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. Make a Process audit plan covering all running parts and all shifts. Process audit plan can be made on yearly basis. During process audit check all specification as per control plan and below check points.
Process Audit checklist:
- Are previous audit observations closed? : Verify that previous audit NC are closed or not.
- Is the operator working as per operation standard/WI? : Check the working of operators as written in WI / OPS. Check that they are doing all activities like cleaning, part inspection by gauge, compare with limit sample etc.
- Verify the Process Flow Chart / Process Sequence of the running component. : Check that all process sequences OK as per PFD.
- Check the availability of Process Control Standards (Operation Standards/WIs) on the machine.: Operation Standard and WI should be displayed on the machine in front of operators.
- Verify the process parameters as per Control Plan / Operation Standard on the machine. : All product and process parameters should be OK as per control plan. Verify with Control Plan for all parameters should be within specification.
- Check the records as mentioned in Control Plan / Operation Standard: There should be record of setup approval and in-process inspection as per defined frequency by a competent inspector.
- Verify that all the measuring instruments/ Gauges are calibrated & check the validity / Expiry date. All instruments in use should be calibrated. Verify with calibration sticker, calibration plan and calibration certificates.
- Verify that the daily machine check sheet is properly filled. Check that daily machine check sheet is filled correctly. Also verify the actual condition of machines as per check points.
- Check for the Legibility/Visibility of all the displayed documents. Documents on the machine should be readable and visible like font size, paper size etc.
- Check for the availability of Master samples / Limit Samples / FOP samples etc. Check condition and due date of limit samples. Also in First parts approval sample date and inspector sign.
- Verify proper disposition of Non-conforming products.: Check the rework record and rejection record for non-conforming parts. Also in Red bins there should not be filled with non-conforming parts.
- Check the competency of Operator / Inspector. Verify the skill level of operators and inspectors as per Skill matrix.
- Verify the Countermeasures of problems (Internal & External): Check for previous one year countermeasures for internal and customer complaints in that part. If no complaint then write no complaint in this part.
- Check & verify the Machine / Tool / Jig / Fixture conditions (Maintenance of Production Equipment / Machine/ Tool). Check records of preventive maintenance as per plan.
- Verify the effective implementation/functioning of the Poka-Yoke Mechanism. Check the poka yoke record and actual working on machines.
- Check for identification & traceability. All the parts must be properly identified & traceable. There should be an identification tag on all parts with batch number or lot number for traceability.
- Verification of Change Management. Inspection records must be maintained for unplanned/abnormal changes (Setup, Retroactive & Containment). Verify the change record with the tracking sheet and 4M change setup approval record.
- Verify the implementation of Safety measures on the shop floor. PPEs (Helmet, Goggles, Gloves, Apron, Nose masks, Shoes, Ear Plugs etc.) must be effectively used on the shop floor as per PPE’s matrix areawise.
- Check the availability of Red/Yellow/Ok Bins on the shop floor. There should not be any shortage of bins and trolleys in the shopfloor. No material should lying on floor. Also no overflow in bins and trolleys.
- Verify Lux level at production & final inspection area. Verify the lux level with Lux meter and Lux level should be as per standard. Generally lux level should be min 750 in final inspection area and 300 in production area.
- Verify FIFO in each area. FIFO should be implemented in each RM, WIP and FG area. There should be a FIFO board in each area for FIFO implementation.
- Verify the process with PFMEA during process audit and check all points are covered in PFMEA. There should be linkage between PFMEA and Control Plan.
- Verify housekeeping in each area. Housekeeping should be maintained. There should be 5S audit plan and 5S audit check sheet.
- Verify Packaging & Labeling as per packing standards. Packaging & Labeling should be done as per packing standards. Packing Standard should be displayed in final packing area.