Reviewing process safety goals

People must be held accountable for results. If action items are not completed in a timely basis, there needs to be an analysis of why and a plan for improvement. If standard operating procedures (SOP) checklists are not used rigorously, there needs to be an analysis of why with appropriate consequences (punishment should be a last resort). There should be reasons why objectives are not met and those barriers need to be removed. Individual sites within an organization may establish specific process safety goals, activities, and behavior on individual performance contracts, which are reflected in the annual performance review process that links to merit pay raises, bonuses, advancement opportunities, and the like. Consequences for poor process safety performance must not be limited to supervisors or facility managers but must be a factor in performance appraisals throughout the organization. 

The IND review is unique among the FDA s application review processes. In many respects, this process and the FDA s treatment of INDs represents a delicate balance between the federal government s responsibility to protect clinical trial subjects from unnecessary risks and its desire to avoid becoming an impediment to the advance of medical research. Given these dual goals, the FDA must perform a safety review of an IND prior to clinical trials, but has only 30 days in which to reach an initial determination on the filing. 

Figure 2.2 shows that a goal-driven approach can be managed with either an internal or a formal plan that can be evaluated and reviewed by external parties. OSHA s process safety standard is an example of an internal plan. Companies are not required to submit anything to OSHA. Only if they are inspected, they will have to share their plans with the regulators. 

With high quality national reports an effective peer review will be feasible. The review process should identify problems, concerns, uncertainties or omissions in national reports. However, the goal of the peer review process under this incentive Convention is not singly to determine whether the individual Parties have achieved the required level of safety. The peer review process should also be a candid discussion of problems encountered, solutions inq)lemented and further actions required to achieve and maintain the required high level of safety. One goal should be to identify opportunities for technical co-operation in the interest of resolving identified safety problems. 

Process improvements. Measure progress against previously identified goals. For example, if completing capital project safety reviews within two weeks of submittal was a facility s objective, is this now being achieved ... 

Reform of the antimicrobial registration process to meet shortened review period goals while still ensuring efficacy and safety. 

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