Thursday, September 10, 2009

Quality Management System

Quality Management System is a set of interlinks procedures of an organization for control, evaluates, and improves the effectiveness of quality policies implementation in order to achieve quality objective meet CUSTOMER requirements.

The international standard specifies requirements for a quality management system where an organization:
a) Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Refer to ISO 9000 that an organization shall establish, document, implement and maintain a quality management system and continually improve its effective in accordance with the requirements of standard, as follows:

1. General Requirements of Quality Management System
i) Determine the process needed for the quality management system and their application throughout the organization,
ii) Determine the sequence and interaction of the processes,
iii) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
iv) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
v) Monitor, measure, and analyze these processes, and
vi) Implement actions necessary to achieve planned results and continual improvement of these processes.

If an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

2. Documentation requirements of Quality Management System

i) The quality management system documentation shall include:
- Documentation statements of a quality policy and quality objectives,
- A quality manual,
- Documented procedures and records required by international standard,
- Documents, including records, determined by organization to necessary to ensure the effective planning, operation and control of its processes.

ii) Quality Manual
Organization shall establish and maintain a quality manual that includes:
- The scope of the quality management system, including details and justification for any exclusion.
- The documented procedures established for the quality management system, or reference to them, and
- A description of the interaction between the processes of the quality management system.

iii) Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given paragraph (iv).
A documented procedure shall be established to define the control needed.
- To approve documents for adequacy prior to issue,
- To review and updates as necessary and re-approve documents,
- To ensure that changes and the current revision status of documents are identified,
- To ensure that relevant versions of applicable documents are available at points of use,
- To ensure that documents remain legible and readily identifiable,
- To ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled and
- To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

iv) Control of records
Records establish to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.
Organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

Refer to the above requirements, the below discussion describes a sample of QUALITY MANAGEMENT SYSTEM that may be applied of CONTRACTOR.

1. Purpose
i) This discussion describes quality management system of an organization in field of construction project that shall be established, documented, implemented, and maintained in accordance with requirements of international standard.
ii) This section describes hierarchy of quality management system, definition of documents, and identification of document.

2. Reference
- Quality Manual

3. Responsibility

3.1. The top management shall approve quality manual prior implemented.
3.2. Management representative shall have responsibility as below:
i) Develop required document procedure in accordance with standard.
ii) Review interlink between operational procedures it self and work instructions.

3.3. General Manager shall have responsibility to issue and approved operational procedures, work instructions and required form.
3.4. Each manager responsible for implementation and improve (if any) of operational procedures.

4. Coordination

4.1. Management representative shall invite related function in coordination meeting prior the quality management system implemented and improved.
4.2. Job activities among function or personnel shall refer to approve operational procedures, work instruction and form.
4.3. Each controlled documents shall be stamped “CONTROLLED” and maintain and documented. Only the latest revision and edition shall be implemented.
4.4. Management representative shall periodically audit the quality management system as per management review article.

5. Quality Document
Activities affecting quality are documented in accordance with written manuals, procedures, work instructions, drawings, and form that contain appropriate criteria for determining whether prescribed activities have been satisfactorily accomplished. The documentations of Quality Management System will be established and maintained in the following 4 (four) levels as follows:

Level-1: Quality Manual
Quality manual is a set of documents describe top management commitment and guidance.
ISO 9001 standard requires four elements of Quality Management System as follows:
General requirements: Requirements of Documentation, hierarchy of quality manual, control of documents, control of records.
Guideline of Management Responsibility
Ensuring top level management shows commitment to the quality system and develops it according to customer’s needs and the business objectives.
It will describe some items, such as: quality policy, customer focus, quality objectives, quality strategy, organization, authority and responsibility, management representative, internal communication, and management review.
Guideline of Resource Management
Ensuring the people, infrastructure and work environment needed to implement and improve quality systems are in place.
It also describes some items, such as: provision of resources, human resources, infrastructure, and work environment.
Guideline of Product Realization
Delivering what customers want, looking at areas such as sales processes, design and development, purchasing, production or service activities.
This section describes some items, such as: planning of product realization, related processes to customer, design & development, purchasing, product & service provision, and control of monitoring and measuring devices.
Guideline of Measurement, Analysis & Improvement
Checking whether an organization have satisfied customers by carrying out other measurements of the system's effectiveness.
It will describe some items, such as: monitoring & measurement; control of nonconforming product, analysis of data, and improvement.

Level-2: Operational Procedures
Operational procedures is a set of documents describe implementation of level-1 “quality manual” in detail interactions activities among some related functions or personnel to do each authorities and responsibilities in order to achieve quality goal meet requirements of standard. The quality manual shall be used as reference of it.

Level-3: Work Instructions
Work Instructions is a set of documents describe implementation of level-1 and/or level-2 in detail step by step guidance of technical/ administration aspects that it shall be done and recorded by personnel.

Level-4: Form, drawings, report, note.
Evidence document shall be fulfilled by staff as required by level-1 or level-2 or level-3 above.

6. Identification of documents
The identification of each level shall be coded as CONTRACTOR procedure, the below is an example:
a) Quality Manual will be mark QM, dot, number (QM.xxxx)
b) Operational Procedure will be marked OP, dot, number (QP.xxxx)
c) Work Instruction will be marked WI, dot, number (WI.xxxx)
d) Supporting form will be marked F, dot, number (F.xxxx)

No comments:

Post a Comment

Please pass on your comments