The Audit Process

The audit process is generally described in the following steps  

An effective audit requires the development of a plan or protocol for the audit, establishing  

The audit process consists of collecting information about the physical conditions of the workplace as well as the safety performance. The most important aspect of the audit process is the action that is implemented following the audit. If the results from the audit indicate that performance is below expectations, then action needs to be taken. All too often, the audit process ends at the collection of the information with no further action, thus making the audit process useless. 

A follow-up or deficiency tracking system should be devised so that appropriate personnel may be held accountable. Assign a tracking number to each deficiency and record the date, location, and a brief description of the finding. What is the appropriate OSHA standard for corrective measures Record its hazard rating by potential consequence and probability. List the corrective action required, step-by-step. What is the estimated cost of correction When was it corrected How much did it actually cost to correct  

Once the audits have been completed, it is equally important to disseminate the results of the audit findings to the organization. Again, to make the audit program effective as 

A third important component of the audit process is the performance indexing of the audit results. The task of performance indexing requires the results of the audit to be quantified in a manner that allows for comparisons against performance benchmarks. While the actual audits may identify the number of unsafe actions performed by personnel during an observation period, the raw numbers are really meaningless until they are placed in a context which is comparable to an established index. The performance indices established from an audit can include the percentages of unsafe acts performed, the frequencies of hazardous conditions identified, or the accident rates for a period of time to name a few. 

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The key steps in the audit process are outlined according to preaudit ac tivities, audit activities, and postaudit activities in Fig. 26-12. These activities are described in detail in Guidelines for Auditing Process Safety Management Systems (CCSP, 1993) and will be only briefly discussed in this sec tion. 

An action plan shoiild be developed by the appropriate personnel of the audited facility to address any deficiencies stated in the audit report. Action plans should state what is to be done, who is responsible for getting it done, and when it is to be completed. Ration e for not taking any action for any of the stated deficiencies should also be documented. The action plan is an important step in closing the audit process. 

Planning is essential to the success of the auditing process. During planning, auditors should select a sufficient number of processes to give a... 

This annex of the Rules contains a flowchart identifying the key stages in the audit process from the initial request for certification through to issue of the certificate. Pre-audit is not a documentation audit. Supplier must provide all required data prior to site visit. 

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. 

Based on the survey we selected individuals at all levels for interviews as part of the audit process... 

Each area of operation should be audited periodically, usually once every twelve months. However, new areas may be audited on a more frequent basis. Ideally, they are planned mid-way between external audits. This process should be planned well in advance and written down in the Quality Manual as a structured audit programme, covering both the timing and the coverage of the audit process. The audit programme can be of two types, either ... 

A laboratory is free to decide which scheme is most appropriate for its own circumstances. Laboratories entering the audit process for the first time may prefer to carry out an initial complete audit to establish if problems exist, followed, after an appropriate interval, by a rolling programme to maintain standards. When auditing to ISO/IEC 17025, the auditor should plan to witness at least one method being carried out. 

Those leading audit teams should be experienced in the audit process. All auditors should have some training in the audit process, particularly in the gathering of data ... 

Audits may be conducted by one person experienced in the audit process with general knowledge of the type of facility to be audited. More often, audits are conducted by a small team of people. The audit team should not be associated with the program or facility under audit in order to provide an unbiased independent perspective. 

For companies having multiple plant sites, it can be useful to staff the audit team with competent people from other sites. In this way, the audit process can provide an outside perspective and a learning experience for the audit team members. 

In practice, the frequency of fire prevention audits ranges from annually to every third year. Longer audit cycles are possible however the longer the audit cycle, the more intense and independent the audit process should be. 

During the audit process the auditors inspect the effective and efficient implementation of the laboratory processes, the capability of processes, the performance results, the improvement activities and they are also looking for opportunities for improvement. The aim of the internal audit is to determine whether the quality management system conforms to the planned arrangements and if it is effectively implemented. 

Time invested by both the data manager and statistician in designing the structure of the database should also reap rewards at the analysis stage. In addition, a good-quality database is essential if the study is to pass the auditing process. 

Programmed audits are conducted to consider the status and importance of the processes and areas to be audited and the results of previous audits. The audit criteria, scope, frequency, and methods are defined. The selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. 

The selection of auditors and conduct of audits ensure the objectivity and impartiality of the audit process. 

On February 10 and 11 (1987, we) met in Geneva, New York and informally audited the Good Laboratory Practices (GLP s) and performed a Quality Assurance (QA) audit of. .. projects chosen at random. It was intended for the laboratory personnel to understand that the audit process would be helpful to their organization and also helpful to the. .. program. The entire staff of the Geneva labs participated in the process in a very cooperative and hospitable manner. 

After visiting and inspecting the supplier, the information obtained is analyzed against the acceptance criteria, current company requirements for the validation of computer systems, and the regulatory expectations for computing environments. A report is produced that documents the audit process, provides information on the current state of validation of the supplier and what may be needed for compliance and, based on the audit findings, provides a recommendation on whether the supplier can be used. 

Standard procedures for conducting the quality audit should also be addressed in the Vendor qualification program. An audit cycle includes the preparation of an audit, performance of the audit, reporting of the results of the audit, and audit closure or follow-up requirements. Figure 2 illustrates the audit process. 

An assessment program is incomplete without the final step of bringing closure to the audit process. This can only be performed after all the quality and compliance enhancements have been implemented and evaluated over a predetermined period of time. This does not necessarily mean that all the action items have been completed, since some corrections may require extensive implementation and assessment. The followup assessment, however, must include a review of the previous action... 

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