Management systems process issues

Sandia National Laboratories (SNL), 1998e, Sandia National Laboratories integrated Safety Management System, EH471000, Issue C, Corporate Process Requirement No CPR400.1.2, Sandia National Laboratories, Albuquerque, NM, July 31, 1998 (SNL Internal Web). 

PSM, which appiies a management systems approach to process safety, is required by OSHA 1910.119. The Center for Chemical Process Safety (CCPS) has issued guidelines for recommended PSM practices. 

Each PSM system can then be examined to determine what system modifications (if any) are needed to address the new issues. For example, the process hazard assessment system might be modified to include participation by industrial hygienists to identify potential sources of exposure. Some process safety management systems (e.g., process documentation) may require no modification to support a wider scope. 

Resolution The development of Quality Management processes starts with a comprehensive review of existing systems and a careful review of the needs the processes must meet. Showing this process should help reassure the manager that all issues will be covered. You should also indicate what staff are likely to be involved in these processes and ask whether there are any others that should be included. 

This chapter addresses all these issues. As with several of the earlier chapters, the overall approach to developing a plan should be modeled on that described in Chapter 5 of the CCPS publication Guidelines for Implementing Process Safety Management Systems. The approach recommended there is summarized in the following paragraphs. 

The team should be realistic about the time required to see improvements in end-of-pipe measures in most cases the pilot project success will be measured on efficiency improvements and other in-process measures alone. In this case it is important to demonstrate that all PSM and ESH issues are being managed. You should consider having a management systems audit (validation) conducted by a group independent of the integration project team. This may be done in conjunction with the next scheduled audit. This may be a corporate or divisional audit function or a consultant engaged specifically for this task. 

As has already been mentioned in Chapter 2, ISO 9001, Management Systems - Requirements , is increasingly being adopted by laboratories to cover the aspects of their business that are not laboratory based. This is because this Standard is more about controlling the process and service enhancement rather than technical issues. It requires continuous improvement, demonstrating that quality is not a static process. The requirements for such matters as documentation, document control, purchasing and management responsibilities are much the... 

A quality management system s process should follow a standard Six Sigma process improvement life cycle that includes the following steps define (process and metrics), measure and control (identify problems and issues), analyze (analyze problems and issues), and improve (implement) circling back to measure and control [11]. An example of a process improvement life cycle can be seen in Figure 9. 

The NARL approach, reported here, has been established, without increasing costs, by re-engineering the process to improve efficiency and focus effort on critical issues. An important part of the process is the quality assurance and quality management systems that have been established. 

In this chapter we will focus on the contents and the design process of systems aimed at the reporting, description, analysis and interpretation of near miss situations. Although certain aspects of the following framework for designing such a "Near Miss Management System" (NMMS for short) will be aimed at issues like implementation, maintenance and acceptability, the main overview of such organisational aspects will be presented in Chapter 6, Chapters 4 and 6 may therefore be considered as "twin chapters". 

At the OQ stage there will be a need for the pharmaceutical manufacturer to ensure that the appropriate management systems in terms of procedures and Business Continuity (Contingency) Plans have been assessed and confirmed as suitable. In some cases it may be that as part of the OQ process draft versions of the procedures and Business Continuity (Contingency) Plans are developed with the revised documentation being issued following the completion of OQ. 

These functions of a management system are reflected by specific processes, procedures, and tools necessary to manage the relevant issues. 

Perhaps most important to the effective function of a management system, the check stage involves a process for recognizing and formally identifying problematic issues or potential opportunities, as well as taking actions to develop solutions or obtain additional benefits. A robust environmental corrective action process should require little modification to be applied to social and economic concepts. 

The implementation of our EHS Management System has required each facility, business unit, and subsidiary to understand and address their EHS issues through an EHS planning process. This process, when integrated into the business strategic planning process, provides better management of business EHS risks and identifies new business opportunities. 

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