merged

PHEN-FORM-00368 rev: 1 Process Improvement Capture Form

t0 Testing Marker Conversion

Member Name(s) Work Cell/Department Category Implementation Date

Shinae Im MMQC November-15

Quality Inventory Financial Impact

Delivery Productivity $1,950 annually

Problem Improvement Idea Result/Benefits

Current requirements for certain media testing require Convert the "t0" maker from a separate fructose probe to the Uracil This change allowed us to achieve the following:
and additional injection and sample preparation to probe already contained in testing mixes used for batch testing.
establish the "t0" maker to establish dead volume. This - 62 base codes updated with new "t0" information.
- Saved approximately 130 hours annually in sample
results in the following: We can provide better measure product consistency. Uracil is in the testing
- Money saving at least $1,950 annually in labor
- Less precise product measurement same testing probe so, tested under same condition with analytical - Reduced mobile phase and probe usage
- Wasted time for analyst and process peaks. Under consistent testing condition, new spec brings more - Improved specification limits to better reflect product
- Wasted testing reagents and materials consistency and better quality to our product. performance
- Decreased testing time
- Increased out of trending batches and TAT - Increased staff productivity

Before Improvement Sketch After Improvement Sketch

TEST PARAMETER TEST PARAMTER

HB PACKING (QC) HB PACKING (QC)
30 min 30 min 30 min 30 min

DERT FRUCTOSE After3pD0iEcmtRuiTimrnep,lcehmaertnotinr ggrtahpehiimc pdreopviectminegnIttNhideEeRraeT.sults from
30 min 25 min 40 min

INERT
40 min

- Total 3 hr testing hour required /media - SAVE at least 30min/media : 130 hr /year

PHEN-FORM-00368 rev: 1 Process Improvement Capture Form

Upgraded CDS Software for MMQC

Member Name(s) Work Cell/Department Category Implementation Date

Si Li, Claudia Martinez, Ignacio Torres MMQC Quality Inventory November-15
EIS
Charles John Financial Impact

Delivery Productivity $39,000

Problem Improvement Idea Result/Benefits

With ChemStation software, no automatic calculation Reduce 'hands-on' and processing time for tested batches release Networked + Enterprise-wide CDS system will greatly
can be set up. Hence there are many manual steps in by using an automatic chromatography data system standardize process flows, automate processing, and
preparing batch packets and to release batches for automate
MMQC & QA. Waste of over process and waiting

Before Improvement Sketch After Improvement Sketch

Existing (blue-color) hands-on instances are many Manual * 6 out of 11 steps with Chromeleon are performed automatically with its capabilities! Estimated Time
processing times long! Slowing moving of batches on to next step! Savings of 60% to 90% !!!
* Approximately, 825 batches were released by MMQC in 2014! So, 70% Time Savings ~ 2660 hrs
* Manual calculations (MMQC) + Manual Reviewing (MMQC) + 2nd saved for MMQC & QA !!!
Checking (QA)

Networked + Enterprise-wide CDS system will greatly standardize process flows,
automate processing, and automate

As seen above, the many steps (...with 'hands-on'… processing… Event Analytical CDS System Time Reduce
review/checking) adds delays! Also, can lead to repeated work: Calculation time 3 min 84%
Manual Process
19 min

2nd Checker Time 20 min 5 min 75%

QA Review Time 45 min 15 min 67%

Historical 2015 Kinetex

2013 2014 Jan Feb Mar YTD Calculation time 32 min 10 min 69%
81% 85%
Right first time 88% 90% 90% 96% 2nd Checker Time 40 min 5 min 88%

QA Review Time 63 min 4 min 94%

PHEN-FORM-00368 rev: 1 Process Improvement Capture Form

Verex Box Redesign

Member Name(s) Work Cell/Department Category Implementation Date

Ronald Mudgett Purchasing Quality Inventory April-15
Faye Salim Purchasing
Kent Landsberg (vendor representative) Delivery Productivity Financial Impact
Derrick DiNucci
$59,000 annually

Problem Improvement Idea Result/Benefits

The current box design for Verex vials has a flaw in The implementation of this idea has:
- Reduced storage space of 100 pack vials by 50%
design. When shipping product in 1000 packs it works Create box configuration that will reduce Phenomenezation time, ($16,351 based on current Inv level).
well, however when the product is Phenomenized down reduce number of boxes used to Phenomenize Verex Vials, and - Utilizing both sides of the vial box cost of 100 pack
to 100 pack we only fill one side of the current box increase shipping efficiency. This was accomplished with one minor packaging is reduced by 50%.
configuration. This causes us to use twice as many vial change in the current box design, adding a perforation between the - 26% decrease in cost per vial box ($6,022 based on
boxes when breaking a 1000 pk down to 100, increases two vial compartments allowing the current design to be "broken" 2013 spend).
workload on Phenomenezation to build boxes remove apart (see after photo) and both side to be used to ship and store - Time to Phenomenize vials from 1000 pk to 100 pk has
and replace product within half the box. Most 100 pack Verex vials. been cut by 2/3.
importantly forces us to ship 50% air inside our current - $10,800 labor reduction (est.)
- Reduced transport cost by 50% from previous method
box configuration (see before photo) ($26,000 annual reduction in shipping to EU subsidiaries
est.).

Before Improvement Sketch After Improvement Sketch