Diference between deviaions and incidents in qc


(Madhusudhanarao Numarsu) #1

diference between deviaions and incidents in Quality Control


(HaripriyaMalireddy) #2

Deviation is the departure from the written procedures. Eg: not performing the calibrations or stability analysis with in defined timeframe,
Incident is a sudden unexpected event that may or may not have impact on product identity, quality and safety. Eg: Instrument breakdowns


(Meenakshi Gupta) #3

Deviations here refer to any process carried out other than specified parameters or processes as documented but incident refers to sudden breakdown in instruments handled.


(Madhusudhanarao Numarsu) #4

Thanks alot for both


(Madhusudhanarao Numarsu) #5

Good afternoon Madam,
can u explain HPLC trouble shooting


(Jigneshkumar N. Solanki) #6

Deviation is the departure from the written procedures/instructions (Deviation: Any non-conformance / disobeyance in written approved procedures of quality system in the organization.
Or
We have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and works against this, then it is called deviation. It means deviation from any written procedure that we have implemented.). Eg: Not performing the calibrations within defined time frame.

Incidence : Any event that may or may not affect our product quality but that is against the cGMP. E.g.: someone is found without gowning in the production area or any insect is found in granulation area. (Incident is a sudden unexpected event that may or may not have impact on product identity, quality and safety.)


(YOGESH NARKHEDE) #7

Deviation means temporary change as per requirements with cGMP and incidence means any unexpected change during the process like any failure


(Venki Uklu) #8

Deviation is Departure from an approved instruction or established standard procedure.
Incidents: An incident is undue, unexpected action, activity or event resulting to non-compliance with procedures/specifications/approved documents.


(Sajjad Ahmad) #9

Deviation: Any non-conformance / disobeyance in written approved procedures of quality system in the organization.

                                                                  Or

We have any written procedure like standard operating procedure, protocol, standard test procedure, BMR etc. and works against this, then it is called deviation. It means deviation from any written procedure that we have implemented.

Deviation can be of two different types:

Planned Deviation

Unplanned Deviation

Planned Deviation : Any deliberate or intentional non-conformance or deviation

Planned prior to the execution of an activity, which is to be undertaken following documented, justifiable and approved rationale.

Any departure from established and approved procedures observed or noticed prior to the execution of an activity, such as SOPs, STPs, processes, systems, standards and protocols, which is done under compulsion or for continuous quality improvement programs will be categorized as planned deviation.

For example: Calibration or validation is not carried out as per schedule due to delay for various reasons.

Unplanned Deviation :An accidental or unanticipated non-conformance or deviation observed or noticed during or after the execution of an activity. An unplanned deviation can be a critical or major or minor in nature.

For example: deviation in failure of procedure, utility, material, equipment or any system is occurred. We can consider it as any change from the previous or our written procedure.

While carrying out day-to-day activities, there is a probability of unplanned deviations (unforeseen deviations) occurring. Such unexpected events may be related to any procedures, processes, systems, equipment and utilities. These deviations may occur for many reasons, such as following (not all inclusive):

Equipment failure / Breakdown / Malfunctioning.

Power supply failure / interruption.

Accident in the plant.

Breakdown in support services / utilities.

Documentation Errors

Laboratory failure / Error.

Unplanned deviations may be critical, major or minor. These can be categorized on their impact of product quality.

Critical Deviation : The deviation is likely to or will have a significant impact on critical attributes of the product.

For example: Manufacturing instructions are not followed, wrong batch details are printed, SOPs or methods of testing not followed during analysis etc.

Major Deviation : The deviation could or may have a significant impact on critical attributes of the product.

For example: Raw material is received in a damaged container, manometer readings in the sampling booth are crossed the action limits etc.

Minor Deviation: The deviation is unlikely to have a detectable impact on critical attributes of the product.

For example: Line clearance is not taken from QA, physician sample wrongly printed with price e

Incidence : Any event that may or may not affect our product quality but that is against the cGMP.

For example: someone is found without gowning in the production area or any insect is found in granulation area. These may have impact on product quality but not every time, sometime it will not impact. These are the deviations from GMP but difference is that these are not related to our manufacturing process. So these will not be categorized as deviations.
Some other examples of incidence: Eating food in production area, spillage of material on floor, break down in any machine during processing, wrong material added in batch, mix-up of two batches etc.

Critical Attribute : A critical attribute is one that defines the product and contributes to safety, identity, purity, strength or quality. Critical attributes are usually detectable during product testing.