Auditing is the on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.
3 Types of audits
- Product audit – An examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements (that is, specifications, performance standards, and customer requirements).
- Process audit – A verification that processes are working within established limits. It evaluates an operation or method against predetermined instructions or standards to measure conformance to these standards and the effectiveness of the instructions. Such an audit may:
- Check conformance to defined requirements such as time, accuracy, temperature, pressure, composition, responsiveness, amperage, and component mixture.
- Examine the resources (equipment, materials, people) applied to transform the inputs into outputs, the environment, the methods (procedures, instructions) followed, and the measures collected to determine process performance.
- Check the adequacy and effectiveness of the process controls established by procedures, work instructions, flowcharts, and training and process specifications.
- System audit– An audit conducted on a management system. It can be described as a documented activity performed to verify, by examination and evaluation of objective evidence, that applicable elements of the system are appropriate and effective and have been developed, documented, and implemented in accordance and in conjunction with specified requirements.
- A quality management system audit evaluates an existing quality program to determine its conformance to company policies, contract commitments, and regulatory requirements.
- Similarly, an environmental system audit examines an environmental management system, a food safety system audit examines a food safety management system, and safety system audits examine the safety management system.
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