Perancangan Sistem Manajemen Mutu ISO 9001:2015 ¬Di Departemen Printing Development PT. X

Robin Jovian Wiguno(1*),


(1) Petra Christian University
(*) Corresponding Author

Abstract


PT. X is a multinational company that produces consumer goods. This research is aimed to get the design of quality management system needed for ISO 9001: 2015 certification in Printing Development department, PT. X. This research was conducted by interview and direct field observation in PT. X. The scope of ISO 9001: 2015 quality management system design is the Printing Development department which includes three functions inside. There are Printing Project Management function, RND and Productivity Printing Project function, and Mock up and Prototyping. The design is done through the making and renewal of SOP, WI, support form, quality plan, and RACI matrix. Risk analysis using the Failure Mode and Effect Analysis (FMEA) method is also applied to three processes in the Printing Development department. Implementation is carried out on one of the processes considered to have a high risk of failure. The preliminary compliance quality score indicates the suitability of 82.21% against the requirements of ISO 9001: 2015, and the final compliance of 93.95%.


Keywords


Quality Management System; ISO 9001:2015;Failure Mode and Effect Analysis (FMEA)

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References


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ISO 9000:2015. Quality Management System - Fundamentals and Vocabulary. Geneva: International Organization for Standardization. 2015.

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Chrysler. Potential Failure Mode and Effect Analysis (FMEA). Chrysler LCC, Ford Motor Company, General Motor Corporation. 1995.


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