Requirements, agreed upon

Conformance to one of the first three ISO standards is verified by third-party audit for which the auditee pays the auditor a fee. Continued conformance is assured through periodic reaudit by the third party. The ISO 9000 standard is not a product quahty standard. Conformance to ISO 9001 or 9002 ensures that the customer receives product in conformance to mutually agreed-upon specifications. Other agreed-upon requirements are also met. 

Nonconformance arises when any aspect of the work of a laboratory does not conform to its procedures, to the standard, or the agreed-upon requirements of the customer. These are detected by customer complaints, internal quality control measures, management audits and reviews, and by observations of staff. They must be dealt with under the appropriate part of the management system and fully investigated and reported. 

Analytical measurements should be made to satisfy an agreed-upon requirement. 

The purchaser should verify that the supplier of raw materials, components, and services for the manufacture of excipients has the capability to consistently meet the agreed-upon requirements. This may include periodic audits of the vendor s plant, if deemed necessary. Purchasing agreements should contain data clearly describing the product ordered, including where applicable, the following ... 

Supply products within delivery time scales agreed upon/required... 

Principle 1 Analytical Measurement Should Be Made to Satisfy an Agreed upon Requirement... 

Process deviation According to Norsok Z-013 (2001), an accidental event is defined as an event or chain of events that may cause loss of life, or damage to health, the environment or assets. So, one may interpret process deviation consists of events or chain of events for which there will be deviation from accepted performance and may cause loss of life property or environment. From task management point of view process deviation could be interpreted as deviation from agreed upon requirement or course of action. It also provides an idea about quantum of such deviation so that performance could be judged [13]. 

The manufacturing design range is a range of pressure within which the marked burst pressure must fail to be acceptable for a particular requirement as agreed upon between the rupture disc manufacturer and the user or his agent. 

Unfortunately, at the present time there does not appear to be a detailed understanding of the relationship between the properties of the raw materials or the ingredients making up an elastomeric compound and the compound s processability. Therefore, the most widely used approach presently being adopted is to use the conventional characteristics with the standard specification limits issued by the supplier or special agreed upon limits with the supplier to accommodate specific requirements in the fabricators manufacturing process. 

Magnetic Particle Examination. All accessible surfaces of the main load carrying components of the equipment shall be examined by a magnetic particle examination method or technique conforming to the requirements of ASTM E709 Recommended Practice for Magnetic Particle Examination. Acceptance limits shall be as agreed upon by the manufacturer and the purchaser. 

Repetitive shutdown work This type of work is developed by experienced maintenance and operations supervision based on prior shutdown experience, job knowledge, and required shutdown preventive maintenance tasks. Each agreed-upon job is assigned an annual work order number frequency, established, work order plans written, and is entered in the work order log. The handling of repetitive work orders will be the same as non-repetitive work orders, except one copy of the work plan will be substituted for the first copy of the work order. 

Where higher quality water is required, there is no single technology that can provide all the answers to impurity removal requirements. Consequently, it is common practice to employ two, three, or even more processes in sequence. In view of the different water sources, final quality requirements, and permutations of technologies and subsets, there is no universally agreed upon order in which the technologies are sequenced. Nevertheless, there are some purification processes that, because of specific technical or economic advantage, enjoy popular appeal and are commonly specified. 

One critical factor that affects the heat release rate is the availability of air. The furnace has to be designed so that many requirements can be met simultaneously (a) time-temperature curve of ASTM E—119, (b) adequate air supply, and (c) pressure requirement inside the furnace. To incorporate the heat release rate measurement into the ASTM E-119 standard, specifications must be made to address these three criteria. If these criteria can be agreed upon, the heat release rate measurement should be made a part of the existing test standard. 

The outcome of planning should include the generation of a method definition requirement document (MDRD) in which all stake holders agree, prior to method development, on the critical attributes of the method. Considerations such as what impurities/degradation products should be monitored, requisite reporting thresholds, the need for an MS-compatible method, if identical methods for DP and DS are required, etc., should be clearly decided and agreed upon by all stakeholders. 

The conditions in the seal chamber required to maintain a stable film at the seal faces, including temperature, pressure, and flow, as well as provisions for assuring the adequacy of the design for sealing against atmospheric pressure when pumps are idle in vacuum service, shall be mutually agreed upon by the pump vendor and the seal manufacturer, approved by the purchaser, and noted on the data sheet. 

The need for cooling shall be mutually agreed upon by the purchaser and the vendor. When cooling is required, the type, pressure, and temperature of the cooling liquid will be specified by the purchaser. The vendor shall specify the required flow (see Appendix D). 

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