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TRAINING ON
QUALITY SYSTEM
AUDIT SHEET - MSIL
AUDIT CHECK SHEET CLAUSE - 1
Category Audit Area Concerning regulation Resp.
1. Production
preparation /
New Product
Development
1
Regarding implementation rule of
production preparation
Do you define the procedure for Product
development including the following ? -scope of
parts, responsibility of each department, control
contents / items?
Mr.
Manish /
Sharad
2
Regarding management / implementation
by production preparation plan / report
(master plan)
Do you implement follow-up to control the
schedule and progress of production preparation
items? Incl top management
3
Defect prevention on the stage of
process design by using FMEA/Matrix
diagram
Do you consider 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
Do you prevent defects by quality improving
activities of cross-function team to evaluate quality
performance?
AUDIT CHECK SHEET CLAUSE - 2
Category Audit Area Concerning regulation Resp.
2.
Regulation for
initial
production
control
1
Regulation for
initial production control
Do you define following items related to initial
production control by standards ?
-controlled parts; -controlled items; -inspection
method;
-initial production control period;
-a person who announce start/end of initial
production control; -finish condition;
Mr.
Manish /
Sharad
How do you define items required special control
during initial production control? Do you set
stricter inspection methods than the ordinary
inspection?
2
Implementation of initial production
control
Do you control process capability and defect rate
during initial production control?
AUDIT CHECK SHEET CLAUSE - 3
Category Audit Area Concerning regulation Resp.
3.
Changing
management
1
Definition and implementation of
changing management
Do you define unexpected change (unusual) and planned
change clearly?
Mr.S. Bhatia /
Sabri
Mr. R.
Srinivasan /
Mohan Lal
Mr. Mukesh
Yadav /
Mohan Roy
Do you define procedure(rules applied from sharing
information to result confirmation) at change occurrence?
2
3
Do you record product quality check results to ensure
traceability? Incl retroactive checks.
1
Definition and control method for
initial part
Do you define and control initial part clearly?
2
Do you control initial parts separately and make quality
records about them?(both internal and outsourced process
are included)
AUDIT CHECK SHEET CLAUSE - 4
Category Audit Area Concerning regulation Resp.
4.
Standards
management
1
Procedure to make process
control standards(QA process
charts)
Do you make and review process control
standards, Inspection specifications, Operation
instructions for all products which is shipped to
SMC / MSIL / Tier 1 ?
Mr. Manish /
Sharad
2
Procedure to control standards
・ Process control standards
・ Inspection specifications
・ Operation instructions
Do you have consistency to keep process control
standard, inspection specification, operation
inspection and parameter chart?
AUDIT CHECK SHEET CLAUSE - 5
Category Audit Area Concerning regulation Resp.
5.
Education
and training
1 Education/ training procedure
Do you clarify the department in charge of promoting
quality education, implement education based on
annual plan?
Are records of education kept?
Mr.
Vinod
Sharma
/ Vivek /
Ritika
Do you define and implement the skill evaluation of
operator to determine whether operator can work
without surveillance?(e.g. acceptable revel/evaluation
frequency/evaluation method)
2
Education for managers/Inspectors/
Special operators
Do you periodically monitor the skill of certificated
operators and follow up to improve their skill?
AUDIT CHECK SHEET CLAUSE - 6
Category Audit Area Concerning regulation Resp.
6.
Quality audit
and process
verification
1 Activity to keep/improve production
quality
Do you conduct quality audit to identify issues and
properly improve them?
Mr.Anil Verma
/ Shiv Parkash
1
Content of process review
Do you confirm consistency between actual operation
and standard?
2
Do you confirm if countermeasures are taken properly to
prevent reoccurring of quality failure?
AUDIT CHECK SHEET CLAUSE - 7
Category Audit Area Concerning regulation Resp.
7.
Supplier
control
1
Evaluation method for new
suppliers
Do you define criteria to certificate new suppliers
and implement them?
Mr. Shiv Parkash/ Mr.
Rishi chopra
Mr. Kuldeep/ Mr.
Joginder
AUDIT CHECK SHEET CLAUSE - 8
Category Audit Area Concerning regulation Resp.
8.
Handling
abnormality in
quality
1
Handling when abnormal situation
occurs
Do you define clearly what is abnormal situation and make
operators know the definition?
Mr.
Mukesh
Chaudh
ary /
Sabri /
K.R.Rak
esh /
Ajeet /
Vimal
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 suspected lot
for abnormal situation?   When abnormal situation occurs,
do you trace suspected   lot based upon the criteria?
1
Prevention of recurrence
・ Customer claims
・ In process failure
・ Suppliers failure
Do you prevent recurrence of issues by analyzing cause of
occurring defect based on process investigation result such
as 5-why analysis?
Do you reflect corrective action to improvement of process
control and review of standards?
2
After corrective action are taken, do you conduct on-site
check up and evaluate the effectiveness? And horizontal
deployment.3
AUDIT CHECK SHEET CLAUSE - 9
Category Audit Area Concerning regulation Resp.
9. 5S
management
1
Location of production site
Do you keep store material, work-in-process, finished
products, inventory and container at appropriate storage
prevented from dust, rust, scratch, deformation and
rainwater?
Mr. Anil Verma /
Shiv Parkash
Do you control material, work-in-process and finished
product by designated location, volume and standard
using visual control?
2
3
Do you implement inspection or critical operation under
the properly controlled environment luminance
/temperature/humidity/vibration/noise/work table, etc.)?
1
Production equipment's
management
Do you keep condition of production equipment's, jigs
and tools properly?
2
Do you keep condition of inspection equipment's
properly to ensure accuracy?
AUDIT CHECK SHEET CLAUSE - 10
Category Audit Area Concerning regulation Resp.
10.
Equipment/Ins
pection
equipment's
management
1
Maintenance of equipment's , jigs
and tools
Do you conduct daily/regularly check of production
equipment's, dies and jigs? Are records of maintenance
kept?
Mr.S. Bhatia /
Mukesh
Chaudhary /
Manish Saini /
Sabri/ Kailash
Do you confirm regularly the function of Pokayoke,
automated stop and alarm? Are records of maintenance
kept?
2
Do you standardize frequency of polishing and
replacement for consumable tools(blade/electrode/rub
stone, etc.)?3
1
Maintenance of inspection
equipment's
Do you calibrate regularly inspection equipment's and
put the expire date on them?
2
Do you control deterioration (expire date) of boundary
samples for objective judgments such as appearance
inspection?
AUDIT CHECK SHEET CLAUSE - 11
Category Audit Area Concerning regulation Resp.
11 .
Implementation
of standards
1
Implementation of
standards
Do you use easy expression (visualizer, onomatopoeia ,etc.) for
operation instructions? So that operator can easily understand
process and critical points.
Mr. Shiv Parkash /
Amit Mishra
2
Do you keep operation instructions on the accessible place and
post important quality points and critical operation points on the
place where operators can see it easily?
Do you regularly monitored that each operator operates
according to the operation instructions ?
3
Is it possible to judge OK/NG specifically by each check sheet (of
daily equipment check, quality control report, etc.) you use?4
AUDIT CHECK SHEET CLAUSE - 12
Category Audit Area Concerning regulation Resp.
12.
Products
management
1
management of
parts flow
Do you keep first-in first-out of finished products and
work-in-process (material, reserve parts ) by using
identification tag or lot indication?
Mr. S. Bhatia / Rishi
Chopra / Sabri
2
Do you control follows production history by product lot
numbers?
-production date; -production volume; -shipping date
Do you control identification of similar parts
separately?3
1
Non-confirming parts
management
Do you control 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 record kept?  
AUDIT CHECK SHEET CLAUSE - 13
Category Audit Area Concerning regulation Resp.
13.
Handling
Management
1
Bins/ Trolley
Management
Do you make arrangements with customers about the
packing style & transportation system to prevent damage
during handling of finished products & perform
accordingly.
Mr. Rishi Chopra /
Kailash / Rohit Khurana /
Anil
2
Do you have system to maintain Bins /Trolleys in Good
Condition.
AUDIT CHECK SHEET CLAUSE - 14
Category Audit Area Concerning regulation Resp.
14.
Critical parts
Management
1
Maru A Parts
Management
Do you have Special checks/Inspection for Maru A
parameters of Maru A part are available .
Mr. C. B. Sharma / Shiv
Parkash / Balbir / Kuldeep
2
Do you have Identification of Maru A
Process/Operator on Shop Floor.
3
Do you keep the repair history when repairing & using
Maru A items
AUDIT CHECK SHEET CLAUSE - 15
Category Audit Area Concerning regulation Resp.
15. Adequate
testing facility
1
Testing Facility
Does the supplier has all inspection instruments required
as per drawing requirements
Mr. Anil Verma / Mukesh
Chaudhary
2
Does the supplier has all Testing Equipments/Rigs
required as per drawing requirements
3
Does the Supplier has trained manpower to operate
these inspection and testing instruments
2 O 43
AUDIT CHECK SHEET CLAUSE - 16
Category Audit Area Concerning regulation Resp.
16. Process
Audit
1
As per PCS
Conduct process audit as per process control
standard
Mr. Shiv Parkash / Amit Mishra
2 Closure of all the observations
MSIL Clause wise action plan mapping sheet
MSIL
Audit
Clause
No.
Main Audit Points
Process Owner
(Primary Responsibility)
Activity
Co-ordinator (Sub-
Responsibility)Name Department
1
Production preparation / New
Product Development
Mr. Manish Engineering Mr. Sharad
2
Regulation for
Initial Production Control Mr. Manish Engineering Mr. Sharad
3 Change Management
Mr.S. Bhatia
Mr. R. Srinivasan
Mr. Mukesh Yadav
Production
Mr. Sabri
Mr. Mohan Lal
Mr. Mohan Roy
4 Standards Management Mr. Manish Engineering Mr. Sharad
5 Education and Training Mr. Vinod Sharma P & A Mr. Vivek
6
Quality audit and process
verification
Mr.Anil Verma QA Mr. Shiv Parkash
7 Supplier control Mr. Shiv Parkash QA MR. Rishi Chopra
8 Handling abnormality in quality Mr. Mukesh Chaudhary QA
Mr. Sabri
Mr. K.R. Rakesh
Mr. Ajeet
Mr. Vimal
9 5S management Mr. Anil Verma QA Mr. Shiv Parkash
10
Equipment /Inspection
equipment's management
Mr. Mukesh Chaudhary QA Mr. Manish Saini
11 Implementation of standards Mr. Shiv Parkash QA Mr. Amit Mishra
12 Products management Mr. S. Bhatia Production MR. Rishi Chopra
13 Handling Management Mr. Rishi Chopra SCM Mr. Rohit Khurana
14 Critical parts Management Mr. C. B. Sharma Mkt. Mr. Balbir
15 Adequate testing facility Mr. Anil Verma QA Mr. Shiv Parkash
16 Process Audit Mr. Shiv Parkash QA Mr. Amit Mishra
ACTUAL SITUATION –Date 25/26 july 16
Any Query ?

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Training on Quality System Audit Sheet

  • 2. AUDIT CHECK SHEET CLAUSE - 1 Category Audit Area Concerning regulation Resp. 1. Production preparation / New Product Development 1 Regarding implementation rule of production preparation Do you define the procedure for Product development including the following ? -scope of parts, responsibility of each department, control contents / items? Mr. Manish / Sharad 2 Regarding management / implementation by production preparation plan / report (master plan) Do you implement follow-up to control the schedule and progress of production preparation items? Incl top management 3 Defect prevention on the stage of process design by using FMEA/Matrix diagram Do you consider 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 Do you prevent defects by quality improving activities of cross-function team to evaluate quality performance?
  • 3. AUDIT CHECK SHEET CLAUSE - 2 Category Audit Area Concerning regulation Resp. 2. Regulation for initial production control 1 Regulation for initial production control Do you define following items related to initial production control by standards ? -controlled parts; -controlled items; -inspection method; -initial production control period; -a person who announce start/end of initial production control; -finish condition; Mr. Manish / Sharad How do you define items required special control during initial production control? Do you set stricter inspection methods than the ordinary inspection? 2 Implementation of initial production control Do you control process capability and defect rate during initial production control?
  • 4. AUDIT CHECK SHEET CLAUSE - 3 Category Audit Area Concerning regulation Resp. 3. Changing management 1 Definition and implementation of changing management Do you define unexpected change (unusual) and planned change clearly? Mr.S. Bhatia / Sabri Mr. R. Srinivasan / Mohan Lal Mr. Mukesh Yadav / Mohan Roy Do you define procedure(rules applied from sharing information to result confirmation) at change occurrence? 2 3 Do you record product quality check results to ensure traceability? Incl retroactive checks. 1 Definition and control method for initial part Do you define and control initial part clearly? 2 Do you control initial parts separately and make quality records about them?(both internal and outsourced process are included)
  • 5. AUDIT CHECK SHEET CLAUSE - 4 Category Audit Area Concerning regulation Resp. 4. Standards management 1 Procedure to make process control standards(QA process charts) Do you make and review process control standards, Inspection specifications, Operation instructions for all products which is shipped to SMC / MSIL / Tier 1 ? Mr. Manish / Sharad 2 Procedure to control standards ・ Process control standards ・ Inspection specifications ・ Operation instructions Do you have consistency to keep process control standard, inspection specification, operation inspection and parameter chart?
  • 6. AUDIT CHECK SHEET CLAUSE - 5 Category Audit Area Concerning regulation Resp. 5. Education and training 1 Education/ training procedure Do you clarify the department in charge of promoting quality education, implement education based on annual plan? Are records of education kept? Mr. Vinod Sharma / Vivek / Ritika Do you define and implement the skill evaluation of operator to determine whether operator can work without surveillance?(e.g. acceptable revel/evaluation frequency/evaluation method) 2 Education for managers/Inspectors/ Special operators Do you periodically monitor the skill of certificated operators and follow up to improve their skill?
  • 7. AUDIT CHECK SHEET CLAUSE - 6 Category Audit Area Concerning regulation Resp. 6. Quality audit and process verification 1 Activity to keep/improve production quality Do you conduct quality audit to identify issues and properly improve them? Mr.Anil Verma / Shiv Parkash 1 Content of process review Do you confirm consistency between actual operation and standard? 2 Do you confirm if countermeasures are taken properly to prevent reoccurring of quality failure?
  • 8. AUDIT CHECK SHEET CLAUSE - 7 Category Audit Area Concerning regulation Resp. 7. Supplier control 1 Evaluation method for new suppliers Do you define criteria to certificate new suppliers and implement them? Mr. Shiv Parkash/ Mr. Rishi chopra Mr. Kuldeep/ Mr. Joginder
  • 9. AUDIT CHECK SHEET CLAUSE - 8 Category Audit Area Concerning regulation Resp. 8. Handling abnormality in quality 1 Handling when abnormal situation occurs Do you define clearly what is abnormal situation and make operators know the definition? Mr. Mukesh Chaudh ary / Sabri / K.R.Rak esh / Ajeet / Vimal 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 suspected lot for abnormal situation?   When abnormal situation occurs, do you trace suspected   lot based upon the criteria? 1 Prevention of recurrence ・ Customer claims ・ In process failure ・ Suppliers failure Do you prevent recurrence of issues by analyzing cause of occurring defect based on process investigation result such as 5-why analysis? Do you reflect corrective action to improvement of process control and review of standards? 2 After corrective action are taken, do you conduct on-site check up and evaluate the effectiveness? And horizontal deployment.3
  • 10. AUDIT CHECK SHEET CLAUSE - 9 Category Audit Area Concerning regulation Resp. 9. 5S management 1 Location of production site Do you keep store material, work-in-process, finished products, inventory and container at appropriate storage prevented from dust, rust, scratch, deformation and rainwater? Mr. Anil Verma / Shiv Parkash Do you control material, work-in-process and finished product by designated location, volume and standard using visual control? 2 3 Do you implement inspection or critical operation under the properly controlled environment luminance /temperature/humidity/vibration/noise/work table, etc.)? 1 Production equipment's management Do you keep condition of production equipment's, jigs and tools properly? 2 Do you keep condition of inspection equipment's properly to ensure accuracy?
  • 11. AUDIT CHECK SHEET CLAUSE - 10 Category Audit Area Concerning regulation Resp. 10. Equipment/Ins pection equipment's management 1 Maintenance of equipment's , jigs and tools Do you conduct daily/regularly check of production equipment's, dies and jigs? Are records of maintenance kept? Mr.S. Bhatia / Mukesh Chaudhary / Manish Saini / Sabri/ Kailash Do you confirm regularly the function of Pokayoke, automated stop and alarm? Are records of maintenance kept? 2 Do you standardize frequency of polishing and replacement for consumable tools(blade/electrode/rub stone, etc.)?3 1 Maintenance of inspection equipment's Do you calibrate regularly inspection equipment's and put the expire date on them? 2 Do you control deterioration (expire date) of boundary samples for objective judgments such as appearance inspection?
  • 12. AUDIT CHECK SHEET CLAUSE - 11 Category Audit Area Concerning regulation Resp. 11 . Implementation of standards 1 Implementation of standards Do you use easy expression (visualizer, onomatopoeia ,etc.) for operation instructions? So that operator can easily understand process and critical points. Mr. Shiv Parkash / Amit Mishra 2 Do you keep operation instructions on the accessible place and post important quality points and critical operation points on the place where operators can see it easily? Do you regularly monitored that each operator operates according to the operation instructions ? 3 Is it possible to judge OK/NG specifically by each check sheet (of daily equipment check, quality control report, etc.) you use?4
  • 13. AUDIT CHECK SHEET CLAUSE - 12 Category Audit Area Concerning regulation Resp. 12. Products management 1 management of parts flow Do you keep first-in first-out of finished products and work-in-process (material, reserve parts ) by using identification tag or lot indication? Mr. S. Bhatia / Rishi Chopra / Sabri 2 Do you control follows production history by product lot numbers? -production date; -production volume; -shipping date Do you control identification of similar parts separately?3 1 Non-confirming parts management Do you control 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 record kept?  
  • 14. AUDIT CHECK SHEET CLAUSE - 13 Category Audit Area Concerning regulation Resp. 13. Handling Management 1 Bins/ Trolley Management Do you make arrangements with customers about the packing style & transportation system to prevent damage during handling of finished products & perform accordingly. Mr. Rishi Chopra / Kailash / Rohit Khurana / Anil 2 Do you have system to maintain Bins /Trolleys in Good Condition.
  • 15. AUDIT CHECK SHEET CLAUSE - 14 Category Audit Area Concerning regulation Resp. 14. Critical parts Management 1 Maru A Parts Management Do you have Special checks/Inspection for Maru A parameters of Maru A part are available . Mr. C. B. Sharma / Shiv Parkash / Balbir / Kuldeep 2 Do you have Identification of Maru A Process/Operator on Shop Floor. 3 Do you keep the repair history when repairing & using Maru A items
  • 16. AUDIT CHECK SHEET CLAUSE - 15 Category Audit Area Concerning regulation Resp. 15. Adequate testing facility 1 Testing Facility Does the supplier has all inspection instruments required as per drawing requirements Mr. Anil Verma / Mukesh Chaudhary 2 Does the supplier has all Testing Equipments/Rigs required as per drawing requirements 3 Does the Supplier has trained manpower to operate these inspection and testing instruments
  • 17. 2 O 43 AUDIT CHECK SHEET CLAUSE - 16 Category Audit Area Concerning regulation Resp. 16. Process Audit 1 As per PCS Conduct process audit as per process control standard Mr. Shiv Parkash / Amit Mishra 2 Closure of all the observations
  • 18. MSIL Clause wise action plan mapping sheet MSIL Audit Clause No. Main Audit Points Process Owner (Primary Responsibility) Activity Co-ordinator (Sub- Responsibility)Name Department 1 Production preparation / New Product Development Mr. Manish Engineering Mr. Sharad 2 Regulation for Initial Production Control Mr. Manish Engineering Mr. Sharad 3 Change Management Mr.S. Bhatia Mr. R. Srinivasan Mr. Mukesh Yadav Production Mr. Sabri Mr. Mohan Lal Mr. Mohan Roy 4 Standards Management Mr. Manish Engineering Mr. Sharad 5 Education and Training Mr. Vinod Sharma P & A Mr. Vivek 6 Quality audit and process verification Mr.Anil Verma QA Mr. Shiv Parkash 7 Supplier control Mr. Shiv Parkash QA MR. Rishi Chopra 8 Handling abnormality in quality Mr. Mukesh Chaudhary QA Mr. Sabri Mr. K.R. Rakesh Mr. Ajeet Mr. Vimal 9 5S management Mr. Anil Verma QA Mr. Shiv Parkash 10 Equipment /Inspection equipment's management Mr. Mukesh Chaudhary QA Mr. Manish Saini 11 Implementation of standards Mr. Shiv Parkash QA Mr. Amit Mishra 12 Products management Mr. S. Bhatia Production MR. Rishi Chopra 13 Handling Management Mr. Rishi Chopra SCM Mr. Rohit Khurana 14 Critical parts Management Mr. C. B. Sharma Mkt. Mr. Balbir 15 Adequate testing facility Mr. Anil Verma QA Mr. Shiv Parkash 16 Process Audit Mr. Shiv Parkash QA Mr. Amit Mishra
  • 19. ACTUAL SITUATION –Date 25/26 july 16