A CAI E-Publication:

OPERATIONAL READINESSTHE PRECURSOR TO OPERATIONAL EXCELLENCEPart I: An introduction in a Series of Papers on
Operational Excellence in the Life Sciences
By Richard Tree

Table of ContentsIntroduction

3

Why Focus on Readiness?

4

Systems Thinking For Problem Prevention

6

Operational Readiness And User Friendly Plants

7

Formal Operational Readiness And Assessment Program

8Conclusion

9INTRODUCTION
Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full ofchallenges. The goal is to startup as soon as possible once the project is completed but also to achieve steadystate throughput as quickly as possible after the startup begins. This type of startup is what is called a “VerticalStartup.” In practice, vertical startups are rare because management teams typically focus their attention
on having the facility and the equipment qualified in time to meet the process qualification milestone. The
consequences of this thinking is that a broad range of workstreams are often neglected or receive inadequate
attention although they are critical to startup. Workstreams like staffing, training, procedure development,
supply chain, analytical methods, etc. must all be ‘ready to go’ by this important milestone. The result canbe like having perfectly tuned race cars lined up on the starting line of a Formula 1 race, but with untrained
drivers, little gas, unpracticed pit crews, and no spare parts.
Vertical Startups do not happen by accident. The first step requires management teams to transition their focus
from a process qualification milestone to an Operational Readiness milestone. Once this happens, operations
departments can achieve a Vertical Startup by applying the principles of Operational Readiness, a provenmethodology used across the spectrum of manufacturing industries. Not only is it ia proven methodology, it
is central to the practice of technology transfer. Despite its importance, Operational Readiness is often not
fully understood, not correctly applied, or is confused with the principles of Operational Excellence.
The primary objective of this article is to inform the reader (particularly those who are a part of managementteams) about Vertical Startups and how Operational Readiness is the organizational state that needs tobe reached in order for vertical startups to exist. The secondary objective is to help the reader build anunderstanding of Operational Excellence in addition to Operational Readiness. The series will also highlightthe need to: (1) design systems which are comprised of production-friendly equipment that is easy and safe
to maintain and operate; (2) implement organizational systems to allow for the swift and smooth startup ofnew equipment recognizing safety, product quality, and cost; and (3) decrease the Life Cycle Cost (LCC) ofequipment and facilities.

Operational Readiness – The Precursor to Operational Excellence 2021

3

WHY A FOCUS ON READINESS?
Getting off to a good start is the essence of Operational Readiness (OR). OR is a management approach
widely used in the chemical production and energy sectors which has direct applicability to drug makers.
These industries use formal Operational Readiness and Assessment (OR&A) programs as a risk management
paradigm to guide management practices for performing pre-startup reviews of (1) new processes regardlessof scale, from big plants to small plant startups, (2) processes that have been shut down for modification,and (3) processes that have been administratively shut down for other reasons. However, being “ready”
needs to go beyond just performing pre-startup reviews – particularly for the life sciences industry. It needs
to include an analysis of the product input and output variances and the control strategy deployed – not tomention evaluating the actual startup afterwards, which is one of the best performance indicators of OR.
For all engineering project startups, anything less than getting up to speed swiftly and smoothly should beconsidered a lack of preparedness. Considering these points and the definition used in other industries, wedefine OR as:
Operational Readiness is the state of preparedness attained by anorganization when they can safely and efficiently startup, achieve design
throughput within the design timeframe, and operate that process incontrol , in a sustainable and environmentally friendly manner.
Whereas the idea of Operational Excellence is broader by nature and involves a focus on the value stream:
Operational Excellence is when each employee is commited
to mastering their role, can see the flow of value to the customer,
and works to continuously improve that flow.
This definition of Operational Excellence is insightful when considering the concept of the Pharma 4.0™
“holistic control strategy,” which is enabled by digitization and targets all stakeholders along the value chain.
“All the necessary data are managed in real time, fully transparent, and available for sound real-time decisionmaking, improving quality, manufacturing process efficiency, and accuracy. In sum, the holistic control strategy
ties regulators, industry members, and patients together in an overall holistic value network structure driven
Operational Readiness – The Precursor to Operational Excellence 2021

4Maximum Design Throughput

Operationally ReadyNot Operationally Ready{Planned Startup Date/Time

Released ProductMarket DemandTime

Design Startup TimeFigure 1 - Startup Profiles for Two Different Companies

by the Pharma 4.0™ operating model.” Given the different domains of both definitions, it is easy to see why
it is necessary to separate the terms from one another.
To become operationally ready, leaders must begin working toward that objective early in the project – ideallyat the beginning stages of the project during the preliminary design review (but no later than the Design
Qualification). This early involvement may surprise most operations managers, but this effort is essential.
The traditional approach at these design review stages is to evaluate design concepts for feasibility, technicaladequacy, risks, and general compliance to requirements. However, with the ever more complicated equipment
being introduced to the market, along with the complex processes being designed, organizations need tostart evaluating how friendly the equipment and processes are to operate and maintain, and procuring resilient
equipment which eliminates unplanned downtime. Traditionally, these earliest design activities frequently
overlook the operators and maintainers, which becomes evident during plant startup. Instead, the inputs
received to the design in the early stages come from scientists who usually don’t have production-scale
manufacturing experience. This is a typical miss and projects lose the opportunity to have people experienced
in manufacturing provide early input into the process design. Consider the following tale of two startups intwo different imaginary companies:
In Figure 1 above, the blue graph represents a company who has invested the time and energy early in thedesign and prepares its operators and supervisors to startup and operate the equipment. Their startup is ontime and it is “vertical.” One could conclude that this company is “Operationally Ready” and they achievedthat preparedness level prior to startup. Whereas, the orange graph represents an average company’s attempt
at readiness. They have a “flat” startup, which is costly to patients and investors, and exhausting to their staff.
Demand goes unmet or competitors launch competing products. Startup costs rise. And despite their best
efforts to reach capacity, their startup period grows longer by the day. Everyone’s been there, but it doesn’t
have to be that way. There are three main areas for consideration by leaders that could ease the challengeof any startup regardless of the end purpose. These are: (1) problem prevention, (2) production friendly
equipment and systems, and (3) an organizational approach that formalizes operational readininess into an
human organizational assessment system.

Operational Readiness – The Precursor to Operational Excellence 2021

5

SYSTEMS THINKING FOR
PROBLEM PREVENTIONFirst, the industry must change when problem identification occurs. Evidence shows that the earlierproblems are identified in any engineering project , the better the project performs both in the short term
and throughout the entire life cycle of the project. In most engineering projects, designers, project teams,
and customers still more or less react and address problems when they arise during the post-construction
testing and startup stage as they rush to project completion. Instead, entering the project with a prevention
mindset will tend to drive problem identification early “on paper.” This is not an easy activity since there isno physical equipment to look and the best you often have is preliminary drawings. This approach succeeds
when using multi-functional teams guided by a rigorous process that requires a “systems thinking” mindset
before construction begins. “Systems thinking” can mean different things to different people but for thispaper it simply means that one should always think in terms of the whole system rather than the parts of thesystem. As an extreme example, thinking strictly about building a greenfield facility without thinking about
getting ready to operate the new facility could reasonably result in a project that delivers ahead of scheduleand under budget but without anyone who is ready to turn it on. Or more commonly, not thinking about howeasy or difficult the plant is to operate when the design is on paper (and changes are less costly to make) andwaiting on a “debugging” period to identify problems before, during, and after plant startup does not follow
a “systems thinking” mindset.
Refer to Figure 2. In this figure, the number of problems identified are now included as a bar graph depicting
a simple count of problems versus time. When comparing the timing to the startup, operationally readycompanies eliminate problems through redesign, procedure development, and training prior to startup. Thenet effect is improved operability and maintainability.

Operational Readiness – The Precursor to Operational Excellence 2021

6

Whereas in Figure 3, problems with maintainability,operability, safety, and supportability are identified
during testing and after startup. This delays the facility
achieving full-scale operational output. Moreover,overall life cycle costs increase as design changes
become cost-prohibitive or are intentionally delayed.

Secondary Axis – Number of Problems Identified (Bars)

Maximum Design Throughput

Primary Axis – Released Batches

Planned Startup Date/Time

Market Demand

The inevitable time pressures from this company’s
poor startup will lead to “heroic,” uniquely designed
fixes that are unsustainable operationally or
financially, creating further waves of problems tosolve long after startup.

{OPERATIONALREADINESS AND USERFRIENDLY PLANTS

Time

Design Startup TimeFigure 2:
Operationally Ready Company Problem Identification Timeline

Second, designers must begin adding a new function
to the design team, someone skilled in the ways ofoperability – similar to the function of a user interface
designer on a software engineering team – to maintain“production friendly” status throughout the project.
Human-machine interface best practices can be used
to greatly improve equipment operability. A properly
designed interface solution not only enhances
productivity of the operator, but also provides systeminsight to control and maintain the machine.

Secondary Axis – Number of Problems Identified (Bars)

Maximum Design Throughput{Much of the pioneering done in this area reliedon carefully documenting lessons learned andconstructing varying levels of mockups in advanceof building the final product. Lessons learned
would have the greatest impact when designs wererepeated in “a cookie cutter” approach which is notas prevalent today. Similarly, mocking up designs
were used when the technology tended to be morestatic and were not expected to undergo substantialchanges throught the life cycle of the equipment.

Planned Startup Date/Time

Primary Axis – Released ProductMarket DemandTime

Design Startup Time

Figure 3:
Not Operationally Ready Company Problem Identification Timeline

The fast pace of change in the industry precludes muchof this from being as effective as it was in the past.
Nevertheless, the end goal of a vertical startup must
incorporate human-machine interface development
in order to improve plant operability, maintainability,and throughput. User friendly equipment makes
the condition of being operationally ready that mucheasier to achieve.

Operational Readiness – The Precursor to Operational Excellence 2021

7

Operational
Readiness

AND

PeopleProcedures

Equipment

AND

Operators

Maintainers

AND

Supervisors

Operability

Maintainability

Accessibility
and Safety

Reliability

Figure 4 - Logic Diagram for Operational Readiness

FORMAL OPERATIONAL READINESSAND ASSESSMENT PROGRAM
Lastly, companies should develop and implement an OR&A program that anticipates problems andeither eliminates them or puts management systems in place to mitigate them. OR&A programs havehistorically recognized that an operational system is comprised of multiple elements: (1) People, (2)Procedures, and (3) Equipment. Consequently, an organization’s preparedness efforts need to addressthese three areas individually as well as in an integrated fashion. Logic trees are frequently used for thiseffort as a visual diagnosis that lays out a problem and all its possible solutions, allowing you to choosethe best course of action.
Figure 4 - Logic Diagram for Operational Readiness
Figure 4 lays out the three key elements to achieving Operational Readiness through an “AND” relationship,
which means all three are required. These three elements provide only half of the analytical picture, however.
Consideration must be given to the interfaces among these elements.
• Do the people match the equipment? Is the equipment properly operable for the people who havebeen selected and trained to operate it; e.g., have we selected people with proper color discrimination
to deal with color-coded equipment elements?
• Do the procedures match the equipment? E.g., have we avoided situations in which the operators havebeen given Version 1 procedures manuals to operate Version 2 equipment?
• Do the procedures match the people who are to use them? Do we have selection procedures whichassure a proper degree of functional literacy for people who must read and understand complex work
procedures; e.g. have we written procedures that focus a person’s attention on the step-by-step task
amid the distracting surroundings?
Operational Readiness – The Precursor to Operational Excellence 20218CONCLUSION
The confusion that surrounds Operational Readiness is understandable. The ideal behaviors needed on
the Operational Excellence journey are the same behaviors needed to achieve Operational Readiness.
Accepting that both have different contexts is critical to eliminating the mix-up. Operational Readiness
requires a mindset of problem identification, anticipation, and elimination in advance of starting up.
Operational Excellence is an obsessive focus on the value chain throughout the life of the product, whichstill requires the same identification, anticipation, and elimination of problems in addition to the otherbehaviors that drive continuous improvement.
Generally speaking, when it comes to OR&A programs companies have two choices: They may invest
time and money to perform the extra early work to prepare as in the case of our imaginary company withthe vertical startup, or they may accept the uncertainties and/or lack of system control that may result by
waiting until the last minute. The evidence clearly favors the former (compare Toyota and GM’s approachand performance in the 1970’s and 1980’s); therefore, all parties involved in engineering projects and thesubsequent startup need to be clear that the objective is to achieve Operational Readiness, as opposed tomerely completing the project.

Operational Readiness – The Precursor to Operational Excellence 2021

9Rich Tree
Chief Operating Officer
Rich is an operations leader with 35 years of experience leading
teams to achieve organizational excellence in supply chain, asset
management, reliability, and human performance. A lean operation
expert, he is credited with the lean transformation of 9 manufacturing
sites, mentoring over 34 manufacturing sites in advanced lean
operations, and designing and implementing asset managementstrategies at 15 manufacturing sites.
Rich’s operations leadership journey began with a 22-year career in theUS Navy and then continued in several key operations leadership rolesin three manufacturing companies prior to starting with CAI.
He is currently working toward a PhD in Operations Management at
the University of Texas Arlington where his research has focused on
Behavioral Operations and Statistics. He holds an MBA from Southern
Methodist University.
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