Internal audits should cover the full spectrum of the company’s processes and be designed to close the loop between the industry’s standards, customers’ specifications, and the company’s people, processes, and product. Checklists are often helpful in training internal auditors and ensuring consistency with internal audits over time. Checklists also can remind auditors to focus on items that require more intense examination. Prepare checklists to align with the elements of the standard to which your company is registering. This ensures the internal auditors comprehend the standard’s elements and how the company is interpreting compliance to these elements.
Auditors should evaluate the metrics used by the company to evaluate quality and productivity of the process and the product. Key performance indicators (KPI), trends of customer complaints and customer satisfaction, and non-conformances observed in previous internal audits will provide the required objective evidence to be documented.
Experienced auditors focus internal audits on “what has changed” between the scheduled internal audits. Personnel and equipment changes can be opportunities for improvement. However, implementation of the changes must include effective personnel training and documented validation of equipment. Evaluation of the associated documents will provide objective evidence that the change(s) were effective or identify areas requiring improvement.
This cleanroom tip was taken from “Audit for Compliance” by Jan Eudy, which appeared in the October 2013 issue of Controlled Environments.
