Quality Control
Human Error
Dimitris Papamatthaiakis
Pharma Life-cycle Consultancy
Outline
 Introduction
 TQM thinking
 Going down the food chain
 Forms of manufacturing advantage
 Human error classification
 Root causes for human error
 Ethical considerations
 Failures of Six Sigma
 Paralysis of the old view
 GWOE
 New view considerations
Human error
Introduction
 A lot of organizations are confronted by desperation.
 Incidents keep occurring (even the same sorts of
incidents), and traditional measures finding “human
errors” do not appear to work
 Labeling human error as cause of trouble said nothing
about the trouble itself, but about the people who do
the labeling—about their beliefs in what exposes the
system to risk
 Pressure on managers or others “to do something”
about the error problem
 The pressures to respond with quick-fix, old-view
countermeasures (reprimands,demotion, exile) could
be enormous and difficult to withstand
Human error
TQM thinking
Human error
TQMthinking
 European Aviation Safety Agency (EASA) worked with
psychologists and quality managers to develop human
factors engineering to prevent system failures and
human fatalities.
 Often contradicts the commercial pressures faced by
businesses to improve quality/safety against the need
to reduce lead times, offer quicker turnarounds and
operate leaner ways of working.
Human error
TQMthinking
 One of the great gurus of Quality Management
 Statistical Product Quality Administration
 Plan-Do-Check-Act
 ...
Human error
TQMthinking
 Placing blame on workforces who are responsible for
only 15% of mistakes while the system designed by
management is responsible for 85% of the unintended
consequences
Human error
TQMthinking
1. Create constancy of purpose toward improvement of
product, with the aim to stay in business, and to provide jobs.
2. Western management must awaken to the challenge, learn
their responsibilities and take on leadership for change.
3. Eliminate the need for inspection on a mass basis by building
quality into the product in the first place.
4. End the practice of awarding business on the basis of price
tag. Move toward a single supplier, on a long-term
relationship of loyalty and trust.
5. Improve constantly the system of production, to improve
quality and productivity, and thus constantly decrease cost.
6. Institute training on the job.
7. Institute leadership — the aim of supervision should be to
help people and machines and gadgets to do a better job.
8. Drive out fear, so that everyone may work effectively for the
company.
Human error
TQMthinking
9. Break down barriers between departments.
10. Eliminate slogans, exhortations and targets for the work force
asking for zero defects and new levels of productivity.
11. Eliminate work standards (quotas) on the factory floor.
12. Eliminate management by objective. Eliminate management
by numbers, numerical goals. Substitute workmanship.
13. Remove barriers that rob the hourly worker of his right to
pride of workmanship.
a. The responsibility of supervisors must be changed from sheer
numbers to quality.
b. Abolish the annual or merit rating and of management by
objective
14. Institute a vigorous program of education and self-
improvement.
15. Put everyone in the company to work to accomplish the
transformation. The transformation is everyone’s work.
Human error
Going down the food chain
Human error
Goingdownthefoodchain
 You don't need to review literature to know that
humans makes mistakes
 You don’t need to analyse what a mistake is
 …But what are the lessons learned?
 How do we achieve continuous improvement?
Human error
Goingdownthefoodchain
 Traditional “Just Culture” method
 Within some industries there is a belief that poor
quality and safety lapses are ‘person based’ and to
control these potential failures it is necessary to engage
traditional forms of direct supervision.
 This school of thinking relies upon increased levels of
management control
Human error
Goingdownthefoodchain
 Traditional “Just Culture” method
 Console, coach, punish
– Console the human error
– Coach the at-risk behaviour
– Punish the reckless behaviour ..regardless of the outcome
– Treating the symptoms
– Don’t rock the boat mentality
– Human error is cheaper
– Have one person perform the tasks of three => more
errors
Human error
Goingdownthefoodchain
 Scapegoat hunting
 When something goes wrong do not question the whole
issue but focus on specific individuals so that they
take responsibility.
 It is neither right nor possible to cause mixed
situations, destructive social relations or contradictory
structures as causes, but it is preferable to attribute
them personally to individuals who lack either
determination, ability or even malice.
 Simplifying it is much easier to ask for the "heads on
the board" than to overturn the issues as they are and
to transform the social dynamics.
Human error
Goingdownthefoodchain
 If the operator was turned into an automaton (or even
replaced by one), we might produce an error-free
system, provided the degree of complexity was
sufficiently low.
 Then mismatches may occur not just because of
mistakes made by the operator during operation, but
also because of mistakes made by the designer during
earlier phases.
 These mistakes would not be contained unless a theory
of human action was applied to literally every aspect of
the system.
This is a free preview copy of the original training “Quality Control Human error”
Are you looking for a personalized solution towards your own needs?
Please contact us: https://pharmalifecycle.kartra.com/page/contactus

Aqbd seminar human error

  • 1.
    Quality Control Human Error DimitrisPapamatthaiakis Pharma Life-cycle Consultancy
  • 2.
    Outline  Introduction  TQMthinking  Going down the food chain  Forms of manufacturing advantage  Human error classification  Root causes for human error  Ethical considerations  Failures of Six Sigma  Paralysis of the old view  GWOE  New view considerations
  • 3.
    Human error Introduction  Alot of organizations are confronted by desperation.  Incidents keep occurring (even the same sorts of incidents), and traditional measures finding “human errors” do not appear to work  Labeling human error as cause of trouble said nothing about the trouble itself, but about the people who do the labeling—about their beliefs in what exposes the system to risk  Pressure on managers or others “to do something” about the error problem  The pressures to respond with quick-fix, old-view countermeasures (reprimands,demotion, exile) could be enormous and difficult to withstand
  • 4.
  • 5.
    Human error TQMthinking  EuropeanAviation Safety Agency (EASA) worked with psychologists and quality managers to develop human factors engineering to prevent system failures and human fatalities.  Often contradicts the commercial pressures faced by businesses to improve quality/safety against the need to reduce lead times, offer quicker turnarounds and operate leaner ways of working.
  • 6.
    Human error TQMthinking  Oneof the great gurus of Quality Management  Statistical Product Quality Administration  Plan-Do-Check-Act  ...
  • 7.
    Human error TQMthinking  Placingblame on workforces who are responsible for only 15% of mistakes while the system designed by management is responsible for 85% of the unintended consequences
  • 8.
    Human error TQMthinking 1. Createconstancy of purpose toward improvement of product, with the aim to stay in business, and to provide jobs. 2. Western management must awaken to the challenge, learn their responsibilities and take on leadership for change. 3. Eliminate the need for inspection on a mass basis by building quality into the product in the first place. 4. End the practice of awarding business on the basis of price tag. Move toward a single supplier, on a long-term relationship of loyalty and trust. 5. Improve constantly the system of production, to improve quality and productivity, and thus constantly decrease cost. 6. Institute training on the job. 7. Institute leadership — the aim of supervision should be to help people and machines and gadgets to do a better job. 8. Drive out fear, so that everyone may work effectively for the company.
  • 9.
    Human error TQMthinking 9. Breakdown barriers between departments. 10. Eliminate slogans, exhortations and targets for the work force asking for zero defects and new levels of productivity. 11. Eliminate work standards (quotas) on the factory floor. 12. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute workmanship. 13. Remove barriers that rob the hourly worker of his right to pride of workmanship. a. The responsibility of supervisors must be changed from sheer numbers to quality. b. Abolish the annual or merit rating and of management by objective 14. Institute a vigorous program of education and self- improvement. 15. Put everyone in the company to work to accomplish the transformation. The transformation is everyone’s work.
  • 10.
    Human error Going downthe food chain
  • 11.
    Human error Goingdownthefoodchain  Youdon't need to review literature to know that humans makes mistakes  You don’t need to analyse what a mistake is  …But what are the lessons learned?  How do we achieve continuous improvement?
  • 12.
    Human error Goingdownthefoodchain  Traditional“Just Culture” method  Within some industries there is a belief that poor quality and safety lapses are ‘person based’ and to control these potential failures it is necessary to engage traditional forms of direct supervision.  This school of thinking relies upon increased levels of management control
  • 13.
    Human error Goingdownthefoodchain  Traditional“Just Culture” method  Console, coach, punish – Console the human error – Coach the at-risk behaviour – Punish the reckless behaviour ..regardless of the outcome – Treating the symptoms – Don’t rock the boat mentality – Human error is cheaper – Have one person perform the tasks of three => more errors
  • 14.
    Human error Goingdownthefoodchain  Scapegoathunting  When something goes wrong do not question the whole issue but focus on specific individuals so that they take responsibility.  It is neither right nor possible to cause mixed situations, destructive social relations or contradictory structures as causes, but it is preferable to attribute them personally to individuals who lack either determination, ability or even malice.  Simplifying it is much easier to ask for the "heads on the board" than to overturn the issues as they are and to transform the social dynamics.
  • 15.
    Human error Goingdownthefoodchain  Ifthe operator was turned into an automaton (or even replaced by one), we might produce an error-free system, provided the degree of complexity was sufficiently low.  Then mismatches may occur not just because of mistakes made by the operator during operation, but also because of mistakes made by the designer during earlier phases.  These mistakes would not be contained unless a theory of human action was applied to literally every aspect of the system.
  • 16.
    This is afree preview copy of the original training “Quality Control Human error” Are you looking for a personalized solution towards your own needs? Please contact us: https://pharmalifecycle.kartra.com/page/contactus