Process design, documentation

Procedural controls, process controls, 98-99 Process controls, 96-100 active controls, 98 inherently safer approach, 97 mitigation techniques, 99 passive controls, 97-98 procedural controls, 98-99 safe operating limits, 99-100 Process definition, documentation, 102-104 Process design, documentation, 105 Process hazard analysis (PHA) risk assessment, 92-93 screening methods, 63 Process risk management decisions, documentation, 105-106... 

Process design documentation (e g., P IDs, ELDs [Engineering Line Diagrams], ULDs [Utility Line Diagrams])... 

Having defined and gathered data adequate for an initial reserves estimation, the next step is to look at the various options to develop the field. The objective of the feasibility study is to document various technical options, of which at least one should be economically viable. The study will contain the subsurface development options, the process design, equipment sizes, the proposed locations (e.g. offshore platforms), and the crude evacuation and export system. The cases considered will be accompanied by a cost estimate and planning schedule. Such a document gives a complete overview of all the requirements, opportunities, risks and constraints. 

P. A. Gupte, M. Nagvekar, R. P. Danner, and T. E. Daubert, Documentation of the Basis for Selection of the Contents of Chapters Phase Equilibrium in Manualfor Predicting Chemical Process Design Data, Design Institute for Physical Property Data (AIChE), (1987). 

Requirement for process design input requirements to be identified, documented, and reviewed... 

The standard requires the supplier to identify, document, and review the process design input requirements. 

As design documents are often produced at various stages in the design process they should be reviewed against the input requirements to verify that no requirements have been overlooked and that the requirements have been satisfied. 

This chapter covers the preparation and presentation of the process flow-sheet. The flowsheet is the key document in process design. It shows the arrangement of the equipment selected to carry out the process the stream connections stream flow-rates and compositions and the operating conditions. It is a diagrammatic model of the process. 

Safety Requirements Specification The instrumentation and electrical (I E) requirements are developed to meet the intent of any H RA findings and the process requirements. The design documentation should establish a clear connection between each process hazard and the design of its SIFs. I E personnel should meet with the process engineering representative responsible for the process requirements to ensure that the intent is understood. 

The notation here is not limited to complete documents delivered within a standard development process. Designers sketch these diagrams on whiteboards when they are discussing their designs with their colleagues. In short, this is a specialized language for communication models and designs. 

Management Practice 7, Design Documentation, which emphasizes the need to develop and retain process description, chemistry, and reaction data. ... 

Before a clinical trial starts, the use of technical aids such as IVRT, remote data entry and electronic diaries has to be considered. In Section 7.5.3.3, mention will be made of the use of electronic tracking system that provide status and monitoring reports. All these systems utilise computer systems that must be validated. Double and McKendry described computer validation as the process which documents that a computer system reproducibly performs the functions it was designed to do. The document Guidance for Industry - Computerised Systems used in Clinical Trials published by the FDA in 1999 gives clear recommendations of what is required (also see Section 7.5.4.1). 

Company). The product of the FEL process is a design-basis package of customized information used to support the production of detailed engineering design documents. Completion of the FEL design-basis package typically coincides with project AFE (Authorization for Expenditure) or project authorization. Project authorization is that point in the project life cycle where the owner organization commits the majority of the project s capital investment and contracts. 

One must also stress the importance of quality considerations during compounding and full adherence to current good manufacturing practices while producing parenteral products. Personnel responsible for the process design and scale-up of the equipment must assure proper documentation... 

Each process owner is required to work closely with his or her QA counterpart. This ensures design and operational issues are clearly reviewed and approved by a representative from the quality assurance function, a regulatory expectation. The quality assurance counterpart must be familiar with the process, understand documentation supporting the process, and able to convey what approval the Quality... 

An important barometer of process performance is the number of nonconformances, corrective and preventive actions taken, and planned deviations initiated against a process. These types of process artifacts must be known and owned by the process owner and stakeholders. The process owner must consider these process metrics for evaluation of and changes to process design, training, documentation, and performance. 

Supervision, administration, documentation Data summary, analysis, and conclusions Process validated, further trials, more process design, and testing... 

There is clearly much to do to validate a biotechnology process. Obviously not all of it can be accomplished prior to entering clinical trials. As a process is designed, documentation should be sufficient so that the rationale for the devel-... 

Application engineering and design for measurement and control instrumentation is an interactive process that is centered on a loop schedule normally generated from an approved set of P IDs and approved manufacturing process data. Because of the interrelationship between the various types of instrument design documentation and the sharing of design information, many of the documents are produced in parallel. 

---