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24    |   Enterprise Risk Management   |  Compliance Risk Management: Applying the COSO ERM Framework




        Third line roles (internal audit):                  responsibilities to include,
          •  Maintains primary accountability to the governing
            body and independence from the responsibilities of   Delegates responsibility and provides resources
            management                                         to management to achieve the objectives of the
                                                               organization while ensuring legal, regulatory, and
          •  Communicates independent and objective assurance   ethical expectations are met.
            and advice to management and the governing body on
            the adequacy and effectiveness of governance and risk   Put more simply, the board is responsible for oversight of
            management (including internal control) to support the   the compliance and ethics functions. The most senior level
            achievement of organizational objectives and to promote   of management, where the CCO sits, is responsible for
            and facilitate continuous improvement           establishing structures and processes aimed at ensuring
                                                            compliance. The next level of management is responsible
          •  Reports impairments to independence and objectivity   for providing expertise, support and monitoring to achieve
            to the governing body and implements safeguards as   compliance and ethics expectations.
            required
                                                            Figure 5.1 shows how this model can be used to design an
        Above these three lines is the organization’s governing   auditing and monitoring plan for a high-risk area (conflict of
        body. The Three Lines Model describes the governing body’s   interest in an academic medical center).

         Figure 5.1  Auditing and monitoring plan for a high-risk area
                             1st Line                          2nd Line              3rd Line
         Risk Area           Management                        Management            Internal Audit
         As Identified During   Structures                     Monitoring            Independent
         Risk Assessment     and policies                      and support           auditing
         Conflict of Interest   • Establish COI policies and procedures   • Annual COI disclosure  • Audit 10% of outside travel
         (COI)               • Educate personnel about COI policies  • Purchasing and   payments against
                                                                                      Accounts Payable travel
                             • Report non-compliance to COI Manager  Pharmacy vendor   reimbursements
                                                                registrations
                             • Report unauthorized vendors                           • Level 2 review of COI
                              representatives and displays     • Open Payments        disclosures
                                                                database
                             • Advise personnel to contact     • Research conflict    • Audit 10% of “nothing to
                              Compliance with questions         database cross-check  disclose”
                             • Review annual COI disclosures                         • “For cause” investigations


        In addition to the auditing and monitoring of high risks,   DOJ to federal prosecutors for their use in assessing C&E
        a review of the C&E program as a whole is necessary to   program effectiveness.  This guidance asks the following
                                                                              2
        provide the needed assurance for the board and executive   three fundamental questions regarding the organization’s C&E
        management, and it is also part of Principle 17 and the   program:
        effort to continually improve the C&E program. This review
        involves periodic assessment of the effectiveness of the C&E   1. Is the organization’s C&E program well designed?
        program as a whole. There are a number of approaches that
        could be taken. The review could be performed by members   2. Is the program being applied earnestly and in good faith;
        of the compliance and ethics function in a self-review, by the   in other words, is the program adequately resourced and
        organization’s internal audit function, or by external service   empowered to function effectively?
        providers. At a minimum, the review should look to see that the
        C&E program incorporates all of the elements of an effective   3. Does the C&E program work in practice?
        compliance program described in the Appendix 1 (or other
        applicable standard) and that they are operating effectively.   Determining the answers to these three questions requires
                                                            further inquiry into each element of an effective program, as
        An additional resource that could be used is the Evaluation   well as evaluating the C&E program as a whole.
        of Corporate Compliance Programs guidance provided by

        . . . . . . . . .
        2  U.S. Dep’t of Justice, Criminal Div., Evaluation of Corporate Compliance Programs (updated June 2020), http://bit.ly/2Z2Dp8R.




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