Records inspections and

Provide a means of recording inspection and test results so that any omissions can be checked at subsequent inspections. 

Purely experimental batches do not require QA approval. All approval must be based on a thorough QA review of the adequacy of the facility, its procedures, methods, records, inspections, and test results, prior to batch release. This applies to both internally manufactured batches and those made by contractors. 

D.2 Other Equipment Used with Compressed Gases 6.D.2.1 Records, Inspection, and Testing... 

Equipment Voltage Check by user Recorded visual inspection Recorded Inspection and test... 

What records Record inspection and maintenance dates ... 

All respiratory protective systems should be stored in clean, dry conditions but be readily accessible. They should be inspected and cleaned regularly, with particular attention to facepiece seals, nonreturn valves, harnesses etc. Issue on a personal basis is essential for regular use otherwise the equipment should be returned to a central position. Records are required of location, date of issue, estimated duration of use of canisters etc. 

The contractors SSAHPs at Sites I and K required that safety and health program inspections be conducted however, these requirements were not effectively implemented at either of these sites. Both Site K contractors required the HSO to conduct daily inspections, and both stated in their written plans that hazards would be immediately corrected. Neither contractor, however, had established hazard abatement procedures to ensure the prompt correction of hazards, and site records for both contractors indicated that hazard abatement activities were either not documented or not completed. For example, the subcontractor s daily safety log contained several notations of safety hazards, including an unstable concrete well and storage of diesel cans near the propane tank however, later log entries and site records did not track the abatement of these hazards. 

At Site I, the prime contractor s SSAHP required daily site inspections, the documentation of safety and health deficiencies, and the abatement of deficiencies. Records of site deficiencies, however, were kept intermittently, and hazard abatement was not documented. The subcontractor s SSAHP did not address site inspections and hazard abatement, but its TSCA permit application included requirements for site inspections. Inspection documentation, however, was not available on site, and the site manager was unaware of these written requirements. The site manager did, however, indicate that he conducted site inspections using a mental checklist and that he conducted inspections of remediation equipment before each use. 

Specify the documentation requirements and format, such as checklists for recording inspections, startup, and functional performance tests. 

Are the required inspections and tests and the records to be produced detailed in documented procedures or quality plans ... 

Are records maintained to provide evidence that product has been inspected and tested and meets the specified requirements ... 

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

The way the requirement is worded implies that the purpose of the procedures is to verify that specified requirements are met rather than this be the purpose of carrying out the inspection and test. Whether the procedures verify that specified requirements have been met or whether the inspections and tests achieve this purpose is immaterial, as you need to verify that you have met the specified requirement and have records which demonstrate this. 

The standard requires that the required inspecting and testing and the records to be established be detailed in the qualify plan or documented procedures. 

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. 

Make provision for the results of the inspections and test to be recorded. 

Provision for the results of the inspections and test to be recorded - these need to be presented in a form that correlates with the specified requirements. 

The standard requires that the supplier establishes and maintains records which provide evidence that the product has been inspected and/or tested. 

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. 

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