Lean Lab
Lean Lab
Easy Implementation
of the Lean Lab
Approach
Dear Reader,
Efficiency is increasingly important in the laboratory, as labs are obliged to generate results quickly, compli-
antly, and cost-effectively, often with limited resources.
Lean Management and Lean Lab imply optimized efficiency, concomitant with the minimization of a ny
activities that do not add value: namely, of the 8 different types of waste that result in unplanned laboratory
“DOWNTIME”:
Defects
Overproduction
Waiting time
Non-engagement of all employees
Transportation
Inventory
Motion / distances
Extra processing
This guide describes each of the 8 wastes and its negative impact on a laboratory. Real examples of labora-
tory equipment such as balances, titrators, and pH meters provide you with concrete suggestions as to how
to identify and eliminate typical inefficiencies, and make it easy to convert theory into practice. For each type
of waste, the guide suggests the most suitable instruments, accessories, and services, highlighting how they
can support you in increasing efficiency.
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Table of Contents
4 Conclusions 30
4.1 Lean: A matter of budget? 30
4.2 Lean Lab in small steps 30
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Lean Lab
The Lean approach is applicable in the laboratory as well as in manufacturing, and holds the potential to
benefit both productivity and profitability.
The Lean Lab assessment is primarily internal, involving process optimization that contributes to an organiza-
tion’s economic efficiency. Improvements to Lean operations can include device standardization, modularity,
streamlining of workflows, optimization of workplaces, compatible software / networks, and competent ser-
vices.
The goal is to speed up processes and build a culture of continuous improvement to sustain the business
benefits derived from the principles of Lean Lab outlined above. This work impacts everyone from customers
to analysts, and encourages lab personnel to draw on new and innovative ideas.
Transformations in mindset and behavior will sustain and augment the impact of Lean Lab. The good news is
that Lean Lab principles can be implemented incrementally, module by module, at any time.
Success is measured by the Magic Triangle, the three corners of which must be balanced for the sustained
implementation of Lean Lab.
Quality
Results
Q
Productivity Capacity
The
Magic
Triangle
Q: Quality
R: Resources
T: Time
R T
Costs Date
Expense Duration
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1 The Lean Lab Approach
The Lean Manufacturing approach aims to increase productivity and efficiency at manufacturing companies,
as well as to focus on customer requirements and gain competitive edge through low costs and high q uality.
It takes into account the entire scope of a business, including management culture and employee satisfaction.
On one hand, Lean Manufacturing tries to optimize utilization of resources, while on the other it strives to
avoid stretching resources too far (Japanese “Mura” and “Muri”). For this purpose, there are a number of dis-
tinctive standards and tools, such as the 5S movement, 7M and 3 Mu checklists, and the 7 (or more) types
of waste, that are involved in analysis and the process of improvement. Ultimately, even just-in-time (JIT) pro-
duction originated from Lean Manufacturing.
Measuring and monitoring the progress of actions that have been initiated through Lean Manufacturing pro-
cesses is an important component of sustainable implementation and success. For participants, it can be
motivating if their success can be tracked graphically in charts placed at conspicuous spots in production.
Measurement criteria must be specified accordingly: for example, the number of claims, sales trends, devel-
opment costs, absenteeism, accidents, etc.
Although it must be noted that there are major differences between the laboratory and production, it is still
possible to adapt several aspects of the Lean approach to the laboratory. The aim is to optimize effectiveness
and efficiency by minimizing all activities that do not add value. Throughput should be maximized and waste
reduced. In other words, Lean attempts to do more with less and encourage cost reduction despite demands
for improved quality or increasing throughput.
Lean objectives can only realistically be implemented by introducing rules through which processes are
streamlined, simplified, standardized, and clearly presented.
This is important, because in most cases, there is no or little budget available for Kaizen. Kaizen is typically
self-financed through savings derived from process improvements.
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改善
The Kaizen path runs through five steps that can be mapped as a circle,
in the spirit of continuous improvement. The five steps are often abbreviated
5S. They are:
4. Seiketsu 1. Seiri
standardize sort
5. Shitsuke
sustain
3. Seiso 2. Seiton
shine set in order
Seiri
Efficient systems are simple systems that permit one to find what is needed without effort. When unneces-
sary working materials are eliminated from the workstation, the materials remaining are understood to be
more important, or even critical. The removal of unimportant or redundant items reduces space requirements.
Distances become shorter, and cleaning becomes easier. Thus, the Kaizen process begins with the elimina-
tion of extra materials (devices, tools, utensils, chemicals, reagents…).
In many cases, employees may have become dependent on specific tools or other working materials even
though they are actually unnecessary. These objects can be stored until it is clear that they are no longer
needed. If required later, materials that have been disposed of can be retrieved or procured again.
Larger objects (furniture, devices, etc.) that have been recommended for disposal are provided with a special
label so that all employees have an opportunity either to discuss their requirements or stop the disposal.
This d irect communication of needs can help create comfort with the Seiri process and is especially suitable
for larger organizations.
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Seiton
With a reduced set of materials identified, the workstation is arranged so that every piece is easy to locate.
Analytical instruments, beakers, gloves, pipettes, tubes, network cables, chemicals, deionized water, and
more have their defined places. In principle, pieces are arranged in order of their use in the workflow, and
should be replaced after use to maintain Kaizen (see also Seiso). Thus, the same w orkflow efficiency is con-
sistently possible, and any missing items can be identified easily.
In production areas, the floor or workbench may be labeled to indicate a space reserved for a particular piece
of equipment. Increasingly, this procedure is used in labs as well to indicate the correct position of pieces on
the lab bench. Initially it might look funny or exaggerated. However, the resulting clear arrangement and order
is immediately visible, and the increased efficiency is measurable.
METTLER TOLEDO supports Seiton tasks with compact and ergonomically designed lab instruments focused
on workflow simplification. For example, with smart titrator design, everything required to carry out a titration
is available in the immediate surroundings of the instrument, including the:
• Titration stand and stirrer
• Burettes
• Rinse unit (manual or automatic)
• Solvent manager (pump system for solvent and waste)
Seiso
The order achieved by the previous steps “only” needs to be properly maintained. However, this requires
that individuals adjust their habits to Kaizen rules. Without convinced, motivated, and appropriately trained
employees, this cannot happen.
The new, simplified system arrangement allows the quick and unambiguous identification of problems.
Any issues that arise must be dealt with in due course in the spirit of continuous improvement (5S).
Seiketsu
The Seiketsu step sets standards. In this step, the new system should become the personal concern of each
of the employees involved so that improvements are sustainable.
Seiketsu aims at cleanliness or tidiness on both the environmental and the personal fronts, and empowers all
involved to maintain performance benchmarks.
Standardized processes, applied across the company, enable employees to adapt quickly to any workstation,
reducing training expenses significantly.
Shitsuke
Changes and improvements should be sustainable. Employees must make it a habit to properly maintain
correct procedures and to work according to the new status quo. This step is often difficult to achieve since it
asks for behavioral change and ongoing motivation.
Signs, posters, and periodic performance reviews are some of the support tools that help to ingrain 5S into
habits and culture.
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1.3 Avoiding waste
The 5S methodology forms a unique circle to continuously improve processes round by round (see Figure 2).
However, to bring the rather theoretical 5S methodology to life in practice, guidance for daily work has been
developed, including the avoidance of waste.
Lean Manufacturing classifies 8 types of waste to be avoided, easily remembered as DOWNTIME. Ultimately,
unplanned downtime is what must be avoided. (Planned downtime can be dealt with.)
Self-assessment
Chapter 2 includes the nine steps supporting the realization of your
Lean Lab. Each sub-chapter includes three to five questions to help you
assess your current lab situation. In Chapter 2.1, you will find an evalu-
ation and feedback on your answers.
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ousekeeping 2 The Nine Steps to Lean
2.1 Housekeeping − keep it simple
Are the workstations clean, tidy, and fit for purpose? Yes No
Analogously, in the lab area, this typically implies that method developers should take into account the
options, capabilities, and resources available at later analysis points. For example, for any methods per-
formed near the production line, the education level and training of shift workers should be considered. This
could include evaluating automation possibilities for analyses to limit operator intervention and produce
higher security and reproducibility.
For the last few years, METTLER TOLEDO has been keenly involved in reducing operational complexity and
has paid special attention to process simplification. Using a graphical user interface (GUI) with One Click™
allows an operator to start even complex processes with a single motion. Additionally, One Click has been
implemented across many different instruments, maximizing user opportunities to leverage these shortcuts
(see Figure 3).
Increasing standardization of interfaces, user management, data security, method setup, etc., simplifies the
learning process and instrument operation for a variety of analytical techniques, as shown in Figure 3 below.
These techniques are common in quality control labs around the world.
An additional level of process security and simplicity is added by METTLER TOLEDO LabX®. LabX is a unified
software platform designed to manage all METTLER TOLEDO laboratory instruments and the data they pro-
duce. The software guides users through full standard operating procedures (SOPs), simplifying and securing
processes. The centralized management of instruments, users, and data strongly supports Lean Lab by elimi-
nating the need for PCs and paper records, reducing training efforts, and more.
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Figure 3: A common interface across all key lab instruments assists the implementation of Lean processes: METTLER TOLEDO standard
and Karl Fischer titrators, density meters, refractometers, melting and dropping point instruments, pH meters, balances, and UV/VIS
spectrophotometers are conceptualized for similar operation.
Even small-scale solutions can yield important process benefits. These may include:
• A barcode reader to log sample IDs and automatically assign methods of analysis
• A fingerprint scanner such as the METTLER TOLEDO LogStraight™, which enhances security and eliminates
the need to save or enter passwords
• A sensor to automatically open balance draft-shield doors or to start measurements without the need to
touch the device (METTLER TOLEDO ErgoSens)
• Use of an active directory enabling single sign-on, etc.
With the integration of LabX software into a superordinate system (e.g. a LIMS or ERP), the transfer of meth-
ods and data is automated and kept safe from transmission errors. Using a common software platform to
integrate several lab instruments into the ERP or LIMS reduces complexity considerably. It also reduces costs
for validation, maintenance (e.g. during upgrades of the operating system), and first-time implementation.
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2.2 Value-stream mapping − minimize overproduction
2.2.1 Refuse
Refuse is a form of overproduction waste inherent to laboratories. Chemicals such as reagents, solvents, buffers,
etc., are expensive to procure and dispose of. Their waste must be minimized to reduce expenditure and create
added value in terms of operator and environmental safety as well as energy savings.
Taking sample size as an example, the optimal burette dosing range of 30% to 90% of the nominal volume
enhances precision while conserving materials. Even small amounts saved can accumulate into a huge vol-
ume over time. Standardized automatic cleaning, level indicators on supply containers, and advanced error /
malfunction notification during sample series can also help minimize solvent waste.
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To obtain these savings, METTLER TOLEDO provides effective tools such as:
• Pulsed cleaning functions of automatic sample changers (PowerShower™)
• Fill level sensors (LevelSens™)
• Electronic smartphone notifications
2.2.2 Over-testing
Measuring too many parameters, testing too many samples or retesting a sample too many times are aspects
of over-testing. Such “excessive checks” are considered waste and can be caused by:
• Laboratory supervisors being misled about technical capabilities and implementing routines that
in general are not necessary
• Operator mistrust of results, leading to repetition of tests
• Customer requests for excessive testing to be sure of the quality of delivered goods
Well-established SOPs, well-trained operators, and mutually agreed-upon test-scope sheets support a leaner
lab and prevent over-testing.
If over-testing becomes the norm, organizational and economic problems may arise. This drives up the cost
of goods and reduces efficiency.
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Production
Laboratory Laboratory
Production Pr
Untoward incidents can be systematically avoided, such as with continuous monitoring of reagent consump-
tion. Levels of titrant, solvent, waste, etc., can be automatically checked using level indicators (e.g. Lev-
elSens). Such indicators can generate an appropriate warning message and trigger a timely refill, change, or
procurement. In addition, Titration Excellence methods contain meters that indicate the consumption of speci-
fied chemicals through the accumulated dosed volume. If a certain amount of consumption is exceeded, a
warning message is triggered.
Equipment wait time can be reduced through automation. Automatic sample changers, combined parameter
measurements, and automatic data / result transfer can spare the lab technician from waiting in front of the
device until a result appears. See Chapters 2.4 and 3.1 for more information regarding automation in the lab.
Nevertheless, how does the lab technician know a batch is ready? How does he or she know when there is a
problem with a measurement series and intervention is required?
This problem can be solved with the help of appropriate software. Network-compatible LabX software allows
the tracking of measurements even from remote office workstations. With the help of a notification function,
LabX can send results or a warning message via e-mail or SMS. With proper installation, measurements can
even be tracked on your smartphone.
Software can also assist with the planning of analyses, more specifically through relevant task-scheduling
tools (task management). This implies that individual samples are distributed to and placed at the proper
instruments (titrator, density meter, refractometer, etc.) as per priorities and instrument availability.
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Once scheduling has occurred, assigned lab technicians carry out the analyses. Task scheduling, as deter-
mined by requirements, can substantially increase efficiency by grouping several analyses of a sample or
substance.
Are the distances between individual steps in the workflow short and sensible? Yes No
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2.4.1 Movement
Wasted “motion” implies the movements of individuals, by contrast with transportation waste, which focuses
on the movement of materials (see Chapter 2.4.2). Looking for data, information, or tools, or moving among
equipment such as laboratory instruments, printers, or copiers, are typical cases. These movements add no
value. Thus, they are waste [14].
Strategically considering office and lab layout helps to minimize wasted movements. However, the implemen-
tation of such measures is often difficult in practice due to limited lab space, building construction restric-
tions, installation requirements, and the like (see figure in Chapter 2.4).
Another approach to the topic is to look for the reasons behind the movements. As an example, striving for a
paperless lab eliminates the need to move to printers and file cabinets. Collecting all measurement data and
results from analytical instruments with LabX software and storing them centrally on a server allows immedi-
ate access to them via any PC on the network. This approach not only saves paper and movements but sim-
plifies the archiving process, and perhaps reduces other wastes.
Setting up appropriate workstations in suitable and dedicated laboratory locations is another solution. Only
instruments, tools, and materials required for tasks at a particular workstation should be accommodated in
the immediate surroundings. This restriction helps operators to find necessary materials quickly and helps to
maintain a simple and clear workstation arrangement. No searching, no distances, no distractions.
Optimization of sample flow can also contribute to reducing transport. For example, if samples are to be
subjected to a series of analyses, these may be undertaken in adjacent workstations. Increasingly, analytical
procedures are grouped together and combined so that in a single processing step, several parameters can
be determined in parallel or in sequence. Examples of such multi-parameter systems from METTLER TOLEDO
and their advantages are described in detail in further papers[2][2][4].
An example is application of an automatic sample changer in order to determine multiple parameters of mul-
tiple samples in succession[3][4]. Automatic transmission of results also cuts down on distances[5][6]. In addi-
tion, a general trend of “near-line” stations has arisen. Analyses are carried out close to the process – where
the sample is generated – and results are sent electronically to the next processing unit.
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Figure 5: A typical workstation in a Lean lab of a major customer. The yellow markings on the lab bench show
the exact location of each item and the location in which it can be found. Thanks to such arrangements and stan-
dardization, even employees from other areas can quickly find their way.
Can you report on productivity without investing additional time and effort? Yes No
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Errors in production lead to unusable goods. However, errors in the lab can lead to incorrect decisions on the
production floor, causing financial impact due to claims of compensation for shortages of goods and conse-
quent losses, customer complaints that necessitate product replacement or exchange, loss of reputation, and
further damage.
Incorrect quantitative results can lead to the over-dosing of valuable substances, with negative repercussions
for production costs. Insufficient dosing can result in ineffective formulation, possibly leading to recalls. There-
fore, it must be ensured that lab measurements are accurate, correct, and properly documented. If analytical
results are determined to be OOS, immediate follow-up investigations must be carried out, particularly in the
pharmaceutical industry. In order to monitor processes and detect any inconsistencies as quickly as possible,
it is important to define suitable key performance indicators (KPIs) and to review them daily. Typical KPIs are
lead time and first pass rate, as they provide immediate evidence as to process errors.
Errors may arise during the transmission of measured values, rather than due to poor measurements. Errors
during transcription of sample names or numbers must be systematically ruled out as well.
Transcription errors can be avoided by coupling devices together, such as connecting a balance to a titrator
or using SmartSample™ RFID tags on titration beakers to electronically transmit sample weight and ID. LabX
SmartCodes™ automatically assign the correct method to a particular sample, preventing errors and worry.
For secure documentation of measuring results, all devices can also be connected to a printer. Alternatively,
data can be collected electronically with the help of LabX laboratory software. LabX connects to LIMS or ERP
systems via a network. Results can be electronically archived without “wasted distances” and lost time and
can be forwarded, for example, for production approval.
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LeanLab / Geräte
Does equipment ease of operation match the level of competency and Yes No
knowledge of the staff?
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2.6.1 Measurement uncertainty
For proper optimization, it must be ensured that the precision of measurement results lies in the specified
range. One option is to calculate measurement uncertainty theoretically, and then determine it empirically (via
experimentation).
Traceability
Uncertainty
Validation
Quality Management System
Figure 6: Measurement uncertainty is one of the three pillars for dependable measuring
results in a quality management system.
Measurement uncertainty provides a confidence range for measuring results. In regulated environments,
the ability to calculate measurement uncertainty must be proven and documented (ISO 17025).
Prerequisites to achieving dependable measurement results – or, in other words, a particular uncertainty – are:
• Well maintained instruments and validated methods
• Instruments certified with traceable reference materials
• Employees with adequate preparation and training
The evaluation of the confidence range allows retroactive conclusions about the lab’s quality management
system.
To support users, METTLER TOLEDO offers services for the calculation of measurement uncertainty.
Other examples that are outside the scope of this discussion include:
• Automatic result validation through feasibility checks or tolerance levels
• Statistical quality control (SQC) for long-term monitoring of results, early detection of trends
• Security while carrying out an analysis: self-controlling automated systems or performance checks
of measuring devices, automatic calibration, and error notification
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2.6.2 Device errors and test-equipment monitoring
METTLER TOLEDO offers EQPacs for equipment qualification. EQPac documents comprise all neces-
sary forms and tools for a proper device qualification (IQ / OQ) that is carried out by certified technicians.
METTLER TOLEDO trains and qualifies all its service technicians accordingly.
Each certified lab has test equipment monitoring in place which also includes the regular maintenance of lab
instruments. METTLER TOLEDO supports customers with service solutions that include calibration, preventive
maintenance, and repair. This support is also in line with Good Measuring Practices, a program that includes
a variety of measurement techniques, such as weighing, titration, and thermal analysis (see also Chapter 3.3).
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2.7 Laboratory personnel skills − release untapped potential
XPE205
XPE205
Untapped potential
Calling on untapped employee potential is a complex social, economic, and human topic and cannot be
solved solely with technical solutions. Because of this, the topic of untapped employee potential will not be
dealt with in greater depth in this guide, despite its importance. However, METTLER TOLEDO offers a variety of
resources, including customer seminars and webinars, framed around this subject. For further information or
to contact your closest METTLER TOLEDO representative, visit www.mt.com.
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2.8 Chemicals and auxiliary material − manage your inventory
Inventory
Inventory waste in a laboratory typically refers to:
• Overstocking of chemicals
• Stocking expired chemicals
• Keeping obsolete equipment
However, inventory waste is also influenced by equipment purchases. Unsuitable, poorly performing equip-
ment may not meet requirements, but still requires the investment of the initial purchase. An example: To meet
the user’s weighing uncertainty requirements a balance of higher performance (i.e. with respect to repeatabil-
ity and minimum weight) may be purchased. Or a less efficient measurement technique may be used in place
of one that would generate savings, such as using a drying oven for moisture-content determination when a
fast, accurate halogen moisture analyzer would perform the same measurement in minutes instead of hours.
Inventory waste also includes documents, files, data sheets, results, and reports which pile up easily in the
lab (see Chapter 3.2, Data integrity). Care must be taken to clean out and discard this waste. Once these stor-
age items are removed and data capture becomes automated / electronic, results- and information-capture
becomes faster and more streamlined, as does data retrieval.
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Figure 7: Overstocking of reagents as inventory waste.
In North America, an electroplating company acquired an ion chromatograph (IC) to determine the nickel
content of electrolytic baths. Such baths have a very high concentration of nickel and a highly saline sample
matrix. A complex procedure is required to prepare bath samples for ion chromatography which, together with
the comparatively long sample measurement, made the company’s entire ion chromatography process long
and complicated. In other words, the method was more susceptible to faults, and hence required more inten-
sive maintenance.
As an alternative, complexometric titration, a robust and approved method that is very simple to automate,
was recommended. In the end, the company was able to reduce quality-control efforts by at least a factor
of two, which made both lab operators and company management happy and highly satisfied.
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2.9 Continuous Improvement Process (CIP) activities – trust your staff
Are there dedicated staff who have been trained in systematic Yes No
process optimization?
Count the number of questions you answered “Yes” to, and add them up.
1–15 Yes x
Start a Lean project in your laboratory. Start with small steps, e.g. following the 5S model. Assign a project
leader who can dedicate approximately 20–50 percent of their time to this project. Analyses are also good to
see where the greatest deficits lie.
16–28 Yes x
You are on the right track, but there is still room for improvement. You may want to reclarify the question of
resources or assign priorities differently.
29–36 Yes x
Congratulations! Your lab is lean. Keep it up! Continuous improvement and follow-up are crucial. Share your
knowledge with your colleagues. Your efforts should be visible in terms of costs, quality, and lead times.
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3 METTLER TOLEDO Solutions
3.1 Automation
METTLER TOLEDO instruments have been designed for easy operation using the One Click function. They can
also be controlled via LabX.
After a long establishment phase and the first five years of its routine application, the economic results were
astonishingly sobering: The quality of the results was indeed higher than before, fewer retests were necessary,
and the results were available more quickly. However, the expected, dramatic, reduction in costs had not been
achieved. Expenses had actually risen.
Figure 8: Custom-built laboratory automation achieved economic efficiency only with difficulty. Savings were spent
on additional expenses [7].
Although the number of laboratory technicians involved was reduced, the complex system required new,
specialized employees to ensure essential system accessibility. High investment costs required an even larger
number of batches to be processed to realize savings.
The investment paid off only after a decade, and was considered largely written off [8].
When compared to this type of customized automation, sample changers and modular analysis instruments
are inexpensive. They can be implemented with low investment risk, are optimized for simple dedicated
operations, and can be paid off very quickly.
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3.1.3 Integrated “monobloc” vs. modular automation
A “monobloc” is a static predefined combination of multiple steps of analysis into one automated system.
As described above, such systems are complex to maintain and troubleshoot. A failure paralyzes the whole
system.
An effective alternative is single workstation automation via independent, compact instruments that are uni-
formly operated. Such a system becomes advantageous with respect to susceptibility to failure and down-
time. It can be integrated into a flexible network and controlled / managed via intelligent laboratory software,
e.g. LabX.
The individual automated instrument plus management software combination is in large part a cost-effective
alternative for purchase, maintenance, and qualification. The probability that all network instruments fail
simultaneously is remote compared to an integrated system in which hardware pieces are highly dependent
on each other. With individual devices, bottlenecks in sample throughput, which can hinder approvals, can
be avoided.
Depending on sample throughput, degree of automation and labor cost savings, the ROI of equipment such
as a titration system can occur typically in a few months.
Although this calculation holds a few uncertainties, it is accurate enough to justify the investment.
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3.2 Data integrity
Results and data may be used at a later time for various purposes, e.g. for audits or as evidence in case
of an incident.
In the pharmaceutical industry, data integrity can be achieved only with high effort. Sample measurements
must be done properly. Automated lab instrumentation generates reproducible results and print records that
prove data integrity and validity. However, the transcription of these results in many labs is still performed
manually. This takes a lot of time and is acutely error-prone.
The list of stories about transcription errors is long. Often heard comments are “In our lab we need 10 min-
utes to record a pH value and 60 minutes to transcribe the result to LIMS or ERP software.” Or, “Manual data
transcription takes 40 percent of the lab technician’s time.” There are also high costs related to unusable
batches, recall actions, and employees who have been dismissed because of improper error-handling.
Manual transcription is expensive and no longer state-of-the-art because there are more efficient solutions
available. The connection of analytical instruments and meters to LIMS or ERP systems avoids transcription
errors and reduces the transcription workload possibly much more than any other Lean measure in this guide.
A typical data flow in many labs before optimization may look like this: An analytical instrument generates
results. Data is printed on paper records. These records are used to transcribe the numbers into reports.
Reports are double-checked for errors and perhaps recalculated for plausibility. Some records require a
second person to check again (the four eyes principle). Reports may also be transcribed into the LIMS or ERP
system. The paper records are stored and then are scanned and stored on a server for up to 50 years.
Modern data flow solutions, on the other hand, provide automated, safe, and fast data transfer. Thus, they can
contribute substantially to the leanness of your lab.
Analytical
Printer Lab Journal
Instrument
Manual data transfer
Figure 9: Data workflow in a lab. Green: Modern solution. Blue: Conventional solution.
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3.2.2 Automated data transfer
Automatic data transfer offers significant benefits; however, its setup must be done very carefully and requires
recources. Before data can be transferred automatically from an instrument to a LIMS or ERP, suitable
software must be installed. Automated data transfer must be set up in a way that avoids errors and can be
validated. When designing and implementing custom software, this is a significant effort that requires IT
department resources and intensive testing. Hence, the process is rather expensive. However, it is also highly
necessary in order to create a secure and efficient data transfer process and to avoid the risk of database cor-
rosion.
The instruments found in a lab are very diverse and sometimes do not even have dedicated software. Never-
theless, they all create valuable data and should ideally be connected to a computer or ERP for easier control
and data capture. It’s important to consider the workload for initial installation and validation as well as later
updates when setting up the lab.
In reality, such projects need high effort: The customer must evaluate requirements carefully and the software
company must implement them. Programmers must become experts in all analytical techniques and reen-
gineer the algorithms. Programmers must also have good contact with all instrument suppliers to get data
protocols. And this not only for the first version: Any changes must be reflected in new protocols and tested for
validity. The scope of the work justifies (almost) any price.
Alternatively, there are “off-the-shelf” solutions available. Usually they are better tested and cheaper, and carry
lower risk. For the world of chromatography there are a number of software solutions that integrate most chro-
matographs on the market and are written by chromatography experts. It makes a lot of sense to standardize
all chromatography applications to one of these packages. This also reduces installation and testing efforts
considerably. Typically one-third of the instruments in a modern laboratory are for chromatography.
Most labs also use balances, titrators, and pH / conductivity meters, as well as instruments for density, refrac-
tometry, and melting point. This instrument family makes up another third of a lab’s equipment. Spectroscopy
is also frequently applied.
METTLER TOLEDO’s LabX software has the capability to connect all of these instruments to the LIMS or ERP
system. However, LabX does not support other suppliers’ instruments.
Data is transferred via .API, .CSV or .XML format*. Many IT experts will not allow communication via API.
However, ERP software often has XML transfer interfaces, which makes data transfer easy to program.
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Lean Lab Guide
Hence, data transfer from LabX via .XML to the LIMS or ERP for all supported instruments is our recommenda-
tion for Lean data integration in order to:
• Save lab technicians’ time
• Increase data quality (eliminate transcription errors)
• Create a system that is easy for the IT department to maintain
There is only one connection to LIMS or ERP to maintain for many instruments. Thus, the IT p rocess is made
Lean as well.
METTLER TOLEDO’s risk-based guidelines for weighing, titration, and all other analytical techniques empower
you to make the right decisions when and where they really matter. The five steps of Good Measuring
Practices cover the entire lifecycle of your instruments and provide you with practical guidance to implement
a sound q uality management system.
1. Evaluation
Analyze your process flow and its associated criteria
to consistently ensure the highest quality of your
applications and data.
2. Selection
Choose the combination of instrument and measuring
technology that best matches your process needs.
3. Installation & Training
Enjoy every confidence in your new device and mas-
ter it with full professional skills right from day one.
4. Calibration & Qualification
Trust the manufacturer-trained METTLER TOLEDO
Service Team when it comes to calibrating and
qualifying your instruments.
5. Routine Operation
Benefit from tangible recommendations for optimal
performance verification, calibration, and mainte-
nance.
METTLER TOLEDO’s Good Measuring Practices are available for weighing, titration, pipetting, electrochemistry
(pH, conductivity, redox potential, dissolved oxygen, and ion concentration), density, refractometry, thermal
analysis, melting point, dropping point, and UV / VIS spectroscopy.
www.mt.com/gp
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Lean Lab Guide
4 Conclusions
4.1 Lean: A matter of budget?
Lean Lab improvements go beyond an iterative procedure. Processes are improved in feasible steps. This is,
therefore, typically a low- or no-budget process that is self-financed thanks to increased efficiency.
In pharmaceutical laboratories, which work under GLP and GMP rules, such changes are not always easy.
If the process is validated, and the equipment qualified and described in the approval documentation and
SOPs, changes can induce high costs and extra work which cannot be recouped in due time. In such cases
one can only hope that enough scope for process customizations and improvements was given. As an exam-
ple, for a specific device (analytical instrument, balance, etc.), the supplement “or equivalent” should not be
omitted in order to allow for later replacement with improved devices or other enhancements.
When in-house knowledge about Lean Lab is lacking, one can try to acquire expertise via consultants.
However, external advisors and consultants may not possess detailed knowledge of lab workflows, internal
requirements, and company regulations [8]. Careful selection of consultants and strict cost control are musts in
order to stay with the Lean idea and keep budgets low.
The Lean Lab approach primarily involves task process optimization with the objective of improving the eco-
nomic efficiency of an organization (lab, factory, company, etc.). This is mainly an internal exercise.
Lean Lab can be initiated even in small steps. Contributions must be made module by module and can be
extended anytime. The main focus of METTLER TOLEDO solutions is on technical aspects such as:
• Standardized operation of different devices
• Modular device combinations
• Standardized network-compatible software
• Competent services
These include products and solutions such as automated analytical instruments, LabX software, universal
One Click operation, and many features of modern balances and analytical instruments that contribute con-
siderably to leanness and help to implement it sustainably.
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Lean Lab Guide
Eliminate Waste Selected METTLER TOLEDO Contributions
Invest in the right • Consultancy for design qualification (DQ) or user requirement specification (URS)
instruments and • Good Measuring Practices: Five steps to improved measuring results.
equipment Go to: www.mt.com/gp
Shorten transport • LabX for data transmission
and d istances • SmartSample: Consolidate sample weight and ID on RFID (radio frequency
identification) tag at balance
• Multiparameter solutions
• Dedicated workstation solutions
• Automatic sample changers
Eliminate waiting time • Workflow automation
• Notification (LabX Mail)
• LevelSens (level indicator for solvent utilization)
Simplify complex • Simple methods
processes • Easy operation (One Click)
• Standardized operation (common interface)
• Standardized software (LabX)
• Modular systems with standard automation solutions
• User guidance
Reduce operator • LabX: Test data stored on server instantly available
movement • Multiparameter solutions
Eliminate errors • Electronic data transmission (printer or LabX)
• Feasibility checks (e.g. bubble check via sample oscillation as well as video view
for density meters, automatic multiple measurement with maximum allowed
standard deviation)
• Secure sample-data flow with SmartSample
• Safe, automatic method selection with SmartCodes
• Instrument check (monitoring test equipment, EQPac)
• Calculation of measurement uncertainty (MUPac)
• Plug-and-play accessories and Intelligent Sensor Management (ISM®) sensors
Reduce waste / • Warning messages to smartphone (LabX Mail), allowing early intervention
disposal costs in case of errors
• Level indicators for solvent utilization (LevelSens)
• Optimization of titrant use
• Fine dosing through precise burette unit
• Automatic cleaning (pulsed, 1 or 2 solvents)
• StatusLight™ (indicates if instrument is ready / ok or needs corrective action)
Table 2: METTLER TOLEDO solutions for the elimination of waste.
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Lean Lab Guide
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Lean Lab Guide
5 Lean Lab Product Examples
Titration Lean Lab setup – example 1
Titration Excellence • T5 Excellence titrator, including burettes and
burette drives
InMotion™ autosampler Complete setup including:
• Electrode
• Propeller stirrer
• Rinsing pumps
• Rinsing bottle
• Waste bottle
• Titrator connection cable
Titration beakers
(e.g. 100 mL polypropylene beakers)
Safety gloves (1 box)
Soft tissues (1 box)
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Lean Lab Guide
Refractive Index Lean Lab setup
Refractometer • R4 or R5 depending on required resolution and
measuring range
Barcode reader
1 or 2 rinsing bottles d epending
on required rinsing solvents
(e.g. deionized water, ethanol)
Safety gloves (1 box)
Soft tissues (1 box)
Waste box
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6 Recommended Literature
Lean Lab Checklist, white paper, METTLER TOLEDO, 30249603B, ©01/2018
Titration Automation Guide, METTLER TOLEDO, 30452157, ©11/2017
Data Integrity Guide: Secure your measuring processes with LabX software, METTLER TOLEDO, LAB00434B,
©07/2019
Safer Food Production – Lean Manufacturing and Due Diligence, white paper, METTLER TOLEDO Safeline,
SLMD-UK-WP-EN, ©08/2013
7 Literature References
[1] Masaaki Imai: Kaizen. Der Schlüssel zum Erfolg der Japaner im Wettbewerb. 7. Auflage. Ullstein,
Berlin. 1996, ISBN 3-548-35332-0 (Ullstein 35332 Ullstein-Sachbuch Management)
[2] Density, Refractive Index, pH and Color Multiparameter Analysis, METTLER TOLEDO, ©06/2012
[3] Titration Automation, Fully Automate your Titration Processes for Maximum Efficiency and Security,
METTLER TOLEDO, 51724170, ©02/2009 Replaced by: Put Your Lab InMotion™, METTLER TOLEDO,
30100369A, ©06/2017
[4] Titration Automation, Automatic Dosing and Pipetting, Versatile and Reliable, METTLER TOLEDO,
51725153, ©02/2009
[5] LabX Titration, Vollständige Übersicht und Kontrolle, Raffinierte Softwarelösung für Titratoren,
METTLER TOLEDO, 51724360C, ©04/2011
Replaced by: Power Your Titration Bench with LabX, METTLER TOLEDO, 30100354A, ©07/2017
[6] LabX: Power the Bench, 30427583, © 07/2017; https://www.mt.com/ch/en/home/products/laboratory-
software/labx-software.html
[7] Bernd Renger, Personal Communication
[8] Bernd Renger, Consultant, Lean Lab Präsentation, METTLER TOLEDO Customer Seminar, Jungholtz,
May 2012
[9] Hasan Yorukoglu, Your time is limited – Kaizen, www.hasanyorukoglu.com/blog, December 11, 2009
and November 17, 2009
[10] Julia von Flotow, Kaizen Lifestyle Management, www.kaizenlifecoach.com/5S.html
[11] Rick Ruzga, Downtime, http://leanvisualblog.bradyid.com, June 2013
[12] Markus Schubnell, Validation in Thermal Analysis, METTLER TOLEDO, 51725141, 12/2008
[13] H. Singer, Kanji A Systematic Approach, 1994, US Library of Congress 94-92402
[14] Debashis Sarkar, 8 Wastes of Lean Manufacturing in a Services Context,
w ww.processexcellencenetwork.com
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8 Abbreviations
5S / 5A Workplace organization method, Japanese: Seiri (sort), seiton (set in order),
seiso (shine), seiketsu (standardize), and shitsuke (sustain)
CAPEX CAPital EXpenditure
CIP Continuous Improvement Process
Cpk The process capability indices Cp and CpK are parameters used in statistical
evaluation of a process in production technology
DLZ Lead time, German: Durchlaufzeit
ERP Enterprise Resource Planning, eg. SAP
Gemba Japanese term meaning “the actual place” or “the real place”: the place where
manufacturing takes place or a service is provided
Kanban Scheduling system for lean and just-in-time (JIT) production
LIMS Laboratory Information and Management System
MES Manufacturing Execution System
Muda Japanese word for a pointless activity = waste
Obsolescence Ensures that discontinued components of products are replaced promptly with
Management suitable alternatives, or otherwise are specifically stockpiled
OEE Overall Equipment Effectiveness
OLE Overall Laboratory Effectiveness
OOS Out of Specification
OPEX Operational Excellence (a term of Lean Laboratory and production),
OPerational EXpenditure (a term of business economics)
POBOS Pharma Operations Benchmarking (McKinsey & Company)
Poka Yoke Prevention of unfortunate errors
RCI Root Cause Investigation or Analysis
RFT Right First Time
Six Sigma A set of techniques and tools for process improvement
SMED Single Minute Exchange of Die = set-up time optimization
TPM Total Productive Maintenance
TPS Toyota Production System
WIP Work in Process
9 Acknowledgments
Our thanks go to all the internal and external Lean Lab experts who contributed to the creation of this
comprehensive and helpful guide. In particular, we would like to thank Christoph Jansen of METTLER TOLEDO,
and Erwin Studer, consultant and partner at PROFACT AG, each of whom has provided invaluable c ontent and
real life Lean Lab examples.
METTLER TOLEDO
Lean Lab Guide
35
Make Your Laboratory Lean
For Efficient and Simplified Processes
Make Lean a part of your company culture with METTLER TOLEDO’s resource collec-
tion. With checklists, webinars, guides, and more, we help you to streamline and
refine your workflows. Learn how an iterative approach can reduce the eight wastes
and boost productivity – so that effort invested continues to pay off over time.
The Lean approach provides a framework for how to organize physical spaces,
digitalize records, coordinate interlinking process steps, and leverage employees’
skills and knowledge. Calling for thorough understanding of operations and a criti-
cal, continuous assessment of inefficiencies, it helps you to navigate the pathway
to improvement. METTLER TOLEDO’s resources can support all stages of the Lean
journey, benefiting beginners and those well along the way alike.
• Ease in gently with webinars: learn the principles of Lean and how METTLER TOLEDO
applies them to its own production. Then discover how to undertake value stream
mapping, with practical examples to achieving efficiencies.
• Conduct a guided assessment with our checklists. Perform a self-audit: consider
how the eight wastes might be affecting your processes; identify how to implement
5S in your lab – and how to keep it going.
• Consolidate and reflect on your knowledge: explore our guides for further details
of the Lean approach, and METTLER TOLEDO’s solutions to reduce bottlenecks.
www.mt.com
For more information