Takings clause

Where a Member State ascertains tliat a product, bearing the CE-marking and used in accordance with its intended use, is liable to endanger the safety of persons or health, it shall take all appropriate measures to withdraw such a product from the market. That Member State shall immediately Inform the Commission which is obliged to investigate whether or not the measure is justified. Where the Commission considers that the measure is justified, it shall immediately inform the Member State which took the initiative and also the other Member States. This entails that the other Member States must also take action against the product concerned. That latter disposition is referred to as the safeguard clause. 

Certain of the above reactions are of practical importance. The oxidation of hydrogen sulfide in a flame is one means for producing the sulfur dioxide required for a sulfuric acid plant. Oxidation of hydrogen sulfide by sulfur dioxide is the basis of the Claus process for sulfur recovery. The Claus reaction can also take place under mil der conditions in the presence of water, which catalyzes the reaction. However, the oxidation of hydrogen sulfide by sulfur dioxide in water is a complex process leading to the formation of sulfur and polythionic acids, the mixture known as Wackenroeder s Hquid (105). 

You will need to produce more than one part to verify that the process is stable. You need to form a sample large enough to take statistical measurement. If the measurements taken on the product fall within the central third of the control limits then the set-up can be approved - if not, then adjustments should be made and further samples produced until this condition is achieved. The Note in clause 4.9.4 indicates that regardless of the number of parts in the sample, it is the comparisons made on the last part that establish the conditions for commencement of production. 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

Element 4.13 of ISO 9001 deals with specific nonconformities and element 4.14 deals with the action to eliminate their cause and prevent their recurrence. This additional ISO/TS 16949 requirement does seem to duplicate what is covered in clause 4.14.2. However, it does add a significant aspect - a reduction plan. One could be complying with elements 4.13 and 4.14 of ISO 9001 but have no reduction plan, since element 4.14 does not impose any time constraints on corrective action or require the incidence of nonconformity to be reduced. It is quite possible to take corrective action continuously and still not reduce the number of nonconformities. The requirement may be in the wrong place (i.e. in 4.13 rather than 4.14) but it is a useful addition nonetheless. 

Returning to the standard, this clause also only addresses the correction and prevention of nonconformities, i.e. departures from the specified requirements. It does not address the correction of defects, of inconsistencies, of errors, or in fact any deviations from your internal specifications or requirements. As explained in Part 2 Chapter 13, if we apply the definition of nonconformity literally, a departure from a requirement that is not included in the Specified Requirements is not a nonconformity and hence the standard is not requiring corrective action for such deviations. Clearly this was not the intention of the requirement because preventing the recurrence of any problem is a sensible course of action to take, providing it is economical. Economics is, however, the crux of the matter. If you include every requirement in the Specified Requirements , you not only overcomplicate the nonconformity controls but the corrective and preventive action controls as well. 

You need to record the results of the investigations but not the corrective action you need to take. Even in clause 4.17 on internal quality audits, the requirement for the agreed corrective action to be recorded has been omitted. The results of the audit, the action taken, and its effectiveness need to be recorded but not the agreed corrective action. ISO 10011-1 does not require agreed corrective actions to be recorded either. 

The impact of this requirement depends upon what constitutes the specified requirements. The standard does not require you to demonstrate conformance with every requirement of ISO 9001. However, if your customer has invoked ISO 9001 in the contract, this clause requires that you maintain sufficient records to demonstrate compliance. As stated elsewhere in this book, there is no definition clarifying what specified requirements are. If specified requirements are a//the requirements that you have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard. A pragmatic approach to take is to declare in your quality manual that the specified requirements are specified customer requirements . 

The subcontractor records that are delivered to you should form part of your records. However, the controls you can exercise over your subcontractor s quality records are somewhat limited. You have a right to the records you have paid for but no more unless you invoke the requirements of this clause of the standard in your subcontract. Your rights will probably only extend to your subcontractor s records being made available for your inspection on their premises therefore you will not be able to take away copies. It is also likely that any subcontractor records you do receive are copies and not originals. Before placing the contract you will need to assess what records you will require to be delivered and what records the contractor should produce and retain. 

The contract is usually for a period ranging from 3 to 9 years, but in this case the amount payable to the contractor is the same or similar to the costs prior to contractor take-over. A further clause is added such that a proportion of the savings made by the contractor are returned to the client (perhaps 2-10 per cent of the previous annual costs). It may also be possible for any further large saving to be shared in agreed proportions between the two parties involved. 

The Competent Authority to which the incident was originally reported usually takes on the role of monitoring and evaluating how the incident is dealt with. When all actions are complete, including any necessary Field Safety Correction Actions, the manufacturer must submit a final report to the Competent Authority. Under a safeguard clause. Competent Authorities may take unilateral action to remove a device from their market, if they believe that it poses an unacceptable health risk, but the Commission must be informed of such actions. In less-urgent situations, concerns may be referred to the Committee for Medical Devices for consideration. 

Theoretically it has been shown (Thayse, 1988) that the DDP formalism is closely related to a simpler form of horn clause logic, i.e., the propositional calculus. This would suggest that we could use the horn clause form to express some of the types of knowledge we are required to manipulate in combinatorial optimization problems. The explicit inclusion of state information into the representation, necessitates the shift from the simpler propositional form, to the first-order form, since we wish to parsimoniously represent properties that can be true, or take different values, in different states. By limiting the form to horn clauses, we are striving to retain the maximum simplicity of representation, whilst admitting the necessary expressive power. 

First-order horn clause logic is the representation that has been adopted by workers in the field of explanation-based learning (Minton et al., 1990). Hence, using this representation allows us take advantage of the results and algorithms developed in that field to carry out the machine learning task. 

These criteria can be used to put forward a hypothesis on the potential toxicity risk level of a substance, which is not listed in labour regulations. The other criteria are either qualitative or take into account biological tests that go beyond the sphere of non-medical staff. It can be interesting to compare LC and LD50 data with clauses concerned with risk offered by the regulations and that appear in our tables. Here are a few examples of common substances, for which there is better information than for the others. 

Fortunately, Houston was out of town enough to provide Phillips with enough time to search his files for a way to void the partnership. It didn t take long, as shipping bills, bank deposit slips and even a copy of a letter instructing a customer not to discuss details of a deal with anyone but him were found. Houston was selling the business out the back door, behind Phillips back. This is where the honesty clauses came into affect, which allowed Phillips to take over completely if this kind of foul play was discovered. 

The simplest method of using intrinsically safe electrical circuits is not to design and certify them yourself, but rather to take advantage of a clause contained in NFPA 493 which states ... 

The reheated vapor is passed through a fixed bed of catalyst where the Claus reaction takes place ... 

If the value of VERTICAL.TUBE.ROTORS is found to be true (or "yes") then clause 2 of the rule is evaluated. The references to "fact" in clause 2 cause the system to refer to a table that contains the facts for particular rotors. References to the facts ROTOR.DESIGN, TUBE.VOLUME, and K.FACTOR are applications of particular constraints to the rotors. For example, two constraints are that the rotor must have a tube volume greater than 1 mL and a k factor less than 50. Clause 3 further pares the set of rotors on the basis of k factor by taking only the best rotor and any rotor with a k factor within 50% of the k factor of the best rotor. 

Rule No. 7 Reware of deed restrictions Most deed restrictions, including those that enforce the maintenance of turf landscaping in specific ways, have an average life span of twenty-five to thirty years. Some are in effect in perpetuity. In many cases, such restrictions have a sunset clause, and after the initial term of twenty-five to thirty years expires, are renewed only by written approval of a specified percent of property owners in a subdivision. Many more restrictions, however, will be automatically renewed unless the owners take action to prevent reactivation. This suggests that vigilance is essential for homeowners interested in alternative landscaping, both at the time of purchase and beyond. 

Advertisements taking the form of inserts, whether loose or bound in, count towards the three pages allowed by Clause 63. A loose insert printed on both sides counts as two pages. 

Persons who have passed the Medical Representatives Examination whose duties change so as to become those specified in Clause 16.3 as being appropriate to the Generic Sales Representatives Examination are exempt from the need to take that examination. 

In the event that the Clinical Trial is part of a multi-centre clinical trial (which for the purposes of this Agreement shall mean that at least one other institution is taking part) the Sponsor may amend the number of Clinical Trial Subjects to be recruited pursuant to clause 4.6 above as... 

The Sponsor will take out appropriate insurance cover or will provide evidence to the satisfaction of the NHS Trust of self-insurance in respect of its potential liability under clauses 5.1 and... 

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