Planning compliance

Rivers, P.A., A. Dobalian, and F.A. Germinario. 2005. A review and analysis of the clinical laboratory improvement amendment of 1988 Compliance plans and enforcement policies. Health Care Manage Rev. 30(2) 93-102. 

Compliance plan Commitment Compliance training Organizational structure Resource allocation... 

Senior management (e.g., the CEO, president, business group responsible head) should establish a compliance plan that defines the quality standards and practices, resources, and activities relevant to its operations. A core element and guiding principle should be the quality policy or mission statement. This policy or mission statement should reflect senior management s quality objectives for the company. It represents the foundation upon which all other quality systems are built. 

Management must not only develop a compliance plan reflective of the overall quality policy or mission, it must assure that the elements of these are clearly known by all employees. This requires training, but more important,... 

Required to retain independent experts to evaluate and audit at least twice a year for 4 years or longer and report to FDA. Abbott within 60 days required to submit a " master compliance plan, proposed validation plan and proposed validation procedure... to bring processes into compliance with QSR within 365 days."... 

Under the direction of the chief compliance officer and the corporate compliance committee, each organization should develop written compliance policies that pertain to the organization s practices that may be at risk for noncompliance. The policy should clearly delineate the organization s commitment to comply with all federal and state standards, with an emphasis on preventing fraud and abuse. The compliance plan should address, at a minimum, the False Claims Act, the Anti-kickback Statutes, physician self-referral laws, and laws regarding bribery and improper gifts. Once the plan is developed, it should be reviewed and approved by the organization s board of directors. 

Three of the Warning Letters referred to a wider organizational review of electronic record/signature requirements beyond the scope of the particular computer systems that were the focus of the original inspection. Pharmaceutical and healthcare companies should ensure that they have a compliance plan that covers the whole part of their organization subject to 21 CFR Part 11. 

These summary and conclusions documents can then be rolled up into an overall Infrastructure Part 11 Compliance Plan. Progress against this plan should be tracked as part of the overall Part 11 comphance program imtil full remediation is complete. 

Development of Compliance Plans. The R,D D tasks, for environmental as well as the other three activities included in the Management Plan are carried out in conjunction with, or as part of, major field projects. These projects, which involves engineering and construction activities, must comply with Federal, state, and local standards, and in particular, with provisions of the National Environmental Policy Act (NEPA). 

Benoit Binette, Secretary GMP Officer, Compliance, Planning and Coordination, BCE Ottawa, ON... 

This factor is a direct statement of the need to commit adequate resources to both the original compliance plan and to continuously improving it. 

Another source that needs to be considered in developing a compliance plan is that portion of the United States Attorneys Manual (the Manual) dealing... 

F) Whenever the employer will not achieve the permissible exposure limit with engineering controls and work practices by December 31, 1979, the employer shall include in the compliance plan an analysis of the effectiveness of the various controls, shall install engineering controls and institute work practices on the quickest schedule feasible, and shall include in the compliance plan and implement a program to minimize the discomfort and maximize the effectiveness of respirator use and... 

The Bureau of Safety and Environmental Enforcement (BSEE) does not provide detailed guidance as to how a SEMS program is to be implemented because the standard is fundamentally nonprescriptive. Each company and facility will need to develop a SEMS compliance plan that addresses their own needs and circumstances. Some thoughts as to how this can be done are presented in this chapter. 

TABLE 5-1 An example integrated PSM/RMP compliance plan and management system... 

Typical Document Title PSM / RMP Compliance Plan Employee Participation Process Safety Information Process Hazard Analysis Procedure Program Training Program Contractors... 

Familiarity with the facility s PSM/RMP compliance plan or organizationally driven internal PSSR requirements... 

Has a Noise Survey been considered and a Noise Compliance Plan prepared, if required ... 

Operating permits are issued to all major sources and a limited number of area sources. The permit stipulates how much of and what types of pollutants a source is allowed to emit. As a part of the permit process, a source must prepare a compliance plan and certify compliance. Each permit issued to a facility will be for a fixed term of up to five years and will include a fee to cover reasonable direct and indirect costs of the permitting program. 

If a facility is out of compliance at the time the permit application is submitted, a schedule for compliance, including enforceable milestones, is required. This compliance plan then becomes an enforceable part of the fadUty permit. 

Date of submittal of the final compliance plan or permit to the appropriate air pollution... 

Date of issuance of an approved compliance plan or permit... 

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