Analysis Kesenjangan (Gap Analysis Dan Perancangan Prosedur Pengendalian Penjaminan Mutu Berdasarkan Klausul Iso 9001:2015 Pada Proses Produksi Ssusu Kemasan Milkk Life Di Pt Global Dairi Alami

Panji Priana; Yayan Mulyana; Agi Agus Setiawan Sufyan

Authors

Panji Priana Universitas Islam Nusantara, Indonesia
Yayan Mulyana Universitas Islam Nusantara, Indonesia
Agi Agus Setiawan Sufyan Universitas Islam Nusantara, Indonesia

Keywords:

Gap Analysis ISO 9001:2015, Pengendalian Mutu, Standard Operating Procedure (SOP)

Abstract

ISO 9001:2015-based Quality Management System (QMS) is a strategic instrument to ensure the consistent quality of liquid food products that have a high risk of contamination. This study aims to analyze the level of gap analysis between the actual condition of the quality assurance system of the "MilkLife" packaged milk production process at PT XYZ—from the upstream process (raw milk reception) to the final stage (finishing & packaging)—and the ISO 9001:2015 Clause standards. The research method used is descriptive qualitative through field observations, in-depth interviews with the Quality Assurance (QA) and Quality Control (QC) teams, and filling out the internal audit checklist for clauses 4 to 10 of ISO 9001:2015. The results of the study indicate that although PT XYZ has an advanced automation technology infrastructure, there is still a qualitative gap in the aspect of standardization of documented information for handling non-conforming products at several process transition points. Based on these findings, a proposed integrated Standard Operating Procedure (SOP) for Controlling Non-Conforming Products was designed to minimize the risk of product defects reaching consumers and strengthen the company's QMS implementation.

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Author Biography

Panji Priana, Universitas Islam Nusantara

ISO 9001:2015-based Quality Management System (QMS) is a strategic instrument to ensure the consistent quality of liquid food products that have a high risk of contamination. This study aims to analyze the level of gap analysis between the actual condition of the quality assurance system of the "MilkLife" packaged milk production process at PT XYZ—from the upstream process (raw milk reception) to the final stage (finishing & packaging)—and the ISO 9001:2015 Clause standards. The research method used is descriptive qualitative through field observations, in-depth interviews with the Quality Assurance (QA) and Quality Control (QC) teams, and filling out the internal audit checklist for clauses 4 to 10 of ISO 9001:2015. The results of the study indicate that although PT XYZ has an advanced automation technology infrastructure, there is still a qualitative gap in the aspect of standardization of documented information for handling non-conforming products at several process transition points. Based on these findings, a proposed integrated Standard Operating Procedure (SOP) for Controlling Non-Conforming Products was designed to minimize the risk of product defects reaching consumers and strengthen the company's QMS implementation.

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