2016, 11 November | |
DOI: 10.14489/td.2016.11.pp.050-054
Nuzhdin G. A., Samoshkin Yu. A., Vvedensky V. Yu. Abstract. The riskbased thinking application is one of the changes in the new version of ISO 9001:2015. That is why the task to develop and test a risk analysis method for use in the NDT equipment (mobile industrial gamma-ray detectors) production based on EMI, JSC (Moscow) has been set. The fourlevel production quality loss or decline risk model with a fivepoint importance rating scale for the first three levels events is offered to use. The third level in risk model corresponds to the capable to generate threats for the productive QMS enterprise factors availability during the analyzed period. The importance of these factors should not exceed existence of the possible remote consequences in the future. The second level in risk model corresponds to loss or decline in products quality threat identification in the enterprise activity. The first level in risk model corresponds to the direct loss or decline in products quality facts identification in the enterprise activity. It is offered to use for risk analysis the algorithm: the risks register formation; the demanding consideration situations identification; the signs, which were under the threat in the allocated situations, identification; the arisen threat level identification; the identified level threat analysis for a previous events chain allocation; events assessment; possible consequences assessment; the level acceptability and quality loss risk value assessment; an earlier made concerning risks actions sufficiency assessment. The developed method was used in the NDT equipment (mobile industrial gamma-ray detectors) production based on EMI, JSC (Moscow) as brainstorming formal process. It is shown that its practical application is productive by preparation for certification on compliance to the new ISO 9001:2015. Keywords: quality management system, risk management, threat, risk register
G. A. Nuzhdin (CONSERCIUM Ltd, Moscow, Russia) E-mail:
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1. Quality management systems. Requirements. (2015). Standard No. GOST R ISO 9001–2015. Moscow: Standartinform. [in Russian language]
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