Quality Assurance audit external

Support for sites is multi-tiered and includes participation by numerous federal, state, private, academic, and tribal organizations. Network operation includes rigorous field and laboratory quality assurance/quality control (QA/QC), including an external quality assurance program and periodic external on-site audits. 

With a combined throughput of around 250 000 samples and over 1.75 M determinations a year, quality assurance is of paramount importance. This is ensured by a continuous process of introspection and audit, both internal and external. 

The introduction of GCP has accelerated the need for quality control and quality assurance, particularly in the field of clinical research. Quality control is carried out by the staff who are responsible for the particular activity, working to SOPs that cover all the tasks under scrutiny. SOPs not only need to be written but must also be updated regularly. Quality assurance is the process which seeks to confirm that SOPs have been observed this is accomplished by the process of auditing. Internal audit departments should be under a separate management from the medical department. Regular audits can not only assure external bodies, such as regulatory authorities, that proper procedures have been followed, but also serve to deter those rare attempts at fraud on the part of clinical investigators, which occasionally become evident. ... 

Quality assurance is not just a process it is a way of thinking. All staff should be well trained and motivated and be working to a common goal the production of a pharmaceutical product of a quality that is safe for the patient. The procedures should not be seen as a chore or burden to make work more difficult, but essential steps in the production of a safe, satisfactory product. Self-inspection and external audit of procedures are important processes in maintaining standards of cleanliness. Even after manufacture and distribution it is vital that the products are used properly, especially multi-use containers that are subject to potential in-use contamination. 

Where, in exceptional circumstances, there is no person wholly engaged in quality assurance, an annual external audit of quality specifications, tests and procedures should be commissioned. 

V.70. Documented procedures should ensure that internal audits are carried out on a regular basis to verify compliance with all aspects of the quality assurance programme and to confirm its continuing effectiveness. Similarly, when conducting external audits, to verify the quality arrangements of suppliers, they should be planned and carried out in accordance with written procedures. Audits should be conducted by qualified persons selected for their independence from the activity under audit. 

VII. A process which includes quality assurance procedures to assure the accuracy and thoroughness of environmental audits. Quahty assurance may be accom-phshed through supervision, independent internal reviews, external reviews, or a combination of these approaches. 

In sub-chapter 18-2, the scope of audits is defined to be applicable to all research, development, design, procurement, construction, fabrication, operation, and decommissioning of the SRS reactors. It further establishes the commitment to report findings as either nonconformances or corrective action reports for tracking and ultimate resolution. Sub-chapter 18-3 sets forth a plan to audit external organizations for their compliance with the QA manual. This allows for the audits of vendors and suppliers and further demonstrates an overall commitment to the assurance of Quality in all aspects of design and its control. The items discussed above demonstrate that the requirements set forth in Restart Criterion 6 are satisfied. 

The internal and external quality audit as per the appropriate clause in the CSA standard CAN 3-Q395 may assure that the quality standards are met in the particular situation. 

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