Additional Safety Process Components

Involvement in Incident Investigations. Representative employees should participate in investigating incidents in their work areas. They are often in the best position to help identify and understand the factors that led to the incident. In addition, their involvement helps create ownership and acceptance of the investigation report and resulting recommendations. Their participation in the 

Safety Orientations for New Employees and Contractors. The orientation of new employees is a critical element of a safety program, and too often safety gets lost in an orientation that is filled with dealing with a variety of human resource issues ranging from company policy to insurance forms. Employees should receive a checklist that includes a list of specific safety items that they need to discuss with their supervisor when they enter the work area for the first time. This is an area to 

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Furthermore, once every process component has been analyzed separately for worst case, stand-alone conditions, there is no additional safety risk created by joining the components into a system. That is, if every process component is fully protected based on its FMEA analysis, a y tern made up of several of these components will also be fully protected,... 

Within the FDA s Center for Food Safety and Applied Nutrition, the Office of Food Additive Safety administers premarket approval processes for new direct food additives and food additives that are components of food contact materials. Most food contact materials are regulated via the food contact notification process and authorization of new food contact materials is administered by the Division of Food Contact Notifications (see Chapter 2 for further information). The notifier has the primary responsibility to demonstrate the safety of the proposed use of the food contact material. Review scientists within FDA perform a fair evaluation of the data in a food contact notification, as well as other relevant information, to determine if the knowledge base supports the finding with reasonable certainty that no harm will result from the intended use of the food additive. FDA maintains a number of public online listings that include useful information... 

The SPINLINE3 software components intended to run within safety processing units or networks have all been developed and qualified according to 1EC60880. They are fully documented and reviewable [5] by licensing bodies, under contractual agreement with confidentiality clauses. The re-usability of the Operational System Software component makes possible additional arguments based on feedback of experience. 

Delayed Outcomes. We often create safety award programs to encourage employees to behave safely. The awards usually provide additional positive outcomes for not getting hurt but are too delayed to be effective consequences. We discussed problems with such programs earlier, yet such programs can be an effective component of a safety process. Figure 21.6 displays a more complete diagram that includes both consequences and outcomes. 

It is important to note, however, that for several reasons we must exercise extreme caution when interpreting these data. First, these studies are the first to scientifically isolate and assess a main component of the observation process. Therefore, additional data and analysis of this effect are necessary to come to truly reliable conclusions about this component s possible implications for a behavioral safety process. Second, because we isolated the observation process, we are unable to discuss any possible interactions with other components of the behavioral safety process. Further, the observer effect was found to occur in a laboratory setting that lacked many common variables that may affect safety performance, such as social pressures and productivity demands. Therefore, we are unable to confirm that similar observer effect results will occur in a real-world setting. We do suggest that future research endeavors should attempt to replicate a similar study within an organization, and we have been working on such replication studies. 

In order to understand System Safety, one must understand the related terms safe and safety, which are closely intertwined, yet each term has different nuances such that they cannot be used interchangeably. In addition, the terms hazard, mishap, and risk must also be understood, as they are important components of the system safety process. 

Equipment used in the compounding of drug products shall be of suitable composition so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive affecting the safety, identity, strength, quality, or purity of the drug product. 

This safety audit is used for identifying inputs and material flows, processes and intermediates, and final products - but with special attention paid to human-material/process/equipment interactions that could result in (a) sudden and accidental releases/spills, (b) mechanical failure-based injuries, and (c) physical injuries - cuts, abrasions, and so on, as well as ergonomic hazards. Additional sources of adverse effects/safety problem areas are records/ knowledge of in-plant accidents/near misses, equipment failures, customer complaints, inadequate secondary prevention/safety procedures and equipment (including components that can be rendered non-operable upon unanticipated events), and inadequacies in suppliers of material and equipment or maintenance services. 

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