EVALUASI PENERAPAN SISTEM MANAJEMEN MUTU (SMM) TERKAIT AUDIT INTERNAL DI PT OTSUKA INDONESIA

Background: The implementation of SMM as a business strategy is supported by increasing globalization. Internal audit is the process of providing independent and impartial advice and assessment to improve a company's operational efficiency. This program can help a company achieve its targets by utilizing systematic and disciplined methods to evaluate and improve the effectiveness of risk-based management systems and strong operational controls.

Objective: To understand the implementation of QSM related to internal quality audits in industry at PT Otsuka Indonesia based on GMP and ISO 9001:2015.

Methods: The research was conducted using a qualitative descriptive method. This research was conducted by collecting company documents related to internal audits. Document analysis was carried out using interactive analysis methods.

Results: The result shows that PT Otsuka Indonesia has carried out a regular internal audit schedule once a year for all department units in accordance with CPOB clause 8.3. The number of findings combined with all existing departmental units in 2021- 2022 has decreased. In 2021, 44 findings were found, while in 2022, 38 findings were found. However, the number of findings may increase within a departmental unit. Meanwhile, in 2022-2023, the number of findings when combined with all existing departmental units will experience an increase in the number of findings. The results of the internal audit program evaluation each year can reach 100% in each departmental unit.

Conclusion: The implementation of QSM related to internal quality audits at PT Otsuka Indonesia is well practiced in accordance with GMP and ISO 9001:2015.