Follow
OBJECTIVE : To provide the guidelines for investigation, root cause analysis, their evaluation and corrective actions to prevent recurrence.
SCOPE : This procedure is applicable for a common failure investigation root & cause analysis process for the failure occurs in set product, process and quality or in an established system in (Company Name).
RESPONSIBILITY :
All Department Heads shall be responsible for investigation of causes for failure and reporting.
Manager QA shall be responsible for effective implementation and planning the action based on the report.
QA Head shall be responsible for review and decision on approval of investigation report.
ACCOUNTABILITY : Head Quality
PRECAUTIONS : NA
PROCEDURE :
Definition: Failure investigation is the process of understanding the key attributes of a particular failure and identifying the likely causes of failure.
Assist in identifying issues for continuous improvement of a process, a few examples are given below.
Product or Component mix-up.
Incorrect printing / Overprinted batch details / deviation from SOP/ Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), Master Formula Record (MFR), specifications which can affect the specifications of a final product.
Use of incorrect item or material.
Any damaged component identified in different steps of a manufacturing process.
Failure can be identified due to deviation or overlooking in the established systems (e.g. change control, Document control).
Failure can be identified either during in process or after completion of manufacturing activity.
If the failure occurs during process, the concerned supervisor shall report to Head of production.
Head of production shall inform about failure occurs during process to Manager QA.
If the failure identified after Out of Specification (OOS) occurrence, Manger QC shall inform to Manager QA for further investigation.
Manager QA shall inform about failure occur after OOS to Head of Production.
Concerned department shall raise the requisition for copy of Failure Investigation report to QA.
QA shall assign a distinct control number to the every Failure Investigation report and record the details in logbook (Annexure –II).
e.g., FR/15/001
Where,
‘FR’ represents Failure Investigation Report
‘15’ represents the last two digits of the year 2015
‘001’ represents for serial number of the failure investigation report, which starts from 001 for the calendar year.
Key process steps for reporting:
It is the team’s responsibilities for successful failure investigation, root cause analysis and CAPA preparation. Manager QA or his designee is responsible for successful implementation of the CAPA with the consultation of concerned department Manager.
First any problem needs to be identified with the consultation of Manager QA or his designee.
Concerned department manager or his designee will be responsible to gather information for the failure.
Brainstorming or other tools (Fishbone, casual factor chart) will be used for casual factor identification.
Depending on the failure and to avoid analysis paralysis some simple technique like commonsense, 5 why, simple question answer might be used. Be sure not to make the problem more complicated than necessary.
Concerned department shall record the failure details in Annexure – I (Description of Failure).
Head production along with QA shall jointly investigate failure occurred and record following details in Annexure – I.
Cause of failure.
Record the corrective action taken/planned.
Summary of test results /data (if any).
Manager QA shall submit duly filled failure investigation report to QA Head for review, decision and close the failure report with signature and date.
Attach analytical reports to failure investigation report wherever applicable.
In case the failure report issued for packaging component, the same should be discussed with QA, concerned department Head, supplier and purchase if necessary.
QA shall send a photocopy of the failure investigation report to originating department and attach a copy to Batch production record and retain the original copy for record.
QA shall prepare trend analysis reports for failure investigation occurrences annually to provide information for continuing improvement of the quality system.
