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Applying Six Sigma for Operational Excellence: Case Study Analysis

Venkata Sai Ram Kowdi

Department of Information Technology, Westcliff University.

Professor Moice Dixon

Introduction

Six Sigma is a methodology which is data-driven, structured and primarily aimed to

identify defects, unpredictable patterns to eliminate and enhance consistency. It is developed by

Motorola and later enhanced and expanded by General Electric which led to development of a

framework which helps achieving operational excellence while helpful in wide range of

industries.

Traditional problem solving methods include Trial and Error, Intuition and Experience

based decision making based on gut feeling, Brainstorming, Firefighting and Root Cause

Analysis. The problem with each of these methods are that they are unstructured and

inconsistent, they don’t have data to back their assumptions, difficult to replicate or scale at large

scale companies, and most importantly they are reactive and not proactive. Six Sigma solves all

these problems by having a structured approach and making decisions based on data. It works on

a defined framework called as DMAIC - Define, Measure, Analyze, Improve and Control. The

goal of DMAIC is to produce products with perfect quality and the benchmark is to have less

than 3.4 defects per million opportunities.

The paper analyses two real-world application of Six Sigma: one in the pharmaceutical

industry, which focussed on standardization and regulatory compliance which other in consumer

product manufacturing where Six Sigma was used to identify and enhance efficiency of product

quality. Both case studies offer deep insights in to the challenges faced and the solution gathered

from the Six Sigma approach.

Case Study 1: FedEx Express - Aircraft Maintenance and Repair

A leading pharmaceutical company encountered a critical issue: one of its top-selling

liquid oncology drugs which is essential to treat cancer patients has a limited shelf life of three

months. Post the three month shelf life, the drug would fall back to 96 percent potency threshold

which is set by FDA. Thus, leaving it ineffective and unusable. The outcome to the problem is

that the drug was to be destroyed at large scale due to limited usage timeline affecting large

volumes of inventory. This also led to production and storage costs which affected the drug

availability, especially during high demands. This issue has the potential to cause financial

instability and also to not meet patient needs.

To address this problem, the company turned to the Six Sigma quality management

program which was already an existing part of their operational management. A Master Black

Belt (MBB) - a senior Six Sigma expert was appointed for this use case and led a

cross-functional team that includes scientists, manufacturing staff, quality assurance professional

and supply chain analysts. The team’s benchmark goal was to use Six Sigma methodology to

identify the root cause of this issue and propose a valid solution which is not only statistically

feasible but also sustainable.

They applied the factional factorial DOE (Design of Experiments) which is a statistical

method used to identify the most influential factors for a product without having to deal with all

possible combinations. This will save time compared to full factorial design where all the

possible outcomes have to be tested. Through the application, the team learned that three factors

has the major contribution to the drug’s shelf life: container color, light exposure, and container
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material. A full factorial DOE was also followed to identify the optimal combinations for the

three variables to extend the drug’s shelf life.

The result after the vigorous experiments helped increase the shelf life from 3 months to

six months - which is essentially doubling the shelf life from the original duration. This

drastically reduced product waste but also lowered production costs. The company saved

millions of dollars in production and also helped consumers by reducing the retail price by 3.8

percent. Thus, improving overall customer satisfaction and providing greater access to the

patients. Moreover, the initiative also helped company to strengthen the ties to data driven

decision making methods and showcasing Six Sigma as a core pillar of their decision making

process which is a sign of quality management.

Case Study 2: Consumer Goods Company – Reducing Waste in Orange Juice Production

This case study is about a multinational company which is primarily known for its orange

juice productions. The problem was significant operational inefficiency at its two major

production facilities: Florida and Texas. Even though, the company operated many plants across

the United States, these two facilities have seen major loss in terms of production wastage,

rejection and financial losses.

The both plants faced distinct but a relatively similar issue. They both had inconsistent

quality control methods, specifically the products produced in the Texas plant weren’t qualified

when they were tested in Florida plant which led to lot of unnecessary rejections, resource

wastage and unavoidable production loss. On the other hand, Texas facility has a mechanical

challenge, the orange juice filling nozzle had a problem of constantly clogging during pulp
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addition to the production. This resulted in unfilled cartons and product wastage due to spill

which led to the rejection in the production lines. Thus, impacting efficiency and product

availability.

The company applied the Six Sigma DMAIC framework led by a certified Master Black

Belt. The entire process was divided into multiple phases. The first phase was focussed on

Measurement System Analysis (MSA) to investigate the root cause which is the variation on

testing methods used in both facilities. The analysis revolted that the Florida and Texas facilities

were using different testing methods and procedures which caused the variation and variability in

the quality assessments. This inconsistency triggered the unnecessary rework and rejection

cycles. The first phase ended with standardizing the testing protocols across all the different

facilities which eliminated redundancy and saved over $895,000.

At the Texas plant, the team focussed on the mechanical fear in the juice filling process.

They integrated control charts to track the juice filling process which used volume over time to

detect any deviations in real time. The charts helped the team to identify the problem to be

manual override of automated controls which disabled a control computer that regulated nozzle

control. The root cause helped track the performance of poor equipment handling and

maintenance methods.

The effectiveness of the nozzle configurations were studied based on the insights. The

facility was able to refine the nozzle configurations and reactivate the automated controls which

significantly reduced the frequency of clogs. The exact figure is from 5.3 percent to just 0.94

percent which is 5 times less the occurrence and increased the overall yield.
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The Six Sigma not only helped to identify the problems but also stabilize the production

problems with quality consistency across the different sites. This case study helped understand

how data-driven analysis and a structured methodology can eliminate cost efficiency and product

quality while maintaining customer trust.

Conclusion

Both the case studies demonstrate the impact Six Sigma can have to improve operational

efficiency by streamlining processes and through cost reduction. In the first case study, the

pharmaceutical company used Design of Experiments to improve the shelf life for better shelf

live and annual cost savings. This not only helped the company but also the customer to save

money. In the case of orange juice company foundational Six Sigma tools were used:

Measurement System Analysis, control charts and root cause analysis to address the quality

inconsistencies and mechanical inefficiencies to save nearly $900,000 annually. These two case

studies highlight how Six Sigma cannot be used as a one-size fits all approach but rather a

dynamic and scalable methodology that can be tailored based on the industry and the problem.
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References

Feldman, K. (2022, April 25). How Design of Experiments (DOE) helped a pharma company

extend product shelf life. iSixSigma.

https://www.isixsigma.com/design-of-experiments-doe/how-design-of-experiments-doe-h

elped-a-pharma-company-extend-product-shelf-life/

Feldman, K. (2022, February 27). Basic Six Sigma tools helped this company reduce waste and

product rejections. iSixSigma.

https://www.isixsigma.com/case-studies/basic-six-sigma-tools-helped-this-company-redu

ce-waste-and-product-rejections/

George, Michael. (2003). Lean Six Sigma for service: How to use lean speed and Six Sigma

quality to improve services and transactions.

Pyzdek, Thomas & Keller, Paul. (2014). The six sigma handbook.