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OCR Quality Control Occurrence Report Form
ID
Assingee
– No Results –
Part I: Initial Report
User
Name
Type of item
(Required)
Equipment
Reagent
Supply
Item name / description
(Required)
Serial / Lot Number
(Required)
Date of occurrence
(Required)
DD slash MM slash YYYY
Occurrence category
(Required)
Equipment
Supply / Reagent
EM excursion
Other
Equipment occurrence type
(Required)
Malfunction
Calibration problem
Accuracy problem
Performance in doubt
Recall
Other
Supply / Reagent occurrence type
(Required)
Defected supply / reagent
Failed acceptance criteria
Inadequate supplier service
Shortage of supply / reagent
Recall
Other
EM excursion type
(Required)
Temp.
RH
Equipment occurrence - other details
(Required)
Supply / Reagent occurrence - other details
(Required)
Other occurrence details
(Required)
Brief description of occurrence
(Required)
Attach supporting documents
Drop files here or
Select files
Accepted file types: pdf, doc, docx, jpg, jpeg, png, Max. file size: 256 MB.
Initial investigation
(Required)
Initial investigation attachments
Drop files here or
Select files
Accepted file types: pdf, doc, docx, jpg, jpeg, png, Max. file size: 256 MB.
Any Cord Blood or Cell Therapy products involved?
(Required)
Yes
No
If yes, list product numbers
(Required)
Taken out of service?
(Required)
Yes
No
"Out of Service" sign on equipment - Date
(Required)
DD slash MM slash YYYY
"Out of Service" sign on equipment - Tech
(Required)
Service call required?
(Required)
Yes
No
Service call made - Date
(Required)
DD slash MM slash YYYY
Service call made - Tech
(Required)
Service call contact
Follow up
(Required)
Yes
No
Follow up Date
(Required)
DD slash MM slash YYYY
Form completed by
(Required)
– No Results –
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Reviewed by
(Required)
– No Results –
Lab Manager
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Reviewed by
(Required)
– No Results –
Quality Director
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Part III: Corrective Action
Reference:
Use the same item details from Part I for corrective action tracking.
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Date of malfunction / recall
DD slash MM slash YYYY
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Corrective action form completed date
DD slash MM slash YYYY
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Service call
No
Yes
Service call date
DD slash MM slash YYYY
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Service engineer
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Description of corrective action taken
(Required)
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Corrective action attachments
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Select files
Accepted file types: pdf, doc, docx, jpg, jpeg, png, Max. file size: 256 MB.
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Completed by
(Required)
– No Results –
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Corrective action taken
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Results of corrective action taken
(Required)
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Results attachments
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Select files
Accepted file types: pdf, doc, docx, jpg, jpeg, png, Max. file size: 256 MB.
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Requalification performed?
Yes
No
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Attach all relevant qualification data
Drop files here or
Select files
Accepted file types: pdf, doc, docx, jpg, jpeg, png, Max. file size: 256 MB.
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Approved for return to service?
Yes
No
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"Out of Service" sign removed - Date
DD slash MM slash YYYY
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"Out of Service" sign removed - Tech
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Completed by
(Required)
– No Results –
Lab Manager
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Part IV: Quality Review
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QM review
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QM review attachments
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Accepted file types: pdf, doc, docx, jpg, jpeg, png, Max. file size: 256 MB.
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Approved by
(Required)
– No Results –
Quality Director
Reviewed by
Lab Director
Dr. Maher Sarraf
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Archiving File
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Max. file size: 256 MB.
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