Clause1:Production preparation / New Product Development
Audit Area
Concerning Regulation
1
Regarding the implementation rule of production preparation
1
Do you define the procedure for Product development including the following? -scope of parts, the responsibility of each department, control contents/items?
2
Regarding management/implementation by production preparation plan/report (master plan)
1
Do you implement follow-up to control the schedule and progress of production preparation items? Incl top management
3
Defect prevention at the stage of process design by using FMEA/Matrix diagram
1
Do you consider the following items and implement corrective and preventive action to the processes and standards before regular production? -Troubles in the past; -Defect items expected; -Defect items unable to capture at customer; -Defect items difficult to repair;
4
Product/process evaluation at the quality evaluation meeting in each trial
1
Do you prevent defects by quality-improving activities of the cross-function team to evaluate quality performance?
Clause2:Regulation for initial production control
Audit Area
Concerning Regulation
1
Regulation for initial production control
1
Do you define the following items related to initial production control by standards? -controlled parts; -controlled items; -inspection method; -initial production control period; -a person who announces start/end of initial production control;Â Â Â -finish condition;
2
How do you define items that required special control during initial production control? Do you set stricter inspection methods than ordinary inspection?
2
Implementation of initial production control
1
Do you control process capability and defect rate during initial production control?
Clause3:Changing Management
Audit Area
Concerning Regulation
1
Definition and implementation of changing management
1
Do you define unexpected change (unusual) and planned change clearly?
2
Do you define procedure(rules applied from sharing information to result confirmation) at change occurrence?
3
Do you record product quality check results to ensure traceability? Incl retroactive checks
2
Definition and control method for the initial part
1
Do you define and control the initial part clearly?
2
Do you control initial parts separately and make quality records about them? (both internal and outsourced processes are included)
Clause4:Standards Management
Audit Area
Concerning Regulation
1
Procedure to make process control standards(QA process charts)
1
Do you make and review process control standards, Inspection specifications, and Operation instructions for all products which are shipped to SMC /MSIL /Tier 1?
2
Procedure to control standards  ・Process control standards  ・Inspection specifications  ・Operation instructions
1
Do you have consistency to keep process control standards, inspection specification, operation inspection, and parameter chart?
Clause5:Education and Training
Audit Area
Concerning Regulation
1
Education/ training procedure
1
Do you clarify the department in charge of promoting quality education, and implementing education based on the annual plan? Are records of education kept?
2
Do you define and implement the skill evaluation of the operator to determine whether an operator can work without surveillance? (e.g. acceptable revel/evaluation frequency/evaluation method)
2
Education for managers/Inspectors/ Special operators
1
Do you periodically monitor the skill of certificated operators and follow up to improve their skills?
Clause6:Quality Audit and Process Verification
Audit Area
Concerning Regulation
1
Activity to keep/improve production quality
1
Do you conduct a quality audit to identify issues and properly improve them?
2
Content of process review
1
Do you confirm consistency between actual operation and standard?
2
Do you confirm if countermeasures are taken properly to prevent reoccurring quality failure?
Clause7:Supplier Control
Audit Area
Concerning Regulation
1
Evaluation method for new suppliers
1
Do you define criteria to certify new suppliers and implement them?
Do you define clearly what is an abnormal situation and make operators know the definition?
2
Do you clarify and standardize the handling rules/routes for customer claims, in-process failure, and supplier failure?
3
Do you have criteria to estimate the scope of a suspected lot for an abnormal situation?　When an abnormal situation occurs, do you trace the suspected lot based on the criteria?
2
Prevention of recurrence  ・Customer claims ・In process failure ・Suppliers failure
1
Do you prevent the recurrence of issues by analyzing the cause of occurring defects based on process investigation results such as 5-why analysis?
2
Do you reflect corrective action to the improvement of process control and review of standards?
3
After corrective actions are taken, do you conduct on-site checks and evaluate the effectiveness? And horizontal deployment.
Clause9:5S Management
Audit Area
Concerning Regulation
1
Location of the production site
1
Do you keep store material, work-in-process, finished products, inventory, and containers at appropriate storage prevented from dust, rust, scratch, deformation, and rainwater?
2
Do you control material, work-in-process, and finished product by designated location, volume, and standard using visual control?
3
Do you implement inspection or critical operation under a properly controlled environment luminance /temperature/humidity/vibration/noise/work table, etc.)?
2
Production equipment’s management
1
Do you keep the condition of production equipment, jigs and tools properly?
2
Do you keep the condition of inspection equipment properly to ensure accuracy?
Do you conduct daily/regular checks of production equipment, dies, and jigs? Are records of maintenance kept?
2
Do you confirm regularly the function of Poka-yoke, automated stop, and alarm? Are records of maintenance kept?
3
Do you standardize the frequency of polishing and replacement for consumable tools(blade/electrode/rub stone, etc.)?
2
Maintenance of inspection equipment
1
Do you calibrate regularly inspection equipment and put the expire date on them?
2
Do you control the deterioration (expire date) of boundary samples for objective judgments such as appearance inspection?
Clause11:Implementation of Standards
Audit Area
Concerning Regulation
1
Implementation of standards
1
Do you use easy expressions (visualizer, onomatopoeia, etc.) for operation instructions? So that operator can easily understand processes and critical points.
2
Do you keep operation instructions in an accessible place and most important quality points and critical operation points in a place where operators can see them easily?
3
Do you regularly monitor that each operator operates according to the operation instructions？Â
4
Is it possible to judge OK/NG specifically by each check sheet (of daily equipment check, quality control report, etc.) you use?
Clause12:Products Management
Audit Area
Concerning Regulation
1
Management of parts flow
1
Do you keep first-in first-out of finished products and work-in-process (material, reserve parts）by using an identification tag or lot indication?
2
Do you control follows production history by product lot numbers? -production date; -production volume; -shipping date
3
Do you control the identification of similar parts separately?
2
Non-confirming parts management
1
Do you control the identification of non-confirming parts and parts on hold? Do you store them separately?
2
Regarding repaired non-conforming parts and parts on hold to re-use, do you define responsibility to implement? Are repair records kept?
Clause13:Handling Management
Audit Area
Concerning Regulation
1
Bins/ Trolley Management
1
Do you make arrangements with customers about the packing style & transportation system to prevent damage during the handling of finished products & perform accordingly?
2
Do you have a system to maintain Bins /Trolleys in Good Condition?
Clause14:Critical Parts Management
Audit Area
Concerning Regulation
1
Maru A Parts Management
1
Do you have Special checks/Inspections for Maru A parameters of the Maru A part available?
2
Do you have the Identification of Maru A Process/Operator on Shop Floor?
3
Do you keep the repair history when repairing & using Maru A items?
Clause15:Adequate Testing Facility
Audit Area
Concerning Regulation
1
Testing Facility
1
Does the supplier have all inspection instruments required as per drawing requirements?
2
Does the supplier have all Testing Equipment/Rigs required as per drawing requirements?
3
Does the Supplier has trained manpower to operate these inspection and testing instruments?
Clause16:Process Audit
Audit Area
Concerning Regulation
1
As per PCS
1
Conduct process audit as per process control standard
2
Closure of all the observations
Clause17:Scale and Top Management Bandwidth
Audit Area
Concerning Regulation
1
Management Bandwidth & Organization Structure
1
Do you have adequate organization structure and defined roles/ responsibilities for key areas such as Plant Head, Quality, Production, and Maintenance?
2
Review Mechanism
2
How frequently Top management visits the shop floor? How frequently Top Management monitors key performances (Performance at the customer end, in-house quality, productivity, maintenance, safety, etc.)?
3
Plant Sales Turnover*
3
Plant Sales Turnover for the audited plant. Group Turnover
4
PAT/Sales
4
PAT/Sales
5
D/E Ratios
5
D/E ratio
6
ROCE
6
ROCE
Clause18:Safety
Audit Area
Concerning Regulation
1
Working Conditions
1
Is the shop floor temperature, noise level, and air quality (fumes) ok? Is the layout and escape route on the shop floor Ok? Are Rest Areas/Toilets Available? Is the area/machine sufficient enough to allow easy movement of machines and tools?
2
Human and Machine Safety
2
Are Safety Standards made (as per process requirement) and taught to all operators? Are PPEs available as per the standards or not?
3
Machine Safety system (Door sensors etc. ) available or not? Is Safety in material movement and tools ensured or not?
4
Are safety standards followed on the shop floor as per the procedure? Are usage of PPEs adhered to and monitored (by supervisor/senior) on the shop floor? What accident reporting mechanism is defined? Countermeasures against accidents taken and periodic verification being done?
3
Fire Safety
5
Audit Conducted by a reputed 3rd party on MSIL defined check sheet?
Clause19:Legal Compliance and Environment
Audit Area
Concerning Regulation
1
Consent to Operate
1
Is consent to operate (Valid as on date) available or not?
2
ESI & PF
2
Are all operators enrolled for ESI and PF? Does management review the status of PF contributions /ESI payments? If ESI& PF are managed by the Contractor, then does management review and check the ESI enrolment/ payments?
3
Hazardous Waste Management
3
Are the different types of wastes identified on the shop floor and standards/ Procedures made? Is Segregation done at the source for different types of waste? Storage and disposal are done as per consent and periodic confirmation at the disposal stage?
