Internal audits are good quality practice.
A company can undergo an audit for many reasons. The federal government can audit because of a complaint or stop in just as routine practice. A company can also do an internal audit as part of a continuous improvement policy to assure compliance with current rules and regulations. During an audit there is a standard checklist that an auditor will use depending on the type of audit being conducted. It is good practice to be aware of the common things an auditor will be inspecting and checking on.
Types of Audits
There are three audit types: third party, second party and first party. A third party audit is conducted by an independent audit organization such as the International Organization for Standardization or The Food and Drug Administration. These audits will be conducted by a government employee or registrar, and the purpose of these audits are for the company's license or certification. A second party audit can be done by customers of the company or the company can audit suppliers. The focus of these audits is an assessment of the company, and the processes used to manufacture a product. A first party audit is an internal company audit. The purpose of these audits is to raise awareness within the company for improvements and to find faults and nonconforming issues.
General Quality System Audit
A general quality system audit will cover several quality areas. The specific areas of focus will be the review of the quality system as a whole. During an audit, the auditor will review the company quality manual that will outline all company policies, procedures and objectives. The auditor will observe the written procedures being implemented by employees. During this audit, the auditor will expect the employee to record all data during the process on the proper controlled document. The supervisory staff will be expected to show the necessary knowledge to review, and verify the work of the employees in a specific department. There must be detailed, documented training records to show all staff has been trained and are up-to-date on the current practices of the company.
Process Audit
During a process audit, the auditor will look at all equipment manuals to assure equipment maintenance is being done in a routine manner and documented appropriately. He will inspect calibration logs, inspection logs and equipment traceability for missing or incomplete data. If the company uses computers or automated equipment in a process, the auditor will inspect the integrity of the data to assure it is fully protected. The data can be backed up, replicated or on a controlled access protection. There must be written procedures that prove the data is protected. If any of the equipment is sub contracted, there must be written proof the subcontractor understands the use, calibration and maintenance of the equipment.
Department Audit
A departmental audit will be a complete review of one specific department. During this audit, the auditor will review the written specifications, procedures and systems of one department. He will also review the training records of the staff and the maintenance records of any department equipment that are relevant to the department under review. He will expect the department manager and the director of quality to be present during the audit to answer questions, present records and review data. During the audit, the auditor will make a list of concerns and nonconforming items that will later be addressed in the auditors official report to the company.
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