quality manual · 2010. 3. 4. · quality manual doc no. : qm-01 section 0.1 revision table &...

QUALITY MANUAL

(ISO 9001:2008 &API Q1:8th & PED 97/23/EC)

Document No. : QM-01 Revision No. : 6

PEACH VALVE (BAVCOS)

□ Controlled Copy (Serial No.: ) ▣ Uncontrolled Copy

QUALITY MANUAL Doc No. : QM-01

Section 0.1 REVISION TABLE & CONTENTS Page : 1 of 2

SIGN

DATE

SIGN

DATE

SIGN

DATE

SIGN

DATE

SIGN

DATE

SIGN 6

DATE 2009.08.13

2009.08.14

Additional revision in

accordance with API

Spec. Q1-8th Edition.

SIGN

5

DATE 2009. 4.

2009.04.17

Addition

4.1.6

4.1.7

SIGN 4

DATE 2006.03.06

2006.03.06

Change Company

name,logo,revision table,

Scope & Organization

chart

SIGN

3 DATE 2004.06.01

2004.06.01

REVISION NO. PREPARATION

( QA TEAM )

REVIEW

( → )

APPROVAL

(PRESIDENT) REMARKS

QUALITY MANUAL Doc No. : QM-01

Section 0.1 REVISION TABLE & CONTENTS Page : 2 of 2

Section T i t l e Rev. No.

0.1 Revision Table & Contents 6

1.0 Scope 4

2.0 Referenced Documents 4

3.0 Terms and Definitions 3

4.0 Quality Management System 5

5.0 Management Responsibility 5

6.0 Resource Management 4

7.0 Product Realization 4

8.0 Measurement, Analysis and Improvement 4

Appendix A Index of Quality Assurance Procedures 4

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QUALITY MANUAL Rev. : 4

Section 1.0 Scope Page : 1 of 2

1.0 SCOPE

Since its establishment in 1975, PEACH has concentrated its core competence

on the industrial valve business, manufactured, and supplied those products and

services to global customers, mainly for nuclear power plants, various

corporations abroad, domestic atomic energy, heating and hydraulic power

plants, gas & oil companies and food pharmaceutical companies.

1.1 History of PEACH is

- 1975 Est. named “ Woon Yong Enterprise” in Seoul, South Korea

- 1981 Est. re-named “ Bok Soong-A Valve Ind. Co.”

- 1985 Changed to legal form named “ Bok Soong-A Valve Co., Ltd.

- 1987 Technical Joint & Affiliation with ASTAM Inc. in Japan for Dual Plate

Wafer Check Valves

- 1989 Opening current Gimpo Factory

- 1992 Manufacturing License of Gas Equipment by Korea Gas Safety Corp.

- 1993 Manufacturing License of Cryogenic Gas Equipment by Korea Gas Safety

Corp

- 1994 API Monogram License

- 1997 ISO 9001 Certificate of Registration QCB in Canada

- 1998 Certificate of EM(Excellent Manufacturer) by National Institute of

Technology & Quality

- 1999 Vendor Approval (MTR-SR-003/00, Product Group 77) by QGPC in Qatar

- 2000 Exhibit Valve World EXPO 2000 in Netherlands

- 2001 Fire Test Certificate from Velosi International Korea (Dual Plate Wafer

Check Valves 150LB & 600LB, Size range 6” and above)

- 2001 Vendor Approval (MSF No. PO/0460/2001) by K.O.C & K.N.P.C in Kuwait

- 2001 Vendor Approval (Quality 74008-2341) by Korea Gas Corp.

- 2002 CE Certificates (CE 0035) by TÜV

- 2002 WRAS Certificate by Water Regulations Advisory Scheme


- 2003 Selected as “ Venture Enterprise by Small & Medium Business

Administration”

- 2004 Vendor Approved by Inno-Biz


- 2005 Begin to Foundry

Extend the Products Items (Gate, Globe, Plug and Ball)

Add to API & ISO Certification for Gate, Globe, Ball and Plug Valve

Fire Test Certificate from Pacific Technical Service Co. (Gate, Globe,

Plug & Ball)

-2006 Renamed “ PEACH VALVE”

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Section 1.0 Scope Page : 2 of 2

1.1.1 Field of Application

Petroleum, petrochemical and natural gas industries and desalination plants,

sewage systems and etc.

1.2 Quality Manual: Scope, Application and Exclusions

1.2.1 This Manual is the top level document of PEACH Quality Management System.

The Manual is divided into four sections modeled on the sectional arrangement

of the ISO 9001-2000.

Those portions which apply specifically to only API application are highlighted

“ italics” .

1.2.2 The purpose of this Manual is to define and describe the quality system, to

define responsibilities and authorities of the management personnel involved in

the implementation of the system, and provide general procedures for all

activities comprising the quality system.

1.2.3 No exclusions have been taken because all requirements of ISO 9001-2000

Section 7 and API Spec. Q1-8th edition apply.

1.2.4 This Manual applies to all activities that affect quality of the PEACH VALVE

(PEACH) in Korea.

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Section 2.0 Referenced Documents Page : 1 of 1

2.0 RELATED DOCUMENTS

·ISO 9001:2000 Quality Management System Requirements

·ISO 9000:2000 Quality Management Systems-Fundamentals and Vocabulary

·API Spec. Q1:8th edition Specification for Quality Programs for the Petroleum,

Petrochemical and Natural Gas Industry.

·Procedures referenced within this Manual

·Work Instructions that directly or indirectly have impact on product or process.

·All Forms used in conjunction with the procedures and work instructions described

·Quality Assurance Procedures listed in Appendix A

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Section 3.0 Terms and Definitions Page : 1 of 3

3.0 Terms and Definitions

For use at PEACH, the definitions of ISO 9001, API Spec. Q1 and PED(97/23/EC)shall

apply.

Terms Definition

PED Refers to European pressure equipment regulating

device 97/23/EC

Acceptance Criteria Defined limits placed on characteristics of materials,

products, and services.

Acceptance Inspection Demonstration through

API-specified requirements

Those requirements, including performance requirements, set forth in the applicable API products specification or specifications and those manufacturer-specified requirements necessary to meet them.

Calibration Comparison and adjustment to a standard of know

accuracy.

Control Feature A documented method to perform an activity to ensure

conformance with specified requirements.

Delivery That point in time and physical location at which the

agreed transfer of ownership takes place.

Design Acceptance

Criteria

Defined limits placed on characteristics of materials,

products, or services established by the manufacturer

to ensure conformance to the product design.

Design Review A formal, documented, comprehensive, and

systematic examination of a design to evaluate the

design requirements and the capability of the design

to meet those requirements and to identify problems

and propose solutions.

Design Verification The process of proving a design by testing.

The required testing is that verification required by the

manufacturer and the applicable API product

specification to demonstrate the conformance of the

product to design requirements.

Documentation Recorded information

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Terms Definition

Licensee Holder of a license to use the API monogram &

PED(97/23/EC)

Manufacturer An API licensee & PED(97/23/EC)/applicant who

makes/processes products.

Manufacturing

Acceptance Criteria

Defined limits placed on characteristics of materials,

products, and services established by the

manufacturer to ensure conformance to the

manufacturing requirements.

Nonconformance Any no fulfillment of or deviation from specified

requirements.

Quality Conformance to specified requirements.

Quality System The organizational structure, responsibilities, control

features, process, and resources needed to manage

quality.

Special processes Processes, the result of which cannot be fully verified

by subsequent inspection and testing of the product.

Supplier Any individual or organization that provides materials,

products, or services to manufacturer.

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Abbreviation Definition

API American Petroleum Institute

CAR Corrective Action Request

Co Company

PEACH PEACH Valve Co., Ltd.

ID Identification

ISO International Organization for Standardization

Lab Laboratory

NCR Nonconformance Report

NDE Nondestructive Examination

PED Pressure Equipment Directive

PO Purchase Order

PQR Procedure Qualification Record

QA Quality Assurance

QAP Quality Assurance Procedure

RIR Receiving Inspection Report

Rev. Revision

MTS Manual Transmittal Slip

WPS Welding Procedure Specification

WPQ Welder/Welding Operator Performance Qualification

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Section 4.0 Quality Management System Page : 1 of 7

4. QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

4.1.1 PEACH has established and implemented a documented quality management

system (QMS), and continually improved its effectiveness as described in this

Quality Manual.

4.1.2 Figure 1 and Figure 2 describes the Quality Management System and the main

processes and their interaction, respectively.

4.1.3 The effectiveness of the Quality Management System is monitored through

Management Reviews and Internal Audits.

4.1.4 The results of these measurements are presented at the Management Review,

where if necessary corrective actions or continual improvement activities are

assigned to ensure that the planned results are obtained and that the processes

are continuously improving.

4.1.5 The follow-up of the corrective actions and improvement activities are monitored

in the subsequent Management Review.

4.1.6 PEACH shall maintain responsibility for product conformance to specified

requirements when processes are outsourced.

4.1.7 Partial outsourcing during manufacturing shall be monitored by PEACH for

Quality Control & Assurance.

4.2 Documentation

4.2.1 General

The Quality System is documented and structured in the following four levels of

documentation:

(1) Level 1: Quality Manual

This document defines the quality policy and the Company structure and

methods for maintaining the Quality Management System.

(2) Level 2: Quality Assurance Procedures

These documents describe the functional responsibilities, the procedures to be

used and the methods of control for each of the four sections of ISO

9001:2000 and API Spec. Q1. The Quality Assurance Procedures also

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reference, if applicable and when practical, departmental work instructions.

(3) Level 3: Work Instructions / Procedures

When required, work instructions are developed to define details as to how

specific tasks must be performed.

For the manufacturing area, work instructions are developed and maintained as

appropriate to supplement engineering drawings and specifications and to

document various manufacturing processes. There are two types of work

instructions:

a) Process work instructions, which may be used on a number of products. /

contracts.

b) Product work instructions, which are associated to a particular product /

contracts. Those can be drawing, bill of materials, process control

documents and etc.

(4) Level 4: Quality Records.

4.2.2 Quality Manual

(1) All the requirements of ISO 9001:2000 apply and API Spec. Q1.

(2) Quality Manual is developed and maintained by QA Manager as the QMS

Management Representative and approved by the President.

(3) Quality Manual is controlled per Quality Assurance Procedure.

(4) Reference

·Document and Data Control Procedure (QAP-422)

4.2.3 Control of Documents

(1) Documents required by the QMS shall be generated, approved, distributed and

revised in accordance with Quality Assurance Procedure.

(2) QA Manager is responsible for establishing the Quality Assurance Procedure to

define the controls needed

(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 current revision status of documents are

identified

(d) To ensure that relevant version of applicable, documents are available at

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points of use,

(e) To ensure that documents remain legible and readily identifiable,

(f) To ensure that documents of external origin are identified and their

distribution controlled, and,

(g) To prevent the unidentified use of obsolete documents and to apply suitable

identification to them if they are retained for any purpose.

(3) Document Approval and Issue

(a) All quality related documents established and issued by PEACH require the

review and approval of the Dept Manager responsible for preparation of

those documents. He may delegate the authority for the review and/or

approvals to qualified staff in case of routine work, where always the same

or similar documents are established, for example simple work instructions.

(b) Approved documents shall carry at least

- the originator’ s name

- name and signature of the approver

- the actual revision status.

(c) Documents free issued by the client are only checked regarding their revision

status against the purchaser order. The client remains responsible for the

content of such documents. They do not require further approvals but

PEACH ensures their proper distribution.

(4) Distribution

(a) Responsible for the distribution of the documents is the originator. He has

to take care that the documents are available at all locations where quality

affecting work is carried out.

(b) A master list is established indicating the

- distributed documents

- actual revision status

- recipient

- date of distribution.

The master list is kept up-to-date by the responsible originator. Each user

of quality affecting documents has free access to the master list and is

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obliged to verify before use that the document he intends to use is actual.

(c) As alternative, a unique distribution list, directly printed on the document,

where the individual recipients are marked, is acceptable.

(5) Changes

(a) Changes to documents have to follow the same rules as the first issue

regarding

- establishment or review

- approval

- release

- distribution.

(b) Changes in re-issued documents shall be marked with a revision indicator at

the margin of the changed section or distributed with attachments or

addenda nominating the changes.

(c) It is the responsibility of the recipient of a document, after having checked

its validity, to scrap or mark “ Invalid” the obsolete document. Obsolete

documents may be retained for legal and / or knowledge preservation

purposes provided they are separated from others and clearly marked

“ Invalid”

(6) Reference

·Document and Data Control Procedure (QAP-422)

4.2.4 Control of Records

(1) Quality records shall be maintained to demonstrate conformance to specified

requirements and to provide objective evidence of QMS effectiveness.

(2) Quality records are also used to analyze trends in quality performance and the

need for preventive actions.

(3) Quality records shall be legible, readily identifiable and retrievable.

(4) Quality records shall stored in manner to ensure safety, protection.

(5) QA Manager is responsible for establishing the Quality Assurance Procedure to

define the controls needed for the identification, storage, protection, retrieval,

retention time and disposition of records.

(6) Retention times of quality records shall be complied with the product lifetime

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or relevant API product Specifications. Records specified to demonstrate

achievement of the effective operation of the quality system shall be

maintained for a minimum of 5 years.

(7) Reference

·Records Control Procedure (QAP-423)

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Section 4.0 Quality Management System Page : 6 of 7 Section 4.0 Quality Management System Page : 6 of 7

Figure 1

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Figure 2

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Section 5.0 Management Responsibility Page : 1 of 7

5. MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.1.1 President shall provide evidence of his commitment to the development and

implementation of QMS and continually improve its effectiveness by

(a) Communicating to all of PEACH employees the importance of meeting

customer, statutory and regulatory requirements through the periodic

communication meeting,

(b) Establishing the quality policy,

(c) Conducting management reviews, and

(d) Establishing the quality objective and ensuring the availability of resources

through management review meetings.

5.2 Customer Focus

5.2.1 PEACH strives to identify current and future customer needs, to meet customer

requirement and to exceed customer expectations

5.2.2 President ensures that customer requirements are clearly defined through the

processes described in the Section 7.2, and that these requirements are met.

The customer satisfaction measurement is described in Section 8.2.1

“ customer satisfaction”

5.3 Quality Policy

“ PEACH are committed to understanding

the needs and expectations of our customers

and providing them products and services that

meet or exceed all of their requirements

through strategic objectives and continual

improvement of our processes.“

PEACH is dedicated to providing our customers with superior products. This Quality

Policy is established by President to provide the framework to develop and improve

the quality management system, and executed in conjunction with other

management functions, and is an integral part of the business strategy.

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The quality policy is provided and explained to every employee, such that it is

implemented and maintained at all levels of the organization. It is included in new

employee training on the quality management system.

President reviews the quality policy at management review meeting to determine

the policy's continuing suitability for our organization (See Section 5.6 )

5.4 Planning

5.4.1 Quality Objectives

(1) President ensures that the quality objectives are flown down the organization

and that the results against these objectives are measured.

(2) These objectives may be broken down into sub-objectives and communicated

to the appropriate level of the organization.

(3) QA Manager monitors and analyzes the performance against these goals and

the results are reviewed at the Management Reviews (See Section 5.6

Management Review).

5.4.2 Quality Management System Planning

(1) Quality Management System is documented and designed in order to

guarantee that all products and processes meet all the requirements of the

customers.

(2) Satisfaction of specified requirements is achieved through the effective

implementation of all processes and related procedures and work instructions

in day-to-day activities.

(3) The Quality System documentation is designed to achieve quality in the

definition of the needs of the customer, in the planning and design of product

realization, in the conformance to the product design and in the support

throughout the product life cycle.

(4) Quality Management System reviewing or planning is performed prior to

addition of significant changes that have an impact on the PEACH's quality

management system in order to minimize the risk of negative effects.

5.5 Responsibility, Authority and Communication

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5.5.1 Responsibility and Authority

(1) Figure 3 illustrates PEACH's organizational structure, levels of authority and line

of communication.

(2) QA Manager is responsible for the development and maintenance of the QMS

(3) Primary responsibility for implementing the QMS resides with the respective

managers for all activities within their sector.

(4) Respective Managers is responsible for

(a) Communicating customer requirements to the appropriate personnel

(b) Ensuring that qualified and trained personnel and other resources are

available to implement the QMS

(c) Ensuring that personnel comply with applicable standard, regulations,

specification, and documented procedure

(5) General responsibilities for PEACH personnel related to the work affecting

quality are summarized in Table A

(6) Additional responsibilities not defined in this Section are described in other

Sections of this Manual and Procedures or Instructions.

(7) Management level personnel are authorized to delegate performance of their

assignments to qualified personnel within their organizations, but to retain full

responsibility and accountability for the quality of the work performed.

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Figure 3. ORGANIZATION CHART

GENERAL AFFAIR TEAM

PRESIDENT

PRODUCTION TEAM

PURCHASING TEAM

DOMESTIC SALES TEAM

BUSINESS DIV.

OVERSEAS SALES TEAM

TECH./DEVELOPEMENT

TEAM

QA TEAM

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Table A. Summary of QMS Responsibilities

Who Responsibility and Authority

President

· Define the Quality Policy and ensure the communication and

understanding of the Quality Policy throughout the organization

· Provide the resources necessary to facilitate the development and

implementation of QMS

· Conduct management reviews

Manager-

QA Team

· Document and maintain QMS

· Report to President on the suitability and effectiveness of QMS

· Conduct the internal and external quality audits

· Qualify and Certify audit personnel

· Evaluate and qualify suppliers

· Perform all quality verification activities associated with the production

· Accept final disposition and documentation of nonconformance

· Initiate corrective and preventive actions

· Maintain the quality records

Manager-

Production

Team

· Develop and control the technical documents associated with the

product for manufacturing, material procurement and procurement

requisition

· Develop and control the documents for manufacturing planning and

fabrication.

· Conduct the qualification of procedures, personnel, and equipment for

special processes

· Manufacture the product

· Ensure that the quality objectives are established and implemented

· Ensure that the resources required for implementing the assignments

are available

· Control the in-coming materials

· Perform the manufacturing processes

· Package and shipping the product(Pack and ship the product)

· Maintain the manufacturing equipment

Manager-

Business Team.

· Carry out sales and contract activities

· Conduct contract review

· Control customer documents

· Coordinating with customers

Manager-

Purchasing Team

· Procure the materials, items, and services

· Maintain interface control with applicable suppliers

Manager-

Tech. & Devel.Team · Perform design and development

Manager-

Administration

Team

· Finance / Accounting

· Hire the new employees

· Maintain the personnel history records

All personnel

· Conduct their work and ensure the quality of their work

· Stop work in progress and make appropriate notification when unsafe

conditions exist or requirements are not being met

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5.5.2 Management Representative

President appoints QA Manager as Management Representative, who has

responsibility and authority that includes

(1) Ensure that the requirements of the ISO 9001:2000 Quality Management

System Standard are established, implemented and maintained;

(2) Report on the performance of the quality management system and any need

for improvement to the President, and maintain records of those reviews; and

(3) Interface with customers, Government and regulatory agencies on matters

relating to the quality management system.

5.5.3 Internal Communication

Data regarding the performance and effectiveness of the quality management

system is shared throughout PEACH organization in the following ways:

(1) Intranet communication,

(2) Meetings with employees, and

(3) Performance data posted on the bulletin boards.

5.6 Management Review

5.6.1 General

(1) President shall review the Quality System at least annually basis in order to

ensure its continuing suitability, adequacy and effectiveness,

(2) An expected outcome of that review is the determination of the need for any

changes to the quality management system, including changes to the quality

policy and quality objectives

(3) Records of the management reviews are filed and maintained in accordance

with Section 4.2.4 of this Manual

5.6.2 Review Input / Output

5.6.2.1 The Management Review input includes:

(1) Result of internal and external audits,

(2) Customer feedback,

(3) Processes performance and product conformity,

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(4) Status of preventive and corrective actions,

(5) Follow-up actions from previous Management Review,

(6) Strategic or operational changes that could affect the quality management

system, and change to applicable oil and gas industry standards

(7) Recommendations for improvement

(8) Monitoring of management review

(9) Monitoring of reports and analysis of field nonconformities

5.6.2.2 The Management Review Output comprises the minutes of the meeting and the

resulting action items regarding:

(1) Improvement of the effectiveness of the quality management system,

(2) Improvement of the product related to customer requirements, and

(3) Resources needed

5.6.3. Reference

Management Review Procedure (QAP-521)

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Section 6.0 Resource Management Page : 1 of 2

6. RESOURCE MANAGEMENT

6.1 Provision of Resources

6.1.1 Respective Managers are responsible for determining and providing the

resources needed to:

(1) Implement, maintain and improve the Quality Management System processes,

(2) Ensure customer satisfaction, and

(3) Meet the quality objectives.

6.1.2 Respective Managers communicate requirements for resources to their

management and/or Presidents

6.2 Human Resources

6.2.1 General

(1) Anyone in PEACH having an assignment associated with any of the processes

of the quality management system is competent through education, skill,

training and experience as necessary.

(2) Requirements for education, skills, training and experience are found in the job

descriptions maintained by the Respective Manager.

6.2.2 Competence, Awareness and Training

(1) The needs for training of personnel are identified by Respective Managers and

the documented procedures for providing that training are established and

maintained.

(2) Appropriate training is provided to all levels of personnel within PEACH

performing activities affecting quality.

(3) Respective Managers ensure that all employees are aware of the importance of

their activities and how they contribute to achieving quality objectives.

(4) The qualifications of personnel performing specialized operations, processes,

tests or inspections are evaluated and documented.

(5) Training plan is updated at least once a year.

(6) The employee's performance review is also used to identify specific individual

training as well as evaluate effectiveness of actions taken to satisfy

competency needs.

(7) Formal training records are maintained by the Respective Dept, including proof

of certification for special processes, as applicable. Additional documented

education and experience records are maintained in the employee personnel

files.

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Section 6.0 Resource Management Page : 2 of 2

(8) Reference

·Training and Indoctrination Procedure (QAP-621)

6.2.2.1 Education & Training Plan shall be made with consideration of subject &

period and should include on-the-job training for personnel in any new ir

modified job

6.3 Infrastructure

6.3.1 PEACH has established and maintained the infrastructure such as buildings,

work space, associated utilities, process equipment, both hardware and software,

and supporting services needed to achieve the conformity to product

requirements

6.3.2 President is ultimately responsible for the provision of all resource needs

6.3.3 Respective managers identify the infrastructure needs and report those needs to

their management and/or President for resolution.

6.3.4 Reference

Facilities Control Procedure (QAP-631)

6.4 Work Environment

6.4.1 Respective Managers establish and maintain the appropriate work environment

needed to achieve conformity to product requirements.

6.4.2 Respective Managers shall not allow the work to be performed in the absence of

applicable safety measures.

6.4.3 Reference

Environmental Control Procedure (QAP-641)

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Section 7.0 Product Realization Page : 1 of 12

7. PRODUCT REALIZATION

7.1 Planning of Product Realization

7.1.1 Respective Managers plan and develop the processes needed for product

realization throughout the documented procedures, and work instructions.

When product requirements are provided from external sources, PEACH shall

define the methods and shall establish control features used to translate these

requirements into the product realization process

7.1.2 In planning product realization, Respective Managers determine the following, as

appropriate:

(1) Quality objectives and requirements for the product

(2) The need to establish processes, and documents, and to provide resources

specific to the product

(3) Required verification, validation, monitoring, inspection and test activities

specific to the product and the criteria for product acceptance

(4) Record needed to provide evidence that the realization processes and resulting

product meet requirements.

7.1.3 The outputs for this planning shall be documented in a suitable form such as

quality plan, design plan, process control sheet and procedures.

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

(1) Sales Manager in conjunction with the concerned Managers shall identify :

(a) Requirements specified by customer, including delivery and post-delivery

activities

(b) Requirements not stated by the customer, but necessary for specified or

intended use, when known,

(c) Statutory and regulatory requirements

(d) Any additional requirements determined by PEACH.

7.2.2 Review of Requirements Related to the Product

(1) Prior to submission of tenders, or acceptance of contracts/contract changes,

Sales Manager in conjunction with the concerned Managers shall review the

requirements related to the product in order to ensure that

(a) Product requirements are defined,

(b) Contract requirements differing from those previously expressed are

resolved,

(c) PEACH has the ability to meet the defined requirements

(2) Records of the result of the review and action arising from the review are

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maintained as a quality records in accordance with Section 4.2.4 of this

Manual.

(3) Where the customer provide no documented statement of requirements, Sales

Manager confirm the requirement before acceptance

(4) Amendment to contracts are reviewed in the same manner as the original with

all affected and concerned parties.

(5) Sales Manager shall establish and maintain documented procedure for review

of requirements related to product.

(6) Reference

·Contract Review Procedure (QAP-721)

7.2.3 Customer Communication

(1) Sales Manager shall establish and maintain effective channels for

communicating customer in relation to :

(a) Product requirement,

(b) Enquiries, contracts, including amendments,

(c) Customer feedback, including complaints.

7.3 Design and Development

7.3.1 Design and Development Planning

(1) Tech. & Devel. Manager shall establish a standard design control procedure to

plan and control the design and development of the product.

(2) The procedure shall specify :

(a) The design and development stages,

(b) The review, verification and validation that are appropriate to each design

and development stage,

(c) The responsibilities and authorities for design and development.

(3) Tech. & Devel. Manager shall manage interfaces between different groups

involved in design and development to ensure effective communication and

clear assignment of responsibility.

(4) When the design and development process of the product or contract may not

be planned and controlled in accordance with a standard procedure, Tech. &

Devel. Manager develop the design plan. Design plan are updated as

appropriate, as the design and development progresses.

(5) Design documentation shall include the methods, assumptions, formulations

and calculations.

7.3.2 Design and Development Inputs

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(1) The inputs shall include :

(a) Functional and performance requirements,

(b) Applicable statutory and regulatory requirements,

(c) Where applicable, information derived from previous similar designs,

(d) Other requirements essential for design and development.

(e) Applicable API specifications and customer specified requirements.

(2) The customer product specification and/or drawing are the principal design

inputs.

(3) The inputs are reviewed for adequacy by Tech. & Devel. Manager.

(4) Any conflicting, incomplete, or ambiguous requirements are resolved with those

responsible for defining the inputs

(5) Records for the inputs are maintained as quality records in accordance with

section 4.2.4

7.3.3 Design and Development Outputs

(1) The output of design and development shall be provided in a form that

enables verification against the input

(2) Design and development outputs shall

(a) Meet the input requirements,

(b) Provide appropriate information for purchasing, production and service

provisions,

(c) Contain or reference product acceptance criteria,

(d) Specify the characteristic, of the product that are essential for its safe and

proper use

(3) Design and development outputs shall be documented in drawings, part lists,

material specifications, and design reports and approved prior to be released

by Tech. & Devel. Manager.

7.3.4 Design and Development Review

(1) Systematic reviews of design and development are conducted as defined in

the procedure or design plan to ensure adequacy of the design to fulfill the

contractual and quality requirements and to identify any problems and

propose necessary actions.

(2) The representative of functions concerned with the design and development

stage being reviewed are included in such reviews.

(3) The results of review are recorded in the applicable design output documents

or appropriate form, and are maintained as quality record in accordance with

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Section 4.2.4 of this Manual

(4) Final design review shall be conducted and documented by individuals other

than the person or persons who developed the design.

7.3.5 Design and Development Verification

(1) Verification shall be conducted to ensure that the design and development

outputs have satisfied the input requirements prior to release.

(2) Verification shall be performed by competent design engineer other than those

who performed the original design.

(3) The results of the verification are recorded in applicable design output

documents or appropriate form and maintained as quality records in

accordance with Section 4.2.2 of this Manual.

(4) The verification may include one or more of following activities.

(a) Comparing the new design with a similar proven design

(b) Undertaking tests and demonstrations

(c) Reviewing the design documents before release

7.3.6 Design and Development Validation

(1) Design and development validation shall be performed in accordance with the

design control procedure or design plan to ensure that the final product meets

the requirements for the specified or intended use or application.

(2) Validation shall be conducted at the final inspection and testing prior to the

delivery unless otherwise specified

(3) The results of validation shall be recorded in appropriate inspection and testing

report, and maintained in accordance with Section 4.2.4 of this Manual.

(4) Design validation is carried out by the procedures prescribed in the design

package and/or other suitable measures and documented in the final

inspection reports.

7.3.7 Control of Design and Development Changes

(1) Design changes shall be reviewed, verified and validated, as appropriate, and

approved in the same manner as the original.

(2) The review of design changes shall include evaluation of the effects of the

changes on constituent parts and delivered products.

(3) Design changes shall be req uired same control as the original design

documentation

(4) Records of the results of the review of changes and any necessary actions

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shall be maintained as quality records in accordance with Section 4.2.4 of

this Manual.

7.3.8 Reference

·Design Control Procedure (QAP-731)

7.4 Purchasing

7.4.1 Purchasing Process

(1) 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.

(2) QA Manager has the responsibility and authority for evaluating and selecting

the suppliers in accordance with the Quality Assurance Procedure.

(3) The Procedure shall define the criteria for evaluation, selection and re-

evaluation.

(4) The Procedure shall define the purchasing process.

(5) An approved supplier list is maintained by QA Dept based on the evaluation

and performance of suppliers.

(6) Records of the evaluation results and any necessary actions arising from the

evaluation shall be maintained as quality records in accordance with Section

4.2.4 of this Manual.

(7) For API application, subcontractors are assessed to ensure continuous

conformance to the purchasing requirements by the QA Manager by means of

one or more of the following :

(a) Inspection of subcontractor’ s final product at subcontractor’ s facility.

(b) Inspection of subcontractor’ s final product upon delivery.

(c) Surveillance of subcontractor’ s conformance to purchasing requirements.

(d) Verification that subcontractor’ s quality system conforms to the API

Specification.

(8) For processes that requires validation, subcontractors shall comply with the

requirements of 7.5.2, as applicable.

(9) Reference

·Vendor Evaluation Procedure (QAP-741)

Note: Purchased products include all products and services that affect

compliance with customer requirements

7.4.2 Purchasing Information

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(1) Purchasing information shall be documented in the purchase specification,

purchase requisition and purchase order.

(2) Purchase documents shall include or reference where appropriate :

(a) Requirements for approval of product, procedures, processes and

equipment

(b) Requirements for qualification of personnel

(c) Quality management system requirements

(d) The type, class, grade or other precise identification

(e) The title or other positive identification, and applicable issue of

specifications, drawings, process requirements, inspection instructions, and

other relevant technical data, including requirements for approval or

qualification of product, procedure, process equipment and personnel.

(3) Purchase documents shall be reviewed and approved by Responsible Manager

for adequacy of the specified requirements prior to release.

(4) Reference

·Purchasing Control Procedure (QAP-742)

7.4.3 Verification of Purchased Product

(1) Receiving inspection and/or verification at supplier`s premises shall be

performed to ensure that the purchased product meets the specified purchase

requirements and maintained records of verification activities

(2) Receiving inspection is specified in Section 8.2.4 of this Manual.

(3) Where PEACH or its customers intends to perform verification at the suppliers

premises, source inspection requirements are added to the purchase

document by QA Dept.

(4) Records of verification activities shall be maintained.

(5) Reference

·Subcontracted Service Control Procedure (QAP-743)

·Inspection and Test Control Procedure (QAP-822)

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

(1) Processes for production and service provision shall be planned and carried

out under controlled conditions.

(2) Controlled conditions shall include, as applicable :

(a) Availability of information that describes the characteristics of the product,

(b) Availability of work instructions,

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(c) Use of suitable equipment,

(d) Availability and use of monitoring and measuring devices,

(e) Implementation of monitoring and measurement, and

(f) Implementation of release, delivery and post-delivery activities.

(3) Production process planning and the result of implementation shall be

documented in accordance with Quality Assurance Procedure, and

maintained as quality records in accordance with Section 4.2.4 of this Manual.

(4) Process controls shall be documented on :

(a) Quality control plan

(including customer’ s inspection hold or witness points)

(b) Checklists

(c) Manufacturing, inspection and test procedures

(d) Work instructions

(e) Process sheets

(f) Inspection and test reports

(5) Process control documents shall include the adequate acceptance criteria and

the requirements for verifying compliance with specified requirements.

(6) Production Control Manager shall establish and maintain documented

procedure for control of production and service activities performed.

(7) Reference

·Process Control Procedure (QAP-751)

·Control Procedure for After-Sales Services(QAP-723)

7.5.2 Validation of Processes

(1) Processes that require validation for production and service provision, where

the resulting output cannot be verified by subsequent monitoring or

measurement, within PEACH's scope of work are :

(a) Welding (include repair welding),

(b) Heat Treatment,

(c) Nondestructive Examination

(d) Processes identified by the applicable product specification

(2) All processes affecting quality, including special processes shall be conducted

by means of validated procedures, equipment and personnel.

(3) The validation of processes including associated equipment and personnel

shall be conducted in accordance with applicable Quality Assurance

Procedure. If any changes of process are occurred, revalidation shall be

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carried out

(4) The nondestructive examination shall be conducted by validated procedures

and personnel of subcontractor, which are certified by the QA Manager.

(5) Records for validation of processes, equipment and personnel shall be

maintained in accordance with Section 4.2.4 of this Manual

(6) PEACH 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

(e) revalidation

(7) Reference

·Process Control Procedure (QAP-751)

·WPS Preparation and Qualification Procedure (QAP-753)

·Welder & Welding Operator Qualification Procedure (QAP-624)

·Heat Treatment Operator Qualification Procedure (QAP-625)

cf. Certification Program for NDE Personnel (Scope of Subcontractor)

7.5.3 Identification and Traceability

7.5.3.1 Identification

(1) Each end product and associated materials, parts, subassembly or assembly

shall be uniquely identified by material heat number, item number, part

number, or serial number.

(2) Product identification shall be maintained throughout product realization by

suitable means such as stencil, tagging or stamping.

(3) Inspection and test status shall be identified by appropriate marking on the

product or indication on the associated documentation.

7.5.3.2 Traceability

(1) When required by the contract, the traceability shall be maintained by the use

of unique identification number of the product and contract.

(2) Materials shall be marked with a unique number such as heat number or item

number which is traceable to material test report.

(3) Appropriate records shall be retained in accordance with Section 4.2.4 of this

Manual.

7.5.3.3 Material identification control procedure describes:

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(1) Identifying the product/material by suitable means through all production

processes as well as delivery, and installation, as required by the company,

the customer, and the applicable product specifications.

(2) Control features available for replacement of identification marks and

identification records.

7.5.3.4 Production Status

(1) PEACH ensures that only product that has passed the required inspections

and test is dispatched through a suitable identification system that throughout

production the inspection and / or test status of a product can be identified.

(2) The inspection and test status is identified by one or more of the following in

accordance with Quality Assurance Procedure:

(a) Tags or labels

(b) Paint marking on the product

(c) Inspector’s signature

(d) Test and / or inspection records

(e) Location in the designated area.

7.5.3.5 Control of API Monogram Application

(1) API monogramming of PEACH products shall be restricted to those which are

manufactured exclusively to the appropriate API product specification.

(2) The QA Manager shall apply the monogram, license number, and date of

manufacture to the monogrammed products in accordance with the marking

procedure of the applicable API product specification. Where there are no API

product specification marking requirements, the Tech. & Devel. Manager shall

define the location(s) where this information is applied.

(3) The API monogram may be applied at any time appropriate to the

manufacturing process but shall be removed if the product is subsequently

found to be in nonconformance with API specified requirements, products

determined to be nonconforming to API specified requirements shall not bear

the API monogram.

(4) The API monogram shall be applied at the works of PEACH (licensed facility).

(5) The QA Manager shall be responsible for applying and removing the API

monogram.

7.5.3.6 Reference

·Material Identification Control Procedure (QAP-754)

·Inspection and Test Control Procedure (QAP-822)

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·Inspection and Test Status Procedure (QAP-755)

7.5.4 Customer Property

(1) Customer property shall be identified, verified, protected, and safeguarded in

the same manner as PEACH property.

(2) Lost, damaged or unsuitable property is documented and reported to the

customer by Sales Dept.

(3) Records of this notification shall be maintained in accordance with Section


(4) Production Control Manager shall establish and maintain documented

procedure for verification, storage, maintenance and control of customer

property.

(5) Reference

·Control Procedure for Customer Property (QAP-722)

7.5.5 Preservation of Product

(1) Product including incoming materials, materials in processes, and finished

product shall be preserved in accordance with the documented procedures.

(2) Procedures shall describe the control measures for handling, packaging,

storage, preservation, and shipping of product.

(3) Products in storage are assessed at appropriate intervals to detect signs of

deterioration and ensure required storage requirements are properly

maintained.

(4) Reference

·Handling, Storage, and Shipping Procedure (QAP-756)

7.6 Control of Monitoring and Measuring Devices

7.6.1 General

(1) Monitoring and measurement process to be undertaken for the

product/contract are identified during planning of product realization as

described in Section 7.1 of this Manual.

(2) Measurements to be made to product during inspection and test are defined in

the associated inspection and test procedures as described in Section 8.2.4

of this Manual. Devices supporting the inspection and test activities are

identified in the applicable procedures.

(3) Calibration of measuring equipment shall be subcontracted to national

calibration agency

(4) QA Manager shall have responsibility to ensure that measuring equipment have

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been calibrated and are selected to be of the proper type, range, accuracy

and tolerance to accomplish the intended function

(5) Respective Managers using the measuring equipment shall be responsible for

assuring that the equipment under their use are properly handled and stored

to maintain accuracy.

(6) Calibration and control procedure for measuring and test eqiupment shall

describe the device type, unique identification, location, frequency of checks,

check method and acceptance criteria.

7.6.2 Calibration and Equipment Control

(1) Measuring equipment shall be calibrated and adjusted, as necessary at

specified intervals, or prior to use.

(2) Calibration shall be conducted against measurements standards traceable to

international or national standards; where no such standards exist, the basis

used for calibration shall be recorded.

(3) Calibration status of the equipment shall be identified with appropriate sticker

showing the identification number and calibration due date.

(4) Seal sticker shall be affixed to measuring equipment to safeguard unauthorized

adjustments that would invalidate the measurement results

(5) Measuring equipment shall be uniquely identified.

(6) Measuring equipment shall be handled, maintained and stored in a controlled

conditions and environments to prevent damage and deterioration.

(7) Calibration records shall be maintained as quality records in accordance with

Section 4.2.4 of this Manual

7.6.3 Discrepancies in Measuring Equipment

(1) When equipment is found to be out of calibration, the equipment shall be

identified with appropriate sticker.

(2) QA Manager shall issue non-conformance report and take appropriate action

on the equipment and any product affected in accordance with Quality

Assurance Procedure.

(3) When equipment is found to be out-of calibration by the responsible

organization, the QA Dept shall receive written notification and a

nonconformance report(NCR) is generated. The equipment shall be subjected

to re-calibration activity and if it is determined to still be within the established

tolerance, the NCR shall be closed. If the equipment is not within the

established tolerance, the QA Dept shall review the applicable past records to

identify all products which were checked with the discrepant equipment since

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the previous valid calibration. The QA Dept shall list the products on the NCR

and shall determine whether re-inspection or re-testing is necessary. The QA

Dept determination shall be documented on the NCR. The NCR shall be

handled in accordance with Section 8.3 of this Manual.

(4) Equipment which has been used after the due dated or re-calibration has

expired shall be considered discrepant and evaluated as described in

paragraph 7.6.3 (3)

(5) Products checked with the discrepant equipment shall be considered

unacceptable until it has been established that all applicable requirements

have been met. In the event a product has been shipped, which was

inspected with the equipment not within the established calibration tolerance

the Customer shall be notified by the QA Manager.

(6) Equipment which is consistently found to be out of calibration shall be repaired

and re calibrated, or replaced by the QA Dept.

7.6.4 Reference

·Calibration and Control Procedure for Measuring and Test Equipment (QAP-761)

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Section 8.0 Measurement, Analysis and Improvement Page : 1 of 7

8. Measurement, Analysis and Improvement

8.1 General

8.1.1 PEACH plans and implement the monitoring, measurement, analysis, and

improvement processes as defined in applicable Sections of this Manual in order

to:

(1) Demonstrate conformity of product,

(2) Ensure conformity of the QMS, and

(3) Continually improve the effectiveness of the QMS.

8.1.2 This includes determination of applicable methods including statistical techniques,

and the extent of their use.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

(1) The success in meeting Customer's requirements and in achieving a high level

of Customer satisfaction with the PEACH's products and services is evaluated

on a regular basis. This is done using warranty analysis, in-service

performance monitoring, customer complaint analysis, annual customer

satisfaction surveys, and other appropriate means.

(2) An efficient method of handling Customer inquiries is established to provide a

rapid response to Customers who have an urgent need for assistance or a

complaint, which would adversely affect Customer satisfaction.

(3) The evaluation results of the customer satisfaction are summarized for

discussion at management reviews.

8.2.2 Internal Audits

(1) Internal audits are conducted according to an established schedule and audit

program to assess compliance with processes and related procedures,

identify any non-conformances, opportunities for improvement, and initiate

preventive and corrective action where required.

(2) Each area, where quality affecting activities take place, shall be audited once

per year, at least. Other frequencies are at the discretion of the QA Manager.

(3) An audit program are planned, taking into consideration the status and

importance of the processes and areas to be audited, as well as the results of

previous audit, and defines the criteria, scope, frequency and methods.

(4)The auditors are selected to ensure objectivity and impartiality of the audit

process. Auditors shall not audit their own work

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(5) The results of the audits such as detected nonconformities are documented

and presented to the Managers responsible for the area being audited to

ensure that appropriate actions are taken.

(6) The audit is complete when the implementation and effectiveness of corrective

actions has been verified and reported.

(7) The responsibilities and requirements for planning and conducting audits,

qualifying auditors, and for reporting results and maintaining records are

defined in the Quality Assurance Procedure.

(8) The audit deficiency report shall include response times for the submission of

an action plan.

(9) Reference

·Internal Audit Procedure (QAP-821)

·Auditor Qualification Procedure (QAP-622)

8.2.3 Monitoring and Measurement of Processes

(1) The QMS processes are monitored and measured as defined in applicable

Sections of this Manual in order to demonstrate their continuing ability of the

processes to achieve the planned results

(2) If the planned results are not achieved, correction and corrective action are

taken, as appropriate to ensure conformity of the product.

(3) PEACH shall maintain records of the effective dates of process changes.

8.2.4 Monitoring and Measurement of Product

8.2.4.1 General

(1) The extent and sequence of the required inspection and test are specified in

documented procedures, work instructions and manufacturing planning

documents in order to demonstrate that the specified requirements are met.

(2) The amount and nature of inspection and test are based on the importance of

the product characteristic, the process control exercised and the specified

requirements.

(3) Inspection and test are conducted by the qualified inspector of QA Dept.

8.2.4.2 Receiving Inspection & Testing

(1) Purchased material designated for ultimate use in deliverable products shall

not be used or processed until it has been inspected or otherwise found to

conform to specified requirements.

(2) The amount and nature of inspection performed are based either on

contractual requirements, past experience with the product, the controls

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exercised at source and objective evidence of conformance provided by the

supplier.

(3) Incoming material is withheld pending completion of required inspection or

receipt of objective evidence of conformance from the supplier. Non-

conforming material is handled in accordance with Section 8.3 of this Manual.

When released under positive recall, it is recorded on an non-conformance

report.

8.2.4.3 In-process Inspection and Testing

(1) Product conformance to specified requirements is verified at appropriate

stages of manufacturing by conducting inspection and test of selected

characteristics as defined in applicable work instructions.

(2) Products are withheld from further processing until there is objective evidence

that the required inspection and test have been performed.

(3) Non-conformances during in-process inspection and test are handled in

accordance with Section 8.3 of this Manual.

8.2.4.4 Final Inspection and Testing

(1) Final inspection and testing are performed on every deliverable product to

demonstrate compliance with contractual requirements and to ensure the

delivery of high quality products.

(2) The final inspection shall also provide evidence that all inspections and tests

that were required during previous stages of manufacturing were performed

and documented to meet the specified requirements.

(3) Nonconforming products are handled in accordance with Section 8.3 of this

Manual.

(4) The shipments are also verified to ensure that they include a release note duly

approved by an authorized individual. The release note shall consist of a

Certificate of Conformance or the applicable release form required by the

customer or regulatory agency. The release of shipments on behalf of the

customer shall be in conformance with applicable agreements.

(5) Quality Control Inspector is independent of the production.

8.2.4.5 Reference

·Inspection and Testing Control Procedure (QAP-822)

·Certification Procedure of Inspection and Test Personnel (QAP-623)

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8.3 CONTROL OF NONCONFORMING PRODUCT

8.3.1 QA Manager implements process controls that provide for identification,

documentation, evaluation, segregation (when practical), and ultimate disposition

of product that has been found to be unacceptable to requirements (i. e.

nonconforming), in order to prevent its unintended use or delivery to customer in

accordance with Quality Assurance Procedure.

8.3.2 The nature and disposition of nonconforming product are documented and

maintained. The disposition possibilities are as follows:

(1) Repair to meet the specified requirements

(2) Authorize its use, release or acceptance under concession by a relevant

authority and, where applicable, by the customer

(3) Reject or scrap

(4) Accept under the following conditions

(a) Accept materials or products that do not satisfy manufacturing

acceptance criteria provided :

- Materials or products satisfy the design acceptance criteria, or

- The violated manufacturing acceptance criteria is categorized as

unnecessary to satisfy the design acceptance criteria, or

- Materials or products are repaired or reworked to satisfy the design

acceptance criteria or manufacturing acceptance criteria.

(b) Accept materials or products that do not satisfy the original design

acceptance criteria provided:

- The original design acceptance criteria is changed per Section7.3 of

this Manual

- The materials or products satisfy the new design acceptance criteria.

(5) If delivered products are not met quality requirement, PEACH shall take

corrective action immediately and its data shall be recorded.

8.3.3 If the product is to be used “ as-is” or “ repair and use” , if applicable, the

customer is informed per the agreement, project plan, or appropriate

documented procedures. Acceptance by customer is maintained as a Quality

Record.

8.3.4 Following any repair of product, the product shall be re-inspected or re-tested to

demonstrate conformity to the requirements.

8.3.5 When nonconforming product is detected after delivery or use, QA Manager shall

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take action appropriate to the effect, or potential effects of the nonconformity.

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

including concessions obtained shall be maintained in accordance with Section


8.3.7 The personnel who identifies the nonconformance shall segregate (where

practical) nonconforming items.

8.3.8 Field Nonconformance

(1) As PEACH does not operate or survey any API equipment or component

outside the works, field nonconformance can only be brought to the

attention of the company by reporting through the customer.

(2) In addition to the corrective action procedure described in Section8.5.2 of

this manual, the following shall apply for monogrammed but

nonconforming API products in use:

Any information available about the field incident shall be collected and

carefully evaluated with regard to the :

- Type of the nonconformance

- Severity of the deficiency

- Reason for the nonconformance.

(3) A subsequent investigation shall be conducted to detect any potential

mistake in the design, manufacturing process, or inspection and testing

procedures. Any mistake or deficiency detected through this investigation

shall be corrected and the corrective action shall be documented.

8.3.9 PEACH shall notify customers in the event that product which does not conform to

design acceptance criteria has been delivered and records of such notification

shall be maintained

8.3.10 Reference

·Nonconformance Control Procedure (QAP-831)

8.4 ANALYSIS OF DATA

8.4.1 PEACH has processes in place to determine, collect and analyze appropriate data

to demonstrate the suitability and effectiveness of the QMS and to evaluate where

continual improvement of the effectiveness of the QMS can be made.

8.4.2 Data that is collected and analyzed provides information relating to

(1) Customer satisfaction

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(2) Conformity to product requirements

(3) Characteristics and trends of processes and products including opportunities

for preventive action, and

(4) Suppliers

8.4.3 In accordance with control procedure for use of statistical techniques, QA

Managers identify, apply, and document the type of information to be gathered

and the statistical technique(s) required for establishing, controlling, and verifying

process capabilities, customer satisfaction, and product characteristics.

8.4.4 Reference

·Control Procedure for Use of Statistical Techniques (QAP-841)

8.5 IMPROVEMENT

8.5.1 Continual Improvement

(1) PEACH continually improves the effectiveness of the QMS through the use of

the quality policy, quality objectives, audit results, analysis of data, corrective

and preventive actions, and management reviews.

(2) QA Manager shall establish and maintain the documented procedure for

continual improvement.

(3) Any corrective or preventive action taken to eliminate the cause of actual or

potential problem shall be to a degree appropriate to the magnitude of

problems and commensurate to the risk encountered.

(4) QA Dept shall implement and record any changes in the procedures resulting

from corrective and preventive action.

(5) Reference

·Continual Improvement Procedure

8.5.2 Corrective/Preventive Action

(1) Corrective or preventive actions to eliminate the actual causes or potential

causes of nonconformance (including customer complaints, nonconforming

products, and nonconforming processes) are taken to prevent their

recurrence or occurrence.

(2) QA Manager establishes and maintains the documented procedures for

implementing corrective and preventive actions. corrective and preventive

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actions are appropriate to the magnitude of the problems and commensurate

with the risks encountered to minimize the impact on safety, performance,

processing cost, quality-related cost, and customer satisfaction.

(3) Corrective action procedures define the requirements for:

(a) Reviewing nonconformities,

(b) Investigating the cause of nonconformities relating to the product, process,

and QMS,

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

(d) Determining and implementing the action needed

(e) Records of the results of action taken

(f) Reviewing the action taken

(4) Corrective action report shall include response times for the submission of an

action plan.

(5) Preventive action procedures provide guidance for:

(a) Evaluating potential nonconformities and their causes

(b) Evaluating the need for action to prevent occurrence of nonconformity

(c) Determining and implementing the action needed

(d) Records of the results of action implemented

(e) Reviewing preventive action implemented

(6) The QMS Management Representative directs the implementation of the

corrective and preventive action control system.

(7) The Responsible Manager ensures that requirements contained in the

documented procedures that implement this policy are communicated and

followed by the individuals responsible for implementing the process.

8.5.3 Reference

·Corrective and Preventive Action Control Procedure (QAP-852)