Testing records

Electromagnetic NDT instruments allow to increase the test records reliability. They are most efficient for detection of the rope durability loss as a result of loss of metallic cross-sectional area (LMA) localized faults (LF) like broken wires, localized corrosion etc. 

If test records are not readily available, test procedures specify the number of test demands or operating test... 

The initial performance test for all local ventilation systems is a smoke test, which provides easy airflow visualization between the source and the hood, it helps to identify, with little effort, the main features of airflow patterns. Such a test, recorded by a video camera, allows performance comparisons to be made before and after improvements. Real contaminant or tracer gas measurements are necessary in the case of more detailed testing. 

Make provision in inspection and test records to capture details of inspection, test, and measuring equipment used. 

The second part of the requirement deals with inspection and test records, which are also covered in clause 4.10.5. The difference between these requirements is that clause 4.10.1 requires you to document the records to be established (in other words define ) in the quality plan or procedures and clause 4.10.5 requires you to produce the records defined in the quality plan or procedures. Your inspection and test procedures therefore need to specify or contain the forms on which you intend to record the results of the inspections and tests performed. The details are covered later in this chapter, but there are two types of record to be considered the record that shows which inspections and tests have been performed and the record that shows the results of these inspections and tests. One may be a route card, shop traveler, or document which acts as both a plan of what to do and a record of the progress made and the other may be a table of results with specified parameters and accept/reject criteria. 

Your inspection and test records or verification records should be of two forms one which indicates what inspections and tests have been carried out and the other which indicates the results of such inspections and test. They may be merged into one record but when parameters need to be recorded it is often cleaner to separate the progress record from the technical record. Your procedures, quality plan, or product specifications should also indicate what measurements have to be recorded. 

The standard requires that the inspection and test records show clearlp whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. 

Provide secure areas for storing inspection and test records. 

In which document do you specify the inspection and test records to be established ... 

The inspection and test records should indicate the original rejection, the disposition, and the results of the re-inspection in order that there is traceability of the decisions that were made. 

Apart from inspection and test records (clause 4.10.5), the standard does not require records to be authenticated, certified, or validated. A set of results without being endorsed with the signature of the person who captured them lacks credibility. Facts that have been obtained by whatever means should be certified for four reasons ... 

If valid and useful relationships are to be established, it is essential that the factors affecting performance be recognised and form part of the test record. Since the performance is determined by interactions between the coating, the substrate and the surrounding environment against which protection is sought, significant factors and their interrelationships will vary with the nature of the service. 

The exposure site is selected according to the service for which the data are to be applicable. For atmospheric service, such factors as marine and industrial contaminants, sunlight, dew and sand abrasion, must be considered. Atmospheric specimens are normally mounted at 45°, facing south. This has been shown to provide about a 2 1 acceleration of failure compared with a vertical exposure. Whether this or other standardised positions are used, the details of the exposure are an important part of the test record. 

The program also has a Matching utility that records the results of two or more searches, stores, and compares them. Matches may be made by material (polymer) or by product model. The Matching utility eliminates test records that do not appear in all of the searches that were made. Matching by product model always eliminates more models as the number of searches increases. Conversely, matching by polymer may increase or decrease the number of models found as the number of searches increases. 

Key elements of reactive hazard identification are owner-initiated review, chemistry review, review of unit operations, review of scenarios, definition of required testing, records testing, and interpretation of results for owner. 

Records include materials transfer records, batch records, materials/inter-mediates/finished product test records, shipping records, water test records, and environmental test records. They provide an audit trail for reviewing all the information related to the production of any batch of drug product. The data are required to be reviewed for product release. 

Consider the VMP as the corporate doctrine of a corporation s general validation, testing, recording and archival practices. Typically, the SOPs within the VPM are too general and, therefore, it is advised that one create specific SOPs for a particular system to be validated. These would be part of an HPLC system s validation plan. Note that the VMP should be thought out and drafted well in advance of developing a specific system Validation Plan. 

Paper—Operating logs, policies, procedures, alarm logs, test records, and training records are examples. 

Response of the sensors to exhaled air was registered after an overnight fast of the subjects in one-minute exposition mode. The measuring unit was controlled before a measurement cycle by test recording of several responses to an action of exhaled air of the investigator. 

The test is declared invalid if validation challenge organisms do not show clearly visible growth of bacteria within 3 days and fungi within 5 days in the test media-containing product. In most cases, unless the sterile product causes turbidity in the media, visual recovery times should be comparable to those of the growth promotion test. Records of validation and/or revalidation tests should be maintained. 

Review and verify chamber leak test records and make entries on the MFM. 

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