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18 | Enterprise Risk Management | Compliance Risk Management: Applying the COSO ERM Framework
The second component of risk severity is impact. Impact is the • Operational — Potential disruption of business operations
result or effect of risk in terms of the organization’s strategy from plant shutdowns, suspensions, debarments, and loss
and business objectives. With compliance risk, one thinks of license
immediately of civil and criminal fines and penalties, and the
possible direct financial consequences of noncompliance. • Reputation (image) — Effect of media coverage; damage
Another significant factor may be the reputational impact of to organization’s image/brand; and subsequent diminished
compliance and ethical issues. This and other consequences attractiveness to current and potential future employees,
(e.g., sanctions, suspension, and debarment) may have a business partners, vendors, and customers
material indirect financial impact, as well as an impact on
morale and other factors that are difficult to measure. • Health and safety — Employee, patient, customer
Impact of noncompliance and ethical failures can be assessed • Ability to pursue strategic goals — Prohibition to added
using a variety of measurement categories. new customers, loss of license
• Legal — Consisting of civil and criminal fines and penalties Figure 4.3 illustrates how these categories might be used to
construct a scale for assessing the impact of compliance risks.
• Financial — Internal and external costs associated
with investigating and remediation (e.g., legal fees,
consultants, investigators)
Figure 4.3 Impact of Compliance Risks
Scale Legal* Financial # Operational Reputation (Image)+ Health and Ability to
(Potential Safety* Pursue
Disruption)* Strategic Goals*
1 In compliance < $1 million < 1/2 day No press exposure No injuries Little or no
Insignificant impact
2 Civil violation with $1–$5 < 1 day Localized negative impact First aid Minor impact
Minor little/no fines million on reputation (such as a treatment
single large customer) but
recoverable
3 Significant civil $5–$25 1 day–1 week Negative media Medical Major impact
Serious fines/penalties million coverage in a treatment
specific U.S. region or a
foreign country
4 Serious violation, $25–$100 1 week–1 Negative U.S. national or Death or Significant
Disastrous criminal prosecution million month international media extensive impact
probable coverage (not front page) injuries
5 Significant violation, > $100 > 1 month Sustained U.S. national Multiple Loss of
Catastrophic criminal conviction million (and international) negative deaths or accreditation
probable, loss of media coverage (front page several or license
accreditation or of business section) permanent
licensure disabilities
# Amounts are examples only; each organization should set amounts to reflect its size and financial strength.
* Adapted from Judith W. Spain, Compliance Risk Assessments: An Introduction (Minneapolis: Society of Corporate Compliance and Ethics, 2020), 39,
https://compliancecosmos.org/compliance-risk-assessments-introduction
+ Adapted from Deloitte, Compliance risk assessments: The third ingredient in a world-class ethics and compliance program, Deloitte Development LLC, 2015.
As with the likelihood scale, each organization would adapt level, determining separate measures can add an additional
the impact scale and factors to its own environmental context. level of precision to the assessment.
The organization’s risk appetite would also be reflected in
setting the values used in the anchor labels. Assessment of each of the risks in the compliance risk
inventory can be made by compliance staff or by a compliance
An additional factor that may enhance the evaluation of committee and can be conducted at different levels of the
severity is the localization or regionalization of the assessment. organization. In conducting assessments, steps should be
For multilocation and multinational organizations, risk may vary taken to minimize bias by avoiding self-assessment and using
from one location or region to another, based on a wide variety multiple assessors from varied disciplines and experience to
of factors. Rather than assessing severity at the organizational ensure that risks are appropriately evaluated.
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