Process Quality Audit
1. Purpose
The audit is a tool to evaluate the effectiveness of processes and their compliance with the current quality standards. The aim of a process audit is to assess the capability and stability of a process. The evaluation covers people, method, material, equipment, environment, and quality control activities.
2. Audit team
The number of people taking parts in a process audit can vary depending on the nature and complexity of the process.
3. Audit
The Supplier provides a process flow chart covering the whole production process with every single production step. The process flow chart contains a short description of the production method, definition of used materials, description of used equipment, and of environmental condition under which the process is carried out and monitored. The lead auditor agrees with the supplier upon the main focus of the audit and set up an audit agenda.
4. Performing of the audit
The typical duration of a process audit at the supplier's site is between one and two days depending on the complexity of the process. The possible deviations from the optimal process are classified as follows.
C= critical deviation / defect: a very serious deviation from requirements resulting in delivery of nonconforming product, potential reliability problems in the finished product, increase in scrap/ rework costs, severe customer complaints, disqualification as a vendor, discontinuation of shipment, etc.
M= major deviation / defect: deviation resulting in product quality degradation, failure to detect non-conformances, wrong or incomplete data, additional quality costs, customer dissatisfaction, etc.
m= minor deviation / defect: error with insignificant impact on the acceptability of product.
r= remark: any comment or recommendation by the audit team (it has no influence on the ranking)
5. Evaluation
The grade of fulfilment is given, according to the VDA 6.1, by
| Overall degree of conformity in % | Grading of the QM-system |
Description of the grading |
| 90 to 100 | Full compliance | A |
| 80 to less than 90 | Predominant compliance | AB |
| 60 to less than 80 | Partial compliance | B |
| Less than 60 | No compliance | C |
6. Follow-up of corrective actions
Non-conformities detected during the audit and documented in the audit report are to be addressed by immediate corrective actions by the auditee. A description of the corrective actions together with deadline for implementation and name of responsible people has to be submitted to the lead auditor in writing.
7. Examples of deviations
Examples of critical deviations
- Use of equipment with calibration sticker "rejected".
- No work instruction available at all.
- Major non-compliance with spefications/work instructions.
- Unidentified lots found in production area.
- No corrective action taken.
- Poor handling that could result in mixing up of product from different lots
or rejected. material being shipped to customers.
- Falsification of records.
- Unauthorised rework.
- Unauthorised bypass of inspection/test procedures.
- Shipment without quality approval.
- Unauthorised substitution of material or use of nonconforming material.
- Uncertified employee performing tasks requiring certification.
- Failure to comply with a "Stop" order.
- Severe non-compliance with clean room instructions.
- Use of invalid drawings/specifications
Examples of major deviations
- Seriously insufficient environmental protection concept.
- Documentation discrepancies.
- No SPC implementation/ lack of understanding of SPC.
- Key equipment with overdue calibration.
- Use to white out stickers to correct errors.
- Improper or incomplete recording of required quality data.
- Unauthorised removal of material from store.
- Improper handling/storage/identification of materials.
- No work instruction available on the shop floor.
- Incomplete lot travellers.
- Insufficient safety practices.
Examples of minor deviations
- Minor non-compliance with work instruction.
- Equipment with overdue preventive maintenance.
- Corrective actions taken but not documented.
