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This article
presents Understanding Operational Waste
different types
of operational from a Lean Biopharmaceutical
wastes (non-
value adding Perspective
activities),
provides
examples by Richard Benson and Niranjan S. Kulkarni
of wastes
common to
pharmaceutical
and biotech
manufacturing,
and lists Introduction
C
The most effective way to reduce costs while
commonly used ompanies of all sizes are vying to in- keeping up with the competition is to become
techniques to crease their market share and profit- Lean by reducing, and preferably eliminating,
analyze and ability in a world of shrinking margins, waste (also referred to as muda Japanese term
patent expirations, and R&D pipelines for waste). Womack and Jones1 define waste as
reduce waste. any activity that does not create value as defined
that are dwindling. Factors such as increased
regulatory requirements and outsourcing by the ultimate customer. They state that even
increase the need to provide quality products a casual evaluation/observation of a process will
at reduced cost. The problem may be further reveal wasteful activities and processes. In the
exacerbated by facility or equipment capacity world of Lean, every activity is differentiated
constraints and limited available capital. Many as either a Value Adding (VA) or Non-Value
pharmaceutical companies are now realizing Adding (NVA) activity. However, it should be
that they can leverage cost saving techniques noted that even some perceived NVA activities
and models used by the automotive, electronics, may be necessary to comply with certain stan-
and semiconductor industries. These industries dards and/or regulatory requirements. Such
pioneered Lean techniques and Six Sigma activities are termed as Essential Non-Value
methodologies, having used them extensively Adding (ENVA) activities. Figure 1 illustrates
to eliminate waste and variability within their the different categories of activities.
processes. Pharmaceutical companies are Pharmaceutical and biotech companies need
now adopting these methods to drive toward to comply with current Good Manufacturing
improved quality at reduced Cost of Goods Practices (cGMPs), GLPs, and GEPs as docu-
Sold (COGS). mented in CFR, Eudralex, and other Rules,
Regulations and consensus
Figure 1. Categorization
guidance documents established
of activities. by the jurisdictional governing
bodies, such as the FDA, EMA,
WHO, CDSCO, etc. A level of
quality that mitigates risk of
potential harm to the patient
is required. Consistent and
validated processing is main-
tained and constantly verified
by applying regulations and by
documenting activities critical
to product quality. Companies
invest heavily in Quality Teams
and Systems in order to comply
with these requirements. Activi-
ties such as internal quality au-
in batch records. Todays technology allows for much of this shortages and delays. This increases raw material inventories
data logging to be performed automatically with any real that occupy valuable real estate in the warehouse. As men-
time deviation or OOS event to be identified immediately, tioned earlier, a lean operation will only carry the inventory
alarming the manufacturer and preventing subsequent necessary to ensure the customer is satisfied and demand is
manufacture of OOS product. The traditional development met.
and maintenance of batch records can be very inefficient when Improper planning and scheduling also contribute to de-
non-critical information is recorded and further confirmed lays. Variability in upstream processes will impact processes
by secondary signatures. Time lost by operators, approvers, downstream. Delays in the upstream process significantly
and/or managers on NVA activities, such as documenting increase waiting time in the downstream process. Unavail-
unnecessary data or duplicating data, further increases the ability of equipment (processing or transport) also can add
product COGs. Increased documentation or human involve- to the waiting time, e.g., unavailability of clean or sterile
ment also increases the chance of making an error. Sometimes equipment, assemblies, and kits required for processing, etc.
approvals cannot be avoided, but the fewer that are required, increase waiting time. Equipment idle time adds no value
the lower are the costs and risks. Electronic Batch Records in a lean operation. Bioprocessing equipment has extremely
(EBR) can help overcome some of the problems associated with high capital value. Not maximizing its utilization can result
manual batch records. However, EBRs should be designed to in higher product COGs.
capture the key artifacts and avoid any unnecessary inputs Whenever an operator or machine is idle, the company is
or information. losing money and other valuable resources. Companies must
Over-processing not only increases the overall cycle time, pay for labor even if an operator was idle (for reasons beyond
but also affects inventory levels. Many times companies his/her control) during the shift. In these cases, operators
over-process as a precautionary measure. Examples of over- can be reassigned to other tasks. However, if the operators
processing include using intensive CIP, SIP, or cleaning are not trained in these tasks, such reassignments may not
regimen when lower grade cleaning/rinse may be adequate, be reasonable and add little value to the overall operator
repeating test sequences in commissioning and qualification, utilization.
performing pre-validation activities that are non value
added, processing closed unit operations in highly classified Transportation and Motion
cleanroom environments, requiring protocol/record approval Excessive movement of raw materials, personnel, or paper-
signatures of personnel or departments that cannot add work can be considered NVA activities. Transportation may
value or are not Subject Matter Experts (SMEs), etc. While seem like an essential activity, but a process where every unit
these activities may be necessary to some extent, they are operation is physically located adjacent to its upstream and
all examples of over-processing and result in loss of material, downstream operations does not require transportation. This
manpower, or money in one way or another. is often not achievable in biopharm facilities where aseptic
processing and environmental cleanroom classifications
Waiting may require segregation of unit operations and therefore
Waiting is time wasted waiting to proceed with value added transfer stations and transporters. However, much of the
activities. Delays can result from a number of factors. Waiting cost associated with transportation and transfer waste can be
for release of material or unavailability of QA/QC personnel attributed to inefficient processes and lack of understanding
for verifications/validations and clearances can be a large of environmental impact on the operation resulting in poor
contributor to increased waiting. In one recent study (confi- facility layout design.
dential client) conducted by the authors, it was observed that Any type of transportation has cost associated with it. Some
time spent waiting for the QA personnel to begin inspection form of equipment is required, e.g., forklift, hand truck, etc.,
contributed up to 42 percent of the overall cycle time. This and these need to be purchased. These equipment items have
waiting time could have been easily eliminated by proper an initial capital cost, recurring maintenance cost, operator
scheduling of activities to ensure that the QA person is not costs, and other indirect costs, such as insurance, training,
required in more than one place at the same time. depreciation, cost to install traffic indicators (overhead traffic
Unavailability of raw materials is another contributor to signals), etc. Automated Guided Vehicles (AGVs) are viable
increased waiting time. This factor is greatly influenced by alternatives to manually operated equipment, but the cost
demand forecasts, reordering strategies, variability in the of purchasing, implementing, and validating an automated
supply chain, environmental factors, etc. A common strategy system may be too high for some companies. For other com-
is to order surpluses of raw materials to mitigate the risk of panies in search of reducing headcount and overhead while
maximizing the productivity of their work force, automation competition, thus eliminating the demand for the product
may be the solution. It should be noted that employing AGVs that has already been made. In such instances, overproduc-
or automation is justified when tasks are similar in nature, tion can lead to significant losses.
repetitive, and have higher frequency. The practice of overproduction leads to many other forms
Significant transportation waste can be seen if portable of waste, including excess transportation and inventory.
equipment and tanks are repeatedly moved around a facil- Part of the sale price of a product is the cost of distributing
ity. When a buffer hold bag is transported from a solution and holding of finished goods inventory, but if the product
prep area to a chromatography suite, the bag holder and cannot actually be sold, these become sunk costs which hurt
operator must pass through air locks. The operator must profitability. If the product must be disposed of, there is the
adorn additional gowning and spend time wiping down the actual cost of disposal to go along with the loss of the sale.
bag holder. Then, once the buffer is consumed, the operator On a smaller scale, any built up WIP is a result of over-
must reverse the process, and spend time de-gowning. production from an upstream processing unit. The same
Layouts should be designed such that sequential process risks and costs apply on the process level as they do at an
steps are adjacent to each other; and material and personnel enterprise wide level. As mentioned earlier, in a truly Lean
movement is minimized. Techniques like spaghetti maps or process, there would be one-piece flow with no intermediate
discrete event simulations can be used to analyze the dis- inventory and the upstream operation would only produce
tance traveled by operators in varying layout configurations. enough to keep the downstream operation satisfied. This is
Such analysis is especially useful to analyze multi-product known as the next operation as customer concept by Dr.
facilities or when the operating philosophies are still being Kaoru Ishikawa3 where each downstream operation becomes
defined. the customer of the upstream operation.
Considerable waste, in terms of time, money, and resources, Demand forecasting and planning are very critical and
also can be seen in supply chains. If a distribution center is need to be as accurate as possible in order to reduce over-
not optimally located, the overall COGs is higher. Similarly, production. Furthermore, determining appropriate service
trucks sent to/from the warehouse without a full load also levels based on customer needs can prove to be valuable
contribute to transportation wastes as the same amount of information to address the issue of over-production. It is
time and resources are being consumed regardless of the ideal to create a pull environment wherever applicable and
load. feasible. Kanbans can be used to indicate when a downstream
Motion itself refers to the amount of movement an operator operation is ready to receive the next batch. In such instances,
performs. Ideally, an operator could stand still and parts would the process will commence only after receiving a customer
arrive in order to achieve maximum productivity - again this order.
is not always feasible. Every second an operator has to spend
gowning, searching for a flex hose, or even sifting through Under-Utilized Talent
computer files represents unproductive time and motion that Improper utilization of talent and creativity loss is another
is not spent adding value to the product. This waste can be form of waste that companies should pay close attention to.
combated by standardizing procedures, ensuring prepared- Examples of this type of waste include selecting an overquali-
ness, efficient layouts, and organized work spaces, such as fied person to perform a menial task or paying for employee
those seen when using the 5S5 concept, a Lean housekeeping training and then not using his/her skills set.
technique. When planning any modifications to a process, one should
always include people who are most familiar with the nu-
Overproduction ances of a specific process. Managers should take inputs and
Making more than is necessary is a very common practice suggestions from the people who operate the equipment or
among biopharm companies. While it may seem logical to they run the risk of missing out on very valuable knowledge
keep the shelves stocked and customers instantly gratified, that comes from working everyday in a specific area/process.
there are some serious risks and costs involved in making This not only gives operators pride in their work, but also
more than necessary, such as product expiration, possible ensures that talent and ideas are not lost.
contamination from outside sources, deteriorating product The costs can sometimes be difficult to quantify, but the
quality, etc. Some of these outcomes could have major con- benefits can be prodigious. Assessing talent is not an easy
sequences to the patient and possibly the corporate image. task, but there are multiple ways a company can maximize
Furthermore, there is also a risk that the product demand the talent they already have and ultimately make more with
could change or a newer/better product is launched by the less. Cross training can help lower overhead (salary, insurance,
gowning, and pension/401k) and maximize productivity. often employed to study what-if scenarios and to optimize
a process or facility. Numerous commercial simulation soft-
Characteristics of Waste ware are now available, including Flexsim, ProModel, Arena,
Though wastes differ by products, processes, facilities, etc., etc.
there are some common traits that are observed: Workplace organization using visual techniques also are
recommended to reduce waste. Markings, colors, and other
Waste, irrespective of type, negatively impacts productiv- visual controls can be used to eliminate excess motion or
ity, flexibility, and profitability. inventory. Techniques such as 5S, visual production control,
Waste will not be always visible. Obvious waste is easy e.g, Kanban, and visual information and performance mea-
to reduce/eliminate. However, it is the unseen waste that surement techniques should be employed. Replacing manual
poses the real threat. This type of waste needs to be identi- operations with automated operations, wherever feasible,
fied and eliminated. will reduce the errors caused by human intervention.
Waste can be concealed even in the (so-called) value added Standardizing equipment, practice, and procedures can
activities. significantly reduce wastes. In many instances, standard-
Wastes are not always independent of each other. One ization improves overall flexibility. Statistical and quality
type of waste can lead to another, e.g., overproduction techniques, such as Design of Experiments (DOE), control
could increase chances of defects, increase inventory, charts, sampling plans, etc., can be effectively used to reduce
transportation, etc. waste in a process and even within supply chains.
Some NVA activities are mis-categorized as ENVA activi-
ties. Some are due to legacy practices no longer applicable Conclusions
with the use of new technologies and better process As pressure to cut costs continues to grow, companies need
understanding. Proper identification of Critical Quality to reflect on their current practices and identify any possible
Attributes will lead to a lean Quality Program based on sources of waste. Lean and Six Sigma methodologies can be
risk to patient. used to help identify non value adding activities and elimi-
nate the causes of waste, along with variability in supply,
Tools and Techniques Used in Waste demand, or processing.
Reduction Efforts Overcoming the initial hurdle of admitting a process is
Using the right tools and techniques can help identify, and not perfect can be the hardest part. There is a perceived
subsequently reduce (or eliminate), waste from the process. high cost to re-validate a process. Many times, the benefits
Selection of an appropriate tool/technique is dependent on gained from process improvements can overcome the cost of
the problem at hand. Numerous tools and techniques can re-validation within the first year. The savings can be realized
be employed for the aforementioned purpose. However, we as increased capacity or reduced inventory in a warehouse.
will restrict the discussion to some of the popular techniques The benefits are not limited to cost savings, but may include
used for waste reduction. quality improvements and increased flexibility.
A common and most popular lean technique to identify When one takes a step back and looks at the process from
waste is Value Stream Mapping (VSM). A value stream map a different perspective, many forms of waste and unneces-
is more than a flow chart. Using unique symbols, it shows sary costs can be seen. A company striving for manufactur-
both information and material flow, while capturing VA and ing excellence must identify their customer and determine
NVA activities and their respective durations. This tool is what is absolutely necessary to manufacture the product the
used not only to depict current process, but also can be used end users desire. Once this is done and the waste has been
to create a vision of future state processes. However, VSM removed, a company can start to see the true variation built
does not capture the impact of variability on a process. Also, into their process and begin to control it using Six Sigma
it cannot be used to understand the dynamic interactions methods. Only then can a process be truly Lean and profits
that occur within the process. can be maximized.
Modeling and simulation can be used to address such
shortcomings. Discrete Event Simulations (DES) are very References
effective in handling variability and interactions. The ability 1. Womack, J. P., and Jones, D. T., Lean Thinking: Banish
to model random (stochastic) events, e.g., equipment failures, Waste and Create Wealth in your Organization, First Free
unavailability of resources, unexpected changes in demand, Press Edition, New York, NY, 2003.
etc., allows DES to mimic the real world operations. DES are
Acknowledgements
The authors would like to thank Marc Pelletier, PhD; Philip
Lyman, PhD; Cory Siddons; and Howard Sneider of CRB
Consulting Engineers for their valuable inputs. Additionally,
the authors thank the Pharmaceutical Engineerings Edito-
rial Review Board for their recommendations.