Performance audits

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

In addition to fulfilling the in-house requirements for quality control, state and local air monitoring networks which are collecting data for compliance purposes are required to have an external performance audit on an annual basis. Under this program, an independent organization supplies externally calibrated sources of air pollutant gases to be measured by the instrumentation undergoing audit. An audit report summarizes the performance of the instruments. If necessary, further action must be taken to eliminate any major discrepancies between the internal and external calibration results. 

In 1991, the Verband der Automobilindustrie e. V. (VDA) published VDA 6.1, Quality Spstem Audit, a questionnaire on quality system evaluation based on DIN EN ISQ 9004. VDA 6 is a series of guides covering the basics for quality audits, auditing, and certification. They were therefore not intended as supplementary requirements to ISQ 9000 but as guides for auditors performing audits of automotive suppliers. Their intention was to improve auditor competency in the industry by providing a uniform interpretation of ISQ 9000 requirements and a common approach to automotive audits. VDA 6.1 has been revised several times and is currently in its fourth edition. There are nine volumes in the series (see Appendix A). 

To receive ISO 9000 accreditation, a certification body must meet the requirements of ISO Guide 62 and EN 45012, which invokes ISO 10011. There is normally a mark of accreditation (a Grown and Tick in the case of UKAS accreditation) that certification bodies use to signify their credibility. Once accredited, a certification body may perform audits on suppliers offering products and services within the scope of accreditation. In theory, accreditation is granted only if the certification body has expertise (i.e. competent auditors) for the particular industry sectors (EAG codes) requested. 

Most certification body auditors who are currently performing audits against one or more of the national automotive quality system requirements (QS-9000, VDA 6, AVSQ, or EAQF) will qualify. To qualify, auditors need to ... 

The auditors perform audits on behalf of the lATF and its subscribing members. 

Perform Audit Quality System and Facility Evaluation Process Audit... 

Personnel bioburden will be analyzed per SOP (provide number). In addition, QC/microbiology will perform audit monitoring of all media hll participants, including themselves. 

Cl Assessment and response actions C2 Reports to management 4.6.3 Systems and performance audits... 

Periodic performance audits are required to validate the accuracy of the air-monitoring system. The Code of Federal Regulations (CFR) requires that performance audits be conducted at least once a year for criteria pollutant analyzers operated at state and local air monitoring stations (SLAMS). The EPA recommends that each analyzer be disconnected from the monitoring station manifold and be individually connected to the audit, from which it will receive the audit gas of known concentration. The audit gas concentrations are usually generated in a van, using a gas calibrator to dilute multiblend gases with zero air. 

If or when sponsors perform audits, as part of implementing quality assurance, they should consider ... 

Audits Specified frequency and methodology of audits of the environmental management system and of environmental performance Audits of the environmental management system (frequency or methodology not specified)... 

In Section 6.3.6, New Mexico s Green Zia Environmental Excellence Program Third-Party EMS Performance Auditing, one state s innovative management systems program will be reviewed New Mexico s Green Zia Environmental Excellence Program. 

New Mexico s Green Zia Environmental Excellence Program Third-Party EMS Performance Auditing... 

Performance auditing—monitoring to ensure that the problem was permanently solved... 

The conduct of audits is not a mandatory requirement in GCP. ICH GCP (1995) mentions in section 5.19 If and when sponsors perform audits, as part of implementing quality assurance - this is not interpreted as an obligation to establish an audit program. Similarly, FDA does not mandate the conduct of audits (FDA Compliance Program Guidance Manual, 2006). 

Performing audits of contracted pharmacy providers (e.g., retail pharmacies contracted to provide pharmacy services). This is done to ensure that both the PBM and the managed care organization (payer) are being charged properly by the dispensing pharmacy for what is actually dispensed to the patients. 

The CRO should allow the sponsor to monitor the studies and to perform audits of the clinical and analytical study and the sites. 

All of these audits brought some new experiences because customers often focused on different points. When SAP was confronted with an exploding number of companies that wanted to perform audits, it became obvious that SAP needed to develop a strategy to organize these audits in a more efficient way because the efforts for accommodating the auditors and the loss of time in the different departments were too cost intensive. 

Audit A systematic check to determine the quality of some function or activity. Two basic types are performance audits and system audits. Performance audits involve a quantitative comparison of the laboratory s results to those of a proficiency sample containing known concentrations of analytes. A system audit is a qualitative evaluation that normally consists of an on-site review of a lab s quality assurance system and physical facilities. 

Performance audit A quantitative evaluation of a measurement system that involves the analysis of standard reference samples or materials whieh are certified as to their chemical composition or physical characteristics. 

The results of the hazard analyses (hazard logs) and performance audits and assessments... 

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