Products conformity

Formulation consists of mixing the effluent streams coming from the different refining units in order to obtain products conforming to the specifications. It is also at this point that additives are added, the reasons for which and whose action will be described later. One can easily see that as far as octane numbers are concerned, or for that matter any other parameter, the... 

Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system procedures ... 

Do the inspections and tests verify that incoming products, semi-finished products, and finished products conform to specified requirements before use, processing, or dispatch ... 

We will comply with NMLs policies and procedures for quality assurance activities. In addition we will develop our own ideas to improve upon NML requirements. We will set quality targets and objectives in line with corporate standards. In support of achieving customer satisfaction we will seek to achieve product conformity by carrying out quality assurance activities at all stages of vehicle manufacture - from planning through to vehicle sales. 

The standard requires suppliers to establish and document a quality system as a means of ensuring that product conforms to specified requirements. 

This requirement clearly defines the purpose of a quality system, that of ensuring that products conform to specified requirements. One of the principal differences between ISO 9000 and ISO/TS 16949 is the emphasis placed on internal efficiency and effectiveness. Implementing the requirements of ISO/TS 16949 will cause the waste, errors, and internal costs to be minimized. Unlike ISO 9001, ISO/TS 16949 requires the system to enable the organization to implement its quality policy and achieve its quality objectives, which after all is its purpose. This fundamental shift in concept is also behind the changes being made to ISO 9000 in the year 2000 edition. 

A system is an ordered set of ideas, principles, and theories or a chain of operations that produces specific results to be a chain of operations, the operations need to work together in a regular relationship. A quality system is not a random collection of procedures (which many quality systems are) and therefore quality systems, like air conditioning systems, need to be designed. All the components need to fit together, the inputs and outputs need to be connected, sensors need to feed information to processes which cause changes in performance and all parts need to work together to achieve a common purpose i.e. to ensure that products conform to specified requirements. You may in fact already have a kind of quality system in place. You may have rules and methods which your staff follow in order to ensure product conforms to customer requirements, but they may not be documented. Even if some are documented, unless they reflect a chain of operations that produces consistent results, they cannot be considered to be a system. 

The standard requires that design validation be performed to ensure that product conforms to defined user needs and/or requirements. 

The standard requires the supplier to establish and maintain documented procedures to ensure that purchased product conforms to specified requirements. 

The standard requires that where specified in the contract the supplier s customer or his/her representative shall be afforded the right to verify at the subcontractor premises and the supplier s premises that subcontracted product conforms to specified requirements. 

You are only required to indicate whether product conforms to the inspections and tests performed. This is not the same as indicating whether the product conforms to the customer requirements. It may well pass the prescribed inspections and tests but these inspections and tests may not be sufficiently comprehensive to verify conformance to all the customer s requirements. However, the only indication you can give is the product s conformance or nonconformance with some verification requirement. It follows therefore that you should not go around putting reject labels on products, or acceptance labels for that matter, if you have not performed a specific inspection to determine conformance. There are only three conditions uninspected , inspected and found conforming , and inspected and found nonconforming . If you have a policy of only applying labels after inspection, anything without a label is therefore deemed uninspected, unless it has been installed and the label removed. 

The only cases where you need to request concession from your customer are when you have deviated from one of the customer requirements and cannot make the product conform. Even when you repair a product, providing it meets all of the customer... 

The purpose for which the analytical data are required may perhaps be related to process control and quality control. In such circumstances the objective is checking that raw materials and finished products conform to specification, and it may also be concerned with monitoring various stages in a manufacturing process. For this kind of determination methods must be employed which are quick and which can be readily adapted for routine work in this area instrumental methods have an important role to play, and in certain cases may lend themselves to automation. On the other hand, the problem may be one which requires detailed consideration and which may be regarded as being more in the nature of a research topic. 

The successful and profitable control of frozen food quality requires workable standards of product quality and condition and suitable methods for determining the degree of product conformance with standards. The frozen fruit and vegetable industry has developed rapidly during the past 20 years and serious concentration upon the development of adequate standards and objective methods for quality measurement is necessary. Such standards and methods should be placed on a uniform basis the country over and given official and legal status. 

The successful and profitable conduct of a frozen food quality program requires suitable and workable standards of product quality and condition, and suitable methods for determining the degree of product conformance with the standards. The methods used may be either subjective or objective in character, or a combination of both the most consistent and reproducible results will be obtained with objective methods. Present-day frozen food standards are, for the most part, based upon subjective methods of quality determination. These are certainly better than none at all but they are subject to considerable misinterpretation and human error, and for this reason leave much to be desired in providing a sound basis for quality control. 

The CE Mark is not specific to medical devices, but is used generally to indicate to European consumers that a product conforms to applicable European performance and safety requirements. It can be found on electrical equipment, children s toys and safety equipment, among other products. 

Aetion limits must be derived from both the specification limits and the charaeteristics of the process they must provide the operators with ample leeway (time, coneentration, temperature, etc.) to react and bring the process back to nominal conditions without danger of the specification limits being exceeded. An important factor, especially in continuous production, is the time constant a slow-to-react process demands narrow action limits relative to the specifieation limits, while many a tightly feed-back controlled process can be run with action limits close to the specifieation limits. If the product conforms to the specifications, but not to the action limits, the technical staff is alerted to look into the potential problem and come up with improvements before a rejection occurs. Generally, action limits will be moved closer to the specification limits as experience accrues. 

And further, that the responsibilities for quality-related activities of the contract giver and contract acceptor should be specified in a written agreement . Similarly, ISO 9001 (2000) states that, Where an organization chooses to outsource any process that affects product conformity, the organisation shall ensure control over such outsourced processes. Control of such outsourced processes shall be identified within the quality management system. ... 

The FDA also introduces the concept of process analytical technology (PAT). PAT refers to systems that are used to analyze, monitor, and control manufacturing processes on a continuous basis. The quality attributes and specifications of raw materials, in-process intermediates, and processes are measured in real time and compared with predetermined parameters so that deviations can be rectified in a proactive nature to assure that the end products conform to the level of quality as expected. It is believed that a system based on PAT being implemented in a real-time manner would improve manufacturing efficiency and simultaneously retain or improve the product quality through these interactive measurements and controls. 

Reproducibility of Manufacturing Processes The aim of GMP is to ensure the manufacture of safe, potent, pure, and effective drug in a consistent manner. The development program exists to evaluate procedures and processes that can be implemented in a large-scale manufacturing environment to ensure the drug product conforms to the intended safety, potency, purity, effectiveness, and consistency on a routine basis. 

Infrastructure includes resources such as buildings, equipment, supporting services, information and communication technology etc. The infrastracture shall be determined, provided and maintained so that the laboratory product conforms to specified requirements. 

The laboratory shall define the characteristics of the materials, reagents and instrument to be purchased and evaluate the ability of the eligible suppliers to supply the required materials and/or services. The verification process that is, the process to ensure that the purchased products conform to the defined requirements shall be defined and the necessary resources, including persormel, shall be provided. 

The monitoring of the laboratory performance is required to demonstrate that the laboratory product conforms to the specified requirements and that the laboratory activity conforms to the quality management system requirements. Moreover, there is a need and it is a requirement that the laboratory continually improves the effectiveness of the quality management system. 

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