Failure investigation

All coils that are subjected to this test must fulfil the test requirements. In the case of a failure, investigations must be carried out to establish the cause and the same rectified before undertaking the insulating process on the next batch of coils. 

For a eatastrophie failure in the aerospaee industry with a high probability of loss of life, whieh relates to an FMEA Severity Rating (S) = 10, a business eould quite possibly need insuranee eover well in exeess of 100 million. This will allow for eosts due to failure investigations, legal aetions, produet reeall and possible loss of... 

Conventional alloy seleetion, eoating speeifieation and failure investigation skills will always be required, as will inspeetion serviees to eonfirm the eondition of the plant. However, the phenomenon labeled eorrosion should no longer be regarded as a neeessary evil as it is only a problem when out of eontrol. The eleetroehemieal behavior eharaeterizing eorrosion is also the means by whieh on-line plant health management ean be aehieved. 

Retrieval by turbine exhaust temperature. The exhaust temperature can be an important parameter in failure investigations. An analysis of this parameter in failure investigations. An analysis of this parameter can verify the existence of a problem with either the combustor or turbine. 

Failure investigation procedure Nonconforming material review procedure Customer complaints procedure Quality system document change procedure Specification change procedure Maintenance procedures... 

The technical service departments of paint manufacturers are a valuable source of free information on their own products. For independent advice on new materials, comparison between materials, specifications not tied to proprietary types and failure investigations, there are consultants and test laboratories that will generally assist on a fee-paying basis. 

O Brien KL, Selanddo JD, Hecdivert C, Placide MF, Louis M, Barr DB et al. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. Acute Renal Failure Investigation Team. JAMA 1998 279(15) 1175-80. 

In the case of an unacceptable media fill, product remains in quarantine pending investigation of results and establishment of the system as being in a state of control. The status of products produced prior to the media fill failure is also evaluated. Products manufactured for a period of at least 60 days preceding the media fill failure will be evaluated. Products manufactured prior to this 60-day period may also be evaluated based on the results of the media fill failure investigation. 

The disposition of product made before or after a failed media fill would depend upon the results of an investigation to determine the cause of the media fill failure. The investigation would be conducted in accordance with manufacturing site SOP for Media Fill Failure Investigations. ... 

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

In case of media-fill failure, apply SOP (provide number), media-fill failure investigation. 

SUBJECT Sterility Test Results Failure Investigation... 

Section Val. 1900 includes four aseptic processes associated with monitoring and qualification programs covering determination of components bioburden before sterilization sterility test failure investigation, bacterial endotoxin determination in WFI, in-process finished product, and monitoring the bioburden, spore bioburden, and endotoxin present on stoppers and unprocessed vials. 

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

Note that Part 820 requires that results of acceptance activities be recorded but not necessarily all raw data. Results must have audit trails. Be sensitive to need for raw data during failure investigations under CAPA. Refer to Part 820 preamble, pp. 52631 and 52646. 

In the context of Part 11, one of the differences between Parts 211 and Part 820 is the scope of the electronic records that must be maintained. Part 21 requires the maintenance of electronic regulated data including raw data. Part 820 requires that the results of acceptance activities are recorded, but not necessarily all of the raw regulated data. The exception in 820 is that raw data is required during failure investigations. As in Part 211, results under Part 820 must have audit trails. Refer to Part 820 preamble, pp. 52631 and 52646. 

For routine production, it is important to adequately record process details (e.g., time, temperature, equipment used) and to record all changes that have occurred. A maintenance log can be useful in performing failure investigations concerning a specific manufacturing lot. Validation data (along with specific test data) may also determine expected variance in product or equipment characteristics. 

The elements of athorough investigation necessarily will vary with the nature of the problem identified. All failure investigations must be performed promptly, however within 30 business days (6 weeks) of the problem s occurrence—and recorded in written investigation or failure reports. 

Deviations and failure investigation data—The failure of any batch to meet any specification, including batches failing in-process, release, or finished-product (shelf life) specifications is a crucial event. Such events must be reported and captured in the APR system. The identification of the root cause and the determination of corrective... 

It is necessary in failure investigation to determine the type of damage, the cause of the damage, potential solutions to either minimize or eliminate the damage, choosing the best solution based on economics, safety and environmental considerations. The final step involves the practical implementation of the best solution in service conditions to confirm the validity and conclusion that it is indeed the best solution. 

One factor, which should always be considered when performing materials failure investigations, is the influence of human error. This section provides three examples of equipment failures due to cracking for which the root cause of failure was found to be... 

The failure investigations described in this paper illustrate two situations where human error during common maintenance and repair activities ultimately played a role in the failure of industrial machinery. The third failure investigation revealed how, even when the potential for failure is known (i.e., SCC of 304 SS), human error during the procurement and/or installation phase of the piping clamps resulted in an SCC-susceptible material being installed and ultimately failing in a catastrophic manner. 

Failure Investigation. The crack shown in Figure 7.42 had propagated through almost the entire cross-sectional area of the crankshaft web. The remaining ligament was broken open to expose the crack faces where, as is shown in Figure 7.43, it became readily... 

Failure Investigation. The clamp was nonmagnetic and the stamped identification on the side of the U-shaped shells indicated that they were fabricated from forged 304 austenitic stainless steel. Visual examination of the fracture surfaces revealed they were entirely brittle and exhibited a very coarse fracture morphology. Liquid penetrant inspection revealed the presence of additional cracks in the fractured half of the clamp. There was no cracking present in the high-strength steel fasteners. 

P. Jones, T. Hetu. A Case Study of Hydrogen Induced Cracking Failure - Investigation, Remedial Action and Maintenance. NACE International, Calgary Section, One Day Seminar on Failure Mechanisms, Calgary, Alberta, Canada, 1998-04-07. 

Please note that figures 7.53 (Plate 2), 7.54 (Plate 3), 7.55 (Plate 4), 7.56 (Plate 5), 7.57 (Plate 6), 7.58 (Plate 7), 7.59, 7.60 and 7.61 are Crown in Right of Canada, sourced from Failure Investigation Report 0505007 (Report on Copper Pipe or Sprinkler Pipes Experiencing MIC), Mr. Nick Dawe, P. Eng, D/Chief Building Services - PSEPC. 

The Quality Control Unit failed to ensure that adequate procedures were in place to dehne and control computerized production operations, failure investigations, equipment, qualifications, and laboratory operations. [FDA Warning Letter]... 

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