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TANTAWAN OIL COMPANY LIMITED

QUALITY MANUAL

1. Table of Contents
Quality Manual: Table of Contents
1. Table of Contents
2. Introduction
2.1 Conformance and Compliance Standard
2.2 Other Relevant Standard
2.3 Abbreviation, Acronyms and Definitions
2.4 Product/Services Offered
2.5 Parent Organization
2.6 Purpose of This Manual
2.7 Scope of Business Management System and Exclusions
3. Distribution and Review
3.1 Circulation List
3.2 Procedures for Updating the Business Operating Manual
4. Quality Management System
4.1 General Requirement
4.2.1 General
4.2.2 Business Operating Manual
4.2.3 Control of Documents
5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6. Resource Management
6.1 Provision of Resource
6.2 Human Resource
6.2.1 Assignment of Personnel
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure
6.4 Work Environment
7. Product/Service Realization
7.1 Planning of Product/Service Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Equipment
7.2.2 Review of Requirements Related to the Equipment

7.2.3 Customer Communication


7.3 Design and Development
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 Production Provision
7.5.1 Control of Production Provision
7.5.2 Validation of Processes for Production Provision
7.5.3 Identification and Traceability
Identification
Traceability
Inspection and Test Status
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Devices
7.6.1 Substitution of Test and Measurement Equipment Used as Measurement
Standards
8. Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action

2. INTRODUCTION
TANTAWAN OIL Company Limited developed and implemented a Quality Management
System to demonstrating our commitment to establish a system that can provide products
that consistently meet statutory and regulatory requirement, focus on our customers, and
keeps on continual improvement.
This Quality Management System is designed in accordance with the requirements defined
in ISO 9001: 2008 Standard.
2.1 Conformance and Compliance Standards
TANTAWANs Quality Manual is aimed to demonstrate conformance to
ANSI/ISO/ASQ Q9001-2008 American National Standard: Quality management
systems Requirements. This standard is the United States legal equivalent of the
ISO 9001:2008 international standard. These two reference numbers may be used
interchangeably in this manual and the quality management system. In all other
references to this conformance standard in this manual or quality management
system documents, the reference to the year of the current edition is not used.
Reference to this conformance standard also implies reference to all guidance
standards contained therein.
2.2 Other Relevant Standards
In addition to the conformance and compliance standards, TANTAWAN uses other
standards documents as guidance in its Quality Management System. These include but are
not limited to current editions of the following:

FSSC 22000: 2013 Requirement for the food safety in the production process. This
standard concurrently incorporates the certification of HACCP and GMP
GMP & HACCP Requirements for the Good Manufacturing Practice (GMP) and the
Hazard Analysis and Critical Control Points (HACCP)

2.3 Abbreviations, Acronyms and Definitions


ANSI

American National Standards Institute

ASQ

American Society for Quality

BOSS

Black Oil Sunflower Seeds

FSSC

Food Safety System Certification

GMP

Good Manufacturing Practice

HACCP

Hazard Analysis and Critical Control Point

ISO

International Organization for Standardization

QMS

Quality Management System.

2.4 Product Offered


TANTAWAN Company Limited was established in 1989 in Dusit District, Bangkok, Thailand.
TANTAWAN was the first Sunflower Seed Oil manufacturer in Asia use Energy-Free PTFCS in
the oil extraction process to product highest standard Sunflower Seed Oil.
Company offer Crude Sunflower Seed Oil as its only one product, which are customer used
as raw material in many industries including food industry, and consumer product such as
vegetable oil, butter, cosmetic, and dietary supplements.
By products from production process, Sunflower Meal, can be applied in many industries.
For instant, in feed mill and factory incinerator.
2.5 Purpose of This Manual
This Quality Manual provides an overview of the quality policies and requirements for the
organization. It is the reference and framework to Quality Management System for all staffs
and management. It is available for inspection by our customers, potential customers,
external quality auditors, and regulatory agencies.
2.6 Scope of the Quality Management System and Exclusions
Scope:

Exclusions:

The scope of the Quality Management System encompasses activities related to


Sunflower Seed Oil manufacturing (from supplier selection, to receiving and
testing of raw materials, through the crushing mill process, and lastly testing and
shipping of finished products). However, in some procedures that effected
product quality, the company has outsourcing them to third party; for example,
oil storage, quality checked before delivering to customer, goods delivery, some
maintenances job, and calibration. Procedure to control and monitoring those
outsources is implemented by QP 4250.
Since Crude Sunflower Seed Oil is selling under international standard together
with specification from customer, Product design and development (7.3) is
exempt from scope of this quality system.

3. DISTRIBUTION AND REVIEW


3.1 Circulation List
The Quality Manual is accessible to all staffs and management, and to other interested and
authorized parties and is kept up company information system
3.2 Procedures for Updating the Quality Manual
The Quality Manual will be reviewed and revised by the TANTAWANs management and
revised as required. After management review if it found that the Quality Manual need to
update, whether minor or major changes must be approved by management
representatives. Procedures for quality policies and procedures documents within the QMS
are covered in section 4.2.3 Control of Documents, and implemented by QP 4230.

4. QUALITY MANAGEMENT SYSTEM


4.1 General Requirements
TANTAWAN has established, documented, and implements a quality management system
consistent with the requirements of ISO 9001:2008 standard. The system is maintained and
continually improved through the use of quality policy quality objectives, internal and
external audit results, analysis of data, corrective and preventative action, and management
review.
The TANTAWANs quality management system is compose of both Core activities and
Supporting activities, which support the core activities. The business processes of the
quality management system are indicated shown in Figure 1.
1. Market Forecast
3. BOSS &
Other material
Purchase

2. Production Planning

Customer
4. Production Process

Order Taken
and reviewed

5. Quality test

7. Storage Tank

8. Transfer to
Warehouse*

9. Warehousing*

10. Quality Check*


* The process is operated by outsourcing

11. Delivery*

Supporting Activities

Calibrate

Figure 1: Business Processes


Core Activities:
The TANTAWANs core activities include;
Market Forecast
Production Planning
BOSS and Other Material Purchase
Production Process
Quality Test
Calibrating Process
Storage in tank
Transferring to Warehouse
Warehousing
Quality Check
Delivery

(QP 4101)
(QP 4102)
(QP 4103)
(QP 4104)
(QP 4105)
(QP 4106)
(QP 4107)
(QP 4108)
(QP 4109)
(QP 4110)
(QP 4111)

Support Activities:
The TANTAWANs support procedures include;
Quality Management
(Quality Manual)
Document and Records Management
(QP 4230, QP 4240)
Warehousing and Equipment Management
(QP 6300, QP 6400)
Information Technology Management
(QP 6301)
Monitoring and Measurement Management
(QP 7600)
Human Resources Management
(QP 6220)
The Sequence and interaction of these processes are shown in section 5.4.2 quality
management system Planning and QP 4100.
To implement the Quality Management System for these processes, TANTAWAN has:
defined and documented the criteria and method in quality plan and work
instructions to ensure that both the operation and control of these processes are
effective.,
ensured that all resources and information necessary to support the operation and
monitoring are available to all employee, and to other parties.,
established system to monitor, measure, and analyze these processes.,
established process to identify and implement actions necessary to achieve planned
results and continual improvement of these processes.
4.2 Documentation Requirements
4.2.1 General
TANTAWAN has documented a quality management system in accordance with the
requirements of the ISO9001:2008 standard. The TANTAWANs quality management system
documentation include statements of a quality policy and quality objectives, quality manual,
procedures and records required by the ISO 9001:2008 standard, and other documents and
records determined by the company to be necessary to ensure the effective planning,
operation and control of our processes.

The quality management system document can be viewed as the hierarchy comprising of
four levels, as shown in Figure 2.

Figure 2: Documentation
4.2.2 Quality Manual
TANTAWANs Quality Manual has been established and maintained that includes:
the scope of the quality management system, including details of and justification
for any exclusions;
the documented procedures established for the quality management system, or
reference to them; and
a description of the sequence and interaction of the processes included in the
quality management system. (section 4.1)
The quality Manual is a controlled document subject to the requirements of section 4.2.3
Control of Documents.
4.2.3 Control of Documents
TANTAWAN ensures that all of quality management system documents
and data is controlled. Documents and data is either in the form of paper-based documents
and files or computer-based documents and files
The internal QMS documents and data are controlled by the document control procedure
include but not limited to, Quality Manual, Quality Plan, Standard operating procedures and
forms, Work instructions, Product Specification, Design Drawing, Bills of Materials.
The external QMS documents and data are controlled by the document control procedure
include but not limited to, data sheets for vendor supplied items, customer quality
specification, and customer product specification.

4.2.3.1 Document and Data Approval and Issue:


All of QMS documents and data are reviewed in a timely manner and approved for
appropriateness and correctness by the appropriate authorized personnel prior to use or
release.
Quality Manual (Level1) and Procedures (Level2) are reviewed for adequacy and approved
by the General Manager.
Work Instructions (Level3) and Records (Level4) are approved and issued by the authorized
personnel in conjunction with Department managers
Each documents are identified the current revision status to prevent the use of obsolete
documents and then are available all locations where operations essential to the effective
functioning of the Management System are performed.
4.2.3.2 Document and Data Changes
Any personnel can request a changes in documents, but the the review and approval those
changes are performed by the same authorized personnel or departments that performed
the original review and approval. Revision documents are distributed together with the
change brief, marked as a current version and then are distributed with a revision
description to all locations where operations essential to the effective functioning of the
Management System are performed.
4.2.3.3 Obsolete Document
At time of a revision documents are issued, the paper-based obsolete documents are
marked OBSOLETE and kept separate from active documents. The computer-based
documents are move from actives files and to reserved files in information system.
4.2.4 Control of Quality Records
TANTAWAN maintains and controls quality Records to demonstrate conformance to
specified requirements and the effective operation of the quality management system.
All quality records are legible and are stored and retained in such a manner that they are
readily identifiable and retrievable. QP 4240 is established to define what records are
maintained in each category and defines the storage locations, protection, retrial, retention
and disposal.

5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
The top management of TANTAWAN is committed to the development and implementation
of Quality Management System together with continual improvement of its effectiveness
by:
Communicating throughout the organization the importance of meeting customer
requirements as well as statutory and regulatory requirements. (Section 5.5.3
Internal Communications.) These is normally communicated in a number of way,
such as postings and bulletin boards, employee meetings, training session, corporate
policies and new hire orientations, and internal communication memo.
Establishing and communicating TANTAWAN Quality Policy and Quality Objectives
(Sections 5.3 Quality Policy and 5.4.1 Quality Objectives.)
Carrying on management reviews. (Section 5.6 Management Review.)
Identifying and acquiring sufficient resources needed for achieving the required
quality, such as equipment, training, and manpower needed.
5.2 Customer Focus
Top management of TANTAWAN ensures that customer requirements
are determined and are met or exceed the customer expectations. Customer requirements
can be determined through the Customer-related process, Customers Supplier Quality
Manual, Customer Complaints, and Customer Satisfaction records.
The department also meets all of its other obligations including regulatory and legal
requirements. This is further described in Section 7.2.1 Determination of Requirements
Related to the Equipment.
5.3 Quality Policy
Top management of TANTAWAN has defined and documented its Quality Policy.
TANTAWAN focus on continuingly improving production of crude Sunflower
Seed Oil and all the related processes to create quality product that perfectly
meet customer requirements in a sustainable and economical way
The customary objectives to achieve the above policy, are as follows;
Effective in producing Sunflower Seed Oil with best practice and budgeting control to
maximize all resources.
Fulfill customer requirement both quality and services.
Equally treat all workers. Ensure proper training; therefore, each staff is capable for
their assignment.
Create good relationship and effective procedureto conduct suppliers to ensure
quality and quantity of incoming product.
Conform to ISO 9001: 2008 standard including other related laws and regulations
Analyze related records and data for improvement opportunity.

The above quality policies and objectives are correlated to the organizational purpose,
customer requirements and the requirement to the effective quality management system,
have been communicated to all employees within the organization, and reviewed for
continuing suitability through periodic Management Reviews.
5.4 Planning
5.4.1 Quality Objectives
Top management of TANTAWAN establishes quality objectives at all relevant functions and
levels within the organization. The Quality Objectives include, but are not
limited to customer satisfaction and on time shipping.
To ensure that quality objectives are measurable and consistent with the quality policy, top
management applies a goals and objective Matrix.
5.4.2 Quality Management System Planning
Top management of TANTAWAN has identified, planned, and documented the resources
needed to achieve its quality objectives. As well as ensured that change is conducted in a
controlled manner so that the integrity of the quality management system is maintained
during this change.
The Quality Plan is assessed for on-going suitability and effectiveness during management
review meetings. The Quality Planning will be initiated when new or revised standard are
introduced to the existing Quality Management System.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
Top management of TANTAWAN has defined responsibilities and authorities of all
employees who manage, perform and verify work affecting quality throughout the quality
management system, the Organization Chart (APPENDIX 001) and the Job Descriptions.
To ensure that responsibilities of all personnel are consistent with the quality policy, top
management applies a responsibility Matrix
All employees have the authority to stop the nonconforming processes, recommend or
initiate correction or/and preventive action.
The managing Director is the top management of TANTAWAN. The managing Director have
the complete responsibility and authority to verity the correction or/and preventive
solutions and to control further processes, delivery or installation of nonconforming product
until the deficiency or unsatisfactory condition has been corrected.
Each department manager is responsibility and authority to provide an adequate resource
for implementing the correction, preventive solutions or/and, continual improvement
program.

5.5.2 Management Representative


The top management of TANTAWAN has appointed the Deputy Managing Director as its
Management Representative. This individual, irrespective of other responsibilities, has the
defined responsibility and authority to:
Ensure that the processes for Quality Management System are established,
implemented and maintained, according to ISO standards.
Verify the effectiveness of Quality Management System including needed for
improvement.
Report the effectiveness of the systems to top management in management review
including needed for improvement
Cooperation and communicating with external parties and certified bodies.
Instruct and support each department in setting up and applying operational
management system.
Promoting awareness of customer requirement throughout organization
5.5.3 Internal Communications
Top management of TANTAWAN ensures that appropriate communication processes are
established and maintained within the organization and that communication take place
regarding to the effectiveness of the quality management system.
This is accomplished by way of annual meetings, weekly department meeting and daily
production meeting, management review meeting, and other general business
communication.

5.6 Management Review


5.6.1 General
Top management of TANTAWAN reviews the quality management system at planned
intervals to ensure its continuing suitability, adequacy and effectiveness. The review
assesses opportunities for improvement and evaluates the need for changes to the
organization's quality management system, including its quality policy and quality
objectives. Records of management reviews are maintained according to 4.2.4., Control of
Quality Records.
5.6.2 Review Input
The Inputs to management review information on the following:
results of audits;
customer feedback;
process performance and product conformance;
status of preventive and corrective actions;
follow-up actions from earlier management reviews;
changes that could effect the quality management system; and
recommendations for improvement of the system.
5.6.3 Review Output
The outputs from the management review include any decisions and actions related to:
improvement of effectiveness of the quality management system and its processes;
improvement of product related to customer requirements; and
resource needs.

6. RESOURCE MANAGEMENT
6.1 Provision of Resources
Top management of TANTAWAN determines and facilitates the resources needed to
implement, maintain, and continually improve the effective Quality Management System
and enhance customer satisfaction.
These resources are formally addressed during Management Review Meetings but may be
identified and provided for during normal day-to-day operations
When there is request of additional resource, top management have the responsibility and
authority to determine if the request additional resource is valid, necessary and feasible.
6.2 Human Resources
6.2.1 General
Personnel performing task affecting conformity to product requirements are determined to
be qualified and competent based on appropriate education, training, skills, and experience.
6.2.2 Competence, Training, and Awareness
TANTAWAN determines the competency requirements, identifies training needs and
provides training of all personnel performing activities affecting quality.
The competency requirements can be defined through Job Description. The job description
includes the recommend minimum qualification such as needed education background,
working experience and skills to perform a task.
Supplementary training assist in equipping the necessary knowledge and skilled needed for
an employee to become competent in their task. All trainees must be evaluated as fully
competent in a discipline of metrology before being allowed to work independently in that
discipline.
A training plan is prepared and scheduled at least an annual basis.
Training is provided either on or off the job, internally or externally, as appropriate. The
ongoing effectiveness of training is periodically assessed by observation, proficiency testing
or other appropriate means.
To ensure that all employees are aware of the relevance of their jobs and important of their
jobs and how they contribute to the achievement of the quality objectives, TANTAWAN
conduct the awareness training including orientation and other training programs are
conducted as part of company training and orientation program. Internal audit measures
the effectiveness of these awareness raising activities.
TANTAWAN securely retains duplicate copies of training records in the form of attendance
sheets, certificates of proficiency and/or completion for all employees. Original copies of

these records are maintained by TANTAWAN Human Resources Department, which is


outside the scope of this quality management system.
Quality Procedure QP 6220 implements the above policies.
6.3 Infrastructure
Top management of TANTAWAN determines, provides and maintains the facilities and
infrastructure needed to achieve conformity to product requirements. Infrastructure
includes, but is not limited to:
building, workspace and associated facilities, including utilities;
process equipment, both hardware and software;
supporting services such as subcontracted operation, information system, etc.
QP 6300 and QP 6301 have been established to further describe and implement the above
policies.
6.4 Work Environment
Top management of TANTAWAN identifies and manages the human and physical factors of
the work environment needed to achieve products conformity.
The suitable work environment includes personnel safety, cleanliness, heat, humidity, light,
noise and ventilation within controlled areas.
Top management manage work environment by annual Safety and Housekeeping Audits,
implementing Safety rules and guidance, facilitating Protection Equipment, labelling
hazardous material, and many others. The work environment management is documented
in more detail in in QP 6400.
7. PRODUCT REALIZATION
7.1 Planning of Product Realization
Upon receipt of new product requirements, or significant changes (modify, add, remove) to
existing requirements, TANTAWAN plans the product realization processes to realize the
specified requirements.
Product Realization plan determine the following:
quality objectives and requirements for the product;
the need to revised or establish processes and documents and to provide resources,
infrastructure, and work environment necessary to produce conforming product;
required verification, validation, monitoring, measurement, inspection and test
activities specific to the product, and the criteria for the determination of acceptable
product;
records needed to provide evidence that the realization processes and resulting
product and process meet requirements.

The output of this planning is documented on the company information system and in the
form of work instructions.
Quality Procedure QP 7100 describes the planning for Product Realization.
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
TANTAWAN reviews an order to determine whether the customer requirements are clearly
defined, and documented. Affirmation of the ability to meet order requirement is done
before accept an order and enter into a contract with the customer. Customer requirements
include, but are not limited to:
the requirements specified by the customer;
the requirements for delivery and post-delivery activities specified by the customer;
the requirements not specified by the customer but necessary for intended or
specified use; and
regulatory and legal requirements related to the product
Quality Procedure QP 7200 is established to implement and provide further guidance
regarding customer-related processes.
7.2.2 Review of Requirements Related to the Product
TANTAWAN review the requirements related to the product. This review is conducted
prior to submission of customer offers, acceptance of an order, or acceptance of changes to
contact or order and ensure that:
a) produced requirement are defined;
b) unclearness and conflicts in contract or order requirements are resolved; and
c) The company is able to meet the requirements specified by the customer
Records of the results of the reviews and any associated action are maintained according
with the Control of Records Procedure (QP 4240).
When the customer provides no documented statement of requirements, the customer
requirements are confirmed by the company prior to acceptance.
Change orders and amendments are processed and reviewed using the same procedures
that apply to the processing of initial orders. Change orders are communicated to all
functions within the company that may be affected by the change of customer
requirements.

7.2.3 Customer Communication


TANTAWAN identifies and implements method for the effective communication with
customers in relation to product information, contracts and customer feedback.
Product information is communicated to the customers through brochures, website, and
quotations.
Contract and order handling, including amendment are communicated to the customer
through Contract Review (QP 4240).
Customer feedback, including customer complaints are communicated to the TANTAWAN
through our customer service channels.
7.3 DESIGN AND DEVELOPMENT
Since Crude Sunflower Seed Oil is selling under international standard and customer
specification. Therefore, clause 7.3 of the ISO 9001 standard Design and Development is not
applicable.
7.4 PURCHASING
7.4.1 Purchasing Process
TANTAWAN ensures that all purchased product conform to specified purchase
requirements. The type and extent of control applied to the supplier and the purchased
product are dependent upon the effect of the purchased product on subsequent product
realization and the final product.
Subcontractors or suppliers are evaluated and selected on the basis of the ability to meet
our needs. The specific criteria for selection, evaluation and re-evaluation are further
described in Section 7.4.3 Verification of Purchased Product.
7.4.2 Purchasing Information
TANTAWAN requires that purchasing documents contain data clearly and completely
describing the product ordered, including, where appropriate:
requirement for approval of produce, procedures, processes, equipment;
requirement for qualification of personnel; and
Quality Management System requirement.
All purchasing documents are reviewed and approved to ensure the adequacy of specified
requirements contained in the purchasing documents prior to orders being placed with
suppliers.
7.4.3 Verification of Purchased Product
TANTAWAN identifies and implements the inspection or activities necessary for verification
of purchased products to ensure that purchased product meets specified purchase
requirements. Inspection of a purchased product at the supplier location must be
preformed prior to the acceptance of the purchased product.

The inspection arrangements and method of product release are stated in the purchasing
documents.
7.5 PRODUCTION PROVISION
7.5.1 Control of Production Provision
TANTAWAN identifies and plans product processes to ensure that these process are carried
out under controlled conditions. Controlled conditions include the following:
The availability of information that describes the product characteristics;
The availability of documented work instructions;
The use of suitable equipment;
The availability and use of measuring and monitoring devices; and
The implementation of defined processes for release, delivery, and any post-delivery
activities.
7.5.2 Validation of Processes for Production Provision
TANTAWAN validates any production processes for production provision where resulting
output cannot be verified by subsequent monitoring or measurement and, as a
consequence, deficiencies is apparent after the product is in use or has been delivered.
The resulting output from almost every processes of producing the Sunflower Seed Oil
cannot be verified through normal inspection and testing techniques. TANTAWAN has
identified sterilizing process, oil extracting process, purifying process as special process
since specialized verifications is required to confirm the integrity of the product.
To ensure that the current special processes are suitable, the following validation activities
and documentation is completed for each of the identified special processes:
Defined criteria for review and approval of the processes;
Approval of equipment;
Qualification of personnel;
Use of specific methods and procedures as common industry practice;
Records of the equipment and employee qualification and test results is maintained
according with the Control of Records Procedure (QP 4240); and
Revalidation of equipment and employee and inspection of the product.
The need for special processes is confirmed or ruled out during product planning. See
Quality Procedure QP 7100.
7.5.3 Identification and Traceability
Company Limited ensures that product is adequately identified by suitable means
throughout the process.
Identification
Company Limited identify the product status by tags, marking, and labels through all stages
of production.

Traceability
When traceability is a specified requirement, Company Limited establishes documented
procedures for controlling the unique identification of product and and maintaining records
via the lot number documented on the labels for each product and the tags for each
product.
7.5.4 Customer Property
Company Limited exercises care with customer property while it is under our control or
being used by the organization. Company Limited identifies, verifies, protects, and
maintains customer property provided for use the product. If any customer property is lost,
damaged or otherwise found to be unsuitable for use, the organization shall report this to
the customer and maintain records according with the Control of Records Procedure (QP
4240).
7.5.5 Preservation of Product
Company Limited preserves the product during internal processing and delivery to the
intended destination. This includes identification, handling, packaging, storage, and
protection. This also applies to the constituent parts of a product.
The Preservation of Production is implemented by QP 7550.
7.6 Control of Monitoring and Measuring Equipment
The TANTAWAN has determined the monitoring and measurement to be undertaken and
the monitoring and measuring equipment needed to provide evidence of conformity of
product to determined requirements.
The TANTAWAN has established processes to ensure that monitoring and measurement can
be carried out and are carried out in a manner that is consistent with the monitoring and
measurement requirements.
TANTAWAN ensures that measuring equipment:
are calibrated or verified, or both, at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement
standards; where no such standards exist, the basis used for calibration or
verification is recording according with the Control of Records Procedure (QP 4240);
are adjusted or re-adjusted as necessary;
have identification in order to determine its calibration status;
are safeguarded from adjustments that would invalidate the measurement result;
and
are protected from damage and deterioration during handling, maintenance and
storage.
In addition, TANTAWAN assesses and records the validity of the previous measuring results
when the equipment is found not to conform to requirements. The company take
appropriate action on the equipment and any product affected.

At the present time, Jaco Manufacturing Co. does not utilize any monitoring and
measurement software to determined product acceptance.
If software is used to control measuring and monitoring of specified requirements, the
ability of computer software to function as intended will be validated prior to initial use and
reconfirmed as a version upgrade is not installed or a skilled operator has reason to suspect
a problem.
Records of the results of calibration and verification will be maintained in accordance with
the Control of Records Procedure (QP 4240).
Quality Procedure QP 7600 provides additional guidance on control of measurement
standards and implements this policy.
8. MEASUREMENT, ANALYSIS & IMPROVEMENT
8.1 General
Company Limited has planed and implemented the monitoring, measurement, analysis and
improvement process activities needed to ensure conformity and achieve improvement.
This includes the determination of use of applicable methodologies including statistical
techniques, and the extent of their use.
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
Company Limited monitors information relating to customer perception as to whether the
organization has met customer requirements.
The methods used to gather this information include, but are not limited to customer
feedback, customer action requests, customer surveys, user surveys, lost business analysis,
warranty claims and dealer reports. Company Limited also get score and report card from
key customers on a monthly basis. These data are reviewed during the management review
meeting (as defined per section 5.6).
8.2.2 Internal Audit
Company Limited conducts periodic internal audits to determine whether the quality
management system:
conforms to the planned arrangements, to the requirements of the ISO9001:2008
Standard and to the quality management system requirements established by the
organization;
is being effectively implemented and maintained.
The internal quality audits are planned and scheduled on the basis of the status and
importance of the activity to be audited as following:

Product Audit are conducted to assess the conformance of product on a monthly


basis or as necessary. One ordered product is randomly select, audited, and
compared against the customer specification.
Manufacturing Process Audit are conducted to assess the efficiency and
effectiveness of process on a monthly basis or as necessary. One order is randomly
select, audited, and compared against performance standard.
Quality Management System Audit are conducted to assess whether the quality
management system consistent with the requirements of ISO standard on annual
basis or as necessary.

The results of audit are records and brought to the attention of the personnel having
responsibility for the area audited. Records of Quality Audit are maintained according with
the Control of Records Procedure (QP 4240).
Management personnel responsible for the area take timely corrective action on the
deficiencies found during the audit and Results of internal audits and the corrective action
are submitted for management review.
QP 8220 implements this policy.
8.2.3 Monitoring and Measurement of Processes
Company Limited applies suitable methods for monitoring and measurement of the quality
management system processes.
Methods for monitoring the quality management system processes include, but not limited
to:
process control checks
process control inspection
proficiency tests
internal audits
management review meeting
continual improvement program
When planned result are not achieved, correction and corrective action is taken as to ensure
product conformity per P-852, corrective and preventive action.
Records for Monitoring and Measurement of Processes are maintained according to the
Control of Records Procedure (QP 4240).
8.2.4 Monitoring and Measurement of Product
Company Limited monitor and measure the characteristics of the product to verify that
product requirements are met. This is carried out at appropriate stages of the product
realization process as required by the quality plan and/or documented work instructions.
Evidence of conformity with the acceptance criteria is documented. Records indicate the
authority responsible for release of product for delivery to the customer.

The product release for shipment does not proceed until all the specified activities have
been satisfactorily completed and the associated data and documentation are available and
authorized unless otherwise approved by the customer.
Records of checking, inspection, functional testing, product measurement criteria, and
release authority are maintained according to the Control of Records Procedure (QP 4240).
8.3 Control of Nonconforming Product
Company Limited ensures that nonconforming product is identified, controlled where
possible to prevent unintended use or delivery to the customer, and corrected if it has been
delivered. This policy is implemented in QP 8300.
Control of Nonconforming Product is defined the controls and related responsibilities and
authorities for dealing with nonconforming product.
Company Limited has defined the disposition of nonconforming product as:
Rework to meet customer requirements;
Reuse (recycle);
Downgrade and sell at lower price
Product that is reworked or reused must be re-verify or sorted to demonstrate conformity
to the requirements.
Product that is downgrade must be sorted, separated and marked before been sold.
Records of nonconforming detail, disposition detail, and correction actions sequent are
maintained according to the Control of Records Procedure (QP 4240).
8.4 Analysis of Data
Company Limited determines, collects and analyzes appropriate data to demonstrate the
suitability and effectiveness of the quality management system and to identify
improvements that can be made. This includes data generated as a result of measurement
and monitoring and from other relevant sources.
The data are analyzed to provide information relating to:
customer satisfaction;
conformance to customer requirements;
characteristics and trends of processes and product including opportunity for
preventive action;
suppliers.

8.5 Improvement
8.5.1 Continual Improvement
Company Limited implement the actions to continually improve the quality management
system through the use of the quality policy, objectives, audit results, analysis of data,
corrective and preventive action and management review.
8.5.2 Corrective Action
Company Limited define the corrective action to eliminate the cause of nonconformities in
order to prevent recurrence.
A documented procedure (QP 8520) defines requirements for:
reviewing nonconformities (including customer complaints);
determining the causes of nonconformity
evaluating of the need for interim actions to ensure that nonconformities do not
recur;
determining and implementing the corrective actions needed;
recording of the results of action taken;
reviewing the action taken to verify the effectiveness of corrective action
Discipline problem solving tools is applied to assist in determining the causes of
nonconformity. Problem solving tools include but not limited to 8Ds, 5 Whys, A3, Ishikawa
diagram, and Brainstorm.
8.5.3 Preventive Action
Company Limited defines the necessary actions to eliminate the causes of identified
potential nonconformities for preventing occurrence and their consequences.
Preventive Action are initiated based on the trends in data analysis (see 8.4 above) that may
indicate the potential causes or root cause of product nonconformity.
A documented procedure (QP 8530) defines requirements for:
determining potential nonconformities and their causes;
evaluating the need for action to eliminate identified causes and prevent occurrence
of nonconformities;
determining which steps to be taken, defining what action should take, and
implementing actions needed;
records of results of action taken;
reviewing the action taken to verify the effectiveness of preventive action