Your Easy Guide to Clinical Studies

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)

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

More

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

References

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

• 8.7 Corrective action for nonconforming output

Documents

• Risk Assessment Form for Clinical Research Projects