Pharmacy Courses

Human Errors in Pharmaceutical Industry


Lot of times, for most of the Deviations, Lab Incidents, Process or Prodict related issues, as the concerned can't show the actual root causes or the real reasons or the hidden truth, it will be diverted to a Human being as a Human Error. But every Instrument error or System problem or Equipment issue can't be extrapolated to Human Error or can't be shown as an Employee mistake.


Types of Human Errors

1. Organizational/systemic

2. Procedural (SOPs)

3. Careless work

4. Voluntary/intentional

5. Involuntary


Example

1. Organizational/systemic

-"Cutting corners” to save time and increase profits

-Taking product and regulatory risks to reduce costs and increase profits


2. Procedural (SOPs)

-SOPs are not clear or are complex

-Instructions in SOPs are contradictory


3. Careless work Forgetfulness

-Inattention

-Carelessness


4. Voluntary/intentional

- An SOP is inadequate and employees decide to deviate from it

-“Cutting corners” to save time

-“Backdating”

- Advance writing (Pre dating)


5. Involuntary

-Human variability


Read also: Human Errors in Analytical Laboratories

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