When it comes to ensuring the safety and compliance of microbiological products, the Microbiology Report Form plays a critical role. Officially known as Form 690, this Microbiology Out of Specification (OOS) Investigation and Report Form is a comprehensive tool designed for documenting investigations into microbiological test results that do not meet specified criteria. It sets out a structured approach for recording initial out-of-specification or out-of-limits results, encompassing both action and alert limit excursions. The form initiates with clear identification of the product or sample under scrutiny, followed by a detailed evaluation of the laboratory testing processes, which includes verification of the test types, control methods, and the equipment used, as well as an assessment of the testing environment. The form also scrutinizes the technical competence of the personnel involved, evidenced by training records and adherence to standard operating procedures (SOPs). Additionally, it mandates a thorough examination of any potential sources of error, ranging from the test execution to the quality of the media and reagents used. Should initial findings validate the OOS results, the form guides users through a retesting protocol, outlining procedures for confirmatory or investigational testing. This meticulous documentation is crucial for identifying root causes and implementing corrective actions, thus ensuring product safety and regulatory compliance. The form, which must be signed off by a micro manager, underscores the importance of accuracy, thoroughness, and accountability in the microbiological testing process.
Question | Answer |
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Form Name | Microbiology Report Form |
Form Length | 3 pages |
Fillable? | No |
Fillable fields | 0 |
Avg. time to fill out | 45 sec |
Other names | oos form sample, oos form fillable, oos form online, fillable treasure report templete |
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Form 690 |
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Issue date: |
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Microbiology Out of Specification (OOS) |
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Investigation and Report Form |
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(Ref. MICLAB 110) |
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Phase 1 |
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Out of Specification Result |
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Out of Limits Result |
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(Action Level Excursions) |
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(Alert Limit Excursions) |
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SECTION A Product or Sample Details |
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Form Initiated by: |
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Unique |
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Identifier |
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Product |
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DR Number |
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Description |
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Batch Production |
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Product Code |
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Number (BPN) |
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Original Test Result |
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Limits/ |
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Specification |
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Micro Manager Notified |
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No |
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By who? |
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Initial and Date |
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SECTION B Evaluation of Laboratory Testing |
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Test Type |
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(tick) |
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SOP Reference |
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Control Method reference |
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(if applicable) |
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MICLAB 075 |
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Water |
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MICLAB 055 |
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Sterility Testing |
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MICLAB 060 |
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Endotoxin |
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KCA |
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MICLAB 085 |
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GEL |
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MICLAB 080 |
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Other ……………………….. |
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Name of Technician who |
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Training records |
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performed the test |
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complete |
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Date Sampled |
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Date Test |
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performed |
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Was test conducted in |
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If No, comment: |
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accordance with SOP & |
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Control method |
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Media/Reagents Used |
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Lot Number |
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Expiry Date |
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Passed QC Checks |
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File Location: |
Date Printed: |
Page 1 of 3 |
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Form 690 |
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Issue date: |
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Microbiology Out of Specification (OOS) |
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Investigation and Report Form |
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(Ref. MICLAB 110) |
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PART B Evaluation of Laboratory Testing (continued) |
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Equipment Used |
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Calibration Due Date |
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Temperature Trends in range |
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Test result record |
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Comments: |
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Attached? |
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Are Calculations Verified |
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Comments: |
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and correct? |
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Negative Controls |
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Comments: |
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passed? |
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Other tests from same |
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Comments: |
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test session within |
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limits? |
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Other Sources of Error? |
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Comments: |
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Technician observations |
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during testing? |
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Brief Description of the |
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Investigation Findings to |
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date. |
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If No, is |
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N/A |
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required |
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Is initial Result Valid? |
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If Yes, is confirmatory or |
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(ie has root cause been |
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investigational testing |
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N/A |
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identified) |
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required? |
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If Yes, DR raised & |
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Yes |
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recorded in Section A |
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Initials & Date |
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Note : If any of the above questions were answered NO, an evaluation of the validity of the test needs to be conducted by the Micro Manager.
Approved By:
Micro Manager
Sign
Date
NOTE: Refer to MICLAB 110 for appropriate Retest Procedures.
File Location: |
Date Printed: |
Page 2 of 3 |
Form 690
Issue date:
Microbiology Out of Specification (OOS)
Investigation and Report Form
(Ref. MICLAB 110)
Phase 2
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PART C Retest Protocol |
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Retest testing of Original Sample(s) |
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Yes |
No |
N/A |
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Confirmatory Testing of Original or retention Sample(s) for |
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Yes |
No |
N/A |
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investigational purposes |
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Retest of Retain samples |
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Yes |
No |
N/A |
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Retest of Both Original and retain sample |
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Yes |
No |
N/A |
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Number of Replicates to be Tested |
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Test Method |
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Limits for Retest |
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Retesting Conducted by |
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Sign and Date |
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Please document the purpose of additional testing as detailed above.
Retest Protocol
Approved By:
Micro Manager
Sign
Date
PART C Retest Protocol (continued) - Retest Results
Document result of Retesting in this section. Please attach hardcopy of raw data.
Approved By:
Micro Manager
Sign
Date
File Location: |
Date Printed: |
Page 3 of 3 |