Q: I am a consultant trying to explain to a commercial sign company president what a quality management system and total quality management (TQM) can do. Determining cost savings versus current costs is difficult. This company has a main office and three other branches in the United States. The branches are all operating separately—there is no uniformity and problems are just solved and forgotten until it happens again. How do I sell a quality program to the decision-makers of the organization, including HR?
A: To effectively sell a quality program, here are some suggestions:
- Request a one-hour meeting with the president and the senior leadership team.
a holistic package on TQM leveraging the Baldrige
Performance Excellence Program, which focuses on seven criteria:
- Strategic planning.
- Customer focus.
- Measurement, analysis and knowledge management.
- Workforce focus.
- Operations focus.
- Highlight the cost of poor quality (COPQ). By measuring and managing COPQ, the organization can improve profit margin and satisfy its customers with improved quality of products and services (Baldrige categories 1, 3, 6 and 7).
- Emphasize the need for the main office and three branches to strategically leverage best practices to improve their bottom line. The key is to collaborate, learn and share good practices internally, and benchmark external best practices (Baldrige categories 1, 2, 4 and 5).
- Stress the need to adopt a continuous improvement philosophy to build a high-performance culture (Baldrige categories 1, 5 and 6).
- State the key role of the HR department to strategically secure the right talent and create good processes to engage, motivate and develop its talent pool to benefit the enterprise (Baldrige category 5).
- After the leadership team buys into the TQM philosophy supported by the Baldrige criteria, offer the team a free leadership assessment tool.1
- Analyze the self-assessment results to help the team focus on key opportunities for improvement (OFI) and maintain areas where it is already doing well.
- Guide the leadership team on key OFIs to show how good results benefit the organization.
Department of Commerce National Institute of Standards and Technology, "Are We
Making Progress as Leaders?" http://www.nist.gov/baldrige/publications/
upload/ProgressAL.pdf (case sensitive).
Chairman and president
Business Excellence Inc.
ASQ fellow and certified quality engineer
Calibration in confined spaces
Q: My question is about monitoring and measuring resources. In a company that works in tanks (confined spaces), is it a requirement to calibrate the gas detector equipment in an accredited laboratory? Is it not possible to send the equipment to the manufacturer for verification?
A: Let’s begin by defining a confined space. Although the definition varies by jurisdiction, it is generally agreed that a confined space has limited means to enter and exit, is large enough to allow a person to enter and perform work, is not designed for continuous occupancy, and has the potential for a significant hazard to be present. This includes pipes, tanks, silos, hoppers, pits, trenches, manholes, underground vaults and ducts.
Confined-space hazards typically fall into two categories: mechanical and atmospheric. Mechanical hazards include getting entrapped by equipment, crushed by collapsing walls, engulfed by fluid or materials or electrocuted. Atmospheric hazards include oxygen deficiency, a build-up of toxic gasses, an oxygen-rich environment that can lead to a fire or explosion, or high levels of dust or particulates. Sometimes, the air in the confined space is acceptable prior to entering, but becomes hazardous due to the nature of the work being performed, such as in the instance of an accumulation of toxic welding gases or combustible fumes from cleaning solvents.
Confined spaces should be considered extremely dangerous. Confined space accidents cause up to 100 deaths per year in the United States.1 Tragically, a significant percentage of the confined space accidents have multiple fatalities involving would-be rescuers who also fall victim to the hazard within the confined space.
Studies show that most of these deaths could have been avoided by following the regulations implemented by the Occupational Health and Safety Act (OSHA) of 1970. These regulations are designed to protect workers from hazards. Whatever your thought on government regulation, when it comes to employee safety, we should never compromise.
One of the key regulations is that a confined space must not be entered without first verifying that the atmosphere within the space is within acceptable limits. The verification is performed using a direct reading portable gas monitor (DRPGM). I reviewed applicable sections of the Safety Act of 1970 and found two requirements that may be contributing to confusion regarding the calibration of gas meters. First is, clause 1910.7(b), which provides the definition and requirements for a nationally recognized testing laboratory (NRTL).2 Second, clause 1910.7(b)(3) requires that the NRTL is "completely independent of employers subject to the tested equipment requirements, and of any manufacturers or vendors of equipment or materials being tested for these purposes …"3
I contacted OSHA and was told that these regulations apply to the certification of safety equipment, such as a self-contained breathing apparatus. Underwriters Laboratories is an example of an NRTL. It tests the breathing apparatus to ensure it will not generate electrical sparks in a combustible environment. Per OSHA, these two regulations do not apply to the calibration of gas monitors. Therefore, you are free to send the gas monitor back to the original equipment manufacturer for calibration.
In addition to complying with the regulations, you should understand the calibration process well enough to be confident that the instrument is suitable for its intended purpose. To do this, you must compare the calibration error of the instrument to the operating range of the process you are measuring. For DRPGM instruments, the limits of the safe operating range for a confined space is defined by the Safety Act, clause 1910.146(b), as follows:4
- Flammable gas, vapor or mist in excess of 10% of its lower flammable limit (LFL).
combustible dust at a concentration that meets or exceeds its LFL.
Note: This concentration may be approximated as a condition in which the dust obscures vision at a distance of five feet (1.52 m) or less.
- Atmospheric oxygen concentration below 19.5% or above 23.5%.
- Atmospheric concentration of any substance for which a dose or a permissible exposure limit is published in Subpart G, Occupational Health and Environmental Control, or in Subpart Z, Toxic and Hazardous Substances, of this part and which could result in employee exposure in excess of its dose or permissible exposure limit.
The calibration error should be small compared to the operating range. For oxygen concentration, the safe operating range is 19.5 to 23.5%, or 4%. OSHA regulations are not specific as to the maximum allowable calibration error. Some authors recommend that calibration error be less than 10% of the operating range. If you adopt this recommendation, the total calibration error for oxygen concentration should be less than +/- 0.2%.
Avoid the temptation of adjusting the allowable calibration error to match the capability of the instrument being tested. Oxygen concentration below 19.5% can lead to worker impairment, and oxygen concentration above 23.5% can be explosive. So there is not much room for error. You can use this same approach to evaluate the calibration errors for toxic and flammable gases.
Keep in mind that calibration error usually has two main components: fixed error and variable error (sometimes called measurement uncertainty). Calibration reports must contain an estimate of the measurement uncertainty, as is required by ISO/IEC 17025:2005 for calibration.5
Figure 1 shows the relationship between fixed and variable calibration error. You can be about 95% confident that the instrument is suitable for use if the fixed error plus two times the measurement uncertainty is less than the maximum allowable error for the application.
Figure 1 also shows that the maximum calibration error is about 2%. While this seems like a small number, it is actually quite large compared to the operating range for oxygen concentration (4%). Therefore, this instrument should be rejected and a more precise instrument should be used.
- ROSO Rescue, "Confined Space Factalities ... A Closer Look at the Numbers," Nov. 1, 2011, http://tinyurl.com/rescuenumbers.
- U.S. Occupational Safety and Health Administration, Occupational Health and Safety Act of 1970, clause 1910.7(b).
- Ibid, clause 1910.7(b)(3).
- Ibid, clause 1910.146(b).
- International Organization for Standardization and International Electrotechnical Commission, ISO/IEC 17025:2005—General requirements for the competence of testing and calibration laboratories.
For more information or to review the OSHA Act of 1970, see www.osha.gov/law-regs.html.
Master Black Belt Director of quality systems
NSF Health Sciences Pharma Biotech