Internal Auditing. Quality Management System standards require that organization have internal audit program that:

• Covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits.
  
  
  • Quality Management System Auditing, using process-approach is to verify compliance with QMS standard. Organizations should also sample customer-specific quality management system requirements for effective implementation.
  
  
  • Manufacturing Process Auditing, using customer-specific approach is to determine the process effectiveness and efficiencies. Organizations should determine the approach if not defined by customer. Organizations need to make sure they include all shifts along with handovers from shift to shift, if multiple shifts exist. PFMEA, Control Plan, and associated documents should be used for the audit.
  
  
  • Layered Process Auditing is a system of audits performed by multiple levels of supervision and management to monitor key process, product, and service characteristics to verify process conformance on an ongoing basis. PMC will establish, develop, and implement an effective LPA program to provide a reduction in variation along the manufacturing line as well as non-manufacturing functions.
  
  
  • Product Auditing using customer-specific approach is to verify product’s conformity to specified requirements. Organizations should determine the approach if not defined by customer.
  
  
• Be prioritized based on risk, internal and external performance trends, and criticality of the processes.


• Needs to include Software development program if the organization is responsible for software development.


• Assures the frequency of audits be reviewed and adjusted, if necessary, based on occurrence of process changes, internal and external nonconformities, and/or customer complaints.


• Guarantees the effectiveness of the audit program shall be reviewed as a part of management program review.

2nd Party Auditing. Organizations should include a second-party audit in their supplier management approach. Some secondary-audit examples are:

• Supplier Risk Assessment
• Supplier Monitoring
• Supplier QMS Development
• Process Auditing
• Product Auditing