Process Based Internal Audit Course
Struggling Against NaturePreventing Human Error in the ISO
9001:2015 StandardCopyright 2016 Cavendish Scott, Inc. All Rights
Reserved. www.CavendishScott.com1
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 1990s. 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 andsince this will never be wholly
effectivecreating 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.
1
The Nature of Human ErrorWhy do humans screw
up?TrapsToolsCopyright 2016 Cavendish Scott, Inc. All Rights
Reserved. www.CavendishScott.com2
Our brains process a lot of information, but we are not innately
capable of discerning the long-term important from the short-term
urgent. Its 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.
2
Human Error TrapsInterpersonal How we interact with
othersCopilot SyndromeAttitude Mental approach to life and our
jobsProximity RuleStress Response to differing
workloadsDistractionsRisk Awareness of and response to
risksAccommodation to RiskAttention Level of concentration and
awarenessStrength of an IdeaLoss of Situational AwarenessTask
Response to unanticipated challengesError/Accident ChainCopyright
2016 Cavendish Scott, Inc. All Rights Reserved.
www.CavendishScott.com3
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.3
Loss of Situational AwarenessDanger ZonesNew situationsEmergency
or high stress situationsRelaxed situationsWarning
SignsFixationAmbiguityComplacencyEuphoriaGut
FeelingOverload/UnderloadCopyright 2016 Cavendish Scott, Inc. All
Rights Reserved. www.CavendishScott.com4
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
problemAmbiguity Known facts do not make senseComplacency The Ive
done this a hundred times trapEuphoria Feeling like everything is
just perfectGut 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)4
Tools for Situational AwarenessRegaining Situational
AwarenessRecognize warning signsVerbalize concernsMaintaining
Situational AwarenessIM SAFEAESOPCopyright 2016 Cavendish Scott,
Inc. All Rights Reserved. www.CavendishScott.com5
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
simpletons 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. IM SAFE is a tool for personal situational
awareness. The AESOP huddle approach can be used by individuals or
teams to maintain situational awareness.5
IM SAFEI IllnessAre you sick?M MedicationAre you taking
medication? Dosage right? Side effects under control? Skip/Need a
dose?S StressIs stress affecting you? Is it good or bad stress?A
Alcohol (and/or Narcotics)Under the influence now? Still reeling
from last night?F FatigueTired? Worn out? Sleepy?E EatingHave you
eaten enough? Have you eaten too much?
Copyright 2016 Cavendish Scott, Inc. All Rights Reserved.
www.CavendishScott.com6
People dont 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. IM 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.6
AESOPAssignment 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? (IM 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. www.CavendishScott.com7
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 members assessment of the teams
situation and performance.7
AESOP Links in ISO 9001Assignment 8.1, 8.5.1a, 8.5.6,
7.1.6Equipment 7.1.1, 7.1.3, 7.1.4, 8.5.1dObstacles 6.1Personnel
7.1.2, 7.1.6, 7.2, 7.3, 8.5.1eSituation 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. www.CavendishScott.com8
ISO 9001:2015 clauses supporting each of the AESOP categories
Assignment:8.1 Operational Planning and Control8.5.1a Control of
Production and Service Provision (availability of documented
information)8.5.6 Control of Changes7.1.6 Organizational
Knowledge
Equipment: 7.1.1 Resources, General7.1.3 Infrastructure7.1.4
Environment for the Operation of Processes8.5.1d 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 People7.1.6 Organizational Knowledge7.2
Competence7.3 Awareness8.5.1e Control of Production and Service
Provision (appointment of competent/qualified persons)
Situation:6.1 Actions to Address Risks and Opportunities6.3
Planning of Changes7.3 Awareness8.5.1 Control of Production and
Service Provision8.5.6 Control of Changes9.1 Monitoring,
Measurement, Analysis, and Evaluation8
Hierarchy of ControlsEliminate the hazard (Remove the risk
source)Substitute with less hazardous materials, processes,
operations or equipment (Reduce consequences and/or likelihood)Use
engineering controls (Reduce likelihood)Use safety signs, markings
and warning devices and administrative controls (Reduce
likelihood)Use personal protective equipment (Reduce
consequences)Copyright 2016 Cavendish Scott, Inc. All Rights
Reserved. www.CavendishScott.com9
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
hazardphysically removing itis 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 hazardfor 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.9
HoC in ISO 9001:2015Eliminate 6.1, 8.1, 8.3.5, 8.5.1,
10.1Substitute 6.1, 8.1, 8.3.5, 8.5.1, 10.1Engineering Controls
7.1.3, 7.1.4, 8.5.1Administrative Controls 7.2, 7.5, 8.1, 8.5.1PPE
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, 9.1Copyright 2016 Cavendish Scott, Inc. All Rights
Reserved. www.CavendishScott.com10
ISO 9001:2015 Clauses that Support Each Hierarchy of
Controls:
Eliminate and Substitute:6.1 Actions to Address Risks and
Opportunities8.1 Operational Planning and Control8.3.5 Design and
Development Outputs8.5.1 Control of Production and Service
Provision10.1 Improvement, General
Engineering Controls:7.1.3 Infrastructure7.1.4 Environment for
the Operation of Processes8.5.1 Control of Production and Service
Provision
Administrative Controls:7.2 Competence7.5 Documented
Information8.1 Operational Planning and Control8.5.1 Control of
Production and Service Provision
Personal Protective Equipment (PPE):7.1.3 Infrastructure7.1.4
Environment for the Operation of Processes7.2 Competence8.1
Operational Planning and Control8.5.1 Control of Production and
Service Provision
All Actions to Change Processes:6.3 Planning of Changes8.5.6
Control of Changes8.5.6 Control of Changes9.1 Monitoring,
Measurement, Analysis, and Evaluation
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The Path ForwardTo err is, indeed humanFind and use tools to
overcome human natureLeverage other ISO 9001 requirements to
support the questCopyright 2016 Cavendish Scott, Inc. All Rights
Reserved. www.CavendishScott.com11
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.11
Cavendish Scott, Inc.ISO Consulting Training, and Internal
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12
ContactMatt [email protected]
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