The Need for an Audit

determine what needs to be audited. You might want to audit specific occupations (e.g., machinist), tasks (e.g., welding), topic (e.g., electrical), team (e.g., rescue), operator (e.g., crane operator), part of the worksite (e.g., loading/unloading), compliance with an OSHA regulation (e.g.. Hazard Communication Standard), or the complete worksite. You may want to perform an audit if any of the previous items or activities have unique identifiable hazards, new tasks involved, increased risk potential, changes in job procedures, areas with unique operations, or areas where comparisons can be made regarding safety and health factors. 

In the process of performing audits, you may discover hazards that are in a new process, hazards once the process has been instituted, a need to modify or change processes or procedures, or situational hazards that may not exist at all times. These audits may verify that job procedures are being followed, and identify work practices that are both positive and negative. They may also detect exposure factors—both chemical and physical—and determine monitoring and maintenance methods and needs. 

Sometimes, audits are driven by the frequency of injury the potential for injury the severity of injuries new or altered equipment, processes, and operations and excessive waste or damaged equipment. These audits may be continuous, ongoing, planned, periodic, intermittent, or dependent upon specific needs. Audits may often 

At many active workplaces, daily site inspections are performed by the supervisor in order to detect hazardous conditions, equipment, materials, or unsafe work practices. At other times, periodic site inspections are conducted by the site safety and health officer. The frequency of inspections is established in the workplace safety and health program. The supervisor, in conjunction with the safety and health officer, determines the required frequency of these inspections, based on the level and complexity of the anticipated activities and on the hazards associated with these activities. In a review of worksite conditions/activities, site hazards, and protecting site workers, the inspections should include an evaluation of the effectiveness of the company s safety and health program. The safety and health officer should revise the company s safety and health program as necessary to ensure the program s continued effectiveness. 

Prior to the start of each shift or new activity, a workplace and equipment inspection should take place. This should be done by the workers, crews, supervisor, and other qualified employees. At a minimum, they should check the equipment and materials that they will be using during the operation or shift for damage or defects that could present a safety hazard. In addition, they should check the work area for new or changing site conditions or activities that could also present a safety hazard. 

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Assess the need for an audit. What is the criticality of the software product in business terms Evaluate the risk to the pharmaceutical product, production process, and quality data associated with the software. 

A purchasing process that addresses compliance issues is presented in Figure 7.5. This covers supplier selection, award of contract, delivery, and validation. The process is initiated with a determination as to whether or not an audit is required. Once the need for an audit has been established, the supplier concerned should be contacted and an audit request made, explaining the context of the audit. 

The supplier should prepare presentation material to introduce the QMS, the quality management organization and an overview of the main procedures. The supplier may well be asked to respond to a postal questionnaire prior to an audit on the supplier s premises. This response may even negate the need for an audit of the supplier s premises if information returned fully answers audit questions. Even if an audit visit is still required, a good postal questionnaire response will enable the customer to focus on open topics during the audit, so it is in the supplier s interest to put sufficient effort into the postal exercise. 

By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of... 

The reason for an Exposition is so that there is a description of the system showing how it works and how it controls the achievement of quality. This is different from the policies and procedures. The policies are a guide to action and decision and as such are prescriptive. The procedures are the methods to be used to carry out certain tasks and as such are task related. They need to be relatively simple and concise. A car maintenance manual, for example, tells you how to maintain the car but not how the car works. Some requirements, such as those on traceability and identification, cannot be implemented by specific procedures although you can have specific policies covering such topics. There is no sequence of tasks you can perform to achieve traceability and identification. These requirements tend to be implemented as elements of many procedures which when taken as a whole achieve the traceability and identification requirements. In order that you can demonstrate achievement of such requirements and educate your staff, a description of the system rather than a separate procedure would be an advantage. The Exposition can be structured around the requirements of ISO/TS 16949 and other governing standards. It is a guide or reference document and not auditable. 

When you start working across the Internet, the chromatography data system becomes an open system and the FDA rule requires controls. Using FDA s definition of electronic records, the laboratory chromatography data system generates electronic records. Based upon the definition, laboratories will need to consider more than just the raw data tiles. One must also include the method tiles, mn sequence tiles, and the integration parameters used for the data analysis. The need for a comprehensive audit trail is a critical component of the FDA regulations. The audit trail is an electronic record and is subject to the same controls. 

The first section is site qualification. Vendors selected to perform regulated work product will be evaluated for compliance with the appropriate s et of regulations. The results of the audit will be reviewed and the need for a site follow-up visit will be determined. Site qualification visits are generally performed on a cyclical basis at least once every 24 months is suggested unless the supplier becomes problematic. A continuous monitoring program is an essential component of a compliant vendor qualification program. 

The study of process may extend to the way in which tlie results are accessed and used. For example, the use of POCT in an emergency department (not in an audit) did not decrease the length of stay despite the fact tliat the dehvery time for the results was much shorter than when results were provided by the laboratory. The authors concluded that the test result was not the rate-limiting step. Murray, in a similar study, did find a reduction in the length of stay and identified a subset of patients in which the POCTs could be used to rule out diagnoses and allow a faster discharge. They noted that in other cases the triage decision was delayed by the need for results jfi om the laboratory. 

The need for documenting exceptions and how they are handled requires a series of features for audits performed by regulatory institutions or customers. Audits generally require a consistent traceability of observations, states, commitments, and corrective actions. An audit module not only reports these factors but also allows for scheduling internal assessments and audits including resource planning. 

Documentation controls apply to system development and maintenance as well as to use. Development practices and procedures need to documented according to a Quality Management System (QMS) [4] and controlled in the same way as other GxP documents. Of particular importance is the establishment of an audit trail for documentation and management of change control and the associated records. The FDA needs to be able to establish unequivocally which version of software was running on what equipment, at which time, when every record was created. One of the effects of this rule is clearly to bring the IT Department, traditionally seen as being on the periphery of GxP, firmly within the fold ... 

The need for CRM training, a proposed methodology for its delivery and collateral which supports it form an integral part of the SMS. Demonstrating that CRM processes are underpinned by effective communication and socialisation adds significant credibility to the approach and raises confidence in its rigour come an audit. Consideration should be given as to ... 

The discussion to do with auditing stressed the formal nature of the audit process and the need for objectivity. The auditor compares actual performance against a clearly defined, agreed-upon standard. He or she then provides a Yes/No result of the item under consideration. If the auditor moves beyond this restricted role he or she is acting as a consultant, not as an auditor. 

Show you care and be hospitable. If possible, provide a private workspace, escorts for individual auditors, a set of references and site information, and a point of contact to provide other materials or respond to questions. Donuts for the inspection team each day would be appreciated. Also, as correctable deficiencies are discovered, they should be corrected on the spot. During an audit, a site might consider having a second shift of one or more persons reacting to and performing corrective action if needed. 

Safety audits are audits of particular safety management arrangements at (normally) a specific plant or location, against internal (company-specific) or external (national or international) standards. There will normally be an internal sponsor of the audit (i.e., someone who is an internal advocate of the need for the audit), although funding may be internal or external, depending on circumstances. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

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