Audit communication during

Thereafter, the primary functions of the study QA specialist fell into two main headings. First, GLP compliance during the collection and documentation of commodity samples had to be assured. This was done via observation of several collections for different shops (collection incidents) at various geographic locations. In these audits, the study QA specialist examined specific items, such as (1) did the shopper follow the written instructions, (2) were the correct types and numbers of samples collected, (3) was the documentation maintained as required, (4) were the samples labeled and packaged correctly, and (5) were the samples delivered to the shipper as required Findings were communicated to study management and used as appropriate in subsequent shops. 

CRAs achieve these tasks through frequent visits to the clinical trial site. During these visits, the monitor will verify source data, audit regulatory documents for accuracy and completion, perform drug accountability assessments, and communicate any concerns, problems, or new information with the study staff. 

During the audit, the team is alert to new technology, good operating practices, new equipment, and operating disciplines which can be communicated to other plants within the Technology Center s scope. 

The traditional audit may still be useful in that it leads one in the direction of identifying a faulty system or process, and if one chooses one can go further. Using the innovative approach offered by the quality assessment has some limitations in that it is not the current approach used during pharmaceutical and biotech inspections. Mock FDA audits should be used on a routine basis to ensure employees communication skills are sharpened and that the facility is inspection-ready. Preparation for an FDA inspection should begin during product development. It is a continuous process of the QAP, which the company should implement as early as phase I. No amount of resources in the last weeks before an inspection can make up for lack of adequate planning and preparation. 

Audits are conducted under rules of continuous communication—when a problem is found, the emphasis is on full understanding of the identified problem as well as identification of potential solutions. Deficiencies are documented and adjudicated. Contentious issues sometimes arise, but an attempt is made to resolve them during the audit process. 

Know what is expected. Be alert to communicate the audit team needs and reiterate the ground rules stated during the first day s audit team presentation. 

If the carrier has an electronic mobile communication/tracking system that does qualify, the carrier must retain and be prepared to present all supporting documents listed in Question 10 during an investigation or audit. 

For carriers that use an electronic mobile communication/ tracking system that does not meet the standards, there is one word of warning. The records from these non-qualified systems must still be retained for six months and can (and will) be requested and used as supporting documents during an investigation or audit. The fact that the system does not qualify only means that the carrier cannot use it to ease the supporting documents recordkeeping requirements. 

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. 

Safety audits perform a valuable function in that they determine the effectiveness or ineffectiveness of the organization s safety and health management systems. In accord with the audit requirements of ZIO, deficiencies noted during safety audits are to be documented and communicated to those who can take action to eliminate them. The deficiencies are to be prioritized for orderly consideration. 

In addition, hazardous situations observed during an audit that might be the causal factors for serious injuries, illnesses, or fatalities are to be immediately communicated to the appropriate decision makers so that actions may be taken on a high-priority basis. This is in concert with one of the principal themes in this book—serious injury prevention. 

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