Perancangan Analisa Risiko pada Sistem ISO 9001:2015 di PT. X

Aryaputra Mattotoran(1*), Jani Rahardjo(2),


(1) Petra Christian University
(2) Petra Christian University
(*) Corresponding Author

Abstract


PT. X is a company engaged in the printing and packaging. This research was conducted to get the design of risk management system risk analysis of ISO 9001: 2015 to help system in company to be better. Risk analysis was conducted on 101 processes in 20 procedures in 9 departments and 1 non-department (QMR). Risk analysis is done by using Failure Mode and Effect Analysis (FMEA). Risks are analyzed in RND, Marketing, and HOD that are not branched out. Risks at branched are analysis in Production Department, PPIC, HRD-GA, and Quality (QA). The result of risk analysis is that there are 53 risk that have high risk and become the main priority that need to be considered. High and low risks need to be considered for the system within the company can be increased and the risk can be reduced.


Keywords


Improvement; ISO 9001: 2015 Quality Management System; FMEA; Risk analysis

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References


British Standards Institution, Quality Management System – Requirement, London: BSI Standards Limited, 2015.

Chrysler LLC, Potential Failure Mode And Effects Analysis, Ford Motor Company, General Motors Corporation, 2008.

Deming, W.E, Out of The Crisis: Quality Productivity and Competitive Position, Cambridge University Press, Cambridge, 1986.

McDermott, Robin E., Mikulak. R., & Beauregard, M., The Basics of FMEA. New York: Productivity Press, 1996.

Pande, P. S., The Six Sigma Way. Edisi 1. Yogyakarta: Andi, 2002.


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