Increase Your Pharmaceutical Laboratory Efficiency with 5S Lean & Track and Trace

Lean is a set of techniques used to manage a work environment by eliminating waste, organizing the workplace, streamlining procedures and establishing clear, visual standards. In a pharmaceutical laboratory, lean initiatives focus on improving safety, eliminating wasted motion, space and supplies, reducing errors, and automating the specimen handling process. The aim is to use less effort, time and resources to test incoming samples, so as to improve measurable performance and reduce costs - to deliver the most efficient and least wasteful process.

1. Work Cell Specimen Processing (WCSP)
One of the most useful lean lab strategies is work cell specimen processing (WCSP)—the physical or logical layout of all testing and processing equipment, technicians, and materials through which a specimen flows. Work cells minimize movement, reduce batch sizes, decrease set up time, improve lab safety and standardize work processes to reduce errors.  Clear and concise identification aids often plays an essential role in such processes, ensuring the right specimen are used each time.

First determine what is needed in your pharmaceutical lab work cell; consider all tasks, tools, materials and information. If you have limited space, implement a lean lab 5S event (read on to learn about 5S) to free up space by eliminating excess supplies and equipment.

Next, cross train your technicians on different types of equipment. This establishes a standardized flow and converts your staff from a "one-person, one-machine" model to a versatile, multi-functional team. This lean lab strategy enables you to adjust your manpower depending on the demand.

If possible, implement a "One Piece Flow" method, where one specimen is moved at a time between operations. Batch processing slows down turnaround time; if a batch of tubes is labeled at once, a technician must then marry each tube to its pharmaceutical specimen, creating a backlog.

2. Remove the Waste
Eliminating any activity that does not add value to a given process helps maintain a lean lab. You can create the first step by specifying value. Identify and categorize every activity in your pharmaceutical laboratory as ‘value add’ or ‘waste’. These should be identified from your customer’s perspective to identify which activities do not serve to increase your product or services’ value. The key focus of any Lean Lab initiative will be to eliminate or reduce the non value add activities or waste. Many pharmaceutical companies are surprised to learn that only a fraction of their activities actually add value for their customers, with 50% or more of a laboratory’s activities considered waste!

Below are some suggestions to reduce common waste in your laboratory:

a) Transportation 
Each time a technician walks around the lab with specimens to get to the next machine, that is time and effort wasted. When planning the layout of your lab, optimize the placement of lab equipment to minimize the distance that samples must travel when processed. It may not seem like major savings, but it all adds up in the long run.

b) Inventory 
Many pharmaceutical labs maintain a high inventory of consumables and materials, which consumes overheads and space. These excess inventories are an inefficient use of resources, and you can cut down on the waste by standardizing consumable types and order replacement using the “Just In Time” (JIT) system. For JIT to be implemented, there must be stringent record keeping and a strict discipline in maintaining inventory levels.

c) Motion 
Each time a technician leaves the work area to find missing supplies, it creates disruption in the workflow and creates a waste of time and effort. Check the lab to reorganize the layout, keeping frequently used items and materials close at hand and well organized for easy retrieval.

d) Waiting 
Specialized cell work stations can only attain efficiencies at a peak flow. In reality, the flow may not be regular or spaced out efficiently. Between peak demand and waiting for specimens to arrive for processing, a flexible staffing model with cross-functional training helps even out work load across stations and keep the lab going.

e) Over Production 
In most pharmaceutical labs, numerous specimens are batch processed at one time, creating a situation where there is a backlog of specimens too large for the technician to handle, and hence creating bottleneck and waste of time down the line. By implementing single piece flow systems that are immediately recognized by LIS, it enables the specimens to quickly flow directly to the next step without waiting.

f) Over Processing 
While it helps to be fastidious about proper paperwork, it is possible to bog down efficiency with too much of it. Poor implementation of documentation process makes tracking down information difficult, which increases turnaround time and wastes productivity. Overcome this issue by implementing standard work protocols and chain of custody tracking.

g) Defective Product
Data error can occur due to illegible handwriting, causing expensive errors in processing samples and specimens. By simplify data entry and data management with bar coding and automated systems that connect to LIS, it is possible to eliminate such errors and increase turnaround time substantially.

3. Optimize Productivity with 5S
The 5S approach emphasizes the importance of maintaining an orderly workplace and using visual cues to reduce the amount of wasted time that is spent searching, looking, waiting and asking, optimizing productivity for your laboratory.
Below are some simple ways you can apply the 5S principles to your pharmaceutical laboratory:

Sort: Reduce laboratory clutter by sorting through all of the items in a given location into essential equipment and unnecessary items. Mark all unnecessary items with a red tag or sticker, and move the red-tagged items into a temporary holding area where management can determine how to dispose of them. A visually neat workplace enhances efficiency by reducing waste of time and effort in locating equipment.

Set in Order: Determine the best location for the remaining items, and use equipment ID to clearly identify flow of samples through the laboratory. Using location identifiers such as labels and tags to clearly identify storage place for every piece of laboratory equipment, and ensure that labels are clearly displayed. Set inventory limits and re-order triggers using replenishment indicators and inventory labels to implement a Just-in-Time re-order system.

Shine: Prevent massive wastage of resources via contaminated testing. Clean your entire laboratory to eliminate the sources of contamination frequently, and use cleaning as a form of inspection to detect equipment abnormalities and impeding failures before they occur. Put in place operator control labels, gauge indicators and hazard warning labels to ensure correct equipment usage and quickly detect operating abnormalities before failure can occur.

Standardize: Create guidelines and procedures for maintaining the first three S’s. Use visual controls like check sheets and schedules to provide daily, monthly or quarterly instructions on how to maintain order. Display operating procedures and maintenance instructions using labels and tags at the point of use to ensure that staffs follow safe and efficient practices consistently.

Sustain: Regularly communicate and train employees to maintain the laboratory’s adherence to the 5S standards. Scoreboards, slogan banners, kaizen improvement displays can inform staff of key initiatives, track performance and recognize their achievements.

4. Implement Track and Trace in your laboratory or production line
Pharmaceutical laboratories conduct expensive and complex tests every day, and it is thus critical that sample carries with it a comprehensive test report to verify the accuracy and authenticity of the sample. Track and trace solutions help laboratories track and trace the pharmaceutical samples as it passes through the various tests in the laboratory, delivering strong financial returns to your operation:

- Improves laboratory or production efficiency- Improves management and reporting

- Improves accuracy and reduce mistakes
- Protects your brand

Track and trace solutions include bar code labels, radio frequency identification (RFiD) tags, holograms and other brand protection devices. Together with software solutions they form a very powerful tool to improve your bottom-line.

Improve laboratory or production efficiency

Many pharmaceutical companies and drug firms invest a lot of money into producing the best drugs, but neglect the track and trace technologies that will protect their investments and increase productivity. For example, can you efficiently and effectively track and trace any error in your laboratory or production line? Can you zero in on defective batches for product recall, or trace the problem to particular lines on the production floor?

Many pharmaceutical companies and drug firms today implement track and trace technologies to improve accuracy, sample tracking and safety. With the implementation of barcode stickers in the laboratory or in the production line, mistakes and production faults can quickly be traced and rectified, increasing productivity and reducing the cost of identifying the faulty machines. You can also easily recall unacceptable product batches with good track and trace practices, since you know exactly which batches are problematic and where they have been shipped. In lean lab terminology, track and trace cuts down on the waste of time and effort it takes to pinpoint and rectify errors in the laboratory or production line. In addition, track technology helps maintain inventories at efficient levels and can trigger re-order statuses for replenishment of stocks for “Just-in-Time” management.

Improve accuracy and reduce mistakes
A laboratory handles hundreds of samples every day, and traditional labeling methods such as handwriting can be time-consuming and error-prone. The ink may smear or fade over time, or the handwriting can be illegible, resulting in misidentified samples and tedious paper trail tracking.

Laboratory barcode labels offers extremely accurate and efficient method of data entry when implementing lean lab operations. A machine-readable barcoding system allows labs to easily identify and retrieve samples, and track the samples’ chain of custody from the time receipt to disposal. Over processing in a lean lab operation can be avoided with laboratory barcode labels to improve tracking of information and improve chain of custody tracking. Even complex pharmaceutical information can fit on to a label, equipping laboratories with advanced tracking capabilities and more detailed data. You can now significantly reduce the amount of errors that take place in a laboratory, and increase workflow productivity.

Brand protection: Defend against counterfeits and grey market
Pharmaceutical companies and drug manufacturers worldwide lose precious revenue to counterfeiters, but through the use of custom-engineered labels and seals, you can create brand protection solutions such as security holograms, color changing film and ink, encrypted data, hidden images, forensic coding and tamper-indicating features. You can consult an expert on brand protection products and services, and learn how a multi-layered and customized solution can serve to protect your brand against diversion, tampering, counterfeiting and piracy.
With an increasingly global market place, the unauthorized sale of authentic drugs requires tighter unit level serialization and track and trace serialization to protect against grey market imports. You should protect your individual markets with track and trace technologies such as barcodes and encrypted serialization for cost-effective unit-level identification and traceability.

Implement a lean laboratory today
Implementing a lean laboratory may seem like a daunting task, but the benefits to pharmaceutical firms and drug manufacturers are well worth the efforts. There are vendors who can assist you in the implementation of lean lab operations, with consultants who can recommend you cost-efficient solutions. Lean lab implementation can be a science in itself, but many of the techniques are logical extensions of any production facilities. You should start your first steps towards a lean lab by inspecting your current operations, and use visual aids such as signs and labels to improve your efficiency and cut waste in your laboratory. Also consider implementing track and trace systems to cut waste in document processing and improve chain of custody tracking.