Process Audit :
The process audit is the determination of the effectiveness of the manufacturing process. It is to ensure conformity to product requirements at appropriate stages of production and delivery to verify the conformity to all specified requirements, such as dimensions, packaging, functionality and labeling.
Process Audit checklist:
- Are previous audit observations closed?
- Is the operator working as per operation standard/WI?
- Verify the Process Flow Chart / Process Sequence of the running component.
- Check the availability of Process Control Standards (Operation Standards/WIs) on the machine.
- Verify the process parameters as per Control Plan / Operation Standard on the machine.
- Check the records as mentioned in Control Plan / Operation Standard
- Verify that all the measuring instruments/ Gauges are calibrated & check the validity / Expiry date.
- Verify that the machine check sheet is properly filled.
- Check for the Legibility/Visibility of all the displayed documents.
- Check for the availability of Master samples / Limit Samples / FOP samples etc.
- Verify proper disposition of Non Conforming products.
- Check the competency of Operator / Inspector.
- Verify the Countermeasures of problems (Internal & External)
- Check & verify the Machine / Tool / Jig / Fixture conditions (Maintenance of Production Equipment / Machine/ Tool).
- Verify the effective implementation/functioning of the Poka-Yoke Mechanism.
- Check for identification & traceability. All the parts must be properly identified & traceable.
- Verification of Change Management. Inspection records must be maintained for unplanned/abnormal changes (Setup, Retroactive & Containment).
- Verify the implementation of Safety measures on the shop floor. PPEs (Helmet, Goggles, Gloves, Aprons, Nose masks, Shoes, Ear Plugs etc.) must be effectively used on the shop floor.
- Check the availability of Red/Yellow/Ok Bins on the shop floor.
- Verify Lux level at production & final inspection area. The Lux level should be as per standard.
- Verify FIFO in each area. FIFO should be implemented in each area
- Verify housekeeping in each area. Housekeeping should be maintained.
- Verify Packaging & Labeling as per packing standards. Packaging & Labeling should be done as per packing standards.