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ISO 9001:2015 Addresses Risk. Is Your Organization Ready? Tracks


execute business decisions. Risk management strategies include avoidance, mitigation, acceptance, diversifi cation and control.


ISO 9001 Improvement Process


Clause 10.2 of ISO/DIS 9001:2015 says an organization should improve its QMS by responding to: • Results of analysis of data. • Changes in the context of the organization. • Changes in identifi ed risk (clause 6.1). • New opportunities.


FMEA


FMEA is a method for risk prioritization and taking preventive action aimed at risk reduction. FMEA is used to examine potential failures in products or processes and helps select remedial actions that reduce risks.


FMEA starts with a description of the parts of a system. Next, the consequences of each part failure are determined. A risk analysis matrix is used to evaluate the severity and likelihood


of occurrence of each failure. The ability of controls to detect failures also is determined.


Actions that could eliminate or reduce the occurrence of failures or improve the ability to detect the risks are identifi ed. Finally, the FMEA helps institute changes to processes and products, which are incorporated to avoid potential failures.


Carl S. Carlson of ReliaSoft Corp. describes an 11- step process for developing an effective FMEA process. He starts with the development of strategic and resource plans and describes generic programs included in design management reviews, quality audits, supplier FMEAs, and methods of execution and follow-up of recommended actions. His fi nal steps are to include software support, links to other processes and testing, and follow- up of fi eld failures.


Risk Control Matrix


A risk control matrix is a tool to manage the risk of a specifi c process. Controls are set up to determine the status of the individual risks to the process. A risk control matrix gives management a picture of the most recent results of the control assessment.


Process


Risk


Control Objective


Control Description


1.1


Close the


Books 1


Financial statements may contain material or immaterial misstatements or ommisions.


1.2


Financial


Statements do not contain material or immaterial misstatements or


ommissions.


2 The accounting manager reviews all journal entries.


J.H. Doe A.3


1


Various review activities are performed throughout the close process to verify financial data. These activities include the finance department's review of intercompany account balances for discrepancies, review of currency translation adjustments, and review of prior and current year accumulated deficit balances.


J.H. Doe A.2


Figure 2: Risk Control Matrix. 48 November/December 2015 www.NATM.com


Key Process Number


Risk Number


Control Number


Control Owner


Detective Manual Primary


Twice weekly Inadequate


Detective Manual Secondary Monthly Adequate


Process Narrative Control Category Control Type


Primary/Secondary Control Frequency Design Assessment


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