An action may be judged as an error only in relation to a reference or standard. So first a standard on how to perform the task must exist. Sometimes such a standard is defined in a documented procedure. On occasion it may also be taught by a master to an apprentice on the job. Most times we just figure it out through a combination of past experience, current observations, and some fiddling. Human error, then, is action by a human that deviates from the standard.
When we judge the root cause of a problem as human error we’re making certain assumptions: 1] that a standard exists, and 2] the standard, if it exists, is adequate to the degree that mindfully following it produces the expected outcome.
Let’s grant that both the above assumptions are true, and even grant that the root cause of a problem was the failure of the worker to follow the standard. What, then, should the corrective action be that will prevent the recurrence of the problem? In my experience it has almost always been defined as “retraining”. But such a corrective action assumes that the worker failed to follow the standard because they don’t know it. Is this true? If not, retraining is pure waste and won’t do a damn thing to prevent the recurrence of the problem.
If a proper standard exists and the worker has been trained to it, then there must be some other reason for their failure to follow it. Skill-based errors (i.e. slips and lapses) can occur when the worker is unable to pay attention to or focus on performing the task they are otherwise familiar with. So it’s not a training issue. In my previous post I wrote about how willpower, our conscious awareness, is like a muscle. It can fatigue from use. As willpower is depleted the mind resorts to mental shortcuts or habits. This is how errors creep in.
We should not rely only on our ability to remain attentive and focused to ensure that the task is performed without failure. For that we must design tasks in such a way that failure is unlikely, if not impossible, to occur. Through design thinking we can develop tools, methods, and systems that help us perform better.
 Understanding human failure. http://www.hse.gov.uk/construction/lwit/assets/downloads/human-failure.pdf Retrieved 2017-06-15
We seem to make decisions in more impulsive ways than before. Many of us don’t seem to practice any reasonable amount of self-control. I feel this may be because most of us today just don’t have strong willpower.
Last year I read a book called “Willpower” by Roy F. Baumeister and John Tierney. In it the authors liken willpower to muscle. And just like a muscle willpower can wear out from fatigue. When willpower is worn out, we behave more impulsively. How quickly we drain our willpower depends on how strong it is.
In using our willpower to make decisions we’re using our conscious mind or “System 2” as Daniel Kahneman refers to it in “Thinking, Fast and Slow”. Conscious decision making or thinking is hard! It requires effort and uses a lot of energy in the process.
The body, however, has a limited store of energy. When we are low on energy, this conscious decision making process shuts down and decision making is shunted to the brain’s default decision making process or “System 1.” It doesn’t require much energy; it’s automatic and occurs outside of our conscious awareness. Many of the decisions we make in the default mode are driven by habit.
Conscious decision making generally produces reliable outcomes. We make better decisions with it. Not so with automatic decision making, which has been shown to be error-prone, often in systematic ways. So it’s important that we exercise our willpower; build it up, and make it stronger.
No one can make you exercise your body or mind. That’s a choice you make for yourself. But the results of your choice affects your behavior which in turn affects society. We live in communities and we have an obligation to them: to be the best version of ourselves.
 Baumeister, Roy F., John Tierney (2012). Willpower: Rediscovering the Greatest Human Strength.
 Kahneman, Daniel (2011). Thinking, Fast and Slow.
In my last post I might have left the impression that conceptualizing the real place is bad or that we should avoid it. This is not a correct impression.
We cannot avoid conceptualizing the real place. It’s automatic; part of our biological structure and the structure of our language. Concepts are how we make sense of the real place. They provide insights into the real place. We need those insights to respond appropriately to the real place. But we shouldn’t lose sight of the fact that concepts are the mind’s representations of the real place and not the real place itself! We can call them images, idols, models, data, or symbols.
D. T. Suzuki shared, “To point at the moon a finger is needed, but woe to those who take the finger for the moon…” Alfred Korzybski wrote in Science and Sanity, “A map is not the territory it represents, but, if correct, it has a similar structure to the territory, which accounts for its usefulness.” George E. P. Box, in Statistics for Experimenters, put it pithily that “all models are wrong; some models are useful.” These reminders, to be consciously aware of the difference between the real place and our mind’s abstractions of it, is the thread that runs through science and religion.
Problems only arise when we hold onto a concept long after it has stopped representing the real place and a gap has developed between what is and what we conceptualize it to be. To know what is, we must first “go and see” the real place. Without that direct experience with the real place, we cannot hope to act in ways appropriate to it. This is my understanding of what Zen and lean teach.
My study of Buddhist thought, and especially Zen, have so far taught me that I am often unaware of the real place. Decades of schooling and acculturation to society have taught me to ignore the real place in favor of concepts manufactured by the human mind; to create and be hypnotized by images and models. Right, wrong, god, devil, me, you, husband, wife, mother, father, boss, servant, friend, enemy, success, failure, good, bad, us, and them are all concepts. These are all creations of the mind. It gives them meaning. They’re not real.
Concepts are static–unchanging and easy to grab a hold of and cling to, while the real place is dynamic–ever changing; sometimes in predictable ways, most times in unpredictable ways. The real place offers nothing to grab on to; nothing to cling to. It is inevitable then that the two will eventually diverge from one another. I believe that that gap between what I see and what I think I see is the source of much, if not all, my suffering–frustration, anxiety, feelings of helplessness, exhaustion, and such. To experience the real place, I must let go of concepts, or rather I should not cling to them. Only then will my actions be appropriate or right for the real place.
Zen has been useful in ferrying me back to the real place every time my mind drifts to concepts.
My most direct experience of this gap, or at least one that I am most aware of, has been in the workplace. Data, charts, procedures, policies, concepts abound. Again, most, if not all, are disconnected from the real processes and systems. How work actually happens. However, like me, organizations remain mostly unaware of the disconnect. They thus suffer in a mire of internal conflict and frustration, too.
Lean can be useful to get organizations back to the real place.
Plan The engineering concept for a part is converted into a detailed drawing. It provides a graphic representation of the part along with all its engineering requirements/specifications. Among other things, it defines the geometry, dimensions, tolerances, and material for the physical part. The drawing of the part acts as the plan for the manufacturer to follow when making the physical part.
Do The manufacturer uses the drawing of the part (plan) to make the physical part (do).
(Note: If you outsource the manufacturing of the part, lead times could be as much as 14 weeks or 3+ months. So, it’s a good idea to involve the manufacturer in the planning phase of the part to address any foreseeable issues as early as possible.)
Check The physical part is inspected (checked) against the drawing of the part (plan) e.g. as part of a first article inspection (FAI) or receiving inspection. Discrepancies between the physical part and its drawing are identified.
Act Decisions are made for each discrepancy to determine whether the part must comply with the existing drawing specifications or whether the drawing specifications—typically the tolerances around an attribute—should be changed.
If it’s decided that the drawing specifications are to be changed, e.g. the tolerances for one or more attributes is to be loosened, then the drawing is revised. This results in another loop through the PDCA cycle with the new drawing or plan.
I have identified 40 procedures required by 21 CFR 820: the Quality System Regulation
- § 820.22 for quality audits…
- § 820.25(b) for identifying training needs…
- § 820.30(a)(1) to control the design of the device in order to ensure that specified design requirements are met
- § 820.30(c) to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient
- § 820.30(d) for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements
- § 820.30(e) to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development
- § 820.30(f) for verifying the device design
- § 820.30(g) for validating the device design
- § 820.30(h) to ensure that the device design is correctly translated into production specifications
- § 820.30(i) for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation
- § 820.40 to control all documents that are required by this part
- § 820.50 to ensure that all purchased or otherwise received product and services conform to specified requirements
- § 820.60 for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups
- § 820.65 for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components
- § 820.70(a) that describe any process controls necessary to ensure conformance to specifications
- § 820.70(b) for changes to a specification, method, process, or procedure
- § 820.70(c) to adequately control these environmental conditions
- § 820.70(e) to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality
- § 820.70(h) for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device’s quality
- § 820.72(a) to ensure that equipment is routinely calibrated, inspected, checked, and maintained
- § 820.75(b) for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met
- § 820.80(a) for acceptance activities
- § 820.80(b) for acceptance of incoming product
- § 820.80(c) to ensure that specified requirements for in-process product are met
- § 820.80(d) for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria
- § 820.90(a) to control product that does not conform to specified requirements
- § 820.90(b)(1) that define the responsibility for review and the authority for the disposition of nonconforming product
- § 820.90(b)(2) for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications
- § 820.100(a) for implementing corrective and preventive action
- § 820.120 to control labeling activities
- § 820.140 to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling
- § 820.150(a) for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed
- § 820.150(b) that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms
- § 820.160(a) for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution
- § 820.170(a) for ensuring proper installation so that the device will perform as intended after installation
- § 820.184 to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part
- § 820.198(a) for receiving, reviewing, and evaluating complaints by a formally designated unit
- § 820.200(a) for performing and verifying that the servicing meets the specified requirements
- § 820.250(a) for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics
- § 820.250(b) to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed
Today on Morning Edition Condoleezza Rice shared that the founders of the American republic understood institutions weren’t built for human perfections, but for human imperfections . If only present day leaders understood institutions in this way, too.
We humans don’t always act in ways that help us achieve our goals. Our imperfections get in the way. So we establish ways of doing things, patterns of behavior, to help us act appropriately. This is particularly valuable during times when our judgment is clouded.
In our pursuit of ever more ambitious goals, goals that require coordinated action of many individuals, we need a system of such procedures that is designed to help us achieve those goals. When we put these procedures into practice, we collectively move toward our goals. When this pattern of behavior persists over time, we give rise to a recognizable entity: an institution.
Institutions exist to help us act in ways that make it possible to achieve the goals we set for them. They are especially valuable at times when we experience uncertainty that stokes our primal fear.
Monday afternoons at two-thirty. That was the time for our weekly staff meeting. When I joined the company everyone was required to attend it: engineers, technicians and operators. The head of our department, the Director of Quality, led it.
It was a rare week when the meeting started on time. Mondays were also when we had our one-on-one meetings with the Director and he had one of those exchanges going on right before our staff meeting. It always went over. So several of us would gather and wait outside of the meeting room until we were noticed and motioned to come in.
Even with this routine delay I don’t remember a single week when everyone was present before the meeting started. There was frequently at least one person who creeped in late. It wasn’t always the same person either. Some late comers might put on an apologetic face at times, but a few were shamelessly indifferent of their indiscretion.
Just as the meeting never started on time, it didn’t end on time either. I recall a few occasions when I wondered whether the meeting actually ended.
The Director got our meeting going by sharing a subset of the highlights and lowlights of the previous week that he gets in an email from the corporate overlords. We cheered the highlights and bemoaned the lowlights even though none of us could draw a connection to any them with the specific work we did. They did not prompt any actions for our department. They were also divorced from similar points shared in the previous week; presented as stand-alone bits of information. On those occasions when someone did make a tentative connection, it unleashed pent up frustrations with people feeding off of each other to blame some nonpresent “they.” So what purpose did this update serve? I couldn’t tell you.
Following the update, the Director shared his schedule for the current week. It always showed back-to-back meetings, sometimes overlapping, from the start of the workday to its end, for the whole week. So when did he have time to think and plan, to draw up an agenda for his meetings, to follow-up on assignments, to analyze, understand, and guide the performance of the system he was charged to direct? At first I had felt sympathy. What sort of monstrous organization drives its people like this? But it didn’t last long. I recognized much of it was self imposed and not a demand of the organization. It was his way of showing others how busy and engaged he was, how hard he was working, how committed he was to the company. It was all light and no heat. Perhaps I’m being harsh, but I don’t think so.
After he finished his update he would ask each staff member if they had anything to share. Most did not. Some, though, shared information on what they were doing in excruciating detail. Usually it was about “unexpected” hurdles, blocks, or breakdowns. They were the same from week to week. This was another opportunity to vent about those others who didn’t follow procedures, the unreasonable surge in demand for our services, or how the system is broken and needs fixing. Who is going to fix it? How should it be fixed? What resources are needed for the fix? That requires a plan. But when is there time and space for that?
Once a month the Director would remind everyone to calculate and report metrics they were responsible for. It shouldn’t come as a surprise that at least one was delayed. Not always the same one, but it came with all the usual excuses.
That was the ritual.
Companies have been proudly proclaiming that they hire only the best and brightest. Ignoring the fact that this is a bogus claim – personal experience at a dozen different companies has demonstrated otherwise – a firm would find it all but impossible to function with the best and brightest.
Back in 1994 Dr Russell Ackoff shared an example that elegantly explains why.
I read in the New York Times recently that 457 different automobiles are available in the United States. Let’s buy one of each and bring them into a large garage.
Let’s then hire 200 of the best automotive engineers in the world and ask them to determine which car has the best engine. Suppose they come back and say Rolls Royce has the best engine. Make a note of it.
“Which one has the best transmission?”, we ask them and they go run tests and come back and say the Mercedes does.
“Which one has the best battery?” [They] come back and say the Buick does.
And one by one, for every part required for an automobile, they tell us which is the best one available.
Now we take that list and give it back to them and say “Remove those parts from those cars. Put them together into the best possible automobile,” because now we’ll have an automobile consisting of all the best parts.
What do we get? You don’t even get an automobile, for the obvious reason that the parts don’t fit!
The performance of the system depends on how the parts fit, not how they act taken separately.
A significant portion of organizational excellence depends on how employees interact with one another i.e. how they fit together, not how they act individually.
Dr. Ackoff’s entire talk titled “Beyond Continual Improvement” is worth listening to.