error Re-structure batch record as above. - Training Operator on documentation practice for the new batch record -
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 New flow of packaging process including IPC and batch record review process Batch record will be reviewed at each defined stage. Reviewers include Prod Spv, Prod Manager, QA Spv, QA Manager ? Delete non-value-added activity i.e., Prod Admin function to check and record doc error. These functions will be integrated to all reviewers. See proposal of new flow in the next slides.
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Improvement Matrix
Potential Xs Proposed Solution Supporting Data
Waiting time for approved QAP of TM Oph Oint The Lab Spv will also sign off the batch record at each stage (Before radiation after radiation) to confirm whether the test result meet or doesnt meet spec. The QAP will be inserted into the batch record after the Lab Spv sign off the BR at the after radiation stage, then the batch record will be circulated to the Prod and QA Manager for final approval. This avoid the delay due to QAP documentation. -
Batch record is accumulated waiting for review and sent to QA. Define standard lead time for review 1) Review at each stage Max 1 business day per reviewer per batch. 2) Final review Max 2 business day per reviewer per batch. -
Standard lead time for batch record review and product release is not clearly defined. Delay time during final review is high. Define standard lead time for review 1) Review at each stage Max 1 business day per reviewer per batch. 2) Final review Max 2 business day per reviewer per batch. -
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Proposal for New Process FlowOff-Line Printing
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Proposal for New Process FlowFolding Leaflet
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Proposal for New Process FlowFilling Packaging
of TM Oph Oint 3.5 g Korea
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Proposal for New Process FlowTM Oph Oint 3.5 g
Batch Record Review Process
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Proposal for New Process FlowBlistering
Packaging of Ponstan 500 mg FCT
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Proposal for New Process FlowPonstan 500 mg FCT
Batch Record Review Process