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Investigations

Last edited 1171 days ago by Garret Ma.

PURPOSE

To provide written instructions for incident investigation reporting of product complaints, adverse events, serious adverse events, out of specification product, incident trending, and other incidents requiring investigation.

RESPONSIBILITY

Quality Control is responsible for:

Conducting incident investigations.

Documenting incident investigations.

Completing Form F-006 – Investigation Report (below)

The record-keeping of all documentation related to incident investigations.

REFERENCE

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F-006 - Investigation Report.docx

16.1 KB

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DEFINITIONS

Corrective action

Action to eliminate the cause of a non-conformity or other undesirable situation.

There can be more than one cause of a nonconformity.

Incident

Any unanticipated occurrence that may impact product quality or safety.

Preventive action

Action to eliminate the cause of a potential non-conformity or other undesirable situation.

There can be more than one cause for a potential nonconformity.

Preventive action is taken to prevent occurrence.

Root Cause

The identifiable factor(s), based on objective evidence, which have been determined to be responsible for an incident.

PROCEDURES

All incidents requiring investigation will be documented on Form F-006 – Investigations Report.

All incidents requiring investigation will be assigned a unique identification number starting with the date in the form of YYMMDD - INV XXX where

YY = Year (e.g., 2023 is 23)

MM = Month (e.g., Feb is 02)

DD = Day (e.g., 6th day is 06)

INV = short for investigation

XXX = Short description

Example: for an investigation of ACNE Recall on Feb 6, 2023 it will be displayed as the follwoing “230206 INV - ACME Recall”

The following sections of all Investigations Reports will be completed by a single primary investigator:

General

Incident Investigation

Root Cause

Corrective Action / Preventive Action

Investigation Follow-Up

Investigation Attachments

Whenever possible, someone from QC who was not the primary investigator must complete the QC Review & Disposition section of the Investigation Report to review and approve the investigation findings and investigation follow-up actions as well as approve the investigation outcome and close the investigation.

The primary investigator may complete the QC Review & Disposition section if no one else from QC can do so.

Per

Records and Recordkeeping⁠

, all documentation Investigation Reports and associated attachments will be retained for a period of six years after the investigation start date.

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