Non-conformity control

Documented procedures should provide for corrective and preventive action to ensure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective or incorrect material and equipment, and any other non-conformities, are promptly identified, corrected and prevented from recurring. Such procedures should provide for  

Corrective and preventive action reports should be documented and provided to appropriate levels of managonent in order to support management review and quality improvement. 

Records relating to appropriate radioactive material packagings should be established and maintained to record the complete manufacturing, operational and service/maintenance history of such packagings. 

Further guidance and examples of what may constitute general quality or package specific records can be found in Safety Series No. 113 [1V.3]. 

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Safety Series No. 50-SG-Q2 Non-conformance Control and Corrective Actions (1996). 

A non-conformity control is being implemented gradually. By non-conformity control is meant the verification of any deficiency in characteristics, documentation and procedures which makes unacceptable or indeterminate the quality of equipment, materials, samples or the result of a study or of an analysis. This may then entail corrective actions. This is particularly important when using facilities not uniquely dedicated to the monitoring effort, but shared with other analytical work, as is the case with the PNRA. 

QA programme Organization Document control Design control Procurement control Material control Process control Inspection and test control Non-conformance control Corrective actions Records Staff training Servicing Audits... 

Measures to minimize safety problems must be initiated at the start of the life cycle of any product, but too often determinations of criticality are left to production or quality control personnel who may have an incomplete knowledge of which items are safety critical (Hammer, 1980). Any potential non-conformity that occurs with a severity sufficient to cause a product or service not to satisfy intended normal or reasonably foreseeable usage requirements is termed a defect (Kutz, 1986). The optimum defect level will vary according to the application, where the more severe the consequences of failure the higher the quality of conformance needs to be. 

Control of Non-conforming Product (Prevent use or delivery of non-conforming product)... 

Control of non-conforming product - Establish procedures for rework, reject, or release under concession... 

Thus, the monofluoroalkene moiety is a non-hydrolysable isostere of the pep-tidic bond, and hence can be used as a peptidomimetic unit in the design of protease inhibitors [59,60]. This type of rigid isosteres of the peptidic bond can facilitate the cisjtrans conformational control of the fragment replaced. Because of the double bond, the bond length and angles of the peptidic bond are suitably mimicked, and the fluorine atom complements the analogy for electronic properties. This approach has been developed in the case of prolylamide fragments, in... 

Control charts based on attribute data include the p chart, np chart, c chart, and chart. The former two are applied when fraction nonconforming or number of non-conforming is a concern, and the latter two are used to deal with the nonconformities. Most pharmaceutical manufacturing industries employ one or more of these charts. 

This approach should be useful in determining the direction of hydrogenation for molecules in which the carbinol group is replaced by carbon-carbon or carbon-nitrogen double bonds. With an alkene, though, the simple conformational model would have to be used and the hydrogenation should be run under conditions that do not promote double bond isomerization, that is, not with palladium or nickel catalysts. With carbonyl compounds the preferred eonditions for selective reaction involve platinum, rhodium or ruthenium catalysts imder non-diffusion control conditions. The use of nickel catalysts, especially Raney nickel, with its basic components, can cause an equilibration of the alcohol product. 

Conformationally Controlled Gas-Solid Brominations in Racemic and Enantiomeric Crystals.—The above approach is elegant because any observed asymmetric induction is a direct consequence of the chirality of the crystal. However, the method does not permit a systematic analysis for the following reasons (/) only a small percentage of non-chiral molecules form chiral crystals, (//) it is not always feasible to prepare large homochiral crystals needed for the experiment, (m) the absolute configuration of both the starting crystal and the products formed requires application of the Bijvoet method of anomolous X-ray scattering, which is sometimes difficult to apply for molecules that do not contain heavy atoms. 

Silica is a moderately strong solid acid, and in this sense it can also be considered as a polyelectrolyte, of course with a fixed geometry and non-conformational flexibility of the charge carriers. Controlled functionalization with a basic component, for example a polyelectrolyte, which is confor-mationally flexible, can be used to produce stable solid polymer hybrids with tailor-made surface properties for a lot of components [31-46]. 

If the migrating group does provide anchimeric assistance, certain consequences should follow. One is kinetic The rate should be faster than the rate of an exactly analogous, but unassisted, reaction. Another is stereochemical The migration terminus should be inverted by the rearrangement. There are obvious problems in the experimental evaluation of these criteria. Rate acceleration is often difficult to ascertain because the rate of the non-assisted reaction cannot be reliably predicted (cf. Section 7.2.). Inversion of the migration terminus may also be a result of ion pairing (Section 4.) or of conformational control (Section 6.). Combined kinetic and stereochemical evidence provides the most powerful support for anchimeric assistance. 

Despite MTR s and COC s, non-conformances can still occur. However, they put the supplier on notice that the receiving site has value for controlling incoming materials. Before requesting MTR s and COC s, answer the following questions ... 

As clearly shown by the ferrichromes and the bacterial ferredoxins, the stability of the coordinated globule immediately reflects the single, non-essential amino acid substitutions. These further introduce positive and negative strains that are not strong enough to overcome the tight conformational control imposed by the iron complexation but which... 

Mention of the conformity or non-conformity of raw materials or packaging materials by the person responsible for the control laboratory. 

The photochemical behavior of the orr/to-(aminoalkyl)slil-benes 92—94 is also dependent upon the polymethylene linker (Scheme II). Irradiation of 93 and 94 results in formation of the benzazepines 96 and 97. These adducts are presumably formed by regioselective N—H transfer to the proximal end of the stilbene double bond in 93 and the distal end in 94, in both cases resulting in the formation of a 1,7-biradical intermediate. Since intramolecular stilbene-amine addition reactions are non-regioselective, the regioselectivily of N-H transfer must be subject to exciplex conformational control. The biradical inter-... 

Readers need to have confidence in the safety case s claims. Whilst evidence of historical operation, conformance with standards and well-managed CRM workshops are non-specific controls they can add up to a rounded and convincing story. 

In addition to the CE marking affixed to a product, customers may demand a European third-party (notified body) approval mark, certification, or test report connoting a higher level of quality to ensure safety/EMC compliance. To control non-conforming products the following clause from the Official Journal of the European Communities (OJEC) applies ... 

The level of safety necessary in special arrangement shipments is normally achieved by imposing operational controls to compensate for any non-conformances in the packaging or the shipping procedures. Some of the operational controls which may be effectively employed are as follows ... 

IV.74. For the purposes of Appendix IV, the following terms, as defined in Safety Series No. 113 [IV.3], apply applicant, assessment, audit, controlled document, corrective action, design input, design output, examination, inspection. Item, maintenance/servicing, measuring and test equipment, non-conformance, objective evidence, procedure, procurement document, qualification, quality, quality elements, quality assurance programme, quality plan, repair, services, specification, supplier, traceability, user, and verification. 

Trend analyses Stability monitoring Retrospective validation Supply chain traceability of active substances Critical in-process controls and finished product results Deviations or non-conformities and the effectiveness of the subsequent corrective and preventive actions Quality-related returns, complaints and recalls Qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc. 

The Standard considers that an effective quality system should comprise management responsibility quality system principles quality system audits quality/cost considerations raw material quality control inspection and testing control of non-conforming product handling, storage, packaging and delivery after sales service quality documentation and records personnel training product safety and liability and statistical data/analyses. 

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