The Audit Program Is Internal Audits Most Common Format

An audit program serves as the cornerstone of internal auditing. It gives auditors a roadmap for examining all processes and procedures, from those to which they perform internal controls.

An audit program typically begins with a collection of management topics such as planning and employee management. Next comes an assortment of audit tests.

1. Documentation and Records

Document control checklists enable organizations to ensure the quality of documents created by employees and contractors for the company. Furthermore, this sets a standard that all contributors to such documents should abide by when creating documents for it.

Maintaining an audit documentation checklist is a fundamental aspect of internal auditor’s job. It contains records detailing engagement planning, execution and procedures conducted during their performance as well as any supporting evidence or findings obtained by them.

Keep in mind that an audit program contains sensitive information that should only be shared with qualified personnel, which makes an EMS document management system with secure and controlled access essential.

2. Production and Process Controls

Operational audits involve inspecting production and manufacturing processes. This involves inspecting infrastructure, production work environment, storage conditions and routine equipment/machinery maintenance processes.

Under this portion of your checklist, you will assess the efficiency and effectiveness of these processes and systems to ensure they will produce products which conform to specifications. Furthermore, this audit includes reviewing incoming orders, supplier management procedures, customer communications/feedback systems as well as customer interactions/feedback.

This table includes similar audit questions as the supplier checklist but includes an opportunity for improvement (OFI) slot for collecting input from employees on how they could improve processes.

3. Quality Planning

An audit examines the quality management systems of a business. An auditor will review documentation, records and interview personnel in order to assess compliance with current standards.

An audit in this area should involve reviewing procedures to identify hazards, measure quality-critical characteristics and ensure both human and technical resources are available as required.

Use the Evidence and Observation section of your checklist to document your conclusions, which will assist your supervisor or manager when reviewing your report. In addition, this is also an ideal place for recording any additional observations or remarks you might have – you could even include audit recommendations here if desired.

4. Customer-Related Processes

Certain processes are of extreme importance to customers and should be examined closely; such as those related to customer service, complaints management and feedback collection.

Auditing these processes requires considerable work, so it is crucial that any auditor be experienced. If internal staff are chosen as auditors, a system should be in place to ensure objectivity of audit results.

Every question in your checklist should have a box for “Evidence and/or Observation.” When making decisions about compliance or non-compliance with requirements, it’s crucial that any observed evidence supports your assessment – this can include reviewing documents/records as well as directly observing activities on-the-ground.

5. Design and Development

Human error can wreak havoc with audit processes and undermine trust in audit results, so following an established audit process is the only sure way to ensure quality internal audits.

This template assists with planning, auditing and record-keeping/reporting. It includes a process audit section as well as a clause-by-clause checklist to verify all ISO requirements are being fulfilled.

Medical device companies can utilize the checklist as part of an MDQMS to assess design and development processes, helping them produce medical devices that meet user needs while complying with regulatory requirements and protecting patient safety.

6. Documentation and Records

Documents and records play an essential part of an audit. An auditor will examine documents such as training manuals, assessment and certification records, procedures, diagrams and policy statements during their inspection of organizations.

Documentation and records serve as early warning systems for problems that might otherwise go undetected, with catastrophic results of hidden flaws in manufacturing processes being seen all too frequently.

By employing an ISO audit checklist, organizations can ensure all processes are documented accurately, eliminating unexpected surprises during quality management system (QMS) audits and helping achieve higher compliance with ISO 9001 certification.