Documentation of inspections

Sign off all documentation of inspections Maintain all records and documentation pertaining to its activities, methodologies, and investigations, including results... 

There are other equivalent tests which can show that the vessel is mechanically strong. For pumps, integrity data would involve the frequency of seal repairs, bearing repairs, nature and intensity of vibration, plugging, and corrosion problems. With the mechanical integrity tests, other data is recorded, such as records of inspections and tests, maintenance procedures, establishment of criteria for acceptable test results, and documentation of inspection results. Preventive maintenance (PM) programs are a big part of the PSM. 

There should be a program for regular inspections of all science and engineering, safety and security practices, and facilities. Conducting an inspection is just the first step issues found should be resolved to achieve a safer and more secure status. Written communication and documentation of inspections and of resolution issues are essential (see Appendix G for sample inspection checklist). 

Documentation of inspections must evidence thoroughness beyond the perfunctory use of checklists. 

Does documentation of inspection include the signature of the person conducting the inspection ... 

The paper documents the results of inspections carried out in a variety of such applications and suggests a procedure to evaluate the application of the method. 

The QAP enables the user to have a consistent documentation of the variable parameters and inspection results (with camera system). A protocol can be printed out to be used as documentation for the equipment and inspection. 

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. 

Equipment used to process, store, or handle highly hazardous chemicals must be designed constructed, installed and maintained to minimize the risk of release. A systematic, scheduled, test and maintenance program is preferred over "breakdown" maintenance " that could compromise safety. Elements of a mechanical integrity program include 1) identification and categorization of equipment and instrumentation, 2) documentation of manufacturer data on mean time to failure, 3 ) test and inspection frequencies, 4) maintenance procedures, 5) training of maintenance personnel, 6) test criteria, and 7) documentation of test and inspection results. 

To meet this requirement for documented procedures you will need two types of procedure procedures which provide for the necessary inspections and tests to be planned and carried out at the appropriate stage of the process and procedures for carrying out the specific inspections and tests. However, this is not to say that you need to document how you conduct every type of inspection or test. You only need procedures which define how inspections and tests are to be performed when the lack of them will adversely affect the result. Where the inspection and test methods are no more than using the tools of the trade, no procedures will be necessary providing the acceptance criteria are specified in a specification, drawing, or other such document. 

In defining your inspection and test requirements it is necessary not only to specify what inspections and tests are required and when, but also to define the acceptance criteria and the frequency of inspection and test. Are the acceptance criteria those defined in the product specification or are the limits to be closed to gain better control over the process Is every product to be inspected or are the quantities so large that it would be economically unviable If sampling is to be performed what are the acceptance criteria Answers to these and other questions need to be provided by your documented inspection and testing requirements. 

In what documents is the process employed for the calibration of inspection, measuring, and test equipment defined ... 

The standard requires the supplier to maintain the identification of inspection and test status of the product, as defined in the quality plan and/or documented procedures throughout production, installation, and servicing to ensure that onty product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used, or installed. 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

There is, as always, a need for good quality data. Most of this is now available in electronic form and Chapter 11 lists some of the databases available. In spite of proclaimed good intentions, there is little systematic documentation of the successful application of plastics and their lifetimes, only examples of unexpected failure. There is a need for medium-term, lightly accelerated tests under intermediate conditions to validate the predictive models. While inspection of components at end-of-life is more prevalent than expected, there is a need for coupling it to predictive techniques to validate these techniques and to close the loop of life prediction. 

Inspections consist of a visual check of the fire protection systems by qualified personnel to ensure the system is available for immediate use. Visual checks should be made using a checklist. The inspection should verify that the fixed and portable equipment is ready to be operated. The associated devices, fittings, piping, and valving are inspected to ensure they have not been tampered with and that there is no obvious deterioration, physical damage, or condition to prevent operation. Documentation of the visual inspections may vary from... 

Checklists are a valuable tool for documenting the inspection, test, and maintenance of fire protection equipment and systems. The CD-ROM accompanying this book contains checklists developed by one company. Many small and medium size companies may not have the resources to develop these checklists. 

Improve documentation of relief valve inspection and pop tests. Annual testing of relief valves is recommended until a valve has a history of good pop tests. Then the frequency can be slowly extended. (Program established by March 2002)... 

For visual observation of the cell interior through the sapphire windows a lamp mounted behind one end is used. A mirror and stereo microscope at the other end facilitate the observation. The microscope is equipped with a normal camera or a video camera. Normally the phenomena within the cell are continuously observed and controlled with video camera and colour monitor. A video recorder serves for documentation, for inspection of short time processes and for the production of standing flame pictures for size and shape determination. Instead of the microscope a Jarrell-Ash diode array rapid scan spectrometer can be attached to the cell to obtain flame spectra in the visible and UV-regions. 

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials. 

As to equipment, the QAU would check to see if it is clean, well maintained, and regularly inspected, as would be evidenced by inspection tags and log books. The unit would want to know if the manuals and log books for equipment use, calibration, and maintenance are readily available and being used properly. The QAU would want to know if calibration is being done correctly and is properly documented, and whether all documentation is recorded in ink. Finally, the unit would check for proper documentation of errors, including initials, dates, and explanations, and whether changes are made so as not to obscure the original entry. 

Completing the Audit At the conclusion of the audit, an exit interview should be conducted so that all concerns can be immediately conveyed to staff. It is important to be aware of questions or concerns the auditors may have before they leave. A file of inspection documents should be maintained... 

Equipment inspection, maintenance, and repair records can be recorded in a logbook especially designed for that purpose. For equipment that is moved from laboratory to laboratory, the logbook should accompany the equipment when it is moved. Documentation of calibrating or standardizing operations, on the other hand, may be more efficiently recorded with the associated records of the data acquisition activities. 

The historical file of SOPs documents what SOPs were in effect at any time during a laboratory s history. Because FDA inspection of a study often occurs years after the completion of that study, the historical file of SOPs will be of special use to an FDA inspector. Including the effective date on the SOP itself will aid in maintenance of the historical file and will also make it easier to ascertain if any one SOP manual contains the current version of any individual SOP. Accessory documentation of effective dates (e.g., in the transmittal memo for the distribution of SOPs) is permissible but not recommended. 

Tests to establish the identity, strength, and purity of the test and control articles need not comply strictly with GLP requirements (e.g., protocol, QAU inspection requirements), but good documentation of anal5dical test results (usually in a laboratory notebook) and retention of raw data for such tests is a good practice. As the development process proceeds and the same material is used in both nonclinical and clinical studies, CGMP principles wiU apply to the production and characterization processes. 

The cliche of the three Ds — documents, documents, and more documents — is apt for FDA PAI inspections. Historically, the regulatory agencies have relied heavily on cross-checking documents to ascertain the state of compliance with the cGMP regulations. The documents of critical importance are the batch records that contain detailed information about the batch history. It is often difficult for a firm to fudge these documents, although many have tried. What is important to understand here is that the entire batch record is cross-checked with the pur-... 

A historic summary of the development of the product serves many purposes. The foremost purpose is to apprise the investigators of the scope of inspection. The investigators learn more about the product from the history of its development than from the analysis report of the finished product. This shows the awareness of the firm about the development process. This document should include a description of the API, the formulation, and the analytical methods. These sections should be clearly marked or presented in separate binders. The summary section should highlight how the biobatch is linked to the full-scale batch with respect to validation and scale-up of production. This section also offers an opportunity for the firm to address the issues that it considers critical. 

Once the cleaning validation has been completed, equipment can be cleaned in a routine manner. This involves records to show that the cleaning followed the proscribed instructions. Also there should be an evaluation of the efficacy of cleaning which can involve documentation of a visual inspection. 

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