Can any one tell me that what is exact difference between deviation and incidence because I am so confused
I have read lots of articles about deviation and incidence.
First of all deviation defination said that departure from approved instructions or established procedure that is called deviation.
So most of the experienced experts said if some one person is entering in the granulation area it is called incidence so my question is why that is called incidence because we have already made a sop for gowning ( entry & exit procedure in granulation area) so that time we are going to against the sop means approved procedure. So i think it will be considered as a deviation.
And second example for unplanned deviation like-
Equipment breakdown
Utility breakdown
Interruption of power supply
In most of the articles above points are considered as a unplanned deviation.
I think that above points we have to consider incidence because its occurring accidentally
Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure. A deviation may occur during sampling and testing, raw materials- and finished product acceptance and manufacturing.
In the industries, there are four types of deviation can that are considered and that is Man, Machine, Material, and Method. But there are many types of deviation and that is Location, Supplier, Quality, Quantity, and Delivery Time deviation.
In your answer you are mentioning deviation both for man,machine etc .and location ,supplier ,quality and quantity also.How to differentiate between deviation and incidence here?
When we have written procedure , BMR, BPR, SOP, SCP, protocol, sampling points etc. But someone works against the written procedure is called deviation.
Planned Deviation-Those deviation form the procedure that iare planned , we know before it occurs.
Example-calibration of weight balance, validation of equipment etc not carried as per schedule due to any reason . In this we have to fill CAPA from.
Unplanned devation-failure of power, machinary, equipment or procedure. There are three types of unplanned devation , critical, major or minor.
An incedence is an event that may effects our products quality or may not, but it is against our written procedure or cGMP.
Someone works in manufacturing area with out hand gloves, not wearing overgrown , area not cleaned, insects found in department .
This will have impact on products but not always
This are the devation form cGMP, not related to manufacturing process .
So it can not be considered as devation.
Example - while weighing the bulk on balance , the container fell down .
An incident is that event that may effects our products or may not, but that is not part of cGMP For example someone enters the manufacturing area without hand gloves, an housefly found in manufacturing area. This can impact on quality but not always. This is part of devation in GMP, but not related to manufacturing process , so it canāt be treated like devation but incident.
Example of man devation -An manufacturing process that is to be done by skilled man, but due to non availability of that skilled man, particular process is performed by unskilled man, this is man devation.
In most of organization workers are divided in two skilled and unskilled labour.
Skilled labour is again divided in A, B and c.
Deviation can be a planned deviation or unplanned.
Planned is when you are trying out something new, a new vendor, a new grade of material, a new piece of equipment, within a validated system for a limited number of batches ,with a view to evaluating its effect on end result/product.
Unplanned deviation is an OOT observation with no assignable cause. It calls for an investigation.
Incidence, could be an OOT or even OOS observation. It could also be a finding of an investigation sequel to an unplanned deviation. An unplanned deviation will be recorded as incidence once a cause-effecr relationship is established.
I donĀ“t know if thereĀ“s a norm or a guideline, but a good way to arrive this I think is with risk management. Of course at first you need to regulate in a procedure, and this instructions should be accepted for the technic comities, to evaluate the risk of include the incidents option in investigations.
If you have a matrix in a risk assessment that evaluate Severity (high 3, medium 2, low 1), Detectability (high 3, medium 2, low 1) and Occurrence (high 3, medium 2, low 1), you can give a number for the incidents value, IĀ“m thinking in a result of 1 in a formula like this ( S2(square)DO).
Whit this, you can say that if you have an incident, the result never could affect de product quality in the whole life of the process. So for that is an incident.
The incidence is lower than minor deviationļ¼its rootcause and risk must be clear and is the lower level and the incidence shouldnot repeatly be happened .You may be donot expend too many time and resource to deal with it, and you have enough konwledge to konw it, such as forget something following the sop, but its impact is small and corrected it very easily.
But the difference of is not extinguished between minor deviation and incidence clearly, its choice base on your accepted capctiy for risk.
In a very easy terms.
A deviation is something which can be termed as moving away from the written procedures these can be planned or unplanned deviations and are addressed through proper CAPA.
Incidence is something which is not a foreseen occurrence but can occur due to unintentional error which is not planned. These are addressed through proper CAPA.
