MANAGEMENT OF LABORATORY INCIDENTS/EVENTS

Events are the errors / unexpected deficiencies occurred during routine activities in the Quality Control/ Analytical laboratory those which are easily identifiable and are also readily correctable. Events are considered to be unplanned, minor, non–quality impacting unexpected deficiencies / departures which occur due to human or instrumental errors and not as a result of faults within quality system.

Once the Event occurs the analyst has to quarantine all the preparation and analytical record along with supporting documents.

Simultaneously the analyst must inform their In-charge or authorized deputy or supervisor.

When an event occurs, Details of events/incidences must be entered/ registered in the ‘Event Report Register’

Event number should be be allocated and “Event report form” to be issued by the concerned personnel to the analyst.

While issuing the Event form, Event number must be mentioned on the form by issuing authority with its sign and date as issued by.

It it necessary to mention the corresponding reference of Event and Event report number in respective analytical record for traceability.

The Event occurred should be investigated / reviewed by the concerned personnel who will propose the further course of action/investigation.

In case if the event / incidence occurred in absence of Head of the Department (e.g., in night shift or on holiday), then authorized deputy should authorized further line of action (corrective action) in consultation with Head and same should be recorded in the event report form.

The original error will need to be identified and further action needs to be proposed to eliminate the error. The investigation conclusion and CAPA shall be recorded in the event form as required.

The Event need to be approved by Quality department.

Based on the nature of Event, training need to be provided to the analyst(s) to eliminate the error occurred during original analysis

All the events occurred during execution of laboratory procedures need to be investigated and closed within the stipulated time after ensuring that the proposed CAPA is successfully implemented.

In case of event investigation if any photographs are used as an evidence if error indication then ensure that, its soft copy archives are handed over to Quality department for proper electronic storage and its retrieval whenever necessary.

Trending of Incidence

? The purpose of trending of laboratory events is to evaluate the reoccurrences of similar types of events.

? Evaluation of laboratory event is carried out to assess the need for further corrective actions.

? Summary report of laboratory events includes an assessment of the following traits:

1) Section wise

2) Instrument wise, instrument errors

3) System ID

4) Analyst/ Human errors

5) Product wise

6) Types of Error

7) Test wise

8) Different trait

These events can be categorized month wise, section wise, Instrument wise, System ID wise, Analyst wise, Product wise, Reason wise, Test wise and Type of errors.

Follow up of events

Periodic follow up and closure for the open events should be done every month.

Periodic follow up of closure of the event specifically where revision in the test procedure involved shall be done every month.

Common Categories of Events:

Typical Human Errors:

1. Improper vial labelling

2. Sequence table error

3. System suitability correlation failure

4. Wrong column use

5. Insufficient mobile phase

6. Vial filled insufficiently

7. In-adherence to STP

Typical Instrumental Errors:

o HPLC set-up error

o Power shut down

o Loss prime (Increase in the HPLC column pressure beyond limit)

o Set up disconnect (Detector stopped)

o Leakage problem

o Retention time variation

o Area variation

o Communication error