Adding a Out of Specification Report (OOS)

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Step #1

Click here to reveal the “CAPA” sub-menu.


Step #2

Click here to enter the “Out of Specification” module.


Step #3

Click here to create a “OOS Report”.


Step #4

Enter a “OOS#” (Required).


Step #5

OOS # is a required field. Please enter to continue this walkthru


Step #6

Click “Create OOS Report”


Step #7

Enter “Date Requested”


Step #8

Enter “Batch Number”


Step #9

Click here to add additional “Owners” to this report.


Step #10

Click here to add a “Subscriber” (Optional).


Step #11

Upload associated files.


Step #12

Select “Impact”


Step #13

Add Departments. (Optional)


Step #14

Enter Sample Name


Step #15

Enter Sample ID


Step #16

Enter COA Number


Step #17

Enter Date


Step #18

Enter Name


Step #19

Enter Description of Laboratory Investigation


Step #20

Select Yes/No based on whether the assignable cause was found.


Step #21

Identify if there are any recommended actions.


Step #22

Click Approve


Step #23

Complete this section by selecting Yes/No.


Step #24

Add other comments if necessary.


Step #25

Select if assignable cause has been identified.


Step #26

Enter Details


Step #27

If yes, enter associated CAPA#.


Step #28

Complete Conclusion


Step #29

Identify recommended action.


Step #30

Click Approval


Step #31

Complete plan for additional testing


Step #32

Enter number of tests


Step #33

Enter number of laboratories.


Step #34

Click Approval


Step #35

Enter results for additional testing.


Step #36

Select Yes/No to whether the results were within specification.


Step #37

Click Approve


Step #38

If results are not within specification, enter CAPA#.


Step #39

Add approval to close OOS Investigation.


Step #40

Click to add signature.


Step #41

This OOS Report can be escalated to a Corrective Action, Change Control, or Deviation Report.


Step #42

Click Save & Close


Step #43

There is an option to re-open the report if necessary.


Step #44

If the report was created as a test run or by accident you may remove the report.