Brigitte Marshall-Pérez & Dhania Silva-Troche; Dr. Betzabé Rodríguez

Department of Industrial Engineering

Sponsor: Johnson & Johnson - Janssen Ortho LLC (Gurabo, Puerto Rico)

Liaison: Miguel Cancio (Sr. Business Excellence Specialist; Black Belt)

Our Capstone Project was conducted on

Janssen Ortho LLC Pharmaceutical

Company of Johnson & Johnson (J&J), a

worldwide company with three main

divisions: Pharmaceutical, Consumer

Goods and Medical Devices. Janssen is

responsible for 8% ($5 billion) of J&J’s

sales worldwide and 20% of Pharma Group

Sales. This manufacturing plant produces

prescription and over-the-counter pills (e.g.

Tylenol). In this novel project, we

implemented industrial engineering

techniques to a service process,

specifically to the Quality

Assurance/Quality Control Laboratory.

This laboratory is responsible of verifying

finish product quality compliance, where

the tasks performed by the laboratory’s

personnel add up to 90 days to the product

manufacturing time. Quicker response

times for the laboratory (less than 18 days)

are crucial to deliver our product on time to

the patients. In 2013 not a single month

this analytic laboratory achieved the cycle

time target which means this is a limitation

for the flow of our products. This project is

the venue to analyze and design an

operating system that identifies

opportunities real-time and tracks the

progress of lots’ testing; while helping

identify root causes of lots’ that are not

achieving cycle time target to develop

accurate improvement projects.

We designed and implemented a data collection tool,

created on Visual Basics for Excel, to facilitate the

monitoring and analysis of all the laboratory

information

Asses and Analyze

• Root Causes Analysis

was conducted to

establish possible

causes of failure (i.e.

long reaction times).

• Generated Solutions

• Brainstorming

• Solutions Prioritization

• Communication Plan

With this new system the laboratory enters

all necessary data in the tool, eliminating the

actual data entry duplicity and reducing

documentation errors. Weekly/ Monthly

Reports, Color-Coded Metric Graphs, and

Root Causes-Pareto Charts are available to

keep track of Key Performance Indicators.

Introduction1 Benefits & Results5

Design of a Method to Improve Janssen’s

Analytical Laboratory Key Performance

Indicators (KPI’s)

Problem Statement2

Objectives3

Methodology4

Recommendations6

AcknowledgementsR

• Collect and Analyze Current Metric System Data

• Conduct a Root Cause Analysis

• Design a New Metric System

• Create a Standardized Procedure to Develop Improvement Projects

Understand Cycle Time Attainment Failure

Lot

ApprovalPeer End

• Quee Time

Finish

Testing

Start

Testing

Receive

Lot

• Quee Time

WASTE WASTE

By applying concepts and techniques

learned in Industrial Engineering courses

(Probability and Statistics, Time Study, and

Engineering Economics & Managerial), this

project linked with the Lean Manufacturing

philosophy conducted on Janssen. The

following figure shows the roadmap

fallowed to complete our project based on

the VAALUE methodology:

Visualize the

Opportunities

Asses and

Analyze

Link the

Tools

Use the

Tools

Ensure

Improvement

They are now able to analyze real-time

data for the development of improvement

projects that will impact their KPI’s

positively on a related metric.

New Metric

System

• Reduced time from 15 to 1.45 minutes

for the documentation of one lot

• Reduced economic impact from $4,326.92 to $418.27 yearly

• Trained a laboratory population of managers, supervisors and scientists for the usage of this new tool

• Created a standardized procedure for the development of improvements projects to achieve metric targets.

Advisor: Dra. Betzabé Rodríguez; Sponsor:

Johnson & Johnson (Janssen Ortho LLC -

Gurabo Puerto Rico), University of Puerto Rico

recruiting; Sr Business Excellence Specialist:

Miguel Cancio; QA/QC Laboratory Managers:

Wilfredo Gonzalez, William Garcia; QA/QC

Laboratory Supervisors: Juan Carlos

Rodríguez, Gisela Algarín, Lilly Melendez, Wanda

Diaz; QA/QC Laboratory Scientist: Carmen

Cruz

Sustain

Changes

• Educate the population about this new implementation, to have the engagement of al the team members

• Assign a metric specialist to take responsibility over the development of continuous improvements projects based on tool results.

• Keep new system up to date according to laboratory processes changes

Benchmarking• Other Laboratory areas: Raw

Material, QATSS, Incoming

Visualize the

Opportunity

• Project Selection

• Project Charter

• Milestones

• Business Case

• Data Collection Plan

• Determine Sample

Size

• Statistics Analysis

Link the Tools

• Visual Factory

• Kaizen Teams

• Key Performance

Indicators

• Mistake Proofing

• 6’S

Use the Tools

• Developed a Pilot

• Change

Management

• Benchmarking

• Solutions Charter

Ensure Improvement

• Validated Process

Benefits

• Validated Financial

Benefits

• Sustainability Plan

• Metric Owner

Training

• Standardize

Procedures

• Work

Instructions