Impact assessment of equipment failure
or equipment calibration failure
Guideline
Purpose and use of this guideline document
On occasion equipment used for the processing, analysis or storage of clinical trial samples will fail, or
will fail a calibration check. The impact on sample integrity and analysis must be assessed and
documented. This document provides guidelines for how to carry out this assessment and may be
used to develop trial-specific procedures.
Scope of this guideline document
This document provides guidelines for assessing the impact of equipment failure or calibration failure
on sample integrity and analysis.
It also references other guideline documents and example forms which it may be necessary to
consider depending upon the circumstances.
Record keeping
 The impact of equipment failure or calibration failure on sample integrity and analysis must be
assessed and documented. An example form is available (see UoB-CLN-LAB-QCD-029
Impact assessment of equipment failure or equipment calibration failure report).
 A number of other records pertaining to equipment failure, analytical failure and adverse event
reporting may also be completed (see references within Guidelines section below).
 All records must be stored safely and securely throughout the trial and archived with the other
trial documents when the trial closes.
Guidelines
 Any equipment failure should be acted upon and recorded.
o Consider completing an adverse event report (see UoB-CLN-LAB-QCD-016 Adverse
Events in the analytical laboratory and UoB-CLN-LAB-QCD-032 Adverse Event report).
o Equipment failure should be documented along with any repairs (see UoB-CLN-LABQCD-002 Equipment maintenance and calibration checks and UoB-CLN-LAB-QCD-021
Equipment maintenance record).
o If the equipment failure involves a storage unit then follow trial-specific procedures (see
UoB-CLN-LAB-QCD-019 Procedures following failure of a storage unit).
o If the equipment failure causes failure of an analytical run then document this separately
(see UoB-CLN-LAB-QCD-009 Analytical assay failure and UoB-CLN-LAB-QCD-028
Analytical failure report).
 Assess the impact of the equipment failure or equipment calibration failure by evaluating and
commenting on the following:
o The type of equipment affected.
o The magnitude of the calibration failure.
o The elapsed time between the previous calibration date and the date of calibration check
failure.
o The analyses conducted using the affected equipment during the period above.
o The effect of the failure on the accuracy and precision of the analytical results.
o Any other relevant factors such as integrity of samples and reagents.
 Document this impact assessment (for an example form see UoB-CLN-LAB-QCD-029 Impact
assessment of equipment failure or equipment calibration failure report) and consider having
the report reviewed and signed off appropriately.
UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration failure v1.0
(EAv1.0)
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Impact assessment of equipment failure
or equipment calibration failure
Guideline
Related documents
 UoB-CLN-LAB-SOP-001 Procedures for GCP compliance in the laboratory
 UoB-CLN-LAB-QCD-002 Equipment maintenance and calibration checks
 UoB-CLN-LAB-QCD-009 Analytical assay failure
 UoB-CLN-LAB-QCD-016 Adverse events in the laboratory
 UoB-CLN-LAB-QCD-019 Procedures following failure of a storage unit
 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 reporting
UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration failure v1.0
(EAv1.0)
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