LEAN Manufacturing

CONTACT: Leonard B. Antosiak - Pharmaceutical Production TechSource® - P.O. Box 1145 -
Ann Arbor, MI 48106-1145 - (Telephone: 734.528.0444) - (eMail: ppt@2020comm.net) - (WEB PAGE: http://PharmaceuticalProductionTechSource.com)

LEAN Manufacturing

LEAN Manufacturing and Much More...
(Eliminating waste from all aspects of your business! Applicable to any industry.)

The following topics are addressed on this page: Simplifying LEAN Manufacturing? - Outsourcing Supplement Production and LEAN Manufacturing Insuring Product Quality and Eliminating Waste - Line Balancing Basics Improving Efficiencies in Repeatable Processes

(If you have interest in any of the articles, send your name and eMail address to: ppt@2020comm.net requesting which article(s) you would like, and we'll eMail you the article.)

TechSource® experts have more than 30+ years of experience in implementing Lean concepts. Not all companies need to install a full-blown Lean program. For many organizations, targeted portions of the philosopy may be all that is needed to reap some of the following benefits: increased product throughput improvements; reductions in defects and rework; improved morale and employee participation (employees behaving like owners); reductions in transport, moving, waiting, space and physical waste; quicker responses to changing customer requirements; increasing inventory turns, reductions to work-in-progress, and inventory capital reductions. These are only some of Lean's benefits.

Simplifying LEAN Manufacturing?
by Paul M. Reece

Lean is derived from a Japanese manufacturing philosophy. Simply stated, it is the elimination of waste from all aspects of your business! Starting a new program, especially in smaller pharmaceutical, supplement, beverage and food companies requires a commitment of resources, and that is an important decision. Why start a Lean program when there are so many ofther needs that require your attention? The following decscribes what is involved in "Lean", and how a company will benefit from a program, or, segment(s) of a program.

Implementing a complete "Lean Manufacturing" program may not be possible for every organization. Many companies can benefit from implementing only portions of the Lean philosophy. Every organization has different needs and resources. There is no one size that fits all companies.

Many smaller manufacturers are reluctant to implement a complete Lean program because they believe that by initiating such a program may require:

Too many resources are needed to be dedicated to Lean, or, they believe those resources can be put to better use elsewhere

Lean requires specific skills and knowledge that only bigger companies can afford

The benefits will be minimal for the investment

The language of Lean, i.e., Value Stream Mapping, TAKT Time, Line Balancing, Synchronous Flow Production, 5S, all sound as though they would need a Lean engineer, or a Lean guru to implement their program to realize its benefits

They may not want to change for fear of Food & Drug Administration (FDA) regulations and oversight, United States Department of Agriculture (USDA) regulations and oversight, or, because of a Standard's organization that may have certified their operation

Or, many companies are just not sure what's involved in Lean manufacturing and fear the unkown?

The dedication of too many resources, needing specific skills, minimal benefits, and language are just not ture. Companies may not wanting change, or, their lack of knowledge about Lean are very real. Every company, regardless of size can benefit from implementing Lean philosophies in part, or, for their entire operation. Lean should not be complicated, and the jargon should not keep companies from the benefits of Lean.

Each business has unique cost drivers. You'll need to determine which areas of your business can benefit the most from Lean. Once you have success in one area, then you can move onto others in their order of priority.

The best place to a Lean program in in housekeeping. It is critical to eliminating waste! Organize the work area, warehouse, and the office. Make sure only those things that required for the work area, are present in the work area. Everything in the work area should be labeled, have a home, a purpose, and always be accessible to the user. The "Lean" method to achieve this goal is called 5S: sort, straighten, shine, standardized, and sustain (service).

It's difficult to assess your needs until you have a structured and organized operation, and 5S is an excellent tool to accomplish that goal. Find a book, or, look up 5S on the Internet, choose a program that will work in your facility and get your started. This will provide immediate returns. Involve everyone in the 5S project in his or her area so everyone has ownership. Once organized, and a high level of organization has been sustained, then begin to identify those areas with the highest levels of waste. However, what is waste?

Spedning time looking for a tool, a chart, waiting for a mahine repair or a changeover, walking around a stack of material not needed for production, waiting for materials to get to the machine or line, are all waste. You can never regain this time. The Japanese have a word, "Muda" which literally translates as "futility", in Lean this is called "waste". There are 7 forms of waste identified in Lean Manufacturing; we'll add two additional forms of waste that we believe are vitally important. Making for a total of 9 forms of Muda/waste:

1.) Defects cost you money and are a part of a process that is out of control.

2.) Waste in the production process, in many instances, can be corrected with line balancing.

3.) Overproduction, when you are making additional product not required by the customer, you are wasting money and resources.

4.) Wait time is inefficiency! Precision planning and scheduling should be emphasized.

5.) Transportation within your facility is a great opportunity to optimize your process.

6.) Inventory, too much or too little of anything is a detriment.

7.) Unnecessary motion is time and money and that can never be recouped. Maximize your work spaces/areas.

8.) Unsafe, or non-ergonomic work conditions, cost money, and impair worker morale.

9.) Underutilized human potential prevents worker skills, talents, and creativity from coming to the forefront, and benefiting the company.

Ask your workforce, they will tell you more than you can imagine about where the waste is in your operation. The difficult part is listening and taking the corrective actions to help insure that your operation is going in a Lean direction.

Track and post Key Performance Metrics so everyone knows how they are performing, and what their goals should be? Ensure that each area of your business is driven by specific goals that dirve continuous improvement, and that each goal ties into your company's long-term goals.

The last form of waste (underutilized human potential) is the most costly and non-recognized from of waste. Not including all employees in solving problems in their areas, in making needed improvements, not getting everyones ideas, not listening, poor or ineffective leadership, poor personnel interactions, a lack of common goals between departments and shifts, and poor morale all result in a tremendous amount of waste. Employees want to be a part of the solution. Employee empowerment is essential to your success.

If your company does not have effective leadership, teamwork and high morale, you have just identified your biggest needs for improvement. Owners, managers, and leaders should start with tehmselves to look for improvement. Everyone has to be on-board. You need to bring the team along through communication, support and training, and the whole team has to have common goals. Provide your people with all the tools necessary to be successful.

A common misconception is that Lean is only for the production process. Lean philosophies should be applied throughout the organization. Look for applications in your manufacturing suite, filling lines, packaging operation, warehouse, quality control, and anywhere you believe that waste can be eliminated. Companies tend to overlook the administrative process; usually, this area does not get the focus it deserves. While it is true there are a lot of opportunities to improve manufacturing, not part of your business is exempt from the need to eliminate waste.

As you begin to implement your Lean program, or parts of a program, you become better at identifying the defining the 7 forms of Muda/waste, and what it means to your organization:

Defects: count and analyze every defect every day and track trends, make decisions based on that data, and make it important (affect employees' bonuses or compensation so they know its important). Reworking or trashing defects costs time and money. The "cost of quality" isn't the price of creating a quality product or service. It's the cost of NOT creating a quality product or service! As stated by W. Edwards Demming.
Waste in production: balance your process, and design your process to TAKT Time (the time available to complete the work), there are many great books about standardized work. This is an area where outside help may be beneficial if you do not have an engineer, or strong technical person on your team.
Over production: build to your customers needs. It is very easy to tie-up a lot of money in raw material, work-in-process, and/or finished goods. You should manufacture to TAKT Time. However, you need to consider variable delivery times for material, and outbound finished goods. Too much inventory ties-up money, and can lead to obsolescence. Inventory has to be stored, counted and rotated. Those activities cost money!
Wait time: operators should be treated like surgeons. They should have everything they need to perform their jobs with the utmost proficiency. Changeovers should be planned and choreographed so there is NO, or minimal wait time. In-line production repairs that stop the process should be taken off-line when possible. An effective documented preventative maintenance program should be in-place to reduce wait times and prevent production interruptions. Operators should never have to wait for a batch for compression, solution for a filler, or bottles to fill product. An effective preventive maintenance program properly implemented and managed can eliminate many issues related to wait time.

Another possible mtehod to eliminate wait time is to use a "water spider". This is a person who ensures that everything is brought to the operator; i.e., trash is removed, material is moved as needed, and performs functions that are non-value-added to your process personnel. The water spider ensures that there are no interruptions to the production process, and that your operators are performing only value-added tasks. Committing to another person in the process should be the result of a cost benefit analysis. Also, line balancing is a very effective method to help identify and elminate wait times.
Transportation: poorly designed internal material routes result in unnecessary congested traffic. Repeatedly handling material, and not having material stored near the point-of-use creates waste. 5S will help to determine where the material, and material moving equipment is stored. This should be done in compliance with your specific governing manufacturing guidelines per FDA, USDA, standards organizations, etc. Analyze your traffic patterns to reduce material movement. Also, analyze human transport within your facility to maximize your personnel's internal walking routes.
Inventory: set your inventory levels (raw material and finished goods) to your lowest comfort level based on customer demand. Each week after that, lower it incrementally again, you will start to see the problems: as the inventory levels are lowered, associated problems will arise, solve those problems, and lower it again. Repeat this exercise until you optimize your inventory levels. You want to stress your system to the point where you become comfortable with the lowest inventory level possible. Too much inventory ties up money, can lead to obsolescence, has to be sotred, counted, and rotated. Those activities cost money. Work-in-process should be at an absolute minimum.
Unnecessary motion: non-value added activities like moving material, handling material multiple times, inspecting material (sometimes you have to inspect), but inspection is a non-value added activity and is the result of a process that is producing defects. Videotape your manufacturing, material movement, packaging, line balancing, 5S, and any other area of your operation that you feel is necessary. Then have your team work-group review the tapes for the purpose of identifying unnecessary motion. This exercise should provide you with good results.
Supplier development: inspecting product (imported or domestic) to esnure its quality creates duplicity in handling material, potential delays (wait time), in addition to paying a premium on top of your initial product cost. While this may be a "necessary non-value add activity", but it should not be at your expense.

The cost of improving your supplier's process should be the supplier's responsibility, along with the cost associated with receiving defective material. You are expected to deliver quality products; your suppliers should have the same expectation. Inspection does not assure quality. Only a process that is in control will produce consistent quality. Don't make the mistake of confusing inspection and testing. In-line process testing that verifies process control and error proofing is a very important effective function, especially when automated and incorporated as part of the process.
Quality: W. Edwards Deming said that "Quality is conforming to specifications." Conforming to specifications is achieved through documented systems and job instructions so the process is repeated. Employee training and reducing variation between shifts can best be addressed with documented repeatable systems and job instructions. To ensure system compliance, process audits should be a very important part of your system. If you do not have documented systems and process audits, you do not have a repeatable process, and you are not manufacturing to specifications. According to the FDA, if its not written down, its not been done!

Why initiate a Lean program? The reality of any business today is:

Costs rise with materials, time, transportation, rent, utilities, insurance, machinery, etc., and continue to increase while income for many companies may be stagnant or even decreasing?

Stock holders/owners want a fair return on their investments, increasing costs put pressure on return-on-investments (ROI).

Customers want lower prices, and competition from off-shore companies continue to drive down selling prices.

Employees want fair compensation and they expect growth in pay and benefits.

How does an organization deal with these realities? Growth is not always and option, and not always within your control. However, eliminating waste in your organization is always possible, and is always within your control. Even the most efficient operations have opportunities for eliminating waste.

Telling your employees to work harder, or, to offer more suggestions may create a short-term improvement (Hawthorne Effect). But identifying the systemic inefficiencies within your oganization will provide sustainable improvement, and will help create the culture necessary to make you become and stay competitive. Developing a culture where all employees have the skills needed to identify waste, take ownership for quality, solve problems, and the motivation to care about the long term success of the company are essential in today's global market.

The elimination of waste through continuous improvement in your production processes, material, work-in process, scrap, administration, quoting, systems, administrative policies and rules is an effective and available way for you to control and reduce the pressures on your bottom-line! Lean principles, leadership skills and ergonomics when improved together will improve output, morale, and the bottom-line. Each are a means to the elimination of waste, waste-in-process, people interactions, and a more focused goals driven direction.

There is no end of material available for Lean manufacturing, just go to the Internet, or to your bookstore for starters. These are good places to start developing, or, evaluating your Lean needs! Some State Governments even provide financial support to companies for Lean training and implementation.

Expected Benefits from Lean Manufacturing:

Improvements in throughput and enhanced bottom line

Reductions in defects and rework

Staff morale improved, their participation in the workplace, and involvement because of their buy-in into the philosophy

Reduced transport, moving, waiting, space and physical waste

Quicker responses to changing customer requirements

Increased inventory turns, reduced work-in-progress, and reduced inventory capital

Production Benefits:

Labor reduction through process improvement (line balancing)

Overproduction reduced or eliminated by manufacturing to customers needs

Space for production processes is reduced, because the amount of space required is being better utilized

Defects are reduced through standardized work, repeatable processes, documented systems, and reduced obsolescence

Unnecessary movement with a reduction in distances for people and equipment

Inventory Benefits:

Raw material reductions

Work-in-process reductions

Finished goods adjusted to customer requirements

Material movement reductions

Leadership Benefits:

Improved problem solving

Overhead reduction

Leadership skills improved

Communication skills improved through posted key performance metrics

Focused goal leadership

Common goals become more focused

Egronomic Benefits:

Injuries reduced through improved ergonomics

Reduction in health care costs due to reduction in work related injuries

Recommended Readings:

"The Toyota Way" by Jeffrey Liker

"The Visual Factory: Building Participation Through Shared Information (See What's Happening in Your Key Processes - At a Glace)" by Michael Grief

"Juran on Leadership and Quality" by Joseph M. Juran

"A Path Less Traveled" by M. Scott Peck

"A World Waiting to Be Born" by M. Scott Peck

"The Goal" by Dr. Eliyahu M. Goldratt

"7 Habits of Highly Effective Leadership" by Stephen R. Covey

"Principle Centered Leadership" by Stephen R. Covey

"The Flight of the Buffalo" by James A. Belasco and Ralph C. Stayer

"One Minute Manager" by Kenneth Blanchard

"The One Minute Manager Builds High Performing Teams" by Kenneth Blanchard

"Leadership and The One Minute Manager" by Kenneth Blanchard

"Hierarchy of Needs" by Abraham Maslow

Outsourcing Supplement Production and Lean Manufacturing
Insuring Product Quality and Eliminating Waste
by Paul M. Reece and Leonard B. Antosiak

Increasing costs are the reality of today's supplement manufacturer! Many are addressing the dichotomy of increasing costs, and a more comptetitive marketplace by implementing and managing Lean manufacturing practices. Lean requires a culture that believes in continuous improvement through the elimination of waste.

There are Lean programs and Lean definitions, but the sole purpose of Lean is driving waste from all aspects of the business. Lean manufacturing, a Japanese philosophy, is simply the elimination of waste through continuous improvement.

Selecting a supplier with a strong Lean culture and proven Lean systems when production is outsourced, is your best insurance for avoiding a supplier's requests for price increases. Also, it helps to insure that your cost and quality objectives are met, and will continue to be met.

Developing the scope of work: planning and creating clear expectations are the key to successful outsourcing. For tablet manufacturing, develop a thorough, exact set of specifications/requirements that paint a clear picture of your desired outcomes. Include everything from the supplier's vendor selection, tablet design, date and method of shipment, and everything in between. Milestones are critical during the supplier planning/approval phase, lauch phase, and production. Developing the initial contract is the most important step in the outsourcing process, although it's not the only critical step.
Values and culture: subcontractors may not share your values, or, they may not have a culture that is conducive to continuous improvement. Your supplier evaluation should include a review of subcontrator's philosophy, employee morale, housekeeping, teamwork, and their commitment to contiuous improvement. Underutilized human potential (9th form of waste) is essential to a successful outsourced product. This is often overlooked, and it encompasses the greatest opportunity for achieving production cost, quality and delivery objectives.
Managing the scope of work: buyers who have their own set of requirements/needs may negotiate your production contract; while the production, sales, and quality teams may all have different expectations or needs from that of the buyer? This is a recipe for a very difficult customer/supplier relationship. This is the time to focus on common goals to ensure that all needs of the affected teams are met. An experienced program manager will ensure the scope of work is clear to all parties, from the negotiation stage to completion. A competent program manager will also ensure the scope of work is met while educating customers and suppliers to the documented agreement. You should get what you agreed to pay for! Defining that in the beginning and managing to those expectations is crucial to a successful outsourced product. A Responsibility RACI (responsibility, accountability, consultation, and information), matrix is an effective tool for clarifying and ultimately managing the scope of work. RACI defines who is responsible for which deliverables: planning, setup, reporting, delivery, trasportation, etc.
Supply chain management: the scope of work needs to define responsibilities not only for your supplier, but also for your supplier's responsibility to manage their supply base. For example, you don't want an ingredient substituted for in your finished tablet, not be told, and not have it identified on the product's label. Subsitutuions are not uncommon, and many times occur somewhere in the supply chain.
Assessing a suppliers Lean capabilities: specific expectations should be spelled-out in the scope of work for continuous improvement, in adherence to the Lean manufacturing principles outlined below. The easiest and most telling place to start assessing a supplier's Lean capabilities are in housekeeping, this area is critical to eliminating waste and to the overall quality of your manufactured tablet! The supplier's work areas, warehouse, and office should be oraginzed, labeled and in showroom condition. The supplier should ensure, things that are required for the work area are present in the work area. Everything in the area should be labeled, have a home, a purpose, and always be accessible to the operator. Housekeeping and cleaning are drop-dead issues for the FDA. For good insight, visit the FDA web site addressing regulatory expectations regarding cleaning: Title 21 Part III in the "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling and Holding Operations for Dietary Supplements".

The Japanese have a word, "Muda" which literally translates as "futility", in Lean this is called "waste". There are 7 forms of waste identified in Lean manufacturing; there are additional forms of waste sometimes identified by different authors. We believe there are 2 additional vitally important forms of waste for a total of 9:

1.) Defects cause reworking or scrapping of product, its an unnecessary cost, and identifies a process that is out of control

2.) Waste in the production process can be corrected with line balancing

3.) Overproduction, making additional product not required by the customer, a waste of money and resources

4.) Wait time is inefficiency, and operators should never have to wait for product

5.) Transportation within your facility is an opportunity to optimize your process

6.) Inventory, too much or too little raw material, work-in-process, finished goods, etc. costs money

7.) Unnecessary motion by employees is time and money that can never be recouped

8.) Unsafe, or non-ergonomic work conditions, cost money, impairs worker morale, and can lead to higher health care costs

9.) Underutilized human potential prevents worker skills, talents, and creativity from coming to the forefront, utilize your personnel's knowledge

Lean philosophies should be applied throughout the supplier's organization. Look for application(s) in their manufacturing suites, filling lines, packaging operations, warehouse, quality control, and anywhere you believe that waste can be eliminated. Companies tend to overlook the administrative process, this area doesn't get the focus is deserves. While its true there are a lot of opportunities to improve manufacturing, no part of a business is exempt from the need to eliminate waste. When assessing supplier capabilities, review their approach to dealing with each of the 7 primary forms of Muda/waste.

Defects: ensure that the supplier counts all defects, tracks trends, and makes decisions based on that data. The "cost of quality" isn't the price of creating a quality product or service. It's the cost of NOT creating a quality product or service; as stated by W. Edwards Demming.
Waste in production: Suppliers should balance their process using effective line balancing practices, and they should design their process to TAKT Time (the time available to complete the work).
Overproduction: suppliers should manufacture to their customers needs. It is very easy to tie-up a lot of money in raw material, work-in-process, and/or finished goods.
Wait time(s): operators should be treated like surgeons. They should have everything they need within their reach to perfrom their jobs. Changeover should be planned and choreographed so there is no wait time, require no special tools, and be should be able to be completed by the operator. An effective documented preventative maintenance program will reduce "wait time(s)" and production interrruptions.
Operators should never have to wait for a batch to be blended for compression, or, a solution to be mixed for the filler, let alone for bottles to be presented to the packaging line for filling capsules. An effective preventative maintenance program properly implemented and managed, along with precision planning and scheduling can eliminate a large source of your wait time(s).
Transportation: poorly designed internal material routes can result in unnecessary transportation times and congested traffic. Repeatedly handling material, and not having material stored near the point-of-use creates waste. This should be done in compliance with your specific governing manufacturing guidelines per FDA, USDA, standards organization(s), etc.
Inventory: suppliers should set inventory levels (raw material, work-in-process, and finished goods) at their lowest comfort level beased on their demands. Too much inventory ties-up money, can lead to obsolescence, has to be stored, counted, rotated and that all consumes resources.
Unnecessary motion: non-value added activities like moving material, multiple handling of product, inspecting material (sometimes you have to inspect things), but inspection is a non-value added acitivity, and is the result of a process that is producting defects.
Non-Ergonomic injury costs: all injuries are preventable, 100% wasteful, destroy trust in management, hurt morale, and increase health care costs. Suppliers must have an aggressive safety program that focuses on prevention and includes all disciplines. The safety program must set priorities that address the highest risks. Injuries at a supplier's facility will impact your costs and security.
Underutilized human potential: this is the most costly and non-recognized form of waste. Not including all employees in solving problems in their areas, in making improvements, not solicitng everyones ideas, not listening, poor or ineffective leadership, poor personnel interactions, a lack of common goals between departments and shifts, and poor morale all result in a tremendous amount of waste. Employees want to be a part of the solution! Employee empowerment is esstial to your suppliers and to your success.

Your outsourcing system should evaluate the supplier's level of empowerment, participative decision-making, gain sharing, and continuous improvement initiatives. You should determine if the supplier has a formal program to solicit employee ideas. Employees can identify waste in an operation better than any other source. They will tell you if asked, and if they feel it is in their best interest to do so. Suppliers should involve their employees, and everyone should feel a sense of ownership for housekeeping and organization.

If the supplier does not have effective leadership, teamwork and high morale, you should find another supplier. Everyone has to be on-board. Your outsourcing system should provide an evaluation of your supplier's leadership effectiveness.

Quality: and Lean are synonymous! W. Edwards Deming said: "Quality is conforming to specifications." Conforming to specifications is achieved through documented systems and job instructions so the process is repeated. Employee training and reducing variation between shifts can best be addressed with documented repeatable systems and job instructions. To ensure system compliance, process audits shoud be a very important part of your system. If you supplier does not have documented systems and process audits, they do not have a repeatable process, and they are not manufacturing to specifications.

Key performance metrics and goal setting: suppliers should track and post key performance metrics so everyone knows how they are performing, and what their goals should be. Ensure that each area of your business is driven by specific goals that drive continuous improvement, that each goal ties into the company's long-term goals, and that your organization agrees with those goals. Ensure that your supplier focuses on first-time quality throughput for your tableting project. Having to reprocess your product can affect tableting flow-ability, change particle morphology, and affect compaction behavior.

The cost of improving your supplier's process should be the supplier's responsibility, along with the costs associated with receiving defective material. You are expected to deliver quality products. Your supplier should have the same expectation. Remember, inspection does not assure quality. Only a process that is in control will produce consistent quality.

Your suppliers telling their employees to work harder, or, to offer more suggestions may create a short-term improvement (Hawthorne Effect). But identifying the systemic inefficiencies within an organization will provide sustainable improvement, and will help create the culture necessary to keep you competitive. Developing a culture where all employees have the skills needed to identify waste, take ownership for quality, solve problems, and the motiviation to care about the long-term success of the company, are essential in today's global market. You need to be able to evaluate your supplier's culture as it relates to Lean and continuous improvement.

Evaluating processes for the elimination of waste through continuous improvement in your supplier's production process, material, work-in-progress, scrap, administration, quoting, systems, administrative policies and rules, is an effective way for you to ensure that you are receiving value. That will reduce the pressures on your bottom-line.

Outsourcing production can be very successful, but you cannont assume that any supplier will perform to your expectations. Unless, you have controls in place to esnure accountability. You will require a constant flow of information, a frequent presence, regular milestone reviews, rewards and penalties, and a very clear initial document that clarifies all your requirements. Outsourcing production can expand your capabilities and help you grow. But you cannot outsource the responsibility for delivery and quality!

Line Balancing Basics
Improving Efficiencies in Repeatable Processes
by Paul M. Reece

Lean manufacturing is eliminating waste through continuous improvement in all aspects of your business. Line balancing is a Lean tool used for identifying and eliminating waste from repeated processes. The Line balancing philosophy enables you to build to a customer's requirements while keeping inventories at their lowest possible levels. In addition, it also helps you to achieve a "sequential flow process".

Line balancing is an effectvie tool in helping you to determine the number of employees required for your process, amount of equipment needed, and the capabilities of the process. Line balancing is especially helpful when there is product variation. Eliminating waste with Line balancing will improve your return-on-investment (ROI), product throughput, help you meet your customer's exceptions, ensure quality, and help you to become more competitive.

How can you determine if a process is balanced? Ask yourself the following questions:

Do employees build ahead (get material or work steps ready during wait times)?

Do employees have a hard time keeping pace (parts stack-up before them)?

Do employees have to wait between each operation or for changeovers?

Can employees finish their work in less time than allotted?

Is overtime frequently needed to meet production requirements?

Are you not meeting targeted labor costs?

Answering yes to one or more of these questions is a sign that your process is not balanced. Line balancing is the process of equally distributing the activities with TAKT time (the time available to complete the work relative to customer demand), to optimize labor and equipment, to eliminate bottlenecks, and eliminate unnecessary non-value added activities. This is accomplished by thoroughly observing and documenting every step the operators take in the process, timing and documenting all the activities within each work cell, and analyzing the steps. This data is then typically represented in a stacked bar graph. Each bar represents one workstation, and that bar is broken down into each step at that workstation.

Once the data is represented in a bar graph, it is straightforward to compare the workload at each station relative to TAKT time. It will help you identify the non-value added activities. In Lean manufacturing, three of the seven forms of waste are normally addressed through Line balancing; they include wait time, unnecessary motion, and waste in production. There are software packages available for line balancing used by larger organizations. For smaller operations a stopwatch, spreadsheet, or, even just a piece of paper with some colored markers are all you may need?

Line Balancing Terminology:

TAKT Time is the time available to complete the work relative to the customer's demand. Resources for fluctuating customer demand can be assessed with a line balancing analysis.

Value add is something that the customer is willing to pay for, and that increases the value of the product. Examples may include a softgel capsule, tablet coating, multi-colored labels, special shipping, etc.

Non-Value add activities are those that do not add value to the product. The customer is not paying for these activities. Examples include moving parts to the line, changeover, waiting for product, inspections, etc.

Wait time is anytime an employee has to wait to complete their job.

Process time is the total time used to make a product.

Throughput is the rate at which product moves through the system.

Constraints are also known as bottle necks that cause disruptions to throughput.

Sequential build is manufacturing a product from beginning to end without interruptions, and in the shortest time possible.

Synchronous flow, the "theory of constraints" is a much broader subject as it applies to the entire business. Elijah Goldratt's book "The Goal" is the best place to start to understand the "theory of constraints."

Standardized work consists of TAKT time, the work sequence to complete the tasks, and the established work-in-process and finished goods. Standardized work requires documented job instructions and process audits to ensure the process is working within the designed specifications.

Process controls are the procedures, tools, or equipment used to esnure throughput and quality.

Batch build is when product is manufactured and stored before the next step in the process. The risks associated with batch build are obsolescence, increased inventory costs, and decreased throughput.

Pull is when product is only made when there is a downstream (customer) need.

Push is when many products are manufactured as possible in anticipation of a customer(s) need(s).

Product variation is when a variety of features are included, i.e., shapes, sizes, colors, etc.

The above information should help you level the workload across all processes in your operation, help to remove bottlenecks and excess capacity. A constraint slows your process down and results in waiting for downstream operations, and excess capacity results in waiting, and absorbs your fixed costs. The objective here is to match your production rate after all waste(s) have been removed to the Takt Time at each station in the process of the value stream. Basically, eliminate all waste in your process, develop a sequential flow process, optimize your labor and equipment, manufacture to your customers needs, and save money!

Credentials: we work with Mr. Paul M. Reece as our Lean Manufacturing expert. Mr. Reece worked for 21 years with the United States EPA were he supervised operations at a testing laboratory in the Correlation/Engineering Group. He was a member of the EPA Institute, and was involved in teaching effective leadership skills to other EPA managers. Upon leaving the EPA he became owner and Director of Operations for Android Industries. Mr. Reece built his company from one plant, to a 14 plant company (facilities in the United States and Mexico) with 3,500 employees and annual sales in excess of $300,000,000.00. He introduced and applied the Lean philosophy and practices into all of his 14 facilities. Mr. Reece was involved in providing leadership and developing policies and procedures for all aspects of the business. Mr. Reece instituted a program to improve product reliability, and institutionalized error proofing at all 14 plants that resulted in a world class (<2%) defective parts per million. He is a seasoned executive with 40+ years of experience in Lean Manufacturing and Systems Development. Mr. Reece is a Certified Lean Manufacturing Executive, and is certified through the Michigan Manufacturing Technology Center. He is an expert speaker in ergonomics at the University of Michigan; in addition, he assists distressed companies in their turnaround efforts to become more efficient and profitable.

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