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What is TS 16949 Process Audit?

A process can be identified by a series of unique, but consistent, characteristics. There are six characteristics of a process that are mandatory for effective quality management.
  1. A process owner exists
  2. The process is defined
  3. The process is documented
  4. The linkages of the process are established
  5. The process is monitored and improved
  6. Records are maintained

Process Based Audit

  • The Audit Plan should have key processes instead of elements
  • Performance – Linked to common metrics for organization and supplier
  • Oversight – Adherence to the “rules” and Common Global Process
  • Use the checklist to make sure you are through, but not as the list of questions.
  • Use the organization’s procedure to do the audit

What is an Audit Trail and why should I care?

16949-audit-trailWhile ISO:9001:2008 utilizes checklists for audits, TS16949:2009 requires process-based audits. This is a significant change and internal auditors need to be trained and developed using the process-based audit approach.

View an Audit Trail Example.

Key Differences between ISO 9001 & TS 16949 Audit

  1. 90 days maximum between readiness review and onsite audit
  2. Identification of nonconformance or opportunity for improvement when detected by auditor
  3. Record of any termination of the audit in the database
  4. Scope includes customer specific requirements
  5. Audit report within 15 day of closing meeting
  6. Corrective action definition and implementation including verification of Nonconformance – 90 days from closing meeting – submission of final report
  7. No certificate issuance unless nonconformance found are 100% resolved in 90 days of the closing meeting.
    • 100% resolved means containment of the condition and documented evidence including assigned responsibilities or follow up visit for verification.

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