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Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
Page 1 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
2. Regulation for
Regulation 1 initial production control
for
initial How do you define items required special control during
production 2 initial production control? Do you set stricter inspection
control methods than the ordinal inspection?
Page 2 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
2.
Name
Regulation
for
initial
Product
production
control
Category
Machined Components
1
Do you define unexpected change (unusual) and planned
change clearly?
3.(*)
Product
Changing
Category
Machined Components
management
Page 4 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
Procedure to make process Do you make and review process control standards,
1 control standards(QA process 1 Inspection specifications, Operation instructions for all
charts) parts.
4.
Standards Procedure to control
management standards
Do you have consistency to keep process control
1 standard, inspection specification, operation inspection
2 ・Process control standards
and parameter chart?
・Inspection specifications
・Operation instructions
Page 5 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
Page 6 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
1
Do you define clearly what is abnormal situation and
make operators know the definition?
Product
Category
Machined Components
Page 8 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
9.
5S
management
Page 9 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
1
Do you keep condition of production equipment's, jigs
and tools properly?
Production equipment's
2 management
2
Do you keep condition of inspection equipment's
properly to ensure accuracy?
Page 10 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
Page 11 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
Product
Category
Machined Components
management of parts flow Do you control follows production history by product lot
1 2 numbers?
-production date; -production volume; -shipping date
12. 3 Do you control identification of similar parts separately?
Products
management Do you control identification of non-confirming parts and
1
parts on hold. Do you store them separately?
Non-confirming parts
2 management
Page 13 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
12.
Products
management
Category Audit Area Concerning regulation
Non-confirming parts
2 management Regarding repaired non-confirming parts and parts on
2 hold to re-use, do you define responsibility to
implement? Are repair record kept?
1
Do you have Special checks/Inspection for critical
parameters of Maru A (Safety Critical) part are available .
14.
Safety Critical (Maru A, HS
Critical parts 1
etc) Parts Management
Management
Page 14 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
3
Do you keep the repair history when repairing & using
Safety Critical (Maru A, HS etc) items
1
Does the supplier has all inspection instruments required
15. as per drawing requirements
Adequate 1 Testing Facility 2
Does the supplier has all Testing Equipments/Rigs
testing required as per drawing requirements
facility 3
Does the Supplier has trained manpower to operate
these inspection and testing instruments
Page 15 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
Category Overall
Green* >=60%
Yellow 20% ~ 60%
Red <20%
*Are critical
clauses:
Page 16 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name
Product
Category
Machined Components
Abnormality Handling in
1 Quality
2 Change Management
3 Education and Training
Maintenance of
4
tools/Equipments
Page 17 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Procedure for Product development including scope of APQP for Roop Polymers parts like
parts, responsibility of each department, control contents / 0 check valve plate, valve body is not
items as per APQP guidelines. available.
- Development Time plan (Master and Micro level) Development Time Plan ( Master and
- Review frequency and evidence Micro) for Roop Polymer parts is not
- Reason of delay and action 0 available.
- Evidence of review by Top management.
QA matrix is not available for Roop
- FMEA Procedure Polymer parts.
- FMEA / QA matrix.
- Past defect history and Potential defect included in 0
FMEA.
- List of Quality issues / defect faced In-house and List of quality issues is not available.
Customer end during trials. 0
- Their complete analysis in the form of PDCA.
Page 18 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Person responsible for Roop Parts is
Initial Supply Control Procedure including
not available.
- Initial Supply Control period (3month for new parts)
- person responsible to announce start/end of initial
supply control 0
- Control items & inspection method (check method) and
criteria for selection of control item
- Criteria for termination of initial supply control period
INitial supply control is not available
Stricter Control during Initial Supply Control period: for Roop Parts like check valve plate
- Increase sample size or frequency and valve body.
- Frequent Process Capability Study (Cpk > 1.33)
- Fast removal of problems / analysis
- Change in Inspection Method 0
- Verification of Standards, operation standards, facility
etc.(Process audit)
- Stricter visual inspection (100% inspection/ 200%
inspection)
Page 19 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Evidence of Process capability study / defect rate Process Capability study/ defect rate
(rejection % or ppm) monitoring and action if not meeting is not available for Roop Parts like
the target as decided for product and critical parameters as 0 check valve plate and valve body.
mentioned in Spec. Meeting or Critical parameters decided
by supplier
Procedure / WI for expected change (4M : Operator, 4M procedure is available.
machine & jig/die, material and method change) and
unexpected changes (Tool breakage, power failure, 2
machine breakdown, inspection equipment failure etc).
Rules to be defined from sharing information to the Rules are defined.
concerned person / Deptt up to the result confirmation of 2
product produced before and after the change.
Recording of product quality check with product details like Recording of product quality check
Lot no, quantity and marking on products etc. 2 with product details like lot no., is
done.
Control Method/ Procedure is not
- Definition of initial part.
- Control method/ system in procedure. 0 available for Roop Parts like valve
- Identification tag plate and valve body.
Page 20 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
- Inspection & test record of initial parts / lots (All Inspection and test records of initail
developments lot including pilot lot). parts/lot are not available.
- Inspection / test reports of sub vendor's required in case 0
part produced by sub vendor.
Page 21 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
- Process control std, control Plan, Inspection standard Available
and operation Instruction of all parts.
- Review system and records of updated std against a 2
change.
Coherence between all documents
like PCS/control plan, inspection
Coherence between all documents like PCS / Control plan, standard is not available.
inspection standard, operation standard and MIS -P. 0
Page 22 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Training procedure / WI including person responsible for Annual Training Plan is not available
Training related to Quality (QS, Process Audit, Inspection, for Staff from April'18 to Nov'18.
Using inspection & testing instruments / equipments etc),
Training need identification and effectiveness check
system.
- Training Calendar for all Operators, Supervisor and 0
Managers
- Training systems and record for New Joinee (Staff /
operator)
- Training Plan v/s Actual records
- Effectiveness check records
WI for skill evaluation is available.
WI for Skill evaluation criteria level wise, evaluation
frequency and method. 2
Cross checking of operator's skill periodically against a Poission Test is not carried out from
decided parameter and by simulating defect. 0 April'18 to Nov'18.
Evidence of retraining plan and effectiveness check.
Page 23 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
ISO/ TS certificate 2 Available
Survelliance Audit closure report 0 Not Available.
Plan and evidence of conducting Internal Quality system Internal audit is not available from
Audit. April'18 to Nov'18.
Action taken for improvement against the Quality Issues 0
observed during audit.
Evidence of process audit based on work instructions / Process audit record is not available
PCS and actual working. 0 from April'18 to Nov'18.
Evidence of Countermeasure effectiveness check at shop Available
floor during process audit. 2
New Supplier selection procedure indicating supplier audit New supplier selection procedure is
check sheet & min qualifying criteria especially for quality. 2 available.
Evidence of audit done and supplier list
Definition of abnormal situation and Operator's awareness Available
about the abnormal situations. 2
Page 24 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Procedure is available.
Procedure for customer complaint handling, in-process
failures (defect/rejection/rework) and supplier failures 2
Page 25 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Storage is good.
Storage of RM, BOP, WIP, FG and bins/trolleys to prevent
from dust, rust, scratch, deformation and rainwater (Shop 2
floor audit)
Page 26 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Available
Storage of RM, BOP, WIP & FG parts at designated
location with tag for visual control 2
Inspection or critical operation under properly controlled Available
environment:
- temperature
- humidity
- noise 2
- Proper layout/ arrangements on work and inspection
table
- lux level etc
Physical condition of production equipment's, jigs and tools Available
Evidence of daily/ regular check 2
Storage arrangements with identification
Physical condition of inspection equipment's properly to Available
maintain accuracy
Evidence of daily/ regular check (Validation report) 2
Proper storage arrangements
Page 27 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Daily and preventive maintenance of production Available
equipment's, dies and jigs 2
Machine/ tool history card and PM check sheet
Available
Regular check of Pokayoke and their record
List of Poka Yoke 2
Not Available.
Frequency of polishing and replacement for consumable
tools and change records 0
Page 28 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Visual confirmation of work done (glowing of Available
green/yellow/red light indicating completion or incompletion
of work) 2
Work Instructions to be made in Local Language Available
Page 29 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Available
Production Date/ Lot/ Qty/ dispatch date to be recorded for
traceability purpose. 2
Similar parts control by different colour bin / tags/packing Available
material 2
Separate area/ red bin for storing NC part with tag Available
Reason marking on NC part 2
Page 30 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Available
- Rework procedure/WI
- Responsibility for Rework and area/table for rework 2
- Inspection record of rework material
- Traceability (Lot detail) of Reworked Material
Page 31 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
Identification of Safety Critical (Maru A, HS etc) processes
by displaying Safety Critical (Maru A, HS etc) symbol on 2 Available
work stations, operator and machine/line
Record of Rework/Repair history of Safety Critical (Maru A,
HS etc) parts 2 Available
Available
Inspection instruments list. 2
Available
Testing equipments list and arrangements. 2
Lab person and inspectors training records and Available
experience. 2
Process audits is not available from
Plan and actual evidence of Process audit. NC list. 0 April'18 to Nov'18.
Closure evidence of observations. 0 Not Available.
eved Score 76
Page 32 of 33
EM AUDIT CUM FOLLOW UP REPORT
Judgment
Requirements Remarks/Observations Follow Up
(0~2)
< 10%
Page 33 of 33