QMS Manual.docx

Quality Management System (QMS) Manual

Quality Management System Company Manual

Document Title Document No

xxxx /QMS

Revision No

00

Effective Date

1 December 2016

Reviewed by

General Manager

Approved by

Managing Director

MASTER UNCONTROLLED COPY

CONTROLLED COPY

Company Manual Quality Management System

Document No : xxxxx /QM Page No : 2 of 41 Revision No. : 00 Effective Date : 1 Dec 2016

Title: QMS Manual This document is the exclusive property of XXXX Xxxx Sdn Bhd (“XXXX ”) and upon request, may distribute on a confidential basis. Further distribution, copying, reproduction in whatever form is to be done only with the express permission of XXXX . This document must be returned to XXXX at the request of XXXX and no copies in whatever form of any part of this document is to be retained without the permission of XXXX . XXXX will seek recourse should this notice be violated.

Rev. No. Page No. 0 All

Revision History Description New Issue

Prepared by

Contents 1.

2. 3. 4.

5.

6.

7.

8.

9.

10.

11.

OVERVIEW OF ORGANIZATION AND QUALITY MANUAL............................................4 1.1 COMPANY BACKGROUND & PROFILE....................................................................4 1.2 SCOPE OF QUALITY MANAGEMENT SYSTEM (QMS) CERTIFICATION......................5 1.3 QUALITY MANUAL OVERVIEW...............................................................................5 REFERENCE............................................................................................................. 6 GLOSSARY............................................................................................................... 6 ORGANIZATION CONTEXT.......................................................................................6 4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT...................................6 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES......7 4.3 SCOPE OF THE QUALITY MANAGEMENT SYSTEM..................................................7 4.4 QUALITY MANAGEMENTSYSTEM AND ITS PROCESSESS.......................................8 LEADERSHIP............................................................................................................ 9 5.1 LEADERSHIP AND COMMITMENT..........................................................................9 5.2 POLICY............................................................................................................... 10 5.3 ORGANIZATION ROLES, RESPONSIBILTY AND AUTHORITY..................................10 PLANNING............................................................................................................. 11 6.1 ACTION TO ADDRESS RISKS AND OPPORTUNITY................................................11 6.2 QUALITY OBJECTIVES AND PLANNING................................................................12 6.3 PLANNING OF CHANGE......................................................................................13 SUPPORT............................................................................................................... 13 7.1 RESOURCE......................................................................................................... 13 7.2 COMPETENCE.................................................................................................... 17 7.3 AWARENESS....................................................................................................... 18 7.4 COMMUNICATION............................................................................................... 18 7.5 DOCUMENTED INFORMATION.............................................................................19 OPERATION........................................................................................................... 22 8.1 OPERATIONAL PLANNING & CONTROL...............................................................22 8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES...............................................23 8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES..............................24 8.4 CONTROL OF EXTERNALLY PROVIDED, PRODUCTS AND SERVICES....................24 8.5 PRODUCTION PROVISION...................................................................................26 8.6 RELEASE OF PRODUCTS.....................................................................................29 8.7 CONTROL OF NONCONFORMING OUTPUTS........................................................29 PERFORMANCE EVALUATION.................................................................................30 9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION..............................30 9.2 INTERNAL AUDIT................................................................................................ 31 9.3 MANAGEMENT REVIEW......................................................................................32 IMPROVEMENT...................................................................................................... 33 10.1........................................................................OPPORTUNITY FOR IMPROVEMENT 33 10.2.......................................................NONCONFORMITY AND CORRECTIVE ACTION 34 10.3...................................................................................CONTINUAL IMPROVEMENT 34 APPENDICES.......................................................................................................... 35

1. OVERVIEW OF ORGANIZATION AND QUALITY MANUAL 1.1

COMPANY BACKGROUND

xxxx Xxxx SDN BHD is an international certified company with project locations across Asia and operates through its affiliates companies such as xxxx Offshore Services, xxxx Oil Field Services and xxxx OFFSHORE SDN BHD. xxxx Xxxx has completed numerous projects successfully in the past with compliance of HSE and Quality requirement. Our Company expertise in: 1. Geotechnical, Piping, Civil, Structure & Marine Xxxx 2. Offshore Pipeline Commissioning, Process Plant Commissioning, Start Up and Offshore Hook-Up and Commissioning 3. Tank Construction Works (API 650) Std 4. Blasting & Painting and Insulation Works 5. Project Management Services/Task Force Manpower Supply for Plant Construction 6. Crude Tank & Petrochemical Tank Cleaning Works COMPANY ADDRESS BUSINESS REGISTRATION Registration CIDB – TOP MANAGEMENT Managing Director (MD) – General Manager ( GM ) – BUSINESS NATURE Provision of Project Management, Xxxx Works: 

Piling, Civil, Structure & Marine Xxxx



Pipeline and Piping Works (Fabrication and Installation)



Task Force and Manpower Supply for Plant Construction

1.2 SCOPE OF QUALITY MANAGEMENT SYSTEM (QMS) CERTIFICATION The scope of Quality Management System in XXXX Xxxx Sdn Bhd is Provision of Project Management, Engineering, Construction and marine Works. Details of scope boundary and requirements applicability are discussed in clause 4.3.

1.3

QMS MANUAL OVERVIEW

This QMS Manual was developed in accordance with the International Standard: ISO 9001:2015 Quality Management System – Requirements The QMS Team Leader / Management Representative (QMR) has established this QMS Manual in consultation with all department and management of the XXXX Xxxx Sdn Bhd, (“XXXX ”). Maintenance and issuance of this Quality Manual are in accordance with Control of Documented Information Procedure. The QMR is responsible to review the QMS Manual when changes occur to reflect current technology, legal requirements, changing customer expectations and improvements to the Quality Management System. The objective of this QMS manual is to specify the requirements for the development, implementation and maintenance of the Quality Management System. XXXX has adopted the 7 principles of Quality Management that have been incorporated into a Quality Management System designed to conform to the requirements. NO

TERMS

DESCRIPTIONS

Customer Focus

We depend on our clients, therefore we shall identify, determine and understand their needs and expectation in order to meet their requirements and strive towards client satisfaction.

2.

Leadership

Management is not an administration activity; and leadership is needed to provide a unity of purpose, direction and to create an environment in which people in the organization become fully involved in achieving our objectives.

3.

Engagement of People

Employee co-operation and involvement allows for their ability to be fully and effectively used for the benefit of the company.

4.

Process Approach

1

For the results to be achieved efficiently, the resources and activities of MOLECOR need to be

managed as a process. 5.

Improvement

Is a permanent objective of XXXX Xxxx Sdn Bhd

6.

Evidence –based Decision Making

Effective decisions are based on the logical and intuitive analysis of data and factual information.

7.

Relationship Management

Such relationship between the organization and its suppliers enchance the ability of both organization to create value.

2. REFERENCE XXXX adopts the ISO 9001:2015 requirements based on the latest references or revision by members of ISO and IEC maintain registers of currently valid international standards. *Refer to ISO 9001:2015, Clause 2 (Normative reference)

3. GLOSSARY Company

:

XXXX Xxxx Sdn Bhd, (“”)

Customer

:

The party who receives goods and services from XXXX

Documented information

:

Information and its supporting medium that can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof

Supplier

:

The party who supplies goods and services to XXXX

HOD

:

Head of Department

Interested party

:

Non Conformity

:

QMR

:

Individual or group concerned with or affected by the Integrated performance of an organization Non-fulfilment of a requirement that can be any deviation from relevant work standards, practices, procedures, legal requirements and QMS requirements. QMS Team Leader / Management Representative

QMS

:

Quality Management System

4. ORGANIZATION CONTEXT 4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT XXXX Xxxx has determined external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its Quality Management System.

This company also has considered external issues arising from customer, legal requirements, suppliers and contractors. Meanwhile, for internal issues the company may consider issues related to values, culture, knowledge and performance of the organization. We determine internal and external issues that might affecting our Quality Management System and business processes based on 4M1E elements and also using FITCOW and PESTLE analysis method. We highlight applicable risk that may arise from these internal and external issues in risk assessment process.

No

1

Related Documentations

Summary of internal and external issues

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES In order for the Company to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, we have determined: (a) Interested parties that are relevant to the Quality Management System; (b) Requirements of these interested parties that are relevant to the QMS; The Company ensures the needs and expectations of the interested parties are fulfilled in order to support its quality management system. Responsibility is assigned to monitor and review information about the interested parties and their requirements. Interested parties that are relevant to XXXX are (but not limited to): N o

Interested Parties

Needs and Expectation

Monitoring by

1

Customer

Service meet requirements & applicable standards; On time project completion

Director & Project team

2

Suppliers and Contractors/ Others

Lead time, quantity, contract

Purchaser & Project team

3

Communities / Neighbours

Safe environment

Safety Officer & Project team

4

Government bodies

Comply to applicable standards

HSE Manager

4.3

(DOE, DOSH, etc)

and legal requirements

5

Employees

Job security, welfare, health and safety

HODs

6

Board of Director

Profit and company growth

HODs

SCOPE OF THE QUALITY MANAGEMENT SYSTEM

The Company has determined the boundaries and applicability of the Quality Management System when establishing its scope for QMS. For this purpose, the company has considered: (a) external and internal issues (b) requirements of relevant interested parties (c) compliance obligations (d) activities, products and services (e) ability and authority to exercise control XXXX has decided that the scope of our Company Quality Management System Provision of Project Management, Xxxx Works. Our Quality Management System include all our business processes such as Human Resources and Administration, Procurement process, Project Management and Control, Maintenance and Engineering works. The Quality Management System is develop to be relevant to the nature of our organization, products, services and customers and regulatory requirements. For this purpose, QMS Team Leader (QMR) and the Top management have identified the requirements of ISO 9001:2015 that are not applicable to the scope of our quality management system. The requirements of ISO 9001:2015 standard that do not apply to our organization are: (1)ISO 9001: 2015 Clause 8.3 (Design and development of products and services). Justification: This is due to the fact that we do not undertake any design and development activities that lead to the completion of our products and services. Any design used in a project will be provided by our customer. (2)ISO 9001: 2015 Clause 8.5.1 (f) (Validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement; Justification: This is due to the fact that the resulting output of our works can be verified by subsequent monitoring or measurement;

However, these non-applicability shall not affect our ability, nor absolves us from the responsibility, to provide product that meets customers and applicable regulatory requirements.

4.4

QUALITY MANAGEMENTSYSTEM AND ITS PROCESSESS

The Company adopts the ISO 9001:2015 requirement as the principle for designing this Quality Management System (QMS). The extent of this Quality Management System (QMS) established is based on the nature of our organization, complexity and interaction of the processes and competence of our personnel. The Top Management fully supports and gives fullest commitment in establishing, documenting, implementing, maintaining and continual improvement of this Quality Management System in accordance with the ISO 9001:2015 requirements. To implement this Quality Management System, We: (a) Determines the processes needed for the quality management system and their application throughout the organization (see Appendix V– business process mapping). (b) Determines the inputs required and the outputs expected from these processes (c) Determines the sequence and interaction of these processes (see Appendix V - business process mapping). (d) Determines criteria and methods required to ensure effective operation and control of these processes (see Clause 8). (e) Determines resources needed for these processes and ensure their availability (see Clause 7) (f) Assigns the responsibilities and authorities for these processes (see Clause 5) (g) Addresses risks and opportunities as determined in accordance with the requirements of clause 6.1 (h) Evaluates these processes and implements any changes needed to ensure they achieve their intended results (see Clause 9) (i) Improves the processes and Quality management system (see Clause 10) (j) Maintains documented information to support the operation of its processes (see Clause 7) (k) Retains documented information to have confidence that the processes are being carried out as planned (see Clause 7).

5. LEADERSHIP 5.1

LEADERSHIP AND COMMITMENT

5.1.1 LEADERSHIP & COMMITMENT FROM TOP MANAGEMENT The Top management demonstrates leadership and commitment to the development and improvement of the Quality Management System by: (a) Taking accountability management system;

for

the

effectiveness

of

the

Quality

(b) Ensure establishment of the QMS Policy and QMS Objectives and are compatible with the context and strategic direction of the organization; (c) Ensure integration of the Quality management system into the company business operations; (d) Promoting the use of process approach and risk-based thinking; (e) Ensure the availability of necessary resources; (f) Communicating to the employees the importance of effective Quality management system and conforming to the ISO 9001 system requirements; (g) Ensure Quality management system achieves its intended result; (h) Engage, direct and support persons to contribute to the effectiveness of the Quality management system; (i) Promoting continual improvements; (j) Support other relevant management roles to demonstrate their leadership as it applies to their area of responsibilities.

5.1.2 CUSTOMER FOCUS The Top Management demonstrates leadership and commitment with respect to customer focus by ensuring that: (a) Customer and applicable statutory and regulatory requirements are determined, understood and consistently met; (b) The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; (c) The focus on enhancing customer satisfaction is maintained.

5.2

POLICY

A Quality Management System (QMS) Policy statement has been defined and documented. The Policy is relevant to all activities related to Quality Management System. The policy includes commitment to comply with all relevant legal and other requirements, and continual improvement of XXXX ’s overall performance. The policy has been formally approved for its release by the Top Management. The policy is reviewed annually as part of the QMS Management Review to ensure that it continues to reflect the activities, products and services of the company. The policy provides the framework for and is supported by objectives and targets, and that its achievements are quantified where possible. The policy is documented, implemented and maintained at all levels throughout the company and communicated to all employees. The policy is also available to the public and interested parties. The policy and objectives for QMS has been rolled out to all employees for their awareness and understanding. Company quality objectives. No

1


Appendix III - Quality Policy

5.3 ORGANIZATION ROLES, RESPONSIBILTY AND AUTHORITY Roles, responsibilities and authorities of the employees within the quality management system are defined in the Job Description. The Top Management ensures that following responsibilities and authorities are carried out adequately: Descriptions of Responsibilities

Responsibility

Ensuring that the quality management system conforms to the requirements of ISO 9001: 2015

Quality Management Representative (QMR)

Ensuring that the processes are delivering their intended outputs

HODs, employees

Reporting on the performance of the quality management system on opportunities for improvement and on the need for change or

QMR, auditor

Internal

Descriptions of Responsibilities innovation, and management

especially

for

Responsibility reporting

to

top

Ensuring the promotion of customer focus throughout the company

Top Management

Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented

QMR, Management

No


1

XXXX /JD Job Description

DC,

6. PLANNING 6.1 ACTION TO ADDRESS RISKS AND OPPORTUNITY When planning for the Quality Management System, considered:

XXXX has

(a) Internal and external issues identified within the organizational context are addressed; (b) Requirements of interested parties are addressed; (c) Compliance obligations; (d) Risks and opportunities for (a) and (b) are determined; Risks and opportunities associated with company Operation, interested parties and legal obligations has been identify and analyzed. The company is responsible for its application of risk based thinking and the actions it takes to address the risks. The action plan shall ensure: 

Quality management system can achieve its intended result(s);



Enhance desirable effects;



Prevent, or reduce, undesired effects;



Achieve improvements.

We has determined what could go wrong in existing plans and practices. The problem causes are assessed according to their likelihood of occurrence and the severity of their consequences. We consider several options to address the identified risks include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

Here in XXXX, preventive actions are taken and contingency plans are developed to ensure identified risks are in control or at least minimize their effect if they do occur. Risk register shall be prepared or updated by the process/risk owner when: (a) Completing a plan for implementing a decision or improvement (b) Monitoring a plan which is in progress (c) Reacting to possible internal or external changes that could affect the company The risk register shall be reviewed yearly and updated upon changes in the process and service specifications. The process owner shall integrate and implement action plan into its Quality Management System processes. Effectiveness of risk control shall be evaluated, analyzed and reported to the management during QMS management review meeting. No

6.2


1

XXXX /SP04 Risk Assessment & Control

2

Risk Register & Action Plan

3

Job Safety Analysis

4

HIRARC

QUALITY OBJECTIVES AND ITS PLANNING

Quality objectives and subsequent targets are established after consideration of risks of company’s activities, financial, operational and business requirements, the applicable legal regulations and the views of interested parties. The objectives and targets are consistent with the Quality policy including the company’s commitment to enhance customer satisfaction, continual improvements and compliance with applicable requirements. The objectives and targets are quantified wherever practicable and where appropriate taken into account all preventative measures. Top management has established the KPI at relevant functions, levels and processes within the organization. The QMR shall ensure quality objectives are monitored, communicated and updated. We shall determine actions to be done, resources and supports required, responsibilities and target of completion for every quality objectives established. The company has also periodically monitors and evaluates

the quality objectives achievements. Action plan shall be recorded in the QMS Management Program. Progress and achievement of Quality Objectives will be reported and reviewed during QMS management review meeting. Appropriate actions shall be taken if the Quality Objectives are not achieved. No

6.3


1

Appendix III XXXX /QM - Quality Objectives

2

QMS Management Program

PLANNING OF CHANGE

When the company determines the need for changes to the Quality management system, XXXX shall carry out the changes in a planned manner by considering: (a) the purpose of the changes and their potential consequences; (b) the integrity of the Quality management system; (c) the availability of resources; (d) the allocation or reallocation of responsibilities and authorities. No

1


XXXX /SP16 Management of Change (MoC)

7. SUPPORT 7.1 RESOURCE 7.1.1 GENERAL The company shall determine and provide in a timely manner the resources needed: (a) To implement and maintain the Quality Management System and continually improve its effectiveness. (b) To enhance requirements.

customer

satisfaction

by

meeting

customers’

(c) The provision of resources shall be reflected in organization chart, process flow chart and etc. (d) The Director shall identify the resources needed during new process, new layout, equipment, environment and new technology required.

7.1.2

PEOPLE

The company determines and provides the persons necessary for the effective implementation of its Quality management system and for the operation and control of its processes.

7.1.3

INFRASTRUCTURE

The company shall identify, provide and maintain the facilities it needs to achieve the conformity of products and services, including maintaining of buildings, workspace and associate utilities. The office and work area shall be safe and of good housekeeping practices. All installed equipment which required maintenance (including of software/ information system, if any) shall be periodical serviced and maintained as per schedules. The company shall identify, provide and maintain the infrastructure for the operation of its processes and to achieve the conformity of our services, including, as applicable: (a) Building and associated utilities; (b) Process equipment (both hardware and software) such as machine, measuring equipment for testing, storage etc. (c) Transportation resources (company vehicles) (d) Information and communication technology We plans and performs the periodic maintenance on the infrastructures required for maintaining the effectiveness of the quality management system. Planning of maintenance shall be based on: 

Criticality of infrastructures



Frequency of usage



Suitability of the infrastructures



Regulatory requirements (e.g. DOSH, DOE) No

1

7.1.4


XXXX /SP12 Infrastructure & Environment

WORK ENVIRONMENT

The company shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. The Company shall identify and manage the social, psychological and

physical factors of the work environment needed to achieve service and process conformity to requirements through implementation of 5S practice, Safety practice and other management system. The relevant work environment will be specified in the relevant work instructions, induction course or on-job training. The human factors considered are;(a) Work methods. (b) HSE procedures, and (c) Ergonomics. The physical factors considered are;(a) Heat, (b) Light, (c) Hygiene, (d) Cleanliness, and (e) Pollution. We endeavours to provide safe and healthy working environment to its employees and contractors and surrounding communities with adherence to several policies such as “HSE Policy“, “Stop Work Policy”, “Drug & Alcohol Policy”. No

1 2 3

7.1.5


XXXX /SP12 Infrastructure & Environment HSE Policies HSE Manual

MEASURING AND MONITORING EQUIPMENT

The company shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The company shall ensure that the measuring and monitoring equipment provided are: (a) Suitable for the specific type of monitoring and measurement activities being undertaken; (b) Maintained to ensure their continuing fitness for their purpose. (c) Retain appropriate documented information as evidence of fitness for

purpose of the monitoring and measurement resources. Monitoring and measuring equipment used to verify compliance are subjected to regular calibration checks, where applicable. Equipment is allocated with a unique reference number and are checked against the master references, which are traceable to national or international standards. Where internal calibration is not possible, an approved in house calibration will be utilized. Calibrated equipment are fixed with a label indicating the validity for use. Records of calibration results are maintained. All inspection and test equipment used to verify compliance will be utilized in an environment controlled to the extent necessary to ensure continued measurements of the required accuracy. When measurement traceability is a requirement, or is considered by the company to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be: (a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; (b) Identified in order to determine their status; (c) Safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results. Equipment user shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. No

1

7.1.6


XXXX/SP13 Calibration

ORGANIZATIONAL KNOWLEDGE

The company determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. The organizational knowledge can be based on internal (such as intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services) and external sources (such as

standards; academia; conferences; gathering knowledge from customers or external providers). In order to maintain organizational knowledge within the company, we retain documented information related to experience and lessons learned from failure or nonconformity incident.

7.2

COMPETENCE

XXXX is committed to the ongoing development of employees. High performance and continuous commitment is expected from all employees. Competency of employees which affects the performance and effectiveness of the quality management system shall be taken into account. Training Needs Assessment is periodically conducted to identify training needs among employees. Training shall be provided to the employees in order for them to acquire the necessary competence and included as part of their personal training plan. The company Training System can be implemented through a series of processes which include: (a) On job training (b) Soft skills/ Management Development Training (c) Other Technical/ Engineering Skills Training Process This is to ensure that employees are trained and knowledgeable in their safety responsibilities, nature of the hazards and the actions necessary to safely perform their jobs. Based on training needs analysis, Training Plan will be established which covers the mandatory and relevant training and also relevant personnel who needs to attend. The Training Plan is reviewed / updated on an annual basis with endorsement from PDR Management. Training evaluation is carried out to verify the effectiveness of the training via: (a) Training Feedback & Evaluation forms (b) Performance appraisal The employee performance and competency which include job knowledge, skills and values will be assessed and any improvements needed to meet job requirements will be identified and included in the Employee Training record. No


1

XXXX /SP06 Recruitment

2

7.3

XXXX /SP07 Training

AWARENESS

The company shall ensure all employees (and where applicable contractors) are aware of: (a) Conformance with the Quality policy, procedures and Management System requirements (b) The significant quality specification, health & safety hazards, environmental effects associated with their work activities and the benefits of improved personnel performance (c) Roles and responsibilities in achieving conformance with the Quality policy, procedures and Management System requirements (d) The potential consequences of deviation from specified operating procedures Awareness platforms:

and

understanding

being

promoted

through

several

(a) Communication on the policy and objectives during induction program. (b) Quality policy and objectives are displayed at various strategic areas. (c) Ongoing quality/ training programs The potential consequences of deviation from processes is shared via several means.

7.4

No


1 2

XXXX /SP06 Recruitment XXXX /SP07 Training

COMMUNICATION

The company shall determine the internal and external communications relevant to the quality management system, including on what it will communicate; when to communicate; with whom to communicate; how to communicate; and who communicates. Internal communication shall be in place to discuss on the performance of quality management system such as: (a) Business planning (company Top management meeting)

(b) Performance of company is communicated during weekly, monthly, quarterly, and QMS management review) (c) Safety, health and environmental related issues is communicated during Toolbox meeting, Monthly meeting, QMS management review) (d) Changes/ update on the requirements of interested parties (e/g: customer, government bodies, contractors, etc.) QMS management review (e) Results of internal or external assessment are communicated during QMS management review) The company ensures communication processes enable persons doing work under the organization’s control to contribute to continual improvement. External communication includes (but not limited to): (a) Briefing to contractors regarding organizational policies, organizational rules in relevant to quality management system (b) Communication with supplier (c) Communication with customer including response to enquiries, contract, complaint and feedback

7.5

DOCUMENTED INFORMATION

XXXX ’s quality management system documentation structure shall include: (a) Documented information required by ISO 9001:2015 Standard; (b) Documented information determined by PDR as being necessary for the effectiveness of the Quality Management System.

7.5.1

Creating and Updating

The company’s quality management system maintained and controlled respective department.

documentation

is

(a) Document is properly identified and described with a title, date, author, review and approval authority, revision number, reference number); (b) Appropriate format of document is used; (c) Document is reviewed and approved for suitability and adequacy

prior to issuance (d) Document is periodically reviewed within stipulated period, and updated as necessary

Structure of the quality management system is shown below:

LEVEL 1MANU AL LEVEL 2 - STANDARD PROCEDURES

LEVEL 3 - METHOD STATEMENT(MS)

LEVEL 4 - FORMS, RECORDS, DRAWING

Level I: The QMS Manual addresses XXXX’s quality management of its activities, products and services. This manual describes the core elements of the Management System and their interaction. Job description manual describes roles, responsibility and authority of a position. Level 2: Standard procedures is a documented work process that describes the organization’s interfaces between different sections or departments, including satisfying the ISO 9001:2015 requirements as well as meeting the needs of the organizations. Level 3: Method Statement / Inspection testing plan (ITP) / test protocol provide specific instructions on tasks and specifies clearly the acceptance criteria (meeting tolerance limits etc).

Level 4: Records and checklists are formats designed for demonstrating conformance to the quality system, product and process quality.

7.5.2 Control of Documented Information The company shall control documented information required by the Quality management system and ISO 9001:2015 Standard to ensure it is available and suitable for use, where and when it is needed; and it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). The Quality Management System Documents established to meet ISO 9001:2015 requirements are controlled documents, these includes level 1 to level 4 of documents. The company shall address the following activities to control the documented information, as applicable: (a) Distribution, access, retrieval and use of documented information; Storage and preservation, including preservation of legibility; (b) Documented information shall remain legible, readily identifiable and retrievable. (c) Quality records are well classified and labelled clearly for easy retrieval and stored in proper storage areas and/or other medium to prevent lost and damages. (d) Control of changes such as: 

Identify the current revision status of documents.



Relevant versions of applicable documents are available at points of use

(e) To prevent the unintended use of obsolete documents (f) Retention and disposition (g) The respective personnel shall be responsible to collect, file, store, maintain and dispose of quality records. Retention period for these records are specified in the Form & Record Master List. After the specified retention period, the records shall be disposed unless otherwise required. (h) Document controller shall ensure document of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and controlled. (i) Documented information retained as evidence of conformity shall be protected from unintended alterations.

No

1 2


XXXX/SP01 Control of Documented Information XXXX/SP14 Drawing Control

8. OPERATION 8.1

OPERATIONAL PLANNING & CONTROL

The company shall plan, implement and control the processes needed to meet the requirements for the provision of products, and to implement the actions determined in Clause 6, by: (a) Determining the requirements for the products requirements, In-full and timeliness of delivery)

(e/g:

service

(b) Establishing criteria for the processes and the acceptance of products based on applicable requirements (e/g: requirements defined by customer, government body); (c) Determining the resources needed to achieve conformity to the product requirements; (d) Implementing control of the processes in accordance with the criteria; (e) Determining, maintaining and retaining documented information to the extent necessary: (f) to have confidence that the processes have been carried out as planned; (g) to demonstrate the conformity of products to their requirements. (h) Control planned changes and reviews the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. (i) Control outsourced processes. The type and extent of control or influence to be applied to the process(es) shall be defined within the environmental management system. XXXX has established implemented and maintained procedures to identify potential for and respond to incidents and emergency situations, and for preventing and mitigating the HSE hazards/risks/impacts that may be associated with them. Where appropriate for a project, XXXX shall establish, implement and maintain a procedure for on-going identification for:

(a) Identification of environmental aspects and evaluation of impacts (activities, products and services that we can control and influence for planned or new development, new or modified activities, products and services). (b) Identification of job safety hazards, risk assessment and determining control measures to reduce the risks level. No

1 2 3

8.2


XXXX/SP08 Tender Process XXXX/SP09 Project Management & Control Quality Manual

REQUIREMENTS FOR PRODUCTS AND SERVICES

Project team leader shall make proper arrangements for communication with Customer relating to products/service information, enquiries and Customer feedback & complaints through meeting, emails and feedback form. Project Manager being the centre point of contact shall maintain effective communication with the customer regarding: (a) Information related to products and production (e/g: product specification, product nonconformity, new crude processing, production processes, etc) (b) Enquiries (c) Customer feedback/ perception towards products and its delivery (d) Complaints (e) Contingency action to prevent disruption to the operation and delivery Head of Operation is responsible to review the requirements for products and services required by the customers prior committing to supply the products and services to the customer. The review is carried out to assess the capability of the company and project team to meet the requirements. Following requirements are reviewed to ensure resources of XXXX are adequate for the provision of products: (a) Customer requirements such as service requirements, acceptance criteria, and expected completion /handover (b) Requirements not stated by the customer, but necessary for the specified or intended use, when known

(c) Requirements of the organization (such as those requirements related to cost control, reputation, safety, protection of environment, etc) (d) Statutory and regulatory requirements (e) Requirements expressed

of

supply

which

deviate

from

those

previously

Project team leader is responsible to ensure any deviation from the initial order is resolved and communicated to the relevant personnel or division in the company. Head of Operation is responsible to communicate the confirmation of provision of products and services to the customer. Changes to requirements for products and services are communicated by the customer to Head of Operation or Project Team Leader. Head of Operation is responsible to notify such changes to Project Team members and/ or relevant interested parties. Work plan shall be revised accordingly (if necessary). Any deviation to the approved initial plan is being reviewed and approved by XXXX Management. No

1 2


XXXX/SP08 Tender Process XXXX/SP09 Project Management & Control

8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES This requirement is not applicable for XXXX and its Quality Management System due to its scope of operation that does not involve any design and development activities.

8.4 CONTROL OF EXTERNALLY PROVIDED, PRODUCTS AND SERVICES The company shall ensure that externally provided products and services conform to requirements in order to assure an effective and efficient quality management system. Due to the nature of its operation and product that it supplies, XXXX is committed to apply stringent controls onto externally provided, products and services. This control is applied when: (a) Products and services from external providers are intended for incorporation into the DTE ’s products and services; (b) A process, or part of a process, is provided by an external provider as a result of a decision by Company Management

The company has determined and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide products and services in accordance with our requirements and applicable standards. When determining the criteria for the evaluation, the company shall take into consideration policies of the organization and the expectation of the interested party. Evaluation criteria and the records of evaluation shall be maintained. Follow-up action arises from this evaluation shall be recorded. The company shall continuously control its externally provided products and services to ensure they do not adversely affect the XXXX’s ability to consistently deliver conforming products to the customers. Therefore, the company shall: (a) Ensure that externally provided processes remain within the control of its quality management system; (b) Define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output. The control applied shall be as adequate as is necessary to meet requirements for the products/services supplied. (c) Take into consideration: 

Potential impact of the externally provided processes, products and services on XXXX’s ability to consistently meet customer and applicable statutory and regulatory requirements;



Effectiveness of the controls applied by the external provider;



Determine the verification, or other activities, necessary to ensure that the externally provided products and services meet requirements.

The company shall periodically review the effectiveness of the control that it applies to the external providers and where deemed necessary, re-define its control to assure external providers conform to requirements. The company shall ensure the adequacy of requirements prior to their communication to the external provider. Relevant personnel shall clearly communicate to external providers its requirements for: (a) Products and services to be provided (b) Approval of: 

products and services;



methods, processes and equipment;



release of products and services;

(c) Competence, including any required qualification of persons and relevant regulatory requirements (d) Certification of management system (e/g: ISO 9001, 14001, 18001, etc) (e) External providers’ interactions with the XXXX; (f) Control and monitoring of the external providers’ performance to be applied by the Company; (g) Verification or validation activities that the company intends to perform at the external providers’ premises (if necessary). Therefore, the personnel shall ensure the adequacy of specified requirements prior to their communication to the external provider. No

1 2

8.5


XXXX/SP10 Procurement Control XXXX/SP11 Control of External Provider

PRODUCTION PROVISION

8.5.1

CONTROL OF SERVICE PROVISION

XXXX has established, implemented and maintained procedures to identify, plans and carries out production, operational and service provision under controlled conditions, including, as applicable: (a) Availability of contracts information characteristics of the product

that

specifies

the

(b) The establishing and maintaining documented procedures to cover situations where their absence could lead to deviations from the policy and the objectives and targets. (c) The availability of information that describes the characteristics of the product and stipulating operating criteria in the procedures. (d) The availability of work instructions / method statement, as necessary. (e) The use of suitable equipment. (f) The availability and use of suitable monitoring and measuring devices. (g) The implementation of suitable monitoring and measurement.

(h) The implementation of release, delivery and activities.

post-delivery

(i) The method in the activities and materials are control correctly and minimize the risks/impacts. (j) Implementation of actions to prevent human error; No

1 2 3 4 5 6

8.5.2


XXXX/SP08 Tender Process XXXX/SP09 Project Management & Control XXXX/SP14 Drawing Control Method Statement Master List Job Safety Analysis (JSA) Quality Manual

IDENTIFICATION AND TRACEABILITY

The status of material and goods received, in-process materials and finished goods are identified with relevant labels, tags or stickers. The operation and purchasing personnel are responsible to confirm the materials purchased and goods received are correct, which are traceable to the quality results and date of services provided. XXXX has established, documented, implemented and maintained a system for the identification and traceability of products and materials from receiving, during all stages of operations and delivery to the customer. All materials shall be purchased and delivered by supplier with delivery order or invoice. When traceability is a statutory or contractual requirement, it shall be controlled using a unique identification starting from raw materials to final product and delivered to the customer in accordance with the relevant procedures. No

1 2 3



8.5.3 PROPERTY BELONGS TO CUSTOMER OR EXTERNAL PROVIDER The Project team shall exercises care with customer or external provider property while it is under our control or being used. Customer or external provider property provided for use or incorporation into the product or services will be suitably identified, verified, protected and safeguarded. Any customer or external provider property that is lost, damaged, or otherwise found to be unsuitable for use will be recorded and reported to the customer. No

1 2 3

8.5.4


XXXX/SP09 Project Management & Control XXXX/SP15 Customer Satisfaction Quality Manual

PRESERVATION

The incoming materials and goods are stored at the designated area to avoid from wet or damaged. There is no material which is sensitive to the climate and stored directly under sunlight. There are additional preservation requirements to the goods during delivery to the customer. Goods are stored in a covered warehouse. The details about handling, storage, preservation of the raw materials and finished goods are defined in the relevant procedure . No

1 2 3

8.5.5


XXXX/SP09 Project Management & Control XXXX/SP05 Continual Improvement Quality Manual

POST DELIVERY ACTIVITIES

The post-delivery activities can include actions under warranty provisions and contractual obligations. XXXX has determined the extent of post-delivery activities by considering below factors: (a) statutory and regulatory requirements; (b) potential undesired consequences associated with its products and services;

(c) customer specified requirements; (d) customer feedback. No

1 2 3 4

8.5.6


XXXX/SP08 Tender Process XXXX/SP09 Project Management & Control XXXX SP15 Customer Satisfaction Quality Manual

CONTROL OF CHANGES

The project team shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. The company shall retain records describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review. No

1 2 3

8.6



RELEASE OF PRODUCTS

XXXX shall implement planned arrangements which include quality inspection and monitoring, at appropriate stages throughout provision of production, to verify that the product requirements have been met. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed. The project team shall retain documented information on the release of products. The documented information shall include: (a) Testing report/ certificate which provide the evidence that product / service fulfils acceptance criteria; (b) Traceability to the person(s) authorizing the release. Products that meet the criteria are released for delivery and the related records shall indicate the person authorizing the release of products. No product can be released for delivery until the necessary action has been carried out.

Urgent release before completing the test is upon the approval from customer or Managing Director. No

1 2

8.7


XXXX/SP09 Project Management & Control Quality Manual

CONTROL OF NONCONFORMING OUTPUTS

XXXX has established, implemented and maintained procedure to ensure that activities, product and services, which does not conform to requirements, is identified and controlled to prevent unintended use or delivery. Effective communication shall be in place to enable proper control on this nonconforming product by relevant party. Project Team shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products. When nonconforming outputs are detected, following action shall be taken (wherever applicable): (a) Applying clear identification (b) Correction (e/g: rework/ re-blending); (c) Carry out proper segregation, containment, return or suspension of provision of products; (d) Informing the customer and/ or external provider; (e) Obtaining authorization for acceptance under concession/ waiver (where applicable) Conformity to the requirements shall be verified when nonconforming outputs are corrected. No

1 2 3


XXXX/SP09 Project Management & Control XXXX/SP05 Continual Improvement Quality Manual

9. PERFORMANCE EVALUATION 9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION 9.1.1 MONITORING AND MEASUREMENT OF PROCESSES, PRODUCT AND SERVICE XXXX applies suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective actions will be taken, as appropriate, to ensure conformity of the product. Incoming, in-process and final inspection or checking are carried out accordingly based on specifications. Test methods or visual inspection or check are carry out to the goods that are to be delivered to the customers.

9.1.2

Customer Satisfaction

Information on customer satisfaction or dissatisfaction is obtained by the sales. The feedback or information from customers’ perception to the XXXX is through calls, reports, complaints or results of customer Survey. The frequency of Customer Satisfaction Survey will be carried out at yearly or project basis. The criteria are defined based on the product quality delivery status, communication and cost. The result of survey will be assessed, evaluated and reported during the management review. Any action taken is documented, and records shall be maintained at least 3 years to study the trend. No

1 2 3

9.1.3


XXXX/SP15 Customer Satisfaction Complaint record Customer NCR

Analysis and Evaluation

XXXX shall determine, collect and analysed the information and data to evaluate the effectiveness of QMS by using appropriate Chart or any statistical means to provide input for continual improvement.

This includes data generated as a result of monitoring and measurement and from any other relevant sources. This data is analysed to provide information relating to: (a) Customer satisfaction (b) Conformance to product requirements. (c) Characteristics of trends of processes and products including opportunities for preventive action. (d) Suppliers performance (e) Result of evaluation of compliance to legal and other requirements (if necessary)

9.2

INTERNAL AUDIT

The Quality Management Representative (QMR) shall arrange periodic internal audit to be conducted to determine whether the quality management system conforms to the requirements of the ISO 9001:2015 standard and has been effectively implemented and maintained. The QMR shall plan the audit program taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. The audit objectives are to measure the system conformity against the ISO 9001:2015 standard as well as the XXXX ’s procedures shall be performed. The audit scope shall cover all requirements by the standard and procedures developed. The internal audit shall be carried out at least once a year. The selection of auditors shall be the people other than whom they perform the activity being audited. Management shall take timely corrective action on any deficiency found during the audit. Follow-up action shall commence include the verification of the implementation of corrective action, and the reporting of verification result.

9.3

No


1

XXXX /SP02 Internal Audit

MANAGEMENT REVIEW

XXXX shall review the QMS at least once a year and at an interval of not more than 12 months to determine whether the QMS is continually managed suitably, adequately and effectively. It also will be used to assess the opportunities for improvement and changes required in the quality management system, quality policy and quality objectives.

The Management Review Team (MRT) shall comprise of follows: (a) Managing Director (b) QMR (c) QMS committee (d) Head of Departments (e) Document controller (f) Other key personnel (where appropriate) The MRT shall ensure necessary information or review input are collected to allow the team to analyse the current performance or evaluation related to the following: (a) status of actions from previous management reviews; (b) changes in external and internal issues that are relevant to the Quality Management System including change on legal or process; (c) Review on objectives and targets including progress of programme; (d) information on the performance and effectiveness of the Quality Management System, including trends in: i.

customer satisfaction and feedback from relevant interested parties;

ii.

the extent to which Quality objectives have been met;

iii.

process performance and conformity of products and services;

iv.

nonconformities and corrective actions;

v.

monitoring and measurement results;

vi.

audit results;

vii.

performance of external providers;

(e) adequacy of resources; (f) effectiveness of actions taken to address risks and opportunities (g) Recommendations for improvements Management Review shall focus on observations, conclusions and recommendations for necessary action. The possible need for changes to the QMS shall include; (a) Policy and the extent to which objectives and targets have been met. (b) Results from internal and external audit

(c) Continuity suitability of the QMS in relation to changing conditions and information or (d) Concern amongst relevant interested parties. The Document controller shall be responsible for maintaining records of Management Review. Before each meeting, the QMR shall prepare an agenda and related information and circulate to all members before the meeting to ensure each person are ready if they need to present any data or information. The MRT shall address the possible need for changes, decisions for improvement and actions related to: (a) Evaluating opportunities for improvement of the effectiveness of the IMS and its processes. (b) Determine suitable strategies for achievement of services related to customer requirements and compliance to updated legal requirements. (c) Resource needs. (d) Monitoring achievement of the services and compliance. The review shall be recorded and kept for at least 3 years. Any plan changes shall be managed according to procedure Management of Change (MoC). No

1

10. 10.1


XXXX /SP03 Management Review

IMPROVEMENT OPPORTUNITY FOR IMPROVEMENT

XXXX shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These shall include: (a) Improving products quality or delivery to meet requirements as well as to address future needs and expectations; (b) Correcting, preventing or reducing undesired effects; (c) Improving the performance management system

and

effectiveness

of

the

Quality

10.2

NONCONFORMITY AND CORRECTIVE ACTION

XXXX shall take action to eliminate the cause of non-conformities in order to prevent recurrence. It shall be appropriate to the effects of the non-conformities encountered. The procedure defines the requirements for: (a) Reviewing non-conformities (including client complaints). (b) Determining the causes of non-conformities. (c) Evaluating the need for action to ensure that non-conformities do not reoccur. (d) Determining and implementing action needed. (e) Records results of action taken. (f) Reviewing corrective action taken.

10.3

CONTINUAL IMPROVEMENT

The following areas are used to improve the effectiveness of QMS through monitoring and measurement data and review their achievements as stated below. The areas are;(a)

Policy

(b)

QMS objectives,

(c)

Internal and external audit results

(d)

Analysis of data

(e)

Corrective action, and Preventive action,

(f)

Incidents statistics,

(g)

Employees suggestion,

(h)

Internal and external feedback, and

(i)

Management review No

1


XXXX/SP05 Continual Improvement

11.

APPENDICES LIST

APPENDIX 1 - Organization Chart APPENDIX II - Mission & Vision APPENDIX III - Quality Policy APPENDIX IV - Quality Objectives APPENDIX V - QMS Processes Interaction

APPENDIX 1 - Organization Chart

APPENDIX II - Mission & Vision

Vision The company’s long term vision is to be recognized as a worldwide complete systems and solution provider in Petrochemical, Oil & Gas, Power Plant Construction, Maintenance and Hook Up commissioning and marine works. XXXX will assist global customers all the way from the design stage through product and customer support up to providing global service network. Whatever your project, whenever and wherever you are planning it; we can provide the energy to make it work and service provider for Oil & Gas, petrochemical, power plant construction and marine works. Misson  To be the best source of total provider for xxxx works.  To provide excellent in working environment for all employees.

 To earn business and loyalty from both our dealers and customers.       

COMPANY CORE VALUE : To maintain Healthy, Safety and Environment Standard Requirement. High Quality of work Team Work and Production Challenge Customer Satisfaction Risk Assessment and Management inputs Continuous Improvement.

APPENDIX III - Quality Policy XXXX Xxxx Sdn Bhd recognizes Quality as an essential element that provides the Company with its continued success within the International xxxx industry. Consequently, it is XXXX Xxxx Sdn Bhd policy to provide our Clients with products and services which fully meet their specified requirements and expectations and comply with relevant regulations, codes and standards. This policy implement in all areas of operations by:  Maintaining a Quality Management System meet the requirements of ISO 9001.  Continually improving the effectiveness of our Quality Management System.  Ensuring a clear understanding of our Client’s requirements.  Responding to client’s needs and expectations.

 Enabling all our employees to meet quality requirements and striving to achieve good work first time, every time and on time.

The Management of XXXX Xxxx Sdn Bhd is committed to active participation in the implementation and regular review of the Quality Management System and the establishment of a corporate climate, which encourage excellence through continuous improvement.

Approved by ………………………………….………………………………………… Managing Director XXXX XXXX SDN BHD DATE: 1st December 2016 APPENDIX IV - Quality Objectives Top Management of XXXX XXXX SDN BHD has established Quality Objectives at relevant functions, levels and processes within the organization. The objectives are consistent with the Quality policy including our commitment to enhance customer satisfaction, continual improvement and comply with applicable requirements. Our Quality Objectives are: •

To attain more than 80% customer satisfaction

•

To ensure nonconformity report issued by client is not more than five (5) per project

• To ensure TIMELY COMPLETION for every project •

To ensure ZERO INCIDENT OR ACCIDENT at project site

•

To ensure at least 80% training plan completion

•

To ensure discrepancy between actual project cost and budget is not more than 5%

Consistent with this policy, specific quality objectives are established at relevant functions and all levels within XXXX organization. By mutual encouragement, commitment and cooperation through teamwork, all XXXX employees will perform their task diligently in contribution to the achievement of our quality objectives. These objectives will be regularly measured and reflected to ensure our strategic objective to maintain in high quality standard.

Approved by ……………………………………………………………… Managing Director XXXX XXXX SDN BHD DATE: 1st December 2016 APPENDIX V - QMS Processes Interaction

QMS Manual.docx

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