Third party, defined

Specifications for gas turbine fuels prescribe test limits that must be met by the refiner who manufactures fuel however, it is customary for fuel users to define quality control limits for fuel at the point of delivery or of custody transfer. These limits must be met by third parties who distribute and handle fuels on or near the airport. Tests on receipt at airport depots include appearance, distfllation, flash point (or vapor pressure), density, freezing point, smoke point, corrosion, existing gum, water reaction, and water separation. Tests on delivery to the aircraft include appearance, particulates, membrane color, free water, and electrical conductivity. 

Kerridge has provided an excellent article on the interface betw een the operating company and the contractor to define all requirements in complete and standardized detail. This includes who is responsible for every deliverable. The operating company and contractor must work as a team. An example of one area that needs to be reviewed often with the contractor is the provision of secondary systems as packages, perhaps from a third party. Such systems can easily become orphans. This problem is discussed in the Process Definition section of Chapter 16. 

The standard allows for undocumented verbal orders but requires that the order requirements are agreed before their acceptance. The third party auditor cannot confirm conformity with this requirement as there will be no objective evidence to substantiate the transaction other than the payment invoice. If the supplier confirms the agreement in writing a written statement of requirement exists. The standard does not stipulate that the agreement has to be documented only that the requirements need to be documented regardless of who produced them. The only evidence that the requirements were adequately defined is therefore the payment from the customer against the supplier s invoice. 

You need to develop documented procedures that define your subcontractor evaluation and selection process and in certain cases this may result in several closely-related procedures for use when certain conditions apply. Do not try to force every purchase through the same selection process. Having purchasing policies that require three quotations for every purchase regardless of past performance of the current subcontractor is placing price before quality. Provide flexibility so that the policies and procedures complexity match the risks anticipated. Going out to tender for a few standard nuts and bolts would seem unwise. Likewise, placing an order for lm of equipment based solely on the results of a third party ISO 9000 certification would also seem unwise. 

Remediation optimization uses defined approaches to improve the effectiveness and efficiency with which an environmental remedy reaches its stated goals. Optimization approaches might include third-party site-wide optimization evaluations conducted by expert teams, the use of mathematical tools to determine optimal operating parameters or monitoring networks, or the consideration of emerging technologies. Since 1999, U.S. EPA has promoted remediation optimization in the following manner ... 

The arm s length approach as a result of lack of funding associated with ethical trade, there is only limited use of third-party auditors. However, the partial use of independent auditors does occur mainly within the context of arm s length relationships between retailers, auditors and suppliers. This can be defined as the contractual relations between companies involving competitive bidding and playing-off of suppliers. Weak social ties and detached social relations are characteristic of such relationships (Doel, 1996, 1999). 

In practice, the Patriot Act and its successors, has circumvented the check and balance system. The Executive Branch has, for example, lowered the threshold of probable cause to the level of suspicion it has equated criminal activity with terrorist activity it has removed or delayed notice requirements for warrants it has required mandatory compliance on third parties for the production of information gathered secredy it has imposed a gag order upon notice and production of information it permits sharing of confidential personal information between investigative units and minimized the role of the judiciary. The overall effect is the Executive Branch and Justice Department are assuming power to define application of the Fourth Amendment. An additional result is the collection of a wide variety of highly personal and sensitive information on law-abiding individuals. 

A manufacturer is defined as the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the EU market under that manufacturer s own name, regardless of whether these operations are carried out by that manufacturer or on their behalf by a third party. The Directives also apply to those who assemble, package, process, fully refurbish or label a product and in certain other situations. 

In principal, the Directive gives each Member State the responsibility to define who should be considered eligible customers (Art. 18 No. 1). However, the Directive requires both a qualitative and a quantitative minimum for those who should be considered as such. These minimum requirements are met as long as all eligible customers are presented with an offer of, or the right to negotiate, system access. The requirements concern only the degree of competition, and not the number of customers who would actually make use of third party access. 

Understand the basic principles of third-party reimbursement for prescription drugs and define commonly used reimbursement terminology. 

This scenario is a common occurrence in pharmacies of all sizes and types across the country. Pharmacy managers and owners are forced to make difficult decisions about whether to accept or reject third-party plans pharmacists and patients deal with the consequences of those decisions. A thirdparty is defined as an organization that reimburses a pharmacy or patient for all or part of the patient s prescription drug costs. Since most prescriptions dispensed in pharmacies today are paid for by third parties, it is essential that pharmacy managers and pharmacists understand the effect of third parties on pharmacy operations. 

PHI may be released without explicit patient authorization under certain circumstances defined in the law and rules. These circumstances (with examples) include treatment (e.g., when a pharmacist discusses a patient s condition with the patient s physician), payment (e.g., when a claim for payment is submitted to a third-party payer), regular health care operations (e.g., the transfer of PHI among departments within a hospital), and when the information has been de-identified. ... 

Internal QA audits must be conducted and documented at a defined frequency to ensure overall compliance, control, and effectiveness of the quality elements. Such audits should be conducted by members of the QAU or third-party compliance specialists and the results reported directly to the senior management of the corporation. The senior management should prepare an action plan to address any deficiencies and follow up to confirm adequate implementation. 

Proprietary information is often transferred between companies after both sign a secrecy or confidentiality agreement. Generally, the agreement defines what information is to be exchanged, limits how long it is to be held confidential (2-10 years is common), prohibits third-party disclosures, and provides exceptions. Common exceptions are if the information transferred is already known or if the information becomes public at a later time. 

GxP regulations require that access to the software and relevant associated documentation should be preserved for a number of years after the system or software has been retired (see Chapter 4 and Chapter 11 for more details). Software licenses do not entitle pharmaceutical and healthcare companies to ownership of the software products they have purchased. All that has been purchased is a license, an official permission or legal right to use it for some period of time under defined conditions of use. Accordingly, some companies have established escrow (third party) accounts with suppliers to retain their access to software, but this is not mandatory. Access agreements directly... 

Electronic record and electronic signatnre reqnirements mnst be specified and taken into acconnt during any selection process for all new compnterized systems. Relevant third-party snppliers of bespoke systems should have requirements contractnally defined. 

In 1960,49% of health care revenues came from out-of-pocket payments from individuals. Out-of-pocket spending is defined as expenditures for coinsurance and deductibles required by insurers, as well as direct payments for services, which are covered by a third party. In 1990, individual consumers spent 144.4 billion ectly for out-of-pocket payments for personal health ser-vices.f This accounted for 38% of all personal health spending. In 1998, consumers spent 183.7billion in out-of-pocket payments, which accounts for 33% of the 558.7 billion in personal health spending. ... 

Requirements for controls are based on definition of closed or open system. Under these definitions there isno direct correlation between, for example, using a publicphone line and an open system. Compliance with closed versus open standards is determined by how access rights to the data or documents are established and controlled by the owner(s) of this information. A system is defined as closed if access to the system containing the records or data is under the control of person(s) responsible for the content of the records or data in the system. A system is defined as open if access to the system is not under the control of the person(s) responsible for the content of the records therein. For example, dial-in retrieval over a public phone is closed where the records being accessed are under the control of the persons responsible for their content, whereas storage of records on a third party system is open because access to the records themselves is under the control of the third party. Sections 11.10 and 11.30 of the Final Rule list, respectively, the control measures required for establishing a closed or open system. 

The overall purpose of an operational planning model is to maximize the net profit of the system in the face of imcertainty in fruit production, third party fruit availability and costs and potential chain disruption events such as unexpected out-of-service of processing plants and storage chambers, reduction in transportation capacity, etc. The total profit is defined as the total income per product sales minus the sum of fruit... 

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