DR Number:
DR Number:
Investigation Type
This should list the type of
investigation
(eg. Process Failure, Operator
Error, etc.).
Executive Summary
The executive summary should contain
a brief description of the event, root cause found during the investigation and
a final summary on product disposition.
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Name (Position)
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Signature
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Date
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Prepared by:
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Checked by:
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Authorised
by:
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Approved by:
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Index
Investigation Type ................................ ................................................................ ......
Executive Summary ................................ ................................................................ ...
Index 2
1.0 Event
................................ ................................................................ .............
2.0 Batch Chronology ................................ ..........................................................
3.0 Suspect Causes and Rationales ................................................................ ....
4.0 Corrective and Preventive actions to be
taken................................ ................
5.0 Risk
Analysis ± Potential impact on other processes ......................................
6.0 Product Disposition ................................................................ ........................
7.0 Summary ................................ ................................................................ .......
7.1 Root Cause ................................ ................................................................ ...
7.2 Repeat
Event................................ ................................................................ .
7.3 Batch Disposition ................................................................ ...........................
7.4 Impact on other batches / processes..............................................................
8.0 List of Attachments ................................ ........................................................
8.1.1 Attachment ± Summary of Investigation Tasks ...............................................
8.1.2 Attachment ± Summary of Corrective Actions Tasks ......................................
8.1.3 Attachment ± Summary of Preventative Actions
Tasks...................................
8.2 Attachment - Investigation meeting minutes ...................................................
8.3 Attachment - Supporting batch documentation ...............................................
8.3.1 Attachment ± Deviation Report/s................................................................ ....
8.3.2 Attachment - Supporting Batch
Documentation / Log Books ...........................
8.3.4 Attachment - Supporting Facilities Data................................ ..........................
8.3.5 Attachment - Supporting Analytical Data ........................................................
8.3.6 Attachment ± Validation Data................................................................ .........
8.4 Attachment - Evidence of actions completed ..................................................
8.4.2 Attachment - Employee Awareness Forms.....................................................
8.4.3 Attachment - SOP Updates ................................ ............................................
8.4.4 Attachment - Training / Assessment Updates .................................................
1.0 Event
Description of event and details to
be added here.
Process Line(s), Product Name(s),
Product Code(s) and Batch No.(s) to be added here.
Initial Scope of the investigation and any immediate
action/segregation/blocking of stock
for sale should be listed here.
2.0 Batch Chronology
This table is an example of events
that may need to be documented in a batch investigation chronology. Table can
be customised (or even omitted) to fit the sequence of events in an investigation.
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Date
(dd/mm/yyyy)
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Time
(24 hrs)
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Description
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dd/mm/yyyy
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00:00
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Example ± Batch planned /
scheduled
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dd/mm/yyyy
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00:00
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Example ± Batch commenced filling
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00:30
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Example ± Shipper No at time of
event
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05:00
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Example ± Line Clearance performed after event
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06:00
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Example ± DR raised at this
point
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3.0 Suspect Causes and Rationales
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No.
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Cause Description
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Primary / Contributing / Unlikely
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3.1
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Enter suspect cause here
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Choose one type
from above
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Rationale:
This is where you enter your
rationale as to why
a suspect cause
is likely to be
correct or why you have
discounted this particular cause
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3.2
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Enter suspect cause here
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Primary / Contributing / Unlikely
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Rationale:
This is where you enter your
rationale as to why a suspect cause is likely to be correct or why you have discounted this particular cause
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3.3
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Enter suspect cause here
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Primary / Contributing / Unlikely
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Rationale:
This is where you enter your rationale as to
why a suspect cause is likely to be correct or why you have discounted this particular cause
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4.0 Corrective and Preventive actions
to be taken
State corrective and
preventive actions, which need to be taken and the reasoning behind decisions
made.
5.0 Risk Analysis
± Potential impact
on other processes
Here is where you outline whether
this event could have an impact on any other equipment or processes and your
rational as to why you have made this conclusion.
You should also explore whether this
is a repeat event or the first time this has occurred.
6.0 Product Disposition
6.1 Product made prior to the event
Here is where you outline the risk assessment and impact to product
made prior to the event and rationale as to why it is either acceptable or not.
6.2 Product made during the event
Here is where
you outline the risk assessment and impact to product made during the event and rationale as to
why it is either acceptable or not.
6.3 Product made after the event
Here is where you outline the risk assessment and impact to product
made after the event and rationale as to why it is either acceptable or not.
7.0 Summary
Here is where you write your
conclusion to the investigation, you
must summarise the overall root cause found during the investigation, the impact on this batch and any other
batches and the overall batch disposition.
7.1 Root Cause
State the root cause or suspect
cause if root cause was not determined.
7.2 Repeat Event
State if a similar event occurred in the last 12 months and DR reference.
7.3 Batch Disposition
State final batch disposition and
reasoning behind the decision.
7.4 Impact on other batches
/ processes
State if other batches/processes are
impacted and reasoning behind the decision.
8.0 List of Attachments
Brief list of attachments to be added here
8.1.1 Attachment ± Summary
of Investigation Tasks
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Task Description
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Responsible
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Date
Due
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Date
Completed
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Enter tasks here
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8.1.2 Attachment ± Summary
of Corrective Actions
Tasks
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Task Description
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Responsible
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Date
Due
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Date
Completed
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Enter tasks here
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8.1.3 Attachment ± Summary
of Preventative Actions
Tasks
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Task Description
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Responsible
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Date
Due
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Date
Completed
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Enter tasks here
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Note: Batch release
may occur prior to the preventative items being completed
8.2 Attachment - Investigation meeting minutes
8.2.1 Meeting Minutes
If there are multiple meetings or discussions
these should be listed on this page
8.3 Attachment - Supporting batch documentation
8.3.1 Attachment ± Deviation Report/s
If there are multiple DR associated
with this event then these should
be listed on this page.
8.3.2 Attachment - Supporting Batch Documentation /
Log
Books
If there are exerts from the batch documentation or copies of log book pages associated
with this event then these should be listed on this page.
8.3.4 Attachment - Supporting Facilities Data
List copies of in-process checks printed from the production lines.
8.3.5 Attachment - Supporting Analytical Data
Copies of Analytical data associated
with this event.
8.3.6 Attachment ± Validation Data
Copies of Validation data
associated with this event.
8.4 Attachment - Evidence of actions completed
8.4.2 Attachment - Employee Awareness
Forms
Employees counselled as a result of this event should sign a form
to say that they understand the nature of their involvement and be filed behind
this attachment.
8.4.3 Attachment - SOP Updates
Evidence of critical updates to SOPs
to be
filed behind this attachment.
8.4.4 Attachment - Training /
Assessment Updates
Evidence of critical updates to
training and assessment be filed behind this attachment.
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