Approval defined

Step 4 Project initiation and approval Define a project to develop and implement the proposed new method or analyzer and get it approved by the sponsor. The documentation required by the sponsor is usually company-specific, but will typically include goal, business value, critical technical issues to be addressed, ramifications, proposed approach, resources needed (including personnel time), deliverables, and timing. 

Most polymer-stabilized UCAs increase image contrast by upward of 20 dB and provide lOOo/o reflection, especially when driven by frequencies at or near resonance.2 "2 Despite these proven benefits, in October 2003 the FDA in the United States added a black box warning to the labeling to previously approved Definity and General Electric s Optison because... 

Table 1 Hsts representative examples of capsule shell materials used to produce commercial microcapsules along with preferred appHcations. The gelatin—gum arabic complex coacervate treated with glutaraldehyde is specified as nonedible for the intended appHcation, ie, carbonless copy paper, but it has been approved for limited consumption as a shell material for the encapsulation of selected food flavors. Shell material costs vary greatly. The cheapest acceptable shell materials capable of providing desired performance are favored, however, defining the optimal shell material for a given appHcation is not an easy task.

The Federal Food, Dmg and Cosmetic (FDAC) Act defines dmgs as "...articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man..." and "articles (other than food) intended to affect the stmcture of any function of the body of man." In the United States and elsewhere, the introduction of a new dmg is subject to a sequence of weU-defined stages of development and approval (4). Each stage involves either scientific testing or submission and preparation of data and analysis review (Fig. 2). 

One general source of pump terrninology, definitions, rules, and standards is the HydrauHc Institute (HI) Standards (9), approved by the American National Standards Institute (ANSI) as national standards. A classification of pumps by type, as defined by the HI, is shown in Figure 1. 

Factory Mutual provides loss prevention data sheets that explain how to protect buildings from wind damage. Pressure coefficients that define increased uplift at corners and edges adjust the calculated uplift pressures. A laboratory uplift pressure test rates roofing assemblies. An uplift pressure of 2.9 kPa (0.42 psi) must be withstood under FM conditions to meet the Class 1-60 requirements. The FM approval guide is revised aimuaHy (37). 

Arrester Testing and Standards Regulatory and approval agencies and insurers impose acceptance testing requirements, sometimes as part of certification standards. The user may also request testing to demonstrate specific performance needs, just as the manufacturer can help develop standards. These interrelationships have resulted in several new and updated performance test procedures. Listing of an arrester by a testing laboratoiy refers only to performance under a defined set of test conditions. The flame arrester user should develop specific application requirements based on the service involved and the safety and risk criteria adopted. 

In addition you will need a process development plan in which you define who does what, when, and how for each new process from conception through to process approval. 

The requirements for product approval are defined in the reference manuals. You may not need to prepare product approval submissions for all the parts you supply. The applicability of product approval procedures is affected by several factors so definitive solutions cannot be offered. The fundamental requirement is that if you supply product to the automotive customers you need a product approval procedure in place to gain ISO/TS 16949 registration. If you have been supplying parts for some time without product approval then you should confirm with your customer that you may continue to do so. 

A Change Notice, which provides instructions defining what has to be changed. This is issued following approval of the change as instructions to the owners of the various documents that are affected by the change. 

An inventory management system should be established - meaning set up on a permanent basis to meet defined inventory policies and objectives approved by executive management. It should be documented - meaning that there should be a description of the system, how it works, the assignment of responsibilities, the codification of best practice, procedures, and instructions. The system should be planned, organized, and controlled in order that it achieves its purpose. A person should therefore be appointed with responsibility for the inventory management system and the responsibilities of those who work the system should be defined and documented. Records should be created and maintained that show how order quantities have been calculated in order that the calculations can be verified and repeated if necessary with new data. The records should also provide adequate data for continual improvement initiatives to be effective. 

Originally the classification of materials was derived from tests of proprietary explosion-proof (flameproof) enclosures. There were no published criteria. Equipment was approved relative to the lowest ignition temperature of any material in the group (Magison 1987). In about 1965 the U.S. Coast Guard asked the National Academy of Sciences (NAS) to form a panel to classify 200 materials of commerce. The Electrical Hazards Panel of the Committee on Hazardous Materials was formed by the NAS. The Panel studied many ways to estimate the hazard classification of materials. The Panel finally reported to die U.S. Coast Guard in 1970 that no workable, predicdve scheme could be defined, and it then proceeded to assign tentative classifications to the 200 materials. 

It clearly defines the capabilities and testing conditions of a flame arrester instead of giving an all-encompassing approval. This is especially tme for in-line deflagradon flame arresters. 

Approvals and Authorizations Appropriate delegations have been established, and authorities are cieariy established for approval of specific routine operations and non-routine or out-of-specification operations. Variance procedures are defined. Approval levels are commensurate with the importance of the task. Appropriate resources are authorized. 

Sealing. Approved seals shall be provided in accordance with Section 501-5. Sealing requirements in Sections 501-5(a) (4) and (b) (2) shall apply to horizontal as well as to vertical boundaries of the defined Class 1 locations. Buried raceways under defined Class 1 locations shall be considered to be within a Class 1, Division 1 location. 

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