5S for the Laboratory

"Who took my stapler?

Wheres the multi-channel pipettor gone?

Can't find the autoclave tape?

Wheres the auto-rep charger?

Why are we hoarding empty pipette tip boxes?

That machine has been used since 2011!

Where has the balance disappeared to this time?

Where is my mind????" 

Sound familiar??? This is a typical case for a 5S intervention! A clean, well organised, visual workspace is essential for structure and efficiency in any working environment. 5S is the first step towards creating a leaner, highly efficient and productive laboratory.

 5S for best lab practice

Sorting (Seiri) 

Seiri literally infers clear the work area and remove unnecessary items. Seiri means dump, discard, donate - clear the area of unnecessary items or items that are not used regularly. Get rid excess pipettes, tip containers, unused/excess inventory and out of date documents. Iif items are no longer needed, or are not being used regularly they should be cleared and not take up valuable lab space. If it doesn't belong to the lab then get rid of it. The Kanban system is a useful tool for this step of 5S. Use Kanban cards for uncertain items - red tagging is a visual management tool to designate the status of an item and help identify unnecessary items. Items are tagged for discarding, recycling, removal or relocation. Establish a red tag holding area for these items and create a clearance inspection schedule to sort held items on a regular basis. Kanban cards are useful for restocking and maintaining inventory. Sorting creates a more spacious ,purposeful workspace that saves time, energy and improves laboratory morale!

Set in order (Seiton) 

After sorting its time to organise the remaining items. Arrange and identify equipment, instruments etc. with visual aids. Give every item a designated area - use tape or paint as demarcators to outline areas and label the item and its designated area. Only the specified objects or instruments should be placed in their respective designated area. Colour coding is an excellent visual management aid that facilitate Seiton. In addition to the order and placement of items, specific storage areas for consumables should also be established. Optimize storage facilities and create more signage. Outline spaces on the floor, identify pathways, storage areas, waste location etc. and ensure there are no obstacles. Shadow boards are excellent for arranging tools and equipment. Set in order helps to arrange items so they can be found easily by anyone and returned to the rightful place by anyone. This is essential in shared work environments. It eliminates waste by duplication and time spent searching for items.

Materials, instruments and equipment set in place in QC labs 

Shining (Seiso) 

Most labs should be spotless, nevertheless it is important to make sure that all areas and all utilities are impeccably clean and kept that way! Shining will provide a more comfortable, pleasant workspace and instills a sense of pride. Shining enhances workplace safety and will also prevent equipment deterioration. Shining makes problems obvious and facilitates regular inspections for leaks, vibrations, breakages, and misalignments. Shining should be a daily routine and should also include inspection and routine maintenance.

Let it shine!!!

Standardizing (Seiketsu)

5S should be a daily routine with regular evaluation. Standardize entails a system of tasks and procedures to ensure continuous implementation of 5S. 5S consistency requires managing people, processes and equipment for effective implementation of 5S. Employees should be made aware of their responsibilities, facilitated by signage and visual awareness. Develop checklists and storage maps and assign tasks to individuals. Develop SOPs, this can improve training, helpful for new employees, saves time and improves efficiency. Allocate a specific time to conduct a 5S audit. Standardise taping, labelling, demarcation - make colour coordination and labelling consistent to minimize confusion.

Taping standards for 5S

Sustaining (Shitsuke)

Now that you have created a 5S workspace it is important to keep it that way! Create a 5S audit to ensure that areas are sorted, set in place and clean! Get everyone involved - motivation and commitment is essential for effective 5S implementation. Create a reward system to encourage people to maintain high standards of 5S - use 5S audit sheets as a scorecard for inter-lab competitions. Make 5S visible by displaying posters or newsletters and signage to create a constant reminder of 5S.

See the difference before and after 5S

Lean Kata

Kata is the Japanese word that means form. A Kata is a detailed choreographed ritual of movements traditionally practiced in martial arts. The skills are handed down from master to student over many generations. Kata is a pattern of behavior, when practiced repetitively it becomes second nature. It is commonly referred to the Toyota Kata and is defined as an integral tool of change throughout the whole company. The key to Kata is habit. In Lean terms, Kata is a routine, standardized, synchronised process, it includes Improvement Kata (IK) and Coaching Kata (CK).

“The systematic pursuit of desired conditions by utilizing human capabilities in a concerted way.”

Mike Rother, author Toyota Kata

Improvement Kata

Kata is an important aspect of a Lean laboratory to implement Kaizen, standardize and sustain Lean initiatives. An improvement Kata is a strategy of moving from a current condition to a new situation in a systematic, directed, meaningful way.

It is based on a four step procedure:

• Understand the Direction

• Grasp the Current Condition

• Define the Next Target Condition

• PDCA - Plan Do Check - toward the Target Condition

 Simple Kata routines in the laboratory could include:

• Gemba - Regular Gemba  ensures that a Lean culture is being implemented through practice and training. For instance, observe 5S, Kaizen projects  and other lean initiatives in the lab.

• Sustainment - sustain successful Kaizen programs - delegate responsibilities and implement regular audits. 

• Repeat and implement - replicate sustained improvements in other processes.

• Bottom-up Improvement - improvement that happens outside of a Kaizen event, start small and build small incremental changes towards improvement. This may involve something simple like relocating an instrument to streamline a process and reduce muda (waste).

Coaching Kata

The Coaching Kata supports Improvement Kata by encouraging learning and training to improve the current condition and ensure that porgress is being made townards the target. Coaching Kata is instrumental in the fourth step of the Improvement Kata, PDCA (Plan, Do, Check, Act) towards attaining the Target Condition. The Coaching Kata question cards are an excellent resource to support IK.

The IK Reference Guide 

by Mike Rother

Further information and resources

Check out the Toyota Kata and the Kanban Kata.

I love Lego so I highly recommend these Kata presentations by Hakan Forss.

Laboratory logistics and process flow

 

Minimize Motion and Transport Muda in the Lab

Continuous operational flow with streamlined processes is the ideal for any analytical lab. This can be achieved by organising the workspace to reduce time wasted by motion and transport. Creating a motion map or a spaghetti diagram can help understand process flow and identify areas of "traffic", unnecessary journeys, obstacles and bottlenecks - see the map I generated for a PCR process below. Draw a basic floor plan of the facility and map every motion involved in a process - record the amount of time spent in motion and gauge distances. Review the map and data and see how process motion can be improved. Can the workspace be reorganised to minimize the amount of travel? Can instruments be relocated? Can consumables or reagents be stored in more accessible area? Many facilities have shared equipment rooms - can the number of visitations be reduced. Consider batch size also, is it better to process smaller amounts or take several journeys to transport a larger batch? Review transportation methods - if there's a trolley available use it! Motion and transport are huge wastes in laboratories and they also contribute to waiting. Not only is time wasted physically, but sample deterioration can also occur, not to mention opportunities for bioburden to accumulate. So when streamlining an analytical process consider levelling sample loads, ensure that the queuing system is optimized for sample storage and enhance logistics by making equipments an instruments readily accessible to minimize journeys and delays. 

Spagetthi Diagram - Motion Map

Spaghetti diagram for my qPCR assay.....clearly we need to rearrange a few things!

Time, money and energy is lost in motion!

An optimized process flow with reduced transport and movements can help minimize errors and reduces fatigue for the lab staff. Continuous flow, creates a more streamlined workload and increases productivity. Mapping a process is an essential step of value stream mapping and is very useful in identifying waste, delays and bottlenecks: 

• Unnecessary motion of people during process sampling

• Unnecessary transport of personnel, product, sample, reagents, information

• Inconvenient location of equipment, instruments and materials

Many companies will have a value stream map (VSM) for a product. However it is worth creating a specific VSM for the QC analysis process of that product to help improve laboratory efficiencies. Time is also lost in the transfer of information and data. Processes should be optimized to ensure there is an efficient system in place for sample collection, data processing and delivering data results. An efficient LIMS system will dramatically improve data transfer and reduce waiting. The Kanban tool can be used in conjunction to help visualise the process, particularly where quesues and volatile workloads are involved (refer to Kanban post).

An example of bioMérieux Work flow Optimization

Spaghetti diagram of current workflow and new implemented workflow

Value Stream Map

Creating a current state value stream map is an efficient tool to understand the logistical flow of a process, provide detail on the value of each step and detect non value added elelments with opportunities for Kaizen events - continuous improvement. A VSM illustrates the flow of information, data, processes, inputs outputs and integrates metrics to evaluate value in terms of time and cost. A current state VSM with Kaizen events can be used to project future efficiencies by generating a projected, future state VSM. The illustration below outlines the flow of infomation, materials and lead time. Each individual step in the process includes metrics relating to cycle time and delays. 

Current state VSM can provide details relating to:

First in First Out Processing

• Queues (backlog) of work items. Queues are organised based on the number of items waiting to be processed. 
• Queues can be prioritized in several ways, i.e. First-In-First-Out (FIFO) 
• Wait time - how long a sample is in a queue
• Work time how long it takes to process/analyse a sample 
• Identifying bottlenecks and causes of delay 
• Identify areas of unproductive work, resource imbalances 
• Areas of automation or manual processing

Current VSM depicting the process flow of a sample from delivery, processing to release of results, with intermittent Kaizen events.

Kanban

Kanban is a Japanese word that means “visual card”. Kanban is a system for organising workflow, task prioritisation and effective use of personnel and resources for just in time delivery (JIT). JIT sample analysis is enhanced by automation, efficient sample levelling and continuous operatioal flow.

1. Process visibility

In a Kanban system it is important to visualize the work flow. This may involve creating a Kanban board, dividing the work process in to smaller steps, each step is identified by a specific coloured card. The card contains the information about the process and the person responsible. The cards are placed on a workflow (Kanban) board outlining samples waiting for analysis, queued, work in progress (WIP), completion and release so that the process flow and progress is clearly visible.

2. Limited WIP (work in progress)

In the Kanban system, increasing the visibility of a process and task status makes it easy to identify backlogs, constraints, overburdened employees and bottlenecks. The system sets specific limits for how many items may be processed at any time. In this way tasks are completed just in time (JIT) to limit backlog.

3. Monitor lead time 

The Kanban system optimizes processes by predicting workflow and reducing the lead time - average amount of time it takes for a task to be processed from the specific start to the finish point. In laboratoty terms, this can relate to the amount of time it takes to process a batch from collection, sample analysis and data transfer. Kanban metrics can be used to analyze the time required to process samples to make improvements for an efficient continous flow operation.

4. Make Process and Policies Explicit

Processes need to be clearly defined, explicit and communicted effectively in order to be understood. Without clear ojectives and general consensus, people are less likely to engage in process improvement and and adopt changes.

5. Collaborative Improvement

The success of Kanban requires small incremental changes for continuous improvement and sustainment. Team engagement and a holistic approach to continuous improvment throughout the facility is essential.

Kanban Inventory 

Managing inventory is an important aspect of minimising waste in laboratories and it complements the 5S initiative. A Kanban system may be used for inventory maintenance, particularly restocking. Other inventory examples where Kanban is apparent include colour indictors for different samples according to urgency or batch, a common practice in clinical labs. 

Kanban Board

A Kanban board is an effective visual management tool that provides an excellent overview of a current work situation by making process flow, tasks and responsibilities clearly visible. It enables clear identification of backlogs, heavy workloads, overburdened resources and personnel. It is also an excellent way for employees to keep track of their own progress and work load management and it simplifies communication within a team to enhance productivity.

Kanban board

There are also numerous digital Kanban software programs which may be a good tool for integration with LIMS to enhance communication and collaborate analyses in real time.

    http://leankit.com/kanban

   https://kanbanize.com/

    

http://kanbantool.com/

https://kanbanflow.com/

Eliminate Waste

Muda is the Japanese word meaning futility, idleness, waste.

Anything that doesn't add value to a process is wasteful.
Identifying waste is critical to Lean practice - the 3M wastes include Muda, Mura, Muri 

            u

Muda

Muda (waste) is any activity that doesn't add value to a process or product. The 8 wastes in Lean are:

• Transportation - movement of material

• Inventory - use of space and funds to hold inventories of material

• Motion - movement of people

• Waiting - queuing or scheduled delays

• Overproduction - producing more than necessary – in lab terms this could be media, buffer or other reagents

• Over processing: excess work or checks in process

• Defects: work (samples) that needs correcting or repeating

• Skills - unused talent or potential

Mura

Mura (unevenness) is the waste associated with variations in work loads - a common occurrence in labs! Samples delivered and analysed in large batches impedes continuous flow. Lab workloads are volatile and are characterised by peaks and troughs. Imbalanced workloads negatively impact productivity and reduce lead time performance. Balancing the workload is an essential aspect of lean implementation to create a continuous flow rate. This can be achieved by levelling incoming samples by implementing a queue system at the start of the process with gradual release of samples to the lab. In biopharma, the sample flow rate is determined by production - lean manufacturing is necessary to alleviate Mura however it is not always possible due to batch processing is and queueing is dependent on sample stability.

The effect of unevenness and instability on lab productivity

Muri

Muri (overburden) is the overloading of people or equipment. Muri is often directly caused by unevenness (Mura) when lab analysts are overloaded by peaks in the workload. Muri can be alleviated by effective resource scheduling levelling the workload to meets demands.

Mura, Muda and Muri operate in synchrony. Eliminating one also eliminates the others. Identifying all aspects of waste is critical to lean implementation. Value Stream Mapping (VSM) is a powerful tool for process improvement. Similarly, statistical process control charts can help evaluate process efficiencies and identify 'special causes' or anomalies within a process. SPC charts can help assess variations within a process. It is most applicable to upstream and downstream bioprocessing, however SPC can also be effective in evaluating throughput efficieincies in laboratory sampling and may be valuable in detecting variation in analytical processes. Check out the case study Statistical Process Control (SPC) and Catalent.

Process Control Chart

SPC chart outlining the upper (UCL) and lower (LCL) control limits. Generally time or sample number is on the X axis and analytical or process parameter on the Y axis 

Go To Gemba!

Observe, Engage, Improve

Gemba is a Japanese word which means “at the site”. In Lean, Gemba means observing a process in action. The first step in the Lean process is go to Gemba - go and see!

Identifying muda or waste in the lab is key to successful implementation of lean. In order to identify wastes and defects it is necessary to go to Gemba and observe, engage in the process. Gemba is essentially a waste walk or audit to get an understanding of a situation, process, purpose and people. Improvement can only occur if the situation is adequately understood. There is no point assessing a process from the desk, muda isn’t evident from remote assessment. During Gemba consider SIPOC: Supply Input Process, Output, Control.

DMAIC applied to Biomanufacturing

DMAIC approach to define, measure, analyze, implement, and control variation

BioPharm International. 2008 Nov;21(11);54–60.

Process Capability

Process capability is defined as the "quantifiable measure of a process. For the qualitative assessment of an organization". In Six Sigma Process capability (Cp) or process capability index (Cpk) determine whether the process is capable and is the process acceptable. Process capability is determined by the upper and lower specification limits and standard deviation a process operating at Six Sigma level has a low degree of variation and a process capability value of 2.

 

Process capability and Statistical Process Control

Process capability values for processes at sigma level 3 to 6. A Cp value less than 1 has a large degree or variance and is not a capable process.