ACCIDENT/ INCIDENT REPORT DATABASE OVERVIEW AND GUIDELINES

Table of Contents
Overview ............................................................................................................................................................. 2
1. AIR statistics ............................................................................................................................................ 2
2. AIR monitoring ......................................................................................................................................... 2
Guidelines ........................................................................................................................................................... 3
1) Issuing AIR ............................................................................................................................................... 3
2) Replying AIR ............................................................................................................................................. 4
3) Approving AIR (HOD)................................................................................................................................ 8
4) Following up the AIR ................................................................................................................................ 9
5) Acknowledged the AIR (QMR) .................................................................................................................. 9
6) Printing the AIR report ............................................................................................................................10
Requirements .....................................................................................................................................................11
Overview
1. AIR statistics
Graphs are automatically plotted and updated after record updated

a) Pie chart for comparison of AIR issued during Daily Operation and Internal Audit
b) Bar chart for total of AIR issued by each department
c) Bar chart for total of AIR received by each department
d) Bar chart for AIR cycle/ status

2. AIR monitoring
Status of AIR is automatically updated after record edited.
1.1. The stages are as below:
a) Pending Immediate Action
b) Pending Root Cause Analysis
c) Pending Corrective/ Preventive Action
d) Pending HOD approval
e) Pending Follow-up Action
f) Pending QMR Review/ Acknowledge
1.2. These status are displayed at:
a) Overall AIR progress displayed on AIR statistic
b) Each AIR status displayed in the indicator at AIR Log

c) Each AIR form has status indicator on top

Guidelines

1) Issuing AIR

When there is new accident/ incident, open the AIR database and click at New AIR button to record new AIR.

Fill up all related fields (green colour). AIR No is automatically generated.

After fill up, press X (close) button to close the form. E-mail the AIR number (e.g. 20110128-FI&AD-00009) to
person in-charge, the HOD and QA.

2) Replying AIR

Person in-charge will open the AIR database and click on AIR Log button to view the AIR log sheet.
Person in-charge will look at the related AIR no. (e.g. 20110128-FI&AD-00009) and click at Edit Details button to
fill up the AIR.

Click at Immediate Action tab to fill up the immediate action details.

Click at Root Cause tab to fill up the root cause details.

Click at CAPA tab to fill up the corrective/ preventive action details.

Click at Before and After tab to insert related photo if necessary.

Click at Disposition tab to decide action to be taken on affected product if applicable. Close the form (press X)
and e-mail the AIR no (e.g. 20110128-FI&AD-00009) to HOD for approval, c.c. to the person who create the AIR
and QA.
 3) Approving AIR (HOD)

,
From the AIR Log sheet, HOD will click at the same Edit Details button to review the AIR.

Click at HOD Approval button fill up the comments and approve the AIR. Close (press X) and reply to person in-
charge, person who create the AIR and QA that the AIR has been approved. The person who create the AIR with
QA will do follow up action.
 4) Following up the AIR

After confirm the action is implemented and effective, QA will update the follow up details in Follow Up tab and
inform QMR.

5) Acknowledged the AIR (QMR)

QMR will acknowledge the AIR in the QMR Acknowledgment tab, comment if necessary and feedback to all
related person.
 6) Printing the AIR report

Once the AIR cycle completed, QA will print the report. Click on related AIR no View Report button to view and
print the report.
Requirements

To successfully implement this database:

1) Microsoft Access 2010 or Microsoft Access 2010 Runtime installed in each PC that use the database
(compulsory)
2) Shared folder/ server (compulsory)
3) The database file on each PC (compulsory)
4) E-mail for communication purpose (optional)