rapid process improvement tools - lab quality confab · education consulting r & d service...

Chris ChristopherVice President Global Customer Solutions

Copyright ©2008, Siemens Healthcare Diagnostics. All rights reserved.

Combining Lab Automation Solutions with the Best Rapid Process Improvement Tools

Siemens Healthcare Diagnostics

Our Healthcare Enterprise is Complex

Hospital

Hospital Clinic

HealthcareSystem

Affiliated Physician Practices

Patient’sHome

Independent Physician Practices

Health SystemPhysician Practices

Laboratory

LTC

Surgi-Center

Imaging Center

Outpatient Rehab

Communications -- Time


Grounding

Automation is playing an important and strategic role in all regions of the world.

Global Drivers:

EMPLOYEE SAFETY - PRODUCTIVITY – Predictable TAT

Regional Drivers:Japan & Korea (early adopters) – lab consolidation U.S. – skilled labor shortagesEurope – consistent turn around times / process improvementCanada – standard work processLatin America – quality Asia Pacific – most of the above

Rapid Process Improvement


Background - Lab Automation Challenges

Many issues and performance problems occur at newly installed automation sites – Why?

Hospital Laboratory• 24/7 with variety

of peak workloads

• STAT demand

• Key Metrics: STAT TAT

• Backup Capability: High

HV Reference Laboratory• 16/6 with peak loads from 1500 to 0800 hours

• Little to No STAT demand• All work to be completed typically by 0700 hours

• Key Metrics: Pending W/L• Backup Capability: Low

Markets Served

Today’s ObjectivesReview common problems encountered with Automation Installations

Provide you with a problem resolution approach using the Rapid Process Improvement and Tools


Agenda

SIEMENS Rapid Process Improvement ApproachGrounding – Automation ChallengesCase Study – Findings – SolutionsLooking Ahead – What’s next?

Quality Driven Approach

Customer Support

One Goal“Taking Diagnostics To The Next Level. Together”

Manufacturing

Education Consulting R & D

Service Marketing IT

LeanSix Sigma


Grounding

Process Identify key processes opportunities where solutions can be quickly implemented without significant capital investments

Focus Continuous ImprovementEliminating Waste

Strategy Working together at all levels and across the organization to improve a process or address a problem with an actionable and executable plan.

Analytical Processes and ToolsValue Stream MappingThe Five Why’sFish Bone

Rapid Process Improvement{ Kaizen }


Automation Challenges / Implementation

Customized Training

Menu Mapping

Quality Control

0 18060Days 90 120 150

Flows & ProcessesChange Mgt.

Going from Instrument W/F to Automation W/F


Early Team Acknowledgements

Needs for both Project and Change Management

Current Transition Future

Project management

Change management

Technical side of the project

People side of the project



Change Management

Recommendation:Implement an Effective Change Mgt. Program

Awareness

Desire

KnowledgeAbility

Reinforce-ment ADKAR

Model

Lower productivityPassive resistanceActive resistance Turnover of valued employeesMore people taking sick days or

not showing upPeople finding work-around’sPeople revert to the old way of

doing things

Consequences of not managing the people side of change



20

Case StudyAutomation Optimization

3 Advia 2400sExpected Capacity:~415 Tubes/ Hour>8,800 Tubers/Day

3 Sample ManagersExpected Capacity:~925 Tubes/ Hour (Load)>20K Tubes/Day

7 Centaur XP/ ClassicsExpected Capacity:~535 Tubes/ Hour> 11K Tubes/Day

21 hrs / day

23 hrs / day

LIS LIS Client



Problem Classification & Priority Setting

Complex Operation with Multiple Levels of Interdependencies

BalanceLoad

Tools

Process

Env ironment/Materials

People

Kno wle d g e L e v e l

C le a r Ro le s fo r T ra y Ma n a g e m e n t

Av a i la b i l i ty o f L a b ou r

L o a d i ng P ro to co l

V isua l ID o f De l iv e ry & Ba la nce Issue s

Ga te S ca nn e rs

Th rou gh p u t Ca p a b i l i ty

Que u e De sig n

Ro u tin g L o g i c

Ho u rs o f Ope ra tio n

T ra y Co n fig u ra tio n

L i ne Con fi gu ra ti o n /L a y o u t

Te st De n si ty

Te st Mix

Tu be Mix (lo a d se nsi ti v e )

S M L oa d i ng P ro to co l

Tra y Co n fig u ra tio n W o rk Instru ctio n

Down tim e

Da shb oa rd

Th ro ug h pu t Ca lcu la to r

S im iu la tio n Too l

Th ro ug hp u t Da ta

No Re a d Qu e ri e s

resp

o nse

t o cue

S ta nd ard w

o rk

Unde

r sta nd C u

e s

Tr a ys/O n/O

f f T i me

l y

Pre

sor t in g

Sta

ndard W

ork

De pl oy m

en t

N umb er

Bre

a ks

Th rough

out D a

y

Va ri abi li t y

Re ad s

N o

S et t in gsMgm

tPu ckPu ck

s &No .Le

n gt h

Li ne

r Mana g

eSa

mpl e

Anal yzer

SIQ

ProcessPa rt i al

S ta rt7 -1 0

a m

r Ana ly ze

By

Pri o

r i t ies

r Man a

g eSa

mpl e

An al yze

r

Equi pm

e nt

A ssa ys

Rep

e at s

Re use of Ho le s

T i me

l y

P re so rt i ng

St a nda

rd W

ork

t rouble

shoot in

g data

Lack of

S IQ tr ay

La ck o

f C /T a

l er t

Cause and Effect (Y = Load Balance)

IT Issues

Tools

Process

Environment/Materials

People

Open Apx/CL/WWL team

Understanding interdependency

Missing orders

Simplify IT strategy

Lack of troubleshooting data

Downtime communication

3 time upload constraint

Communication errors

Lack of IT process map

Assay enable/disable

Change control and testing

Standard work

Lack of C/T alert

SIQ tray

dataLack of troubleshooting

Joint work pro cedure s

Availabilit y

Ease of use

Timelines s

Channel traff ic

Delay

Not sca nned a t CDS

LIS orderChecke d in, but no

(2400 stop s)

LAS errors- reboo t

SIQ (75% tray)

acknowledgement t o

2400 timeout

disabledM

a nual load whileOrder

stops)reboot (2400

LAS errors-

tra y)nt to SIQ (75%

acknowledgeme

2400 timeout

Equipmen t

Assay

Av ailabilit y

Ease of us e

T imeliness

No read data

changeExport pre tray

>60 mins

Cause and Effect (Y = IT Issues)

DowntimeAnalyzer

Process

Environment/Materials

People

Siemens response insuff icient

LL maintenance not dilligent

maintenance/service correctlySiemens not managing

LL not self sufficient on all maintenance

Design

Workspace for FSE

Reagent changeover

Insufficient spare parts

Troubleshooting process

Service call protocol

Standard work not in place

PM

Contingency plans

Root cause analysis

Agreed metrics

Recovery process

Dispatch failures

Update procedure

Escalation procedure tr ainin gadvance d

super use r

with usage

Misaligned

PM'sIn complete

PM plan nin g

fre quencyInsuff ic ient PM

to volumeNot balanced

levelExperience

st aff in gI nadequat e

Right par ts

(LL/Siemens)

Location

On consu mpt ion

Lot change

Con sultat ion

Locked

Han dover

ChecklistQC

Ca libra tion

ove rlapNot dur ing downt ime

T oo long

Cause and Effect (Y = Analyzer Downtime)

(Operator)nceQC-Maintena

Tools

Process

alsEnvironment/Materi

People

QC Schedule Adherence

Maintenance of SIQ, Partial Process tray

off-lineUnderstand QC,Calibration and taking assays

QC and Cal material handling and storage

Lot # Changes vs. SLA's

ProcessCloser Working relationship between QC and

Calibration Process and Schedule

Freq. and VolumeOperator Maintenance - I s it adequate?

Advia Mapping - Optimization

Stand alone QC vs Running QC as sample

Define on-board stability

Reagant Work Instructions and Training

interact every 8hrs (unless 3SD violation)Review QC Process run every 4 hrs but

Minimise No of samples front loaded

Automate production log from Centaur

automatedData availability currently manual can it be

Advia Pilot

off-lineVisual controls to know when assays are

QC fai lsEn able/ Di sa ble i f

Freq .

Dec is io n

F requen cy

U nsc he dule d

S che du le d

da tatroub le sho oting

La ck o f

S IQ tra y

La ck o f C/ T alert

Cause and Effect (Y = QC-Maintenance (Operator))



Capacity

Conduct an Analysis based on current Test Mix

Identify Actionable Steps that can Increase Throughput

Achieving Operational Excellence



Capacity Analysis based on Work Flows

ProcessObtain Data – LIS, LabCell (Instruments,

Automation Line, and Sample Managers)Monitor operations and document any

anomalies or key factors that may affect output

Compile Data by Instrument / WorkstationConsiderations – Total Chemistry volume

processed

Measurement Period24 hours on two different high volume

dates



Facts:Automation Output Interdependencies

System Capacity is dependent upon many related interactions including:Tube/Test MixTube Arrival TimesSystem Operations (hours)System DowntimeBarcode DependabilityOrder Availability (Scanning)Test MapsRepeat Rates & Add-Ons

System Avg. Tests/hr

Avg. Tubes/hr Systems Tubes/

SystemOperation

HrsTot.

Tubes Tot. Test

ADVIA Centaur 130 75 7 525 21 11,025 19,110ADVIA Chemistry 1,053 135 3 405 21 8,505 66,339

Total 1,183 210 10 930 21 19,530 85,449

Note: This capacity is based on 23.5 hours per day of track operations (excl. Mondays) and analytical instruments on line for 21 hours per day with specimen loads available



Measurement: AutomationSample Manger Loading (log files)

0100200300400500600700800900

1,000

0:00 2:00 4:00 6:00 8:00 10:00 12:00 14:00 16:00 18:00 20:00 22:00 0:00

Time of Day

Number of Unique Samples Checked Into ADVIA LabCell By Hour (May 6/7)

Hour No.0:00 3231:00 7712:00 6003:00 6954:00 6195:00 4896:00 4807:00 08:00 09:00 010:00 32411:00 35812:00 34013:00 52614:00 61315:00 79516:00 69117:00 75218:00 73419:00 67220:00 70721:00 38222:00 61823:00 473Total 11962

Total: 11,962 tubes

Hours: 20.2 hours

Average Throughput: 592 tubes/hourData Source: Wonderware Logger File, 7 May 2008

Note: does not include samples checked into the line more than once for repeats, dilutions, re-routing, sorting, etc.

Throughput is Lower than expected


Measurement: Automation Actual Total Sample Loading

Total Check Ins: 14,851 tubes

Hours: 20.2 hours

Average Throughput: 735 samples/hourNote: Includes samples checked into the line more than once for repeats, dilutions, re-routing, add-ons, sorting, etc. (19.8%)

Data Source: WWL Files, 7 May

0

100200

300

400

500600

700

800

9001,000

6:00 8:00 10:00 12:00 14:00 16:00 18:00 20:00 22:00 0:00 2:00 4:00

Time of Day

Number of Samples Loaded Onto ADVIA LabCell By Hour (May 6/7)

Hour No. Repeats Totals6:00 480 159 6397:00 0 15 158:00 0 0 09:00 0 0 010:00 324 9 33311:00 358 91 44912:00 340 133 47313:00 526 51 57714:00 613 163 77615:00 795 128 92316:00 691 206 89717:00 752 155 90718:00 734 165 89919:00 672 133 80520:00 707 128 83521:00 382 72 45422:00 618 186 80423:00 473 268 7410:00 323 448 7711:00 771 9 7802:00 600 90 6903:00 695 116 8114:00 619 87 7065:00 489 77 566Total 11962 2889 14851

Capacity Exceeds 900 samples / Hr.

1200 clinical repeats, 400 dilutions, etc.


Expected Tube Capacity / Throughput by Hour

Track Operation: 23.5 hrsInst. Maint/Startup:

Staggered every 8 hoursTotal Tubes: 19,850

Hr 6:00 7:00 8:00 9:00 10:00 11:00 12:00 13:00Tubes 600 350 600 700 950 925 950 925

Hr 14:00 15:00 16:00 17:00 18:00 19:00 20:00 21:00Tubes 950 600 700 950 925 950 950 925

Hr 22:00 23:00 0:00 1:00 2:00 3:00 4:00 5:00Tubes 950 600 700 950 925 950 925 900

Data Source: WWL Files

0100200300400500600700800900

1000

6:00 8:00 10:00 12:00 14:00 16:00 18:00 20:00 22:00 0:00 2:00 4:00

Maximum Tube Throughtput

Track plus InstrumentMaintenance,Calibration,QC


Percent Capacity Achieved on ADVIA Automation (with repeats)

Based on tubes with reruns, repeats, add-on orders, and SIQ tubes

Note: This capacity is based on 23.5 hours per day of track operations (excl. Mondays) and analytical instruments on line for 21 hours per day with specimen loads available

Comparison of Tubes Processed vs. Maximum Capacity on ADVIA LabCell on 9-10 May 2008

722

532588

394

0

288

910 881 852928

803

682

859

693

785734

777850

652692

735772

688729

0

100

200

300

400

500

600

700

800

900

1000

6:00

7:00

8:00

9:00

10:00

11:00

12:00

13:00

14:00

15:00

16:00

17:00

18:00

19:00

20:00

21:00

22:00

23:00 0:0

01:0

02:0

03:0

04:0

05:0

0

Time of Day

Uniq

ue T

ubes

No. Complete Max Cap.

HourNo.

Complete Repeats Total No. Max Cap.6:00 560 162 722 6007:00 464 68 532 3508:00 392 196 588 6009:00 320 74 394 70010:00 0 0 0 95011:00 243 45 288 92512:00 781 129 910 95013:00 688 193 881 92514:00 720 132 852 95015:00 748 180 928 60016:00 592 211 803 70017:00 565 117 682 95018:00 683 176 859 92519:00 603 90 693 95020:00 632 153 785 95021:00 540 194 734 92522:00 624 153 777 95023:00 701 149 850 6000:00 527 125 652 7001:00 560 132 692 9502:00 657 78 735 9253:00 623 149 772 9504:00 572 116 688 9255:00 578 151 729 900Total 13,373 3,173 16,546 19,850

Loaded 16,546 tubes on the Automation System


Capacity and Workload Summary

Improvements in Operation will Increase CapacityReduction of no-readsReduction of tubes in the SIQ (800-1,000/day)Reduction in operator enable/disable systems23.5 Hours Automation Track OperationMaintaining Two Chemistry systems on-lineChanging start-up proceduresReducing unnecessary repeats, add-ons

Automation CapacityAdding an additional Sample Manager will increase capacity up to26,500 tubes, enable sorting to the offline ADVIA 2400, and provide a backup.


Operational Excellence

Execute New QC Program

Maximize Line Operations -- Develop and Implement Rules regarding Overall Automation Operations

Optimize Test Mapping

Optimize Supply Chain and Stocking – reduce lead times

Recognize and Reward broadly



Product Training & Education

Conduct Needs Analysis for the entire line forService and Users

Develop Customized Programs for Service and Users

Deliver Training


Knowledge Transfer


Establish Visual Controls:• Automatic File Processing• Real time analysis for Problem Analysis• Productivity analysis

Develop New Service and Support Tool for Performance Monitoring

Dashboard

File GenerationFile ProcessingReport Generation

Empty Gate

Visual Controls and Work Instructions

Identified Needed Tools for Effective Support


Performance Monitoring


Overall Findings

The Ultimate Key to Success requires a comprehensive upfront andexecuted plan that includes these essential elements:

Understanding and Focus on customer’s operations, capabilities, and future projections in order to clearly identify needs / gapsPlanning, staffing, and training before the installationEffective project managementEffective handoffs and smooth communications across each participating function within DXAssisting the customer with “Change Management”Implementing programs and tools that enable the customer to manage the entire line for optimal performance (does not exist today) Customized training planFocus on “Workflow Optimization” after installation


Siemens Healthcare Diagnostics / Informatics

rapid process improvement tools - lab quality confab · education consulting r & d service...

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