Audits Program compared

So, in a way, safety audits are similar to safety inspections. There is much to be gained in performing audits, inspections, and similar types of activities. These activities are what I consider to be cheap insurance. If we are paying our insurance premiums, we should consider retention of safety audit activities however, due to the longer-term effects that an audit has when compared to an inspection, some adjustments to the audit program would be acceptable. 

Establish that a program of regular internal audits exists for each important program element, to assess actual field performance as compared to written standards of performance. 

Significant deficiencies in the security and control of samples have been well documented. " " In fact, it has been estimated that just over half of samples actually reach patients. Samples may be used by prescribers and staff, or they may be diverted. Personal use of drug samples by physicians and other healthcare providers raises ethical concerns and is not without risk." Limaye and Paauw described three medical residents who self-prescribed antimicrobials and were subsequently diagnosed with Clostridium difficile infection." Tong and Lien reported self-medication with samples and distribution of samples to nonphysicians by almost 60% of pharmaceutical representatives surveyed at a Canadian family practice office. A contributing factor to some of these issues is that institutional or facility sample policy and procedures are often absent, or compliance is poor. One institution found only 10% compliance when the inventory of samples was compared with the required written documentation. Even after an educational program in which the policy was explained to the house staff, a second audit found only 26% compliance. " Poor compliance with policy and procedure may jeopardize patient safety, as well as put the institution at risk for JCAHO recommendations or Board of Pharmacy penalties. 

In other words, an audit compares what is with what should be. A management program is measured against an external standard such as a regulation or corporate benchmark. It is fundamentally a pass/fail test. For example, paragraph 1910.119(a)(1) of the Occupational Safety and Health Administration (OSHA) Process Safety Standard states that ... 

An inspection is a structured assessment of an activity or an item that includes measures and tests to determine whether it possesses certain characteristics compared with specified requirements or standards. An audit is a systematic evaluation of an activity or program to determine whether it is being managed or maintained according to a set of accepted standards. This section reviews the requirements for inspections and audits given in 30 CFR 585. 

A safety and health audit of the work being done to control loss measures the safety program and highlights its strengths and weaknesses. The audit compares work being done, and standards being maintained, with accepted safety and health standards. 

Dupont committed to improving the reactor maintenance program at the Savannah River Site (SRS) based on the results of audits performed by the National Academy of Scientists and Engineers (NAS E) and the Institute of Nuclear Power Operations (INPO). In February 1989, Dupont issued an SRS-wide Maintenance Improvement Plan identifying eight key elements that were in need of improvement. One of these elements was the performance of a self-assessment by the Reactor Maintenance Department based on the elements identified in INPO 85-038, Guidelines for the Conduct of Maintenance at Nuclear Power Stations (Reference 1). The self-assessment was to include a review of (1) work control procedures, (2) maintenance requests, (3) supervision of maintenance activities, (4) review of completed maintenance requests, (5) temporary repairs, and (6) control of contractor personnel. This assessment (Reference 2) was completed in January 19.90. The results of the assessment, which were compared against draft DOE Order 5480, established the foundation for the Reactbr Maintenance Improvement Plan (MIP)(Reference 3), which was issued the end of April 1990. 

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