You are on page 1of 44

QUALITY MANUAL

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

Document No. : QM-01


Revision No. : 6

□ Controlled Copy (Serial No.: )


▣ Uncontrolled Copy

PEACH VALVE
(BAVCOS)
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 Additional revision in


6 accordance with API
DATE 2009.08.13 2009.08.14 Spec. Q1-8th Edition.

Addition
SIGN
4.1.6
5
DATE 2009. 4. 2009.04.17 4.1.7

Change Company
SIGN name,logo,revision table,
4 Scope & Organization
DATE 2006.03.06 2006.03.06 chart

SIGN
3
DATE 2004.06.01 2004.06.01

PREPARATION REVIEW APPROVAL


REVISION NO. REMARKS
( QA TEAM ) ( → ) (PRESIDENT)
QUALITY MANUAL Doc No. : QM-01

Section 0.1 REVISION TABLE & CONTENTS Page : 2 of 2

Section Title 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


Doc No. : QM-01
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
- 2002 Exhibit Valve World EXPO 2002 in Netherlands
- 2003 Selected as “ Venture Enterprise by Small & Medium Business
Administration”
- 2004 Vendor Approved by Inno-Biz
- 2004 Exhibit Valve World EXPO 2004 in Netherlands
- 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”
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
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.
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
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
Doc No. : QM-01
QUALITY MANUAL Rev. : 3
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 Those requirements, including performance
requirements 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 Defined limits placed on characteristics of materials,
Criteria 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
Doc No. : QM-01
QUALITY MANUAL Rev. : 3
Section 3.0 Terms and Definitions Page : 2 of 3

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 Defined limits placed on characteristics of materials,
Acceptance Criteria 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.
Doc No. : QM-01
QUALITY MANUAL Rev. : 3
Section 3.0 Terms and Definitions Page : 3 of 3

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


Doc No. : QM-01
QUALITY MANUAL Rev. : 5
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
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 4.0 Quality Management System Page : 2 of 7

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


Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 4.0 Quality Management System Page : 3 of 7

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 4.0 Quality Management System Page : 4 of 7

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 4.0 Quality Management System Page : 5 of 7

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)


Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 4.0 Quality Management System Page : 6 of 7

Figure 1
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 4.0 Quality Management System Page : 7 of 7

Figure 2
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
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.
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 5.0 Management Responsibility Page : 2 of 7

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


Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 5.0 Management Responsibility Page : 3 of 7

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.
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 5.0 Management Responsibility Page : 4 of 7

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 5.0 Management Responsibility Page : 5 of 7

Table A. Summary of QMS Responsibilities


Who Responsibility and Authority

· Define the Quality Policy and ensure the communication and


understanding of the Quality Policy throughout the organization
President · Provide the resources necessary to facilitate the development and
implementation of QMS
· Conduct management reviews
· 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
Manager-
· Evaluate and qualify suppliers
QA Team
· 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
· 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
Manager- special processes
Production · Manufacture the product
Team · 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
· Carry out sales and contract activities
Manager- · Conduct contract review
Business Team. · Control customer documents
· Coordinating with customers
Manager- · Procure the materials, items, and services
Purchasing Team · Maintain interface control with applicable suppliers
Manager-
· Perform design and development
Tech. & Devel.Team
Manager- · Finance / Accounting
Administration · Hire the new employees
Team · Maintain the personnel history records
· Conduct their work and ensure the quality of their work
All personnel · Stop work in progress and make appropriate notification when unsafe
conditions exist or requirements are not being met
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 5.0 Management Responsibility Page : 6 of 7

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,
Doc No. : QM-01
QUALITY MANUAL Rev. : 5
Section 5.0 Management Responsibility Page : 7 of 7

(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)
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
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.
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
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)


Doc No. : QM-01
QUALITY MANUAL Rev. : 4
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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 2 of 12

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 3 of 12

(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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 4 of 12

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 5 of 12

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 6 of 12

(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,
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 7 of 12

(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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 8 of 12

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:
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 9 of 12

(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)
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 10 of 12

·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
4.2.4 of this Manual.
(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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 11 of 12

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 7.0 Product Realization Page : 12 of 12

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)
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 8.0 Measurement, Analysis and Improvement Page : 2 of 7

(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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 8.0 Measurement, Analysis and Improvement Page : 3 of 7

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)
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 8.0 Measurement, Analysis and Improvement Page : 4 of 7

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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 8.0 Measurement, Analysis and Improvement Page : 5 of 7

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
4.2.4 of this Manual.
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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 8.0 Measurement, Analysis and Improvement Page : 6 of 7

(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
Doc No. : QM-01
QUALITY MANUAL Rev. : 4
Section 8.0 Measurement, Analysis and Improvement Page : 7 of 7

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)