Safety requirement specification information

B.2.3.1 Available information from LOPA safety requirements specification and SIL for the... 

Each safety instrumented function is documented in the safety requirements specification. That document (or collection of documents) includes all functional information, logic, performance information, timing, b q)ass/maintenance requirements, reset requirements, the safety integrity level for each safety instrumented function, and any other requirement information that the designers may need. 

The conceptual design process for a safety instrumented function begins with a Safety Requirements Specification (SRS). The SRS is an important document. It should contain complete specifications for designing all the safety instrumented functions. For each SIF the following information should be included ... 

Solution For each piece of equipment related to the safety instrumented function, one must ask if that equipment is needed to protect against the specified hazard. In this SIF, the hand-switch was added only to meet local regulatory requirements and is not part of the automatic protection so it is excluded. The pump is turned off to protect it from overload so it is not part of this SIF. The inlet valve for the other unit does not have to close to protect against this hazard so it is excluded. Although the need for the inlet valve closure is debatable, it does help reduce downstream pressure and was therefore included in the SIF. The SIF primary equipment is the LT-2025 level sensor, the VI-2002 Inlet Valve and the VI-2003 Outlet Valve. This is marked in the cause and effect diagram with an X. Other equipment is auxiliary. It is marked in the cause and effect diagram with an A. This information must be documented in the Safety Requirements Specification (SRS). 

Application software safety requirements specification To specify the requirements for the software safety instrumented functions for each SIS function necessary to implement the required safety instrumented functions 12.2.2 SIS safety requirements specification Safety manuals of the selected SIS SIS application software safety requirements specification Verification information... 

Application software safety validation planning To develop a plan for validating the application software 12.3.2 SIS application software safety requirements specification SIS application software safety validation plan Verification information... 

Application software design, and development. Support tools and programming languages To identify a suitable set of configuration, library, management, and simulation and test tools, over the whole safety life cycle of the software (utility software) 12.4.4 SIS application software safety requirements specification Description of the architecture design Manuals of the SIS List of procedures for use of utility software Verification information... 

The application software safety requirements specification shall provide information allowing proper equipment selection. The following shall be considered ... 

Safety Requirements Specification Percent SIF with incomplete SRS information % KPI = 100 X (No. SIF with incomplete SRS information / Total No. SIF)... 

Safety requirements specification and/or brief product specification (e.g., datasheet) including environmental and application information Section of this... 

To a large degree the response from the contractor will depend on the information provided to them by the client. In order to formulate a comprehensive tender the contractor will require specific information about the technical requirements of the contract, which is often dealt with very well. However, they will also require information about the safety conditions of the contract and any risks which the client has identified, which they will need to consider during the project works. 

In accordance with lEC 61508/61511, the overall required safety management and proper technical activities relates with all documentation for SIS are summarized in safety life cycle. The purpose of analysis phase is to identify hazards and assess safety requirements of SIS. Safety Requirements Specification (SRS) of SIS should contain critical information which includes functional description... 

The safety requirements specification is followed by SIL assignments in the safety lifecycle. In order to fulfill a complete SRS, the required safety input information should be accessible. A typical set of input information includes process conditions, existing hazards, required SISs, required SIFs,... 

The starting point for an SIS is the safety requirements specification or SRS. If we look at the input requirements for developing an SRS, we will see that much of the information needed stems from a good knowledge of the manufacturing process, its normal operations, and its potential hazards. 

The information required from the process hazards analysis (PHA), or a process design team, to develop the safety requirements specifications includes the following ... 

The information gathered for the preliminary estimate is the same as that required to generate the safety requirements specification for the next stage of the SLC. Hence, if the hazard study team accepts the initial proposals fi-om the instrument engineer the next stage of the SLC can proceed. 

The objective of a safety requirements specification is to capture all the information necessary for the future design and continuing support of a safety function. Two versions of SRS are created during the development stage. These are ... 

Fig 4.2 describes the activities involved in progressing from the hazard study stage through to the completion of the detailed safety requirements specification. The development of the SRS is an iterative process carried out by the instrument engineer in co-operation with the plant design team and any associated safety specialists. Most of the information required for the SRS flows from the hazard analysis stages as we have seen in Chapter 3. 

Often an organization will strive for the elimination of a specific toxic material from a given process. Alternatives will also have other hazards and risks that require an informed choice. The industrial hygienist, chemist, and safety engineer play an important role in developing the information for making the selection between alternatives. 

The use of food additive petitions and GRAS procedures to evaluate the safety of a proposed new excipient would apply to the oral route of administration for the excipient and would not generally apply to other routes of administration. Some routes of administration (e.g., inhalation) result in unique toxicological requirements, and data would have to be developed for the specific route of administration. While toxicological data from systemic studies are important for excipients used for nonoral applications, separate data would be needed for the specific route of administration. Nevertheless, the amount of safety data, specifications, and intake information required for a food additive review is extensive, and therefore could provide a firm basis of safety for a new excipient. 

Gather the requirements for the systems including functional (e.g. operational checks) requirements, nonfunctional (e.g., coding standards) requirements, users, company-wide regulatory compliance (e.g., Part 11 technical control), safety, process, and other applicable requirements Characterize information, assess its value to the organization, and incorporate information quality as part of the project plan Conduct a system (hardware, software, and process) risk analysis. New requirements may be found as the result of the risk analysis. Any new requirements must be documented in the requirements specification deliverable... 

Disposal. Acetone and alcohol can be saved for future cleaning, or recovered by distillation. None of the halogenated hydrocarbons should ever be poured down the sink. If poured on a rag to wipe a stopcock, you may be able to leave the rag in a fume hood to dry before disposing of the rag. However, such a rag may classify as a toxic waste and may require special handling and disposal. There are many laws that govern the disposal of organic solvents, so check with the safety coordinator where you work for specific information. 

Finally, the pharmaceutical company files a new drug application (NDA) for approval. The NDA should contain comprehensive data including the safety of the drug and its effectiveness. The regulations worldwide require specific and detailed information about the NDA ... 

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