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Lir

This document defines laboratory errors and how to classify them as major or minor. Major errors result in wrong production decisions, impacted product quality, time losses, or injuries. Minor errors are near misses, testing delays, or contamination. The laboratory investigation report (LIR) should be used when protocol was not followed, calculations were wrong, results were wrong, improper procedures/reagents/calculations were used, anomalies were not reported, or testing was untimely. The LIR records the incident details, root cause, suggested actions, and signatures of involved personnel.

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1K views5 pages

Lir

This document defines laboratory errors and how to classify them as major or minor. Major errors result in wrong production decisions, impacted product quality, time losses, or injuries. Minor errors are near misses, testing delays, or contamination. The laboratory investigation report (LIR) should be used when protocol was not followed, calculations were wrong, results were wrong, improper procedures/reagents/calculations were used, anomalies were not reported, or testing was untimely. The LIR records the incident details, root cause, suggested actions, and signatures of involved personnel.

Uploaded by

Himatush
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Chemicals Incorporated

Prepared by: Hima Konuru

QA/QC Lab
Laboratory investigation report

Date: 1-14-2016
Rev: 0

Definition: Laboratory error is an occurrence or an event that has a negative impact on


Laboratory, which includes personnel, product, equipment, or the environment.
Classification of Errors:
Major: The error resulted in (not limited to)
a.
b.
c.
d.
e.
f.

Resulted in wrong decisions in the production causing major/minor incident


Direct impact on the quality of the product(s) in production
Resulted in substantial time loss in production
Resulted in other lab personnel getting injured
Resulted in irreversible contaminations
Repetition of mishaps

Minor: The error resulted in (not limited to)


a.
b.
c.
d.
e.

A Near miss situation


Delay in testing
Contamination of lab reagents
Wasting time and reagents
First three non fatal mistakes

This LIR (Laboratory Investigation Report) should be used in case of:


1. The technician failed to follow the required protocol (starting from receiving the
sample until proper disposing off the reminder of the sample after the testing(s) is
complete.
2. The calculations were wrong
3. The reported results were wrong
4. Used wrong procedure/reagents/calculations
5. Technician failed to report anomaly in the test result(s) in a timely manner
6. The testing was not done in a timely manner
7. There are significant negative reports on particular technician
8. The technician failed to follow the basic laboratory guidelines, such as
a. Must always read the label before using any chemical - DO NOT ASSUME
b. Must ware proper/suggested PPE
c. Must convey/relay correct and accurate information to the fellow technicians
d. Must not leave any test, including heating unattended
e. Tardiness and paying attentions to the testing details
f. Re-checking in case of any little doubt
g. Reporting any incident immediately to the supervisor

Chemicals Incorporated
Prepared by: Hima Konuru

QA/QC Lab
Laboratory investigation report

Date: 1-14-2016
Rev: 0

Report Number
Open date:

Closing Date:

Report Prepared by

Person(s) involved

Date discovered

Nature of the incident

Product quality effected

Fatal

Major

Minor

Yes

No

Yes

No

If Yes how many batches

Is the customer notified

Frequency of occurrence

Chemicals Incorporated
Prepared by: Hima Konuru

QA/QC Lab
Laboratory investigation report

Description of the incident:

Problem root Cause:

Actions suggested:

Effective date of actions required


Follow up comments/Sign/Date/Print Name

Date: 1-14-2016
Rev: 0 , Continued

Chemicals Incorporated
Prepared by: Hima Konuru

QA/QC Lab
Laboratory investigation report

Date: 1-14-2016
Rev: 0, Continued

Lab Personnel (present when the incident occurred and or involved with the incident):
Name

Signature

Date

__________________________

___________________________

________

__________________________

___________________________

________

__________________________

___________________________

________

__________________________

___________________________

________

__________________________

___________________________

________

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