Quality conformance - meaning

Non-conformity means that a requirement is not fulfilled. Non-conformities can occur related to any of the quality characteristics and its related quality objectives. Non-conformities may refer to defects, mistakes and errors in processes, violations and deviations of regulations or procedures, problems with equipment, customer complaints, etcetera. Near misses, incidents and adverse events in clinical or occupational health context can be treated as non-conformities concerning patient or employee safety. 

It is the intention that Health Foods will be of the best practicable quality. This means that the following set of standards embodied in the Code of Practice are to be interpreted in the spirit as well as the letter, and that all products covered by the standards should conform to good manufacturing practices in their preparation. It is realised that as different ingredients become available, manufacturers will need to be advised of changes which can help them not only to keep their products up to a high standard but to attain the overall objective of improving standards where possible. 

J Kuszewski, AM Gronenborn, CM Clore. Improving the quality of NMR and crystallographic protein stiaictures by means of a conformational database potential derived from structure databases. Protein Sci 5 1067-1080, 1996. 

Most ISO 9000 registered organizations claim to provide quality products and services, so why should there be so many dissatisfied customers when there are over 270,000 organizations in the world certified to ISO 9001, 9002, or 9003 One of the principal requirements in the standard is for the supplier to establish a quality system as a means of ensuring that product or service meet specified requirements. If an organization s products or services do not meet specified requirements then clearly the system has failed, but the failure is no fault of the standard - it is a fault of the way the standard has been applied and interpreted both by the organizations themselves and by the auditors who determine conformity. If the specified requirements are less than those of the customers, it is inevitable that products will bring dissatisfaction. This realization has, in the case of the automotive industry, led to two distinct needs ... 

Like VDA 6.1, AVSQ 94 does not include the requirements of ISO 9001. In this way issues of copyright are overcome, a practice shared by VDA and EAQF but not QS-9000. However, unlike VDA 6.1, AVSQ 94 follows the 20 elements of ISO 9001 with two additional elements, covering financial considerations and product safety. Those questions that go beyond ISO 9001 are marked and as every question is numbered it simplifies the evaluation process. A scoring method is employed to classify organizations in terms of a conformity index. Each question is awarded a point (0, 2.5, 5, 7.5, or 10), where 10 points means full compliance, 7.5 points means minor inadequacies, 5 points means inadequacies in application requiring improvement, 2.5 points means serious inadequacies in application, and 0 points is used for criteria not applied. Unfortunately all questions carry the same weight as no account of the impact of omission on product quality or customer satisfaction is included. 

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

Next is a questionnaire which only covers the specific requirements of the standard. This breaks down the requirements into their individual components where it is likely that the solutions for each part will be different. It can be used as a basic checklist for verifying that the quality system you have designed addresses all the requirements, or as a means of creating policy or of assessing conformity. 

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

It should also not be assumed that these requirements are only intended for implementation by a department with the title Inspection or Test. Whenever a product is supplied, produced, or repaired, rebuilt, modified, or otherwise changed, it should be subject to verification that it conforms with the prescribed requirements and any deficiencies corrected before being released for use. That is what control means. Control is not just the inspection part of the process and hence quality control , which for years was the name given to inspection departments, was misunderstood. Inspection and test don t control quality. Inspection and test merely measure the quality achieved and pass the results to the producer for remedial action. 

Within your procedures you need to provide a means of identifying which items have been subject to inspection at the subcontractor s premises and the receipt inspection action to be taken depending on the level of that inspection. In one case, the product may have been accepted by your representative on the subcontractor s premises. In another case, a product from the same batch may have been accepted by your representative but not the one that has been delivered. Alternatively your representative may have only performed a quality audit to gain a level of confidence. You need to specify the inspection to be carried out in all such cases. The standard emphasizes that consideration should also be given to the recorded evidence provided. Even if someone has performed inspection at the subcontractor s premises, if there is no evidence of conformance the inspections are of little value. The fact that an inspection was carried out is insufficient. There has to be a statement of what was checked and what results were obtained and a decision as to whether conformance has been achieved. Without such evidence you may need to repeat some of the inspections carried out on the subcontractor s premises. 

New regulatory initiatives (e.g., from OSHA and EPA) and industry programs (e.g., the Chemical Manufacturers Association s Responsible Cate effort) have stimulated increased attention to PSM. While compliance is certainly a requirement in deciding to implement PSM, it is by no means the only ben t. Rather, compliance is the baseline from which other benefits evolve. The quality and effectiveness of the system your company ultimately adopts could well depend on how persuasively those benefits are conveyed. Remember, at this point in your initiative, the goal is to win endorsement of a concept, not approval of a full-fledged plan. The core of that concept is the idea that PSM offers benefits over and above compliance with new regulations, or conformance with an industry initiative. 

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

High quality is one of the criteria defined in the requirements section above. Since the program should run automatically in batch mode, we mean by quality control an internal check of the 3D structures produced by the structure generator itself. In general, the abilities of a fast, automatic structure builder to assess the quaUty of its models are rather limited since, for example, an exhaustive conformation analysis and energy optimization is impossible in most cases. However, there are a Umited number of simple quaUty checks to avoid trivially distorted structures ... 

There are various ways to check the quality of the resulting structures with respect to experiment. A typical check would be to compare the mean square end-to-end distance with results from scattering experiments. However, since the experimental samples are highly polydisperse, the results from scattering experiments are somewhat questionable [195]. Furthermore, a crucial check is the direct comparison of conformations of systems. In order to be able to compare the conformations resulting from simulations unanimously to experiment we reintroduce the chemical details into the coarse-grained chain. This is one of the reasons why it is so important to device a mapping procedure which stays close to the chemical structure of the objects. We have a one-... 

Surprisingly, the MP2/6-31G model is not as satisfactory as any of the density functional models, both insofar as mean absolute error and in terms of individual errors. Use of the 6-311+G basis set in place of 6-3IG leads to marked improvement, and the results are now of comparable quality to those of the best density functional models. Given the large difference in cost between density functional and MP2 models, and given the apparent need for basis sets larger than 6-3IG for the latter, it seems difficult to recommend use of MP2 models for the purpose of conformational analysis involving acyclic systems. 

The term quality is used in many industries and in everyday Ufe and can have various meanings depending on context. For the purposes of discussion here quality means the product requirements or attributes that have a bearing on the product s specified requirements. Quality assurance activities are those processes and activities conducted to assure that a product or service consistently satisfies its requirements and is fit for its intended use. In the pharmaceutical manufacturing environment, this means the activities conducted to assure that the pharmaceutical product s identity, strength, purity, potency, and other quality attributes conform to approved specifications. 

A quality management system is established, maintained, and documented as a means to ensure that products and services conform to specilied requirements. This quality system is designed to comply with the ISO 9001 2000 standard. The quality systems responsibilities are tabulated in Table 1 (amend the table as relevant to your company). 

Among other approaches, a theory for intermolecular interactions in dilute block copolymer solutions was presented by Kimura and Kurata (1981). They considered the association of diblock and triblock copolymers in solvents of varying quality. The second and third virial coefficients were determined using a mean field potential based on the segmental distribution function for a polymer chain in solution. A model for micellization of block copolymers in solution, based on the thermodynamics of associating multicomponent mixtures, was presented by Gao and Eisenberg (1993). The polydispersity of the block copolymer and its influence on micellization was a particular focus of this work. For block copolymers below the cmc, a collapsed spherical conformation was assumed. Interactions of the collapsed spheres were then described by the Hamaker equation, with an interaction energy proportional to the radius of the spheres. 

ISO/DIS 13485 The supplier shall establish, document, and maintain a quality system as a means of ensuring that product conforms to specified requirement. The supplier shall prepare a quality manual covering the requirements of ISO 9001. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system. 

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