Quality Manual: Tianjin Dehua Petroleum Equipment Manufacturing Co., LTD
Quality Manual: Tianjin Dehua Petroleum Equipment Manufacturing Co., LTD
QUALITY MANUAL
QM/TDPM-2009
Formulated By:
Reviewed By:
Approved By:
First Edition Issued and Implemented on 5-1-2007 Second Edition Issued and Implemented on 7-20-2009
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TianJin DeHua Petroleum Equipment Manufacturing Co., Ltd.
QUALITY MANUAL Edition:1
TianJin DeHua Petroleum
Page:Ⅰ/Ⅵ
Equipment Manufacturing Co., Ltd. Order of Issue Revision:2
Order of Issue
In order to adapt to market changes, promptly learn customer demand, develop new
product, continually improve resource arrangement and quality management system,
continually meet customer stated and potential requirements to quality, improve product
and service quality, ensure that the ratio of qualified products reaches 100%, our company
formulated the second edition of this quality manual as per API Spec Q1: 2007
“Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas
Industry” and ISO 9001:2008 (GB/T 19001-2008) “Quality Management System—
Requirements” and the practical situation of our company. Now I approve to issue this
quality manual. All employees are requested to strictly stick to the quality manual and
perform the post responsibilities stipulated in the quality management system to ensure the
effective operation of the quality system of our company.
In order that all the contents of the quality manual can be completely implemented, I
authorize Mr. Jiao Jian as the Management Representative who shall be responsible for
dealing with the relevant matters relating to quality management system.
This Second edition of the quality manual shall be implemented since July 20, 2009.
General Manager:
July 20, 2009
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Equipment Manufacturing Co., Ltd. Contents Revision:2
Contents
1 Scope .............................................................................................................................1
2. Normative References ...................................................................................................2
3 Terms and Definitions ....................................................................................................3
4 Quality Management System..........................................................................................4
4.1 General Requirements ..........................................................................................4
4.2 Documentation Requirements ...............................................................................4
4.2.1 General .......................................................................................................4
4.2.2 Quality Manual ...........................................................................................4
4.2.3 Control of Documents .................................................................................5
4.2.4 Control of Records ......................................................................................6
4.2.5 Applicable Documents ................................................................................7
5 Management Responsibility ...........................................................................................8
5.1 Management Commitment....................................................................................8
5.2 Customers Focus ..................................................................................................8
5.3 Quality Policy.......................................................................................................8
5.4 Planning ...............................................................................................................8
5.4.1 Quality Objectives ......................................................................................8
5.4.2 Quality Management System Planning ........................................................9
5.5 Responsibility, Authority and Communication ....................................................10
5.5.1 Responsibility and Authority .....................................................................10
5.5.2 Management Representative ..................................................................... 11
5.5.3 Internal Communication............................................................................ 11
5.6 Management Review ..........................................................................................12
5.6.1 General .....................................................................................................12
5.6.2 Review Input ............................................................................................13
5.6.3 Review Output ..........................................................................................13
5.7 Applicable Documents ........................................................................................14
6 Resource Management .................................................................................................15
6.1 Provision of Resources .......................................................................................15
6.2 Human Resources ...............................................................................................15
6.2.1 General .....................................................................................................15
6.2.2 Competence, Awareness and Training .......................................................15
6.3 Infrastructure ......................................................................................................16
6.4 Work Environment .............................................................................................16
6.5 Applicable Documents ........................................................................................16
7 Product Realization ......................................................................................................17
7.1 Planning of Product Realization..........................................................................17
7.2 Customer-Related Processes ...............................................................................17
7.2.1 Determination of requirements related to the product ................................18
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1 Scope
1.1 General
This quality manual is formulated as per API Spec Q1: 2007 “Specification for
Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry” and ISO
9001:2008 (GB/T 19001-2008) “Quality Management System—Requirements”.
1.2 Application
This quality manual is applicable for quality assurance of complete process of drill
pipe, casing and tubing and coupling production of API and other specifications, including
raw material purchasing, manufacturing, inspection, sales and servicing, for prevention and
control of nonconformity in various stages as well as the continual improvement of quality
management.
Our company manufactures products in accordance with API specification and does
not accept customer property, therefore section 7.3 design and development and 7.5.4
customer property relevant item will be excluded in this quality manual.
For this quality manual to be applicable to the certification of API monogram license
and ISO 9001:2008 quality management system, it is edited on the format of ISO
9001:2008, and the requirements of API Spec Q1: 2007 are edited into various chapters.
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2. Normative References
The following standards contain provisions, which through reference in this text,
constitute provisions of this manual. The latest editions of the referenced standards shall be
applied.
2.1 API Spec Q1: 2007 “Specification for Quality Programs for the Petroleum,
Petrochemical and Natural Gas Industry”
2.2 API Spec 5CT: Specification for Casing and Tubing
2.3 API Spec 5B: Specification for Threading, Gauging, and Thread Inspection of Casing,
Tubing and Line Pipe Threads
2.4 API Spec 5DP: Specification for Drill Pipe
2.5 ISO 9000:2008 (GB/T 19000-2008) “Quality Management System—Foundation and
Vocabulary”
2.6 ISO 9001:2008 (GB/T 19001-2008) “Quality Management System—Requirements”
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Equipment Manufacturing Co., Ltd. Terms and Definitions Revision:2
For the purposes of this quality manual, the terms and definitions given in the
following standards and specifications shall be applied.
3.1 API Spec Q1: 2007 “Specification for Quality Programs for the Petroleum,
Petrochemical and Natural Gas Industry”
Where our company chooses to outsource any process that affects product conformity
with requirements, our company shall control them according to Clause 7.4 and
procedural documents “Control Procedure of Purchasing”, and for these processes, Our
Company shall maintain responsibility for product conformance.
4.2 Documentation Requirements
4.2.1 General
The quality management system documentation of our company shall include quality
policy and objectives, quality manual, documented procedures, work instructions
(documents needed by effective planning, operation and control of processes related to
quality management system, including technical documents, standards and materials of
external origin, such as customer supplied technical requirements, and drawings, and etc.),
and quality records (including electronic medium), to ensure that quality management
system can operate as per the effective documents of latest edition.
4.2.2.2 The manual describes the quality policy, organizational structure, management
responsibility, quality management system requirements, control process, and the main
procedures of the resources, management and product realization. It stipulates the
requirements, principles and procedures for necessary quality activities, surrounding the
various stages of the whole process of about casing, tubing and drill pipe quality formation,
according to PDCA circulation model and we identifies all processes and interactions of the
quality management system and adopt “flowing chart”(appendix 4) to express it.
4.2.3.2 Management representative shall organize top management class and all
department ministers to formulate the quality manual while the top manager should
approve the quality manual. The department in charge is responsible for organizing
formulating and reviewing the documented procedures, work instructions and quality
record forms, which shall be approved to issue by Management Representative.
Management Representative shall organize reviewing the quality documents and issue a
list of effective documents annually, in which the edition and current revision status of
documents shall be identified, to ensure their continual effectiveness.
4.2.3.3 The issued quality documents shall be given the clear serial numbers, identification
and implementation date, and signed by formulator, reviewer and approver. Approving
table of document distribution range shall be filled out when the documents are distributed,
and the effective documents shall be distributed to the relevant departments, posts and
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Manufacturing Co., Ltd. Quality Management System Revision:2
persons according to the stipulated quantity. The documents shall be well protected, legible
and clear, and easy to be identified and used. The invalid documents shall be destroyed;
and any obsolete documents retained for knowledge preservation purpose shall be sealed
with “invalidation” and be strictly distinguished from the effective ones. The effective
document shall be signed as “controlled version”, the document that be supplied to
customer for reviewing should be signed as “uncontrolled version”. Ensure that the
relevant versions of applicable documents are available at points of use.
4.2.3.4 Changes to documents and data shall be reviewed and approved by the post
personnel of the same departments that performed the original formulation, review and
approval. The other designated personnel shall have access to pertinent background
information upon which to base their review and approval. Changes to documents and data
shall ensure that all of the relevant controlled documents have been changed to keep their
unity. To describe the changing status of the present documents and data, document
changes shall be identified in the document or in the appropriate attachments.
4.2.3.5 The responsible departments are responsible for identifying and managing the
documents of external origin, such as statutory and regulatory requirements related to
quality, customer supplied technical conditions, product standards, and etc. The
distribution of documents of external origin shall ensure that they are under control.
4.2.4 Control of Records
4.2.4.1 Our Company is responsible for establishing control procedure of quality records.
Quality Assurance Department is responsible for the management of quality records.
4.2.4.3 The determination of quality record forms is proposed by the using department
according to the actual needs, reviewed by Quality Assurance Department and the relevant
functions, sent to Management Representative for approval after countersign, catalogued
and formulated into volumes according to the stipulations of archives, and distributed to be
implemented. Electronic medium can also be used for quality records, but the form shall be
reviewed and approved as well.
4.2.4.4 Quality records shall remain legible and readily identifiable, and they mustn’t be
daubed. They must be signed by the recorders, and noted with the date. When the records
must be changed for some reasons, the original data shall be scratched, and the corrective
data shall be written on the top, and the changer must sign or seal at the location.
4.2.4.5 Quality records (including floppy discs) shall be kept by the using departments, and
then sent to the responsible department for pigeonhole. All quality records shall be stored
and maintained in such a way that they are readily retrievable in facilities that provide a
suitable environment to prevent them from damage, deterioration and loss. All kinds of
quality records shall be kept for 5 years
4.2.4.6 When the customers require, the quality records can be provided only after being
approved by Management Representative.
4.2.5 Applicable Documents
(1) “Control Procedure of Documentation and Data”
(2) “Control Procedure of Quality Records”
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5 Management Responsibility
5.1 Management Commitment
Management responsibilities of our company shall mainly include determining quality
policy and objectives; establishing and implementing quality management system and
continually improving its effectiveness; establishing functional departments, posts and
personnel, and stipulating their responsibilities and authority; transmitting the importance
of satisfying the requirements of customers and laws to the organization; ensuring to equip
the necessary resources; and implementing management review according to stipulations to
ensure the continual effectiveness of quality management system.
5.2 Customers Focus
Satisfying the customers’ requirements is the key point of realizing production,
benefit, product quality management and continual improvement of our company. The Top
Management shall pay a close attention to it, communicate with the customers, seriously
comprehend the customers’ requirements to ensure that the customer requirements shall be
determined and met.
5.3 Quality Policy
Our company’s quality policy is: Obtaining the glorification by quality; continually
improvement to QMS.
Quality policy is one of the important elements of general management policies and the
quality commitment to the customers of our company. General Manager shall be
responsible for organizing its formulation and approving it and ensure quality policy
provides a framework for establishing and reviewing quality objectives. Our company
shall extensively propagate it in order that the connotation of the quality policy can be
understood by all of employees and embodied in their work.
General Manager and the Top Management shall be responsible for the review of
quality policy to ensure its continual suitability.
5.4 Planning
5.4.1 Quality Objectives
The quality objective of the company is that Qualified product rate achieves 98% or
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5.4.2.2.1 Our company shall establish the quality plans on important quality activities,
development of new products, or the products, projects and contracts with customer special
requirements.
5.4.2.2.3 Quality plans can quote the regulations of this quality manual and it’s
supporting documented procedures to ensure the compatibility of design, technology,
installation, servicing, inspection, test procedures and the applicable documentation.
5.4.2.2.4 According to the requirements of quality plans, the company shall confirm and
equip the necessary resources of staff, finance and materials, including inspection and
testing equipment. When necessary, the technology should be renewed and the equipment
shall be added. The measuring instruments must meet the requirements of measurement.
5.4.2.2.5 The product acceptance criteria shall be specified and necessary verification
shall be conducted during the process of product formulation.
5.4.2.2.6 The whole process of quality plan formulation shall be controlled and all
records shall be maintained
(1) Ensuring that the processes needed for quality management system are
established, implemented and maintained;
(2) Reporting to Top Management on the performance of the quality management
system and any need for improvement;
(3) Ensuring the promotion of awareness of customer requirements throughout the
organization;
(4) Being responsible for the liaison with external parties on matters relating to the
quality system;
(5) Having authority to deal with all kinds of the quality issues.
Board Chairman
General Manager
Purchase Dep.
Sale Dep.
Financial Dep.
Production Equipment Dep.
5.6.1 General
The General Manager is responsible for organizing the quality system review to
ensure its continual suitability, adequacy and effectiveness. The management review shall
be performed at least once a year or at any time when necessary. The review shall be based
on satisfying the requirements of ISO 9001: 2008, according to the related product
standards, such as API Spec Q1, API Spec 5DP and API Spec 5CT. The management
review shall cover the chances of evaluation and improvement and the need to change
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quality policy and objective, including quality policy and objectives changing
requirement. The review records shall be managed as per “Control Procedure of Quality
Records”.
quality objectives;
(2) The suitability and effectiveness of quality management system, and the
(3) The results of internal and external quality system audits, and the implementation
(7) The follow-up measures adopted from the last management review;
(10)The revision of relevant standards such as API Spec Q1 and API Spec 5CT, API
In management review, the unfitness elements of the quality system and the quality
problems shall be discussed; the relevant solutions and improving measures shall be
proposed on the effectiveness of quality management system and its process, improving
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requirements for product related to the customer, and the need for resources. The
6 Resource Management
6.1 Provision of Resources
According to the properties of the product and the being implemented quality
activities, as per the requirements of investors, the Top Management shall establish
organizational structure, equip necessary resources, review the resources annually, and
confirm the resources which need adding or supplementing, to ensure the normal operation
and the continual effectiveness of the quality management system, and to satisfy the
customer requirements and enhance the customer satisfaction.
To ensure the normal operation of quality management system, and to guarantee that
the product can meet the customer requirements, all personnel performing work affecting
product requirement conformance shall be provided with appropriate quality training, post
skill indoctrination and safety training.
All personnel performing work affecting product requirement conformance shall have
appropriate education, training, skills and experience and are qualified for evaluation to
ensure to be competent for post requirements.
6.2.2 Competence, Awareness and Training
6.2.2.1 Human Resources Department is responsible for determining the necessary
competence for personnel performing work affecting product quality and formulating the
procedure of training, indoctrination and qualification control; the requirements of post
responsibility and post qualification; and the training plan, training period and training
implementation.
6.2.2.2 Training includes quality training, important post training, qualification training of
special process and internal auditor training. It is necessary to ensure that its personnel are
aware of the relevance and importance of their activities and how they contribute to the
achievement of the quality objectives.
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6.2.2.3 According to the requirements of quality management system, the human resources
shall be evaluated annually to determine the minimum requirements for education, training,
skills, experience, and qualification identification of employees.
6.2.2.4 Qualification of the personnel shall be documented, and such records shall be
maintained.
6.3 Infrastructure
Our company is responsible for controlling the infrastructure and providing suitable
working conditions, including buildings, office facilities, energy resources, equipment and
apparatus, software and hardware, transportation and communication instruments.
Equipment & Power Dep. and Office are responsible for this management.
6.4 Work Environment
Our company is responsible for controlling the work environment, including suitable
temperature, moisture, lighting, noise controlling, constructions in reasonable layout,
clear roads, and qualified virescence. Workshop is responsible for this management.
6.5 Applicable Documents
1) “Control Procedure of Process”
2) “Control Procedure of Training, Indoctrination and Qualification”
3) “Control Procedure of Quality Records”
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7 Product Realization
7.1 Planning of Product Realization
As per the requirements of product specifications and in the range of quality
management system, our company shall implement product planning and development,
and organize production according to “Process Flow Chart of Tubing & Casing and Drill
Pipe Production”, to ensure that product meets the requirements of product specifications
and satisfies the customer requirements.
7.1.1 The Technology Department is responsible for organizing product planning required
by product realization, paying special attention to the operation process of production,
inspection and servicing. It is required that product planning shall be consistent with the
other management elements and resources, and is suitable for the operation of our
company.
(1) Quality objectives and technical requirements that the product and the project shall
meet;
(2) All of the procedures and routes of product realization;
(3) Responsibility, authority of the relevant personnel and the necessary resources;
(4) Technological flow, specific procedures, methods and work instructions;
(5) Required verification, validation, monitoring and measuring activities specific to
the product, and the criteria for product acceptance;
(6) Records needed to provide evidence that the realization processes the resulting
product meet the requirements.
7.1.2 The Technology Department is responsible for formulating the quality plans to a
specific product, project or contract.
7.2 Customer-Related Processes
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7.2.2.3 Only after the contract review, can our company sign a formal contract with the
customer. Sales Department is responsible for delivering the contract to the relevant
departments and carrying out the implementation of contract. The changed contract shall
be reviewed once again, and the Sales Department shall be responsible for transferring the
changes of the contract in written form to the relevant functional departments.
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7.2.3.1 Our Company pays attention to the communication with the customers, and
requires to implement servicing activities in the whole process of product sales. Our
company shall:
(1) Seriously treat the customer enquiries and consults by means of letter, phone call,
fax, and e-mail, maintain the records, and reply in time;
(2) Establish files about contract customers, go to visit customers, investigate the
customers, and continually strengthen the liaison with customers, to ensure that the
customer requirements can be effectively replied in time;
(3) Other servicing requirements of the customers shall be recorded, implemented and
satisfied.
7.4 Purchasing
7.4.1 Purchasing Process
7.4.1.1 To manufacture the product meeting the customer requirements, the purchased
product and materials are classified into two types according to their affect to the product
quality, i.e. the important and the common. The former primarily includes the plain pipes
for casing, tubing and drill pipes while the latter refers to paint, protector, etc. For all the
resources, the Purchase Department is responsible for choosing the qualified supplier and
controlling the purchase.
Purchase Department is responsible for selection of suppliers on the basis of the effect
degree of supplied product on the quality of final product of the company or on the quality
audit reports and/or quality records of the previously demonstrated capability and
performance of the suppliers.
7.4.1.4 After the evaluation of suppliers, a list of acceptable suppliers shall be established
according to the results of comprehensive evaluation, and these suppliers shall be
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(1) The specification, type, grade (group) and quality requirements of product;
(2) Product specifications, inspection standards, and other relevant technical
information;
(3) Applicable quality management system.
As to the product with special requirements, our company shall state the intended
verification arrangements and the method of product release at the suppliers’ premises in
purchasing information.
When the purchased product shall be inspected, tested and measured in our company,
the qualification documents from suppliers shall be checked.
Where specified in the contract, the customer or the customer’s representative shall be
allowed to verify the product in our company or at the supplier’s premises for ensuring that
supplier product meets specified requirements. The persons of our company can assist the
customers or their representatives to conduct the verification. However, our company shall
not use such verification as evidence of effective control of quality by the suppliers.
Verification by the customer shall not absolve our company of the responsibility to
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7.5.1.1 As per the requirements of product properties, our company is responsible for
supplying suitable working and servicing conditions, periodically transmitting the
production plans to all levels, reasonably organizing production; formulating the relevant
control procedure and working instructions. The Production & Equipment Department is
responsible for continually monitoring the suitable process parameters and product
properties, periodically implementing the suitable inspection and maintenance of
production equipments, and keeping the process capability. Quality Assurance Department
is responsible for inspection and testing process control and approval of production
processes. Production & Equipment Dep. is responsible for the recognition of production
and equipments while the Human Resource Department is responsible for acquisition of
the operators with certain qualification.
7.5.1.2 The control of production and servicing processes shall be conducted as per
“Control Procedure of Process” to ensure that product meets the requirements of relevant
standards and customers. Process controls shall be documented in routings, travelers,
checklists, technical specifications or graphic media, which shall be implemented after
being approved to ensure that they conform to relevant product specifications, quality
plans, design and inspection plans.
7.5.1.4 Our Company shall control the product release, delivery and post delivery
activities.
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Note: The use and management of API 5CT and API 5DP Monogram is specified in
Section 9.
7.5.3.3 Our Company adopts the following methods for identification, such as hard die,
painting and nameplates. The unique identification of our company’s product is the serial
number of each product, and it can be traced to the number of batch. Other methods shall
be determined by consulting with the customers. Appropriate action for preservation and
transferring of identification shall be taken during production process of product to ensure
that the identification is clear and accurate, and relevant records shall be made, The records
of product identification and trace ability shall be managed according to “Control
Procedure of Quality Records”.
7.5.3.4 The monitoring and inspection status of raw materials, semi-product and finished
product shall be identified by suitable means, which indicate the conformance or
nonconformance of product with regard to inspection and tests performed. The monitoring
and inspection status in our company are classified as “Hold”, “Accepted” and “Not
accepted”. Our company identifies the monitoring and measurement status of product in
inspection records and travelers.
7.5.5 Preservation of Product
7.5.5.1 General
Our company establishes and maintains the documented procedure for product
preservation: “Control Procedure of Product Preservation” to ensure that product quality
meets the requirements of customers. The Resource Distribution Department (Export
Department) is responsible for management of identification, handling, packaging, storage,
protection and delivery of product.
7.5.5.2 Handling
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According to the characteristics of the product, our company shall provide the suitable
methods and means of handling such as rollers, cranes, etc., and put the damping substrates
on easily being bumped spots to protect the product from damage and deterioration.
7.5.5.3 Storage
Our company shall use designated storage areas or stock rooms to prevent damage or
deterioration of product, pending use or delivery. Appropriate methods for authorizing
receipt and the dispatch to and from such areas shall be stipulated. In order to detect
deterioration, the condition of product or constituent parts in stock shall be assessed at
specified intervals. Records shall be maintained properly.
7.5.5.4 Package
Our company’s casing, tubing and drill pipe product shall be packaged according to
the relevant product specifications. Special package can be used if required by customers.
7.5.5.5 Preservation
According to the characteristics of product, our company shall adopt suitable methods
to protect the products from corrosion and damage, such as stock rooms, installing
protectors, etc.
7.5.5.6 Delivery
7.5.5.7 Marking
In the processes of handling, package, storage and delivery, product marking shall be
carefully protected to prevent from being damaged, scribbled or lost.
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7.6.2 Quality Assurance Department is responsible for the control and management of
monitoring and measuring equipments, and establishing the table account, definitely
recording the type, amount, accuracy, applicable scope and calibrated records of monitoring
and measuring equipments.
7.6.3 Quality Assurance Department is responsible for selecting suitable monitoring and
measuring equipments, whose performance and accuracy meet the requirements of product
specifications; and for calibrating or verifying these devices at specified intervals, or prior
to use, against measurements standards traceable to international or national measurement
standards. As to the self-made measuring and inspection tools, our company shall conduct
calibration or adjustment according to specified self-inspection regulations. Calibration and
adjustment intervals shall be stipulated and meet the requirements.
7.6.4 Only the qualified monitoring and measuring equipments after calibration can be
used for production, inspection and tests. All the equipments shall have calibration
certificates and corresponding marking on them, which specifies the following contents if
necessary title, serial number, accuracy, calibration agency or staff, validity period of
calibration, etc. Unqualified after calibration shall be repaired or discarded.
7.6.5 When used in the monitoring and measurement of specified requirements, the ability
of computer software to satisfy the intended application shall be confirmed. This shall be
undertaken prior to initial use and reconfirmed as necessary.
7.6.7 Quality Assurance Department shall examine the status of monitoring and measuring
equipments (including both test hardware and software) at any time and safeguard them
from adjustments, which would invalidate the calibration setting. When there are any
malfunctions or found beyond specified calibration period, our company shall review the
relevant inspection results according to specified procedures, judge and dispose them.
7.6.8 Quality Assurance Department shall assess and record the validity of the previous
measuring results. When the equipment is found not to conform to requirements, take
appropriate measures on the equipment and any product affected.
7.6.9 Quality Assurance Department is responsible for maintaining the calibration records
of monitoring and measuring equipments for future reference. The control records of
monitoring and measuring equipments shall be made available to customers according to
specified procedures when required by customers.
7.7 Applicable Documents
1) “Control Procedure of Contract Review”
2) “Control Procedure of Documents and Data”
3) “Control Procedure of Purchasing”
4) “Control Procedure of Product Identification and Trace ability”
5) “Control Procedure of Process”
6) “Control Procedure of Monitoring and Measuring Equipments”
7) “Control Procedure of Monitoring and Measuring Status of Product”
8) “ Control Procedure of Nonconforming Product”
9) “Control Procedure of Product Preservation”
10) “Control Procedure of Quality Records”
11) “Control Procedure of Training, Indoctrination and Certification”
12) “Control Procedure of Servicing”
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Improvement
8.2.1.2 Sales Department shall regulate the information of customer satisfaction in time,
learn about how our product or service satisfies the customer requirements and expectation,
analyze the changing trends of customer requirements and expectation, and the aspects
needed for improvement, and transfer it to Quality Assurance Department, which shall
organize taking the corrective, preventive or improving actions. Improvement is regarded
as one evaluation to the performance of our company’s quality management system.
8.2.2 Internal Audit
8.2.2.1 General
Our company shall conduct internal audits at planned intervals to validate whether the
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Improvement
quality activities and the relevant results meet the requirements of quality management
system, and to determine that the quality management system is effectively implemented
and maintained.
8.2.2.2 Responsibility
Internal quality audits shall be approved by Management Representative. Quality
Assurance Department is responsible for organizing the implementation.
8.2.2.3 The Procedure of Internal Quality Audits
Internal quality audits shall be implemented on “Control Procedure of Internal Quality
Audits”
8.2.2.4 Audit Planning
Internal quality audit shall be planned and conducted on all elements of the quality
system and the results of previous audits. The audit shall cover all of the relevant
departments, and be conducted at least once a year. When necessary, the extra audit shall
be implemented after being approved by Management Representative.
8.2.2.5 Audit Implementation
Audit plans shall be established annually and documented, and the audit plan and
check lists shall be formulated as the auxiliary means. Internal quality audit shall be carried
out by the personnel with qualification of internal auditor and independent from those
having directly responsibility for the activity being audited.
8.2.2.6 Reports of Audit Results
The results of every internal audit shall be compiled into audit reports. The reports
include the basic situation of the audited items and the report on nonconformities, and they
shall be distributed to the audited departments and kept in the archives.
Our company shall identify the response times for addressing detected nonconformity.
The responsible person of the department is responsible for taking timely corrective actions against
the nonconformities found during the audit. In the follow-up audit activities, Review group shall verify
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and record the implementation and effectiveness of the corrective actions taken.
8.2.3.2 According to the characteristics of each process and its effecting degree to the
whole production or servicing process, our company shall monitor and control the process
by individually adopting the following methods: process capability analysis, statistics of
product one-time acceptance ratio and qualification ratio, equipment integrity ratio, and so
on.
8.2.3.3 As to the abnormity or scarcity of process capability, Production & Equipment Dep.
shall propose the improving application, and responsible for establishing improving plans,
which shall be implemented after being approved by the leader in charge. The improvement
actions can include adjusting technology and maintenance period, increasing the times of
maintenance or overhaul, replacing or improving equipment, and so on.
8.2.4 Monitoring and Measurement of Product
8.2.4.1 Quality Assurance Department shall monitor and measure the characteristics of the
product, and be responsible for the implementation.
8.2.4.2.1 The product shall not be used or processed until it has been monitored and
measured.
8.2.4.2.2 Receiving monitoring and measurement shall adopt different controls, based on
the quality grade and standards, quality control degree of supplier’s product, and the
qualification certificate supplied, and determines the amount and nature of receiving
monitoring and measurement.
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8.2.4.2.3 Where incoming product is released for urgent production purposes prior to
verification, it shall be applied by the related department, approved by Management
Representative, and positively identified and recorded to permit immediate recall and
replacement in the event of nonconformity to specified requirements.
8.2.4.3.2 Hold product until the required monitoring and measurement have been
completed or necessary reports have been received and verified. Our company shall not
conduct release for exception.
8.2.4.4.1 The qualified identification for finished product shall be made and recorded only
after all specified monitoring and measurement have been carried out and that the results
meet specified requirements.
The product monitoring and measurement records shall show clearly whether the
product meets the intended requirements and be maintained. These records shall be signed
by authorized inspector and reviewer.
8.2.4.6 No product shall be released or delivered to customers for use until all the
monitoring and measuring activities have been satisfactorily completed, unless approved
by the related authorized personnel, or the customers where appropriate.
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8.3.2.2 Nonconforming product after being assessed shall be individually disposed, and it
may be:
8.3.2.4 Nonconforming products found in inspection, which don’t satisfy the original
design acceptance criteria shall be accepted provided: the original design acceptance
criteria is changed as per the related stipulations, and the nonconforming products satisfy
the new design acceptance criteria.
8.3.2.5 Reworked or repaired product shall be re-inspected, and the inspection records shall
be maintained.
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8.3.3 Sales Department is responsible for dealing with nonconforming product found
during the delivery and in the fields, filling in a report of field nonconforming product on
specified procedures, and reporting to our company’s Management Representative.
Management Representative organizes relevant departments and persons to conduct
discussion and analysis to find out the causes of field nonconforming product. The causes
found to be induced by the customers shall be fed back to them immediately, and if it is our
problem, the company shall investigate the responsibility, propose corrective and
preventive actions and correct it in specified time period. If there is the concession in the
product, our company shall explain the situation to the customers.
8.3.4 If field nonconforming products were found on products with API monogram, Sales
Department should assign appointed persons to remove the API monogram from the
nonconforming product.
8.3.5 In the event that the product delivered fails to meet the design acceptance criteria,
our company shall notify customers and maintain records of customer notification.
8.4 Analysis of Data
8.4.1 Our Company shall collect and analyze date to demonstrate the effectiveness of the
quality management system and to valuate where continual improvement of the
effectiveness of the quality management system can be made. Production & Equipment
Department is responsible for the application and management of statistical technologies
while the Quality Assurance Department for the confirmation of the statistical technologies
selected by the functional departments.
8.4.2 The statistical technologies in our company mainly include: investigation form, cause
and effect chart, flow chart, control chart and bar chart, and are applied in the following
fields: analysis and research of customer satisfaction, product conformance, suppliers,
process monitoring and control, corrective and preventive actions, measurement, data
analysis, process capability analysis, product characteristics and product quality trend
analysis, etc. It shall be conducted on “Control Procedure of data analyses”.
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8.5 Improvement
8.5.1 Continual Improvement
8.5.1.1 Our company shall take the actions, such as internal quality audit, management
review, statistical analysis and relevant corrective and preventive actions, to eliminate the
causes of actual or potential nonconformities, to avoid the potential trend of
nonconformities, to update quality policy and objectives, and to accelerate the normal
operation of quality system and its continual improvement.
8.5.2.2 Based on the quality records and reports of customer complaints on product
quality, our company shall investigate and find out the causes of nonconformities,
formulate corrective measures if appropriate and evaluate the effectiveness of the
corrective measures to ensure that nonconformities are prevented from re-occurrence.
8.5.2.4 Quality Assurance Department is responsible for organizing the tracing and
verification of implementation and effectiveness of corrective actions.
8.5.3.2 According to the risk degree of the potential causes, define the disposal procedures
and measures required. Then, define the requirements of evaluating the preventive
measures and evaluate its effectiveness to prevent the occurrence of nonconformities.
8.5.3.3 Quality Assurance Department is responsible for tracing the implementation effects
of adopted preventive actions, and report all preventive actions and effects for the
management review.
9.3 After getting API production license, our company guarantees that we only mark the
API monogram, licensee number and manufacturing date on the products meeting API
specifications.
9.4 Our company shall apply the monogram, license number, and date of manufacture to
monogrammed products in accordance with a marking procedure as specified by the
applicable API product specification.
9.5 Quality Assurance Department is responsible for the application and management of
API monogram; the Quality Assurance Department shall appoint the special persons to
mark the monogram, licensee number and manufacturing date on the products meeting
API specifications; and Quality Assurance Department appoints the special person for
supervision and checking.
9.6 If the problems are found during the production process at any time, Quality Assurance
Department shall organize the persons to strictly check the related semi-products and
finished products immediately. The unqualified products mustn’t be marked with API
monogram, and the ones marked by API monogram, licensee number and manufacturing
date shall be removed by the personnel appointed by the Production & Equipment
Department; and Quality Assurance Department shall appoint persons for supervision and
checking. The products accepted with concession after being approved mustn’t be marked
with API monogram, licensee number and manufacturing date, if they don’t meet API
specifications. If the product is found to be in nonconformance with API specified
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requirements in the application fields, the Sales Department of our company shall appoint
persons to remove the monogram.
9.7 Quality Assurance Department is responsible for recording the application and removal
of API monogram, and the records shall be maintained for the period of time specified by
the management procedure of documents and materials. Records demonstrating the
performance of the effective operation of the quality management system shall be
maintained for a minimum of 5 years.
9.8 Quality Assurance Department is responsible for keeping in touch with API on
application and management of API monogram, and reporting all of the problems
encountered with API monogrammed products to the API.
9.9 Applicable Document
“Control Procedure of API Monogram Use and Management”
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Technology Dep.
Purchase Dep.
Elements of Quality
Management System
▲ △ △ △ △ △ △ △ △ △ △ △
4 Quality Management System
▲ △ △ △ △ △ △ △ △ ▲ △ △
4.2.2 Quality Manual
▲ △ △ △ △ △ △ △ ▲ △ △
4.2.3 Control of Document
▲ △ △ △ △ △ △ △ ▲ △ △
4.2.4 Control of Quality Records
△
5.5 Responsibility, Authority and Communication ▲ △ △ ▲ △ △ △ △ ▲ △ △
▲ △ △ △ △ △ △ △ △ ▲ △ △
5.6 Management Review
6.3 Infrastructure ▲ △ ▲ ▲
▲ △ ▲ △ △ △ △ △ △ △ △ ▲
6.4 Work Environment
△ ▲ △ △ ▲ △ △ △ △ △ △
7.1 Planning of Product Realization
△ △ △ ▲ △ ▲ △ △ △ △ △
7.2 Customer-Related Processes
△ ▲ ▲ △ △
7.4 Purchasing
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10
11
12
13
14
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Appendix 4 Revision:2
Internal Audits
System and Measurement,
Analysis Continuous
Analysis and improvement
Monitoring and of Data Improvement
Of process
measurement of processes
Customer
Customer
Planning Quality Policy and Objectives Provision of resources Management Review Communication
of product
production
Preparation of
Planning
Control of Quality
Inspection
Service
Planning of
process
Satisfaction
Purchasing Warehouse Process of Pro. Process of Site
Requirements