Tag Archives: standards

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.

Most Frequently Cited OSHA Standards in 2010

The following were the top 10 most frequently cited Occupational Safety and Health Administration (OSHA) standards in fiscal year 2010 (October 1, 2009 through September 30, 2010):

  1. Scaffolding, general requirements, construction: 29 CRF 1926. 451
  2. Fall protection, construction: 29 CFR 1926.501
  3. Hazard communication standard, general industry: 29 CFR 1910.1200
  4. Ladders, construction 29 CFR 1926.1053
  5. Respiratory protection, general industry: 29 CFR 1910.134
  6. Control of hazardous energy (lockout/tagout), general industry: 29 CFR 1910.147
  7. Electrical, wiring methods, components and equipment, general industry: 29 CFR 1910.305
  8. Powered industrial trucks, general industry: 29 CFR 1910.178
  9. Electrical systems design, general requirements, general industry: 29 CFR 1910.303
  10. Machines, general requirements, general industry: 29 CFR 1910.212

The following are the standards for which OSHA assessed the highest penalties in fiscal year 2010 (October 1, 2009 through September 30, 2010):

  1. Fall protection, construction: 29 CFR 1926.501
  2. Electrical, general requirements, construction: 29 CFR 1926.403
  3. Safety training and education, construction: 29 CFR 1910.21
  4. Control of hazardous energy (lockout/tagout), general industry: 29 CFR 1910.147
  5. Machines, general requirements, general industry: 29 CFR 1910.212
  6. General duty clause: Section 5(a)(1) of the OSHA Act
  7. Excavations, requirements for protective systems, construction: 29 CFR 1926.652
  8. Lead, general industry: 29 CFR 1910.1025
  9. Grain handling facilities: 29 CFR 1910.272
  10. Ladders, construction: 29 CFR 1926.1053

For more detailed information, visit Frequently Cited OSHA Standards. At that site, you can generate a report on the most frequently cited federal or state OSHA standards by your SIC code and the number of employees in your establishment.

Source: OSHA.gov

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