bGMP means Behavioral GMP. Where bGMP discuss about why people don't comply with procedures, either by error or perhaps deliberately, and what can be done about it.
Do really exist the human errors? No it's not an error! Human errors are very frequent among the main causes of deviations.
“ The great majority of reported defective medicinal products has resulted from human error or carelessness, not from failures in technology” - MHRA , Orange Guide 2002
The Person has read the procedure, maybe he even did some training and qualified, but nothing ... Errare Humanum Est.
Can this really be true? If most defects are caused by non-compliance with GMPs, and most non-compliances are caused by human error or carelessness, then what causes human errors or carelessness?
Most of the time, retraining is assigned between CAPAs.
However, many procedures, training or processes are not well received by the staff and often even a retraining is not enough to avoid the repetition of the error.
There may also be other causes behind human error, such as a process that is not designed to prevent error or an environment that hinders optimal resource performance.
Human Factors Engineering (HFE) is the science of designing systems to fit human capabilities and limitations - in perception, cognition, and physical performance.
Poka Yoke is a device or method that prevents people from making mistakes. The word in Japanese means mistake proofing or error proofing. (Originally the word Baka-Yoke or idiot proofing was used!)
On 25th January 2000, Dr Lucian Leape (a Harvard professor of health) told Congress that the single greatest impediment to error prevention in the medical industry is that
"We punish people for making mistakes"
Should people be punished for deliberate non-compliance? Should they be held personally accountable?
Must consider:
– Unintentional errors
– Risky behaviour
– Reckless behaviour
Atrisk behaviour is when the person believes the benefit of NOT complying exceeds the benefit of complying.
Becomes entrenched because there is no harm caused therefore no blame. Or worse, it may be rewarded because it may help to meet other goals.
There is a risk that certain kinds of (GMP) noncompliant behaviour become the norm and therefore represents (organisational) compliant behaviour.
Reckless behaviour is when the risk associated with the behaviour outweighs the benefits of the behaviour.
Does not mean there is an intent to do harm
- Console the human error
- Coach the at-risk behaviour
- Punish the reckless behaviour ……regardless of the outcome
This is known as a Just Culture – that is, a fair culture.
A new mindset is needed that characterizes people as a necessary driver of success rather than as a variable that can cause failure through error!!
A great first step is to recognize that human error is always a symptom — a starting point — for an investigation and is never the answer or cause.