Problem report procedure

To provide staff with the necessary organizational freedom you will need one or more problem-reporting procedures and some policies that give staff the freedom to identify, record, and report problems relating to the product, process, and quality system. 

In addition to the CIR process the cosmetic industry has instituted a second, important, self-regulatory procedure the voluntary reporting of adverse reactions, which is intended to provide data on the type and incidence of adverse reactions noted by consumers or by their medical advisors. This reporting procedure creates early awareness of problems handled outside hospital emergency facilities or centers for acute poisoning. 

In an acetone extract from a neoprene/SBR hose compound, Lattimer et al. [92] distinguished dioctylph-thalate (m/z 390), di(r-octyl)diphenylamine (m/z 393), 1,3,5-tris(3,5-di-f-butyl-4-hydroxybenzyl)-isocyanurate m/z 783), hydrocarbon oil and a paraffin wax (numerous molecular ions in the m/z range of 200-500) by means of FD-MS. Since cross-linked rubbers are insoluble, more complex extraction procedures must be carried out (Chapter 2). The method of Dinsmore and Smith [257], or a modification thereof, is normally used. Mass spectrometry (and other analytical techniques) is then used to characterise the various rubber fractions. The mass-spectral identification of numerous antioxidants (hindered phenols and aromatic amines, e.g. phenyl-/ -naphthyl-amine, 6-dodecyl-2,2,4-trimethyl-l,2-dihydroquinoline, butylated bisphenol-A, HPPD, poly-TMDQ, di-(t-octyl)diphenylamine) in rubber extracts by means of direct probe EI-MS with programmed heating, has been reported [252]. The main problem reported consisted of the numerous ions arising from hydrocarbon oil in the recipe. In older work, mass spectrometry has been used to qualitatively identify volatile AOs in sheet samples of SBR and rubber-type vulcanisates after extraction of the polymer with acetone [51,246]. 

Reporting and verification has just started so that the extent of the burden is not fully known. Similar size thresholds in US systems have not resulted in transaction costs that have created a noticeable problem despite similar reporting procedures.1 The only way around this burden would seem to be an upstream point of regulatory obligation - at the refinery, gas terminal or coal mine - that would result in a fuel price that included the price of carbon. This would have the same effects on abatement by small installations without the transaction costs involved in a downstream monitoring and reporting requirement. 

A procedure should be documented and established for the review of Deviation Reports (see Other Supportive Documents—Clause 558) and other indicators of quality or procedural problems. The procedure should require analysis of the data, assessment of whether a significant problem exists and allocation of the task(s) for corrective action. 

Lots of recommendations for changes could be generated from this part of the analysis, such as providing rigorous procedures for hazard analysis when a hazardous condition is detected and training and assigning personnel to do such an analysis. Better communication channels are also indicated, particularly problem reporting channels. 

The software ehange procedure and the configuration management system shall include an adequate problem reporting and tracking system. 

Problem Reporting and Corrective Action. A familiar problem with management systems is that although problems and issues might be effectively and accurately identified and recorded, their resolution can sometimes escape proper control. Procedures need to be in place to ensure that the quality loop is complete so that defect reports are properly tracked to their final resolution. 

The following references provide some examples of major applications of evaluation tests and of problems associated with sensitization. The uses of evaluation tests for the study of the effects of complex microstructures on corrosion have been illustrated in a detailed investigation of titanium stabilized, Type 321 stainless steel [33]. Industrial experience at Du Pont with the application of evaluation tests to more than 10 000 specimens of Type 300 series steels has been reported by Brown [34], On the subject of IGSCC at weldments of Type 304 stainless steel piping on boiling water nuclear plants, a detailed report is available from the U.S. Nuclear Regulatory Commission [35], which provides information on the origin and extent of the problem, remedial procedures, and the selection of replacement alloys. 

Cross [2] determined neutral oil (NFM) in a-olefin sulphonates, alkyl sulphates, alkylbenzene sulphonates and alkylether sulphates by this technique. He reported good accuracy and reproducibility, and complete elimination of emulsion problems. His procedure was as follows. Celite 545 is a diatomaceous earth supplied by Johns Manville. 

Many of the potential problems during the project works can be avoided by establishing effective communication channels between all of the parties involved in the works. Once again, the type and extent of communications established would depend on the nature of the project, but the communication channels which may be needed would include accident/incident reporting procedures, to ensure the client is fully aware of all accidents and dangerous occurrences. 

Collect data in a proactive but nonpunitive manner. Learn from errors to identify trends that may reveal problems with care. Two incentives for reporting include immunity and confidentiality. Effective reporting procedures help determine educational and training needs. Accurate reporting of errors can help identify policies needing revision. Reporting systems should collect information... 

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