P I O N E E R I N G D I A G N O S T I C S

FSS - 2019

The Lean Approach to

Optimize and Improve Efficiency

for Pathogen and Quality Indicator Testing in a

Food microbiological laboratory

May, 2019

2

Mohammed T. Ahmed M.Sc., C.Chem (Senior Consultant / Manager Laboratory Optimization)

A Certified Lean Six Sigma Black Belt with an in-depth knowledge of

Microbiology including lab instrumentation and over 15 years of

experience in applying Lean and Six Sigma Methodology in process and

performance improvement.

Area of expertise is lean enterprise and six sigma, Kaizen, Advanced

Statistical techniques (SPC, MSA and DOE), business process

management, business analysis, project management and facilitation

skills.

Mohammed is a Charted Chemist and holds a M.Sc degree in

Chemistry.

Email: mohammed.ahmed@biomerieux.com

Mobile: 905-867-0666

BIOS

3

5S and LEAN training results:

staff removed unnecessary items from lab

4

Expenditure: ……….

Lab Efficiency: Case Study Results

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LAB EFFICIENCY – OPTIMIZATION?

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EFFECTIVENESS & EFFICIENCY

Effective (adj.) – Adequate to accomplish a purpose; producing the intended or expected result.

Efficient (adj.) – Performing or functioning in the best possible manner with the least waste of time and effort.

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Elements of Time

Value-Adding Activities:Transform products or information into

products and services the customer

wants.

Non-Value-Adding Activities:Consume resources, but don't directly

contribute to process or service.

Value is always defined from the customer’s perspective

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TIMWOOD – 7 types of waste

Non Value Added Work

Transportation of

Samples

Excess Inventory:

i.e. 1 large batch of

plates

Motion within the

work station.

Waiting for Results

or next processDefects/Re-workOver - ProcessingOver - Production

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Value Added & Non Value Added Examples

Value Added:1. Sample reception – Logging samples.2. Ordering supplies.3. Sample Preparation.4. Incubation.5. Reading 6. Sending Report to Customer(s).

Non Value Added:1. Waiting2. Moving3. Inspection4. Checking5. Copying and Filing.

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Making the Lab more Efficient

Value Added ActivitiesNon-value Activity

Lead Time

Efficient companies focus on eliminating non value added activities

to make larger, lasting improvements in lead time

NVAVA

Current State Process

NVAVA

Traditional Focus Of Process Improvement

NVAVA

Focus On Reducing Non Value Added ActivityMinor

Improvement

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Lean Six Sigma: What does it mean?

The CONTINUOUS IMPROVEMENT OF

QUALITY, ACCURACY AND THE REDUCTION OF

PROBLEMS AND PROCESS VARIABILITY

OPTIMIZATION OF PROCESS WITH REDUCTION OR

ELIMINATION OF TASKS WITHOUT ADDED VALUE AND REDUCTION OF TIME DELAY IN

DELIVERY

COMBINATION OF BOTH METODOLOGIS TO ENSURE THE

BEST RESULTS IN TERMS OF PRODUCTIVITY, QUALITY, COSTS

AND OPTIMIZING PERFORMANCE

The Lean accelerates the Six Sigma: resolution of problems and

improvement of processes to a more rapid and efficient

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MAIN OBJECTIVES

Improve efficiency and productivity

Operational cost reduction

Quality assurance of products and services Decrease the

Processing time (Turn Around Time)

Increase the capacity of analysis and flexibility for demand

management variables

Process standardization - Workflow Optimization - Improving

Traceability

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It starts with Current State

Statistical Analysis:

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RECEPTION AND SAMPLE INFO RECORDCURRENT SITUATION

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REGISTRATION OF SAMPLES. INFORMATION ENTRY VERY

MANUAL AND INVOLVES DUPLICATION IN

DOCUMENTATION

1

23

4

56

SIGNIFICANT ADMINISTRATIVE TASK I

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CULTURE MEDIA PREPARATIONCURRENT SITUATION

CULTURE MEDIA PREPARATION 100%

MANUAL

MANUAL IDENTIFICATION OF TUBES AND PLATES DURING THE CULTURE MEDIA

PREPARATION

MANUAL RECORDS FOR CONTROL OF

CULTURE MEDIA PRODUCED

EXCESS OF MANUAL TRANSCRIPTION

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SAMPLE PREPARATION | INOCULATIONCURRENT SITUATION

NOT ERGONOMIC LOCALIZATIONOF

SAMPLE BLENDER AND HEARING

INSTRUMENT IMPACT

THE VOLUME OF

DILUENTS ARE

MEASURED MANUALLY IN

THE INOCULATION STEP

MANUAL IDENTIFICATIONOF

PLATES ANDPETRIFILM

UNIFICATION OF PROCESS OFWEIGHING

AND INOCULATION (PRIMARY DILUTION)

INTO A SINGLE STEP BY AUTOMATION

USE OF LABELS FOR THE

IDENTIFICATION OF TUBES AND

PLATES

STANDARIZATION

REDUCTION OF MANUALTASKS

TECHNICAL TIMESAVINGS

PROCESSING TIMESAVINGS

IMPROVEMENT OFTRACEABILITY

REDUCTION OF TRANSCRIPTIONERRORS

STORAGE FOR INOCULATION IN

"BATCH“ PROCESS

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INCUBATION

CURRENT SITUATION & RECOMMENDATIONS

THERE IS NO

MANAGEMENT OF

INCUBATION TIMES /

READING

MANUAL TEMPERATURES

RECORD OF INCUBATORSAND

REFRIGERATORS

VISUAL MANAGEMENT DATE / TIME INCUBATION /

READING

READINGS OS CULTURES IN APPROPRIATE TIME

AUTOMATION OF THE WAY TO MANAGE THE

TEMPERATURE OF INCUBATORS, AUTOCLAVES

AND REFRIGERATORS

IMPROVEMENT OF QUALITY

IMPROVEMENT OFTRACEABILITY

REDUCTION OF MANUAL TASKS

SOME READINGS

ARE OCCURRING

WITH INCUBATION

18H LESS

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SIGNIFICANT ADMIN WORK

1

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OBSERVATION ON FOUR(4) ACTIVITY

CATEGORIES

Technical

Processing of samples, Performing productive tasks,

Unpacking sample boxex, Unpacking samples, Loading or

unloading instruments, Looking in Microscope

AdministrativeIdentification, results keyboarding, Typing information on PC

Writing Information. Scanning label, Labeling sample

Transportation Transporting specimens to bench, Transporting plates to

incubators, Transporting reagents to bench.

Movement

Moving items on workplace, Arranging or Sorting plates

Searching in / around workplace.

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THE RESULT: WORKLOAD ANALYSIS

Lean waste – 16%

??

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QUALITY INDICATORS ANALISYS

CURRENT X PROPOSED SITUATION |

BIOMÉRIEUX SOLUTION

PROPOSED

TAT

(DAYS)

1,00

1,00

1,00

1,00

1,00

1,00

3,00

PARAMETER OFANALISYS

CURRENT TAT (DAYS)

AVERAGE MEDIAN 3º QUARTIL

AERÓBIOS MESÓFILOS 3,60 3,00 4,00

ENTEROBACTERIACEAE 3,41 3,00 4,00

COLIFORMES TOTAIS 4,11 3,00 5,00

ESCHERICHIACOLI 4,03 3,00 5,00

STAPHYLOCOCCUS 3,98 3,00 5,00

BACILLUSCEREUS 4,43 4,00 5,00

BOLORES ELEVEDURAS 6,11 6,00 7,00

TAT

REDUCTION

(DAYS)

-3,00

-3,00

-4,00

-4,00

-4,00

-4,00

-4,00

FASTERRESULTS

REDUCTION IN UP TO 4 DAYS THE RELEASETIME

(*) Global TAT –Considering only the analysis times. Not considering the processing timevariations

TAT – CURRENT x PROPOSED

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QUALITY INDICATORS ANALISYS

CURRENT X PROPOSED SITUATION |

BIOMÉRIEUX SOLUTION

Preparation of Media

1

Dilution

3Inoculation

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Sample Preparation

Fill

5

Incubation6

Reading7 Release of

Results

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WORKFLOW – TRADITIONAL METHOD x TEMPO

REMOVED STEPS WITH AUTOMATION

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Summary

Expenditure: ……….

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Classifying activities

• Aligning staffing with workload• Read multiple

batches• Cross training

Do more

•Multiple Touches•Holding results•Over-processing

Stop doing

• Add new procedures & technologies

• Balance Cost/Quality/TAT

Keep doing

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Lessons Learned

Management buy-in is “CRITICAL” for change

Continuous Improvement Mind-set, Go & See (Gemba)

Just DO IT (kaizen)

Respect for People

Thank You for Attention

Contact:

Mohammed T. Ahmed, M.Sc., C.Chem.

Certified Lean-Six Sigma Black Belt.

Consultant / Manager, Laboratory Optimization

Mobile: 905-867-0666

Email: mohammed.ahmed@biomerieux.com