4.2.2 Error and incident management

​​​​​​​​​​​​​​​​​​​​​​​​​​​​A. Background & Definitions​

This item refers to one of the Core Requirements (Core Requirement 16 - "Critical incidents and errors during study conduct must be analyzed and appropriately managed​") and is, therefore, considered essential.

Critical Incident: An unexpected deviation from the intention (e.g. study protocol) with a larger or longlasting impact on the experimental outcome​ or on the research unit (RU).

B. Guidance & Expectations

The EQIPD QS recogizes two levels of error and incident management - mandatory (to meet the EQIPD Core Requirement) and voluntary (for systematic error management).

The EQIPD Core Requirement on error and incident reporting

Basic reporting of errors and incidents is important to create transparency of the experimental work performed in a research unit. The following is expected:

• Error documentation
  • All errors affecting the outcome of experiments must be documented during study conduct within the experimental records
• Impact assessment
  • The researcher must assess the incident and decide whether the error has to be communicated (click​ HERE for a decision tree​​)
  • This is an informal step and no documentation is required
• Mitigation approach
  • Depending on the impact and scope, the mitigation approach must either be developed by the researcher themselves, by the lab supervisor or in a dedicated team. It could also be discussed in a lab meeting if most group members are affected.
  • The mitigation approach should be documented (e.g. with a formal template, as a note with the experimental record, as an Email trail in a dedicated mailbox or any other way)
  • If applicable, measures should be taken to avoid this error in the future

To fulfill this Core Requirement, it is expected that awareness about the error culture is created (e.g. during lab meetings).​

Voluntary approaches providing a systematic error management

To report and document errors at this level the following approach may be applied:

• Identify a person responsible for collecting errors and incidents
• Report errors via a document (please see below for a template) or electronic tool (e.g. LabCIRS)
• The person overseeing errors and incidents is informed (anonymously)
• Countermeasures shall be discussed and established to prevent reoccurence
• The error and the countermeasures shall be presented and discussed with the whole team (e.g. during lab meetings)

PLEASE DO NOT FORGET​

• To actively facilitate a positive and transparent error culture. This can be done with short trainings when onboarding new team members or during an annual training. The presentation created by the EQIPD team can provide a starting point (LINK).

RISK ASSESSMENT

• Admitting and handling errors and incidents is a sensitive topic as it may be perceived as embarrassing and shameful. Hence, special care has to be applied while discussing, documenting and dealing with erros and incidents.​

C. Resources​

Template for documenting errors and critical incidents - 4.2.2 Error Reporting.docx

Powerpoint presentation for creating awareness about Error management - EQIPD training slides on Error Management 200331.pptx

LabCIRS:

• software [1]
• publication [2]

Other publications:

• Errors and error management in biomedical research [3]

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