What is it? Why is it important?

A non-conformity (NC) is a non-fulfillment of some given requirement that can or might affect the characteristics and/or the quality of Biological Material (BM) and/or the QMS of the biobank (e.g. non-compliance with Quality-Control-Indicators). Once detected, the NC is documented and evaluated regarding further actions.


NCs are a consequence of but not limited to:

  • Staff errors (e.g. centrifugation at room temperature instead of required 4°C, data error entries)
  • Lack or erroneous staff trainings
  • Erroneous biobanking forms lacking relevant processing instructions, and lack of applicable SOPs/WIs
  • Equipment failure (e.g. freezer breakdown)
  • Misuse of equipment (e.g. use of non-calibrated pipettes)
  • Deliberate actions (e.g. destruction of BM, abstain from using proper storage conditions, data hacking)
  • Catastrophic events (e.g. fire or flood)


Occurrence of NCs trigger:

  • Corrective and preventive actions (CAPAs) with the aim to prevent re-occurrence of NCs (e.g. risk control-measures)
  • Documentation of these actions and their associated results (satisfying or not) in a Risk Assessment Form (RAF)

What do I need to do?

Based on defined sample workflow procedures set-up a NC surveillance and reporting system that includes the:

  • Identification of NCs. For each workflow activity:
    • Provide instructions (e.g. SOPs/WIs / Checklists) that must be adhered to (e.g. train staff)
    • Perform a risk assessment and define NC risks. Train staff on risk identification
    • Plan intermittent quality compliance checks
  • Reporting of NCs: Through quality checks and/or spontaneous staff reporting. Provide a reporting form for the description of NCs (e.g. date of event, affected activities, responsible person(s), if applicable risk control-measures)
  • Management of reported NCs: Make a root cause analysis and decide if immediate or delayed corrective actions are needed. Define corrective and preventive actions (CAPAs) and follow-up procedures. Document its strategy in a RAF


Regarding NC management additional questions to address are:

  • Who is responsible for NC root-cause analysis?
  • Who and how are CAPA actions implemented?
  • Who is responsible to evaluate the efficacy of implemented CAPAs (e.g. follow-up procedures)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

SOPs, Forms and Templates – see in particular

  • Non-conformity management SOP
  • Non-conformity Report
  • Non-conformity Log


ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section

  • 8.7 Corrective action for nonconforming output


  • BM – Biological Material
  • CAPA – Corrective and Preventive Actions
  • CTU – Clinical Trials Unit
  • ISO – International Organization for Standardization
  • NC – Non-Conformities
  • QMS – Quality Management System
  • RAF – Risk Assessment Form
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
  • WI – Working Instruction
Development ↦ Biobanking ↦ Documentation ↦ Non-Conformities

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Biobanking ↦ Documentation ↦ Non-Conformities

Please note: the Easy-GCS tool is currently under construction.