Analysis and management of non-conformities in a quality laboratory for chemotherapeutics control

5 October 2012

Sophie He1, Laetitia Minh Mai Lê1, 2, Laurent Havard1, Patrice Prognon1, 2, Eric Caudron1, 2 1 Hôpital Européen Georges Pompidou, AP-HP, Paris, France
2 Université Paris-Sud EA4041, Châtenay-Malabry, France


In a context of continuous improvement, analytical quality control is essential to guarantee chemotherapeutic drugs process quality and security before administration. However, none system is totally safe. Non conformities (NC) can occur and delay chemotherapeutic drugs liberation.

The aim of the study is to classify non conformities according to a critical index (CI), to investigate their root causes in order to target priority corrective actions.

Materials and method

This study concerns NC listed from January 2011 to March 2012. CI is defined as the multiplication of 3 scores: the NC frequency, the severity for the production (production delay) and the severity for the laboratory (control delay). Then, an Ishikawa diagram was established to identify their causes and the priority forthcoming corrective actions.

Results and discussion

Over 25 246 controlled preparations, 224 NC (0,88%) were reported and classified into 14 categories. 50,0% of NC were due to a lack of mixing (CI=14). The 3 most critical NC (errors of dose (CI = 60), errors of drug (CI = 36) and absence of drug (CI = 24)) lead to the destruction of 70 preparations (0,27%). Material inventory, procedures revision and supplementary formation are the first actions to set up to institute a real security culture.


Therefore, quality control is an essential tool for quality improvement and iatrogenic risk management in order to avoid severe side effects. Prioritizing the corrective actions is the key when time and human resources are limited.

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