Optimizing Workplaces and Workflows: Lean Lab Guide
Optimizing Workplaces and Workflows: Lean Lab Guide
Optimizing Workplaces and Workflows: Lean Lab Guide
4 Conclusions 30
4.1 Lean: a matter of budget? 30
4.2 Lean lab in small steps
4.3 The instrument manufacturer’s viewpoint 30
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Lean Lab
The successful implementation of ‘Lean Manufacturing’ in several fields has inspired many businesses to adopt
this model in laboratories as well. Laboratories have different challenges compared to manufacturing environ-
ments; while most of the key principles of traditional Lean still apply, there are many unique points to be adopted
in laboratories.
From our point of view, Lean Lab is primarily an internal organization task for process optimization.
The objective is to contribute towards improving the economic efficiency of an organization. The operational changes
that lead to a Lean Lab (which can be initiated in small steps, module-by-module, at any time) are as follows: the stan-
dardized operation of several different devices, optimized workplaces and work processes, modular device combina-
tions, standardized network-compatible software, and competent services.
Build a culture of continuous improvement to sustain business benefits, from the customer down to the analyst level,
drawing on new and innovative ideas, and sustaining its impact with mindset and behavior transformations across the
laboratory. Below are some fields for improvements that we identify as important for the Lean Lab concept.
Quality
Result
Q
Productivity Capacity
The
Magic
Triangle Q: Quality
R: Resources
T: Time
R T
Costs Date
Expense Duration
Figure 1: Success is measured by the ‘Magic Triangle‘. The three corners must be balanced.
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1 The Lean Lab Concept
Lean Lab Guide
It encompasses the entire business scope, including the management culture and employee satisfaction.
On the one hand it tries to optimize resource utilization and on the other it strives to avoid its overstretching
(Japanese “Mura” and “Muri”).
For this purpose, there are a number of distinctive standards and tools such as the 5S-movement, 7M and 3 Mu
checklists, and the 7 types of wastage (or more) that are involved in analysis and the process of improvement.[17]
Ultimately, even JIT production originated from “Lean Manufacturing” (JIT = “just in time”).
Measuring/monitoring the progress of actions that were initiated through such processes is an important compo-
nent of sustainable implementation and success. For the participants, it can be motivating if their success can be
tracked graphically in charts placed at conspicuous spots in production. The measurement criteria must be speci-
fied accordingly, for example, the number of claims, sales trends, development costs, absenteeism, accidents, etc.
Although there are major differences between laboratory and production, of which we must take careful note,
it is still possible to adopt several aspects of the Lean Concept in the laboratory.
The aim is to optimize productivity and efficiency while minimizing all activities that do not add value.
Throughput shall be maximized and wastage reduced. The Lean thought attempts to “do more with less”:
cost reduction despite growing demands, be they with regard to quality or throughput.
Such objectives can only realistically be implemented by introducing rules with which the processes are stream-
lined, simplified, standardized, and clearly presented.
The Lean Concept does not expect to implement in the first attempt everything recorded for improvement
and implement all the resulting measures at once. The objective of Kaizen[1][11] [18] is continuous improvement.
With the help of small steps, it is ensured that the implementation barrier remains surmountable.
In most of the cases, there is no or little budget only provided for Kaizen. Kaizen shall be self-financed through savings.
The term kaizen originates from Japanese and means betterment, amelioration. Kai stands for be renewed,
change. Zen means good[15].
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The process runs through five steps, which can be mapped as a circle.
In the sense of continuous improvements, one can pass the circle again
and again. The 5 steps are often abbreviated with “5S”.
4. Seiketsu 1. Seiri
standardize sort
5. Shitsuke
sustain
3. Seiso 2. Seiton
shine set in order
Seiri
Efficient systems are simple systems. One quickly finds what is required without searching for it. When working
materials are classified as unnecessary or less important ones in the immediate surroundings of the worksta-
tion, the space requirement becomes lesser, distances become shorter, and cleaning becomes easier. Thus,
the Kaizen process begins by eliminating unnecessary working material (devices, tools, utensils, chemicals,
reagents…) from the workstation.
For this, one agrees to dispose such unnecessary materials. Many times employees have become dependent on
specific tools or other working materials even though unnecessary. These objects are stored at a remote warehouse
till everyone is sure that they are no longer in need of it. If actually required later, disposed material is retrieved or must
probably be procured again.
Larger objects (furniture, devices etc.) that have been recommended for disposal are provided with a special
label so that all the employees get an opportunity either to notify their requirements or to stop the disposal.
This simple way of direct communication is especially suitable
for larger organizations.
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5
Seiton
Lean Lab Guide
With the reduced set of working materials, the new workstation is then neatly arranged so that every piece is
easy to locate. Analytical instrument, beakers, gloves, pipettes, tubes, network cables, chemicals, deionized
water, etc, each piece has its defined place. In principle, the pieces are arranged in the order of the workflow.
It is very important and crucial to achieve the kaizen targets, that after each use, the piece is placed back
at the same location (see also chapter seiso). Thus, the same workflow efficiency is available again and
again. Furthermore, one is enabled to find quickly something that is missing.
In production, yellow lines on the floor or at the workbench are often applied with the labeling of the piece
within the reserved area. Increasingly, this procedure is used in labs as well to indicate the right position
of the pieces on the lab bench. Initially it might look funny and exaggerated. However, the resultant clear
arrangement and order is immediately visible and the increased efficiency is measurable.
METTLER TOLEDO supports the seiton tasks with its compact and ergonomically designed lab instruments
focused on workflow simplification. A neat arrangement of the workstation is enabled. For example,
all of which is required for carrying out a titration is available in the immediate surroundings of the
instrument including e.g.
▪ 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 needs “only” to be properly maintained. However, this requires
individual habits to adjust to the kaizen rules. Without convinced, motivated, and accordingly trained employees,
this cannot happen.
The lucid arrangement of the system allows quick and unambiguous identification of problems.
Problems then must be appropriately dealt with in due time.
Seiketsu
The Seiketsu step sets standards. It is the next pillar after the first three 5S have been implemented and standard-
izes best practices. In this step, the new system shall become the personal concern of each of the employee
involved so that the improvements are sustainable.
It aims at cleanliness or tidiness both on the environmental and personal fronts and empowers all involved
persons to maintain performance benchmarks. Seiketsu is also about prevention.
It prevents
▪ Accumulation of unneeded things
▪ Breakdown of procedures and processes
▪ Instruments getting “dirty”, failing calibrations and being unoperationable
▪ Equipment deterioration
Standardized processes, applied across the company, enable employees to adapt quickly to any workstation
and reduce training expenses significantly.
Shitsuke
All changes and improvements have to be made sustainable. Making 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 behaviour change and an ongoing motivation.
Signs, posters, periodic performance reviews are some of the helping tools to make the 5S “the way things are done”.
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1.3 Avoiding wastage
The 5S principles form a unique circle to continuously improve processes round by round (see Fig. 2). However,
to bring the rather theoretical 5S principles to life in practice, guidance for the daily work has been developed.
One such guidance to practice is the avoid wastage approach.
1. Defects: Defective products lead to correction efforts or to output that is lost in rejection
(process failure). Further, the interrupted process must be restarted (reactive process).
2. Over-production: All products and outputs that are produced although they are not requested
by customers. Over-production uses up labor force and financial resources.
Thus, it blocks the manufacturing of the requested products.
3. Waiting time: Stagnant or idle processes, missing materials, defective or unsuitable
resources, etc., tie down the resources that can no longer be used for adding value during these periods.
4. Untapped potential: The know-how of the employees involved in the process that has not been utilized to im-
prove the overall process is likewise considered as wastage.
5. Transport: Unnecessary material transport provides no direct costumer benefit. However, it uses resources.
6. Inventory: Stocks as a production buffer hide weak spots. As over-production they tie down capital and space,
and generate worthless handling costs. Inventory however may be required to maintain readiness to deliver
and short order response time.
7. Motion: People or equipment moving or walking more than is required to perform the processing.
8. Complex processes: By not including production sufficiently in the development process, by having inappropriate
resources and unsuitable systems, and so on, processes generally become difficult to monitor. This causes errors,
reduces flexibility, and leads to process failures and to unproductive waiting periods [1].
D Defects
O Over-production
W Waiting
N Not engaging all employees
T Transportation
I Inventory
M Motion
E Extra-processing
Self-assessment
In the following chapter 2 you will find the nine steps supporting the
implementation of your Lean Lab. Each sub-chapter includes three to
five questions for a self-assessment of your current lab situation.
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2 The Nine Steps to Lean
Lean Lab Guide
ousekeeping
Can your employees find and fetch tools quickly and easily? Yes No
Are the workstations clean, tidy and designed for purpose? Yes No
Are the general laboratory tools stored in an orderly manner and are Yes No
they easy to locate?
Complex processes
The following type of waste – “complex processes” – as example from Lean Manufacturing, stands for lack of in-
teraction between development and production departments. The development department shall make sure that
the process is in line with the available options in production. Otherwise, the process becomes “unrealistic” and
practical conditions unsuitable.
A transfer to the lab area typically implies that method developers take into account the options, capabilities and
resources available at the later point of analysis. For example, methods performed „near line“ in the production
area must consider the educational and training qualifications of shift workers. Method developer may evaluate
analysis automation also with respect of lesser operator interventions and higher security and reproducibility.
For the last few years, METTLER TOLEDO has been keenly involved in this complex theme and has paid special
attention to simple operations and “made easy” processes. Using a graphical user interface (GUI) with One
Click® allows to start even complex processes with just one click. The benefits is even higher since One Click is
applied on many different instruments. Hence, users of modern instruments can retrieve the most and profit daily
from these developments (see Figure 8).
Increasing standardization of the operating elements, standard touch screens with standard user management,
data security, method setup procedures etc., simplify the learning process and the operation even for varied analy-
sis techniques such as titration, density measurement, refractometry, determination of melting point, dropping point,
pH meter or spectrophotometry. Such methods can typically be found in many quality control labs.
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Figure 4: Common GUI (touch-screen) for several analytical devices: Titration, Karl Fischer, density, refractometry, melting point, dropping
point, pH meter, balances, UV/VIS spektrophotometer
LabX software, that runs in the background of the instruments and balances or that is used for complex analysis
tasks, is likewise standardized as well. This profoundly contributes to the simplification of processes as well as
for learnability. Common software for multiple lab instruments adds to the lean idea of the whole lab. It also as-
sists to the lifecycle management of lab instruments: Design, qualification, installation, integration, validation,
maintenance, upgrades and retirement.
With the integration of LabX Software into a superordinate system (LIMS, ERP), transfer processes such as
analysis requests and transfer of results are automated and are secured from transmission errors.
Using only one software to connect to many lab instruments and linked to ERP or LIMS reduces complexity consid-
erably. It also essentially reduces costs for validation, maintenance (e.g. during upgrades of the operating system)
and first time implementation. A practically well proven example for such a software is LabX from METTLER TOLEDO.
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2.2 Value stream mapping − minimize over-production
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Do you know the proportion of non-value adding but necessary steps Yes No
in your workflow?
Do you know the proportion of value added steps in your workflow? Yes No
2.2.1 Refuse
Refuse is an over-production type of waste inherent to laboratories. Chemicals such as regents, solvents, buffers,
etc are expensive to procure and dispose. They are a woe that has to be minimized for saving costs and creating
added value in terms of operator’s safety, ecology and energy savings.
By using the optimal burette dosage range of 30% to 90% of the nominal volume, the precision can
be enhanced. Even small amounts saved can accumulate into a huge volume over time.
Standardized automatic cleaning after a titration, level indicators on supply containers or waste bins and advance
notification in case of errors and malfunction during sample series can help in minimizing the solvent waste.
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Fig. 5: LabX® Mail: Results or warning messages can be sent from the LabX software to the Smartphone via e-mail or SMS
2.2.2 Over-testing
Measuring too many parameters, testing too many samples or repeating a sample too many times are aspects
of over-testing. Such “excessive checks“ are considered as wastage.
This can be due to various reasons:
▪ Laboratory supervisors can be misled by the technical possibilities and implement
routines that in general would not be necessary
▪ Operators may mistrust results and repeat tests again and again
▪ Customers ask for excessive testing to be sure about the quality of delivered goods
Well established standard operating procedures (SOPs), well trained operators and mutually agreed scope
of test sheets can guide to the way of Lean Lab and avoid over-testing.
If over-testing becomes state-of-the-art, organizational and economical problems may arise driving costs
of goods increasingly upwards.
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Production
2.3
LeanLab Workload − reduce waiting time
Lean Lab Guide
– Workload LeanLab – Workload
Laboratory Laboratory
Production P
Procurement of chemicals, instruments, equipments and other materials by eliminating waiting time is an opti-
mization task for the purchase department. However, it’s a matter of the lab to call for supply in a timely manner
and stock critical chemicals, reagents and solvents.
Untoward incidents can be systematically avoided, e.g. via continuous monitoring the consumption of reagents.
While titrating levels of titrant, solvent, waste, etc. can be automatically checked using level indicators (LevelSens™).
Such level indicators can generate an appropriate warning message and trigger a timely refill, change or pro-
curement. In addition, methods of Titration Excellence titrators contain meters that indicate the consumption of
a chemical through the accumulated dosed volume. If a certain amount of consumption is exceeded, a warning
message is given.
Waiting time for equipment can be reduced through lab automation. Automatic sample changers, combined pa-
rameter measurements and automatic data and result transfer can spare the lab technician from waiting in front
of the device until the result appears. See chapters 8 and 9 for more information regarding automation in the lab.
Nevertheless, how does the lab technician know that his batch is ready? How does he/she know when within
the measurement series a problem has emerged and he/she needs to intervene?
This problem can be solved with the help of appropriate software: The network-compatible LabX® software allows
the tracking of measurements even from remote office workstations. With the help of a notification function,
the LabX software can send a result info or warning message via e-mail or SMS. With proper installation, measure-
ments can be tracked even on the Smartphone.
Software can also assist the execution planning of analyses namely through relevant “task scheduling tools”
(task management). This implies that the individual samples are distributed to and placed at the proper instru-
ments (titrator, density meter, refractometer, melting point instrument, spectrophotometer, etc) as per the priori-
ties and availabilities.
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Then the respective authorized lab technicians carry out the analyses. The task scheduling, mainly determined
by the analysis requirements, can make a significant contribution to increasing the efficiency, because one or
more analyses of a sample (i.e. a substance) are carried out at the appropriate time.
Are the distances between individual steps in the workflow short and sensible? Yes No
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2.4.1 Motion
Lean Lab Guide
Waste of motion deals with movements of persons contrary to the waste of transportation, where items and materials are
in the focus (see chapter 2.4.2). Persons looking around in the lab for data and information, moving back and forth to
filing cabinets, printers, copiers or other machines and searching for equipment and tools are typical cases. These move-
ments add no value. Thus, they are waste[16].
Elaborate office and lab layout help minimize motion waste. This is one aspect. The implementation of such measures
however is often difficult in practice due to limited lab space availability, building construction restrictions, installation
requirements and the like (see infographics above).
An other approach to the topic is to look for the reasons behind the movements. As an example, striving for a paperless
lab eliminates the need for moving to printers and file cabinets. Collect all measurement data and results from ananlytcal
instruments with LabX software and store them centrally on a server for immediate access via any PC of the network.
Thus, no printer or copier is required. Hence, no motion involved anymore. Such an approach delivers additional advan-
tages: It makes file cabinets obsolete, saves paper, simplifies the archiving process and perhaps reduces other wastes.
This aspect can be technically resolved by setting up appropriate workstations in suitable and dedicated labora-
tory locations. Only instruments, tools and materials required for the work tasks at this workstation are accom-
modated in its immediate surroundings. This restriction to include only the relevant required material enable
operators to find the necessary materials quickly and helps in maintaining a simple and clear arrangement.
No searching, no distances, no distractions.
Optimization of the sample flow can also contribute to avoiding transport routes. For example, a series of analy-
ses which a sample must go through can be undertaken in neighboring work stations. Increasingly, analysis
procedures are grouped together and combined so that in just one single processing step, several parameters
can be determined in a sequence or parallel. METTLER TOLEDO has given already few solution options [2][3][4]
under the keyword “Multiparameter” and in chapter 7.
An improvement of this is the application of an automatic sample changer in order to determine multiple samples
successively with multiple parameters [5][6]. In case of automatic transmission of analysis results via network
cable, additional distances can be cut down [7][8].
In addition, a general trend of “near line stations” has evolved. Analyses are carried out close to the process – i.e. where
the sample is generated – and results are sent electronically, for example via network, to the next processing unit.
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Figure 6: A typical workstation in a lean lab of a major customer. The yellow markings on the lab table show
the exact location of a work-material and the location where it can be found. Thanks to such nice arrangements
and to standardization, even employees from other areas can quickly find their way
Are the most important indicators such as OOS, RFT, etc. Yes No
Can you report on productivity without investing additional time and effort? Yes No
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While considering the importance of quality measurements for a production approval, avoiding errors in the lab
Lean Lab Guide
plays an important role. An error in the production leads to unusable goods. An error in the lab can lead to wrong
decisions: An unusable good can be marked as usable or vice versa. Hence, errors in the lab can cause heavy
financial losses due to compensation claims for unaccounted shortage of goods and consequential losses, com-
plaints with free substitution, loss of reputation and further damages.
Incorrect quantitative results can lead to over dosage of valuable substances with negative consequences
for the production costs. Insufficient dosage can imply ineffective/malfunction or leads to legal problems.
Therefore, it must be ensured that lab measurements are certain and correct and properly documented. If analysis
results are obtained, which do not fulfill the specification and those termed in the pharmaceutical field as “OOS”
(Out of Specification), it must be ensured that immediate follow-up investigations are carried out.
Often errors are not only due to poor measurement. Even during the transmission of measuring values
(e.g. weighed quantity), errors can occur. Errors during transcription of sample names and numbers shall
be systematically ruled out.
Transcription errors can be avoided by coupling of devices: For example, connecting a weighing balance to a titra-
tor or using SmartSample™ RFID tags on titration beakers and by electronically transmitting sample weight and ID.
LabX SmartCodes™ assign automatically the correct method to a particular sample avoiding errors and worries.
For secure documentation of measurement results, all the devices can be connected to the printer. Alternatively,
the data can be collected electronically with the help of LabX laboratory software. LabX connects to LIMS or ERP
systems via network solution. The 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 the ease of operation match the level of competency and Yes No
knowledge of the staff?
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2.6.1 Measurement uncertainty
Lean Lab Guide
For all optimization efforts, it must always be ensured that the precision of measurement results lies in the speci-
fied range. There is the option to calculate measurement uncertainty through theoretical considerations before
experimentally determining them.
Traceability
Uncertainty
Validation
Quality Management System
Figure 7: Measurement uncertainty is one of the three pillars for dependable measurement results in quality management system
Calculation of measurement uncertainty provides a confidence range for the measurement results. In regulated
environments, the ability for calculating measurement uncertainty must be proven and documented (ISO 17025).
Prerequisites for achieving dependable measurement results – or in other words a certain uncertainty – are
▪ Instruments well maintained with validated methods
▪ Instruments certified with traceable reference materials
▪ Instruments familiar to employees
▪ Well trained/educated employees
As such, the evaluation of the confidence range allows retroactive conclusions on the lab’s quality management system.
To support titration users, METTLER TOLEDO offers the ‘MuPac’ service for the calculation of measurement uncertainty.
Other examples that shall not be discussed in detail are:
▪ Automatic result validation through feasibility checks or tolerance levels.
▪ SQC (Statistical Quality Control) for long term monitoring of results, early detection of trends.
▪ Security while carrying out the analysis: Self-controlling automated systems, that is, performance
check of pH-sensors, automatic calibration, and error notification.
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2.6.2 Avoid device errors, test equipment monitoring
METTLER TOLEDO offers equipment qualification packets (EQPac) for the qualification of instruments (devices).
This includes necessary documentation to operate a device as per the specification.
For the routine checking of specification-based function, relevant documentations and tools are provided. The EQPac
documents comprise all necessary forms for a proper device qualification (IQ/OQ) that shall be carried out by qualified
persons. METTLER TOLEDO takes care and efforts to train and qualify all its service technicians accordingly. Around
the world, they are ready locally.
Each certified lab with quality management uses a system of test equipment monitoring which also includes the
regular maintenance of lab instruments. METTLER TOLEDO supports the customers with service solutions that in-
clude performance verification, calibration, precautionary maintenance and repair. This support is also in line with
the Good Measuring Practices, a program which includes a variety of measurement techniques such as weighing,
titration, thermal analysis, and more. See also chapter 6.
MQ
5. Routine 1.
Operation Evaluation
4.
PLC 2.
DQ
Qualification Selection
3.
Installation
IQ/OQ
Fig. 8: Care for analysis devices: METTLER TOLDEO covers the entire life cycle (PLC, Product Life Cycle) right from evaluation until routine function checks
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2.7 Skills of laboratory personnel − release untapped potential
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XPE205
XPE205
Untapped potential
Calling on untapped employees’ potential is a complex social, economic and human topic and cannot be solved
technically only. It shall not be dealt with in greater depth in this guide despite its importance. Around the topic
of staff training, METTLER TOLEDO offers many customer seminars, live or on demand webinars and provides
numerous guides, handbooks and whitepapers on a broad range of products and applications. For further infor-
mation or to contact your closest METTLER TOLEDO representative, check out www.mt.com.
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2.8 Chemicals and auxiliary material − manage your inventory
Inventory
Yet it includes information such as documents, files, datasheets, results, reports which easily pile up in a laboratory.
Then documents wait to be proceeded further. Result delivery may be delayed or datasheets become outdated.
See also chapter 3.2 about data integritiy. Once cleaned and discarded/deleted, overviewing and managing of the
remaining materials and data stocks is much easier and faster. No time spent anymore on searching for the right
item. And: Information proceeds in a timely manner!
Inventory waste accounts also for buying the right lab equipment, balances and analytical instruments. Unsuitable,
too low performing equipment and instruments cannot meet requirements but have caused investment costs which
are wasted. An example: To meet the user’s weighing uncertainty requirements a balance of higher performance
(i.e. repeatability, minimum weight) may be needed.
Depending on the sample’s water content, requirements of result accuracy and precision, acceptable measurement
uncertainty, feasible time to result, compatibility with historic data and compliance with regulations, the best fitting
measurement technique is selected.
This may be a halogen moisture analyzer, a volumetric or coulometric Karl Fischer titrator or the loss on drying method
with an analytical balance. The application of the wrong technique ends in inventory waste.
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Lean Lab Guide
In eastern USA, an electroplating company acquired an ion chromatograph (IC) for determining nickel in electro-
lytic baths. Such baths have a very high concentration of nickel and a highly saline sample matrix. They require
complex sample preparation, which, together with the comparatively long sample measurement, made the entire
IC analysis process longer and more complicated. Or in other words, the IC method was more susceptible to
faults, and hence required more intensive maintenance.
As an alternative, the complexometric titration, a robust and approved method that is very simple to automate,
was recommended. In the end, this company was able to reduce quality control efforts by at least factor of
two which made both lab operators and company management happy and highly satisfied – a very much ap-
preciated consequence.
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2.9 CIP activities − trust your staff
Are systematic methods such as value flow analyses, used for process Yes No
improvement?
Yes No
Are staff sufficiently involved in these processes?
Are there dedicated staff who have been trained in systematic Yes No
process optimization?
Count the number of questions you answered with a 'Yes' and add them up.
1-15 Yes
Start a Lean project in your laboratory. Start with small steps. 5S is an effective way to start. Assign a project
leader who can dedicate approximately 20-50 % of their time to this project. Analyses are also good to see
where the greatest deficits lie.
16-28 Yes
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.
29-35 Yes
Congratulations! Your LAB is lean. Keep it up. Continuous improvement and follow-ups 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
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3.1 Automation
Many of these instruments can be operated easily in similar ways using the One Click® function. They can also
be controlled via LabX®, the common laboratory software.
„After a long establishment phase and first five years of routine application, the economical result was astonish-
ingly sobering: The quality of the results was indeed higher than before, lesser retests were necessary and the
results were available quicker. However, the expected dramatic cost reduction could not be attained. It was quite
the contrary”.
Figure 9: Custom-built laboratory automation: Attained economic efficiency only with difficulty. Savings were spent on
additional expenses [9]
Although through automation, the number of laboratory technicians involved could be reduced, the complex
system required new and specialized employees at engineering level to ensure essential system accessibility.
High investment costs therefore needed even larger number of batches to be more economical.
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The economical balance of the system was positive only after a good decade, as the investment was considered
largely as written off.[10]
When compared to this, automatic sample changers and modular analysis instruments are inexpensive. They can be
implemented with low investment risk. They are optimized for simple dedicated operations and are paid off very quickly.
An effective alternative is the single position automations via independent, compact instruments to be uniformly
operated. Such an automated system becomes advantageous with respect to susceptibility to failure and down-
time periods. It can be integrated into a flexible network, controlled and managed via an intelligent laboratory
software, e.g. LabX.
This combination is also largely a still more cost efficient alternative in purchasing, maintenance and qualification.
The probability that simultaneously all instruments in this network fail is far lesser than that of a highly integrated system
whose hardware is dependent on each other. Through individual substitute devices, bottlenecks in sample throughput,
which can hinder the sample approval, can be avoided.
Depending on sample throughput, degree of automation and labor cost savings, ROI of titration systems can
occur typically in a few to several months.
Although this calculation holds a few uncertainties, it is accurate enough to justify the investment.
External consultants too, cannot be more accurate.
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3.2 Data Integrity
Lean Lab Guide
Integer results and data may be used at a later time for various purposes, e.g. for audits, evidence in case
of an incident.
In pharmaceutical industries the requirements for optimal data integrity is extremely high and can be achieved
only with high effort. The measurements of samples have to be done properly. Automatic lab instruments gen-
erate well reproducible results and print records that prove the data integrity and validity of data. However, the
transcription of those 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 minutes
to record a pH value and 60 minutes to transcribe the result to LIMS or ERP software“ or „The manual data tran-
scription takes 40% of the lab technician‘s time“. Also high cost for unusable batches, call back actions and
employees who got fired because of improper error handling are reported.
Manual transcription is expensive and no longer state of the art because there are more efficient solutions avail-
able. There is a high potential for process optimization on the way to a lean lab. The connection of analytical in-
struments and meters to LIMS or ERP systems avoids transcription errors and reduces the transcribing workload
probably more than any other lean measure in this relation.
The data flow in many labs looks like this: The analytical instrument generates results. The data are printed on
paper records. These records are used to transcribe the numbers into reports. Reports are double checked for
errors and maybe results are recalculated just to check if the result is plausible. Some records require a second
person to check again („4 eyes principle“). Reports may also be transcribed into the LIMS or ERP system.
The paper records are stored for a while and then get scanned and stored as pdf on a server for up to 50 years.
Modern data flow solutions provide automated, safe and fast data transfers. Thus, they can contribute sub-
stantially to “Lean Lab“ setups.
Analytical
Printer Lab Journal
Instrument
Report Report
Server Manual data transfer
PC Screen
Approval
Automatic data transfer
ERP
Approval
LIMS
Figure 11: Data workflow in a lab. Green: Modern solution. Blue: Conventional solution
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Lean Lab Guide
3.2.2 Automatic data transfer
Before data can be transferred automatically from an instrument to a LIMS or ERP, a suitable software has
to be installed. The automatic data transfer has to be set up in a way that avoids errors and has to be validated.
This is a remarkable effort and requires IT department resources. Intensive testing is required. Hence, the process
is rather expensive.
If a single transcription error might ruin one result and maybe one batch, a systematic error in a data system
could in worst case destroy the whole data base – a much higher impact. That‘s why each software package
is well tested before it is allowed to get connected to ERP.
A lab has many different instruments. Even in a modern lab, some of theses instruments have no software at all
or one that is not safe enough to exclude manipulation (e.g. „drop at cursor“). Nevertheless, persons in the lab
would like to connect them to a computer for easier control and data capture. As much as 50 instruments and
other devices may add up in a lab. This creates a gigantic workload at the IT department for initial installation
and validation as well as for later updates. All software updates have to be reconsidered with a risk assessment.
In worst case, the whole setup has to be revalidated.
In reality, such kind of projects need high efforts: The customer has to evaluate requirements carefully and the
software company has to implement them. The programmers need to become experts in all analytical tech-
niques and reengineer the algorithms. They need to have good contact to all instrument suppliers in order to get
the data protocols. And this not only for the first version: Any change has to be reflected in new protocols. A large
number of system testers has to test each release and each technique for valid results. The scope of work justi-
fies (almost) any high price.
Alternatively, there are “off-the-shelf” solutions available. Usually they are better tested, cheaper and carry
a lower risk. For the world of chromatography there are a number of software solutions that integrate most chro-
matography instruments on the market. They are written by chromatography experts. It makes a lot of sense to
standardize all chromatography applications to one of these packages. This also reduces the efforts consider-
ably. Typically one third of the instruments in a modern laboratory are chromatography instruments.
Most labs also use balances, titrators, meters for pH, conductivity and dissolved oxygen, as well as instruments
for density, refractometry and melting point. This instrument family makes roughly another third of the lab equip-
ment. Also spectrophotometry is frequently applied.
The METTLER TOLEDO Software LabX has the capability to connect them all to the LIMS or ERP system. It is well
tested for each release and it is an affordable „off-the-shelf“ solution. However, LabX does not support other sup-
pliers‘ instruments.
The data transfer work either via an .API, .CSV or xml format*. Many IT experts will not allow the communication
via API. However, ERP software often has .xml transfer interfaces which makes the data transfer easy to program.
METTLER TOLEDO
Lean Lab Guide
27
Hence, data transfer from LabX via .xml to the LIMS or ERP for all supported instruments is our recommendation
Lean Lab Guide
for lean data integration:
▪ Save lab technicians‘ time
▪ Increase data quality (eliminate transcription errors)
▪ A system that is easy to maintain for the IT department.
Figure 12: Possible network setup with LabX for three labs
LabX is only sold by instrument licenses. Hence, many terminal servers can be installed in the lab without extra fees.
• There is only one connection to LIMS or ERP to maintain for many instruments.
Thus, also the IT process is made lean.
28 METTLER TOLEDO
Lean Lab Guide
3.3 Good Measuring Practices
METTLER TOLEDO’s risk-based guidelines for weighing, titration and all other analytical techniques empower
you to take the right decision when and where it really matters. The five steps of Good Measuring Practices
cover the entire lifecycle of your instruments and provide you with practical guidance to implement a sound
quality management system.
1. Evaluation
Analyze your process flows and its associated criteria to consistently assure the highest quality of your
application and your data.
2. Selection
Choose the ideal combination of instrument and measuring technology to best match your process needs.
3. Installation & Training
Enjoy every confidence in your new device and master 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 maintenance.
Good Measuring Practices.
METTLER TOLEDO’s Good Measuring Practices are available for weighing, titration, pipetting, electrochemistry
(pH), density, refractometry, thermal analysis, melting point, dropping point and UV/VIS spectroscopy.
www.mt.com/gp
METTLER TOLEDO
Lean Lab Guide
29
4 Conclusions
Lean Lab Guide
“Lean laboratory” improvements go beyond just an iterative procedure. In feasible steps, the processes shall be
improved. Therefore, for this, no budget or only a low budget is necessary and granted. The process shall be
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, the equipment qualified and described in the approval documentation and SOPs, changes
can induce high costs and extra work which cannot be recuperated in due time. In such cases one can only
hope that enough scope for process customizations and improvements were given. As an example, to a specific
device (analytical instrument, balance, etc) the supplement “or equivalent” shall not be missed, in order to allow
for later replacement by improved devices or other enhancements.
When knowledge about “Lean Lab” is missing, one can try to acquire expertise via consultants. However, ex-
ternal advisors and consultants often lack the detailed knowledge of lab workflows, internal requirements and
company regulations[10]. Careful selection of the consulting persons and a strict cost control are a must in order
to stay with the “lean” idea and keep budgets low.
“Lean Lab” can be initiated even in small steps. Contributions result module by module and can be extended
anytime. The main focus is on technical aspects such as
▪ Standardized operation of several different devices
▪ Modular device combinations
▪ Standardized network-compatible software
▪ Competent services
The Lean Lab concept is primarily a task of process optimization with the objective to improve the economic
efficiency of the organization (i.e. company, factory, laboratory, etc). This is mainly an internal organizational duty.
With respect to the organizational parts of a Lean Lab concept, METTLER TOLEDO can help only to a small
extent. However, products and solutions such as automated analytical instruments, LabX software, universal
One Click operation and many features of modern balances and analytical instruments contribute considerably
to Lean Lab concepts and help implementing them sustainably.
30 METTLER TOLEDO
Lean Lab Guide
Lean Lab Aspect
– Eliminate wastes Selected METTLER TOLEDO contributions
Invest in the right ▪ Consultancy for design qualification (DQ) or user requirements specification (URS)
instruments and ▪ Good Measuring Practices: Five steps to improved measuring results.
equipment Go to: www.mt.com/gp
METTLER TOLEDO
Lean Lab Guide
31
5 Lean Lab Product Examples
Lean Lab Guide
Titration beakers
(e.g. 100 mL polypropylene beakers)
Safety gloves (1 box)
Soft tissues (1 box)
Titration beakers
(e.g. 100 mL polypropylene beakers)
Rising bottle (deionized water)
Safety gloves (1 box)
Soft tissues (1 box)
32 METTLER TOLEDO
Lean Lab Guide
Helpful Lab Weighing Solutions, Training and Services
from METTLER TOLEDO
weighing funnels
• Optional draftshields, MinWeigh Door for accurate dispensing
TM
Reliable results
• Accreditated calibration services
• Qualification, maintenance and repair services 24/7
• Global reach – local presence, specialists in more
than 140 countries
Skills improvement
• Extended training programs with eLearning
• Internal and external courses and seminars
• Free expertise eg. white papers, checklists, SOP templates
• On-demand webinars and videos
www.mt.com/balances
www.mt.com/lab-accessories
For more information about lean laboratories and lean production www.mt.com/service
with METTLER TOLEDO solutions visit: www.mt.com. www.mt.com/Lab-eLearning
www.mt.com/webinars
METTLER TOLEDO
Lean Lab Guide
33
6 Recommended literature
Lean Lab Guide
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] High Performance Automated Ion Analysis, METTLER TOLEDO, 30019126, ©12/2012
[3] Density, Refractive Index, pH and Color Multiparameter Analysis, METTLER TOLEDO, ©06/2012
[4] Efficiency & Convenience, A Refreshingly New Concept in Juice Analysis, METTLER TOLEDO, ©06/2012
[5] 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,
30100369, ©10/2013
[6] Titration Automation, Automatic Dosing and Pipetting, Versatile and Reliable, METTLER TOLEDO,
51725153, ©02/2009
[7] 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, 30100354, ©10/2013
[8] LabX Software, Simply Powerful, METTLER TOLEDO, 30037208, ©01/2012
[9] Bernd Renger, Privat
[10] Bernd Renger, Consultant, Lean Lab Präsentation, METTLER TOLEDO Customer Seminar, Jungholtz, May 2012
[11] Hasan Yorukoglu, Your time is limited – Kaizen, www.hasanyorukoglu.com/blog, December 11, 2009
and November 17, 2009 and November 17, 2009
[12] Julia von Flotow, Kaizen Lifestyle Management, www.kaizenlifecoach.com/5S.html
[13] Rick Ruzga, Downtime, http://leanvisualblog.bradyid.com, June 2013
[14] Markus Schubnell, Validation in Thermal Analysis, METTLER TOLEDO, 51725141, 12/2008
[15] H. Singer, Kanji A Systematic Approach, 1994, US Library of Congress 94-92402
[16] Debashis Sarkar, 8 Wastes of Lean Manufacturing in a Services Context, www.processexcellencenetwork.com
[17] Lean Manufacturing, e.g. Wikipedia, Oct 13/2015
[18] Kaizen, e.g. Wikipedia, Oct 13/2015
34 METTLER TOLEDO
Lean Lab Guide
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
Management are replaced promptly with 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 optimisation
TPM Total Productive Maintenance
TPS Toyota Production System
WIP Work in Process
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Lean Lab Guide
35
9 Acknowledgments
Lean Lab Guide
Our thanks go to all the internal and external Lean Lab experts who contributed to the creation of this comprehen-
sive and helpful guide.
In particular, we would like to thank Christoph Jansen, Market Manager at METTLER TOLEDO, and Erwin Studer,
consultant and partner of PROFACT AG, who have provided invaluable content and some real life examples.
36 METTLER TOLEDO
Lean Lab Guide
Special Notes
LeanLab – Workload
Laboratory
Production
Laboratory Laboratory
Production Production
www.mt.com
For more information
Mettler-Toledo GmbH
CH-8606 Greifensee, Switzerland
Tel. +41-44-944 22 11