Handling of Deviations In Medical Devices

Handling of Deviations In Medical Devices

1. Definition of Deviation:

Deviation means any departure from an approved instruction, procedure, established standard, or specification.

2. Examples of Deviations:

·??Expired or rejected component/ raw materials used.

·??Skip of FEFO principle (first expired-first out) in raw material handling.

. Pressure differential out of established limits in production clean area.

3. Handling process:

·??Deviation Detection.

·? Decision Making Process / Deviation Categorization.

·??Deviation Treatment.

·?? Root cause investigation.

·??CAPA.

3.1. Deviation Detection:

• Deviation observer can be internal or external.
• Anyone noticed any deviation shall immediately inform the area owner.
• Area owner shall immediately notify QA.

3.2. Categorization:

• Minor: When the deviation does not affect any quality attribute, a critical process parameter, or an equipment or instrument critical for process or control
• Major: When the deviation affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel/environment) is unlikely.

If, minor deviation is repeated a significant number of times, it could turn into a major deviation

• Critical: When the deviation affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel or environment) is highly probable, including life threatening situation.

3.3. Deviation Treatment:

?A) Contain The Problem by Correction:???

Corrections should be taken to correct and contain the problem (including immediate actions), based on sufficient documented evidence.

Corrections are immediate actions taken based on a simplified analysis of the deviation.

They should be QA approved before implemented if possible, and if this is not

feasible, the authorized and qualified responsible personnel may approve and

carry out the correction, and approved by QA as soon as possible.?

B) Establish Investigation Team by QA.

?C) Risk Assessment:

• Investigation team shall conduct risk assessment related to the deviation to assess the impact of this deviation on QMS processes, Products, equipment, areas, users of medical devices and patients.
• in this process you need to identify all hazards associated with the deviation and their possible harm and assign values for severity and probability of occurrence.
• Evaluate if investigation is required or not, and if the decision is no rational shall be provided.

D) Root Cause Identification:

• Root Cause Investigation is a powerful tool used for quality improvement. Among the different tools available for Root Cause Investigation, the “5 Whys” and “Ishikawa Fish Bone Diagram” are the simplest and most used ones.
• A “vertical” analysis to identify the root cause should always be accompanied by a “horizontal” analysis on the possible events that could be avoided in the future by extending the scope of the investigation to evaluate the possible impact of the deviation on other lots of the same product or on other similar manufacturing processes.

E) CAPA :

• Additional correction can be taken based on results of investigation.
• Corrective Actions are taken to eliminate the root causes of deviations, and should be based on good quality investigations. Corrective actions should be QA approved before implemented.
• Not all corrective actions will have associated preventive actions. Corrective actions are “reactive” in nature and are triggered in response to detected deviations and could generate preventive actions as well. These preventive actions (linked originally to nonconformities) will act on similar processes, manufacturing lines or different sites, where there has not been yet a deviation.

D) Effectiveness of CAPA:

Evaluation of effectiveness shall be conducted after sufficient period of implementation of those CAPA according to ISO 13485:2016.