Master Sheet Process Audit Check Sheet
Master Sheet Process Audit Check Sheet
Master Sheet Process Audit Check Sheet
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IFB Industries Ltd Audit date:
Company: Audit Summary This audit Previous audit 2nd Previous audit Audit Guide Lines :
Audit Date 1. Understand about regular audit,new vendor
SAMCO CO., LTD Audit Rating audit, new processaudit & audit related to
Audit Grade quality issues.
2. Understand in detail the Process Audit
Format
3. Collect quality reports (both IQC & Line
Quality Management System rejection), development issues & test related
Control Of Non Conforming Product Document And Data Control Record
200.0% issues of the parts supplied during last few
months
Control Of Inspection, Measuring And Test Equipment Management Responsibility
100.0% 4. Verify pending actions as agreed during
QUALITY last audit
ASSURANCE 0.0%
5. For new Supplier: Obtained score should be
SYSTEM Handling, Storage, Packaging, Preservation And Delivery Resource Management - Training
>70% for each check point.
Initial audit for new supplier Audit due to process change (e.g. relocation) Other
Process released (Incase of new process) Yes No Vendor approved (Incase of new supplier) Yes No
Yes No Completeness of this document is verified Yes No
Completeness of this document is verified
Comments: Comments:
POINTS
Sect. EVALUATION ITEMS 0 1 2 3 4 5 REMARKS
1.1 Is company ISO certified?. Check the validity of the certificate. Are documented Quality Manual, 5
Quality Policy and procedures available?
1.2 Does supplier have organization structure? Are roles & responsibilities defined? A quality control 5
manager has been assigned
1.3 The progress of quality - related programs and the level of achievement of Quality Targets have 5
been monitored monthly.
1.4 Quality manual and procedures have been set up. 5
3 Management Responsibility
3.1 Specific Management Policies, Quality Policies and Quality Targets have been Given 5
3.2 A review has been conducted by the management and record is maintained 5
3.3 Specific program to achieve Quality Policies and Quality Targets has been clearly planned. 5
3.4 Are Customer satification(Quality, delivery, Cost, Satification) being monitored and reviewed in 5
MRM? Is there any action plan for improvements available?
4.1 It has been made clear, what kind of education and training is necessary to improve your quality. 5
4.2 Training programs for new employees have been defined and implemented. 5
4.3 Training records are available. 4
4.4 Posters of quality policies, targets, slogans etc. have been displayed. 4
4.5 The quality conditions, targets, etc. have been displayed at manufacturing section. 5
4.6 The names of members of QC circles and other small group activities have been identified. 5
5.1 Are supplier selection process defined? Are suppliers evaluated before approving? 5
5.2 Is approved list of suppliers available and updated ? 5
5.3 Is supplier audit plan available? Is audit conducted as per plan ? Is gap analysis monitored? 4
5.4 Are suppliers monitered for performance(QCDR)? Is there action plan available to improve rating? 4
5.5 Are the PPAP documents and master sample kept in safe place and available for reference? 4
5.6 Has Process FMEA been carried out for all process involved? Are all customer requirements 5
addressed in FMEA? Have actions been implemented for high risk failures?
Production Control
6.1 The organization shall determine and manage the work environment needed 5
to achieve conformity to product requirements. ( Work environment : clean factory, noise,
temperature, humidity, lighting orweather )
6.2 The places and equipment where safety consideration is required have been properly marked. 5
6.3 The storage area for WIP and defective goods have been clearly indicated. 5
6.4 The operators are aware of the contents and methods of operations (SOP or WI) to be carried out. 5
6.5 Work instructions have been prepared based on product specifications. 5
6.6 Safety processes and Critical processes have been indicated. 4
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Control of Equipment
6.14 Equipment which affects safety has been labeled. 4
6.15 Safety measures to protect workers have been applied to the equipment. 4
6.16 The persons incharge of equipment control are aware of measures to be taken when abnormalities 4
occur.
Preventive Maintenance
6.17 Is preventive maintenance plan (Daily, Monthly, Yearly) available for machines and is carried 3
out as per plan. Are Daily, Monthly, Yearly Maintenance Check Sheet available and update?
6.18 Is maximum Tool life is determined and the current usage status of the tools are monitored? Is there 2
any evidence of major tool correction/maintenance w.r.t history card and is the tool recalibrated?.
6.19 Are critical spares identified and minimum stocks maintained for machine and Tool/Mold? 4
Continual Improvement
6.20 Are Kaizen / 5S approach used by organization for continual improvement? 4
6.21 Is Poke Yoke technique apply by supplier for process and detection? 4
6.22 Are All QC-7 tool used by organization for "root cause analysis" 4
Incoming Inspection
7.1 Are latest drawings and specifications available with the supplier? 4
7.2 Are Incoming goods inspected systematically according to the control plan(Sampling Plan, 5
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7.3 Inspections are carried out based on inspection specifications and given procedures and result 5
recorded.
7.4 Limit samples have been approved and date of expiry have been defined. 4
7.5 Is shelf life material identified and monitored? 5
Final Inspection
7.14 Is final inspection product inspected as per control planSampling Plan, Judgment Instruction, 5
Inspected parameter & reaction plan)?
7.15 Is list of authorize persons available to certify the final product as per customer requirements? 5
7.16 Is material properly identified in the inventory after the final inspection? 5
7.17 Is packaging standard / packing instruction available? Are the finished product packaged according 5
to customer specification? (Weight / Quantity/Bin or Box)
9.1 All material storage (IQC Material, Line Material & Store Material) location should be defined with 5
3R(Right Location, Right Qty, Right Container) Tag
9.2 Things have been put in order in their places. 5
9.3 Appropriate markings for identification have been made (product names, parts names, serial 5
numbers, date of stocking and statuses).
9.4 Operating instructions for packaging processes have been prepared. 4
9.5 Environmental conditions have been defined to prevent deterioration while in storage. 4
9.5 The first in first out principle of products has been observed. 4
10.1 Check for the list of available gauges, instruments & Fixture? 5
10.2 Are the calibrations carried out as per defined frequency? Are calibration records available for 5
all the gauges / Instruments?
10.3 The identification of validity of calibration is clear. 5
10.4 Contents and procedures for calibration of "Regular inspections before start " have been defined. 5
(Verification of Gauge/Instrument before used on line for daily inspection)
10.5 Is there any "Zero Error" in calibration certificate, If yes, how it is communicated to user? 5
11.1 Non-conforming goods (IQC, PQC & OQC) have been identified and marked. 5
11.2 Methods of operation and control points of repair work have been defined? 4
11.3 Are QC-7, Why-Why, Six SIgma Tool used for root cause analysis? Are corrective action and 3
preventive action taken for all the non conformances?
11.4 Are control plan and PPAP updated as a result of the root cause analysis and taken action? 4
11.5 The methods for dealing with non-conforming products have been defined. 5
11.6 Person incharge of customer service (Quality-in-charge) have been appointed. 5
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11.7 The procedure for dealing with market quality information, from obtaining 5
11.8 Corrective measures have been taken based on market quality information. 5
11.9 The effects of corrective measures have been confirmed. 5
12.1 Is Annual RoHS testing plan available? Is it carried out as per plan? 5
12.2 Is RoHS Standard available for use? Are the results meting the specification? 5
12.3 Are test certificate ( Raw Materials), supplier inspection reports available? 5
12.4 Is there any plan for in-house/3rd party material testing? 5
12.5 Are material Standard available for use? Are the results meting the specification? 5
12.6 Is there any plan for in-house/3rd party Assy reliability and performance testing? 5
12.7 Are the reliability and performance meting the specification? 5
93.71% A
MARKING CODE GRADING SYSTEM
MARK REMARK GRADE EVALUATION RESULT
0 No plan A 90% and above EXCELLENT
1 Planned but not carried out B 80% to 90% excl. GOOD
2 Planned carried out with no result C 70% to 80% excl. PASS
3 Planned carried out with little result D 60% to 70% excl. FAIR
4 Planned carried out with good result E 50% to 60% excl. POOR MUST IMPROVE WEAKNESSES
5 Planned carried out with best result F Below 50% FAIL FOR NEXT FOLLOW-UP
Responsible
Deviation No. Audit Question No. Finding / Improvement area Corrective action Verification Closed / Open
By when