Drive Out Fear on International Workers Day

Happy International Workers Day. Let’s celebrate by Driving Out Fear!

Thirty-five years ago Deming wrote that “no one can put in his best performance unless he feels secure.” Unfortunately, today we still live in a corporate world where fear and management by fear is ubiquitous. That fear is growing after more than a year of a global pandemic. As quality professionals we must deal with it at every opportunity.

Fear undermines quality, productivity, and innovation. The existence of fear leads to a vicious downward spiral.

Some sources of fear include:

  • Competition: Many managers use competition to instill fear. Competition is about winners and losers. Success cannot exist without failure. Managers deem the anxiety generated by competition between co-workers a good thing as they compete for scarce resources, power and status. Therefore, management encourage competition between individuals, between groups and departments and between business units.
  • “Us and Them” Culture: The “us and them” culture that predominates in so many organizations proliferated by silos. Includes barriers between staff and supervisors.
  • Blame Culture: Fear predominates in a blame culture. Blame culture can often center around enshrining the idea of human error.

We drive out fear by building a culture centered on employee well-being. This is based on seven factors.

FactorMeansObtained by
ResponsibilityWell defined responsibilities and ownershipThe opportunity an employee has to provide input into decision making in his department
An individual employees’ own readiness to set high personal standards
An individual employee’s interest in challenging work assignments
The opportunity an employee has to improve skills and capabilities
Excellent career advancement opportunities
The organization’s encouragement of problem-solving and innovative thinking
Management CompetenceManagers trained with skills that lend themselves to contributing to the work of their team ensures that they will be looked to for help. Managers need to be able to guide.Direct Supervisor/Manager Leadership Abilities Management is engaged and leads by example (Gemba walks)
Management by Facts
ConsiderationWhen managers act as if employees have no feelings and just expect them to do their work as if they are robots, it can make employees uneasy. Such behavior makes them feel detached and merely a tool to carry out an end. In such environments, many times the only times employees hear from the manager is when something goes well or really bad. In either case, the perception could be that the manager has mood swings and that also adds to the employee’s insecurity. They may feel reluctant to talk to their manager for fear he is in one of his bad moods.Senior Management’s sincere interest in employee well-being
An individual employee’s relationship with their supervisor
Open and effective communication
Trust in management and co-workers
CooperationThe feeling that every person is on their own to look out for their interest is a sad state to be in. Yet when everyone has a fear that the other workers will take advantage of them or make them look bad at the first opportunity, a selfish and insecure environment will result. Employees should be able to work together for the benefit of the company. They should focus on group goals in addition to their personal goals, recognizing that individually there will be failures, but that the whole is more important than the individual parts.Trust Well trained employees Collaboration as a process Organizational culture (psychological safety) Hire and promote the right behaviors & traits to match the culture
FeedbackInformation that is given back to the employee regarding their performance on the job.Know what is expected of them (clear job descriptions)
Effective processes for timely feedback
Recognition
Know their opinion matters
InformationTransparency is critical. When employees know nothing about how a company is doing in terms of where they should be, it is a source of uneasiness. Without that knowledge, for all they know the company could be doing very poorly and that could be a bad thing for everyone. When they have a better sense of where the company is in the scheme of their objectives set by management, it helps them feel more secure. That is not to say it is the news being good or bad that affects their security, but rather the fact that they actually have the news.Strategy and Mission — especially the freedom and autonomy to succeed and contribute to an organization’s success
Organizational Culture and Core/Shared
Values
Feel that their job is important
StabilityEmployees feel more secure when their role does not change frequently and they understand what tomorrow will mean.Job Content — the ability to do what I do best
Availability of Resources to Perform the Job Effectively
Career development – opportunities to learn and grow
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Levels of Problems in Culture

When thinking about root cause analysis it is useful to think of whether the problem is stemming from a cultural level or when it may be coming from an operational. We can think of these problems as hazards stemming from three areas:

  • Culture/philosophy is the over-arching view of how the organization conducts business from top-level decision-makers on through the corporate culture of an organization.
  • Policies are the broad specifications of the manner in which operations are performed. This includes the end-to-end processes.
  • Policies lead to the development of process and procedures, which are specifications for a task or series of tasks to accomplish a predetermined goal leading to a high degree of consistency and uniformity in performance.
Hazards unrecognized (risks not known or correctly appraised)Hazards forseen (risks anticipated but response not adequate)
Culture/Philosophy
Quality not source of corporate pride
Regulatory standards seen as maxima
Culture/Philosophy
Quality seen as source of corporate pride
Regulatory standards seen as minima
Policy
Internal monitoring schemes inadequate (e.g. employee concerns not communicated upwards)
Insufficient resources allocated to quality
Managers insufficiently trained or equipped
Reliance on other organization’s criteria (e.g. equipment manufacturer)
Policy
Known deficiencies (e.g. equipment, maintenance) not addressed
Defenses not adequately monitored
Defenses compromised by other policies (e.g. adversarial employee relations, incentive systems, performance monitoring)
Procedures
No written procedures
Procedures
Documentation inadequate
Inadequate, or Loop-hole in, controls
Procedures conflict with one another or with organizational policy

This approach on problems avoids a focus on the individuals involved and avoids a blame culture, which will optimize learning culture. Blaming the individuals risks creating an unsafe culture and creates difficulties for speaking up which should be an espoused quality value. Focus on deficiencies in the system to truly address the problem.

What prevents us from improving systems?

Improvement is a process and sometimes it can feel like it is a one-step-forward-two-steps-back sort of shuffle. And just like any dance, knowing the steps to avoid can be critical. Here are some important ones to consider. In many ways they can be considered an onion, we systematically can address a problem layer and then work our way to the next.

Human-error-as-cause

The vague, ambiguous and poorly defined bucket concept called human error is just a mess. Human error is never the root cause; it is a category, an output that needs to be understood. Why did the human error occur? Was it because the technology was difficult to use or that the procedure was confusing? Those answers are things that are “actionable”—you can address them with a corrective action.

The only action you can take when you say “human error” is to get rid of the people. As an explanation the concept it widely misused and abused. 

Human performance instead of human error
AttributePerson ApproachSystem Approach
FocusErrors and violationsHumans are fallible; errors are to be expected
Presumed CauseForgetfulness, inattention, carelessness, negligence“Upstream” failures, error traps; organizational failures that contribute to these
Countermeasure to applyFear, more/longer procedures, retraining, disciplinary measures, shamingEstablish system defenses and barriers
Options to avoid human error

Human error has been a focus for a long time, and many companies have been building programmatic approaches to avoiding this pitfall. But we still have others to grapple with.

Causal Chains

We like to build our domino cascades that imply a linear ordering of cause-and-effect – look no further than the ubiquitous presence of the 5-Whys. Causal chains force people to think of complex systems by reducing them when we often need to grapple with systems for their tendency towards non-linearity, temporariness of influence, and emergence.

This is where taking risk into consideration and having robust problem-solving with adaptive techniques is critical. Approach everything like a simple problem and nothing will ever get fixed. Similarly, if every problem is considered to need a full-on approach you are paralyzed. As we mature we need to have the mindset of types of problems and the ability to easily differentiate and move between them.

Root cause(s)

We remove human error, stop overly relying on causal chains – the next layer of the onion is to take a hard look at the concept of a root cause. The idea of a root cause “that, if removed, prevents recurrence” is pretty nonsensical. Novice practitioners of root cause analysis usually go right to the problem when they ask “How do I know I reached the root cause.” To which the oft-used stopping point “that management can control” is quite frankly fairly absurd.  The concept encourages the idea of a single root cause, ignoring multiple, jointly necessary, contributory causes let alone causal loops, emergent, synergistic or holistic effects. The idea of a root cause is just an efficiency-thoroughness trade-off, and we are better off understanding that and applying risk thinking to deciding between efficiency and resource constraints.

In conclusion

Our problem solving needs to strive to drive out monolithic explanations, which act as proxies for real understanding, in the form of big ideas wrapped in simple labels. The labels are ill-defined and come in and out of fashion – poor/lack of quality culture, lack of process, human error – that tend to give some reassurance and allow the problem to be passed on and ‘managed’, for instance via training or “transformations”. And yes, maybe there is some irony in that I tend to think of the problems of problem solving in light of these ways of problem solving.

Human Performance and Data Integrity

Gilbert’s Behavior Engineering Model (BEM) presents a concise way to consider both the environmental and the individual influences on a person’s behavior. The model suggests that a person’s environment supports impact to one’s behavior through information, instrumentation, and motivation. Examples include feedback, tools, and financial incentives (respectively), to name a few. The model also suggests that an individual’s behavior is influenced by their knowledge, capacity, and motives. Examples include training/education, physical or emotional limitations, and what drives them (respectively), to name a few. Let’s look at some further examples to better understand the variability of individual behavioral influences to see how they may negatively impact data integrity.

Kip Wolf “People: The Most Persistent Risk To Data Integrity

Good article in Pharmaceutical Online last week. It cannot be stated enough, and it is good that folks like Kip keep saying it — to understand data integrity we need to understand behavior — what people do and say — and realize it is a means to an end. It is very easy to focus on the behaviors which are observable acts that can be seen and heard by management and auditors and other stakeholders but what is more critical is to design systems to drive the behaviors we want. To recognize that behavior and its causes are extremely valuable as the signal for improvement efforts to anticipate, prevent, catch, or recover from errors.

By realizing that error-provoking aspects of design, procedures, processes, and human nature exist throughout our organizations. And people cannot perform better than the organization supporting them.

Design Consideration

Human Error Considerations

Manage Controls

Define the Scope of Work

·       Identify the critical steps

·       Consider the possible errors associated with each critical step and the likely consequences.

·       Ponder the "worst that could happen."

·       Consider the appropriate human performance tool(s) to use.

·       Identify other controls, contingencies, and relevant operating experience.

When tasks are identified and prioritized, and resources

are properly allocated (e.g., supervision, tools, equipment, work control, engineering support, training), human performance can flourish.

 

These organizational factors create a unique array of job-site conditions – a good work environment – that sets people up for success. Human error increases when expectations are not set, tasks are not clearly identified, and resources are not available to carry out the job.

The error precursors – conditions that provoke error – are reduced. This includes things such as:

·       Unexpected conditions

·       Workarounds

·       Departures from the routine

·       Unclear standards

·       Need to interpret requirements

 

Properly managing controls is

dependent on the elimination of error precursors that challenge the integrity of controls and allow human error to become consequential.

Apply proactive Risk Management

When risk is properly analyzed we can take appropriate action to mitigate the risks. Include the criteria in risk assessments:

·       Adverse environmental conditions (e.g. impact of gowning, noise, temperature, etc)

·       Unclear roles/responsibilities

·       Time pressures

·       High workload

·       Confusing displays or controls

Addressing risk through engineering and administrative controls are a cornerstone of a quality system.

 

Strong administrative and cultural controls can withstand human error. Controls are weakened when conditions are present that provoke error.

 

Eliminating error precursors

in the workplace reduces

the incidences of active errors.

Perform Work

 

Utilizing error reduction tools as part of all work. Examples include:

·       Self-checking

o   Questioning attitude

o   Stop when unsure

o   Effective communication

o   Procedure use and adherence

o   Peer-checking

o   Second-person verifications

o   Turnovers

 

Engineering Controls can often take the place of some of these, for example second-person verifications can be replaced by automation.

Appropriate process and tools in place to ensure that the organizational processes and values are in place to adequately support performance.

Because people err and make mistakes, it is all the more important that controls are implemented and properly maintained.

Feedback and Improvement

 

Continuous improvement is critical. Topics should include:

·       Surprises or unexpected outcomes.

·       Usability and quality of work documents

·       Knowledge and skill shortcomings

·       Minor errors during the activity

·       Unanticipated workplace conditions

·       Adequacy of tools and Resources

·       Quality of work planning/scheduling

·       Adequacy of supervision

Errors during work are inevitable. If we strive to understand and address even inconsequential acts we can strengthen controls and make future performance better.

Vulnerabilities with controls can be found and corrected when management decides it is important enough to devote resources to the effort

 

The fundamental aim of oversight is to improve resilience to significant events triggered by active errors in the workplace—that is, to minimize the severity of events.

 

Oversight controls provide opportunities to see what is happening, to identify specific vulnerabilities or performance gaps, to take action to address those vulnerabilities and performance gaps, and to verify that they have been resolved.