Quality Manual ISO/IEC 17025:
The document will be the controlled version and revision announcements will be distributed via e-mail to relevant parties and published on the Internet.
CONTROLLED INTRANET COPY
Copies or extracts of this manual, which have been downloaded from the Intranet, are uncontrolled copies and cannot be guaranteed to be the latest version.
This document is the property of “GASCO ASAB Laboratory.” No part of this publication may be reproduced, stored in a retrieval system in any form, or transmitted by any means, without the prior written permission of the GASCO ASAB Laboratory Section Head
ATM/L1 ATM/L ATM
9 30-Oct-15
Annexures List revised
8 26th Jun 2015
4.1.1 QMS process interaction included As identified in Internal audit
7 5th DEC 2014 4.1.5.C & Inclusion of 4.2.6.3 authorities of Quality Manager.
6 30th Oct2014 Revised the list of Key personnel
5 8thOct2014 Annexures list revised.
Management committee given as Annexure 6.1.B
(previous number. 6.2)
6.2 Renamed as “List of Key personnel”
6.3 “List of personnel& delegatio
6.4 List of test method
4 6thJAN 2014 Clause4.14(IA)& 5.5Equipment
Key personnel with Quality responsibilities.Annexture6.3
3 28thMAY 2013 Sub contract mentioned
2 2ndJAN 2013 ISO 9001 excluded
1 01/11/2011 All Pages
0 Draft -
Rev No. Date Revision History Prepared by Reviewed by Approved by
TABLE OF CONTENTS
SECTION 1 4
1.0 INTRODUCTION 4
1.1 ASAB PLANT 4
1.2 The Laboratory 5
1.3 ATM-Laboratory Identity of the Laboratory 6
1.4 Scope of the Laboratory 7
SECTION 2 7
2.0 NORMATIVE REFERENCES 7
SECTION 3 8
3.0 TERMS AND DEFINITIONS 8
3.1 DEFINITIONS 8
SECTION 4 11
4.0 MANAGEMENT REQUIREMENTS 11
4.1 Organization 11
4.2 Management System 17
4.3 Document Control 26
4.4 Review of Requests 27
4.6
4.8 Complaints 32
4.9 Control of Non-conforming Testing 31
4.10 Improvement 33
4.11 Corrective Actions 33
4.12 Preventive Actions 35
4.13 Control of Quality and Technical Records 36
4.14 Internal Audits 38
4.15 Management Reviews 39
SECTION 5 41
5.1 Technical Requirements 41
5.2 Personnel 41
5.3 Accommodations and Environmental conditions. 42
5.4 Test Methods and Method Validation 44
5.5 Equipment 46
5.6 Measurement Traceability 48
5.7 Sampling 49
5.8 Handling of Test Items 50
5.9 Quality Assurance of Test Results 50
5.10 Reporting the Results 51
6.0 Annexures 53
6.1 ANNEXURE-A : Organization Chart ..54
Annexure-B : Management committee-------------------------------------------------------54
6.2 List of Key personnel----------------------------------------------------------------------------55
6.3 List of Key personnel with delegation of duties…………….…......................................…..56
6.4 Lisof tests under scope of Accreditation, -------------------------------------------------58
SECTION 1
1.0 INTRODUCTION
Abu Dhabi GAS Industries Ltd. (GASCO) is the operating company in Abu Dhabi responsible for processing onshore natural gas and associated gas from onshore oil production.
The Company began as a US $2 Billion joint venture incorporated in 1978 with ownership shared between Abu Dhabi National Oil Company (ADNOC) as a major shareholder (68%), Shell Abu Dhabi (15%), Total (15%) and Partex (2%).
In April 2001, Abu Dhabi Gas Company (ATHEER), with 100% ownership by ADNOC, was integrated with GASCO. In addition, the 100% ADNOC ASAB Gas Plant operations were also transferred to GASCO in March 2004, leading to further enhancement to Company’s position as one of the largest gas processing companies in the world and one of the biggest industrial projects in the U.A.E.
The gas processing and Natural Gas Liquids (NGL) extraction takes place at the four plants located in the desert area namely: Habshan-Bab Gas Complex, Bu Hasa NGL Plant, Asab NGL Plant and Asab Gas Plant. The NGLs are transferred to the Ruwais Fractionation Plant, where they are treated and fractionated in to Ethane, Propane, Butane and Paraffinic Naphtha. Ethane and part of Propane are exported to Abu Dhabi Polymers Company Ltd. (BOROUGE), while Propane, Butane and Paraffinic Naphtha are stored in special tanks for shipment worldwide via the loading facility at GASCO Ruwais Jetty.
1.1 Asab Plant
The Asab plant is located onshore near ADCO-ASAB. Asab plant currently has a total of 5 gas processing trains and 2 gas injection trains with a feed gas capacity Asab/0 of 307 MMSCFD, Asab/1 of 870 MMSCFD & 90,000 BBL
ASAB-3 Plant is expansion of ASAB-0 plant, as ADCO in future increasing oil production from 411000 BPD to 600,000,Due to increase of oil production associated gas production will also raise from 306 MMSCFD to 450 MMSCFD.( MMSCFD Standard cubic feet per day ).
condensate, Asab/2 of 790 MMSCFD,
1.2 The Laboratory
GASCO ASAB Laboratory (ATM-LABORATORY) was established in 1981 to provide products quality control support, through testing of feed, intermediate streams and products as well as utilities.
The laboratory building and testing facilities continued to expand along with Asab new projects Asab-1, Asab-2 & Asab-3. The Laboratory incorporated the latest technology in the Residue gas; Natural gas liquid; Amine, Glycol, Hydrocarbon condensate and Water testing processes and has highly skilled and experienced work-force. The Laboratory is fully supported by the dynamic and customer focussed management who believes in total customer satisfaction and being a good corporate citizen.
The laboratory operations revolve around a quality assurance policy which is fundamentally split into the following philosophies to achieve quality results so that our internal customers can efficiently plan and execute their refinery processes most efficiently. The laboratory focuses in ensuring accurate and reliable test results based on the following:
a) Well Qualified, experienced staff is employed and individual’s talent developed so as to motivate each individual to contribute towards the overall performance of the team.
b) Most recent and internationally accepted analytical methods are used for analysis of process streams and intermediate products for certification. Latest ASTM standard methods are used for analysis. Additionally, SMS, UOP, IP & GPA standard methods are used for confirmation and validation of analysis.
c) Use state-of-the-art instrumentation to carry out the analysis, with each instrument undergoing a validation procedure to ensure that statistically viable results are obtained with each instrument.
d) Comprehensive Preventative Maintenance and repair programmes are in place for each instrument both internally from GASCO maintenance department and vendor local representatives. Obsolete instruments are replaced on a regular basis.
e) Quality and safety at work are of paramount importance in our commitment to provide services that consistently meet the customer’s requirements in a safe, timely and cost effective manner. Each employee is urged to inculcate Quality Culture for persistent introspection and improvement in the process.
1.3 ATM-Laboratory Identity
ATM-LABORATORY operates at a permanent facility and is a part of:
Abu Dhabi Gas Industries Limited:
Asab Plant, P.O. Box: 665, ASAB Area, Abu Dhabi
United Arab Emirates
Tel #: 02-6030970
Fax #: 02-6030442
1.3.1 Distribution
This manual has two categories of distribution:
Controlled distribution
Issued under the control of the Quality Manager and updating is carried whenever changes affected. This document will be maintained live on the GASCO Intranet. The Intranet based document will be the controlled version and revision announcements will be distributed via e-mail to relevant parties and published on the Intranet.
Uncontrolled distribution
Issued, when required, to potential customers with the approval of the Technical Services Manager. The copies are stamped as “uncontrolled” and these documents are not updated with any subsequent revisions made to and the distribution list will not be maintained.
1.4 Scope
Asab laboratory is engaged in the testing of Residual Gas, Natural Gas Liquid- NGL, Amine, Glycol, Water: Boilers & sour and Hydrocarbon Condensate produced by the Asab Plant.
The testing scope for ISO 17025 is as follows:
This Quality Manual is documented in accordance with the requirements of ISO/IEC 17025:2005 (General Requirements for the Competence of Testing and Calibration Laboratories). The scope of the QMS is to comply with the requirements of ISO/IEC 17025:2005.
This manual outlines the policies, procedures and requirements of ISO/IEC 17025:2005. Laboratory Section demonstrates its ability to consistently provide the services that meet the requirements of the customer and applicable ADNOC code of practices and enhances customer satisfaction through effective application of Quality Management System including processes for continual improvement.
To ensure the quality of products of Natural Gas Liquid (NGL), Sale Gas and H.C. Condensate are within customer defined limits and follow all standard requirements for analysis, sampling to HSE requirements.
SECTION 2
2.0 NORMATIVE REFERENCES
The following references have been used in the development of this manual
• ISO/ IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories.
• ISO/ IEC 17000:2004, Conformity assessment — Vocabulary and general principles.
• ISO 9000:2005, Quality Management Systems – Fundamentals and Vocabulary
• ISO 9004:2009, Managing for the sustained success of an organization – A Quality Management Approach.
* ISO/IEC 19011: Guidelines for Quality and/or Environmental Management System Auditing
SECTION 3
3.0 TERMS AND DEFINITIONS
The terms and abbreviations used in this manual are:
ATM-LABORATORY: GASCO Asab Laboratory Section
QMS: Quality Management System
QM: Quality Manual
MR: Management Representative
ADNOC: Abu Dhabi National Oil Company
ASTM:
GPA, IP, UOP, ISO
3.1 DEFINITIONS
3.1.1 Assurance of Conformity: Procedure resulting in a statement giving confidence that a product, process or service fulfils specified requirements
3.1.2 Audit: Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
3.1.3 Conformity: Fulfillment by a product, process or service of specified requirements.
3.1.4 Continual Improvement: Recurring activity to increase the ability to fulfil requirements.
3.1.5 Customer Satisfaction: Customer's perception of the degree to which the customer's requirements have been fulfilled.
3.1.6 Correction: On-the-spot or immediate corrective action to correct or repair non-conforming data, reporting or equipment, which is an action routinely made by analysts, technicians and supervisors.. However correction does not address root causes.
3.1.7 Corrective Action: Corrective actions are steps that are taken to remove the root causes of a detected non-conformity or undesirable situation.
3.1.8 Customer: A person/organisation who receives product/services. A customer can be internal or external to the organization.
3.1.9 Customer Satisfaction: It is a customer perception. It is also a question of degree. It can vary from high satisfaction to low satisfaction.
3.1.10 Effectiveness: Extent to which planned activities are realised and planned results achieved.
3.1.11 Evaluation of Conformity: Systematic examination of the extent to which a product, process or service fulfils specified requirements.
3.1.12 Efficiency: It is a relationship between results achieved (outputs) and resources used (inputs). Efficiency can be enhanced by achieving more with the same of fewer resources.
3.1.13 Infrastructure: The term infrastructure refers to the entire system of facilities, equipment and services that the mechanical Section needs in order to function.
3.1.14 Internal Audit: Internal audits are referred to as first-party audits.
3.1.15 Management: The term management refers to all the activities that are used to coordinate, direct, and control the department/Section.
3.1.16 Management System: A management system is a set of interrelated or interacting elements that use to implement policy and achieve objectives.
3.1.17 Management Review: The overall purpose of a management review is to evaluate the suitability, adequacy, and effectiveness of the QMS, and to look for improvement opportunities.
3.1.18 Non conformity: Non conformity refers to a failure to comply with requirements.
3.1.19 Objective evidence: It is a data that shows or proves that something exists or is true. Objective evidence can be collected by performing observations, measurements, and tests or by using any other suitable method.
3.1.20 Outsourced process: It is any process that is part of Section QMS but performed by a party that is external to Section.
3.1.21 Preventive Actions: These are steps that are taken to remove the causes of potential non-conformities or potential situations that are undesirable.
3.1.22 Procedure: Step by step activity carrying out a process of activity.
3.1.23 Process: A process is a set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs. Processes are interconnected because the output from one process becomes the input for another process.
3.1.24 Product/Result: Result of a process/activity
3.1.25 Service realization: Customer requirements are realized or actualized by following set of service realization processes.
3.1.26 Quality: The quality of product / service can be determines by comparing a set of inherent characteristics with a set of requirements. If those inherent characteristics meet all requirements, high or excellent quality is achieved.
3.1.27 Quality Objectives: A quality objective is a quality oriented goal. A quality objective is something you can aim for or try to achieve. Quality objectives are generally based on or derived from quality policy and must be consistent with it.
3.1.28 Quality Improvement: Part of quality management focussed on increasing the ability to fulfil quality requirements.
3.1.29 Record: A record is a type of document. Records provide evidence that activities have been performed or results have been achieved.
3.1.30 Requirement: A requirement is a need, expectation, or obligation. It can be stated or implied by its customers, or other interested parties.
3.1.31 Reference Equipment/ Material: An equipment/material generally of the highest meteorological quality available at a given location from which measurements at that location can be derived.
3.1.32 Standard: A standard is a document. It is a set of rules that control how people develop and manage materials, services, technologies, processes and systems.
3.1.33 Supplier: A supplier is the one who delivers products / equipment / services to Laboratory Section.
3.1.34 Traceability: It is the ability to identify and trace the history, distribution, location and application of services and materials. A traceability system records and follows the trail as services and materials come from suppliers and are processed and ultimately distributed as end service.
3.1.35 Validation: Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
3.1.36 Verification of Conformity: Conformation, by examination of evidence, that a product, process or service fulfills specified requirements.
3.1.37 Work environment: The term work environment refers to working conditions. It refers to all of the conditions and factors that influence work. Work environment includes lighting, temperature, and noise factors, as well as the whole range of ergonomic influences.
3.1.38 Working Standard: A standard which, usually calibrated against a reference standard, is used routinely to calibrate or check material measures or measuring instruments. (WIM 6.09)
3.1.39 Uncertainty of Measurement: An estimate characterizing the range of values within which true value of measured lies (WIM 3.09).
3.1.40 Intermediate Precision- Intermediate precision expresses within-laboratory variation, as on different days, or within different Analysts or equipment within the same laboratory. .
SECTION 4
4.0 MANAGEMENT REQUIREMENTS
4.1 Organization
4.1.1 ATM-LABORATORY is a part of GASCO Technical Department at ASAB. The ATM-Laboratory identity of the laboratory and its relation with the parent organisation GASCO ASAB plants has been defined clearly in Section-1 of this document.
ATM-LABORATORY has established, documented implemented and maintained a Quality Management System (QMS) ISO/IEC 17025:2005. The system is maintained and continually improved through the use of the Quality Policy, Objectives, audit results, analysis of data, corrective and preventive actions and management review. The internal audit cycle covers full scope of the system as well as the clauses of ISO 17025:2005 standards in order to demonstrate that the requirements are fulfilled.
To design and implement the Management system, ATM-LABORATORY has;
• Identified the processes needed for the QMS and their application throughout the Laboratory Section as shown in the Key Process Interaction flow chart;
• Determined the sequence and interaction of these processes;
• Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented them in process maps, quality plans, work procedures, etc.;
• Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes as detailed in per quality plans and process maps in the Key Process Interaction flow chart;
• Established systems to monitor, measure and analyse these processes;
• Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes as per Key Process Interaction flow chart.
ATM-LABORATORY implemented the procedure ensure control on outsourcing of any process that affects product conformance with requirements. The control of outsource processes implemented the procedure be identified, implemented and where appropriate, reviewed at both fixed intervals and opportune times with a view to process improvement.
Notes:
Beginning with this section (4.0), all sections aligned with the matching section numbers from the ISO 17025:2005 standard.
ATM-LABORATORY Process interaction model with other sections:
ASAB Business Managing and Control Process:
Laboratory Process interaction
QMS process interaction diagram:-
QUALITY MANAGEMENT SYSTEM
PROCESS IDENTIFICATION & INTERACTION
SUPPORT MANAGEMENT PROD. REALIZATION
PROCESSES PROCESSES PROCESSES
ATM-LABORATORY is responsible for the testing of Natural Gas, NGL, and Hydrocarbon Condensate as per the international standard testing methods (ASTM, GPA, IP, UOP, ISO, Shell …etc.) as well as meeting the requirements of ISO/IEC 17025:2005. The laboratory is also responsible to comply with the requirements of GASCO/ ADNOC and other applicable regulations of the Federal Government. The laboratory testing work is carried out at its permanent location as specified in the Section l. 1.2 - ATM-Laboratory identity
ATM-LABORATORY tests the products which are transferred to the local customers. It implements the Management Principles at all levels and demonstrates that it is impartial; its personnel are free from any undue internal, commercial, financial and other pressures which might influence their technical judgment. The management declares that the laboratory is not engaged in any activities that may endanger the trust in its independence of judgment and integrity in relation to its testing activities.
4.1.2 The intent of ATM-LABORATORY under GASCO Technical Department at ASAB, Abu Dhabi, is to operate laboratory according to the following requirements;
• Policies and Procedures set by the GASCO Technical Department at ASAB, Abu Dhabi
• ISO/IEC 17025:2005 management system and testing services for customers
• United Arab Emirates laws and regulations
• American Association of Laboratory Accreditation (A2LA) Accreditation Criteria for ISO/IEC 17025
4.1.3 Management Commitment
ATM-LABORATORY Management is committed for the following requirements:
ATM-LABORATORY staff implemented the procedure have the authority and resources needed to carry out their duties including the implementation and improvement of the QMS and control the process non-conformities detected by taking appropriate corrective and preventive actions.
The management and personnel are free from any undue internal and external, commercial, financial and other pressures and influences that may adversely affect their quality of work.
Customer’s property such as information, proprietary rights including procedures for protecting the storage and transmission of results.
The management ensures that ATM-LABORATORY is not indulged in any activity that would diminish confidence in its competence, impartiality, judgement and operational integrity.
The management has defined the organisational structure which indicates the responsibility, authority and inter-relationship of all its key personnel who perform, manage or verify the work which affects the quality.
Adequate supervision is provided to ensure adequate process control as well as reliability of laboratory results.
Management ensures the provision of required resources for the effective operation of its QMS and sustainability.
ATM-LABORATORY has defined delegates/deputies and authorised signatories for all its key functions to ensure the smooth running of the organization.
ATM-LABORATORY operates at permanent facilities for the addresses identified in the section 1 under 1.3.
4.1.4 Responsibilities and Authorities:
The organizational structure of ATM-LABORATORY is illustrated in Annexure-A which also identifies the key personnel. The responsibilities of key personnel namely: Technical Services Manager(s), Head of Laboratory Section and Quality Manager are described in 4.2.6. Job description, responsibilities and authorities of laboratory employees are documented and maintained by the Head of Laboratory Section as well as the Quality Manager.
4.1.5
a) The ATM-LABORATORY has managerial, administration and laboratory staff with the authority to discharge their duties as reflected in their job descriptions. This authority includes the implementation, maintenance, and improvement of the management system. The resources needed to discharge these duties are also identified in Section 5.2 to Section 5.3. The identification of departures from the management system and testing requirements is documented according to the corrective action procedure.
b) Employee Confidentiality Agreement: ATM-LABORATORY employees sign the “Employee Confidentiality Agreement” and the signed agreement is retained by the Quality Manager. During internal audits, staff members are interviewed to ensure that they are free from any undue internal, external commercial, financial and other pressures and influences that may affect the quality of work.
c) Protection of Customer Confidential Information and Proprietary Rights: ATM-LABORATORY has set out a policy to ensure the protection of customer’s confidential information and proprietary rights; including protecting the electronic storage and transmission of results.
Top Management of ATM-LABORATORY is committed to protect the confidential information and proprietary rights of its customer including the electronic storage and transmission of results.
ATM-LABORATORY personnel will not copy or reproduce any confidential or proprietary document. Confidential or proprietary documents provided by the customers will be returned when the work is completed. Access to the customer’s test reports and confidential information is limited to the Head of Laboratory Section, the Quality Manager and other authorized staff only. Confidentiality of customers test results is maintained at all time. The information will not be discussed with anyone, even those within the customer’s company not designated as a contact, without written permission.
ASAB Laboratory implemented procedure ATM-L-PR-4-003 covering all above clauses.
And all laboratory staff signed an ethics agreement # ATM-L-QP-FRM-001
d)Ethics:
Policy:
Top Management ensures that all personnel are free from any undue internal, external, commercial, financial and other pressures that may adversely affect the quality of their work. Employees are never instructed or forced to alter or falsify data.
4.1.6 Effective communication from management occurs through the use of but not limited to memos, newsletters, electronic presentations, emails, or verbally to laboratory personnel regarding the effectiveness of the management system.
4.2 Management System
ATM-LABORATORY Management System has established documentation and describes the processes required to implement the QMS. The documentation is kept to the minimum for effectiveness and can be in any form or type of medium.
4.2.1 General
This ATM-LABORATORY Management System has been developed to describe and address the requirements of ISO 9001:2008 and ISO/IEC 17025:2005. The system is applicable to the fields of testing and other activities in which the laboratory is involved and/or it undertakes. The manual references documented procedures and process maps relating to the requirements outlined herein. A description of the interaction between the processes of the ISO/IEC 17025:2005 & ISO 9001:2008 is found in respective process maps and implementation controlled by respective procedures.
Management System Awareness and Implementation: The Management of ATM-LABORATORY has conducted awareness training on ISO 9001:2008 as well as ISO/IEC 17025:2005 which ensures that staff members are familiar with the management system documentation and implementation of the quality policies and procedures in their work. A briefing on the quality policy as well as the requirements of the management system are communicated to all staff members and also included in the induction training for all new staff. The quality policy is reviewed during the management review meetings, for its suitability. Senior officials are vested with the responsibility of spreading and maintaining the quality culture throughout the organization.
The purpose of the management system is to ensure that all services satisfy the customer’s requirements and have been designed and customized under controlled conditions.
The effectiveness of the Management System is assessed in several ways:
• Planned internal quality audits, covering all aspects of the operation of the management system.
• Management reviews for the suitability and effectiveness of the management system, at least twice a year.
• Analysis of potential and actual problems as shown by customer complaints and supplier and subcontractor assessments.
• Regular participation in the external quality control programs.
4.2.2 Quality Policy
ATM-LABORATORY has established a quality policy to ensure that the policy:
• Is appropriate for the needs of Laboratory Section and its customers Includes a commitment to meeting requirements and continual improvement.
• Provides a frame work for establishing and reviewing quality objectives.
• Is communicated, understood and implemented throughout Division.
• Is regularly reviewed for continuing suitability.
Quality Policy
• Management of ASAB Laboratory is committed to comply with the requirements of ISO/IEC 17025:2005, providing high quality and timely testing services {RG, NGL and Condensate} and to following good professional practices which fully meet or exceed the expectations of our customers as well as working on the principles for continuous improvement and development of the management system.
• ASAB Laboratory also ensures that all staff concerned in the testing activities are familiar with quality documentation and implementation of the quality policies and procedures in their work.
Ramakrishna S. & Afif Harhara
Tech. Services Manager(s)
GASCO - ATM
THE OBJECTIVES
The objectives of ATM-LABORATORY, in line with the objectives of GASCO, are to ensure the supply of high quality hydrocarbon products which meets or exceed the standards required by GASCO, its shareholders and UAE laws. To ensure the supply of quality hydrocarbon products, the Laboratory has put in place the following objectives:
• Strive to meet and/or exceed the needs and expectations of customers --- (KPIs)
• Provide accurate and reliable laboratory test results
- To establish a level for the performance of the laboratory
- To modify test methods to improve performance
- To participate in proficiency testing or quality evaluation programs with peer laboratories.
- To improve and validate laboratory methodologies by participation in method validation and collaborative studies.
• Improve employee competency at all levels
- To ensure that all personnel are trained to a level of familiarity with the quality management system appropriate to the individual’s degree of responsibility
• Continually improve processes and services
• Establish and maintain National and International recognition through compatibility with the requirements of relevant standards
• To establish and report on quality savings
To achieve above objectives ATM-LABORATORY incorporates into the system the following:
• Quality control is an integral part of the production process and implemented the procedure be conducted in accordance with the quality directives contained in the Laboratory Quality Assurance System.
• The Laboratory Quality Assurance System is designed to integrate human, technical and material resources in a manner that results in optimum production consistent with the highest quality standards.
• All laboratory staff, including its management, is expected to understand and work towards the quality commitment.
• Success requires satisfied customers. The Laboratory Quality Assurance System reflects the total commitment to achieve the goal of meeting the needs of customers efficiently and satisfactorily.
• Pursue the goal of no harm to people, protect the environment and use material as well as energy efficiently in providing quality products.
• Report quality product results publicly within the GASCO organization.
• Play leading role in promoting best practices in the GASCO organization as well as ASAB industrial area.
• Promote a culture in which all GASCO employees share the commitment of delivering quality products.
The objectives along with targets for the each year are outlined in Annexure – E (attached separately)
THE VISION
To become the first choice among the World Class laboratories, by providing accurate and reliable testing services, aiming at customer’s satisfaction with a focus on Health, Safety & Environment through continual improvement of performance.
THE MISSION
To conduct our testing services professionally and efficiently with state of the art technology to deliver the best, to the utmost satisfaction of the customers. To strive continuously to increase the value of shareholders, with a commitment of growth of the employees.
4.2.3 Commitment to the Management System
Policy:
The top management of the ATM-LABORATORY is committed to the development and implementation of the management system and continually improving its effectiveness.
ATM-LABORATORY enjoys the total commitment and support of the Top Management. The Quality Policy statement has the total support of the Technical Manager, who is the signatory to it, and senior management at all levels. All staff members are required to read, understand and implement the Policy; and to support the Management System, in all its aspects, for its compliance with the ISO/IEC 17025:2005 Standard.
The results of the management system are regularly reviewed during management review and continual improvements are made as outlined in the improvement 4.10.
Evidence of management’s commitment, to ensure the effectiveness of the system and its continual improvement, is demonstrated by but not limited, participation of the managers in the management reviews, review of internal audit reports, proficiency testing results, and quality control data.
4.2.4 Communication Requirements
Policy:
Top management and the management of the ATM-LABORATORY communicate to the organization the importance of meeting customer requirements, as well as statutory and regulatory requirements.
Effective communication from management occurs through the use of but not limited to memos, newsletters, electronic presentations, emails, or verbally to laboratory personnel regarding the importance of meeting customer, statutory, and regulatory requirements.
In general, the underlying message in all oral and written management communication involves meeting the aforementioned requirements. Meeting customer requirements ensures that on-going business relationships secure the contracts that keep organizational development. Meeting statutory and regulatory requirements ensures that laboratory operations will not be disrupted and the organization can continue to meet customer needs.
Head of Laboratory Section and Quality Manager are responsible and authorized for any external communication. Communication from management occurs through the use of but not limited to memos, newsletters, electronic presentations, e-mails, or verbal communication with laboratory personnel regarding the effectiveness of the management system.
4.2.5 Quality Manual
This Quality Manual outlines the structure of the documentation used in the management system. This Quality Manual makes reference to the supporting procedures & technical procedures and ensures they are maintained up-to-date.
This management system is structured in four tiers of documentation. These tiers are as follows:
• Quality Manual
• Quality System Procedures
• Work Procedures (Standard Operating Procedures (SOPs), Work Instructions and reference documents
• Forms and worksheets
For most customers, this Quality Manual and the associated documents form a general Quality Plan. If necessary, specific Quality Plans will be prepared on a ‘per-customer’ basis. These Quality Plans will modify the general requirements stated in the Manual and associated documents.
4.2.6 Roles and Responsibilities
The overall authority rests with the Section Head(s) and Management Representatives (MRs) and both are responsible for establishing, implementing and maintaining the QMS. An organizational chart has been established at each division/section to show the interrelation of personnel in the organization. Job descriptions define the responsibilities and authorities of each of the positions on the organizational chart.
Vice-President of the Asab plant has delegated the responsibilities to Head of Laboratory through the Technical Services Manager- to direct the overall laboratory operation and activities. The Quality Manager manages all aspects of the Quality Assurance and Quality Control of the laboratory. The Asab Technical Services Manager works to foster, support and sustain an ethical environment that facilitates the highest quality analytical services and ensures the implementation and maintenance of quality assurance system in compliance with the ISO/IEC 17025:2005.
The Head of Laboratory Section (Technical Manager) is responsible for the management of laboratory and providing assistance in the provision of procedures and/or work instructions as required to adequately controlling the activities relevant to the scope of work. The Head of Laboratory Section reports to the Asab Technical Services Manager (ATS). The Head of Laboratory Section is also responsible for ensuring that staff members are familiar with all technical requirements of the standard and understood related procedures.
The Quality Manager has the overall responsibility for maintaining the quality and compliance with the relevant standards. Quality Manager also reports to the Technical Services Manager/ for certain quality related issues.
The responsibilities of the Technical Services Manager, Laboratory Section Head (Laboratory Technical Manager) and Quality Manager are as under:
4.2.6.1 Technical Services Manager:
- Responsible for all activities of the Technical Services Department under which ATM-LABORATORY is operating.
- To establish ATM-LABORATORY quality policy and objectives
- To ensure that processes needed for the ISO/IEC 17025 standard is established, implemented and maintained.
- Ensure compliance with ISO/IEC 17025 standard, Management Systems policies and procedures.
- To be the Chairman of Management Committee
- Responsible for provision of required resources to ATM-LABORATORY
- Take appropriate decisions to ensure effective management and running of the organization leading to increased productivity
- Communicate with the higher management, customers and suppliers
- Take appropriate decisions and implement procedures to ensure customer and employee satisfaction
- Ensure promotion of awareness of the customer requirements throughout the organization
- Responsible for reporting to the higher management on the performance of the management system and its improvements.
4.2.6.2 Laboratory Section Head (Laboratory Technical Manager):
- Responsible for all activities of the ATM-LABORATORY, including Quality Control of the Laboratory.
- Responsible for planning of tests, provide adequate supervision of testing, assessment/evaluation of test results and reporting opinions and interpretations.
- Responsible for method modification and development and validation of test methods; and measurement of uncertainty of tests
- Responsible for inspection, testing and acceptance of raw materials and finished feeds.
- Ensure compliance with ISO/IEC 17025 standard, Management Systems policies and procedures.
- Acquire current knowledge in the areas of feed composition and nutritional quality, technical management of laboratories, development and validation test methods and explore opportunities through attending conferences, seminars etc. for new and improved systems
- Maintain confidentiality of information at all times
- Other duties, as assigned by the Technical Services Manager and Higher Management.
4.2.6.3 Quality Manager:
Ensures that-
Management system related to quality is implemented and followed at all times
in compliance with the Quality Policy, Quality Manual, ISO/IEC 17025 standards.
- Manage the QA/QC function of the ATM-LABORATORY.
- Responsible for leading the internal quality audit program, including scheduling, conduct, follow up and accountability for adding and closing all corrective actions. Liaise for external quality audits and ensure implementation of any resulting non-conformance.
- Evaluate QA/QC standards, manuals, policies, and programs currently in place, making recommendations for change to the higher management.
- Provide recommendations to the management on purchases, performance of staff with respect to quality, addressing customer complaints and resolving problems.
- Creating, maintaining and reporting performance and compliance metrics on a regular basis, including presenting the metrics to the higher management.
- Evaluate on-going processes and identify opportunity for improvement, and make recommendations to the higher management.
- Acquire current knowledge and developments in the area of quality management and explore opportunities through attending conferences, seminars etc. for new and improved system.
- Maintain confidentiality of information at all times.
- Perform other duties, as assigned by the Technical Services Manager and Higher Management.
- Authority: is authorised to access top level management regarding the issues concerning QMS implementation, review, updating.
- Authorised to stop any activity which is noncompliance to the system.
4.2.7 The management system process and procedures as defined in this manual maintain the integrity of the management system when changes such as a change in the structure of the organization or management, or a change in policy or procedure are made.
4.3 Document Control
ATM-LABORATORY has a documented a procedure for the control of quality system documents under procedure CE-PR-001. The procedure briefly covers following issues:
• Approval and adequacy criteria prior to issue
• Review, update and re-approval of documents
• Identification of revisions and changes in the documents at the place of use
• Ensuring that relevant versions of applicable documents are available at points of use;
• Ensuring that documents remain legible and readily identifiable;
• Ensuring that documents of external origin are identified and their distribution controlled;
• Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.
• Review mechanism and software control;
Laboratory management system documents such as Quality Manual & Procedures, Standard Operating Procedures and, reference documents (such as regulations, standards, reference test methods, drawings, software, and specifications are controlled by the Quality Manager.
4.3.1 Issue of Documents
Quality Manager implemented the procedure, issues documents controlled through intranet distribution or uncontrolled and/or his designates whenever demanded contractually.
4.3.2 Amendments to Documents:
Upon receipt of any document change request from the process owners, the Quality Manager reviews the required amendments and incorporates them into the appropriate document(s). All quality system documents are reviewed as per CE-PR-001 guidelines for their effectiveness against the set objectives and continual improvement. The Quality Manager maintains master copies of amendments as well as obsolete copies.
The Quality Manager is the Process Owner of the document control process. All quality system documents are issued under the authority of the Technical Services Manager/Laboratory Section Head of Asab Plant.
Supporting Procedure: CE-PR-001: Document Control
4.4 Review of Requests
Policy:
Management of ATM-LABORATORY is committed to provide agreed services to its customers and ensures that each laboratory has the capability and resources to provide the requested services in its testing capability.
The laboratory has established the procedure for the review of test requests, for testing and/or contracts. Typically the procedure addresses the following:
• The requirements including the test method to be used is adequately defined.
• The laboratory has the capability and resources to meet the requirements based on annual work plans.
• The selected test method is capable of meeting the customer’s requirements.
Any differences between the request and the contract implemented the procedure be resolved before any work commencement.
Records of reviews including any significant changes are maintained by the laboratory. Any discussion or oral agreements are also recorded as a part of the contract review.
The routine work coming from the parent organisation need not form the contract review. Only a copy of the onetime contract review is maintained. For outside customers having routine testing work, the review is maintained in the test request register. The review is also containing any testing work that is sub-contracted by the laboratory.
Any deviation from the contract implemented the procedure be communicated to the customer whenever required.
Any changes to contract after the commencement of testing work implemented the procedure be reviewed again and changes communicated to all concerned staffs in the laboratory.
4.5 Sub-Contracting of Tests and Calibration Services
ATM-LABORATORY does not sub-contact its main testing work. However, ATM-LABORATORY may sub-contract some non-routine tests and under unforeseen circumstances, to a competent laboratory, preferably accredited to ISO 17025:2005. The competence of sub-contracted laboratory(s) implemented the procedure be evaluated prior to subcontracting the testing work. The customer implemented the procedure be informed of the sub-contracting arrangements in writing. ATM-LABORATORY undertakes all responsibility for its sub-contracted work.
All GASCO sites’ laboratories made an agreement with GEOCHEM (Third party Laboratory) for testing of specialized & non-routine samples. This Laboratory is accredited for ISO 17025.Sub contracting is reviewed by top management. Agreement No. CMN.12.067.
Third party services is for Specialized tests on samples covering routine & non routine samples.
Scope of the contract is mentioned in this agreement.
4.6 Purchasing Services and Supplies
Policy:
ATM-LABORATORY is committed to optimize its resources through cost effective purchases without compromising quality of the purchased products. ATM-LABORATORY also ensures that purchased supplies, reagent and consumable materials that affect the quality of test are not used until they have been verified as per specification.
ATM-LABORATORY, in line with the GASCO purchase policy, has established a documented procedure for the selection and purchasing services and supplies following the purchase process set by the GASCO Commercial Division (CD). The purchase request will be raised using MAXIMO and will be processed further as per the established procedure. The procedure addresses the procurement of laboratory chemicals, reagents and consumable materials and their storage. The procedure ensures that the purchased goods are not used until they have been inspected. Necessary records of compliance of such purchased goods are maintained.
Laboratory Section implemented the procedure the procedure ensure that the specifications for all the purchased products/services are established complying with the laboratory, customer and regulatory requirements. All the purchased products that are required for the effective functioning of the section and to satisfy the customer’s needs specified requirements. The control of purchase process and evaluation and re-evaluation, records for the same and other requirements of ‘purchase process’ and purchase information’ are maintained as per the GASCO purchase policy.
The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with the supplier. Purchase orders are ensured to have correct and implicit description of the items required along with specification details. The purchase requests (PR’s) are reviewed for technical content of the purchasing document and approved by the Laboratory Section Head before for further processing by Commercial Division.
Laboratory Section implemented the procedure necessary for verification of purchased product.
The laboratory management also evaluates the suppliers on a continuous basis and rate them for the services required. Suppliers not meeting the minimum rating are blacklisted and removed from approved suppliers list. The supplies are procured only from the list of approved suppliers only.
Supporting Procedure: ATM/L-PR-04-07: Purchasing Services
4.7 Service to the Customer
The laboratory has documented procedure for its services to its customer. As a policy of the laboratory, all staffs must cooperate with the customers or their representatives in clarifying the test requests and other testing matters, such as test methods used, equipments and validation of testing etc.
Upon a specific request and contractual agreement customers will be allowed to witness the testing and make their observation and forward to the laboratory section head. Feedback both positive and negative are used by the laboratory section head to improve the laboratory services. However, care shall be taken to ensure confidentiality and conflict of interest with the customers’ competitors.
Customer feedback forms & Data analysis of Customer feedback available
4.8 Complaints
Policy:
ATM-LABORATORY top management is committed to resolve all complaints from internal & external customers and staff in a satisfactory manner and ensure the implementation of process changes.
The laboratory has a procedure for handling and resolution of complaints. All complaints are registered by the Quality Manager in as CAPA (Corrective Action Preventive Action) in Q-Pulse (Online Action Tracking System). They are further evaluated for its significance and relevance. Only the relevant and significant complaints are acted upon.
The Laboratory Section Head, in discussion with Quality Manager, resolves all complaints at a reasonable time and inform the customer of the actions taken. Complaints are further evaluated for any adverse trends and/or root cause analysis to install adequate corrective and preventive actions wherever required.
Register for Customer Complaints related to Laboratory can be extracted at a given point of time from Q-Pulse system. All complaints, investigations and corrective actions are recorded.
All complaints are discussed in the management review meeting.
4.9 Control of Non-conforming Products and Services
Policy:
ATM-LABORATORY management is committed to resolve and implement corrective action when any aspect of testing work, or the results of this work, does not conform to requirements of the management system, testing methods, or requests of the customer.
ATM-LABORATORY has established documented procedure and its implementation in situations when any aspect of testing or the results do not conform to its own procedures or the agreed requirements of customers. Laboratory Section Head implemented the procedure ensure that product/service which does not conform to requirements is identified and controlled to prevent its unintended use or delivery.
The procedure defines the responsibility and authority for the handling of non-conforming product/testing work. The Laboratory Section Head or any staff member who has the authority to suspend non-conforming testing work to halt the testing work temporarily until the non-conformance is resolved satisfactorily. Upon such resolution, the Laboratory Section Head authorizes the resumption of work.
The responsible staff members are asked to carry out root cause analysis of the non-conformance and take appropriate corrective actions to mitigate its recurrence. Where necessary the customer is notified of non-conforming work and the work is recalled.
• Identify the non-conforming product with suitable mean.
• Record discrepancy in Non-conformance and corrective / preventive action form.
• Conduct investigation to identify the cause for non-conformity.
• Ensure that non-conforming product is not released in intended application.
• Ensure that non-conforming product is either returned or disposed off in a controlled manner. Proper work procedures are implemented to dispose off in a controlled manner.
• Records of non-conformities are maintained.
Any nonconforming product/service, which has been corrected, implemented the procedure be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use, Laboratory Section takes action appropriate to the effects, or potential effects, of the nonconformity. An evaluation of the significance of the non-conforming work is carried out by the Quality Manager.
The controls and related responsibilities and authorities for dealing with nonconforming product are defined in the centralized procedure “Control of Non-Conformance procedure CE-PR-004”. A laboratory specific procedure is documented based on the centralized procedure.
Supporting Procedure: ATM/L-PR-4-06: Handling of Non-conforming work
4.10 Measurement, Analysis and Improvement
Laboratory Section collects and analyses appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data including:
• Key Performance Indices (based on the objectives)
• Statistical charts (if any) that are generated for analysing the data - Mean Control Charts
• Conformance to product/service requirements and quality
• Internal and External Quality Audit Results
• Reports of nonconformities, actions, corrective actions and preventive actions.
• Characteristics and trends
• Customer Satisfaction Surveys
ATM-LABORATORY implemented the procedure continually improve the effectiveness of the QMS through the use of the Quality policy, objectives, audit results, analysis of data, corrective and preventive actions and management review.
ATM-LABORATORY has established procedure for improvements and emphasizes on continual improvement so that its customers are satisfied and their requirements are met. The laboratory has set the effectiveness of its management system through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive actions and management review.
Improvement efforts are made through carefully analyzing the data coming from various aforesaid sources. Meaningful decisions are taken based on the result of analysis and appropriate strategies and policy changes are made to improve the laboratory management.
A laboratory specific procedure is documented based on the centralized procedure for Corrective & Preventive Action CE-PR-005
4.11 Corrective Actions
Policy:
ATM-LABORATORY is committed to identify corrective actions, investigate the problem for root cause analysis and correct the causes of existing non-conformances including complaints in the management system and opportunities for needed improvements.
ATM-LABORATORY has established and maintained a documented procedure for implementing corrective actions. Causes of nonconforming conditions arising out of processes, internal quality control and audits or complaints by customers are investigated and corrective actions are implemented. Controls are applied to ensure that corrective actions that are implemented are effective. The procedure covers:
• Identifying, reviewing and documenting nonconforming conditions relating to laboratory services, processes, or management system (including customer complaints);
• Investigating and determining the root cause of nonconforming conditions.
• Evaluating the need for corrective actions to prevent recurrence.
• Determining and implementing corrective actions.
• Results of corrective actions are recorded.
• Verifying the effectiveness of the actions taken.
• Results of corrective actions are submitted to management for review.
The Quality Manager is responsible to determine the effectiveness of the corrective action which is also verified during management review ensures that all corrective action implementation is effective.
Wherever required an additional audit is conducted for the actions which casts doubt on laboratory’s compliance with its own policies and procedures or meeting the requirements of ISO/IEC 17025:2005. The additional audits are conducted only when a serious issue or risk to the testing business is identified.
A laboratory specific procedure is documented based on the centralized procedure for Corrective & Preventive Action CE-PR-005
Supporting Procedure: ATM/L-PR-4-011: Corrective Actions
4.12 Preventive Actions
Policy:
ATM-LABORATORY is committed to identify potential sources of non-conformances and implement needed improvements to the management system.
ATM-LABORATORY has established preventive action procedure to establish a controlled method to implement preventive actions and to consider actions needed to implement the needed improvement either in technical or in the management system.
The preventive action process include:
• Determining potential nonconformities and their causes
• Evaluating the need for action to prevent occurrence of nonconformities
• Determining and implementing action needed
• Records of results of action taken
• Reviewing preventive action taken
• Verifying the effectiveness of the actions taken
When these improvement opportunities are identified or if preventive action is required, the management develops the action plan. The action plans are then reviewed and implemented. After successful implementation the effectiveness is determined to ensure improvement in the system.
The documented procedure sets out steps of initiation of such actions including application and control to ensure its effectiveness. Mainly it’s a pro-active process to identify opportunities for improvements. The laboratory management takes all such actions very seriously in order to improve its processes.
Apart from the review of operational procedures, often it involves analysis of data including trend analysis and proficiency testing results.
A laboratory specific procedure is documented based on the centralized procedure for Corrective & Preventive Action CE-PR-005
Supporting Procedure: ATM/L-PR-4-012: Preventive Actions
4.13 Control of Records
ATM-LABORATORY maintains all records to provide evidence of conformity to requirements and of the effective operation of the Management System. ATM-LABORATORY has documented procedure for the control of records based on the centralized Control of Records Procedure CE-PR-002. The procedure briefly covers that records remain legible, readily identifiable, traceable and retrievable. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of records. Records may be in any form or type of media.
Identification and legibility of records
• Place of record
• Accessibility
• Protection and retrieval
• Staff authorization for access of archived records
• Review mechanism
• Retention and disposal criteria
All process owners have together developed and designed appropriate process forms for their respective processes and are controlled. These forms when filled become the evidence of the conformity to the requirements and effective use of the management system, which are termed as quality records. As a regulatory and company policy all records are retained for a minimum period of five years.
ATM-LABORATORY retains all its technical records of original observations, derived data and sufficient information to establish the audit trail. Toward this end, the laboratory maintains all work-sheets, calculations, and equipment and authorisation records of staffs. Technical records also include maintaining the method validation sheets and uncertainty budget and required details of calculations. All observations are recorded at the time they are made and are traceable to the testing request which is identifiable to the specific task in LIMS data base which has backed-up under GASCO corporate IT policy. The identity of the personnel responsible for sampling, performing and checking the result known through Daily Sampling Schedule and Electronic log book.
The procedure also states that all mistakes in records implemented the procedure be crossed out by a straight line and not erased. They implemented the procedure be corrected by the side of it made legible and initialled by the person who makes the correction. For electronic records, the laboratory section head is authorised to correct such records.
The Laboratory Section Head and other responsible staff ensures that records are stored properly and securely from preventing damages or loss of original data by providing necessary environment suitable for operating condition.
The retention periods of both electronic and hard copies of records are established.
ISO/IEC17025:2005 Quality records generated are electronically backed-up and protected to prevent unauthorized access to or amend these records.
Supporting Procedure: ATM/L-PR-4-002: Control of Records
4.14 Internal Audits
ATM-LABORATORY implemented the procedure schedule and conduct internal audits at least once before the External audit as per CEQ procedure CE-PR-003 determine compliance of the Quality management system to international standards. An annual audit plan and schedule implemented the procedure be designed based on the importance of the areas to be audited, covering each area at least once in a year. Audits implemented the procedure be planned in co-operation with Corporate Excellence – Quality Management Department (CEQ) located at the GASCO Head Quarters.
The audit program implemented the procedure:
• Conforms to the planned arrangements, to the requirements of the International Standards and to the management system requirements established by the organization.
• Is effectively implemented and maintained.
An audit schedule is prepared based on the audit criteria, scope, frequency, methods, responsibilities and requirements for planning, conducting audits, reporting and maintaining results, is defined in the centralized Internal Audit procedure CE-PR-003. The management is responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results. Qualified personnel independent of those who perform or directly supervise the activity being audited implemented the procedure conduct audits. This also ensures objectivity and impartiality of the audit process. The procedure also details the competencies required for the auditor.
ATM-LABORATORY has established and implemented a documented procedure of Internal Audits. Internal audits are conducted at pre-determined frequencies, to ensure the effectiveness of the laboratory management system. The audit program ensures that all management system activities are audited at least once in a year. An Internal Audit Schedule has been prepared according to ISO 17025:2005 to improve the system
Technical audits are performed to ensure the continuing suitability of the technical methods employed by the laboratory and are proportionate to the amount of testing done in a year.
All internal audits are carried out by the competent personnel and the Quality Manager co-ordinates the activity. Auditors are selected such that they are independent of the scope of audit (to ensure that auditors will not audit their own activity).
The results of all Internal Audits implemented the procedure be documented as per the Procedure and any identified and agreed corrective actions implemented the procedure be completed in accordance with the procedure. The results of Audits are also reviewed during the Management Review Meetings.
Supporting Procedure: ATM/L-PR-4-014 : Internal Audits
4.15 Management Reviews
ATM-LABORATORY implemented the procedure plan and conduct management reviews at least once in six months to review the suitability, adequacy, effectiveness and implemented the procedure and identify opportunities for improvement. Also review the need for changes to all elements of the QMS, including the Quality Policy and objectives. It is ensured that the necessary information is collected from respective process owners through involvement and presented for evaluation. This meeting is attended by all the process owners. Records are maintained for each management review meeting and distributed for actions to the concerned.
4.15.1 Review input
Assessment of the Management System is based on a review of information inputs to management review. Agenda for the Management Review Meeting implemented the procedure include but not limited to:
• The suitability of policies and procedures
• reports from managerial and supervisory personnel;
• the outcome of recent internal audits;
• corrective and preventive actions;
• assessments by external bodies;
• the results of inter laboratory comparisons or proficiency tests;
• changes in the volume and type of the work;
• customer feedback;
• complaints;
• recommendations for improvement;
• other relevant factors, such as quality control activities, resources and staff training.
• analysis Internal quality control and PTP data
• process performance and product conformity
•
• follow-up actions from previous management reviews,
• changes that could affect the quality management system, and
4.15.2 Review output
During these review meetings, management identifies appropriate actions to be taken regarding the following issues:
• Improvement of the effectiveness of the Quality management system and its processes;
• Improvement of product related to customer requirements; and,
• Resource needs (Manpower, Methods, Machine, Material, & Environment)
• Changes to Objectives and Targets.
ATM-LABORATORY has established and documented a laboratory specific management review procedure which defines the review inputs and outputs along with the conduct of it on an annual basis.
The reviews are conducted under the chairmanship of the Technical Services Manager, along with the Head of Laboratory Section, Quality Manager, other specified staff, invitees and the Management Representative. The Quality Manager takes the minutes of the meeting and ensures that action plans and policy decisions are implemented within the agreed timeframe.
Supporting Procedure: ATM/L-PR-4-005: Management Review
SECTION 5
5.1 Technical Requirements
Asab management believes that accuracy and reliability of laboratory tests are critical in assessing the quality of products. Many factors may influence the correctness and reliability of laboratory data. Quality Control plays an important role in assessing the quality of data. Management focuses its attention on:
• Employee skills
• Accommodation and environmental conditions
• Production and testing equipment used
• Procedures followed during production of feeds
• Test methods and method validation
• Sampling and sample handling
• Measurement traceability
• Handling of test items and calibration items
• Procedures followed during analysis of samples
• Verifying analysis reliability
5.2 Personnel
Policy:
ATM-LABORATORY management is committed employ personnel with adequate qualification and skills, provide training to its management, administrative and technical staff which is relevant to the present and anticipated needs of the ATM-LABORATORY.
Technical Services Manager, implemented the procedure to ensure that personnel performing work are competent. Competence of personnel implemented the procedure be determined through job descriptions identifying the qualifications, education, skills and experience. Appropriate qualifications, along with required training, provide the competence required for each position.
ATM-LABORATORY management believes in its human resource as the most important resource. Emphasis is given to the staff being competent and skilled in their area of work. ATM-LABORATORY Management identifies training needs and opportunities. The effectiveness of the training actions taken is also evaluated.
The Head of Section, based on the work load and future expansion plans, in consultation with the key staff, prepares the staff requirements and annual plan for training for both new and old staff. Either external or internal or both training are planned as per the requirement.
Technical Services Manager approves the plans and sent to the Central Training Department. Upon further approval, the Training Department, in cooperation with ATM-LABORATORY, arrange and schedule the training. Training is imparted and the effectiveness is evaluated.
Training is planned through the trained engineer of OEM (Original Equipment Manufacturer)
For the operation, troubleshooting, calibration of critical equipments.
The laboratory maintains current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations.
5.2.1 Training
The laboratory attaches critical importance to ensuring that all personnel performing testing activities must have adequate qualifications. This is achieved by recruitment of suitably qualified personnel and provision of adequate training.
The procedure has been established, requiring that all new personnel will be given induction training, which will include introduction to laboratory’s Quality Policy, QMS and employee’s own responsibility for quality.
The procedure also requires that the training needs of personnel are reviewed by the Head of Laboratory and/or ATM at least once every year. Based on this assessment the plan for further training is established.
The procedure assigns responsibility for provision of any such further training. Appropriate records for personnel qualification, Job description and training are maintained.
All laboratory staff after training is evaluated for the skills acquired and are authorised to perform specific tasks and use of concerned equipment depending on the skill levels.
Supporting Procedure: ATM/L-PR-5-001 Training
5.3 Accommodations and Environmental Conditions
5.3.1 Infrastructure
Asab management has provided the laboratory infrastructure at the ASAB plant premises. The buildings are purpose built to accommodate laboratory. The buildings are provided with air conditioning and are sufficiently ventilated. Storage facilities have been provided with adequate safe handling of the various materials. The facility is provided with proper water, electricity, gas rooms and compressed air, so as to ensure that the jobs are completed in the correct time frame.
Laboratory management ensures that accommodation and environmental conditions are adequate to produce accurate and reliable test results. Necessary instruments and tools are provided to ensure that all testing jobs are carried out in a satisfactory manner. An important highlight of the facility is the use of Certified Reference Materials (CRM)s, which is an essential feature of any modern testing facility.
The company provides necessary transport facilities for its employees to ensure timely completion of job. This also ensures timely delivery of the materials to the site and to the stores. The necessary material handling is provided for ensuring damage free transport of materials inside and outside the laboratory.
5.3.2 Work Environment
ATM-LABORATORY maintains necessary work environment required to achieve conforming testing process. The laboratory ensures adequate environmental conditions such that it does not invalidate the results or adversely affect the measurement results. The laboratory monitors, control and records the temperature and humidity. Access to the laboratory’s’ various sections is restricted unless permitted by the Head of Laboratory Section in order to maintain customer confidentiality.
The laboratory area is effectively separated from the other areas so as to maintain shock proof and dust free conditions inside the laboratory.
Throughout the company, good housekeeping is maintained. Appropriate storage areas and facilities are provided to achieve this.
Supporting Procedure: ATM/L-PR-5-003
5.3.3 Safety:
Safety at work is the utmost priority of ATM-LABORATORY. All laboratory employees are instructed to follow the HSE rules implemented by GASCO. ATM-LABORATORY building has been provided adequate safety systems (such as smoke detectors, fire alarms), adequate safety tools such as first aid kits, respirators oxygen cylinders etc. Safety systems are continuously monitored. Adequate training on fire fighting, CPR and first aid has been provided. Evacuation of employees during emergency has been planned and Emergency Assembly Points (EAP) has been identified.
Supporting Procedure: ATM-LABORATORY-QP-4-006: Accommodation and Environmental Conditions
5.4 Test Methods and Method Validation
5.4.1 Selection of Test Methods
ATM-LABORATORY uses test and calibration/performance verification methods, which meet the needs of the customer and are appropriate for the testing. ATM-LABORATORY uses mostly the methods published in as International standards (ASTM, UOP, GPA, IP, ISO, SHELL etc.) The laboratory management ensures the use of latest valid editions of these standards is used after due capability studies. Several work procedures have been documented to facilitate use of equipment, method validation, uncertainty of measurement, handling of test items, equipment maintenance and calibration etc.
It is obligatory on the part of ATM-LABORATORY to advise the customers whenever an inappropriate or out dated method is specified by the customer.
5.4.2 Laboratory Developed Methods
ATM-LABORATORY develops some methods, when required, to cater the requirements of its own activities.
5.4.3 Non-standard Methods
Upon development of non-standard test methods, the laboratory agrees the use of such methods with customer. Such methods require validation before being use. Appropriate procedure for method validation is documented.
5.4.5 Validation of Methods
As a policy matter, all non-standard/ laboratory developed methods are validated before being used as per the documented procedure. Method validation carried out to ensure that it meets the intended use and fit for the purpose. The laboratory records all relevant data of method validation. The laboratory ensures method is validated for appropriate performance characteristics from the following list
• Specificity & Selectivity
• Sensitivity
• Limit of Detection
• Limit of Quantization
• Linearity & Range, where applicable
• Accuracy
• Precision
• Recovery
• Uncertainty
• Other performance characteristics as appropriate to the method
Non-standard and laboratory developed methods undergo full validation where as method performance is verified for all standard methods.
Supporting Procedure: ATM/L-PR-5-007: Test Methods and Method Validation
5.4.6 Estimation of Uncertainty of Measurement
A documented procedure has been established for the estimation of uncertainty of measurement. The procedure uses the uncertainty arising at different stages of the test method, uncertainty of internal calibrations, uncertainty reported from calibration certificates of equipment and reference standards, certified reference materials used and standard deviation of the method. A reasonable estimation is made based on the knowledge of the performance of the method and on the measurement scope. Uncertainty of the test method for each analyte is reported at 95% confidence level using a coverage factor, K = 2. Uncertainty is used to decide upon when acceptance/rejection of the product where the test results falls on the border line of the specification.
With certain test methods, where contribution of uncertainty arising from other sources in the method factor is negligible, then precision of the method (standard deviation taken over a period of time (intermediate precision) is multiplied by a coverage factor of 2 is used to get the uncertainty.
Supporting Procedure: ATM/L-PR-5-008 Uncertainty of Measurement
5.4.7 Control of Data
ATM-LABORATORY controls all manual and instrumental data generated during its testing work. ATM-LABORATORY uses Laboratory Information Management System (LIMS) in its testing activity. All transactions such as data transfers are checked in a systematic manner. Computer software is ensured to be suitable for use through proper validation/verification. Data collection, transmission of results/ files is ensured to be adequately protected so as to maintain confidentiality and integrity.
Supporting Procedure: ATM/L-PR-5-009: Data Transfer and Control
5.5 Equipment
ATM-LABORATORY is equipped with adequate equipment required to perform all aspects of its testing activity. ATM-LABORATORY ensures that equipment and its software used for testing is capable of achieving the accuracy required and complies with the relevant requirements of standard. The equipment is used in a manner, which ensures that the measurement uncertainty is known and consistent with the required measurement capability.
When new equipment is purchased, care is taken for its proper installation following manufacturer's instructions. All new equipment is then given an Identification Number and is added to the equipment inventory.
ATM-LABORATORY ensures that equipment are properly identified, calibrated and maintained according to stipulated intervals. ATM-LABORATORY put in place a calibration and maintenance schedule for its analytical equipment. Breakdown maintenance is carried out whenever required. Equipment is recalibrated after each preventive or breakdown maintenance. Critical laboratory equipment is calibrated either by a calibration laboratory, preferably accredited to ISO/IEC 17025:2005, or trained/factory certified service engineers from the equipment suppliers. Some equipment is calibrated by the end user. Laboratory equipment are maintained and calibrated following a calibration and preventive schedules. Equipment In-charge of ATM-LABORATORY prepares a calibration and preventive maintenance schedule in consultation with the Head of Lab Section. The frequency of calibration/performance check depends on the criticality of the equipment and the method; sensitivity requirements; its use and age; and previous experience with such type of equipment. In-house procedures have been documented for calibration/performance check of equipment, where no calibration facility is available. Equipment In-charge maintains the calibration records of each instrument. Equipment are labelled with the calibration status, where required. All equipment is safeguarded from tampering of settings.
Laboratory ensures that trained and authorised personnel only handle the equipment. All required intermediate checks are carried out to maintain the confidence in testing activity. ATM-LABORATORY ensures the handling and maintenance of equipment is done in such a way that the accuracy and fitness for use is maintained.
ATM-LABORATORY maintains the records pertaining to each equipment (equipment history files and log sheets). ATM-LABORATORY also maintains its equipment inventory and ensures that only trained and authorized personnel handle the equipment.
When equipment is sent outside the laboratory (outside the direct control), upon return its calibration status ensured prior to its use by the laboratory.
While transporting proper care is maintained to avoid damage .Safe handling & storage are taken care
All equipment is safeguarded from tampering of settings.
When new equipment is purchased, care is taken to install it properly as per the manufacturer's instructions. All new equipment is then given Identification number and added to the inventory.
Supporting Procedure: ATM/L-PR-010: Equipment Management
5.6 Measurement Traceability
5.6.1 General
ATM-LABORATORY provides traceability through all stages of its operations namely sampling, sample handling, testing, certified reference materials and reference equipment.
Traceability is established through a unique system of identification to ensure accountability for all activities and operations, which may affect the quality of the product. This will allow traceability to jobs, and customers as required.
When the customer specifies traceability, the company provides details containing identification of product in the format required by the customer.
5.6.2 Specific Requirements
Calibration; All calibrations performed for the equipment are traceable to National/ International system of units.
The laboratory has established traceability of its own equipment by means of an unbroken chain of calibrations or comparisons linking them to relevant primary standards.
External calibration services are ensured that all requirements of the calibration procedures are met.
5.6.3 Reference Standards and Reference Materials
The laboratory has reference standards. All reference standards are calibrated by approved calibration bodies, which provide adequate traceability. The reference standards are always used for its intended purpose and prevented for any other use.
As a requirement reference standards are calibrated before and after any adjustments.
Where possible reference materials are ensured for their traceability to SI units of measurement
ATM-LABORATORY has documented a procedure for measurement of traceability including transport, storage, safe handling, and use of reference materials in order to prevent contamination, deterioration and in order to protect their integrity.
Supporting Procedures: ATM/L-PR-5-011: Measurement of Traceability
ATM/L-PR –5-010: Equipment Management
5.7 Sampling
Sampling for testing is carried out as per the stated plan of the laboratory. The sampling procedure refers to various technical standards of sampling.
ATM-LABORATORY has developed a sampling and sample handling procedure to extrapolate the laboratory results to the products manufactured. Sampling is carried out by trained personnel following a plan. Samples are identified and registered in the LIMS. Samples are processed by the sample management, received by the laboratory for analysis and a reference sample is maintained by the sample management if required.
Head of Laboratory Section has developed testing regimes (for different analytes/tests) for routine samples collected from the process. Samples are analysed, under supervision, following documented test methods (SOPs), raw data and test results are recorded on identified worksheets. Proper internal quality control procedures are followed and required quality checks are performed by the specialists/technicians. Worksheets and results are checked and approved.
Data of Samples collected as per schedule and non – routine samples are recorded in LIMS data base. Special sample which does not have LIMS identity will be recorded as special sample request.
Supporting Procedures: ATM/L-PR -5-012: Sampling and Sample Handling
ATM/L-PR -5-013, Analysis of Samples by the Laboratory
5.8 Handling of Test Items
ATM-LABORATORY has established procedures for receipt, handling, protection, storage, retention and/or disposal of testing items in order to protect the interest of the laboratory and customer. All abnormalities from normal or specified conditions are recorded upon the receipt of items and customer is informed.
The procedure also ensures the appropriate facilities provided to avoid deterioration, damage or loss to the test item during storage, handling and preparation.
Supporting Procedure: ATM/L-PR -011: Handling of Test Items
5.9 Quality Assurance of Test Results
ATM-LABORATORY has put in place a procedure for verifying its analysis reliability. ATM-LABORATORY has established an internal quality control (IQC) program to ensure the validity of test results. It also participates in proficiency testing program (PTP) and inter-laboratory comparisons, where ever applicable, as a part of its external quality control. Several performance checks such as blanks, replicates, analysis of reference materials and repetition of analysis are carried out during the analysis of batch of samples. Appropriate quality checks will be included in the analysis of each batch of samples. Correlation of results for different characteristics of a test sample is also used as an additional quality assurance measure.
Quality control data is subjected to statistical evaluation and control charts are maintained, where appropriate.
Supporting Procedure: ATM/L-PR —5-003: Quality Assurance of Test Results
5.10 Reporting the Results
The test reports of an item carried out by the laboratory are reported accurately, clearly, unambiguously and objectively and in accordance with test methods.
The reports include all requested information by the customer and necessary for the interpretation of the test results.
Test reports are transmitted to the Production Department electronically . Confirmation for receipt of report xxxxxxxxxx. Other test reports and Certificates are issued on request basis only. These reports include the following information:
• Title of report
• The name and address of the laboratory/location where test was carried out
• Unique identification and page number
• Name and e-mail address of the customer
• Test method used
• Date of testing
• Reference to the procedure (wherever required)
• Test results with appropriate units of measurements
• Authorised to signature
• Where relevant, statement to the effect that the results relate only to the item tested.
• A2LA accreditation mark will be used only for the accredited test following the A2LA, “P101-Reference to A2LA Accredited Status-A2LA Advertising Policy”..
Opinion and Interpretations
ATM-LABORATORY interprets test reports, when requested for interpretation. The interpretation includes the following:
• A Statement of compliance/non-compliance with requirements and specifications, where relevant.
• Where appropriate, opinion on the quality of the product.
• Any additional information based on the test results.
Additional Information
In addition to the requirements stated in clause 5.10.2, additional information on the conditions under which the test(s) were made and uncertainty of the measurements is provided when requested by the customer.
Test reports obtained from the Sub-Contractors
When testing either full or in part is subcontracted, the results of sub-contracted tests are clearly identified. The sub-contractor implemented the procedure report the results in writing directly to the Laboratory Section Head.
Electronic Transmission of Results
ATM-LABORATORY when transmitting results electronically to its customer(s) ensures the procedural requirements are met with. Electronic reports implemented the procedure not carry authorised signature for security and confidentiality reasons. However, a scanned copy of the report is sent electronically when specifically requested by the customer.
Reports and Certificates
ATM-LABORATORY uses approved format for issuing test reports to ensure proper presentation of sample and test information which minimises the possibility of misunderstanding.
Amendments to Test Reports
ATM-LABORATORY while making amendments, if any, to the test reports after their issue, makes in the form of a further document, which includes the statement: "This report supersedes the earlier report”. Record of superseded report/ implemented the procedure be maintained.
Supporting Procedure: ATM/L-PR-5-004: Reporting Results
6.0 Annexures
6.1 ANNEXURE – A: Organization Chart of the Laboratory
ANNEXURE – 6.1. B: Management Committee
Sl. No. Name Designation
1 Ramakrishna S. ATM Manager Tech.Services
2 Mischel ATM Manager Tech.Services
3. Muayed Al Faour ATM/L
&
Moh’d Ali Hasher ATM/L Section Head
4. Sarma.G ATM/L1 Sr.Chemist
5 Sundar ATM/L2 Chemist
6.2 ANNEXURE –: List of Key Personnel
Sr.
No. Responsibilities Nominated Employee Delegation
Name Designation Name Designation
1 Laboratory Section Heads & & Technical Manager
& Technical Manager
&
Muayed Al Faour & Moh’d Hasher
&
Moh’d Hasher
ATM/L Back to back
2 Quality Manager Sarma ATM/L1
3 Senior Chemist Sarma ATM/L1
4 Chemist Sundar ATM/L2
6 Senior Technician Manoj ATM/L6
7 Senior Technician Shadi ATM/L7
8 Senior Technician Arif ATM/L8
9 Senior Technician Badawi ATM/L12
10 Senior Technician Santosh ATM/L10
11 Technician Sonny ATM/L9
12 Technician Bidyut ATM/L11
13 Technician Hasan ATM/LS16
14 Sample Man Hussain ATM/LS13
15 Sample Man Nadir ATM/LS14
16 Sample Man Ravi ATM/LS15
17 Sample Man Ihsan ATM/LS17
18 Sample Man Mahmood ATM/LS18
6.3 ANNEXURE –: List of Key Personnel & Delegation of Duties
SL.NO Quality Responsibilities Description Delegation
Name Designation Name Designation
1 Management Representative –MR Muayed Al Faour/Moh’d Ali Hasher ATM/L Back to back ATM/L
2 Quality Manager G. Sarma ATM/L1 Muayed AL Faour /
Moh’d Ali Hasher ATM/L
3 Equipment Manager Sundar/Manoj
ATM/L2
ATM/L6 Back to back ATM/L2/
ATM/L6
4 Materials Manager Shadi/Arif ATM/L7
ATM/8 Santosh/
Bidyut
ATM/L4
ATM/L11
5 Documentation Manager Sonny/
Hasan ATM/L9
ATM/LS16 Santosh/
Ravi ATM/L10
ATM/LS15
6 Training Manager Bidyut ATM/L11 Shadi ATM/L7
7 Sample Manager Nadir/Ravi/Hussain ATM/LS13
ATM/LS15/ATMLS14 Hasan/
Ihsan ATM/LS16
ATM/ LS17
8 Safety Manager Manoj ATM/L5 Sundar ATM/L2
9 Stores Manager Bidyut/Badawi ATM/L11
ATM/L12 Santosh/Badawi ATM/L10
ATM/L12
10 Records Manager Arif/ Badawi ATM/L8
ATM/L12 Nadir/
Ihsan ATM/LS14
ATM/LS17
6.4 ANNEXURE – : List of Tests under the Scope of Accreditation
Test Method Product Reference Method
Determination of sale gas composition by Gas Chromatography Sale gas ASTM D-1945
Determination of Density by Anton Parr density meter Condensate ASTM D-4052
Determination of Reid Vapour Pressure by Mini Vapour Pressure Garbner Condensate ASTM D-6378
Determination of total sulphur in condensate samples by Total Sulphur Analyser Condensate ASTM D-5453
Determination of Natural Gas Composition by Gas Chromatography Natural Gas Liquid (NGL) ASTM D-2597
The document will be the controlled version and revision announcements will be distributed via e-mail to relevant parties and published on the Internet.
CONTROLLED INTRANET COPY
Copies or extracts of this manual, which have been downloaded from the Intranet, are uncontrolled copies and cannot be guaranteed to be the latest version.
This document is the property of “GASCO ASAB Laboratory.” No part of this publication may be reproduced, stored in a retrieval system in any form, or transmitted by any means, without the prior written permission of the GASCO ASAB Laboratory Section Head
ATM/L1 ATM/L ATM
9 30-Oct-15
Annexures List revised
8 26th Jun 2015
4.1.1 QMS process interaction included As identified in Internal audit
7 5th DEC 2014 4.1.5.C & Inclusion of 4.2.6.3 authorities of Quality Manager.
6 30th Oct2014 Revised the list of Key personnel
5 8thOct2014 Annexures list revised.
Management committee given as Annexure 6.1.B
(previous number. 6.2)
6.2 Renamed as “List of Key personnel”
6.3 “List of personnel& delegatio
6.4 List of test method
4 6thJAN 2014 Clause4.14(IA)& 5.5Equipment
Key personnel with Quality responsibilities.Annexture6.3
3 28thMAY 2013 Sub contract mentioned
2 2ndJAN 2013 ISO 9001 excluded
1 01/11/2011 All Pages
0 Draft -
Rev No. Date Revision History Prepared by Reviewed by Approved by
TABLE OF CONTENTS
SECTION 1 4
1.0 INTRODUCTION 4
1.1 ASAB PLANT 4
1.2 The Laboratory 5
1.3 ATM-Laboratory Identity of the Laboratory 6
1.4 Scope of the Laboratory 7
SECTION 2 7
2.0 NORMATIVE REFERENCES 7
SECTION 3 8
3.0 TERMS AND DEFINITIONS 8
3.1 DEFINITIONS 8
SECTION 4 11
4.0 MANAGEMENT REQUIREMENTS 11
4.1 Organization 11
4.2 Management System 17
4.3 Document Control 26
4.4 Review of Requests 27
4.6
4.8 Complaints 32
4.9 Control of Non-conforming Testing 31
4.10 Improvement 33
4.11 Corrective Actions 33
4.12 Preventive Actions 35
4.13 Control of Quality and Technical Records 36
4.14 Internal Audits 38
4.15 Management Reviews 39
SECTION 5 41
5.1 Technical Requirements 41
5.2 Personnel 41
5.3 Accommodations and Environmental conditions. 42
5.4 Test Methods and Method Validation 44
5.5 Equipment 46
5.6 Measurement Traceability 48
5.7 Sampling 49
5.8 Handling of Test Items 50
5.9 Quality Assurance of Test Results 50
5.10 Reporting the Results 51
6.0 Annexures 53
6.1 ANNEXURE-A : Organization Chart ..54
Annexure-B : Management committee-------------------------------------------------------54
6.2 List of Key personnel----------------------------------------------------------------------------55
6.3 List of Key personnel with delegation of duties…………….…......................................…..56
6.4 Lisof tests under scope of Accreditation, -------------------------------------------------58
SECTION 1
1.0 INTRODUCTION
Abu Dhabi GAS Industries Ltd. (GASCO) is the operating company in Abu Dhabi responsible for processing onshore natural gas and associated gas from onshore oil production.
The Company began as a US $2 Billion joint venture incorporated in 1978 with ownership shared between Abu Dhabi National Oil Company (ADNOC) as a major shareholder (68%), Shell Abu Dhabi (15%), Total (15%) and Partex (2%).
In April 2001, Abu Dhabi Gas Company (ATHEER), with 100% ownership by ADNOC, was integrated with GASCO. In addition, the 100% ADNOC ASAB Gas Plant operations were also transferred to GASCO in March 2004, leading to further enhancement to Company’s position as one of the largest gas processing companies in the world and one of the biggest industrial projects in the U.A.E.
The gas processing and Natural Gas Liquids (NGL) extraction takes place at the four plants located in the desert area namely: Habshan-Bab Gas Complex, Bu Hasa NGL Plant, Asab NGL Plant and Asab Gas Plant. The NGLs are transferred to the Ruwais Fractionation Plant, where they are treated and fractionated in to Ethane, Propane, Butane and Paraffinic Naphtha. Ethane and part of Propane are exported to Abu Dhabi Polymers Company Ltd. (BOROUGE), while Propane, Butane and Paraffinic Naphtha are stored in special tanks for shipment worldwide via the loading facility at GASCO Ruwais Jetty.
1.1 Asab Plant
The Asab plant is located onshore near ADCO-ASAB. Asab plant currently has a total of 5 gas processing trains and 2 gas injection trains with a feed gas capacity Asab/0 of 307 MMSCFD, Asab/1 of 870 MMSCFD & 90,000 BBL
ASAB-3 Plant is expansion of ASAB-0 plant, as ADCO in future increasing oil production from 411000 BPD to 600,000,Due to increase of oil production associated gas production will also raise from 306 MMSCFD to 450 MMSCFD.( MMSCFD Standard cubic feet per day ).
condensate, Asab/2 of 790 MMSCFD,
1.2 The Laboratory
GASCO ASAB Laboratory (ATM-LABORATORY) was established in 1981 to provide products quality control support, through testing of feed, intermediate streams and products as well as utilities.
The laboratory building and testing facilities continued to expand along with Asab new projects Asab-1, Asab-2 & Asab-3. The Laboratory incorporated the latest technology in the Residue gas; Natural gas liquid; Amine, Glycol, Hydrocarbon condensate and Water testing processes and has highly skilled and experienced work-force. The Laboratory is fully supported by the dynamic and customer focussed management who believes in total customer satisfaction and being a good corporate citizen.
The laboratory operations revolve around a quality assurance policy which is fundamentally split into the following philosophies to achieve quality results so that our internal customers can efficiently plan and execute their refinery processes most efficiently. The laboratory focuses in ensuring accurate and reliable test results based on the following:
a) Well Qualified, experienced staff is employed and individual’s talent developed so as to motivate each individual to contribute towards the overall performance of the team.
b) Most recent and internationally accepted analytical methods are used for analysis of process streams and intermediate products for certification. Latest ASTM standard methods are used for analysis. Additionally, SMS, UOP, IP & GPA standard methods are used for confirmation and validation of analysis.
c) Use state-of-the-art instrumentation to carry out the analysis, with each instrument undergoing a validation procedure to ensure that statistically viable results are obtained with each instrument.
d) Comprehensive Preventative Maintenance and repair programmes are in place for each instrument both internally from GASCO maintenance department and vendor local representatives. Obsolete instruments are replaced on a regular basis.
e) Quality and safety at work are of paramount importance in our commitment to provide services that consistently meet the customer’s requirements in a safe, timely and cost effective manner. Each employee is urged to inculcate Quality Culture for persistent introspection and improvement in the process.
1.3 ATM-Laboratory Identity
ATM-LABORATORY operates at a permanent facility and is a part of:
Abu Dhabi Gas Industries Limited:
Asab Plant, P.O. Box: 665, ASAB Area, Abu Dhabi
United Arab Emirates
Tel #: 02-6030970
Fax #: 02-6030442
1.3.1 Distribution
This manual has two categories of distribution:
Controlled distribution
Issued under the control of the Quality Manager and updating is carried whenever changes affected. This document will be maintained live on the GASCO Intranet. The Intranet based document will be the controlled version and revision announcements will be distributed via e-mail to relevant parties and published on the Intranet.
Uncontrolled distribution
Issued, when required, to potential customers with the approval of the Technical Services Manager. The copies are stamped as “uncontrolled” and these documents are not updated with any subsequent revisions made to and the distribution list will not be maintained.
1.4 Scope
Asab laboratory is engaged in the testing of Residual Gas, Natural Gas Liquid- NGL, Amine, Glycol, Water: Boilers & sour and Hydrocarbon Condensate produced by the Asab Plant.
The testing scope for ISO 17025 is as follows:
This Quality Manual is documented in accordance with the requirements of ISO/IEC 17025:2005 (General Requirements for the Competence of Testing and Calibration Laboratories). The scope of the QMS is to comply with the requirements of ISO/IEC 17025:2005.
This manual outlines the policies, procedures and requirements of ISO/IEC 17025:2005. Laboratory Section demonstrates its ability to consistently provide the services that meet the requirements of the customer and applicable ADNOC code of practices and enhances customer satisfaction through effective application of Quality Management System including processes for continual improvement.
To ensure the quality of products of Natural Gas Liquid (NGL), Sale Gas and H.C. Condensate are within customer defined limits and follow all standard requirements for analysis, sampling to HSE requirements.
SECTION 2
2.0 NORMATIVE REFERENCES
The following references have been used in the development of this manual
• ISO/ IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories.
• ISO/ IEC 17000:2004, Conformity assessment — Vocabulary and general principles.
• ISO 9000:2005, Quality Management Systems – Fundamentals and Vocabulary
• ISO 9004:2009, Managing for the sustained success of an organization – A Quality Management Approach.
* ISO/IEC 19011: Guidelines for Quality and/or Environmental Management System Auditing
SECTION 3
3.0 TERMS AND DEFINITIONS
The terms and abbreviations used in this manual are:
ATM-LABORATORY: GASCO Asab Laboratory Section
QMS: Quality Management System
QM: Quality Manual
MR: Management Representative
ADNOC: Abu Dhabi National Oil Company
ASTM:
GPA, IP, UOP, ISO
3.1 DEFINITIONS
3.1.1 Assurance of Conformity: Procedure resulting in a statement giving confidence that a product, process or service fulfils specified requirements
3.1.2 Audit: Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
3.1.3 Conformity: Fulfillment by a product, process or service of specified requirements.
3.1.4 Continual Improvement: Recurring activity to increase the ability to fulfil requirements.
3.1.5 Customer Satisfaction: Customer's perception of the degree to which the customer's requirements have been fulfilled.
3.1.6 Correction: On-the-spot or immediate corrective action to correct or repair non-conforming data, reporting or equipment, which is an action routinely made by analysts, technicians and supervisors.. However correction does not address root causes.
3.1.7 Corrective Action: Corrective actions are steps that are taken to remove the root causes of a detected non-conformity or undesirable situation.
3.1.8 Customer: A person/organisation who receives product/services. A customer can be internal or external to the organization.
3.1.9 Customer Satisfaction: It is a customer perception. It is also a question of degree. It can vary from high satisfaction to low satisfaction.
3.1.10 Effectiveness: Extent to which planned activities are realised and planned results achieved.
3.1.11 Evaluation of Conformity: Systematic examination of the extent to which a product, process or service fulfils specified requirements.
3.1.12 Efficiency: It is a relationship between results achieved (outputs) and resources used (inputs). Efficiency can be enhanced by achieving more with the same of fewer resources.
3.1.13 Infrastructure: The term infrastructure refers to the entire system of facilities, equipment and services that the mechanical Section needs in order to function.
3.1.14 Internal Audit: Internal audits are referred to as first-party audits.
3.1.15 Management: The term management refers to all the activities that are used to coordinate, direct, and control the department/Section.
3.1.16 Management System: A management system is a set of interrelated or interacting elements that use to implement policy and achieve objectives.
3.1.17 Management Review: The overall purpose of a management review is to evaluate the suitability, adequacy, and effectiveness of the QMS, and to look for improvement opportunities.
3.1.18 Non conformity: Non conformity refers to a failure to comply with requirements.
3.1.19 Objective evidence: It is a data that shows or proves that something exists or is true. Objective evidence can be collected by performing observations, measurements, and tests or by using any other suitable method.
3.1.20 Outsourced process: It is any process that is part of Section QMS but performed by a party that is external to Section.
3.1.21 Preventive Actions: These are steps that are taken to remove the causes of potential non-conformities or potential situations that are undesirable.
3.1.22 Procedure: Step by step activity carrying out a process of activity.
3.1.23 Process: A process is a set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs. Processes are interconnected because the output from one process becomes the input for another process.
3.1.24 Product/Result: Result of a process/activity
3.1.25 Service realization: Customer requirements are realized or actualized by following set of service realization processes.
3.1.26 Quality: The quality of product / service can be determines by comparing a set of inherent characteristics with a set of requirements. If those inherent characteristics meet all requirements, high or excellent quality is achieved.
3.1.27 Quality Objectives: A quality objective is a quality oriented goal. A quality objective is something you can aim for or try to achieve. Quality objectives are generally based on or derived from quality policy and must be consistent with it.
3.1.28 Quality Improvement: Part of quality management focussed on increasing the ability to fulfil quality requirements.
3.1.29 Record: A record is a type of document. Records provide evidence that activities have been performed or results have been achieved.
3.1.30 Requirement: A requirement is a need, expectation, or obligation. It can be stated or implied by its customers, or other interested parties.
3.1.31 Reference Equipment/ Material: An equipment/material generally of the highest meteorological quality available at a given location from which measurements at that location can be derived.
3.1.32 Standard: A standard is a document. It is a set of rules that control how people develop and manage materials, services, technologies, processes and systems.
3.1.33 Supplier: A supplier is the one who delivers products / equipment / services to Laboratory Section.
3.1.34 Traceability: It is the ability to identify and trace the history, distribution, location and application of services and materials. A traceability system records and follows the trail as services and materials come from suppliers and are processed and ultimately distributed as end service.
3.1.35 Validation: Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
3.1.36 Verification of Conformity: Conformation, by examination of evidence, that a product, process or service fulfills specified requirements.
3.1.37 Work environment: The term work environment refers to working conditions. It refers to all of the conditions and factors that influence work. Work environment includes lighting, temperature, and noise factors, as well as the whole range of ergonomic influences.
3.1.38 Working Standard: A standard which, usually calibrated against a reference standard, is used routinely to calibrate or check material measures or measuring instruments. (WIM 6.09)
3.1.39 Uncertainty of Measurement: An estimate characterizing the range of values within which true value of measured lies (WIM 3.09).
3.1.40 Intermediate Precision- Intermediate precision expresses within-laboratory variation, as on different days, or within different Analysts or equipment within the same laboratory. .
SECTION 4
4.0 MANAGEMENT REQUIREMENTS
4.1 Organization
4.1.1 ATM-LABORATORY is a part of GASCO Technical Department at ASAB. The ATM-Laboratory identity of the laboratory and its relation with the parent organisation GASCO ASAB plants has been defined clearly in Section-1 of this document.
ATM-LABORATORY has established, documented implemented and maintained a Quality Management System (QMS) ISO/IEC 17025:2005. The system is maintained and continually improved through the use of the Quality Policy, Objectives, audit results, analysis of data, corrective and preventive actions and management review. The internal audit cycle covers full scope of the system as well as the clauses of ISO 17025:2005 standards in order to demonstrate that the requirements are fulfilled.
To design and implement the Management system, ATM-LABORATORY has;
• Identified the processes needed for the QMS and their application throughout the Laboratory Section as shown in the Key Process Interaction flow chart;
• Determined the sequence and interaction of these processes;
• Determined criteria and methods needed to ensure that the operation and control of the processes are effective, and documented them in process maps, quality plans, work procedures, etc.;
• Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes as detailed in per quality plans and process maps in the Key Process Interaction flow chart;
• Established systems to monitor, measure and analyse these processes;
• Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes as per Key Process Interaction flow chart.
ATM-LABORATORY implemented the procedure ensure control on outsourcing of any process that affects product conformance with requirements. The control of outsource processes implemented the procedure be identified, implemented and where appropriate, reviewed at both fixed intervals and opportune times with a view to process improvement.
Notes:
Beginning with this section (4.0), all sections aligned with the matching section numbers from the ISO 17025:2005 standard.
ATM-LABORATORY Process interaction model with other sections:
ASAB Business Managing and Control Process:
Laboratory Process interaction
QMS process interaction diagram:-
QUALITY MANAGEMENT SYSTEM
PROCESS IDENTIFICATION & INTERACTION
SUPPORT MANAGEMENT PROD. REALIZATION
PROCESSES PROCESSES PROCESSES
ATM-LABORATORY is responsible for the testing of Natural Gas, NGL, and Hydrocarbon Condensate as per the international standard testing methods (ASTM, GPA, IP, UOP, ISO, Shell …etc.) as well as meeting the requirements of ISO/IEC 17025:2005. The laboratory is also responsible to comply with the requirements of GASCO/ ADNOC and other applicable regulations of the Federal Government. The laboratory testing work is carried out at its permanent location as specified in the Section l. 1.2 - ATM-Laboratory identity
ATM-LABORATORY tests the products which are transferred to the local customers. It implements the Management Principles at all levels and demonstrates that it is impartial; its personnel are free from any undue internal, commercial, financial and other pressures which might influence their technical judgment. The management declares that the laboratory is not engaged in any activities that may endanger the trust in its independence of judgment and integrity in relation to its testing activities.
4.1.2 The intent of ATM-LABORATORY under GASCO Technical Department at ASAB, Abu Dhabi, is to operate laboratory according to the following requirements;
• Policies and Procedures set by the GASCO Technical Department at ASAB, Abu Dhabi
• ISO/IEC 17025:2005 management system and testing services for customers
• United Arab Emirates laws and regulations
• American Association of Laboratory Accreditation (A2LA) Accreditation Criteria for ISO/IEC 17025
4.1.3 Management Commitment
ATM-LABORATORY Management is committed for the following requirements:
ATM-LABORATORY staff implemented the procedure have the authority and resources needed to carry out their duties including the implementation and improvement of the QMS and control the process non-conformities detected by taking appropriate corrective and preventive actions.
The management and personnel are free from any undue internal and external, commercial, financial and other pressures and influences that may adversely affect their quality of work.
Customer’s property such as information, proprietary rights including procedures for protecting the storage and transmission of results.
The management ensures that ATM-LABORATORY is not indulged in any activity that would diminish confidence in its competence, impartiality, judgement and operational integrity.
The management has defined the organisational structure which indicates the responsibility, authority and inter-relationship of all its key personnel who perform, manage or verify the work which affects the quality.
Adequate supervision is provided to ensure adequate process control as well as reliability of laboratory results.
Management ensures the provision of required resources for the effective operation of its QMS and sustainability.
ATM-LABORATORY has defined delegates/deputies and authorised signatories for all its key functions to ensure the smooth running of the organization.
ATM-LABORATORY operates at permanent facilities for the addresses identified in the section 1 under 1.3.
4.1.4 Responsibilities and Authorities:
The organizational structure of ATM-LABORATORY is illustrated in Annexure-A which also identifies the key personnel. The responsibilities of key personnel namely: Technical Services Manager(s), Head of Laboratory Section and Quality Manager are described in 4.2.6. Job description, responsibilities and authorities of laboratory employees are documented and maintained by the Head of Laboratory Section as well as the Quality Manager.
4.1.5
a) The ATM-LABORATORY has managerial, administration and laboratory staff with the authority to discharge their duties as reflected in their job descriptions. This authority includes the implementation, maintenance, and improvement of the management system. The resources needed to discharge these duties are also identified in Section 5.2 to Section 5.3. The identification of departures from the management system and testing requirements is documented according to the corrective action procedure.
b) Employee Confidentiality Agreement: ATM-LABORATORY employees sign the “Employee Confidentiality Agreement” and the signed agreement is retained by the Quality Manager. During internal audits, staff members are interviewed to ensure that they are free from any undue internal, external commercial, financial and other pressures and influences that may affect the quality of work.
c) Protection of Customer Confidential Information and Proprietary Rights: ATM-LABORATORY has set out a policy to ensure the protection of customer’s confidential information and proprietary rights; including protecting the electronic storage and transmission of results.
Top Management of ATM-LABORATORY is committed to protect the confidential information and proprietary rights of its customer including the electronic storage and transmission of results.
ATM-LABORATORY personnel will not copy or reproduce any confidential or proprietary document. Confidential or proprietary documents provided by the customers will be returned when the work is completed. Access to the customer’s test reports and confidential information is limited to the Head of Laboratory Section, the Quality Manager and other authorized staff only. Confidentiality of customers test results is maintained at all time. The information will not be discussed with anyone, even those within the customer’s company not designated as a contact, without written permission.
ASAB Laboratory implemented procedure ATM-L-PR-4-003 covering all above clauses.
And all laboratory staff signed an ethics agreement # ATM-L-QP-FRM-001
d)Ethics:
Policy:
Top Management ensures that all personnel are free from any undue internal, external, commercial, financial and other pressures that may adversely affect the quality of their work. Employees are never instructed or forced to alter or falsify data.
4.1.6 Effective communication from management occurs through the use of but not limited to memos, newsletters, electronic presentations, emails, or verbally to laboratory personnel regarding the effectiveness of the management system.
4.2 Management System
ATM-LABORATORY Management System has established documentation and describes the processes required to implement the QMS. The documentation is kept to the minimum for effectiveness and can be in any form or type of medium.
4.2.1 General
This ATM-LABORATORY Management System has been developed to describe and address the requirements of ISO 9001:2008 and ISO/IEC 17025:2005. The system is applicable to the fields of testing and other activities in which the laboratory is involved and/or it undertakes. The manual references documented procedures and process maps relating to the requirements outlined herein. A description of the interaction between the processes of the ISO/IEC 17025:2005 & ISO 9001:2008 is found in respective process maps and implementation controlled by respective procedures.
Management System Awareness and Implementation: The Management of ATM-LABORATORY has conducted awareness training on ISO 9001:2008 as well as ISO/IEC 17025:2005 which ensures that staff members are familiar with the management system documentation and implementation of the quality policies and procedures in their work. A briefing on the quality policy as well as the requirements of the management system are communicated to all staff members and also included in the induction training for all new staff. The quality policy is reviewed during the management review meetings, for its suitability. Senior officials are vested with the responsibility of spreading and maintaining the quality culture throughout the organization.
The purpose of the management system is to ensure that all services satisfy the customer’s requirements and have been designed and customized under controlled conditions.
The effectiveness of the Management System is assessed in several ways:
• Planned internal quality audits, covering all aspects of the operation of the management system.
• Management reviews for the suitability and effectiveness of the management system, at least twice a year.
• Analysis of potential and actual problems as shown by customer complaints and supplier and subcontractor assessments.
• Regular participation in the external quality control programs.
4.2.2 Quality Policy
ATM-LABORATORY has established a quality policy to ensure that the policy:
• Is appropriate for the needs of Laboratory Section and its customers Includes a commitment to meeting requirements and continual improvement.
• Provides a frame work for establishing and reviewing quality objectives.
• Is communicated, understood and implemented throughout Division.
• Is regularly reviewed for continuing suitability.
Quality Policy
• Management of ASAB Laboratory is committed to comply with the requirements of ISO/IEC 17025:2005, providing high quality and timely testing services {RG, NGL and Condensate} and to following good professional practices which fully meet or exceed the expectations of our customers as well as working on the principles for continuous improvement and development of the management system.
• ASAB Laboratory also ensures that all staff concerned in the testing activities are familiar with quality documentation and implementation of the quality policies and procedures in their work.
Ramakrishna S. & Afif Harhara
Tech. Services Manager(s)
GASCO - ATM
THE OBJECTIVES
The objectives of ATM-LABORATORY, in line with the objectives of GASCO, are to ensure the supply of high quality hydrocarbon products which meets or exceed the standards required by GASCO, its shareholders and UAE laws. To ensure the supply of quality hydrocarbon products, the Laboratory has put in place the following objectives:
• Strive to meet and/or exceed the needs and expectations of customers --- (KPIs)
• Provide accurate and reliable laboratory test results
- To establish a level for the performance of the laboratory
- To modify test methods to improve performance
- To participate in proficiency testing or quality evaluation programs with peer laboratories.
- To improve and validate laboratory methodologies by participation in method validation and collaborative studies.
• Improve employee competency at all levels
- To ensure that all personnel are trained to a level of familiarity with the quality management system appropriate to the individual’s degree of responsibility
• Continually improve processes and services
• Establish and maintain National and International recognition through compatibility with the requirements of relevant standards
• To establish and report on quality savings
To achieve above objectives ATM-LABORATORY incorporates into the system the following:
• Quality control is an integral part of the production process and implemented the procedure be conducted in accordance with the quality directives contained in the Laboratory Quality Assurance System.
• The Laboratory Quality Assurance System is designed to integrate human, technical and material resources in a manner that results in optimum production consistent with the highest quality standards.
• All laboratory staff, including its management, is expected to understand and work towards the quality commitment.
• Success requires satisfied customers. The Laboratory Quality Assurance System reflects the total commitment to achieve the goal of meeting the needs of customers efficiently and satisfactorily.
• Pursue the goal of no harm to people, protect the environment and use material as well as energy efficiently in providing quality products.
• Report quality product results publicly within the GASCO organization.
• Play leading role in promoting best practices in the GASCO organization as well as ASAB industrial area.
• Promote a culture in which all GASCO employees share the commitment of delivering quality products.
The objectives along with targets for the each year are outlined in Annexure – E (attached separately)
THE VISION
To become the first choice among the World Class laboratories, by providing accurate and reliable testing services, aiming at customer’s satisfaction with a focus on Health, Safety & Environment through continual improvement of performance.
THE MISSION
To conduct our testing services professionally and efficiently with state of the art technology to deliver the best, to the utmost satisfaction of the customers. To strive continuously to increase the value of shareholders, with a commitment of growth of the employees.
4.2.3 Commitment to the Management System
Policy:
The top management of the ATM-LABORATORY is committed to the development and implementation of the management system and continually improving its effectiveness.
ATM-LABORATORY enjoys the total commitment and support of the Top Management. The Quality Policy statement has the total support of the Technical Manager, who is the signatory to it, and senior management at all levels. All staff members are required to read, understand and implement the Policy; and to support the Management System, in all its aspects, for its compliance with the ISO/IEC 17025:2005 Standard.
The results of the management system are regularly reviewed during management review and continual improvements are made as outlined in the improvement 4.10.
Evidence of management’s commitment, to ensure the effectiveness of the system and its continual improvement, is demonstrated by but not limited, participation of the managers in the management reviews, review of internal audit reports, proficiency testing results, and quality control data.
4.2.4 Communication Requirements
Policy:
Top management and the management of the ATM-LABORATORY communicate to the organization the importance of meeting customer requirements, as well as statutory and regulatory requirements.
Effective communication from management occurs through the use of but not limited to memos, newsletters, electronic presentations, emails, or verbally to laboratory personnel regarding the importance of meeting customer, statutory, and regulatory requirements.
In general, the underlying message in all oral and written management communication involves meeting the aforementioned requirements. Meeting customer requirements ensures that on-going business relationships secure the contracts that keep organizational development. Meeting statutory and regulatory requirements ensures that laboratory operations will not be disrupted and the organization can continue to meet customer needs.
Head of Laboratory Section and Quality Manager are responsible and authorized for any external communication. Communication from management occurs through the use of but not limited to memos, newsletters, electronic presentations, e-mails, or verbal communication with laboratory personnel regarding the effectiveness of the management system.
4.2.5 Quality Manual
This Quality Manual outlines the structure of the documentation used in the management system. This Quality Manual makes reference to the supporting procedures & technical procedures and ensures they are maintained up-to-date.
This management system is structured in four tiers of documentation. These tiers are as follows:
• Quality Manual
• Quality System Procedures
• Work Procedures (Standard Operating Procedures (SOPs), Work Instructions and reference documents
• Forms and worksheets
For most customers, this Quality Manual and the associated documents form a general Quality Plan. If necessary, specific Quality Plans will be prepared on a ‘per-customer’ basis. These Quality Plans will modify the general requirements stated in the Manual and associated documents.
4.2.6 Roles and Responsibilities
The overall authority rests with the Section Head(s) and Management Representatives (MRs) and both are responsible for establishing, implementing and maintaining the QMS. An organizational chart has been established at each division/section to show the interrelation of personnel in the organization. Job descriptions define the responsibilities and authorities of each of the positions on the organizational chart.
Vice-President of the Asab plant has delegated the responsibilities to Head of Laboratory through the Technical Services Manager- to direct the overall laboratory operation and activities. The Quality Manager manages all aspects of the Quality Assurance and Quality Control of the laboratory. The Asab Technical Services Manager works to foster, support and sustain an ethical environment that facilitates the highest quality analytical services and ensures the implementation and maintenance of quality assurance system in compliance with the ISO/IEC 17025:2005.
The Head of Laboratory Section (Technical Manager) is responsible for the management of laboratory and providing assistance in the provision of procedures and/or work instructions as required to adequately controlling the activities relevant to the scope of work. The Head of Laboratory Section reports to the Asab Technical Services Manager (ATS). The Head of Laboratory Section is also responsible for ensuring that staff members are familiar with all technical requirements of the standard and understood related procedures.
The Quality Manager has the overall responsibility for maintaining the quality and compliance with the relevant standards. Quality Manager also reports to the Technical Services Manager/ for certain quality related issues.
The responsibilities of the Technical Services Manager, Laboratory Section Head (Laboratory Technical Manager) and Quality Manager are as under:
4.2.6.1 Technical Services Manager:
- Responsible for all activities of the Technical Services Department under which ATM-LABORATORY is operating.
- To establish ATM-LABORATORY quality policy and objectives
- To ensure that processes needed for the ISO/IEC 17025 standard is established, implemented and maintained.
- Ensure compliance with ISO/IEC 17025 standard, Management Systems policies and procedures.
- To be the Chairman of Management Committee
- Responsible for provision of required resources to ATM-LABORATORY
- Take appropriate decisions to ensure effective management and running of the organization leading to increased productivity
- Communicate with the higher management, customers and suppliers
- Take appropriate decisions and implement procedures to ensure customer and employee satisfaction
- Ensure promotion of awareness of the customer requirements throughout the organization
- Responsible for reporting to the higher management on the performance of the management system and its improvements.
4.2.6.2 Laboratory Section Head (Laboratory Technical Manager):
- Responsible for all activities of the ATM-LABORATORY, including Quality Control of the Laboratory.
- Responsible for planning of tests, provide adequate supervision of testing, assessment/evaluation of test results and reporting opinions and interpretations.
- Responsible for method modification and development and validation of test methods; and measurement of uncertainty of tests
- Responsible for inspection, testing and acceptance of raw materials and finished feeds.
- Ensure compliance with ISO/IEC 17025 standard, Management Systems policies and procedures.
- Acquire current knowledge in the areas of feed composition and nutritional quality, technical management of laboratories, development and validation test methods and explore opportunities through attending conferences, seminars etc. for new and improved systems
- Maintain confidentiality of information at all times
- Other duties, as assigned by the Technical Services Manager and Higher Management.
4.2.6.3 Quality Manager:
Ensures that-
Management system related to quality is implemented and followed at all times
in compliance with the Quality Policy, Quality Manual, ISO/IEC 17025 standards.
- Manage the QA/QC function of the ATM-LABORATORY.
- Responsible for leading the internal quality audit program, including scheduling, conduct, follow up and accountability for adding and closing all corrective actions. Liaise for external quality audits and ensure implementation of any resulting non-conformance.
- Evaluate QA/QC standards, manuals, policies, and programs currently in place, making recommendations for change to the higher management.
- Provide recommendations to the management on purchases, performance of staff with respect to quality, addressing customer complaints and resolving problems.
- Creating, maintaining and reporting performance and compliance metrics on a regular basis, including presenting the metrics to the higher management.
- Evaluate on-going processes and identify opportunity for improvement, and make recommendations to the higher management.
- Acquire current knowledge and developments in the area of quality management and explore opportunities through attending conferences, seminars etc. for new and improved system.
- Maintain confidentiality of information at all times.
- Perform other duties, as assigned by the Technical Services Manager and Higher Management.
- Authority: is authorised to access top level management regarding the issues concerning QMS implementation, review, updating.
- Authorised to stop any activity which is noncompliance to the system.
4.2.7 The management system process and procedures as defined in this manual maintain the integrity of the management system when changes such as a change in the structure of the organization or management, or a change in policy or procedure are made.
4.3 Document Control
ATM-LABORATORY has a documented a procedure for the control of quality system documents under procedure CE-PR-001. The procedure briefly covers following issues:
• Approval and adequacy criteria prior to issue
• Review, update and re-approval of documents
• Identification of revisions and changes in the documents at the place of use
• Ensuring that relevant versions of applicable documents are available at points of use;
• Ensuring that documents remain legible and readily identifiable;
• Ensuring that documents of external origin are identified and their distribution controlled;
• Preventing the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.
• Review mechanism and software control;
Laboratory management system documents such as Quality Manual & Procedures, Standard Operating Procedures and, reference documents (such as regulations, standards, reference test methods, drawings, software, and specifications are controlled by the Quality Manager.
4.3.1 Issue of Documents
Quality Manager implemented the procedure, issues documents controlled through intranet distribution or uncontrolled and/or his designates whenever demanded contractually.
4.3.2 Amendments to Documents:
Upon receipt of any document change request from the process owners, the Quality Manager reviews the required amendments and incorporates them into the appropriate document(s). All quality system documents are reviewed as per CE-PR-001 guidelines for their effectiveness against the set objectives and continual improvement. The Quality Manager maintains master copies of amendments as well as obsolete copies.
The Quality Manager is the Process Owner of the document control process. All quality system documents are issued under the authority of the Technical Services Manager/Laboratory Section Head of Asab Plant.
Supporting Procedure: CE-PR-001: Document Control
4.4 Review of Requests
Policy:
Management of ATM-LABORATORY is committed to provide agreed services to its customers and ensures that each laboratory has the capability and resources to provide the requested services in its testing capability.
The laboratory has established the procedure for the review of test requests, for testing and/or contracts. Typically the procedure addresses the following:
• The requirements including the test method to be used is adequately defined.
• The laboratory has the capability and resources to meet the requirements based on annual work plans.
• The selected test method is capable of meeting the customer’s requirements.
Any differences between the request and the contract implemented the procedure be resolved before any work commencement.
Records of reviews including any significant changes are maintained by the laboratory. Any discussion or oral agreements are also recorded as a part of the contract review.
The routine work coming from the parent organisation need not form the contract review. Only a copy of the onetime contract review is maintained. For outside customers having routine testing work, the review is maintained in the test request register. The review is also containing any testing work that is sub-contracted by the laboratory.
Any deviation from the contract implemented the procedure be communicated to the customer whenever required.
Any changes to contract after the commencement of testing work implemented the procedure be reviewed again and changes communicated to all concerned staffs in the laboratory.
4.5 Sub-Contracting of Tests and Calibration Services
ATM-LABORATORY does not sub-contact its main testing work. However, ATM-LABORATORY may sub-contract some non-routine tests and under unforeseen circumstances, to a competent laboratory, preferably accredited to ISO 17025:2005. The competence of sub-contracted laboratory(s) implemented the procedure be evaluated prior to subcontracting the testing work. The customer implemented the procedure be informed of the sub-contracting arrangements in writing. ATM-LABORATORY undertakes all responsibility for its sub-contracted work.
All GASCO sites’ laboratories made an agreement with GEOCHEM (Third party Laboratory) for testing of specialized & non-routine samples. This Laboratory is accredited for ISO 17025.Sub contracting is reviewed by top management. Agreement No. CMN.12.067.
Third party services is for Specialized tests on samples covering routine & non routine samples.
Scope of the contract is mentioned in this agreement.
4.6 Purchasing Services and Supplies
Policy:
ATM-LABORATORY is committed to optimize its resources through cost effective purchases without compromising quality of the purchased products. ATM-LABORATORY also ensures that purchased supplies, reagent and consumable materials that affect the quality of test are not used until they have been verified as per specification.
ATM-LABORATORY, in line with the GASCO purchase policy, has established a documented procedure for the selection and purchasing services and supplies following the purchase process set by the GASCO Commercial Division (CD). The purchase request will be raised using MAXIMO and will be processed further as per the established procedure. The procedure addresses the procurement of laboratory chemicals, reagents and consumable materials and their storage. The procedure ensures that the purchased goods are not used until they have been inspected. Necessary records of compliance of such purchased goods are maintained.
Laboratory Section implemented the procedure the procedure ensure that the specifications for all the purchased products/services are established complying with the laboratory, customer and regulatory requirements. All the purchased products that are required for the effective functioning of the section and to satisfy the customer’s needs specified requirements. The control of purchase process and evaluation and re-evaluation, records for the same and other requirements of ‘purchase process’ and purchase information’ are maintained as per the GASCO purchase policy.
The purchasing documents are reviewed to ensure the adequacy of requirements before orders are placed with the supplier. Purchase orders are ensured to have correct and implicit description of the items required along with specification details. The purchase requests (PR’s) are reviewed for technical content of the purchasing document and approved by the Laboratory Section Head before for further processing by Commercial Division.
Laboratory Section implemented the procedure necessary for verification of purchased product.
The laboratory management also evaluates the suppliers on a continuous basis and rate them for the services required. Suppliers not meeting the minimum rating are blacklisted and removed from approved suppliers list. The supplies are procured only from the list of approved suppliers only.
Supporting Procedure: ATM/L-PR-04-07: Purchasing Services
4.7 Service to the Customer
The laboratory has documented procedure for its services to its customer. As a policy of the laboratory, all staffs must cooperate with the customers or their representatives in clarifying the test requests and other testing matters, such as test methods used, equipments and validation of testing etc.
Upon a specific request and contractual agreement customers will be allowed to witness the testing and make their observation and forward to the laboratory section head. Feedback both positive and negative are used by the laboratory section head to improve the laboratory services. However, care shall be taken to ensure confidentiality and conflict of interest with the customers’ competitors.
Customer feedback forms & Data analysis of Customer feedback available
4.8 Complaints
Policy:
ATM-LABORATORY top management is committed to resolve all complaints from internal & external customers and staff in a satisfactory manner and ensure the implementation of process changes.
The laboratory has a procedure for handling and resolution of complaints. All complaints are registered by the Quality Manager in as CAPA (Corrective Action Preventive Action) in Q-Pulse (Online Action Tracking System). They are further evaluated for its significance and relevance. Only the relevant and significant complaints are acted upon.
The Laboratory Section Head, in discussion with Quality Manager, resolves all complaints at a reasonable time and inform the customer of the actions taken. Complaints are further evaluated for any adverse trends and/or root cause analysis to install adequate corrective and preventive actions wherever required.
Register for Customer Complaints related to Laboratory can be extracted at a given point of time from Q-Pulse system. All complaints, investigations and corrective actions are recorded.
All complaints are discussed in the management review meeting.
4.9 Control of Non-conforming Products and Services
Policy:
ATM-LABORATORY management is committed to resolve and implement corrective action when any aspect of testing work, or the results of this work, does not conform to requirements of the management system, testing methods, or requests of the customer.
ATM-LABORATORY has established documented procedure and its implementation in situations when any aspect of testing or the results do not conform to its own procedures or the agreed requirements of customers. Laboratory Section Head implemented the procedure ensure that product/service which does not conform to requirements is identified and controlled to prevent its unintended use or delivery.
The procedure defines the responsibility and authority for the handling of non-conforming product/testing work. The Laboratory Section Head or any staff member who has the authority to suspend non-conforming testing work to halt the testing work temporarily until the non-conformance is resolved satisfactorily. Upon such resolution, the Laboratory Section Head authorizes the resumption of work.
The responsible staff members are asked to carry out root cause analysis of the non-conformance and take appropriate corrective actions to mitigate its recurrence. Where necessary the customer is notified of non-conforming work and the work is recalled.
• Identify the non-conforming product with suitable mean.
• Record discrepancy in Non-conformance and corrective / preventive action form.
• Conduct investigation to identify the cause for non-conformity.
• Ensure that non-conforming product is not released in intended application.
• Ensure that non-conforming product is either returned or disposed off in a controlled manner. Proper work procedures are implemented to dispose off in a controlled manner.
• Records of non-conformities are maintained.
Any nonconforming product/service, which has been corrected, implemented the procedure be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use, Laboratory Section takes action appropriate to the effects, or potential effects, of the nonconformity. An evaluation of the significance of the non-conforming work is carried out by the Quality Manager.
The controls and related responsibilities and authorities for dealing with nonconforming product are defined in the centralized procedure “Control of Non-Conformance procedure CE-PR-004”. A laboratory specific procedure is documented based on the centralized procedure.
Supporting Procedure: ATM/L-PR-4-06: Handling of Non-conforming work
4.10 Measurement, Analysis and Improvement
Laboratory Section collects and analyses appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data including:
• Key Performance Indices (based on the objectives)
• Statistical charts (if any) that are generated for analysing the data - Mean Control Charts
• Conformance to product/service requirements and quality
• Internal and External Quality Audit Results
• Reports of nonconformities, actions, corrective actions and preventive actions.
• Characteristics and trends
• Customer Satisfaction Surveys
ATM-LABORATORY implemented the procedure continually improve the effectiveness of the QMS through the use of the Quality policy, objectives, audit results, analysis of data, corrective and preventive actions and management review.
ATM-LABORATORY has established procedure for improvements and emphasizes on continual improvement so that its customers are satisfied and their requirements are met. The laboratory has set the effectiveness of its management system through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive actions and management review.
Improvement efforts are made through carefully analyzing the data coming from various aforesaid sources. Meaningful decisions are taken based on the result of analysis and appropriate strategies and policy changes are made to improve the laboratory management.
A laboratory specific procedure is documented based on the centralized procedure for Corrective & Preventive Action CE-PR-005
4.11 Corrective Actions
Policy:
ATM-LABORATORY is committed to identify corrective actions, investigate the problem for root cause analysis and correct the causes of existing non-conformances including complaints in the management system and opportunities for needed improvements.
ATM-LABORATORY has established and maintained a documented procedure for implementing corrective actions. Causes of nonconforming conditions arising out of processes, internal quality control and audits or complaints by customers are investigated and corrective actions are implemented. Controls are applied to ensure that corrective actions that are implemented are effective. The procedure covers:
• Identifying, reviewing and documenting nonconforming conditions relating to laboratory services, processes, or management system (including customer complaints);
• Investigating and determining the root cause of nonconforming conditions.
• Evaluating the need for corrective actions to prevent recurrence.
• Determining and implementing corrective actions.
• Results of corrective actions are recorded.
• Verifying the effectiveness of the actions taken.
• Results of corrective actions are submitted to management for review.
The Quality Manager is responsible to determine the effectiveness of the corrective action which is also verified during management review ensures that all corrective action implementation is effective.
Wherever required an additional audit is conducted for the actions which casts doubt on laboratory’s compliance with its own policies and procedures or meeting the requirements of ISO/IEC 17025:2005. The additional audits are conducted only when a serious issue or risk to the testing business is identified.
A laboratory specific procedure is documented based on the centralized procedure for Corrective & Preventive Action CE-PR-005
Supporting Procedure: ATM/L-PR-4-011: Corrective Actions
4.12 Preventive Actions
Policy:
ATM-LABORATORY is committed to identify potential sources of non-conformances and implement needed improvements to the management system.
ATM-LABORATORY has established preventive action procedure to establish a controlled method to implement preventive actions and to consider actions needed to implement the needed improvement either in technical or in the management system.
The preventive action process include:
• Determining potential nonconformities and their causes
• Evaluating the need for action to prevent occurrence of nonconformities
• Determining and implementing action needed
• Records of results of action taken
• Reviewing preventive action taken
• Verifying the effectiveness of the actions taken
When these improvement opportunities are identified or if preventive action is required, the management develops the action plan. The action plans are then reviewed and implemented. After successful implementation the effectiveness is determined to ensure improvement in the system.
The documented procedure sets out steps of initiation of such actions including application and control to ensure its effectiveness. Mainly it’s a pro-active process to identify opportunities for improvements. The laboratory management takes all such actions very seriously in order to improve its processes.
Apart from the review of operational procedures, often it involves analysis of data including trend analysis and proficiency testing results.
A laboratory specific procedure is documented based on the centralized procedure for Corrective & Preventive Action CE-PR-005
Supporting Procedure: ATM/L-PR-4-012: Preventive Actions
4.13 Control of Records
ATM-LABORATORY maintains all records to provide evidence of conformity to requirements and of the effective operation of the Management System. ATM-LABORATORY has documented procedure for the control of records based on the centralized Control of Records Procedure CE-PR-002. The procedure briefly covers that records remain legible, readily identifiable, traceable and retrievable. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of records. Records may be in any form or type of media.
Identification and legibility of records
• Place of record
• Accessibility
• Protection and retrieval
• Staff authorization for access of archived records
• Review mechanism
• Retention and disposal criteria
All process owners have together developed and designed appropriate process forms for their respective processes and are controlled. These forms when filled become the evidence of the conformity to the requirements and effective use of the management system, which are termed as quality records. As a regulatory and company policy all records are retained for a minimum period of five years.
ATM-LABORATORY retains all its technical records of original observations, derived data and sufficient information to establish the audit trail. Toward this end, the laboratory maintains all work-sheets, calculations, and equipment and authorisation records of staffs. Technical records also include maintaining the method validation sheets and uncertainty budget and required details of calculations. All observations are recorded at the time they are made and are traceable to the testing request which is identifiable to the specific task in LIMS data base which has backed-up under GASCO corporate IT policy. The identity of the personnel responsible for sampling, performing and checking the result known through Daily Sampling Schedule and Electronic log book.
The procedure also states that all mistakes in records implemented the procedure be crossed out by a straight line and not erased. They implemented the procedure be corrected by the side of it made legible and initialled by the person who makes the correction. For electronic records, the laboratory section head is authorised to correct such records.
The Laboratory Section Head and other responsible staff ensures that records are stored properly and securely from preventing damages or loss of original data by providing necessary environment suitable for operating condition.
The retention periods of both electronic and hard copies of records are established.
ISO/IEC17025:2005 Quality records generated are electronically backed-up and protected to prevent unauthorized access to or amend these records.
Supporting Procedure: ATM/L-PR-4-002: Control of Records
4.14 Internal Audits
ATM-LABORATORY implemented the procedure schedule and conduct internal audits at least once before the External audit as per CEQ procedure CE-PR-003 determine compliance of the Quality management system to international standards. An annual audit plan and schedule implemented the procedure be designed based on the importance of the areas to be audited, covering each area at least once in a year. Audits implemented the procedure be planned in co-operation with Corporate Excellence – Quality Management Department (CEQ) located at the GASCO Head Quarters.
The audit program implemented the procedure:
• Conforms to the planned arrangements, to the requirements of the International Standards and to the management system requirements established by the organization.
• Is effectively implemented and maintained.
An audit schedule is prepared based on the audit criteria, scope, frequency, methods, responsibilities and requirements for planning, conducting audits, reporting and maintaining results, is defined in the centralized Internal Audit procedure CE-PR-003. The management is responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results. Qualified personnel independent of those who perform or directly supervise the activity being audited implemented the procedure conduct audits. This also ensures objectivity and impartiality of the audit process. The procedure also details the competencies required for the auditor.
ATM-LABORATORY has established and implemented a documented procedure of Internal Audits. Internal audits are conducted at pre-determined frequencies, to ensure the effectiveness of the laboratory management system. The audit program ensures that all management system activities are audited at least once in a year. An Internal Audit Schedule has been prepared according to ISO 17025:2005 to improve the system
Technical audits are performed to ensure the continuing suitability of the technical methods employed by the laboratory and are proportionate to the amount of testing done in a year.
All internal audits are carried out by the competent personnel and the Quality Manager co-ordinates the activity. Auditors are selected such that they are independent of the scope of audit (to ensure that auditors will not audit their own activity).
The results of all Internal Audits implemented the procedure be documented as per the Procedure and any identified and agreed corrective actions implemented the procedure be completed in accordance with the procedure. The results of Audits are also reviewed during the Management Review Meetings.
Supporting Procedure: ATM/L-PR-4-014 : Internal Audits
4.15 Management Reviews
ATM-LABORATORY implemented the procedure plan and conduct management reviews at least once in six months to review the suitability, adequacy, effectiveness and implemented the procedure and identify opportunities for improvement. Also review the need for changes to all elements of the QMS, including the Quality Policy and objectives. It is ensured that the necessary information is collected from respective process owners through involvement and presented for evaluation. This meeting is attended by all the process owners. Records are maintained for each management review meeting and distributed for actions to the concerned.
4.15.1 Review input
Assessment of the Management System is based on a review of information inputs to management review. Agenda for the Management Review Meeting implemented the procedure include but not limited to:
• The suitability of policies and procedures
• reports from managerial and supervisory personnel;
• the outcome of recent internal audits;
• corrective and preventive actions;
• assessments by external bodies;
• the results of inter laboratory comparisons or proficiency tests;
• changes in the volume and type of the work;
• customer feedback;
• complaints;
• recommendations for improvement;
• other relevant factors, such as quality control activities, resources and staff training.
• analysis Internal quality control and PTP data
• process performance and product conformity
•
• follow-up actions from previous management reviews,
• changes that could affect the quality management system, and
4.15.2 Review output
During these review meetings, management identifies appropriate actions to be taken regarding the following issues:
• Improvement of the effectiveness of the Quality management system and its processes;
• Improvement of product related to customer requirements; and,
• Resource needs (Manpower, Methods, Machine, Material, & Environment)
• Changes to Objectives and Targets.
ATM-LABORATORY has established and documented a laboratory specific management review procedure which defines the review inputs and outputs along with the conduct of it on an annual basis.
The reviews are conducted under the chairmanship of the Technical Services Manager, along with the Head of Laboratory Section, Quality Manager, other specified staff, invitees and the Management Representative. The Quality Manager takes the minutes of the meeting and ensures that action plans and policy decisions are implemented within the agreed timeframe.
Supporting Procedure: ATM/L-PR-4-005: Management Review
SECTION 5
5.1 Technical Requirements
Asab management believes that accuracy and reliability of laboratory tests are critical in assessing the quality of products. Many factors may influence the correctness and reliability of laboratory data. Quality Control plays an important role in assessing the quality of data. Management focuses its attention on:
• Employee skills
• Accommodation and environmental conditions
• Production and testing equipment used
• Procedures followed during production of feeds
• Test methods and method validation
• Sampling and sample handling
• Measurement traceability
• Handling of test items and calibration items
• Procedures followed during analysis of samples
• Verifying analysis reliability
5.2 Personnel
Policy:
ATM-LABORATORY management is committed employ personnel with adequate qualification and skills, provide training to its management, administrative and technical staff which is relevant to the present and anticipated needs of the ATM-LABORATORY.
Technical Services Manager, implemented the procedure to ensure that personnel performing work are competent. Competence of personnel implemented the procedure be determined through job descriptions identifying the qualifications, education, skills and experience. Appropriate qualifications, along with required training, provide the competence required for each position.
ATM-LABORATORY management believes in its human resource as the most important resource. Emphasis is given to the staff being competent and skilled in their area of work. ATM-LABORATORY Management identifies training needs and opportunities. The effectiveness of the training actions taken is also evaluated.
The Head of Section, based on the work load and future expansion plans, in consultation with the key staff, prepares the staff requirements and annual plan for training for both new and old staff. Either external or internal or both training are planned as per the requirement.
Technical Services Manager approves the plans and sent to the Central Training Department. Upon further approval, the Training Department, in cooperation with ATM-LABORATORY, arrange and schedule the training. Training is imparted and the effectiveness is evaluated.
Training is planned through the trained engineer of OEM (Original Equipment Manufacturer)
For the operation, troubleshooting, calibration of critical equipments.
The laboratory maintains current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations.
5.2.1 Training
The laboratory attaches critical importance to ensuring that all personnel performing testing activities must have adequate qualifications. This is achieved by recruitment of suitably qualified personnel and provision of adequate training.
The procedure has been established, requiring that all new personnel will be given induction training, which will include introduction to laboratory’s Quality Policy, QMS and employee’s own responsibility for quality.
The procedure also requires that the training needs of personnel are reviewed by the Head of Laboratory and/or ATM at least once every year. Based on this assessment the plan for further training is established.
The procedure assigns responsibility for provision of any such further training. Appropriate records for personnel qualification, Job description and training are maintained.
All laboratory staff after training is evaluated for the skills acquired and are authorised to perform specific tasks and use of concerned equipment depending on the skill levels.
Supporting Procedure: ATM/L-PR-5-001 Training
5.3 Accommodations and Environmental Conditions
5.3.1 Infrastructure
Asab management has provided the laboratory infrastructure at the ASAB plant premises. The buildings are purpose built to accommodate laboratory. The buildings are provided with air conditioning and are sufficiently ventilated. Storage facilities have been provided with adequate safe handling of the various materials. The facility is provided with proper water, electricity, gas rooms and compressed air, so as to ensure that the jobs are completed in the correct time frame.
Laboratory management ensures that accommodation and environmental conditions are adequate to produce accurate and reliable test results. Necessary instruments and tools are provided to ensure that all testing jobs are carried out in a satisfactory manner. An important highlight of the facility is the use of Certified Reference Materials (CRM)s, which is an essential feature of any modern testing facility.
The company provides necessary transport facilities for its employees to ensure timely completion of job. This also ensures timely delivery of the materials to the site and to the stores. The necessary material handling is provided for ensuring damage free transport of materials inside and outside the laboratory.
5.3.2 Work Environment
ATM-LABORATORY maintains necessary work environment required to achieve conforming testing process. The laboratory ensures adequate environmental conditions such that it does not invalidate the results or adversely affect the measurement results. The laboratory monitors, control and records the temperature and humidity. Access to the laboratory’s’ various sections is restricted unless permitted by the Head of Laboratory Section in order to maintain customer confidentiality.
The laboratory area is effectively separated from the other areas so as to maintain shock proof and dust free conditions inside the laboratory.
Throughout the company, good housekeeping is maintained. Appropriate storage areas and facilities are provided to achieve this.
Supporting Procedure: ATM/L-PR-5-003
5.3.3 Safety:
Safety at work is the utmost priority of ATM-LABORATORY. All laboratory employees are instructed to follow the HSE rules implemented by GASCO. ATM-LABORATORY building has been provided adequate safety systems (such as smoke detectors, fire alarms), adequate safety tools such as first aid kits, respirators oxygen cylinders etc. Safety systems are continuously monitored. Adequate training on fire fighting, CPR and first aid has been provided. Evacuation of employees during emergency has been planned and Emergency Assembly Points (EAP) has been identified.
Supporting Procedure: ATM-LABORATORY-QP-4-006: Accommodation and Environmental Conditions
5.4 Test Methods and Method Validation
5.4.1 Selection of Test Methods
ATM-LABORATORY uses test and calibration/performance verification methods, which meet the needs of the customer and are appropriate for the testing. ATM-LABORATORY uses mostly the methods published in as International standards (ASTM, UOP, GPA, IP, ISO, SHELL etc.) The laboratory management ensures the use of latest valid editions of these standards is used after due capability studies. Several work procedures have been documented to facilitate use of equipment, method validation, uncertainty of measurement, handling of test items, equipment maintenance and calibration etc.
It is obligatory on the part of ATM-LABORATORY to advise the customers whenever an inappropriate or out dated method is specified by the customer.
5.4.2 Laboratory Developed Methods
ATM-LABORATORY develops some methods, when required, to cater the requirements of its own activities.
5.4.3 Non-standard Methods
Upon development of non-standard test methods, the laboratory agrees the use of such methods with customer. Such methods require validation before being use. Appropriate procedure for method validation is documented.
5.4.5 Validation of Methods
As a policy matter, all non-standard/ laboratory developed methods are validated before being used as per the documented procedure. Method validation carried out to ensure that it meets the intended use and fit for the purpose. The laboratory records all relevant data of method validation. The laboratory ensures method is validated for appropriate performance characteristics from the following list
• Specificity & Selectivity
• Sensitivity
• Limit of Detection
• Limit of Quantization
• Linearity & Range, where applicable
• Accuracy
• Precision
• Recovery
• Uncertainty
• Other performance characteristics as appropriate to the method
Non-standard and laboratory developed methods undergo full validation where as method performance is verified for all standard methods.
Supporting Procedure: ATM/L-PR-5-007: Test Methods and Method Validation
5.4.6 Estimation of Uncertainty of Measurement
A documented procedure has been established for the estimation of uncertainty of measurement. The procedure uses the uncertainty arising at different stages of the test method, uncertainty of internal calibrations, uncertainty reported from calibration certificates of equipment and reference standards, certified reference materials used and standard deviation of the method. A reasonable estimation is made based on the knowledge of the performance of the method and on the measurement scope. Uncertainty of the test method for each analyte is reported at 95% confidence level using a coverage factor, K = 2. Uncertainty is used to decide upon when acceptance/rejection of the product where the test results falls on the border line of the specification.
With certain test methods, where contribution of uncertainty arising from other sources in the method factor is negligible, then precision of the method (standard deviation taken over a period of time (intermediate precision) is multiplied by a coverage factor of 2 is used to get the uncertainty.
Supporting Procedure: ATM/L-PR-5-008 Uncertainty of Measurement
5.4.7 Control of Data
ATM-LABORATORY controls all manual and instrumental data generated during its testing work. ATM-LABORATORY uses Laboratory Information Management System (LIMS) in its testing activity. All transactions such as data transfers are checked in a systematic manner. Computer software is ensured to be suitable for use through proper validation/verification. Data collection, transmission of results/ files is ensured to be adequately protected so as to maintain confidentiality and integrity.
Supporting Procedure: ATM/L-PR-5-009: Data Transfer and Control
5.5 Equipment
ATM-LABORATORY is equipped with adequate equipment required to perform all aspects of its testing activity. ATM-LABORATORY ensures that equipment and its software used for testing is capable of achieving the accuracy required and complies with the relevant requirements of standard. The equipment is used in a manner, which ensures that the measurement uncertainty is known and consistent with the required measurement capability.
When new equipment is purchased, care is taken for its proper installation following manufacturer's instructions. All new equipment is then given an Identification Number and is added to the equipment inventory.
ATM-LABORATORY ensures that equipment are properly identified, calibrated and maintained according to stipulated intervals. ATM-LABORATORY put in place a calibration and maintenance schedule for its analytical equipment. Breakdown maintenance is carried out whenever required. Equipment is recalibrated after each preventive or breakdown maintenance. Critical laboratory equipment is calibrated either by a calibration laboratory, preferably accredited to ISO/IEC 17025:2005, or trained/factory certified service engineers from the equipment suppliers. Some equipment is calibrated by the end user. Laboratory equipment are maintained and calibrated following a calibration and preventive schedules. Equipment In-charge of ATM-LABORATORY prepares a calibration and preventive maintenance schedule in consultation with the Head of Lab Section. The frequency of calibration/performance check depends on the criticality of the equipment and the method; sensitivity requirements; its use and age; and previous experience with such type of equipment. In-house procedures have been documented for calibration/performance check of equipment, where no calibration facility is available. Equipment In-charge maintains the calibration records of each instrument. Equipment are labelled with the calibration status, where required. All equipment is safeguarded from tampering of settings.
Laboratory ensures that trained and authorised personnel only handle the equipment. All required intermediate checks are carried out to maintain the confidence in testing activity. ATM-LABORATORY ensures the handling and maintenance of equipment is done in such a way that the accuracy and fitness for use is maintained.
ATM-LABORATORY maintains the records pertaining to each equipment (equipment history files and log sheets). ATM-LABORATORY also maintains its equipment inventory and ensures that only trained and authorized personnel handle the equipment.
When equipment is sent outside the laboratory (outside the direct control), upon return its calibration status ensured prior to its use by the laboratory.
While transporting proper care is maintained to avoid damage .Safe handling & storage are taken care
All equipment is safeguarded from tampering of settings.
When new equipment is purchased, care is taken to install it properly as per the manufacturer's instructions. All new equipment is then given Identification number and added to the inventory.
Supporting Procedure: ATM/L-PR-010: Equipment Management
5.6 Measurement Traceability
5.6.1 General
ATM-LABORATORY provides traceability through all stages of its operations namely sampling, sample handling, testing, certified reference materials and reference equipment.
Traceability is established through a unique system of identification to ensure accountability for all activities and operations, which may affect the quality of the product. This will allow traceability to jobs, and customers as required.
When the customer specifies traceability, the company provides details containing identification of product in the format required by the customer.
5.6.2 Specific Requirements
Calibration; All calibrations performed for the equipment are traceable to National/ International system of units.
The laboratory has established traceability of its own equipment by means of an unbroken chain of calibrations or comparisons linking them to relevant primary standards.
External calibration services are ensured that all requirements of the calibration procedures are met.
5.6.3 Reference Standards and Reference Materials
The laboratory has reference standards. All reference standards are calibrated by approved calibration bodies, which provide adequate traceability. The reference standards are always used for its intended purpose and prevented for any other use.
As a requirement reference standards are calibrated before and after any adjustments.
Where possible reference materials are ensured for their traceability to SI units of measurement
ATM-LABORATORY has documented a procedure for measurement of traceability including transport, storage, safe handling, and use of reference materials in order to prevent contamination, deterioration and in order to protect their integrity.
Supporting Procedures: ATM/L-PR-5-011: Measurement of Traceability
ATM/L-PR –5-010: Equipment Management
5.7 Sampling
Sampling for testing is carried out as per the stated plan of the laboratory. The sampling procedure refers to various technical standards of sampling.
ATM-LABORATORY has developed a sampling and sample handling procedure to extrapolate the laboratory results to the products manufactured. Sampling is carried out by trained personnel following a plan. Samples are identified and registered in the LIMS. Samples are processed by the sample management, received by the laboratory for analysis and a reference sample is maintained by the sample management if required.
Head of Laboratory Section has developed testing regimes (for different analytes/tests) for routine samples collected from the process. Samples are analysed, under supervision, following documented test methods (SOPs), raw data and test results are recorded on identified worksheets. Proper internal quality control procedures are followed and required quality checks are performed by the specialists/technicians. Worksheets and results are checked and approved.
Data of Samples collected as per schedule and non – routine samples are recorded in LIMS data base. Special sample which does not have LIMS identity will be recorded as special sample request.
Supporting Procedures: ATM/L-PR -5-012: Sampling and Sample Handling
ATM/L-PR -5-013, Analysis of Samples by the Laboratory
5.8 Handling of Test Items
ATM-LABORATORY has established procedures for receipt, handling, protection, storage, retention and/or disposal of testing items in order to protect the interest of the laboratory and customer. All abnormalities from normal or specified conditions are recorded upon the receipt of items and customer is informed.
The procedure also ensures the appropriate facilities provided to avoid deterioration, damage or loss to the test item during storage, handling and preparation.
Supporting Procedure: ATM/L-PR -011: Handling of Test Items
5.9 Quality Assurance of Test Results
ATM-LABORATORY has put in place a procedure for verifying its analysis reliability. ATM-LABORATORY has established an internal quality control (IQC) program to ensure the validity of test results. It also participates in proficiency testing program (PTP) and inter-laboratory comparisons, where ever applicable, as a part of its external quality control. Several performance checks such as blanks, replicates, analysis of reference materials and repetition of analysis are carried out during the analysis of batch of samples. Appropriate quality checks will be included in the analysis of each batch of samples. Correlation of results for different characteristics of a test sample is also used as an additional quality assurance measure.
Quality control data is subjected to statistical evaluation and control charts are maintained, where appropriate.
Supporting Procedure: ATM/L-PR —5-003: Quality Assurance of Test Results
5.10 Reporting the Results
The test reports of an item carried out by the laboratory are reported accurately, clearly, unambiguously and objectively and in accordance with test methods.
The reports include all requested information by the customer and necessary for the interpretation of the test results.
Test reports are transmitted to the Production Department electronically . Confirmation for receipt of report xxxxxxxxxx. Other test reports and Certificates are issued on request basis only. These reports include the following information:
• Title of report
• The name and address of the laboratory/location where test was carried out
• Unique identification and page number
• Name and e-mail address of the customer
• Test method used
• Date of testing
• Reference to the procedure (wherever required)
• Test results with appropriate units of measurements
• Authorised to signature
• Where relevant, statement to the effect that the results relate only to the item tested.
• A2LA accreditation mark will be used only for the accredited test following the A2LA, “P101-Reference to A2LA Accredited Status-A2LA Advertising Policy”..
Opinion and Interpretations
ATM-LABORATORY interprets test reports, when requested for interpretation. The interpretation includes the following:
• A Statement of compliance/non-compliance with requirements and specifications, where relevant.
• Where appropriate, opinion on the quality of the product.
• Any additional information based on the test results.
Additional Information
In addition to the requirements stated in clause 5.10.2, additional information on the conditions under which the test(s) were made and uncertainty of the measurements is provided when requested by the customer.
Test reports obtained from the Sub-Contractors
When testing either full or in part is subcontracted, the results of sub-contracted tests are clearly identified. The sub-contractor implemented the procedure report the results in writing directly to the Laboratory Section Head.
Electronic Transmission of Results
ATM-LABORATORY when transmitting results electronically to its customer(s) ensures the procedural requirements are met with. Electronic reports implemented the procedure not carry authorised signature for security and confidentiality reasons. However, a scanned copy of the report is sent electronically when specifically requested by the customer.
Reports and Certificates
ATM-LABORATORY uses approved format for issuing test reports to ensure proper presentation of sample and test information which minimises the possibility of misunderstanding.
Amendments to Test Reports
ATM-LABORATORY while making amendments, if any, to the test reports after their issue, makes in the form of a further document, which includes the statement: "This report supersedes the earlier report”. Record of superseded report/ implemented the procedure be maintained.
Supporting Procedure: ATM/L-PR-5-004: Reporting Results
6.0 Annexures
6.1 ANNEXURE – A: Organization Chart of the Laboratory
ANNEXURE – 6.1. B: Management Committee
Sl. No. Name Designation
1 Ramakrishna S. ATM Manager Tech.Services
2 Mischel ATM Manager Tech.Services
3. Muayed Al Faour ATM/L
&
Moh’d Ali Hasher ATM/L Section Head
4. Sarma.G ATM/L1 Sr.Chemist
5 Sundar ATM/L2 Chemist
6.2 ANNEXURE –: List of Key Personnel
Sr.
No. Responsibilities Nominated Employee Delegation
Name Designation Name Designation
1 Laboratory Section Heads & & Technical Manager
& Technical Manager
&
Muayed Al Faour & Moh’d Hasher
&
Moh’d Hasher
ATM/L Back to back
2 Quality Manager Sarma ATM/L1
3 Senior Chemist Sarma ATM/L1
4 Chemist Sundar ATM/L2
6 Senior Technician Manoj ATM/L6
7 Senior Technician Shadi ATM/L7
8 Senior Technician Arif ATM/L8
9 Senior Technician Badawi ATM/L12
10 Senior Technician Santosh ATM/L10
11 Technician Sonny ATM/L9
12 Technician Bidyut ATM/L11
13 Technician Hasan ATM/LS16
14 Sample Man Hussain ATM/LS13
15 Sample Man Nadir ATM/LS14
16 Sample Man Ravi ATM/LS15
17 Sample Man Ihsan ATM/LS17
18 Sample Man Mahmood ATM/LS18
6.3 ANNEXURE –: List of Key Personnel & Delegation of Duties
SL.NO Quality Responsibilities Description Delegation
Name Designation Name Designation
1 Management Representative –MR Muayed Al Faour/Moh’d Ali Hasher ATM/L Back to back ATM/L
2 Quality Manager G. Sarma ATM/L1 Muayed AL Faour /
Moh’d Ali Hasher ATM/L
3 Equipment Manager Sundar/Manoj
ATM/L2
ATM/L6 Back to back ATM/L2/
ATM/L6
4 Materials Manager Shadi/Arif ATM/L7
ATM/8 Santosh/
Bidyut
ATM/L4
ATM/L11
5 Documentation Manager Sonny/
Hasan ATM/L9
ATM/LS16 Santosh/
Ravi ATM/L10
ATM/LS15
6 Training Manager Bidyut ATM/L11 Shadi ATM/L7
7 Sample Manager Nadir/Ravi/Hussain ATM/LS13
ATM/LS15/ATMLS14 Hasan/
Ihsan ATM/LS16
ATM/ LS17
8 Safety Manager Manoj ATM/L5 Sundar ATM/L2
9 Stores Manager Bidyut/Badawi ATM/L11
ATM/L12 Santosh/Badawi ATM/L10
ATM/L12
10 Records Manager Arif/ Badawi ATM/L8
ATM/L12 Nadir/
Ihsan ATM/LS14
ATM/LS17
6.4 ANNEXURE – : List of Tests under the Scope of Accreditation
Test Method Product Reference Method
Determination of sale gas composition by Gas Chromatography Sale gas ASTM D-1945
Determination of Density by Anton Parr density meter Condensate ASTM D-4052
Determination of Reid Vapour Pressure by Mini Vapour Pressure Garbner Condensate ASTM D-6378
Determination of total sulphur in condensate samples by Total Sulphur Analyser Condensate ASTM D-5453
Determination of Natural Gas Composition by Gas Chromatography Natural Gas Liquid (NGL) ASTM D-2597
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