QMS Q&a

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1. What is ISO?

• ISO is the world's largest developer of standards. It is a non-governmental


organization composed of a network of the national standards.
• Impartial third party responsible for maintaining secure and economic
operation of an open-access electrical transmission system on a regional
basis.
• An organization established to promote the development of standards to
facilitate the international exchange of goods and services, and to develop
mutual cooperation in areas of intellectual, scientific, technological, and
economic activity
• The International Organization for Standardization (ISO) is a worldwide
federation of national standards bodies from some 140 countries, one from
each country. ISO is responsible for the development of ISO 14001.
• A network of national standards institutes from 148 countries working in
partnership with international organizations, governments, industries,
business and consumer representatives.
• International Standards Organization - A body that sets standards and
promotes their use throughout several industries around the world.
• ISO is a worldwide federation of national standards bodies from some 130
countries, one from each country. It is a non-governmental organization
established in 1947 to promote the development of standardization facilitating
international trade.
• Developed by the International Standards Organization, the ISO network
model specifies seven layers of communications protocol.

2. What is ISO 9001?


• An international standard for the management of the quality system used in
the company.
• An international family of specifications and standards for quality assurance
management systems involving a third party for inspection and registration.
• Model for QA in design, development, procurement, production, installation,
and services.
• Quality Management System requirements, which specify an organization
needs to demonstrate its ability to provide products that, fulfill customer and
applicable regulatory requirements and aims to enhance customer
satisfaction.

3. What is ISO 9000?


• Guidelines & assurances of method & procedure standards for quality
assurance systems.
• A family of international standards for quality management and assurance.
• QMS-Fundamentals and vocabulary, specifies terminology.
4. What is QC?
• Operational techniques and activities undertaken with quality management
system to verify requirements are met.
• Product quality checks.

5. What is QA?
• Planned and systematic actions established to ensure that process performed,
data are generated, documented, activities implemented within QMS and
demonstrated as needed, to provide adequate confidence that entity
(services, product, process activity, or organization) will fulfill quality
requirements.
• Process of monitoring specific results to determine if they comply with
relevant quality standards, and identifying ways to eliminate causes of
unsatisfactory performances.
• System of procedures, checks, audits & corrective actions to ensure that
quality requirements are fulfilled / exceeded.

6. What is difference between QA, QC & Testing?


• QC is a set of activities for evaluation of a developed product, QA is a set of
activities designed to ensure that the development process is adequate to
ensure a system will meet its objectives and Testing is a process of executing
a system with the intent of finding defects.

7. What is the difference between ISO 9000 & ISO 9001?


• ISO 9000 standard mentions terms & definition (definitions & vocabulary)
applicable in QMS & ISO 9001 standard mentions QMS requirements to adopt
Plan-Do-Check-Act principles and Process Management

8. What's the difference between a Quality Manual and a Quality System?


• A quality manual is just a document, while a quality system is a network
of processes.

9. What's the difference between a procedure and a work instruction?


• A procedure describes how a process is performed, while a work instruction
describes how a task is performed. Work instructions tend to be more detailed
than procedures.

10. What's the difference between a work instruction and a record?


• Work instructions describe how tasks should be done, while records document
how tasks were actually done.
11. What's the difference between corrective and preventive action?
• Corrective actions are steps that are taken to remove the causes of existing
nonconformities, while preventive actions are steps that are taken to remove
the causes of potential nonconformities. Corrective actions address actual
problems, ones that have already occurred, while preventive actions address
potential problems, ones that haven't yet occurred. In general, the corrective
action process is a problem solving process, while the preventive action
process is a risk analysis process.

12. What's the difference between design verification & design validation?
• Design verification is a process whose purpose is to examine design
outputs and to use objective evidence to confirm that outputs meet design
input requirements. Your purpose here is to see whether your design outputs
meet your organization's design goals. Design validation is a process whose
purpose is to examine products and to use objective evidence to confirm that
these products meet customer needs and expectations. Your purpose here is
to see whether your product does what your customer or user wants it to do
under real-world conditions.

13. What is Quality Management System?


• The set of procedures for determining and implementing the intentions of an
organization as regards quality.

14. What is the documents requirement as per schedule Q?


• Project Quality Plans (30), Organization Chart (with PQP), Quality Personnel
qualifications (prior to assignment), Quality Audit schedules (with PQP), Audit
reports (14 days of audit completion), Inspection Schedule (14 days before),
NCR (48 Hour) NCR Summary (after 1st NCR) & status, QM Report (60 days
after effective date of contract), Inspection/Fabrication Report (1 Week after
first PO), IAP (21 days prior to PIM), PIM reports (10 days after pre inspection
visit), Vendor Inspection Reports (10 days after first inspection visit),
Inspection Disposition Reports (whenever materials are released),
Construction ITP’s (30 d prior), special processes (30 d prior).

15. What is Management Responsibility?


• Responsibility for the quality management system from quality assurance to
top management. This ensures that customer satisfaction is achieved,
customer requirements are fully understood and met, planning activities
include objectives at each relevant function and level within the organization,
internal communications are established, and information within the system
(e.g., data, internal audit results, customer measures) is used to facilitate
improvement.

16. What is Resource Management?


• It is the efficient and effective deployment of an organization's resources
when they are needed, aims at smoothing the stock of resources on hand,
reducing both excess inventories and shortages.
17. What is Project Realization / Execution?
• Realization provides a system for doing more projects faster, and delivering
them on time. Execution is the critical link between planning and results.

18. What is Measurement?


• Measurement is the estimation of the magnitude of some attribute of an
object, such as its length or weight, relative to a unit of measurement.

19. What is Analysis?


• Systematic investigation of the component parts of a whole and their relations
in making up the whole
20. What is Improvement?
• An activity undertaken based on strategic objectives such as reduced cycle
time, reduced cost, and increased customer satisfaction.

21. How to control NC?


• By ensuring on integrity of processes while reducing rework and costs,
trending information, using SPC alarms & alerts, providing its data to
production process to eliminate defects before its shipping.

22. How to raise NC?


• NCR to be raised where there are problems and agree corrective actions with
timescales.

23. What are important details in NCR?


• Name/Function of Auditee, Auditor, date, scope, reference, details of NC, CA
agreed with timescale, verification status, and signatures.

24. What is Schedule-Q.?


• Specific Quality Management System developed for particular Contractor
Scope of Work by Saudi Aramco, derived from ISO 9001, which shall have
precedence over ISO 9001 in case of any conflicts.
• Quality Assurance and Control, Inspection & Testing.

25. What is the structure of Schedule Q?


• Saudi Aramco Project specific quality requirements, reference documents &
standards including contractor scope of work, QMS requirements,
documentation requirements, management responsibility, resource
management, project realization / execution, personnel qualification
requirements, material quality requirements, quality system deliverables, etc.
26. What is SAEP 1154?
• Saudi Aramco Engineering Procedure providing guidelines to assist
contractors in preparation, review, acceptance and revision of Quality Plan as
applicable activities like design, procurement, construction, installation, and
pre-commissioning. It meets requirements of ISO 9001:2000 and Schedule-
Q.

27. What is the structure of Project Quality Plan?


• Contract specific project quality requirements covering all related Aramco
Standards, Schedule-Q, & Scope of work. Quality Policy, Objectives,
procedures, records, formats, methodology, etc.

28. Why QA/QC Organization Chart is important?


• For ensuring on effective implementation of QMS/Schedule-Q/Scope of Work
/Quality Plan requirements and that are documented, records are maintained,
continuous improvements are clearly observed from data.

29. What are processes?


• Welding, Brazing, NDT, PMI, Pressure Testing, Coating, Lining, Gasket
installation & verification, bolt tightening, hot taps, vessel installation,
installations of EPS, OTS, DCS, installation of machinery & equipments, HV
Cable splicing, termination, pulling, etc.

30. What is 2 week look ahead & what is its important?


• Planning of schedule of activities to be carried out in advance with respect to
scope of work with timescale it’s important to monitor the project progress
and quality which should go parallel.

31. Why & what is important of submitting monthly quality management report?
• It’s a record showing project progress of quality function and activities at
stages of procurement & construction to ensure that objectives are met as per
schedule-Q & project quality plan requirements.

32. What is traceability?


• Ability to trace the history, application or location i.e. origin of materials and
parts, processing history, and distribution or location of the product after
delivery.

Inspection Assignment Package: A set of documents that include details of purchased


material / equipment and their quality requirements needed to perform full inspection at the
vendor/sub-vendor facility.

Quality Plan: Document specifying which procedures and associated resources shall be
applied by whom and when to a specific project, product, process or contract. [ISO 9000]

Quality System: Organizational structure, procedures, processes and resources needed to


implement quality management. [ISO 9000]
Pre-Commissioning: Testing of system components for continuity, operability and in the
case of the process plants, their ability to withstand operating pressure prior to the
introduction of feedstock or other final products into the facility.

Type Test: Test or series of tests directed towards approval of a design conducted to
determine that is capable of meeting the requirements of the product specifications.

Hold Point: Inspection or Test may not proceed without the QA/QC organization
representative in attendance.

Witness Point: It defines a point that provides QA/QC organization with the opportunity to
attend the Inspection or Test, at their option.

Shall: "Shall" expresses a provision that is binding between two or more parties.

Will: "Will" expresses a declaration of purpose or intent by one party.

Should: “Should" expresses a recommendation among other possibilities

Product then becomes “result of a set of interrelated or interacting activities which


transforms inputs into outputs”.

Process is defined as “set of interrelated or interacting activities which transforms inputs


into outputs”.

Quality: Degree to which a set of inherent characteristics fulfils requirements

Requirement: Need or expectation that is stated, generally implied or obligatory

Customer Satisfaction: customer’s perception of the degree to which the customer%


requirements have been fulfilled

Capability: Ability of an organization, system or process to realize a product that will fulfill
the requirements (3.1 .2) for that product

System: set of interrelated or interacting elements

Management System: System to establish policy and objectives and to achieve those
objectives.

Quality Policy: Overall intentions and direction of an organization related to quality as


formally expressed by top management

Quality Objective: Something sought, or aimed for, related to quality

Quality Management: Coordinated activities to direct and control an organization with


regard to quality

Quality Planning: Part of quality management focused on setting quality objectives and
specifying necessary operational processes and related resources to fulfill the quality
objectives
Quality Improvement: Part of quality management focused on increasing the ability to
fulfill quality requirements.

Effectiveness: Extent to which planned activities are realized and planned results achieved

Efficiency: Relationship between the result achieved and the resources used

Project: Unique process, consisting of a set of coordinated and controlled activities with
start and finish dates, undertaken to achieve an objective conforming to specific
requirements, including the constraints of time, cost and resources

Design and Development: Set of processes that transforms requirements into specified
characteristics or into the specification of a product, process or system.

Procedure: specified way to carry out an activity or a process

Traceability: Ability to trace the history, application or location of that which is under
consideration
- the origin of materials and parts,
- the processing history, and
- the distribution and location of the product after delivery.

Conformity: Fulfillment of a requirement

Nonconformity: Non-fulfillment of a requirement

Defect: Non-fulfillment of a requirement related to an intended or specified use

Preventive action: Action to eliminate the cause of a potential nonconformity or other


undesirable potential situation. There can be more than one cause for a potential
nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is
taken to prevent recurrence.

Corrective action: Action to eliminate the cause of a detected nonconformity or other


undesirable situation. There can be more than one cause for nonconformity. Corrective
action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence. There is a distinction between correction and corrective action,

Correction: Action to eliminate a detected nonconformity. A correction can be made in


conjunction with a corrective action. A correction can be, for example, rework or re-grade.

Concession: Permission to use or release a product that does not conform to specified
requirements. A concession is generally limited to the delivery of a product that has
nonconforming characteristics within specified limits for an agreed time or quantity of that
product.

Deviation Permit: Permission to depart from the originally specified requirements of a


product prior to realization. A deviation permit is generally given for a limited quantity of
product or period of time, and for a specific use.
Document information and its supporting medium: Record, specification, procedure
document, drawing, report, standard. The medium can be paper, magnetic, electronic or
optical computer disc, photograph or master sample, or a combination thereof. A set of
documents, for example specifications and records, is frequently called “documentation”.
Some requirements (e.g. the requirement to be readable) relate to all types of documents;
however there can be different requirements for specifications (e.g. the requirement to be
revision controlled) and records (e.g. the requirement to be retrievable).

Specification, document stating requirements: A specification can be related to


activities (e.g. procedure document, process, products (e.g. product specification,
performance specification and drawing).

Inspection: Conformity evaluation by observation and judgment accompanied as


appropriate by measurement, testing or gauging

Test: Determination of one or more characteristics according to a procedure.

Verification: Confirmation, through the provision of objective evidence, that specified


requirements have been fulfilled. The term “verified is used to designate the corresponding
status. Confirmation can comprise activities such as
- Performing alternative calculations,
- Comparing a new design specification with a similar proven design specification.
- Undertaking tests and demonstrations, and
- Reviewing documents prior to issue.

Validation: Confirmation, through the provision of objective evidence, that the


requirements for a specific intended use or application have been fulfilled. The term
“validated is used to designate the corresponding status.

Audit program: Set of one or more audits planned for a specific time frame and
directed towards a specific purpose

Audit criteria: Set of policies, procedures or requirements used as a reference

Audit evidence: Records, statements of fact or other information which are relevant to the
audit criteria and verifiable. Audit evidence can be qualitative or quantitative.

Audit findings: Results of the evaluation of the collected audit evidence against audit
criteria. Audit findings can indicate either conformity or nonconformity with audit criteria,
or opportunities for improvement.

Audit conclusion: Outcome of an audit provided by the audit team after consideration of
the audit objectives and all audit findings.

Measurement control system: Set of interrelated or interacting elements necessary to


achieve metrological confirmation and continual control of measurement processes.

Measurement process: Set of operations to determine the value of a quantity.

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