Microbiology Report Form PDF Details

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.

QuestionAnswer
Form NameMicrobiology Report Form
Form Length3 pages
Fillable?No
Fillable fields0
Avg. time to fill out45 sec
Other namesoos form sample, oos form fillable, oos form online, fillable treasure report templete

Form Preview Example

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Form 690

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issue date:

 

 

 

 

 

 

 

 

Microbiology Out of Specification (OOS)

 

 

 

 

 

 

 

 

 

 

 

 

Investigation and Report Form

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Ref. MICLAB 110)

 

 

 

 

 

 

 

 

Phase 1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Out of Specification Result

 

 

 

 

 

Out of Limits Result

 

 

 

(Action Level Excursions)

 

 

 

 

(Alert Limit Excursions)

 

 

SECTION A Product or Sample Details

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Form Initiated by:

 

 

 

 

 

 

 

 

 

 

 

Unique

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Identifier

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

 

 

 

 

 

 

 

 

 

 

DR Number

 

 

 

 

 

 

 

 

 

Description

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Batch Production

 

 

 

 

 

 

 

 

 

 

 

Product Code

 

 

 

 

 

 

 

 

 

Number (BPN)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Original Test Result

 

 

 

 

 

 

 

 

 

 

 

Limits/

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Specification

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Micro Manager Notified

 

Yes

 

No

 

 

By who?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Initial and Date

SECTION B Evaluation of Laboratory Testing

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Test Type

 

 

(tick)

 

 

SOP Reference

 

 

Control Method reference

 

 

 

 

 

 

 

 

 

 

 

(if applicable)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-Sterile Testing

 

 

 

 

 

 

MICLAB 075

 

 

 

 

 

 

 

 

 

 

Water

 

 

 

 

 

 

MICLAB 055

 

 

 

 

 

 

 

 

 

 

Sterility Testing

 

 

 

 

 

 

MICLAB 060

 

 

 

 

 

 

 

 

 

 

Endotoxin

 

 

KCA

 

 

 

 

 

 

MICLAB 085

 

 

 

 

 

 

 

 

 

 

 

 

GEL

 

 

 

 

 

 

MICLAB 080

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other ………………………..

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Name of Technician who

 

 

 

 

 

 

 

 

 

 

 

Training records

 

Yes

No

 

performed the test

 

 

 

 

 

 

 

 

 

 

 

complete

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Date Sampled

 

 

 

 

 

 

 

 

 

 

 

Date Test

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

performed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Was test conducted in

 

 

 

 

 

 

 

If No, comment:

 

 

 

 

 

 

 

 

 

accordance with SOP &

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Control method

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Media/Reagents Used

 

 

Lot Number

 

 

Expiry Date

 

 

 

Passed QC Checks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

File Location:

Date Printed:

Page 1 of 3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Form 690

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issue date:

 

Microbiology Out of Specification (OOS)

 

 

 

 

 

 

Investigation and Report Form

 

 

 

 

 

 

 

 

 

 

(Ref. MICLAB 110)

 

 

 

 

 

 

PART B Evaluation of Laboratory Testing (continued)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equipment Used

 

 

 

Calibration Due Date

 

Temperature Trends in range

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Yes

No

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Test result record

 

 

Yes

No

 

 

Comments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Attached?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Are Calculations Verified

 

 

Yes

No

 

 

Comments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

and correct?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Negative Controls

 

 

Yes

No

 

 

Comments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

passed?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other tests from same

 

 

 

 

 

 

 

Comments:

 

 

 

 

 

 

 

test session within

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

limits?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Sources of Error?

 

 

 

 

 

 

 

Comments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Technician observations

 

 

Yes

No

 

 

 

 

 

 

 

 

 

 

 

during testing?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Brief Description of the

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investigation Findings to

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

date.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

If No, is re-testing

 

 

 

Yes

No

N/A

 

 

 

 

 

 

 

 

 

required

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Is initial Result Valid?

 

 

 

 

 

 

 

If Yes, is confirmatory or

 

 

 

 

 

 

(ie has root cause been

 

 

Yes

No

 

 

investigational testing

 

 

Yes

No

N/A

 

identified)

 

 

 

 

 

 

 

required?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

If Yes, DR raised &

 

 

 

Yes

 

 

 

 

 

 

 

 

 

 

 

recorded in Section A

 

 

 

Initials & Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

Print

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

 

PART C Retest Protocol

 

 

 

 

 

 

Retest testing of Original Sample(s)

 

Yes

No

N/A

 

 

 

 

 

 

 

 

 

 

 

Confirmatory Testing of Original or retention Sample(s) for

 

Yes

No

N/A

 

 

investigational purposes

 

 

 

 

 

 

 

 

 

 

Retest of Retain samples

 

Yes

No

N/A

 

 

 

 

 

 

 

 

 

 

 

Retest of Both Original and retain sample

 

Yes

No

N/A

 

 

 

 

 

 

 

 

 

 

 

Number of Replicates to be Tested

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Test Method

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Limits for Retest

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Retesting Conducted by

 

 

 

 

 

 

 

 

 

Print

 

 

Sign and Date

 

 

Please document the purpose of additional testing as detailed above.

Retest Protocol

Approved By:

Micro Manager

Print

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

Print

Sign

Date

File Location:

Date Printed:

Page 3 of 3