Professional Documents
Culture Documents
PEACH VALVE
(BAVCOS)
QUALITY MANUAL Doc No. : QM-01
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4 Scope & Organization
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1.0 Scope 4
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.
1.2.1 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
For use at PEACH, the definitions of ISO 9001, API Spec. Q1 and PED(97/23/EC)shall
apply.
Terms Definition
Terms Definition
Abbreviation Definition
Co Company
ID Identification
Lab Laboratory
PO Purchase Order
QA Quality Assurance
Rev. Revision
4.1.2 Figure 1 and Figure 2 describes the Quality Management System and the main
processes and their interaction, respectively.
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.
4.2 Documentation
4.2.1 General
The Quality System is documented and structured in the following four levels of
documentation:
This document defines the quality policy and the Company structure and
methods for maintaining the Quality Management System.
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:
(1) All the requirements of ISO 9001:2000 apply and API Spec. Q1.
(4) Reference
(1) Documents required by the QMS shall be generated, approved, distributed and
revised in accordance with Quality Assurance Procedure.
(c) To ensure that changes and current revision status of documents are
identified
points of use,
(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.
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.
(2) Quality records are also used to analyze trends in quality performance and the
need for preventive actions.
(6) Retention times of quality records shall be complied with the product lifetime
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Section 4.0 Quality Management System Page : 5 of 7
Figure 1
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Section 4.0 Quality Management System Page : 7 of 7
Figure 2
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Section 5.0 Management Responsibility Page : 1 of 7
5. MANAGEMENT RESPONSIBILITY
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.
5.2.1 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”
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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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.
5.4 Planning
PRESIDENT
PRODUCTION TEAM
PURCHASING TEAM
BUSINESS DIV.
TECH./DEVELOPEMENT
TEAM
QA TEAM
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Section 5.0 Management Responsibility Page : 5 of 7
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
5.6.2.2 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
6.1.1 Respective Managers are responsible for determining and providing the
resources needed to:
(1) Implement, maintain and improve the Quality Management System processes,
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.
(1) The needs for training of personnel are identified by Respective Managers and
the documented procedures for providing that training are established and
maintained.
(3) Respective Managers ensure that all employees are aware of the importance of
their activities and how they contribute to achieving quality objectives.
(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
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
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
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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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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Section 7.0 Product Realization Page : 6 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:
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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
8.1 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.
(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.
8.3.6 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)
8.5 IMPROVEMENT
8.5.3 Reference
·Corrective and Preventive Action Control Procedure (QAP-852)