Developing a Compliance Program

One of the most important tasks for a safety and health professional is the development of a written compliance program. The written compliance program provides guidance to the management and employees as well as serves as proof for the purposes of compliance. So, where do you start  

Evaluate and analyze the standard to ensure its applicability to your situation. 

Locate the standard in the Code of Federal Regulations (CFR) or on the Occupational Safety and Health Administration (OSHA) website www.osha.gov. 

Ensure all elements of the standard are addressed. Insert operational elements necessary for implementation in your workplace. 

Review your program and have your program reviewed within your corporate structure. 

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All pollution prevention programs start the same - with an audit. The objective of an audit is to gather information aimed at developing a baseline description of the operations. Once we understand how much the costs of compliance to air and other pollution media are, then we can apply engineering tools and management practices to reduce these costs. 

Given that these compliance programs and FDA expectations for clinical trial material are discussed in detail in Chap. 3 of this book, the topics will not be further reviewed here. The importance of GMPs compliance in development of a new drug cannot be overemphasized, as the consequences of noncompliance can be high in that the FDA can delay approval of an NDA if significant noncompliance is discovered during a preapproval inspection. 

Validation is a defined program, which, in combination with routine production methods and quality control techniques, provides documented assurance that a system is performing as intended and/or that a product conforms to its predetermined specifications. When practiced in a life-cycle model, it incorporates design, development, evaluation, operational and maintenance considerations to provide both operating benefits and regulatory compliance [3]. 

Comprehensive programs to identify compliance issues and thoroughly address corrective and preventative action are worth the investment. The investigator s view of the severity of an issue will be significantly reduced if the firm has already identified the problem and developed a formalized plan for correction. The plan must prioritize appropriately and represent realistic time frames for meeting its commitments. 

In Jime 2004 with authorization of the Main Technical Department of the Russian Navy specialists of Expert-center Research and Engineering Office together with NIKIET performed a detailed radiation examination inside and outside all compartments (save for RC) of NSs 175 and 610 in compliance with a specially-developed and approved program. Dose control and spectrometric measurements allowed revealing the following maximal exposure dose rates were measured in adjacent-to-RC compartments on bulkheads from RC side (0.1-0.38 mSv/h for NS 175 and 0.83-0.9 mSv/h for NS 610). 

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