From Elsmar Cove Quality Assurance and Business Standards Wiki
Process Audit - There are several types of Process Audits.
A Manufacturing Process Audit uses the Control Plan and Work Instructions as the audit criteria, following the Process Flow Chart 'down stream' or 'up stream'.
A Layered Process Audit (both DCX and GM/Delphi have used them) is a check by 'layers' of management to see if Work Instructions are being followed (mainly since DCX, the loudest proponent of LPA's don't utilize Control Plans as their suppliers do). The Layered Process Audit focus is getting 'issues' escalated to higher management to get them resolved.
The QMS (Quality Management System) process audit
- Audit preparation – establishing controlled conditions; undertaking the ‘virtual’ audit; concepts of the Audit Check List.
- Dealing with processes that do not have documented procedures.
- Identify main process activities and Support Processes.
- Evaluating the use of ‘core tools’ and customer-specific requirements.
- Linking processes to ISO/TS 16949:2002 clause requirements.
- Developing an effective Audit Check List.
- Working with Turtle Diagrams and Process Maps.
- Dealing with ‘what if’ and infrequent situations.
- Developing probing automotive audit questions from QMS documentation.
- Develop Audit Check List(s).
- Using check-lists in the design, development and manufacturing environment – Search for objective evidence.
- Incorporate internal laboratory requirements.
- Conducting the audit – the entry meeting; questioning techniques; open and closed questions; active listening; recording the evidence; making your decision (conformance/nonconformance); categorizing nonconformances.
- Presenting audit findings – preparing nonconformance notes; the exit meeting; working with executive management.
- Address the findings – delineation of the roles of the auditor and management; determining root cause(s) and actions; recording corrective actions; monitoring implementation.
- Close out the audit – follow-up activities; the need for a follow-up audit; dealing with tardiness and ineffective corrective actions; preparing an audit (summary) report.
- Scheduling Internal Audit s – planning audits (understanding the criteria)
- Designing a effective and user-friendly audit planner; tracking progress; updating the audit planner.
- Audit results input to management review and their role in continual improvement
The Manufacturing process audit
- Definition of a Manufacturing Process Audit – objectives of the audit; what must be established; working with ‘big rules’; determining that the entire manufacturing process is capable.
- Applying a manufacturing process audit to verify that ISO/TS 16949:2002 mandatory requirements are met.
- Mapping the major manufacturing process activities – using the manufacturing Process Flowchart Operator factors; Customer complaints/problems; Part certification requirements.
- Manufacturing process audit preparations – identifying the essential documents and information (e.g. the PPAP file; product engineering specification; production and inspection information; FMEAs, Control Plans; set-up specification; Work Instructions; etc).
- Check identified documents and records.
- Check part approval and capability of special characteristics.
- Check for customer complaints and internal/external ‘problems’.
- Check manufacturing sequence.
- Determine the manufacturing sequence – swim-lane process mapping and process layout diagrams – validating the process flowchart/layout.
- Generic manufacturing process audit questionnaire – customizing a questionnaire
- Assessing customer satisfaction with the part – part quality, delivery performance, customer disruptions, customer notifications (quality and delivery issues), etc.
- Opening meeting.
- Conducting the audit – the need for a photographic record.
- Recording evidence as-you-go – feedback to production personnel.
- Dealing with ‘recalls’, ‘notifications’ and ‘service concerns’.
- Evaluation and reporting – responsibilities for action.
- Presenting the results—management, supervision, operators.
- Verification of Corrective Actions.
- Follow-up activities and manufacturing process audit closure.
Some Elsmar Cove Forum Process Audit discussion threads
