Audits purpose

Auditors should select the audit method most appropriate for their intended audit purpose. Initial quality system audits or regularly scheduled audits are likely candidates for the top-down approach, while audits conducted as part of a root cause analysis, for example, may best employ a bottom-up approach. The FDA employs a similar approach to inspections. Regular scheduled biennial inspections are more likely to employ a top-down methodology. For cause inspections conducted in response to a specific product issue such as a recall are more likely to employ a bottom-up approach. FDA investigators may employ a combination approach during biennial inspections if investigators are aware of specific quality problems that they wish to include in the inspection. 

We have focused our attention thus far on the physical characteristics of a foamed polymer. If the foam that will be used is purchased other than for audit purposes, the information above should be sufficient. If, however, the foam is to be produced as part of a design, it will be necessary to supplement the analysis of the final product with procedures to ensure that the raw materials used are of consistent quality. 

We have described a process by which small quantities of foam can be made by the prepolymer method. A number of methods are available to bring the variables involved in prepolymer making under control. We assume that the starting point for such processes is the acquisition of commercial isocyanates, polyols, and additives. Other than for audit purposes, we will assume they arrive with certification that they are of the so-called urethane grade. In the case of polyols, this typically means they contain less than 0.01% water and have good color. Free acids and low metal and chloride contents are important considerations for isocyanates. Manufacturers are well aware of the problems that will arise if these contaminants are not controlled and the materials cannot be used with confidence. 

Opening meeting agenda—introductions, review of audit purpose and scope, review of audit schedule, discussion of audit logistics, including guide for auditors, special clothing requirements, and location for auditors to work... 

For clinical trial and audit purposes in large samples, three simple questions group patients into those who are completely recovered, those who are still symptomatic but independent, and those who are dependent, or dead (Dermis et al. 1997a,b). Various more detailed assessment instruments are available that are designed to test different domains (Lyden and Hantson 1998 Warlow et al. 1996) ... 

Figure 1.5 contains an example of a clinical intervention form. This is a form used within a pharmacy to record any clinical interventions made. During the professional check of a prescription form, the pharmacist may note areas that require further action (for example, contacting the prescriber to confirm a dose, etc.). Once any appropriate action has been taken, a note of the action taken is made on a clinical intervention form. These forms can then also be used for audit purposes. 

At the end of the preassessment, the plant personnel should be well informed of audit purposes. Resources should be secured, and readily implemented waste-reduction measures should be identified and, if possible, implemented. 

In 1999 Ashland had a turnover of US 6800 million and employed 23000 people worldwide. Its head office is in Covington, USA. Neither the annual report nor the CER clearly state the number and location of the manufacturing sites, most of which appear to be in the USA, since there is no mention of any elsewhere. The CER does indicate that 150 sites have been classed as medium to higher risk for auditing purposes. 

For quality auditing purposes, it shall be possible to obtain meaningful printed copies of electronically stored data... 

Technical Agreements outlining who is responsible for specific activities relating to the manufacture, analysis, servicing and quality control at each stage of the process must be compiled and signed by the responsible persons in each company. These may form part of the contract or may be separate agreements. Copies must be available for audit purposes. 

History or a Change Control section is also imperative. It defines the reason for issuing an SOP and why it is being revised. This is very important while a department is fine-tuning its operation or as a response to an observation. It is very helpful for auditing purposes as well. 

To comply with the new legislation the sponsor needs to develop a set of standard operation procedures (SOPs) to cover all areas of trial activities. A quality system should be in place to ensure record-keeping and verification of data entry or extraction of data from the case report form (CRF), capture adverse events (AEs), serious adverse events (SAEs) and unexpected serious adverse reactions (SUSARs) and report in an expedited manner data transfer from source data to database and archiving of the source data for audit purpose. GCP and trial specific training should be carried out and recorded in a timely manner. 

DOE-2.1 - A computer software program that simuiates energy consumption of commerciai buiidings used for design and auditing purposes. 

Provide compliance substantiation to the certification authority through the provision of lifecycle evidence for audit purposes at certification authority nominated milestones within the project, and for final certification. 

Topics addressed in this chapter include audit purpose, QA interface, internal and external audits, conduct of audits, lessons learned, and information about the Chemical Safety and Hazard Investigation Board. Conduct of audits will include a section on the mechanics of an individual audit that should be most helpful during the periodic review process. 

In case any of these scenarios develop. Road Safety Auditors are advised to maintain good records of their Road Safety Audit process, including any checklists used during the process, and to spell out precisely what information has been used for Road Safety Audit purposes. In the case of receiving an Exception Report on a problem at an early stage of the Road Safety Audit, Road Safety Auditors are advised to repeat the road safety problem at subsequent stages. 

Intermediate In this there will be sufficient discussions within the team and incidents are noted even if no action is recommended. If there is any action it is noted, but here deviations are also noted that are realistic but well guarded by the safeguard system in service (no action). This can be used at a later stage for general and audit purposes. 

In the calibration of thermal desorption tubes, the same conditions should predominate as in sample collection. Methods such as the liquid application of a calibration solution to the adsorption materials or the comparison with direct injections have been shown to be unsatisfactory. Alternatively, Certified Reference Standards (CRSs) are available (e.g. Markes Int., UK). CRS tubes are recommended in many key standard methods (e.g. US EPA Method TO-17) for auditing purposes and as a means of establishing analytical quality control. CRS tubes are often certified traceable to primary standards, have a minimum shelf life of typically 6 months. They are available ready for use with concentrations... 

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