Documentation and inspections

In spite of the attempt to avoid procedural, documentational and inspectional overloads that are not usefiil, the inputs required for the classification scheme imply that in most cases the safety elassification of components cannot be done until ar-chiteeture and design are eompleted. For this reason comphance requires the application of the strietest proeess to the initial phases of the design for all items. 

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. 

The principal equipment for the ultrasonic examination is the P-scan system, PS-4, which is a computerised ultrasonic system, developed by FORCE Institute, for automatic, mechanical and manual ultrasonic examination of welds and materials. The system has documentation and storage facilities for all data related to each inspection operation, and includes visualisation of the inspection results in the form of images of the material volume examined. 

All correspondence, inspection reports, and other documents pertaining to the project, particularly those validating visits and inspections conducted by outside enforcement agencies, shall be kept in the project file. 

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. 

After preparation, a checklist may be used by less expert engineers than the preparers for inspecting the process areas to compare the process equipment and operations with the checklist oidrcr on hardcopy or laptop computer. The analyst fills in the checklist according to observations from their inspection, process documentation, and interviews with operators and their perceptions. 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

Document the methods you employ to denote inspection and test status for hardware, software, documents, and services. 

Accepted solutions are usually covered by specifications and codes of practice. These documents are important for three reasons they form part of the contract they define methods of design and fabrication proven by experience and they act as a means of communication between the parties involved in design, fabrication, construction and inspection. There is a strong incentive to use standard solutions as unexpected problems or misunderstandings are less likely to occur than if a novel solution is attempted such problems lead to the cost of rectification, but the delay that they cause is usually more importantConsequently project managers are often reluctant to be the first to use a novel solution. 

Inspection tolerance can be divided into two major components the accuracy variability of the instruction and the repeatability of the measuring method. The calibration and accuracy of the instrument are documented and certified by its manufacturer, and it is periodically checked. Understanding the overall inspection process is extremely useful in selecting the proper method for measuring a specific dimension. When all the inspection methods available provide an acceptable level of accuracy, the most economical method should be used. 

Archival study This involved a review of relevant documents and records, including dmg laws and executive orders inspection checklists DRA annual reports economic, health and other indicators and reports of other studies available (e.g. opinion surveys, dmg use studies). 

All validation procedures must be carefully designed and fully documented in written format (Box 7.2). The results of all validation studies undertaken must also be documented, and retained in the plant files. As part of their routine inspection of manufacturing facilities, regulatory personnel will usually inspect a sample of these records, to ensure conformance to GMP. 

Informed Consent. This must be obtained from study participants in writing before any study-related activities are performed. Regulations clearly describe the required elements of the consent document and the consent process to be followed. A good informed consent process can help ensure that potential subjects understand the nature of the studies they will enter, the type of treatments they will undergo, alternative therapies currently available, and any particular hazards they might experience. They must be informed that they can withdraw from the study at any time without penalty. Subjects are to be asked for their consent to release information from their medical records and told that the medical information may be inspected by sponsor company and regulatory agency representatives. They are to be informed that the results of the trials may be used publicly, but anonymously. 

PIC/S is a cooperative entity for member countries to work on harmonization of documents and procedures and mutual recognition processes with respect to GMP inspections being performed. 

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. 

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. 

Experienced senior staff of the sponsor must always visit the investigator site before a new clinical trial starts, even if the investigator has been involved in previous studies. Most pharmaceutical companies have checklists and SOPs of the requirements of an investigator site. Key questions will need to be answered relating to staff support and the present workload of the site. The competence of the staff to conduct any procedures, the maintenance, calibration and QC of any equipment to be used, and whether other clinical trials demand too much resource are aU questions that need answers. In addition, the facilities should be inspected to establish whether the site could store and securely archive the large amounts of documents and study drugs that will be present. The pharmacy may play a major role in the study and therefore the facility and the pharmacist should be visited. 

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. 

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