During the Inspection

Brief overview of the documentation systems of the company, for exampie, QM manuai, process instruction (Pi) sheets, test procedures and associated protocois, operating procedures (SOPs). 

Immediately after the company presentation, the inspectors should be invited to ask questions. When all questions are answered, the lead inspector will introduce the team and reveal the contents of the inspection. This should bring no surprises, because already in the preparation phase of the inspection, it is of the utmost importance to strictly clarify the scope of the upcoming FDA inspection. 

After agreement on the contents of the inspection, a little break to drink coffee, tea, or soft drinks can be used to give the participants who do not belong to the core team of the audit room, the opportunity to leave the room. 

The audit room is the room, in which the inspectors and the core team stay during the inspection and where the documents and records are reviewed by the inspectors. This is also where the opening meeting and the closeout meeting take place. The management or management representatives must be present both at the beginning and at the end of the inspection. 

The back office is the communication center in the background of an FDA inspection. Here, all information from the audit room about the questions or needs of the inspectors is gathered. These requests can be reported to the back office, either directly from the audit room or during the company-walkthrough. All documents, records, or samples requested by the inspectors shall be verified first in the back office and then transferred to the audit room. Similarly, the persons who have to present issues of their field of responsibility in the audit room will be prepared in the back office (briefing). These persons are kept ready and wait in the back office until they are called by the note-taker of the audit room to present their topic. These activities are to be documented by the note-taker in the back office tracking fist. 

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The application of Acoustic Emission Examination (AE) during the inspection of pressure equipments, P Tscheliesnig - presented at the 3. Hungarian Conference on Safety Budapest, 1997... 

During the inspection of an unknown object its surface is scanned by the probe and ultrasonic spectra are acquired for many discrete points. Disbond detection is performed by the operator looking at some simple features of the acquired spectra, such as center frequency and amplitude of the highest peak in a pre-selected frequency range. This means that the operator has to perform spectrum classification based on primitive features extracted by the instrument. 

Besides simulation of the robot motion, a full virtual inspection includes simulation of the ultrasonic sound propagation during the inspection. For this purpose the UltraSIM/UlSim simulation module is used. 

Field notes should be taken during the inspection to use in preparing a report on the visit. Observations should include the following ... 

It should not come as a surprise during the inspection that a boiler needs cleaning. Unfortunately, for the owners and operators of many smaller plants, it can be just that, simply because there are no MU water meters or steam charts installed, fuel consumption records are not studied, and water analysis sheets are not properly interpreted and proactive steps taken. 

Personnel met during the inspection The names and titles of key personnel met should be specified (listed in annex). 

Friedrich Stromeyer (1776-1835). During the inspection of a pharmacy, Stromeyer confiscated zinc carbonate as it did not meet the purity standards when calcined, it showed a yellow residue cadmium oxide. 

During the inspection, the inspector should proceed with particular emphasis on the critical points. This system guarantees that the internal quality assurance is oriented to the risks associated with the particular type of production. It is a preventive approach. The employees who identify with the organic objective , who are involved in the process and assume responsibility for it, are more careful, because they understand the sense of quality assurance and do not feel that it is an additional burden, impractical, bothersome, a mere formality and bureaucratic. 

For unrevealed failures the failure becomes obvious only after regular inspection. This situation is shown in Figure 11-7. If ru is the average period of unavailability during the inspection interval and if r is the inspection interval, then... 

Each facility needs a system to manage the deficiencies found during the inspections, testing, and maintenance of the systems. Managing deficiencies in fire protection systems is time-critical and an appropriate system must be developed to recognize, prioritize, and manage these deficiencies. It is important that the system addresses how to ... 

For health professionals in consultations with patients complaining of diarrhea, it is pertinent to ask "Is it oily " and "Have you consumed fish " If answers are confirmative, the case should be reported to food inspection agencies. To follow up on the alert, food inspection agencies should collect the expelled oil sample, a residual sample of the cooked fish (if available), and any uncooked fish from the same source to check for wax esters. If wax esters are detected, DNA analysis should be applied, if possible, to identify the source species. Concurrently during the inspection process, food safety agencies should trace back to the supply source of the fish to see if proper labels were in place. If not,... 

Firefighter Green arrives at an apartment building for a routine inspection. During the inspection, she notices several fire safety violations in the building across the street. The best course of action for her to take would be to... 

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. 

The data for the analysis were compiled by the FDA and derived from 614 Turbo EIR reports completed from 2001 to 2003. (FDA investigators enter their inspections observations on the FDA s Turbo EIR system. The Turbo s electronic format prompts investigators to select the specific cGMP violation in question and then to explain their findings uncovered during the inspection.)... 

Example 1 A medical device manufacturer is concerned about the nonconforming (defective) and the nonconformity (defect) produced in its recently set-up production line. Twenty batches of this medical device were randomly selected from the production line. Each batch contained 100 units. Each unit is inspected and is classified as either conforming or nonconforming. During the inspection, the number of nonconformities (defects) was also counted. The data collected are shown in Table 3. 

A supervisor of the unit being observed normally accompanies the auditor. During the inspection, the supervisor is informed of practices, equipment, or devices needing correction. This enables the supervisor to take or consider corrective measures before the audit report is presented to management. 

The best time to respond to an FDA-483 is during the inspection before it is issued. The importance of this timing cannot be stressed too strongly. Most companies make efforts to learn of investigator concerns in a timely manner. A first step is obtaining a commitment from the investigator that perceived... 

It was suggested earlier that responses to FDA should focus on the systems that underlie the observation or deficiency. During the inspection, there may not be time to do so, so it is acceptable during the course of the inspection for the company to offer the short-term corrective measure and subse-... 

The ISP has the right to retain portions of all samples taken or to take duplicate samples (CWC VA Part II paragraph 54) therefore, any sample collected during an inspection is split into several fractions. In case of off-site analysis, split portions of the respective sample are sent to a minimum of two designated laboratories. These split portions are prepared, packed, and sealed on site during the inspection and are only opened at designated laboratories. 

At the beginning of an inspection, an individual inspection notebook is issued to each IT member. The inspector must record all information gathered during the inspection preparation phase and on-site activities in his/her inspection notebook. The notebooks never leave the custody of the IT. 

All activities and factual findings during the inspection period are reported in the Preliminary Findings (PF, for all inspections except CWDF) or monthly Interim Report (IR, for continuous monitoring CWDF inspections) (see CWC VA Part II Paragraph 60). An inspection report includes annexes concerning samples taken and analytical results. As part of these Annexes, an on-site Analytical Report is attached, which consists of... 

Documentation During the Inspection Period Handling of Authentic Samples from Inspection Sites at the OPCW Laboratory Packing and Transport of Off-Site Samples Destruction of Sample Material... 

Nondestructive evaluation (NDE) of composites will be an important area of future development. NDE refers to the use of inspection techniques which can characterize a material or component without damaging it during the inspection process. In general, the types of testing described above are... 

During the inspection of the structures generated by the SPS generator, the user could edit all structures which do not fulfill his/her esthetic requirements. 

There was no indication during the inspection that the XXXX system [and associated electronic records and signatures] was being validated. In fact there was no evidence that a concurrent manual system was in place. [FDA Warning Letter, 2001]... 

At this stage the pharmaceutical or healthcare company may wish to consider asking the inspector to sign a confidentiality agreement. During the inspection proprietary information must be respected. 

Identify what information and resources may be needed during the inspection what was reviewed and outcome of previous inspections, and what corrective actions are closed, in progress, and not started. Review problem logs and change control records. Consider if there are any topics the company would like to take the opportunity to brief the inspector with. 

Provide knowledge of how computer systems are used Support inspection of validation documentation from retrieval of appropriate documents to walking through validation conducted Keeps minutes of inspector s comments and observations Keeps a record of documents requested and provides to inspector Accompanies the inspector during the inspection at all times Brings and removes documents requested by the inspector... 

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