Conformity safety

Within the European Conformity safety/EMC context, three types of quality assessments are addressed in terms of the entities they relate to ... 

Meeting the European Conformity safety testing and design requirements for CE marking is as simple as one, two, three (1) components, (2) construction, and (3) testing. A product s compliance with the European requirements relies on the application of good conunon sense, experience, and knowledge of the European safety philosophy and standards. Of utmost importance is consumer protection via conformity to the harmonized standards. The standards and directives were not established to get in our way but to help us to comply with one common set of rules, a total harmonization that builds consumer confidence in what we do. 

This vision was evidently originally foreseen by the drafter of Directive 93/42/EEC (see the note in the last row of Table 6.1), where Article 5 of the Directive cites the European Pharmacopoeia as a standard applicable in the conformity safety essential requirements assessment of the MD, equating the European Pharmacopeia to a de facto harmonized standard that leads to the possibility of applying the principle of presumption of conformity [21]. 

Non-conforming safety criteria if there is a common understanding of exactly what the definitions of terms such as improbable, probable, unlikely, minor, major, hazardous, catastrophic, etc., mean, the effort to integrate the safety argument into a system safety assessment will be greatly reduced and auditability will be improved. 

Small size, ruggedness, simple cabling and the ability to operate the equipment under adverse conditions in the field has also been design goals. The system should also conform with the regulations necessary for the CE-marking (i. e. standards and directives for EMC, Electrical Safety and Machine Safety). 

The scope of the directive covers the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0,5 bar. A pressure equipment in the sense of the directive is any vessel, piping, safety accessory or pressure accessory. An assembly means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole. It is important to be aware that the directive relates exclusively to the pressure risk and that therefore other directives, such as for machinery, low voltage may be applicable to the equipment concerned. 

Based on these considerations, the conformity assessment tables comprise 4 tables for vessels and 4 tables for piping. A further table relates to fired or otherwise heated equipment. Specific procedures are set out for the assessment of assemblies and of safety accessories. 

NDT equipment imported in lots in the process of state testing are examined both on their conformity to the requirements of safety standards (ISO, CEN, lEC) and standards of the manufacturer and its availability for calibrartion in service. 

Flame-Retardant Resins. Flame-retardant resins are formulated to conform to fire safety specifications developed for constmction as well as marine and electrical appHcations. Resins produced from halogenated intermediates (Table 5) are usually processed at lower temperatures (180°C) to prevent excessive discoloration. Dibromoneopentyl glycol [3296-90-0] (DBNPG) also requires glass-lined equipment due to its corrosive nature. Tetrabromophthahc anhydride (TBPA) and chlorendic anhydride (8) are formulated with ethylene glycols to maximize fiame-retardant properties reaction cycle times are about 12 h. Resins are also produced commercially by the in situ bromination of polyester resins derived from tetrahydrophthahc anhydride... 

Measures to minimize safety problems must be initiated at the start of the life cycle of any product, but too often determinations of criticality are left to production or quality control personnel who may have an incomplete knowledge of which items are safety critical (Hammer, 1980). Any potential non-conformity that occurs with a severity sufficient to cause a product or service not to satisfy intended normal or reasonably foreseeable usage requirements is termed a defect (Kutz, 1986). The optimum defect level will vary according to the application, where the more severe the consequences of failure the higher the quality of conformance needs to be. 

The issues in these evaluations are safety as related to toxicity and flammability, environmental impact as related to the generation of volatile organic compounds and global warming, product performance as related to insulating properties, conformity to fire codes, and the like, cost and availability, and regulatory requirements. 

A copy of the general safety rules accompanied by a receipt form shall be included with the prequalification letter to a prospective contrac-tor/subcontractor. This document sets forth in broad terms the safety requirements with which a contractor/subcontractor is expected to conform while working under contract for the host organization. 

Like VDA 6.1, AVSQ 94 does not include the requirements of ISO 9001. In this way issues of copyright are overcome, a practice shared by VDA and EAQF but not QS-9000. However, unlike VDA 6.1, AVSQ 94 follows the 20 elements of ISO 9001 with two additional elements, covering financial considerations and product safety. Those questions that go beyond ISO 9001 are marked and as every question is numbered it simplifies the evaluation process. A scoring method is employed to classify organizations in terms of a conformity index. Each question is awarded a point (0, 2.5, 5, 7.5, or 10), where 10 points means full compliance, 7.5 points means minor inadequacies, 5 points means inadequacies in application requiring improvement, 2.5 points means serious inadequacies in application, and 0 points is used for criteria not applied. Unfortunately all questions carry the same weight as no account of the impact of omission on product quality or customer satisfaction is included. 

Delivery decisions are more than decisions about conformance to specification. They are about conformance to contract and those responsible for the production processes may not be able to determine whether contractual conditions have been met. Much more may hang on the resolution of a problem than mere conformance to specification. The decision in some circumstances may be taken by the CEO. There may have been a safety problem or a product liability problem so your system needs to recognize these fine distinctions. Those making the delivery decisions need possession of all the information required to protect the company as well as meet customer needs. 

It is important that the inspection and maintenance activities be docn-mented as reqnired per company practice and any process safety management regnlatory reqnirements. Maintenance records shonld indicate the inspection resnlts and the scope of maintenance work performed, if any. Before the flame arrester is reinstalled in the process, it shonld be visnally inspected to make snre that reassembly conforms to the mannfactnrer s recommendations. Some companies affix a tag to the flame arrester indicating the inspection and maintenance date. 

The specific PSM systems that are finalized for installation will act as the core of your company s overall system for process safety management. For this reason, it s wise to approach their development in a manner that s consistent with your company s practices, to minimize the need for reconstructing detailed text to conform to company standards. 

An additional reason for investing resources in error reduction measures is to improve the ability of the industry to conform to regulatory standards. It is likely that as the relationship between hximan error and safety becomes more widely recognized, regulatory authorities will place more emphasis on the reduction of error-inducing conditions in plants. It is therefore important that the Chemical Process Industries take the lead in developing a systematic approach and a defensible position in this area. 

Figure 7-19 illustrates a newer approach at simplifying the dual safety relief valve installation, ASME Sect. VIII, Div. 1, UG-135(b) [1] and API RP-520, Part II Conformance [33]. Note that the SRV valves are mounted on top of each of one dual vertical connections and are bubble tight. Also see cross section view. The flow C, valves for each size device are available from the manufacturer. 

Inlet piping is held to a minimum, with the safety device preferably mounted directly on the equipment and with the total system pressure drop loss to pres.sure relief valve inlet not exceeding 3% of the set pressure in psig, of maximum relief flowing conditions [10]. To conform to code (see ASME code. Sect. Vlll, Div. l-UG-127 [1]) avoid high inlet pressure drop and possible valve chatter ... 

The following sections include the relevant sections of the complete Act and indicate those parts of the legislation within the different plant categories to which the inspections provided by the independent engineering inspection companies will conform. It should, however, be appreciated that while the inspections provided will fulfill the statutory requirements for inspection, the actual responsibilities under the various Acts to conform remains the responsibility of the plant owner/user. It must be appreciated that the interpretation of any Act is a matter for the local Health and Safety Inspectorate, who should be consulted at all times if doubt exists as to whether any item of machinery and plant requires inspection to comply with a statutory provision. 

The number and quality of the safety shut-off valves required is specified in the relevant Standards and Codes of Practice. These are usually electrically operated valves conforming to class 1 or class 2 as defined in BS 5963, Specification for electrically-operated automatic gas shutoff valves (1981). This specifies forward pressures and reverse pressures that the valve must withstand in the closed position together with closing times. 

For much plant the manufacturers will provide detailed maintenance schedules which should be followed at all times. This may necessitate the use of spares and tools specific to that appliance. Attention is drawn to Regulation 25(7) of the Gas Safety (Installation and Use) Regulations, which states that No person shall carry out any work in relation to a gas appliance which bears an indication that it conforms to a type approved by any person as complying with safety standards in such a manner that the appliance ceases to comply with those standards . 

We have seen that only certain micro-organisms that conform to nutritional and safety requirements are suitable for food or feed, and that food has more strict requirements than feed. In addition, for use as food, SCP should have a reduced nudeic add content and should be palatable. Most often this means that its use is limited to processed foods, in which food technologists can produce acceptable tastes, smells and textures. 

Safety Valve normally used for steam service, but suitable for gases or vapors. When used in steam generation and process steam service the valves conform to the ASME Power Boiler Code as well as the ASME Pressure Vessel... 

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

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