Tartan Energy
Solutions Ltd.
Subject: Quality Manual
Manual No.:TESL-QM
QMS Section: Manual
Revise No.:1.0
Last Revise Date:8/1/2014
Page:1of44
QUALITY
MANUAL
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Tartan Energy
Solutions Ltd.
Subject: Quality Manual
Manual No.:TESL-QM
QMS Section: Manual
Revise No.:1.0
Last Revise Date:8/1/2014
Page:2of44
Contents
Forward1 Management Statement .................................................................................................. 5
Forward 2 Enterprise Introduction ................................................................................................... 5
1Scope ............................................................................................................................................. 6
1.1 Purpose .................................................................................................................................. 6
1.2 Scope ..................................................................................................................................... 6
1.3 Management of This Manual ................................................................................................. 6
1.4 Process Approach Application ............................................................................................... 6
2 Normative References .................................................................................................................. 7
3 Terms and Definitions ................................................................................................................... 8
4 Quality Management System Requirements ................................................................................ 8
4.1Quality Management System .................................................................................................. 8
4.1.1 General ............................................................................................................................ 8
4.1.2 Quality Policy ................................................................................................................... 9
4.1.3 Quality Objectives ........................................................................................................... 9
4.1.4 Planning ........................................................................................................................ 10
4.1.5 Communication ............................................................................................................. 10
4.2 Management Response ....................................................................................................... 11
4.2.1 General .......................................................................................................................... 11
4.2.2 Responsibility and Authority .......................................................................................... 12
4.2.3 Management Representative ........................................................................................ 15
4.3 Organization Capability ........................................................................................................ 15
4.3.1 Provision of Resources ................................................................................................. 15
4.3.2 Human Resource .......................................................................................................... 15
4.3.3 Work Environment ......................................................................................................... 16
4.4 Documentation Requirements ............................................................................................. 16
4.4.1 General .......................................................................................................................... 16
4.4.2 Procedure ...................................................................................................................... 17
4.4.3 Control of Documents.................................................................................................... 17
4.4.4 Use of External Documents in Production Realization ................................................. 18
4.5 Control of Records ............................................................................................................... 18
4.5.1 Control of Records ........................................................................................................ 18
5 Production Realization ................................................................................................................ 19
5.1 Contract Review ................................................................................................................... 19
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5.1.1 General .......................................................................................................................... 19
5.1.2 Determinationof Requirement ....................................................................................... 19
5.1.3 Review of Requirement ................................................................................................. 19
5.2 Planning ............................................................................................................................... 19
5.3 Risk Assessment and Management .................................................................................... 20
5.4 Design and Development..................................................................................................... 21
5.4.1 Design and Development Planning ............................................................................... 21
5.4.2 Design and Development Input ..................................................................................... 21
5.4.3 Design and Development Output .................................................................................. 22
5.4.4 Design and Development Review ................................................................................. 22
5.4.5 Design and Development Verification and Final Review .............................................. 22
5.4.6 Design and Development Validation and Approval ....................................................... 23
5.4.7 Control of Design and Development Changes .............................................................. 23
5.5 Contingency Planning .......................................................................................................... 23
5.5.1 General .......................................................................................................................... 23
5.5.2 Planning Output ............................................................................................................. 24
5.6 Purchasing ........................................................................................................................... 24
5.6.1 Purchasing Control ........................................................................................................ 24
5.6.2 Purchasing Information ................................................................................................. 25
5.6.3 Verification of Purchased Productsor Activities ............................................................ 26
5.7 Production and service provision ......................................................................................... 26
5.7.1 Control of Production and Service ................................................................................ 26
5.7.2 Product Quality Plans .................................................................................................... 28
5.7.3 Identification and Traceability ........................................................................................ 29
5.7.4 Product Inspection/Test Status ..................................................................................... 29
5.7.5 Customer-SuppliedProperty .......................................................................................... 30
5.7.6 Preservation of Product ................................................................................................. 30
5.7.7 Inspection and Testing .................................................................................................. 30
5.7.8 Preventive Maintenance ................................................................................................ 31
5.8 Control of Testing, Monitoring and Measuring Equipment .................................................. 31
5.8.1 Control of Testing, Monitoring and Measuring Equipment ............................................ 32
5.8.2 Environmental Conditions ............................................................................................. 32
5.9 Product Release .................................................................................................................. 32
5.10 Control of Nonconforming Product .................................................................................... 32
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Revise No.:1.0
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5.10.1 General ........................................................................................................................ 32
5.10.2 Nonconforming Product............................................................................................... 33
5.10.3Release of Nonconforming Product UnderConcession ............................................... 33
5.10.4 Customer Notification .................................................................................................. 34
5.10.5 Records ....................................................................................................................... 34
5.11 Management of Change (MOC) ........................................................................................ 34
5.11.1 General ........................................................................................................................ 34
5.11.2 MOC Implementation .................................................................................................. 34
6 Quality management system monitoring, measurement, analysis and improvement ................ 34
6.1 General ................................................................................................................................ 34
6.2 Monitoring, measurement and improvement ....................................................................... 35
6.2.1 Customer Satisfaction ................................................................................................... 35
6.2.2 Internal Audit ................................................................................................................. 35
6.2.3 Process Evaluation........................................................................................................ 36
6.3 Analysis of Data ................................................................................................................... 37
6.3.1 Analysis of Data ............................................................................................................ 37
6.4 Improvement ........................................................................................................................ 37
6.4.1 General .......................................................................................................................... 37
6.4.2 Corrective Action ........................................................................................................... 38
6.4.3 Preventive Action .......................................................................................................... 38
6.5 Management Review ........................................................................................................... 39
6.5.1 General .......................................................................................................................... 39
6.5.2 Review Input .................................................................................................................. 39
6.5.3 Review Output ............................................................................................................... 40
Attachment 1 List of Element-Document ..................................................................................... 411
Attachment 2 Organization Chart ................................................................................................ 433
Attachment 3 Chart for Processes Relationship .......................................................................... 444
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Manual No.:TESL-QM
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Revise No.:1.0
Last Revise Date:8/1/2014
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Subject: Quality Manual
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Forward1 Management Statement
With the aggravation of global competition, quality management system has become one of focus
of the organization. In order to enhance the quality of products continuously, total employees of
the company shall defer to the quality management system established according to API Spec
th
Q1 9 standard to meet customers’ current requirements and to identify customers’ future
expectation. This is to build up experience to continually improve Tartan Energy Solution system.
The quality manual is in line with national laws, regulations, actual situation of enterprises and
API Q1-2013 standard. The quality manual is a programmatic document. This manual determined
quality policy and quality objectives of Tartan Energy Solutions Ltd. It states the general
principles of establishment, maintenance, and improvement of the quality system. It defines the
guide to establish and implement of the quality management system and it specifies the principles
to harmonize the implementation of the quality management system over all of the company. This
is one of the criteria for third party certification. If necessary, it can be a brief introduction of
Tartan’s quality management system.
st
It is approved and issued from now on and became effective from August 1 2014. The total
employees are required to implement of these requirements, and sum up experiment from
practices to improve Tartan system.
Management Representative: Terry Lau
Date: Aug 1, 2014
Forward 2 Enterprise Introduction
Tartan Energy Solutions Ltd. is a reputable integrated equipment/technology supplier and service
provider in petroleum, petrochemical and natural gas industries, with major products and services
covering drilling and completion.
Tartan Energy Solutions Ltd. is located in Airdrie, Alberta, Canada. Over the past years, Tartan
has distributed its products across all spheres of offshore and onshore oil exploration,
development and production all over the world in connection with conventional drilling and
completion tools, drag and torque reducers, floatation collars, cementing accessories, Y- tool and
accessories, etc. Tartan has in house manufacturing that ensure quality and product specification.
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Subject: Quality Manual
Manual No.:TESL-QM
QMS Section: Manual
Revise No.:1.0
Last Revise Date:8/1/2014
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1Scope
1.1 Purpose
The purpose of this manual is to standardize activities of manufacturing, sales and service of
Tartan products to satisfy customer requirements, and to continual improve quality of products,
management institutions, ensure product’s quality, and protect nonconformity from occurring.
1.2 Scope
This manual is applicable to the quality management system for products of drilling and
completion tools and related components used in petroleum production, such as Inflatables
Products, Packer and Bridge Plug, Drag and Torque Reducers, Floatation collars, Cementing
accessories, Y- tool and accessories, etc.
1.3 Management of This Manual
This manual is prepared by management representative of the company, and reviewed by the
general manager of the company. It is effective after approved by the general manager.
This manual is to control all other documents. All managements in departments of the company
hold the current effective quality manual. Document Controller is responsible to release the
quality manual after it has been approved.
The revising of the quality manual shall be reviewed and approved by general manager. The old
version documents shall be replaced by current ones and be obsolete.
The releasing of the quality manual to external shall be granted by general manger on the request
of customers or other organization. “Reference Only” stamp shall be marked on theses copies.
The general manager, and management representative are responsible to ensure the updating of
the quality manual to accommodate the changes if internal and external environments, and
provide sufficient resources to meet the changed requirements. Changed requirements shall be
communicated to total employees via different means.
The general manager, management representative shall review the suitability of quality manual
and evaluation the effectiveness of quality management system by management review and
appoint specific persons to implement necessary actions.
1.4 Process Approach Application
The process approach is used to enhance customer satisfaction through the effective application
of the quality management system. With the application of process approach, we focused on the
important of followings:
a) Understanding and meeting requirements,
b) The need to consider processes in terms of added value,
c) Obtaining results of process performance and effectiveness,
d) Continual improvement of processes based on objective measurement.
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Manual No.:TESL-QM
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Revise No.:1.0
Last Revise Date:8/1/2014
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Figure 1 illustrates the process linkages of processes. This illustration shows that customers play
a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires
the evaluation of information relating to customer perception as to whether the organization has
met the customer requirements.
Continual improve of the quality management system
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Management
Responsibility
Resources Management
Measurement, analysis
and improvement
Input
Output
Product Realization
Product
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Figure 1 Model of process-based quality management system
In addition, the methodology, known as “Plan-Do-Check-Act”(PDCA),can be applicable to all
processes. PDCA can be briefly described as follows.
Plan: Establish the objectives and processes necessary to deliver results in accordance with
customer requirements and the organization’s policies.
Do: Implement the processes.
Check: Monitor and measure processes and product against policies, objectives and
requirements for the product and report the results.
Act: Take actions to continually improve process performance.
2 Normative References
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ISO9000: 2005Quality Management System---Fundamentals and vocabulary.
ISO9001: 2008Quality Management System----Requirements
API SPEC Q1:2013 Specification for Quality Programs for the Petroleum and Natural Gas
Industry
3 Terms and Definitions
For purpose of this manual, terms given in ISO9001:2008 and API SPEC Q1:2013 shall apply.
In addition, following are applied:
SOP: Standard Operation Procedure;
SIP: Standard Inspection Procedure;
GM: General Manager;
MR: Management Representative.
NDT: Non Destructive Testing
MTR: Material Test Report
4 Quality Management System Requirements
4.1Quality Management System
4.1.1 General
In order to forward quality management to continually meet customer requirements, Tartan shall
establish, implement, maintain, and improve the quality management system according to the
requirements of ISO 9001:2008 and API Spec Q1:2013 and its addendums. Documented
requirements for design, manufacture, and delivery activities established to continually improve
the quality of products.
The processes needed for the quality management system and their application throughout the
organization is showed in Figure 1.
The sequence and interaction of these processes showed in Attachment 3 of this manual.
Criteria and methods are needed to ensure that both the operation and control of these
processes are specified in documented procedures, control features, quality plan, and SOPs/SIPs.
The effective will be verified through processes monitoring, internal audit, and management
review.
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Subject: Quality Manual
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GM and MR are responsible to ensure the availability of resources and information necessary to
support the operation and monitoring of these processes.
Monitor measure and analyze of these processes will performed by GM, MR, department leaders
and inspectors.
Implement actions necessary to achieve planned results and continual improvement of these
processes are through implementation of corrective and preventive actions.
4.1.1.1 Outsourced Processes and/or Services
In light the limits of the resources in Tartan, processes of heat treatment and NDT are outsourced.
Tartan implements the control features defined in related procedures of Product Design and
Development Control procedure, and Procurement Control procedure to ensure the conformity of
these outsourced processes.
4.1.2 Quality Policy
GM determines and approves the quality policy and ensures the quality policy:
a) Is appropriate to the purpose of the organization,
b) Includes a commitment to comply with requirements and continually improve the effectiveness
of the quality management system,
c) Provides a framework for establishing and reviewing quality objectives,
d) Is communicated and understood within the organization through the training, document
releasing
e) Is reviewed for continuing suitability at annual management review meetings and if necessary,
the quality policy shall be revised and reapproved by GM.
Quality Policy is: To satisfy customers with high quality products and services and
continuous improvement in quality, delivery, reliability and performance based on the risk
assessment.
4.1.3 Quality Objectives
GM ensure objectives been established at relevant functions and levels throughout the company.
The quality objectives shall be measurable and consistent with the quality policy. Suitability of
objectives shall be reviewed at annual management review. If necessary, objectives can be
changed by the review outputs.
Tartan quality objectives are in the following:
a) Customer satisfaction index is more than 98%；
b) Finish goods pass rate is more than 99%；
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Subject: Quality Manual
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Revise No.:1.0
Last Revise Date:8/1/2014
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c) Outgoing delivery rate is 100%
d) Nonconforming Rate is less than 2%
e) Correction rate is 100% when nonconforming happened；
f) Outsource product and services quality pass rate is 100%
Data of performances of quality objectives shall be collected by relative departments, and
reported to MR monthly. MR ensures the quality objectives are reviewed at annually management
review meeting to ensure the objectives are consistent with the quality policy.
4.1.4 Planning
GM and MR shall ensure that quality objectives, including those needed to meet requirements for
product are established at relevant functions and levels within the organization.
MR is responsible to planning of the management system. QMS planning shall meet
requirements ISO9001:2008, API Q1-2013, as well as the quality objectives.
Planning of management system shall consider the requirements of ISO9001, API Q1-2013,
customer, products specification, statuary and regulatory, and the current resources of the
company. When business environment changes identified, implemented, the integrity of the
quality management system shall be maintained. Changes of product specifications, statuary and
regulatory shall be reviewed on time. Any impact that may affect quality management system
shall be addressed, relevant document(s) shall be changed to ensure changed requirements
been met.
Outputs for quality management system planning include but not limited to the following:
organization chart, responsibility for departments and positions, quality policy and objectives,
documented procedures for needed processes, operation and inspection/testing activities, and
resources allocation.
4.1.5 Communication
4.1.5.1 Internal
GM and MR shall ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the quality
management system.
To standardize the effectiveness communication of quality management system performance and
responsibility, an Internal Communication Control Procedure is established.
Information to be communicated comes from leaders of all departments. Manner to
communication include but not limited to:
a) Meeting;
b) Document;
c) Proposal, public notice, internet, and internal notification;
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d) Training, daily report, summary report and management review; summary report, document,
and proposal are used for up going communication;
e) Meeting, internal notification, and training are used for down going communication;
f) Meeting, internal notification, and liaison letter are used for horizontal communication.
Communicated Information related to quality management shall be documented and retained the
communication records.
4.1.5.2 External
a) Management representative is responsible to communicate quality issues with external parties
through telephone, fax, and email.
b) Sales is responsible to communicate with customers in relation to product information, product
changes, order changes and enquiry,
c) Purchase department is responsible to communicate with suppliers in relation to purchasing
order, products and nonconformity of purchased products;
d) Quality department is responsible to communicate with customers related to customer
compliant, product return, and enquiry of products.
e) Technical department is responsible to communicate with design team in relation to product
technical issues.
4.2 Management Response
4.2.1 General
GM shall provide evidence of its commitment to the development and implementation of the
quality management system and continually improving its effectiveness by:
a) Communicating to the organization the importance of meeting customer as well as statutory
and regulatory requirements,
b) Establishing the quality policy,
c) Ensuring that quality objectives are established,
d) Conducting management reviews,
e) Ensuring the availability of resources.
GM promises that:
a) Tartan products, processes and quality management system shall meet requirements of
customers, products specifications, and applicable statutory and regulatory requirements
simultaneously. The importance of meeting requirements shall be communicated to every
employee in the company through training, document releasing and meetings.
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b) To establish quality policy and communicate it to employees at all level of the company. The
quality policy will be reviewed for its continual suitability at management review with consideration
of business environments.
c) To perform annual review of the quality system to evaluate the suitability, adequacy, and
effectiveness with other managements.
d) Provide resources needed to implement and maintain the quality management system and
continually improve its effectiveness, and to enhance customer satisfaction by meeting customer
requirements.
4.2.2 Responsibility and Authority
The organization structure chart determined in Attachment 2 of this manual. Responsibility and
authority defined in below shall be communicated in the company.
The responsibility and authority for managements defined in bellow:
A. GM
a) Develop annual plan and vision of the company;
b) Develop quality policy and objectives; supervise the establishment, implementation, and
continual improvement of quality;
c) Approve quality manual and other important documents;
d) Authorize the responsibility of the MR;
e) Determined quality functions for all relevant departments and supervise them carrying out the
assigned responsibility;
f) With the highest power of human resources, appoint middle level managers, and authorize
responsibility for them; evaluation the performance of middle level mangers
g) Host the management review meeting to evaluate the implementation performance of the
system;
h) Audit the expenses and investment plan, and handle important affairs of the company.
B.MR
a) Responsible to establish, implement, and improve of quality management system;
b) Coordinate and supervise the implementation of all processes, ensure the operation of quality
management system meet requirements;
c) Initial and management of internal audit;
d) Responsible to communicate, promote of the quality policy and objectives;
e) Communicate the internal and external on matters relating to the quality management system;
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f) Report to GM the conditions/status of quality management system operation, provide
information for review and improvement;
g) Quality assurance to external parties;
h) Organize, propagate, and conduct ISO9001 and API Q1 training to promote the awareness of
customer requirements throughout the company.
C.HR and Adm. Department
a) Employee recruit, dismiss, and promote affairs;
b) Organize, and conduct trainings, and personnel competence evaluation;
c) Check on work attendance management, and HR files management;
d) Company bulletin publish, and manage affairs of bonus and penalty;
e) Conciliate relationship between company and workforces;
f) Logistics management.
D. Financial
a) Financial calculation;
b) Responsible to arrange income and expense plan;
c) Count of salary;
d) 6S management
E. Production department
a) Develop production plan and tracking production progressing;
b) Perform production capacity analysis, and production planning;
c) Call, and return material; collect and analyze data of material ware;
d) Manage materials, substance separate storage, identification and place;
e) Product packaging: integrated package, exact quantity and clearly identification;
f) Conduct equipment maintenance, and preventive/corrective action implementation;
g) Prepare necessary Risk Assessment and Contingency Plan according to design, delivery and
production process;
h) 6S to implement management of the department.
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F. Technical department
a) Examine, analyze product data and draw engineering drawings for machining, assembly;
b) Prepare and review technical documents and other needed documents;
c) Review the scheme of product changes and improvement;
d) Fix material amount and control material use to reduce material cost;
e) Control the operational documents;
f) Measure and draw the components and develop the machining technology;
g) Prepare necessary Risk Assessment and Contingency Plan according to design, delivery and
production process.
G. Quality department
a) QC inspects the materials once received, and help in supplier evaluation;
b) QC inspects parts/components in-processing, when abnormal quality issue found, reports and
follow-up the issue.
c) QA inspects/tests the finished products, and help sales to handle with customer compliant and
products returned from customers;
d) Provide accurate data to review and improve quality management system;
e) Rights to make decision on product quality, and to adjudge quality issues on the name of
company with the external parties;
f) Develop inspection/testing specifications and conduct them, follow-up the performance of
quality objectives;
g) Establish the list of measurement and monitoring equipment; and responsible to calibrate
measuring tools;
h) Collect data of quality issues and product maintenance from customers;
i) Analyze the causes of customer compliant and determine corrective actions.
H. Purchase department
a) Purchase materials and contact the supplier to handle with the abnormal quality of purchased
products;
b) Investigate, select, and organize the evaluation of suppliers;
c) Evaluate the suppliers and establish supplier’s files;
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d) 6S management
I. Stock keeper
a) Control of in-and-out of stock of materials, semi-finished products, and finished products;
b) Keep materials in suitable storage places to protest from damage;
c) Check the quality and quantity status of stocked products;
d) 6S management
J. Sales
a) Organize the contract review, and receive customer compliant and follow-up the treatment
results of compliant;
b) Follow-up the status of contract progressing, received and organize the review of customer
provided materials and data.
c) Ship of the products and co-ordinate the service after sales;
d) Conduct survey and evaluation of customer satisfaction.
4.2.3 Management Representative
Mr. Terry Lau is appointed the management representative. He is in charge of Quality system that
have been established, implement according to this manual through the company. His
responsibility and authority stated in 4.2.2 B.
4.3 Organization Capability
4.3.1 Provision of Resources
Resources are vital to management system and the basic prerequisites to achieve the quality
policy and objectives. GM ensures the necessary resources to be provided on time to:
a) Implement, maintain, and improve of the effectiveness of quality management system;
b) Accommodate the changes of internal and external business environment;
c) Enhance customer satisfaction by meeting customer requirements.
4.3.2 Human Resource
4.3.2.1 General
The HR & ADM department shall arrange suitable human resources to ensure the employees
performing works affecting conformity and product requirements are competent based on their
education, training, experience and skills.
4.3.2.2 Personnel Competence
HR & Adm. Department shall:
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a) Determine required competence for positions in Job Descriptions. It is the rulers and criteria for
human resource department to evaluation the competence of specific employee at a determined
position.
b) Develop annual training plan based on the evaluation results, human resources department.
Other actions like position change, recruit new employee can be also taken to ensure employees
achieve necessary competence.
c) Give training in accordance with the training procedure. On-job training will be given to
employee whose job shifting may affect the conformity and product requirements. The awareness
of the relevance and importance of their activities and how they contribute to the achievement of
the quality objectives shall be increased by continual training and quality education.
d) After training, evaluate the effectiveness of training via paper exams, job performance
evaluation, onsite observation and crossover assessment.
e) Retain records of competence evaluation, training, education and experience.
4.3.2.3 Training and Awareness
In Human Resources Control Procedure, there are ways to identify training needs and provide
training is determined. Quality management system training for employees who perform activities
addressed in the quality management system will be given prior to position taken. Job training
will be given prior to performing work independently. Continual training will be given in specific
intervals and when changes of QMS and/or product requirements occur.
4.3.3 Work Environment
Technical and Production departments should establish and maintain Work Enviorment Control
Procedure to ensure conformity. Production department is responsible to manage the work
environment.
After analyzing of the product characteristics, production department identify the environment
requirements that affect product quality and maintain the environment meet requirements.
Storage area for sealing materials shall be protected from direct sunshine, excessive cold or hot
temperature, and radiographic rays.
The order and clearness of workshop will kept through 6S management activities.
4.4 Documentation Requirements
4.4.1 General
The quality management system documentation shall include:
a) Documented statements of a quality policy and quality objectives,
b) Quality manual,
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c) Documented procedures and records required by this International Standard,
d) Documents, including records, determined by the organization to be necessary to ensure the
effective planning, operation and control of its processes. To determine relationships of
processes, quality manual is developed as the guiding principle. It stated quality policy and
general quality objectives of Tartan.
For the purpose of effectively planning, operate and control of quality management system,
procedures, control features, and work instructions developed, records needed to demonstrate
the effectiveness of quality management system are developed as well.
Level 1：Manual (including Policy and objectives)
Level 2：Procedures and control features
Level 3：Work Instructions, external docs, and other required docs,
Level 4：Recording forms and other evidences docs
Figure2 Structure of Documentation System
4.4.2 Procedure
All procedures referenced within this specification shall be established, documented,
implemented, and maintained for continued suitability.
NOTE 1 A single document can address the requirements of one or more procedures.
NOTE 2 A requirement for documented procedures can be satisfied by more than one document.
4.4.3 Control of Documents
Documents formed the basis of quality management system. Suitable documents promote the
effective operation of the quality system. Documents used in Tartan will be controlled in
accordance with the requirements determined in Document Control Procedure. This procedure
defines the control needed
a) To approve documents for adequacy prior to issue,
b) To review and update as necessary and re-approve documents,
c) To ensure that changes and the current revision status of documents are identified,
d) To ensure that relevant versions of applicable documents are available at points of use,
e) To ensure that documents remain legible and readily identifiable,
f) To ensure that document 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,
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g) To prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.
4.4.3.1 Document Control List
A master list of applicable documents shall be established by document controller. It shall show
the status of revising of each document.
4.4.3.2 Document Changes
Changes to documents shall be reviewed and approved by the same functions that performed the
original review and approval. The background material shall be obtained when it is done by the
original review and approval.
4.4.4 Use of External Documents in Production Realization
When API product or other external specification requirements, including addenda and updates,
are used in the design or manufacture of the product, the organization shall maintain a
documented procedure for the integration of these requirements into the product realization
process and any other affected processes.
4.5 Control of Records
Quality records are evidences to demonstrate the compliance of products, effectiveness of
processes and quality system. It can provide necessary information to analysis, and to improve of
the product quality and effectiveness of processes and quality systems.
All required records shall be controlled in accordance with the requirements determined in Quality
Records Control Procedure. This procedure specified the methods of identification, collection,
storage, retrieval, protection, retention time and disposition of the quality records.
Responsibility to collect and maintain the required records, retention time of records is
determined in the Quality Records Control Procedure. The collected quality records will be
archived by the administration department.
All quality records shall be stored in such a way that they are retrievable in facilities. Suitable
protection shall be given to minimize deterioration or damage and to prevent from loss.
4.5.1 Control of Records
A list of quality records shall be established by administration office to determine the retention
time and the responsibilities for each department.
Product design records shall be retained at least 10 years, other records shall be retained for at
least 5 years.
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5 Production Realization
5.1 Contract Review
5.1.1 General
Contract Review Control Procedure shall be established and maintained by the company.
5.1.2 Determination of Requirement
The sales shall determine
a) Requirements specified by the customer, including the requirements for delivery and postdelivery activities,
b) Requirements not stated by the customer but necessary for specified or intended use, where
known,
c) Statutory and regulatory requirements applicable to the product,
d) Any additional requirements considered necessary by the organization.
Using the enquiry information from fax, email, telephone of the customers, all requirements
related to the products shall be documented.
5.1.3 Review of Requirement
Requirements related to the product shall be reviewed prior to commitment to supply a product to
the customer. The review shall ensure
a) Product requirements are defined,
b) Contract or order requirements differing from those previously expressed are resolved,
c) The organization has the ability to meet the defined requirements.
When any conflict found in review, the conflict shall be resolved prior to commitment to customer.
Where the customer provides no documented statement of requirement, the customer
requirements shall be confirmed by the organization before acceptance.
Review records and actions raised from review shall be recorded and retained.
Changes of product quality, quantity, and delivery dates shall be documented and reviewed, the
review results shall be communicated with customers. Confirmed changes shall be noted to the
related departments and persons in the document.
5.2 Planning
Product realization processes begin with product requirements determination and end with
product shipped to the specific places. Technical Department should establish and maintain the
Product Realization Planning Control Procedure.
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a) Product quality objectives and requirements shall be determined through contract review by
design, technical, and sales departments;
b) The needed processes for specific product shall be determined by Technical department using
the processing flow chart. Needed technical documents shall be developed by Technical
department.
c) Required verification, validation, monitoring, measurement, inspection and test activities
determined in QC engineering chart, SIP. Acceptance criteria determined in material
specifications, Drawings for parts, and SIPs.
d) Required records to demonstrate the compliance of the processes and products.
For specific products not covered by the previous technical documents, a quality plan shall be
developed by the Technical department.
The Technical department develops technical documents to guide of purchasing, machining,
assembly and testing activities. These documents include but not limited to the followings, if
applicable:
a) BOM, and material specifications;
b) Process flow chart;
c) Drawings for parts, marking and packaging;
d) Process routers/processing cards
e) SOP for machining, heat treatment, and assembly
f) QC engineering chart;
g) Required records.
Consideration of requirements determined in product specification, customer specification, and
statuary and regulatory shall be given when preparing these technical documents.
5.3 Risk Assessment and Management
The Technical and production departments are required to analysis and document risk control
associated with impact on delivery and quality of product. Risk control shall be conducted in
accordance with Risk assessment and Management Procedure.
Risk assessment associated with product delivery shall include but not limited to the following,
a) Facility/equipment availability and maintenance; and
b) Supplier performance and material available/supply.
Risk assessment associated with product quality shall include but not limited to the following,
a) Delivery of nonconforming product
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b) Availability of competent personnel.
5.4 Design and Development
5.4.1 Design and Development Planning
The design will be completed by The Technical Department. However, the Technical Department
shall establish and maintain the Product Design and Development Control procedure to control
and verify the product design processes. The Design Department has the ultimate responsible to
ensure the product design meet requirements of design inputs.
The Technical Department shall be responsible for the planning, organization, coordination and
supervision of the design and development of new products. The Planning shall include:
a) The objective, activities, resource, input and output requirement of design and development.
b) Identify the stages, responsibilities, requirements, time, arrangement and the methods of
review, verification and validation.
c) The design and development activities shall be performed by qualified personnel; and shall be
allocated resources and information.
d) The design and development plan shall be changed with the design proceeding.
e) The interfaces between different groups involved in design and development shall be managed
to ensure effective communication and clear assignment of responsibility.
f) Design documentation shall include the methods, assumptions, formulas and calculations.
g) The output shall be updated as the design evolves.
5.4.2 Design and Development Input
The sales shall identify products requiring design and transfer the requirements related to the
product to Technical Department. The Technical Department shall determine the needed design
inputs:
a) Functional and performance requirements on the basis of contract requirements, contract
review result and relevant API product specification(s);
b) Applicable statutory and regulatory requirements;
c) Information from former similar design;
d) Other requirements necessary including package, storage and delivery etc;
e) Customer specified requirements for product.
Design input shall be documented and reviewed for adequacy. Requirements shall be complete,
unambiguous and not in conflict with each other. When conflict found, the Technical Department
shall communicate with customers.
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Design input review shall be conducted by engineering prior to manufacture
5.4.3 Design and Development Output
The design and development output shall be documented in a form that enables verification
against the design and development input and shall be approved prior to use.
The outputs of design process shall provide information for purchasing, production and service
provision.
These documents contain but not limited to the following:
a) Meet the input requirements for design and development;
b) Material specifications (for purchasing), processing procedure and working instruction for
machining, assembly, inspection and testing (for production);
c) Processing cards, key components tracking card, inspection and test procedures (for
production and inspection/testing)
d) Data sheet and user manuals for products, including the characteristics of the product that are
essential for its safe and proper use (for service provision).
The inspection/testing procedures shall contain or reference the acceptance criteria.
Design and development outputs shall be documented prior to manufacture.
5.4.4 Design and Development Review
In the appropriate design stages, the design and development review shall be conducted in
according to the design and development plan. Participants in such reviews shall include
representatives of functions concerned with the design and development stages being reviewed.
The personnel attending the final review activity shall be independent of those having direct
responsibility for the work being performed. The design and development review shall evaluate
the ability of the results of design and development to meet the requirement, identify problems
and propose follow-up actions. The final design and development review shall be conducted and
by engineers in Tartan. Individual other than the person who developed the design shall approve
the final design.
The design and development review and subsequent follow-up actions shall be recorded. The
technical Department shall maintain the records as quality records.
5.4.5 Design and Development Verification and Final Review
The design and development verification and final review shall be planned, established and
documented so that the design output meets the design-input requirements. The personnel
attending the verification and final review activity shall be the competent personnel functions for
verifying the design and independent of those having direct responsibility for the work being
performed. The design and development verification and final review shall be recorded. The
records shall be maintained as quality records.
The methods of design and development verification and final review may be:
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a) Performing alternative calculations;
b) Comparing the new design with a similar proven design;
c) Undertaking tests and demonstrations;
d) Review the design stage documents before release.
5.4.6 Design and Development Validation and Approval
To ensure the products meet the requirements of customers and specified requirements, the
design and development validation should be made in specified operation condition after the
design is successfully verified.
The validation is normally performed on the final product. According to the requirements defined
in API 11D1, the validation test shall be conducted by an API Monogrammed test agency.
The validation test shall be conducted according to the test requirements defined in API 11D1.
Test results shall be reviewed to ensure the tests meet relevant requirements.
The design validation and approval shall be documented and the records shall be maintained as
quality records by the engineer department.
5.4.7 Control of Design and Development Changes
The authorized personnel shall approve the design and development changes. The design and
development changes, including changes to design documents shall require the same control
features as the original design and development, and design documentation. The significant
design and development changes shall be reviewed, verified and validated if necessary. The
review of design and development changes shall include evaluation of the effect of the changes
on constituent parts and product already delivered. The design and development changes
contrary to the contract requirements shall be consented and confirmed by the purchaser. The
design and development changes and subsequent follow-up actions shall be recorded. The
records shall be maintained as quality records
The changes to design and development must be identified, documented and recorded; the
notice of change shall be transmitted to the relevant departments and persons.
For API products, the design and development planning, input, output, review, verification,
validation and changes shall be included in the same document package.
5.5 Contingency Planning
5.5.1 General
The Technical and production departments shall be responsible for contingency planning towards
risk associated with impact on delivery and quality of product in Tartan.
Contingency Planning Procedure shall be established and maintained based on assessed risks,
and its output shall be documented and communicated to the relevant personnel and updated as
required.
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5.5.2 Planning Output
The contingency plan shall be documented in a form that enables to be verified and implemented
by Technical and production department.
The planning output should be include, but not limited to the following,
a) Actions required in response to significant risk scenarios to mitigate effects of disruptive
incidents;
b) Identification and assignment of responsibilities and authorities; and
c) Internal and external communication controls.
5.6 Purchasing
5.6.1 Purchasing Control
5.6.1.1 Procedure
The purchase department shall be responsible for the control and implementation of the
purchasing process so as to ensure the purchased product conforms to the specified requirement.
The type and extent of control applied to the supplier and the purchased product shall be
dependent upon the effect of the purchased product on subsequent product realization of product.
5.6.1.2 Initial Supplier Evaluation-Critical Purchase
For purchase of critical products, components or activities, the criteria for the initial evaluation of
suppliers by the organization shall be site-specific for each supplier and shall include the following:
a) Verification that the supplier’s quality management system conforms to an internationally
recognized quality management system standard/technical specification.
b) Assessment of the supplier to ensure its capability to meet the organization’s purchasing
requirements by:
i) Performing an on-site evaluation of relevant activities, or
ii) Performing first article inspection to ensure conformance to stated requirements, or
iii) Identifying how the supplied product conforms to stated requirements when limited by
proprietary, legal, and/or contractual arrangements.
5.6.1.3 Initial Supplier Evaluation—Noncritical Purchases
For purchase of noncritical products, components, or activities that impact product realization or
the final product, the criteria for evaluation of suppliers by the organization shall meet the
requirements or satisfy one or more of the following:
a) Verification that the supplier’s quality management system conforms to the quality system
requirements specified for suppliers by the organization; or
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b) Assessment of the supplier to meet the organization’s purchasing requirements; or
c) Assessment of the product upon delivery or activity upon completion.
5.6.1.4 Supplier Reevaluation
For reevaluation of all suppliers (critical and noncritical), the criteria for evaluation of suppliers by
the organization shall meet the requirements or satisfy one or more of the following:
a) Verification that the supplier’s quality management system conforms to the quality system
requirements specified for suppliers by the organization; or
b) Assessment of the supplier to meet the organization’s purchasing requirements; or
c) Assessment of the product upon delivery or activity upon completion.
5.6.1.5 Supplier Evaluation—Records
Records of the results of all evaluations and any necessary actions arising from the evaluations
shall be maintained.
5.6.1.6 Outsourcing
Where any process requiring validation has been outsourced, Tartan will require the supplier
comply with the requirements in according with Outsourcing Control Procedure.
For the outsourced Heat Treatment process, Tartan will review and approve the heat treatment
procedures, ask the supplier perform processes qualification, equipment qualification and
personnel qualification. Tartan will review results of these qualifications to ensure the processes
meet relative requirements.
For the outsourced NDT processes, Tartan will review the processes validation results of NDT
processes to ensure the personnel, equipment and test procedure meet relative requirements.
5.6.2 Purchasing Information
The purchase department shall be responsible for the management of the purchased information,
which shall describe the product to be purchased, including where appropriate
a) Requirements for approval of product, produces, processes and equipment,
b) Requirements for qualification of personnel, and
c) Quality management system requirements.
The purchaser shall ensure the adequacy and suitability of specified purchase requirements prior
to their communication to the supplier.
Purchasing information provided to the supplier shall be documented and shall describe the
product to be purchased, including
a) The type, class, grade or other precise identification, and
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b) The title or other positive identification, and applicable issues of specifications, drawings,
process requirements, inspection instructions and other relevant technical data.
5.6.3 Verification of Purchased Products or Activities
The quality department shall establish control features for the verification of purchased product or
activities, namely as inspection specification.
The quality department shall be responsible for the quality testing and verification of the
purchased products, inspect the machining precision, audit the statement of MTR provided by the
supplier, fill out receiving inspection record, and maintain records of verification activities so as to
ensure the purchased products meet the specified purchase requirement.
Where the company or its customer intends to perform verification at the supplier’s premises, the
purchase department shall state the intended verification arrangements and method of product
release in the purchasing information.
The control of purchased process shall be conducted in accordance with Procurement Control
Procedure.
5.7 Production and service provision
5.7.1 Control of Production and Service
5.7.1.1 Production
The sales shall propose production orders. After obtaining the approval from the general manager,
the production department shall prepare production plan and implement it.
The plan and carry out production and service provision shall be performed under controlled
conditions. Controlled conditions shall include, as applicable
a) The availability of information that describes the characteristics of the product;
b) Implementation of the product quality plan, when applicable;
c) Ensuring design requirements and related changes are satisfied, when applicable;
d) The availability and use of suitable production, testing, monitoring, and measurement
equipment;
e) The availability of work instructions, when applicable;
f) Process control documents;
g) Implementation of monitoring and measurement activities; and
h) Implementation of product release, including applicable delivery and post-delivery activities.
5.7.1.2 Servicing
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The organization shall maintain a documented procedure that describes controls associated with
the servicing of products. The procedure shall address the following:
a) Review and implementation of the organization’s, customer-specific, product servicing, and
other servicing requirements;
b) The availability and use of suitable servicing, testing, monitoring, and measurement equipment;
c) The availability of work instructions, when applicable;
d) Ensuring identification and traceability requirements are maintained throughout the servicing
process;
e) The implementation of monitoring and measurement activities;
f) Process control documents; and
g) Requirements for release of the product that was serviced.
5.7.1.3 Process Control Documents
The Technical department shall establish control features and process controls shall be
documented in routings, travelers, checklists, process sheets, or other types of control features
and shall include requirements for verifying compliance with quality plans, control features, and
reference standards/codes. The process control documents shall include or reference instructions,
workmanship and acceptance criteria for processes, tests, inspections, and customer’s inspection
hold or witness points.
The production and service process shall be conducted in accordance with the Production
Processes Control Procedure.
5.7.1.4 Product Realization Capability Documentation
The organization shall develop and maintain documentation that includes but is not limited to
product realization plans and records of review/verification, validation, monitoring, measurement,
inspection, and test activities, including criteria for product acceptance that demonstrates the
capability of the organization to satisfy specified product and/or servicing requirements.
NOTE: Product realization documentation is evidence of the capability of the organization to manufacture
products or families of products and does not extend to every work order or individual product manufactured.
5.7.1.5 Validation of Processes for Production
The company shall validate any processes for production where the resulting output cannot be
verified by subsequent monitoring or measurement. Precautions shall be taken in the planning
process of product realization. This includes any processes where deficiencies become apparent
only after the product is in use or the service has been delivered.
The Technical Department shall establish arrangements for heat treatment and NDT processes
including, as applicable:
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a) Define criteria for review and approval of processes so as to confirm whether the process
method used meets the requirement and is effectively implemented.
b) Approve the equipment used and the capacity of infrastructure (including accuracy, safety,
usability, etc.), exert a strict requirement on up-keep and maintenance, and maintain records
thereof.
c) Conduct the on-the-job training for the relevant production staff and evaluate their qualification.
It is required that certain qualification certificate shall be obtained.
d) Have the operation instruction and manufacturing instruction.
e) Record the production monitoring of these process to prove that the production process is
trustworthy and up to the standard.
f) Revalidation: As the production condition varies (i.e. materials, facilities, personnel), the above
process shall be revalidated to ensure that a timely response shall be made to the change
affecting the process capacity.
The Technical and Quality departments shall validate those processes identified by the applicable
product specification as requiring validation. The processes requiring validation are heat
treatment NDT and process.
In light of the resource status of the company, the heat treatment and NDT processes have been
outsourced. The Technical, quality and purchase departments shall validate the capacity of the
outsourcing party to provide such processes.
5.7.2 Product Quality Plans
When required by contract, the technical and production departments shall develop a product
quality plan that specifies the processes of the quality management system (including the product
realization processes) and the resources to be applied to a product.
The product quality plan required by contract shall include but not limited to the following:
a) Description of the product to be manufactured;
b) Required processes and documentation, including required inspections, tests, and records, for
conformance with requirements;
c) Identification and reference to control of outsourced activities;
d) Identification of each procedure, specification, or other document referenced or used in each
activity; and
e) Identification of the required hold, witness, monitor, and document review points.
These product quality plans and any revisions to them shall be documented and approved by the
Technical and production Department. To ensure customer requirements are met. These product
quality plans and any revisions shall be communicated to the customer.
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5.7.3 Identification and Traceability
In order to protect from misuse of materials, parts and products, and keep traceability to
manufacture histories, Identification and Traceability Control Procedure implemented.
The production department shall be responsible for the work of identification and traceability. It
shall identify product by using suitable means throughout the processes needed for product
realization to prevent confusion and misuse of product. The production department shall also
establish the Identification and Traceability Control Procedure for identification and traceability of
the product by suitable means from receipt and during all stages of product, delivery and
installation, as required by the organization, the customer, and the applicable product
specifications.
The product identification shall refer to the name, symbol, category, etc. The identification of
inspection status shall refer to the product to be inspected and judged, already qualified or
disqualified, etc. Such identification shall be in the charge of the technical & quality department.
Where traceability is required in some occasions, the method of traceability shall be specified and
the record shall be kept. The company shall control and record the unique identification of the
product s to trace to the origin. Serial numbers of parts are the unique identification for traceability.
5.7.3.1 Identification and Traceability Maintenance and Replacement
In Identification and Traceability Control Procedure, following requirements for identification and
traceability marks and records stated:
a) Material in stock shall have the marks of material designation, HT No, heat treatment lot
number on the surface.
b) Cut off materials shall be replaced the marks on mother materials on the surface of cut
materials using water proof pen, paints, die stamps or labels.
c) Process traveler shall show serial number of parts, materials designation, HT No., and heat
treatment lot number of materials used. If necessary, serial numbers of parts shall be marked with
die stamp on the surface of parts and finished products.
5.7.4 Product Inspection/Test Status
A Product Inspection and Test Control Procedure developed and maintained.
Inspection status of in-processing products identified with separated areas, inspection marks in
convenient places, or signatures of inspectors in travelers or machining/assembly records.
The product identification and inspection status identification method may be any or multiple
choice of the follows:
a) Area classification
b) Layout in a certain position
c) Classified batch
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d) Label
e) Name plate
f) Record
5.7.5 Customer-Supplied Property
Tartan established and maintained Customer-Supplied Property Control Procedure to identify,
verify, protect and safeguard customer property provided for use or incorporation into the product.
Customer property be controlled or used in Tartan facility include product drawings,
materials/parts used in products.
Materials/ parts used in products shall be verified by QC in accordance with determined
acceptance criteria. If any question found, reports to customers shall be issued through sales.
Materials and parts shall be protected from damage, deterioration in accordance with the
requirements defined in Product Preservation Control Procedure, or the specific requirements
determined by customer.
Materials and parts provided by customers shall be identified with special marks, and stored in
separated area in stock.
If any customer property is lost, damaged or otherwise found to be unsuitable for use before and
after using, the sales shall report this to the customer and maintain records.
Customer provided drawings shall controlled as external documents in accordance with the
requirements defined in Document Control Procedure. Tartan promise to keep confidential of
customer intellectual property.
5.7.6 Preservation of Product
5.7.6.1 General
In order to preserve products during internal processing and delivery to the intended destination
in order to maintain conformity to requirements, Product Preservation Control Procedure
implemented.
5.7.6.2Storage and Assessment
Storage area for sealing materials shall be protected from direct sunshine, excessive cold or hot
temperature, and radiographic rays.
In order to detect deterioration, the condition of product or constituent parts in stock shall be
assessed at specified intervals identified by the procedure. The interval shall be appropriate to
the products or constituent parts being assessed.
Records of the results of assessments shall be maintained
5.7.7 Inspection and Testing
5.7.7.1 General
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The production and quality departments shall maintain Product Inspection and Testing Control
Procedure for inspection and testing to verify that product requirements have been met. The
procedure shall include requirements for in-process and final inspection and testing. Records of
required inspection and testing shall be maintained per documented procedures.
5.7.7.2 In-process Inspection and Testing
The production and quality department shall inspect and test the product at planned stages as
required by the product quality plan, process control documents, and/or documented procedures.
Evidence of conformity with the acceptance criteria shall be maintained.
5.7.7.3 Final Inspection and Testing
The QC shall perform all final inspection and testing in accordance with the product quality plan
and/or documented procedures to validate and document conformity of the finished product to the
specified requirements.
Personnel other than those who performed or directly supervised the production of the product
shall perform final acceptance inspection at planned stages of the product realization process.
5.7.8 Preventive Maintenance
The production department shall establish and maintain Equipment Control Procedure for
equipment used in product realization. The procedure shall identify requirements for:
a) Type of equipment to be maintained;
b) Frequency; and
c) Responsible personnel.
Records of preventive maintenance shall be maintained.
5.8 Control of Testing, Monitoring and Measuring Equipment
The monitoring and measuring equipment is important to the accuracy of monitoring and
measuring results. To ensure the measurement capacity meets the measurement requirements,
a Testing, Measuring and Monitoring Equipment Control Procedure be implemented
The Technical department shall determine the required monitoring and measurement to be
undertaken and the monitoring and measuring equipment needed to provide evidence of
conformity of product to determined requirements. The quality department shall establish
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.
Where appropriate, monitoring and measuring equipment shall include:
a) Be calibrated or verified 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 shall be recorded.
b) Be adjusted or re-adjusted as necessary.
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c) Be identified so as to ensure the calibration status
d) Prevent the adjustment which may render the measurement results invalid
e) Be protected from damage and deterioration during handing, maintenance and storage.
Where testing hardware (such as clamps, localizer, plate, mold) or testing software (such as
pressure test procedure software) other than measuring equipment is used in the monitoring and
measurement of specified requirements as checking means, the quality control department shall
perform verification and configuration management before use to demonstrate ability to verify
serviceability in the production process and to maintain records as evidence of control.
In addition, the Technical and Quality departments shall assess and record the validity of the
previous measuring results when the equipment is found not to conform to requirement.
Appropriate actions shall be taken on the equipment and any product affected. Record of the
results of calibration and verification shall be maintained.
When used in the monitoring and measurement of specified requirements, the ability of computer
software to satisfy the intended application shall be confirmed. This shall be undertaken prior to
initial use and reconfirmed as necessary.
5.8.1 Control of Testing, Monitoring and Measuring Equipment
The Quality department shall establish List of Testing, Monitoring and Measuring Equipment to
control, calibrate and maintain monitoring and measuring equipment. Control features shall
include device type, unique identification and location, frequency of checks, check method, and
acceptance criteria.
History records of each Testing, Monitoring and Measuring Equipment shall be established.
5.8.2 Environmental Conditions
The company shall ensure that the environmental conditions are suitable for the calibrations,
inspections, measurements and tests being carried out.
5.9 Product Release
The Quality department shall maintain a Product Release Procedure to ensure release of product
to the customer shall not proceed until the planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant authority and, where applicable, by the
customer.
Records shall be maintained to enable identification of the individual releasing the product.
5.10 Control of Nonconforming Product
5.10.1 General
Quality department shall develop and maintain the Nonconforming Product Control Procedure to
ensure that product which does not conform to product requirements is identified and controlled
to prevent its unintended use or delivery.
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The procedure for addressing nonconforming product identified during product realization shall
include controls for:
a) Product identification to prevent unintended use or delivery;
b) Addressing the detected nonconformity;
c) Taking action to preclude its original intended use or delivery; and
d) Authorizing its use, release, or acceptance under concession by relevant authority and, where
applicable, by the customer.
The procedure for addressing nonconforming product identified after delivery shall include
controls for:
a) Identifying, documenting, and reporting nonconformance or product failure identified after
delivery;
b) Ensuring the analysis of product nonconformance or failure, provided the product or
documented evidence supporting the nonconformity is available to facilitate the determination of
the cause;
c) Taking action appropriate to the effects, or potential effects, of the nonconformance when
nonconforming product is detected after delivery.
5.10.2 Nonconforming Product
The quality department shall address nonconforming product by performing one or more of the
following:
a) Repair or rework with subsequent inspection to meet specified requirements;
b) Re-grade for alternative applications;
c) Release under concession; and/or
d) Reject or scrap.
5.10.3 Release of Nonconforming Product Under Concession
The process of evaluation, release and acceptance of nonconforming product shall include one or
more of the following:
Accepting products that do not satisfy manufacturing acceptance criteria provided that
a) Products continue to satisfy the applicable design acceptance criteria and/or customer criteria;
or
b) The violated manufacturing acceptance criteria are categorized as unnecessary to satisfy the
applicable design acceptance criteria and/or customer criteria; or
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c) The design acceptance criteria are changed and the products satisfy the revised design
acceptance criteria and associated manufacturing acceptance criteria requirements.
5.10.4 Customer Notification
In the event of that product that does not conform to design acceptance criteria has been
delivered, a customer notification shall be issued to customer. Such notification shall be recorded
and retained.
5.10.5 Records
Records of the nature of nonconformities and any subsequent actions taken, including
concessions obtained, shall be maintained.
5.11 Management of Change (MOC)
5.11.1 General
The Technical and Production departments shall maintain Management of Change Procedure to
ensure that the integrity of the quality management system is maintained when changes to the
quality management system are planned and implemented. For MOC, Technical and production
departments shall identify the potential risks associated with the change and any required
approvals prior to the introduction of such changes. Records of MOC activities shall be
maintained.
5.11.2 MOC Implementation
The Technical and Production departments shall use the MOC process for any of the following
that may negatively impact the quality of the product:
a) Changes in the organizational structure;
b) Changes in key or essential personnel;
c) Changes in critical suppliers; and/or
d) Changes to the management system procedures, including changes resulting from corrective
and preventive actions.
5.11.3 MOC Notification
The Technical and production departments shall notify relevant personnel, including the customer
when required by contract, of the change and residual or new risk due to changes that have
either been initiated by the organization or requested by the customer.
6 Quality management system monitoring, measurement, analysis and
improvement
6.1 General
To monitor, measure, analyze and improve the product, processes and system, Tartan
determined to:
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Conduct Inspection and testing to demonstrate the conformity to the product requirements.
Survey and analyze the information of customer satisfaction annually according to the
requirements defined in Customer Satisfaction Control Procedure. Customer dissatisfaction shall
be analyzed to find the root causes, and take appropriate actions to enhance customer
satisfaction.
Collected and analyzed KPI data for management processes at planned intervals to find chances
of improvement.
Conduct Internal audit and management review at planned intervals, to find where can be
improved.
Collect and analyze data in accordance with the requirements defined in Data Analysis Control
procedure. Applicable methods, including statistical technical shall be determined for specific data.
Review the monitoring and measuring results to decide where and what required improvement.
Implement preventive and /or corrective actions to improve the product quality level and the
effectiveness of processes and system to meet customer future expectations.
6.2 Monitoring, measurement and improvement
6.2.1 Customer Satisfaction
Customer satisfaction shall be monitored in accordance with the requirements defined in
Customer Satisfaction Control Procedure.
Sales shall monitor information relating to customer perception as to whether the organization
has met customer requirements. Information shall be collected by customer survey sheet,
complaints sheet, recommendations or requests on quality and delivery, and service report.
Use appropriate methods to analyze the information and determine the satisfaction level
combining the customer survey score, complaint time and strength, payment delay dates.
Customer dissatisfaction shall be analyzed and appropriate actions shall be taken to enhance
customer satisfaction.
Information of customer satisfaction shall be input to management review.
6.2.2 Internal Audit
6.2.2.1 General
Tartan conduct internal audit at least annually to determine the conformity and effectiveness of
the quality management system.
Internal audit shall be conducted in accordance with the requirements defined in Internal Audit
Control Procedure.
Planning of Internal audit shall consider the status and importance of the processes and areas to
be audited, as well as the results of previous audits. The audit criteria, scope, frequency and
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methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity
and impartiality of the audit process. Auditors shall not audit their own work.
A documented procedure shall be established to define the responsibilities and requirements for
planning and conducting audits, establishing records and recording results.
Records of the audits and their results including nonconformity report shall be retained.
6.2.2.2 Performance of Internal Audit
Audits shall be performed by competent personnel independent of those who performed or
directly supervised the activity being audited to ensure objectivity and impartiality of the audit
process. Records of the audits shall provide objective evidence that the quality management
system is implemented and maintained.
All processes of the quality management system required to meet this specification shall be
audited prior to claiming conformance to the requirements of this specification.
6.2.2.3 Audit Review and Closure
The response times for addressing detected nonconformities shall be identified in NCR or audit
report. The management responsible for the area being audited shall ensure that any necessary
corrections and corrective actions follow the requirements of 6.4.2. The results of internal audits
and the status of corrective actions shall be reported in the management review. Records of
internal audits shall be maintained.
6.2.3 Process Evaluation
The MR shall determine and apply suitable methods to monitoring and measurement of QMS
processes.
a) Customer-related processes: customer satisfaction evaluation;
b) Product realization processes including design, planning, purchasing, production and
inspection/ testing: review of processes inputs and outputs; validate processes outputs,
qualification of equipment and personnel, monitoring processes activities to determine the
conformity to the desired results;
c) Support processes like document control, records control, and training and qualification:
routine and periodic checking, sampling documents to review and select persons to
interview/observe.
d) Management processes like management responsibility, policy, objectives: internal and
external audits, management review.
When planned results are not achieved, correction and corrective action shall be taken to ensure
conformity of the product. The company shall maintain records of the effective dates of process
changes.
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6.3 Analysis of Data
The quality department and MR shall determine, collect and analyze appropriate data to
demonstrate the suitability and effectiveness of the quality management system and to evaluate
where continual improvement of the effectiveness of the quality management system can be
made. This shall include data generated as a result of monitoring and measurement and from
other relevant sources.
The analysis of data shall provide information relating to
a) Customer satisfaction;
b) Conformity to product requirements;
c) Nonconformities and product failures identified after delivery or use, provided the product or
documented evidence is available to facilitate the determination of the cause
d) Characteristics and trends of processes and products including opportunities for preventive
action;
e) Suppliers, and
f) Quality objectives.
Use of the analysis results of data of customer satisfaction, product conformity performance,
processes and products characteristics, and supplier information to evaluate the quality
management system, product and process performance trends to find the opportunities for
preventive action.
6.3.1 Analysis of Data
The Quality department shall use Data Analysis Control Procedure for identification and use of
Technical of data analysis.
6.4 Improvement
6.4.1 General
Tartan shall continually improve the effectiveness of the quality management system through the
use of the quality policy, quality objectives, audit results, analysis of data, corrective and
preventive actions and management review.
a) To create an atmosphere of inspiring improvement by establishing a quality culture under the
guideline of quality policy and objectives;
b) To set improvement goal by establishing quality objectives and target;
c) To evaluate opportunities for improvement through data analysis, internal audit;
d) To carry out the improvement through implementation of corrective and preventive actions
e) To evaluate improvement performance and appoint new direction of improvement by
management review.
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6.4.2 Corrective Action
MR and quality department shall determine actions to eliminate causes of nonconformity of
products, processes, and system shall be carried out in accordance to Corrective and Preventive
Action Control Procedure.
Corrective and Preventive Action Control Procedure is established to define requirements for:
a) Reviewing nonconformities (including customer complaints),
b) Determining and implementing corrections
c) Identifying the root cause of the nonconformity and evaluating the need for corrective actions;
d) Implementing corrective action to reduce the likelihood that nonconformity recurs;
e) Identifying the timeframe and responsible person(s) for addressing corrections and corrective
action;
f) Verification of the effectiveness of the corrections and corrective action taken; and
g) MOC when the corrective actions require new or changed controls within the quality
The quality department and MR shall ensure any corrective action is effective.
Causes of nonconformity shall be analyzed and required actions shall eliminate the causes to
prevent the re-occurrence of the nonconformity.
Need actions shall be documented. Results of actions taken shall be verified. Records of action
and results of actions taken shall be retained.
Corrective actions status shall be input to management review.
6.4.3 Preventive Action
GM, MR and quality department shall determine actions to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to
the effects of the potential problems.
Preventive actions needs come from results of internal audit, management review, and data
analysis and process monitoring. Preventive actions shall be taken in accordance with Corrective
and Preventive Action Control Procedure.
The procedure shall define requirements for:
a) Identifying the opportunities for improvements;
b) Identifying a potential nonconformity and its potential cause;
c) Evaluating the need for preventive action, including any immediate or short-term action
required, to prevent occurrence of nonconformity;
d) Identifying the timeframe and responsible person(s) for implementing a preventive action;
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e) Reviewing the effectiveness of the preventive action taken; and
f) MOC when the preventive actions require new or changed controls within the quality
management system.
The MR and quality department shall ensure the preventive actions are effective.
The quality department and relative departments shall investigate and determine the causes
result of the potential nonconformity.
Records of potential nonconformity, required actions and results of action taken shall be retained.
Permanent changes resulting from preventive actions shall be documented. And response time to
preventive actions, dates of these action implemented shall be specified.
Results of preventive actions shall be input to management review.
6.5 Management Review
6.5.1 General
Management review shall be hosted by GM at least annually to evaluate the continuing suitability,
adequacy and effectiveness. This review shall include assessing opportunities for improvement
and the need for changes to the quality management system, including the quality policy and
quality objectives.
Management review shall be conducted in accordance with the Management Review Control
Procedure.
Records of inputs, outputs, improvement actions, and the results of actions taken shall be
retained.
6.5.2 Review Input
Sufficient and accurate information of management review inputs are essential to an effective
review. Inputs from all departments shall contain the recommendations for improvement. Inputs
shall include current performance and improvement opportunities related to the following:
a) Effectiveness of actions resulting from previous management reviews;
b) Results of audits;
c) Changes that could affect the quality management system, including changes to legal and
other applicable requirements (such as industry standards);
d) Analysis of customer satisfaction, including customer feedback;
e) Process performance;
f) Results of risk assessment;
g) Status of corrective and preventive actions;
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h) Analysis of supplier performance;
i) Review of the analysis of product conformity, including nonconformities identified after delivery
or use; and
j) Recommendations for improvement.
6.5.3 Review Output
Recommendations in review input shall be discussed by review team, and final decision for each
recommendation shall be made.
Management review outputs are the summary evaluation report of the quality management
system. The outputs shall contain:
a) Improvement of the effectiveness of the quality management system and its processes,
b) Improvement of product related to customer requirements, and
c) Resource needs.
Improvement actions raised from management review outputs shall be planned and followed by
MR.
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Attachment 1List of Element-Document
Quality Element
Doc. No.
CW-QP-001
Documented Procedure
Product design and development control procedure
(also refer to 5.4)
4.1 Quality Management System
CW-QP-002
Procurement Control Procedure (also refer to 5.6)
CW-QP-003
Internal Communication Control Procedure
CW-QP-004
Human Resources Control Procedure
CW-QP-005
Work Environment Control Procedure
4.4 Document Requirements
CW-QP-006
Document Control Procedure
4.5 Control of Records
CW-QP-007
Quality Records Control Procedure
5.1 Contract Review
CW-QP-008
Contract Review Control Procedure
5.2 Planning
CW-QP-009
Production Realization Planning Control Procedure
5.3 Risk Assessment and
CW-QP-010
4.3 Organization Capability
Risk Assessment and Management Procedure
Management
5.5 Contingency Planning
CW-QP-011
Contingency Planning Procedure
5.6 Purchasing
CW-QP-012
Outsourcing Control Procedure
CW-QP-013
Production Processes Control Procedure
CW-QP-014
Identification and Traceability Control Procedure
CW-QP-015
Product Inspection and Test Control Procedure
CW-QP-016
Customer-supplied Property Control Procedure
CW-QP-017
Product Preservation Control Procedure
CW-QP-018
Equipment Control Procedure
5.7 Production and Service
Provision
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5.8 Control of Testing, Monitoring CW-QP-019
and Measuring Equipment
Testing, Monitoring and Measurement Equipment
Control Procedure
5.9 Product Release
CW-QP-020
5.10 Control of Nonconforming
CW-QP-021
Production Release Procedure
Nonconforming Product Control Procedure
Product
5.11 Management of Change
CW-QP-022
Management of Change Procedure
6.1 General
CW-QP-023
Customer Satisfaction Control Procedure
CW-QP-024
Internal Audit Control Procedure
6.2 Monitoring, Measurement
CW-QP-025
Data Analysis Control Procedure
6.3 Analysis of Data
6.4 Improvement
CW-QP-026
Corrective and Preventive Action Control Procedure
6.5 Management Review
CW-QP-027
Management Review Control Procedure
Appendix A
CW-QP-028
API Monogram Control Procedure
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Attachment 2 Organization Chart
Tartan Energy Solutions Ltd.
Management System, GM.
Office Manager
Administration
and HR
Accounting
Payable Clerk
Receivable
Clerk
Quality Manager
Quality
Controlle
r
QMS
Controller
Operation Manager
Sales
Controller
Sales
Tech
Controller
Procurement
Controller
Resources
Controller
Production
Controller
Inventory
Assembly
and Testing
Field Service
Document
Controller
Design
Engineer
Drafter
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Attachment 3
GM
Technical
Customer
order 5.1.2
Purchase
Production
Purchase
approval 5.6.3
Accept
inspection5.7.7
Responsibility
and authority
4.2.2
Management
review6.5
Resource
provision 4.3.1
Internal audit
6.2.2
Monitoring and
measurement
of processes
6.2.3
Design 5.4
Supplier
evaluation
Design change
5.4.7
Delivery to
customer
571
In-process
inspction8.2.4
Process
Technology
5.7.1Process
validation 5.2
Production
5.7.1
In stock
5.7.6
Monitoring and
measurement
equipment 6.2
HR & Adm.
Receiving
inspection
5.7.7
Release control
5.9
Preservation
577
Process
control 6.2.3
Shipping
5.7.7
Process validation
5.7.2Identification and
traceability
5.7.3Preservation 5.6
Work Environment
4.3
Quality
Purchase
requirements
5.6.2
Purchase
order 5.6.3
Contract
review 5.1
Stock
Preventive and
corrective
action5.7.8/6.4.2
Customer
satisfaction
6.2.1
NG product
control 5.10
Document and
record control
4.4.3/4.5.1
Data analysis 6.3----------continual improvement （preventive and corrective action）6.4
44
Human resource control 4.3.2
Management
commitment
4.2.1 Quality
policy 4.1.2
Quality
objectives4.1.3
Sales
Chart for Processes Relationship