CAPA investigation template

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Reference number

• Incident Summary (reason for investigation)

Incident Category:

• What is the incident category?

  Observation

  Minor

  Major

• Level One investigation is required

Designate Team

• Team Leader:

Team Members:

• Name of team member

Define Problem

• When was the incident?

  Date

• Where did the accident occour in the facility?

  Warehouse

  Office

  Yard

  Offsite

  Whole Facility

• What process was involved in the incident (include the process number and add as .pdf)?

• Who was involved (please use initials only)

• What is their employment status?

  Full time employee

  Part time employee

  Contractor

  Visitor

  Agency

• What is their shift pattern?

  Day Shift

  Night Shift

  Crossover Shift

• What was the incident type?

  Select Documentation Error Financial Error Customer Complaint Internal Issue Audit non-conformance Other

  • Documentation Error
  • Financial Error
  • Customer Complaint
  • Internal Issue
  • Audit non-conformance
  • Other

• Has this person received training in the task where the accident occurred?

  Yes

  No

• Provide evidence of training such as certificate or attendance record

• What level of experience does this person have?

  Novice

  Competent

  Expert

  Trainer

• Please describe the incident in detail (sticking to facts known - not assumptions)

• What was the immediate response?

  Select Quarantined the area/ equipment Communication to effected parties Reported to line manager Other

  • Quarantined the area/ equipment
  • Communication to effected parties
  • Reported to line manager
  • Other

• Describe the immediate response

• How was communication delivered?

  Select E-mail Phone Call Heads Up Face to Face Whats App/ Text Other

  • E-mail
  • Phone Call
  • Heads Up
  • Face to Face
  • Whats App/ Text
  • Other

• Who was contacted by phone call?

• What was communicated?

• Who was contacted?

• What was communicated?

• Describe communication route

• How was quarantine implemented?

• Where was quarantine implemented?
  Address

• Who was reported to?

• Were any witness statements documented?

  Yes

  No

• Please attach the documents

• Was Violence or Aggression involved?

  Yes

  No

• The HR department must be involved

• This incident requires a brief investigation

• When was the incident?

  Date

• Where did the incident occur in the facility?

  Warehouse

  Office

  Yard

  Offsite

  Whole Facility

• Who was involved (please use initials only)

• What is their employment status?

  Full time employee

  Part time employee

  Contractor

  Visitor

  Agency

• Describe the incident

• Has their manager been informed?

  Yes

  No

• Describe what has been put in place to stop the issue from escalating?

  Select Human factors Materials Measurement Equipment Process Environment

  • Human factors
  • Materials
  • Measurement
  • Equipment
  • Process
  • Environment

• What corrective actions have been implemented to improve the human factor cause of this accident?

  Select Lessons Learnt communicated Re-trianing Other

  • Lessons Learnt communicated
  • Re-trianing
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the materials used in this accident?

  Select New supplier Improved materials Other

  • New supplier
  • Improved materials
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the measurement aspects of this accident?

  Select Re-calibration Delays managed Other

  • Re-calibration
  • Delays managed
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Describe corrective action implemented

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the equipment used in this accident?

  Select Fixed equipment Quarantined equipment Disposed of equipment Other

  • Fixed equipment
  • Quarantined equipment
  • Disposed of equipment
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Describe the action required to improve the equipment used in the accident

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the process related to this accident?

  Select Process reviewed Process written Other

  • Process reviewed
  • Process written
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the environment associated with this accident?

  Select Improved waste management Additional spill equipment Controlled work area Other

  • Improved waste management
  • Additional spill equipment
  • Controlled work area
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

Sign off

• No further investigation is necessary and the template can be finished here

• Name of person reporting incident

  Sign

Interim Containment

• Describe what has been put in place to stop the issue from escalating?

  Select Human factors Materials Measurement Equipment Process Environment

  • Human factors
  • Materials
  • Measurement
  • Equipment
  • Process
  • Environment

• What corrective actions have been implemented to improve the human factor cause of this accident?

  Select Lessons Learnt communicated Re-trianing Other

  • Lessons Learnt communicated
  • Re-trianing
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the materials used in this accident?

  Select New supplier Improved materials Other

  • New supplier
  • Improved materials
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the measurement aspects of this accident?

  Select Re-calibration Delays managed Other

  • Re-calibration
  • Delays managed
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Describe corrective action implemented

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the equipment used in this accident?

  Select Fixed equipment Quarantined equipment Disposed of equipment Other

  • Fixed equipment
  • Quarantined equipment
  • Disposed of equipment
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Describe the action required to improve the equipment used in the accident

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the process related to this accident?

  Select Process reviewed Process written Other

  • Process reviewed
  • Process written
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• What corrective actions have been implemented to improve the environment associated with this accident?

  Select Improved waste management Additional spill equipment Controlled work area Other

  • Improved waste management
  • Additional spill equipment
  • Controlled work area
  • Other

• Please describe the action implemented

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

• Has this action been completed?

  Yes

  No

Verify and Determine the root cause

• You can use the simple Ishikawa principle to determine a potential root cause as a brain storming tool with the colleagues or the 5 Why process

  

• Which root cause analysis will you use?

  Select 5 Why Ishikawa Other

  • 5 Why
  • Ishikawa
  • Other
5 Why Analysis (click the green + button to complete)

• What is the problem you are going to root cause analyse

• Why?

• Why?

• Why?

• Why?

• Why?

• As determined by the 5Why above, what are the Immediate/Direct Causes (circumstances that immediately precede the accident)

  Select Slip Trip Stab / Puncture Cut / Laceration Lifting / Carrying Pushing / Pulling Fall (same level) Fall from height Unauthorised use of equipment Not wearing required PPE Not following training Struck by moving vehicle Equipment Fault or Failure Personal attack Contact with moving machinery Struck by falling / flying objects Contact with electricty Struck against fixed / stationary object Removal of safety guards Exposure / contact with harmful substance(s) Burns / Scalds from exposure to Fire or Heat Trap or Pinch Horseplay Non- Injury i.e. fainting, nose bleed, black out, rash, bee sting, etc.

  • Slip
  • Trip
  • Stab / Puncture
  • Cut / Laceration
  • Lifting / Carrying
  • Pushing / Pulling
  • Fall (same level)
  • Fall from height
  • Unauthorised use of equipment
  • Not wearing required PPE
  • Not following training
  • Struck by moving vehicle
  • Equipment Fault or Failure
  • Personal attack
  • Contact with moving machinery
  • Struck by falling / flying objects
  • Contact with electricty
  • Struck against fixed / stationary object
  • Removal of safety guards
  • Exposure / contact with harmful substance(s)
  • Burns / Scalds from exposure to Fire or Heat
  • Trap or Pinch
  • Horseplay
  • Non- Injury i.e. fainting, nose bleed, black out, rash, bee sting, etc.

• As determined by the 5Why above, what is the Basic/Root Cause for the accident?

  Select Personal/ Human Factors Job/ System Factors

  • Personal/ Human Factors
  • Job/ System Factors

• What was the Person/ Human Factor Root cause?

• What is the job/ system factor of the root cause

Define and implement Corrective Actions (e.g what actions can be taken to rectify the root causes identified in previously)

• Include a Actions and assign a SMART objective

Verify Permanent Corrections (PCs) for Problem

• Can the issue be recreated by removing one or more of the results identified in section 5?

  Yes

  No

• Can the problem be corrected again by reinstating the results identified above?

  Yes

  No

Prevent Recurrence

• Has the problem has reoccurred since implementation of all actions.

  yes

  no

• The root cause analysis should be reviewed and additional prevenatative actions implemented

• Has the procedure/ process been updated?

  Yes

  No

• Have the results and improvements been communicated to all affected persons?

  Yes

  No

• Has the corrective action been witnessed?

  Yes

  No

• If the answer is yes to all of the above in this section, then the investigation is ready to be closed

End of Investigation - Sign off

• What time was lost due to the accident (mins/ hours/ days)?

• Team Leader sign off:

  Sign

• First Aider sign off:

  Sign

• Completion Date

  Date