by | PART 1: INTIMATION OF INCIDENT | |||||||||||||||
| Section Name: | Incident Investigation No: | ||||||||||||||
| Incident Occurred Date | Incident Identified Date | ||||||||||||||
| Identified By (Name) | Incident Report to QA (Date) | ||||||||||||||
| Specify if Incident an audit source | |||||||||||||||
| Incident Scope | [ ] Document [ ] Equipment/Instrument [ ] Sample Handling [ ] Procedure/Method System [ ] Other (Specify) | ||||||||||||||
| Description of Incident: | |||||||||||||||
| Initiator (Sign. /Date) | Section In Charge/ Designee (Sign. /Date) | Technical Manager / Designee (Sign. /Date) | |||||||||||||
| Name: | Name: | Name: | |||||||||||||
| PART 2 : IMMEDIATE ACTION PERFORMED | |||||||||||||||
| Specify the Details: [ ] Operation suspended/Hold [ ] Status labeled & segregated/Cover [ ] Additional samples collected and activity continued [ ] Others | |||||||||||||||
| Incident Reported by: (Name, Signature/date) | |||||||||||||||
| Incident Reported to: (Name, Signature/date) | |||||||||||||||
| PART 3 : PRELIMINARY VERIFICATION BY CONCERN SECTION / DEPARTMENT | |||||||||||||||
| Mark tick (√) as applicable Verified: [ ] Area [ ] Machine [ ] Material [ ] Procedure [ ] Man (Person) [ ] Measurement [ ] Method [ ] Environment | |||||||||||||||
| Details of finding / Investigation: | |||||||||||||||
| Section In Charge / Designee Sign. / Date: | Technical Head/ Designee Sign. /Date: | ||||||||||||||
| PART 4 : REVIEW AND ASSESSMENT OF INCIDENT | |||||||||||||||
| Review by Quality Assurance | |||||||||||||||
| History evaluation of Incident | Occurrence: [ ] First [ ] Repeat (In-case of repeat incident check below) | ||||||||||||||
| Refer incident No: Status: [ ] Open [ ] Closed | |||||||||||||||
| Incident Categorization: [ ] Critical [ ] Major [ ] Minor | |||||||||||||||
| Selection of impacted Department: [ ] Chemical Section [ ] Instrument Section [ ] Microbiology Section [ ] Food Section [ ] Report All [ ] Sample Cell [ ] Others (Specify details) | |||||||||||||||
| Review and assessment (Evaluation) by impacted department: | |||||||||||||||
| Department | Review and Recommendations | ||||||||||||||
| Review and approval of customer (If Required): | |||||||||||||||
| Approved by (QA): Sign/Date | |||||||||||||||
| PART 5: DETAILS OF INVESTIGATION: | |||||||||||||||
| Investigation Completion Date: | |||||||||||||||
| Description of Root Cause: | |||||||||||||||
| Probable Root Cause: [ ] Man [ ] Material [ ] Method/Specification [ ] Facility [ ] Instrument/Utility/Software [ ] Dilution and pipetting [ ] Other (Specify Details) (Tick √ as applicable) | |||||||||||||||
| Impact Assessment: | |||||||||||||||
| Corrective action and preventive action (CAPA): | |||||||||||||||
| Proposed By: (Sign/Date) | Technical Manager/Designee (Sign/Date) | QM/Designee (Sign/Date) | |||||||||||||
| CAPA Reference No. | Assigned by QA (Sign/Date) | ||||||||||||||
| PART 6 : MONITORING AND CLOSURE OF THE INCIDENT: | |||||||||||||||
| Monitoring of time line extension of closure Items | |||||||||||||||
| Initiating Department | Pending Actions | ||||||||||||||
| Existing Date | |||||||||||||||
| Proposed Date | Justification | ||||||||||||||
| Requested By: (Sign & date) | Reviewed By QA: (Sign & date) | Approved By QA: (Sign & date) | |||||||||||||
| Closure Recommended Correction: | |||||||||||||||
| Description of Closure action | Action Closed Date | Attachment No. | Reviewed By QA | Remarks | |||||||||||
| Review Comments on closure actions by QA Comments: All relevant action completed as proposed : [ ] Yes [ ] No All relevant and reference documents are attached (as applicable) : [ ] Yes [ ] No | |||||||||||||||
| Name (Sign/Date) | |||||||||||||||
| Closure Comments By Quality Manager: Name: Sign/Date: | |||||||||||||||
| Incident Closure Date: | |||||||||||||||
| Log Updated By QA: | |||||||||||||||
