Why Lean

Why Lean Management Systems?

The Lean approach initially was originated in Japan. Firstly, companies applied the concept to manufacturing and production processes. The objective of the Lean approach is very simple: eliminate or minimize waste within the process without impacting the results.

According to research by the Lean Enterprise Research Centre (LERC), 60% of production activities in a typical manufacturing operation are waste! Various businesses continually report significant Lean efforts and success stories in multiple industries for production and manufacturing processes. Based on our surveys, very few companies apply Lean techniques to their management and documentation systems. The Lean methodology can eliminate waste in ISO 9001, ISO 13485, ISO 14001, ISO 45001, and other management systems.

Lean ISO Management Systems allow companies to apply Lean methodology to:

  • Streamline the management system structure
  • Establish Lean process flow for the document management process
  • Reduce the number of documents
  • Optimize contents of procedures
  • Improve the quality of instructions
  • Improve the effectiveness of the management system
  • Reduce the cost of maintenance of the documentation system

Lean management and documentation system focus on two areas:

  • Quality of procedures, instructions, and other information, and
  • Quality of the overall document process flow

Quality of a procedure, or how Lean a procedure is, may be judged by how concise the document is. Can a twenty-word message convey the same information as a forty-word paragraph? Can the same message be expressed by two pictures instead of 6 pages of text? Is this information essential for performing the task?

One can judge the quality of a documentation system by measuring the time it takes to locate needed information: procedures, records, drawings, etc. In most cases inefficiency of a system is caused by:

  • Use of multiple documentation systems
  • Use of numerous locations for retention of documents
  • Use of various locations for deposition of records
  • Poorly defined process flow of the system, and
  • Lack of clear documentation of the process flow

To establish a transparent process flow for an ISO management system one may utilize a well-known technique called PDCA:

  • Plan — the process flow may focus on the development of standardized steps for creation, revision, storage, distribution, and retrieval of documents
  • Do — use the established process flow
  • Check — assess the effectiveness of the process and
  • Adjust — update and modify steps that do not meet planed results