Monthly Archives: April 2011

Lean and ISO Working Together

Some people think that compliance with ISO 9001:2008 inhibits innovation and Lean transformational change. This is very far from the truth. I previously wrote about how compatible and complementary both methods are when implemented in the same timeframe. I will explain in more detail below.

ISO requires the organization to be engaged in Continual Improvement.  Lean provides one vehicle for a company to be focused on the customer, while constantly working at making the organization’s processes more effective.

ISO 9001 is designed in a Plan-Do-Check-Act (PDCA) format for Continual Improvement.  In implementing ISO, we plan for the development (Plan), we implement it (Do), we audit against the standard (Check) and we take corrective action when necessary and continue the cycle by identifying and pursuing opportunities for improvement (Act).

During the Planning stage, we can use the Lean principles to assure that the documentation is “value-added”, that they are truly needed, that procedures are written in a simple concise manner and that work instructions are made as visual as possible and easily understood by the user.  Procedures and work instructions should encourage their use and facilitate training and cross-training.

The key for the ISO implementation is to get a “snap-shot” of the Current State and to document it.  Value Stream Mapping, a Lean method, is useful in identifying process steps  and opportunities for improvement in the Current State and to document the possible improvements in a Future State Map.  A Continual Improvement Plan could then be developed to identify actions, responsibilities, and target dates for the improvements.

Significant improvements will be documented as “Preventive Actions” for follow-up in the ISO system.  Any improvement that reduces lead-time or increases product/service Quality is a valid candidate as a Preventive Action as it will prevent customer dissatisfaction.

In Lean, Rapid Improvement Events (Kaizen) address solutions to the opportunities identified in the Continual Improvement Plan. Once such solutions are identified, tested and implemented (again, P-D-C-A), the new process needs to be documented in the ISO system.

Lean uses the concept of “standard work”, a method that identifies the sequence of activities, the use of the resources needed, and the time planned to keep up with customer demand.  Standard work provides an excellent vehicle for identifying the “inputs” and “outputs” for each process as required by ISO standards.

Sustainability of Lean methods, such as the 5s workplace organization, requires following up and auditing to assure that the organization does not return to the “old ways”.  The ISO systems for conducting Internal Audits and taking Corrective and Preventive Actions provide methods for sustaining the Lean improvements made, provided these processes are standardized and documented.  Checklists can be written to include these improved processes so that they can be audited and monitored.

It all fits together.  There is no need to be concerned with a “chicken/egg” argument, as to which should be done first. Just plan what you want to do, then do it, check it and act on it! You will always want to make it better, and should.

Developing Quality Policy and Objectives

Some people get stuck soon after starting an ISO 9001:2008 implementation with developing a Quality Policy and, soon after, in developing Quality Objectives.  Once you know what is expected, the process of developing them is very simple.

You could think of a Quality Policy as a company’s mission statement from the customer’s point of view. The policy should mention that your company is dedicated to meeting customer requirements and exercising continual improvement of the Quality Management System (QMS).  The policy informs everyone inside and outside the organization of the company’s Quality perspective, taking the customer’s requirements as primary consideration.

The Quality Policy needs to be appropriate to the business of the company. It should be stated in simple terms that everyone in the organization can relate to and make it their own.  This also means that the policy needs to reflect the overall values of the company and be consistent with other company public statements.

The policy should be developed early in the process of building the QMS.  It then becomes the guiding light for the QMS. Top management needs to be closely involved in its development and needs to disseminate it throughout the organization.  Ideally, top management should involve the management team and get consensus on its final form.

If the Quality Policy is a true reflection of the organization, the Quality Objectives will be easy to develop. The Quality Objectives are measurable and achievable statements that support the policy.

What measures do you need to assure that you are meeting customer requirements?  This will vary from company to company and even will vary for different type of customers within the company.  For instance, if you are encountering customer complaints, customer returns, high internal reject rates, poor supplier quality, or late deliveries, these are all good areas to target.  You need to first establish your metrics and develop a baseline, so that you can determine what level of improvement is attainable. The metrics and targets become your Quality Objectives –usually three or four.

In many cases, the company is already using these metrics to measure its business, but has not established clear measurable improvement goals. The performance against the objectives should be tracked frequently and reviewed formally at Management Review meetings. The suitability of the objectives, the policy and the effectiveness of the QMS, in general, should be reviewed at these meetings as well.

The Quality Policy and Objectives are the keystone of the QMS in guiding the organization in complying with customer requirements and the need for Continual Improvement.

Job Safety Analysis

A hazard is the potential for harm often associated with a condition or activity that, if left uncontrolled, can result in an injury or illness.  Conversely, identifying hazards and eliminating or controlling them as early as possible will help prevent injuries and illnesses.

A Job Safety Analysis determines what the employee needs to know in order to perform the job safely.  This focuses on the job tasks to be performed in order to identify hazards before they occur.  The job safety analysis recognizes the relationship between worker, task, tools, and work environment.

Job Safety Analysis is a procedure that:

  • Studies and records each step of a job
  • Identifies existing or potential hazards
  • Determines the best way of reducing or eliminating the risks of performing the job

After identifying uncontrolled hazards, steps need to be taken to eliminate or reduce them to an acceptable risk level.

Information obtained from the Job Safety Analysis can be used to develop the training program for that operation and to investigate accidents where the employee’s performance may have been deficient.

The Job Safety Analysis can be developed by examining engineering data on new equipment, the safety data sheets on unfamiliar substances, specific Federal or State OSHA standards applicable to the process, and the company’s accident and injury records.

Another method for developing a Job Safety Analysis is requesting employees to write a  description of their jobs in their own words. These descriptions should include the tasks performed and the tools, materials and equipment used.

Observing employees as they perform tasks, asking about the work, and recording their answers can also provide valuable insights to be included in the Job Safety Analysis.

Hazards can also be identified by asking employees if anything about their jobs frightens them, if they have had any near-miss incidents, if they feel they are taking risks, or if they believe that their jobs involve hazardous operations or substances.

Lean Manufacturing Basics

Lean Manufacturing grew out of the Toyota Production System or TPS. Today, Lean Manufacturing is most often referred to as Lean with its concepts and techniques being applied to many fields outside of manufacturing in sectors such as:

  • Financial
  • Health
  • Services

Lean Manufacturing roots go back to Henry Ford in the USA, but the techniques were developed and refined in Japan.

James Womack and colleagues brought these concepts back to the USA after studying the Toyota methods, then coined and popularized the term “Lean Manufacturing.”  Lean is characterized by speed– better, cheaper and faster–and its’ focus on customer demand. By zeroing on what the customer wants and when he wants it, Lean teaches the wastefulness of excess inventories and their impact on responsiveness.

Toyota developed the system called “Just in Time” or JIT that provides for delivery of parts and components just at the time they are needed. JIT is applied internally to reduce work-in-process inventories and externally to reduce raw material inventories deliverd by suppliers.

Waste Elimination is the underlying principle of Lean. Waste is equivalent to non-value added activities.  According to the Manufacturing Extension Partnership, 95% of an organization’s activities do not add any value to the product or service provided. By reducing or eliminating these non-value-adding wasteful activities, more time is spent on those activities that do provide a  value-added benefit to the customer.

Eight types of waste are recognized that are generally present in most organizations:

  1.  Excess Inventories: above and beyond what is needed
  2.  Over-processing: putting more effort than is required
  3.  Over-production: Making more product than is needed by the next operation or customer
  4.  Transportation: moving the product in the plant or to the customer
  5.  Excessive Worker Motions: unnecessary motions that add time and can cause injuries
  6.  Defects/Errors: cause rejects and rework
  7.  Waiting: for parts, deliveries, approvals, and
  8.  Underutilized Workers: not using the full physical, emotional and intellectual capabilities of workers

The typical approach to eliminating waste is to decide on a product line family that shares the same operations or resources. All the activities (both value-added and non-value-added) are mapped in sequence. The characteristics of each operation are recorded such as cycle time and downtime. These series of activities is called a Value Stream and the map is called a Value Stream Map or VSM. After the Value Stream Map of the Current State is plotted, the team brainstorms the elimination of wastes that become apparent on the map and depicts a Future State that eliminates these wastes.

Kaizens (to-make-better) are concentrated improvement efforts that enable arriving at the Future State. In Japan, work groups often conduct these exercises on a daily basis looking for daily or “continuous” improvements of their processes. In the USA, it is more common to use a Kaizen Blitz in which a team devotes concentrated effort over a few days to obtain some of the improvements needed to arrive at the Future State.

These events could concentrate on material/information flow, inventory reduction and defects elimination. A 5S event is a special type of Kaizen that deals with Workplace Organization. 5S will be discussed in a later article.

Lean uses the eight wastes mentioned above as symptoms of the underlying root cause for the problems. For instance, excess inventories may be an indication of unbalanced workloads, machine breakdowns, misunderstood customer requirements, and unreliable suppliers.

As Lean has been adopted in other fields analogous examples of waste can be found.

Excess Inventories

  • Patients waiting in the emergency room
  • Large number of loan applications waiting to be processed


  • Excess copies or blueprints
  • Extra tests not contributing to diagnosis
  • Designs including features not required


  • Making more product than is needed or wanted


  • Excessive trips to deliver prescriptions to in-patients
  • Scheduling more face-to-face meetings than needed

Excessive Worker Motions

  • Reaching
  • Bending
  • Poor ergonomics


  • Prescription errors
  • Misreading blueprints


  • For parts or components
  • Searching for tools or documents
  • Waiting for loan approvals
  • Waiting for doctor prescriptions

Underutilized Workers

  • People watching a machine or each other work
  • Not engaging employees in problem detection and solution

Being on the lookout for the evidence of waste provides a starting point for the investigation of the root causes and for finding solutions to the problems. Lean focuses on the customer and the organization’s performance in meeting the customer demand and customer quality requirements.

Manufacturing and Innovation

There is no doubt that the key to long-term success in manufacturing is innovation in every facet of the business, from developing unique products, like the iPod, to finding new ways of getting products into people hands, like

Pharmaceutical and consumer products companies, among others, have historically shifted their mature products overseas, while maintaining at least some of their domestic operations for the development and early production of new products and line extensions. US based manufacturing has heavily relied on the rate of innovation of the organization. This trend continues and is the key to our manufacturing base.

High margin products, such as medical devices, are less sensitive to relative production costs as long as they have a unique product. Even in those cases, as volume increases the financial pressures to migrate production to locations with lower labor costs also increase. Such high margin industries continue to be significant to our manufacturing base.

In South Florida, manufacturing is not considered by local governments as a target sector for expansion. No effort is made to attract new manufacturing plants. Municipalities and county governments are more interested in attracting and retaining “cleaner” industries, such as, tourism and entertainment. On a national scale, manufacturing has not been recognized as the significant sector that it is.

The role of government at every level is to provide the conditions needed for innovative manufacturing to flourish and to prevent other countries from establishing barriers to the entry of our products while our doors are wide open to the world’s products.

To summarize, I agree that innovation is the key to continued success combined with forward thinking leadership at every level of government.