Beruflich Dokumente
Kultur Dokumente
QAM-2008
ISSUE DATE : July 24th, 2009
SECTION NO. : 0
REV. 1
QAM-2008
1st EDITION
(Making a copy of this manual or taking out of the company are prohibited without
management representatives permission.)
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 0.1
REV.1
0 Cover 1
0.1 Contents 2
1 Purpose and distribution 6
2 History of Revision 7
5 Management responsibility 19
Management commitment 19
Customer focus 19
Quality policy 20
Planning 22
Quality objectives 22
Quality management system planning 22
Responsibility, authority and communication 23
Responsibility and authority 23
Management representative 27
Internal communication 27
Management review 28
General 28
Review input 29
Review output 29
Page 3 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 0.1
REV.1
6 Resource management 30
Provision of resources 30
Human resources 31
General 31
Competence, awareness and training 31
Infrastructure 33
Work environment 34
7 Product realization 35
Planning of product realization 35
Customer-related processes 36
Determination of requirements related to the products 36
Review of requirements related to the products 36
Communication with customer 38
Design and development 39
Design and development planning 39
Design and development input 40
Design and development output 41
Design and development review 42
Design and development verification 43
Design and development validation 43
Control of design and development changes 44
Purchasing 45
Purchasing process 45
Purchasing information 46
Verification of purchasing products 47
Manufacturing and service 48
Control of manufacturing and service 48
Validation of processes for manufacturing and service 49
Identification and traceability 49
Property of customer 52
Page 4 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 0.1
REV.1
Storage of product 53
Control of monitoring and measuring devices 54
9 API-controls 64
Introduction 64
API-monogram control 64
API-manufacturing control 64
API-conformance control 65
Conformity of API products 65
API-acceptance status 65
API-segregation control 66
API-non-conformance control 66
Nonconformity review and disposition 67
Review analysis 67
API monogram issue 68
API monogram register 68
In-process inspection and testing 69
Page 5 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 0.1
REV.1
Acceptance status 69
Valve release 70
Inspection records 70
Rejection and segregation 70
Non-conformance 71
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 1
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 2
REV.1
2. History or Revision
1. Distribution
All quality assurance manuals to distribute to our inter-company should be
controlled copy. (But, the quality assurance manual for outside survey should
be controlled copy .)
As for the distribution to the outside of the company, it is limited to the person
whom management representative in charge permitted. In that case, the
indication ofnon-controlled copy on the cover is cleared , and the stamp of "
non-controlled copy " is stamped on all the pages.
A quality assurance division manager controls the text of the quality manual, and
a place of distribution of the control copy is shown in the following. And, the
quality manual prepared with electronic document which quality assurance
division controls can be read by our employees freely in our office so that they
can make use of it for the business.
Note) Controlled copy is the document that the latest edition is controlled for
every revision after the distribution, and non-controlled copy is a document
that is not controlled by latest revision.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 2
REV.1
2. History of Revision
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 3
REV.1
1. Company outline
2. Scope
(1) This quality assurance manual is applied to the quality assurance activities from
the design of the Ball Valves which are manufacturing by our own company to
the service.
(2) As for other valve products ( such as Gate, Globe , Check Valves and so on ),
well manufacture based on our customers specification, the drawing, and so on,
and control.
Page 10 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
4.2.1 General (2/4)
MANAGEMENT QUALITY PROCUREMENT/
WORKING ITEMS& ENGINEERING
USER PRESIDENT REPRESENTATIV ASSURANCE SALES DIV. MANUFACTURIN STANDARDS/ PROCEDURES DOCUMENTS
REQUIREMENTS DIV.
E DIV. G DIV.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
4.2.1 General (3/4)
DOMESTIC OVERSEAS
MANAGEMENT QUALITY
WORKING ITEMS& SALES/ ENGINEERING PROCUREMENT/
USER PRESIDENT REPRESENTATIV ASSURANCE STANDARDS/ PROCEDURES DOCUMENTS
REQUIREMENTS OVERSEAS DIV. MANUFACTURIN
E DIV.
SALES G DIV.
WORKING INSTRUCTION
WORKING INSTRUCTION STANDARD
MANUFACTURING OF DOCUMENT
MANUFACTURING WORKING SCHEDULE CONTROL
WORKING SCHEDULE CONTROL
PROTOTYPE STANDARD
7.5 MANUFACTURING AND CARD
QC PROCESS TABLE STANDARD
SERVICE QC PROCESS TABLE
IN-PROCESS INSPECTION
VALIDATION IN-PROCESS INSPECTION
STANDARD
RECORD
INSPECTION STANDARD
STANDARD FOR PREPARATION OF
QUALITY PLANNING DOCUMENT
PRODUCT/DELIVERY INSPECTION
INSPECTION STANDARD
SPECIAL APPOINTMENT
7.6 CONTROL OF ACCEPTANCE/DELIVERY
PRODUCT/DELIVERY PROCESSING STANDARD
MONITORING AND INSPECTION RESULT
PRODUCT IDENTIFICATION
INSPECTION SPECIAL APPOINTMENT
MEASURING DEVICES CONTROL STANDARD
APPLICATION FORM
8.2.4 MONITORING AND MEASURING DEVICES CONTROL
MEASURING DEVICES CONTROL
MEASUREMENT OF STANDARD
LEDGER
PRODUCT 8.3 MEASURING DEVICES
MEASURING DEVICES
PROOFREADING STANDARD
CONTROL OF NON- PROOFREADING RECORD
MEASURING DEVICES SELECTION
CONFORMING PRODUCT
STANDARD
ACCEPTANCE INSPECTION
PROCEDURE
MEASURING DEVICES PROCEDURE
FOR USE
CUSTOMER'S SAMPLING
SATISFACTION QUESTIONNAIRE STANDARD FOR MARKET
MARKET COMPLAINTS RECORD
8.2.1CUSTOMER'S COMPRAINTS TREATMENT
SATISFACTION
Page 14 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
4.2.1 General (4/4)
DOMESTIC OVERSEAS
MANAGEMENT QUALITY
WORKING ITEMS& SALES/ ENGINEERING PROCUREMENT/
USER PRESIDENT REPRESENTATIV ASSURANCE STANDARDS/ PROCEDURES DOCUMENTS
REQUIREMENTS OVERSEAS DIV. MANUFACTURIN
E DIV.
SALES G DIV.
QUALITY SYSTEM REVIEW
STANDARD
CORRECTIVEPREVENTIVE
CORRECTIVE/PREVENTIVE
ACTION RECORD OF QUALITY SYSTEM
CORRECTIVE ACTION / PREVENTIVE ACTION ACTION PROCEDURE
8.5.2 CORRECTIVE ACTION AUDIT REVIEW
CORRECTIVE ACTION
8.5.3 PREVENTIVE ACTION
PROCEDURE OF IN-PROCESS NON-
CONFORMING PRODUCT
CONTROL OF DOCUMENTS
STANDARD
QUALITY MANUAL STANDARD
STANDARD FOR PREPARATION OF
CONTROL OF DOCUMENTS QUALITY STANDARD QUALITY MANUAL ISSUANCE
4.2.2 QUALITY MANUAL QUALITY RECORD CONTROL RECORD
4.2.3 CONTROL OF CONTROL OF DOCUMENTS STANDARD QUALITY STANDARD ISSUANCE
DOCUMENTS CONTROL OF DOCUMENTS RECORD
PROCEDURE
PROCEDURE FOR CONTROL OF
DOCUMENTS,ISSUANCE AND
ABOLITION
TRAINING
6.2.2 TRAINING STANDARD
TRAINING TRAINING RECORD
COMPETENCE,AWARENESS TRAINING PROCEDURE
AND TRAINING
Page 15 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
4.2.3 Control of documents
1. Control of documents
Documents required by the quality management system shall be established and
controlled as follows.
(1) Primary documents : Prepared by Quality Assurance Division, surveyed by Quality
Assurance Committee and approved by President. Quality
Assurance Division controls the documents.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 4.2
REV.1
The documented procedure shall identify the functions responsible for the collection
and maintenance of records.
Records required by applicable industry product standards shall be retained for not
less than the period of time specified by the industry standard or five years,
whichever is longer. Records required to provide evidence of conformity to
requirements and of the effective operation of the quality management system shall
be retained for a minimum of five years.
Page 19 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.1-5.2
REV.1
5. Management responsibility
5.1 Management commitment
President executes following actions surely and provide the documents to show the
commitment of implementation of quality management system.
1. To inform importance of satisfying requirements of laws, rules and customer to
the organization and specifies this requirements in the Quality policy.
2. Establishing the Quality policy
3. Ensuring that Quality objectives are established
4. Conducting management review
5. Ensuring the availability of resources (such as personnel, facility and
equipment) to effect quality management system.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.3
REV.1
Basic policy of KVCs quality assurance is to manufacture the products with best
quality and fully assure their quality.
Though it is a principle to follow the mind of the reliable management, we set our basic
management policy to offer products with good quality and service efficiently, respond
our customers, and gain their reliance and satisfaction to succeed in internal and
international market.
Based on this policy, we keep continuous and strong willingness and offer products with
quality which is required by requirements, applicable standard, and laws in contract with
the customer.
Furthermore, we check the quality system once every year, specify working items in the
Quality policy and quality objectives and keep everyone fully understood.
As for the final responsibility and authority for all activities and quality-related items
mentioned in quality assurance manual are belong to the president.
Page 21 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.3
REV.1
3 Principles of Sales
Make it a principle to be sincerity and dedicate to customer
Expand new market (new customer and new field) and innovate new products
Try to make our customers full of prosperities and by doing so, we receive
adequate rewards, then we strive to contribute to our society.
Koichi Kobayashi
President
Page 22 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.4
REV.1
5.4 Planning
5.4.1 Quality objectives
The organization enacts and announces quality objectives once every year to
realize our quality policy. Each section replaces presidents quality objectives
to their definite quality objectives and after presidents approval, each section
executes their objectives.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.5
REV.1
Management Division
Business management and control of document.
Personnel, labor, education training, welfare and control of safety sanitation.
Investigation and management of legal controls.
Action for improvement in working.
Financial affairs and accounting.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.5
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.5
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.5
REV.1
Table for responsibility for each section, authority and mutual relationship
Quality
Section Management Sales Procurement Manufacturing Engineering
Assurance
Division Division Division Division Division
Division
item Manager Manager Manager Manager Manager
Manager
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.5
REV.1
(2) Management review and the check of the quality management system is
enforced.
2. Management representative
(1) Shall have responsibility and authority that includes ensuring that processes
needed for the quality management system are established, implemented and
maintained.
(2) Reporting to the president of performance of the quality management system
and necessity of the improvement.
(3) Ensuring the promotion of awareness of customer requirements throughout the
organization.
(4) Correspondence to the external audit organization.
(5) Effecting internal audit and inform of cooperation to each section for internal
audit.
(6) To order each section to take an Effective and preventive action and the result
of the action shall be verified.
(7) Check and Discussing of the problem for which preventive action is necessary.
(8) To revise, maintain and control of quality manual
(9) Revise the organization chart ( Sec.5.5.1)
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.6
REV.1
1. Management review
President enforces a periodical quality management review once a year. After this
review, the results are reflected on next years quality objectives.
Manager of each section review his own sections system and submit the subject
for the monthly quality meeting. However, when the president decides quality
management systems review is necessary, provisional management review is
enforced.
Management review consists of President, management representative and each
sections manager and the President plays the chairman.
2. Quality record
(1) Minutes of the meeting of management review
(2) Report of the management review results
(3) Minutes of monthly quality meeting
(4) Minutes of quality assurance committee
Above quality records are kept as the records of management review by management
representative.
Page 29 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 5.6
REV.1
2. Quality record
Above mentioned results shall be documented as Report of result in management
review, and management representative maintains and control the documents after
approval of president.
Page 30 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 6.1
REV.1
6. Resource management
6.1 Provision of resources
President shall determine and provide the management resource needed,
(1) To implement and maintain the quality management system and continually
improve its effectiveness, and
(2) to enhance customer satisfaction by meeting customer requirements.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 6.2
REV.1
Our facility maintains training frequency for all personnel performing activities
addressed in API Spec Q1, Section 4.1 through 4.20.
Because abilities are demanded in each section, the basis of judgments for
aforementioned suitability of skill and experiences are specified in Appropriate ability
standard (KGD103).
We order our products in overseas and should pay the more attention to quality.
Through not only education in The organization, but interchange between companies,
we share common consciousness of quality enhancement.
(3) Education and training in case of change in the quality management system
Page 32 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 6.2
REV.1
2. Documentation of procedures
The organization establishes the process of the education and training to all the
employees engaged in the business which have an influence with product quality in
" Education and training standard and maintain it.
3. Qualification authorization
(1) Internal auditor is qualified by appropriate education and training in accordance with
Education and training standard.
(2) President authorizes specified personnel who have been engaged in the operation for
more than 3 years and additional 1 year experience in The organization.
5. To carry out education, meeting, and so on for all the employee to recognize the
meaning and importance of their own business. All the employee come to recognize
what action to carry out to achieve quality objectives.
6. To record education, training, skill and experiences to maintain and control as the
quality management system records.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 6.3
REV.1
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure need to
achieve conformity to product requirements, Infrastructure includes, as applicable,
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 6.4
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.1
REV.1
7. Product realization
7.1 Planning of product realization
Product realization in The organization begins with design, manufacturing and
delivery.
Following items are decided and effected for the necessary process plan of product
realization.
(2) The need to establish processes and documents, and to provide resources
specific to the product
(4) Preparation and storage of the record related to the process and product
prove that the product conforms to the requirements is verified in
organization of quality assurance. Defined record shall be maintained and
controlled.
The output of this planning shall be in a form suitable for the organizations
method of operations.
Page 36 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.2
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.2
REV.1
(1) If order contents are changed, change items are discussed with manager of each
section, reported to related division of in-company and outside of the company
and reconsidered.
(2) Manager of each section obtains approved and revised quotation from president,
submits to customer and obtains approval. (Order sheet from customer substitutes
for customers approval)
(3) To control new order sheet and old order sheet respectively.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.2
REV.1
1. Product information
Product information review to the customer is provided by means of catalog,
previous supply record, visiting customer, telephone, facsimile, mailing and
e-mail.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.3
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.3
REV.1
(5) Relationship with purchased product
Engineering division exchanges information efficiently (similar product in
the past and manufacturing problem and so on) and record.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.3
REV.1
6 Our documents
: Specification of new product and reports of laws and regulations
requirements.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.3
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.3
REV.1
2. Results of design audit and necessary action (if any) are to be controlled and
maintained as record of quality management system.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.3
REV.1
(4) Long-term reliance, service and inspection
4. Results of validation and following necessary actions are maintained and controlled
as the record of quality management system.
7.4 Purchasing
7.4.1 Purchasing process
Page 45 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.4
REV.1
1. General
Purchasing section identifies specification and quality in the document in
accordance with manufacturing instructions. As for the products except Ball
Valves (such as Gate, Globe and Check Valves and so on), Purchacing section
shall control outsourcing process from design to delivery which is based on
customers specification and outsourcing drawings.Manager of Procurement
division is responsible for domestic and overseas purchase.
2. Applicable scope
(1) Raw material, parts and packing material of product
(2) Products (Ball, Gate, Glove and Check Valve and so on)
(3) Manufacturing facility, inspection equipment and the parts for maintenance
(4) Service trust business of transportation, warehouse storage, system preparation
and composition of equipments.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.4
REV.1
Requirement ( about quality, cost and delivery )
Manufacturing process
Necessary control process to maintain quality
Communication system and action in case of problem happens.
3. Specification and drawing which is attached to the order sheet and delivered to the
supplier are instructed to be abolished and controlled in order to prevent misuse.
4. Purchasing section issues order sheet which has product name, quantity, and
delivery date and submit to the supplier after presidents or upper class personnels
approval.
5. Procedure to the supplier to be defined in Purchase requirements issuance
standard, maintained and controlled.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.4
REV.1
7.4.3 Verification of purchasing products
1. The Quality Assurance Division shall establish and implement the inspection or
other activities necessary for ensuring that purchased product meets specified
purchase requirements. This procedure is defined in Acceptance inspection
standard (KQD102).
2. Verification of purchased product by customer
(1) Our customer or its agent is able to enter and inspect our suppliers facility to
verify the conformance to the product requirements. (This is not applicable in
case of special reason.)
(2) The organization does not consider result of entering inspection to the
suppliers facility as the evidence whether the supplier does effective quality
control.
(3) Entering inspection by customer does not release The organizations
responsibility nor disturb subsequent disqualification notice from customer.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
1. Manufacturing control
In-company manufactured product (except new product) is controlled in
accordance with following procedures.
(a) the availability of information that describes the characteristics of the product. The
organization inform information in Order notification issued by sales division.
(b) The availability of work instructions such as Manufacturing instruction and
Process drawing from engineering division and control delivery of material, order
of parts and product and Working instruction also manufacturing division fill
out Ordering record which is controlled by each month and assemble product in
accordance with Working instruction.
(c) The use of suitable equipment
(d) The availability and use of measuring devices.
(e) The implementation of measurement
(f) The implementation of release, delivery and post-delivery activities.
2. As for the process of products except Ball Valves are mostly outsourced to outside
organization, The organization requests the supplier to submit Standard
(procedure) and Process table and then we verify, approve and control in
accordance with 7.4.1 Purchasing process
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
7.5.1.1 Control of production and service provision
REFER TO KQD103 Procedure of production and quality control.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
a)Welding
1.Get WPS,PQR and WPQ from outsource company.
2. KVC QC approve the submiital documents.
3. Return the docs to the outsource company and start welding as per approved
docs.
b)NDE
1.Get NDE procedure from outsource company.
2. KVC QC approve the submiital documents.
3. Return the docs to the outsource company and start NDE as per approved docs.
4. After NDE, get NDE record and review by QC.
5.NDE record shall be controlled in accordance with 7.5.3
c)Heat Treatment
1. The standard of heat treatment shall be discribed in the purchace order.
2. After heat treatment, get Heat Treatment Chart.
3. The Chart shall be reviewed by QC.
4. Heat Treatment record shall be controlled in accordance with 7.5.3
Page 51 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
(5) Quality assurance division fills in name of inspector and person in charge
of inspection (or substitute person) of acceptance inspection to the
Acceptance inspection record document.
(6) Manufacturing division fills in name of inspector and person in charge of
inspection (or substitute person) of in-process inspection to the
Inspection sheet.
(7) Quality assurance division fills in name of inspector and person in charge
of inspection (or substitute person) of product inspection to the
Inspection sheet.
(8) Special process record (Welding, NDE, Heat Treatment) keep the
document for 10 years.
6. Identification control
(1) Identification in acceptance inspection
Products of before-inspection and after-inspection are identified by the
storage place
Product which is under inspection is kept same as the product of
before-inspection, but identified by In-inspection indication.
Inspection section issues the Certificate of success for successful
product and keep the product with the certificate attached in place for
the successful product.
Inspection section clarified the disqualified part in the product, and
keep in place for disqualified product.
Page 53 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
(2) Identification in manufacturing process
Manufacturing division attaches Inferior product tag only to the
product which is out of the process and identifies.
Manufacturing division attaches Non-conforming card to the
non-conforming product and send back to the supplier.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.5
REV.1
6. Delivery
(1) Manufacturing division is responsible for quality securing regarding delivery and
transportation to the customer.
(2) Quality assurance division instructs special protection regarding transportation of
the products if necessary.
7. As for the product consisting parts, material and unit parts are kept in the same
manner if necessary
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 7.6
REV.1
In addition, the organization shall assess and record the validity of the previous
measuring results when the equipments is found not to conform to requirements. The
organization shall take appropriate action on the equipment and any product affected,
records of the results of calibration and verification shall be maintained.
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 8.1
REV.1
8.1 General
The organization shall plan and implement the monitoring, measurement, analysis and
improvement and enforces as follows:
1. It is carried out based on "8.2.3 monitoring of the process and measurement" and
"8.2.4 monitoring of the product and measurement" to demonstrate conformity to
product requirement.
2. Monitoring, measurement, analysis and improvement will be done by internal audit to
ensure conformity of the quality management system. This is to be reflected to
management review. In case of nonconformity to the requirements, nonconformity
action will be adapted.
3. To continually improve the effectiveness of the quality management system the
validity is examined at the quality meeting based on 8.5 Improvement and tied to
the improvement.
4. Monitoring, measurement, analysis and improvement should be effected. This shall
include determination of applicable methods, including statistical techniques, and the
extent of their use.
57
Page 58 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 8.2
REV.1
8.2 Monitoring and measurement
8.2.1 Customers satisfaction
1. The organization effect followings to monitor and measure customers satisfaction.
(1) Questionnaire to the customer and final user ( by sampling)
During the visit to the customer, collect the information about customer
opinion, investigation of the reason for lost order, compliment from the
customer and so on , and shall report in the Report of business trip.
(2) In-company monitoring, measurement, analysis and improvement of the
information to confirm the quality management system.
2. For the feed-back to the customers claim, details of information to be measured,
analyzed and improved.
58
Page 59 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 8.2
REV.1
3. After monitoring process, and if scheduled process is not completed and product
conformity is not be assured, process should be revised or corrective action to be taken
in accordance with non-conformity report.
The monitoring and measurement of the products should be effected. For verification of
individual products, inspection results (at adequate stage) to be recorded in valuation
sheet of sample and verified as scheduled.
59
Page 60 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 8.3
REV.1
Records of the nature of nonconformities and any subsequent actions taken, including
concessions obtained, shall be maintained.
When nonconforming product is corrected it shall be subject to re-verification to
demonstrate conformity to the requirements.
When nonconforming product is detected after delivery or use has started, the
organization shall take action appropriate to the effects, or potential effects, of the
nonconformity.
60
Page 61 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 8.3
REV.1
b) Accepting products that do not satisfy the original design acceptance criteria
provided that
---- the original design acceptance criteria are changed per 7.3.7 and
---- the materials or products satisfy the new design acceptance criteria
61
Page 62 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 8.5
REV.1
c) Characteristics and trends of processes and products including opportunities for
preventive action consideration of prevention of occurrence o nonconformities and
investigation of the theme of improvement by monitoring and measuring the
of process and product characteristics,
8.5 Improvement
62
Page 63 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : 8.5
REV.1
8.5.2.1 Corrective actions
The organization shall ensure that any corrective action is effective and record of
corrective action shall be maintained and controlled as record of quality
management.
63
Page 64 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 1- A.3
REV.1
A.API-Controls
A.1 Introduction
Within the requirements of both API (SPEC Q1) Edition 8 and production
Specification 6D ,to which KVC makes particular, address regarding the type
and range of Valve Products. There is a specific need to address requirements
unique to the activities of KVC as a future licensee with authority to use the API
Monogram.
For purposes of this annex, the following terms and definitions apply
A.2.1 API specified requirements
A.2.2 Licencee
A.2.3 API monogrammable product
A.2.4. API product specification
64
Page 65 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 3- A.4
REV.1
A.3.3 Each licensee shall control the application of the API Monogram in accordance
with following
a) Each Licensee shall develop and maintain an API Monogram Marking Procedure
that documents the marking / monogramming requirements specified by the API
product specification to be used for application of the API Monogram by the
Licensee. The marking procedure shall define the location where the Licensee shall
apply the API Monogram and require that the Licensees license number and date of
manufacture be marked on monogrammed products in conjunction with the API
Monogram. At a minimum, the date of manufacture shall be two digits representing
the month and two digits representing the year (e.g., 03-09 for March 2009) unless
otherwise stipulated in the applicable API product specification, Where there are no
API product specification marking requirements, the Licensee shall define the
locations where this information is applied.
b) The API Monogram may be applied at anytime appropriate during the production
process but shall be removed in accordance with the Licensees API Monogram
Marking Procedure if the product is subsequently found to be nonconforming with
API specified requirements. Products that do not conform to API specified
requirements shall not bear the API Monogram.
c) Only API Licensee may apply the API Monogram and its license to API
monogrammable products. For certain manufacturing processes or types of products,
alternative monogram marking procedures may be acceptable.
A.4.1 In particular the Quality Assurance Manager shall control the application of
the monogram activities conducted within The organization in accordance with
the management details as specified within current issues of the API Product
Specifications.
A.4.2 Within the preceding stages of this quality assurance manual, reference is
made to the API-Monogram.
65
Page 66 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 5- A.8
REV.1
A.7.1 The organization shall ensure that all parts which are scheduled to become part
of an API Monogrammed Product conform in very detail to the API specified
requirements in effect at the date of manufacture.
A.8.1 The organization shall ensure that the acceptance status of Inspection and
Testing activities shall be in accordance with the specified details provided
Within this section of this quality assurance manual.
66
Page 67 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 9- A.11
REV.1
A.10.1 The organization takes exceptional steps to ensure the acceptance and rejection
of materials or products which do not conform to the Acceptance Criteria as
defined by the API specified requirements.
A.10.1.1 The organization makes the clear statement that materials or products which do
not conform to the established acceptance criteria as defined by the appropriate
API Product Specification shall not bear the API Monogram.
67
Page 68 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 12- A.13
REV.1
A.12.3 Details of the disposition action taken are recorded on the relevant inspection
reports, and job pack information file.
A.12.4 The customer or his nominated representative (can be in some cases 3rd
inspection) shall be informed for formal disposition purposes, should the
contract so specify.
A.13.1 Review analysis of data, Viz.: Nonconforming reports shall from a constituent
element of the Quality Assurance Division Managers
Management review activity.
68
Page 69 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 14- A.15
REV.1
A.15.1 Once the valve(s) has successfully passed all prescribed inspection and test
requirements and meets the API product specification, The organization shall
make an entry into the API monogram register.
A.15.2 API monogram register is the means whereby the details of all valves
issued with API monogram are recorded.
A.15.3 KVCs API monogram register is held under the control of the Quality
Assurance Division Manager and all entries into the register shall be as defined
in the undernoted sub-paragraphs.
A.15.3.1 Name of Customer
A.15.3.2 Customer Order Number
A.15.3.3 Our Manufacturing Number
A.15.3.4 Size : Type : Class : Serial No. :
A.15.3.5 Nos off valves assigned the API monogram
A.15.3.6 Date of issue of API monogram to the valve
A.15.3.7 The final entry into the register shall be the endorsement of the
Engineering Division Manager as proof that the valves meet all aspects of
The applicable API product API product specification, and the making
procedure, as defined within the API specification Q1 8th Edition.
69
Page 70 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 16- A.17
REV.1
70
Page 71 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 18-A.20
REV.1
A.18.2 The chief inspector is the sole authority for release of completed valves from
The organization to the customer.
A.18.2.1 In the event of absence of the chief inspector, the Engineering Manager
shall be responsible for release of the completed and inspected valve(s).
71
Page 72 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 21
REV.1
A.21 Non-conformance
The organization controls evaluation and disposition of material and product
nonconformities that are accepted but do not satisfy manufacturing acceptance criteria
and original design acceptance criteria.
A.21.2 All Non-conformances shall be reviewed by the Quality Assurance Manager, and
he shall be responsible to initiate, and ensure the appropriate disposition action is taken
as detailed within Section 8.3 of this Quality Assurance Manual.
72
Page 73 of 73
QAM-2008
ISSUE DATE : July 24, 2009
SECTION NO. : A. 22
REV.1
A.22.2.2 The results of inspection and test have been recorded and are acceptable.
A.22.2.3 Hold or witness points have been signed off or waivers obtained from the
customers authorized representative, when required.
A.25.2 The Quality Assurance Division Manager shall be responsible for the
measurement and recording of any such failures and shall implement the
appropriate corrective actions which shall ensure that any trends uncovered
is analyzed to establish the root cause and that such corrective action
implemented shall be capable of avoiding recurrence.
73