Process assurance

CCPS G-34. Contractor and Client Relations to Assure Process Safety. American Institute of Chemical Engineers, Center for Chemical Process Safety, New York. 

The use of installed spares and rotating equipment out of service for periodic maintenance should reduce the impacts on production rate from failures in equipment. This conclusion assumes that the resulting complexity of piping layout and increased manipulation of piping connections does not negate the goal of assuring process reliability. 

The approach described is appropriate for assuring process safety for the preliminary design and is commonly used in industry where hazardous materials are handled. The committee further notes that a full-scale quantitative risk assessment (QRA) will be required in conjunction with the completion of the final design to assure that all process safety issues have been fully addressed. 

The SST was empowered by plant management and had members from every discipline involved in the shipping and handling of monomers at the plant shipping, pumping, production, quality assurance, process chemistry, chemical engineering, and safety/risk analysis. Consequently, it was not difficult to obtain cooperation when requests were made of various entities. 

Government agencies such as the U.S. Environmental Protection Agency set requirements for quality assurance for their own labs and for certification of other labs. Published standard methods specify precision, accuracy, numbers of blanks, replicates, and calibration checks. To monitor drinking water, regulations state how often and how many samples are to be taken. Documentation is necessary to demonstrate that all requirements have been met. Table 5-1 summarizes the quality assurance process. 

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

PAT is an automated quality-assurance process originally developed in the petrochemical industries. It is defined by three general principles continuous, cybernetic, and potentially remote monitoring of processes. 

But that sense of control can be regained and the result made rational and predictable through a careful Quality Assurance process that checks the submission against FDA established criteria and through the use of an internal, self-regulating review process that applies the checklist criteria used by the FDA to the submission development process. 

Quality assurance processes that will be implemented to ensure that all data management procedures are compliant with regulatory governance. 

All forms, reports, lists etc referred to during the quality assurance process. 

Process integrity addresses the reactions, physical chemistry, and dynamics of a plant s operation. If these are allowed to mn out of control or exceed standards, process conditions may exceed the mechanical design limits of the equipment. Some of the following approaches and methods used to assure process integrity are described in Guidelines for Technical Management of Chemical Process Safety (CCPS, 1989b) ... 

More emphasis on quality control to assure process and product safety and reliability. More green chemistry to avoid pollution. 

Although the GLP and quality assurance processes and principles are critical for the maintenance of a toxicology study system that is valid and credible, it is unusual for findings in the unaudited draft toxicologic report of the completed studies to change during the production of the final, quality-assured individual study reports in ways important to determining whether use in humans is safe. 

Assure processes are performed, measured, controlled, and documented as designed. 

Define quality assurance processes to be built into the audit process. 

Due professional care, including sufficient time to effectively carry out the assurance process and... 

Competence, as demonstrated through an appropriate level of experience and professional judgment, to meet the objectives of the assurance process. 

Conclusion. Successful implementation of a sustainable development mindset in an organization requires true integration of the values and principles behind sustainability, and not a shallow, cursory, stand-alone project. That is, sustainability is only one small piece of a larger approach to organizational responsibility in the global environment. The audit or assurance process is an important and valuable step in this approach that cannot and should not be overlooked. 

Quality assurance process according to ASME/ ANSI B31.8S, section 12. 

Actionable Assurance Process. The results of analyses performed by the pharmacometrics enterprise will not always align with stakeholder expectations. In fact, expectations may themselves be invalidated by changes in the environment, includ-... 

The observations made during the execution of the VMP provide strength to significantly reduce the regulatory risks related to the systems and initiation of the proactive corrective actions required. The plan provides visibility for the completion of individual tasks and assures system evaluation, process validation, equipment validation, facility and utilities qualification, documentation, environmental control, and monitoring implementation and execution of the VMP assures process reproducibility control over the applicable changes and modifications as a result in facilities, equipment, personnel, and materials. 

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