Compliance and initiative: A discussion on the relationship between standards and activities in radiopharmaceutical production

Abstract

This study investigated how a standard could become reality-based in a workplace where certain types of deviations are not permitted, such as a radiopharmaceutical production unit. Compliance with standards is necessary to ensure the safety of individuals who manufacture such substances as well as the security of patients receiving treatment. In this qualitative case study, an ergonomic analysis of work (also known as activity analysis) was performed, with noncompliance recorded in internal audits as a starting point: the lack of double-checking in radiopharmaceutical synthesis cassette assembly. Field observations and self-confrontation interviews with workers from a production unit were conducted to analyze the activities. Although a double-check did not occur, the radiopharmaceutical synthesis operator apparently developed another risk control strategy, focusing his attention to the equipment assembly details, which necessitated continuous control and verification actions to ensure that there were no problems at this stage of production. A multilevel approach was used to demonstrate how the safety and quality of production processes based on standard compliance only become effective and adherent to the activity after resolving various conflicts at work, including control systems (external and internal audits), work collectives, the contradiction of the activity itself, and the discussion of singular situations arising daily. This study contributes to the discussion on workplace safety considering standardization and advances the discussion on changing perspectives regarding rule compliance.

Keywords

• Radiopharmaceuticals
• Activity analysis
• Adherence to standards
• Risk control