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All Journal Sains Medisina Majalah Cendekia Mengabdi
Fhahira Alifiya
Universitas Sari Mulia
Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Education Environmental Science Immunology & microbiology Languange, Linguistic, Communication & Media Medicine & Pharmacology Public Health Social Sciences

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Overcoming Regulatory Barriers: A Narrative Review of Implementation Strategies and Cultural Challenges of Lean Six Sigma in a GMP Environment Fhahira Alifiya; Andi Fadilla
Sains Medisina Vol 4 No 2 (2025): Sains Medisina
Publisher : CV. Wadah Publikasi Cendekia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.63004/snsmed.v4i2.885

Abstract

Pharmaceutical manufacturing is required to achieve operational efficiency while strictly complying with Good Manufacturing Practice (GMP) regulations. This dual demand often limits process improvement initiatives. Lean Six Sigma (LSS) provides a structured management approach that integrates efficiency improvement with regulatory compliance. This narrative review aims to analyze LSS implementation strategies in pharmaceutical manufacturing from a management and regulatory perspective. A focused literature review was conducted using major scientific databases. Due to the limited number of empirical studies conducted in highly regulated GMP environments, five relevant case studies were selected and analyzed using a narrative reflection approach. The analysis focused on managerial strategies, regulatory constraints, and organizational culture influencing LSS implementation. The results show that LSS strengthens GMP compliance by providing data-driven justification for process changes through the DMAIC framework. Lean tools, particularly Value Stream Mapping, enable managers to identify non-value-added activities that are not mandated by regulation. However, cultural resistance and risk-averse organizational behavior remain significant challenges, requiring strong leadership and employee involvement. In conclusion, Lean Six Sigma is an effective management strategy for overcoming regulatory and cultural barriers in pharmaceutical manufacturing while supporting sustainable operational excellence and product quality.
Edukasi Perilaku Hidup Bersih dan Sehat Melalui Praktik Cuci Tangan pada Siswa SDN Belitung Selatan 1 Banjarmasin Fhahira Alifiya; Febby Yulia Hastika; Maria Amelinda Tania; Marcellina Putri; Rismah
Majalah Cendekia Mengabdi Vol 4 No 3 (2026): Majalah Cendekia Mengabdi
Publisher : CV. Wadah Publikasi Cendekia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.63004/mcm.v4i3.1727

Abstract

Perilaku Hidup Bersih dan Sehat (PHBS) merupakan fondasi utama dalam menjaga kesehatan masyarakat, khususnya pada anak usia sekolah dasar yang berisiko tinggi terhadap penularan penyakit infeksi. Pada siswa kelas 2 SDN Belitung Selatan 1 Banjarmasin, masih ditemukan rendahnya kesadaran siswa untuk mencuci tangan menggunakan sabun serta ketidaktahuan mengenai teknik 6 langkah cuci tangan standar WHO, sehingga berpotensi meningkatkan risiko diare dan Infeksi Saluran Pernapasan Akut (ISPA). Kegiatan pengabdian kepada masyarakat ini bertujuan untuk meningkatkan pengetahuan dan keterampilan siswa dalam mempraktikkan cuci tangan yang benar sebagai upaya pencegahan penyakit menular. Metode pelaksanaan meliputi penyuluhan interaktif menggunakan media Power Point, demonstrasi dan praktik langsung 6 langkah cuci tangan, pemasangan poster edukasi di area sanitasi sekolah, serta sesi tanya jawab dan kuis untuk mengevaluasi pemahaman siswa. Kegiatan dilaksanakan secara tatap muka dengan melibatkan siswa sebagai peserta utama. Hasil kegiatan menunjukkan peningkatan pengetahuan dan keterampilan siswa dalam mempraktikkan 6 langkah cuci tangan dengan benar, ditandai dengan antusiasme dan partisipasi aktif peserta selama sesi edukasi dan praktik. Siswa juga menunjukkan pemahaman yang lebih baik mengenai pentingnya mencuci tangan sebelum makan dan setelah beraktivitas. Luaran kegiatan berupa poster edukasi enam langkah cuci tangan yang dipasang secara permanen di lingkungan sekolah sebagai media pengingat visual berkelanjutan bagi siswa.
Co-Authors Andi Fadilla Febby Yulia Hastika Marcellina Putri Maria Amelinda Tania Rismah