SUPPLIER QUALITY SYSTEM AUDIT CUM FOLLOW UP REPORT

Supplier Supplier Attendees:

Name

Product
Machined Components
Category
Judgmen
Category Audit Area Concerning regulation Requirements t Remarks/Observations Follow Up
Do you define the procedure for Product development (0~2)
Procedure for Product development including scope of APQP for Roop Polymers parts like
Regarding implementation
1 including the following ? -scope of parts, responsibility parts, responsibility of each department, control contents / 0 check valve plate, valve body is not
1 rule of production preparation
of each department, control contents / items? items as per APQP guidelines. available.
Regarding management / - Development Time plan (Master and Micro level) Development Time Plan ( Master
Do you implement follow-up to control the schedule and
1. implementation by - Review frequency and evidence and Micro) for Roop Polymer parts is
2 production preparation plan /
1 progress of production preparation items? Incl top
- Reason of delay and action
0
Production management not available.
preparation report (master plan) - Evidence of review by Top management.
Do you consider following items and implement QA matrix is not available for Roop
/ New corrective and preventive action to the processes and - FMEA Procedure
Defect prevention on the Polymer parts.
Product standards before regular production? - FMEA / QA matrix.
Developmen 3
stage of process design by 1
-Troubles in the past; -Defect items expected; - Past defect history and Potential defect included in
0
t using FMEA/Matrix diagram
-Defect items unable to capture at customer; FMEA.
-Defect items difficult to repair;
Product/process evaluation - List of Quality issues / defect faced In-house and List of quality issues is not available.
Do you prevent defects by quality improving activities of
4
at the quality evaluation 1
cross-function team to evaluate quality performance?
Customer end during trials. 0
meeting in each trial - Their complete analysis in the form of PDCA.
Initial Supply Control Procedure including Person responsible for Roop Parts is
Do you define following items related to initial
- Initial Supply Control period (3month for new parts) not available.
production control by standards ?
- person responsible to announce start/end of initial
-controlled parts; -controlled items; -inspection method;
1
-initial production control period;
supply control 0
- Control items & inspection method (check method) and
-a person who announce start/end of initial production
criteria for selection of control item
control; -finish condition;
- Criteria for termination of initial supply control period
Regulation for Stricter Control during Initial Supply Control period: INitial supply control is not available
２．
1 initial production control - Increase sample size or frequency for Roop Parts like check valve plate
Regulation
- Frequent Process Capability Study (Cpk > 1.33) and valve body.
for
How do you define items required special control during - Fast removal of problems / analysis
initial
production
2 initial production control? Do you set stricter inspection - Change in Inspection Method 0
methods than the ordinal inspection? - Verification of Standards, operation standards, facility
control
etc.(Process audit)
- Stricter visual inspection (100% inspection/ 200%
inspection)
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
Do you control process capability and defect rate during
2
Implementation of initial 1
initial production control?
the target as decided for product and critical parameters 0 check valve plate and valve body.
production control as mentioned in Spec. Meeting or Critical parameters
decided by supplier
Procedure / WI for expected change (4M : Operator, 4M procedure is available.
Do you define unexpected change (unusual) and planned machine & jig/die, material and method change) and
1
change clearly? unexpected changes (Tool breakage, power failure,
2
Definition and machine breakdown, inspection equipment failure etc).
Do you define procedure(rules applied from sharing Rules to be defined from sharing information to the Rules are defined.
implementation of changing
1
management
2 information to result confirmation) at change concerned person / Deptt up to the result confirmation of 2
３．(*) occurrence? product produced before and after the change.
Changing Do you record product quality check results to ensure Recording of product quality check with product details like Recording of product quality check
managemen
3
traceability? Incl retroactive checks Lot no, quantity and marking on products etc.
2 with product details like lot no., is
t done.
- Definition of initial part. Control Method/ Procedure is not
1 Do you define and control initial part clearly? - Control method/ system in procedure. 0 available for Roop Parts like valve
Definition and control - Identification tag plate and valve body.
- Inspection & test record of initial parts / lots (All Inspection and test records of initail
2 method for initial part Do you control initial parts separately and make quality
developments lot including pilot lot). parts/lot are not available.
2 records about them?(both internal and outsourced
- Inspection / test reports of sub vendor's required in case
0
process are included)
part produced by sub vendor.

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 SUPPLIER QUALITY SYSTEM AUDIT CUM FOLLOW UP REPORT

Supplier Supplier Attendees:

Name

Product
Machined Components
Category
Judgmen
Category Audit Area Concerning regulation Requirements t Remarks/Observations Follow Up
- Process control std, control Plan, Inspection standard (0~2)
Procedure to make process Do you make and review process control standards, Available
and operation Instruction of all parts.
1
control standards(QA 1 Inspection specifications, Operation instructions for all
- Review system and records of updated std against a
2
４． process charts) parts.
change.
Standards Procedure to control Coherence between all documents
managemen standards like PCS/control plan, inspection
Do you have consistency to keep process control
t Coherence between all documents like PCS / Control standard is not available.
2 ・Process control standards
1 standard, inspection specification, operation inspection
plan, inspection standard, operation standard and MIS -P.
0
and parameter chart?
・Inspection specifications
・Operation instructions 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
Do you clarify the department in charge of promoting
system.
quality education, implement education based on annual
1
plan?
- Training Calendar for all Operators, Supervisor and 0
Managers
Education/ training procedure Are records of education kept?
５．(*) 1 - Training systems and record for New Joinee (Staff /
Education operator)
and training - Training Plan v/s Actual records
- Effectiveness check records
Do you define and implement the skill evaluation of WI for skill evaluation is available.
operator to determine whether operator can work WI for Skill evaluation criteria level wise, evaluation
2
without surveillance?(e.g. acceptable revel/evaluation frequency and method.
2
frequency/evaluation method)
Education for Cross checking of operator's skill periodically against a Poission Test is not carried out from
Do you periodically monitor the skill of certificated
2
managers/Inspectors/ 1
operators and follow up to improve their skill?
decided parameter and by simulating defect. 0 April'18 to Nov'18.
Special operators Evidence of retraining plan and effectiveness check.
Quality Systems
1 The Unit have any ISO/ TS certification ISO/ TS certificate 2 Available
1 2 Survelliance Audit coducted and all NC's are closed Survelliance Audit closure report 0 Not Available.
６． Plan and evidence of conducting Internal Quality system Internal audit is not available from
Quality Do you conduct quality audit to identify issues and Audit. April'18 to Nov'18.
2 Activity to keep/improve 1
properly improve them? Action taken for improvement against the Quality Issues
0
audit and production quality
process observed during audit.
Do you confirm consistency between actual operation Evidence of process audit based on work instructions / Process audit record is not available
verification 1
and standard? PCS and actual working.
0
3 Content of process review from April'18 to Nov'18.
Do you confirm if countermeasures are taken properly to Evidence of Countermeasure effectiveness check at shop Available
2
prevent reoccurring of quality fail? floor during process audit.
2
７． New Supplier selection procedure indicating supplier audit New supplier selection procedure is
Evaluation method for new Do you define criteria to certificate new suppliers and
Supplier 1
suppliers
1
implement them?
check sheet & min qualifying criteria especially for quality. 2 available.
control Evidence of audit done and supplier list
Do you define clearly what is abnormal situation and Definition of abnormal situation and Operator's awareness Available
1
make operators know the definition? about the abnormal situations.
2
Do you clarify and standardize the handling rules/routes Procedure is available.
Procedure for customer complaint handling, in-process
Handling when abnormal
2 for customer claims, in process failure and supplier
failures (defect/rejection/rework) and supplier failures
2
1 situation occurs failure?
Do you have criteria to estimate the scope of suspected Procedure for handling suspected parts at the time of Procedure is available.
lot for abnormal situation?　When abnormal situation abnormal situation including criteria for estimating
８．(*) 3
occurs, do you trace suspected　lot based upon the suspected parts (quantity produced before abnormal
2
Handling criteria? situation)
abnormality 5 Why Analysis/Root Cause Analysis to be done for the Supplier failures are not available.
Do you prevent recurrence of issues by analyzing cause
in quality defects
Prevention of recurrence 1 of occurring defect based on process investigation
Criteria for raising A-3 sheet/DAR/QPR for internal and
0
result such as 5-why analysis?
supplier issue
・Customer claims Do you reflect corrective action to improvement of Standardization (Review of standards) of Standardization is not available for
2
・In process failure
2
process control and review of standards? countermeasures as decided in Defect Analysis Sheet
2
supplier issues.
・Suppliers failure After corrective action are taken, do you conduct on-site Onsite check up of countermeasure at regular interval Available
3 check up and evaluate the effectiveness? And horizontal 2
deployment. Evidences of horizontal Deployment of countermeasures

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 SUPPLIER QUALITY SYSTEM AUDIT CUM FOLLOW UP REPORT

Supplier Supplier Attendees:

Name

Product
Machined Components
Category
Judgmen
Category Audit Area Concerning regulation Requirements t Remarks/Observations Follow Up
Do you keep store material, work-in-process, finished (0~2)
Storage of RM, BOP, WIP, FG and bins/trolleys to prevent Storage is good.
products, inventory and container at appropriate storage
1
prevented from dust, lust, scratch, deformation and
from dust, rust, scratch, deformation and rainwater (Shop 2
floor audit)
rainwater?

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 SUPPLIER QUALITY SYSTEM AUDIT CUM FOLLOW UP REPORT

Supplier Supplier Attendees:

Name

Product
Machined Components
Category
Judgmen
Category Audit Area Concerning regulation Requirements t Remarks/Observations Follow Up
Do you control material, work-in-process and finished (0~2) Available
Storage of RM, BOP, WIP & FG parts at designated
2 product by designated location, volume and standard
location with tag for visual control
2
Location of production site using visual control?
1 Inspection or critical operation under properly controlled Available
environment:
９． Do you implement inspection or critical operation under - temperature
5S 3 the properly controlled environment luminance - humidity 2
managemen /temperature/humidity/vibration/noise/work table, etc.)? - noise
t - Proper layout/ arrangements on work and inspection
table
Physical condition of production equipment's, jigs and Available
Do you keep condition of production equipment's, jigs tools
1
and tools properly? Evidence of daily/ regular check
2
Production equipment's Storage arrangements with identification
2 management Physical condition of inspection equipment's properly to Available
Do you keep condition of inspection equipment's maintain accuracy
2
properly to ensure accuracy? Evidence of daily/ regular check (Validation report)
2
Proper storage arrangements
Do you conduct daily/regularly check of Daily and preventive maintenance of production Available
1 production equipment's, dies and jigs? Are equipment's, dies and jigs 2
records of maintenance kept? Machine/ tool history card and PM check sheet
Maintenance of equipment's , Do you confirm regularly the function of Pokayoke, Available
１０(*) Regular check of Pokayoke and their record
1 jigs and tools 2 automated stop and alarm? Are records of maintenance
List of Poka Yoke
2
Equipment/I
kept?
nspection Do you standardize frequency of polishing and Not Available.
equipment's Frequency of polishing and replacement for consumable
3 replacement for consumable tools(blade/electrode/rub
tools and change records
0
stone, etc.)?
managemen Calibration record of inspection equipments Available
Do you calibrate regularly inspection equipment's and
t 1
put the expire date on them?
Calibration status on inspection equipments (Calibration 2
Maintenance of inspection date & due date)
2 equipment's Do you control deterioration (expire date) of boundary Available
Expiry date on limit samples (for objective judgments such
2 samples for objective judgments such as appearance
as appearance inspection)
2
inspection?
Visual confirmation of work done (glowing of Available
Do you use easy expression (visualizer, onomatopoeia
green/yellow/red light indicating completion or
1 ,etc.) for operation instructions? So that operator can
incompletion of work)
2
easily understand process and critical points.
Work Instructions to be made in Local Language Available
Do you keep operation instructions on the accessible
１１． place and post important quality points and critical Display of WI's, Quality Check points & instructions
Implementat
2
operation points on the place where operators can see it related to critical operations at easy accessible location
2
1
Implementation of standards
ion of easily? (so that operator can read and take out them easily for
standards reference)
Periodic records of operator observance audit to check Available
Do you regularly monitored that each operator operates
3
according to the operation instructions？
operator working as per various standard such as WI, 2
PCS, Daily check etc.
Is it possible to judge OK/NG specifically by each check Judgment criteria should be mentioned on each check Available
4 sheet (of daily equipment check, quality control report, sheet (e.g..- Upper/ Lower tolerance, check method and 2
etc.) you use? criteria )
Do you keep first-in first-out of finished products and Incoming Material stored in wooden
Incoming Material / WIP / Finish Goods to be maintained
1 work-in-process (material, reserve parts） by using
with Identification Tags and storage location at each stage.
0 box insteed of steel trolleys.
identification tag or lot indication?
Do you control follows production history by product lot Available
management of parts flow Production Date/ Lot/ Qty/ dispatch date to be recorded for
1 2 numbers?
traceability purpose.
2
１２． -production date; -production volume; -shipping date
Similar parts control by different colour bin / tags/packing Available
Products 3 Do you control identification of similar parts separately?
material
2
managemen
Do you control identification of non-confirming parts and Separate area/ red bin for storing NC part with tag Available
t 1
parts on hold. Do you store them separately? Reason marking on NC part
2

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 SUPPLIER QUALITY SYSTEM AUDIT CUM FOLLOW UP REPORT

Supplier Supplier Attendees:

Name

Product
Machined Components
Category
Judgmen
Category Audit Area Concerning regulation Requirements t Remarks/Observations Follow Up
(0~2)
Non-confirming parts Available
2
Regarding repaired non-confirming parts and parts on - Rework procedure/WI
management 2 hold to re-use, do you define responsibility to - Responsibility for Rework and area/table for rework 2
implement? Are repair record kept? - Inspection record of rework material
- Traceability (Lot detail) of Reworked Material
Do you make arrangements with customers about the
13. packing style & transportation system to prevent
1
damage during handling of finished products & perform
Packing standard and transpiration mode 2 Available
Handling
1 Bins/ Trolley Management accordingly.
Managemen
WI to maintain Bins/Trolleys ( WIP & FG) in good condition WI is available.
t Do you have system to maintain Bins /Trolleys in Good
2
Condition.
Cleaning and repairing area and check points of good 2
bin/trolleys
Special check points for Maru A (Safety Critical) parts in
Do you have Special checks/Inspection for critical
14. 1
parameters of Maru A (Safety Critical) part are available .
Inspection standards (in-process & final) as per inspection 2 Available
Critical standard/drawing
Safety Critical (Maru A, HS Identification of Safety Critical (Maru A, HS etc) processes
parts 1 Do you have Identification of Safety Critical (Maru A, HS
Managemen
etc) Parts Management 2
etc) Process/Operator on Shop Floor.
by displaying Safety Critical (Maru A, HS etc) symbol on 2 Available
work stations, operator and machine/line
t Do you keep the repair history when repairing & using Record of Rework/Repair history of Safety Critical (Maru
3
Safety Critical (Maru A, HS etc) items A, HS etc) parts
2 Available
Does the supplier has all inspection instruments Available
15. 1
required as per drawing requirements
Inspection instruments list. 2
Adequate Does the supplier has all Testing Equipments/Rigs Available
1 Testing Facility 2
required as per drawing requirements
Testing equipments list and arrangements. 2
testing
Does the Supplier has trained manpower to operate Lab person and inspectors training records and Available
facility 3
these inspection and testing instruments experience.
2
16. Process audits is not available from
1 Conduct process audit as per process control standard Plan and actual evidence of Process audit. NC list. 0
Process 1 As per control plan April'18 to Nov'18.
Audit 2 Closure of all the observations Closure evidence of observations. 0 Not Available.
Judgment 0 NO SYSTEM DEFINED Achieved Score 76
SYSTEM DEFINED BUT POOR
Judgment 1
ADHERENCE
Maximum Score 110
SYSTEM ADHERENCE & REVIEW AS
Judgment 2
PER DEFINED SYSTEM
Audit Rating 69.09

Category Overall Minimum in critical clauses

Green* >=60% >=40%
Yellow 20% ~ 60%
Red <20% < 10%
*Are critical
clauses:
Abnormality Handling in
1 Quality
2 Change Management

3 Education and Training

Maintenance of
4
tools/Equipments

Format No: RPL-FMT-PUR-006, REV. NO.-03, REV. DATE- 30.10.18

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