Compliance audit - meaning

Once all the elements of the Process Safety Management system are in place and are being implemented, the Compliance Audit [29 CFR 1910.119 (o)] element provides a means to evaluate the program s compliance level. Every three years, the program must be audited to ensure that it is being implemented as per the regulation. The audits can be done internally, but some companies hire outside consultants to get the viewpoint of an unbiased expert. ... 

Pattern (of violations) means, with regard to any compliance audit or review activity, more than one violation. When the number docrunents are reviewed, the number of violations required to meet a pattern is equal to at least 10 percent of those examined. 

The safety audits required are not to be merely compliance oriented, meaning that they are not limited to determining compliance with laws, standards, or regulations. Although compliance may be considered during the audit process, the intent is for the audit to be system oriented so as to evaluate the effectiveness of the standard s management processes. 

You can show compliance with this requirement by defining where the auditors fit into the organization by means of an organization chart and by giving position titles in the reports of the audit. 

These checklists may be used to indicate compliance with standard procedures. As indicated above, a checklist is easy to use and can be applied to each stage of a project of plant development. A checklist is a convenient means of communicating die minimal acceptable level of liazard evaluadon diat is required for any Job, regardless of scope. As such, it is particularly useful for an inexperienced engineer to work tlirougli die various requirements in the checklist to reach a satisfactory conclusion. However, a system checklist should be audited and updated regularly. 

It has to be shown by means of internal audits, that the operation (i.e. the daily work in the laboratory) is in compliance with the quality system. This must be stated in the quality manual A schedule has to be defined and a standard procedure for internal audits has to be prescribed. 

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... 

Most companies have set in place procedures to meet the requirements of the international quality standard e.g. ISO 9001 or national equivalents, as discussed in Section B, 3.2.23. The requirement of these standards are that procedures are in place for all activities carried out in the workplace, that these procedures are recorded and that the activities are carried out, by staff, as described in the procedures. The operation of these procedures is subject to an external audit, to confirm that there is compliance in the day-to-day activities of a work group. It should be noted that having procedures written down does not necessarily mean that an organisation has the best procedures in place. They will need to be constantly monitored and modified in the light of experience. 

All of the standards of working practice mentioned are regulated by official national and international bodies, which means that in order to claim compliance with any of these standards, the laboratory must be audited and accredited (GLP) or licensed (GMP) by a nationally authorized body. 

It might be added here, that these responsibilities will certainly be transferred to their full extent to an eventual replacement Study Director. Since a permanent replacement will entail the privilege - or the burden, whichever describes the situation better - of accepting, with the signature under the statement of GLP compliance of the final report, the full responsibility for the quality, integrity and reliability of the data and the report, it will be one of the first activities of this person to assure him- or herself, as soon as practicable after taking over the new position, and preferably with the assistance of Quality Assurance personnel, of the GLP compliance in the study as it has been conducted to date. If this were to be done by means of an interim review or data audit, the results of such a GLP review should be fully documented, especially in such cases where deficiencies or deviations were found. 

National) GLP Compliance Programme The particular scheme established by a Member country to monitor good laboratory practice compliance by test facilities within its territories, by means of inspections and study audits. 

Compliance with the requirements of ISO/IEC 17025 2005 is essential if a laboratory is to become accredited for particular analytical procedures. External audit by a recognized national or international body is a prerequisite for this process. For example, in the United Kingdom, accreditation is awarded by the UK Accreditation Service (UKAS) and in Canada by the Standards Council of Canada. The benefits of accreditation will be discussed in more detail below, but accreditation for a particular function by a recognized body means that the laboratory has been assessed against internationally recognized standards to demonstrate their competence, impartiality, and performance capability. 

Mechanisms for systematically assuring that compliance policies, standards and procedures are being carried out, including auditing. .. periodic evaluation. .. and a means. .. to report violations. .. without fear of retaliation ... 

A Mexico-domiciled motor carrier committing certain types of violations identified through roadside inspections, or any other means, may be subjected to an expedited safety audit or compliance review, or may be required to submit a written response demonstrating corrective action. 

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