Professional Documents
Culture Documents
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
SL.
Ref.
Requirement What to look for Assessor Notes/Objective Evidence
Clause
NO.
1 5.3 Is the Quality Policy implemented, Direct interview with randomly selected
understood & maintained in the Press people of the shop .
shop ?
2 5.5.1 Has the Responsibility, Authority, Inter Responsibility & Authority as defined in
relationship of personnel who Manage, job description, responsibilities matrices,
Perform & Verify work affecting quality procedures, accountabilities documents.
been defined & documented ?
3 5.5.1.1 Whether all the shifts have been provided Q.A. responsible personnel in all shift.
with personnel to handle QA responsibility
?
4 7.1 Does the quality plan include the Verify the PCS . ( It should be as per
customer requirement and references to Control Plan & Customer Drawings )
appropriate specification?
6 8.2.3.1 Do you perform process studies and verify Verify the Cp & Cpk Data , Control Charts
process capability? , Awareness about SPC among Technical
staff .
7 6.3.1 Does the press shop layout minimise Process flow analysis. Plant
material travel and handling facilitate layout (Current) planned.
synchronous material flow and maximize
value added use of floor space?
8 7.5.1.5 Have you established and implemented a Tool management process. Proper Storage
system for tool management that includes of Dies & Mode of maintenance / Repair.
maintenance and repair facilities?
9 8.5.1 Do you have a prioritised action plan for Continual Improvement plan Vs Current
continual improvement? status.
10 4.2.3 Are all documents(WI/PCS) and data Document receipt record. Verify all the
reviewed and approved by authorised PCS & Work Instruction having authorised
personnel with revision no. ? signature.
13 7.5.3 List of Dies & Fixtures (Existing), Quick Tracibility. Verify tool storage in
Identification code & Storage location in accordance with displayed position
the Press Shop ? ( Updated Chart )
19 7.5.1.6 Daywise monthly production plan & Daily Daily plan/work sheet Daily
plan? prodn. Report
Daily line rejection report
22 8.2.3.1 Are significant process events recorded on Process control record & Control Charts.
the control chart?
23 8.2.3.1 Do you initiate the appropriate reaction Evidence of such data , if any.
plan from the control plan for unstable or ( Rework & scrap data )
noncapable characteristics?
24 8.2.3.1 Does the reaction plan include as Contents of reaction plan for unstable and
appropriate:- non capable process.
- Containment & 100% inspection? Verify PCS / Procedure
- Specific C.A. timing? Verify PCS / Procedure
- Responsibility Assignment? Verify PCS / Procedure
- Customer Approval? Verify PCS / Procedure
25 8.2.3.1 Do you maintain record of process change Process change records / ECN data
effective dates?
26 8.2.4 Do you verify job set-ups and use Job set-up records asa per PCS. Control
statistical methods where applicable? Chart Study etc.
27 8.2.4 Are job instruction available for set-up Set up instruction (W.I. / PCS)
personnel?
29 7.1 R/M issue procedure from store to press Store requisition slip
shop?
30 7.1 Tool loading process on the press? Daily plan cum work sheet
31 7.5.1.3 M/C & process parameter set-up? Verify parameters as per PCS
34 7.5.1.4 Die maintenance procedure & record Die rectification request & Procedure for
Tool Maintenance.
35 8.2.4 Does the Q.A.Engineer inspect and test Inprocess inspection, Control plan, PCS &
product as required by the quality Records
plan(control plan) and/or the documented
procedure?
37 8.3.1 Does the control of N.C. product & Follow one or more N.C. case and verify
suspect material or product provided for the flow (Identification, segrigation etc.)
evaluation and for notification of all Obsolete product.
appropriate functions?
38 8.3 Does we quantify and analyse N.C. Plan for N.C. product reduction.
product, establish prioritised reduction Monitoring system , QPCR .
plan and track progress
39 8.3.3 Is the customer promptly informed when Method to communicate with the
N.C. material has been shipped? customer for N.C. product. (Internal
QPCR)
41 8.3 Are N.C. & Suspected products reviewed As per procedure , verify the actual
in accordance with documented procedure method being followed.
43 8.3 Is the description of N.C. that has been Record of customer acceptance of N.C.
done accepted,and or repairs, recorded to material.
denote the actual condition ?
44 8.3 Are repaired and/or reworked/product re- Reworked product flow must guarantee
inspected and/or documented procedure? the re-inspection in according to control
plan & inspection record.
46 8.5.2 Are the appropriate C.A.& P.A. developed Coherence between action and document
to eliminate the cause of actual or change Record of change
potential N.C.?
49 8.5.3 Do procedure for P.A. include Source of information used for preventive
action
The use of appropriate source of Root cause determination(FMEA,CP ETC.)
information's
e.g.-product quality, deviation,audit result Records & results analysis
etc. to develop P.A.
Initiation of P.A., application of controls to Effectiveness Monitoring
ensure that it is effective
51 7.5.5 Have methods for the handling of product Facilities appropriate for product handling
to prevent damage or deterioration been
provided?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
S. Ref.
Requirement What to look for Accessor Notes/Objective Evidence
NO Clause
1 5.3 Is the Quality Policy implemented, Direct Interview with randomly selected
understood & maintained in the Weld people of the shop.
Shop ?
3 5.5.1.1 Are the Weld Shop shift Staffed adequately Q.A responsible personnel in all shift.
with personnel for Q.A responsibility ?
4 7.1 Does the Quality Plan include the Verify PCS (As per Control Plan, FMEA
Customer requirement & References to etc.)
appropriate Specification ?
6 8.2.3.1 Do you perform Process Studies & verify Verify Cp & Cpk , Control Charts &
Process Capability ? understanding of SPC among technical
staff.
7 6.3.1 Does the Weld Shop layout minimise Process Flow Analysis. Plant layout
Material travel & Handling facilitate (Current planned).
Synchronous Material Flow & Maximize
value added use of Floor Space ?
8 7.5.1.5 Have you established and implemented a Tool management process , Maintenance
system for tool management that includes of Jigs & Fixtures , Welding Equipments
maintainance and repair facilities? Plan Vs Actual status
9 8.5.1 Do you have a prioritized action plan for Continual Improvement plan, Iniatiative.
continual improvement?
10 4.2.3 Are all documents(WI/PCS) and data Document receipt record & Authorised
reviewed and approved by authorised signatory.
personnel with revision no?
15 6.4.2 Are the premises maintained in a state of Tour of plant 5'S' & Kaizen.
order, cleanliness and repair appropriate
to the product manufactured?
19 7.5.1.6 Daywise monthly, production plan & Daily Daily Plan/actual Report Daily
plan Prodn Report Daily Line
Rejection report
- SPC Requirements?
- Relevent engg. & mfg. Standards?
- Inspection & test instructions?
- Reaction plan?
- Revision date & approvals?
21 8.2.3.1 Product manufactured in the shop exceed Current Cpk/Ppk versus customer
the Cpk or performance as approved by approved Cpk/Ppk/ Existing reaction
customer PAP through the implementation plan/ Verifying the accuracy of Cpk/Ppk .
and adherance to the Control plan, Check the awareness of SPC among
Process flow diagram, Measurement technical staff
Technique, Sampling plan/Reaction plan
when Acceptance criteria are not met
22 8.2.3.1 Are significant process events recorded on Process control record / Control Charts
the control chart?
23 8.2.3.1 Do you initiate the appropriate reaction Verify the actions against Non
paln from the control paln for unstable or Conformities
uncapable characteristics
24 8.2.3.1 Does the reaction plan include as Contents of reaction plan for unstable and
appropriate:- non capable process
Containment & 100% inspection?
Specific C.A. timing?
Responsibility Assignment?
Customer approval?
25 8.2.3.1 Do you maintain record of process change Process Change Recors /ECN
effective dates?
26 8.2.4 Do you verify job setups and use Job set-up records and FOP/LOP approval
statistical methods where applicable?
27 8.2.4 Are job instruction available for setup Set-up Instruction / PCS
personnel?
30 7.1 Are Consumable Tools (i.e. electorde for Record of checking Frequency of Tool
spot weld ) replacement / maintenance Maintenance & replacement
frequency defined?
31 7.5.1.3 Setup & control of M/C & welding Record & PCS
parameter ?
35 8.2.4 Does the Q.A. Engineer inspect and test Inprocess inspection, PCS / Control Plan,
product as required by the quality plan Records of inspection / tests / rejections
(PCS/Control plan) and / as per the etc.
documented procedure ?
37 8.2.4 Nugget dia. Test(spot weld) using chisel & Record of checking
hammer as per PCS
40 8.2.4 Continuous monitoring of product visually Record of Weld Related Defects & their
for weld deffect e.g. spot burn, spot burr, Countermeasures / Reasons
spot dent and spot puncher etc.
42 8.3 Does the control of N.C. product & Follow one or more N.C. case and verify
suspect material or product properly the flow (identification,segrigation, etc.)
identified, well documented, properly
evaluated, segrigation & disposition
details exists ?
43 8.3 Does we quantify and analyze N.C. Plan for Reduction of Non Conforming
product establish prioritized reduction products & actual status.
plan and track progress.
44 8.3 Is the customer promptly informed when Method to communicate with the
N.C. material has been shipped? customer for N.C. product
48 8.3 Is the description of N.C. that has been Record of customer acceptance of N.C.
accepted,and of repairs,recorded to denote material.
the actual condition ?
49 8.3 Are repaired and/or reworked/product re- Reworked product flow must guarantee
inspected and/or documented procedure? the re-inspectio in according to control
plan & inspection record.
51 8.5.2 Are the appropriate C.A.& P.A. developed Coherance between action and document
to eliminate the cause of actual or change Record of change
potential N.C.?
56 7.5.5 Have methods for the handling of product Facilities appropriate for product
to prevent damage or deterioration been
provided?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
S.
Ref.
Requirement What to look for Assessor Notes/Objective Evidence
Clause
NO.
1 5.3 Is the quality policy Direct interview with randomly selected
implemented,understood and maintained people of the shop .
in the F/T Assy. shop ?
3 5.5.1.1 Are the F/T Assy. shop shift staffed Q.A. responsible personnel in all shift.
provided personnel for Q.A. responsibility?
4 7.1 Does the quality plan include the Verify Process Control Sheet
customer requirement and references to
appropriate specification?
6 8.2.3.1 Do you perform process studies and verify Process capability measurement results
process capability? as appropriate for all new processes.
7 6.3.1 Does the F/T Assy. shop layout minimise Process flow analysis. Plant
material travel and handling facilitate layout (Current planned).
synchronous material flow and maximize
value added use of floor space?
9 8.5.1 Do you have a prioritized action plan for Continual Improvement plan on the basis
continual improvement? of previous Internal & External defects
analysis
10 4.2.3 Are all documents(WI/PCS) and data Document receipt record , Verify the
reviewed and approved by authorised PCS / W.I. Duly approved.
personnel with revision no?
12 7.5.3 How is tracibility maintained and recorded Verify Batch Code System / MMC Tag
when required by the customer?
14 7.5.3 Bins of F/T Assy. shop containing Verify presence of MMC & physical
component to be provided with MMC verification of matter written on it.
Part code/No.
Shift & Date of processing
15 6.4.2 Are the premises maintained in a state of Tour of plant
order, cleanliness and repair appropriate 5'S' & KAIZEN
to the product mfd?
19 7.5.1.6 Daywise monthly production plan & Daily Daily plan/work sheet Daily
plan? prodn. Report Daily line
rejection report
20 8.2.3.1 Do process monitoring and job Verify PCS , for the job instructions ,
instructions include or reference,as being effectively implemented
appropriate
Operation name & number keyd to
process flow diagram?
Part name & part no.?
Current engg. Level/date?
Required tools,gauges and other
equipment?
Material identification&disposition
instruction?
Customer & supplier designated special
characteristics?
SPC requirements?
Relevent engg. & mfg. Standards?
Inspection & test instructions?
Reaction plan?
Revision date & approvals?
21 8.2.3.1 Product manufactured in the shop exceed Current Cpk/Ppk versus customer
the Cpk or performance as approved by approved Cpk/Ppk. Existing reaction
customer PAP through the implementation plan Verifying the accuracy of
and adherance to the control plan,process Cpk/Ppk
flow diagram,measurement
technique,sampling plan/reaction plan
when acceptance criteria are not
23 8.2.3.1 Do you initiate the appropriate reaction Verify the Reaction Plan in PCS
plan from the control plan for unstable or
noncapable characteristics?
24 8.2.3.1 Does the reaction plan include as Contents of reaction plan for unstable and
appropriate:- non
Containment&100% inspection? capable process
Specific C.A. timing?
Responsibility Assignment?
Customer Approval?
25 8.2.4 Do you maintain record of process change Process change records
effective dates?
26 8.2.4 Do you verify job setups and use Job set-up records and approval
statistical methods where applicable?
27 8.2.4.2 Are job instruction available for setup Verify Set up instruction as mentioned in
personnel? Daily Check sheet / PCS
Are the masters and evaluation equipment Calibration stickers verification for expiry
maintained and controlled? & Master Samples must be approved
Is there any verification that personnel Training record Verification / Skill Matrix
making appearance eveluation are Verification
qualified?
29 7.1 R/M issue procedure from store to F/T Store requisition slip
Assy. shop?
35 8.2.4 Does the Q.A.Engg. inspect and test Inprocess inspection Report, Control
product as required by the quality plan,Records
plan(control plan) and/or the documented
procedure?
37 8.2.4 Nugget dia. Test(spot weld) using chisel & Record of checking frequency
hammer as per PCS
38 8.2.4 Pillow test using chisel & hammer in case Record of checking frequency
of (Seam welding)
39 8.2.4 Leakage test for all brazing/welding. Record & checking frequency
40 8.2.4 Carbon test for proper contact of electrode Record & checking frequency
tip.
42 8.3 Does the control of N.C. product & Follow one or more N.C. case and verify
suspect material or product provide for the flow (identification,segrigation,etc.)
identification,documentation,eveluation, Obsolete product.
segrigation,disposition and for notification
of all appropriate functions?
43 8.3 Does we quantify and analyze N.C. Plan for N.C. product reduction.
product establish prioritized reduction Monitoring system
plan and track progress?
44 8.3 Is the customer promptly informed when Method to communicate with the
N.C. material has been shipped? customer for N.C. product
46 8.3 Are N.C. & suspect products reviewed in Verify the things as per Process Approach
accordance with documented procedure for Corrective & preventive actions &
and handling Non - Conformities
Reworked to meet the specified
requirement?
Accepted with or without repair by
concession
Regarded for alternatiove application
Rejected or Scrapped?
48 8.3 Is the description of N.C. that has been Record of customer acceptance of N.C.
done accepted,and of repairs,recorded to material / QPCR
denote the actual condition ?
49 8.3.2 Are repaired and/or reworked/product re- Reworked product flow must guarantee
inspected and/or documented procedure? the re-inspection in according to control
plan & inspection record.
50 8.3.2 Are the rework instructions accessible and Plant tour to verify the Rework instruction
utilized by the appropriate personnel in being imparted to all & being implemented
their areas?
54 8.5.3 Do procedure for P.A. include Source of information used for preventive
action
The use of appropriate source of Root cause determination (FMEA,CP ETC.)
informations
57 7.5.5 Have methods for the handling of product Facilities appropriate for product
to prevent damage or deterioration been
provided?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
3 5.5.1.1 Are the Paint shop shift staffed provided Q.A. responsible personnel in all shift.
personnel for Q.A. responsibility?
6 8.2.3.1 Do you perform process studies and verify process capability measurement results
process capability? as appropriate for all new processes.
7 6.3.1 Does the paint shop layout minimise Process flow analysis. Plant
material travel and handling facilitate layout(Current planned).
synchronous material flow and maximize
value added use of floor space?
8 8.5.1 Do you have a prioritized action plan for Continual Improvement plan, Iniatiative.
continual improvement?
13 6.4.2 Are the premises maintained in a state of Tour of plant 5'S' & KAIZEN
order, cleanliness and repair appropriate
to the product mfg?
17 7.5.1.6 Daywise monthly production plan & Daily Daily plan/work sheet Daily
plan? prodn. Report Daily line
rejection report
19 8.2.3.1 Product manufactured in the shop exceed Current Cpk/Ppk versus customer
the Cpk or performance as approved by approved Cpk/Ppk. Existing reaction
customer PAP through the implementation plan Verifying the accuracy of
and adherance to the control plan,process Cpk/Ppk
flow diagram,measurement
technique,sampling plan/reaction plan
when acceptance criteria are not met.
22 8.2.3.1 Does the reaction plan include as Contents of reaction plan for unstable and
appropriate:- non
Containment&100% inspection? capable process
Specific C.A. timing?
Responsibility Assignment?
Customer Approval?
24 8.2.4 Do you verify job setups and use Job set-up records and approval
statistical methods where applicable?
27 7.1 R/M issue procedure from store to paint Store requisition slip
shop?
32 8.2.4 Does the Q.A.E. inspect and test product Inprocess inspection, Control
as required by the quality plan(control plan,Records
plan) and/or the documented procedure?
35 8.3.1 Does the control of N.C. product & Follow one or more N.C. case and verify
suspect material or product provide for the flow(identification,segrigation,etc.)
identification,documentation,eveluation,se Obsolete product.
grigation,disposition and for notification of
all appropriate functions?
36 8.3 Does we quantify and analyze N.C. Plan for N.C. product reduction.
product establish prioritized reduction Monitoring system
plan and track progress?
37 8.3.3 Is the customer promptly informed when Method to communicate with the
N.C. material has been shipped? customer for N.C. product
41 8.3 Is the description of N.C. that has been Record of customer acceptance of N.C.
done accepted,and of repairs,recorded to material.
denote the actual condition ?
42 8.3 Are repaired and/or reworked/product re- Reworked product flow must guarantee
inspected and/or documented procedure? the re-inspectio in according to control
plan & inspection record.
44 8.5.2 Are the appropriate C.A.& P.A. developed Coherance between action and document
to eliminate the cause of actual or change Record of change
potential N.C.?
47 8.5.2 Do procedure for P.A. include Source of information used for preventive
action
The use of appropriate source of Root cause determination(FMEA,CP ETC.)
informations
49 7.5.5 Have methods for the handling of product Facilities appropriate for product
to prevent damage or deterioration been
provided?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
S. Ref.
Requirement What to look for Accessor Notes/Objective Evidence
NO Clause
1. 5.3 Is the Quality Policy implemented, Direct interview with randomly selected
understood & maintained in the Deptt. ? people of the deptt.
3. 4.2.7 Do you have a prioritized action plan for Continual Improvement plan, Iniatiative.
Continual Improvement ?
5. 4.2.3 Are all Documents & Data reviewed & Document receipt record
approved by authorised personnel with
revision no ?
6. 7.4.1 How do you plan for net Material Follow one or more case and verify the
requirement ? flow. Raw material requirement report
Description of Material
Specification
Inspection / Acceptance criteria.
Test Certificate, if any
Inspection report required, if any.
Quantity
Packing requirements
Delivery schedule
Price
Other Terms & Conditions, if any
10. 7.4.1 Procedure for Purchasing of non regular Follow one or more case and verify the
items. flow for Raw material requirement report
14. 8.3 Action plan in case of Delivery less than Supplier Countermeasure report
100%
16. 7.4.1 How do you Eveluate your Suppliers ? Vendor Eveluation Check Sheet, Visit
report
17. 7.4.1.2 Process to develop the Supplier Quality Assessment schedule of Suppliers,
Systems ? Supplier System Development
observation.
21. 7.4.1 Have you decided the targets for Targets for Inventory
achievements & improvements on current
Inventory Policy ?
22. 6.2.2 Are personnel qualified based upon Training plan, Employees experience,
appropriate education, Training Training requirements, Training records,
requirements & have the training needs Job description.
for all personnel performing activities
affecting Quality been met ?
23. 6.2.2 Training effectiveness, Is training Audit Performance, Reviews, Pre & Post
periodically eveluated for effectiveness? Testing, Comparison between Customer
Needs & Training content programme.
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
S. Ref.
Requirements What to look for Accessor Notes/Objective Evidence
NO Clause
1. 5.3 Is the Quality Policy implemented, Direct interview with randomly selected
Understood & Maintained in the people of the department.
Maintainance Department ?
4. 4.2.3 Are all Documents & Data reviewed & Document Receipt Record
approved by authorised personnel with
Revision Number ?
9. 7.5.1.4 Do you have a list of Essential Spare parts Interact with Store Incharge & Weekly
with minimum stock level required for Review
smooth operation ?
11. 8.4 Record of repeated failure, any Major M/C History Card
Spare part replacement & History of M/C.
13. 7.5.1.4 Is there any Register to enter the Breakdown Register/ Maintainance log
Maintainance complaint by plant / office book
staff?
14. 7.5.1.4 Maintainance job pending register and Job Pending Register review
pending job completed on next Sunday.
16. 8.4 Trend Chart, Action plan & Analysis Record & Effectiveness
17. 8.5.2.2 Are Mistake Proofing Techniques utilized, Examples of Mistake Proofing.
where appropriate ?
19. 7.5.1.4 Are all the Manual /Circuit Diagram of Controlled & Proper storage
Machines are available ?
21. 6.2.2 Are personnel qualified based upon Training plan, Employees
appropriate education, Training experience,Training requirements,Training
requirements, & Experience as required & records, Job description
have the training needs for all personnel
performing Maintainance activities ?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
4 6.3.1 Does the Tool Room layout minimise Process flow analysis. Plant
material travel and handling facilitate layout(Current planned).
synchronous material flow and maximize
value added use of floor space?
6 8.5.1 Do you have a prioritized action plan for Continual Improvement plan, Iniatiative.
continual improvement?
8 7.1 Is there any system to get the material / Indent / Store requisition slip
availability of material from store /
outside ?
11 6.4.2 Are the premises maintained in a state of Tour of plant 5'S' & KAIZEN
order, cleanliness and repair appropriate
to the product mfd?
14 7.1 Daywise monthly production plan & Daily Daily plan/work sheet
plan?
16 7.5.1.5 Is there any sheet to follow the processing Job card with sketch / Drgs.
sequence & sketch ?
17 7.5.1.3 Do you verify job setups ? Job set-up records and approval
23 7.5.1.5 New developed tool (Inhouse / Out side ) Record of try out
try out jointly by Head TR & Head prodn.
24 8.3 Does the control of N.C. product & Follow one or more N.C. case and verify
suspect material or product provide for the flow(identification,segrigation,etc.)
identification,documentation,eveluation,se Obsolete product.
grigation,disposition and for notification of
all appropriate functions?
25 8.3 Does we quantify and analyze N.C. Plan for N.C. product reduction.
product establish prioritized reduction Monitoring system
plan and track progress?
29 8.5.2 Are the appropriate C.A.& P.A. developed Coherance between action and document
to eliminate the cause of actual or change Record of change
potential N.C.?
33 7.5.5 Have methods for the handling of product Facilities appropriate for product
to prevent damage or deterioration been
provided?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
S. Ref.
Requirement What to look for Accessor Notes/Objective Evidence
NO Clause
1 5.3 Is the Quality Policy implemented, Direct Interview with the selected people
understood & maintained in the Weld in the shop.
Shop ?
3 5.5.1.1 Is the final inspection area staffed with Responsible person in all shifts
responsible persons in all shifts?
5 6.2 Is the competence record available of the Educational, training, skill & experience
personnel whose work can affect the records
quality of product?
6 6.2.2 Is the training needs identification & Training Needs Identification, Training
training plan available for final inspection Plan & Records of training
deptt? Is the training
being provided to the personnel as per
plan?
11 7.5.5.1 What is the procedure for handling over Procedute of handover of production
the production to final inspection?
B
1 Is Design FMEA raised and are the
improvement measures established?
C
1 Are “Product Requirements”
available?
2 Is a process development plan
available and are targets determined
& maintained?
3 Are the “Resources” for realization of
Serial Production Planned?
4 Have the process requirements been
determined and considered?
5 Are necessary personnel and
technical preconditions for the project
process planned / available?
6 Is Process FMEA raised and are
improvement measure establi-shed?
D
F-1705-00
RASANDIK ENGINEERING INDUSTRIES INDIA LTD.
DATE
AUDIT CHECK LIST-PRODUCT DEVELOPMENT
ELEMENT 6 : PRODUCTION
F-1705-00
RASANDIK ENGINEERING INDUSTRIES INDIA LTD.
DATE
AUDIT CHECK LIST-PRODUCT DEVELOPMENT
A PERSONAL / QUALIFICATION
6.1 Are the employees given responsibility
& authority for monitoring the product /
process quality?
F-1705-00
RASANDIK ENGINEERING INDUSTRIES INDIA LTD.
DATE
AUDIT CHECK LIST-PRODUCT DEVELOPMENT
F-1705-00
AGRO ENGINEERING WORKS
INTERNAL AUDIT CHECK SHEET - TOP MANAGEMENT (ISO/TS-16949:2009)
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
What are the inputs used for establishing Quality Policy and Quality
5.3 Objectives? i.e. Mission, Vision, Corporate Policy, Top Management
Interests and priorities
e) How is the Quality Policy reviewed for continuing suitability i.e.
Policy shall be under “Control of documents”?
5.4.1 Are the Quality Objectives sufficient to deploy the Quality Policy?
(Note)
What are the inputs to you for identification of areas for continual
8.5
improvement?
6.1 How do you determine and make provisions for availability of resources,
What are the inputs provided to you that the customer requirements are
5.2
determined and met?
What are the input decided by you and get to ensure enhancement in
5.2
Customer Satisfaction?
5.5.1 How do you ensure that the responsibilities and authorities are defined?
5.5.3 What are the actions taken to improve the effectiveness of communication?
h) Changes that could affect QMS i.e. Reorganization, New products,
New Markets, Revised procedures
Are all the inputs of Management review given above, discussed and
5.6 actions and decisions included in the records for the following three
outputs:
5.6 Are the decision and actions communicated to the various departments?
4.1 Which are the processes identified in the QMS in the organization?
Which processes are you directly responsible for? i.e. Internal audits,
4.1 Management Reviews, Documentation, Customer Complaints, Identification
of Resources, Continual Improvement, etc.
a) Approval
4.2.4 How the retention period for QMS related documents is decided?
INTERNAL AUDITS
8.2.2 Is Annual Audit Plan prepared for all shifts?
8.2.2.4
8.2.2.4
Does Audit Schedule include audit criteria, scope, frequency and method of
8.2.2
audits?
Does selection criteria of auditors considers that auditors do not audit their
own activity?
8.2.2 How does audit planning ensures objectivity and impartiality during audit?
AUDITEE SIGNATURE
Comment
2009
AUDITOR SIGNATURE
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
6.4.2 Are the premises maintained in state of order, cleanliness and repair?
8.2.3 and Are trend charts plotted for characteristics of processes and products to
8.2.4 identify opportunities of preventive actions?
b) Reliability
c) Availability
8.2.3 Are correction and corrective actions taken in case the Criteria are not met?
Are action plans assigning responsibilities and targets for making the
8.2.3.1
processes, stable and capable made?
Are such action plans reviewed and approved with customer when
8.2.3.1
required?
What actions are taken on feed back from layout inspection included
8.2.4
in the control plans?
8.3.2 Do work instructions for re-working for the type of defects exist?
Are the inputs identified for carrying out the production and service
7.5.1
provisions under controlled conditions?
When and how the Job Setups are verified? Are statistical methods
7.5.1.3
used during verification, where applicable?
6.4.1 Are the personnel using PPEs where potential risks are identified?
7.5.4.1 Are there any customer-supplied tools, inspection tools & equipment?
Are records maintained for the customer property that is lost, damaged and
7.5.4
is reported to the customer?
i.e. also includes intellectual property?
Are the products and their constituents identified, handled, packed, stored
7.5.5
and protected to preserve conformity?
i.e. welding, heat treatment, food preparation, image processing, air traffic
control services, etc.
Are the feed backs on inspection and tests activities carried out for the
8.2.4
product at the in-process stages are received?
a) Reviewed
8.5.2.1 Is there customer prescribed format and if yes, are the same utilized?
8.5.2
Are records of results of action taken maintained?
· Reviewed
6.2 Is the competence defined for the personnel performing production process.
6.2 Are inputs for HRD process identified in terms of training needs?
What are the inputs communicated to various departments and how they
5.5.3
are communicated?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
4.1 Are Criteria determined to ensure that the quality processes are effective?
7.5.4.1 If yes, how such tools / gauges are identified for tool ownership?
8.2.3 Are correction and corrective actions taken in case the Criteria are not met?
Are such action plans reviewed and approved with customer when
8.2.3.1
required?
Who is authorized to stop production till the quality problems are not
5.5.1.1
resolved?
How many working shifts are there and are all shifts have been staffed
5.5.1.1 with responsibilities for ensuring product quality? Any notification for
same.
4.1 Are all the inputs available for monitoring and measurement of product?
Are approvals taken by the relevant authority or customer for the deviation
from the planned arrangements?
How the feed back on layout inspections is utilized for correcting the
8.2.4.1
problems?
Are the instruments / Gauges / Test Soft Wares used for testing /
7.6
verification in quality calibrated or verified?
Is MSA carried out for such instruments which are referred in Control
7.6
Plans?
6.2 Is the competence defined for the personnel performing quality process?
8.5.2.1 Is there customer prescribed format and if yes, are the same utilized?
Are the actions also taken to prevent the occurrence of such non-
8.5.2.4
conformances?
What are the inputs communicated to various departments and how they
5.5.3
are communicated?
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
Are correction and corrective actions taken in case the Criteria are
8.2.3
not met?
Are all the inputs taken from the various departments? i.e.
4.1
monitoring and measurements to be done, desired accuracy.
7.6.3.1
Is Laboratory (Standard Room) Management System For Internal
Calibrations / Testing, exists?
7.6.3.1
Does Laboratory (Standard Room) comply with technical
requirements including :
(A)
Look for MSA Study Data for correctness of study and the
7.6.1
understanding of the analyst?
Are Criteria determined to ensure that the customer related processes are
4.1
effective?
8.2.3 Are correction and corrective actions taken in case the Criteria are not met?
AUDITEE SIGNATURE
DATE :
NAME OF AUDITEE :
Comment
AUDITOR SIGNATURE
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
7.5.1.5 Are resources available for tool and gauge design, fabrication and
verification activities?
4.1 Are Criteria determined to ensure that the design processes are effective?
(Note)
7.1.1 Are customer requirements and reference to their technical
specifications considered during planning of product realization?
7.1.1 Has Quality Plan for newly developed products been established
incorporating customer requirements and references of their technical
specifications?
7.1.4 Is there a process defined to control and react to the changes, which
can have impact on product realization including suppliers?
7.1.4 How the effects of any changes are assessed and consequential
verification and validation activities defined to meet customer
requirements?
7.1.4 Applicable to only Proprietary Designing Co. – Does the process exist
to assess the impact on form / fit function including performance
durability? Is it reviewed with the customer?
4.2.3.1 What is the system of updating the other documents based on the
desired changes?
7.1.2 Is acceptance criteria for attribute data sampling is “Zero Defect” and
the same is included in respective control plans?
6.3.1 Is plant layout available and used for optimizing material travel,
automation, handling and value-added use of floor space?
8.1.1 Are appropriate Statistical Tools identified for each process and
included in Control Plans?
7.5.1.1 Are control plans available for all systems, sub-systems, component
and/or material / parts?
7.5.1.1 Are the control plans compatible with FMEA outputs?
7.5.1.1 Are control plans reviewed and updated as and when any changes
occur affecting product, manufacturing process, measurement
logistics, supply sources or FMEA?
8.4 Are trends charts plotted for characteristics of processes and products to
identify opportunities of preventive actions?
8.2.3 Are correction and corrective actions taken in case the Criteria are not met?
7.5.4 Are customer intellectual property i.e. drawings, samples identified and
protected and safeguarded?
6.2 Is the competence defined for the personnel performing Design process?
8.2.2 Are actions taken for the non-conformities identified in internal audit
without any undue delay?
5.5.3 What are the inputs communicated to various departments and how they
are communicated?
· reliability,
· availability
7.3.6 Are there some of the out-source activities? If yes, how the
same are monitored to meet Prototype Programming?
7.3.1 Does the organization plan and control its design process?
i.e. the objectives of this plan is to identify all relevant activities so that
they can be performed in a systematic manner.
b) the review, verification and validation that are appropriate to each
design and development stage
7.3.2 Are inputs relating to the product requirements determined and include:
6.4.1 Does Design Input also include the requirements of product safety?
7.3.2 Are these inputs reviewed for adequacy before commencing the process and
records maintained?
d) Specify the characteristics of the product that are essential for its
safe and proper use.
7.3.3 Are Design Outputs verified and validated against Design Input
requirements?
73.4.1 Are the specified stages defined where measurements (e.g. quality
risk, cost, lead time, critical path etc) are to be carried out?
7.3.4.1 Is analysis carried out after Product Design Review with respect to
above?
7.3.4.1 Are the results of such reviews reported in Management review for
progress on design & any constraints of resources?
7.3.5 Is verifications performed as per the design plan to ensure that outputs
meets the input requirements?
7.3.6 Is design validation performed as per the design plan to ensure that the
product meets specified application or intended use, where known?
7.3.6 Are there out-source activities? If yes, how the same are monitored to
meet Prototype Programming?
7.1 (Note) What is the mechanism of notification for any changes in Product and
manufacturing process to the customer?
7.3.7 Are the design changes reviewed, verified and validated and approved
before implementation?
8.2.1 What is the system for getting feed back on monitoring the
performance of manufacturing processes for compliance with customer
requirements and efficiency (OEE) of Processes to co-relate with
enhancement in customer satisfaction?
8.2.1 Are corrective actions identified if the customer requirements are not full
filled?
7.2.2 Are the requirements reviewed and necessary inputs from the various
departments obtained prior to organization commitment?
Are the records of above reviews and actions arising due to this review
maintained?
6.1 Are the resources required for the process identified and available?
6.2 Is the competence defined for the personnel performing marketing process?
8.2.2 Are actions taken for the non-conformities identified in internal audit
without any undue delay?
5.5.3 What are the inputs communicated to various departments and how they
are communicated?
AUDITEE SIGNATURE
DATE :
NAME OF AUDITEE :
Comment
AUDITOR SIGNATURE
7.5.4.1 Are there any customer supplied tools, inspection tools & equipment?
7.5.1.5 Are maintenance and repair facilities including personnel available for
tools / gauges?
7.5.1.5 Is there adequate system for storage and recovery of tools / gauges?
7.5.1.5 Are tool change / repair programs established for perishable tools?
7.5.1.5 Are records for such tools / gauges maintained? Are these records
reviewed for change in frequency of maintenance?
7.5.1.5 Does records indicate the tool modification and revision to respective
documentation?
7.5.1.5 Are the tools / gauges properly identified and their status known e.g.
For Production, repair or disposal?
AUDITEE SIGNATURE
DATE :
NAME OF AUDITEE :
Comment
2009
AUDITOR SIGNATURE
4.1 Are Criteria determined to ensure that the HRD processes are effective?
i.e. No. of re-trainings required, Training hrs. per employee, gaps between
competence required and actual, etc.
8.4 Are trend charts plotted for characteristics of processes and products to
identify opportunities of preventive actions?
8.2.3 Are correction and corrective actions taken in case the Criteria are not met?
4.1 What inputs are communicated to HRD department for the various needs?
Are there any gaps between the above needs and actual?
6.2.2.4 Does the organization have a process for motivating the employees to
achieve quality objectives and continuous improvement. (Incentive
schemes etc.)
6.2.2.4 Is there any process established at all levels for promoting quality /
technological awareness throughout the organization? (Structural
Training, Quality Circle, Visual Aids etc.)
6.2.2.4 What is the process of measurement that the persons understand and
are aware of the relevance and importance of their activities in
achieving Objectives? (Evaluation and measurement Criteria of
involvement)
8.2.2 Are actions taken for the non-conformities identified in internal audit
without any undue delay?
5.5.3 What are the inputs communicated to various departments and how they
are communicated?
AUDITEE SIGNATURE
DATE :
NAME OF AUDITEE :
Comment
AUDITOR SIGNATURE
7.5.5.1 Is frequency of such assessment defined and what is the basis taken
for the same?
7.5.5.1 What is the basis taken while defining and optimizing the inventory?
7.5.5.1 What action plans are available to optimize the same in order to
reduce the inventory costs?
AUDITEE SIGNATURE
DATE :
NAME OF AUDITEE :
Comment
AUDITOR SIGNATURE
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
3 5.5.1.1 Are the PPC shift staffed provided PPC responsible personnel in all shift.
personnel for PPC responsibility?
4 7.5.1.6 Is there a production planning system Customer schedule & Day wise monthly
established in order to meet Customer Production Plan.
requirement just in time and is order
driven ?
9 Review the previous month:s pending Statement of Pending Customer Orders &
schedule which have been not executed in analysis of DI Failures.
the current month so far from Delivery
performance monitoring and DI FAILURES
must be analysed.
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
3 5.5.1.1 Are the Despatch shift staffed provided Despatch responsible personnel in all
personnel for Despatch responsibility? shift.
4 In case any finished products are not Statement of Slow despatch Items.
despatched since last " six month" prepare
a statement of such parts and get the
same re- verified from Head q.a for
physical conditions. If required, clean
them and re-apply suitable rust preventive
oil on metal p[arts.
10 In case the Customer desires the actions QPCR/ Customer Prescribed Format
to be taken by plant be reported to them,
send the details either through QPCR Or
any format as specified by Customer.
11 Ensure that freight paid for transportation Extra Freight Paid Records
is as per agreement made with Customer.
In case any extra freight is paid by the
company for sending the consigment ,
keep record of the same. Review the same
every month in CFT meeting for
improvements.
DATE :
NAME OF AUDITOR : NAME OF AUDITEE :
4.1 Are Criteria determined to ensure that the quality processes are effective?
7.5.4.1 If yes, how such tools / gauges are identified for tool ownership?
8.2.3 Are correction and corrective actions taken in case the Criteria are not met?
Are such action plans reviewed and approved with customer when
8.2.3.1
required?
Who is authorized to stop production till the quality problems are not
5.5.1.1
resolved?
How many working shifts are there and are all shifts have been staffed
5.5.1.1 with responsibilities for ensuring product quality? Any notification for
same.
4.1 Are all the inputs available for monitoring and measurement of product?
Are approvals taken by the relevant authority or customer for the deviation
from the planned arrangements?
How the feed back on layout inspections is utilized for correcting the
8.2.4.1
problems?
Are the instruments / Gauges / Test Soft Wares used for testing /
7.6
verification in quality calibrated or verified?
Is MSA carried out for such instruments which are referred in Control
7.6
Plans?
6.2 Is the competence defined for the personnel performing quality process?
8.5.2.1 Is there customer prescribed format and if yes, are the same utilized?
Are the actions also taken to prevent the occurrence of such non-
8.5.2.4
conformances?
What are the inputs communicated to various departments and how they
5.5.3
are communicated?