Monthly Archives: July 2011

Developing Customer Focus in a Lean ISO System

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In Lean applications, it is very important to assess “value” from the customer’s vantage point. Activities that don’t add value to the product or service are by definition “waste.”

Delivering what the customer wants when he wants it is the primary thrust of Lean.  The vehicle for accomplishing this is the elimination of waste from processes.  ISO 9001:2008 emphasizes meeting customer requirements and continually improving the Quality System.

Quality objectives in the ISO Quality Management System can be derived by focusing on the customer needs and requirements and by using Lean tools in helping with the attainment of these objectives.

To maintain customer focus, you must:

  1. Research and understand your customer’s requirements–needs and expectations.
  2. Ensure that your company’s objectives are linked to these requirements.
  3. Communicate the importance of meeting these requirements to your employees.
  4. Track your performance against the Quality objectives.
  5. Use Lean and statistical tools to improve performance, eliminate waste, and reduce variation.
  6. Measure and track customer satisfaction; act on the results–complaints, as well as, compliments.
  7. Manage the details of customer relationships in a systematic manner.

Continued customer satisfaction results in improved customer loyalty leading to repeat business.  Obtaining customer loyalty should be one of your most important goals.

A Lean ISO system is one of the best means of achieving long-term customer loyalty by focusing on the customer requirements and making the customer the driving force of your organization.

IWA 4: ISO 9001 Applied to Local Governments

The International Workshop Agreement (IWA) system allows guidelines to be issued for compliance with ISO standards for specific sectors. These guidelines are not new requirements, nor do they change the requirements of the standard; the intention is not to be used for compliance or certification, but serve as guidelines for better application of the standard.

The document IWA 4, revised in 2009, is an International set of guidelines created by approval of the ISO Technical Management Board and under the leadership of the Mexican Government Directory of General Norms of the Secretary of the Economy. The objective was to provide “Guidelines to facilitate the application of ISO 9001:2008 to Local Governments.”

This document provides alignment for the application of ISO 9001:2008 to local governments and provides timely examples to facilitate interpretation. In addition, Attachment A provides a process map as a guide for the organization of local government initiatives.

The IWA 4 Attachment B contains an integrated tool for the self-assessment of parameter metrics for the minimum elements that a local government must have in order to comply, or exceed the directives.

The structure of IWA 4 is based on ISO 9001:2008 with the addition of the two attachments as follows:

  1. Objective and scope
  2. Normative references
  3. Terms and definitions
  4. Quality Management System
  5. Management Responsibility
  6. Resource Management
  7. Product Realization
  8. Measurement Analysis and Improvement

Attachment A – Process Map

Attachment B – Assessment for Reliable Governments

The IWA-4:2009 document can be purchased from the ISO website.

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Adapted from FIDEGOC (Fundacion Internacional para el Desarrollo de Gobiernos Confiables: International Foundation for the Development of Reliable Goverments).

6 Myths to Dispel Before a Lean ISO Implementation

People not familiar with the ISO 9001 standard may think of it as being bureaucratic with lots of extra paperwork.  In reality, this is far from the truth.

The ISO 9001:2008 standard requires that you establish controls for your business, that you monitor customer satisfaction and that you continually improve your processes.  These basic elements are essential for any organization to succeed.

The ISO standard does not specify “how” these elements are to be implemented, thereby giving each organization the flexibility of complying while conducting its business in an effective manner. Using Lean concepts in the implementation of ISO 9001 enables the organization to gain all the benefits of the structure of this system without creating a bureaucratic burden.  Following are some of the popular myths regarding ISO requirements that often prevent a Lean implementation.

1)     Myth. The Quality Manual needs to be very detailed in describing the quality system.

Truth. The manual should briefly state the key processes and their interactions.  It needs to make reference to the procedures and flow diagrams that describe the processes in more detail. The manual does not contain any proprietary information and does not have a minimum length.

2)    Myth. Several “controlled” hard copies of the Manual are needed.

Truth. The entire document and records control system can be in electronic format.  Although many organizations prefer having a certain number of “controlled” hard copies, the standard does not require it. The key here is control; making sure that only the latest valid information (procedures, forms, etc.) are used.  Having several sets of “controlled” copies makes it more difficult to maintain the documentation.  Maintaining one controlled “hard copy” set may be a good idea as a quick reference.

3)    Myth. Employees must have easy access to a “hard copy” of the procedures and “work instructions” that apply to them.

Truth. Again, these procedures and work instructions can be available in a controlled electronic format. Documentation must be readily available and securely stored and a method needs to be developed for revision and approval.

4)    Myth. A procedure is needed for everything.

Truth.  ISO requires only six procedures which can be condensed to five: document control, records control, non-conforming product handling, internal auditing, preventive and corrective actions. Other procedures should be developed when they add value to an internal customer or external customer viewpoint or improves communications between the functions that will use it.

5)    Myth. ISO prevents Lean implementation because all changes need to be documented and approved.

Truth.  The ISO standard expects Continual Improvement to take place and Lean provides a set of concepts and tools to reduce waste and thereby improve processes.  Lean improvements should be documented once the new procedure is confirmed to result in improved results.  

6)    Myth. All procedures and work instructions need to be written in a consistent format.

Truth.  ISO documentation can take many forms including written procedures, pictures, drawings, flow charts, and screen shots.  Procedures need not be wordy or complex.  The key is that the information be understood and accessible by the people using it.

Will people with different language and cultural backgrounds be able to understand the procedure or work instruction without much need for interpretation? Dispelling these myths will allow for the implementation of a highly effective Lean Quality Management System using the ISO 9001 structure.

Lean ISO and the Eighth Waste

The elimination of waste is the main focus of Lean Manufacturing.  In recent years, many organizations have incorporated the concept of the “eighth waste” in their implementation of Lean Manufacturing.  Many early sources spoke about the Seven Wastes that are found in most processes:

  • Overproducing
  • Transporting
  • Waiting
  • Inappropriate processing
  • Building unnecessary inventories
  • Conducting unnecessary movements
  • Defects and errors

Lean practitioners have come to recognize that elimination of these seven wastes is highly dependent on getting people involved in the Improvement process.  This failure to fully utilize the workforce talents and fully engage employees is now considered the most significant waste of all and is referred to as the eighth waste.

These wastes are symptoms of the underlying root cause for the real problems. For instance, excess inventories may be an indication of unbalanced workloads, machine breakdowns, misunderstood customer requirements, and unreliable suppliers.

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.  Employees are not only closer to the symptoms, but also closer to the root causes of the problems.

In a previous article, I explained the compatibility of ISO 9001:2008 and Lean Manufacturing.  ISO 9001:2008 specifies that the organization must disseminate its’ Quality Policy and Objectives so that all employees understand them and how their jobs contribute to them. It also specifies that the organization must be engaged in the continual improvement of its Quality Management System.

The eighth waste can be described as “underutilized minds.”  Although ISO has some built-in requirements for improvement such as internal audits, corrective and prevention action systems, it does not prescribe how employees, in general, should be involved in the continual improvement of the organization.

To address the eighth waste, organizations desiring to institute a Lean ISO system need to:

  • Train employees early in the process on the Quality Policy and Objectives  so that they begin to understand their roles in the process.
  • Engage employees in the documentation process including involvement in writing the initial drafts of procedures or work instructions.
  • Select and train employees as Internal Auditors so that they learn about other areas within the company when participating in audits.
  • Involve employees in Internal Audits as both Auditors and Auditees.
  • Engage employees in workspace organization and standardization (5S) and in improvement events such as Value Stream Mapping and Kaizen activities.
  • Train employees in root cause analysis and basic problem solving techniques so that they can assist in maintaining the Corrective and Preventive Action Systems (CAPA).
  • Develop workplace organization score cards and train your Internal Auditors in their use.

These actions will significantly reduce the eighth waste in the organization by engaging the workforce in the Continual Improvement process.