Accident Investigation Report
INCIDENT INVESTIGATION AND REPORTING
 Accident and Incident
Accident -an unplanned and uncontrolled event in which the
action or reaction of an object, substance, person or radiation
results in personal injury or the probability there of. Defined by
Heinrich in 1930.
Incident-referred to as a work-related events in which an injury or
ill health (regardless of severity) or fatality occured, or could have
occurred.
-An accident is regarded as a particular type of incident in which
an injury or illness actually occurs.
 Essence of Conducting an Accident Investigation
 Prevent injuries and illnesses
• Save lives
• Save money
• Demonstrate commitment to health and safety
• Promote positive workplace morale
• Improve management1
ESTABLISHING AN INCIDENT INVESTIGATION PROGRAM
• How and when the management is to be notified of the incident.
• Notifying DOLE- Occupational Safety and Health Center, which
must comply with reporting requirements that are:
 Work related fatalities within 8 hours
 All work related hospitalizations, injuries within 24 hours.
• Who is authorized to notify outside agencies (fire, police,
hospital etc.).
• Who will conduct investigations and what training they should
have received.
• Timetables for completing the investigation and developing
recommendations.
• Who will receive investigation recommendations.
• Who will be responsible for implementing corrective actions. 1
PRINCIPLES OF INCIDENT INVESTIGATION PROGRAM
• Clearly state easy to follow writen procedures.
• Provide for personnel to be trained on incident investigation and
company procedure.
• Ofer collaboration between workers, worker representatives and
management.
1-more efective, investigation should conducted by team
Design of incident investigation team based on efect of incident
 Type A (Extreme Risk Category) - when there's fatality, serious
damage, damage to property greater than $100,000. Team
Member: Director, Manager of the Department, Director of
Facilities Management and Director of the Department of Health
and Safety.
 Type B (High Risk Category) -when there is a lost time injury
required medical aid treatment or damage to property greater
than $10,000 but less than $ 100,000. Team Member: Manager
and the Supervisor of the department in which the injury occurred
and Director of Facilities Management.
 Type C (Medium Risk Category) - medical treatment injuries
resulting in lost time, damage property greater than $1,000 but
less than $10,000. Team Member: the supervisor responsible for
the department in which the injury occurred will conduct this
investigation.1
 Type D (Low Risk Category) - First aid cases where the incident did
not cause a more serious injury. No detailed investigation is
required however documentation is to be made in the First Aid
Register. This include: full name, age, occupation, nature of the
injury or illness, a short description of cause of the injury, nature
of work in which the worker was engaged at the time of sustaining
the injury, treatment given and disposition of the case.
Other companies trained their employees in incident investigations based
on their positions:
 Employee Responsibilities-Immediately reports to his/her
supervisor any work related injury/ illness and also if an incident
happened when he is around.
 Supervisor Responsibilities- First priority is to ensure the well-
being of his employees. Upon first being aware of the incident,
evaluate the nature of the incident.
 Head/ Director Responsibilities- Ensure that complete IRs are
forwarded to the Director of the Department of Health and Safety
within 24 hours and fatalities within 8 hours
  Health and Safety Department- Reviews all IRs to ensure  Warning Tape
information is complete, understandable and analyzes the  Photo Marking Cones
corrective actions and make recommendations to administration  Personal Protective Equipment
as necessary.  Magnifying Glass
 Focus on identifying root cause not on establishing fault and  First Aid Kit
emphasize correcting it.  Compass
 Investigate programs, not behaviors  ampling Containers L
 Investigate all incidents including “Close Calls”.  atex Gloves
 Implement timely corrective actions based on investigation
findings.
 Provide for annual program review to identify and correct
Preserve and Document the Scene:
program deficiencies and identify incident trends.
Preserve the scene to prevent material evidence from being
removed or altered; Document the incident facts such as the date of the
investigation and who is investigating. Investigators can also document the
CONDUCTING AN INCIDENT INVESTIGATION scene by video recording, photography and sketching.
 Preserve/Document Scene
 Collect Information
 Determine Root Causes Collect Information
 Implement Corrective Actions
Incident information is collected through
MATERIALS NEEDED FOR INCIDENT INVESTIGATIONS
 Straight Edge Ruler interviews, document reviews and other means.
 Leveling Rod In addition to interviews, investigators may find
 Measuring Tape other sources of useful information. These include:
 Protractor Equipment manuals
 Inclinometer Industry guidance documents
 Carpenter’s Ruler Company policies and records
 Pen, Pencils, Marker Maintenance schedules, records and logs
 Clipboard and Papers
Training records (including communication to
 Identification Tags
 Graph Paper
employees)
 Paint Stick Audit and follow‐up reports
 Chalk Enforcement policies and records
 Camera Previous corrective action recommendations
 Charged Bateries
 Audio Recorder An incident investigation always involves
 Flashlight interviewing and possibly re‐interviewing some of
 the same or new witnesses as more information
becomes available, up to and including the highest
levels of management. Carefully question witnesses
to solicit as much information as possible related to
the incident.
Determine Root Cause
Determining the root cause is the result of
persistently asking “why”. Determining the root
cause is the most effective way to ensure the
incident does not happen again. Finding the root
causes goes beyond the obvious proximate or
immediate factors; it is a deeper evaluation of the
incident.
Implement Corrective Actions
The investigation is not complete until
corrective actions are implemented that address the
root causes of the incident. Implementation should
entail program level improvements and should be
supported by senior management.
IDENTIFICATION OF CORRECTIVE ACTION AND PREVENTIVE ACTION
Corrective Action or Preventive Action-CAPA
- improvements to an organization's processes taken to eliminate causes of
non-conformities or other undesirable situations.
Diference between Corrective Action and Preventive Action
-Preventive actions are implemented in response to the identification of
potential sources of non-conformity3
-Corrective actions are implemented in response to customer complaints,
unacceptable levels of product non-conformance
Purpose/Importance
The purpose of the corrective and preventive action subsystem is to collect
information, analyze information, identify and investigate product and
quality problems, and take appropriate and efective corrective and/or
preventive action to prevent their recurrence.
Developmental Action Process (Treated as Preventive Actions)
 Initiate an improvement project, with project plans, justification for
planned expenditures, resource controls and evaluation.
 Contain a related series of actions, often separated by long periods so
you can wait and see progress and results.
 Use a variety of appropriate disciplines at diferent times during the
project.
 Establish a means for communicating what has been done and what
has to be done to facilitate communication about changes to project
team members.
 Include a clear trail of actions taken and decisions made to substantiate
the decision to proceed, document lessons learned and avoid needless
reinvention on future similar projects.
The PDCA Cycle
Preventive action is any proactive methodology used to
determine potential discrepancies before they occur and to ensure
that they do not. It can be seen that both fit into the PDCA (plan-do-
check-act) philosophy as determined by the Deming-Shewhart cycle.
PLAN
Establish the objectives and processes necessary to deliver results in
accordance with the expected output (the target or goals).
DO
Implement the plan, execute the process, make the product. Collect data
for charting and analysis in the following "CHECK" and "ACT" steps.
CHECK
Study the actual results (measured and collected in "DO" above) and
compare against the expected results (targets or goals from the "PLAN") to
ascertain any diferences. CAPA Data Analysis –Analyzing processes, work operations and other
sources of quality data to identify existing and potential causes of
ACT nonconforming product, or other quality problems.
If the CHECK shows that the PLAN that was implemented in DO is an
Common Statistical Techniques
improvement to the prior standard (baseline), then that becomes the new
• Pareto charts
standard (baseline) for how the organization should ACT going forward • Run charts
(new standards are enACTed). • Control charts
The CAPA Process • Mean and standard deviation
Internal • T tests for comparisons
 Inspection/ Test Data • Experimental design (DOE)
 Non conforming Material Reports • Graphical methods (fishbone diagrams,
 Equipment Data histograms, scater plots, spreadsheets, etc.)
Other Analysis Techniques
 Scrap/ Yield Data
• Management reviews
 Process Control Data
• Quality review boards
External Sources
• Material review boards
 Field Service Reports • Other internal reviews
 Legal Claims
 Material Device Reports CAPA Investigation –Investigating the cause of nonconformities relating to
 External Audits product, process, and the qualitysystem
Typical Investigation Steps
CAPA subsystem • Identify problem and characterize.
Material review board (MRB) • Determine scope and impact.
Out of Specification (OOS) • Investigate data, process, operations and other sources of information.
Validation • Determine root cause, if possible.
Trending
Audits Possible Root Causes
Recall • Training
Deviation • Design
APR annual percentage rate of interest • Manufacturing
Change control • Management
Training • Change Control
Management review • Purchasing/Supplier Quality
Complaints • Testing
• Documentation • Ensure that controlled documents are reviewed and approved if changes
• Maintenance. are made.
Implemented changes may directly link to design or production and
Identify Required Actions –Identify the action(s) needed to correct and process controls
prevent recurrence of non-conforming product and other quality problems
Disseminate Information –Ensuring that information related to quality
Taking Action problems or nonconforming product is disseminated to those directly
• Identify solutions. responsible for assuring the quality of such product
• Develop action plan for corrective action and/or preventive action. or the prevention of such problems
• Should consider the risk posed by the problem.
– Not all problems require the same level of investigation and action. Management Review –Submitng relevant information on identified
– It is appropriate to “elevate” some issues at the expense of others quality problems, as well as corrective and
preventive actions, for management review the significance of the problem
CAPA and Risk Management impacts the level of management review.
• Risk analysis allows a manufacturer to:
– Determine priorities Documentation –
– Assign resources All activities required under this section, and their results, shall be
– Determine the severity of impact documented.
– Determine the depth of investigation
• Common tools
– Hazard analysis
• Used early for potential problems
– Failure Mode Efects Analysis (FMEA)
• Botom up
– Fault Tree Analysis (FTA)

Verify and Validate –Verifying or validating the corrective and preventive

action to ensure that such action I sefective and does not adversely afect
the finished device.

Implement and Record Changes –Implementing and recording changes in

methods and procedures needed to correct
and prevent identified quality problems.

Implementing Changes
• Tie CAPA implementation to:
– Document control for products and processes
– Change control