Investigations and Corrections

Lamping, G.A. and AiTowood, R.M. "Manual for Investigation and Correction of Boiler Tube Failures." EPRI Research Project CS-3945, April 1985. 

Customer Complaints. A failure in a company s quaUty system often shows up in the form of a customer complaint. These reports of nonconformances, whether for product or service deficiencies, are typically received by the sales or customer service organization and then channeled to QA. Quahty assurance often tracks the progress and coordinates the complaint investigation. Once completed, it is QA that reviews the report of the investigation and corrective action for thoroughness and efficacy. QuaUty assurance then either passes the information along to the sales or customer service organization or contacts the customer direcdy. 

Where there is an imminent threat to human health and the environment, as well as in some nonemergency situations, the regulatory agency may ascertain that a response is appropriate prior to the completion of the RCRA Facility Investigation or the Corrective Measures Study. Hence, the decision for interim measures can be made based on the immediacy as well as the magnitude of the potential threat to human health or the environment the nature of appropriate Corrective Action the implications of deferring Corrective Action until the RCRA Facility Investigation and Corrective Measure Study is complete and other factors. 

Is there a program for handling customer complaints, complaint investigations, and corrective actions ... 

The laboratory shall have a policy and procedure for the resolution of complaints received from clients or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory. The laboratory shall have a policy and procedmes that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not coirform to "... 

In this way the contribution of the different factors to the total variance is determined. Suppose that the contribution of the factor instruments was most significant in the example of Figure 3.5. If one then wants to obtain a better overall reproducibility the reason for the large variance due to the instruments must be investigated and corrected. 

If three consecutive mns over action levels occur, a media-fill failure investigation and corrective action report must be issued. 

The laboratory must maintain records of complaints, together with investigations and corrective actions. 

The noncompliance detected is extended for investigation and corrective action (as relevant) ... 

Periodic reviews may also be prompted by reported or suspected problems with GMP compliance. When a periodic review determines a deviation from approved conditions or practices this must be investigated and corrective action approved. If there is a need to redocument or retest the computer system, then the need for revalidation must be assessed and the resulting rationale documented. 

The cost increase should be offset by cost reduction for quality control and failure investigation and correction. 

Lidocaine is indicated for the treatment of ventricular tachycardias (Fig. 12.4). Electrolyte abnormalities should be investigated and corrected prior to lidocaine administration. Lidocaine is administered as i.v. bolus doses of 0.5 mg/kg every 5 min, up to a total dose of 4 mg/kg (Table 12.3) (Muir Mcguirk 1987). Although lidocaine is used frequently in anaesthetized horses, quinidine gluconate or procainamide are preferred in conscious horses because they do not produce CNS side effects. 

Review the reports of previous inspections, reports of adverse drug experiences and complaints, if any exist, as investigations and corrective action taken by the manufacturer should be verified during inspections. 

Any time the yearly MKT of a facility approaches 25°C, the occurrence should be documented, the cause for such an occurrence should be investigated, and corrective actions should be taken to ensure that the facility is maintained within the established conditions for drug product storage. The FDA recognizes that, when the yearly MKT of a facility begins to exceed 25°C, it may not necessarily have an effect on products that have been stored for less than 1 year at the time, but it should be a warning that the facility itself may not be under adequate control. 

Multiprobe temperature and humidity distribution profiles should be obtained for empty preconditioning chambers, and temperature penetration profiles should be obtained with probes located within loads. The purpose of these studies is to demonstrate that the load is being uniformly equilibrated to the temperature (and by inference to the humidity) of the sterilizer within the proposed preconditioning time frame. Any serious lack of uniformity detected during validation studies should be investigated and corrected (even if Only by extending the time of the preconditioning cycle). 

On the other hand non-viral vectors, which have only been used for the past two decades, have yet to become a marketing reality because they still do not meet adequate safety profiles, the standards for efficient delivery, or the rigorous testing of clinical trials. Non-viral vectors involving cationic liposomes have been most widely used in pre-clinical and clinical trials however, apart from the non-viral delivery of genetic material, which is inefficient when compared to the delivery associated with viral vectors, non-viral vectors stiU suffer from some of the same toxicity issues from which viral vectors suffer. Some of the delivery issues such as hpoplex instability in the blood stream, interaction with plasma proteins, and non-specific cellular interactions persist, despite the extensive investigations and corrective maneuvers that have been conducted over the past decade. Therefore, currently, the only advantage with cationic lipids seems to be their inability to transform host cells into cancerous cells (3,4). 

Dresen MD, Nichols EM. 1987. Environmental protection investigations and corrections series Distribution of VOCs (Volatile organic compounds) in ground water in the southeast area of LLNL and vicinity. Washington, DC U.S. Department of Energy, Issue 13. 

For investigative and corrective purposes it may be necessary to determine whether an environment has become dangerous because of a chemical leak. An air pack and chemical suit might be required in this instance. 

Warnings went unheeded - Findings indicated that most incidents were often preceded by a series of smaller accidents, near misses, or accident precursors. Operations and maintenance procedures must include analysis, root cause investigation, and corrective action. 

However, the reasons for the plant being idle shall be thoroughly investigated and corrective steps planned carefully before investing in an attempt for revival. 

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