Application of the FMECA method at the purchase/procurement process of chemotherapy drugs and devices: how to secure the steps?

J. Saillard, A. Ferre, S. Sellin, C. Fronteau, P. Thomaré Oncologic Clinical Pharmacy Unit (UPCO), Nantes University Hospital Center, France

Introduction

UPCO realizes 38 000 preparations per year for all the Hospital’s sites. It is essential to have a quality procurement process of chemotherapy drugs and devices necessary for the preparation of chemotherapies.

Objective

To secure and to optimize the process.

Materials and methods

Potential risks analysis using the FMECA method.

  • Multidisciplinary meetings: pharmacists, intern, pharmacy technician, quality engineer
  • Description of process items
  • Failure modes causes and effects analysis using the 5M model
  • Scoring of failure mode and calculation of the criticality index
  • Research of corrective and preventive measures

Results

  • Various identified stages: expression of a need, processing of the request, receipt, stock inventory
  • 49 potential failures have been highlighted
    Criticality 1: 20% of the cases of which 57% involve the Method. They concern largely the receipt step
    Criticality 2: 67% of the cases of which 42% involve the Man power. They concern mostly stock management
    Criticality 3: 13% of the cases of which 50% involve the Method. They concern the processing of the request
  • Action plan: priority to criticalities 2 and 3, efforts on the method and the man power: to strengthen procedures and staff training.

Conclusion

This approach requires a close cooperation between the various stakeholders and allows to target critical points. After the implementation of corrective measures, a second analysis will allow to measure the residual risk. This continual improvement approach is in line with the essential evolution of ISO 9001 standard which aims to implement actions to deal with risks and opportunities.

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