Analytical assay failure
Guideline
Purpose and use of this guideline document
On occasion an analytical run of clinical trial samples may fail. This may be due to equipment failure
or because a calibration curve or control sample(s) falls outside of the specified acceptance limits
determined during the assay validation procedure. Analytical assay failures should always be
recorded, reviewed and acted upon.
This document provides guidelines as to how to handle analytical failures during the analysis of
clinical trial samples and can be used for the development and implementation of trial-specific written
procedures.
Scope of this guideline document
This guideline document does NOT cover the repeat analysis of patient samples which may give an
anomalous result/alert value when the analytical assay has proceeded to completion without issue.
Guidelines for this are available (see UOB-CLN-LAB-QCD-018 Repeat analysis).
Record keeping
 You are strongly advised to develop a means of documenting analytical failures and the
corrective and preventative action(s) undertaken as a result. An example form for this is
available (see UoB-CLN-LAB-QCD-028 Analytical failure report).
 Note that if an analytical run fails due to equipment failure, additional procedures and actions
may be necessary (see UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or
equipment calibration failure, UoB-CLN-LAB-QCD-016 Adverse events in the analytical
laboratory, UoB-CLN-LAB-QCD-021 Equipment maintenance record, UoB-CLN-LAB-QCD029 Impact assessment of equipment failure or equipment calibration failure report and UoBCLN-LAB-QCD-032 Adverse Event report).
 All records must be stored safely and securely throughout the trial and archived with the other
trial documents when the trial closes.
Developing written procedures
You are advised to include the following:
 The name or job title of the person(s) responsible for reviewing analytical failures, reporting
the failure and to whom (if appropriate) and deciding upon corrective and preventative
action(s).
 The name or job title of the person(s) responsible for documenting the analytical failure and
corrective and preventative action(s).
 Procedures developed from the guidelines below.
Guidelines
 Correct equipment malfunctions immediately wherever possible so that the analysis may
continue. If this is not possible consider using the guideline documents and example forms
UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration
failure, UoB-CLN-LAB-QCD-016 Adverse events in the analytical laboratory, UoB-CLN-LABQCD-021 Equipment maintenance record, UoB-CLN-LAB-QCD-029 Impact assessment of
equipment failure or equipment calibration failure report and UoB-CLN-LAB-QCD-032
Adverse Event report for additional procedures and actions.
 If analytical failure is because the calibration curve or control samples fall outside of the
specified acceptance limits, prepare fresh standards and control and run the analysis again
(this may depend upon the availability and stability of the samples concerned).
 Document the analytical failure and the corrective and preventative action(s) undertaken as a
result (see UoB-CLN-LAB-QCD-029 Impact assessment of equipment failure or equipment
calibration failure report).
 Consider having the report reviewed and signed off appropriately.
UoB-CLN-LAB-QCD-009 Analytical assay failure v1.0 (EAv1.0)
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Analytical assay failure
Guideline
Related documents
 UoB-CLN-LAB-SOP-001 Procedures for GCP compliance in the laboratory
 UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration failure
 UoB-CLN-LAB-QCD-016 Adverse events in the analytical laboratory
 UoB-CLN-LAB-QCD-018 Repeat analysis
 UoB-CLN-LAB-QCD-021 Equipment maintenance record
 UoB-CLN-LAB-QCD-028 Analytical failure report
 UoB-CLN-LAB-QCD-029 Impact assessment of equipment failure or equipment calibration failure
report
 UoB-CLN-LAB-QCD-032 Adverse event report
UoB-CLN-LAB-QCD-009 Analytical assay failure v1.0 (EAv1.0)
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