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ISO 9000 & AUDITS WORLD CONFERENCE

Audit Nonconformity Grading Using a Risk-Based Approach

Presenter:  Mark Allen Durivage, Managing Principal Consultant, Quality Systems Compliance, LLC, Lambertville, MI, USA

Keywords: Nonconformity, Audit, Risk

Industry: Manufacturing

Level: Intermediate

ABSTRACT

Audit findings have been traditionally graded qualitatively using the generally accepted and widely used terms minor and major provided in ISO 17021-1 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements. The latest edition of ISO 19011 Guidelines for auditing management systems suggests that "Nonconformities can be graded depending on the context of the organization and its risks. This grading can be quantitative (e.g. 1 to 5) and qualitative (e.g. minor, major). Minor and major audit nonconformity terminology, although widely used, their definitions are not standardized from industry to industry or organization to organization and can be somewhat subjective which frequently leads to confusion, misunderstanding, misinterpretation, and unsuitable corrective actions. The Global Harmonization Task Force (GHTF) Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange authored by Study Group 3 provides a quantitative model based upon a numerical scoring system of rating audit nonconformities from 1 to 5 which considers product impact and other pre- established criteria. This quantitative model can be easily adapted to satisfy the requirements of ISO 9001 and other similar business management systems. This presentation will provide an alternative to the traditional qualitative nonconformity grading system subjectively rating findings as minor and major and offer an alternative risk-based approach using a quantitative system of grading audit nonconformities using a rating scale from 1-5 using a risk-based approach. The session will demonstrate how to apply the quantitative audit scoring process to comply with ISO 9001 internal audit obligations requiring the organization to “plan, establish, implement and maintain an audit program (s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits.”

Government Organizations




Corporations

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(*) based on previous conference attendance





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