Contract specification systems

The quality system developed to meet the requirements of ISO/TS 16949 is likely to be a generic system, not specific to any particular product, project, or contract other than the range of products and services which your organization supplies. By implementing the policies and procedures of the documented quality system, product, project, or contract specific plans, procedures, specifications, etc. are generated. ISO 9001 contains a series of quality system requirements, not product quality requirements. For a given product, project, or contract there will be specific product, project, or contract requirements and it is these requirements to which this clause of the standard refers. 

Planned arrangements is another unusual term, especially when throughout the standard the terms documented quality system and documented procedures have been used. However, so that audits are not restricted to documented procedures and policies, the term planned arrangement has been used. It encompasses contracts, specifications, plans, objectives, strategies - in fact any arrangement made by the organization to satisfy customer needs. You therefore need to define what constitutes your planned arrangements. 

Next to sales contract specifications, coiTosion protection ranks highest among the reasons for the removal of acid gases. The partial pressure ol the acid gases may be used as a measure to determine whether treatment IS required. The partial pressure of a gas is defined as the total pressure of the system times the mole % of the ga,seous component. Where ( 02 is present with free water, a partial pres.sure ot. hi psia or greater would indicate that CO2 corrosion should be expected. If CO2 is not removed, inhibition and special metallurgy may be required. Below 15 psia, COt corrosion is not normally a problem, although inhibition may be required. 

The K coefficient values for each of the items of pipe, bends, valves, fittings, contractions, enlargements, entrance/exits into/from vessels are additive as long as they are on the same size basis (see Table 2-2 and Figures 2-12A through 2-16). Thus the resistance equation is applicable to calculate the head or pressure loss through the specific system when the combined Rvalue is used. 

Of all the requirements that have to be fulfilled by a manufacturer, starting with responsibilities and reporting relationships, warehousing practices, service contract policies, airhandUng equipment, etc., only a few of those will be touched upon here that directly relate to the analytical laboratory. Key phrases are underlined or are in italics Acceptance Criteria, Accuracy, Baseline, Calibration, Concentration range. Control samples. Data Clean-Up, Deviation, Error propagation. Error recovery. Interference, Linearity, Noise, Numerical artifact. Precision, Recovery, Reliability, Repeatability, Reproducibility, Ruggedness, Selectivity, Specifications, System Suitability, Validation. 

As an attempt to connect the first discussion, which was concerned with diffusion-reaction coupling, with Dr. Williams presentation of enzymes as dynamic systems, I wanted to direct attention to a number of specific systems. These are the energy-transducing proteins that couple scalar chemical reactions to vectorial flow processes. For example, I am thinking of active transport (Na-K ATPase), muscular contraction (actomyosin ATPase), and the light-driven proton pump of the well-known purple... 

Quality-related critical parameters, data, and functions are essential for specification and contract considerations, system design and development, qualification testing of the computer system, and PQ for the validation of the process. GMP-related system requirements need to be traceable throughout the specification, design, development, testing, and operation of a system. This can readily be achieved by having a traceability matrix that will identify corresponding sections and data in the key life-cycle documents. 

The specific system that we use to explore these questions is the conventional myosin, also termed myosin 11, which plays key physiological functions in muscle contraction and cell division. It is an ideal system for in-depth theoretical and computational analysis because its structural and kinetic properties have been characterized by a large body of diverse experimental techniques." For example, at the time our research was initiated, myosin 11 was one of the few motor systems for which high-resolution x-ray structures are available for multiple functional states " since then, multiple high-resolution x-ray structures have also been obtained for myosin V and VI, two other widely studied members of the myosin superfamily that are more processive in nature compared to myosin 11. The functional cycle of myosin 11 is best described by the celebrated Lymn-Taylor schane (Figure 2.1a)," in which... 

Individual conductors may be installed in trunking or conduit and individual cables may be clipped directly to a surface or laid on a tray using the wiring system which is most appropriate for the particular installation. The installation method chosen will depend upon the contract specification, the fabric of the building and the type of installation - domestic, commercial or industrial. 

Does this wiring system meet the contract specification ... 

In this paper, we report on a case study developed in the SafeCer project, where we combined contract-based design and model-based testing. A contract-based approach has been used to formalize the safety requirements to detect communication failures. The formal specification shows under which assumptions the AUTOSAR protection mechanism fulfills these requirements. A model-based testing approach has been used to test the software implementing such protection mechanism. The model used for testing has been model checked against the contract specification ensuring that the system-level safety requirements are met. 

Table 10-56 gives values for the modulus of elasticity for nonmetals however, no specific stress-limiting criteria or methods of stress analysis are presented. Stress-strain behavior of most nonmetals differs considerably from that of metals and is less well-defined for mathematic analysis. The piping system should be designed and laid out so that flexural stresses resulting from displacement due to expansion, contraction, and other movement are minimized. This concept requires special attention to supports, terminals, and other restraints. 

The drive for these additional requirements has come not from the suppliers but from users, such as the automotive, utilities, telecommunications, software, and aerospace industries which purchase millions of products and services used to produce the goods and services they provide to the consumer. Rather than invoke customer-specific conditions in each contract, the larger purchasers perceive real benefits from agreeing common quality system requirements for their industry sector. Quite often a supplier will be supplying more than one customer in a particular sector and hence costs increase for both the supplier and the customer if the supplier has to meet different requirements that serve the same objective. All customers desire products and services that consistently/ meet their requirements. While the physical and functional requirements for the product or service will differ, the requirements governing the manner in which their quality is to be achieved, controlled, and assured need not differ. Differences in quality system requirements may arise between industry sectors where the technology, complexity, and risks are different. 

As stated in Chapter 1, ISO/TS 16949 harmonizes the quality system requirements of the automotive industry in the USA, Germany, France, and Italy. It does not contain all automotive quality system requirements. All participating organizations have customer-specific requirements in addition, which may be issued separately or included in individual contracts for the supply of products and services. 

Delivery decisions are more than decisions about conformance to specification. They are about conformance to contract and those responsible for the production processes may not be able to determine whether contractual conditions have been met. Much more may hang on the resolution of a problem than mere conformance to specification. The decision in some circumstances may be taken by the CEO. There may have been a safety problem or a product liability problem so your system needs to recognize these fine distinctions. Those making the delivery decisions need possession of all the information required to protect the company as well as meet customer needs. 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

The standard provides a choice as to whether you define the inspections and tests required in a quality plan or in documented procedures. You may of course need to do both. As the quality system is often designed to accommodate all products and services you supply, it may not specify inspections and tests which are needed for particular products. This is one of the roles of the quality plan. Within such a plan you should identify the verification stages during product development, production, installation, and servicing as applicable. These stages will vary depending on the product, so your quality plan will be product, contract, or project specific (see Part 2 Chapter 2). There may... 

If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated this. If we decompose the definition further, requirements for quality are defined in ISO 8402 as the expression of the needs or their translation into a set of quantitatively stated requirements for the characteristics of an entity to enable its realization and examination. Clearly, such a requirement would be a contract, product specification, design requirement, etc. This implies that any product verification records are quality records, but it rules out any recorded information as being a quality record. 

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 . 

All audits should be conducted against a standard for the performance being measured. Examinations without such a standard are surveys, not audits. Audits can also be conducted against contracts, project plans, specifications - in fact any document with which the organization has declared it will comply. The standard now requires system audits to be conducted to verify compliance with ISO/TS 16949 and any other system requirements. 

In some hydraulic systems, it is necessary to maintain the system pressure within a specific pressure range for long periods. It is very difficult to maintain a closed system without some leakage, either external or internal. Even a small leak can cause a decrease in pressure. By using an accumulator, leakage can be compensated for and the system pressure can be maintained within acceptable range for extended periods. Accumulators also compensate for thermal expansion and contraction of the liquid due to variations in temperature or generated heat. 

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