Struggling Against Nature - Preventing Human Error in the new ISO 9001 2015 Standard

President at Cavendish Scott Inc
Mar. 31, 2016

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Struggling Against Nature - Preventing Human Error in the new ISO 9001 2015 Standard

  1. Struggling Against Nature Preventing Human Error in the ISO 9001:2015 Standard Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 1
  2. The Nature of Human Error • Why do humans screw up? • Traps • Tools Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 2
  3. Human Error Traps • Interpersonal – How we interact with others – Copilot Syndrome • Attitude – Mental approach to life and our jobs – Proximity Rule • Stress – Response to differing workloads – Distractions • Risk – Awareness of and response to risks – Accommodation to Risk • Attention – Level of concentration and awareness – Strength of an Idea – Loss of Situational Awareness • Task – Response to unanticipated challenges – Error/Accident Chain Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 3
  4. Loss of Situational Awareness • Danger Zones – New situations – Emergency or high stress situations – Relaxed situations • Warning Signs – Fixation – Ambiguity – Complacency – Euphoria – Gut Feeling – Overload/Underload Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 4
  5. Tools for Situational Awareness • Regaining Situational Awareness – Recognize warning signs – Verbalize concerns • Maintaining Situational Awareness – I’M SAFE – AESOP Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 5
  6. I’M SAFE • I – Illness – Are you sick? • M – Medication – Are you taking medication? Dosage right? Side effects under control? Skip/Need a dose? • S – Stress – Is stress affecting you? Is it good or bad stress? • A – Alcohol (and/or Narcotics) – Under the influence now? Still reeling from last night? • F – Fatigue – Tired? Worn out? Sleepy? • E – Eating – Have you eaten enough? Have you eaten too much? Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 6
  7. A…E…S…O…P • Assignment – Is the assignment clear? Any problems foreseen? Time and resources adequate? • Equipment – What equipment is available? Is it appropriate? Is it working properly? • Obstacles – Are there any obstacles to completing the assignment with the equipment available? • Personnel – What personnel are necessary to completed the assignment? Are they available? What is their competence and experience? (I’M SAFE) • Situation – Assess the overall situation and determine best course of action in light of risks identified. Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 7
  8. AESOP Links in ISO 9001 • Assignment – 8.1, 8.5.1a, 8.5.6, 7.1.6 • Equipment – 7.1.1, 7.1.3, 7.1.4, 8.5.1d • Obstacles – 6.1 • Personnel – 7.1.2, 7.1.6, 7.2, 7.3, 8.5.1e • Situation – Based on the situation, use 6.1, 6.3, 7.3 8.5.1, 8.5.6, 9.1 to prevent human error based on the AESOP evaluation. Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 8
  9. Hierarchy of Controls 1. Eliminate the hazard (Remove the risk source) 2. Substitute with less hazardous materials, processes, operations or equipment (Reduce consequences and/or likelihood) 3. Use engineering controls (Reduce likelihood) 4. Use safety signs, markings and warning devices and administrative controls (Reduce likelihood) 5. Use personal protective equipment (Reduce consequences) Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 9
  10. HoC in ISO 9001:2015 • Eliminate – 6.1, 8.1, 8.3.5, 8.5.1, 10.1 • Substitute – 6.1, 8.1, 8.3.5, 8.5.1, 10.1 • Engineering Controls – 7.1.3, 7.1.4, 8.5.1 • Administrative Controls – 7.2, 7.5, 8.1, 8.5.1 • PPE – 7.1.3, 7.1.4, 7.2, 8.1, 8.5.1 • All actions to change processes to prevent human error supported by 6.3, 8.5.6, 9.1 Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 10
  11. The Path Forward • To err is, indeed human • Find and use tools to overcome human nature • Leverage other ISO 9001 requirements to support the quest Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. 11
  12. Cavendish Scott, Inc. • ISO Consulting Training, and Internal Auditing Since 1985 – ISO 9001, AS9100, ISO 13485, ISO 14001, ISO 17025, ISO 27001 • Guaranteed Success (audits and consulting) • Registered Lead Auditors • Thousands of successful consulting registrations • Thousands of trained ISO auditors • Experience with most industries including manufacturing and service industries 12Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved.
  13. Contact • Matt Leiphart • • ISO 9001:2015 packages now • Training, auditing and gap analysis • Cavendish Scott 30+ years in business • ISO Lead Auditor Training • Consulting • Internal Auditing Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved.

Editor's Notes

  1. ISO 9001:2015 now includes a requirement in 8.5.1g stating, “The organization shall implement production and service provision under controlled conditions. Controlled conditions shall include, as applicable:… g) the implementation of actions to prevent human error.” This new requirement has caused much concern among ISO 9001 implementers, due to the difficulty involved with eradicating human error. Quality professionals have been attempting to prevent human error since the invention of the wheel, with mediocre success (based on the fact that human error still exists). This presentation will discuss the nature of human error, present some tools that can be used to address one cause of human error, and point out how the requirements of ISO 9001:2015 contain many clauses that assist in the effort of preventing human error. While it is important to learn new techniques for preventing human error, ISO 9001:2015 already provides many tools to assist in the effort. One popular theory regarding human error is the Swiss Cheese Model, developed by James Reason in the 1990’s. The Swiss Cheess model categorizes human error as caused by either Active Failures, or Latent Conditions. Active Failures are the typical, “Someone screwed up,” basis for human error, while Latent Conditions reflect the overarching management system weaknesses that may create conditions where the active failure could become present. The error prevention tools I will present are aligned with the active failures portion of the Swiss Cheese model. The sections of ISO 9001:2015 cited in this presentation address the latent conditions within the management system that could lead to errors if weak controls are present. “Error management has two components: limiting the incidence of dangerous errors and—since this will never be wholly effective—creating systems that are better able to tolerate the occurrence of errors and contain their damaging effects.” I have a few tools to limit the incidence. Think of management systems like ISO9001:2015 as methods of creating systems to better tolerate occurrence an contain damaging effects.
  2. Our brains process a lot of information, but we are not innately capable of discerning the long-term important from the short-term urgent. It’s easy to see a tiger leaping at you, and you probably would not make the mistake of inaction. You ‘d do something, and probably make no mistake while doing it. In the absence of a short-term obvious threat, we could focus on some concern from the past (the fight with a spouse or parents), or future (that big presentation and the accompanying worry), or get distracted by something that is present but is not important (TV, conversation, shiny objects). When we are not present, not focused on the critical aspects of a task, we can make mistakes. There are patterns in human error called traps. Depending on the trap involved, different tools can be used as a remedy to the trap.
  3. The human error traps presented here and the tools to avoid situational awareness traps are based on materials developed by the Human Error Prevention Institute. Look them up and take one of their excellent courses. Several categories of human error are presented here, along with one or more examples of specific traps within that category. Copilot Syndrome – The comforting premise that one or more other people or systems have the situation under control, resulting in someone just being along for the ride. Proximity Rule – The chance of a conservative decision is directly proportional to the distance to the destination or time remaining to project completion. In other words, the closer you are to where you are going, the harder it is to decide to turn around or stop. Distractions – Inability to maintain focus of attention. Accommodation to Risk – Not being aware of risks involved in an activity or decision, or tendency to minimize risks, especially risks the deal with every day. Strength of an Idea – An unconscious attempt to make available evidence fit a preconceived idea. Once a person or group of people get a certain idea, it can be difficult or impossible for them to alter that idea no matter how much conflicting information is received. Loss of Situational Awareness – Failure to notice and react to information present in the environment, leading to inappropriate action or failing to take action, leading to a mistake. This presentation will discuss specific tools to avoid this trap (which is why the font is red on this slide). Error/Accident Chain – A chain of risk factors and poor judgements, sometimes stretching back days, weeks, months, or even years before the actual incident. Each risk factor brings that person or team closer to the mistake or accident. Each poor judgement increases the availability of false information, which may then negatively influence decisions that follow. As the chain grows, situational awareness becomes impaired and the alternatives for getting the project back on track decrease.
  4. Loss of situational awareness is more likely when someone has entered a danger zone. It is easier to keep situational awareness if one is aware a danger zone has been entered. Another way to detect a danger zone has been entered is detecting the following warning signs. If one or more of these symptoms is present, operations may be happening with a danger zone, and human error may soon follow: Fixation – Focused on only one problem Ambiguity – Known facts do not make sense Complacency – The “I’ve done this a hundred times…” trap Euphoria – Feeling like everything is just perfect Gut Feeling – Indicates the subconscious is putting out a warning. Also called a, “Pinch.” Overload/Underload – Too busy or too bored (There are others not listed here, these are what I believe to be the most common)
  5. After entering a danger zone, and if loss of situational awareness is a risk, it is important to regain situational awareness as soon as possible. Two key tools is to first recognize the warning signs, and verbalize concerns about the possibility of situational awareness loss. Verbalizing concerns may sound like a simpleton’s approach, but it is an effective method of snapping oneself (and everyone around) back into awareness of the tasks underway and the associated risks. We will now discuss two specific tools to help maintain situational awareness. I’M SAFE is a tool for personal situational awareness. The AESOP huddle approach can be used by individuals or teams to maintain situational awareness.
  6. People don’t come to work planning to make mistakes. Often the seeds of a mistake are sown outside work, only to blossom at the worst possible time for an organization. I’M SAFE can help personnel identify if they have the seeds of a mistake growing (without their knowledge). This is loss of personal situational awareness, which can lead to human error.
  7. Even when every person has their individual situational awareness under control, work teams must have a collective understanding of their current situation to avoid mistakes. The AESOP huddle model helps all team members assess the overall situation, and provide indicators for what needs to be done to get a situation back under control. This can be done at set points throughout a work day, at predefined times based on events, and/or when called for based on a team member’s assessment of the team’s situation and performance.
  8. ISO 9001:2015 clauses supporting each of the AESOP categories Assignment: 8.1 Operational Planning and Control 8.5.1a Control of Production and Service Provision (availability of documented information…) 8.5.6 Control of Changes 7.1.6 Organizational Knowledge Equipment: 7.1.1 Resources, General 7.1.3 Infrastructure 7.1.4 Environment for the Operation of Processes 8.5.1d Control of Production and Service Provision (use of suitable infrastructure and environment…) Obstacles: 6.1 Actions to Address Risks and Opportunities Personnel: 7.1.2 People 7.1.6 Organizational Knowledge 7.2 Competence 7.3 Awareness 8.5.1e Control of Production and Service Provision (appointment of competent/qualified persons…) Situation: 6.1 Actions to Address Risks and Opportunities 6.3 Planning of Changes 7.3 Awareness 8.5.1 Control of Production and Service Provision 8.5.6 Control of Changes 9.1 Monitoring, Measurement, Analysis, and Evaluation
  9. Another approach for preventing human error is reflected in Hierarchy of Control approach. Ranked from one to five, with one being the most effective, and five the least effective, management systems can focus actions to change latent conditions and remove opportunities for human error. The Hierarchy of Controls concept also appears in OHSAS 18001:2007 section 4.3.1, addressing health and safety management systems. In this context, Hierarchy of Controls is used to address human error. For each control discussed, the risk treatment equivalent from ISO 31000:2009 is identified in parenthesis. (Definitions below from Wikipedia) Elimination - Eliminating the hazard—physically removing it—is the most effective hazard control. For example, if employees must work high above the ground, the hazard can be eliminated by moving the piece they are working on to ground level to eliminate the need to work at heights. Substitution - Substitution, the second most effective hazard control, involves replacing something that produces a hazard (similar to elimination) with something that does not produce a hazard—for example, replacing lead based paint with acrylic paint. To be an effective control, the new material, process, etc. must not produce another hazard. Engineering controls - The third most effective means of controlling hazards is engineered controls. These do not eliminate hazards, but rather isolate people from hazards. Administrative controls - Administrative controls are changes to the way people work. Examples of administrative controls include procedure changes, employee training, and installation of signs and warning labels. Administrative controls do not remove hazards, but limit or prevent people's exposure to the hazards, such as completing road construction at night when fewer people are driving. Personal protective equipment - Personal protective equipment (PPE) is the least effective means of controlling hazards.
  10. ISO 9001:2015 Clauses that Support Each Hierarchy of Controls: Eliminate and Substitute: 6.1 Actions to Address Risks and Opportunities 8.1 Operational Planning and Control 8.3.5 Design and Development Outputs 8.5.1 Control of Production and Service Provision 10.1 Improvement, General Engineering Controls: 7.1.3 Infrastructure 7.1.4 Environment for the Operation of Processes 8.5.1 Control of Production and Service Provision Administrative Controls: 7.2 Competence 7.5 Documented Information 8.1 Operational Planning and Control 8.5.1 Control of Production and Service Provision Personal Protective Equipment (PPE): 7.1.3 Infrastructure 7.1.4 Environment for the Operation of Processes 7.2 Competence 8.1 Operational Planning and Control 8.5.1 Control of Production and Service Provision All Actions to Change Processes: 6.3 Planning of Changes8.5.6 Control of Changes 8.5.6 Control of Changes 9.1 Monitoring, Measurement, Analysis, and Evaluation
  11. It is true, we will never eliminate human error. It is also true we have been working diligently to eliminate human error from our processes. There are many requirements within ISO9001:2015 that assist in the quest to prevent human error. What the new requirement in ISO9001:2015 clause 8.5.1g does is hold us accountable for exactly what we are doing to prevent human error, and opens the door for auditors to ask the question and make us demonstrate what we are doing. There are many tools that exist to help us understand human error and take steps to prevent it. The two tools presented here are the tip of a very big iceberg. It is best for all of us to research methods teach techniques to those we work with to help them avoid errors. Nobody wants to make mistakes, but we all do. Our management systems must take this into consideration, and our work practices must continue to be made more robust. The 8.5.1g requirement will help us keep this important operational aspect front and center in all our minds. We appreciate the time you spent exploring Preventing Human Error with Cavendish Scott.