Process-Specific Compliance

Three important ENABLE processes in this category are described here. The first, align supply chain unit plan with financial plan, assures that the supply chain plan uses the same assumptions as company financial plans. The alignment includes both the numbers generated by the plan as well as the related assumptions. 

The preceding description of SCOR demonstrates its completeness. As discussed at the outset of this chapter, this is a tool that will find application by process designers when the time comes to prepare detail process designs. The process standards from the CSCMP support front-end assessment with an easy-to-use format. 

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Establish approvable validation protocols and conduct process validation by monitoring, sampling, testing, challenging, and/ or auditing the specific manufacturing process for compliance with design limits, specifications, and/or requirements. 

I would emphasize that environmental impact anlysis, the development of environmental control strategies, and energy conservation are an integral part of each project. In fact, we have a division that not only assures compliance with the various statutes in PETC s daily operations but also performs research on process specific, site specific environmental and energy conservation activities. 

III. Confirming Sterility by Compliance with Process Specifications... 

III. CONFIRMING STERILITY BY COMPLIANCE WITH PROCESS SPECIFICATIONS... 

GM and UAW safety personnel had the responsibility to perform a safety Buy off on equipment at the vendor s place of business. Their purpose was to validate that the vendor was meeting the safety design specifications in the equipment being buUt. Implementation of this process drove compliance in the early design stages. 

The specific requirements to complete the NSR process will vaiy depending on the source location and characteristics, the federal and state regulations which apply, the compliance status of the facihty if it is existing, and the nature of other sources in the area. Atmospheric dispersion modehng is often necessary to determine the maximum offsite ambient air concentrations of the various pollutants that will be... 

Contractors If contractors are working at a toller s site, this element of process safety demands that they be informed of any hazards the new toll could present. If contractors are specifically involved with the toll in question and the company is subject to PSM compliance, other aspects of this element must be met. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

Management must institute procedures to assess levels of compliance with agreed standards for safety. Techniques include environmental and/or biological monitoring, health surveillance, safety audits, safety inspections, and procedures for accident reporting, investigation and analysis. Communication is essential, e.g. by provision of information (on specific chemicals, processes, etc.), safety meetings, notices, safety bulletins etc. 

Except as specifically provided in the U.S. CFR, any existing point source subject to this subpart must achieve the effluent limitations shown in Table 9.19 which represents the degree of effluent reduction attainable by applying the BAT. Alternatively, for the metal finishing industrial facilities with cyanide treatment, and upon agreement between a source subject to those limits and the pollution control authority, the amenable cyanide limit shown in Table 9.20 may apply in place of the total cyanide limit specified in Table 9.19. No user subject to the provisions of these regulations shall augment the use of process wastewater or otherwise dilute the wastewater as a partial or total substitute for adequate treatment to achieve compliance with this limitation. 

QA/QC laboratories. The QA/QC lab is responsible for the testing of feedstocks and raw materials, process intermediates, and finished goods, and may, in addition, be responsible for the development of standards for materials, processes, and procedures. The QA/QC lab is usually characterized by the routine, repetitive nature of its workload. Testing is primarily to specification and, where lot acceptance or rejection is involved, is often on a grade category or pass/fail basis. Data may be archived for compliance with regulatory directives and for analyses of trends In material or process performance. 

Chemical manufacturers submitted 1,031 Premanufacture Notifications in 1980 and 1981. In the same time period, they submitted 290 notifications of commencement of commercial manufacture. In other words, only 28)1 of the substances for which Premanufacturing notices were filed in the past two years of compliance have become commercial. Specifically, for the reactive polymer segment, about 29% of the reported substances have become commercial. These percentages indicate that much of what has constituted the impacts of TSCA has been "protective" filing of notifications. The length and complexity of the process mandated by TSCA has led to unnecessary resource diversion. A more liberal definition of what constitutes a commercial event could have significantly increased the percentages and reduced this type of impact, at least since July, 1979. 

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