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8.
Handling
abnormality in
quality
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Handling when abnormal
Category 1 situation occurs
Audit Area Concerning regulation Judgment Remarks Follow Up
Do you have criteria to estimate the 4M change procedure (IMS:QA:18) and abnormality work
scope of suspected lot for abnormal instruction
PRAVESH
3 situation? When abnormal situation /ABHISHEK
8. occurs, do you trace suspected lot based
Handling upon the criteria?
abnormality in
quality Do you prevent recurrence of issues by P_QA_10 recurence of issues by analysing
1
analysing cause of occurring defect Suddep negi /
based on process investigation result Vikas
such as 5-why analysis?
Prevention of recurrence
Do you reflect corrective action to yes
Suddep negi /
2 ・Customer claims 2 improvement of process control and Vikas
・In process failure review of standards?
・Suppliers failure Through corrective action effectiveness monitoring sheet
After corrective action are taken, do you
3
conduct on-site check up and evaluate Suddep negi /
the effectiveness? And horizontal Vikas
deployment.
Do you keep store material, work-in- Material degradation and verification sheet
process, finished products, inventory
1 and container at appropriate storage Upendra
prevented from dust, rust, scratch,
deformation and rainwater?
Do you control material, work-in-process Identification tag
and finished product by designated Raj Vinod / Pravesh
Location of production site 2
1 location, volume and standard using / Abhishek /
visual control?
9.
5S Do you implement inspection or critical Lab testing enviorment and temperature monitoring
management operation under the properly controlled
3 environment luminance Rajesh
/temperature/humidity/vibration/noise/wo
rk table, etc.)?
1
Do you keep condition of production
equipment's, jigs and tools properly?
Production equipment's
Tool and gauge handling Work instruction Pravesh /Abhishek
2 management Do you keep condition of inspection
2 equipment's properly to ensure
accuracy?
Do you conduct daily/regularly check of
1 production equipment's, dies and jigs? Tool and gauge handling Work instruction Pravesh/Abhishek
Are records of maintenance kept?
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PAT/Sales* PAT/Sales
4 4
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D/E ratio
5 D/E Ratios* 5
ROCE* ROCE
6 6
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Are different type of wastes identified on 1.) Procedure of waste management (handling and disposal)
shop floor and standards/ Procedures hazardous waste management
made?
Hazardous Waste Is Segregation done at source for
3 3 KARTIKEY
Management different type of wastes?
Storage and disposal being done as per
consent and periodic confirmation at
disposal stage?
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