Organizational considerations

Necessary roles in PA implementation can be filled by personnel from different departments, depending on the organizational setup of the company and the complexity of the analyzer installation. A list of required expertise/necessary roles includes  

As has been stated before, not all of these roles need to be occupied based on the scope of the project. Nevertheless, a subset of these skills is required for most implementations, and the coordination of efforts is a key element of success. 

Based upon our collective experience, successful process analytical personnel have some 

Most expertise/resources for all phases of process analytical methodology development are typically available in the different functional areas of a manufacturing plant that has some laboratory capacity. But these need to be effectively organized. Thus, there is not necessarily the need for additional personnel in manufacturing to implement process analytics. However, the coordination of this existing expertise in the different areas, and the approval of the area management to redirect some resources to process analytics and not merely consider this an add-on project are critical for long-term success. Alternatively, most expertise 

Installation type Temporary, often mobile setup Permanent, hard-wired and integrated 

Flexibility Very flexible to changing needs, continuous method improvement Typically dedicated analysis as part of integrated system solution 

Analytical support Readily available specialized analytical support Site analytical support less specialized and with more limited resources 

Method validation Basic method validation (short-term use, fit for purpose, little robustness), data will see expert eye prior to release Extended method validation, robustness and ruggedness tests important for unsupervised operation 

---

With general audience and organizational considerations in mind, let s next examine excerpts of Methods sections from the chemistry literature in more depth. We analyze excerpts in two parts ... 

Can subordinates be trusted to base solutions on organizational considerations ... 

The point at which stereodifferentiation occurs in these reactions is not obvious (vide infra). If the asymmetric induction is the result of thermodynamic considerations or kinetically preferred cyclization, then an additional organizational consideration such as the exo-anomeric effect in 21.5 may be important. 

Nature designs thousands of enzymes in the manner described here for D-xylose isomerase. Account is taken of the overall thermal stability, of carefully controlled substrate binding and the elimination of product, of protection from other enzymes, of the correct solubility and of placement in the organism in vivo. All of these requirements, and many not fisted here, are met. The palette is merely the 20 amino acids, but a wide range of electrostatic, hydrophilic or hydrophobic, space-filling and organizational considerations have been necessary for the final arrangement. The end product is unique and a marvel. 

Sage, A. (1981), Behavioral and Organizational Considerations in the Design of Information Systems and Processes for Planning and Decision Support, IEEE Transactions on Systems, Man, and Cybernetics, Vol. SMC-11, pp. 61-70. 

The two categories of data described above relate to immediate causes of error. However, the question of how these factors came to be as they are, involves a consideration of the effects of organizational, and management and cultural issues. 

The theme running through the above is that the key ingredient is clarity, both in specification and organizational terms. This does not need to mean a major effort or input on the part of the owner, but rather careful consideration, at an early stage, of what is actually required. 

---