6 Quality Control
6 Quality Control
6 Quality Control
5. About ISO9000S..........................................................................................................................17
(1) What are ISO9000S?.............................................................................................................17
(2) Outline of ISO9000S.............................................................................................................17
(3) 20 items of requirements of ISO9000S..................................................................................17
(4) How to obtain ISO9000S Certification..................................................................................17
(5) Merits of Obtaining ISO9000S Certification.........................................................................18
(6) Current Situations in the Automobile Industry......................................................................18
(7) Response to ISO9000S..........................................................................................................19
1. Fundamentals of Quality Control
(1) Definitions of Quality Assurance and Quality Control
A. What is Quality Assurance (QA)?
Quality assurance means engaging for quality of the products that consumers can buy with a
sense of safety and with a feeling of satisfaction and can use for a long period of time with
the same feelings. In other words, quality assurance is to supply products which quality
satisfies consumers.
Sense of safety: Our products shall not cause consumers to worry about safety.
(Consumers can buy them with high reliability.)
Feeling of satisfaction: Our products shall provide sufficient performance and functions
being up to consumers' expectations.
Long-term use: Our products shall ensure sufficient durability and trouble-free operations
and shall be backed up by satisfactory levels of after-sale service.
Means Means
Objective Quality Assurance
Means Means
(Quality Control)
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(2) Historical Development of Quality Assurance
① Age of no need to think about quality assurance
(Focusing on the consumers who were ready to buy what we produced)
② Age of emphasis on inspections
(Defective products were simply repaired or replaced after they were found.)
③ Age of “in-process quality assurance” concept
(For product quality assurance, the “product-out” concept changed to “market-in” concept.)
④ Age of total quality control (TQC)
(It has become difficult to completely eliminate defects, no matter how effectively processes
are controlled, if new product development is made without carefully considering reliability
and durability. … Source Control)
* The above-mentioned qualities of design, conformance and service are the determining factors for
consumers to choose our products in terms of quality.
Good quality products are the products showing satisfactory levels of those three kinds of quality.
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(4) What is Control?
”Control” means a chain of group activities cycling from plan to action in order to rationally
and efficiently achieve a certain goal.
For efficient control, the following four steps shall be followed to achieve the company’s
goal.
①P: Plan ②D: Do ③C: Check ④A: Action
The circle shown below, which is called Deming's circle or management cycle, indicates how
to proceed with the four steps.
Action Plan
Check Do
(5) Standardization
“In-process quality assurance” means building the quality into the product in each process by
establishing and standardizing a system to control “5M” factors, which are basic factors of each
process to produce good products. This system is the basics of good product manufacturing.
What is 5M?
① Man
② Machine
③ Method
④ Material
⑤ Measurement
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(6) Operation Standard
Operation Standard shall be prepared to enable safe and efficient production, while reducing
quality-related problems caused by variations in quality due to difference in worker’s skill. It
also allows supervisors to effectively control and improve his process. Therefore, it is the
first step toward “zero defects.”
Purposes of Operation Standard
① Determining proper procedures for operations.
② Standardizing operation methods to enable every worker to perform operations in the
same way.
③ Making clear division of work.
④ Enabling new workers to learn proper operations as early as possible.
⑤ Ensuring safe operations.
⑥ Identifying levels of importance of individual operations and fostering quality awareness
among workers.
⑦ Making clear control points and performing periodic check to prevent outflow of defects.
Important Points on Preparing Operation Standard
① Make clear the instructions. (Concrete descriptions)
② Identify acceptable value. (Identification of control range)
③ Specify volume that can be directly controlled.
④ Describe points and knacks of operations.
⑤ Identify frequency of check and points to be checked.
⑥ Use easy-to-understand expressions.
Important Points for Supervisors
① Provide education and job training to new workers and helpers (from other sections) until
they fully understand the operation standard. (Education)
② Go around the site to check if operations are properly performed in accordance with the
standard.
③ If the standard is not followed, investigate the cause and, revise the standard to allow
every worker to follow it without difficulty.
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automatic transmission; failure in oil supply to engine … It shall be issued when even
single defect is found concerning these items.
② Other items … It shall be issued when the same defect is found in three or more pieces in
a one-day lot produced according to the production plan.
<Points on cause investigation>
① Sufficiently analyze the situation where the defect occurred.
② Don't be judgmental on a certain cause.
③ Do not make a decision only based on experience.
④ Consider the relation between the cause and 5M factors of the process.
⑤ Consider the reason for outflow of the defect.
<Points on defect prevention>
① Take preventive action concerning the potential or possible causes found during cause
investigation.
② Standardize the preventive measures that have been taken.
③ Take follow-up action to check the effect of the preventive measure.
④ Implement cross development of the preventive measures (to similar processes,
equipment and parts).
⑤ Consider whether it is possible to introduce “fool proof device.”
Chronic Defect Reduction Activity
① Avoid concentrating on one point.: Take necessary measures against all potential factors.
② Review all factors.: Grasp all factors that may cause the defect.
③ Recognize defects.: Quantify the bound and detect the sign of each defect.
④ Grasp equipment’s quality characteristics.: Make clear the relation between equipment
and quality characteristics.
⑤ Grasp the changing status of factors to be controlled.: Analyze the changes in
chronological order and make clear the action limit that requires some measures.
In-Process Defect (Handling in each section)
Defects that occur in each section due to the section’s fault shall be reduced as follows.
① Identify the procedures for handling the defect in each section.
Route of communication Ledger sheets to be used
Procedure for taking corrective and preventive measures (record)
② Make clear how to dispose of defective products
Identification Defective products box Procedure for returning defective products
Procedure for scrapping defective products
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2. Concept of Statistical Quality Control
(1) Quality Control and Data
For effective process control, it is necessary to indicate objective facts that everybody can
acknowledge, such as the data on the status of process and product quality, instead of abstract
concept or experience. (Fact-based control)
In daily operations, various kinds of data are collected, sometimes purpose is unclear. We
need to clarify the purpose of collecting data. In general, data are collected for the following
purposes.
①Current situation check, ②Process investigation, ③Process control,
④Inspection, ⑤Process analysis and improvement
Techniques and tools used for effective data analysis are called statistical techniques (or QC
techniques), and quality control performed with the use of such statistical techniques is called
statistical quality control (SQC).
(2) Seven Tools for QC techniques (For more details, refer to the attached sheet)
The following “Seven tools for QC” are used in QC techniques. They can be easily prepared and
used, allowing field workers to easily understand the current situation.
① Cause and effect diagram: Indicates the relation between quality and processes, with wisdom
of many people in charge of control and improvement.
② Pareto chart: Used to determine important control and improvement points and problems to
be solved.
③ Histogram: Indicates variations in data.
④ Check sheet: Simplifies data for ease of use.
⑤ Stratified data: Used to find which factors result in quality variation.
⑥ Scatter chart: Indicates the relation between two kinds of data.
⑦ Graph (control chart): Facilitates understanding of the communication through visualization
of numeric data.
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3. Recall System and Product Liability (PL)
(1) Recall System
① Japan
Recall
For the vehicles designated by regulations or notified by the manufacturer, which have a defective
structure, device or function that has caused or may cause an unsafe condition not conforming to
the vehicle safety standard (nonconforming state) due to failure in design or manufacturing, the
automobile manufacturer shall immediately report a recall to Minister of Transport.
Corrective Measures
For a certain range of vehicle models designated by regulations or notified by the manufacturer,
which has a problem (due to failure in design or manufacturing) with structure, device or
function that cannot be ignored in terms of safety assurance or pollution control although it is
not in a nonconforming state, the automobile manufacturer shall immediately notify the chief of
Road Transport Bureau, Ministry of Transport, of corrective measures.
Service Campaign
For a certain range of vehicle models designated by regulations or notified by the manufacturer,
which do not require a recall or corrective measures, but need notification to users about taking some
measures, the automobile manufacturer shall notify Vehicle and Component Approvals Division,
Engineering and Safety Department of Road Transport Bureau, Ministry of Transport, of the
measures to be taken.
② Other countries
U.S.A
<Safety related matters>
Vehicles that are deemed to have a defect affecting safety or not to conform to the safety
standard (FMVSS) by the automobile manufacturer or Secretary of the Transportation
shall be recalled.
<Emission related matters>
Recall is done in the case that a large number of vehicles or engines are deemed not to
meet the exhaust gas requirements.
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Canada
Vehicles that are deemed not to conform to the safety or exhaust standard due to a defect
in structure, design or function shall be recalled.
U.K.
Recall is done in the case where there is an evidence indicating that a certain registered
model has a defect affecting safety, and that the defect exists in a large number of the
same model vehicles that have already been sold.
Australia
Vehicles that are deemed to have a defect affecting the safety by the manufacturer shall be
recalled.
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etc.)
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4. Suzuki’s Quality Assurance System
Product Planning New product development plan/New product plan (Product Planning
Department)
Model review (Product Planning & Styling Design Departments)
New product schedule (Product Planning Department)
Prototype and finalized drawings (Design Department)
Trial Production Performance and function tests (Design and Experiment Departments)
Initial function and durability tests (Quality Assurance Department)
Trial development Quality improvement action (Quality Assurance Department)
Production Products check & check meetings (Quality Assurance Department)
Trial design Design change (Design Department)
production Initial parts inspections (Inspection Department)
Trial production Approval of process control standards and parts inspection standards
Trial (Inspection Department)
masptoduction
Process design and equipment arrangement (Manufacturing Engineering
Department)
Preparation of operation standard (Plant)
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5. About ISO9000S
(1) What is ISO9000S?
It is international standard established in March 1987 concerning quality control and quality
system, listing 20 items of quality-related requirements.
An organization to B
assess, register and
certify quality systems
in Japan C
Approval Certification
(Other
countries) A
Approval Certification
ISO9000S certificate is that being approved that our quality system is taken along with the
quality system requirements specified in ISO9000S by certification body (third party).
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(5) Merits of Obtaining ISO9000S Certification
① Establishment of quality assurance system through:
Development (standardization and registration) of in-company document control system
Identification of responsibility and authority
Improvement in quality consciousness and moral of workers
Better communications among in-company departments
Reduction of unnecessary documents
② Exemption from initial assessment required in WVTA (Unified European standard)
③ Enhanced customer confidence in quality
④ Increased global recognition (international passport)
⑤ Enhanced competitiveness
⑥ Sharing the world’s common rule
⑦ Satisfying requirements (from government authorities and customers)
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(7) Response to ISO9000S
(Foreman’s tasks related to ISO 9000S)
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Quality system
No. Foreman’s tasks related to ISO 9000S
requirements
1 Manager ① Make clear what to do in your section to achieve the department’s
responsibility and group’s annual goals set in accordance with the company’s
annual policy.
② Make your staff understand the annual goals.
③ Set your section’s criteria for evaluating results compared to the
annual goals.
④ Identify the person in charge of quality in your section.
2 Quality system ① Develop an appropriate quality plan (standard, manuals, etc).
② Make clear what to control in your section to achieve the required
quality.
③ Identify quality records to be retained in your section.
3 Contract review -----------------------------------------------
4 Design control -----------------------------------------------
5 Document control ① Make clear procedures and persons in charge of preparing,
approving, issuing and distributing documents (quality system-
related documents and data) in your section.
② Make clear the history of necessary documents (dates of issuance,
distribution, revision, abolishment, etc) in the ledger.
③ Make sure that the department manager’s signature is indicated on
each document issued.
④ Make sure that obsolete or unnecessary documents have been
removed from the section’s files, which shall be kept updated.
⑤ Make clear the procedure for revising documents.
6 Purchasing -----------------------------------------------
7 Customer-supplied -----------------------------------------------
product
8 Product identification Make sure that products are identified (during all stages from
and traceability acceptance to shipment), and that the procedures for identifying them
have been made clear.
9 Process control ① Make sure that critical processes which directly affect quality are
identified.
② Make sure that control methods for critical processes are made
clear.
③ Make sure that processes are carried out under controlled
conditions with the record retained.
④ Make sure that operation standard(latest version) has been prepared
and is available.
Quality system
No. Foreman’s tasks related to ISO 9000S
requirements
⑤ Make sure that workers who are required to have qualification have
been properly trained and qualified.
Those workers include operators, final inspectors, and stamping
workers.
⑥ Make clear how to control processes and equipment, which shall be
maintained under controlled conditions, with the record retained.
⑦ Make clear what to do when any trouble occurs.
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⑧ Make sure that boundary samples are determined in accordance
with Suzuki’s procedures.
⑨ Make sure that accuracy of manufacturing equipment is guaranteed.
10 Inspection and testing ① Make sure that the required inspections on purchased parts are
carried out according to the standards. (Initial parts inspections,
check inspections, data check, etc.)
② Make clear the purchase parts verification method.
③ Make clear the procedure for in-process check (SOS).
④ Make sure that proper check or inspection is performed at the right
time in each process. (e.g. initial product inspections, setup check,
automatic inspections, in-process inspections, sampling
inspections)
⑤ Make sure that identified control before and after inspections is
implemented.
⑥ Make sure that nonconforming parts are identified and properly
controlled.
⑦ Make clear how to check final products.
⑧ Make sure that person in charge confirms the final check.
⑨ Make sure that passed products at final inspections are ready to
shipment.
⑩ Make sure that the inspection records are retained.
⑪ Make clear the details on how to maintain and control the
inspection records (storage period, responsible section, approval
process, etc.)
11 Control of inspection, ① Make sure suitable measuring devices for inspections are used.
measuring and test ② Make sure that accuracy of inspection equipment (in-process
equipment inspection devices, measuring devices, gages, facilities, etc) is
obtained and ensured in accordance with Suzuki’s control
procedure.
③ Make sure that the accuracy of inspection equipment is recorded
and maintained.
④ Make sure that an inspection equipment calibration plan is made,
and that the calibration is performed according to the plan.
Quality system
No. Foreman’s tasks related to ISO 9000S
requirements
⑤ Make sure that inspection equipment, which is required to be
identified with a label indicating that its accuracy is ensured
according to Suzuki’s standard, is certainly identified.
⑥ Make clear how to perform daily check on inspection equipment.
⑦ Make clear what to do when any problem is found on inspection
equipment during daily check, and make sure that the records are
maintained.
⑧ Make clear how long the calibration record shall be retained.
⑨ Make sure that it is prohibited for other than qualified persons to
adjust the calibrated equipment.
⑩ Make sure that the calibration records are filed and neatly arranged.
12 Inspection and test Make sure that the inspection status is identified and controlled.
status (Before or after inspections, acceptable or unacceptable parts, etc)
13 Control of ① Make clear how to control nonconforming parts.
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nonconforming product ② Make sure that the records on nonconforming parts control are
maintained.
③ Make sure what to do with nonconforming parts (use, rework, or
scrap it) and identify the persons in charge.
④ Make sure that nonconforming parts are not used unintentionally.
⑤ Make clear a proper route of communication when any
nonconforming part is found.
⑥ Make clear how to recheck the reworked or repaired parts.
⑦ Make clear the procedure for accepting nonconforming parts by
concession, and make sure that the records are retained.
⑧ Make sure that the records of the rejected or scrapped
nonconforming parts are retained.
14 Corrective action ① Make clear the procedure for corrective action. (Information flow,
report, investigation, recurrence prevention, ledger sheet, etc.)
② Make sure that the records of corrective actions are retained.
③ Make sure that necessary corrective action is taken in your section
based on the quality information from other sections, with the
importance taken into account.
④ Make sure necessary preventive action is taken to prevent
recurrence of the same nonconformance.
⑤ Make sure that every corrective action is reported to the supervisor,
and the records are properly retained.
Quality system
No. Foreman’s tasks related to ISO 9000S
requirements
15 Handling, storage, ① Make clear procedures for handling, storage, and delivery of
packaging, and delivery products.
② Make clear how to prevent deterioration of products.
③ Make sure that periodic inspections are carried out on products in
stock (especially on the long-term stored products).
④ Make clear how to prevent deterioration of long-term stored
products.
⑤ Make clear how to protect the quality of products in stock that
passed final inspections.
16 Control of quality ① Make sure that quality records are properly made and maintained
records under proper conditions.
② Make clear procedures for filing the quality records.
③ Make clear storage periods of the quality records.
④ Make sure that the maintained quality records are searchable and
made available at any time.
⑤ Make clear how to dispose of quality records after the storage
period.
17 Internal quality audits -----------------------------------------------
18 Training and Education ① Make clear procedures for training workers in your section, and
make sure that the records are maintained.
② Make sure that workers who are required to have qualification have
been properly qualified, and that the records are maintained.
③ Make sure that records of training and education on individual
workers are maintained.
④ Make sure that necessary training and education to foster quality
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awareness is provided to workers in your section.
19 Servicing -----------------------------------------------
20 Statistical techniques ① If it is needed to use statistical techniques in your section, make
clear the scope of their applications.
② If some control chart (x-R control chart, etc) is used in your section,
make clear the control procedure with it.
③ If any statistical technique was used previously as a prevention of
defect, retain the records.
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