Design/production changes, review

It is important that the Product Design Report is reviewed by the project team at milestones in the project life and updated if necessary. It is imperative that some information will change with time, for example, competitor activity. The introduction of a new competitor product to the market with unexpected product attributes may result in a re-evaluation of the desired product profile for the new product being developed. This, in turn, can result in subsequent modifications to the preformulation and formulation development programme. It is hoped that this will not be a complete change in direction, but if it is, the product design review will have alerted the company sooner rather than later to address this, and not to develop a product that is not wanted or needed. 

In this chapter, we aim to provide an overview of the status of hydrothermal processing technologies and recent research. The chapter includes a description of associated process chemistry including a description of how the properties of water change when heated under pressure and the reaction steps in each of the hydrothermal routes. The impact and influence of different feedstocks on process operation and product distribution and composition is reviewed. Recent advances in reactor design, product upgrading, commercialization and techno-economic and Ufecycle analysis are presented before conclusions are drawn on the status of the technology. 

Performing product design verification and validation (clauses 4.4.7 and 4.4.8.1) Reviewing product design changes (clause 4.4.9.1)... 

The standard requires all design changes to be reviewed and approved bp authorized personnel before their implementation (including changes to proprietary designs). The standard also requires the supplier to address the impact of a design change on the systems in which the product is used, the customer assembly process, and other related products and systems. 

This element covers the translation of customer specifications for the product into the corresponding specifications for materials, products, and processes. Design reviews, product and process acceptance criteria, design change control, and design requalification are all addressed. 

Direct kinetic measurements from the changes in diffracted beam intensities with time during heating of the reactant are illustrated in the work of Haber et al. [255]. Gam [126] has reviewed the apparatus used to obtain X-ray diffraction measurements in thermal analysis. Wiedemann [256] has designed equipment capable of giving simultaneous thermo-gravimetric and X-ray data under high vacuum. X-Ray diffraction studies enable the presence, or absence, of topotactic relationships between reactant and product to be detected [92,102,257—260], Results are sometimes considered with reference to the pseudomorphic shape of residual crystallites. 

In addition, it is necessary to determine the time span of the design project and also assess how the Q system wiU be continuously reviewed and updated due to changes in the process, product recipe, legislative requirements, and other factors. 

Design and development changes are identified, and records are maintained. The changes are reviewed, verified, and validated as appropriate and are approved before implementation. The review of design and development changes includes evaluation of the effect of the changes on constituent parts and the delivered product. 

The documents are reviewed for their adequacy before approval. The document control system is designed to ensure that the information used in the production of the product or parts is clear, complete, correct, and current. No changes can be made without authorization. The system operates within a contractual constraint that requires all products or parts to be built to blueprints, drawings, or other specifications. All personnel are required to immediately report any discrepancy to the proper supervisor so that corrective action can be taken. Documentation shall include one or more of the following, but is not limited to ... 

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