Process-compliant design

Everyone knows that a well-organized standardization of purchased parts, comp o-nents and assemblies improves logistics and cuts costs. In this case, designers resort to what they have already got. Reams of recommendations have been written on this subject which is why we will not amplify it here. 

But at this point, let me repeat the recommendation that I made earlier in the book give up the Tayloristic divisions, at least between designers and work schedulers, and combine them to form technology teams. 

Another suggestion for developers, designers, and work schedulers (or even better technology teams) also cuts costs and is paid much too little attention today  

The process-compliant structuring of the increase in value of yourproducts during manufacturing. 

The value accumulation curve (Fig. 69) can be plotted for each cost unit in the simulation. 

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Ifyou want to shape the process, you had better start with a process-compliant product design "... 

Calculation, cost unit Calculations (forecast, preliminary) Calculations inch overhead costs Capacity scheduling Core competence Design, process-compliant Cost structure, corporate Cost drivers... 

Concepts and Processes. Contemporary dosage forms are dmg dehvery systems, designed and manufactured to achieve safe and effective therapeutic responses each time the forms are used as part of an appropriate regimen. Thus, the intent of the prescriber is accompHshed when the product is used compliantly by the patient (12—14). Each dmg product involves several interrelated concepts that must be considered in its design and manufacture (15). Examples include the following ... 

Having designed the additional processes, you need to examine existing processes and establish the extent to which they are compliant with the relevant requirements of ISO/TS 16949. Remember that the requirements are a framework. They are not exhaustive. Your processes should possess characteristics that are compliant but are likely to possess many other characteristics that are not addressed by the requirements. 

A host of laboratory QC checks are encoded into data qualifier conventions designed to indicate specific QC deficiencies. Different laboratories may have different letters for identifying the same non-compliant events. The meaning of the data qualifier must be explicitly annotated in the reported data. During data evaluation in the assessment phase of the data collection process, the data user will determine the effect of these deficiencies on data quality and usability. 

To illustrate this principle, the interim results from a laboratory where electronic signatures have been designed into the process will be presented and discussed. The CDS is installed in a pharmaceutical quality control laboratory where the system is used for both raw material and finished product analysis there are approximately 50 part-time users of the system. The current CDS version was not fully comphant with the technical requirements of 21 CFR Part 11 and was to be upgraded to a new compliant version of the software from the same vendor. Before the implementation of the new version, the current process was mapped and analyzed to see if there were any opportunities for improvement and to make effective use of electronic signatures. 

Knowing the problems and improvement ideas from the analysis of the eurrent ways of working, a new proeess can be designed to exploit the nse of eleetronic signatures. It is important at this stage to ensure that the new process is compliant with 21 CFR Part 11 and any predicate rule requirements, and that the new version of the CDS ean support the new proeess as well. For example, where in the process will signatures be used and where will identihcations of aetions be sufficient ... 

The S88 methodology described in the previous section can provide both highly automated and remote manual modes of operation. With careful design and implementation, S88-compliant systems should cope with process changes without major reconfiguration and validation effort being required. 

Installation Qualification (IQ) FDA (1995) Establishing confidence that process equipment and ancillary systems [including computer systems] are compliant with appropriate codes and approved design intentions, and that manufacturer s recommendations are suitably considered. 

The Decision Ontology has been developed in IMPROVE to complement the product data, document and design process models. Its architectural principles are fully compliant with those of OntoCAPE and the Process Ontology. The Decision Ontology is an extension of DRL, an existing decision model, to cover the requirements identified in engineering design processes. 

The specific goal of the Clean Fuels PEPS project is to design a system that, when installed and operational, will demonstrate that the PEPS Gasification process is efficient, environmentally compliant, and cost competitive for alternative fuel production with specific emphasis on using petcoke as a feedstock. The initial phase of the project was divided into three subtasks ... 

The GLP principles are a managerial concept defining the organizational processes and conditions under which laboratory and field research is planned, performed, monitored, recorded, and reported. They were designed to ensure that sampling and analytical procedures and results are complete and of known, documented quality. When a study is GLP compliant, an auditor, regulator, or analyst should be able to review the smdy some years after its completion and easily determine what work was done, when, where, by whom, and with what equipment and methods who supervised the study what results were obtained and whether there were any problems encountered and, if so, how they were handled. Considerable effort and dedication in planning, support, and implementation is required to achieve this standard of documentation and attention to detail. Successful implementation of GLP provides reliable data for which the precision, accuracy, comparability, and completeness is known. 

The P IDs will identify the major equipment components to be modified or procured for the new process. It will outline the new equipment and associated controls required to run the process. The API manufacturer may have preferred suppliers of this equipment because of operability or maintenance issues. Most of the vessel and component suppliers in the industry are capable of supplying cGMP compliant equipment. The design firm or the API manufacturer will specify the equipment to include the necessary appurtenances to make the equipment cleanable. 

Several computer programs have been developed for doing lifecycle assessments, and a number of databases are available to provide inventory information. All are designed to facilitate the process and reduce its costs. Some software provides the abiiity to run fully ISO compliant studies other programs are simphfled to be much easier to use, and are targeted at certain segments of industry such as packaging. A fuii discussion of LCA is beyond the scope of this book. The U.S. EPA has a... 

A detailed description of each of the stages shown in Figure 1 is provided in lEC 61508 standards, Table 1 (lEC, lEC Functional Safety and lEC 61508, 2014). This detailed table provides a description of the objectives, inputs and outputs for each of the stages involved in designing a SIL 3 brake system (or any other SIL compliant functional safety system) complying to lEC 61508. As clearly shown in Table 1 of lEC 61508, one can see that there are many stages involved in the process and appropriate documentation is a requirement for each stage. 

In the making of assumptions of design information, usually related to information from a third party, the progress of design work is based on the best (or sometimes most conservative) estimate of the information. For example, structural steelwork design may be based on the anticipated mass and dimensions of a supported equipment item for which final vendor s information is not yet available. Evidently the accuracy of the assumptions, the designed-in flexibility to acconnnodate incorrect assumptions, and the ability to influence the equipment item vendor to comply with the assumptions (or the freedom to choose a compliant vendor) will affect the efficiency of this process. 

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