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William A. Levinson


Use Comprehensive Process Assessment to Support ISO 45001

‘Can’t rather than don’t’ also applies to compliance

Published: Wednesday, May 23, 2018 - 12:03

A job safety analysis (JSA) worksheet is almost identical in organization to a job breakdown sheet and standard work, all of which assess a job (or process) on a step-by-step basis. This suggests combining standard work with job safety analysis to support ISO 45001.

The concept can be carried even further by adding quality to support ISO 9001, and environmental considerations to support ISO 14001. The result is a comprehensive process assessment worksheet (CPAW) that empowers workers who are most familiar with the job to identify risks and opportunities, and recommend improvements. This article will focus primarily on the recently released ISO 45001 standard due to its role in occupational health and safety (OHS).

Chad Kymal’s recent Quality Digest webinar gave an excellent overview of ISO 45001.1 The standard provides an excellent framework modeled on Annex SL, which defines the structure of all the new ISO standards, for an OHS management system. “Management system” is important because, although workplace safety has been mandatory for decades, traditional safety departments had the same limitations as traditional quality departments: The activity in question was limited to an organizational silo as opposed to being part of a comprehensive and integrated management system.

Workforce participation in ISO 45001

One of the most important and distinguishing features of ISO 45001 is its focus on worker participation. For example, Section 5 is “Leadership and Worker Participation,” while the corresponding ISO 9001:2015 and ISO 14001:2015 sections are simply “Leadership.” ISO 45001—“Clause 5.4—Consultation and participation of workers,” has no corresponding clause in ISO 9001 or ISO 14001, even though all three standards follow the structure of Annex SL.

The takeaway is therefore that workforce participation in OHS is particularly important, and workplace safety committees are an excellent way to achieve this. Pennsylvania employers with qualified safety committees can even get a 5-percent workers’ compensation premium discount, but the safety committees’ deliverable—fewer workplace injuries—will have a favorable effect on the experience modification rating (EMR) regardless of the employer’s location.

A presentation by the Pennsylvania Dept. of Labor and Industry recommends a job safety analysis (JSA) or job hazard analysis as a tool for hazard identification, and depicts five steps for a JSA:2
1. Break the job down into specific tasks. (Note the obvious correspondence to the job breakdown sheet and standard work.)
2. Identify the associated existing or potential hazards. (This is consistent with ISO 45001 clause 6.1.2,—“Hazard identification and assessment of risks and opportunities.”)
3. Assess the hazards
4. Identify and implement controls to mitigate or (preferably) eliminate the hazards
5. Revise the JSA to reflect the changes

This is similar to the process for a failure mode and effects analysis (FMEA), in which the failure modes and their effects (or consequences) are identified and assessed, controls are implemented to reduce or eliminate them, and the FMEA is then updated to reflect the changes. OSHA adds, and this is consistent with ISO 45001’s focus on workforce participation:3

“Nearly every job can be broken down into job tasks or steps. When beginning a job hazard analysis, watch the employee perform the job and list each step as the worker takes it.... Include the employee in all phases of the analysis—from reviewing the job steps and procedures to discussing uncontrolled hazards and recommended solutions.”

Standard work and JSA

The breakdown of the job into specific tasks or steps is entirely consistent with the job breakdown sheet from training within industry (TWI) as well as standard work. The job breakdown sheet and standard work are very closely related, and standard work consists of three key elements:4
1. Takt time, or standard time necessary to produce one unit
2. The standard work sequence
3. The standard work-in-process inventory

The step-by-step organization suggests combining the job breakdown sheet, standard work, and job safety analysis into a single document, much as a dynamic control plan combines an FMEA and its associated control plan into a single document. We were surprised to find fewer than 50 Google search results for “job breakdown sheet” and “job safety analysis” together, although one reference states, “Everything of above [hazard-related] findings should be recorded on Job Breakdown Sheet (Job sheet or Job instruction sheet), and it should be explained to operators and trainees to perform the job safely.”5

Why not, then, combine standard work and JSA into a single document as shown in figure 1?

Figure 1: Combined standard work and job-safety analysis

The OHS section in figure 1 includes not only a column for the potential hazards in support of Clause 6.1.2, but also columns for the current risk rating (low to extremely high) and the type of control—e.g., Engineering, administrative, or personal protective equipment—that eliminates or mitigates the risk. FMEA and the U.S> Army’s Risk Management Process (ATP-19) do not permit a rating of less than medium for any kind of hazard with potentially catastrophic (i.e., serious injury or fatality) consequences. FMEA actually uses a risk priority number rather than a risk rating, but any failure mode with a severity of 9 or 10 (danger to human life, or risk of noncompliance with government regulation) requires attention regardless of the risk priority number.

Controls can be similarly graded according to the guidelines provided by ISO 45001 itself. “Eliminate the hazardous condition,” the most desirable approach, removes the hazard from the list. “Substitute a less hazardous condition” replaces the listed hazard with a less serious one. As an example, cryogenic machining replaces potentially hazardous cutting fluids with liquid nitrogen. The latter is not entirely safe due to the potential for frostbite and displacement of oxygen from a confined space, but it is also less hazardous than the original consumable; if we bring ISO 14001 into the picture, it is not an environmental issue, either.

This leaves us with, in order of preference for unresolved hazards, engineering controls (e.g., poka-yoke, error-proofing, “can’t rather than don’t”); administrative or compliance-dependent controls; and personal protective equipment. PPE is emphatically a last line of defense rather than a license to permit routine exposure to hazardous conditions. Engineering controls are the only controls that can reduce the risk rating to low by making the incident physically impossible regardless of the frequency with which the task is performed. “Impossible” must mean exactly that because if the incident is even remotely possible, it will occur sooner or later, given enough opportunities.

If the worksheet shows a hazard but no control other than an admonition to “be careful,” the worker should realize immediately that there is a problem. If the worker recognizes a hazard that is not listed, he should be empowered to file a hiyari hatto, or “experience of almost accident situation.” This is a near-miss reporting process that initiates corrective and preventive action (CAPA) for incidents that have yet to happen. It’s also another example of worker participation in ISO 45001.

“Incident” should, by the way, be used instead of “accident” because “accident” suggests common rather than special cause variation.8 Any problem for which CAPA can be performed is special or assignable cause variation, which is also why we dislike control charts for medical errors, days worked without lost-time injuries, and so on. A control chart implies that even a low level of incidents is unavoidable, common cause variation and therefore acceptable as long as the chart remains “in control.” “Incident” makes it clear that there is probably an assignable cause that can be removed from the system in which people have to work.

Figure 2 uses an actual example from the Ford Motor Co. We have made up the standard work times and the date, but the hazards and controls are real.6 The reference, taken from Luis Resnick’s 1920 article, “How Henry Ford Saves Men and Money,” adds that the “...two-hand push button tripping device [was] developed by the Director of the Department of Safety and Factory Hygiene,” Robert A. Shaw, although he admittedly did not create the example in figure 2.

Figure 2: Ford Motor Co. example

Edwin Norwood summarizes the principle behind engineering controls in four words: “Can’t rather than don’t.”7 In the example in figure 2, the company does not tell workers, “Don’t put your hand in the press when it closes”—an administrative or compliance-dependent control that failed to prevent thousands of amputation injuries in the United States every year. The two-hand, push-button tripping mechanism requires instead that each worker press and hold down two buttons simultaneously to close the press. These buttons are well away from the press’s moving parts, so the worker can’t put her hand in the press while it closes.

Even though Shaw may well have done for OHS what Joseph Juran, Walter Shewhart, and W. Edwards Deming did for quality, I learned about him only through the Resnick article. This underscores a story connected with Sun Tzu’s Art of War. Three brothers became medical doctors in ancient China. The youngest cured serious diseases, so his name was known throughout the realm. The middle brother cured diseases in their early stages, so his name never went beyond his village. The eldest prevented the diseases, so nobody even knew his name.

We rarely think of the number of people—probably tens or even hundreds of millions—who didn’t get smallpox or polio because of Edward Jenner and Jonas Salk, respectively, and we will similarly never know how many workplace injuries and fatalities didn’t happen because of Shaw’s innovations. The number might now be in the millions because controls such as machine guarding and lockout-tagout seem to have originated at the Ford Motor Co., or were at least widely adopted there before they became common practice. OSHA, for example, developed the Control of Hazardous Energy regulation in 1982, but forms of lockout-tagout were in use at Ford more than 50 years earlier. The phrase “invisible when present, conspicuous when absent” reinforces the takeaway that people (and standards) rarely get credit for the quality or safety problems that don’t happen because of their presence.

The Resnick article also emphasizes the fact that Shaw’s safety program had the direct support of upper management, as is now required by ISO 45001—“Clause 5.1—Leadership and commitment.” When the manager of the compensation department asked Henry Ford for authorization to build a hospital to care for injured workers, Ford denied the request with the explanation, “If we owe it to our men to care for them when they are hurt, we certainly owe it to them to do everything in our power to keep them from getting hurt; and if it would be a good investment for us to build a larger industrial hospital, it certainly will be a better investment for us to get rid of accidents.” The reference adds that machines were redesigned, and equipment even discarded if it could not be made safe.

Figure 3 shows how the process assessment would have looked under the pre-improvement conditions, when operators used a tap signal to indicate that it was safe to close the press, or a green light (visual control) gave the same indication. The fact that the risks exceed low, and that the controls are administrative rather than engineering, show immediately that changes are necessary to transform “don’t” into “can’t.” The risk levels were probably high due to the fact that thousands of fingers were lost annually under the indicated conditions.

Figure 3: Pre-improvement assessment

Extension to quality (ISO 9001) and environmental (ISO 45001) management systems

We could go even further and add quality and environmental considerations so a single document addresses safety (ISO 45001:2018), quality (ISO 9001:2015), and environmental (ISO 14001:2015) issues for each job step. The quality-related portion corresponds to the control plan in advanced quality planning (AQP), although it will probably be necessary to refer to detailed quality controls that range from statistical process control (SPC) to calibration and measurement systems analysis (MSA). Meanwhile, workers can and should identify everything that is thrown away, including consumables, for each job step to force material waste into the open. The result could be called a “comprehensive process assessment worksheet,” or CPAW for short.

Additional resources

For anybody who wants to implement ISO 45001, we recommend the Pennsylvania Training for Health and Safety (PATHS) resource from the state’s department of labor and industry. Although free onsite training is available only to Pennsylvania employers, anybody can attend the free webinars that cover topics such as workplace safety committees, near-miss reporting, and job safety analysis.

See also this annotated copy of Louis Resnick’s “How Henry Ford Saves Men and Money,” which even though it is now almost 100 years old, illustrates common-sense OHS principles that are directly applicable to ISO 45001 implementation.

Sources cited
1. Kymal, Chad. “ISO 45001 Released as an International Standard,” Quality Digest webinar, April 10, 2018.
2. Pakosh, Steve. “Workplace Safety Committee Training.” Pennsylvania Dept. of Labor and Industry webinar, 2018.
3. “Job Hazard Analysis.” OSHA 3071 2002 (Revised).
4. Productivity Press Development Team. Standard Work for the Shopfloor. NY: Productivity Press, p. 36, 2002.
5. Sharma, Kumar, and Veerendra Suryawanshi. “Hazard Identification and Evaluation in Construction Industry.” International Journal of Science Technology & Engineering, Vol. 1 No. 10, April 2015.
6. Resnick, Louis. “How Henry Ford Saves Men and Money.” National Safety News, September 18, 1920.
7. Norwood, Edwin P. Ford: Men and Methods. Garden City, NY: Doubleday, Doran & Co., Inc., 1920.
8. “Building a Business Case for Safety,” Pennsylvania Department of Labor and Industry webinar, May 2, 2018.


About The Author

William A. Levinson’s picture

William A. Levinson

William A. Levinson, P.E., FASQ, CQE, CMQOE, is the principal of Levinson Productivity Systems P.C. and the author of the book The Expanded and Annotated My Life and Work: Henry Ford’s Universal Code for World-Class Success (Productivity Press, 2013).


Best article on safety 45001 Ive seen yet

Hi William. Great article and very good breakdown of the new ISO 45001 standard which we (and I suspect many others) have begun working with. We consult for companies wanting this standard as part of their IMS. I like that your first big emphasis was on worker consultation as this is vital to genuine success. Please keep sharing, it seems Quality Digest  has a wealth of good knoweldge amonsgts its writers.