Clause
1. Production
preparation /
New Product
Development
２．
Regulation for
initial
production
control
３．
Changing
management
４．
Standards
４．
Standards
management
５．
５．
Education and
training
６．
Quality audit
and process
verification
７．
Supplier control
７．
Supplier control
８．
Handling
abnormality in
quality
９．
5S management
９．
5S management
１０．
Equipment/
Inspection
equipment's
management
１１．
Implementation
of standards
１２．
Products
management
13.
Handling
Management
14.
Critical parts
Management
15. Adequate
testing facility
16. Process
Audit
16. Process
Audit
17. Scale and
Top
Management
bandwidth
18. Safety
19. Legal
Compliance and
Environment
Check Point
1. Procedure for product development from receipt of order to SOP at custom
guidelines) to be available.
2. APQP matrix for deciding development activities based on categorisation o
Roles and Responsibilities defined in APQP matrix. Activities matching with pr
3. Team feasibility study format(especially for skilled manpower & training re
4. RFQ register
5. Understanding of Team
1. Timing plan approved by top management.
2. Customer events (sample approval, trial dates, SOP at customer end) and v
submission, pilot lot submission, SOP) to be mentioned in timing plan
3. Activities matching with procedure and APQP matrix
4. Review frequency of project leader and top management
5. Evidence of review by project leader and top management in the timing pl
6.MOM or record of reviews (for evidence)
7. Micro timing plan matching with MACRO plan (wrt timing)
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 lea
sheet)
3. List of problems expected
4. List of problems which can't be captured at customer end (warranty relate
5. List of problems difficult to repair
6. Rating of FMEA as per AIAG guidelines and having back up data for rating. A
detection as per AIAG manual
7. Cut off criteria for taking action as per latest AIAG manual (actions to be ta
8. Review of FMEA as per decided criteria and at decided frequency
9. Understanding of Team
10. Evidence of implementation (FMEA)
Summary in PDCA sheet, adequacy of analysis and effectiveness of counterm
Initial Production Control procedure having following:
1.Scope (for new parts and modifications)
2.Special controls (increased inspection, increased sample size etc. at all stage
3.Frequent process audit
4.Initial production control start date (from SOP at vendor's end) and end dat
after SOP at customer end)
5.Initial production control period
6.Minimum quantity to be produced during IPC period
7.Persons responsible for start/end
8.Finish conditions (including following):
Targets of customer complaints, rejection at customer end, in-house rejection
capability, defect rate, process audit c/ms closure, effectiveness of counterm
reported during development and effectiveness of countermeasures taken fo
production control.
9.Meeting above targets for 3 continuous months and results should have im
10.Action to be taken in case targets are not met(to be extended)
1. Evidence of implementation of special controls as defined in the IPC proced
- Increased sample size and/or inspection frequency (special control plan fo
- Change in Inspection Method (checking dimns instead of gauging)
- Process audit for verification of Standards, operation standards, facility et
- Stricter visual inspection (100% inspection/ 200% inspection)
2. Sticker targets for IPC and evidence of monthly monitoring them
3. Analysis of quality problems reported during IPC and their summary in PDC
4. Special colour tags on the packing/bin/trolley on the parts produced during
5. Special control plan for IPC period
6. Termination sheet
1. Identification of parameters for which process capability study and de
2. Set target for Cpk (Cpk > 1.33)
3. Process capability study reports
4. Defect rate monitoring record (for critical non-measureable defects)
5. Action plan to improve Cpk and reduce defect rate in case of not me
6. Extension of IPC period in case termination criteria is not met
7. Understanding of team
4M change procedure defining following
1.Definition of changes (Detail as per Annexure)
2.Categorisation of changes into planned/unplanned changes
3.Actions to be taken at change point
4.Display of definition of changes in shop floor
5.Visual control of changes (4M change indication)
6.Information rule
7.Awareness of change management among the shop floor personnel
1.Evidences of implementation of actions
2.Record of changes (4M change record), evidence of signatures of quality an
3.approval of quality head during 4M changes
1. Check record of parts produced after change
2. Retroactive check record in case of unplanned (unexpected) changes
3. Traceability to invoice : Yes/No
1. Definition of initial part (upto pilot lot)
2. Initial part control - separate locked area, identification tags, log of initial p
1. Separate tags to identify initial parts
2. Inspection report of initial parts
3. Separate locked area
4. Summary of initial parts prepared, sent to customer and balance quantity.
after customer feedback.
1. Availability of control plans for all the parts being manufactured by the ven
2. Procedure for preparation and control of documents defining following:
- department in charge of making;
- a person in charge of making;
- a person in charge of authorizing;
- revision rule;
- retention period;
3. Master list of documents (control plans, operation standard, inspection sta
4. Master copies of the controlled documents
5. Availability of documents (control plans, operation standard, inspection sta
6. System for review and control revisions of controlled documents
1. All Product and process parameters to be defined in the control plans
2. Reference of WI or other standards, sample size, checking frequency, chec
Poka Yoke to be defined in the control plans
3. Consistency among documents (process control standards/control plans, o
standards and customer inspection standards)
Procedure for training defining following.
1. Training need identification done; Y/N
2. Training plan made as per above need (TNI): Y/N
3. Plan vs actual followed: Y/N
4. Training content is to be checked
5. Effectiveness of training is checked; Y/N
6. New operator training given: Y/N
(standard induction training program available and followed)
(above requirements must be checked with one example for operator and sta
1. For each operator, skill evaluation is done: Y/N
2. For each skill level (e.g. defining a operator at Level 1,2,3,4), specific criteri
(implementation check)
3. Minimum skill level to perform any operation : defined and followed check
1. Skill evaluation frequency using criteria followed above (clause no 5.1.2) : Q
(skill evaluation must be done at least 2 time/year)
2. For QA inspector, Poisson test plan and plan vs actual done: Y/N
3. Skill upgradation plan for Operators (in case the skill level is reduced) (plan
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 workin
5. Evidence of conducting audits as per plan (check sheet records) (in all shift
6. Evidence of improvement in case of issues identified (NC's reported)
7. NC summary report (for internal audits)
1. Evidence of conducting audit as per control plan during process audit.
2. Evidence of checking actual working as per operation standard during proc
defined in process audit check sheet)
1. Evidence of checking effectiveness of countermeasures of customer and in
2. Last audit NC closure
1. Procedure for new supplier selection: Y/N
2. Acceptance criteria (criteria for selection/hold/rejection and includes check
management) for new supplier selection based on system audit available: Y/N
one example for above procedure.
1. Definition of abnormal situations (Detail as per Annexure)
2. Display of abnormal situations in shop floor
3. Awareness of abnormal situations among the shop floor personnel
1. Procedure for handling customer complaints, in-process failure and supplie
2. Criteria for raising QPCR's
3. Customer complaint register
4. QPCR control registers (for in-house and supplier defects)
1. Criteria to estimate suspected quantity produced during abnormal situatio
lot produced based upon the criteria
2. Check record of parts produced during abnormal situations for traceability
1. Analysis sheet for analysing customer complaints, in-house defects and sup
2. Monthly in-house rejection analysis (defect wise pareto and analysis)
3. Quality of analysis
1. Countermeasures detail & evidence of standardisation (revision/updation o
Inspection standard, check sheets etc.)
1. Evidence of onsite verification of countermeasures
2. Horizontal deployment of countermeasures
Materials to be kept in covered condition away from dust, rust, scratches ( RM
Designated area for RM/BOP, WIP, FG material storage
Environment of inspection area for incoming, WIP and FG material meeting:
1) Lux value: as per IS Standard
2) Noise level
3) inspection on working table
General condition of tool/machine such as
1) Condition of wiring of machine
2) Oil leakages around machines
3) Tool stored in racks
1. Storage of inspection Equipments when not in use: in boxes or in open
2. Damages of instruments -OFFLINE
Procedure for maintenance defining following.
1. Daily maintenance check sheet filled by operator: Y/N
2. Cross checking of above check sheet by supervisor: Y/N
3. PM of machine: frequency, plan, plan vs actual, history card, check sheet fi
break down points covered in PM check sheet or not, Spares (list and availab
4. PM of Tool: frequency, plan, plan vs actual, history card, check sheet filled
down points covered in PM check sheet or not, Spares (list and availability)
Procedure/Work instruction/Information sheet for Poka-Yoke defining follow
1. List of pokayoke available: Y/N
2. Cross checking of pokayoke: Y/N
3. 100%
1. Life ofbreakdown analysis for poka-yoke.
various consumables/tools monitored: Y/N
1) press: trimming, blanking & hole punching punches
2) machining: cutting tool
3) Welding electrodes for spot welding
4) Polishing Frequency)
(above will change based on type of industry)
1. Calibration plan -ONLINE
2. Plan vs actual.
3. Delayed calibration.
4. In case of in-house: procedure, soaking: Y/N, frequency, master calibration
5. Acceptance certificate/acceptance criteria.
6. Calibration sticker on measuring instruments & testing equipments.
1. Limit sample availability.
2. Expiry date of limit sample.
3. Visual display of OK and NG process/part at WIP/FG stage.
Visualizer or alarm at critical operations for confirmation of completion of wo
Display of Work Instruction and critical process and quality parameters for ea
local language so that operator can read and understand it.
1. Operator wise operator monitoring plan for all production areas.
2. Check record of operator monitoring as per check sheet covering all the ac
during working time.
3. Training plan for operators for weak areas.
1. Judgment criteria should be mentioned on check record sheet of product a
Lower tolerance).
2. Space for giving judgement and proper judgement after check.
1. Availability of system to ensure FIFO.
2. Evidence of FIFO to be checked for incoming, WIP, FG material
3. Sample from line also need to check
Tags on RM, WIP, FG material with route card no/ batch no /lot no/ heat cod
Similar part management in WIP, FG and dispatch area (different color of I ta
1. NG part identification should be defined and evident. Each NG part and pa
properly by tag with defect details.
2. Colour of bin for keeping NG parts to be identified and bin should be acces
3. Check for NC parts handling system.
4. NG part analysis report to be checked.
5. Decision for scrap, rework or salvage of part should be done by QA.
1. Check for the rework procedure is defined or not.
2. Record for NG parts repair or salvaged should be available.
3. Traceability of person doing rework and person approving the part after re
rework records.
4. Person skilled and trained for doing rework should be authorized and displ
1. Approved packing norms with customer
2. Evidence of above
3. Transportation method to avoid damage during transit
1. Condition of packing (bin/trolley) used in WIP and FG material
2. Guidelines for repairing of bins/trolley
3. Bin cleaning area
Identification of Maru A check points in WI at Maru A station and in final insp
Display of names & photographs of operators authorised to work at Maru A s
A part.
1. Rework instruction for rework of Maru A parts.
2. Display of names & photographs of operators authorised to rework of Mar
3. Rework record of Maru A parts.
4. Traceability of person doing rework and approving the reworked parts.
Availability of inspection instruments as per drg/control plan/inspection stan
Availability of Test equipments as per drg/control plan/inspection standards.
Availability of trained manpower to operate the inspection instruments and t
Audit by auditor.
Closure of observations of previous audit.
1. Adequate organisation structure.
2. Roles and responsibilities.
3. All positions filled (no position vacant).
4. Stability of manpower.
1. Top management visit frequency : daily/weekly/monthly
2. Monitoring of KRA by Mgt
3. Evidence of review.
1. T/o of the plant
2. Group T/o
PAT/Sales
D/E
ROCE
1. Noise level in shop floor.
2. Air quality.
3. Rest Area.
4. Condition of toilets.
5. Sufficient space for easy movement of machines and tools.
6. Layout and escape routes.
1. Availability of safety standards.
2. Awareness of safety to operators.
3. Availability of PPEs as per standard.
1. Door sensors on machines.
2. Double hand operation.
3. Double spring (in presses).
4. Insulating jacket on barrel, Jam bar/drop bar (in plastic molding General - M
sensors, emergency switch.
5. Safety in material movement : Lifters, hydraulic forklifts, stackers, corner g
6. Bin trolley stacking height defined or not.
7. Safety in tool room : Skilled manpower deployed or not, availability of over
1.Usage of PPEs by operators.
2. Accident reporting mechanism.
3. Countermeasures against accidents.
4. Periodic verification of countermeasures.
Fire safety audit report by reputed 3rd part agency.
Consent to operate (CTO) certificate.
1. Enrolment of all operators for ESI.
2. Enrolment of all employees to PF.
3. Check Management review status for direct enrolment or for 3rd part enro
1. Waste segregation system.
2. Awareness among operators.
3. Segregation facility on shop floor
4. Check disposal system and implementation for last 1 year
4M change procedure defining following
1.Definition of changes (Detail as per Annexure)
2.Categorisation of changes into planned/unplanned changes
3.Actions to be taken at change point
4.Display of definition of changes in shop floor
5.Visual control of changes (4M change indication)
6.Information rule
7.Awareness of change management among the shop floor personnel
1.Evidences of implementation of actions
2.Record of changes (4M change record), evidence of signatures of quality and
３． production head
Changing
managem 3.approval of quality head during 4M changes
ent 1. Check record of parts produced after change
2. Retroactive check record in case of unplanned (unexpected) changes
3. Traceability to invoice : Yes/No
1. Definition of initial part (upto pilot lot)
2. Initial part control - separate locked area, identification tags, log of initial parts
1. Separate tags to identify initial parts
2. Inspection report of initial parts
3. Separate locked area
4. Summary of initial parts prepared, sent to customer and balance quantity. Action
taken of balance quantity after customer feedback.
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