| Author | Costa, Gerferson André Silva | |
| Author | Silva, Julie Micheline Amaral | |
| Author | Soares, Raquel Guimarães | |
| Author | Modena, Celina Maria | |
| Author | Oliveira, Fabiana Goulart de | |
| Author | Lima, Francisco de Paula Antunes | |
| Access date | 2024-03-25T14:16:00Z | |
| Available date | 2024-03-25T14:16:00Z | |
| Document date | 2024 | |
| Citation | COSTA, Gerferson André Silva et al. Compliance and initiative: A discussion on the relationship between standards and activities in radiopharmaceutical production. Heliyon, v. 10, n. 4, p. 1-14, e26003, Feb. 2024. | en_US |
| ISSN | 2405-8440 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/63194 | |
| Language | eng | en_US |
| Publisher | Science Direct | en_US |
| Rights | restricted access | |
| Title | Compliance and initiative: A discussion on the relationship between standards and activities in radiopharmaceutical production | en_US |
| Type | Article | |
| DOI | 10.1016/j.heliyon.2024.e26003 | |
| 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. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil. | en_US |
| Affilliation | Universidade do Estado de Minas Gerais. Divinópolis, MG, Brazil. | en_US |
| Affilliation | Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brazil. | en_US |
| Subject | Radiopharmaceuticals | en_US |
| Subject | Activity analysis | en_US |
| Subject | Adherence to standards | en_US |
| Subject | Risk control | en_US |
| Embargo date | 3100-12-31 | |
