Dados do Trabalho

Title

Non-conformances management in IVF laboratories

Objective

The purpose of this study is to guide laboratory teams to structure effective approaches to managing non-conformances.

Methods

Analyzes were performed from the NCBI and Pubmed database. The search keywords were “quality management in IVF laboratory”, “IVF errors”, “non-conformance in IVF laboratory”, “cost of non-conformance”, “risk assessment in laboratory” and “corrective action”.

Results

The scarcity of published data regarding non-conformances shows that the phrase “to err is human” may not be applicable in the IVF (in vitro fertilization) context. This lack of information is directly associated with the scenario of the infertility treatment journey itself, which tends to be challenging, stressful and decisive for families. In this circumstance, the activities in IVF laboratories must be performed in a standard way, with monitoring and control.
The literature portrays that the standardization of procedures drastically reduces the possibilities of error, in this sense, the concept of non-conformance was established as the non-fulfillment of a previously established requirement.
In general, two types of non-conformances can occur in the IVF laboratory: active errors and latent errors. Active errors are generated by insecurity that can cause harm to patients or the system, such as human errors and communication errors. Latent errors arise due to inefficiencies in the system, such as understaffing, ineffective management, poorly maintained equipment, and inaccurate protocols.
The non-conformances management requires the implementation of several actions with the objective of solving occurrences, avoiding rework, waste and loss. Structured dynamics must be able to identify and address the root cause and propose actions to minimize the risk of recurrence.
The culture of identifying the root cause, implemented by the institutions, has proven to be an effective strategy for managing the quality of laboratories. Studies highlight the importance of recording non-conformances, both to show, in audits, the actions that were carried out and to track opportunities for improvement.
After registration, the team will be able to use tools capable of identifying the causes of problems, such as: Ishikawa diagram, 5 whys and Pareto chart. From the identification of the root cause, it is necessary to structure an action plan to deal with occurrences with corrective and preventive actions.
As evidenced in the Deming cycle (PDCA), the steps that promote continuous process improvement are based on “plan’, “do”, “check” and “act”. This tool is also widely used in the treatment of non-conformances. In this way, the search for the root cause and the elaboration of action plans are inserted in the planning phase (P) according to the PDCA.
Once the root cause analysis has been well structured it will be possible to plan assertive actions so that recurrences do not occur. According to the literature, one of the most used strategies for the elaboration of action plans is the 5W2H. This tool is capable of structuring all the necessary actions to deal with a non-conformance through the following criteria: what to do, where to do it, why, when, who, how, how much.
After preparing the action plan, it is necessary to implement it in the institution, this phase corresponds to “doing” (D), later, it will be essential to check (C) whether the processes are working as planned so that actions can be taken (A) adapting to routine.

Conclusion

Despite the diversity of non-conformities faced by institutions, it is possible to define a general basis of approaches that prove to be effective when using specific management tools. Therefore, the management of non-conformances is based on the identification, registration, classification, analysis, implementation of corrective actions, monitoring and continuous improvement.

Keywords

Non-conformance, IVF laboratory, Quality management