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.
- A process owner exists
- The process is defined
- The process is documented
- The linkages of the process are established
- The process is monitored and improved
- 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?
While 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
- 90 days maximum between readiness review and onsite audit
- Identification of nonconformance or opportunity for improvement when detected by auditor
- Record of any termination of the audit in the database
- Scope includes customer specific requirements
- Audit report within 15 day of closing meeting
- Corrective action definition and implementation including verification of Nonconformance – 90 days from closing meeting - submission of final report
- 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.