Informal safety review

Figure 10-9 Original design of phosgene reactor before informal safety review.

The informal safety review is used for small changes to existing processes and for small bench-scale or laboratory processes. The informal safety review procedure usually involves just two or three people. It includes the individual responsible for the process and one or two others not directly associated with the process but experienced with proper safety procedures. The idea is to provide a lively dialogue where ideas can be exchanged and safety improvements can be developed. 

Figure 10-11 Final design of phosgene reactor after informal safety review.

Conduct an informal safety review on this process. 

Describe an informal safety review process for using a cylinder of phosgene to charge gaseous phosgene to a reactor. Review up to the reactor only. 

Safety Review. The safety review was perhaps the very first hazard analysis procedure developed. The procedure begins by the preparation of a detailed safety review report. The purpose of this report is to provide the relevant safety information regarding the process or operation. This report is generally prepared by the process engineer. A typical outline for this report follows. 

Most hazard identification procedures have the capabiUty of providing information related to the scenario. This includes the safety review, what-if analysis, hazard and operabiUty studies (HAZOP), failure modes and effects analysis (FMEA), and fault tree analysis. Using these procedures is the best approach to identifying these scenarios. 

Pilot plants are often more hazardous than process plants, even though they are smaller ia size, for many reasons. These iaclude a tendency to relax standard safety review procedures based on the small scale, exceptionally qualified personnel iavolved, and the experimental nature of the research operations the lack of estabhshed operational practice and experience lack of information regarding new materials or processes and lack of effective automatic iatedocks due to the frequendy changing nature of pilot-plant operations, the desire for wide latitude in operating conditions, and the lack of hill-time maintenance personnel. 

Did the Process Safety Information Change O YES O NO ( items indicates PSI) (If YES, initiate PSM-ADM-08, Pre-Startup Safety Review)... 

After the background information is developed, the inherent safety review can be arranged. The review steps are summarized in Figure 7.2. Steps proposed for the review are as follows ... 

It is not unusual to have several inherent safety reviews during the product/process development effort. Early reviews will often not have all of the information required for Steps 1 to 9. The follow-up items will describe what is necessary to obtain the missing information such as toxicity data on new intermediates or products of undesired reactions. 

The completeness of the information described in Steps 1 to 9 prior to the review will determine the quality of the inherent safety review. The chemist needs to define the desired reactions, and to develop an understanding of potential side reactions. Effects on reaction chemistry need to be developed for mischarges or process deviations. These information requirements on process chemistry are discussed in Section 4.2. 

Companies may wish to develop workshops to train potential team members in the inherent safety review process. The workshop can provide background information on inherent safety concepts, the extensive systems required to manage hazardous materials, and information on the inherent safety review process. Videos, problems, examples, and team exercises can be included to enliven the education process. 

Another method that is commonly used to identify safety problems in laboratory and process areas and to develop solutions is the safety review. There are two types of safety reviews the informal and the formal. 

Prevention program safety information hazard review operating procedures training maintenance incident investigation compliance audit. 

Plant Performance Comparisons New Technology and Know-How Design Guidelines Safety Loss Information Competitive Information Technology Reviews Operating Discipline... 

Critical instruments assigned a Class 1 include those necessary to avoid a failure which may cause the perils listed above or instruments which fail to inform of upset conditions which may result in perils. Testing of these instrument systems may be mandated by regulatory agencies, in-house technical safety review committees, HAZOP studies, or designated as critical by operations supervisors. All of these shutdown systems and alarms must be prooftested in accordance with a proper schedule. [8]... 

Prior to startup of new facilities or facilities that have undergone changes, a Pre-Startup Safety Review (PSSR) must be performed by a supervisor of the affected process unit. If the supervisor is assured that construction and equipment are in accordance with design specifications and that affected procedures, process safety information, and training are updated, he completes the PSSR Form 11—3. If any of the pre-startup requirements have not been met satisfactorily, the supervisor sees to it that the deficiencies are corrected and... 

Critical Consequence—Class 1. Safety Critical instruments whose failure would either cause, or fail to inform of, situations resulting in accidental fire, explosion, uncontrolled release of dangerous materials, reportable environmental releases, or major property or production losses. The safety critical instruments assigned a Class 1 include those that have been mandated as such by regulating agencies an in-house technical safety review committee reliability studies and specific shutdown systems and specific alarms deemed critical by operations supervisors. 

Pre-Startup Safety Review. Employers must perform a pre-startup safety review for new facilities and for modified facilities when the modification is significant enough to require a change in the process safety information. The safety review shall confirm that prior to the introduction of highly hazardous chemicals to a process ... 

Under all three processes, the submitter bears the burden of demonstrating that the intended use of the FCS is safe. In reviewing the submitter s determination of safety, FDA uses the reasonable certainty of no harm safety standard (codified in 21 CFR 170.3(i)). Thus, the data and information in all three processes are generally comparable for a given level of exposure and, internally, FDA s safety review and standard are equivalent for the three options. To date, the FDA has received and processed hundreds of TOR exemption requests and FCNs for food contact articles. 

As discussed in the toxicology guidance document for FCSs (Table 2.3), the recommended toxicology information includes both an overall safety narrative and a comprehensive toxicological profile for the ECS and each of its constituents. The safety narrative summarizes all the information relevant to a conclusion that the intended use of the FCS is safe. The comprehensive toxicological profile consists of summaries and critical evaluations of all the available toxicological information pertinent to the safety evaluation for each substance. This information includes reviews and conclusions of toxicity studies on the FCS and other relevant substances that are either published in the literature or available elsewhere. 

Contains toxic effects data (with citations) on over 157 000 chemicals identified by NIOSH and mandated by the Occupational Safety and Health Act of 1970. Acute and chronic effects, selected regulatory information, lARC reviews, TSCA status, GENE-TOX data, and NTP documents cited. Data selectively included, not comprehensive. This database is compiled, maintained, and updated by MDL Information Systems, Inc., under the authority of the US government (CIS, Data-Star, DIALOG, DIMDI, STN CD version contained in CCINFOdisc Core Series C2 from CCOHS and CHEMBANK from Silver Platter). 

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