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1. Reliability Engineering
in Biomanufacturing
Michael K. Andrews
Senior Reliability Engineer
Bristol-Myers Squibb
Manufacturing, Clinical, R&D

2. Overview
• Definition
• Purpose
• Emergence of Reliability Engineering
• The need
• Skills
Where does it all go wrong?
• Challenges
• Obstacles
• Impacting Factors
• Industry Data Reality
• Reliability in Design Phase
Applying Reliability Principles
• Applying Reliability Principles
• Tools and Methods: RAM, FMEA, RCA
Agenda:

3. Defining Reliability
“System or component to function as intended, under stated
conditions, for a specified period of time”
• We expect our car to start every
morning
• We expect the plane to arrive
safely
• We expect food to be on shelves
in grocery store
• We expect clean drinkable
water from the faucet

4. To identify, manage and mitigate asset/process
risks that could adversely affect plant or
business operations
Purpose of Reliability Engineering
Main focus areas:
• Risk Management
• Loss Elimination
• Life Cycle Asset Management (LCAM)

5. Emergence of Reliability Engineering
1940-1950
- Fix it when it breaks 1960-1970
- Higher plant availability
- Longer Equipment Life
- Lower Costs
1980-2000
- Higher plant availability and
reliability
- Greater Safety
- Better product quality
- No environmental impact
- Longer equipment life
- Greater cost effectiveness
Prior to WWI industry
was not highly
mechanized, high
availability of manpower.
Manufacturing of
equipment was simple
and lower skills needed to
maintain.
WWII manpower became
limited. Manufacturing
became more
mechanized and complex.
Dawn of preventative
maintenance and soring
maintenance cost and
expensive capital
machines.
Highly mechatronic systems
(computerized integrated with
mechanical) and extremely complex
system interdependencies. Niche skills
develop and a loss of overall cohesion
and mission focus deteriorate.

6. • Manufacturing costs continue to rise. Managing Risk is essential
to controlling costs.
• Expanding Regulations (environmental, health, safety and
quality) impact cost. Preventing/reducing incidents are critical to
avoid fines and branding damage.
• Reliability has evolved beyond a maintenance function. It is
essential to have it tied to the business strategy which will affect
Total Cost of Ownership.
• Shortage of Reliability Engineers who require knowledge of
multiple engineering disciplines (Mechanical, Process, IT,
Automation and Business)
• Overall shortage of engineers and technical trade skills
The Need

7. • Develop a reliability and maintainability (R&M) plan and goals, evaluate field data for R&M improvement
• Data analysis, trending and other data mining to find solutions to chronic problems
• Manage asset risk as related to health, safety and environment (HES), production, quality, regulatory compliance and cost.
• Be an integral part of the design, installation and buy off of assets - for new assets and major changes to assets. This is
important because over 90 percent of the lifecycle cost is decided early in a project.
• Take systems-thinking approach (machinery, equipment, controls, processes, utilities, safety, environmental, people and
more) to ensure reliability
• Monitor production and maintenance losses to improve throughput and reduce cost (MTTR, MTBF and Availability)
• Conduct failure mode and effects analysis (FMEA)
• Perform maintainability prediction calculation and demonstration
• Develop and implement R&M specifications for purchasing, apply to meet R&M design requirements.
• Perform reliability modeling to make trade-off decisions (what to implement)
• Use R&M analysis tools to identify low reliability and high level of maintenance components/tasks to enable redesign of
selecting other approaches.
• Uses historical maintenance data, production data, safety data and other sources to deliver a comprehensive strategy for
improvements.
• Protects people from unexpected outcomes.
• Evaluates a situation and knows whether or not to use maintenance predictive technologies, condition based monitoring,
time based intervention, or run to failure.
Skills Source ReliabilityWeb.com

8. Many companies struggle and unfortunately fail at
implementing effective Reliability strategies due to:
Challenges in Applying Reliability Principles
1) Lack of Culture, Vision, connecting Business Plan
2) Dedicating resources needed
3) “Short Term” memory
4) Inability to let go of myths

9. • Culture, Vision, Plan – Reliability is holistic approach requiring “buy-in”
from all departments. “Reliability” is everyone's job. Leaders must
understand – believe – reinforce! This must be tied to Business Strategy.
• Resources – Silo mentality of companies – departments become mini cost
centers unwilling to dedicate resources. Cross functionality input is
required to be successful.
• “Short Term” memory – Management inability to stick with long term
strategies due to fiscal year blinders and only focus on “cost cutting”. This
is a fundamental lack of understanding the Impacting Factors.
• Inability to let go of myths – Companies tend to resist change. This is
coupled with a risk adversity mainly because they don’t truly understand
their risk position and how it impacts Total Cost of Ownership.
Biomanufacturing tends to be PM heavy and Quality departments can be
overly conservative making it a greater challenge.
Obstacles to overcome!

10. • Loss of market share
• Unit cost too high
• Maintenance cost too high
• Chronic product quality issues
• Excessive downtime
• Variability in processes and
practices
• Inadequate budgets
• Not enough people
• Undependable suppliers
Impacting Factors
A comprehensive
Reliability Program
aims to address these
factors

11. Impacting Factors • Cost Avoidance
– Elimination of unnecessary
costs, such as overtime, contract
labor, etc.
– Elimination of losses and waste,
such as scrap, excess energy
usage, etc.
• Increased Revenue
– Improved Asset Utilization (AU)
or OEE
– Elimination of unnecessary
planned and
unplanned downtime

12. “A” Companies that
implore some Reliability
Principles effectively
manage Unit Cost.
“B” Companies struggle
and can be close to failing
- it may only take certain
market conditions to drive
them under if they don’t
change.
“C” Companies have
passed the inflection point
and exceeded the ability
for turnaround and are on
path to going out of
business.
Data reality: Business Extinction
Source LifeCycle Engineering

13. Data reality: Causes of un-reliability
Companies still to
hold on to the myth
and focus on
“costs” due to
maintenance. Belief
that equipment
breakdowns are
due to this. They
focus on cost
managing this area
largely ignoring the
other 83% causes.
Source LifeCycle Engineering

14. Data reality: Causes of lack of production
Utilization
Companies also hold
on to the myth belief
that lack of
production utilization
is due to poor
maintenance, largely
ignoring the other
93% of contributing
factors.
Source LifeCycle Engineering

15. 80% Design Decisions Impact Total Life Cycle Cost. Proper Design for Reliability
applied in first design phase can account for 40% reduction in Capital Cost
Unreliable Design: Capital Cost
Souce: © 2011 WERF, Water Research Foundation, GWRC, GHD Consulting Inc.

16. 95% of Life
Cycle Cost is
determined
before the
equipment first
turns on
Unreliable Design: Life Cycle Cost
95%
Source: Engineering Economic Analysis

17. Changes to fix
design issues
later become
difficult and
very
expensive!
Reliable Design: Changing after fact
Source: Engineering Economic Analysis

18. Applying Reliability Process
RAM Modeling
User
Requirements
Engineering
Design Specs
Pre-Design
Final Design
Operation
Criticality
Assignment /
Maintenance
Strategy
Maintenance
Implement
Maintenance
Strategy / Design
Change
KPI’s & Metrics
Periodic Alignment
Business Strategy
Failure Trending
Failure Event
RCA
Change
Maintenance
Strategy / Re-
Design?
Build/Install
Commissioning
& Validation
YES

19. RAM (Reliability, Availability and Maintainability)
RAM modeling is
paramount in plant
and process design.
When done in the
design stage Total Cost
of Ownership can be
understood.
This is done by
modeling process flow
and throughput,
availability, critical
failure points,
maintenance strategy
and costs.
Source: SoHar, inc

20. FMEA (Failure Modes and Effect Analysis)
Source: Megha Thakkar, NDDS, Cipla, LTD
Risk Priority Number = Severity x Occurrence x Detectability
The FMEA starts with defining the
Risk Matrix which serves as the
criteria for assessing the Functional
Failures
A RPN (Risk Priority Number) is
calculated by taking into account
the three variables: Severity,
Detectability and Likelihood of
Occurrence

21. FMEA
Source: Mark A. Morris, ASQ Automotive Division

22. FMEA Example
Source: Mark A. Morris, ASQ Automotive Division

23. Root Causes
Analysis
Method /
Tool?
Defines
Problem?
Defines all
known Causes?
Provides a
Casual Path to
Root Causes?
Delineates
Evidence?
Explains How
Solutions
Prevent
Recurrence?
Score
Apollo Method Method Y Y Y Y Y 6
Fault Tree Method Y Y Y N Y 4
FMEA Tool Y N Limited N Limited 2
5 Why’s Method Y N Y N N 2
Events & Casual
Factors
Method Y Limited N N N 1.5
Pareto Tool Y N N N N 1
Tree Diagrams Method Y N N N N 1
Barrier Analysis Tool Y N N N N 1
Source: Reality Charting, Dean L. Gano
Comparison of Root Causes Analysis Tools & Methods

24. RCA Apollo Method Example

25. Questions?