Valve Teck - Quality Manual Apiq

Document No.:VT-01-0001

QUALITY ASSURANCE MANUAL

for

Manufacturing of Industrial Ball, Gate and Check Valves In Accordance With The Requirements of The API Q1, Spec.6D.

P. O. BOX 35-59 ,Taichung, Taiwan,R.O.C.

Tel: 886 4 2231 2299 Fax. 886 4 2231 3399

NO PART OF THIS DOCUMENT MAY BE REPRODUCED IN ANY FORM,IN AN ELECTRONIC RETRIEVAL SYSTEM OR OTHER-WISE ,WITHOUT THE PRIOR WRITTEN PERMISSION OF JIN LUN Enterprise Co., Ltd.

Revision No. ：8

Issue Date ：2009/05/21

Quality Manual VT-01-0001

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Contents

Sections Page

1.0 Introduction ................................................................................................................. 6

2.0 Quality policy .............................................................................................................. 8

3.0 Organization chart .................................................................................................... 10

4.0 Quality management system................................................................................... 11

4.1 General requirements............................................................................................... 11

4.2 Documentation requirements.................................................................................. 12

4.2.1 General.................................................................................................................... 12

4.2.2 Quality manual ....................................................................................................... 13

4.2.2.1 Issue and distribution control........................................................................ 15

4.2.2.2 Revision control.................................................................................................. 15

4.2.3 Control of documents ........................................................................................... 16

4.2.4 Control of records ................................................................................................. 17

5 Management responsibility ........................................................................................ 18

5.1 Management commitment ....................................................................................... 18

5.2 Customer focus ........................................................................................................ 18

5.3 Quality policy ............................................................................................................ 18

5.4 Planning..................................................................................................................... 19

5.4.1 Quality objectives.................................................................................................. 19

5.4.2 Quality management system planning ............................................................... 19


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5.5 Responsibility, authority and communication ...................................................... 20

5.5.1 Responsibility and authority ................................................................................ 20

5.5.2 Management representative ................................................................................. 20

5.5.3 Internal communication ........................................................................................ 21

5.6 Management review.................................................................................................. 21

5.6.1 General.................................................................................................................... 21

5.6.2 Review input........................................................................................................... 22

5.6.3 Review output ........................................................................................................ 22

6 Resource management process ................................................................................ 23

6.1 Provision of resources............................................................................................. 23

6.2 Human resources ..................................................................................................... 23

6.2.1 General.................................................................................................................... 23

6.2.2 Competence, awareness and training................................................................. 24

6.3 Infrastructure............................................................................................................. 25

6.4 Work environment .................................................................................................... 25

7 Product Realization ..................................................................................................... 26

7.1 Planning of product realization............................................................................... 26

7.2 Customer-related processes................................................................................... 27

7.2.1 Determination of requirements related to the product ..................................... 27

7.2.2 Review of requirements related to the product ................................................. 27

7.2.3 Customer communication .................................................................................... 28

7.3 Design and development process.......................................................................... 29

7.3.1 Design and development planning...................................................................... 29

7.3.2 Design and development inputs .......................................................................... 30


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7.3.3 Design and development outputs........................................................................ 31

7.3.4 Design and development review.......................................................................... 31

7.3.5 Design and development verification ................................................................. 32

7.3.6 Design and development validation.................................................................... 32

7.3.7 Control of design and development changes.................................................... 33

7.4 Purchasing process ................................................................................................. 34

7.4.1 Purchasing process……………………………………………………………………34

7.4.1.1 Purchasing process ........................................................................................... 34

7.4.1.2 Criteria for supplier selection, evaluation, and re-evaluation....................... 34

7.4.1.3 Supplier provided special processes............................................................... 35

7.4.2 Purchasing information ........................................................................................ 35

7.4.3 Verification of purchased product....................................................................... 36

7.5 Production and service provision .......................................................................... 36

7.5.1 Control of production and service provision ..................................................... 36

7.5.1.2 Process controls................................................................................................. 37

7.5.2 Validation of processes for production and service provision/Special processes .................................................................................................................... 38

7.5.2.1 Control features for validation of processes for production and service provision ...................................................................................................................... 38

7.5.3 Identification and traceability............................................................................... 39

7.5.3.1 Control features for Identification and traceability, and control features for Identification and traceability maintenance and replacement .............................. 40

7.5.3.2 Identification and traceability maintenance and replacement ...................... 40

7.5.3.3 Cntrol features for product status.................................................................... 40

7.5.4 Customer property ................................................................................................ 41


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7.5.5 Preservation of product ........................................................................................ 41

7.5.5.1 Control features for preservation of product.................................................. 41

7.5.5.2 Periodic assessment of stock........................................................................... 42

7.6 Control of monitoring and measuring devices ..................................................... 42

7.6.1 Control features for monitoring and measuring devices ................................. 43

7.6.2 Environmental conditions .................................................................................... 43

8 Measurement, analysis and improvement................................................................ 45

8.1 General....................................................................................................................... 45

8.2 Monitoring and measurement ................................................................................. 45

8.2.1 Customer satisfaction........................................................................................... 45

8.2.2 Internal audit .......................................................................................................... 46

8.2.3 Monitoring and measurement of processes ...................................................... 47

8.2.4 Monitoring and measurement of product........................................................... 47

8.2.4.2 Final acceptance of product.............................................................................. 47

8.3 Control of nonconforming product ........................................................................ 49

8.3.1 Release or acceptance of nonconforming product under concession. ......... 49

8.4 Analysis of data......................................................................................................... 51

8.5 Improvement ............................................................................................................. 52

8.5.1 Continual improvement ........................................................................................ 52

8.5.2 Corrective action ................................................................................................... 52

8.5.2.1 Corrective action response times .................................................................... 53

8.5.3 Preventive action ................................................................................................... 53

9.0 API monogram .......................................................................................................... 54


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1.0 Introduction

1.1 Company Introduction

VALVE‐TEK was established in 1986, we focus in development stainless steel valves, joint all

kinds of exhibition and keep in touch with Valves’ Industry. It is realized all standard form,

quality standard and service item, execute and understand business opportunity. High

quality, super efficiency and no defect is our goal.

We spare no pains to train administrant and invest high efficiency machine tools, we

aggravate not only enforce training supervisor and studying, but also renew our equipment

and inspection gauge. It is expect to acceptable by our clients for our ability in design and

manage all kinds of products and parts.

In order to match the national market need, besides, offer quality assurance for using our

products. We are under construction revision INTERANTIONAL QUALITY ASSURANCE

SYSTEM ISO 9001 (rev. 2008) in May, 2001. in order to build new documents quality

management system, ensure quality of products and service, continue to content with

clients and raise quality improvement’s required.

1.2 General

The quality system is meant standardization management system:

The manual outline specific requirement of Quality system, in order to avoid to occurring

any ineligibility condition during operation procedure from receiving order, purchasing,

machining, producing and delivering; approach quality assurance.

This manual outline quality system requirement, in order able to working on each step for

products quality assurance and ability for offer products.


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]This manual is base working in documents for quality management and quality guarantee

system of ISO 9001, it is base on our quality policy ensure our management and quality

assurance can be property effected working.

This manual delivers to major clients in order to make clients comprehend deeply our

quality management system, move up satisfaction and confidence.

Offering necessarily control process ensure manufacturing products is matched the required

and available to progress.

All employees will follow any change and development quality management system, quality

plan and any relative system, besides, will reach to any other staff.

New employee will be introduced and trained how to use quality system and affect.


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2.0 Quality Policy

QUALITY POLICY

To engage in manufacturing of industrial vales to ISO9001:2008, API Q1 and API

Specification 6D, our quality policy are: High Quality, High Efficiency, No

Defects.。

To implement this policy, Valve-Tek Enterprise Co. Ltd. (hereinafter called Valve-Tek)

established the quality system and documented in this Quality Manual (hereinafter

called Manual).

Through formal reporting systems and direct observation, the management is made

aware of problems involving product quality and take action as required to enforce the

requirements of the API Q1 and API Spec. and this Manual.

In order to fully support this Policy and Quality Control System, I the undersigned,

give the Quality Control Manager the freedom to identify Quality Control problems and

to provide solutions. The Quality Control Manager is responsible for the preparation

and revision of the Quality Control Manual and, after approval by me, for its issue and

implementation in the shop.

Tasks detailed in this Manual may be delegated to suitable qualified personnel within

the organization but the responsibility for the activity may not be delegated.


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All personnel are hereby instructed to give full compliance to this Manual and API

Specification.

Any problems concerning API Specification compliance that cannot be resolved by the

Quality Control Manager shall be brought to me for final resolution without

compromise of the Specification and this Quality Control Manual.

This manual may be translated into Chinese for the use of Non-English speaking

personnel however in the case of any conflict in understanding the requirements of the

English language version shall prevail.

Managing Director

Date


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3.0 Organization Chart

President Manageng

Director

Quality Assurance

Management

Representative

Production Department

Purchasing Department

Quality Control

Sales Department

Assembling section

Delivery section

Purchasing section

Sub‐Suppliers

Document Management

Warehouse section

Inspection Testing section

Design section

Financial Department


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4.0 Quality Management System

4.1 General requirements

Valve-Tek’s top management shall establish, document, implement and maintain a quality

management system and continually improve its effectiveness in accordance with the

requirements of ISO9001:2000 International Standard and API Q1.

Valve-Tek’s top management shall

a) identify and determine the processes needed for the quality management system and their

application throughout the company (refer to section 1.2).

b) determine the sequence and interaction of these processes.

c) determine criteria and methods needed to ensure that both the operation and control of

these processes are effective.

d) ensure the availability of resources and information necessary to support the operation and

monitoring of these processes.

e) appropriately monitor, measure and analyze these processes.

f) implement actions necessary to achieve planned results and continual improvement of these

processes.

The necessary processes of quality management system stated as above include management

operation, resource provision, product achievement, measurement, analysis and improvement.

These processes shall be managed by Valve-Tek in accordance with the requirements of the

International Standard.

Where Valve-Tek chooses to outsource any process that affects product conformity with

requirements, Valve-Tek shall ensure such process need to be involved under control. Control


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model and range of such outsourced process shall be identified within the quality management

system.

4.1.1 Outsourcing process is the process needed for quality management system to a company,

additionally, it is implemented by the external organization that selected by this company.

Ensure the control of outsourcing process, Valve-Tek shall regard the responsibility for conformity of all

customers, statutes and regulations as an essential condition. The control model and range applied in

outsourcing process will be affected by the following elements:

a) Through the outsourcing process, the potential effect of the company’s capability to provide products

in accordance with requirements.

b) Through the outsourcing process, the mutual control level.

c) The necessary control ability that has achieved through the section 7.4 application.

The quality management system of Valve-Tek includes all clauses of ISO9001: 2008 and API

Spec. Q1, without any exclusion.

4.2 Documentation requirements

4.2.1 General

The documentation of quality management system shall include following item:

a) documented statements of a quality policy and quality objectives.

b) a quality manual.

c) documented procedures and records required by the Standards.

d) documents needed by the Valve-Tek to ensure the effective planning, operation and control

of its processes, include the related records and


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e) quality records which required by ISO9001:2008, API Q1 and Product Spec. (refer to section

4.2.4)

The phrase documented procedure in this Standard is defined as an establishment,

documented operation, implement and maintenance of the procedure. One document could

be requested to state into one procedure or more. The requirement of documented

procedure could be involved in several documents.

Where the term “documented procedure” appears within this international Standard, this means

that the procedure is established,documented, implemented and maintained.

The extent of the quality management system documentation can differ from one organization

due to

a) the size of organization and type of activities.

b) the complexity of processes and their interactions, and

c ) the competence of personnel.

The documentation can be in any form or type of medium.

4.2.2 Quality Manual

The quality manual shall include:

a) the scope of the quality management system.

b) the documented procedures established for the quality management system, or

reference to them.

c) a description of the interaction between the processes of the quality management

system.

The processes which implementing company products, the supporting sequence and

interactions between quality management system are as follow.


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First Level:Quality Manual

Second Level:Procedure Book

Third Level:Working Standard

Fourth Level:Table Record

Notes:

quality, cost, quantity and delivery time; operate this quality system; cycle management, maintain

and keep improving to move up quality of products and service in order to match the requirement.

According to this system shall be satisfied by clients and confided in executive.

The quality manual shall identify the manner in which Valve-Tek addresses each specific

requirement of the Technical Specification, including the requirements of ISO 9001:2008 , API

Q1, API Product Spec and the supplemental requirements.

Policy

Objectives

Plan

Reviews &

Action

Monitoring &

Measure & Analyse


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4.2.2.1 ISSUE AND DISTRIBUTION CONTROL

The quality manual shall identify the manner in which the organization addresses each

Specific requirement of this Technical Specification , including both the requirements of ISO

9001:2008 and the supplemental requirements.

a) This Manual is classified in controlled copy and uncontrolled copy according to their intended use. Each controlled copy of Manual shall be assigned a unique control number. "Uncontrolled" Manual shall be issued as deemed necessary by the Q.A. Manager, Each Manual shall be stamped "Controlled" or "Uncontrolled" as applicable, only "Controlled Manual" will be used at Valve-Tek for API Monogram product.

b) This Manual shall be issued, distributed and controlled according to Valve-Tek’s “Document and Data Control Procedure, VT-02-4021”.

4.2.2.2 REVISION CONTROL

a) Each page of the Manual shall contain, as a minimum, revision number, date and section of the Manual.

b) The Manual shall be reviewed by Valve-Tek’s management to evaluate the quality system's continuing suitability and effectiveness when there are changes to applicable petroleum, petrochemical and natural gas industry standards that could affect the quality management system.

c) Revisions shall be sent to API for final acceptance.

d) Revisions shall be issued to all "controlled" Manual holders as shown in the Quality Manual Distribution Record.

e) Recipient of uncontrolled copies will not receive further revisions.


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4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a

special type of document and shall be controlled according to the requirements given in 4.2.4.

of this Manual.

The detail control features for control of quality management system documents and data shall

be according to Valve-Tek’s “Document and Data Control Procedure, VT-02-4021”.

A documented procedure shall be established to define the controls needed for the purpose of

a) to approve documents for adequacy prior to issue,

b) to review and update as necessary and re-approve documents,

c) to ensure that changes and the current revision status of documents are identified,

d) to ensure that relevant versions of applicable documents are available at points of use,

e) to ensure that documents remain legible and readily identifiable,

f) to ensure that external origin documents determined by the company for planning and

operation in quality management shall be identified and their distribution shall be

controlled, and

g) to prevent the unintended use of obsolete documents, and to apply suitable identification

to them if they are retained for any purpose.

h) Changes to documents shall be reviewed and approved by the same functions that

performed the original review and approval.

4.2.3.1 Control of documents


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A master list shall be used to identify the documents required by the quality management

system, and their current revision status.

4.2.3.2 Control of document changes

Changes to documents shall be reviewed and approved by the same functions that

Performed the original review and approval.

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to the

requirements and of the effective operation of the quality management system. Records shall

remain legible, readily identifiable and retrievable.

A documented procedure shall be established to define the controls needed for the

identification, storage, protection, retrieval, retention time and disposition of records. Records

shall remain legible, readily identifiable and retrievable.

4.2.4.1 All records required by applied industry product standards or to provide evidence of

conformity to requirements and of the effective operation of the quality management system

shall be retained for not less than the period of time specified by the industry standard or five

years, whichever is longer.

The detail control features for control of Valve-Tek quality management system records shall

according to Valve-Tek’s “Quality Records Control Procedure, VT-02-4023”.


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Collection the process of obtainining,assembling and/or organizing applicable documentation

with the intent of meeting requirements of 4.2.4.

5 Management responsibility

5.1 Management commitment

Valve-Tek’s top management shall made a commitment to the development and implement of

the quality management system and continually improving its effectiveness by

a) communicating to the Valve-Tek the importance of fulfilling of customer’s requirements as

well as statutory and regulatory requirements,

b) establishing the quality policy,

c) ensuring that quality objectives are established,

d) conducting management reviews, and

e) ensuring the availability of resources.

5.2 Customer focus

Valve-Tek’s top management shall ensure that the customer requirements are determined and

are met with the aim of enhancing customer satisfaction.

5.3 Quality policy

Valve-Tek’s top management shall ensure that the quality policy

a) is appropriate to the goal of the Valve-Tek,


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b) includes a commitment to comply with requirements and continually improve the

effectiveness of the quality management system,

c) provides a framework for establishing and reviewing quality objectives,

d) is communicated and understood within the Valve-Tek, and

e) is reviewed for continuing suitability.

5.3.1 Quality policy

Top management shall document its approval of the quality policy.

Valve-Tek’s top management shall document its approval of the quality policy as stated in

section 2 of this manual.

5.4 Planning

5.4.1 Quality Objectives

Valve-Tek’s top management shall ensure that quality objectives, including those needed to

meet requirements for products, are established at relevant functions and levels within the

company. The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planning

Valve-Tek’s top management shall ensure that


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a) the planning of the quality management system is carried out in order to meet the

requirements given in section 4.1 of this Manual, as well as the quality objectives, and

b) the integrity of the quality management system is maintained when any changes to the

quality management system are planned and implemented.

See also 5.6,7.1,7.1.1,7.3.1,7.5.1,8.1 and 8.2.2 for other planning requirements.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Valve-Tek’s top management shall ensure that the responsibilities and authorities are defined

and communicated within the Valve-Tek.

The detail control features for control of Valve-Tek’s responsibilities and authorities shall be

according to Valve-Tek’s “Responsibilities and Authorities Control Procedure, VT-02-5011”.

Valve-Tek’s organization of the quality management system is described as in section 3.0

organization charts of this manual.

5.5.2 Management representative

Valve-Tek’s top management shall appoint a member who, irrespective of other responsibilities,

shall have the responsibility and authority of following items,

a) ensuring that the processes needed for the quality management system are established,

implemented and maintained,


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b) reporting to Valve-Tek’s top management on the performance of the quality management

system and any need for improvement,

c) ensuring the promotion of awareness of customer requirements throughout the company.

d) The responsibility of a management representative can include liaison with external parties

on matters relating to the quality management system.

5.5.3 Internal communication

Valve-Tek’s top management shall ensure that appropriate communication processes are

established within the Valve-Tek and that communication takes place regarding the

effectiveness of the quality management system.

5.6 Management review

5.6.1 General

Valve-Tek’s top management shall review the quality management system, at least annually, to

ensure its suitability, adequacy and effectiveness. This review shall include assessing for the

improvement and the need for changes to the quality management system. The assessment

shall including the quality policy and quality objectives. Part of the management review shall

include monitoring of quality objectives.

Records from management reviews shall be maintained.(see 4.2.4)

5.6.1.1 General

The Management review shall be conducted at least annually.

5.6.1.1 includes monitoring of quality objectives as part of the management review.


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5.6.2 Review input

The input of management review shall include following information:

a. Continuing suitability for Quality policy.

b. Performance and improvement needed for Quality objectives.

c. Results of audits, including the second and third party audits, if applicable.

d. Customer feedback (positive and negative feedback, customer satisfaction).

e. Process performance, product conformity, and in conjunction with data analysis,

includes trends of product nonconformity.

f. Reports and analysis of field nonconformities, if applicable.

g. Status of preventive and corrective actions.

h. Follow-up actions from previous management reviews.

i. changes that could affect the quality management system.

j. changes to applicable petroleum, petrochemical and natural gas industry standards

that could affect the quality management system.

k. recommendations for improvement,

5.6.2 c) in conjunction with 8.4 c) includes trends of product nonconformity. 5.6.2 c)

5.6.2 f) includes changes to applicable petroleum,petroleum,petrochemical and natural gas

industry standards.

5.6.2 c) includes reports and analysis of field nonconformities(see 3.1.9),if applicable. 5.6.2 c)

5.6.3 Review output


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The output from management review shall include any decisions and actions related to

following items,

a) improvement of the effectiveness of the quality management system and its processes,

b) improvement of product related to customer requirements, and

c) resource needs.

6 Resource management Process

6.1 Provision of resources

Valve-Tek shall determine and provide the resources needed

a) to implement and maintain the quality management system and continually improve its

effectiveness, and

b) to enhance customer satisfaction by meeting customer requirements.

6.2 Human resources

6.2.1 General

Personnel in Valve-Tek performing work affecting product quality shall be competent on the

basis of appropriate education, training, skills and experience.

In the quality system, personnel who implements work shall directly or indirectly affects the conformity

of requirement of product.


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6.2.2 Competence, awareness and training

Valve-Tek shall

a) determine the necessary competence for personnel performing work which affect the product

quality,

b) appropriately provide training or take other actions to satisfy these needs,

c) evaluate the effectiveness of the actions taken,

d) 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, and

e) maintain appropriate records of education, training, skills and experience.

f) provide on-the-job training for personnel in any new or modified job affecting product quality,

including contract or agency personnel.

6.2.2.1 Trainingl

The organization shall establish control features (see 3.1.4) for identifying training needs and Providing for training of personnel who perform activities addressed in quality management

system. The training requirements shall provide for quality management system training and

for job training personnel. The frequency of training shall be defined by the organization.

6.2.2.1 provides on-the-job training for personnel in any new or modified job affecting product

quality, including contract or agency personnel.

6.2.2.1 includes having a process to measure the extent to which its personnel are aware of

the relevance and importance of their activities and how they contribute to the achievement of

the quality objectives [see 6.2.2 d]. personnel whose work can affect quality should be informed

about the consequences to the customer of nonconformity to quality requirements.


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The training requirements shall be provided for quality management system training and for

job training of personnel and shall be according to Valve-Tek’s “Resource Offering

Management Procedure, VT-02-6011”. The frequency of training shall be defined in this

procedure.

6.3 Infrastructure

Valve-Tek shall determine, provide and maintain the infrastructure needed to achieve

conformity product requirements. Infrastructure includes, as applicable.

a) buildings, workspace and associated utilities,

b) process equipment (both hardware and software), and

c) supporting services (such as transport , communication or information system).

Valve-Tek’s infrastructure shall be controlled and maintained in accordance with Infrastructure

control procedure, VT-03-7056 to ensure the production capabilities can be sustained.

6.4 Work environment

Valve-Tek shall determine and manage the work environment needed to achieve conformity to

product requirements and maintain its premises in a state of order, cleanliness and repair

consistent with the product and manufacturing process needs.

The phrase work environment in this Standard is defined as a situation under working, includes

physical, environmental and other elements (such as noise, temperature, humidity, illumination

and weather).

6.4 includes maintaining its premises in a state of order, cleanliness and repair consistent with

the product and manufacturing process needs.


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7 Product Realization

7.1 Planning of product realization

Valve-Tek shall plan and develop the processes needed for product realization. Planning of

product realization shall be consistent with the requirements of the other processes of the

quality management system.

In planning product realization, Valve-Tek shall determine the following, as appropriate:

a) quality objectives and requirements for the product;

b) the need to establish processes, documents, and provide resources specific to the product;

c) required verification, validation, monitoring, inspection, measurement and test activities

specific to the product and the criteria for product acceptance;

d) records needed to provide evidence that the realization processes and resulting product

meet requirements.

The output of this planning shall be in a form suitable for Valve-Tek’s method of operations.

A document specifying the processes of the quality management system (including the product

realization processes) and the resources to be applied to a specific product, project or contract,

shall be referred to as a quality plan.

The organization may also apply the requirements given in 7.3 to the development of product

realization processes.

7.1.1 Planning of product realization


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When product requirements are provided from external sources, the organization shall the

methods and shall establish control features (see 3.1.4) used to translate these requirements

into the product realization process.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

Valve-Tek shall determine

a) requirements specified by the customer, including the requirements for delivery and post-

delivery activities,

b) requirements not stated by the customer but necessary for specified or intended use, where

known,

c) statutory and regulatory requirements suitable for use in product, and

d) any additional requirements Valve-Tek demands.

After‐shipment activities include the service in accordance with engagement clause, maintenance service and

obligation of contract, additional recycling and waste disposal.

7.2.2 Review of requirements related to the product

Valve-Tek shall review the requirements related to the product. This review shall be conducted

prior to Valve-Tek’s commitment to supply a product to the customer (e.g. submission of

tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and

shall ensure that


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a) product requirements are defined,

b) contract or order requirements differing from those previously expressed are resolved, and

c) Valve-Tek has the ability to meet the defined requirements.

Records of the review results and actions arising from the review shall be maintained .

Where the customer provides no documented statement of requirement, the customer

requirements shall be confirmed by Valve-Tek before acceptance.

Where product requirements are changed, Valve-Tek shall ensure that relevant documents are

amended and that relevant personnel are made aware of the changed requirements.

The detail control features for review of requirements related to the products shall be according

to “Contract/Order Review Control Procedure, VT-02-7021”.

7.2.3 Customer communication

Valve-Tek shall determine and implement effective arrangements for communicating with

customers in relation to

a) product information,

b) enquiries, contracts or order handling, including amendments, and

c) customer feedback, including customer complaints.

The detail control features for management of the customer communication shall be according

to “Customer communication Control Procedure, VT-02-8021”.


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7.3 Design and Development Process

7.3.1 Design and development planning

Design Manager shall be in charge of planning and controlling the design and development of

product.

He shall determine following item during the design and development planning

a) the design and development stages,

b) the review, verification and validation that are appropriate to each design and development

stage, and

c) the responsibilities and authorities for design and development.

The interfaces between different groups involved in design and development to ensure

effective communication and clear assignment of responsibility shall be managed.

Planning output shall be updated, as appropriate, as the design and development progresses.

7.3.1.1 Design and development planning- Supplemental

The organization shall establish control features (see 3.1.4) for the design of the product.

When design and development are outsourced, the Design Manager shall ensure the supplier

meets all the requirements of section 7.3 of this Manual and provide objective evidence that the

supplier has met these requirements.

7.3.1.2 Design documentation – Supplemental

Design documentation shall include the methods, assumptions, formulas, and calculations.


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The review and verification of design & development is namely the procedures that affirm the

unambiguous purpose, respectively or identically implement and record according to the

appropriate circumstances of product and organization.

The detail control features for the design and development of the product shall be according to

Valve-Tek’s “Product Design and Development Control Procedure, VT-02-7031.

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained. These

inputs shall include (see 4.2.4)

a) functional and performance requirements,

b) applicable statutory and regulatory requirements,

c) where applicable, information derived from previous similar designs, and

d) other requirements essential for design and development

e) design and development inputs of new products shall include customer specified

requirements

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous

and not in conflict with each other.

7.3.2.1 Design and development inputs

The organization shall identify, document and review the product design input requirements.

Design and development inputs shall include customer specified requirements (see 7.2.2).


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7.3.3 Design and development outputs

The outputs of design and development shall be verified under an appropriate form against the

design and development input and shall be approved prior to release.

Design and development outputs shall

a) meet the input requirements for design and development,

b) provide appropriate information for purchasing, production and for service provision,

c) contain or reference product acceptance criteria, and

d) specify the characteristics of the product that are essential for its safe and proper use.

The information provided from production and service includes the specification of product’s protection.

7.3.3.1 Design and development outputs- Supplemental

Design and development outputs shall be documented.

7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in

accordance with planned arrangements.

a) to evaluate the ability of the results of design and development to meet requirements, and

b) to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the

design and development stage(s) being reviewed. Records of the results of the reviews and

any necessary actions shall be maintained.


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The Design Manager, or designated person other than the person who developed the design,

shall conduct the final design review. The design review shall be defined and documented in

design planning.

7.3.4.1 Design and development review

A final design review shall be conducted and documented. Individual(s) other than the person or persons who developed the design shall approve the final design.

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements to ensure that the

design and development outputs have met the design and development input requirements.

Design verification activities can include one or more of the following:

a. Confirming the accuracy of design results through the performance of alternative

calculations.

b. Review of design output documents independent of activities of 7.3.4.

c. Comparing new designs to similar proven designs.

Records of the results of the verification and any necessary actions shall be maintained.

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned

arrangements to ensure that the resulting product is capable of meeting the requirements for


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the specified application or intended use, where known. Wherever practicable, validation shall

be completed prior to the delivery or implementation of the product.

Design validation can include one or more of the following:

a. Prototype tests.

b. Functional and/or operational tests of production products.

c. Tests specified by industry standards and/or regulatory requirements.

d. Entrust customer to perform field performance tests and reviews.

e. Entrust national or international supervising and testing body to perform identification test.

Records of the results of validation and any necessary actions shall be maintained.

7.3.7 Control of design and development changes

Design and development changes shall be identified and records maintained. The changes

shall be reviewed, verified and validated, as appropriate, and approved before implementation.

The review of design and development changes shall include evaluation of the effect of the

changes on constituent parts and product already delivered. Records of the results of the

review of changes and any necessary actions shall be maintained. (refer to section 4.2.4)

7.3.7.1 Design and development changes, including changes to design documents, shall

require the same controls as the original design and development, and design documentation.


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7.4 Purchasing Process

7.4.1 Purchasing process

Valve-Tek shall ensure that purchased products and services that affect customer

requirements conform to specified purchase requirements. The type and extent of control

applied to the supplier and the purchased product shall be dependent upon the effect of the

purchased product on subsequent product realization or the final product. The detail control

features for the purchasing process shall be according to Valve-Tek’s “ Purchasing Process

Control Procedure, VT-02-7041”

7.4.1.1 Purchasing process

The organization shall establish control features (see 3.1.4) for the purchasing process and

supplier selection.

Purchased products above include all products and services that affect compliance with

customer requirements.

Valve-Tek shall evaluate and select suppliers based on their ability to supply product in

accordance with Valve-Tek’s requirements Criteria for selection, evaluation and re-evaluation

shall be established.

Records of the results of evaluations and any necessary actions arising from the evaluation

shall be maintained.

7.4.1.2 Criteria for Supplier Selection, Evaluation, and Re-evaluation.

The criteria for the selection, evaluation and re-evaluation of Valve-Tek’s suppliers shall include

one or more of the following:


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a) inspection of supplier’s final product by Valve-Tek at supplier’s facility,

b) inspection of supplier’s final product by Valve-Tek upon delivery,

c) surveillance of supplier’s conformance to Valve-Tek’s purchasing requirements,

d) verification by Valve-Tek that the supplier’s quality management system conforms to an

internationally recognized quality management system standard/technical specification.

The detail control features and criteria for selection, evaluation and re-evaluation shall be

according to Valve-Tek’s “Purchasing Management Procedure, VT-02-7041.

When there are mergers, acquisitions or affiliations associated with suppliers, consideration

includes the organization verifying the continuity of the supplier’s quality management system

and its effectiveness.

7.4.1.3 Supplier provided special processes

Where Valve-Tek chooses to outsource any special process, Valve-Tek shall require the

supplier comply with the requirements of 7.5.2 of this Manual, as applicable.

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where

appropriate

a) requirements for approval of product, procedures, processes and equipment,

b) requirements for qualification of personnel, and

c) quality management system requirements, and

d) the type, class, grade or other precise identification, and

e) the title or other positive identification, and applicable issues of specifications, drawings,

process requirements, inspection instructions and other relevant technical data.


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Valve-Tek shall ensure the adequacy of specified purchase requirements prior to their

communication to the supplier.

7.4.2.1 Purchasing information

Purchasing information provided to the supplier shall be documented and shall describe the

product to be purchased including, where appropriate, the items in 7.4.2, as well as

a) the type,class,grade or other precise identification,and

b) the title or other positive identification, and applicable issues of specifications, drawings,

process requirements, inspection instructions and other relevant thchnical data.

7.4.3 Verification of purchased product

Valve-Tek shall establish and implement the inspection or other activities necessary for

ensuring that purchased product meets specified purchase requirements.

Where Valve-Tek or its customer intends to perform verification at the supplier’s premises,

Valve-Tek shall state the intended verification arrangements and method of product release in

the purchasing information.

The organization shall establish control features (see 3.1.4) for the verification of purchased

product. The organization shall maintain records of verification activities (see 4.2.4) VT-02-

8023”.

7.5 Production and service provision

7.5.1 Control of production and service provision

Valve-Tek shall plan and carry out production and service provision under controlled conditions.

Controlled conditions shall include, as applicable


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a. the availability of information that describes the characteristics of the product,

b. the availability of work instructions, as necessary,

c. the use of suitable equipment,

d. the availability and use of monitoring and measuring devices,

e. the implementation of monitoring and measurement, and

f. the implementation of release, delivery and post-delivery activities.

7.5.1.1 Control of production and service provision

The detail control features for the control of production and service activities performed shall be

according to Valve-Tek’s “Production Process Control Procedure, VT-02-7051”.

The organization shall establish control features (see 3.1.4) that describe the control of

production and service activities performed.

7.5.1.2 Process controls

Process controls shall be documented in routings, travelers, checklists, process sheets, or

other types of control features and shall include requirements for verifying compliance with

quality plans, control features, and reference standards. The process control documents shall

include or reference instructions, workmanship and acceptance criteria for processes, tests,

inspections, and customer’s inspection hold or witness points.

The Process Control/Quality Plan is prepared for the documentation of process controls. The

QA Manager is responsible for approval of the quality plan.


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The Process Control/Quality Plan shall include and acceptance criteria for processes/special

process, tests, inspections, test frequency and customer’s inspection hold or witness points, as

appropriate. The criteria for workmanship shall be stipulated in written standards or

representative samples.

The Process Control/ Quality Plan also describes, but not be limited to, the processes

(operations), control status, relevant procedures or instructions to be used for the monitoring

and/or control of the processes and product characteristics as required to meet API specified

requirements.

7.5.2 Validation of processes for production and service provision/Special processes

Valve-Tek shall validate any processes or special processes for production and service

provision where the output cannot be verified by subsequent monitoring or measurement, and

any processes where deficiencies become apparent after the product is in use or the service

has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

Valve-Tek shall establish arrangements for these processes including, as applicable

a. defined criteria for review and approval of the processes,

b. approval of equipment and qualification of personnel,

c. use of specific methods and procedures,

d. requirements for records (see 4.2.4), and

e. revalidation.

7.5.2.1 Control features for Validation of processes for production and service provision


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Valve-Tek’s control features that include activities of 7.5.2 for the qualification and validation of

special processes for production and service provision shall be according to Valve-Tek’s

“Production Process Control Management Procedure, VT-02-7051”. Such control features shall

include the qualification and validation of special processes.

7.5.2.2 Valve-Tek’s special processes for production and service provision

a) Special Processes conducted in Valve-Tek are Welding, Repair Welding, Heat treatment and NDE/NDT of Steel Casting or Forging used in Industrial Valves.

b) All welding/repair welding shall carry out according to qualified Welding procedure Specification (WPS) by Qualified Welders or Welding Operators. The WPS and welders shall be qualified in accordance with the ASME Boiler And Pressure Vessel Code Section IX, Welding and Brazing Qualification or API Std 1104. The results shall be documented in the PQR and Welder Qualification Test Record (WPQ).

c) All heat treatment and NDE/NDT operation of raw material shall be according to qualified control procedures established by Valve-Tek.

d) All Special Processes conducted by Valve-Tek shall be validated/re-validated in accordance with above mentioned to demonstrate the processes are achieved to planned results.

e) The Special Processes may be outsorced /subcontracted. However, the Quality manager shall be responsible for the monitoring and controlling that the validation/re validation of these subcontracted special processes are in accordance with above mentioned requirements from 7.5.2.2 a) to 7.5.2.2 d).

7.5.3 Identification and traceability


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Where appropriate, Valve-Tek shall identify the product by suitable means throughout

product realization.

Valve-Tek shall identify the product status with respect to monitoring and measurement

requirements through the production procedure.

Where traceability is a requirement, Valve-Tek shall control the unique identification of the

product and maintain the record.

7.5.3.1 Control features for Identification and traceability, and control features for

Identification and traceability maintenance and replacement

Valve-Tek shall control identification and traceability of the product by suitable means from

receipt, during all stages of production, delivery to installation, as required by Valve-Tek, the

customer, and the applicable product specifications.

7.5.3.2 ldentification and traceability maintenance and replacement

The detail control features for the control of identification and traceability of the product and the

requirements for maintenance or replacement of identification and traceability marks, and

records shall be according to Valve-Tek’s “Product Identification and Traceability Control

Procedure, VT-02-7052”.

7.5.3.3 Cntrol features for product status

The detail control features for the identification of product status shall be according to Valve-

Tek’s “Inspection and Test Management Procedure, VT-02-8023”.


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7.5.4 Customer property

Valve-Tek shall exercise care with customer property while it is under Valve-Tek’s control

or being used by Valve-Tek. Valve-Tek’s Design Manager shall identify, verify, protect and

safeguard customer property provided for use or incorporation into the product. If any

customer property is lost, damaged or otherwise found to be unsuitable for use, this shall

be reported to the customer and records maintained by Valve-Tek. (refer to section 4.2.4)

Customer property can include intellectual property(ies) and personal information.

7.5.4.1 Customer property

The detail control features for the verification, storage, maintenance and control of customer

property shall be according to Valve-Tek’s “Customer Property Control Procedure, VT-02-

7053”.

7.5.5 Preservation of product

Valve-Tek shall preserve the product to maintain its conformity during internal processing and

delivery to the intended destination. As available, this preservation shall include identification,

handling, packaging, storage and protection. Preservation shall also apply to the constituent

parts of a product.

7.5.5.1 Control features for Preservation of product

Valve-Tek shall control the methods used to preserve the conformity of product for the activities

of 7.5.5.


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The detail control features for the verification, storage, maintenance shall be according to

Valve-Tek’s “Preservation of product Control Procedure, VT-02-7054”.

7.5.5.2 Periodic assessment of stock

To detect deterioration, the condition of product or constituent parts in stock shall be assessed

at least annually.

Valve-Tek should use an inventory management system to optimize inventory turns over time

and assure stock rotation, such as “first-in-first-out” (FIFO).

7.6 Control of monitoring and measuring devices

Valve-Tek shall determine the monitoring and measurement to be undertaken and the

monitoring and measuring devices needed to provide evidence of conformity of product to

determined requirements.

Valve-Tek shall establish processes to ensure that monitoring and measurement can be

carried out and are carried out in a manner that is consistent with the monitoring and

measurement requirements.

Where necessary to ensure valid results, measuring equipment shall

a. be calibrated or verified at specified intervals, or prior to use, against measurement

standards traceable to international or national measurement standards or both of them;

where no such standards exist, the basis used for calibration or verification shall be

recorded; (refer to section 4.2.4)

b. be adjusted or re-adjusted as necessary;

c. be provided with identification to enable the calibration status to be determined;

d. be safeguarded from adjustments that would invalidate the measurement result;


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e. be protected from damage and deterioration during handling, maintenance and storage.

In addition, Valve-Tek shall assess and record the validity of the previous measuring results

when the equipment is found not to conform to requirements. Valve-Tek shall take appropriate

action on the equipment and any product affected. The records of correction and verification

results shall be maintained (refer to section 4.2.4).

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.

Records of the results of calibration and verification shall be maintained (refer to section 4.2.4).

Confirm that if the computer software device fulfills the application capability as anticipation,

typically its verification and model management shall be included to maintain the

appropriateness in use.

7.6.1 Control features for monitoring and measuring devices

Valve-Tek’s control features to control, calibrate and maintain monitoring and measuring

devices shall be according to Valve-Tek’s “Inspection, Testing, Measuring and Examination

Devices Control Procedure, VT-02-7061”.

Control features shall include device type, unique identification, location, frequency of checks,

check method, and acceptance criteria.

7.6.2 Environmental conditions

The environmental conditions shall be ensured for the compliance with requirement of established control features for the calibrations being carried out.


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The Quality Engineers shall ensure that the environmental conditions are in compliance with requirement of established control features for the inspections, measurements and tests being carried out.

Records of the calibration/verification activity for all gauges, measuring and test equipment,

needed to provide evidence of conformity of product to determined requirements, including

employee and customer owned equipment should include:

equipment identification, including the measurement standard against which the

equipment is calibrated,

revisions following engineering changes,

any out-of-specification readings as received for calibration verification,

an assessment of the impact of out-of-specification condition, and

notification to the customer if suspect product or material has been shipped.


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8 Measurement, analysis and improvement

8.1 General

Valve-Tek shall plan and implement the monitoring, measurement, analysis and improvement

processes needed

a) to demonstrate conformity of the product requirement,

b) to ensure conformity of the quality management system, and

c) to continually improve the effectiveness of the quality management system.

This shall include determination of applicable methods, including statistical techniques, and the

extent of their use.

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

As one of the measurements of the performance of the quality management system, Valve-

Tek shall monitor information relating to customer perception as to whether Valve-Tek has met

customer requirements. The methods for obtaining and using this information shall be

according to “Customer Service Management Procedure, VT-02-8021”..

Customer satisfaction monitoring is various input resources included such as: the investigation

of customer satisfaction, customer information for product quality, examination of user

opinion, analysis of loss business, appreciation, undue compensation, distributor report and so

on.


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8.2.2 Internal audit

Valve-Tek shall conduct internal audits at planned intervals to determine whether the quality

management system

a) conforms to the planned arrangements, to the requirements of this International Standard

and to the quality management system requirements established by Valve-Tek, and

b) is effectively implemented and maintained.

An audit program shall be planned, taking into consideration the status and importance of the

processes and areas to be audited, as well as the results of previous audits. The audit criteria,

scope, frequency and methods shall be defined. Selection of auditors and conduct of audits

shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own

work.

Documented process shall be established to classify responsibility and requirement in use for

planning, audit implement, record foundation and result report.

The records of audit and its results shall be maintained (refer to section 4.2.4).

The management responsible for the area being audited shall ensure that actions are taken

without undue delay to eliminate detected nonconformities and their causes. Follow-up

activities shall include the necessary modification and correction of the actions taken and the

reporting of verification results.

The control features for responsibilities and requirements for planning and conducting audits,

and for reporting results and maintaining records shall be according to documented Internal

audit control procedure, VT-02-8022.

See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidande.


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8.2.2.1 Internal audit

Internal audits shall be scheduled and conducted at least annually by personnel independent of those who performed or directly supervised the activity being audited.

8.2.2.2 Response times- Supplemental

Response times for submission of an action plan to address detected nonconformities shall be identified.

8.2.3 Monitoring and measurement of processes

Valve-Tek shall apply suitable methods for monitoring and, where applicable, measurement of

the quality management system processes. These methods shall demonstrate the ability of the

processes to achieve planned results. When planned results are not achieved, correction and

corrective action shall be taken, as appropriate.

Any processes changes, the record of effective dates should be maintained.

Once the appropriate method is taken, Valve‐Tek shall examine the suitable model and range

of monitoring and measurement for achieving the conformity of product requirement and the

effectiveness of quality management of each process.

8.2.3 includes maintaining records of the effective dates of process changes.

8.2.4 Monitoring and measurement of product

Valve-Tek shall monitor and measure the characteristics of the product to verify that product

requirements have been met. This shall be carried out at appropriate stages of the product

realization process in accordance with the planned arrangements (refer to section 7.1).

Evidence of conformity with the acceptance criteria shall be maintained.


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Records shall indicate the person(s) authorizing product release for customer (refer to section

4.2.4).

Product release and service delivery shall not proceed until the planned arrangements have

been satisfactorily completed (refer to section 7.1), unless otherwise approved by a relevant

authority and, where applicable, by the customer.

8.2.4.1 Monitoring and measurement of product- Supplemental

The detail control features for monitoring and measuring the characteristics of the products shall be according to Valve-Tek’s “Inspection and Test Management, VT-02-8023”.

The organization shall establish control features (see 3.1.4) to monitor and measure the characteristics of the product.

8.2.4.2 Final Acceptance of Product.

Valve-Tek shall assign a person other than the persons who performed or directly supervised the production of the materials or products to perform final acceptance and product release.


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8.3 Control of nonconforming product

Valve-Tek shall ensure that product which does not conform to product requirements is

identified and controlled to prevent its unintended use or delivery. The controls and related

responsibilities and authorities for dealing with nonconforming product shall be defined in an

establishment of documented procedure.

As available, Valve-Tek shall deal with non-conforming product by one or more of the following

ways

a) by taking action to eliminate the detected nonconformity;

b) by authorizing its use, release or acceptance under concession by a relevant authority and,

where applicable, by the customer;

c) by taking action to preclude its original intended use or application.

d) When nonconforming product is detected after delivery or use has started, the Valve‐Tek shall take action appropriate to the effects, or potential effects, of the nonconformity.

e)

Records of the nature of nonconformities and any subsequent actions taken, including

concessions obtained, shall be maintained (refer to section 4.2.4).

When nonconforming product is corrected it shall be subject to re-verification to demonstrate

conformity to the requirements.

8.3.1 Release or Acceptance of Nonconforming Product Under Concession.

The process of evaluation, release and acceptance of nonconforming product shall include one

or more of the following:


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The QA Manager and Design Manager shall be responsible for evaluation, release and

acceptance of nonconforming product(s). The process of evaluation, release and acceptance

of nonconforming product shall include one or more of the following:

a. Accepting products that do not satisfy manufacturing acceptance criteria provided:

a) Products satisfy the design acceptance criteria, or

b) The violated manufacturing acceptance criteria are categorized as unnecessary to

satisfy the design acceptance criteria, or

c) Products are repaired or reworked to satisfy the design acceptance criteria or

manufacturing acceptance criteria.

b. Accepting products that do not satisfy the original design acceptance criteria provided:

a) the original design acceptance criteria are changed per 7.3.7 of this Manual, and

b) the materials or products satisfy the new design acceptance criteria.

The control features for non conformity shall be according to documented non conformity

control procedure, VT-02-8031.

8.3.2 Field nonconformity analysis

The documented procedure for nonconforming product shall include requirements for

identifying, documenting and reporting incidents of field nonconformities of product failures

(see 3.1.9 ). The documented procedure shall ensure the analysis of field nonconformities,


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product of documented evidence supporting the nonconformity is available to facilitate the

determination of the cause.

8.3.3 Customer notification

The organization shall notify customers in the event that product which does not conform to

design acceptance criteria (see 3.1.6) has been delivered. The organization shall maintain

records of such notifications (see 4.2.4).

8.4 Analysis of data

Valve-Tek shall determine, collect and analyze appropriate data to demonstrate the suitability

and effectiveness of the quality management system and to evaluate where continual

improvement of the effectiveness of the quality management system can be made. This shall

include data generated as a result of monitoring and measurement and from other relevant

sources.

The analysis of data shall provide information relating to

a) customer satisfaction,

b) conformity to product requirements(refer to section 8.4.2),

c) characteristics and trends of processes and products including opportunities for

preventive action (refer to section 8.2.3 and 8.2.4), and

d) suppliers (refer to section 7.4).

8.4.1 Analysis of data

The detail control features for identification and use of the techniques for the analysis of data

shall be according to Valve-Tek’s “Statitic Technique Management Procedure, VT-02-8041”.


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8.5 Improvement

8.5.1 Continual improvement

Valve-Tek shall continually improve the effectiveness of the quality management system

through the use of the quality policy, quality objectives, audit results, analysis of data,

corrective and preventive actions and management review.

The process and control features for continual improvement of the QMS shall be according to

Valve-Tek’s “Corrective & Preventive Action Management Procedure, VT-02-8051”.

8.5.2 Corrective action

Valve-Tek shall take action to eliminate the cause of nonconformities in order to prevent

recurrence. Corrective actions shall be appropriate to the effects of the nonconformities

encountered.

A documented procedure shall be established to define requirements for

a) reviewing nonconformities (including customer complaints),

b) determining the causes of nonconformities,

c) evaluating the need for action to ensure that nonconformities do not recur,

d) determining and implementing action needed,

e) records of the results of action taken, and


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f) reviewing the effectiveness of corrective action taken.

QA Manager shall ensure that any corrective action is effective.

8.5.2.1 Corrective action response times

The organization shall ensure that any corrective action is effective.

8.5.2.2 Response times

The detail control features for corrective action shall be according to Valve-Tek’s “Corrective

Actions/Preventive Actions Control Procedure, VT-02-8051”.

8.5.3 Preventive action

Valve-Tek shall determine action to eliminate the causes of potential nonconformities in order

to prevent their occurrence. Preventive actions shall be appropriate to the effects of the

potential problems.

A documented procedure shall be established to define requirements for

a) determining potential nonconformities and their causes,

b) evaluating the need for action to prevent occurrence of nonconformities,

c) determining and implementing action needed,

d) records of results of action taken (see 4.2.4), and


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e) reviewing the effectiveness of preventive action taken.

8.5.3.1 Preventive action

Valve‐tek shall ensure that any preventive action is effective.

The detail control features for preventive actions shall be according to Valve-Tek’s “Corrective Actions/Preventive Actions Control Procedure, VT-02-8051”.

9.0 API Monogram

Valve-Tek shall control the application of the API Monogram in accordance with the following:

a. The marking / monogram for API 6D products shall be according to established “API

Monogram Marking Procedure, VT-02-9001 “ that documents the marking /

monogramming requirements specified by the API Q1, API 6D and API 600 specification

to be used for application of the API Monogram to API monogrammable products.

The marking procedure shall define the location(s) where the Licensee shall apply the

API Monogram and require that the authorized Valve-Tek’s license number and date of

manufacture be marked on monogrammed valve 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., 01-05 for January 2005) unless otherwise

stipulated in the applicable API product specification. Where there are no API product


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specification marking requirements, Valve-Tek shall define the location(s) where this

information is applied in Valve-Tek API Monogram Marking Procedure, VT-02-9001.

b. The API Monogram may be applied at any time appropriate during the production

process but shall be removed 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. The API Monogram shall be applied to API monogrammable products at Valve-Tek

facility only. In certain instances when a subcontractor to the Valve-Tek performs

operations on the product that unavoidably remove or obliterate the API Monogram,

does not allow the subcontractor to reapply the API Monogram and all required marking

information provided the reapplication is controlled by the Valve-Tek per the “ API

Monogram Marking Procedure”.

d. The API Monogram shall be applied to API monogrammable products at the Valve-Tek

facility only. When required, the API Monogram information may be reapplied as

described above in c.

e. The QA Manager shall be responsible for applying and removing the API Monogram ,

which is defined in Valve-Tek’s “ API Monogram Marking Procedure, VT-02-9001”.

Valve Teck - Quality Manual Apiq

Documents

teks top management

quality management

detail control

teks control

establish

api monogrammable

current revision

implementing