Audit operations, conducting

Only experienced quality auditors, such as the chemists who are knowledgeable in the analysis being audited, should conduct external audits. Audit findings give rise to corrective action that is implemented and documented by laboratory operations personnel. However, even the most detailed and frequent audits may be ineffective in disclosing data fraud (Popek, 1998b). External audits are expensive and are usually conducted for government project or major industry client work. 

Periodic performance audits are required to validate the accuracy of the air-monitoring system. The Code of Federal Regulations (CFR) requires that performance audits be conducted at least once a year for criteria pollutant analyzers operated at state and local air monitoring stations (SLAMS). The EPA recommends that each analyzer be disconnected from the monitoring station manifold and be individually connected to the audit, from which it will receive the audit gas of known concentration. The audit gas concentrations are usually generated in a van, using a gas calibrator to dilute multiblend gases with zero air. 

Safety Audit. A safety audit is a method of reviewing the actual construction and operation of a facility. Often, safety audits are conducted by a small interdisciplinary team. At least some of the members of the team are not connected with the plant. The audit may be carried out before startup and also is repeated later at intervals of, typically, one to five years. 

An energy efficiency audit and a general pollution prevention assessment of the operations for a building industry, to determine if waste reduction and cost reduction are possible. Operations conducted at this facility include form fabrication, concrete mixing and pouring, and sand blasting and acid washing to impart the finish. These concrete slabs are formulated with a variety of sands and stone specific to the needs of the customer. 

Audits are conducted as a management tool for assessing the quality level of an operation. They are used to identify nonconformance and to make corrective actions as needed, and prevent reoccurrence of potentiail problems that can adversely affect a product. Audits are conducted internally and externally. Supplier audits may be directed for cause , such as a customer complaint, for change control, or for a product problem. Audits may be scheduled on a regular basis (e.g., every 3 years) for suppliers of key or critical materials. 

Critical to the ongoing success of storage and warehousing operations is the continuous antilysis and evaluation of the day-to-day operations to identify opportunities for improvement. A formal, periodic audit of the existing operations, conducted in a systematic manner, can be an effective tool for achieving continuous improvements. While a numtjer of specific methodologies can be utilized to conduct such an audit, the following discussion will define one approach that has been successfully used. 

The focus of the product-maintenance stage is to ensure continued product success in the market. The manufacturing and operations teams ensure that product meets all requirements and continues to be robust. This activity ensures stable shipment of product to customers. In addition, periodic quality assurance audits are conducted to determine continued compliance relative to quality system requirements. This is the stage where all required design and platform activities are validated using large samples and appropriate corrective actions and continuous improvement activities are implemented. 

With the exception of a list of PINCs for renewable energy, BOEM s procedures and requirements for inspecting and auditing an offshore wind farm s SMS are not yet well developed. As formal policies of inspections and audits are developed, BOEM will need to ensure that its inspection process places the responsibility of safety compliance on the lessee and not on BOEM itself through a checklist of PINCs. Internal or operator audits help a company internalize a safety culture and encourage ownership of the company s safety program. BOEM can ensure that the lessee s internal audits are conducted appropriately through its own audits. The next section discusses the importance of properly trained personnel. 

You must ensure that a hazards analysis (facility level) and a JSA (operations/task level) are developed and implemented for all of your facilities and activities identified or discussed in your SEMS. You must document and maintain a current analysis for each operation covered by this section for the life of the operation at the facility. You must update the analysis when an internal audit is conducted to ensure that it is consistent with your facility s current operations. 

The focus will depend on the overall objectives of the audit. A good way to approach this is by conducting a brainstorming session with operators and environmental specialists. 

Process flow reduction should be targeted and must be in such a way that it will not impact upon the operation of the process or plant. The normal first response by a plant engineer is that air flow reduction cannot be done. However, subsequent investigation has resulted in that most of the time flow reduction can be done. This should be a significant area to focus on when conducting a pollution prevention audit. 

The regular internal auditing of a quality system is a fundamental requirement. These audits should be conducted by persoimel independent of the operational area being audited for example a quality department should not audit its own activities. The results of such audits, together with those from outside inspection bodies, will invariably identify areas for improvement. 

Regular internal audits of GMP operations should be conducted according to an audit master schedule. Records of the findings and any follow-up actions should be maintained. Audits of key suppliers should also be conducted as part of a vendor qualification programme. 

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. 

As can be seen, the real cause of most accidents is what might be classified as human errors. Most people have good intentions to perform a function properly, but where shortcuts, easier methods or considerable economic gain opportunities appear or present themselves, human vulnerability usually succumbs to the temptation. Therefore it is prudent in any organization, especially where high risk facilities are operated, to have a system in place to conduct considerable independent checks, inspections, and safety audits of the design and construction of the installation. 

Sponsor companies use quality assurance units independent of the clinical research group to audit medical operations. Their role is to ensure that regulatory standards and company policies and procedures for clinical research are being followed in all countries where research is being conducted. 

Internal audits are very important elements in ensuring that the qnality management system is always np to date. The laboratory shall periodically and in accordance with a predetermined schedule and procedure conduct internal audits of its activity to verily that its operations continue to comply with the requirements of the management system and ISO/IEC 17025. 

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