Organizational integration requirements

Integrity requires that the systems engineer be accountable for the quality of the work performed and that the engineering results be completely open and honest. Any possible conflict of interest, whether individual or organizational, real or perceived, should be declared before the start of the project so that it can be mitigated. 

From a safety point of view, keeping the integrity of offshore facilities during the life extension period is vital. Thus, formal assessments are needed to danonstrate that there is sufficient technical, operational, and organizational integrity to continue safe operation throughout a life extension, something that requires detailed information on history, the current state, and prediction on the future state of the facility [4]. 

Outages, Shutdowns, and Decommissioning— Processes are provided to ensure outages, shutdowns, and permanent abandonment/removals are properly planned, executed, and managed to maintain the mechanical integrity and value of equipment and facilities when required, and also maintain organizational SHE requirements. 

TQM has frequently been used to focus on and improve processes in order to meet customer requirements, but not necessarily to look beyond processes for integration opportunities and organizational changes. Thus, it may need to be used in conjunction with another Quality Management system for the purposes of integrating PSM and ESH activities. 

To integrate an organizational unit that uses multipurpose batch plants into the company, IT infrastructure with its ERP system, a hierarchical planning approach is most often used. Starting from a material requirements planning (MRP) run, capacity requirements are determined and roughly checked, although the check of the capacity requirements is not directly combined with the material requirements. 

Prospective validation is a requirement (Part 211), and therefore it makes validation an integral part of a carefully planned, logical product/process developmental program. An outline of the development sequence and requirements relevant to process validation is presented in Figure 1. After briefly discussing organizational aspects and documentation, the integration of validation into the product development sequence is discussed. At the end of the chapter there is a... 

Executive management must be an integral part of resource allocation and any organizational restructuring that may be necessary. Correcting audit action items and continuous improvement requires a team effort spearheaded by effective leadership. 

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. 

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