Organization audit

An audit organization is an organization that regularly conducts quality assurance management system audits to a required standard. 

How long is the audit estimated to take (Do not let the audited organization dictate the duration of the audit take the time needed to do a proper job.)... 

For medical devices, inspectors expect to see a process improvement program in place encompassing all activities within the supply chain, including the systems that support it. Activities that would provide evidence that such a program is in place include the implementation of documented processes such as Corrective and Preventative Action (CAPA), self-inspection, and internal audits." Organizations should ensure that where an SOP has been put in place to initiate a process improvement activity, the SOP is adhered to. For example, if a quality audit SOP states that all areas shall be subject to audit at least once every 2 years, then inspectors will expect to see evidence that this has been the case. Failure to do so is likely to result in a citation similar to that issued to Krieger Medical, Inc. ... 

The audit plan, including the schedule, the personnel involved, procedures, and checklist is the responsibility of the audit organization. A copy of this document should be filed with the QAP to record the extent of the audit. All information, comments, and recommendations provided by the audit team at the exit interview and in the visit report should be added to the filed audit plan. 

Internal audits (organization and performance, management review)... 

Bell, X, Marrs, F., Solomon, I., and Thomas, H., Auditing Organizations Through a Strategic-Systems Lens The KPMG Business Measurement Process, KPMG, New York, 1997. 

One auditing organization provided a list of top SMS areas to improve based on their audits of several... 

Are individuals from outside the audited organization included in the audit team ... 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

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... 

Is R D s role in the business understood Are technology plans developed and broadly understood Are R D resources organized in the best way to carry out its mission Is the organizational climate assessed Does the organization have measures for success Does the organization learn Audits in place ... 

Self-audit is a monitoring device used to establish any vaiyiiig degrees of detail or performance of an organization to define areas of deficiency and to correct such deficiencies before they cause further problems. 

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. 

An environmental audit is a systematie, doeumented, periodie and objeetive evaluation of how well environmental organization, management and equipment are performing. The aim is to help safeguard the environment by ... 

Baird is the 20-acre site of a former chemical mixing and batching company. Poor waste disposal practices resulted in the contamination of groundwater, soil, the municipal water supply, and a brook adjacent to the site. Over one hundred contaminants, including chlorinated and nonchlorinated volatile organics, heavy metals, pesticides, herbicides, and dioxins, had been identified in site soil and groundwater. Remediation activities included soil excavation and incineration, and groundwater treatment (the audit focused on the soil excavation and incineration... 

Audits are carried out on behalf of the organization seeking certification, not on behalf of the industry that created the requirements, and hence requirements are prone to an interpretation to suit clients and retain business. 

The trade associations that are members of lATF perform an assurance function and have set up a panel to administer certification activities in their country. This involves witness audits of certification bodies to verify that they are adhering to the lATF agreement. They will monitor the scheme on behalf of the vehicle manufacturers in ensuring that certificates are only awarded to organizations that are 100% compliant with the requirements. These activities should provide added confidence that the certification bodies are fulfilling their obligations. 

If your organization is registered to one or more of the existing automotive quality system requirements and the scope is unchanged, the required man-days for the initial audit may be reduced by 50%, but if you decide to change certification body or have changed the scope, there will be no reduction. 

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