Quality management programs auditing

Guidelines for auditing quality systems - management of audit programs... 

ISO 10011-3 1991, Guidelines for Auditing Quality Systems — Part 3 Management of Audit Programs. 

Qualifications of personnel Services available Offered procedures Capability to complete project Quality controls program Quality assurance program Review and approve contracts Future compliance audits Database management Validation/verification needs Contract laboratories Procedures Facilities/equipment Personnel qualification Training Methodology... 

Source Code Reviews are used to ensure that controlled development and a consistent programming style have been used. It also checks GMP critical features. Source Code Reviews need a standard against which to check, and programming practices for all programs should be documented. An audit of the supplier s compliance with its own quality management procedures should have been carried out to ensure that appropriate quality is being built into the system. 

Annual safety system audit subteam An audit of the entire safety system or program ought to be conducted annually in the same way the company s financial and quality systems are audited. This should be a management review with some senior leadership and the safety team leadership both involved in conducting the audit. 

Audits or some equivalent means of operational reviews are an important segment of any quality assurance program. They provide feedback to management and are the means of ensuring a continuous improvement of the system and overall facility. In the context of audits for process safety there is a close linkage with quality assurance. Quality assurance encompasses the spectrum of not only ensuring that the requirements are met, and it also provides a system to achieve continuous improvement, in addition to compliance. 

For PSM managers, PSM compliance audit team members and PSSR program developers, this chapter presents some approaches to maintaining a high quality PSSR program over time through self-assessment. 

Quality audit program. (Under this program, the Quality Manager or Supervisor periodically makes unannounced checks on inspected units, accuracy of gauges and test equipment, etc., to verify the accuracy as well as adequacy of quality assurance systems)... 

Product verification requires inspection and testing programs to confirm that product meets the quality requirements. In PSM and ESH terms, the product is the management of environmental, health and safety issues and may be difficult to separate from measurement (Chapter 7) and Audit. 

Quality Assurance, the responsibility of the quality assurance unit, is the nitpicking, but totally necessary, job of determining the quality of conformance to regulations established by managers and their chemists and is done via audits and inspections. To develop a thorough quality program both quality control... 

Executive management total commitment to quality and the quality audit program... 

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