Hazard analysis principles

The safety status of the process should be periodically reviewed against the guiding principles for the original design. Monitoring of add-ons can detect potentially dangerous modifications. Process hazards analysis or process safety audits are useful tools for this review. Documentation of inherently safer principles is critical to ensure that future changes don t nullify the positive features of the initial installation. 

Bayer (Pilz, 1995) uses a procedure based on hazard analysis, focusing on the application of inherent safety principles to reduce or eliminate hazards. 

While quality was formerly achieved by inspection of final products, it is accomplished now by prevention through controlling critical steps in the production processes along the agri-food chain. Hazard analysis critical control points (HACCP) represent a typical example of such a preventive approach. Although this concept was developed primarily to assure food safety, the basic principle is also applicable to assuring non-safety quality attributes such as color, flavor, and nutritional value. " This section translates the HACCP principles into a critical quality control point (CQP) concept that can be part of a system to assure food quality. 

Reilly, A. and Kaferstein, F. (1997). Food safety hazards and the application of the principles of the hazard analysis and critical control point (HACCP) system for their control in aquaculture production. Aquae. Res. 28, 735-752. 

Another nontraditional approach to assessing quality systems is the hazard analysis and critical control point (HACCP). The Pillsbury Company conceived the HACCP in the early 1960s with the cooperation and participation of the National Aeronautic and Space Administration. Essentially, HACCP is a system that identifies and monitors specific food-borne hazards that can potentially affect the safety of food. Some medical device and diagnostics companies are implementing the same principles as the HACCP program. 

FIGURE 8.6 Critical Control Point Decision Tree. (Based on FDA (1997), Hazard Analysis and Critical Point Principles and Application Guidelines, National Advisory Committee on Microbiological Criteria for Foods, August.)... 

The National Advisory Committee s Hazard Analysis and Critical Control Point (HACCP) program has been endorsed as an effective and rational means of assuring food safety from harvest to consumption [8], The basic principles used to develop a HACCP plan include hazard analysis, verification procedures, critical control point identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record keeping and documentation. This same approach could be loosely applied to the identification and control of microbiological hazards encountered by consumers in their environment. 

Key to this chapter is the recognition that hazard identification, though generally imphed rather than being directly stated, is an underlying principle of hazard analysis, since without first being properly identified, hazards cannot be analyzed or evaluated for ultimate mitigation. 

Hazard analysis using STPA will provide information about the types of feedback needed and when. Some additional guidance can be provided to the designer, once again, using general safety design principles. 

Level 2 System Principles External interfaces Task analyses Task allocation Controls, displays Logic principles, control laws, functional decomposition and allocation Validation plan and results, System Hazard Analysis... 

The principles are linked to the related higher-level requirements, constraints, assumptions, limitations, and hazard analysis as well as to lower-level system design and documentation and to other information at the same level. Assumptions used in the formulation of the design principles should also be specified at this level. 

Design principle 2.51 describes the conditions under which reversals of TCAS advisories can result in incompatible senses and lead to the creation of a hazard by TCAS. The pointer labeled HA-395 points to the part of the hazard analysis analyzing that problem. The hazard analysis portion labeled HA-395 would have a complementary pointer to section 2.51. The design decisions made to handle such... 

The third style of hazards analysis consists of those methods that make use of logical analytical techniques—generally based on the principles of Boolean algebra. This approach attempts to provide an understanding of hazards and risk in a strictly logical and rational manner. The techniques of FTA and Monte Carlo simulation fall into the logical/rational category. 

Quantification, particularly the use of the Pareto Principle (see Chapter 15), helps get around many of the I think/you think discussions that can arise during a hazards analysis. Yet most analyses are not quantified beyond use of a simple risk matrix such as that shown in Chapter 1. 

The original intent of the preliminary hazard analysis technique was to serve as the initial effort to identify and evaluate hazards in the early stages of the design process. But, in actual practice the technique has attained broader use. The principles on which preliminary hazard analyses are based are used not only in the initial design process, but also in reassessing the safety of existing products or operations. 

For example, the hazard analysis and risk assessment requirements of the European Standard ISO 14121, Safety of Machinery—Principles for risk assessment (formerly EN 1050), have been adequately met in some companies in the design or redesign stages by applying an adaptation of the preliminary hazard analysis technique. 

As from 2002 the Danish Veterinary and Food Administration (DVFA) has made it mandatory for businesses in the food industry to launch selfinspection programmes, which direct businesses to self-inspections and subsequently documenting and reporting failures to comply with the governmental food safety standards. These standards follow the EU-legislation and are organized in accordance with the principles embodied in the HACCP system (Hazard Analysis and Critical Control Points). 

A systematic, preventive approach to food and pharmaceutical safety that includes physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. It has seven key principles, which are conduct a hazard analysis, identify critical control points, establish critical limits for each critical control point, establish critical control point monitoring requirements, establish corrective actions, establish record-keeping procedures, and establish procedures for ensuring the HACCP system is working as intended. HACCP is used in the food industry to identify potential food safety hazards, so that key... 

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