Program compliance audit

Essential requirements for a successful internal quality/compliance audit program are as follows ... 

Several of these guidances had their genesis in the EPA s Compliance Audit Program (CAP), which was a voluntary self audit program announced... 

As previously discussed in the chapter, there are many complex facihty operations and chemically intensive processes used in the manufacture of semiconductor devices. At a minimum, the scope of an environmental compliance audit program should cover the following ... 

To assist you in the development of an environmental compliance audit program, a sample environmental compliance and environmental management audit checklist is included in Appendix B of this chapter. The checklist has been developed to cover the eleven subject compliance areas discussed earlier. To maximize the use of the model checklist, each semiconductor facility audit team should tailor it to reflect the scope of their manufacturing activities, specific site conditions, chemical usage patterns, and inclusion of applicable state, regional and local regulatory requirements. 

A key objeetive of the CAT is to correct the deficiencies identified as part of the environmental compliance audit program through the use of sound management systems and controls. The CAT must have the following eharacteristics, including the responsibility, authority, and aceountability to act ... 

You may be able to achieve some economies by linking the PSM baseline assessment with other, scheduled review programs in your company, e.g., annual safety reviews, compliance audits, etc. 

Prevention program safety information hazard review operating procedures training maintenance incident investigation compliance audit. 

Qualifications of personnel Services available Offered procedures Capability to complete project Quality controls program Quality assurance program Review and approve contracts Future compliance audits Database management Validation/verification needs Contract laboratories Procedures Facilities/equipment Personnel qualification Training Methodology... 

To verify the adoption of good programming practices (e.g., headers, version control. Change Connol) and compliance with documented, audited programming standards... 

The conduct of audits is not a mandatory requirement in GCP. ICH GCP (1995) mentions in section 5.19 If and when sponsors perform audits, as part of implementing quality assurance - this is not interpreted as an obligation to establish an audit program. Similarly, FDA does not mandate the conduct of audits (FDA Compliance Program Guidance Manual, 2006). 

Once all the elements of the Process Safety Management system are in place and are being implemented, the Compliance Audit [29 CFR 1910.119 (o)] element provides a means to evaluate the program s compliance level. Every three years, the program must be audited to ensure that it is being implemented as per the regulation. The audits can be done internally, but some companies hire outside consultants to get the viewpoint of an unbiased expert. ... 

A good transportation risk management system includes periodic audits of the management system, its technical elements, and compliance across the supply chain. The purpose of an audit program is to provide feedback on transportation risk management efforts to improve or enhance current operations such as determining ... 

Note that this penalty reduction is greater than the 75 percent penalty reduction that would have been available under the Audit Policy for a violation that was self-reported but was not discovered as the result of an audit or application of a compliance monitoring program. 

The Audit Policy does not say much about what a company must do to prevent recurrence of the violation, other than that it may need to improve its auditing program or compliance management system. 

Compliance verification in SUBSAFE is treated as a process, not just one step in a process or program. The Navy demands that each Navy facility participate fully in the process, including the use of inspection, surveillance, and audits to confirm their own compliance. Audits are used to verily that this process is working. They are conducted either at fixed intervals or when a specific condition is found to exist that needs attention. 

One lesson learned has been that developing a robust compliance verification program is difficult. Along the way they learned that (1) clear ground rules for audits must be established, communicated, and adhered to (2) it is not possible to audit in requirements and (3) the compliance verification organization must be equal with the program managers and the technical authority. In addition, they determined that not just anyone can do SUBSAFE work. The number of activities authorized to perform SUBSAFE activities is strictly controlled. 

This section will focus on showing how motor carriers can develop and implement a self-audit program. This self-audit will focus on what DOT considers the acute and critical regulations of the Federal Motor Carrier Safety Regulations (FMCSRs) that DOT examines compliance against during a compliance review. 

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