SASG_N31-01A_E_form
SASG_N31-01A_E_form
SASG_N31-01A_E_form
Issue No.:
FY20XX Manufacturing Process Audit Plan Date:
A. Periodic Process Audit Prepared by (Dept).:
Check Column*
* Schemed plan, changed plan and progress of audit schedule shall be reported to and approved by the Section Manager or higher position..
To:
Approved by
2. Date of Audit:
3. Processes to be audited:
5. Purpose of Audit:
7. Others:
Audit Result
Approved by Checked by
Hitachi Astemo, Ltd.
Control. No.:
Date:
Hitachi Astemo, Ltd.
Quality Assurance Division
Checked by Prepared by
Prepared by
(SASG)N31-01A: B-4
Form C
QA Process Audit Report
* Fill blank columns Report No.
Company Name,
Group Name
Audit Date Reported by
Attendants
2. Process Control
3. Supplier Control
4. Traceability Diagnosis
A
Comment
Process Control
pplier Control
2) Information Analysis 9.1.3 Analysis and evaluation Is the analyzing method concerning field claims standardized? (Characteristics of defect, claim, (1) Managed using pareto diagram, etc. There is no field claim; However method exist for the same
etc.) (2) System for recovering defective products is established.
3) Problem Analysis 10.2.3 Problem solving Is guideline for cause analysis concerning field claims and customer line claim standardized? (1) A guideline for cause analysis is in place and shared between groups. Procedure exist for Handling the Customer Line Claim
(2) The approaches are defined. Customer defined approach been considered
(3) Customer-defined approaches are carried out. Verification of the effectiveness been done
(4) Verification of the effectiveness
4) Recurrence Prevention 10.2 Nonconformity and corrective Is strategy that links analysis results of defective products with recurrence prevention (1) Recurrence prevention - 8D is implemented and a system for horizontal deployment to new products 8D approach is implemented & horizontal deployment also
action established? and other processes exists. (No occurrence of the same symptom) been done for the existing product/process as well new
(2) A list of past troubles has been created and utilized. product/process
(3) Risk analysis has been updated. Past trouble list is available
5) Progress Management of 10.2.6 Customer complaints and field Is progress management implemented regarding defect observations and investigation Progress control sheets have been created, follow up on timely response is implemented by quality Progress control sheets are available & been reviwed on timely
Individual Defect failure test analysis requests? Is follow up system for delays established? meeting, etc. to ensure no delay. basis via quality meeting
Specific Requirements 6)Specific Requirements from Customer 4.3.2 Customer-specific requirements Are customer specific requirements (quality manual provided by customer, etc.) controlled and Customer specific requirements have been updated to the latest, with a system in which personnel can
from Customer the environment is ready for its operation? access to the content as required.
Are customer specific requirements surely implemented? Quality activity before manufacturing or quality improvement activity after mass production, etc. are
implemented as requested by customer.
1 Change Control 1) Process Change 8.5.6 Control of changes Are procedures for changing process/plant (work flow, control standards, etc.) established and (1) Definition of process change is determined, standardized and operable. Also, standards are 1) Change control procedure is available and in the procedure
operated? documented. definition of changes is defined as well as Planed, Unplanned
(2) The documented approval request for mass production has been submitted and approved without and abnormal situation also defined in the procedure
omissions. 2)Process flow available mange the any change control , there
(3) Comparison of quality before and after change is implemented. (Including early stage variation control) is no chance of miss the documents submission and approval
(4) Evidence of risk analysis 3) Before and After change all comparison sheet available for
(5) The documented list of alternate process controls, including the primary and back-up methods. related to all quality parameter like Performance, fitment and
(6) Standard work instructions and traceability of alternate methods are maintained. appearance etc.
4) Before change of any process risk analysis done for impact
changes
5)List of alternate process control available including primary
and backup
6) Work standard is available for alternate process controls and
record also maintained for the same
In case of change made by stopping production line, are there standards for action planning at Preparations before change such as securing inventory to eliminate potential risk after change have been Inventory securing point available in change control procedure
the time of an anomaly, such as inventory shortage, quality defect, equipment failure? done. for eliminate the any risk during process change, record also
・Change schedule sheet containing stockpile, etc. available for secure the inventory before process change
2) Design Change 8.3.6 Design and development changes Are procedures for design (product) change (work flow, control standards, etc.) established and (1) Definition of design change is determined, standardized and operable. 1) Design control procedure is available and in the procedure
operated? (Is change request method to Design dept. appropriate?) definition of changes is defined , process flow also available for
(2) Required tests for quality characteristics are performed and verified. to flow the change request
(3) Comparison of quality between before and after change is implemented. 2) All required test that related to quality characteristics
(4) Documented information is available, including approval. performed and verified like performance, fitment and
appearance
3)Before and After change all comparison sheet available for
related to all quality parameter like Performance, fitment and
appearance etc.
4) Formats and check sheet available for control and mange
the change from Beginning to end including approval
3) 4M Change Point 8.5.6 Control of changes Is Change in 4M controlled? The system for detecting changes in 4M in daily manufacturing process is established.
2 Control of Purchased 4) Control of Receiving Process of 8.6.4 Verification and acceptance of Is the packaging determined through consultation with the supplier not to impair quality? The system for determining and periodically reconsidering packaging through consultation with the supplier
Parts Materials, Parts conformity of externally provided not to impair quality is established.
products and services
Are check items inspected according to the control plan in the receiving process with the (1) Check items set forth in the control plan are inspected and recorded. Indication of check results on
inspection record retained? accepted parts is made in the internal laboratory, etc.
Is the capability study available from the supplier that does not conduct inspection? (2) Statistical data provided by the supplier
8.7 Control of nonconforming outputs In case of non-conformity found in the inspection results (including suspicious parts), is the In case of non-conformity, the feedback is immediately provided to the supplier with the system established If any Non-Confirmity been found in parts been supplied
feedback provided to the supplier? to separate such products to not to use them. by the supplier, Information been given to the supplier
Segregation also been marked
Is the principle of first-in, first-out observed? The principle of first-in, first-out is standardized and operable.
Is the check record duly signed by checker and supervisor? Records of inspection are confirmed without omission and results of actions against irregularity is supported
by judgment of the supervisor.
In case of change in setup, is it confirmed if the setup is correctly performed? (1) When setup is changed, there is a system in place to verify if parts, jig, equipment conditions, etc. are
appropriate.
Also, the setup information is documented. (Comparison of of first piece produced to last piece produced,
results of setup, etc.)
(2) Critical processes in position accuracy such as welding process provides preventive devices of
dislocation for equipment or work. <Technology Transfer of past critical defects: See (QA Div.) 2011-No.
0501>
6) Equipment Criteria Control 8.5.1 Control of production and service Is the equipment criteria control carried out based on the control plan? The control plan is placed on the side of an operator and process condition (parameters for equipment
provision criteria) is checked and recorded according to the Control Plan.
4 Control Plan, Work 7) Control Plan 8.5.1.1 Control plan The latest adopted drawing and control plan and/or work instructions are consistent? (1) The control plan in use is prepared based on the latest drawing and any modification due to corrective
Instructions actions (lessons learned) has been recorded in history.
(2) Control plan and work instructions are consistent.
Does the control plan thoroughly include all processes from receiving materials to the finished The numbers of process flow charts and control plan are consistent and actual work in each process is
product? aligned. It covers complete processes from receiving to shipment. (including rework process, etc.)
Does the control plan thoroughly describe the requirements of customers (or equivalent)? The customers' signs of specific characteristics, etc. are described without omission.
10.2.4 Error-proofing Does the control plan describe the process setting of the error-proofing device? Is the definition The system to set error-proofing for securing quality is provided based on P-FMEA, QFD, etc. and the
of error-proofing device setting standardized? control plan reflects control items from P-FMEA.
Is there a documented procedure that describes the use of error-proofing methodologies?
8) Work Instructions 8.5.1.2 Standardised work - operator Do the work instructions describe important points for securing quality? (1) The sensory inspection provides contrivance to minimize judgement variations between inspectors.
instructions and visual standards (boundary samples, regular evaluation of judgement results, etc.)
Are the work instructions understood by the personnel who need them? (language) (2) Work Instructions are always displayed at the workplace and visible to operators, and they are
Do the work instructions include rules for safety? understood by the operators.
9.1.1.1 Monitoring and measurement of Do operators perform work as instructed in work instructions? (1) Operators perform according to work instructions (Procedure, tact, etc.)
manufacturing processes (Confirm by work instructions) (2) The supervisor observes operation once a month.
5 Utilization of Statistical 9) Utilization of Statistical Method 9.1.1.2 Identification of statistical tools Is the system to control process capacity and daily quality by using SPC sheet in place? (1) Items to perform SPC are defined and necessary items are performed.
Method (2) Irregularities are defined in the SPC sheet and utilized for prevention of issues, including reaction plans.
(3) Operators are instructed about the control purpose of SPC sheet, usage of control drawings and
methods, and the operators understand them well.
6 Education, Training 10) Education of Operators 7.2.2 Competence - on-the-job training Do the standards of the education and training of operators (procedures) document items of (1) Education and training are given as planned and skill levels are evaluated and recorded.
[Operation based on Work Instructions, Handling of Con-conformity, Handling of Measuring (2) There are standards to evaluate the skills of newly assigned operators before being engaged in the
Equipment, Matters to be followed in Control Plan, Record of Education, Handling of regular operation.
Irregularity, Laws and Regulations] and are operated? (3) Product quality is confirmed when a newly assigned or assisting operator starts operation.
Are operators aware of the implications of not conforming with the quality management system (4) Retraining is implemented and to an operator who has a break from the work and is recorded.
requirements?
Is the system in which only qualified operators perform work in the line for which qualification is The system is in place to qualify operators concerning special characteristics or special process, internal
required established? auditors, internal calibrators, etc.
Are operators informed about the consequences of nonconformity?
8.6.6 Acceptance criteria Are judgement criteria clarified by numerical values, boundary samples, etc.? Are they properly Boundary samples are stored and maintained to not to loose the judgement. Example: No dust on the
stored? appearance samples or they are in a dust free environment.
8.5.1.3 Verification of job set-ups Is the system for recording data of the first product before operation start and at the time of Inspection standards are provided and quality results are recorded at an appropriate frequency.
setup in place? Records are confirmed by the signature of a supervisor.
9.1.1.1 Monitoring and measurement of Are the inspection standards provided for measuring instruments (equipment) and are results (1) Inspection standards are provided and inspection records are retained for a defined period.
manufacturing processes recorded? (2) Standards of actions for no pass in the inspection at the start of operation are in place, as well as a
system to evaluate the effectiveness of judgement results in the past.
7.1.4 Environment for the operation of Is the inspection area in an appropriate condition for inspection (luminosity, noise, space, etc.)? The environment of an inspection area is considered so that it will not affect judgement.
processes Example: Rules of background noise at noise measuring area / Temperature control of products whose
characteristics are largely affected by temperature / Luminosity of appearance inspection area / State of
cleanliness and repair
12) Control of Shipment Process 8.5.2 Identification and traceability Do stored/delivered products clearly indicate certification of inspection and pass? (1) Products that passed the inspection are identified. The certificate is at a visible location and designed
(Shipment packaging) Are traceability plans well-organized for each product? not to be extinguished.
(2) Stock area of products less than unit quantity is specified and mixture is prevented by the indication of a
product type. The system for first-in, first-out is also implemented.
(3) The system to prevent mixture with wrong products is in place. (Ex: A container molded in the shape of
a product)
(4) Traceability plans are well-organized to define internal, customer, and regulatory traceability
requirements for each product.
8.5.4.1 Preservation - supplemental Is the shipped packaging (including temporary one) verified, standardized and operated to not (1) Packaging is agreed with customers in the form of packing specifications.
to impair the quality? (2) Packaging is designed so as not to be contaminated and their stock area is maintained with 5S(Sort,
Set in order, Shine, Standardize, Sustain).
8 Handling, Storing, 13) Storing (Warehouse, Depository) 8.5.4 Preservation Is storing location defined and followed (in warehouse or intermediate depository)? (1) Products are stored at the specified place and controlled within set height of piling.
Packing (2) Products are stored at the storing area taking account of an environment so that their quality is not
harmed.
8.5.4 Preservation Does the layout allow first-in, first-out? (1) Standards of First-in, First-out are available and well operated.
7.1.4.1 Environment for the operation of (2) It is controlled by product lot and when they are used is tracked.
processes - supplemental (3) The system enabling first-in and first-out is in place for receiving/delivery process
(roller conveyer, etc.)
8.5.4 Preservation Is the system to protect intermediate inventory from damage in place and operated? (1) Products are protected from any damage such as contamination with 5S, etc.
(2) Packing is designed to not to sustain damages from vibration during transportation.
Is the system to prevent wrong products from mingling provided? No similar products are stocked in the vicinity. No products drop out by vibration during transportation.
9 Control of Test, 14) Calibration of Instruments 7.1.5.2.1 Calibration/verification records Are periodical inspection and calibration carried out as planned pursuant to standards? (1) Annual plans are scheduled based on the standards for equipment inspection and progressing as
Measurement & Test scheduled.
Equipment (2) The effective term of calibration is indicated on equipment.
(3) There is a documented process for calibration/verification records.
8.5.1.6 Management of production tooling Is inspection or exchange of jigs, tools and blades of equipment carried out based on standards (1) Procedures and schedule for inspection or exchange of jigs and tools are provided, implemented and
and manufacturing, test, (procedures) and recorded? recorded.
inspection tooling and equipment (2) The system for recording quality results after exchange is in place.
(3) Identification number of customer-owned tools and ownership information
7.1.5.2.1 Calibration/verification records Is the periodical calibration of gauge and measuring instruments carried out as planned? (1) Annual plan is scheduled based on the measuring Instruments Inspection Standards and is progressing Calibration of all measuring & monitoring instruments
Has all external calibration been completed by the laboratory that is accredited to ISO 17025? as scheduled. been done as per plan from the external agency
Does the certificate of calibration include the accreditation mark? (2) The effective term of calibration is indicated on applicable equipment. accrediated from NABL
(3) Procedures for validity assessment of past measured results are clarified when calibration is not
acceptable. Calibration certificate are having the accreditation mark
(4) The laboratory is accredited to ISO 17025 with the ILC mark.
7.1.5.2.1 Calibration/verification records Is there a three tools set of calibration records for measuring instruments (measuring The three tools set of measuring instruments for newly procured/renewed instruments is provided.
equipment, standard equipment)? (Traceability Chart, Calibration Certificate, Inspection Result Sheet) Instruments History Card, Calibration certificate &
Inspection Results are available
7.1.5.3.1 Internal laboratory Are all tests and calibration included in the documented laboratory scope? There is a document that defines the laboratory scope.
Is the system to qualify internal calibration personnel through education provided? Calibration personnel is knowledgeable equal to or better than such as Grade 2 of Machine Inspection
national trade certification (acceptable by the rules of internal education), continuously educated and Calibration Lab sope is available
qualified.
7.1.5.2.1 Calibration/verification records Are measuring instruments used on a daily basis inspected and recorded as an assurance? Standards for daily inspection are provided and results of inspection are recorded.
15) Assurance of Process 7.1.5 Monitoring and measuring Are measuring instruments, jigs and tools used in process maintained in the conditions where Their storage location is set and maintained so that no dust or dirt affects their accuracy.
resources accuracy is not affected?
Are inside and outside of processes to be daily cleaned? (Non-operating area) (1) Implementation guidelines for 5S are provided and cleaning is carried out at the specified frequency on
a daily basis.
(2) No dropping (part) is on the floor.
17) Warranty Level Concerning 8.5.4 Preservation How are products in-process controlled? (1) There is a mechanism that indicates the status of work in process and prevents them from skipping a
Contamination process.
(2) They are controlled by protection cover so as not to be affected from contamination, etc.
Aren't products affected by dust, dirt or powered metal on the line or on the floor? (within (1) Contamination Control rules are provided and cleaned at the frequency specified on a daily basis.
operation area) (2) No dropping (part) is on the floor.
11 Control of Non- 18) Standards of Non-conformity Control 8.7 Control of nonconforming outputs Is the system to handle non-conforming products according to standards of non-conforming Standards of non-conformity control are provided and non-conforming products are controlled based
conformance products in place? thereon (Operators are instructed through training and aware of the method.)
19) Deposition and Reuse of Non- 8.7.1.7 Nonconforming product disposition Is disposition of non-conforming products standardized so that they are rendered unusable? Defective or scrap parts are defined and are decided to be handled based on non-conforming level.
conforming Products The procedure is established to render non-conforming products unusable.
8.7.1.4 Control of reworked product Are the rework instructions easy to understand for operators to read at their workplace and to The rework instructions provides explanation so that causes are identified through FTA, etc., and rework
make use of them? can be done for the causes. The work area is maintained and can be used right away. (Identification of
Is rework described in the control plan? Has its risk assessment been completed? reworked products from finished products, etc.)
Rework is described in the control plan and PFMEA, or other risk analysis.
8.7.1.4 Control of reworked product Is the system to assure repaired or reworked products in place? (1) The process for repaired or rework products to be load in is specified. Any product excluded by error-
8.7.1.5 Control of repaired product proofing or inspection process is loaded in a process that can be reconfirmed. (reconfirmation on areas
other than those reworked to check overlooked area, etc.)
(2) Rework instructions indicate reinspection guidelines and they are followed.
20) Prevention of Mixture of Non- How is prevention of contamination of non-conforming products standardized? (1) Non-conforming products are placed at the stock area (or container) of non-conforming products and
Conforming Products separated so that they will not be used.
(2) The system where non-conforming products are controlled in quantity with traceability in place.
(3) There is a rule that non-conforming products shall be identified.
12 Handling of Irregularity 21) Handling of Irregularity 8.7.1.3 Control of suspect product Is irregularity of a product defined and are corrective actions carried out upon occurrence and (1) The definition of irregularity of a product (product being suspected whether acceptable or non-
recorded? conforming) is specified and corrective actions upon occurrence is standardized and operated.
Is handling of dropped products or trial shot products determined and controlled? (1) Any dropped product is immediately picked up and disposed as a waste or scrap.
(2) Trial shot product is put into a separate container as a system so that it will not be mixed with
acceptable products.
How is the prevention of dropping of products approached? A system is in place in which, by perceiving the dropping as an irregularity, the cause of an occurrence is
identified and countermeasure is taken.
8.5.2 Identification and traceability How are the product warranted upon occurrence of irregularity? (1) When irregularity is found, conformity of quality of products produced before perception is verified
through immediate retrospective confirmation.
(2) When irregularity is perceived but its coverage cannot be identified or irregular products may have flown
out, there are standards for quick communication to the customer.
13 Special Characteristics 22) Special Characteristics 8.2.3.1.2 Customer-designated special Is the ID mark for special characteristics flawlessly mentioned or indicated in the control plan, The special characteristics shall be identified in the control plan, FMEA, work instructions and equipment
*
8.3.3.3 characteristics FMEA, work instructions and equipment pursuant to drawings? and is clearly indicated.
Special characteristics
Is there a hardware system in place to warrant the value of special characteristics and is it (1) The error-proofing device with interlock function precludes operations unless non-conformity is
verified? (Error-proofing, etc.) accurately eliminated and corrective measures are taken.
(2) The standards for the warranty of special characteristics are created with warranty level determined
based on their evaluation and controlled.
Is it evaluated that the variations are not only within controlled boundary but also stable to (1) The standards of items to be controlled using SPC sheet, etc. are created and activities to prove the
maintain process capacity using control drawing, etc.? stability of process capacity are implemented.
(2) The process capability index is controlled to immediately find out if Cpk≧1.33 is secured.
Are the standards for actions at occurrence of non-conforming product itemized? (1) The standards for handling non-conformity are provided and operators are fully aware of them.
(2) The system is in place in which occurrence of non-conformity is surely recorded and operated.
Are all requesting forms kept and retained? (1) The records whereby the forms of customer requirements and quality certificate can be retrospectively
Is there a documented symbol conversion table available that describes the customer's and the proved are available and controlled.
organization's special characteristics? (2) The retention term is mentioned in the standards so any documents are retained for the required time by
the customer or by the internal rules.
(3) If required,the symbol conversion table is available for all customer-specified special characteristics.
Can the rework product be distinguished in the form of a final product and is it recorded? The description of the identification, the portion and the lot information of reworked products are recorded in
detail.
* Special Does indication of serial number, etc. conform to requirements? Indications mentioned in drawings, etc. are clear and easy to read, evaluated on a daily basis and
Characteristics include recorded. Indications are avaliable on Drawings, It can be easily
vital critical readable
characteristics.
Are lot numbers, mold numbers, dates of manufacture, inspection and shipment and quantity They are controlled based on the "individual request" from customer or the internal "lot management." Lot Number, Mold Number, Date of Production, Date of
recorded? Inspection, Shipment detail been recorded
Is the lot number defined and controlled? The standards for lot control and operation standards are available and operated. Lot Number been defined & controlled
Lot Number contains the complete information as Machine
Number, Mold Number, Date of Manufacturing & Shift etc
15 Continuous 24) Workplace Improvement 10.3 Continual improvement What initiative is implemented as daily improvement activities for quality enhancement? There are daily meetings held between not only concerned departments but also held cross-functionally. Daily Morning Meeting been done among with all concern
Improvement Effective improvement has been progressing day by day and target has been attained. person
Target for the individual been marked & also been reviwed
by the Management
25) Attainment of Reduction Target for What initiative is implemented and have process failures been reduced? ・Contents of failures have been statistically analyzed and activities are properly prioritized and
Process Failure implemented with no temporizing.
・Hardware measures (design change, error-proofing, etc.) against process failure have been taken and
activities for preventing recurrence are taking place.
10.2.3 Problem solving Are non-conforming products in process analyzed according to the procedures? (1) There are means to identify the cause of non-conforming products before rework and procedures to
9.1.3 Analysis and evaluation eliminate the root cause are available.
(2) The countermeasure is applied to similar processes.
(3) The countermeasure is evaluated for the continuing effectiveness.
16 Special Process 26) Special Process 8.3.5.2 Manufacturing process design (1) Do definitions for special processes cover relevant processes without fault? (1) Processes of heat treatment, plating, coating, welding and soldering are defined as special processes
output (2) Is the ID mark of special process mentioned or indicated in the and requirements are managed.
control plan, work instructions, inspection scheme sheet and (2) Indication of special process is easy to read in the control plan, work instructions, equipment and
8.5.1 Control of production and service equipment without fault? processes.
provision
Have equipment, operation conditions, procedures and methods been approved? (1) The process design sheet is created and operation conditions and jig and tool control are clarified.
(2) The process review between departments concerned (Design, Manufacturing, QA,
Production Engineering and Purchasing) has been held by the Manufacturing Div.
Are special processes evaluated that the variations are not only within controlled boundary but (1) The standards of items to be controlled using SPC sheet, etc. are created and activities to prove the
also stable to maintain process capacity using control drawing, etc.? stability of process capacity are implemented.
(2) For the special processes, the process capability index is controlled to immediately find out if Cpk≧1.33
is secured.
Are the standards for actions at occurrence of non-conforming product in a special process (1) The standards for handling non-conformity in special processes are provided and operators are fully
itemized? aware of them.
(2) The system is in place in which occurrence of non-conformity in special processes is surely recorded
and operated.
Are all requesting forms for controlled parts of special processes kept and retained? (1) The records whereby the forms of customer requirements and quality certificate can be retrospectively
proved are available and controlled.
(2) The retention term is mentioned in the standards so any documents are retained for the required time by
the customer or by the internal rules.
7.2.2 Competence - on-the-job training Is training given to operators to be engaged in operation of special processes and is Learning records and qualification system are available with updating education annually given and
qualification given to them and is such training recorded? recorded.
3. Supplier Control
1 1) Awarding Suppliers 1) Creation of Standards 8.4.1.2 Supplier selection process Are the standards for awarding and assessing new suppliers provided? Suppliers' financial status, quality system and quality control capacity have been assessed. Supplier selection procedure available and same has been
and Management followed for supplier selection and in the Supplier selection
Method procedure mention all point for confirmation like financial
status, quality system and quality control capacity etc.
Are the Quality Assurance Standards (including control plan, process change, first product Quality assurance agreements are concluded with suppliers based on customer requirements. Quality assurance agreements been signed off with supplier
control, non-conforming control, etc.) furnished to suppliers? Are contracts concluded with during new supplier selection and in the starting of every
them? financial year
2 2) Auditing and 2) Quality Performance 8.4.2.4 Supplier monitoring Has quality performance of suppliers been assessed? Are improvement activities carried out? Quality performance is annually and monthly controlled and suppliers are directed by setting the control Monthly supplier rating is available and supplier meet done
Directing Plans of level. (Instructions for strengthening quality control to the worst supplier, etc.) every month with top worst supplier
Suppliers
3) Directing Plan 8.4.2.4.1 Second-party audits Are the standards for auditing and directing plans provided and operated? The audit standards are provided and assistance to quality improvement of suppliers is annually carried out Supplier audit plan available for supplier audit based on
Are auditors qualified according to customer requirements? and improvement has been achieved. supplier PPM like worst supplier audit done once in 6 month
and other supplier audit done once in year
3 3) Information 4) Change Control 8.5.6 Control of changes How is information of changes in suppliers acquired? Is there any system in place for acquiring (1) The provision of change control in the contracts with suppliers is available so that information on any 1) Change control agreement available with supplier also
Management of information? change shall be communicated. Monthly 4M change summary received from every supplier for
Changes by Suppliers (2) Quality records of changed products (reliability tests, dimensions, etc.) has been submitted and manage and control if change the happened at supplier end
proposed change is made after approval. 2)All Quality characteristic related record received from
supplier if change done in product and process.
1 Traceability Diagnosis 8.5.2 Identification and traceability Test whether or not retroactive sorting of the lot of a subject part can be achieved within (1) The lot can be identified within 2 hours. Complete Traceability System is in place
defined time. (Selected part at audit) (2) Quantity including production or shipment volume can be identified. It can be Identified from Raw Material to Dispatch with
Number of Qty within defined Time
1 Verification of Characteristics Required for Product 8.6.2 Layout inspection and functional Verify characteristics and functions based on drawings and inspection standards. Smaller deviation in measurement results in comparison with daily data. Inspection Standards been made as considering all
testing Critical Characteristics marked in Drawing as well other
requirement asked by Customer
Inspection been done as frequency specified into
Inspection Standard & record for the same been kept
Are product audit and inspection on layout periodically carried out? Plans are created with the applicable types of products and the date of implementation. Product Audit & Layout Plan is available
It been carried out as per plan
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Material Delivery
Component Part Machining Date (Lot) Assembly Date (Lot)
Date (Lot)
5) Quality Record:
Sc
[Notes]
(1) Critical safety characteristics and important characteristics must be sortable for component parts.
(2) Confirm a documentation in which 4M-Changes or in-process non-conformities
is clearly understandable. (such as daily records etc. )
(3) Assumption of non-conformity and subject lot shall be prepared before the audit date.
(The lot card or delivery card from product delivered to the plant may be brought on the day.)
(4) 5 points shall be allocated for traceability diagnosis.
[Guide for Scoring] 5: Product lots including component parts can be identified. (Target sorting time: within 2 hours)
4: Product lots including component parts can be identified. (Little more than 2 hours)
3: Product lots except for component parts can be identified. (Little more than 2 hours)
2: Product lots are not fully identified. (Largely exceeding 2 hours)
1: Product lots cannot be identified or can be hardly identified.
Parts Number:
Score
(SASG)N31-01A: E-2
Form F
Product Inspection Check Sheet
Parts Name
Reduction Items for * The number of items that ・No instruction or manual for measurement
correspond to the items listed in ・No expiration date for the use of measuring instruments.
Product Inspection right column shall be reduced ・No check on measuring instruments is carried out at the start of operation.
from the score ・Repeat accuracy of measuring equipment is not stable.
* The number of items that
correspond to the items listed in
right column shall be reduced
from the score
・Setting of parts and handling of measuring instruments are problematic.
・The measuring unit of 1/10 is not used in the measuring instruments.
2 Points Score
Some of the verified characteristics
Points x 1
required for product are out of the
tolerance.
※1 The cause investigation shall use 5-Why analysis, etc. ※2 Direct actions and recurrence prevention shall be mentioned.
Due Responsibility Confirmation Results of Confirmed
No. Category Item Observations / Requests Cause※1 Corrective Action※2 Date
Date Corrective Action
(2) Obtain approval of the check results from the Section Manager or equivalent or higher position of Quality Assurance Group by 3 working days prior to the audit.
* For problem countermeasure audit, if it is difficult to adjust production of the target products due to the batch production (heat treatment, service
parts, etc.) despite an urgent matter, the similar product may be put in production instead. In this case, at that time, determine the necessity of
whether to witness the next production of the target products for confirmation.
(e) Have auditors been suitably selected according to the audit purpose? (2) Process control related:
* Production engineering experts, QMS experts, and other experts Various forms at shop floor, various check sheets, FP control, product handling, etc.
(f) Has the audited group been informed of the specific audit purpose and been requested to make the necessary preparations?
(g) Have attendees from the audited group been suitably selected according to the audit purpose? Or, have they been requested to attend the audit?
[Supplementary explanation of check items, etc.] (e.g., State a view on items without a tick.)
B: QA process audit
(a) Has the applicable manufacturing method been investigated in the same manner as stated in "A: Periodic process audit"?
(b) With respect to the histories of change points/4M change points in the past, has the audited group been requested to check if change applications
and change records exist?
(2) Obtain approval of the check results from the Section Manager or equivalent or higher position of the auditing group by 3 working days prior to the audit.
(e) Have auditors been suitably selected according to the audit purpose?
* Production engineering experts, QMS experts, and other experts
(f) Has the supplier been informed of the specific audit purpose and been requested to make the necessary preparations?
(g) Have attendees from the supplier been suitably selected according to the audit purpose? Or, have they been requested to attend the audit? (2) Process control related:
Various forms at shop floor, various check sheets, FP control, product handling, etc.
(h) Has the audit check sheet to be used been prepared?
The content and purpose of each check item on the check sheet shall be able to be explained to the supplier.
(i) Have control plans and other forms suitable for the audit purpose been checked in advance?
(j) Have the following items been checked: KAKOTORA (lessons learned), previous audit reports, past corrective action reports for defects, and process
change application records?
(k) Have processes been compared with those of another supplier who has the actual production experience, and has the equivalence of process control and
quality assurance been verified? (3) Others (Not stated above)
(l) Has the supplier's company profile been checked, such as capital, international QMS certification, and machining equipment / inspection equipment they
own?
[Supplementary explanation of check items, etc.] (e.g., State a view on items without a tick.)
(2) Have specific audit check items been decided and shared by audit members? 3. Details of audit members
A: Periodic process audit ○: Yes, ×: No
Has the applicable manufacturing method been investigated in terms of critical control points; impact of the preceding process; quality variations; other Knowledge of
technical features; and inspection methods? Qualification of No. of supplier audits No. of internal audits for
Department Working title Name applicable mfg.
internal auditor for the past 3 years the past 1 year
* Tick a box(es) in the "Applicable manufacturing method" column. method
If an investigation has been made on the technical feature, tick a box(es) in the "Investigation" column.
Investi- Investi- Investi- Investi-
Applicable manufacturing method Applicable manufacturing method Applicable manufacturing method Applicable manufacturing method
gation gation gation gation
(b) Has the supplier been requested to evaluate change points and 4M change points in advance that are particularly critical for process control? (such
as instructions specified in internal rules; status of compliance to internal rules; existence (or not) of change applications submitted to (Astemo)Gr.;
existence (or not) of change records; and designation/cancellation of initial control of variation)