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T2 VSA With Requirement

1. The document discusses a vendor quality system audit checklist covering various quality requirements and regulations. 2. It addresses procedures for new product development, production planning, defect prevention, quality evaluation and initial production control. 3. The vendor is evaluated on implementing these quality processes as per guidelines and standards like having supporting documents, reviews, corrective actions and cross-functional team evaluations.
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100% found this document useful (3 votes)
2K views

T2 VSA With Requirement

1. The document discusses a vendor quality system audit checklist covering various quality requirements and regulations. 2. It addresses procedures for new product development, production planning, defect prevention, quality evaluation and initial production control. 3. The vendor is evaluated on implementing these quality processes as per guidelines and standards like having supporting documents, reviews, corrective actions and cross-functional team evaluations.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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MARUTI VENDOR QUALITY SYSTEM AUDIT CU

Vendor Attendees
Supplier
Name

Part Name
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
1. Procedure for product development from receipt of
order to SOP at customer end (preferably as per APQP
guidelines) to be available and the team should
understand it
Regarding 2. Training of existing manpower for new product
Do you define the procedure for Product requirements & testing of new products as per
implementation rule
development including the following ? - requirement to be part of development procedure
1
(procedure) of 1
scope of parts, responsibility of each 3. APQP matrix for deciding development activities based
production
department, control contents / items? on categorisation of parts (for new and modifications)
preparation
4. Team feasibility study (especially for skilled manpower
& training requirements if not capable)
5. Defined roles and Responsibilities.
6. Procedure to be controlled with latest revision no
1. Timing plan approved by top management
2. Customer events (sample approval, trial dates, SOP at
customer end) and vendor's events (sample submission,
pilot lot submission, SOP) to be mentioned in timing plan
Regarding 3. Activities to match with procedure and APQP matrix
management / 4. Review frequency of project leader and top
Do you implement follow-up to control
implementation by
2
1 the schedule and progress of production management
production 5. Evidence of review by project leader and top
preparation items? Incl top management
1. Production preparation plan / management in the timing plan
preparation / report (master plan) 6.MOM or record of reviews (for evidence)
New Product 7. Micro timing plan matching with Macro plan (wrt timing)
Development 8. Capturing delays in plan v/s actual in timing plans

1. Procedure for FMEA with CFT approach


2. List of problems reported in past at customer end and in-
house (lessons learnt from past experience/kakotora
Do you consider following items and sheet)
implement corrective and preventive 3. List of problems expected
action to the processes and standards 4. List of problems which can't be captured at customer
Defect prevention on
before regular production? end (warranty related problems)
the stage of process
1 -Troubles in the past; 5. List of problems difficult to repair
3 design by using
-Defect items expected; 6. Rating of FMEA as per AIAG guidelines and having
FMEA/Matrix diagram back up data for rating. Allocation of severity, occurrence
-Defect items unable to capture at
customer; & detection as per AIAG manual
-Defect items difficult to repair; 7. Back up data for giving occurrence rating
8. Cut off criteria for taking action as per latest AIAG
manual (actions to be taken for high Severity, Occurrence,
Detection & top 3 RPN processes)
9. Complete
1. Review of analysis
FMEA asofper decidedreported
problems criteria and at decided
during
Product/process
Do you prevent defects by quality development
evaluation at the
4
1 improving activities of cross-function 2. Summary in PDCA sheet
quality evaluation
team to evaluate quality performance?
meeting in each trial
MARUTI VENDOR QUALITY SYSTEM AUDIT CU
Vendor Attendees
Supplier
Name

Part Name
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
1. Procedure and checklist for handover from development
to production
2. Start date of initial production control
3. Initial Production Control procedure having following:
- Scope (for new parts and modifications)
- Special controls (increased inspection, increased
sample size etc. at all stages - incoming, in-process &
final, process capability study/defect rate, process audit)
- Initial production control start date (from SOP at
vendor's end) and end date (after completion of period
1
Do you define following items related to after SOP at customer end)
initial production control by standards ? - Initial production control period
-controlled parts; - Minimum quantity to be produced during IPC period
-controlled items; - Persons responsible for start/end
-inspection method; - Finish conditions (including following):
-initial production control period; - Targets of customer complaints, rejection at
-a person who announce start/end of customer end, in-house rejection, supplier parts rejection,
initial production control; process capability, defect rate, effectiveness of
-finish condition; countermeasures taken for problems reported during
development and effectiveness of countermeasures taken
for problems reported during initial production control.
Regulation - Action plan in case targets are not met
(procedure) for - Meeting above targets for 3 continuous months and
1 Initial Production results should have improving trend
Control - Action to be taken in case targets are not met(to be
extended)
2. 4. Communication of initial production control information
Regulation for to other departments (by mail/meetings/display boards)
Initial 5. Procedure to be controlled
Production 1. Evidence of implementation of special controls as
Control defined in the IPC procedure:
- Increased sample size and/or inspection frequency
(special control plan for IPC)
- Frequent Process Capability Study (Cpk > 1.33)
- Change in Inspection Method (checking dimns instead
of gauging)
How do you define items requiring
- Process audit for verification of Standards, operation
special control during Initial Production
2 standards, facility etc. as per control plan
Control? Do you set stricter inspection - Stricter visual inspection (100% inspection/ 200%
methods than the ordinary inspection? inspection)
2. Sticker targets for IPC and evidence of monthly
monitoring them
3. Analysis of quality problems reported during IPC and
their summary in PDCA sheet
4. Special colour tags on the packing/bin/trolley on the
parts produced during initial production control period
1. Identification of parameters for which process capability
study and defect rate is to be done
2. Set target for Cpk
3. Process capability study reports
Do you control process capability and 4. Training record of persons responsible for process
Implementation of
2
1 defect rate during Initial Production capability
Initial Production
Control? 5. Defect rate monitoring record (for critical non-
Control
measureable defects)
6. Action plan to improve Cpk and reduce defect rate in
case of not meeting target
MARUTI VENDOR QUALITY SYSTEM AUDIT CU
Vendor Attendees
Supplier
Name

Part Name
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
1. 4M change procedure defining following:
- Definition of changes (Detail as per Annexure)
- Categorisation of changes into planned/unplanned
changes
- Actions to be taken at change point
Do you define unexpected change - Display of definition of changes in shop floor
1 (unusual/unplanned) and expected - Visual control of changes (4M change indication)
change (usual/planned) clearly? - Awareness of change management among the shop
floor personnel (supervisors)
- Record of changes (4M change record)
- Check record of parts produced after change
- Retroactive check record in case of unplanned
Definition and (unexpected) changes
implementation of 1. Actions to be taken in case of changes (as defined in
1
Change Management the procedure)
2. Awareness of operators about 4M changes and the
Do you define procedure(rules applied actions required to be taken by them (stop production,
2 from sharing information to result inform supervisor and follow supervisor's direction)
3. confirmation) at change occurrence? 3. Evidence of implementation of 4M change when
Change changes take place (e.g. operator change, m/c
Management breakdown)
4. Display of changes in 4M change management board
1. Check record of parts produced after change
Do you record product quality check 2. Retroactive check record in case of unplanned
3 results to ensure traceability? Incl (unexpected) changes
retroactive checks

1. Definition of initial part (pilot lot)


2. Initial part control
Do you define and control Initial Part - Initial part to be kept in non-production area in QA
1
(First Part/Lot) clearly? custody under lock and key. Special care to be taken in
Definition and case of ECN's
Control method for - Inspection report of initial part
2 Initial Part (First 1. Separate tags to identify initial parts (pilot lot parts)
Part/Lot) Do you control Initial Parts separately 2. Inspection report of initial parts (pilot lots)
and make quality records about
2
them?(both internal and outsourced
process are included)

1. Availability of control plans for all the parts being


manufactured by the vendor
2. Procedure for preparation and control of documents
defining following:
- department in charge of making;
- a person in charge of making;
Do you make and review Process Control - a person in charge of authorizing;
Procedure to make Standards (Control Plans), Inspection - making period;
Process Control Standards, Operation - timing to submit to customer;
1 - revision rule;
1 Standards (QA Instructions/Standards for all products
process charts) which are shipped to SMC / MSIL / Tier 1 - retention period;
? 3. Master list of documents (control plans, operation
standard, inspection standards) with latest revision nos
4. Master copies of the controlled documents
4.
5. Availability of documents (control plans, operation
Standards
standard, inspection standards) for all parts under supply
Management
6. System for review and control revisions of controlled
documents
MARUTI VENDOR QUALITY SYSTEM AUDIT CU
Vendor Attendees
Supplier
Name
4.
Standards
Part Name
Management
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
1. All Product and process parameters to be defined in the
control plans
Procedure to control 2. Reference of WI or other standards, sample size,
standards checking frequency, checking method, boundary samples
・Process Control Do you have consistency to keep & Poka Yoke to be defined in the control plans
Standards Process Control Standard, Inspection 3. Consistency among documents (drawing, FMEA. PFD,
1
2 ・Inspection Standard, operation Instruction and process control standards/control plans, operation
Standards parameter chart? standards, inspection standards and customer inspection
・Operation standards)
instructions

1. Procedure of training
2. Training need identification
Do you clarify the department in charge 3. Training plan & plan v/s actual status
of promoting quality education (training), 4. Training contents to match with TNI
1 implement education (training) based on 5. Training plan for new operators, training duration, timing
annual plan? of evaluating skill and record
Are records of education (training) kept? 6. Evidence of trainings given (attendance sheets)
Education/ Training 7. Evidence of checking effectiveness of trainings
1 procedure 8. Employee history cards for trainings (for regular
employees)
1. Skill evaluation criteria for operators and evaluation
Do you define and implement the skill
5. record
evaluation of operator to determine
Education and 2. Minimum skill level required for a operation
whether operator can work without
2
Training surveillance?(e.g. acceptable
level/evaluation frequency/evaluation
method)
1. Skill evaluation frequency (min 2 times in a year)
2. Plan for periodic monitoring of skill evaluation of
operators
Education for Do you periodically monitor the skill of
3. Plan for re-training of operators in case skill is found
managers/Inspectors/ 1 certificated operators and follow up to
2 less than last check
Special operators improve their skill?
4. Evidence of periodic monitoring of skill evaluation of
operators
5. Poison test for checking skill of inspectors
1. Internal audit, process audit and product audit
procedure defining audit method, audit frequency, check
sheet to be used for audit and authorised auditors
2.Plan for internal audit,
3. Plan for product audit for all the parts under production
4. Plan for process audit covering all manufacturing
processes and all working shifts
Activity to Do you conduct quality audit to identify 5. Process audit check sheet (check point for checking
1
1 keep/improve issues and properly improve them? coherence of documents)
6. production quality 6. Evidence of conducting audits as per plan (check sheet
records)
Quality audit
7. NC closure time
and process
8. Evidence of communicating NC's to CFT and top
verification
management
9. Evidence of improvement in case of issues identified
(NC's reported)
10. NC summary report (for internal audits)
MARUTI VENDOR QUALITY SYSTEM AUDIT CU
Vendor Attendees
Supplier
6. Name
Quality audit
and process
verification
Part Name
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
1. Evidence of conducting audit as per control plan during
Do you confirm consistency between process audit.
1
Content of process actual operation and standard? 2. Evidence of checking actual working of operator as per
2 review operation standard during process audit
Do you confirm if countermeasures are Evidence of checking effectiveness of countermeasures
2 taken properly to prevent reoccurring of during process audit
quality fail?
1. Procedure for selection of new suppliers
7. 2. Minimum score required for selecting supplier (overall
Evaluation method Do you define criteria to certify new and in quality) (min score in quality to be more than min
Supplier 1 1
for new suppliers suppliers and implement them? overall score)
control

1. Definition of abnormal situations (Detail as per


Do you define clearly what is abnormal Annexure)
1 situation and make operators know the 2. Display of abnormal situations in shop floor
definition? 3. Awareness of abnormal situations among the shop floor
personnel ( upto oparators and helpers)
1. Procedure for handling customer complaints, in-process
Do you clarify and standardize the failure and supplier defects
Handling when handling rules/routes for customer
2 2. Criteria for raising QPCR's
abnormal situation claims, in process failure and supplier
1 3. Customer complaint register
occurs failure? 4. QPCR control registers (for in-house and supplier
defects)
Do you have criteria to estimate the 1. Criteria to estimate suspected quantity produced during
scope of suspected lot for abnormal abnormal situations and system to trace suspected lot
3 situation? When abnormal situation produced based upon the criteria
8.
occurs, do you trace suspected lot based 2. Check record of parts produced during abnormal
Handling situations for traceability
upon the criteria?
abnormality in
quality 1. Analysis sheet for analysing customer complaints, in-
Do you prevent recurrence of issues by
house defects and supplier defects
analysing cause of occurring defect
1 2. Quality of analysis
based on process investigation result
such as 5-why analysis?
Prevention of
recurrence Countermeasures detail & evidence of standardisation
Do you take corrective actions for (revision/updation of PFMEA, Control Plan, WI/OS
2 ・Customer claims 2 improvement of process control and Inspection standard, check sheets etc.)
・In process failure review the standards?
・Suppliers failure
After corrective action are taken, do you 1. Evidence of onsite verification of countermeasures
conduct on-site check up and evaluate 2. Horizontal deployment of countermeasures
3
the effectiveness? And horizontal
deployment.
MARUTI VENDOR QUALITY SYSTEM AUDIT CU
Vendor Attendees
Supplier
Name

Part Name
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
Do you keep store material, work-in- 1. Storage of material (RM,BOP, WIP & FG) and
process, finished products, inventory and bins/trolleys in covered area to prevent it from dust, rust,
1 container at appropriate storage rainwater etc.
prevented from dust, rust, scratch, 2. Storage of material & bins/trolleys to prevent it from
deformation and rainwater? scratch, deformation etc.

1. Locations for storage of material (RM & BOP), WIP and


Do you control material, work-in-process FG products
Location of and finished product by designated 2. Max volume (max height up to which material can be
2
1 production site location, volume and standard using stored, max not of boxes, bins, bags which can be stored
visual control? one above other)
3. Max quantity which can be kept in a bin/box/trolley
1. Min lux level at critical operation and inspection station
Do you implement inspection or critical as per IS
9.
operation under the properly controlled 2. Working condition of critical operation and inspection
5S
3 environment station (noise level, vibration, humidity etc.)
management
(luminance/temperature/humidity/vibratio 3. Work table for critical operation and inspection
n/noise/ work table, etc.)?

1. Checking of machines for any leakage (water, oil etc.)


2. Checking of machines/equipments for loose wiring,
Do you keep condition of production temporary connections
1
equipments, jigs and tools properly? 3. Condition of dies, tools, jigs (no damage, temporary
Production repair etc.)
2
equipments 4. Proper storage of tools/dies
management 1. Condition of inspection equipments (no damage,
Do you keep condition of inspection temporary binding etc.)
2
equipments properly to ensure accuracy? 2. Storage of inspection equipments safely (in boxes etc.)

1. Daily check record of machines/dies by operators and


and understanding of operator of the check points
2. Check on check by supervisor
3. Preventive maintenance record of machines/dies
Do you conduct daily/regular check of (preventive maintenance plan, preventive maintenance
1 production equipments, dies and jigs? check sheets, history cards)
Are records of maintenance kept? 5. Spares list and availability of spares
6. M/c/die breakdown record and analysis
7. Checking of breakdown data of equipment at the time of
preventive check
8. Mention observation of OK points also
Maintenance of 1. List of Poka Yokes
equipments , jigs and Do you confirm regularly the function of 2. Regular checking of Poka Yoke, checking method and
1
tools 2 Pokayoke, automated stop and alarm? evidence of checking
Are records of maintenance kept? 3. Maintenance record of Poka Yoke
10.
Equipment/Ins 1. Resharpening and replacement frequency of
pection consumable tools (tool life)
equipment's 2. Monitoring of resharpening and replacement of tools as
management Do you standardize frequency of per decided frequency
polishing and replacement for Consumable Tools (examples):
3
consumable tools(blade/electrode/rub - press: trimming & blanking die, punches, springs
stone, etc.)? - Molding: springs, deflashing cutter, ejector pin and
other consumable, etching frequency
- Heat Treatment: thermocouple (1 year as per CQI9 std)
, quenching oil cooling curve checking
1. Calibration plan of all measuring instruments
Do you calibrate regularly inspection 2. Calibration certificates
1 equipments and put the expiry date on 3. In case of in-house calibration, standard being used for
Maintenance of them? calibration and its implementation
2
inspection 4. Calibration of gauges, calibration method
equipments Do you control deterioration (expiry date) 1. Availability of limit samples as per control plan
of boundary samples for objective 2. Expiry date on limit samples
2
judgments such as appearance 3. Visual display of OK & NG parts at work station and at
inspection? final inspection
MARUTI VENDOR QUALITY SYSTEM AUDIT CU
Vendor Attendees
Supplier
Name

Part Name
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
Visualizer or alarm at critical operations for confirmation of
Do you use easy expression (visualizer, completion of work
onomatopoeia (alarm) ,etc.) for operation
1
instructions? So that operator can easily
understand process and critical points.

Do you keep operation instructions on Display of Work Instruction and critical process and quality
the accessible place and post important parameters for easy assess ability to operator. In local
2 quality points and critical operation language so that operator can read and understand it
points on the place where operators can
11.
Implementation of see it easily?
Implementatio 1 standards 1. Operator wise operator monitoring plan for all
n of standards
production areas
Do you regularly monitored that each
2. Check record of operator monitoring as per check sheet
3 operator operates according to the
covering all the activities to be done by operator during
operation instructions?
working time
3. Training plan for operators for weak areas
Is it possible to judge OK/NG specifically Judgment criteria (OK/NG status) should be mentioned on
by each check sheet (of daily equipment check record sheet of product and process checks (e.g..-
4 Upper/ Lower tolerance)
check, quality control report, etc.) you
use?
1. FIFO System
Do you keep first-in first-out of finished 2. Evidence of implementation of FIFO in store, WIP parts
products and work-in-process (material, storage and FG parts storage
1
reserve parts) by using identification
tag or lot indication?

Management of parts Do you control following production Identification tags on WIP and FG products for traceability
1 flow history by product lot numbers? with production lot and date
2
-production date; -production volume; -
shipping date
System to avoid mix up of similar parts (use of different
Do you control identification of similar colour tags, different colour bins/boxes, different colour
3
parts separately? packings)
1. Identification of NG parts with identification tag or
12. marking describing the defect detail
Products 2. Colour of bins to be used for keeping NG parts to be
management Do you control identification of non- defined (red).
1 confirming parts and parts on hold. Do 3. Rejection bins to be kept near work station
you store them separately? 4. System for handling NG parts
5. Disposal of NG parts (scrap/rework) to be done by QA
6. Evidence of analysis of NG parts
Non-confirming parts
2 management 1. Procedure/WI for rework of parts
2. Display of name of the persons authorized to rework
Regarding repaired non-confirming parts and their skill level in the rework station
3. Rework record with detail of person who has done
and parts on hold for re-use, do you
2 rework and approved
define responsibility to implement? Are
repair record kept?

Do you make arrangements with 1. Packing standards approved by customer to prevent


customers about the packing style & damage during handling & transportation
1 transportation system to prevent damage 2. Display of packing standards at packing area
during handling of finished products &
13.
Bins/ Trolley perform accordingly.
Handling 1
Management 1. Condition of bins/trolleys being used in WIP and FG
Management
material
Do you have system to maintain Bins
2 2. WI for checking & cleaning bins/trolleys
/Trolleys in Good Condition.
3. Display of bin check points
4. WI for repairing bins/trolleys
MARUTI VENDOR QUALITY SYSTEM AUDIT CU
Vendor Attendees
Supplier
Name

Part Name
Category Audit Area
Concerning Regulation (Check Point) Requirements (Revised)
(Main Clause) (Sub Clause)
Do you have Special checks/Inspection of Identification of Maru A check points in WI at Maru A
1 Maru A parameters of Maru A/Critical station and in final inspection of Maru A parts
parts are available.
Display of names & photographs of operators authorised
Do you have Identification of Maru A to work at Maru A station and final inspection of Maru A
2
14. Process/Operator on Shop Floor. part
Maru A/Critical Parts
Critical parts 1
Management
Management 1. Rework instruction for rework of Maru A parts
2. Display of names & photographs of operators
Do you keep the repair history when authorised to rework of Maru A parts
3 3. Rework record of Maru A parts
repairing & using Maru A items
4. Traceability of person doing rework and approving the
reworked parts.

Does the supplier has all inspection


Availability of inspection instruments as per drg/control
1 instruments required as per drawing
plan/inspection standards
15. requirements
Does the supplier has all Testing
Adequate Availability of Test equipments as per drg/control
1 Testing Facility 2 Equipments/Rigs required as per drawing
testing plan/inspection standards
requirements
facility Does the Supplier has trained manpower Availability of trained manpower to operate the inspection
3 to operate these inspection and testing instruments and test equipments
instruments
Conduct process audit as per process Audit by auditor
1
16. Process control standard
1 As per PCS
Audit 2 Closure of all the observations
Closure of observations of previous audit

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