| MANUFACTURING PROCESS AUDIT CHECKLIST | |||||||
| Product Under Manufacture (Description & No.).: | Auditor (Name): | ||||||
| Date of audit (DD/MM/YYYY): | Auditee (Name): | ||||||
| Department: Machine No. | Process No. as per Process Flowchart: | ||||||
| Sl. No. | Check Point Question | Element | Sl. No. | Sub-Element | CP No. | Actual Observation at time of audit | NCR No. |
| 1 | Is material identification provided for input material? | Material | 1.1 | Input Material | 1.1.1 | ||
| Is the input material inspected and approved for this process? | 1.1.2 | ||||||
| Is the input material of the correct grade and size required for the product? | 1.1.3 | ||||||
| Are the input material containers / crates / trolleys as per defined standard? | 1.1.4 | ||||||
| Is the material container clean and suitable for protecting the material? | 1.1.5 | ||||||
| Is the storage condition of input material satisfactory (free from dirt, dust, fibres, foreign materials, burrs, etc.)? | 1.1.6 | ||||||
| Does the material require any specific humidity and temperature controls? | 1.1.7 | ||||||
| If yes, are the required storage and preservation conditions provided? | 1.1.8 | ||||||
| Does the material have any limited shelf life / expiry date? | 1.1.9 | ||||||
| If the material has any expiry date, are expired materials used in production? | 1.1.10 | ||||||
| Is FIFO (First-In-First-Out) system followed in issuing/consuming the input materials? | 1.1.11 | ||||||
| Is Raw Material / Input Material traceability required? | 1.1.12 | ||||||
| If traceability is required, are traceability records maintained legibly? | 1.1.13 | ||||||
| Does the material require any pre-conditioning / pre-treatment before the process? (Ex. Sieving, pre-heating, cleaning, oiling, etc.). | 1.1.14 | ||||||
| If yes, is the required pre-conditioning done before use? | 1.1.15 | ||||||
| Does the material require any specific handling equipments? If yes, are they available in good condition and required quantities? (Ex. Sleeves on trolleys, resting pad condition, etc.). | 1.1.16 | ||||||
| Are the required quantities of the material available for the process? (This is to prevent having to wait for materials in-between the process). | 1.1.17 | ||||||
| Is the material usage rate as per norms? (Ex. Yield, output-input ratio etc.) (Write Target Vs. Actual Value in Observation box) | 1.1.18 | ||||||
| Is material identification provided for the consumables / packing materials? | 1.2 | Process Consumables and interim / primary / secondary packing materials | 1.2.1 | ||||
| Are the consumables / packing materials inspected and approved for this process? | 1.2.2 | ||||||
| Is the material container clean and suitable for protecting the items? | 1.2.3 | ||||||
| Is the storage condition of consumables and packing materials satisfactory (free from dirt, dust, foreign materials, burrs, damage, deterioration etc.)? | 1.2.4 | ||||||
| Do the consumables require any specific humidity and temperature controls? | 1.2.5 | ||||||
| If yes, are the required storage and preservation conditions provided? | 1.2.6 | ||||||
| Does the material have any limited shelf life / expiry date? | 1.2.7 | ||||||
| If the material has any expiry date, are expired materials used in production? | 1.2.8 | ||||||
| Is FIFO (First-In-First-Out) system followed in issuing/consuming the consumable and packing materials? | 1.2.9 | ||||||
| Is Raw Material / Input Material traceability required? If yes are they provided? | 1.2.10 | ||||||
| Are the required quantities of all consumables / packing items available? | 1.2.11 | ||||||
| Are suitable containers / chutes available for keeping output materials? | 1.3 | Output materials | 1.3.1 | ||||
| Are the output material containers / crates / trolleys as per defined standard? | 1.3.2 | ||||||
| Are the containers clean, free of burr, dust, fibres, damages, etc? | 1.3.3 | ||||||
| Are the parts touching each other / rubbing on containers when stored? | 1.3.4 | ||||||
| Is the storage location suitable to protect the output material from damage, environmental conditions, etc.? | 1.3.5 | ||||||
| Are suitable identification (and traceability if applicable) provided on outputs? | 1.3.6 | ||||||
| Are proper storage bins available for NC, Obsolete & Suspect Materials? | 1.4 | Control of NC, Obsolete and Suspect Materials | 1.4.1 | ||||
| Are proper identification provided for NC, Obsolete & Suspect Materials? | 1.4.2 | ||||||
| Are NC, Obsolete & Suspect materials kept segregated from good material? | 1.4.3 | ||||||
| Are records kept for the NC, Obsolete & Suspect Materials? | 1.4.4 | ||||||
| Are NC, Obsolete & Suspect Materials disposed off regularly? | 1.4.5 | ||||||
| Sl. No. | Check Point Question | Element | Sl. No. | Sub-Element | CP No. | Actual Observation at time of audit | NCR No. |
| 2 | Is the Machine and Tools used same as that specified in Control Plan / WI? | Machines, Fixtures and Tools, Work Environment, Facilities | 2.1 | Machine Condition | 2.1.1 | ||
| Is the Machine / Work Station under Preventive Maintenance (PM or TBM)? | 2.1.2 | ||||||
| Has scheduled PM / TBM been carried out on the Machine? | 2.1.3 | ||||||
| Is the Machine / Work Station under Predictive Maintenance (CBM)? | 2.1.4 | ||||||
| Is the Machine covered under periodic geometric accuracy checks? | 2.1.5 | ||||||
| Has scheduled CBM / Accuracy Checks been carried out on the Machine? | 2.1.6 | ||||||
| Are all the required spare parts replaced on time? | 2.1.7 | ||||||
| Has JH been carried out on the machine / work station as per Checklist? | 2.1.8 | ||||||
| Are the specified Poka-yokes provided and installed as per Control Plan? | 2.1.9 | ||||||
| Are all Poka-yokes provided on the machine / work station working satisfactorily? | 2.1.10 | ||||||
| Are all safety features of the Machine / work station working satisfactorily? | 2.1.11 | ||||||
| Has machine capability (Cm / Cmk) studies been conducted on the machine? | 2.1.12 | ||||||
| If yes, is the Cm / Cmk ≥ 2.00, or in worst case, not lesser than 1.67? | 2.1.13 | ||||||
| Is the machine and set up clean? | 2.1.14 | ||||||
| Is the machine and set up really ready for production? | 2.1.15 | ||||||
| Are the tool materials / inserts used of the correct specification / grade? | 2.2 | Fixture & Tool Condition | 2.2.1 | ||||
| Are the fixtures and tools covered under periodic pro-active verification plan? | 2.2.2 | ||||||
| Are tool life monitoring charts being maintained? | 2.2.3 | ||||||
| Are the fixtures and tools periodically verified as per plan and records available? | 2.2.4 | ||||||
| Are the wear parts of the fixtures / worn tools replaced on time? | 2.2.5 | ||||||
| Are torque wrenches (if used) calibrated? | 2.2.6 | ||||||
| Are torque wrenches (if used) set for correct value? | 2.2.7 | ||||||
| Are the automatic tool change programmes working satisfactorily? | 2.2.8 | ||||||
| Are any special accessories / supporting devices required for the machine / tool operation? | 2.2.9 | ||||||
| If yes, are they provided and also adequate? | 2.2.10 | ||||||
| Are work environment requirements (lighting, dust control, air flow, humidity, temperature, noise level, electrostatic protection, earthing, vibration levels, etc.) documented? | 2.3 | Work Environment | 2.3.1 | ||||
| Are the work environment conditions monitored regularly? At what frequency? | 2.3.2 | ||||||
| Is each of the work environment conditions within specifications given in the documentation? | 2.3.3 | ||||||
| Is the work environment clean and free of obstructions for effective operations? (Ex. Ergonomics, ease of operation, part and operator travel). | 2.3.4 | ||||||
| Are corrections and corrective actions evident when the work environment is found unsatisfactory? | 2.3.5 | ||||||
| Are the quality of services (compressed air, water, electricity, coolant contamination levels, coolant flow, etc.) defined? | 2.4 | Services | 2.4.1 | ||||
| Are the quality of services being monitored? | 2.4.2 | ||||||
| Are the quality of services maintained and available as required for the process? | 2.4.3 | ||||||
| Is 3-R and 5-S maintained in the work area? Is it satisfactory? | 2.4.4 | ||||||
| Is separate area ear-marked and provided for rework / rectification? | 2.4.5 | ||||||
| Is there a potential for mix-up of NC material with conforming material? | 2.4.6 | ||||||
| Are the required process control instruments available as per Control Plan? | 2.5 | Measurement Systems (Instruments, Test Equipment, Gauges, etc.) | 2.5.1 | ||||
| Are the process control instruments and gauges under calibration control and calibrated? | 2.5.2 | ||||||
| Are the required product checking instruments available exactly as specified in Control Plan (both variable gauges and attribute gauges)? | 2.5.3 | ||||||
| Are the product checking gauges / instruments under calibration control and calibrated? | 2.5.4 | ||||||
| Are proper storage arrangements made for the instruments and gauges so that they are protected from burr, dust, damage, etc. | 2.5.5 | ||||||
| Are required part holding devices available for inspection activities? | 2.5.6 | ||||||
| Has relevant MSA studies (Bias, Linearity, Stability, Variable R&R, Attribute R&R) been conducted for the relevant measurement systems? | 2.5.7 | ||||||
| Are the MSA study reports showing that the measurement systems are capable for the measurements to be made? (See Point No. 3.2.9 also). | 2.5.8 |
| Sl. No. | Check Point Question | Element | Sl. No. | Sub-Element | CP No. | Actual Observation at time of audit | NCR No. |
| 3 | Is the operator fully aware of the requirements of the Control Plan, WI’s, etc.? | Man | 3.1 | Awareness | 3.1.1 | ||
| Is the operator aware of special characteristic symbols and their significance? | 3.1.2 | ||||||
| Is the operator aware of his roles and responsibilities? | 3.1.3 | ||||||
| Is the operator aware of the customer needs & expectations? | 3.1.4 | ||||||
| Is the operator aware of customer complaints and actions taken on them? | 3.1.5 | ||||||
| Is the operator aware of Quality Alerts for rejections / customer complaints? | 3.1.6 | ||||||
| Is the operator aware of how to plot Control Charts, if applicable for the process? | 3.1.7 | ||||||
| Is the operator aware of safety precautions to be taken? | 3.1.8 | ||||||
| Is there a skill card available for the operator? | 3.2 | Skill & Competence | 3.2.1 | ||||
| Does the skill card indicate that the operator is fully qualified for this process? | 3.2.2 | ||||||
| Is the operator qualified to independently carry out the process? | 3.2.3 | ||||||
| Does the operator take the specified reaction plans for NC products? | 3.2.4 | ||||||
| Does the operator take the specified reaction plans for NC processes? | 3.2.5 | ||||||
| Does the operator plot, and correctly plot control charts, if applicable? | 3.2.6 | ||||||
| Does the operator know how to identify process instability from control charts and how to interpret the control charts? | 3.2.7 | ||||||
| Is the operator using the instrument / gauges correctly? | 3.2.8 | ||||||
| Is the operator handling and storing the measuring devices with due care in order to protect them from damage and deterioration? | 3.2.9 | ||||||
| Has the operator’s vision been tested by a qualified doctor and found fit for the process / inspection? | 3.2.10 | ||||||
| Is the operator wearing the specified spectacles / contact lenses / vision correction devices if applicable while carrying out the process? | 3.2.11 | ||||||
| Has MSA studies been conducted and operator’s capability to use the instruments, gauges etc. and / or visual inspection been established? | 3.2.12 | ||||||
| Is the operator punctual in process monitoring? | 3.3 | Motivation | 3.3.1 | ||||
| Is the operator punctual in checking product characteristics? | 3.3.2 | ||||||
| Does the operator follow all the specified safety precautions, including wearing / use of Personal Protective Equipment? | 3.3.3 | ||||||
| Does the operator inform the supervisor of process abnormalities? | 3.3.4 | ||||||
| Does the operator make entries in all records legibly? | 3.3.5 | ||||||
| Does the operator make entries in all records immediately after checks? | 3.3.6 | ||||||
| Is the required number of operators for the process defined? | 3.4 | Manpower Availability | 3.4.1 | ||||
| Are the required number of operators with required competence provided for the process? | 3.4.2 |
| Sl. No. | Check Point Question | Element | Sl. No. | Sub-Element | CP No. | Actual Observation at time of audit | NCR No. |
| 4 | Are all required documents (Drawings, Process Flowcharts, Control Plans, WI, Checklists, Formats, etc.) available at the Machine / Workstation? | Methods | 4.1 | Availability of Documentatio n | 4.1.1 | ||
| Are there any obsolete documents and / or obsolete formats in use? | 4.1.2 | ||||||
| Are the available documents legible, clear and easily readable and understandable? | 4.1.3 | ||||||
| Are there any un-approved corrections in any of these documents? | 4.1.4 | ||||||
| Are these documents displayed / stored at places where the operator can easily see them and read / refer to them without straining himself / herself? | 4.1.5 | ||||||
| If the process is a special process, has it been qualified? Are process qualification records available? | 4.1.6 | ||||||
| Are the process parameters defined in the Control Plan / WI exactly what is qualified for the special process? | 4.1.7 | ||||||
| Has the special process been re-qualified for changes if any made? | 4.1.8 | ||||||
| In case of changes in line balance, has the relevant work instructions been revised and approved? | 4.1.9 | ||||||
| Is each of the process parameters set on the machine / programme / workstation exactly as specified in Control Plans / Work Instructions? | 4.2 | Adherence to documentatio n | 4.2.1 | ||||
| Is the operator following the process sequence exactly as specified in CP / WI? | 4.2.2 | ||||||
| Is the operator finding it difficult to carry out any process? | 4.2.3 | ||||||
| Are there any process changes implemented which have not been validated yet? | 4.2.4 | ||||||
| Are there any product changes implemented which have not been validated yet? | 4.2.5 | ||||||
| 5 | Is set-up verification carried out for new set-ups and when set-up is changed? (Note: Set-up verification need be done and approved before allowing production to start for all new set-ups and whenever set up is changed for any reason. Ex. Machine breakdown, tool change, process parameter change, etc.). | Monitoring & Measurement | 5.1 | Set-up Verification | 5.1.1 | ||
| Are set-up verification records available and authorised by competent person? | 5.1.2 | ||||||
| Are process parameters monitored at intervals specified in Control Plans? | 5.2 | Process Monitoring | 5.2.1 | ||||
| Are the process parameter monitoring records legibly maintained? | 5.2.2 | ||||||
| Are deviations if any approved by specified competent personnel? | 5.2.3 | ||||||
| Are reaction plans implemented when the process become unstable/non-capable? | 5.2.4 | ||||||
| Are the reaction plans effective? That is, has the problem been resolved with the implementation of the specified reaction plan? | 5.2.5 | ||||||
| Are significant process events recorded in Control Charts / other records? (Ex. Material batch changes, machine breakdowns, tool changes, shift changes, etc.). | 5.2.6 | ||||||
| Is 1st Piece Inspection / Testing carried out and records maintained? (Note: 1st piece inspection here does not mean inspection of just one piece, but inspection of whatever quantity is specified in Control Plan for approval before allowing full scale regular production). | 5.3 | Product Monitoring | 5.3.1 | ||||
| Does the 1st Piece inspection record show that all characteristics are met? | 5.3.2 | ||||||
| Are in-process inspections carried out on the products as specified in Control Plan? | 5.3.3 | ||||||
| Are in-process inspection records legibly maintained? | 5.3.4 | ||||||
| Does the in-process inspection record show that all characteristics are met? | 5.3.5 | ||||||
| Are final inspections carried out on the products as specified in Control Plan? | 5.3.6 | ||||||
| Are final inspection records legibly maintained? | 5.3.7 | ||||||
| Does the final inspection record show that all characteristics are met? | 5.3.8 | ||||||
| Are deviations if any approved by specified competent personnel? | 5.3.9 | ||||||
| Are Control Charts plotted as per specified in Control Plan? | 5.3.10 | ||||||
| Does the Control Chart show that the process is stable and capable? | 5.3.11 |
| Sl. No. | Check Point Question | Element | Sl. No. | Sub-Element | CP No. | Actual Observation at time of audit | NCR No. |
| 6 | Is rejection and rework in the process tracked? | Process Effectiveness & Efficiency | 6.1 | Process Effectiveness | 6.1.1 | ||
| Are the rejection values within targets over last 3 months? (Write Target Value Vs. Average Value for 3 months in Observation box). | 6.1.2 | ||||||
| Are the rework values within targets over last 3 months? (Write Target Value Vs. Average Value for 3 months in Observation box). | 6.1.3 | ||||||
| Is process performance (Ppk) higher than 1.67 for special characteristics? | 6.1.4 | ||||||
| Is process performance (Ppk) higher than 1.33 for other characteristics? | 6.1.5 | ||||||
| Are root cause analysis and corrective actions evident for rejections, rework and low process capability? | 6.1.6 | ||||||
| Are there any unresolved customer complaints / complaints from next process? | 6.1.7 | ||||||
| Is productivity / cycle time monitored? | 6.2 | Process Efficiency | 6.2.1 | ||||
| Is the productivity / cycle time maintained as per process design targets? | 6.2.2 | ||||||
| Is line balance maintained based on cycle times? | 6.2.3 | ||||||
| Are there any recent safety incidents at the machine / work station? | 6.2.4 | ||||||
| Are there any potential for safety incidents at the machine / work station? | 6.2.5 | ||||||
| 6.3. | Any other Observation | 6.3.1 | |||||
| 6.3.2 | |||||||
| 6.3.3 | |||||||
| Signature of Auditor: Signature of Auditee: Date: | |||||||
