Sie sind auf Seite 1von 33

SUPPLIER QUALITY SYSTEM AUDIT

Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

Do you define the procedure for Product development


Regarding implementation
1 including the following ? -scope of parts, responsibility
1 rule of production preparation
of each department, control contents / items?
Regarding management /
Do you implement follow-up to control the schedule and
implementation by production 1 progress of production preparation items? Incl top
1.
2 preparation plan / report
management
Production (master plan)
preparation / Do you consider following items and implement
New Product corrective and preventive action to the processes and
Developmen Defect prevention on the
standards before regular production?
t stage of process design by 1
3 -Troubles in the past; -Defect items expected;
using FMEA/Matrix diagram
-Defect items unable to capture at customer;
-Defect items difficult to repair;
Product/process evaluation at
Do you prevent defects by quality improving activities of
the quality evaluation meeting 1
4 cross-function team to evaluate quality performance?
in each trial

Page 1 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

Do you define following items related to initial production


control by standards ?
1
-controlled parts; -controlled items; -inspection method;
-initial production control period;
-a person who announce start/end of initial production
control; -finish condition;

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

Category Audit Area Concerning regulation

Do you control process capability and defect rate during


Implementation of initial 1
2 initial production control?
production control

1
Do you define unexpected change (unusual) and planned
change clearly?

Definition and implementation


1 of changing management Do you define procedure(rules applied from sharing
2 information to result confirmation) at change
occurrence?
3.(*)
Do you record product quality check results to ensure
Changing 3
traceability? Incl retroactive checks
management

1 Do you define and control initial part clearly?

Definition and control method


2 for initial part
Page 3 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

3.(*)
Product
Changing
Category
Machined Components
management

Category Audit Area Concerning regulation


Definition and control method
2 for initial part Do you control initial parts separately and make quality
2 records about them?(both internal and outsourced
process are included)

Page 4 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

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

Category Audit Area Concerning regulation

Do you clarify the department in charge of promoting


1
quality education, implement education based on annual
plan?
Are records of education kept?
1 Education/ training procedure
5.(*)
Education
and training
Do you define and implement the skill evaluation of
2
operator to determine whether operator can work without
surveillance?(e.g. acceptable revel/evaluation
frequency/evaluation method)
Education for
Do you periodically monitor the skill of certificated
managers/Inspectors/ 1
2 operators and follow up to improve their skill?
Special operators

Page 6 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

1 The Unit have any ISO/ TS certification


1 Quality Systems
2 Survelliance Audit coducted and all NC's are closed

6. Do you conduct quality audit to identify issues and


Quality audit 2 Activity to keep/improve 1
properly improve them?
and process production quality
verification
1
Do you confirm consistency between actual operation
and standard?
3 Content of process review
2
Do you confirm if countermeasures are taken properly to
prevent reoccurring of quality fail?
7.
Evaluation method for new Do you define criteria to certificate new suppliers and
Supplier 1 1
suppliers implement them?
control

1
Do you define clearly what is abnormal situation and
make operators know the definition?

Handling when abnormal Page 7 of 33


1 situation occurs
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

Do you clarify and standardize the handling rules/routes


2 for customer claims, in process failure and supplier
Handling when abnormal failure?
1 situation occurs
Do you have criteria to estimate the scope of suspected
3
lot for abnormal situation? When abnormal situation
8.(*) occurs, do you trace suspected lot based upon the
Handling criteria?
abnormality
in quality Do you prevent recurrence of issues by analyzing cause
1 of occurring defect based on process investigation result
Prevention of recurrence such as 5-why analysis?

2 ・Customer claims Do you reflect corrective action to improvement of


2
・In process failure process control and review of standards?
・Suppliers failure After corrective action are taken, do you conduct on-site
3 check up and evaluate the effectiveness? And horizontal
deployment.

Page 8 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

Do you keep store material, work-in-process, finished


1
products, inventory and container at appropriate storage
prevented from dust, lust, scratch, deformation and
rainwater?

1 Location of production site

9.
5S
management

Page 9 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

Do you control material, work-in-process and finished


2 product by designated location, volume and standard
using visual control?
1 Location of production site

9. Do you implement inspection or critical operation under


5S 3 the properly controlled environment luminance
management /temperature/humidity/vibration/noise/work table, etc.)?

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

Category Audit Area Concerning regulation

Do you conduct daily/regularly check of


1 production equipment's, dies and jigs? Are
records of maintenance kept?
Maintenance of equipment's , Do you confirm regularly the function of Pokayoke,
1 jigs and tools 2 automated stop and alarm? Are records of maintenance
10(*) kept?
Equipment/I Do you standardize frequency of polishing and
nspection 3 replacement for consumable tools(blade/electrode/rub
equipment's stone, etc.)?
management
1
Do you calibrate regularly inspection equipment's and
put the expire date on them?
Maintenance of inspection
2 equipment's Do you control deterioration (expire date) of boundary
2 samples for objective judgments such as appearance
inspection?

Page 11 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

Do you use easy expression (visualizer, onomatopoeia


1 ,etc.) for operation instructions? So that operator can
easily understand process and critical points.

Do you keep operation instructions on the accessible


2
place and post important quality points and critical
11. operation points on the place where operators can see it
Implementati easily?
Implementation of standards
on of 1
standards
3
Do you regularly monitored that each operator operates
according to the operation instructions?

Is it possible to judge OK/NG specifically by each check


4 sheet (of daily equipment check, quality control report,
etc.) you use?
Do you keep first-in first-out of finished products and
1 work-in-process (material, reserve parts) by using
identification tag or lot indication?

1 management of parts flow Page 12 of 33


SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

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? 

Do you make arrangements with customers about the


1
packing style & transportation system to prevent damage
13. during handling of finished products & perform
Handling 1 Bins/ Trolley Management accordingly.
Management
2
Do you have system to maintain Bins /Trolleys in Good
Condition.

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

Category Audit Area Concerning regulation


14.
Safety Critical (Maru A, HS
Critical parts 1 Do you have Identification of Safety Critical (Maru A, HS
etc) Parts Management 2
Management etc) Process/Operator on Shop Floor.

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

16. Process 1 As per control plan


1 Conduct process audit as per process control standard
Audit 2 Closure of all the observations

Judgment 0 NO SYSTEM DEFINED Achieved Score

Page 15 of 33
SUPPLIER QUALITY SYSTEM AUDIT
Supplier Attendees:
Supplier
Name

Product
Category
Machined Components

Category Audit Area Concerning regulation

SYSTEM DEFINED BUT POOR


Judgment 1
ADHERENCE Maximum Score
SYSTEM ADHERENCE & REVIEW AS
Judgment 2
PER DEFINED SYSTEM Audit Rating

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

Category Audit Area Concerning regulation

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

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

Procedure for handling suspected parts at the time of Procedure is available.


abnormal situation including criteria for estimating
suspected parts (quantity produced before abnormal 2
situation)
5 Why Analysis/Root Cause Analysis to be done for the Supplier failures are not available.
defects
Criteria for raising A-3 sheet/DAR/QPR for internal and 0
supplier issue
Standardization (Review of standards) of countermeasures Standardization is not available for
as decided in Defect Analysis Sheet 2 supplier issues.
Onsite check up of countermeasure at regular interval Available
2
Evidences of horizontal Deployment of countermeasures

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

Calibration record of inspection equipments Available


Calibration status on inspection equipments (Calibration 2
date & due date)
Available
Expiry date on limit samples (for objective judgments such
as appearance inspection) 2

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

Display of WI's, Quality Check points & instructions


related to critical operations at easy accessible location 2
(so that operator can read and take out them easily for
reference)
Periodic records of operator observance audit to check Available
operator working as per various standard such as WI, 2
PCS, Daily check etc.
Judgment criteria should be mentioned on each check Available
sheet (e.g..- Upper/ Lower tolerance, check method and 2
criteria )
Incoming Material stored in wooden
Incoming Material / WIP / Finish Goods to be maintained box insteed of steel trolleys.
with Identification Tags and storage location at each stage. 0

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

Packing standard and transpiration mode 2 Available

WI to maintain Bins/Trolleys ( WIP & FG) in good condition WI is available.


Cleaning and repairing area and check points of good 2
bin/trolleys
Special check points for Maru A (Safety Critical) parts in
Inspection standards (in-process & final) as per inspection 2 Available
standard/drawing

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)

mum Score 110

dit Rating 69.09

Minimum in critical clauses


>=40% 

< 10%

Page 33 of 33

Das könnte Ihnen auch gefallen