Need for an Audit

In the process of performing audits, you may discover hazards which are in a new process, hazards once the process has been instituted, a need to modrfy 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 or negative. They may also detect exposure factors both chemical and physical, and determine monitoring and maintenance methods and needs. 

At times audits are driven by the fiequency of injury potential for injuiy 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 also determine employee comprehension of procedures and rules, the effectiveness of workers training, to assess the work climate or perceptions held by workers and others, and to evaluate the effectiveness of a supervisor regarding his or her commitment to safety and health. 

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 which 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. 

All employees should immediately report any identified hazards to their supervisors. All identified hazardous conditions should be eliminated or controlled immediately. When this is not possible  

Interim control measures should be implemented immediately to protect workers. 

determine what needs to be audited. You might want to audit specihc occupations (e.g., machinist), tasks (e.g., welding), topics (e.g., electrical), teams (e.g., rescue), operators (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 lists or activities have unique identihable hazards, new tasks involved, increased risk potential, changes in job procedures, areas with unique operations, or areas where comparison can be made regarding safety and health factors. 

At many active workplaces, daily site inspections are performed by the supervisor or foremen 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. When audits address site hazards or protect site workers as well as review worksite conditions and activities, 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. 

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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... 

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 ... 

Step 1.1 Getting Ready. A thorough preparation for a P2 audit is a prerequisite for an efficient and cost-effective evaluation. Gaining support for the assessment from top-level management, and for the implementation of results, is particularly important. Otherwise, there will be no real action on recommendations. Early in the process, management needs to accept that, at a bare minimum, the audit is a worthwhile exercise and that resources - human and financial - should be diverted from other activities to the task of auditing. 

You need an improvement system that causes improvement opportunities to be identified. Relying on chance encounters will not create the conditions needed for continuous improvement. The data that needs to be analyzed will be generated by a particular process and this process governed by particular documented procedures. By having already placed instructions in these procedures for certain data to be transmitted to your data analysts, you can cause opportunities to be identified. Other opportunities that are less dependent on product or process data may arise from the audit process and particular projects such as benchmarking, customer and supplier surveys. 

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. 

Over the past decade, a major trend has been the development of the use of proficiency testing (PT) or evaluation materials (Fox 2000). PT materials are a type of reference material, which aid in assessment of analytical laboratory measurement quality. There will be an increased use of such materials as part of laboratory accreditation programs and other new quality assurance efforts, including internal audits. At the same time, a number of providers have used PT schemes to produce a form of RM intended to meet the ever-growing need for RMs required for routine QC use (Jenks 1995,1997). 

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 review process of filled-out spreadsheets will be in question from a regulation perspective. Incorrectly completed spreadsheets will normally be revised and reprinted. The first, incorrect version will be destroyed. An audit trail of the review process is not possible. This can be overcome by keeping the incorrect version(s). Another system to track the review process is the introduction of check boxes close to data-entry cells or columns on the spreadsheet that will demonstrate the correctness of the entry. It should be noted that the requirements for ER/ES compliance and for an appropriate audit trail is needed only if a spreadsheet is saved. If the PC is used as a typewriter, the requirements are not applicable. 

This information would be determined by measuring the heat and airflow at various points of the chamber and then calculating the variability of these conditions in it. Since this kind of information on heat distribution provides assurance that the process equipment is properly designed for the required process, it will be the focus of future QA audits. Furthermore, this knowledge is also essential when a very specific drying temperature is needed for thermally labile materials. The qualification thus not only becomes an integral part of the validation program, but also demonstrates how the information may be used. 

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. 

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