Field audits

After you have completed your operator interviews, take a walk around the unit and look at the condition of their safety instrumented systems. Do the devices look well maintained, are they properly labeled and tagged, do you see any unauthorized or undocumented bypasses, etc.  

---

Mackintosh DR, Zepp VJ. Detection of negligence, fraud and other bad faith efforts during field auditing of chnical trial sites. Drug Inf ] 1996 30 645-53. 

Crist FIL, Mitchell WJ. 1986. Field audit results with organic gas standards on volatile organic ambient air samplers equipped with Texas GC. Environmental Science and Technology 20 1260-1262. 

Following the discussion, the committee makes a field audit, checking the suitability and placement of equipment, the impact of the process on the area, and the impact of the area on the process. 

Summary This chapter describes a four-component program of a program to avoid materials mix-ups on your site 1) effective identification of materials and parts in your procurement database. 2) selection of competent suppliers. 3) organization of efficient receiving inspections, and 4) implementing field audit before parts are used. The regulatory background that drives us to avoid materials mix-ups is also described. 

Perform Field Audit Before Use. The mechanic or craftsperson must verify that the part is indeed correct. Despite a seamless quality chain through to the receiving warehouse, the final delivery system could have switched parts. Thus, the mechanic or craftsperson is the inspector of... 

Figure 1 -7. The field audit is the "inspection of last chance."... 

Incoming materials must be checked for conformance with the specification and purchase order, and then labeled accordingly. Materials received and stored must be compared with the purchase order and accompanying paperwork. Mechanics and crafts people must conduct a field audit of the materials before putting them into service. 

Only by reviewing the procedures, interviewing the plant personnel, reviewing the records and conducting a field audit will the auditors gain the answer to these questions. 

A field audit of whether or not the procedure is being used... 

There are two commonly used and effective ways to measure field compliance field safety inspections and hands-on field audits. Notice that the terms field and hands-on are used in the previous sentence. These are key words because trying to perform inspections and audits from the office or the ivory tower is just not the same as being there. 

Critical to the successtlil completion of this process are the software tools required to store and analyse the inspection and related data. This is a major task and to achieve this OIS has produced, in conjunction with a major specialist technical software provider, the Asset Condition Evaluation Tool (Acet). Acet is a comprehensive suite of programs which draws on the extensive experience of engineers working in this field for many years, to provide a readily usable and highly auditable package for this application. 

The energy audit has seven components as-it-is balance, field survey, equipment tests, checking against optimum design, idea-generation meeting, evaluation, and foUow-up. 

The audit/inspeetion form that you should use ean be developed from the safety plan. A qualified person should examine the safety plan and eome up with a eheeklist that should serve as an audit/inspeetion form. Allowanees should be made to inelude items not speeifieally noted in the safety plan but that may be observed during field walk-throughs. Certain highly pertinent seetions of what OSHA uses when performing a eomplianee inspeetion of hazardous waste sites is ineluded in Appendix D. This inspeetion/audit form eovers many of the basies and ean be used a general guide. 

Support for sites is multi-tiered and includes participation by numerous federal, state, private, academic, and tribal organizations. Network operation includes rigorous field and laboratory quality assurance/quality control (QA/QC), including an external quality assurance program and periodic external on-site audits. 

The form or format of the notebook is not as critical from a GLP compliance standpoint as the completion of the record in an accurate, timely, readable, and attributable manner. Company and PI conventions typically have evolved into cost-effective and very efficient data notebooks for field residue trials. These notebooks contain the actual raw data for the trial and once begun become extremely valuable legal parts of the study record. The notebooks should be audited by QA during the field phase of the study as well as at the end of the trial before the notebook is returned to the sponsor organization. The quality of the trial is easily refiected in the quality of the field notebook at the end of the season. 

The records required for field residue study authentication are the same records that would be required to reconstruct the study. Although this total volume of information is a necessary part of the GLP study record, the field summary report is a small fraction of that record. The field summary report is simply the information the EPA reviewers wish to see as they consider the data and determine how well they represent the crop situation for which the pesticide tolerance is being requested. At the current time, the field summary report should contain the information requested on pp. 48 and 49 of OPPTS 860.1500. The summary report for each test site in a study will typically form an appendix in the final study report. This information must be accurately extracted from the raw data notebook or field record and must be audited by... 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

---