Exception clause

You could be forgiven for restricting your quality system to the products or services you supply because all the requirements in the standard except clause 4.3 focus on an end product or service conforming to specified requirements. Contract or order requirements will go beyond end product or service requirements. They will address delivery, quantity, warranty, payment, and other legal obligations. With every product one provides a service for instance one may provide delivery to destination, invoices for payment. 

The use of the exception clause traps errors in any of the isosmiles, cansmiles, or fp functions. The creation of the error log table is shown above to contain these errors for later inspection and correction. 

A derivative of the Claus process is the Recycle Selectox process, developed by Parsons and Unocal and Hcensed through UOP. Once-Thm Selectox is suitable for very lean acid gas streams (1—5 mol % hydrogen sulfide), which cannot be effectively processed in a Claus unit. As shown in Figure 9, the process is similar to a standard Claus plant, except that the thermal combustor and waste heat boiler have been replaced with a catalytic reactor. The Selectox catalyst promotes the selective oxidation of hydrogen sulfide to sulfur dioxide, ie, hydrocarbons in the feed are not oxidized. These plants typically employ two Claus catalytic stages downstream of the Selectox reactor, to achieve an overall sulfur recovery of 90—95%. 

This requirement illustrates some ambiguity over terminology. Clause 4.1.1.4 mentions improvement in quality which implies improvement in product and process characteristics, thereby making this additional requirement superfluous. Little more is needed than was given in Part 2 Chapter 1 except to state that when setting priorities for improvement you need to focus on the special characteristics first. 

Figure 5.3 shows some examples of the different classes of documents and their relationship. All the controlled documents except records are governed by clause 4.5 of the standard. Records are governed by clause 4.16 of the standard. 

The corrective action requirements fail to stipulate when corrective action should be taken except to say that they shall be to a degree appropriate to the risks encountered. There is no compulsion for the supplier to correct nonconformities before repeat production or shipment of subsequent product. However, immediate correction is not always practical. You should base the timing of your corrective action on the severity of the nonconformities. All nonconformities are costly to the business, but correction also adds to the cost and should be matched to the benefits it will accrue (see later under Risks). Any action taken to eliminate a nonconformity before the customer receives the product or service could be considered a preventive action. By this definition, final inspection is a preventive action because it should prevent the supply of nonconforming product to the customer. However, an error becomes a nonconformity when detected at any acceptance stage in the process, as indicated in clause 4.12 of the standard. Therefore an action taken to eliminate a potential nonconformity prior to an acceptance stage is a preventive action. This rules out any inspection stages as being preventive action measures - they are detection measures only. 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

The attitude of the Federal Food and Drug Administration revolves basically upon two sections of the federal law Section 402(a), A food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance... or if it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of Section 406. The applicable portion of Section 406 is Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice, shall be deemed to be unsafe for the purposes of the application of Clause 2 of Section 402(a) but when such substance is so required or cannot be so avoided, the administrator shall promulgate regulations.. .. ... 

If sulfuric acid is produced, the S02 containing gas does not require fuel gas or reducing gas, except for providing process heat. If elemental sulfur is to be produced, it is generally done by the Claus reaction previously discussed. In that case, two-thirds of the S02 is catalytically hydrogenated to S02 ... 

The statute covers all employers and their employees in all the states and federal territories, with certain exceptions. Generally, the statute does not cover self-employed persons, farms employing solely family members, and those workplaces covered under other federal statutes. Refiners must evaluate whether the chemicals they manufacture and sell are hazardous. Under the General Duty Clause of OSHA, employers are required to provide an environment that is free from recognized hazards that could cause physical harm or death. 

Except in the United States of America and New Zealand, where direct to consumer (DTC) advertising of prescription medicines is allowed, companies are not allowed to communicate directly with patients. The Association of the Pharmaceutical Industry (ABPl) Code of Practice has been relaxed a little in this area in recent years and companies can now communicate in a very limited fashion with the general public. Clause 20.2 of the Code allows the provision of non-promotional information either in response to a direct enquiry from an individual or via press conferences, press announcements, lectures and media reports, public relations activities and the like. 

The Code applies to the promotion of medicines to members of the health professions and to appropriate administrative staff as specified in Clause 1.1. This includes promotion at meetings for UK residents held outside the UK. It also applies to promotion to UK health professionals and administrative staff at international meetings held outside the UK, except that the promotional material distributed at such meetings will need to comply with local requirements. 

The provisions of the Code apply in their entirely to the promotion of medicines to appropriate administrative staff except where the text indicates otherwise. For example, the prescribing information required under Clause 4 must be included in promotional material provided to administrative staff but it is not permissible to provide samples of medicines to them as this is proscribed by Clause 17.1. 

The prescribing information listed in Clause 4.2 must be provided in a clear and legible maimer in all promotional material for a medicine except for abbreviated advertisements (see Clause 5) and for promotional aids which meet the requirements of Clause 18.3. 

Attention is drawn to the provisions of Clause 9.9 which prohibit the use of the telephone, text message, email, telemessages and facsimile for promotional purposes, except with the prior permission of the recipient. 

In November, 1985, the Commission submitted to the Council a draft regulation that would ban natural hormones, except for therapeutic purposes, and banned synthetic hormones altogether. In December, 1985, the Commission s proposal to amend Directive 81/602 to prohibit use of anabolics was adopted by the Council and became Council directive EC 85/649. The directive banned the use of natural hormones except for therapeutic purposes and absolutely banned the use of synthetic hormones. The directive also imposed a trade clause that required Member States to prohibit importation from third countries of live animals and of meat from animals to which have been administered in any way whatever substances with a thyreostatic, estrogenic, androgenic, or gestagenic action. Member States were required to bring this directive into force no later than January 1, 1988. 

Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in clause (1), except that these substances shall not include the isoquinoline alkaloids of opium. 

In Clause (A), the byproduct material defined in Section 11(e)(2) of AEA (1954) essentially is uranium or thorium mill tailings. LLRWPAA contains a similar definition, except transuranic waste is not excluded. Thus, the two laws differ in regard to whether transuranic waste is distinct from low-level waste. 

Transformers are considered as not subject to intertum short-circuits or to breakdown between windings when they comply with intrinsic safety - i clause 7.1 of EN 50020 or clause 8.1 of IEC 60079-11, except those of type 2(a) of clause 7.1.2 of EN 50020 or clause 8.1 of IEC 60079-11. 

Since the early 1960s there have been developed some excellent laboratory experimental techniques, which unfortunately have largely been ignored by the industry. A noteworthy exception was described by Ouwerkerk Hydrocarbon Process., April 1978, pp. 89-94), in which it was revealed that both laboratory and small-scale pilot-plant data were employed as the basis for the design of an 8.5-m- (28-ft-) diameter commercial Shell Claus off-gas treating (SCOT) plate-type absorber. It is claimed that the cost of developing comprehensive design procedures can be kept to a minimum, especially in the development of a new process, by the use of these modern techniques. 

A statement by the manufacturer indicating that he does not produce a medicinal product with an identical formula to that of the product in his application with the exception of generic products not subjected to purchase contractual clauses of raw materials or to territorial marketing limitation ... 

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