Audits conducting

Besides internal quaUty audits, there are audits conducted by external authorities for conformance to estabUshed quaUty systems. The two chief standards affecting the chemical industry are the U.S. Food and Dmg Administration Current Good Manufacturing Practice (GMP) regulation and the International Organization for Standardization ISO 9000 series. A quaUty system performance-related standard is the Malcolm Baldrige National QuaUty Award... 

Failure to make corrections that were found in a safety audit conducted two years before the accident... 

Number of audits conducted. This measure is most useful when compared to the planned number of audits and the number of findings per audit. These data allow the number and frequency of audits to be varied, for example, if the number of findings per audit is low the number of audits might be reduced. This measure can also be used to compare to the number of audits that were required before the systems were integrated. 

Sec. 820.22 Quality audit - Conduct regular audits of the quality system... 

External audit Audits conducted by external independent organizations (third-party audits) or by persons having an interest in the organization, e.g. customers (second-party audits). 

Internal audit Audits conducted by the organization itself for management review purposes - also called first-party audits. 

How does a laboratory prepare for a government audit How is an audit conducted What happens at the conclusion of an audit ... 

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. 

The QMS models require periodic audits but do not specify audit frequency. Audit frequency must be determined based on the risk associated with the matters to be audited and other factors including results of previous audits and other quality data. Periodic audits should be conducted over the entire product life cycle and follow-up audits conducted as appropriate to verify that previously identified quality problems have been corrected in accordance with applicable quality system and regulatory requirements. 

A well-conducted program of internal self-audits is important to a site s overall safety and loss prevention efforts. The discussion in this section is applicable to internal audits as well as to external audits conducted by audit teams from other Dow units. 

Failure to conduct planned and periodic internal audits of the quality assurance program in accordance with written procedures. For example, no internal audit conducted since 1995. Interestingly, this organization had the foresight to establish a quality assurance program that required periodic internal audits. Unfortunately, they not only violated their own internal policy, but violated FDA s requirement that FDA regulated companies as part of their quality assurance, periodically monitor their operations. 

Representing the management on the occasion of any audit conducted on the organisation by a second or third party. 

Supplier Forum (2000), Guidance Notes on Supplier Audits Conducted by Customers, available through GAMP Forum (www.ispe.org). 

This requirement is usually met by means of the audit conducted by the pharmaceutical or healthcare company. The audit examines the quality assurance attributes of the supplier s process, the firm s general capability maturity, and the suitability of its equipment or service suggested for use on the project. Suppliers in this context may be understood to include equipment vendors, service suppliers, or the pharmaceutical or healthcare company s in-house software development department. Regulators hold pharmaceutical and healthcare companies accountable for the use of suppliers whose capability assessment indicates their inability to deliver validatable, compliant software. ... 

Number of previous audits conducted by each audit team member X... 

The number of SOPs and their topics depend on the scope of audits performed, the set up and size of the QA department and whether audits are outsourced to external contractors which may decrease the scope of audits conducted by internal QA members. The QA department may also be tasked with activities such as SOP management and staff training SOPs would also be needed for these areas. 

ICH GCP (1995) defines an audit report as A written evaluation by the sponsor s auditor of the results of the audit . Format and layout of audit reports vary greatly between companies and can range from a simple list of audit findings to a detailed description of all audit areas, observations and conclusions. The lead auditor is responsible for preparing the audit report and should be assisted by the entire audit team. Ideally, the audit report should be prepared as soon as possible after the audit. The report should be a complete and accurate representation of the audit conducted, and not include opinions or assumptions. 

Investigator site audits are probably the most frequent type of audits conducted by clinical QA departments and, therefore, deserve particular attention. The purpose of investigator site audits is to assess compliance with the GCP regulations (with a focus on the country-specific regulatory requirements) and the protocol. Further, thesafety of the trial participants, the ethical conduct of the trial and the validity, completeness and accuracy of the data collected and recorded are verified during the audit. 

Apart from systems audits conducting to assess the capability of an external provider, such audits can also be conducted to verify compliance throughout the clinical trial or retrospectively after trial termination. 

An audit is a detailed check of the Quality Assurance System by IT specialists. An audit is carried out on the basis of a SOP containing a checklist with the respective questions. Audits conducted by other companies may be referenced. (Supplier audits are discussed in more detail within Chapters 14 and 15.)... 

At some point near the end of the new construction period, usually lasting five or so years, every submarine obtains its initial SUBSAFE certification. This process is very formal and preceded by scrutiny and audit conducted by the shipbuilder, the supervising authority, and finally, by a NAVSEA Certification Audit Team assembled and led by the Office of Safety and Quality Assurance at NAVSEA. The initial certification is in the end granted at the flag officer level. 

The benefits of having a quality management system are that we have a form of internal quality control that allows us to have consistency of the service we provide. Our work will be verified, documents checked, and internal quality audits conducted. This means that we are continually assessing the practices set down in the documents of the quality management system. 

The results of a number of assessments and audits conducted at the plant by national and international organizations in the 1990-ties indicated that the plant operation could continue till the year 2025, as a minimum. To ensure the achievement of such a goal an extensive and comprehensive program has been launched to support the plant long time competitiveness and public acceptability. This program is also intended, to the extent reasonably achievable, for the plant harmonization with the current safety requirements and practices. 

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. 

Both the PSM and RMP rules state that employers must certify that they have evaluated compliance to verify that the procedures and practices developed under the standard are adequate and are being followed. This chapter provided information about the relationship of audits to QA, the audits themselves, audit conduct, lessons learned, and some related information about the Chemical Safety and Hazard Investigation Board. It was stressed that the OSHA Inspection Manual is an essential reference at any site with process safety responsibilities. 

In British Columbia, New Brunswick and Alberta, Road Safety Audits have been successfully used on three Public—Private Partnership highway projects. These routes had Road Safety Audits conducted at all stages of design and construction. The auditors were an integral part of the bidding, design and build process. This type of project usually has a well-defined design-build specification. Experience has shown that this document must have the safety aspects and the safety risk well defined. 

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